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All Reason.com articles with the "FDA" tag.



Published: Sat, 10 Dec 2016 00:00:00 -0500

Last Build Date: Sat, 10 Dec 2016 23:23:43 -0500

 



Tomato Growers Lose Millions Thanks to False FDA Warning, Courts' Failure to Act

Sat, 10 Dec 2016 08:00:00 -0500

Last week the Fourth Circuit Court of Appeals ruled that the federal government could not be held financially responsible for issuing erroneous warnings about the source of an outbreak of foodborne illness that caused the loss of millions of dollars of tomatoes. The warnings, issued by the FDA in 2008, turned out to be wildly inaccurate and deeply damaging. The first, issued on June 3, warned consumers in New Mexico and Texas not to consume several types of raw tomatoes because they may be tainted with salmonella, a bacteria that can sicken and kill those who consume it. A few days later, on June 8, the FDA expanded the warning to include similar types of tomatoes across the country. Soon after, on June 13, the FDA held a press conference that strongly inferred Florida tomatoes might be to blame. ("I'm not wanting to put the focus on Florida specifically, but...") But on July 17, the agency reversed course. "After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak," reads an agency press release, which concluded instead that consumers "should avoid eating raw jalapeño and raw serrano peppers." At the time of the first warning, on June 3, the FDA documented several dozen cases of foodborne illness it wrongly claimed were caused from eating tomatoes. By the time the agency admitted its error on July 17, the FDA acknowledged more than 1,200 such cases had occurred. By that time, the salmonella cases had mushroomed into "the largest foodborne outbreak in the United States in more than a decade." Clearly, the FDA warning hadn't helped consumers, who continued to buy and be sickened by contaminated hot peppers. And it didn't help consumers who stopped buying perfectly good tomatoes at the agency's urging, or who threw away tomatoes they'd already purchased. But if the FDA's misplaced warning was unhelpful at best and harmful at worst to consumers, it was downright devastating to tomato growers and handlers. The agency's warnings had spread like wildfire. For example, the New Mexico Restaurant warned its members against using tomatoes. Newspapers around the country warned consumers to avoid eating tomatoes. Demand for tomatoes plummeted by up to 40 percent in the wake of the warning, and prices fell by half. The industry lost hundreds of millions of dollars. Congress held hearings in the wake of the FDA's retraction of its tomato warning. "Shipments ground to a halt," Anthony DiMare, whose family's company suffered enormous losses, told Congress. "Tomatoes were left in the fields, in the packinghouses and on trucks that were turned away by our customers." DiMare criticized the FDA and CDC for acting without "knowledge they clearly lacked" and urged the agencies to work with industry so that they wouldn't repeat their mistakes. A group of tomato growers and handlers, including DiMare, sued the FDA in federal claims court in 2013, arguing that the incorrect warnings had served effectively as a regulatory taking under the Fifth Amendment. They argued, as a judge wrote in a 2014 order in the case, "all or almost all of the value of plaintiffs' perishable tomatoes was destroyed by the collapse in the market for tomatoes triggered by the FDA's warnings." Nevertheless, the judge rejected the claims of the tomato growers and handlers. "A regulatory takings claim is not plausible and cannot proceed when the government action at issue has no legal effect on the plaintiff's property interest," the judge ruled. "Advisory pronouncements, even those with significant financial impact on the marketplace, are not enough to effect a taking of property under the Fifth Amendment." I wrote an amicus brief in support of the plaintiffs in the case. "The FDA's improper warning cost the tomato producers millions of dollars and turned tons of good tomatoes into tons of food waste," I told Law360 in the wake of the ruling. "For the court to say that producers of food—here, tomatoes—have no recourse is to set a dangerous precedent." That brings us to la[...]



Is Your State Part of the War on Vaping?

Fri, 09 Dec 2016 15:32:00 -0500

A new report from Surgeon General Vivek Murthy released this week called for the federal government to hit electronic cigarettes with high taxes, regulatory restrictions, limits on advertising for vaping products, and bans on the sale of some vaping products. The alarmist report could pave the way for the U.S. Department of Health and Human Services to take action to curb the growth of vaping, even though doing so would make it harder for smokers to switch to e-cigarettes, which are undeniably safer than traditional, combustible cigarettes. Some state and local governments are already way ahead of Murthy. Two states in particular—California and Massachusetts—account for more than 200 local-level restrictions on the sale or use of electronic cigarettes. A new report from Halo Cigs, a leading producer of e-cigarettes and other vaping products, takes a look at the wide range of regulations on vaping at the state and local levels. Massachusetts, despite its small size, has the most local restrictions on where e-cigarettes can be bought or used. The state is one of several that apply the same rules to vaping products as traditional cigarettes and other tobacco products—despite the fact that e-cigarettes contain no tobacco. That's a common fallacy surrounding the regulations of e-cigarettes, and one that Murphy used repeatedly in his new report, as Reason's Jacob Sullum pointed out yesterday. While the graphic above gives you some idea about which states are most and least welcoming to vaping, it doesn't tell the whole story. Local and state-level restrictions on the use of e-cigarettes are only one way that governments have wacked the vaping industry. In Pennsylvania, for example, there are few local rules prohibiting vaping (as the map above indicates), but a new tax 40 percent wholesale tax on vaping products passed by state lawmakers in June has forced some vape shops to close their doors. None of those local and state-level restrictions may matter much in the long run, since new rules from the FDA could drive the vast majority of e-cigarette products out of the market. Starting next year, manufacturers will have to pay up to $1 million per product to clear the FDA's new permitting process for vaping products. Shutting down vaping with onerous taxes or regulatory decrees makes it harder for nicotine-addicted smokers to kick the habit by taking up a safer alternatives. Many e-cigarettes contain nicotine extracted from tobacco, but considering them the equivalent of cigarettes is an affront to common sense and medical science. There's no combustion, no smoke and no tar in e-cigarettes, along with fewer cancer-causing chemicals. One study from the United Kingdom found that e-cigarettes are 95 percent safer than their combustible cousins. Government-led efforts to keep people from accessing or using e-cigarettes is not a victory for public health, but, like so many other things, the federal government should let states experiment with different policies to see what works. In 10 years, we might be able to tell whether Massachusetts and Calfornia's heavy-handed approach to vaping has prevented e-cigarettes from being widely used and what consequences that had on general smoking rates and smoking-related diseases. We could compare that to what will have happened in states that took a lighter touch on regulating vaping. If the FDA and the surgeon general get their way, though, the federal government will close that possibility in favor of restrictive policies that hurt small businesses and smokers trying to kick the habit. This post has been updated to correct the spelling of the surgeon general's name.[...]



Reactions to Trump FDA Chief Rumor: Unmitigated, and Unsupported, Fear of a Libertarian Planet

Thu, 08 Dec 2016 20:50:00 -0500

A rumor, not linked to any named source, is circulating (Bloomberg seems to have first reported it yesterday) that Donald Trump is likely to name Jim O'Neill to head the Food and Drug Administration (FDA). O'Neill is currently a managing director at Mithril Capital, an investment firm co-launched by Peter Thiel, who is on Trump's transition team. Gizmodo is hitting the panic button hard at this rumor, with its headline: "Trump is Considering an Insane Silicon Valley Libertarian to Head the FDA." The bill of indictment against this dangerous madman, who they find "pretty freaking terrifying"? he has advocated for the FDA to give up on vetting the efficacy of new drugs before they come to market. O'Neill, in other words, would like the FDA to stop performing one of its primary functions and let all of us act as lab mice. Such a move might allow drug makers to rake in tons of cash on untested medical treatments that might not ever work. "We should reform [the] FDA so there is approving drugs after their sponsors have demonstrated safety—and let people start using them, at their own risk," O'Neill said in a 2014 speech at the conference Rejuvenation Biotechnology. "Let's prove efficacy after they've been legalized." Those "insane" ideas that relate to the FDA may seem familiar to readers of Reason as they have been defended at length and intelligently here by our science correspondent Ronald Bailey, at most detail in this 2012 article. In it Bailey presents some facts and analysis Gizmodo might not be aware of, or maybe not care about. (Gizmodo does not make the slightest attempt to actually explain why O'Neill's ideas are allegedly insane or bad for America.) Bailey notes that "a 2010 study in the Journal of Clinical Oncology by researchers from the M.D. Anderson Cancer Center in Houston, Texas found ...that the delays caused by requirements for lengthier trials have instead resulted in the loss of 300,000 patient life-years while saving only 16 life-years." Bailey reports skyrocketing costs and time to get potentially lifesaving drugs through the FDA gantlet, and that it is Phase III trial on efficacy and potential side effects that are the largest cause of this time and money sink, "Between 1999 and 2005, clinical trials saw average increases in trial procedures by 65 percent, staff work by 67 percent, and length by 70 percent," Bailey writes. Writing about health policy analyst Avrik Roy's call, like O'Neill's, for allowing drugs that have passed Phase I and Phase II to be conditionally marketed, Bailey notes: Speeding up drug approvals saves lives. A 2005 National Bureau of Economic Research study found that, on balance, the faster FDA drug approvals made possible by new funding legislation passed in the 1990s saved far more lives than they endangered. In fact, new drugs saved up to 310,000 life-years compared to 55,000 life-years possibly lost to the side effects of drugs that were eventually withdrawn from the market. Conditional approval would accelerate access to more drugs, especially drugs that aim to treat the common diseases that afflict more of us. Not only would conditional approval get drugs faster to sick people willing to take a risk on a new treatment, sales of the drug would help fund the Phase III trials needed for full approval.... Roy is not alone in his advocacy for conditional approval. In a February 14 Wall Street Journal op-ed, former FDA Commissioner Andrew von Eschenbach argued that "after proof of concept and safety testing, the [new therapeutic] product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies."... Delaying access to new drugs kills people. As Competitive Enterprise Institute general counsel Sam Kazman has observed [PDF], "Whenever FDA announces its approval of a major new drug or device, the question that needs to be asked is: If this drug will start saving lives tomorrow, then how many people died yesterday waitin[...]



Are E-Cigs the Market Solution that Can Save a Billion Lives?: New at Reason

Thu, 08 Dec 2016 13:50:00 -0500

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"This is a market solution to one of the biggest health crises we've ever seen in the history of the world," says Aaron Biebert, director of A Billion Lives, a documentary that makes the case that regulatory agencies and non-governmental organizations are engaged in a campaign of misinformation against e-cigarettes. "It's disturbing to me that something that's working is being demonized."

Biebert sat down with Reason TV's Zach Weissmueller to discuss the film and the state of the vaping industry in the wake of new Food and Drug Administration (FDA) guidelines that the American Vaping Association, a pro-vaping industry group, claims could wipe out 99 percent of existing e-cigarette manufacturers and retailers. The FDA, for its part, plans to "hire additional Office of Small Business Assistance staff to provide assistance to small tobacco product entities wherever possible." And just today, the Surgeon General issued a report claiming that e-cigarettes are "now a major public health concern."

But are e-cigarettes actually dangerous, or is this simply fear-mongering propaganda from public health agencies that are slow to adapt to innovation?

Watch the full interview above to hear more on that question.

Interview by Zach Weissmueller. Shot by Alex Manning and Lexy Garcia. Music by Chris Zabriskie.

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Are E-Cigs the Market Solution that Can Save a Billion Lives?

Thu, 08 Dec 2016 13:33:00 -0500

"This is a market solution to one of the biggest health crises we've ever seen in the history of the world," says Aaron Biebert, director of A Billion Lives, a documentary that makes the case that regulatory agencies and non-governmental organizations are engaged in a campaign of misinformation against e-cigarettes. "It's disturbing to me that something that's working is being demonized."

Biebert sat down with Reason TV's Zach Weissmueller to discuss the film and the state of the vaping industry in the wake of new Food and Drug Administration (FDA) guidelines that the American Vaping Association, a pro-vaping industry group, claims could wipe out 99 percent of existing e-cigarette manufacturers and retailers. The FDA, for its part, plans to "hire additional Office of Small Business Assistance staff to provide assistance to small tobacco product entities wherever possible." And just today, the Surgeon General issued a report claiming that e-cigarettes are "now a major public health concern."

But are e-cigarettes actually dangerous, or is this simply fear-mongering propaganda from public health agencies that are slow to adapt to innovation?

Watch the full interview above to hear more on that question.

Interview by Zach Weissmueller. Shot by Alex Manning and Lexy Garcia. Music by Chris Zabriskie.

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Like us on Facebook.

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Subscribe to our podcast at iTunes.




FDA Salt Guidance Could Kill More People Than It Saves

Fri, 02 Dec 2016 11:10:00 -0500

The Food and Drug Administration issued proposed guidance in June to the food industry aiming to reduce the amount of sodium in many prepared foods. In its draft guidance, the agency stated: Average sodium intake in the U.S. is approximately 3,400 mg/day. The draft short-term (two-year) and long-term (10-year) voluntary targets for industry are intended to help the American public gradually reduce sodium intake to 2,300 milligrams (mg) per day, a level recommended by leading experts and the overwhelming body of scientific evidence. The targets are also intended to complement many existing efforts by food manufacturers, restaurants, and food service operations to reduce sodium in foods. The FDA further asserted: CDC has compiled a number of key studies, which continue to support the benefits of sodium reduction in lowering blood pressure. In some of these studies, researchers have estimated lowering U.S. sodium intake by about 40 percent over the next decade could save 500,000 lives and nearly $100 billion in healthcare costs. So, the science of salt is settled, right? Actually, no. The FDA asked for public comments on its draft guidelines and it evidently received sufficient pushback that it extended the deadline for comments until December 2, 2016. As I reported earlier more and more studies are calling into question that idea that reducing salt consumption at the population level will actually result in net health benefits. For example, the New England Journal of Medicine published a study in August 2014 finding that people who consume less 1,500 milligrams of sodium (about 3/4ths of a teaspoon of salt) are more likely to die than people who eat between 3,000 to 6,000 milligrams of sodium per day (1.5 and 3 teaspoons of salt). The free-market think tank, the Competitive Enterprise Institute has submitted comments that show that the FDA's confident claim that reducing salt consumption by Americans will save lives is at best, a hope, and at worst, tragically wrong. The CEI comments to the FDA nicely summarizes the relevant scientific studies. Here is the nub of the issue: Reduced sodium consumption affects different individuals in different ways. Only an estimated 17 to 25 percent of the population is "salt sensitive"—they experience higher blood pressure with increased dietary sodium—while 75 percent are considered salt resistant and will experience no change in blood pressure with altered dietary sodium. However, an estimated 11 to 16 percent of the population are inverse salt sensitive, which means reduced dietary sodium can increase their blood pressure. With this heterogeneity in response to salt, trying to force a population-wide reduction in sodium availability in order to reduce incidences of hypertension would be ineffective at best and counterproductive at worst. Among other evidence, CEI cites a 2014 metanalysis in the American Journal of Hypertension of more than two dozen sodium studies which concluded that risk of death appeared to be lowest among individuals consuming between 2,565mg and 4,796 mg of sodium a day with higher rates of death in the upper and lower range. The FDA itself notes that average daily consumption - 3,400 mg - is right in the middle of that range. CEI correctly argues: For a minority of the population, reducing dietary sodium can be an effective means of lowering cardiovascular and hypertension risk. But identifying for whom sodium restriction may be beneficial and by how much is something that individuals and their doctors must determine. For the general population, sodium reduction is, by no means, a silver bullet to reducing hypertension and has the potential to increase risks for a large portion of the population. Treat people as individuals not just as members of an undifferentiated public health herd. Let's hope that the FDA will heed this advice and withdraw its misguided draft guidance.[...]



FDA Approves Final Stage of MDMA Drug Trials

Wed, 30 Nov 2016 08:15:00 -0500

(image) More than three decades after the Drug Enforcement Administration banned MDMA, federal regulators have approved research that could make the compound legally available as a psychotherapeutic catalyst by 2021. The New York Times reports that researchers studying MDMA as a treatment for posttraumatic stress disorder (PTSD) yesterday received permission from the Food and Drug Administration for Phase 3 clinical trials, the final step before approval of a new medicine.

The Multidisciplinary Association for Psychedelic Studies (MAPS), which is sponsoring the research, funded six Phase 2 studies involving a total of 130 subjects. Hundreds of subjects will participate in the next phase.

In one Phase 2 study, scores on the Clinician-Administered PTSD Scale fell by almost two-thirds, on average, among 19 subjects who underwent MDMA-assisted psychotherapy. A follow-up study found that the improvements generally persisted an average of almost four years later.

"It changed my life," an Iraq and Afghanistan veteran who participated in one of the Phase 2 trials told the Times. "It allowed me to see my trauma without fear or hesitation and finally process things and move forward." Another subject, a firefighter traumatized by "years of responding to gory accidents," said MDMA-assisted psychotherapy "gave me my life back."

The psychotherapeutic potential of MDMA, which enhances empathy, reduces fear, and encourages openness, was apparent back in the late 1970s and early '80s, when the drug gained a following among psychiatrists. But once it was dubbed Ecstasy and became popular as a party drug, its fate was sealed. Like marijuana, LSD, and psilocybin, it has only recently re-emerged as a subject of legitimate medical research.

Reason TV covers the MAPS-sponsored MDMA research:

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What Trump's Win Means for Food and Agricultural Policy

Sat, 19 Nov 2016 08:00:00 -0500

The looming presidency of Donald Trump has left many (perhaps most) Americans uncertain of what the future might hold. On my beat—food and agricultural law—that future is no clearer. Eight years of food and agricultural policy under President Barack Obama was mostly chaff. First Lady Michelle Obama planted an organic garden on the White House grounds and sought to work with the food industry to reduce calories, reformulate foods, and promote exercise in an unsuccessful attempt to reduce obesity rates in this country. Obama's activist FDA banned trans fats, pushed for "added sugar" labeling on packaged foods, and adopted sweeping new food safety regulations under the Food Safety Modernization Act. The Affordable Care Act, Obama's signature legislation, contains requirements for nationwide calorie labeling on many restaurant menus. Farm subsidies administered by the USDA ballooned to unprecedented levels during the Obama administration. The USDA co-published controversial new dietary guidelines. And the First Lady championed changes to the USDA National School Lunch Program that mandated the serving of more whole grains, fruits, and vegetables. Save for the first lady's White House garden, I've been mostly critical of these actions. Given Trump's putative status as the anti-Obama, how might a Trump administration differ from his predecessor when it comes to food and agricultural policy? We've gotten an early glimpse. And so far, supporters of stricter regulations appear alarmed. A set of Trump food and agriculture talking points obtained by Politico suggests "a shift back to conventional agriculture, to promises for the Trump White House to be an 'active participant' in writing the next Farm Bill, to fighting the so-called good food movement and undoing Obama-era agricultural and environmental policies." As the Washington Examiner's Paul Bedard noted this week, a recent report by the American Action Forum suggests the Trump administration could cut a recent slew of regulations that would cost more than $40 billion under a law known as the Congressional Review Act. According to the AAF list, many recent food and agricultural rules—several billion dollars' worth—could be repealed as early as January. The Trump administration also appears likely to roll back Michelle Obama's school lunch reforms. That sounds promising. But, as I detail in my book, Biting the Hands that Feed Us, any reversal of course that simply returns the failing program to the flailing program it was five or ten years ago is untenable. Trump's stance on immigration—not just a human rights issue but also a key food and agricultural issue, as many of the people who grow, pick, cook, and buy our food are immigrants—is frighteningly bad. Ditto his position on (or, rather, against) free trade. Outside of specific laws and regulations the administration might embrace, some other indicators have emerged recently. For example, Quartz reports the Trump transition team is being headed by a veteran food lobbyist. And while the lists of potential cabinet heads of the USDA and HHS (which houses the FDA) are still reasonably long, they're not terribly inspiring. So food and agricultural policy will likely look very different under Trump than it's looked under Obama, who, in the words of one Associated Press writer this week, "made healthier, safer and better labeled food a priority[.]" That characterization is, in my view, quite a reach. The Obama administration made regulating food a priority. But many of its regulations don't appear to have made us healthier, or our food safer or better labeled. Even Obama supporters found his administration's stance on food to be "more symbolic than substantive." Maybe that's also what we should hope for under Trump. I'll stomach Trump's cruel symbolism on immigration and trade over any substantive action by him that reflects his vie[...]



Biting the Hands that Feed Us: Food Laws vs. Culinary Reality

Mon, 14 Nov 2016 15:25:00 -0500

As our world becomes more hyper-individualized, our taste in food is following suit. From cooking in our own kitchens to finding new creative dishes at restaurants, we're all becoming artisanal chefs and demanding gourmands. Yet politicians and activists, often in a misguided attempt to keep us safe, are passing increasingly bizarre and counterproductive laws to keep us from buying, making, and eating the food we want.

In Biting the Hands that Feed Us: How Fewer, Smarter Laws Would Make Our Food System More Sustainable, lawyer Baylen Linnekin gives readers a view of the overlooked consequences of the many absurd rules baked into America's food system. Since at least the New Deal, he writes, overreaching buttinskies on the federal and local level have tried to shut down entrepreneurs, charities, and even home gardeners who are just trying feed themselves and others. From the U.S. Department of Agriculture dictating how butchers cure meat to New York City's then-Mayor Michael Bloomberg banning food donations to homeless people to banning berry-picking in public parks, no food practice seems too small to regulate in the name of safety.

A solution, says Linnekin in an interview with Reason's Nick Gillespie, is to simply emphasize good outcomes rather than rigid processes. Linnekin, who founded the nonprofit Keep Food Legal and has served as an expert witness in an ongoing federal First Amendment food-labeling lawsuit, also writes about "food freedom" at Reason.com every Saturday (check out his archive here).

Edited by Joshua Swain. Cameras by Todd Krainin and Swain. Music by Podington Bear.

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Of Course People Should Have Access to Their Genetic Data!

Thu, 03 Nov 2016 15:45:00 -0400

The idiots, ah regulators, over at the Food and Drug Administration bascially shut down the consumer genetics company 23andMe (and its competitors) back in 2013 based on entirely specious worries that consumers would be confused by the genotype screening test results the company offered in its Personal Genome Service. In one scenario the FDA idiots, ah regulators, suggested that women who received results suggesting that they carried genetic variant of BRCA cancer propensity genes would panic and take butcher knives to their breasts. All right I exaggerate just a bit, but what the agency did write was: For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. What sort of supposedly misleading information did 23andMe actually give its customers about BRCA mutations: Understanding Your Results This report covers three of the most common mutations that cause HBOC syndrome – 185delAG, 5382insC, and 6174delT. These mutations are most common in people with Ashkenazi Jewish ancestry. Keep in mind that having one of these mutations does not necessarily mean you will develop cancer. Similarly, you can still develop cancers associated with HBOC syndrome even if you don't have these mutations. Many other rare mutations in the BRCA1 and BRCA2 genes are associated with HBOC syndrome, but are not reported here. ... This is not a diagnostic test. If your results show that you have a mutation, consult with a healthcare provider about confirming the result. Genetic conditions run in families so consider also sharing your results with family members. If you don't have any of the mutations but you think you may still be at risk for HBOC syndrome due to family or personal history of cancer, you should also consult with a healthcare provider. The actual reports to which customers like me had access were quite extensive and linked to all of the studies upon which 23andMe researchers based their interpretations. Lots of bioethicists are still telling researchers to withhold genetic information from their patients and subjects. I am happy to report that human genetics researcher Sarah Nelson has a terrific article in Nature arguing that "geneticists should offer data to participants." About damned time! When she was asked to join a whole genome sequencing project she was told that she would not be given access to her results. This is crazy. Ignorance is not bliss for everybody. Among her salient points are: As awareness and usefulness of this information increases, I fear that potential volunteers who are refused access to their genetic data will become less willing to donate them to science. The genetics-research community must therefore update its stance on returning personal data. ... ...beyond the lab, more people now want and expect access to all kinds of personal data, a trend that shows no signs of slowing. Health data are no exception, as evidenced by the flood of wellness and 'mobile health' apps that are now coming to market. Future generations will take for granted that our personal computing devices are vehicles for almost unlimited 'quantified self' and self-tracking activities. Several online platforms exist to help people to explore their genetic data, developed by for-profit companies, academic groups or by self-taught citizen scientists. Since launching in 2011, the site openSNP has drawn more than 4,000 users, half of whom have uploaded genetic data. The DNA.LAND platform has attracted more than 32,000 contributors since its release last October. Launched in 2008, and therefore one of the earliest third-party i[...]



Criticism Has Delayed a Kratom Ban but Probably Won't Prevent It

Thu, 13 Oct 2016 08:30:00 -0400

The Drug Enforcement Administration's decision to withdraw its ban on kratom, a pain-relieving leaf from Southeast Asia, underlines the arbitrariness of the federal government's pharmacological taboos, which are based on undefined terms subjectively interpreted by bureaucrats with broad discretion to decide which substances Americans may ingest. The DEA's backtracking was prompted by complaints from kratom consumers, the companies that serve them, researchers who study the drug, and members of Congress. But despite the agency's newfound interest in public input on the question of kratom's legal status, it seems likely that we will end up with the same prohibitory result after a somewhat more elaborate process of post hoc rationalization. When the DEA announced at the end of August that it was temporarily placing kratom's main active ingredients in Schedule I, the most restrictive category under the Controlled Substances Act (CSA), it declared that a ban was "necessary to avoid an imminent hazard to the public safety." When the ban did not take effect on September 30 as expected, DEA spokesman Russell Baer assured Washington Post drug policy blogger Christopher Ingraham that "it's not a matter of if—it's simply a matter of when, in terms of DEA publishing the final order to temporarily schedule kratom." Since Acting DEA Administrator Chuck Rosenberg "has determined that kratom represents an imminent hazard to public safety," Baer said, "I have a sense that publishing our final order will be sooner as opposed to later." Rosenberg's determination was based on an unpersuasive, weakly supported analysis that dismissed kratom's benefits and exaggerated its hazards. Critics pointed out that the DEA's emergency scheduling authority, which Congress approved in 1984 at the agency's behest, was aimed at dangerous new synthetic drugs that might cause many injuries and deaths during the time required by the standard scheduling process. Here is how then-DEA Administrator Francis Mullen explained his understanding of "imminent hazard to the public safety" in a letter to legislators: The "imminent hazard" implies a need for immediate response to a drug trafficking and abuse situation that has occurred with such rapidity and with insufficient warning that normal control mechanisms would result in a large number of deaths and injuries or the continuance of an uncontrolled trafficking situation....The burden would be on the Government to prove that such an urgency exists and that the public safety would be jeopardized during the period that a drug would remain uncontrolled during routine scheduling action. As examples of substances that would be covered by the new provision, Mullen cited "newly synthesized drugs or uncontrolled analogs of existing drugs such as PCP and fentanyl," which "can cause widespread deaths and injuries in a very short period of time following their synthesis." Kratom, a "minimally toxic" natural substance that humans have used for centuries with little evidence of serious harm except in exreme cases, hardly fits that description. "The use of this emergency authority for a natural substance is unprecedented," noted Sen. Orrin Hatch (R-Utah) in a September 29 letter to Rosenberg. Whatever legislators may have had in mind when they created this prohibition shortcut, they did not define "imminent hazard to the public safety." The CSA says only that the attorney general (who has delegated his scheduling authority to the DEA) should consider a substance's "history and current pattern of abuse," "the scope, duration, and significance of abuse," and "what, if any, risk there is to the public health." That formulation leaves bureaucrats like Rosenberg free to describe any uncontrolled psychoactive substance, no matter how favorable its risk-to-benefit[...]



EpiPens and Government Cheese

Tue, 04 Oct 2016 06:00:00 -0400

At the end of August, the U.S. Department of Agriculture bought 11 million pounds of cheese—that's a cheese cube for every man, woman, and child in America—in order to bail out the nation's feckless cheesemongers. Secretary of Agriculture Tom Vilsack touted the aid package, worth $20 million, as a win-win: "This commodity purchase is part of a robust, comprehensive safety net that will help reduce a cheese surplus that is at a 30-year high while, at the same time, moving a high-protein food to the tables of those most in need." (Most of the federal government's new stockpile will go to food banks.) This bailout of Big Cheese came on top of an $11.2 million infusion earlier in the month to dairy farmers enrolled in a 2014 federal financial aid scheme. The deal comes after months of lobbying by the National Farmers Union, the American Farm Bureau, and the National Milk Producers Federation, who were too antsy to wait for their next big cash cow to come ambling in with the farm bill. The same week, Sen. Chuck Grassley (R–Iowa) wrote a letter to the pharmaceutical company Mylan, demanding an explanation for why EpiPens, the epinephrine auto-injectors that severely allergic people carry in case of an emergency, have quadrupled in price since 2007. Grassley cited constituents paying $500 to fill their prescriptions. Hillary Clinton issued a statement about the price increases as well: "Since there is no apparent justification in this case, I am calling on Mylan to immediately reduce the price of EpiPens." Donald Trump used the occasion to score points, tweeting out a story about hundreds of thousands of dollars in donations to the Clinton Foundation from the disgraced company. Sen. Amy Klobuchar (D–Minn.) echoed Clinton's sentiment in a letter to the Federal Trade Commission: Lamenting that "antitrust laws do not prohibit price gouging," she asked the regulatory body to look into whether Mylan has used "unreasonable restraints of trade" to keep prices high. The summer's cheese bailout and EpiPen price scandal are ideological Rorschach blots.Where one observer sees only the evils of the profit motive, another looks at the same fact pattern and sees the perils of an overweening regulatory state. Vox sided solidly with the profit shamers, declaring: "We are the only developed nation that lets drugmakers set their own prices, maximizing profits the same way sellers of chairs, mugs, shoes, or any other manufactured goods would." But pseudonymous blogger Scott Alexander of Slate Star Codex responded with a tidy reverse Voxsplanation: The cronyist Food and Drug Administration (FDA) and other government forces have squelched nearly every effort to compete with Mylan's EpiPens, distorting the market beyond recognition via a process he chronicles in painful detail. Mylan acquired the EpiPen from Merck in 2007, by which time the product was already 25 years old, which means the question of paying back research costs was moot. In 2009, Teva Pharmaceuticals tried to enter the market—and Mylan sued. Teva managed to get its product to the FDA anyway, only to be told that it had "certain major deficiencies," unspecified. In 2010, Sandoz Inc. tried its luck and got bogged down in the courts, where the case still dwells. In 2011, the French drug company Sanofi made a bid to gain approval for a generic, which was delayed for years because the FDA didn't like the proposed brand name. Which brings us to this year, when Adamis decided to sell plain old pre-filled epinephrine syringes directly to patients without the fancy injector. Cue an FDA recall, on the rather vague basis that insufficient study had been done on standard administration of a drug whose medical properties have been known since the turn of the last century. And sometimes the [...]



First 'Three Parent' Baby Born in Mexico

Wed, 28 Sep 2016 09:30:00 -0400

Great news! American fertility specialists replaced defective mitochondria in a embryo resulting in the birth of a healthy baby boy five months ago. The bad news is that due to a fifteen year Food and Drug Administration ban, the procedure had to be performed in Mexico. Mitochondria are the energy producing organelles in each of our cells which carry their own small genomes and are passed down to children from their mothers. Broken mitochondrial genes cause a wide variety of illnesses from which about 1 in 4,000 people suffer (that is about the same rate as cystic fibrosis among European-descended Americans). In this specific case, the mother carries a mitochondrial mutation associated with Leigh's Disease that causes brain lesions and which killed her first two children. The cure was achieved, as the New Scientist explains: [New Hope Fertility Center specialist John] Zhang ... removed the nucleus from one of the mother's eggs and inserted it into a donor egg that had had its own nucleus removed. The resulting egg – with nuclear DNA from the mother and mitochondrial DNA from a donor – was then fertilised with the father's sperm. Zhang's team used this approach to create five embryos, only one of which developed normally. This embryo was implanted in the mother and the child was born nine months later. Hearty congratulations are in order to the parents, the baby, and the team that made it possible! Well, not everyone actually agrees with that sentiment. CNN reports: "It's unfortunate to have people decide they're just going to quite willingly engage in this kind of reproductive tourism -- to go outside of a system that is in place to create the safest, most scientifically reproducible way forward," said Lori P. Knowles, assistant professor, adjunct, at the University of Alberta School of Public Health. "That's the precedent then, that if you think you can do it, then let's just hop the border and see what happens, hope for the best." Cannot bioethicists hear themselves! Having endured four miscarriages and two dead children, this mother had already seen "what happens," so of course, she was hoping for best. So should we all. The parents in this case obviously felt forced to engage in reproductive tourism because the "system that is in place to create the safest ... way forward" has, in fact, blocked all progress in this field for a decade and a half. While headlines around the world hailed this achievement as the first three-parent baby, that's actually not the case. Back in 2000, researchers at St. Barnabas Hospital in New Jersey developed the same technique that Zhang used. As I reported earlier: Researchers hit on the idea of curing mitochondrial diseases by replacing defective mitochondria with healthy ones derived from eggs donated by other women. Back in 2001, fertility specialist Jacques Cohen and his colleagues at St. Barnabas Hospital in New Jersey transferred ooplasm containing mitochondria from healthy donor eggs to the eggs of women experiencing infertility. The experiments resulted in the births of 15 healthy babies. ... When the Food and Drug Administration (FDA) got wind of the new development, the agency asserted that it had jurisdiction over the treatments and promptly banned them. And that is where matters have ever since stood, as women continued to endure infertility and more babies were born suffering from mitochondrial diseases. Very ethical. The "safest system" is evidently the system that says take no risks at all. Better more babies born naturally with dread diseases than allowing parents to try to have healthy children by availing themselves of the unnatural methods of science. If regulators and bioethicists don't want "reproductive tourism," then stop banning rese[...]



California Becomes 32nd State to Pass "Right to Try" Law for Terminally Ill

Tue, 27 Sep 2016 19:48:00 -0400

Arizona's Goldwater Institute has been the national leader in promoting "right to try" legislation, which allows terminally-ill Americans to legally try medications that have passed just Phase I of the Food and Drug Administration's (FDA) approval process but are not as yet legally available via doctors. Passing Phase I means that the agency is at least satisfied that the medicine can be used safely.

Today the Institute announces that, with a bill signed into law by California Gov. Jerry Brown, that state becomes the 32nd state to pass a version of that law. Brown had vetoed a similar law last year. The Institute's press release notes that "Right To Try is limited to patients with a terminal disease that have exhausted all approved treatment options and cannot enroll in a clinical trial. All medications available under the law must have successfully completed basic safety testing and be part of the FDA's on-going approval process."

KPCC radio's website has more details on the California politics:

Patients must meet a number of requirements to qualify for the program, including that they have only a matter of months to live and that two doctors recommend they try the experimental drug.

The passage of the measure caps a two-year effort by Calderon. Last year, Brown vetoed similar legislation Calderon authored. The governor said he did so because he first wanted to see whether changes in the FDA's Compassionate Use program reduced the minimum 30-day wait for experimental drugs.

And while the feds did streamline some parts of that program, patient wait times remained the same, the bill's supporters say.

Alex Manning's Reason TV video on the right-to-try movement:

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The Secret Tool the FDA Uses to Control News Reports About Its Decisions

Fri, 23 Sep 2016 10:59:00 -0400

The Food and Drug Administration (FDA), apparently not satisfied with exerting a considerable and often wildly inappropriate amount of control over what people can put in their bodies, has also taken extraordinary and secretive steps to control what sorts of information people can read about the agency's decisions. To understand how the FDA controls news about its policies, you have to understand news embargoes, in which a source agrees to provide information if reporters agree to hold the news until a specific time. Embargoes are a widely employed and often useful part of journalism: They can help give reporters time to go over stories—especially those with complex, technical aspects—carefully, and can help ensure that critics and opinion writers don't feel pressured to rush to judgment. Embargoes, in other words, give reporters the opportunity to think, clarify, and work through a story without worrying about getting scooped. And in the process, they can help create better journalism. Or at least that's the hope. The flip side, of course, is that embargoes can also be used by sources to control stories, at least to some extent. By forcing every outlet to agree to the same embargo, PR operators can ensure that there's a flood of stories all at once, making it seem like something—usually a product that someone is trying to sell—is suddenly everywhere in the news. Embargoes can also be used to keep negative news and reviews from leaking before a product hits the market. In at least one case I'm aware of, video game critics, in exchange for early access to a game, were forced to agree to an embargo that didn't lift until 12 hours after the game was available to buy online. Traditionally, the limiting factor on embargoes stories is just time. But according to scathing report in Scientific American, the FDA has recently been adding another factor for sharing news with early reporters: No outside sourcing. This turns into what is called a "close-hold embargo." The FDA initially attempted to impose a close-hold embargo in 2011, according to the story, but updated its official embargo policy to allow reporters to contact third parties following complaints by journalists. Except that apparently the FDA secretly went ahead with a close-hold embargo strategy anyway, despite its own publicly posted rules. And according to snippets from an agency memo published by Scientific American, the explicit goal is to shape and control news coverage: The FDA, too, quietly held close-hold embargoed briefings, even though its official media policy forbids it. Without a source willing to talk, it is impossible to tell for sure when or why FDA started violating its own rules. A document from January 2014, however, describes the FDA's strategy for getting media coverage of the launch of a new public health ad campaign. It lays out a plan for the agency to host a "media briefing for select, top-tier reporters who will have a major influence on coverage and public opinion of the campaigns.… Media who attend the briefing will be instructed that there is a strict, close-hold embargo that does not allow for contact with those outside of the FDA for comment on the campaign." Why? The document gives a glimpse: "Media coverage of the campaign is guaranteed; however, we want to ensure outlets provide quality coverage of the launch," the document explains. "The media briefing will give us an opportunity to shape the news stories, conduct embargoed interviews with the major outlets ahead of the launch and give media outlets opportunities to prepare more in-depth coverage of the campaign launch." The FDA has apparently relied on this practice not only to control when news[...]