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Published: Sat, 03 Dec 2016 00:00:00 -0500

Last Build Date: Sat, 03 Dec 2016 19:05:57 -0500

 



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 In its draft guidance, the agency stated: Average sodium intake in the U.S. is approximately 3,400 mg/day.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 views in these areas. And if the Trump administration reins in the FDA and slashes farm subsidies—neither a sure bet, but essential starti[...]



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 interpretation tools, Promethease reports performing hundreds of analyses daily. Other tools, such as GEDMatch and Genome Mate Pro, attra[...]



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 ratio, as "an imminent hazard to the public safety." The unscientific nature of that determination is clear from the fact that the DEA h[...]



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 tangled, dysfunctional relationship between big business and big government gets even more personal. The CEO of Mylan, Heather Bresch, is[...]



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 research here. Instead of better safe than sorry, we will instead end up more sorry than safe.[...]



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 is published, and who reporters talk to for their stories, but which news organizations get access to information. As the Scientific Ame[...]



Dairy Lobby Sides with Florida in Orwellian Attempt to Redefine 'Skim Milk'

Sat, 10 Sep 2016 08:00:00 -0400

Natural skim milk in Florida still can't be labeled as "skim milk." At least not yet. You may recall the Ocheesee Creamery case, which I wrote about in April. As I described in that column, a Florida state agriculture department inspector ordered Ocheesee, a small, all-natural creamery located along the state's panhandle, to stop selling its skim milk in 2012. He claimed Ocheesee's skim milk ran afoul of Florida's standard of identity for skim milk, which requires creameries and dairies to add vitamin A to their skim milk. Ocheesee, which prides itself on its all-natural milk, proposed to label its skim milk as "Pasteurized Skim Milk, No Vitamin A Added." The state countered with "Non-Grade 'A' Milk Product, Natural Milk Vitamins Removed" and ordered there be no mention of "skim milk" on the label. The state later changed its tune, arguing instead that Ocheesee could sell its 100% skim milk only if it were labeled as "imitation skim milk." Finding the state's Orwellian proposals to be as untenable and ridiculous as they sound, Ocheesee—working with the Florida office of the Arlington, Virginia-based Institute for Justice—sued to overturn Florida's rules on First Amendment grounds. A federal judge in Florida upheld the state's rules this spring. Ocheesee soon appealed the judge's decision. That appeal is pending. Last month, Florida's lawyers argued in a filing in the case that labeling a skim milk as "skim milk," if said skim milk "fails to meet the standard of identity for skim milk," is either "inherently" or "potentially" deceptive speech the state claims "may be banned." Nevermind that Ocheesee's skim milk meets what's been the dictionary definition of skim milk for hundreds of years. The state went so far as to malign Ocheesee's all-natural skim milk as "an inferior product." Florida's lawyers also claim that its "unrefuted evidence shows that consumers expect skim milk to meet the standard of identity." But that evidence has indeed been refuted. I should know. I was retained as an expert in the case, and drafted a report describing how Florida's standard of identity for skim milk misleads and fails to serve the interests of consumers. I refuted. "Reasonable consumers have not been and would not be not misled by Ocheesee Creamery's use of the term 'pasteurized skim milk' to describe its pasteurized skim milk," I write in my report. This past week, a global dairy-industry lobbying group added its two cents in the case. The International Dairy Foods Association (IDFA), a Washington, D.C.-based group that "represents the nation's dairy manufacturing and marketing industries and their suppliers, with a membership of 550 companies within a $125-billion a year industry," filed an amicus brief in the case. If you thought the IDFA might have ridden in on a milk-white horse to stick up for Ocheesee, which at last count had three employees, then you're new to how the world works. The IDFA sided with Florida regulators and against Ocheesee. I describe this case at length in my new book, Biting the Hands that Feed Us: How Fewer, Smarter Laws Would Make Our Food System More Sustainable (which you can pre-order at Amazon or pick up in bookstores on September 15). Not coincidentally, my discussion of the case appears in the second chapter, the one titled "'Big Food' Bigger Thanks to 'Big Government.'" "It is clear that giant dairy conglomerates are scared that they might lose customers to local creameries who provide more choices and better products," said Justin Pearson, head of IJ's Florida office and lead attorney in the case, in comments to me this week. "We see this in many of our cases. Whenever there is a ridiculous regulation, there was usually a powerful and politically connected group pushing for it, at the expense of hard-working small-business ow[...]



How To Build a Better EpiPen—or Something Totally Different That's Much Better

Sun, 04 Sep 2016 12:24:00 -0400

In 2015, about 3.5 million people were prescribed an EpiPen, an injection device with a pre-measured dose of epinephrine used to treat potentially fatal allergic reactions. Controversy over the fast-rising costs of the device has been used to indict the American health-care system as a playground for corporate greed. Over the past five years or so, the list price of a two-pack of EpiPends has increased about 400 percent, to $600. (Of course, what any customer might pay out-of-pocket is dependent on many factors such as insurance company, income level, and more.) Well, there's no question that the maker of the EpiPen, Mylan, is in business to make money. The CEO of the company, which is the largest maker of generic drugs in the country, says, "I am a for-profit business. I am not hiding from that." It's actually kind of great to hear a CEO unapologetically say so. But as Scott Shackford recently noted at Reason.com, the main problem is that Mylan has been granted a de facto monopoly over the market for epinephrine injectors. That isn't because it built a better mousetrap but because the Food & Drug Administration (FDA) has shot down virtually every alternative device for one reason or another. As I write in a new Daily Beast column, Mylan's path to monopoly pricing in EpiPens has everything to do with politics and nothing to with laissez-faire economics. The approval process isn't just long and expensive, it also opens things up to politics. That's one of the reasons why Mylan, which bought the rights to EpiPen in 2007, spent more than $2 million lobbying Washington in 2015. The company's PAC has spent about $80,000 so far in the 2016 election cycle. Maybe it's just coincidence, but Mylan, one of the largest generic drug companies on the planet, faces little competition from other companies that want to make devices similar to the EpiPen. As the pseudonymous doctor Scott Alexander documents at Slate Star Codex, the amount of epinephrine in an EpiPen's pre-measured dose costs about 10 cents a shot. But every time a new company tries to bring a rival product to market, the Food and Drug Administration (FDA) finds a reason to just say no. Sandoz, Teva Pharmaceuticals, Sanofi, and Adamis have all tried and failed. That seems more than a little fishy given the relative simplicity of the basic drug and delivery system involved. We're not talking brain surgery here—we're talking about a pre-loaded, single-use syringe. Let's be clear: The basic protocols that the FDA uses to approve drugs and devices are outdated and make new products far more limited and far more expensive than they need to be. Indeed, as medical researchers push forward into an era of hyper-personalized "molecular medicine" that is based on individual genomic differences among patients, the FDA insists on clinical trials that are based on average experiences. Some drugs work for some patients but not others, notes researcher Peter Huber of the Manhattan Institute. It costs somewhere between $1 billion and $5.8 billion and between 10 years and 15 years to bring new drugs to market (where maybe 20 percent become blockbusters). Yet for politicians on both sides of the aisle, the fix to the EpiPen is to threaten price controls. Here's an excerpt from a letter released by Hillary Clinton, in which she avers that the EpiPen price hike is just the latest troubling example of a company taking advantage of its consumers. I believe that our pharmaceutical and biotech industries can be an incredible source of American innovation, giving us revolutionary treatments for debilitating diseases. But it's wrong when drug companies put profits ahead of patients, raising prices without justifying the value behind them. "That's why I've put forward a plan to address exorbitant dru[...]



Most Adolescent Vapers Are Not Nicotine Users

Fri, 02 Sep 2016 10:20:00 -0400

The Food and Drug Administration (FDA), having decided to regulate tobacco-free e-cigarettes as tobacco products because they deliver tobacco-derived nicotine, now has the challenge of explaining how even nicotine-free e-liquids can qualify for the same label. E-cigarette alarmists at the U.S. Centers for Disease Control and Prevention (CDC) have a similar problem. They insist on counting vaping as "tobacco use," which leads them to claim there has been "no decline in overall youth tobacco use since 2011," even though that is clearly not true. Now a new study in the journal Tobacco Control reveals the CDC's position to be even more ridiculous than it already seemed, showing that a large majority of teenagers who vape are not only not consuming tobacco; they are not consuming nicotine either. Based on data from the 2015 Monitoring the Future Study, which surveys students in the eighth, 10th, and 12th grades, Richard Miech and three of his colleagues at the University of Michigan's Institute for Social Research (which conducts the survey) report that nearly two-thirds of teenagers who have tried vaping consumed "just flavoring" the last time they did it. "Nicotine use came in a distant second," Miech et al. write, "at about 20% in 12th and 10th grade and 13% in 8th grade." The other options were marijuana and "don't know." The survey data indicate that the more frequently teenagers vape, the more likely they are to vape nicotine. Among high school seniors, 47 percent of those who had vaped six or more times in the previous month reported consuming nicotine, compared to 23 percent of those who had vaped one to five times in the previous month. But "in no case did the prevalence of nicotine vaping reach 50% or greater." The fact that most adolescent vapers do not vape nicotine was mentioned in a summary of the 2015 survey results published last year, as Pennsylvania anti-smoking activist (and harm reduction advocate) Bill Godshall pointed out at the time. I noted that finding in a blog post last April and a column last June. But the Tobacco Control article presents more-detailed data on this question and highlights the CDC's mendacity. It was already absurd to claim teenagers were using tobacco when they weren't, especially since the CDC used that inaccurate terminology to imply that the rising popularity of vaping somehow cancels out the health gains from the continuing decline in smoking, a far more dangerous habit. Now that it's clear the typical adolescent vaper is not even using nicotine, the CDC cannot assume any chemical connection between e-cigarettes and tobacco. Furthermore, its warnings that teenagers might start smoking after they get hooked on nicotine by vaping look even more overblown than they did before. As Meich et al. note, even the practice of referring to vaporizers as "electronic nicotine delivery systems" (as both the CDC and the FDA do) is quite misleading, at least in the context of adolescent use. "The majority of US youth who use vaporisers and e-cigarettes do not vape nicotine," the authors write. "This finding challenges many common assumptions and practices." The numbers "suggest that the recent rise in adolescent vaporiser use does not necessarily indicate a nicotine epidemic," and they show how misleading the CDC's equation of vaping with tobacco use is. Meich et al. note that counting every vaper as a tobacco user doubles the supposed prevalence of tobacco use among 12th-graders and nearly triples it among 10th- and eighth-graders. If vapers are counted as tobacco users only when they vape nicotine (still a dubious maneuver), the effect is much less dramatic. "If vaporiser users are considered nicotine users only if they last vaped nicotine in the last 30 days," the rese[...]



Friday Funnies: Government Granted EpiPen Monopoly

Fri, 02 Sep 2016 07:00:00 -0400

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Want to Reduce the Price of EpiPens? Approve Some Competition!

Thu, 25 Aug 2016 11:50:00 -0400

Angry lawmakers and Democratic presidential candidate Hillary Clinton are going to want us to see them as heroes for their efforts to shame pharmaceutical company Mylan into lowering the cost of an allergy treatment for some people. EpiPens, used to provide injections of epinephrine in cases of severe, potentially life-threatening allergy attacks, have been creeping up in price from $100 to $600 per dose since 2009. This has become a political issue right now (at the height of an election cycle—go figure) partly because of attention by Sen. Amy Klobuchar (D-Minn.), whose daughter uses them. Clinton has waded into the debate and called the price hikes "outrageous, and just the latest example of a company taking advantage of its consumers." It would be more accurate to say that the company is taking advantage of the fact that the federal government's own regulatory scheme has given them a medical monopoly. Clinton wants to cast herself and the government as the cure for this problem. It's actually the cause in any number of ways. The Wall Street Journal detailed extensively as Clinton threw herself into the conflict that the Food and Drug Administration (FDA) has made it very difficult for competitors to enter the marketplace and push prices downward. Epinephrine is cheap and EpiPens have been around for decades. Their prices should be trending downward not upward. But the FDA's complicated (and ambiguous) process of approving other drug delivery systems has kept competitors off the market. And to be clear, there are other companies trying to participate and demonstrate they can provide safe alternatives: But no company has been able to do so to the FDA's satisfaction. Last year Sanofi withdrew an EpiPen rival called Auvi-Q that was introduced in 2013, after merely 26 cases in which the device malfunctioned and delivered an inaccurate dose. Though the recall was voluntary and the FDA process is not transparent, such extraordinary actions are never done without agency involvement. This suggests a regulatory motive other than patient safety. Then in February the FDA rejected Teva's generic EpiPen application. In June the FDA required a San Diego-based company called Adamis to expand patient trials and reliability studies for still another auto-injector rival. Mylan's CEO, Heather Bresch, is the daughter of Democratic West Virginia Sen. Joe Manchin, by the way. Bresch is pointing the finger (accurately) toward the many different folks who have their hands in the till when it comes to drug sales. Part of the company's solution will be to allow people to order EpiPens directly from Mylan because "more than half the amount paid by the health care system for EpiPens goes to pharmacy benefit managers, insurers, wholesalers and pharmacy retailers, not to the company itself." Yet, even as it's clear that both a lack of competition and the contributions of heavy regulation and bureaucracy play big roles in driving up drug prices, some people still want to lay the blame on capitalism. It shouldn't come as a surprise if the ultimate outcome of the fight is some mild reduction of price so that lawmakers (and Clinton) can claim that they've fought the drug companies and won. Few will consider that approving those other delivery systems the Wall Street Journal mentioned might actually drive the costs to consumers down even further. Nobody's going to win votes that way.[...]