Published: Wed, 26 Oct 2016 00:00:00 -0400
Last Build Date: Wed, 26 Oct 2016 03:17:16 -0400
Thu, 13 Oct 2016 08:30:00 -0400The 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 has reconsidered it in response to political pressure, as opposed to new evidence. Suddenly Rosenberg's contrived kratom crisis no longer [...]
Tue, 04 Oct 2016 06:00:00 -0400At 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 the daughter of U.S. Sen. Joe Manchin (D–W. Va.), which probably makes things awkward in the Senate cafeteria. But Manchin has joined[...]
Wed, 28 Sep 2016 09:30:00 -0400Great 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.[...]
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:
src="https://www.youtube.com/embed/nerWf9Vydn4" allowfullscreen="allowfullscreen" width="560" height="340" frameborder="0">
Fri, 23 Sep 2016 10:59:00 -0400The 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 American story notes, major outlets such as Fox News and National Journal sometimes didn't receive invites to pre-release press briefings a[...]
Sat, 10 Sep 2016 08:00:00 -0400Natural 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 owners," says Pearson. Sure enough. "Food processors, such as Ocheesee, who choose not to replenish essential nutrients to the standardized[...]
Sun, 04 Sep 2016 12:24:00 -0400In 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 drug price hikes like these. As part of my plan, I've made clear that pharmaceutical manufacturers should be required to explain significant[...]
Fri, 02 Sep 2016 10:20:00 -0400The 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 researchers say, "then national estimates of nicotine prevalence increase by a much smaller percentage of 23–38% across the three grades,"[...]
Fri, 02 Sep 2016 07:00:00 -0400
Thu, 25 Aug 2016 11:50:00 -0400Angry 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.[...]
Wed, 24 Aug 2016 06:30:00 -0400
(image) Rick Doblin, who as head of the Multidisciplinary Association for Psychedelic Studies (MAPS) has been trying for years to jump through the hoops required to get marijuana approved as a medicine, says the Drug Enforcement Administration's new willingness to license more than one producer of cannabis for research will finally make it at least theoretically possible to complete that process.
The National Institute on Drug Abuse (NIDA) has long had exclusive control over the legal supply of marijuana, which is grown by a single contractor at the University of Mississippi. In a legal battle that lasted more than a decade, MAPS tried to break that monopoly, which was a crucial barrier to meeting the Food and Drug Administration's requirements for approving a new medicine. The problem was not just the quality and variety of marijuana available from NIDA, or the agency's lack of enthusiasm for studies aimed at demonstrating the drug's benefits rather than its hazards. It was also the fact that NIDA's marijuana is available only for research, not for sale to patients following FDA approval.
"The FDA requires the Phase III studies be conducted with the exact same drug that the sponsor of the research is trying to market," Doblin explained in a recent interview on the Pacifica drug policy show Century of Lies. "So as long as the NIDA monopoly was in existence, FDA would never accept its marijuana for use in Phase III, and we could never get data that was necessary to reschedule."
MAPS is about to start a Phase II study of marijuana as a treatment for post-traumatic stress disorder in veterans, for example, but it has to use marijuana from NIDA. Since federally approved researchers are not allowed to buy marijuana from state-licensed suppliers in Colorado or Washington, NIDA is the only legal source. One problem with that is MAPS could not get all the strains it wanted: It asked for one with 12 percent THC and 12 percent cannabidiol (CBD), which NIDA did not have. But even if NIDA had a bigger variety, its marijuana would not be suitable for Phase III studies should the Phase II results look promising.
Now that the DEA has agreed to authorize other growers, research sponsors like MAPS can apply for licenses or contract with new licensees, which will make it possible to ensure that the marijuana used in their studies is the same as the marijuana they plan to make available as a medicine. "What's been so frustrating [is] that, on the one hand, the federal government has said there's not enough evidence to reschedule marijuana," Doblin said, "but on the other hand, they've blocked the ability to get the evidence. And so now that DEA has said that they'll end the NIDA monopoly, that evidence can be gathered....It's going to take four to six years, it could be $15 to $25 million, to gather it. But at least it's possible now, whereas before it was not possible."
Sat, 20 Aug 2016 08:00:00 -0400A recent survey published by the International Food Information Council found that Americans are concerned about food safety. Foodborne illness resides as the top concern of survey respondents. These facts may sound worrying. Thankfully, they don't tell the whole story. The survey also reveals that fully two-thirds of Americans are confident in the safety of the nation's food supply. Data support that confidence. For example, the number and severity of foodborne illnesses appears to be trending downwards in many places, including California. Part of our confidence in our food supply no doubt stems from regulations. But rules can (and often are) imperfect, something I detail at length in my forthcoming book, Biting the Hands that Feed Us: How Fewer, Smarter Laws Would Make Our Food System More Sustainable. And, as I wrote about in a 2012 law-review article, regulations intended to make our food safer often impose new costs but fail to improve safety. Earlier this week—keeping the above facts in mind—the FDA published final rules to clarify and update its "GRAS" classification system. The acronym "GRAS," which stands for "generally recognized as safe," refers to the status of permissible food additives. GRAS rules have been controversial for some time. On the one hand, critics have viewed the self-policing approach favored by the rules as too heavily weighed in favor of food producers and, ergo, bad both for consumers and food safety. On the other hand, the rules may give consumers a false sense of safety. Even then, the FDA is hardly handcuffed by GRAS. In 2015, for example, the agency effectively banned partially hydrogenated oils that contain trans fats, declaring these oils "are no longer GRAS." Many, me included, viewed the ban as a foolhardy attack both on food freedom and on the food industry, and an overstepping of the agency's powers under the GRAS rules. It probably comes as no surprise that the new rules have also proven controversial, and for some of the same old reasons. Sen. Ed Markey (D-Mass.) blasted the updated rules, which include continued voluntary reporting by the food industry, as the equivalent of "a self-graded take home exam that industry doesn't even have to hand in." Food Safety News reported "publication of the final rule has generated opposition from some of the so-called food police groups." But a group of toxicologists surveyed by Food Navigator, a source of news on the food industry, argued "critics have not provided any evidence that the GRAS system is putting the public at risk." Neither is the food industry. And it's America's food producers who I believe are rightly due a great deal of credit not just for the safety of the nation's food supply but also for our confidence in that food supply. Take McDonald's. The company, which has seen its stock rebound after it switched to an all-day breakfast menu, has been testing out fresh beef in some restaurants. (The company's burgers are currently made from frozen beef.) Though that's something consumers appear to want, many of the company's franchisees worry that the switch could lead to increased incidents of foodborne illness. Competitors, including Wendy's and In-N-Out Burger, already use fresh beef. Whatever the ultimate decision is from McDonald's, it's likely one that will strive to balance consumer demands with food safety. Businesses outside the food industry are also working to make food safer. A recent study by IBM researchers on the use of "big data" to mitigate outbreaks of foodborne illness found promising results. "IBM announced its scientists have discovered that analyzing retail-scanner data from grocery stores against maps of confirmed cases of foodborne illness can speed early investigations," reports the website Phys.org. Thank[...]
Fri, 19 Aug 2016 09:16:00 -0400This week, responding to one of the lawsuits challenging its e-cigarette regulations, the Food and Drug Administration (FDA) further muddied the question of whether those regulations apply to products that do not contain tobacco-derived nicotine. The lawsuit, which was brought by Nicopure, a manufacturer of e-liquids and vaping systems, argues that such a result would be unfair, illogical, and illegal. In response, the FDA says Nicopure has failed to show that any of its nicotine-free liquids are actually covered by the regulations and therefore has no standing to challenge that aspect of the rules. At the same time, the FDA concedes that "e-liquids marketed as 'nicotine-free' may properly be considered tobacco products—or components or parts thereof—under certain circumstances." What circumstances are those? "Some e-liquids 'claiming to be nicotine-free actually contain high levels of nicotine," the FDA says, quoting its regulations. "Others are tobacco flavored, and are thus 'made or derived from tobacco' regardless of their nicotine content." Does that mean e-liquids are not subject to the FDA's burdensome, prohibitively expensive regulations as long as they do not contain nicotine or any other tobacco derivative? No, because the FDA's definition of "tobacco product" does not require nicotine or any other tobacco derivative. The Family Smoking Prevention and Tobacco Control Act, the statute that gave the FDA authority over tobacco products, defines them as products "made or derived from tobacco that [are] intended for human consumption, including any component, part, or accessory of a tobacco product." In deeming e-cigarettes to be tobacco products, the FDA defined "component or part" as "any software or assembly of materials intended or reasonably expected...to alter or affect the tobacco product's performance, composition, constituents, or characteristics" or "to be used with or for the human consumption of a tobacco product." Hence vaping equipment, whether a closed, disposable e-cigarette or an open system with a refillable tank and parts that can be switched out, is a "component or part" of a tobacco product, which means it is also a tobacco product. Does that mean a nicotine-free e-liquid is a "component or part" of a tobacco product—i.e., the vaporizer? The FDA can't or won't give a straight answer to that question. "The only nicotine-free e-liquids that the rule brings under the FDA's regulatory authority are those that are made or derived from tobacco (such as tobacco-flavored varieties) or that otherwise meet the definition of a 'component' or 'part,'" it says. "Thus, nicotine-free e-liquids not made or derived from tobacco are subject to the deeming rule only where they meet the definition of a 'component or part.'...Whether nicotine-free e-liquids meet this definition 'will be evaluated on a case-by-case basis.'" That means a company like Nicopure cannot know ahead of time which of its products are covered by the regulations. It can only find out by asking the FDA about each one, a process that will carry its own costs, even if they do not rise to the hundreds of thousands or millions of dollars that each "premarket tobacco product application" is expected to cost. The FDA's position is that Nicopure can't challenge the potential regulation of its nicotine-free e-liquids because it does not know whether they will actually be regulated. Never mind that it doesn't know because the FDA won't say.[...]
Wed, 17 Aug 2016 15:40:00 -0400After a bad batch of shampoo made some customers hair fall out, the New York Times ran a front page story on Tuesday asking whether Congress should give the Food and Drug Administration more regulatory authority over hair and skin products. The entire piece is an exercise in "do-somethingism," since there are already better ways for the market—and yes, even the government—to deal with the problems created by Wen Hair Care, the shampoo product at the center of a $26 million class action lawsuit. It appears that the article was prompted by ongoing congressional efforts to apply more regulations to the cosmetics industry and give the FDA authority to issue recalls of skin and hair products. More on that in a moment. First, the facts. The piece starts off wanting you to know that Los Angeles hairstylist Chaz Dean made "millions" by selling a variety of scented hair care products. Those same products ended up prompting more than 21,000 complaints from consumers who experienced unwanted itching, rashes and even widespread hair loss after using Dean's Wen Hair Care products. Without even pausing to consider whether those people have another sort of recourse besides an expensive expansion of federal regulatory power (spoiler alert: they do), the Times turns to U.S. Sens. Dianne Feinstein, D-California, and Susan Collins, R-Maine, who are pitching new legislation to require the FDA to do additional testing of cosmetic products and give the FDA authority to issue mandatory recalls for "products found to be unsafe." There's good reason to feel sympathy for the victims here—no one expects to end up temporarily bald because they purchased a bottle of supposedly "revolutionary" shampoo and they are right to be upset about it—but the lack of federal regulations on cosmetics didn't cause this problem and isn't the best way to fix it. Let's start by looking at what happened to those "millions" that Chaz Dean made by apparently swindling unsuspecting consumers. A class action lawsuit against Wen Hair Care and its manufacturer, Guthy-Renker LLC, resulted in a $26 million settlement for the plaintiffs. The settlement awards $25 to any person who bought a bottle of Wen and up to $20,000 to anyone who experienced bodily harm or hair loss after using the product. That's how the government should be involved in a situation like this: in a judiciary role to work out a settlement between the aggrieved parties and the business responsible for misleading them. The system works! The Times article suggests this application of government is not enough; that the federal authorities must be more active to prevent this sort of thing from happening at all or at least to respond more quickly when it does. The FDA must be able to force companies to recall potentially problematic products, Feinstein and Collins argue. When trying to decide whether the government should have the authority to force businesses to recall products, it's important to know how recalls work. In almost all cases, recalls are voluntary actions taken by manufacturers. That's true whether we're talking about cosmetic products regulated by the FDA or whether you're looking how the National Highway Traffic Safety Administration oversees recalls of defective automotive parts. Even when comes to issues of food safety—certainly an area where there is a greater potential threat to public health and safety than what is created by bad shampoo—the FDA can only request a recall. The final decision rests with the food supplier, and oftentimes businesses will initiate their own recalls without being asked by the FDA because it's generally accepted that lying to your customers or making them sick isn't good for business. The same is true h[...]
Mon, 15 Aug 2016 19:20:00 -0400I'm pleased as punch today to play a very small role in the launch of media site Freethink. If that media outlet name sounds familiar, it may be from one of two things (or both!): Freethink's Honor Flight Veterans Day documentary that we've highlighted here at Reason; or from Freethink Media partner Kmele Foster, formerly of The Independents and currently participating in "The Fifth Column" podcast with Matt Welch. Today they've rolled out the first of a series of "shows," video segments about innovation in tech, policy, and culture, with some additional useful contextual articles. Here's Freethink's stated mission: Each week, we release a new video featuring passionate innovators who are solving humanity's biggest challenges by thinking differently. From aerospace engineers in the Mojave Desert to entrepreneurs in South America's biggest slum, our videos give you an intimate look at not only what they're doing but also why they're doing it, the obstacles they face, and what motivates them to keep driving forward. We're betting that after you watch these stories, you'll come away with insights and inspiration you can use to make a difference in your own way. Today's release is titled "Superhuman," a package about the scientific, medical, and engineering innovations that are helping cure diseases once thought incurable, replace body parts, and otherwise improve and prolong human life. My own contribution is a short background piece explaining how AIDS activism in the late 1980s and early 1990s served as the spiritual precursor to the current "right to try" movement. That's the increasingly successful effort to grant citizens with life-threatening conditions to right to try to get access to potentially helpful drugs before the full government testing process has been completed. Here's an excerpt: In the late 1980s, Americans were dying by the thousands from the opportunistic infections that came from full-blown AIDS. There was a single drug approved by the Food and Drug Administration permitted to help prolong the lives of people with AIDS. This first drug, azidothymidine—or AZT—was approved for use in AIDS patients in what was a remarkably fast process for the FDA at the time: 25 months. But AZT had some very serious side effects that caused other health threats, and not all AIDS patients could endure the treatment. The lack of "officially" approved treatment options gave rise to a large black market to provide access to non-permitted and foreign medicines in order to bypass the FDA. This black market was most famously highlighted in the 2013 Academy Award-winning film "Dallas Buyers Club," based on real-life drug smuggler (and AIDS patient) Ron Woodroof. Woodroof was not unique. There were groups of people across the country working to bring drugs into the United States from Mexico, Europe, and elsewhere, regardless of the FDA's approval process. Read my full piece here. And watch and read the other components of "Superhuman" at Freethink here. Some additional pieces are contributed by a name many Reasoners may find familiar: former Reason Associate Editor Mike Riggs.[...]