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The agency cited evidence that the drugs could cause dangerously slowed breathing in some children, which could lead to death.\u003c/p>\n\u003cp>Multiple prescription drugs contain codeine or tramadol. For example, the painkiller Tylenol 3 contains acetaminophen and codeine. Drugs containing codeine already carry a black-box warning against using it to treat pain in children who have their tonsils removed.\u003c/p>\n\u003cp>\"This is something we've been watching for several years,\" says Douglas Throckmorton, the deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research. \"They are powerful, effective medicines when used right [but] they can cause a lot of harm when they're not.\"\u003c/p>\n\u003cp>The agency also warned against using the drugs in young people between 12 and 18 who are obese or have breathing problems such as sleep apnea or lung disease.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The new warnings did not further restrict over-the-counter medicines that contain codeine, such as popular types of cough syrup and medication marketed for cold and flu symptoms. The FDA recommends that parents talk to a doctor before giving their children such drugs and notes that colds and coughs in kids \"are generally mild and go away in a few days, so they may not need to take any medicine.\"\u003c/p>\n\u003cp>Thursday's announcement was a partial acceptance of 2015 recommendations by an independent advisory committee that recommended the agency restrict prescription of codeine-containing drugs for children and also voted overwhelmingly against over-the-counter sale of codeine-containing cough syrup for children.\u003c/p>\n\u003cp>At the time, pharmacist Maria Pruchnicki, an associate professor at the Ohio State University College of Pharmacy, told NPR's Rob Stein, \"My concern, were I to be prescribing codeine in children, would be that I would, frankly, kill them.\"\u003c/p>\n\u003cp>As Stein reported, the FDA is not required to follow the committee's 2015 advice, although the agency generally acts in line with advisory committee recommendations.\u003c/p>\n\u003cp>In this case, the agency did act on prescription drugs but did not act on the over-the-counter recommendation.\u003c/p>\n\u003cp>It was unclear why more than a year passed between the committee recommendations and their partial adoption by the agency. In a press briefing, Throckmorton said the agency had received \"additional information.\"\u003c/p>\n\u003cp>Diana Zuckerman, president of the consumer group National Center for Health Research, called the move a \"long-overdue step to protect our children\":\u003c/p>\n\u003cp>\"The science is clear, so why did it take almost 18 months since the FDA's public meeting on the exact same issue? FDA needs to do more to warn patients about the known risks of medical products as soon as data are available. A change in the label is important, but unfortunately many doctors and patients don't read these labels. We need a public education campaign to warn parents and nursing women about these risks.\"\u003c/p>\n\u003cp>In 2015, the FDA acknowledged that although tramadol is not approved for use in children, it is used off-label to treat pain in kids. In that warning, the agency noted that some people are what's known as ultra-rapid metabolizers of tramadol and codeine. Those people have a variant of a liver enzyme that breaks down the drugs more quickly, leading to a rapid and potentially dangerous spike in the level of active opioids in the bloodstream.\u003c/p>\n\u003cp>The drugs can make their way into breast milk in nursing mothers and potentially harm infants, the FDA warns. The proportion of people with the enzyme variant, which is genetic, is thought to be between 1 and 10 percent.\u003c/p>\n\u003cp>\"Because we can't easily determine which children or nursing mothers specifically are at greater risk of ultra-rapid metabolism of codeine or tramadol, we are requiring manufacturers ... to make important labeling changes to protect those children who are at the greatest risk,\" explains Throckmorton.\u003c/p>\n\u003cp>As for future action on over-the-counter medicines that contain codeine, the American Academy of Pediatrics has made its position clear.\u003c/p>\n\u003cp>In a report published last year in the journal Pediatrics, members of the academy's committee on drugs wrote that although over-the-counter cough and cold medicines containing codeine were available in 28 states and Washington, D.C., \"neither the value of suppressing cough nor the effectiveness of codeine in children with acute illnesses has been shown.\"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Regulators in Europe, Canada and Australia have all restricted the use of medicines containing codeine for children. According to the FDA's public label database, more than 100 medications containing codeine are approved for sale without a prescription in the U.S.\u003c/p>\n\n","blocks":[],"excerpt":"The drugs, used to treat things like coughs or pain, could cause dangerously slowed breathing in some children.\r\n","status":"publish","parent":0,"modified":1492793784,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":21,"wordCount":827},"headData":{"title":"Kids Should Not Take Drugs Containing Codeine or Tramadol, FDA Says | KQED","description":"The drugs, used to treat things like coughs or pain, could cause dangerously slowed breathing in some children.\r\n","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Kids Should Not Take Drugs Containing Codeine or Tramadol, FDA Says","datePublished":"2017-04-21T16:51:32.000Z","dateModified":"2017-04-21T16:56:24.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"320798 https://ww2.kqed.org/stateofhealth/?p=320798","disqusUrl":"https://ww2.kqed.org/stateofhealth/2017/04/21/kids-should-not-take-drugs-containing-codeine-or-tramadol-fda-says/","disqusTitle":"Kids Should Not Take Drugs Containing Codeine or Tramadol, FDA Says","nprByline":"Rebecca Hersher\u003cbr />\u003ca href=\"http://www.npr.org/sections/health-shots/\">NPR Shots\u003c/a> ","path":"/stateofhealth/320798/kids-should-not-take-drugs-containing-codeine-or-tramadol-fda-says","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The Food and Drug Administration says children under 12 should not be given prescription medicines that contain codeine or another narcotic, tramadol, and that such drugs can also be dangerous to youth between 12 and 18.\u003c/p>\n\u003cp>On Thursday, the FDA said it will require that prescription drugs containing codeine or tramadol carry a warning on the label against using them in children under 12 or in women who are breast-feeding. The agency cited evidence that the drugs could cause dangerously slowed breathing in some children, which could lead to death.\u003c/p>\n\u003cp>Multiple prescription drugs contain codeine or tramadol. For example, the painkiller Tylenol 3 contains acetaminophen and codeine. Drugs containing codeine already carry a black-box warning against using it to treat pain in children who have their tonsils removed.\u003c/p>\n\u003cp>\"This is something we've been watching for several years,\" says Douglas Throckmorton, the deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research. \"They are powerful, effective medicines when used right [but] they can cause a lot of harm when they're not.\"\u003c/p>\n\u003cp>The agency also warned against using the drugs in young people between 12 and 18 who are obese or have breathing problems such as sleep apnea or lung disease.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The new warnings did not further restrict over-the-counter medicines that contain codeine, such as popular types of cough syrup and medication marketed for cold and flu symptoms. The FDA recommends that parents talk to a doctor before giving their children such drugs and notes that colds and coughs in kids \"are generally mild and go away in a few days, so they may not need to take any medicine.\"\u003c/p>\n\u003cp>Thursday's announcement was a partial acceptance of 2015 recommendations by an independent advisory committee that recommended the agency restrict prescription of codeine-containing drugs for children and also voted overwhelmingly against over-the-counter sale of codeine-containing cough syrup for children.\u003c/p>\n\u003cp>At the time, pharmacist Maria Pruchnicki, an associate professor at the Ohio State University College of Pharmacy, told NPR's Rob Stein, \"My concern, were I to be prescribing codeine in children, would be that I would, frankly, kill them.\"\u003c/p>\n\u003cp>As Stein reported, the FDA is not required to follow the committee's 2015 advice, although the agency generally acts in line with advisory committee recommendations.\u003c/p>\n\u003cp>In this case, the agency did act on prescription drugs but did not act on the over-the-counter recommendation.\u003c/p>\n\u003cp>It was unclear why more than a year passed between the committee recommendations and their partial adoption by the agency. In a press briefing, Throckmorton said the agency had received \"additional information.\"\u003c/p>\n\u003cp>Diana Zuckerman, president of the consumer group National Center for Health Research, called the move a \"long-overdue step to protect our children\":\u003c/p>\n\u003cp>\"The science is clear, so why did it take almost 18 months since the FDA's public meeting on the exact same issue? FDA needs to do more to warn patients about the known risks of medical products as soon as data are available. A change in the label is important, but unfortunately many doctors and patients don't read these labels. We need a public education campaign to warn parents and nursing women about these risks.\"\u003c/p>\n\u003cp>In 2015, the FDA acknowledged that although tramadol is not approved for use in children, it is used off-label to treat pain in kids. In that warning, the agency noted that some people are what's known as ultra-rapid metabolizers of tramadol and codeine. Those people have a variant of a liver enzyme that breaks down the drugs more quickly, leading to a rapid and potentially dangerous spike in the level of active opioids in the bloodstream.\u003c/p>\n\u003cp>The drugs can make their way into breast milk in nursing mothers and potentially harm infants, the FDA warns. The proportion of people with the enzyme variant, which is genetic, is thought to be between 1 and 10 percent.\u003c/p>\n\u003cp>\"Because we can't easily determine which children or nursing mothers specifically are at greater risk of ultra-rapid metabolism of codeine or tramadol, we are requiring manufacturers ... to make important labeling changes to protect those children who are at the greatest risk,\" explains Throckmorton.\u003c/p>\n\u003cp>As for future action on over-the-counter medicines that contain codeine, the American Academy of Pediatrics has made its position clear.\u003c/p>\n\u003cp>In a report published last year in the journal Pediatrics, members of the academy's committee on drugs wrote that although over-the-counter cough and cold medicines containing codeine were available in 28 states and Washington, D.C., \"neither the value of suppressing cough nor the effectiveness of codeine in children with acute illnesses has been shown.\"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Regulators in Europe, Canada and Australia have all restricted the use of medicines containing codeine for children. According to the FDA's public label database, more than 100 medications containing codeine are approved for sale without a prescription in the U.S.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/stateofhealth/320798/kids-should-not-take-drugs-containing-codeine-or-tramadol-fda-says","authors":["byline_stateofhealth_320798"],"categories":["stateofhealth_14"],"tags":["stateofhealth_2850","stateofhealth_3081","stateofhealth_2892","stateofhealth_48","stateofhealth_2808","stateofhealth_3082","stateofhealth_2519","stateofhealth_2888"],"featImg":"stateofhealth_320813","label":"stateofhealth"},"news_11273732":{"type":"posts","id":"news_11273732","meta":{"index":"posts_1591205157","site":"news","id":"11273732","score":null,"sort":[1484687777000]},"guestAuthors":[],"slug":"drugmakers-manipulate-orphan-drug-rules-to-create-prized-monopolies","title":"Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies","publishDate":1484687777,"format":"standard","headTitle":"The California Report | KQED News","labelTerm":{"term":72,"site":"news"},"content":"\u003cp>Lookup Tool: \u003ca href=\"http://khn.org/news/orphan-drugs-lookup-interactive/\">Orphan Drugs Database\u003c/a>\u003cbr>\nVideo: \u003ca href=\"http://khn.org/news/video-former-u-s-rep-henry-waxman-shares-deep-concerns-about-orphan-drugs/\">Interview With Henry Waxman\u003c/a>\u003cbr>\nTimeline: \u003ca href=\"http://khn.org/news/timeline-the-orphan-drug-act/\">The Orphan Drug Act\u003c/a>\u003c/p>\n\u003cp>More than 30 years ago, Congress overwhelmingly passed \u003ca href=\"https://history.nih.gov/research/downloads/PL97-414.pdf\">a landmark health bill\u003c/a> aimed at motivating pharmaceutical companies to develop new drugs for people whose rare diseases had been ignored.\u003c/p>\n\u003cp>By the drugmakers’ calculations, the markets for such diseases weren’t big enough to bother with.\u003c/p>\n\u003cp>But lucrative financial incentives created by the Orphan Drug Act signed into law by President Ronald Reagan in 1983 succeeded far beyond anyone’s expectations. More than 200 companies have brought almost 450 “orphan drugs” to market since the law took effect.\u003c/p>\n\u003cp>Yet a Kaiser Health News investigation shows that the system intended to help desperate patients is being manipulated by drugmakers to maximize profits and to protect niche markets for medicines already being taken by millions. The companies aren’t breaking the law but they are using the Orphan Drug Act to their advantage in ways that its architects say they didn’t foresee or intend. Today, many orphan medicines, originally developed to treat diseases affecting fewer than 200,000 people, come with astronomical price tags.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>And many drugs that now have orphan status aren’t entirely new. More than 70 were drugs first approved by the Food and Drug Administration for mass market use. These medicines, some with familiar brand names, were later approved as orphans. In each case, their manufacturers received millions of dollars in government incentives plus seven years of exclusive rights to treat that rare disease, or a monopoly.\u003c/p>\n\u003cp>Drugmakers of popular mass market drugs later sought and received orphan status for the cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin, and rheumatoid arthritis drug Humira, the best-selling medicine in the world.\u003c/p>\n\u003cp>More than 80 other orphans won FDA approval for more than one rare disease, and in some cases, multiple rare diseases. For each additional approval, the drugmaker qualified for a fresh batch of incentives. Botox, stocked in most dermatologists’ offices, started out as a drug to treat painful muscle spasms of the eye and now has three orphan drug approvals. It’s also approved as a mass market drug to treat a variety of ailments, including chronic migraines and wrinkles.\u003c/p>\n\u003cp>Altogether, KHN’s investigation found that about a third of orphan approvals by the FDA since the program began have been either for repurposed mass market drugs or drugs that received multiple orphan approvals.\u003c/p>\n\u003cp>“What we are seeing is a system that was created with good intent being hijacked,” said Bernard Munos, a former corporate strategy advisor at drug giant Eli Lilly and Co. who reviewed the KHN analysis of several FDA drug databases. It’s “quite remarkable that it has gone on for so long.”\u003c/p>\n\u003cp>And the proportion of \u003ca href=\"http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm534863.htm\">new drugs\u003c/a> approved as orphans has ballooned. In 2015, 21 orphan drugs were approved, accounting for 47 percent of all new medicines, up from just 29 percent in 2010; in 2016, nine more orphans won approval, 40 percent of the total.\u003c/p>\n\u003cp>When a drugmaker wins approval of a medicine for an orphan disease, the company gets seven years of exclusive rights to the marketplace, which means the FDA won’t approve another version to treat that rare disease for seven years, even if the brand name company’s patent has run out. The exclusivity is compensation for developing a drug designed for a small number of patients whose total sales weren’t expected to be that profitable.\u003c/p>\n\u003cp>But the exclusivity is a potent pricing tool. Drugmakers can charge whatever they want by shielding their medicine from competition. The market exclusivity granted by the Orphan Drug Act can be a vital part of the protective shield that companies create. What’s more, manufacturers can return to the FDA with the same drug again and again, each time testing the drug against a new rare disease.\u003c/p>\n\u003cp>Critics have assailed drugmakers in the past for gaming the orphan drug approval process. But the extent to which companies have been winning approval for drugs that aren’t what advocates call “true orphans” hadn’t been documented until the Kaiser Health News investigation.\u003c/p>\n\u003cp>Munos said he was “shocked” by the sheer number of mass market drugs being repurposed as well as those approved multiple times.\u003c/p>\n\u003cp>Even agency officials said they weren’t aware of the scope of the issue. After reviewing KHN’s findings for two weeks, Dr. Gayatri Rao director of the FDA’s Office of Orphan Products Development said she “appreciated the work” and expressed interest in studying how often drug companies are “repurposing” a drug for a new rare disease, or taking “multiple bites of the apple.”\u003c/p>\n\u003cp>“We are going to look into this,” she said, adding that she could consider a regulatory change.\u003c/p>\n\u003cp>Rao pointed out that the “repurposing” of drugs does have scientific and patient benefits. For example, cancer drugs approved for one type of malignancy can be tested and approved for others. Gleevec, a drug that revolutionized the treatment of chronic myeloid leukemia, now has nine orphan approvals.\u003c/p>\n\u003cp>But in a \u003ca href=\"http://www.hopkinsmedicine.org/news/media/releases/orphan_drug_loophole_needs_closing_johns_hopkins_researchers_say\">2015 commentary\u003c/a> published in the American Journal of Clinical Oncology, Dr. Martin Makary at the Johns Hopkins University School of Medicine focused on cancer drugs including Gleevec, arguing that the drug was never meant to serve an orphan population. Instead, Makary and his team wrote, drugmakers purposely identify small patient populations to gain additional approvals — a process he described as “salami slicing.”\u003c/p>\n\u003cp>“By salami slicing the disease into subgroups, it allows them to get the orphan drug approval with all the government benefits and even some of the subsidies,” Makary said. The prices of such medications often rise because they have seven years without competition for a new set of patients, Makary added.\u003c/p>\n\u003cp>The FDA has taken a different view of repurposing.\u003c/p>\n\u003cp>“We always talked about how we permit the second bite of the apple, third bite of the apple, as one small way to incentivize repurposing,” Rao said, noting that industry and patient groups have been pressing the FDA for even stronger incentives. “Now, all of sudden, it seems like, wow, this practice may be driving up prices.”\u003c/p>\n\u003cp>Novartis, which owns Gleevec, said in an email statement that the company is advancing research and following the science to “bring the right treatments to the right patients based on unmet need, not the size of the patient population.”\u003c/p>\n\u003cp>Two KHN reporters spent six months analyzing data and talking to lawmakers, patients, advocates, doctors and companies to understand how the FDA’s orphan drug program has evolved amid a national uproar over soaring drug prices. President-elect Donald Trump vowed on the campaign trail to \u003ca href=\"http://www.reuters.com/article/us-usa-trump-pharmaceuticals-idUSKBN13W21I\">bring down\u003c/a> prescription drug prices and during a Jan. 11 press conference said the drug industry is \u003ca href=\"https://www.nytimes.com/2017/01/11/us/politics/trump-press-conference-transcript.html?_r=0\">“getting away with murder.”\u003c/a>\u003c/p>\n\u003cp>The investigation examined how drugmakers use the law to their advantage — often with the guidance of former FDA officials — and have made the development of medicines that were once thought to be business backwaters into one of the pharmaceutical industry’s hottest sectors.\u003c/p>\n\u003cp>Orphan drugs now account for seven of the 10 top-selling drugs of any kind, ranked by annual sales, according to EvaluatePharma.\u003c/p>\n\u003cp>“Orphans are wicked hot,” said Dr. Tim Coté, a former FDA official who now runs a consulting firm that advises drugmakers on orphan drugs.\u003c/p>\n\u003cp>No one disputes that orphan drugs have helped or saved hundreds of thousands of patients suffering from debilitating or even fatal rare diseases. Exactly how many is difficult to estimate because the FDA doesn’t track such information.\u003c/p>\n\u003cp>And drug industry officials say companies should be rewarded, not punished, for making those treatments possible and for pursuing new drugs that aren’t always an economic success.\u003c/p>\n\u003cp>Research and development is “long, costly, risky,” said Anne Pritchett, vice president, policy and research at industry lobbying group PhRMA. “When you look at cystic fibrosis it was 25 years to the development of an effective therapy … I think we would be concerned about anything that would undermine the current [orphan drug] incentives.”\u003c/p>\n\u003cp>Former U.S. Rep. Henry Waxman, D-Calif., a champion of the 1983 Orphan Drug Act takes a different view.\u003c/p>\n\u003cp>“The Orphan Drug Act has been a great success because many people with diseases that affect very few people now have drugs available to them,” Waxman said. “But it’s been in some ways turned on its head when it becomes the basis of manipulating the system for the drug company to make much more money than they would in an open, competitive market.”\u003c/p>\n\u003cp>Booming Business\u003c/p>\n\u003cp>On a late summer day, Tim Coté sat in a corner office of his Sandy Spring, Md., consulting firm, Coté Orphan. He leaned into his computer microphone to dispense insider knowledge about the orphan drug approval process on a webcast hosted by FDAnews, a trade news organization. Listeners paid about $300 a head, but Coté said he wasn’t paid for doing it.\u003c/p>\n\u003cp>The FDA is more flexible in evaluating drugs for rare diseases, he said, explaining that “about half of them get through with just one pivotal clinical trial. Not so for common diseases.” The FDA, citing \u003ca href=\"http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/OOPDNewsArchive/UCM294773.pdf\">a report\u003c/a> from the National Organization for Rare Disorders, said about two-thirds of orphan drugs were approved with one adequate and well-controlled trial with supportive evidence. It typically requires two or three such trials to approve a mass market drug.\u003c/p>\n\u003cp>Coté also told the webinar audience that clinical trials for orphan drugs are usually smaller and the approval is a “different scientific and regulatory experience.”\u003c/p>\n\u003cp>Coté knows his stuff. He was Rao’s immediate predecessor as chief of the FDA’s Office of Orphan Products Development. It’s not unusual for government officials to leave FDA and other regulatory agencies and \u003ca href=\"http://www.npr.org/sections/health-shots/2016/09/28/495694559/a-look-at-how-the-revolving-door-spins-from-fda-to-industry\">obtain jobs as consultants or industry executives\u003c/a>.\u003c/p>\n\u003cp>Coté’s website, headlined “The Inside Track,” notes that he oversaw applications that led to the approval of at least 150 orphan drugs when he was at the FDA and that his firm is now the largest submitter of orphan drug applications.\u003c/p>\n\u003cp>“We write the entire application,” the website for Coté’s company notes, adding that his staff of 25 includes regulatory scientists with deep knowledge and experience in FDA’s “unwritten rules” regarding orphan drugs.\u003c/p>\n\u003cp>Many of Coté’s more than 300 clients are small biotech companies begun by researchers or even passionate parents who found investment backing. Parents Ilan and Annie Ganot, for example, started Solid Biosciences to find treatments and potentially a cure for their son with Duchenne muscular dystrophy.\u003c/p>\n\u003cp>Coté guides them through the regulatory process since most don’t have the expertise. He can offer his expertise and develop an application that makes it easier for the FDA to designate and approve the drug.\u003c/p>\n\u003cp>“When you make the FDA smile, the value of your asset goes up. And that’s how the game is played,” he said in an interview, adding quickly, “It’s really not a game because people’s lives are what is in balance.”\u003c/p>\n\u003cp>Coté and other ex-FDA officials play a vital role in helping drugmakers choose rare disease targets and get through the FDA approval process.\u003c/p>\n\u003cp>A small cottage industry has grown around the Orphan Drug Act. Dr. Marlene Haffner, who preceded Coté in the FDA’s orphan office, started her own consulting firm, too, to advise small and large companies on orphan drug applications. A third company is Camargo Pharmaceutical Services, led by industry veterans and former FDA officials, which advises companies focused on repurposing drugs for orphan approval. The firm tries “to be in front of the FDA a lot — three to four times a month,” said Jennifer King, Camargo’s director of marketing. Fees for consulting on orphan drugs industry wide range from $5,000 to $100,000, depending upon what services are provided, Coté said.\u003c/p>\n\u003cp>Getting through the orphan approval process involves a series of steps.\u003c/p>\n\u003cp>First, drugs must be designated by the FDA as potential candidates for approval. A company has to demonstrate that its drug is a promising treatment for a disease that affects fewer than 200,000 patients. If the FDA agrees and makes the formal designation, financial incentives kick in, including a 50 percent tax break on research and development (R&D) and access to federal grants.\u003c/p>\n\u003cp>When drugs get orphan designation, companies often reap other financial rewards. Shares in publicly traded companies often rise on the news — sometimes soaring \u003ca href=\"http://www.bizjournals.com/triangle/news/2014/02/25/dara-stock-soars-on-orphan-drug.html\">as high as 30 percent\u003c/a>. That happens, in part, because orphans have a track record of being approved at much higher rates than drugs for common diseases.\u003c/p>\n\u003cp>The 50 percent R&D tax credit pays off, too. In 2012, one of the biggest orphan drug companies, BioMarin, received \u003ca href=\"http://files.shareholder.com/downloads/ABEA-3W276N/2866327224x0x664042/776E8656-30BA-4937-A2A0-3AB6450BCA00/2012_Annual_Report.pdf\">$32.6 million\u003c/a> from a combination of federal and state of California tax credits. BioMarin spokeswoman Debra Charlesworth confirmed that the orphan credit made up the “vast majority” of that deferred tax benefit. She also noted that credit “has successfully fueled an industry that didn’t previously exist” and led to more rare disease research.\u003c/p>\n\u003cp>Industry-wide, orphan drug tax credits cost the federal government $1.76 billion in fiscal 2016 — roughly what President Barack Obama asked Congress to spend to fight \u003ca href=\"https://www.washingtonpost.com/news/post-politics/wp/2016/02/08/obama-to-ask-congress-for-1-8-billion-to-combat-zika-virus/\">the Zika virus\u003c/a> before a $1.1 billion expenditure was approved. And, because so many orphan drugs are under development, the U.S. could grant nearly $50 billion in tax credits from 2016 to 2025, estimates \u003ca href=\"https://www.treasury.gov/resource-center/tax-policy/Documents/Tax-Expenditures-FY2017.pdf\">the Treasury Department\u003c/a>.\u003c/p>\n\u003cp>There’s a lot of creativity behind figuring out how to make a drug an orphan.\u003c/p>\n\u003cp>In Coté’s webinar and in multiple interviews, he described many ways companies can win orphan status. They can test their drugs on children with adult diseases, such as schizophrenia, or find drugs for ailments like malaria that are uncommon in America.\u003c/p>\n\u003cp>“African sleeping sickness: horrible problem in Africa but not here, not in the U.S.,” Coté told his webinar audience. “So a drug development effort that was aimed toward some of these tropical diseases can actually get all the benefits of the Orphan Drug Act.”\u003c/p>\n\u003cp>Another popular strategy is to create “follow-on drugs” that represent incremental steps forward.\u003c/p>\n\u003cp>About 30 percent of Coté’s clients are companies looking to improve upon some other orphan drug “which just made billions and billions,” he said in an interview.\u003c/p>\n\u003cp>Repurposing an already approved drug is another strategy his firm promotes. In a \u003ca href=\"https://www.linkedin.com/pulse/re-purposing-drugs-orphans-timothy-cote?published=t\">video\u003c/a> posted on his website in July, Coté explained the advantages for companies that can move directly into a clinical trial without much preparatory work because the drug’s safety has already been demonstrated.\u003c/p>\n\u003cp>“All you gotta do is establish that the product can work in this new orphan indication,” he said, adding tips on how to do it and still make money.\u003c/p>\n\u003cp>‘That Is Not A True Orphan Drug’\u003c/p>\n\u003cp>Turning mass market drugs into orphans has been a familiar path for some of the most popular drugs ever discovered.\u003c/p>\n\u003cp>AbbVie’s Humira is the best-selling drug in the world, and most of its sales are in the U.S. where revenue reached $7.6 billion through \u003ca href=\"https://news.abbvie.com/news/abbvie-reports-third-quarter-2016-financial-results.htm\">the third quarter\u003c/a> of 2016 and $11.8 billion worldwide, according to the company’s latest financial report.\u003c/p>\n\u003cp>Humira was approved by the FDA in late 2002 to treat millions of people who suffer from rheumatoid arthritis. Three years later, AbbVie asked the FDA to designate it as an orphan to treat juvenile rheumatoid arthritis, which they told the FDA affects between 30,000 and 50,000 Americans. That pediatric use was approved in 2008, and Humira subsequently was approved for four more rare diseases, including Crohn’s and uveitis, an inflammatory disease affecting the eyes.\u003c/p>\n\u003cp>The ophthalmologic approval would extend the market exclusivity for Humira for that disease until 2023. When asked why AbbVie sought multiple orphan designations and approvals for Humira, the company declined to comment.\u003c/p>\n\u003cp>Peter Saltonstall, executive director of the National Organization for Rare Disorders, said that Humira is “not a true orphan drug.” But, he said, the company has “the ability to go out and get orphan designation. That’s the way the law reads right now … they can do whatever they want to do.”\u003c/p>\n\u003cp>It is difficult to say exactly how or if orphan exclusivity affects the price of Humira, which is a complex biologic drug and also has been protected by \u003ca href=\"http://www.nytimes.com/2016/07/16/business/makers-of-humira-and-enbrel-using-new-drug-patents-to-delay-generic-versions.html?_r=3\">numerous patents\u003c/a>. The drug has long been AbbVie’s top seller, accounting for 63 percent of its revenues, according to its most recent financial filing.\u003c/p>\n\u003cp>EvaluatePharma notes \u003ca href=\"http://info.evaluategroup.com/rs/607-YGS-364/images/EPOD15.pdf\">in its recent report\u003c/a> that Humira, as well as a handful of other top drugs, receive less than 25 percent of their sales from orphan uses. Still, if Humira’s orphan uses accounted for just 10 percent of annual sales, the revenue would surpass $1 billion.\u003c/p>\n\u003cp>By stacking up a series of orphan disease approvals, one seven-year exclusivity period leads into another, maximizing the length of a company’s monopoly. Sigma-Tau Pharmaceuticals, for example, had some form of orphan exclusivity over its metabolic disorder drug for more than 20 years. The drug, Carnitor, received a second orphan approval four months before its first exclusivity was set to expire. And it won its third orphan approval, for an IV formulation of the drug, just one day before its second exclusivity period was set to expire in December of 1999.\u003c/p>\n\u003cp>“The sequence and timing of regulatory filings for Carnitor reflect the time required to conduct large controlled clinical trials, as well as evolving medical strategies and regulatory pathways pursued by different sponsors over many years,” said GianFranco Fornasini, senior vice president of scientific affairs at Sigma-Tau.\u003c/p>\n\u003cp>The FDA’s Rao said each new exclusivity period is disease-specific and once any seven-year period runs out, generics can come in. Gleevec, for example, won FDA approval to treat several kinds of rare cancer. All but one of its orphan exclusivity periods had expired by 2015, allowing two generics to enter the marketplace. But Gleevec still has exclusivity until 2020 to treat newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in patients who are also on chemotherapy.\u003c/p>\n\u003cp>It’s also true, Rao explained, that some of the drugs that go through the orphan process may not specifically treat a rare disease. For example, a very toxic cancer drug might may not work well in earlier stages because its risks outweigh the benefits. But the company may propose that it will help a smaller group of later-stage cancer patients and win orphan approval just for that group.\u003c/p>\n\u003cp>Former FDA orphan drug director Haffner said her FDA office worked on rules defining how companies could legitimately pursue approval for a small group of patients with a specific unmet medical need.\u003c/p>\n\u003cp>“People have played games with the Orphan Drug Act since it was passed,” said Haffner, who first took a job with drugmaker Amgen after leaving the FDA and then became an independent consultant. “It’s the American way, I don’t mean that in a nasty way. But we take advantage of what’s in front of us.”\u003c/p>\n\u003cp>In 2013, the \u003ca href=\"https://www.federalregister.gov/documents/2013/06/12/2013-13930/orphan-drug-regulations\">FDA clarified the Orphan Drug Act’s regulations\u003c/a> and said it wanted to avoid the possibility that some companies could “potentially ‘game’ approvals by seeking successive narrow approvals of a drug.”\u003c/p>\n\u003cp>In reality, Rao said, the regulations did not really change “much of what our practice was.” The agency wanted to address what Rao said were “common misconceptions” and frequently asked questions so officials changed wording in the regulations to better define exactly what could be considered an orphan drug.\u003c/p>\n\u003cp>Breaking down larger, broader diseases into smaller groups is still allowed under certain conditions and companies can still win multiple orphan approvals for a single drug — even if the total population served rises above the 200,000 mark.\u003c/p>\n\u003cp>Amgen Inc.’s Repatha won marketing approval and exclusive rights in 2015 for the orphan disease homozygous familial hypercholesterolemia, which affects a population of \u003ca href=\"http://www.lipidjournal.com/article/S1933-2874(13)00309-7/abstract\">about 300 people\u003c/a> in the U.S. On the very same day, the drug was approved as a mass market drug to treat up to 11 million people with uncontrolled levels of LDL cholesterol, said Amgen spokeswoman Kristen Davis.\u003c/p>\n\u003cp>Dr. Steven Nissen of the Cleveland Clinic, who ran a broader trial on Repatha, said, “It’s certainly not considered by any of us to be an orphan drug.”\u003c/p>\n\u003cp>Safeguarding The ‘Prize’\u003c/p>\n\u003cp>Considering the long history of what’s happened, Tim Coté acknowledges that there are “some loopholes” in the Orphan Drug Act. Perhaps 3 percent or less of approved orphans were not in the “spirit” of the law, he said.\u003c/p>\n\u003cp>But Coté, rare disease advocates, patients and people in the drug industry expressed fear that changing the Orphan Drug Act or questioning its success would hurt the development of drugs for rare patients.\u003c/p>\n\u003cp>Former U.S. Rep. Jim Greenwood, R-Pa., now president of the Biotechnology Innovation Organization, an industry trade group, said that concerns about high prices for orphan drugs aren’t justified. The incentives, he said, should not be altered because rare diseases are “tragically killing and brutalizing mostly children.”\u003c/p>\n\u003cp>Greenwood seemed unaware that dozens of orphan approvals stemmed from the repurposing of mass market drugs, like Humira or Enbrel, another drug developed first for rheumatoid arthritis. Still, he said, “I would argue that the risk of losing incentives in the system far outweighs the benefit of trying to save a few pennies on the health care dollar.”\u003c/p>\n\u003cp>It’s a sentiment that Coté and other advocates share. While talking about the $311,000 annual price tag for cystic fibrosis drug Kalydeco, Coté said any parent whose child has the disease would be a big fan of the drug.\u003c/p>\n\u003cp>“The price point is justified because actually it has a dramatic effect on the children. Dead children … people are willing to pay a lot to prevent that,” Coté said. “And that’s a real good thing that we have this drug. OK?”\u003c/p>\n\u003cp>The first drug to specifically target the underlying biochemical defect of cystic fibrosis, Kalydeco is approved to treat a subset of patients who have specific mutations in their genes. Development of the drug was financed by the Cystic Fibrosis Foundation, which sold its rights to sales royalties from Kalydeco and other cystic fibrosis drugs for $3.3 billion in 2014.\u003c/p>\n\u003cp>Others, including Henry Waxman, are far more critical and have tried to do something about it over the years. Waxman proposed multiple bills to rein in corporate profits by amending the orphan drug law that he sponsored, but none succeeded.\u003c/p>\n\u003cp>The FDA has also tried but failed, to keep corporations in check.\u003c/p>\n\u003cp>In 2012, drugmaker Depomed Inc. filed suit against the FDA for refusing to give its drug Gralise seven years of market exclusivity as a treatment for pain related to shingles.\u003c/p>\n\u003cp>Rao said the agency wanted to see proof that Gralise was clinically superior to other drugs, noting there “were a bunch of other generics on the market” with different formulations and dosing requirements. Grasile’s active ingredient, gabapentin, is the same one as in Pfizer’s mass market blockbuster \u003ca href=\"http://www.pfizer.com/products/product-detail/neurontin\">Neurontin\u003c/a>, which is also approved for treatment of shingles pain.\u003c/p>\n\u003cp>The FDA approved Gralise but denied seven years of exclusivity.\u003c/p>\n\u003cp>In response, the drugmaker sued the agency and won its case, arguing that according to the law, they didn’t have to prove their drug was clinically superior to gain the monopoly.\u003c/p>\n\u003cp>Today, the drug is one of Depomed’s top products with sales of $81 million in 2015. And, in a \u003ca href=\"http://investor.depomedinc.com/phoenix.zhtml?c=97276&p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTEwODc0NDE5JkRTRVE9MCZTRVE9MCZTUURFU0M9U0VDVElPTl9FTlRJUkUmc3Vic2lkPTU3\">recent proxy statement\u003c/a>, Depomed listed “protecting Gralise exclusivity” as a corporate objective under the category of “enhance and protect future cash flow.” Its orphan exclusivity ends in 2018. Depomed spokesman Christopher Keenan said Gralise wanted patent exclusivity to block competition. But, Keenan said, “Had the patent effort failed on all fronts, the Orphan Drug Designation would have been very important.”\u003c/p>\n\u003cp>After reviewing KHN’s analysis, Rao said she wants to better understand why drugmakers are applying for multiple approvals and has asked for a case-by-case review of all orphan designations granted in 2010 and 2015. She said the agency lacks the resources to run an analysis of the entire orphan drug database.\u003c/p>\n\u003cp>“Our goal is to try to get it right,” she said. “There are over 7,000 rare diseases, likely more, the vast majority of which have nothing … I want to ensure that we continue to keep our eye on that prize.”\u003c/p>\n\u003cp>Contributors: John Hillkirk, Scott Hensley at NPR, Diane Webber, Marilyn Thompson (editors); Elizabeth Lucas (data editing); Joe Neel at NPR (radio editing)\u003c/p>\n\u003cp>Interactives, video and presentation: Lydia Zuraw, Emily Kopp, Meredith Rizzo at NPR (digital presentation); Francis Ying (videos, motion graphic); Heidi de Marco (videos, photos, audio); Alley Interactive (database lookup)\u003c/p>\n\u003cp>KHN’s coverage of prescription drug development, costs and pricing is supported in part by the \u003ca href=\"http://www.arnoldfoundation.org/\">Laura and John Arnold Foundation\u003c/a>.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003ca href=\"http://www.kaiserhealthnews.org/\">Kaiser Health News\u003c/a> (KHN) is a national health policy news service. It is an editorially independent program of the \u003ca href=\"http://www.kff.org/\">Henry J. Kaiser Family Foundation\u003c/a>.\u003c/p>\n\n","blocks":[],"excerpt":"Orphan drugs were meant for patients with rare diseases, but drugmakers are increasingly using the special designation to land lucrative federal incentives and monopoly control for every drug that gets approved.","status":"publish","parent":0,"modified":1484696546,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":98,"wordCount":4413},"headData":{"title":"Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies | KQED","description":"Orphan drugs were meant for patients with rare diseases, but drugmakers are increasingly using the special designation to land lucrative federal incentives and monopoly control for every drug that gets approved.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"NewsArticle","headline":"Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies","datePublished":"2017-01-17T21:16:17.000Z","dateModified":"2017-01-17T23:42:26.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png","isAccessibleForFree":"Y","publisher":{"@type":"NewsMediaOrganization","@id":"https://www.kqed.org/#organization","name":"KQED","url":"https://www.kqed.org","logo":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}}},"disqusIdentifier":"11273732 http://ww2.kqed.org/news/?p=11273732","disqusUrl":"https://ww2.kqed.org/news/2017/01/17/drugmakers-manipulate-orphan-drug-rules-to-create-prized-monopolies/","disqusTitle":"Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies","nprByline":"\u003ca href=\"http://khn.org/news/author/sarah-jane-tribble/\">\u003cstrong>Sarah Jane Tribble\u003c/strong>\u003c/a> and \u003ca href=\"http://khn.org/news/author/sydney-lupkin/\">\u003cstrong>Sydney Lupkin\u003c/strong>\u003c/a>\u003c/br>Kaiser Health News","path":"/news/11273732/drugmakers-manipulate-orphan-drug-rules-to-create-prized-monopolies","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Lookup Tool: \u003ca href=\"http://khn.org/news/orphan-drugs-lookup-interactive/\">Orphan Drugs Database\u003c/a>\u003cbr>\nVideo: \u003ca href=\"http://khn.org/news/video-former-u-s-rep-henry-waxman-shares-deep-concerns-about-orphan-drugs/\">Interview With Henry Waxman\u003c/a>\u003cbr>\nTimeline: \u003ca href=\"http://khn.org/news/timeline-the-orphan-drug-act/\">The Orphan Drug Act\u003c/a>\u003c/p>\n\u003cp>More than 30 years ago, Congress overwhelmingly passed \u003ca href=\"https://history.nih.gov/research/downloads/PL97-414.pdf\">a landmark health bill\u003c/a> aimed at motivating pharmaceutical companies to develop new drugs for people whose rare diseases had been ignored.\u003c/p>\n\u003cp>By the drugmakers’ calculations, the markets for such diseases weren’t big enough to bother with.\u003c/p>\n\u003cp>But lucrative financial incentives created by the Orphan Drug Act signed into law by President Ronald Reagan in 1983 succeeded far beyond anyone’s expectations. More than 200 companies have brought almost 450 “orphan drugs” to market since the law took effect.\u003c/p>\n\u003cp>Yet a Kaiser Health News investigation shows that the system intended to help desperate patients is being manipulated by drugmakers to maximize profits and to protect niche markets for medicines already being taken by millions. The companies aren’t breaking the law but they are using the Orphan Drug Act to their advantage in ways that its architects say they didn’t foresee or intend. Today, many orphan medicines, originally developed to treat diseases affecting fewer than 200,000 people, come with astronomical price tags.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>And many drugs that now have orphan status aren’t entirely new. More than 70 were drugs first approved by the Food and Drug Administration for mass market use. These medicines, some with familiar brand names, were later approved as orphans. In each case, their manufacturers received millions of dollars in government incentives plus seven years of exclusive rights to treat that rare disease, or a monopoly.\u003c/p>\n\u003cp>Drugmakers of popular mass market drugs later sought and received orphan status for the cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin, and rheumatoid arthritis drug Humira, the best-selling medicine in the world.\u003c/p>\n\u003cp>More than 80 other orphans won FDA approval for more than one rare disease, and in some cases, multiple rare diseases. For each additional approval, the drugmaker qualified for a fresh batch of incentives. Botox, stocked in most dermatologists’ offices, started out as a drug to treat painful muscle spasms of the eye and now has three orphan drug approvals. It’s also approved as a mass market drug to treat a variety of ailments, including chronic migraines and wrinkles.\u003c/p>\n\u003cp>Altogether, KHN’s investigation found that about a third of orphan approvals by the FDA since the program began have been either for repurposed mass market drugs or drugs that received multiple orphan approvals.\u003c/p>\n\u003cp>“What we are seeing is a system that was created with good intent being hijacked,” said Bernard Munos, a former corporate strategy advisor at drug giant Eli Lilly and Co. who reviewed the KHN analysis of several FDA drug databases. It’s “quite remarkable that it has gone on for so long.”\u003c/p>\n\u003cp>And the proportion of \u003ca href=\"http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm534863.htm\">new drugs\u003c/a> approved as orphans has ballooned. In 2015, 21 orphan drugs were approved, accounting for 47 percent of all new medicines, up from just 29 percent in 2010; in 2016, nine more orphans won approval, 40 percent of the total.\u003c/p>\n\u003cp>When a drugmaker wins approval of a medicine for an orphan disease, the company gets seven years of exclusive rights to the marketplace, which means the FDA won’t approve another version to treat that rare disease for seven years, even if the brand name company’s patent has run out. The exclusivity is compensation for developing a drug designed for a small number of patients whose total sales weren’t expected to be that profitable.\u003c/p>\n\u003cp>But the exclusivity is a potent pricing tool. Drugmakers can charge whatever they want by shielding their medicine from competition. The market exclusivity granted by the Orphan Drug Act can be a vital part of the protective shield that companies create. What’s more, manufacturers can return to the FDA with the same drug again and again, each time testing the drug against a new rare disease.\u003c/p>\n\u003cp>Critics have assailed drugmakers in the past for gaming the orphan drug approval process. But the extent to which companies have been winning approval for drugs that aren’t what advocates call “true orphans” hadn’t been documented until the Kaiser Health News investigation.\u003c/p>\n\u003cp>Munos said he was “shocked” by the sheer number of mass market drugs being repurposed as well as those approved multiple times.\u003c/p>\n\u003cp>Even agency officials said they weren’t aware of the scope of the issue. After reviewing KHN’s findings for two weeks, Dr. Gayatri Rao director of the FDA’s Office of Orphan Products Development said she “appreciated the work” and expressed interest in studying how often drug companies are “repurposing” a drug for a new rare disease, or taking “multiple bites of the apple.”\u003c/p>\n\u003cp>“We are going to look into this,” she said, adding that she could consider a regulatory change.\u003c/p>\n\u003cp>Rao pointed out that the “repurposing” of drugs does have scientific and patient benefits. For example, cancer drugs approved for one type of malignancy can be tested and approved for others. Gleevec, a drug that revolutionized the treatment of chronic myeloid leukemia, now has nine orphan approvals.\u003c/p>\n\u003cp>But in a \u003ca href=\"http://www.hopkinsmedicine.org/news/media/releases/orphan_drug_loophole_needs_closing_johns_hopkins_researchers_say\">2015 commentary\u003c/a> published in the American Journal of Clinical Oncology, Dr. Martin Makary at the Johns Hopkins University School of Medicine focused on cancer drugs including Gleevec, arguing that the drug was never meant to serve an orphan population. Instead, Makary and his team wrote, drugmakers purposely identify small patient populations to gain additional approvals — a process he described as “salami slicing.”\u003c/p>\n\u003cp>“By salami slicing the disease into subgroups, it allows them to get the orphan drug approval with all the government benefits and even some of the subsidies,” Makary said. The prices of such medications often rise because they have seven years without competition for a new set of patients, Makary added.\u003c/p>\n\u003cp>The FDA has taken a different view of repurposing.\u003c/p>\n\u003cp>“We always talked about how we permit the second bite of the apple, third bite of the apple, as one small way to incentivize repurposing,” Rao said, noting that industry and patient groups have been pressing the FDA for even stronger incentives. “Now, all of sudden, it seems like, wow, this practice may be driving up prices.”\u003c/p>\n\u003cp>Novartis, which owns Gleevec, said in an email statement that the company is advancing research and following the science to “bring the right treatments to the right patients based on unmet need, not the size of the patient population.”\u003c/p>\n\u003cp>Two KHN reporters spent six months analyzing data and talking to lawmakers, patients, advocates, doctors and companies to understand how the FDA’s orphan drug program has evolved amid a national uproar over soaring drug prices. President-elect Donald Trump vowed on the campaign trail to \u003ca href=\"http://www.reuters.com/article/us-usa-trump-pharmaceuticals-idUSKBN13W21I\">bring down\u003c/a> prescription drug prices and during a Jan. 11 press conference said the drug industry is \u003ca href=\"https://www.nytimes.com/2017/01/11/us/politics/trump-press-conference-transcript.html?_r=0\">“getting away with murder.”\u003c/a>\u003c/p>\n\u003cp>The investigation examined how drugmakers use the law to their advantage — often with the guidance of former FDA officials — and have made the development of medicines that were once thought to be business backwaters into one of the pharmaceutical industry’s hottest sectors.\u003c/p>\n\u003cp>Orphan drugs now account for seven of the 10 top-selling drugs of any kind, ranked by annual sales, according to EvaluatePharma.\u003c/p>\n\u003cp>“Orphans are wicked hot,” said Dr. Tim Coté, a former FDA official who now runs a consulting firm that advises drugmakers on orphan drugs.\u003c/p>\n\u003cp>No one disputes that orphan drugs have helped or saved hundreds of thousands of patients suffering from debilitating or even fatal rare diseases. Exactly how many is difficult to estimate because the FDA doesn’t track such information.\u003c/p>\n\u003cp>And drug industry officials say companies should be rewarded, not punished, for making those treatments possible and for pursuing new drugs that aren’t always an economic success.\u003c/p>\n\u003cp>Research and development is “long, costly, risky,” said Anne Pritchett, vice president, policy and research at industry lobbying group PhRMA. “When you look at cystic fibrosis it was 25 years to the development of an effective therapy … I think we would be concerned about anything that would undermine the current [orphan drug] incentives.”\u003c/p>\n\u003cp>Former U.S. Rep. Henry Waxman, D-Calif., a champion of the 1983 Orphan Drug Act takes a different view.\u003c/p>\n\u003cp>“The Orphan Drug Act has been a great success because many people with diseases that affect very few people now have drugs available to them,” Waxman said. “But it’s been in some ways turned on its head when it becomes the basis of manipulating the system for the drug company to make much more money than they would in an open, competitive market.”\u003c/p>\n\u003cp>Booming Business\u003c/p>\n\u003cp>On a late summer day, Tim Coté sat in a corner office of his Sandy Spring, Md., consulting firm, Coté Orphan. He leaned into his computer microphone to dispense insider knowledge about the orphan drug approval process on a webcast hosted by FDAnews, a trade news organization. Listeners paid about $300 a head, but Coté said he wasn’t paid for doing it.\u003c/p>\n\u003cp>The FDA is more flexible in evaluating drugs for rare diseases, he said, explaining that “about half of them get through with just one pivotal clinical trial. Not so for common diseases.” The FDA, citing \u003ca href=\"http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/OOPDNewsArchive/UCM294773.pdf\">a report\u003c/a> from the National Organization for Rare Disorders, said about two-thirds of orphan drugs were approved with one adequate and well-controlled trial with supportive evidence. It typically requires two or three such trials to approve a mass market drug.\u003c/p>\n\u003cp>Coté also told the webinar audience that clinical trials for orphan drugs are usually smaller and the approval is a “different scientific and regulatory experience.”\u003c/p>\n\u003cp>Coté knows his stuff. He was Rao’s immediate predecessor as chief of the FDA’s Office of Orphan Products Development. It’s not unusual for government officials to leave FDA and other regulatory agencies and \u003ca href=\"http://www.npr.org/sections/health-shots/2016/09/28/495694559/a-look-at-how-the-revolving-door-spins-from-fda-to-industry\">obtain jobs as consultants or industry executives\u003c/a>.\u003c/p>\n\u003cp>Coté’s website, headlined “The Inside Track,” notes that he oversaw applications that led to the approval of at least 150 orphan drugs when he was at the FDA and that his firm is now the largest submitter of orphan drug applications.\u003c/p>\n\u003cp>“We write the entire application,” the website for Coté’s company notes, adding that his staff of 25 includes regulatory scientists with deep knowledge and experience in FDA’s “unwritten rules” regarding orphan drugs.\u003c/p>\n\u003cp>Many of Coté’s more than 300 clients are small biotech companies begun by researchers or even passionate parents who found investment backing. Parents Ilan and Annie Ganot, for example, started Solid Biosciences to find treatments and potentially a cure for their son with Duchenne muscular dystrophy.\u003c/p>\n\u003cp>Coté guides them through the regulatory process since most don’t have the expertise. He can offer his expertise and develop an application that makes it easier for the FDA to designate and approve the drug.\u003c/p>\n\u003cp>“When you make the FDA smile, the value of your asset goes up. And that’s how the game is played,” he said in an interview, adding quickly, “It’s really not a game because people’s lives are what is in balance.”\u003c/p>\n\u003cp>Coté and other ex-FDA officials play a vital role in helping drugmakers choose rare disease targets and get through the FDA approval process.\u003c/p>\n\u003cp>A small cottage industry has grown around the Orphan Drug Act. Dr. Marlene Haffner, who preceded Coté in the FDA’s orphan office, started her own consulting firm, too, to advise small and large companies on orphan drug applications. A third company is Camargo Pharmaceutical Services, led by industry veterans and former FDA officials, which advises companies focused on repurposing drugs for orphan approval. The firm tries “to be in front of the FDA a lot — three to four times a month,” said Jennifer King, Camargo’s director of marketing. Fees for consulting on orphan drugs industry wide range from $5,000 to $100,000, depending upon what services are provided, Coté said.\u003c/p>\n\u003cp>Getting through the orphan approval process involves a series of steps.\u003c/p>\n\u003cp>First, drugs must be designated by the FDA as potential candidates for approval. A company has to demonstrate that its drug is a promising treatment for a disease that affects fewer than 200,000 patients. If the FDA agrees and makes the formal designation, financial incentives kick in, including a 50 percent tax break on research and development (R&D) and access to federal grants.\u003c/p>\n\u003cp>When drugs get orphan designation, companies often reap other financial rewards. Shares in publicly traded companies often rise on the news — sometimes soaring \u003ca href=\"http://www.bizjournals.com/triangle/news/2014/02/25/dara-stock-soars-on-orphan-drug.html\">as high as 30 percent\u003c/a>. That happens, in part, because orphans have a track record of being approved at much higher rates than drugs for common diseases.\u003c/p>\n\u003cp>The 50 percent R&D tax credit pays off, too. In 2012, one of the biggest orphan drug companies, BioMarin, received \u003ca href=\"http://files.shareholder.com/downloads/ABEA-3W276N/2866327224x0x664042/776E8656-30BA-4937-A2A0-3AB6450BCA00/2012_Annual_Report.pdf\">$32.6 million\u003c/a> from a combination of federal and state of California tax credits. BioMarin spokeswoman Debra Charlesworth confirmed that the orphan credit made up the “vast majority” of that deferred tax benefit. She also noted that credit “has successfully fueled an industry that didn’t previously exist” and led to more rare disease research.\u003c/p>\n\u003cp>Industry-wide, orphan drug tax credits cost the federal government $1.76 billion in fiscal 2016 — roughly what President Barack Obama asked Congress to spend to fight \u003ca href=\"https://www.washingtonpost.com/news/post-politics/wp/2016/02/08/obama-to-ask-congress-for-1-8-billion-to-combat-zika-virus/\">the Zika virus\u003c/a> before a $1.1 billion expenditure was approved. And, because so many orphan drugs are under development, the U.S. could grant nearly $50 billion in tax credits from 2016 to 2025, estimates \u003ca href=\"https://www.treasury.gov/resource-center/tax-policy/Documents/Tax-Expenditures-FY2017.pdf\">the Treasury Department\u003c/a>.\u003c/p>\n\u003cp>There’s a lot of creativity behind figuring out how to make a drug an orphan.\u003c/p>\n\u003cp>In Coté’s webinar and in multiple interviews, he described many ways companies can win orphan status. They can test their drugs on children with adult diseases, such as schizophrenia, or find drugs for ailments like malaria that are uncommon in America.\u003c/p>\n\u003cp>“African sleeping sickness: horrible problem in Africa but not here, not in the U.S.,” Coté told his webinar audience. “So a drug development effort that was aimed toward some of these tropical diseases can actually get all the benefits of the Orphan Drug Act.”\u003c/p>\n\u003cp>Another popular strategy is to create “follow-on drugs” that represent incremental steps forward.\u003c/p>\n\u003cp>About 30 percent of Coté’s clients are companies looking to improve upon some other orphan drug “which just made billions and billions,” he said in an interview.\u003c/p>\n\u003cp>Repurposing an already approved drug is another strategy his firm promotes. In a \u003ca href=\"https://www.linkedin.com/pulse/re-purposing-drugs-orphans-timothy-cote?published=t\">video\u003c/a> posted on his website in July, Coté explained the advantages for companies that can move directly into a clinical trial without much preparatory work because the drug’s safety has already been demonstrated.\u003c/p>\n\u003cp>“All you gotta do is establish that the product can work in this new orphan indication,” he said, adding tips on how to do it and still make money.\u003c/p>\n\u003cp>‘That Is Not A True Orphan Drug’\u003c/p>\n\u003cp>Turning mass market drugs into orphans has been a familiar path for some of the most popular drugs ever discovered.\u003c/p>\n\u003cp>AbbVie’s Humira is the best-selling drug in the world, and most of its sales are in the U.S. where revenue reached $7.6 billion through \u003ca href=\"https://news.abbvie.com/news/abbvie-reports-third-quarter-2016-financial-results.htm\">the third quarter\u003c/a> of 2016 and $11.8 billion worldwide, according to the company’s latest financial report.\u003c/p>\n\u003cp>Humira was approved by the FDA in late 2002 to treat millions of people who suffer from rheumatoid arthritis. Three years later, AbbVie asked the FDA to designate it as an orphan to treat juvenile rheumatoid arthritis, which they told the FDA affects between 30,000 and 50,000 Americans. That pediatric use was approved in 2008, and Humira subsequently was approved for four more rare diseases, including Crohn’s and uveitis, an inflammatory disease affecting the eyes.\u003c/p>\n\u003cp>The ophthalmologic approval would extend the market exclusivity for Humira for that disease until 2023. When asked why AbbVie sought multiple orphan designations and approvals for Humira, the company declined to comment.\u003c/p>\n\u003cp>Peter Saltonstall, executive director of the National Organization for Rare Disorders, said that Humira is “not a true orphan drug.” But, he said, the company has “the ability to go out and get orphan designation. That’s the way the law reads right now … they can do whatever they want to do.”\u003c/p>\n\u003cp>It is difficult to say exactly how or if orphan exclusivity affects the price of Humira, which is a complex biologic drug and also has been protected by \u003ca href=\"http://www.nytimes.com/2016/07/16/business/makers-of-humira-and-enbrel-using-new-drug-patents-to-delay-generic-versions.html?_r=3\">numerous patents\u003c/a>. The drug has long been AbbVie’s top seller, accounting for 63 percent of its revenues, according to its most recent financial filing.\u003c/p>\n\u003cp>EvaluatePharma notes \u003ca href=\"http://info.evaluategroup.com/rs/607-YGS-364/images/EPOD15.pdf\">in its recent report\u003c/a> that Humira, as well as a handful of other top drugs, receive less than 25 percent of their sales from orphan uses. Still, if Humira’s orphan uses accounted for just 10 percent of annual sales, the revenue would surpass $1 billion.\u003c/p>\n\u003cp>By stacking up a series of orphan disease approvals, one seven-year exclusivity period leads into another, maximizing the length of a company’s monopoly. Sigma-Tau Pharmaceuticals, for example, had some form of orphan exclusivity over its metabolic disorder drug for more than 20 years. The drug, Carnitor, received a second orphan approval four months before its first exclusivity was set to expire. And it won its third orphan approval, for an IV formulation of the drug, just one day before its second exclusivity period was set to expire in December of 1999.\u003c/p>\n\u003cp>“The sequence and timing of regulatory filings for Carnitor reflect the time required to conduct large controlled clinical trials, as well as evolving medical strategies and regulatory pathways pursued by different sponsors over many years,” said GianFranco Fornasini, senior vice president of scientific affairs at Sigma-Tau.\u003c/p>\n\u003cp>The FDA’s Rao said each new exclusivity period is disease-specific and once any seven-year period runs out, generics can come in. Gleevec, for example, won FDA approval to treat several kinds of rare cancer. All but one of its orphan exclusivity periods had expired by 2015, allowing two generics to enter the marketplace. But Gleevec still has exclusivity until 2020 to treat newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in patients who are also on chemotherapy.\u003c/p>\n\u003cp>It’s also true, Rao explained, that some of the drugs that go through the orphan process may not specifically treat a rare disease. For example, a very toxic cancer drug might may not work well in earlier stages because its risks outweigh the benefits. But the company may propose that it will help a smaller group of later-stage cancer patients and win orphan approval just for that group.\u003c/p>\n\u003cp>Former FDA orphan drug director Haffner said her FDA office worked on rules defining how companies could legitimately pursue approval for a small group of patients with a specific unmet medical need.\u003c/p>\n\u003cp>“People have played games with the Orphan Drug Act since it was passed,” said Haffner, who first took a job with drugmaker Amgen after leaving the FDA and then became an independent consultant. “It’s the American way, I don’t mean that in a nasty way. But we take advantage of what’s in front of us.”\u003c/p>\n\u003cp>In 2013, the \u003ca href=\"https://www.federalregister.gov/documents/2013/06/12/2013-13930/orphan-drug-regulations\">FDA clarified the Orphan Drug Act’s regulations\u003c/a> and said it wanted to avoid the possibility that some companies could “potentially ‘game’ approvals by seeking successive narrow approvals of a drug.”\u003c/p>\n\u003cp>In reality, Rao said, the regulations did not really change “much of what our practice was.” The agency wanted to address what Rao said were “common misconceptions” and frequently asked questions so officials changed wording in the regulations to better define exactly what could be considered an orphan drug.\u003c/p>\n\u003cp>Breaking down larger, broader diseases into smaller groups is still allowed under certain conditions and companies can still win multiple orphan approvals for a single drug — even if the total population served rises above the 200,000 mark.\u003c/p>\n\u003cp>Amgen Inc.’s Repatha won marketing approval and exclusive rights in 2015 for the orphan disease homozygous familial hypercholesterolemia, which affects a population of \u003ca href=\"http://www.lipidjournal.com/article/S1933-2874(13)00309-7/abstract\">about 300 people\u003c/a> in the U.S. On the very same day, the drug was approved as a mass market drug to treat up to 11 million people with uncontrolled levels of LDL cholesterol, said Amgen spokeswoman Kristen Davis.\u003c/p>\n\u003cp>Dr. Steven Nissen of the Cleveland Clinic, who ran a broader trial on Repatha, said, “It’s certainly not considered by any of us to be an orphan drug.”\u003c/p>\n\u003cp>Safeguarding The ‘Prize’\u003c/p>\n\u003cp>Considering the long history of what’s happened, Tim Coté acknowledges that there are “some loopholes” in the Orphan Drug Act. Perhaps 3 percent or less of approved orphans were not in the “spirit” of the law, he said.\u003c/p>\n\u003cp>But Coté, rare disease advocates, patients and people in the drug industry expressed fear that changing the Orphan Drug Act or questioning its success would hurt the development of drugs for rare patients.\u003c/p>\n\u003cp>Former U.S. Rep. Jim Greenwood, R-Pa., now president of the Biotechnology Innovation Organization, an industry trade group, said that concerns about high prices for orphan drugs aren’t justified. The incentives, he said, should not be altered because rare diseases are “tragically killing and brutalizing mostly children.”\u003c/p>\n\u003cp>Greenwood seemed unaware that dozens of orphan approvals stemmed from the repurposing of mass market drugs, like Humira or Enbrel, another drug developed first for rheumatoid arthritis. Still, he said, “I would argue that the risk of losing incentives in the system far outweighs the benefit of trying to save a few pennies on the health care dollar.”\u003c/p>\n\u003cp>It’s a sentiment that Coté and other advocates share. While talking about the $311,000 annual price tag for cystic fibrosis drug Kalydeco, Coté said any parent whose child has the disease would be a big fan of the drug.\u003c/p>\n\u003cp>“The price point is justified because actually it has a dramatic effect on the children. Dead children … people are willing to pay a lot to prevent that,” Coté said. “And that’s a real good thing that we have this drug. OK?”\u003c/p>\n\u003cp>The first drug to specifically target the underlying biochemical defect of cystic fibrosis, Kalydeco is approved to treat a subset of patients who have specific mutations in their genes. Development of the drug was financed by the Cystic Fibrosis Foundation, which sold its rights to sales royalties from Kalydeco and other cystic fibrosis drugs for $3.3 billion in 2014.\u003c/p>\n\u003cp>Others, including Henry Waxman, are far more critical and have tried to do something about it over the years. Waxman proposed multiple bills to rein in corporate profits by amending the orphan drug law that he sponsored, but none succeeded.\u003c/p>\n\u003cp>The FDA has also tried but failed, to keep corporations in check.\u003c/p>\n\u003cp>In 2012, drugmaker Depomed Inc. filed suit against the FDA for refusing to give its drug Gralise seven years of market exclusivity as a treatment for pain related to shingles.\u003c/p>\n\u003cp>Rao said the agency wanted to see proof that Gralise was clinically superior to other drugs, noting there “were a bunch of other generics on the market” with different formulations and dosing requirements. Grasile’s active ingredient, gabapentin, is the same one as in Pfizer’s mass market blockbuster \u003ca href=\"http://www.pfizer.com/products/product-detail/neurontin\">Neurontin\u003c/a>, which is also approved for treatment of shingles pain.\u003c/p>\n\u003cp>The FDA approved Gralise but denied seven years of exclusivity.\u003c/p>\n\u003cp>In response, the drugmaker sued the agency and won its case, arguing that according to the law, they didn’t have to prove their drug was clinically superior to gain the monopoly.\u003c/p>\n\u003cp>Today, the drug is one of Depomed’s top products with sales of $81 million in 2015. And, in a \u003ca href=\"http://investor.depomedinc.com/phoenix.zhtml?c=97276&p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTEwODc0NDE5JkRTRVE9MCZTRVE9MCZTUURFU0M9U0VDVElPTl9FTlRJUkUmc3Vic2lkPTU3\">recent proxy statement\u003c/a>, Depomed listed “protecting Gralise exclusivity” as a corporate objective under the category of “enhance and protect future cash flow.” Its orphan exclusivity ends in 2018. Depomed spokesman Christopher Keenan said Gralise wanted patent exclusivity to block competition. But, Keenan said, “Had the patent effort failed on all fronts, the Orphan Drug Designation would have been very important.”\u003c/p>\n\u003cp>After reviewing KHN’s analysis, Rao said she wants to better understand why drugmakers are applying for multiple approvals and has asked for a case-by-case review of all orphan designations granted in 2010 and 2015. She said the agency lacks the resources to run an analysis of the entire orphan drug database.\u003c/p>\n\u003cp>“Our goal is to try to get it right,” she said. “There are over 7,000 rare diseases, likely more, the vast majority of which have nothing … I want to ensure that we continue to keep our eye on that prize.”\u003c/p>\n\u003cp>Contributors: John Hillkirk, Scott Hensley at NPR, Diane Webber, Marilyn Thompson (editors); Elizabeth Lucas (data editing); Joe Neel at NPR (radio editing)\u003c/p>\n\u003cp>Interactives, video and presentation: Lydia Zuraw, Emily Kopp, Meredith Rizzo at NPR (digital presentation); Francis Ying (videos, motion graphic); Heidi de Marco (videos, photos, audio); Alley Interactive (database lookup)\u003c/p>\n\u003cp>KHN’s coverage of prescription drug development, costs and pricing is supported in part by the \u003ca href=\"http://www.arnoldfoundation.org/\">Laura and John Arnold Foundation\u003c/a>.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003ca href=\"http://www.kaiserhealthnews.org/\">Kaiser Health News\u003c/a> (KHN) is a national health policy news service. It is an editorially independent program of the \u003ca href=\"http://www.kff.org/\">Henry J. Kaiser Family Foundation\u003c/a>.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/news/11273732/drugmakers-manipulate-orphan-drug-rules-to-create-prized-monopolies","authors":["byline_news_11273732"],"programs":["news_6944","news_72"],"categories":["news_457","news_8"],"tags":["news_20402","news_1930"],"featImg":"news_11273798","label":"news_72"},"stateofhealth_278362":{"type":"posts","id":"stateofhealth_278362","meta":{"index":"posts_1591205157","site":"stateofhealth","id":"278362","score":null,"sort":[1483384955000]},"guestAuthors":[],"slug":"will-californias-new-right-to-try-law-empower-or-exploit-patients","title":"Will California’s New 'Right to Try' Law Empower or Exploit Patients?","publishDate":1483384955,"format":"standard","headTitle":"State of Health | KQED News","labelTerm":{"site":"stateofhealth"},"content":"\u003cp>With the enactment of a new “Right to Try” law, California joins 31 other states that have already passed legislation to support patients’ efforts to access experimental drugs.\u003c/p>\n\u003cp>As of Jan. 1, state agencies and licensing boards will not penalize California doctors or hospitals that want to help patients directly petition pharmaceutical companies for the investigational drugs.\u003c/p>\n\u003cp>Proponents of the “Right to Try” movement had contended that doctors could be hesitant to help such patients because of the risk of using drugs or devices that haven’t passed FDA tests for safety and effectiveness.\u003c/p>\n\u003cp>[soundcloud url=\"https://api.soundcloud.com/tracks/300768363\" params=\"color=ff5500&auto_play=false&hide_related=false&show_comments=true&show_user=true&show_reposts=false\" width=\"100%\" height=\"166\" iframe=\"true\" /]\u003c/p>\n\u003cp>The new law makes it clear that California doctors can proceed without fear of censure from the state’s medical board. It also eliminates other possible regulatory obstacles on the state level and creates processes for patient consent and data collection.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"The idea is to kind of get government out of the way in this situation and allow people to just go at it with a doctor to try to get access to these potentially life-saving medications,” said the law’s sponsor \u003ca href=\"http://asmdc.org/members/a57/\" target=\"_blank\">Ian Calderon\u003c/a>, the Democratic majority leader in the California Assembly.\u003c/p>\n\u003cp>Supporters of “Right to Try” laws sometimes frame them as the logical counterpart to “Right to Die” laws, which allow physician-assisted suicide for terminally ill patients. California enacted such a law in 2016.\u003c/p>\n\u003cp>\"The patient community is saying, ‘We are smart, we’re informed, we feel it is our right to try some of these therapies, because we’re going to die anyway,’” said Lina Clark, a patients’ rights \u003ca href=\"http://www.hopenowforals.org\" target=\"_blank\">activist\u003c/a> in San Diego.\u003c/p>\n\u003cp>Clark’s husband, \u003ca href=\"http://sci.sdsu.edu/geology/remembering-dr-david-huntley/\" target=\"_blank\">David Huntley\u003c/a>, had wanted to try an experimental drug before his death in 2015 from \u003ca href=\"https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Amyotrophic-Lateral-Sclerosis-ALS-Fact-Sheet\" target=\"_blank\">amyotrophic lateral sclerosis\u003c/a> (ALS).\u003c/p>\n\u003cfigure id=\"attachment_278363\" class=\"wp-caption alignnone\" style=\"max-width: 720px\">\u003cimg class=\"size-full wp-image-278363\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento.jpg\" alt=\"David Huntley testified in favor of California's "Right to Try" bill in April, 2015. He died three months later. \" width=\"720\" height=\"960\" srcset=\"https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento.jpg 720w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-160x213.jpg 160w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-240x320.jpg 240w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-375x500.jpg 375w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-520x693.jpg 520w\" sizes=\"(max-width: 720px) 100vw, 720px\">\u003cfigcaption class=\"wp-caption-text\">David Huntley testified in favor of California's \"Right to Try\" bill in April 2015. He died three months later. \u003ccite>(Courtesy of Lina Clark)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>The FDA already offers a \u003ca href=\"http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm\" target=\"_blank\">process\u003c/a>, called “expanded access” or “compassionate use,” for some patients to obtain experimental drugs. But critics say it’s too slow and cumbersome, even though the FDA approves more than 99 percent of requests that come through that pipeline.\u003c/p>\n\u003cp>“It just takes so long, it’s inefficient, it’s ridiculous,” Calderon said of the FDA process. “I don’t understand.”\u003c/p>\n\u003cp>As the state laws proliferate, clinicians and medical ethicists are growing increasingly concerned about the potential safety and financial risks to patients.\u003c/p>\n\u003cp>“If we take the FDA out of it, how do we protect people from physicians or drug companies that will want to sell them things and will want to prey on their desperation?” asked \u003ca href=\"http://healthpolicy.ucsf.edu/people/r-adams-dudley-md-mba\" target=\"_blank\">Dr. R. Adams Dudley\u003c/a>, director of UCSF’s \u003ca href=\"http://healthvalue.ucsf.edu/\" target=\"_blank\">Center for Healthcare Value\u003c/a>.\u003c/p>\n\u003cp>Dudley says the FDA and the clinical trial process were put in place for a reason.\u003c/p>\n\u003cp>\"Have we somehow gotten better at managing snake oil salesmen now, than we were back when we decided we needed an FDA in the first place?\" Dudley said.\u003c/p>\n\u003cp>Under the new law, all that patients and doctors can really do is \u003cem>ask\u003c/em> for an experimental drug. Drug companies don’t have to give it to them, and insurance companies don’t have to pay for it.\u003c/p>\n\u003cp>Dudley fears that family members of a patient might exhaust their life savings trying a drug that hasn’t been proven to work -- and could even speed up death or increase end-of-life suffering.\u003c/p>\n\u003cp>That’s one reason the \u003ca href=\"http://www.nationalnursesunited.org/site/entry/california-nurses-association\" target=\"_blank\">California Nurses Association\u003c/a>, among other groups, strongly opposed the bill.\u003c/p>\n\u003cp>“It basically turns patients -- terminally-ill patients -- into guinea pigs,” said Don Nielsen, the CNA's director of government relations.\u003c/p>\n\u003cp>“There’s really no demonstrated need for this,” Nielsen said. “This so-called \"Right to Try\" movement is nothing more than boilerplate legislation promoted by the far-right Goldwater Institute.”\u003c/p>\n\u003cp>(While the Arizona-based Goldwater Institute has taken an active role in \u003ca href=\"http://goldwaterinstitute.org/en/work/topics/healthcare/right-to-try/right-try/\" target=\"_blank\">promoting\u003c/a> the laws, in California and other states, Calderon insists he came upon the issue independently, while researching physician-assisted suicide for California.)\u003c/p>\n\u003cp>It’s unclear how effective the state laws have been. There’s no data yet on how many patients have used the state laws, compared to the FDA’s expanded access process.\u003c/p>\n\u003cp>Dudley predicts the state-based Right to Try laws may eventually face a court challenge and be declared unconstitutional. That’s because federal law gives the power to regulate pharmaceuticals to the FDA, not the states.\u003c/p>\n\u003cp>But Clark thinks Congress might be open to amending that authority.\u003c/p>\n\u003cp>“It’s kind of parallel with what’s going on with medical marijuana,” Clark said. “It’s legal at the state level, but we still have a federal Drug Enforcement Agency to whom it is illegal. It’s not an ideal situation. It’s kind of similar to that. We ultimately need a federal law.”\u003c/p>\n\u003cp>A federal version of Right to Try was introduced in the Senate last year. In the meantime, a recently passed federal law addressing medical research, the \u003ca href=\"http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf\" target=\"_blank\">21st Century Cures Act\u003c/a>, contains a \u003ca href=\"https://www.statnews.com/pharmalot/2016/11/28/21st-century-experimental-drugs/\" target=\"_blank\">provision\u003c/a> that requires drug companies to be more transparent about how they decide who gets access to experimental drugs and how long it will take.\u003c/p>\n\u003cfigure id=\"attachment_278364\" class=\"wp-caption alignnone\" style=\"max-width: 800px\">\u003cimg class=\"size-medium wp-image-278364\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-800x800.jpg\" alt='Lina Clark and her husband David Huntley on vacation in Croatia in 2014, before he succumbed to ALS. The disease made both of them activists for the \"right to try\" in California. ' width=\"800\" height=\"800\" srcset=\"https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-800x800.jpg 800w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-160x160.jpg 160w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-768x768.jpg 768w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing.jpg 960w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-240x240.jpg 240w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-375x375.jpg 375w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-520x520.jpg 520w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-32x32.jpg 32w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-50x50.jpg 50w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-64x64.jpg 64w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-96x96.jpg 96w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-128x128.jpg 128w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-150x150.jpg 150w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Lina Clark and her husband David Huntley on vacation in Croatia in 2014, before he succumbed to ALS. The disease made both of them activists for the \"Right to Try\" in California. \u003ccite>(Courtesy of Lina Clark)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>Editor's note: The original version of this article incorrectly stated the California \"Right To Try\" law allowed access to an experimental drug at any stage. The law actually only allows a patient to request a drug that has passed through Phase I of the FDA clinical process, when a candidate drug is tested for toxicity on otherwise healthy subjects.\u003cbr>\n\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"California is the 32nd state to pass a law supporting patients’ efforts to access experimental drugs. But critics say the movement poses potential safety and financial risks to vulnerable patients. ","status":"publish","parent":0,"modified":1488395641,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":29,"wordCount":1037},"headData":{"title":"Will California’s New 'Right to Try' Law Empower or Exploit Patients? | KQED","description":"California is the 32nd state to pass a law supporting patients’ efforts to access experimental drugs. But critics say the movement poses potential safety and financial risks to vulnerable patients. ","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Will California’s New 'Right to Try' Law Empower or Exploit Patients?","datePublished":"2017-01-02T19:22:35.000Z","dateModified":"2017-03-01T19:14:01.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"278362 http://ww2.kqed.org/stateofhealth/?p=278362","disqusUrl":"https://ww2.kqed.org/stateofhealth/2017/01/02/will-californias-new-right-to-try-law-empower-or-exploit-patients/","disqusTitle":"Will California’s New 'Right to Try' Law Empower or Exploit Patients?","path":"/stateofhealth/278362/will-californias-new-right-to-try-law-empower-or-exploit-patients","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>With the enactment of a new “Right to Try” law, California joins 31 other states that have already passed legislation to support patients’ efforts to access experimental drugs.\u003c/p>\n\u003cp>As of Jan. 1, state agencies and licensing boards will not penalize California doctors or hospitals that want to help patients directly petition pharmaceutical companies for the investigational drugs.\u003c/p>\n\u003cp>Proponents of the “Right to Try” movement had contended that doctors could be hesitant to help such patients because of the risk of using drugs or devices that haven’t passed FDA tests for safety and effectiveness.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003cdiv class='utils-parseShortcode-shortcodes-__shortcodes__shortcodeWrapper'>\n \u003ciframe width='100%' height='166'\n scrolling='no' frameborder='no'\n src='https://w.soundcloud.com/player/?url=https://api.soundcloud.com/tracks/300768363&visual=true&color=ff5500&auto_play=false&hide_related=false&show_comments=true&show_user=true&show_reposts=false'\n title='https://api.soundcloud.com/tracks/300768363'>\n \u003c/iframe>\n \u003c/div>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The new law makes it clear that California doctors can proceed without fear of censure from the state’s medical board. It also eliminates other possible regulatory obstacles on the state level and creates processes for patient consent and data collection.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"The idea is to kind of get government out of the way in this situation and allow people to just go at it with a doctor to try to get access to these potentially life-saving medications,” said the law’s sponsor \u003ca href=\"http://asmdc.org/members/a57/\" target=\"_blank\">Ian Calderon\u003c/a>, the Democratic majority leader in the California Assembly.\u003c/p>\n\u003cp>Supporters of “Right to Try” laws sometimes frame them as the logical counterpart to “Right to Die” laws, which allow physician-assisted suicide for terminally ill patients. California enacted such a law in 2016.\u003c/p>\n\u003cp>\"The patient community is saying, ‘We are smart, we’re informed, we feel it is our right to try some of these therapies, because we’re going to die anyway,’” said Lina Clark, a patients’ rights \u003ca href=\"http://www.hopenowforals.org\" target=\"_blank\">activist\u003c/a> in San Diego.\u003c/p>\n\u003cp>Clark’s husband, \u003ca href=\"http://sci.sdsu.edu/geology/remembering-dr-david-huntley/\" target=\"_blank\">David Huntley\u003c/a>, had wanted to try an experimental drug before his death in 2015 from \u003ca href=\"https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Amyotrophic-Lateral-Sclerosis-ALS-Fact-Sheet\" target=\"_blank\">amyotrophic lateral sclerosis\u003c/a> (ALS).\u003c/p>\n\u003cfigure id=\"attachment_278363\" class=\"wp-caption alignnone\" style=\"max-width: 720px\">\u003cimg class=\"size-full wp-image-278363\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento.jpg\" alt=\"David Huntley testified in favor of California's "Right to Try" bill in April, 2015. He died three months later. \" width=\"720\" height=\"960\" srcset=\"https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento.jpg 720w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-160x213.jpg 160w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-240x320.jpg 240w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-375x500.jpg 375w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-520x693.jpg 520w\" sizes=\"(max-width: 720px) 100vw, 720px\">\u003cfigcaption class=\"wp-caption-text\">David Huntley testified in favor of California's \"Right to Try\" bill in April 2015. He died three months later. \u003ccite>(Courtesy of Lina Clark)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>The FDA already offers a \u003ca href=\"http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm\" target=\"_blank\">process\u003c/a>, called “expanded access” or “compassionate use,” for some patients to obtain experimental drugs. But critics say it’s too slow and cumbersome, even though the FDA approves more than 99 percent of requests that come through that pipeline.\u003c/p>\n\u003cp>“It just takes so long, it’s inefficient, it’s ridiculous,” Calderon said of the FDA process. “I don’t understand.”\u003c/p>\n\u003cp>As the state laws proliferate, clinicians and medical ethicists are growing increasingly concerned about the potential safety and financial risks to patients.\u003c/p>\n\u003cp>“If we take the FDA out of it, how do we protect people from physicians or drug companies that will want to sell them things and will want to prey on their desperation?” asked \u003ca href=\"http://healthpolicy.ucsf.edu/people/r-adams-dudley-md-mba\" target=\"_blank\">Dr. R. Adams Dudley\u003c/a>, director of UCSF’s \u003ca href=\"http://healthvalue.ucsf.edu/\" target=\"_blank\">Center for Healthcare Value\u003c/a>.\u003c/p>\n\u003cp>Dudley says the FDA and the clinical trial process were put in place for a reason.\u003c/p>\n\u003cp>\"Have we somehow gotten better at managing snake oil salesmen now, than we were back when we decided we needed an FDA in the first place?\" Dudley said.\u003c/p>\n\u003cp>Under the new law, all that patients and doctors can really do is \u003cem>ask\u003c/em> for an experimental drug. Drug companies don’t have to give it to them, and insurance companies don’t have to pay for it.\u003c/p>\n\u003cp>Dudley fears that family members of a patient might exhaust their life savings trying a drug that hasn’t been proven to work -- and could even speed up death or increase end-of-life suffering.\u003c/p>\n\u003cp>That’s one reason the \u003ca href=\"http://www.nationalnursesunited.org/site/entry/california-nurses-association\" target=\"_blank\">California Nurses Association\u003c/a>, among other groups, strongly opposed the bill.\u003c/p>\n\u003cp>“It basically turns patients -- terminally-ill patients -- into guinea pigs,” said Don Nielsen, the CNA's director of government relations.\u003c/p>\n\u003cp>“There’s really no demonstrated need for this,” Nielsen said. “This so-called \"Right to Try\" movement is nothing more than boilerplate legislation promoted by the far-right Goldwater Institute.”\u003c/p>\n\u003cp>(While the Arizona-based Goldwater Institute has taken an active role in \u003ca href=\"http://goldwaterinstitute.org/en/work/topics/healthcare/right-to-try/right-try/\" target=\"_blank\">promoting\u003c/a> the laws, in California and other states, Calderon insists he came upon the issue independently, while researching physician-assisted suicide for California.)\u003c/p>\n\u003cp>It’s unclear how effective the state laws have been. There’s no data yet on how many patients have used the state laws, compared to the FDA’s expanded access process.\u003c/p>\n\u003cp>Dudley predicts the state-based Right to Try laws may eventually face a court challenge and be declared unconstitutional. That’s because federal law gives the power to regulate pharmaceuticals to the FDA, not the states.\u003c/p>\n\u003cp>But Clark thinks Congress might be open to amending that authority.\u003c/p>\n\u003cp>“It’s kind of parallel with what’s going on with medical marijuana,” Clark said. “It’s legal at the state level, but we still have a federal Drug Enforcement Agency to whom it is illegal. It’s not an ideal situation. It’s kind of similar to that. We ultimately need a federal law.”\u003c/p>\n\u003cp>A federal version of Right to Try was introduced in the Senate last year. In the meantime, a recently passed federal law addressing medical research, the \u003ca href=\"http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf\" target=\"_blank\">21st Century Cures Act\u003c/a>, contains a \u003ca href=\"https://www.statnews.com/pharmalot/2016/11/28/21st-century-experimental-drugs/\" target=\"_blank\">provision\u003c/a> that requires drug companies to be more transparent about how they decide who gets access to experimental drugs and how long it will take.\u003c/p>\n\u003cfigure id=\"attachment_278364\" class=\"wp-caption alignnone\" style=\"max-width: 800px\">\u003cimg class=\"size-medium wp-image-278364\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-800x800.jpg\" alt='Lina Clark and her husband David Huntley on vacation in Croatia in 2014, before he succumbed to ALS. The disease made both of them activists for the \"right to try\" in California. ' width=\"800\" height=\"800\" srcset=\"https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-800x800.jpg 800w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-160x160.jpg 160w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-768x768.jpg 768w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing.jpg 960w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-240x240.jpg 240w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-375x375.jpg 375w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-520x520.jpg 520w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-32x32.jpg 32w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-50x50.jpg 50w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-64x64.jpg 64w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-96x96.jpg 96w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-128x128.jpg 128w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-150x150.jpg 150w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Lina Clark and her husband David Huntley on vacation in Croatia in 2014, before he succumbed to ALS. The disease made both of them activists for the \"Right to Try\" in California. \u003ccite>(Courtesy of Lina Clark)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>Editor's note: The original version of this article incorrectly stated the California \"Right To Try\" law allowed access to an experimental drug at any stage. The law actually only allows a patient to request a drug that has passed through Phase I of the FDA clinical process, when a candidate drug is tested for toxicity on otherwise healthy subjects.\u003cbr>\n\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/stateofhealth/278362/will-californias-new-right-to-try-law-empower-or-exploit-patients","authors":["11314"],"categories":["stateofhealth_2407","stateofhealth_14","stateofhealth_13"],"tags":["stateofhealth_3017","stateofhealth_3019","stateofhealth_48","stateofhealth_2808","stateofhealth_2904","stateofhealth_2519","stateofhealth_3018"],"featImg":"stateofhealth_279626","label":"stateofhealth"},"stateofhealth_216805":{"type":"posts","id":"stateofhealth_216805","meta":{"index":"posts_1591205157","site":"stateofhealth","id":"216805","score":null,"sort":[1469491644000]},"guestAuthors":[],"slug":"problems-after-using-hair-conditioner-prompt-an-fda-warning","title":"Problems After Using Hair Conditioner Prompt An FDA Warning","publishDate":1469491644,"format":"standard","headTitle":"State of Health | KQED News","labelTerm":{"site":"stateofhealth"},"content":"\u003cp>Hair products aren't at the top of most people's health worry list, but the Food and Drug Administration is investigating a surprisingly high number of reports of problems after people used a particular cleansing conditioner.\u003c/p>\n\u003cp>As of July 7, the FDA had received 127 complaints of \"hair loss, hair breakage, balding, itching, and rash\" after people used Wen by Chaz Dean cleansing conditioner products — more reports than the agency has ever received for a cosmetic hair product.\u003c/p>\n\u003cp>\"This kind of report is very rare,\" says \u003ca href=\"https://mydoctor.kaiserpermanente.org/ncal/provider/pmirmirani\">Paradi Mirmirani\u003c/a>, a dermatologist in Vallejo, Calif. \"For the most part, shampoo products out there are all very safe.\" The agency's \u003ca href=\"http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm511890.htm\">safety alert \u003c/a>says it has not determined a possible cause for the problems reported.\u003c/p>\n\u003cp>Late last year, mediation began for a \u003ca href=\"http://ww2.kqed.org/wp-content/uploads/gunthy_renker_wen_complaint.pdf\">class-action lawsuit\u003c/a> in California against Guthy-Renker, the company that markets and manufactures Wen.\u003c/p>\n\u003cp>The FDA doesn't approve cosmetics before they go on the market, though it does set upper limits for \u003ca href=\"http://www.npr.org/sections/health-shots/2015/02/23/387766821/there-s-bacteria-in-your-soap-and-everywhere-else\">bacteria in cosmetics\u003c/a> and hygiene products. Instead, says Linda Katz, director of the FDA's Office of Cosmetics and Colors, the agency monitors consumer complaints for many factors to decide whether to investigate a product.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>In this case, the sheer number of complaints played a role in the decision. The agency says it is investigating more than 21,000 complaints reported to Chaz Dean Inc. and Guthy-Renker. (Gianna Cesa, a PR representative for Chaz Dean, says the company did not receive this number of complaints.)\u003c/p>\n\u003cp>Katz says she can't discuss any working hypotheses associated with the investigation, though she did say investigators have no reason to believe the product was contaminated with something foreign, like microbes. For now, the FDA is still gathering information. Officials will look at the product's quality testing and whether there have been any changes to how the product is made.\u003c/p>\n\u003cp>In an email, a spokesman for Chaz Dean said the company stands behind its products and that \"the brand has consistently cooperated with the FDA and will continue to do so.\"\u003c/p>\n\u003cp>Dermatologists say hair care products can cause these sorts of symptoms. One common reason is allergy.\u003c/p>\n\u003cp>\"There are thousands of ingredients that are in personal hair products,\" says \u003ca href=\"https://www.pennmedicine.org/providers/profile/bruce-brod\">Bruce Brod\u003c/a>, a clinical professor of dermatology at the University of Pennsylvania. \"While most people in the population won't react to them, there's a small subpopulation that will.\"\u003c/p>\n\u003cp>Common allergy triggers include surfactants, the ingredients in shampoos and conditioners that make them sudsy, as well as preservatives that increase shelf life and chemicals used to create fragrances.\u003c/p>\n\u003cp>These allergic reactions can occur regardless of whether a product is \"all natural,\" says Mirmirani. \"Lots of plants give people a reaction as well,\" she says, citing poison oak as an example. And because allergic reactions can take a while to occur, people may not immediately realize a hair product is causing issues.\u003c/p>\n\u003cp>But there are also causes of scalp problems that have nothing to do with cosmetics, says \u003ca href=\"http://www.oldmetairiedermatology.com/index.php/AboutUs/MeetDrRogers\">Nicole Rogers\u003c/a>, an assistant clinical professor of dermatology at Tulane Medical School. For example, she says, male-pattern or female-pattern baldness are both common causes of hair loss. Or a patient could suffer from alopecia areata, a disease in which the immune system attacks hair follicles. She says she believes it's unlikely the consumers' complaints are tied to Wen.\u003c/p>\n\u003cp>Stress, changes in diet and pregnancy can cause hair loss as well, says \u003ca href=\"https://www.mskcc.org/cancer-care/doctors/anthony-rossi\">Anthony Rossi\u003c/a>, a dermatologist who serves as a consultant to Chaz Dean's PR firm.\u003c/p>\n\u003cp>That said, all the doctors told Shots that people with scalp problems should visit a dermatologist and discuss hair products, along with other possible factors. Doctors can do allergy tests on patients to analyze as many as 55 potential allergy triggers. It's important, says Brod, to look at all potential causes of symptoms, rather than looking at Internet chat rooms alone.\u003c/p>\n\u003cp>\"Often, there's a suggestive herd effect,\" he says. \"If somebody says, 'I'm using something and it itches my scalp,' the person next to him will say, 'You know what? Me too.' \"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Katz of the FDA also urges people to visit doctors in addition to \u003ca href=\"http://www.fda.gov/Cosmetics/ComplianceEnforcement/AdverseEventReporting/default.htm\">reporting complaints\u003c/a> to the FDA. And if someone decides to switch from Wen to a different conditioner, Mirmirani says, \"There's plenty more out there.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Problems+After+Using+Hair+Conditioner+Prompt+An+FDA+Warning&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n","blocks":[],"excerpt":"After more than 100 consumers complained about symptoms like itchiness and balding, the FDA says hair conditioner is a potential culprit. But doctors warn against jumping to conclusions.","status":"publish","parent":0,"modified":1469491644,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":19,"wordCount":735},"headData":{"title":"Problems After Using Hair Conditioner Prompt An FDA Warning | KQED","description":"After more than 100 consumers complained about symptoms like itchiness and balding, the FDA says hair conditioner is a potential culprit. But doctors warn against jumping to conclusions.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Problems After Using Hair Conditioner Prompt An FDA Warning","datePublished":"2016-07-26T00:07:24.000Z","dateModified":"2016-07-26T00:07:24.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"216805 http://ww2.kqed.org/stateofhealth/?p=216805","disqusUrl":"https://ww2.kqed.org/stateofhealth/2016/07/25/problems-after-using-hair-conditioner-prompt-an-fda-warning/","disqusTitle":"Problems After Using Hair Conditioner Prompt An FDA Warning","nprImageCredit":"Jesse Grant","nprByline":"Natalie Jacewicz\u003cbr />\u003ca href=\"http://www.npr.org/sections/health-shots/\">NPR Shots\u003c/a>","nprImageAgency":"WireImage for Kari Feinstein PR/Getty Images","nprStoryId":"486904436","nprApiLink":"http://api.npr.org/query?id=486904436&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"http://www.npr.org/sections/health-shots/2016/07/25/486904436/problems-after-using-hair-conditioner-prompt-an-fda-warning?ft=nprml&f=486904436","nprRetrievedStory":"1","nprPubDate":"Mon, 25 Jul 2016 17:29:00 -0400","nprStoryDate":"Mon, 25 Jul 2016 12:43:00 -0400","nprLastModifiedDate":"Mon, 25 Jul 2016 17:29:32 -0400","path":"/stateofhealth/216805/problems-after-using-hair-conditioner-prompt-an-fda-warning","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Hair products aren't at the top of most people's health worry list, but the Food and Drug Administration is investigating a surprisingly high number of reports of problems after people used a particular cleansing conditioner.\u003c/p>\n\u003cp>As of July 7, the FDA had received 127 complaints of \"hair loss, hair breakage, balding, itching, and rash\" after people used Wen by Chaz Dean cleansing conditioner products — more reports than the agency has ever received for a cosmetic hair product.\u003c/p>\n\u003cp>\"This kind of report is very rare,\" says \u003ca href=\"https://mydoctor.kaiserpermanente.org/ncal/provider/pmirmirani\">Paradi Mirmirani\u003c/a>, a dermatologist in Vallejo, Calif. \"For the most part, shampoo products out there are all very safe.\" The agency's \u003ca href=\"http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm511890.htm\">safety alert \u003c/a>says it has not determined a possible cause for the problems reported.\u003c/p>\n\u003cp>Late last year, mediation began for a \u003ca href=\"http://ww2.kqed.org/wp-content/uploads/gunthy_renker_wen_complaint.pdf\">class-action lawsuit\u003c/a> in California against Guthy-Renker, the company that markets and manufactures Wen.\u003c/p>\n\u003cp>The FDA doesn't approve cosmetics before they go on the market, though it does set upper limits for \u003ca href=\"http://www.npr.org/sections/health-shots/2015/02/23/387766821/there-s-bacteria-in-your-soap-and-everywhere-else\">bacteria in cosmetics\u003c/a> and hygiene products. Instead, says Linda Katz, director of the FDA's Office of Cosmetics and Colors, the agency monitors consumer complaints for many factors to decide whether to investigate a product.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>In this case, the sheer number of complaints played a role in the decision. The agency says it is investigating more than 21,000 complaints reported to Chaz Dean Inc. and Guthy-Renker. (Gianna Cesa, a PR representative for Chaz Dean, says the company did not receive this number of complaints.)\u003c/p>\n\u003cp>Katz says she can't discuss any working hypotheses associated with the investigation, though she did say investigators have no reason to believe the product was contaminated with something foreign, like microbes. For now, the FDA is still gathering information. Officials will look at the product's quality testing and whether there have been any changes to how the product is made.\u003c/p>\n\u003cp>In an email, a spokesman for Chaz Dean said the company stands behind its products and that \"the brand has consistently cooperated with the FDA and will continue to do so.\"\u003c/p>\n\u003cp>Dermatologists say hair care products can cause these sorts of symptoms. One common reason is allergy.\u003c/p>\n\u003cp>\"There are thousands of ingredients that are in personal hair products,\" says \u003ca href=\"https://www.pennmedicine.org/providers/profile/bruce-brod\">Bruce Brod\u003c/a>, a clinical professor of dermatology at the University of Pennsylvania. \"While most people in the population won't react to them, there's a small subpopulation that will.\"\u003c/p>\n\u003cp>Common allergy triggers include surfactants, the ingredients in shampoos and conditioners that make them sudsy, as well as preservatives that increase shelf life and chemicals used to create fragrances.\u003c/p>\n\u003cp>These allergic reactions can occur regardless of whether a product is \"all natural,\" says Mirmirani. \"Lots of plants give people a reaction as well,\" she says, citing poison oak as an example. And because allergic reactions can take a while to occur, people may not immediately realize a hair product is causing issues.\u003c/p>\n\u003cp>But there are also causes of scalp problems that have nothing to do with cosmetics, says \u003ca href=\"http://www.oldmetairiedermatology.com/index.php/AboutUs/MeetDrRogers\">Nicole Rogers\u003c/a>, an assistant clinical professor of dermatology at Tulane Medical School. For example, she says, male-pattern or female-pattern baldness are both common causes of hair loss. Or a patient could suffer from alopecia areata, a disease in which the immune system attacks hair follicles. She says she believes it's unlikely the consumers' complaints are tied to Wen.\u003c/p>\n\u003cp>Stress, changes in diet and pregnancy can cause hair loss as well, says \u003ca href=\"https://www.mskcc.org/cancer-care/doctors/anthony-rossi\">Anthony Rossi\u003c/a>, a dermatologist who serves as a consultant to Chaz Dean's PR firm.\u003c/p>\n\u003cp>That said, all the doctors told Shots that people with scalp problems should visit a dermatologist and discuss hair products, along with other possible factors. Doctors can do allergy tests on patients to analyze as many as 55 potential allergy triggers. It's important, says Brod, to look at all potential causes of symptoms, rather than looking at Internet chat rooms alone.\u003c/p>\n\u003cp>\"Often, there's a suggestive herd effect,\" he says. \"If somebody says, 'I'm using something and it itches my scalp,' the person next to him will say, 'You know what? Me too.' \"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Katz of the FDA also urges people to visit doctors in addition to \u003ca href=\"http://www.fda.gov/Cosmetics/ComplianceEnforcement/AdverseEventReporting/default.htm\">reporting complaints\u003c/a> to the FDA. And if someone decides to switch from Wen to a different conditioner, Mirmirani says, \"There's plenty more out there.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Problems+After+Using+Hair+Conditioner+Prompt+An+FDA+Warning&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/stateofhealth/216805/problems-after-using-hair-conditioner-prompt-an-fda-warning","authors":["byline_stateofhealth_216805"],"categories":["stateofhealth_12"],"tags":["stateofhealth_48","stateofhealth_2519"],"featImg":"stateofhealth_216806","label":"stateofhealth"},"stateofhealth_107689":{"type":"posts","id":"stateofhealth_107689","meta":{"index":"posts_1591205157","site":"stateofhealth","id":"107689","score":null,"sort":[1447454548000]},"guestAuthors":[],"slug":"its-final-fda-issues-long-awaited-food-safety-rules","title":"It's Final: FDA Issues Long-Awaited Food Safety Rules","publishDate":1447454548,"format":"standard","headTitle":"State of Health | KQED News","labelTerm":{},"content":"\u003cp>Five years ago, Congress promised an overhaul of the nation's food safety system, passing the Food Safety Modernization Act.\u003c/p>\n\u003cp>It took much longer than expected, but the Food and Drug Administration has now released the centerpiece — or at least, the most contested — part of that overhaul. These are rules that cover farmers who grow \u003ca href=\"http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm#dates\" target=\"_blank\">fresh produce\u003c/a>, as well as \u003ca href=\"http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm\" target=\"_blank\">food importers\u003c/a>.\u003c/p>\n\u003cp>\"This is a giant step forward,\" said Michael Taylor, the FDA's deputy commissioner for foods.\u003c/p>\n\u003cp>Earlier drafts of the regulations on vegetable farming generated howls of protest. The rules are intended to prevent disease-causing bacteria from contaminating vegetables that people often eat raw.\u003c/p>\n\u003cp>But small farmers, in particular, complained that some requirements, such as those calling for regular testing of irrigation water, were onerous and costly. Organic farmers \u003ca href=\"http://www.npr.org/sections/thesalt/2013/11/21/246386290/organic-farmers-bash-fda-restrictions-on-manure-use\" target=\"_blank\">protested\u003c/a> against restrictions on the use of manure for fertilizer.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The final regulations contain compromises on some of those requirements. The FDA is conducting more research on the risks of using fresh manure, but in the meantime, it \"does not object\" to farmers simply following rules that already govern the use of manure in organic farming.\u003c/p>\n\u003cp>New regulations on food importers, meanwhile, require them to have programs in place to verify that their foreign suppliers are taking just as many safety precautions as farmers in the U.S. And the FDA will check up, sending safety inspectors around the world to visit food suppliers.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Both rules will start to go into effect in two years. Enforcing the new rules will require a boost in the FDA's budget, and Congress will have to approve it. \"It will not succeed without resources,\" said the FDA's Taylor.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2015 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=It%27s+Final%3A+FDA+Issues+Long-Awaited+Food+Safety+Rules&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\" alt=\"\">\u003c/div>\n\n","blocks":[],"excerpt":"The Food and Drug Administration's regulations cover farmers who grow fresh produce, as well as importers. The agency has been working on the rules for five years.","status":"publish","parent":0,"modified":1447454717,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":10,"wordCount":293},"headData":{"title":"It's Final: FDA Issues Long-Awaited Food Safety Rules | KQED","description":"The Food and Drug Administration's regulations cover farmers who grow fresh produce, as well as importers. The agency has been working on the rules for five years.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"It's Final: FDA Issues Long-Awaited Food Safety Rules","datePublished":"2015-11-13T22:42:28.000Z","dateModified":"2015-11-13T22:45:17.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"107689 http://ww2.kqed.org/stateofhealth/?p=107689","disqusUrl":"https://ww2.kqed.org/stateofhealth/2015/11/13/its-final-fda-issues-long-awaited-food-safety-rules/","disqusTitle":"It's Final: FDA Issues Long-Awaited Food Safety Rules","source":"NPR","nprByline":"Dan Charles","nprStoryId":"455902270","nprApiLink":"http://api.npr.org/query?id=455902270&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"http://www.npr.org/sections/thesalt/2015/11/13/455902270/its-final-fda-issues-long-awaited-food-safety-rules?ft=nprml&f=455902270","nprRetrievedStory":"1","nprPubDate":"Fri, 13 Nov 2015 16:42:00 -0500","nprStoryDate":"Fri, 13 Nov 2015 16:17:00 -0500","nprLastModifiedDate":"Fri, 13 Nov 2015 16:42:17 -0500","path":"/stateofhealth/107689/its-final-fda-issues-long-awaited-food-safety-rules","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Five years ago, Congress promised an overhaul of the nation's food safety system, passing the Food Safety Modernization Act.\u003c/p>\n\u003cp>It took much longer than expected, but the Food and Drug Administration has now released the centerpiece — or at least, the most contested — part of that overhaul. These are rules that cover farmers who grow \u003ca href=\"http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm#dates\" target=\"_blank\">fresh produce\u003c/a>, as well as \u003ca href=\"http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm\" target=\"_blank\">food importers\u003c/a>.\u003c/p>\n\u003cp>\"This is a giant step forward,\" said Michael Taylor, the FDA's deputy commissioner for foods.\u003c/p>\n\u003cp>Earlier drafts of the regulations on vegetable farming generated howls of protest. The rules are intended to prevent disease-causing bacteria from contaminating vegetables that people often eat raw.\u003c/p>\n\u003cp>But small farmers, in particular, complained that some requirements, such as those calling for regular testing of irrigation water, were onerous and costly. Organic farmers \u003ca href=\"http://www.npr.org/sections/thesalt/2013/11/21/246386290/organic-farmers-bash-fda-restrictions-on-manure-use\" target=\"_blank\">protested\u003c/a> against restrictions on the use of manure for fertilizer.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The final regulations contain compromises on some of those requirements. The FDA is conducting more research on the risks of using fresh manure, but in the meantime, it \"does not object\" to farmers simply following rules that already govern the use of manure in organic farming.\u003c/p>\n\u003cp>New regulations on food importers, meanwhile, require them to have programs in place to verify that their foreign suppliers are taking just as many safety precautions as farmers in the U.S. And the FDA will check up, sending safety inspectors around the world to visit food suppliers.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Both rules will start to go into effect in two years. Enforcing the new rules will require a boost in the FDA's budget, and Congress will have to approve it. \"It will not succeed without resources,\" said the FDA's Taylor.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2015 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=It%27s+Final%3A+FDA+Issues+Long-Awaited+Food+Safety+Rules&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\" alt=\"\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/stateofhealth/107689/its-final-fda-issues-long-awaited-food-safety-rules","authors":["byline_stateofhealth_107689"],"categories":["stateofhealth_14"],"tags":["stateofhealth_48","stateofhealth_2519"],"featImg":"stateofhealth_107690","label":"source_stateofhealth_107689"},"stateofhealth_22706":{"type":"posts","id":"stateofhealth_22706","meta":{"index":"posts_1591205157","site":"stateofhealth","id":"22706","score":null,"sort":[1416888069000]},"guestAuthors":[],"slug":"fda-to-announce-rules-on-calorie-counts-for-restaurant-menus","title":"FDA to Announce Rules on Calorie Counts for Restaurant Menus ","publishDate":1416888069,"format":"aside","headTitle":"State of Health | KQED News","labelTerm":{"site":"stateofhealth"},"content":"\u003cfigure id=\"attachment_22711\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003ca href=\"https://www.flickr.com/photos/kevharb/3641982466/in/photolist-6xQ7v9-6LZfbL-9s4sos-28T2DM-99ViPn-dgmguP-9hR3h5-Nfmzh-8jdH2d-889SFr-88cDJL-NfmyU-Nfmyj-Nfmyo-6ixKhz-2UciR8-4bE85E-5ckU7S-58NFYU-6Kp8JA-Fzdrf-9xZjq2-kN2xrR-6ET9dj-dNcpt-6iBiAA-5oycY5-9oGNDL-6ENY4e-mGu2Yh-fzviWT-4xUBVm-dvoC4q-8r2NmF-fpMyLQ-4NJj85-6v3Vmq-a2QAyx-bD4Xj7-6VZXzw-21Evoi-4RTWeU-bD4Vah-3jkDPy-pCK7sy-bmPfZg-5mqi2H-5mqhRD-2jzJR4-eysUag\">\u003cimg class=\"size-large wp-image-22711\" title=\"\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2014/11/3641982466_0c8b7270c6_o-copyCROP-640x383.jpg\" alt=\"A menu board in New York City, the first city to require calories on chain restaurant menus. (Kevin Harber/Flickr)\" width=\"640\" height=\"383\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">A menu board in New York City, the first city to require calories on chain restaurant menus. (Kevin Harber/Flickr)\u003c/figcaption>\u003c/figure>\n\u003cp>Washington (AP) -- Counting your calories will become easier under new government rules requiring chain restaurants, supermarkets, convenience stores — and even movie theaters, amusement parks and vending machines — to post the calorie content of food \"clearly and conspicuously\" on their menus.\u003c/p>\n\u003cp>The Food and Drug Administration plans to announce the long-delayed rules on Tuesday. The regulations will apply to businesses with 20 or more locations and they will be given until November 2015 to comply.\u003c/p>\n\u003cp>The idea is that people may pass on that bacon double cheeseburger at a chain restaurant, hot dog at a gas station or large popcorn at the movie theater if they know that it has hundreds of calories. Beverages are included, and alcohol will be labeled if drinks are listed on the menu.\u003c!--more-->\u003c/p>\n\u003cp>\"Americans eat and drink about one-third of their calories away from home and people today expect clear information about the products they consume,\" said FDA Commissioner Margaret Hamburg. She said the effort is just one way that Americans can combat obesity.\u003c/p>\n\u003cp>The menus and menu boards will tell diners that a 2,000-calorie diet is used as the basis for daily nutrition, noting that individual calorie needs may vary. Additional nutritional information beyond calories, including sodium, fats, sugar and other items, must be available upon request.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The rules deal a blow to the grocery and convenience store industries, which have lobbied hard to be completely exempted since the menu labels became law in 2010 as a part of health overhaul. Even before the new rules were announced, Republicans in Congress had expressed concern that they would be too burdensome for businesses.\u003c/p>\n\u003cp>The law came together when the restaurant industry agreed to the labeling in an effort to dodge a growing patchwork of city and state rules. But supermarkets, convenience stores and many other retailers that sell prepared food said they wanted no part of it. The restaurant industry pushed to include those outlets as they have increasingly offered restaurant-like service.\u003c/p>\n\u003cp>The FDA issued proposed rules in 2011 that included supermarkets and convenience stores but excluded movie theaters. The final rules being released Tuesday include all of them.\u003c/p>\n\u003cp>The restaurant industry, along with nutrition and consumer advocates, has said that any business that sells prepared foods should be included. If a rotisserie chicken is labeled with a calorie count at a takeout restaurant, it should be labeled at a grocery store, they argued.\u003c/p>\n\u003cp>Representatives for the supermarket industry have said it could cost them up to a billion dollars to put the rules in place — costs that would be passed on to consumers. They said the rules could cover thousands of items in each store, unlike restaurants, which typically have fewer items.\u003c/p>\n\u003cp>To assuage some of their concerns in the final rules, FDA excluded prepared foods that are typically intended for more than one person to eat and require more preparation, like deli meats, cheeses or bulk deli salads.\u003c/p>\n\u003cp>But a sandwich for sale at the same counter would have to have a calorie label nearby, and the majority of prepared foods in the grocery store will have to be labeled — from the salad bar to the hot food bar to cookies and birthday cakes in the bakery.\u003c/p>\n\u003cp>The pizza industry, led by delivery giant Domino's, has also vigorously fought the rules, saying there are millions of ingredient combinations possible. The FDA attempted to mollify some of their concerns by allowing pizza restaurants to label pizza calories by the slice, as they had requested, but would still force the labeling on menu boards in take-out restaurants.\u003c/p>\n\u003cp>The delivery pizza industry had asked to post information online instead, saying that only a small percentage of customers walk into their stores and about half order online.\u003c/p>\n\u003cp>As in the proposed rules, the final version still exempts airplanes, trains, food trucks and other food served on forms of transportation.\u003c/p>\n\u003cp>The idea of menu labeling is to make sure that customers process the calorie information as they are figuring out what to eat. Many restaurants currently post nutritional information in a hallway, on a hamburger wrapper or on their website. The new law will make calories immediately available for most items.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>New York City was the first in the country to put a calorie posting law in place, and other cities and states have followed since then. Several restaurant chains have already put calories on menus and menu boards nationwide.\u003c/p>\n\n","blocks":[],"excerpt":"The information is required on menus, so customers can see the calorie counts as they are deciding what to eat.","status":"publish","parent":0,"modified":1416888069,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":19,"wordCount":764},"headData":{"title":"FDA to Announce Rules on Calorie Counts for Restaurant Menus | KQED","description":"The information is required on menus, so customers can see the calorie counts as they are deciding what to eat.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"FDA to Announce Rules on Calorie Counts for Restaurant Menus ","datePublished":"2014-11-25T04:01:09.000Z","dateModified":"2014-11-25T04:01:09.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"22706 http://blogs.kqed.org/stateofhealth/?p=22706","disqusUrl":"https://ww2.kqed.org/stateofhealth/2014/11/24/fda-to-announce-rules-on-calorie-counts-for-restaurant-menus/","disqusTitle":"FDA to Announce Rules on Calorie Counts for Restaurant Menus ","path":"/stateofhealth/22706/fda-to-announce-rules-on-calorie-counts-for-restaurant-menus","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cfigure id=\"attachment_22711\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003ca href=\"https://www.flickr.com/photos/kevharb/3641982466/in/photolist-6xQ7v9-6LZfbL-9s4sos-28T2DM-99ViPn-dgmguP-9hR3h5-Nfmzh-8jdH2d-889SFr-88cDJL-NfmyU-Nfmyj-Nfmyo-6ixKhz-2UciR8-4bE85E-5ckU7S-58NFYU-6Kp8JA-Fzdrf-9xZjq2-kN2xrR-6ET9dj-dNcpt-6iBiAA-5oycY5-9oGNDL-6ENY4e-mGu2Yh-fzviWT-4xUBVm-dvoC4q-8r2NmF-fpMyLQ-4NJj85-6v3Vmq-a2QAyx-bD4Xj7-6VZXzw-21Evoi-4RTWeU-bD4Vah-3jkDPy-pCK7sy-bmPfZg-5mqi2H-5mqhRD-2jzJR4-eysUag\">\u003cimg class=\"size-large wp-image-22711\" title=\"\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2014/11/3641982466_0c8b7270c6_o-copyCROP-640x383.jpg\" alt=\"A menu board in New York City, the first city to require calories on chain restaurant menus. (Kevin Harber/Flickr)\" width=\"640\" height=\"383\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">A menu board in New York City, the first city to require calories on chain restaurant menus. (Kevin Harber/Flickr)\u003c/figcaption>\u003c/figure>\n\u003cp>Washington (AP) -- Counting your calories will become easier under new government rules requiring chain restaurants, supermarkets, convenience stores — and even movie theaters, amusement parks and vending machines — to post the calorie content of food \"clearly and conspicuously\" on their menus.\u003c/p>\n\u003cp>The Food and Drug Administration plans to announce the long-delayed rules on Tuesday. The regulations will apply to businesses with 20 or more locations and they will be given until November 2015 to comply.\u003c/p>\n\u003cp>The idea is that people may pass on that bacon double cheeseburger at a chain restaurant, hot dog at a gas station or large popcorn at the movie theater if they know that it has hundreds of calories. Beverages are included, and alcohol will be labeled if drinks are listed on the menu.\u003c!--more-->\u003c/p>\n\u003cp>\"Americans eat and drink about one-third of their calories away from home and people today expect clear information about the products they consume,\" said FDA Commissioner Margaret Hamburg. She said the effort is just one way that Americans can combat obesity.\u003c/p>\n\u003cp>The menus and menu boards will tell diners that a 2,000-calorie diet is used as the basis for daily nutrition, noting that individual calorie needs may vary. Additional nutritional information beyond calories, including sodium, fats, sugar and other items, must be available upon request.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The rules deal a blow to the grocery and convenience store industries, which have lobbied hard to be completely exempted since the menu labels became law in 2010 as a part of health overhaul. Even before the new rules were announced, Republicans in Congress had expressed concern that they would be too burdensome for businesses.\u003c/p>\n\u003cp>The law came together when the restaurant industry agreed to the labeling in an effort to dodge a growing patchwork of city and state rules. But supermarkets, convenience stores and many other retailers that sell prepared food said they wanted no part of it. The restaurant industry pushed to include those outlets as they have increasingly offered restaurant-like service.\u003c/p>\n\u003cp>The FDA issued proposed rules in 2011 that included supermarkets and convenience stores but excluded movie theaters. The final rules being released Tuesday include all of them.\u003c/p>\n\u003cp>The restaurant industry, along with nutrition and consumer advocates, has said that any business that sells prepared foods should be included. If a rotisserie chicken is labeled with a calorie count at a takeout restaurant, it should be labeled at a grocery store, they argued.\u003c/p>\n\u003cp>Representatives for the supermarket industry have said it could cost them up to a billion dollars to put the rules in place — costs that would be passed on to consumers. They said the rules could cover thousands of items in each store, unlike restaurants, which typically have fewer items.\u003c/p>\n\u003cp>To assuage some of their concerns in the final rules, FDA excluded prepared foods that are typically intended for more than one person to eat and require more preparation, like deli meats, cheeses or bulk deli salads.\u003c/p>\n\u003cp>But a sandwich for sale at the same counter would have to have a calorie label nearby, and the majority of prepared foods in the grocery store will have to be labeled — from the salad bar to the hot food bar to cookies and birthday cakes in the bakery.\u003c/p>\n\u003cp>The pizza industry, led by delivery giant Domino's, has also vigorously fought the rules, saying there are millions of ingredient combinations possible. The FDA attempted to mollify some of their concerns by allowing pizza restaurants to label pizza calories by the slice, as they had requested, but would still force the labeling on menu boards in take-out restaurants.\u003c/p>\n\u003cp>The delivery pizza industry had asked to post information online instead, saying that only a small percentage of customers walk into their stores and about half order online.\u003c/p>\n\u003cp>As in the proposed rules, the final version still exempts airplanes, trains, food trucks and other food served on forms of transportation.\u003c/p>\n\u003cp>The idea of menu labeling is to make sure that customers process the calorie information as they are figuring out what to eat. Many restaurants currently post nutritional information in a hallway, on a hamburger wrapper or on their website. The new law will make calories immediately available for most items.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>New York City was the first in the country to put a calorie posting law in place, and other cities and states have followed since then. Several restaurant chains have already put calories on menus and menu boards nationwide.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/stateofhealth/22706/fda-to-announce-rules-on-calorie-counts-for-restaurant-menus","authors":["240"],"categories":["stateofhealth_12","stateofhealth_14"],"tags":["stateofhealth_48"],"featImg":"stateofhealth_22711","label":"stateofhealth"},"stateofhealth_18928":{"type":"posts","id":"stateofhealth_18928","meta":{"index":"posts_1591205157","site":"stateofhealth","id":"18928","score":null,"sort":[1398815975000]},"guestAuthors":[],"slug":"silicon-valley-health-tech-entrepreneurs-wrestles-with-the-fda","title":"Silicon Valley Health-Tech Wrestles with the FDA","publishDate":1398815975,"format":"aside","headTitle":"State of Health | KQED News","labelTerm":{"site":"stateofhealth"},"content":"\u003cfigure id=\"attachment_18948\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003ca href=\"https://www.flickr.com/photos/hongiiv/3129766406/in/photolist-5LySvL-5weVaD-4tHu8p-5LyQXU-5LyQDm-5LuCbn-5LuAcv-5LuC58-5wjffw-5LyPSC-hKsNWb-6Fg42Y-4bG9Qy-9tLWy1-5wjfcw-5LyQds-5LuBmK-5LuBDr-5weV7r-5LuB7Z-5LuBPc-5PbrNx-5LyR5A-4tHu98-5LyQQw-4tHu7T-5PfFv7-5weV8g-5LuAi6-5wjfdy-5LuBui-4fYr81-5HDkKA-8mM5aA-5nLnEy-9yFvui-4nQTup-2wGsW7-4nVtjy-4T1jMh-iEassb-4pdB6y-4oDoyx-CS7Rc-4m61oD-4Yqs7k-czsfKw-d6MJns-5kDcJH-4mzerB\">\u003cimg class=\"size-large wp-image-18948\" title=\"\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2014/04/3129766406_3f62c12d6a_o-640x426.jpg\" alt=\"The FDA's recent enforcement action against genetic testing firm 23andme rattled health-tech executives. (Hong Chang Bum/Flickr)\" width=\"640\" height=\"426\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">The FDA's recent enforcement action against genetic testing firm 23andme rattled health-tech executives. (Hong Chang Bum/Flickr)\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>By Christina Farr\u003c/strong>\u003c/p>\n\u003cp>Health care entrepreneurs are a different breed than most entrepreneurs. Rather than hunkering down to build a cool product, they need to think about regulation and red tape -- right from the start.\u003c/p>\n\u003caside class=\"pullquote alignleft\">Ignoring the FDA and pushing ahead with a product is not a viable option. \u003c/aside>\n\u003cp>As boring as it may sound, health-tech founders need to develop a relationship with the U.S. Food and Drug Administration (FDA). This process might drag on for some time, as this authority has the unenviable job of overseeing an explosion of \u003ca href=\"http://mobihealthnews.com/28361/rock-health-1-97b-invested-in-digital-health-startups-in-2013/\" target=\"_blank\">new medical technology\u003c/a>, whether it’s a new electronic health record or a device that turns your smartphone into an ear scope.\u003c/p>\n\u003cp>As the recent \u003ca href=\"http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm\" target=\"_blank\">enforcement action\u003c/a> against genetic testing firm 23andMe demonstrated, ignoring the FDA and pushing ahead with a product is \u003ca href=\"http://venturebeat.com/2014/03/12/23andme-ceo-we-need-to-return-to-delivering-health-information/\" target=\"_blank\">not a viable option\u003c/a>.\u003c/p>\n\u003cp>In recent years, Silicon Valley's entrepreneurs have become increasingly critical, attacking the agency's antiquated processes in a string of interviews and \u003ca href=\"http://www.usatoday.com/story/opinion/2014/02/15/fischer-king-health-information-technology/5464693/\" target=\"_blank\">op-eds\u003c/a>.\u003c!--more-->\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“There is this perceived myth that the FDA will change its mind on a dime,” said Ellie Cachette, an entrepreneur and health advocate who has served on a number of committee boards for the National Institutes of Health.\u003c/p>\n\u003cp>The crux of the problem is a mismatch of priorities.\u003c/p>\n\u003cp>The FDA's chief mandate is to \u003ca href=\"http://www.fda.gov/aboutfda/transparency/basics/ucm194877.htm\" target=\"_blank\">protect public health\u003c/a>, but some (perhaps many) entrepreneurs fear that it’s under-resourced, overwhelmed, and a roadblock to life-saving innovation. Life sciences-focused venture capitalists say the FDA is prone to delays and abrupt policy changes, making health care a precarious bet.\u003c/p>\n\u003cp>“The first cause of death for our startups is a lack of capital, and if investors aren’t confident that they can scale the FDA hurdles, they simply won’t invest,” said Kyra Davis, a program manager at the Entrepreneurship Center at UCSF, who works closely with budding health-tech entrepreneurs.\u003c/p>\n\u003cp>Life sciences startups are in a particularly tough spot, with investment in a downward spiral. (Note: The picture looked a bit rosier in the first quarter of 2014, in part due to a few successful \u003ca href=\"http://medcitynews.com/2014/04/biotech-attracts-1b-in-venture-capital-funding-medical-device-deal-size-trends-higher/\" target=\"_blank\">recent biotech IPOs\u003c/a>.)\u003c/p>\n\u003cp>Whether it’s justified or not, the FDA is often cited by health investors as the reason for this decline.\u003c/p>\n\u003cp>“We have been pushing the FDA on how difficult it is to get products approved,” said Michael Carusi, a general partner at \u003ca href=\"http://www.atvcapital.com/\">ATV Capital\u003c/a>, in an interview for a series I wrote in April, 2013 for \u003cem>VentureBeat\u003c/em> on Silicon Valley’s perceptions of the FDA.\u003c/p>\n\u003cp>\u003ca href=\"http://venturebeat.com/2013/04/30/stifled-by-regulation-entrepreneurs-take-life-saving-devices-overseas/\">For that article,\u003c/a> the FDA responded that it is doing its best with entrepreneurs and VCs to “develop smart regulation that balance patient safety and innovation.”\u003c/p>\n\u003cp>\u003cstrong>Tension Between Protecting Public Health and Regulating Innovation\u003c/strong>\u003c/p>\n\u003cp>The FDA’s crack down on 23andMe last November prompted health entrepreneurs to quake in their boots and angry Internet commentators to rail against \"Big Government.\" In February, Senators Angus King (I-Maine) and Deb Fischer (R-Nebraska) \u003ca href=\"http://venturebeat.com/2014/02/26/new-digital-health-bill-proposes-to-undermine-the-fda-draws-mixed-reactions/\" target=\"_blank\">proposed a bill \u003c/a>in Congress to prevent the agency from regulating “low risk” health IT altogether.\u003c/p>\n\u003cp>But the FDA has stepped up in one important regard. After demurring for several months, it released its \u003ca href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369431.htm\" target=\"_blank\">final guidance\u003c/a> on how it plans to regulate the explosion in mobile medical technology, a particularly trendy space. Most mobile medical apps do not require federal regulation, the FDA found, so developers and investors could breathe a bit easier.\u003c/p>\n\u003cp>According to John Wilson, a health policy expert and advisor to the \u003ca href=\"http://www.newmeaccelerator.com/\" target=\"_blank\">NewMe startup accelerator\u003c/a>, the FDA is doing its job and doesn’t deserve the bad rep.\u003c/p>\n\u003cp>“Entrepreneurs have a tendency to over-promise and under-deliver. But in health care, people’s lives are at stake,” he explained.\u003c/p>\n\u003cp>“When the company doesn’t work out, the FDA is often blamed. Startups are looking for a fall guy.\"\u003c/p>\n\u003cp>While Wilson believes in a “checks and balancing” body like the FDA, he does admit that the agency has plenty of work to do.\u003c/p>\n\u003cp>It’s a boom time for technology, and some of it is genuinely breaking new ground. It will take some time to determine whether this new tech is potentially harmful, and how it should be classified. For instance, it’s a matter of ongoing debate among geneticists and lawyers whether 23andMe should have been treated as a medical device. This field of consumer genetic reporting is nascent, making it a particularly problematic area for the FDA.\u003c/p>\n\u003cp>Meanwhile, Silicon Valley expects to move quickly -- and doesn’t respond well to hesitation and delays.\u003c/p>\n\u003cp>“The pendulum swings with the FDA -- or at least it has in my 25 years,” added Joe Kiani, chief executive of California-based Masimo Corp., a medical technology company that was founded in 1989 and went public in 2007.\u003c/p>\n\u003cp>“Sometimes, the agency can be very difficult, and other times it’s easy and formulaic. Right now, it’s one of those difficult periods.”\u003c/p>\n\u003cp>\u003cstrong>\"Don't View the FDA As This Scary Thing\"\u003c/strong>\u003c/p>\n\u003cp>Even those who are sympathetic to the FDA would admit that the regulatory processes are no small matter.\u003c/p>\n\u003cp>Amy Sheng, founder of a company that develops a low-risk medical device, estimates that it required \"hundreds of thousands of dollars\" and a “truck-load” of paperwork to implement a full quality system.\u003c/p>\n\u003cp>Sheng hired several consultants to navigate legislation, as well as a few key employees. She advises health-tech entrepreneurs to raise significant funding at the outset -- and bring the right set of legal and quality assurance experts on board.\u003c/p>\n\u003cp>\"I've been speaking the medical device language my whole career, so I don't view the FDA as this scary thing,\" said Sheng. \"Just keep in mind that the agency's mission is to protect patients and make sure your product is safe and accurate.\"\u003c/p>\n\u003cp>Meanwhile, Malay Gandhi, chief strategy officer at digital health accelerator \u003ca href=\"http://rockhealth.com/\">Rock Health\u003c/a>, would advise entrepreneurs to take a deep breath and relax. He has a far more optimistic view about regulatory processes, and doesn’t believe that the FDA is \"out to get” health entrepreneurs.\u003c/p>\n\u003cp>“There is some level of fear but the process is well defined and you can get through it,” he said. “There are countless numbers of people who have done it already.”\u003c/p>\n\u003cp>According to Gandhi, the entrepreneurs in Rock Health will often approach the FDA for clarification and typically receive a response within a few weeks. In the past few years, none of the founders were publicly admonished in a similar manner to 23andMe.\u003c/p>\n\u003cp>“At the end of the day, there aren’t that many health companies that are anything like 23andMe,” he added.\u003c/p>\n\u003cp>For those who don’t have the requisite funding, another good option is to take the business overseas.\u003c/p>\n\u003cp>Kiani often advises newcomers to launch their products in Europe first, where regulation is far more predictable. It can take years (and those hundreds of thousands of dollars) for U.S.-based entrepreneurs to gain approval from the FDA -- and in that time, many founders will find success in international markets.\u003c/p>\n\u003cp>“China and Japan and Brazil have their own regulatory difficulties, Japan is a predictable process, but Europe is probably best,” said Kiani. “It’s the fastest way to market.”\u003c/p>\n\u003cp>Ultimately, the experts stress that the FDA is unlikely to pay attention unless something is seriously wrong. Pass the regulatory checks, file the paperwork, do the research, and avoid making overblown statements in marketing to patients.\u003c/p>\n\u003cp>For health entrepreneurs, getting in the FDA’s good graces is money and time well-spent, Walter de Brouwer, founder of Scanadu, a hand-held medical device, told \u003cem>Fast Company.\u003c/em> Despite the efforts of politicians like Senators King and Fisher, the agency is not going anywhere anytime soon, so de Brouwer advises getting in its good graces.\u003c/p>\n\u003cp>“Trying to do something medical and avoiding the FDA, that is a lost battle. It’s like asking the Vatican to become atheist.”\u003c/p>\n\u003cp>\u003cem style=\"color: #1f1f1f\">Christina Farr is a San Francisco-based journalist covering health technology. She previously wrote for Venture Beat, The Bay Citizen and SFGate.\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>[contextly_auto_sidebar id=\"CNmeBBlBPPwQslZMYMxjOTuOuvmvqRlu\"]\u003c/p>\n\n","blocks":[],"excerpt":"Why ignoring the FDA and pushing ahead with a product is not a viable option.","status":"publish","parent":0,"modified":1398885603,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":43,"wordCount":1413},"headData":{"title":"Silicon Valley Health-Tech Wrestles with the FDA | KQED","description":"Why ignoring the FDA and pushing ahead with a product is not a viable option.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Silicon Valley Health-Tech Wrestles with the FDA","datePublished":"2014-04-29T23:59:35.000Z","dateModified":"2014-04-30T19:20:03.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"18928 http://blogs.kqed.org/stateofhealth/?p=18928","disqusUrl":"https://ww2.kqed.org/stateofhealth/2014/04/29/silicon-valley-health-tech-entrepreneurs-wrestles-with-the-fda/","disqusTitle":"Silicon Valley Health-Tech Wrestles with the FDA","path":"/stateofhealth/18928/silicon-valley-health-tech-entrepreneurs-wrestles-with-the-fda","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cfigure id=\"attachment_18948\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003ca href=\"https://www.flickr.com/photos/hongiiv/3129766406/in/photolist-5LySvL-5weVaD-4tHu8p-5LyQXU-5LyQDm-5LuCbn-5LuAcv-5LuC58-5wjffw-5LyPSC-hKsNWb-6Fg42Y-4bG9Qy-9tLWy1-5wjfcw-5LyQds-5LuBmK-5LuBDr-5weV7r-5LuB7Z-5LuBPc-5PbrNx-5LyR5A-4tHu98-5LyQQw-4tHu7T-5PfFv7-5weV8g-5LuAi6-5wjfdy-5LuBui-4fYr81-5HDkKA-8mM5aA-5nLnEy-9yFvui-4nQTup-2wGsW7-4nVtjy-4T1jMh-iEassb-4pdB6y-4oDoyx-CS7Rc-4m61oD-4Yqs7k-czsfKw-d6MJns-5kDcJH-4mzerB\">\u003cimg class=\"size-large wp-image-18948\" title=\"\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2014/04/3129766406_3f62c12d6a_o-640x426.jpg\" alt=\"The FDA's recent enforcement action against genetic testing firm 23andme rattled health-tech executives. (Hong Chang Bum/Flickr)\" width=\"640\" height=\"426\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">The FDA's recent enforcement action against genetic testing firm 23andme rattled health-tech executives. (Hong Chang Bum/Flickr)\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>By Christina Farr\u003c/strong>\u003c/p>\n\u003cp>Health care entrepreneurs are a different breed than most entrepreneurs. Rather than hunkering down to build a cool product, they need to think about regulation and red tape -- right from the start.\u003c/p>\n\u003caside class=\"pullquote alignleft\">Ignoring the FDA and pushing ahead with a product is not a viable option. \u003c/aside>\n\u003cp>As boring as it may sound, health-tech founders need to develop a relationship with the U.S. Food and Drug Administration (FDA). This process might drag on for some time, as this authority has the unenviable job of overseeing an explosion of \u003ca href=\"http://mobihealthnews.com/28361/rock-health-1-97b-invested-in-digital-health-startups-in-2013/\" target=\"_blank\">new medical technology\u003c/a>, whether it’s a new electronic health record or a device that turns your smartphone into an ear scope.\u003c/p>\n\u003cp>As the recent \u003ca href=\"http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm\" target=\"_blank\">enforcement action\u003c/a> against genetic testing firm 23andMe demonstrated, ignoring the FDA and pushing ahead with a product is \u003ca href=\"http://venturebeat.com/2014/03/12/23andme-ceo-we-need-to-return-to-delivering-health-information/\" target=\"_blank\">not a viable option\u003c/a>.\u003c/p>\n\u003cp>In recent years, Silicon Valley's entrepreneurs have become increasingly critical, attacking the agency's antiquated processes in a string of interviews and \u003ca href=\"http://www.usatoday.com/story/opinion/2014/02/15/fischer-king-health-information-technology/5464693/\" target=\"_blank\">op-eds\u003c/a>.\u003c!--more-->\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“There is this perceived myth that the FDA will change its mind on a dime,” said Ellie Cachette, an entrepreneur and health advocate who has served on a number of committee boards for the National Institutes of Health.\u003c/p>\n\u003cp>The crux of the problem is a mismatch of priorities.\u003c/p>\n\u003cp>The FDA's chief mandate is to \u003ca href=\"http://www.fda.gov/aboutfda/transparency/basics/ucm194877.htm\" target=\"_blank\">protect public health\u003c/a>, but some (perhaps many) entrepreneurs fear that it’s under-resourced, overwhelmed, and a roadblock to life-saving innovation. Life sciences-focused venture capitalists say the FDA is prone to delays and abrupt policy changes, making health care a precarious bet.\u003c/p>\n\u003cp>“The first cause of death for our startups is a lack of capital, and if investors aren’t confident that they can scale the FDA hurdles, they simply won’t invest,” said Kyra Davis, a program manager at the Entrepreneurship Center at UCSF, who works closely with budding health-tech entrepreneurs.\u003c/p>\n\u003cp>Life sciences startups are in a particularly tough spot, with investment in a downward spiral. (Note: The picture looked a bit rosier in the first quarter of 2014, in part due to a few successful \u003ca href=\"http://medcitynews.com/2014/04/biotech-attracts-1b-in-venture-capital-funding-medical-device-deal-size-trends-higher/\" target=\"_blank\">recent biotech IPOs\u003c/a>.)\u003c/p>\n\u003cp>Whether it’s justified or not, the FDA is often cited by health investors as the reason for this decline.\u003c/p>\n\u003cp>“We have been pushing the FDA on how difficult it is to get products approved,” said Michael Carusi, a general partner at \u003ca href=\"http://www.atvcapital.com/\">ATV Capital\u003c/a>, in an interview for a series I wrote in April, 2013 for \u003cem>VentureBeat\u003c/em> on Silicon Valley’s perceptions of the FDA.\u003c/p>\n\u003cp>\u003ca href=\"http://venturebeat.com/2013/04/30/stifled-by-regulation-entrepreneurs-take-life-saving-devices-overseas/\">For that article,\u003c/a> the FDA responded that it is doing its best with entrepreneurs and VCs to “develop smart regulation that balance patient safety and innovation.”\u003c/p>\n\u003cp>\u003cstrong>Tension Between Protecting Public Health and Regulating Innovation\u003c/strong>\u003c/p>\n\u003cp>The FDA’s crack down on 23andMe last November prompted health entrepreneurs to quake in their boots and angry Internet commentators to rail against \"Big Government.\" In February, Senators Angus King (I-Maine) and Deb Fischer (R-Nebraska) \u003ca href=\"http://venturebeat.com/2014/02/26/new-digital-health-bill-proposes-to-undermine-the-fda-draws-mixed-reactions/\" target=\"_blank\">proposed a bill \u003c/a>in Congress to prevent the agency from regulating “low risk” health IT altogether.\u003c/p>\n\u003cp>But the FDA has stepped up in one important regard. After demurring for several months, it released its \u003ca href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369431.htm\" target=\"_blank\">final guidance\u003c/a> on how it plans to regulate the explosion in mobile medical technology, a particularly trendy space. Most mobile medical apps do not require federal regulation, the FDA found, so developers and investors could breathe a bit easier.\u003c/p>\n\u003cp>According to John Wilson, a health policy expert and advisor to the \u003ca href=\"http://www.newmeaccelerator.com/\" target=\"_blank\">NewMe startup accelerator\u003c/a>, the FDA is doing its job and doesn’t deserve the bad rep.\u003c/p>\n\u003cp>“Entrepreneurs have a tendency to over-promise and under-deliver. But in health care, people’s lives are at stake,” he explained.\u003c/p>\n\u003cp>“When the company doesn’t work out, the FDA is often blamed. Startups are looking for a fall guy.\"\u003c/p>\n\u003cp>While Wilson believes in a “checks and balancing” body like the FDA, he does admit that the agency has plenty of work to do.\u003c/p>\n\u003cp>It’s a boom time for technology, and some of it is genuinely breaking new ground. It will take some time to determine whether this new tech is potentially harmful, and how it should be classified. For instance, it’s a matter of ongoing debate among geneticists and lawyers whether 23andMe should have been treated as a medical device. This field of consumer genetic reporting is nascent, making it a particularly problematic area for the FDA.\u003c/p>\n\u003cp>Meanwhile, Silicon Valley expects to move quickly -- and doesn’t respond well to hesitation and delays.\u003c/p>\n\u003cp>“The pendulum swings with the FDA -- or at least it has in my 25 years,” added Joe Kiani, chief executive of California-based Masimo Corp., a medical technology company that was founded in 1989 and went public in 2007.\u003c/p>\n\u003cp>“Sometimes, the agency can be very difficult, and other times it’s easy and formulaic. Right now, it’s one of those difficult periods.”\u003c/p>\n\u003cp>\u003cstrong>\"Don't View the FDA As This Scary Thing\"\u003c/strong>\u003c/p>\n\u003cp>Even those who are sympathetic to the FDA would admit that the regulatory processes are no small matter.\u003c/p>\n\u003cp>Amy Sheng, founder of a company that develops a low-risk medical device, estimates that it required \"hundreds of thousands of dollars\" and a “truck-load” of paperwork to implement a full quality system.\u003c/p>\n\u003cp>Sheng hired several consultants to navigate legislation, as well as a few key employees. She advises health-tech entrepreneurs to raise significant funding at the outset -- and bring the right set of legal and quality assurance experts on board.\u003c/p>\n\u003cp>\"I've been speaking the medical device language my whole career, so I don't view the FDA as this scary thing,\" said Sheng. \"Just keep in mind that the agency's mission is to protect patients and make sure your product is safe and accurate.\"\u003c/p>\n\u003cp>Meanwhile, Malay Gandhi, chief strategy officer at digital health accelerator \u003ca href=\"http://rockhealth.com/\">Rock Health\u003c/a>, would advise entrepreneurs to take a deep breath and relax. He has a far more optimistic view about regulatory processes, and doesn’t believe that the FDA is \"out to get” health entrepreneurs.\u003c/p>\n\u003cp>“There is some level of fear but the process is well defined and you can get through it,” he said. “There are countless numbers of people who have done it already.”\u003c/p>\n\u003cp>According to Gandhi, the entrepreneurs in Rock Health will often approach the FDA for clarification and typically receive a response within a few weeks. In the past few years, none of the founders were publicly admonished in a similar manner to 23andMe.\u003c/p>\n\u003cp>“At the end of the day, there aren’t that many health companies that are anything like 23andMe,” he added.\u003c/p>\n\u003cp>For those who don’t have the requisite funding, another good option is to take the business overseas.\u003c/p>\n\u003cp>Kiani often advises newcomers to launch their products in Europe first, where regulation is far more predictable. It can take years (and those hundreds of thousands of dollars) for U.S.-based entrepreneurs to gain approval from the FDA -- and in that time, many founders will find success in international markets.\u003c/p>\n\u003cp>“China and Japan and Brazil have their own regulatory difficulties, Japan is a predictable process, but Europe is probably best,” said Kiani. “It’s the fastest way to market.”\u003c/p>\n\u003cp>Ultimately, the experts stress that the FDA is unlikely to pay attention unless something is seriously wrong. Pass the regulatory checks, file the paperwork, do the research, and avoid making overblown statements in marketing to patients.\u003c/p>\n\u003cp>For health entrepreneurs, getting in the FDA’s good graces is money and time well-spent, Walter de Brouwer, founder of Scanadu, a hand-held medical device, told \u003cem>Fast Company.\u003c/em> Despite the efforts of politicians like Senators King and Fisher, the agency is not going anywhere anytime soon, so de Brouwer advises getting in its good graces.\u003c/p>\n\u003cp>“Trying to do something medical and avoiding the FDA, that is a lost battle. It’s like asking the Vatican to become atheist.”\u003c/p>\n\u003cp>\u003cem style=\"color: #1f1f1f\">Christina Farr is a San Francisco-based journalist covering health technology. She previously wrote for Venture Beat, The Bay Citizen and SFGate.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>[contextly_auto_sidebar id=\"CNmeBBlBPPwQslZMYMxjOTuOuvmvqRlu\"]\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/stateofhealth/18928/silicon-valley-health-tech-entrepreneurs-wrestles-with-the-fda","authors":["8344"],"categories":["stateofhealth_14"],"tags":["stateofhealth_48","stateofhealth_461"],"featImg":"stateofhealth_18948","label":"stateofhealth"},"stateofhealth_3585":{"type":"posts","id":"stateofhealth_3585","meta":{"index":"posts_1591205157","site":"stateofhealth","id":"3585","score":null,"sort":[1331158418000]},"guestAuthors":[],"slug":"fda-investigating-two-canadians-for-distributing-fake-avastin","title":"FDA Investigating Two Canadians for Distributing Fake Avastin","publishDate":1331158418,"format":"aside","headTitle":"State of Health | KQED News","labelTerm":{"site":"stateofhealth"},"content":"\u003cfigure id=\"attachment_3592\" class=\"wp-caption alignleft\" style=\"max-width: 146px\">\u003ca href=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/03/AvastinVial_20111118.jpg\">\u003cimg class=\"size-medium wp-image-3592\" title=\"(Image: Genentech)\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/03/AvastinVial_20111118-300x615.jpg\" alt=\"(Image: Genentech)\" width=\"146\" height=\"300\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">(Image: Genentech)\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>By Kamal Menghrajani\u003c/strong>\u003c/p>\n\u003cp>Last month the Food and Drug Administration warned 19 doctors and clinics that counterfeit vials of the chemotherapy drug \u003ca title=\"http://www.avastin.com/patient/index.html\" href=\"http://www.avastin.com/patient/index.html\" target=\"_blank\">Avastin\u003c/a> had been identified in the U.S. \u003ca title=\"http://ww2.kqed.org/stateofhealth/2012/02/16/fda-warns-california-clinics-of-fake-avastin/\" href=\"http://ww2.kqed.org/stateofhealth/2012/02/16/fda-warns-california-clinics-of-fake-avastin/\" target=\"_blank\">Most of those doctors were in California\u003c/a>. Today the \u003ca title=\"http://online.wsj.com/article/SB10001424052970203370604577261343974214110.html\" href=\"http://online.wsj.com/article/SB10001424052970203370604577261343974214110.html\" target=\"_blank\">Wall Street Journal reports\u003c/a> that the FDA is investigating two businessmen from Canada who may be the source of these vials. One of them had admitted to shipping fake Avastin last year, although he says he did not know the vials contained counterfeit drugs. While it is generally illegal for anyone but the manufacturer to import prescription drugs into the U.S., it happens frequently and has proven difficult to police, the Journal reports.\u003c/p>\n\u003cblockquote>\u003cp>\"We're deeply horrified by this counterfeit [product] being sold by one of my companies,\" said Thomas Haughton, a Canadian citizen who runs a network of drug distributors that sell to U.S. doctors. At the same time he said that his business operated legally. \"We're doing everything we can to be sure that this never happens again.”\u003c/p>\n\u003cp>While experts say most U.S. drugs are safe, the probe may raise new concerns about the weakly regulated gray market in foreign drugs aimed at U.S. patients. The importation of foreign drugs by third parties, which takes advantage of the large price differential between the U.S. market and others abroad, is believed to represent a small but growing portion of the $300 billion U.S. prescription pharmaceutical business.\u003c/p>\u003c/blockquote>\n\u003cp>\u003c!--more-->Haughton’s brother-in-law, Kris Thorkelson, is the second man under investigation. Both Haughton and Thorkelson sell low-cost medicines to doctors or directly to patients in the U.S. According to the \u003cem>Journal\u003c/em> their Canada-based businesses are thought to be the end of a supply chain of counterfeit Avastin that may have started in China and made its way through Turkey, Egypt, Sweden, and Denmark before going through Canada to get to Tennessee. Tennessee-based Volunteer Distribution was then suspected of funneling those vials out to various clinics throughout the country, most of which were in Southern California. Again, from the \u003cem>Journal\u003c/em>:\u003c/p>\n\u003cblockquote>\u003cp>In the last several days, the U.S. Attorney in Los Angeles has subpoenaed California physicians for documents about their dealings with and products purchased from Messrs. Haughton and Thorkelson, three people who have worked for them and 12 companies that are affiliated with one or the other man, according to a copy of a subpoena reviewed by The Wall Street Journal.\u003c/p>\n\u003cp>At least some of the doctors who received a subpoena were warned last month by the FDA that they may have purchased fake Avastin from three companies named in the subpoena and linked to Mr. Haughton. The FDA, which is leading the investigation, declined to comment on the subpoenas or the ongoing investigation.\u003c/p>\n\u003cp>The fake Avastin contained starch, salt, cleaning solvents and other chemicals and none of the drug's active ingredient, bevacizumab, according to Roche. The packaging didn't match U.S.-approved labels for the product, regulators said. As of Monday, the FDA hadn't received any reports of the fake Avastin being administered to patients.\u003c/p>\u003c/blockquote>\n\u003cp>The FDA is pursuing a criminal investigation against the Canadian drug sellers for shipping non-FDA approved drugs into the U.S.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\u003cp>\u003c/p>\n","blocks":[],"excerpt":"Last month the Food and Drug Administration warned 19 doctors and clinics that counterfeit vials of the chemotherapy drug Avastin had been identified in the U.S. Most of those doctors were in California. Today the Wall Street Journal reports that the FDA is investigating two businessmen from Canada who may be the source of these vials. One of them had admitted to shipping fake Avastin last year, although he says he did not know the vials contained counterfeit drugs. While it is generally illegal for anyone but the manufacturer to import prescription drugs into the U.S., it happens frequently and has proven difficult to police, the Journal reports.","status":"publish","parent":0,"modified":1331158418,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":11,"wordCount":547},"headData":{"title":"FDA Investigating Two Canadians for Distributing Fake Avastin | KQED","description":"Last month the Food and Drug Administration warned 19 doctors and clinics that counterfeit vials of the chemotherapy drug Avastin had been identified in the U.S. Most of those doctors were in California. Today the Wall Street Journal reports that the FDA is investigating two businessmen from Canada who may be the source of these vials. One of them had admitted to shipping fake Avastin last year, although he says he did not know the vials contained counterfeit drugs. While it is generally illegal for anyone but the manufacturer to import prescription drugs into the U.S., it happens frequently and has proven difficult to police, the Journal reports.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"FDA Investigating Two Canadians for Distributing Fake Avastin","datePublished":"2012-03-07T22:13:38.000Z","dateModified":"2012-03-07T22:13:38.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"3585 http://blogs.kqed.org/stateofhealth/?p=3585","disqusUrl":"https://ww2.kqed.org/stateofhealth/2012/03/07/fda-investigating-two-canadians-for-distributing-fake-avastin/","disqusTitle":"FDA Investigating Two Canadians for Distributing Fake Avastin","path":"/stateofhealth/3585/fda-investigating-two-canadians-for-distributing-fake-avastin","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cfigure id=\"attachment_3592\" class=\"wp-caption alignleft\" style=\"max-width: 146px\">\u003ca href=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/03/AvastinVial_20111118.jpg\">\u003cimg class=\"size-medium wp-image-3592\" title=\"(Image: Genentech)\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/03/AvastinVial_20111118-300x615.jpg\" alt=\"(Image: Genentech)\" width=\"146\" height=\"300\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">(Image: Genentech)\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>By Kamal Menghrajani\u003c/strong>\u003c/p>\n\u003cp>Last month the Food and Drug Administration warned 19 doctors and clinics that counterfeit vials of the chemotherapy drug \u003ca title=\"http://www.avastin.com/patient/index.html\" href=\"http://www.avastin.com/patient/index.html\" target=\"_blank\">Avastin\u003c/a> had been identified in the U.S. \u003ca title=\"http://ww2.kqed.org/stateofhealth/2012/02/16/fda-warns-california-clinics-of-fake-avastin/\" href=\"http://ww2.kqed.org/stateofhealth/2012/02/16/fda-warns-california-clinics-of-fake-avastin/\" target=\"_blank\">Most of those doctors were in California\u003c/a>. Today the \u003ca title=\"http://online.wsj.com/article/SB10001424052970203370604577261343974214110.html\" href=\"http://online.wsj.com/article/SB10001424052970203370604577261343974214110.html\" target=\"_blank\">Wall Street Journal reports\u003c/a> that the FDA is investigating two businessmen from Canada who may be the source of these vials. One of them had admitted to shipping fake Avastin last year, although he says he did not know the vials contained counterfeit drugs. While it is generally illegal for anyone but the manufacturer to import prescription drugs into the U.S., it happens frequently and has proven difficult to police, the Journal reports.\u003c/p>\n\u003cblockquote>\u003cp>\"We're deeply horrified by this counterfeit [product] being sold by one of my companies,\" said Thomas Haughton, a Canadian citizen who runs a network of drug distributors that sell to U.S. doctors. At the same time he said that his business operated legally. \"We're doing everything we can to be sure that this never happens again.”\u003c/p>\n\u003cp>While experts say most U.S. drugs are safe, the probe may raise new concerns about the weakly regulated gray market in foreign drugs aimed at U.S. patients. The importation of foreign drugs by third parties, which takes advantage of the large price differential between the U.S. market and others abroad, is believed to represent a small but growing portion of the $300 billion U.S. prescription pharmaceutical business.\u003c/p>\u003c/blockquote>\n\u003cp>\u003c!--more-->Haughton’s brother-in-law, Kris Thorkelson, is the second man under investigation. Both Haughton and Thorkelson sell low-cost medicines to doctors or directly to patients in the U.S. According to the \u003cem>Journal\u003c/em> their Canada-based businesses are thought to be the end of a supply chain of counterfeit Avastin that may have started in China and made its way through Turkey, Egypt, Sweden, and Denmark before going through Canada to get to Tennessee. Tennessee-based Volunteer Distribution was then suspected of funneling those vials out to various clinics throughout the country, most of which were in Southern California. Again, from the \u003cem>Journal\u003c/em>:\u003c/p>\n\u003cblockquote>\u003cp>In the last several days, the U.S. Attorney in Los Angeles has subpoenaed California physicians for documents about their dealings with and products purchased from Messrs. Haughton and Thorkelson, three people who have worked for them and 12 companies that are affiliated with one or the other man, according to a copy of a subpoena reviewed by The Wall Street Journal.\u003c/p>\n\u003cp>At least some of the doctors who received a subpoena were warned last month by the FDA that they may have purchased fake Avastin from three companies named in the subpoena and linked to Mr. Haughton. The FDA, which is leading the investigation, declined to comment on the subpoenas or the ongoing investigation.\u003c/p>\n\u003cp>The fake Avastin contained starch, salt, cleaning solvents and other chemicals and none of the drug's active ingredient, bevacizumab, according to Roche. The packaging didn't match U.S.-approved labels for the product, regulators said. As of Monday, the FDA hadn't received any reports of the fake Avastin being administered to patients.\u003c/p>\u003c/blockquote>\n\u003cp>The FDA is pursuing a criminal investigation against the Canadian drug sellers for shipping non-FDA approved drugs into the U.S.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/stateofhealth/3585/fda-investigating-two-canadians-for-distributing-fake-avastin","authors":["240"],"categories":["stateofhealth_14","stateofhealth_13"],"tags":["stateofhealth_47","stateofhealth_48"],"label":"stateofhealth"},"stateofhealth_3239":{"type":"posts","id":"stateofhealth_3239","meta":{"index":"posts_1591205157","site":"stateofhealth","id":"3239","score":null,"sort":[1329959160000]},"guestAuthors":[],"slug":"new-supply-of-cancer-drugs-from-abroad","title":"New Supply of Cancer Drugs ... from Abroad","publishDate":1329959160,"format":"aside","headTitle":"State of Health | KQED News","labelTerm":{"site":"stateofhealth"},"content":"\u003cfigure id=\"attachment_3247\" class=\"wp-caption alignleft\" style=\"max-width: 300px\">\u003ca href=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/02/Vials_Zaldylmg_Flickr_02222012.jpg\">\u003cimg class=\"size-medium wp-image-3247\" title=\"(Zaldylmg: Flickr)\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/02/Vials_Zaldylmg_Flickr_02222012-300x225.jpg\" alt=\"(Zaldylmg: Flickr)\" width=\"300\" height=\"225\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">(Zaldylmg: Flickr)\u003c/figcaption>\u003c/figure>\n\u003cp>Stories of critical drug shortages--including cancer drugs--have been \u003ca title=\"http://www.npr.org/blogs/health/2011/10/04/140958404/shortages-lead-doctors-to-ration-critical-drugs\" href=\"http://www.npr.org/blogs/health/2011/10/04/140958404/shortages-lead-doctors-to-ration-critical-drugs\" target=\"_blank\">making news\u003c/a> for months. Now the Food and Drug Administration is \u003ca title=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm292658.htm\" href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm292658.htm\" target=\"_blank\">announcing\u003c/a> that replacement supplies of two of those drugs, Doxil and methotrexate, should be available within weeks.\u003c/p>\n\u003cp>Both drugs are used to treat cancer. Methotrexate is used for many conditions, but of particular concern is its use for a type of childhood leukemia. If a child does not get the drug, the cancer can easily recur.\u003c/p>\n\u003cp>As the \u003ca title=\"http://www.nytimes.com/2012/02/22/health/policy/fda-approves-imports-amid-shortage-of-2-cancer-drugs.html?ref=health\" href=\"http://www.nytimes.com/2012/02/22/health/policy/fda-approves-imports-amid-shortage-of-2-cancer-drugs.html?ref=health\" target=\"_blank\">New York Times reports\u003c/a>, some experts say the new supplies are only a temporary solution:\u003c!--more-->\u003c/p>\n\u003cblockquote>\u003cp>Dr. Peter C. Adamson, chairman of the \u003ca title=\"Web site\" href=\"http://www.childrensoncologygroup.org/\">Children’s Oncology Group\u003c/a>, which is financed by the \u003ca title=\"Web site\" href=\"http://cancer.gov/\">National Cancer Institute\u003c/a>, said he was pleased that the immediate threat of a methotrexate shortage had passed. “But this is at best a Band-Aid approach to the problem,” he said.\u003c/p>\n\u003cp>Shortages of both drugs developed when \u003ca title=\"Message about shortage\" href=\"http://www.benvenue.com/\">Ben Venue Laboratories\u003c/a> temporarily closed its manufacturing facility in Bedford, Ohio, because it could not guarantee product safety.\u003c/p>\n\u003cp>In the case of Doxil, which is used to treat \u003ca title=\"In-depth reference and news articles about Ovarian Cancer.\" href=\"http://health.nytimes.com/health/guides/disease/ovarian-cancer/overview.html?inline=nyt-classifier\">ovarian cancer\u003c/a>, \u003ca title=\"In-depth reference and news articles about Multiple myeloma.\" href=\"http://health.nytimes.com/health/guides/disease/multiple-myeloma/overview.html?inline=nyt-classifier\">multiple myeloma\u003c/a> and \u003ca title=\"In-depth reference and news articles about AIDS/H.I.V..\" href=\"http://health.nytimes.com/health/guides/disease/aids/overview.html?inline=nyt-classifier\">AIDS\u003c/a>-related Kaposi’s sarcoma, the F.D.A. has decided to allow temporary shipments from India of Lipodox, which is similar to Doxil and is made by Sun Pharma Global.\u003c/p>\u003c/blockquote>\n\u003cp>The FDA says it is also permitting the pharmaceutical company \u003ca title=\"http://www.hospira.com/Products/pharmaceuticals.aspx\" href=\"http://www.hospira.com/Products/pharmaceuticals.aspx\" target=\"_blank\">Hospira\u003c/a> to ship 31,000 vials of methotrexate from its overseas facilities to hospitals and treatment centers across the U.S. This quantity of vials is enough to meet U.S. demand for one month.\u003c/p>\n\u003cp>At UC San Francisco, oncologist \u003ca title=\"http://cancer.ucsf.edu/people/venook_alan.php\" href=\"http://cancer.ucsf.edu/people/venook_alan.php\" target=\"_blank\">Alan Venook\u003c/a>, said drug shortages have affected his practice as well. But he expressed concern about drugs coming from overseas. \"You do worry about quality assurance, this is a real issue,\" he told me. \"is it a good solution? I don't think so, but it probably will be fine.\"\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Venook treats patients with gastrointestinal cancers. Last summer, his group experienced a shortage of a chemotherapy drug. \"We didn't have enough drug for all 40 patients we would have treated,\" he said. \"Each week we would have a conference call on Thursday where we would decide who we were going to treat next week.\"\u003c/p>\n\u003cp>One of those 40 patients was Jay Cuetara who was being treated for stage 4 rectal cancer. One day last August he came to the clinic, only to discover there was no drug for him. \"I was shocked,\" he said. \"I wasn't angry. I was shocked. How can we not have the drug I need in the United States? How does that work?\"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Ultimately, that one session was the only one he missed. But that was all it took. He has become an activist on the issue and has testified before Congress. There are bills before both the House and the Senate to give the FDA more legal authority to prevent drug shortages.\u003c/p>\n\n","blocks":[],"excerpt":"Stories of critical drug shortages--including cancer drugs--have been making news for months. Now the Food and Drug Administration is announcing that replacement supplies of two of those drugs, Doxil and methotrexate, should be available within weeks.\r\n\r\nBoth drugs are used to treat cancer. Methotrexate is used for many conditions, but of particular concern is its use for a type of childhood leukemia. If a child does not get the drug, the cancer can easily recur.","status":"publish","parent":0,"modified":1329959160,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":13,"wordCount":499},"headData":{"title":"New Supply of Cancer Drugs ... from Abroad | KQED","description":"Stories of critical drug shortages--including cancer drugs--have been making news for months. Now the Food and Drug Administration is announcing that replacement supplies of two of those drugs, Doxil and methotrexate, should be available within weeks.\r\n\r\nBoth drugs are used to treat cancer. Methotrexate is used for many conditions, but of particular concern is its use for a type of childhood leukemia. If a child does not get the drug, the cancer can easily recur.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"New Supply of Cancer Drugs ... from Abroad","datePublished":"2012-02-23T01:06:00.000Z","dateModified":"2012-02-23T01:06:00.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"3239 http://blogs.kqed.org/stateofhealth/?p=3239","disqusUrl":"https://ww2.kqed.org/stateofhealth/2012/02/22/new-supply-of-cancer-drugs-from-abroad/","disqusTitle":"New Supply of Cancer Drugs ... from Abroad","path":"/stateofhealth/3239/new-supply-of-cancer-drugs-from-abroad","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cfigure id=\"attachment_3247\" class=\"wp-caption alignleft\" style=\"max-width: 300px\">\u003ca href=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/02/Vials_Zaldylmg_Flickr_02222012.jpg\">\u003cimg class=\"size-medium wp-image-3247\" title=\"(Zaldylmg: Flickr)\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/02/Vials_Zaldylmg_Flickr_02222012-300x225.jpg\" alt=\"(Zaldylmg: Flickr)\" width=\"300\" height=\"225\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">(Zaldylmg: Flickr)\u003c/figcaption>\u003c/figure>\n\u003cp>Stories of critical drug shortages--including cancer drugs--have been \u003ca title=\"http://www.npr.org/blogs/health/2011/10/04/140958404/shortages-lead-doctors-to-ration-critical-drugs\" href=\"http://www.npr.org/blogs/health/2011/10/04/140958404/shortages-lead-doctors-to-ration-critical-drugs\" target=\"_blank\">making news\u003c/a> for months. Now the Food and Drug Administration is \u003ca title=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm292658.htm\" href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm292658.htm\" target=\"_blank\">announcing\u003c/a> that replacement supplies of two of those drugs, Doxil and methotrexate, should be available within weeks.\u003c/p>\n\u003cp>Both drugs are used to treat cancer. Methotrexate is used for many conditions, but of particular concern is its use for a type of childhood leukemia. If a child does not get the drug, the cancer can easily recur.\u003c/p>\n\u003cp>As the \u003ca title=\"http://www.nytimes.com/2012/02/22/health/policy/fda-approves-imports-amid-shortage-of-2-cancer-drugs.html?ref=health\" href=\"http://www.nytimes.com/2012/02/22/health/policy/fda-approves-imports-amid-shortage-of-2-cancer-drugs.html?ref=health\" target=\"_blank\">New York Times reports\u003c/a>, some experts say the new supplies are only a temporary solution:\u003c!--more-->\u003c/p>\n\u003cblockquote>\u003cp>Dr. Peter C. Adamson, chairman of the \u003ca title=\"Web site\" href=\"http://www.childrensoncologygroup.org/\">Children’s Oncology Group\u003c/a>, which is financed by the \u003ca title=\"Web site\" href=\"http://cancer.gov/\">National Cancer Institute\u003c/a>, said he was pleased that the immediate threat of a methotrexate shortage had passed. “But this is at best a Band-Aid approach to the problem,” he said.\u003c/p>\n\u003cp>Shortages of both drugs developed when \u003ca title=\"Message about shortage\" href=\"http://www.benvenue.com/\">Ben Venue Laboratories\u003c/a> temporarily closed its manufacturing facility in Bedford, Ohio, because it could not guarantee product safety.\u003c/p>\n\u003cp>In the case of Doxil, which is used to treat \u003ca title=\"In-depth reference and news articles about Ovarian Cancer.\" href=\"http://health.nytimes.com/health/guides/disease/ovarian-cancer/overview.html?inline=nyt-classifier\">ovarian cancer\u003c/a>, \u003ca title=\"In-depth reference and news articles about Multiple myeloma.\" href=\"http://health.nytimes.com/health/guides/disease/multiple-myeloma/overview.html?inline=nyt-classifier\">multiple myeloma\u003c/a> and \u003ca title=\"In-depth reference and news articles about AIDS/H.I.V..\" href=\"http://health.nytimes.com/health/guides/disease/aids/overview.html?inline=nyt-classifier\">AIDS\u003c/a>-related Kaposi’s sarcoma, the F.D.A. has decided to allow temporary shipments from India of Lipodox, which is similar to Doxil and is made by Sun Pharma Global.\u003c/p>\u003c/blockquote>\n\u003cp>The FDA says it is also permitting the pharmaceutical company \u003ca title=\"http://www.hospira.com/Products/pharmaceuticals.aspx\" href=\"http://www.hospira.com/Products/pharmaceuticals.aspx\" target=\"_blank\">Hospira\u003c/a> to ship 31,000 vials of methotrexate from its overseas facilities to hospitals and treatment centers across the U.S. This quantity of vials is enough to meet U.S. demand for one month.\u003c/p>\n\u003cp>At UC San Francisco, oncologist \u003ca title=\"http://cancer.ucsf.edu/people/venook_alan.php\" href=\"http://cancer.ucsf.edu/people/venook_alan.php\" target=\"_blank\">Alan Venook\u003c/a>, said drug shortages have affected his practice as well. But he expressed concern about drugs coming from overseas. \"You do worry about quality assurance, this is a real issue,\" he told me. \"is it a good solution? I don't think so, but it probably will be fine.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Venook treats patients with gastrointestinal cancers. Last summer, his group experienced a shortage of a chemotherapy drug. \"We didn't have enough drug for all 40 patients we would have treated,\" he said. \"Each week we would have a conference call on Thursday where we would decide who we were going to treat next week.\"\u003c/p>\n\u003cp>One of those 40 patients was Jay Cuetara who was being treated for stage 4 rectal cancer. One day last August he came to the clinic, only to discover there was no drug for him. \"I was shocked,\" he said. \"I wasn't angry. I was shocked. How can we not have the drug I need in the United States? How does that work?\"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Ultimately, that one session was the only one he missed. But that was all it took. He has become an activist on the issue and has testified before Congress. There are bills before both the House and the Senate to give the FDA more legal authority to prevent drug shortages.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/stateofhealth/3239/new-supply-of-cancer-drugs-from-abroad","authors":["240"],"categories":["stateofhealth_14"],"tags":["stateofhealth_48"],"label":"stateofhealth"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.","airtime":"SUN 2pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Possible-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.possible.fm/","meta":{"site":"news","source":"Possible"},"link":"/radio/program/possible","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/possible/id1677184070","spotify":"https://open.spotify.com/show/730YpdUSNlMyPQwNnyjp4k"}},"1a":{"id":"1a","title":"1A","info":"1A is home to the national conversation. 1A brings on great guests and frames the best debate in ways that make you think, share and engage.","airtime":"MON-THU 11pm-12am","imageSrc":"https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/1a.jpg","officialWebsiteLink":"https://the1a.org/","meta":{"site":"news","source":"npr"},"link":"/radio/program/1a","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=1188724250&at=11l79Y&ct=nprdirectory","tuneIn":"https://tunein.com/radio/1A-p947376/","rss":"https://feeds.npr.org/510316/podcast.xml"}},"all-things-considered":{"id":"all-things-considered","title":"All Things Considered","info":"Every weekday, \u003cem>All Things Considered\u003c/em> hosts Robert Siegel, Audie Cornish, Ari Shapiro, and Kelly McEvers present the program's trademark mix of news, interviews, commentaries, reviews, and offbeat features. Michel Martin hosts on the weekends.","airtime":"MON-FRI 1pm-2pm, 4:30pm-6:30pm\u003cbr />SAT-SUN 5pm-6pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/All-Things-Considered-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.npr.org/programs/all-things-considered/","meta":{"site":"news","source":"npr"},"link":"/radio/program/all-things-considered"},"american-suburb-podcast":{"id":"american-suburb-podcast","title":"American Suburb: The Podcast","tagline":"The flip side of gentrification, told through one town","info":"Gentrification is changing cities across America, forcing people from neighborhoods they have long called home. Call them the displaced. Now those priced out of the Bay Area are looking for a better life in an unlikely place. American Suburb follows this migration to one California town along the Delta, 45 miles from San Francisco. But is this once sleepy suburb ready for them?","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/American-Suburb-Podcast-Tile-703x703-1.jpg","officialWebsiteLink":"/news/series/american-suburb-podcast","meta":{"site":"news","source":"kqed","order":"13"},"link":"/news/series/american-suburb-podcast/","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?mt=2&id=1287748328","tuneIn":"https://tunein.com/radio/American-Suburb-p1086805/","rss":"https://ww2.kqed.org/news/series/american-suburb-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkMzMDExODgxNjA5"}},"baycurious":{"id":"baycurious","title":"Bay Curious","tagline":"Exploring the Bay Area, one question at a time","info":"KQED’s new podcast, Bay Curious, gets to the bottom of the mysteries — both profound and peculiar — that give the Bay Area its unique identity. And we’ll do it with your help! You ask the questions. You decide what Bay Curious investigates. And you join us on the journey to find the answers.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Bay-Curious-Podcast-Tile-703x703-1.jpg","imageAlt":"\"KQED Bay Curious","officialWebsiteLink":"/news/series/baycurious","meta":{"site":"news","source":"kqed","order":"4"},"link":"/podcasts/baycurious","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/bay-curious/id1172473406","npr":"https://www.npr.org/podcasts/500557090/bay-curious","rss":"https://ww2.kqed.org/news/category/bay-curious-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93dzIua3FlZC5vcmcvbmV3cy9jYXRlZ29yeS9iYXktY3VyaW91cy1wb2RjYXN0L2ZlZWQvcG9kY2FzdA","stitcher":"https://www.stitcher.com/podcast/kqed/bay-curious","spotify":"https://open.spotify.com/show/6O76IdmhixfijmhTZLIJ8k"}},"bbc-world-service":{"id":"bbc-world-service","title":"BBC World Service","info":"The day's top stories from BBC News compiled twice daily in the week, once at weekends.","airtime":"MON-FRI 9pm-10pm, TUE-FRI 1am-2am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/BBC-World-Service-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.bbc.co.uk/sounds/play/live:bbc_world_service","meta":{"site":"news","source":"BBC World Service"},"link":"/radio/program/bbc-world-service","subscribe":{"apple":"https://itunes.apple.com/us/podcast/global-news-podcast/id135067274?mt=2","tuneIn":"https://tunein.com/radio/BBC-World-Service-p455581/","rss":"https://podcasts.files.bbci.co.uk/p02nq0gn.rss"}},"code-switch-life-kit":{"id":"code-switch-life-kit","title":"Code Switch / Life Kit","info":"\u003cem>Code Switch\u003c/em>, which listeners will hear in the first part of the hour, has fearless and much-needed conversations about race. Hosted by journalists of color, the show tackles the subject of race head-on, exploring how it impacts every part of society — from politics and pop culture to history, sports and more.\u003cbr />\u003cbr />\u003cem>Life Kit\u003c/em>, which will be in the second part of the hour, guides you through spaces and feelings no one prepares you for — from finances to mental health, from workplace microaggressions to imposter syndrome, from relationships to parenting. The show features experts with real world experience and shares their knowledge. Because everyone needs a little help being human.\u003cbr />\u003cbr />\u003ca href=\"https://www.npr.org/podcasts/510312/codeswitch\">\u003cem>Code Switch\u003c/em> offical site and podcast\u003c/a>\u003cbr />\u003ca href=\"https://www.npr.org/lifekit\">\u003cem>Life Kit\u003c/em> offical site and podcast\u003c/a>\u003cbr />","airtime":"SUN 9pm-10pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Code-Switch-Life-Kit-Podcast-Tile-360x360-1.jpg","meta":{"site":"radio","source":"npr"},"link":"/radio/program/code-switch-life-kit","subscribe":{"apple":"https://podcasts.apple.com/podcast/1112190608?mt=2&at=11l79Y&ct=nprdirectory","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93d3cubnByLm9yZy9yc3MvcG9kY2FzdC5waHA_aWQ9NTEwMzEy","spotify":"https://open.spotify.com/show/3bExJ9JQpkwNhoHvaIIuyV","rss":"https://feeds.npr.org/510312/podcast.xml"}},"commonwealth-club":{"id":"commonwealth-club","title":"Commonwealth Club of California Podcast","info":"The Commonwealth Club of California is the nation's oldest and largest public affairs forum. As a non-partisan forum, The Club brings to the public airwaves diverse viewpoints on important topics. The Club's weekly radio broadcast - the oldest in the U.S., dating back to 1924 - is carried across the nation on public radio stations and is now podcasting. Our website archive features audio of our recent programs, as well as selected speeches from our long and distinguished history. This podcast feed is usually updated twice a week and is always un-edited.","airtime":"THU 10pm, FRI 1am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Commonwealth-Club-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.commonwealthclub.org/podcasts","meta":{"site":"news","source":"Commonwealth Club of California"},"link":"/radio/program/commonwealth-club","subscribe":{"apple":"https://itunes.apple.com/us/podcast/commonwealth-club-of-california-podcast/id976334034?mt=2","google":"https://podcasts.google.com/feed/aHR0cDovL3d3dy5jb21tb253ZWFsdGhjbHViLm9yZy9hdWRpby9wb2RjYXN0L3dlZWtseS54bWw","tuneIn":"https://tunein.com/radio/Commonwealth-Club-of-California-p1060/"}},"considerthis":{"id":"considerthis","title":"Consider This","tagline":"Make sense of the day","info":"Make sense of the day. Every weekday afternoon, Consider This helps you consider the major stories of the day in less than 15 minutes, featuring the reporting and storytelling resources of NPR. Plus, KQED’s Bianca Taylor brings you the local KQED news you need to know.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Consider-This-Podcast-Tile-703x703-1.jpg","imageAlt":"Consider This from NPR and KQED","officialWebsiteLink":"/podcasts/considerthis","meta":{"site":"news","source":"kqed","order":"7"},"link":"/podcasts/considerthis","subscribe":{"apple":"https://podcasts.apple.com/podcast/id1503226625?mt=2&at=11l79Y&ct=nprdirectory","npr":"https://rpb3r.app.goo.gl/coronavirusdaily","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5ucHIub3JnLzUxMDM1NS9wb2RjYXN0LnhtbA","spotify":"https://open.spotify.com/show/3Z6JdCS2d0eFEpXHKI6WqH"}},"forum":{"id":"forum","title":"Forum","tagline":"The conversation starts here","info":"KQED’s live call-in program discussing local, state, national and international issues, as well as in-depth interviews.","airtime":"MON-FRI 9am-11am, 10pm-11pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Forum-Podcast-Tile-703x703-1.jpg","imageAlt":"KQED Forum with Mina Kim and Alexis Madrigal","officialWebsiteLink":"/forum","meta":{"site":"news","source":"kqed","order":"8"},"link":"/forum","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/kqeds-forum/id73329719","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkM5NTU3MzgxNjMz","npr":"https://www.npr.org/podcasts/432307980/forum","stitcher":"https://www.stitcher.com/podcast/kqedfm-kqeds-forum-podcast","rss":"https://feeds.megaphone.fm/KQINC9557381633"}},"freakonomics-radio":{"id":"freakonomics-radio","title":"Freakonomics Radio","info":"Freakonomics Radio is a one-hour award-winning podcast and public-radio project hosted by Stephen Dubner, with co-author Steve Levitt as a regular guest. It is produced in partnership with WNYC.","imageSrc":"https://ww2.kqed.org/news/wp-content/uploads/sites/10/2018/05/freakonomicsRadio.png","officialWebsiteLink":"http://freakonomics.com/","airtime":"SUN 1am-2am, SAT 3pm-4pm","meta":{"site":"radio","source":"WNYC"},"link":"/radio/program/freakonomics-radio","subscribe":{"npr":"https://rpb3r.app.goo.gl/4s8b","apple":"https://itunes.apple.com/us/podcast/freakonomics-radio/id354668519","tuneIn":"https://tunein.com/podcasts/WNYC-Podcasts/Freakonomics-Radio-p272293/","rss":"https://feeds.feedburner.com/freakonomicsradio"}},"fresh-air":{"id":"fresh-air","title":"Fresh Air","info":"Hosted by Terry Gross, \u003cem>Fresh Air from WHYY\u003c/em> is the Peabody Award-winning weekday magazine of contemporary arts and issues. One of public radio's most popular programs, Fresh Air features intimate conversations with today's biggest luminaries.","airtime":"MON-FRI 7pm-8pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Fresh-Air-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.npr.org/programs/fresh-air/","meta":{"site":"radio","source":"npr"},"link":"/radio/program/fresh-air","subscribe":{"npr":"https://rpb3r.app.goo.gl/4s8b","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=214089682&at=11l79Y&ct=nprdirectory","tuneIn":"https://tunein.com/radio/Fresh-Air-p17/","rss":"https://feeds.npr.org/381444908/podcast.xml"}},"here-and-now":{"id":"here-and-now","title":"Here & Now","info":"A live production of NPR and WBUR Boston, in collaboration with stations across the country, Here & Now reflects the fluid world of news as it's happening in the middle of the day, with timely, in-depth news, interviews and conversation. Hosted by Robin Young, Jeremy Hobson and Tonya Mosley.","airtime":"MON-THU 11am-12pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Here-And-Now-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"http://www.wbur.org/hereandnow","meta":{"site":"news","source":"npr"},"link":"/radio/program/here-and-now","subsdcribe":{"apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?mt=2&id=426698661","tuneIn":"https://tunein.com/radio/Here--Now-p211/","rss":"https://feeds.npr.org/510051/podcast.xml"}},"how-i-built-this":{"id":"how-i-built-this","title":"How I Built This with Guy Raz","info":"Guy Raz dives into the stories behind some of the world's best known companies. How I Built This weaves a narrative journey about innovators, entrepreneurs and idealists—and the movements they built.","imageSrc":"https://ww2.kqed.org/news/wp-content/uploads/sites/10/2018/05/howIBuiltThis.png","officialWebsiteLink":"https://www.npr.org/podcasts/510313/how-i-built-this","airtime":"SUN 7:30pm-8pm","meta":{"site":"news","source":"npr"},"link":"/radio/program/how-i-built-this","subscribe":{"npr":"https://rpb3r.app.goo.gl/3zxy","apple":"https://itunes.apple.com/us/podcast/how-i-built-this-with-guy-raz/id1150510297?mt=2","tuneIn":"https://tunein.com/podcasts/Arts--Culture-Podcasts/How-I-Built-This-p910896/","rss":"https://feeds.npr.org/510313/podcast.xml"}},"inside-europe":{"id":"inside-europe","title":"Inside Europe","info":"Inside Europe, a one-hour weekly news magazine hosted by Helen Seeney and Keith Walker, explores the topical issues shaping the continent. No other part of the globe has experienced such dynamic political and social change in recent years.","airtime":"SAT 3am-4am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Inside-Europe-Podcast-Tile-300x300-1.jpg","meta":{"site":"news","source":"Deutsche Welle"},"link":"/radio/program/inside-europe","subscribe":{"apple":"https://itunes.apple.com/us/podcast/inside-europe/id80106806?mt=2","tuneIn":"https://tunein.com/radio/Inside-Europe-p731/","rss":"https://partner.dw.com/xml/podcast_inside-europe"}},"latino-usa":{"id":"latino-usa","title":"Latino USA","airtime":"MON 1am-2am, SUN 6pm-7pm","info":"Latino USA, the radio journal of news and culture, is the only national, English-language radio program produced from a Latino perspective.","imageSrc":"https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/latinoUsa.jpg","officialWebsiteLink":"http://latinousa.org/","meta":{"site":"news","source":"npr"},"link":"/radio/program/latino-usa","subscribe":{"npr":"https://rpb3r.app.goo.gl/xtTd","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=79681317&at=11l79Y&ct=nprdirectory","tuneIn":"https://tunein.com/radio/Latino-USA-p621/","rss":"https://feeds.npr.org/510016/podcast.xml"}},"live-from-here-highlights":{"id":"live-from-here-highlights","title":"Live from Here Highlights","info":"Chris Thile steps to the mic as the host of Live from Here (formerly A Prairie Home Companion), a live public radio variety show. Download Chris’s Song of the Week plus other highlights from the broadcast. Produced by American Public Media.","airtime":"SAT 6pm-8pm, SUN 11am-1pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Live-From-Here-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.livefromhere.org/","meta":{"site":"arts","source":"american public media"},"link":"/radio/program/live-from-here-highlights","subscribe":{"apple":"https://itunes.apple.com/us/podcast/id1167173941","tuneIn":"https://tunein.com/radio/Live-from-Here-Highlights-p921744/","rss":"https://feeds.publicradio.org/public_feeds/a-prairie-home-companion-highlights/rss/rss"}},"marketplace":{"id":"marketplace","title":"Marketplace","info":"Our flagship program, helmed by Kai Ryssdal, examines what the day in money delivered, through stories, conversations, newsworthy numbers and more. Updated Monday through Friday at about 3:30 p.m. PT.","airtime":"MON-FRI 4pm-4:30pm, MON-WED 6:30pm-7pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Marketplace-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.marketplace.org/","meta":{"site":"news","source":"American Public Media"},"link":"/radio/program/marketplace","subscribe":{"apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=201853034&at=11l79Y&ct=nprdirectory","tuneIn":"https://tunein.com/radio/APM-Marketplace-p88/","rss":"https://feeds.publicradio.org/public_feeds/marketplace-pm/rss/rss"}},"mindshift":{"id":"mindshift","title":"MindShift","tagline":"A podcast about the future of learning and how we raise our kids","info":"The MindShift podcast explores the innovations in education that are shaping how kids learn. Hosts Ki Sung and Katrina Schwartz introduce listeners to educators, researchers, parents and students who are developing effective ways to improve how kids learn. We cover topics like how fed-up administrators are developing surprising tactics to deal with classroom disruptions; how listening to podcasts are helping kids develop reading skills; the consequences of overparenting; and why interdisciplinary learning can engage students on all ends of the traditional achievement spectrum. This podcast is part of the MindShift education site, a division of KQED News. KQED is an NPR/PBS member station based in San Francisco. You can also visit the MindShift website for episodes and supplemental blog posts or tweet us \u003ca href=\"https://twitter.com/MindShiftKQED\">@MindShiftKQED\u003c/a> or visit us at \u003ca href=\"/mindshift\">MindShift.KQED.org\u003c/a>","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Mindshift-Podcast-Tile-703x703-1.jpg","imageAlt":"KQED MindShift: How We Will Learn","officialWebsiteLink":"/mindshift/","meta":{"site":"news","source":"kqed","order":"2"},"link":"/podcasts/mindshift","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/mindshift-podcast/id1078765985","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkM1NzY0NjAwNDI5","npr":"https://www.npr.org/podcasts/464615685/mind-shift-podcast","stitcher":"https://www.stitcher.com/podcast/kqed/stories-teachers-share","spotify":"https://open.spotify.com/show/0MxSpNYZKNprFLCl7eEtyx"}},"morning-edition":{"id":"morning-edition","title":"Morning Edition","info":"\u003cem>Morning Edition\u003c/em> takes listeners around the country and the world with multi-faceted stories and commentaries every weekday. 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On Our Watch brings listeners into the rooms where officers are questioned and witnesses are interrogated to find out who this system is really protecting. 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