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All articles with the "FDA" tag.

Published: Sun, 24 Sep 2017 00:00:00 -0400

Last Build Date: Sun, 24 Sep 2017 04:24:55 -0400


FDA Pushing Forward with Terrible Menu-Labeling Rules

Sat, 02 Sep 2017 00:01:00 -0400

The Food and Drug Administration (FDA) has announced the agency will forge ahead with implementing the Obama administration's costly, misguided, pointless, reckless, and potentially unconstitutional menu-labeling rules. "As a doctor, father[,] and the head of the U.S. Food & Drug Administration, I believe that everyone is entitled to the information they need to make informed decisions about the food they eat," FDA Commissioner Scott Gottlieb said in a statement earlier this week. "We serve as the nation's expert on food labeling, which is why Congress entrusted us with the responsibility of crafting predictable, uniform federal standards that will benefit the health of families across America by ensuring access to essential calorie and nutrition information on food and menu labels." I will give Gottlieb that he's a doctor, father, and the head of the FDA. After that, the facts become murky. For example, if the FDA were indeed "the nation's expert on food labeling," as Gottlieb claims, one way the agency might demonstrate that expertise is by not forcing America's food manufacturers to change their food labels every couple years. Nevertheless, Gottlieb's rationale about Americans' nebulous entitlement to information is predictably familiar. It's been trumpeted in recent years by those who support mandatory labeling of genetically modified (GMO) foods, mandatory "added sugar" labeling, mandatory trans fat labeling, and pretty much every other potential food-labeling requirement under the sun. So what's wrong with mandatory menu labeling? For one, as Politico reported this week in a piece on the FDA's menu labeling plans, there's some debate over its effectiveness. "[E]vidence on whether it works is mixed," Politico notes. "Some studies have found that it helps certain individuals, especially women, eat slightly fewer calories, but others have found no effect." I wish Politico had also reported perhaps the most significant evidence around menu labeling: Its very basis is a ruse. Research has shown mandatory menu labeling doesn't help most people choose to eat fewer calories, and may in fact push people to eat more calories. "Who cares about calories?" asked a 2013 NBC News headline. "Restaurant menu labels don't work, study shows." "[A]t no time did the labels lead to a reduction in the calories of what diners ordered," the New York Times reported in 2015. "Even if people noticed the calorie counts, they did not change their behavior." Estimates of the escalating costs of complying with the FDA rules is another reason to hate the rules. A new study by the National Association of Convenience Stores (NACS), estimates the regulations will cost its members more than $84 million each year. "The way the FDA rule is written makes it virtually impossible for businesses to comply with the regulations even though they will spend billions over the next several years trying to do so," says economist David Zorn, who authored the NACS study. Compliance costs for the entire food industry are estimated to run somewhere north of $300 million per year. Even with all those costs, attempting to comply with the rules may prove futile. As I wrote earlier this summer, complying with these rules may be somewhere between difficult and impossible for many food sellers. Take, for example, pizza-delivery outfits like Domino's. "With 34 million ways to make a pizza, it makes no common sense to require this industry—which already discloses calories voluntarily, for the most part—to attempt to cram this information on menu boards in small storefronts," said Lynn Liddle, who chairs the American Pizza Community, a coalition representing much of the American pizza industry, in an email to me in 2013. If menu labeling is costly, impossible, and ineffective—something I've written time and again—then why doesn't the FDA just scrap the plan altogether? The truth is that the issue is largely out of the agency's hands. Congress passed a law that requires the FDA to develop menu-labeling rules as part of the Affordable Care Act. "Unfortunately, the FDA do[...]

Vaccines, Peter Thiel and the Fine Art of the Journalistic Hatchet Job

Fri, 01 Sep 2017 18:10:00 -0400

"Peter Thiel Funds 'Unethical' Offshore Herpes Vaccine Trial," blared a headline over at the DailyBeast. The single problem is that it's false. The story is illustrated with a photoshop of venture capitalist Peter Thiel holding a menacing syringe. Even more damning, the editors added, "The Trump adviser is part of a group of wealthy businessmen spending millions to test the vaccine on people—while evading Food and Drug Administration regulations." Which is also false. The DailyBeast article was published on August 27. The headline for the biotech news site genomeweb's summary of the story reads, "A Libertarian Vaccine?" The headline and the story appear to be an instance of never letting facts get in the way. Unwary readers encountering the artfully constructed article would likely be led to conclude that a cabal of greedy libertarian venture capitalists had experimented on desperate people without their consent. The problem that the startup in the story, Rational Vaccines, is taking on is huge. In the United States, more than 23 million people—about one in seven people ages 14 to 49 —have genital herpes. As many as three million suffer herpes outbreaks four to 24 times per year. Those who suffer frequent outbreaks experience open sores, considerable pain, frequent headaches, and the infection sometimes results in blindness and life-threatening bouts of meningitis. Chronic sufferers experience stigma and social isolation. The vaccine trial referred to in the story took place more than a year ago. Thiel Capital actually invested on August 23. So what gives? What actually happened is that in 2015 and 2016 Southern Illinois University viral immunologist William Halford set up a trial of his attenuated herpes simplex 2 (HSV-2) vaccine. He inoculated 20 volunteers from the U.S. and U.K. at a site on the Caribbean island country of Nevis and St. Kitts. Rational Vaccines reported in an October, 2016 press release participants had, on average, experienced a 3-fold reduction in their herpes symptom-days per month relative to their experience taking standard treatment antiviral drugs. Halford submitted his results to a peer-reviewed journal that initially rejected his paper and asked for further data. Halford had years earlier contracted a rare form of cancer and died in June at age 48. Halford had been researching herpes viruses for more than two decades. Eventually he came to question the medical consensus that vaccines should be developed using viral protein subunits. Previous virus vaccines including polio, measles, rubella, and chickenpox had been created using live-attenuated viruses. Such vaccines used weakened versions of viruses that could not cause disease to prime the immune system protect against natural strains. By the 1980s, many vaccine researchers concluded that using proteins derived from disease-causing viruses was safer. However, Halford's research convinced him an HSV subunit vaccine would be relatively ineffective because HSV genomes are much more complicated than simpler human papillomavirus and hepatitis B viruses. Attempts to develop HSV subunit vaccines have so far not borne fruit. In lab mice his live-attenuated vaccine elicited 10 to 100 times greater protection against genital herpes than a subunit vaccine did, Halford reported. To check its safety, Halford injected himself with his own vaccine. Rational Vaccines is developing both a therapeutic vaccine for people who are already infected and a prophylactic vaccine to protect the rest of from becoming infected. Halford and Augustin Fernandez III, CEO investor in Rational Vaccines approached Thiel Capital and other possible venture investors in April 2017, after the preliminary results of the initial trial were in. Fernandez says he never spoke with Thiel, but met with Jason Camm, chief medical officer of Thiel Capital. In an interview, Fernandez confirmed that Thiel Capital did not formally invest in the current $7 million round of financing until August 23. Then all hell broke loose. As usual with clinical trials, Rati[...]

Pizza Is Awesome and the FDA Sucks

Fri, 01 Sep 2017 07:02:00 -0400

Don't get me wrong: Food and Drug Administration (FDA) Commissioner Scott Gottlieb is my dude. He's is one of the best things about the Donald Trump administration. In his short time as the head of America's top regulator of stuff we put into our faces, he's been doing good work and saying good stuff on drug pricing, vaping (mostly), and health tech regs. Matt Welch gives him a high-five in Reason's June cover story about deregulation. And I understand that, pace Littlefinger, he can't be fighting every battle, everywhere, always. But Gottlieb whiffed on this one: On Friday last week, when you might have been distracted by a few other small news items, he declared himself "pleased to announce" that he's caving on long-delayed implementation of Obama era regulations (Section 4205 of the Affordable Care Act, "Nutritional Labeling of Standard Menu Items at Chain Restaurants") that require a huge swath of restaurants, cafes, and other vendors to slap calorie counts and other nutritional information all over their menu boards. The battle over menu labeling has been lengthy and arduous. As I wrote more than six years ago in "The Federal Government Wants You to Know That Your Pizza Contains Between 1,840 to 3,740 Calories. You're Welcome," these rules are ill-suited to the way the fast casual sector of the food industry functions. When restaurants have lots of options for customization and many different sizes, labeling each option becomes cumbersome quickly. Blessed are the pizzamakers for they have been on the front lines, since Domino's and co. feared they would suffer most as regs made getting a pie a little more expensive and a little more annoying for every single one of their customers. But as some provisions were gradually tweaked to accommodate folks with big lobbying shops, that opposition has dwindled. In fact, the restaurant industry has basically more or less given in on this, having already spent many of the hundreds millions of bucks compliance costs as the deadlines drew ever closer. And Gottlieb, bless his heart, retreated to the highest ground available to him: transparency. He's right that transparency is good. (He might want to mention that to his boss, incidentally.) As a doctor, father and the head of the U.S. Food & Drug Administration, I believe that everyone is entitled to the information they need to make informed decisions about the food they eat. But elaborate hyper-specific federal regulations are not the appropriate way to achieve that transparency, and they come with an epic list of unintended consequences. So here's my last cry into the darkness: They're now a fait accompli, but menu labeling mandates are still bad. They're expensive, as even the FDA itself acknowledges. They're ineffective tools to reduce obesity. They are redundant to existing regulations which already require restaurants to make nutrition information available online and in handouts, doubly so in a country where nearly everyone carries all of human knowledge in their pockets every day all day. The regulations lag change in private industry, where many restaurants were already responding voluntarily (and more intelligently) to demand for more information and healthier choices. The government's commitment to the labeling rules will almost certainly outlast the validity nutrition science they are based on. Plus they encourage bad graphic design.[...]

FDA Lies About Vaping While the CDC Inches Toward the Truth

Thu, 31 Aug 2017 14:15:00 -0400

Between 2011 and 2016, according to survey data from the U.S. Centers for Disease Control and Prevention, cigarette smoking by teenagers fell by half, cigar smoking fell by a third, pipe smoking fell by two-thirds, and smokeless tobacco use fell by a quarter. Yet according to the Food and Drug Administration, there were "no significant declines in overall high school tobacco use" during that period. How is that possible? Let me answer that riddle by posing another one. If you call an e-cigarette a tobacco product, and the incidence of past-month vaping among high school students more than sextupled from 2011 to 2016, how does that affect the trend in overall tobacco use? The answer is that it does not affect the trend in overall tobacco use at all, because calling an e-cigarette a tobacco product does not make it a tobacco product. Yet that is what FDA does, partly for regulatory reasons. E-cigarette fluid often contains nicotine derived from tobacco, which supposedly transforms a tobacco-free product into a tobacco product, giving the FDA authority to regulate it. The FDA maintains that pretense even when reporting what is happening in the real world. The result, as Boston University public health professor Michael Siegel notes on his tobacco policy blog, is an alternative reality where dramatic declines in adolescent tobacco consumption never happened. The CDC plays the same game, falsely claiming "current use of any tobacco product did not change significantly" among high school students from 2011 to 2016. This blatant misrepresentation magnifies a problem (underage tobacco use) that the FDA and the CDC are charged with addressing, making their work seem more urgent and more worthy of funding. It also conflates e-cigarettes, a noncombustible, tobacco-free alternative to conventional cigarettes, with products that are far more dangerous, obscuring the enormous harm-reducing potential of this innovation. By lumping e-cigarettes in with tobacco products, the FDA and CDC may hope to scare kids away from them. But the message to current smokers—that they might as well keep puffing away, since all these nicotine sources are essentially the same—is potentially deadly. A new CDC webpage about e-cigarettes gives some ground on that score, conceding that "e-cigarettes have the potential to benefit adult smokers who are not pregnant if used as a complete substitute for regular cigarettes and other smoked tobacco products." But by insisting that e-cigarettes be a "complete substitute," the CDC dismisses the health benefits of smoking less, even if the number of cigarettes per day does not fall to zero. "Dual use is not an effective way to safeguard your health," the CDC says. "Because smoking even a few cigarettes a day can be dangerous, quitting smoking completely is very important to protect your health." This slippery formulation deliberately obscures the fact that smoking a few cigarettes a day is less dangerous than smoking a pack or two a day. If e-cigarettes help smokers make that change, they are reducing tobacco-related harm. The CDC's discussion of how the health hazards of vaping compare to those of smoking is similarly misleading. "Are e-cigarettes less harmful than regular cigarettes?" it asks. "Yes—but that doesn't mean e-cigarettes are safe. E-cigarette aerosol generally contains fewer toxic chemicals than the deadly mix of 7,000 chemicals in smoke from regular cigarettes. However, e-cigarette aerosol is not harmless. It can contain harmful and potentially harmful substances, including nicotine, heavy metals like lead, volatile organic compounds, and cancer-causing agents." Sadly, it counts as an improvement that the CDC is willing to explicitly say e-cigarettes are less harmful than regular cigarettes instead of dodging the question entirely. But you would not guess from its gloss that vaping is something like 95 percent safer than smoking, that potentially harmful substances in e-cigarette aerosol are typically present only in[...]

FDA Deems MDMA, Banned Since 1985, a 'Breakthrough Therapy'

Mon, 28 Aug 2017 12:30:00 -0400

Two decades after the Drug Enforcement Administration banned MDMA, classifying it as a dangerous intoxicant with no accepted medical use, the Food and Drug Administration has deemed the same substance a "breakthrough therapy." The designation should speed MDMA's approval as a prescription medicine, which could happen as soon as 2021. That remarkable turnaround is thanks to the hard work of a plucky and persistent organization known as the Multidisciplinary Association for Psychedelic Studies (MAPS), founded the year after the DEA banned MDMA. Last fall the FDA gave MAPS a green light for Phase III studies of MDMA as a treatment for posttraumatic stress disorder (PTSD), the last stage before approval of a new medicine. MAPS, which plans to start enrolling subjects for its first Phase III study this spring, announced on Saturday that MDMA had qualified as a breakthrough therapy. The designation, created by the Food and Drug Administration Safety and Innovation Act of 2012, means the FDA thinks MDMA "may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development." It is not hard to see why the FDA reached that conclusion, given the very promising results of the MAPS-sponsored Phase II studies conducted by Charleston, South Carolina, psychiatrist Michael Mithoefer and his wife, Annie, a psychiatric nurse. The subjects in the first study were crime victims, mainly women who had been raped or sexually abused. More than four-fifths of the subjects who received MDMA in conjunction with psychotherapy showed a clinical response, meaning they saw reductions greater than 30 percent in the severity of their PTSD, as measured by the Clinician-Administered PTSD Scale (CAPS). The mean CAPS score in this group fell from about 80 to less than 30. Ten of the 12 subjects, all of whom began with CAPS scores indicating severe PTSD, no longer qualified for the diagnosis. By comparison, 25 percent of the subjects who received placebos saw improvements of more than 30 percent. Seven of the eight subjects in the control group subsequently chose to take MDMA, and all of them showed a clinical response. That study, published by the Journal of Psychopharmacology in 2011, had a small sample, and blinding probably was less than fully effective, since subjects may have surmised they were getting the real thing based on the effects they perceived. But follow-up evaluations conducted 17 to 74 months after the last treatment found that the improvements experienced by the subjects who received MDMA generally persisted. While two of the 16 subjects who completed all of the evaluations relapsed, the average CAPS score was essentially unchanged. A subsequent MAPS-sponsored study involved 21 Iraq and Afghanistan veterans, plus three firefighters and one police officer. The results, which have been shared with the FDA but have not been published yet, were similarly impressive. Instead of using an inactive placebo, as the earlier study did, this one randomly assigned subjects to receive either 30 milligrams, 75 milligrams, or 125 milligrams of MDMA, followed by supplementary doses equal to half the original upon request. Summarizing the results at a MAPS conference last April, Mithoefer said there was "not much improvement" in the 30-milligram group but "quite a lot of improvement with the other doses." Mean CAPS scores, which ranged from 80 to 90 at the beginning, fell to between 70 and 80 in the low-dose group, less than 50 in the high-dose group, and less than 30 in the medium-dose group. In addition to the breakthrough-therapy designation, the FDA has reached an agreement with MAPS on the design for the Phase III studies. Among other things, the FDA agreed with Rick Doblin, founder and executive director of MAPS, that an inactive placebo, as in the first Phase II study, was more appropriate than the active one used in the vet[...]

Lawsuit Shows Muddied Waters over What Counts as 'Spring Water'

Sat, 26 Aug 2017 08:00:00 -0400

Earlier this month, a group of plaintiffs filed a federal class-action lawsuit against food and beverage maker Nestlé. The 325-page suit, filed in U.S. District Court in New Jersey, argues Nestlé's Poland Spring Water is not actually spring water but is instead "common groundwater that doesn't meet the [FDA] definition of spring water." Consequently, the suit claims, Poland Spring Water's marketing amounts to "a colossal fraud perpetrated against American consumers." The suit seeks damages and injunctive relief for the alleged fraud under both federal law and the consumer-protection laws of several states. The lawsuit comes just as Poland Spring plans to open a new $50 million bottling facility in Maine, where it plans to add 80 new jobs. The company refutes the claims in this month's lawsuit. "[T]he claims made in this lawsuit are without merit and an obvious attempt to manipulate the legal system for personal gain," the company says in a statement. "We are highly confident in our legal position and will vigorously defend ourselves against the frivolous claims in this lawsuit." This isn't the first time Poland Spring has landed in hot water (so to speak) over its marketing claims. The company settled a 2003 class-action lawsuit, filed in state court in Connecticut, that claimed, the New York Times reported at the time, "Nestlé draws its water from a site 30 miles away from the original Poland Spring and often uses ground water and a spring that is near the site of a former garbage dump." Bottled water sales and marketing are tightly regulated. Though there are myriad rules that apply to bottled water, no rules require a bottled water maker to identify its source. For example, neither Aquafina (Pepsi) nor Dasani (Coca-Cola) claims to be a "spring water." Both source their water from municipal water supplies. They sell packaged tap water, in other words, and don't claim otherwise. Fiji, on the other hand, markets its spring water as "spring water." Its spring water comes from springs in Fiji. When a seller chooses to make claims about its source—such as Fiji and Poland Spring—then they open themselves up both to government scrutiny and lawsuits if those claims are of dubious validity. FDA rules, for one, state that water may be referred to as "spring water" only if the water is 1) collected at the spring or via "a bore hole tapping the underground formation feeding the spring" and 2) the location of the spring is identified. Poland Spring indicates online that its waters come from eight springs in Maine. The company admitted in 2013 that about one-third of its spring water came from Poland Spring. Today, Nestlé isn't exactly hiding the ball about its use (or lack thereof) of Poland Spring's eponymous spring. The company's website notes they "no longer use the original Poland Spring source" to bottle their water. So who's right here: Nestlé, or the people suing them? I don't really have an opinion. As I've written countless times, questions such as whether Nestlé's Poland Spring Water is or is not fraudulent are exactly the sort of matters that are best addressed by courts. This is part of my belief, firmly rooted in the First Amendment, that food labels should be open "to any and all statements that aren't demonstrably false," as I wrote in a 2012 column. Who should decide the question of falsity? Courts. That's the ideal outcome for any First Amendment question. But the FDA's involvement in crafting definitions for foods of many sorts—known as "standards of identity"—unfortunately serves to muddy the waters. Like every standard of identity, the FDA's standard of identity for spring water, which the plaintiffs in the present lawsuit cite in support of their claims, tends to confuse consumers and food makers alike, and can spur litigation where none might otherwise exist. Remember the lawsuit challenging a Florida standard of identity for skim milk that said a small creamery[...]

Canadians Can Eat Genetically Enhanced Salmon; Americans Can't

Wed, 16 Aug 2017 10:25:00 -0400

Our neighors to the north can now enjoy salmon genetically enhanced to grow faster and eat less feed. Thanks to absurd overregulation, Americans can't. The Atlantic salmon are enhanced using a Chinook salmon gene that enables them to grow much faster using less feed. Nature News reports that AquaBounty Technologies, which developed the fish, has now sold nearly five tons of it to customers in Canada. The company applied to the Food and Drug Administration (FDA) to get approval for its genetically enhanced salmon back in 1995; it took the agency til 2015 to rule that AquAdvantage salmon, as the product is known, "is as safe to eat as any non-genetically engineered (GE) Atlantic salmon, and also as nutritious." Health Canada approved it for sale six months later. But you still can't buy it here in the U.S. The usual claque of anti-science activists are suing the FDA in an effort to block the company from marketing the fish. And Alaska Sen. Lisa Murkowski, aiming to protect her state's salmon fishers from competition, has inserted a rider in the agriculture spending bill that bans the sale of enhanced salmon until the the FDA publishes its final labeling guidelines. Murkowski claims that Americans must be warned that AquAdvantage salmon are "frankenfish." As a general regulatory principle, genetically enhanced foods do not have to be labeled unless they are nutritionally different than their conventional versions. Canada sensibly does not require special labels on AquAdvantage salmon. AquaBounty is currently raising its sterile triploid salmon in an onshore facility in Panama. In June the company announced that it will expand a Prince Edward Island production facility and has acquired a fish farm in Indiana, where it plans to begin raising its enhanced fish for the U.S. market. Aquabounty sold its fish at wholesale for $5.30 per pound in Canada. In comparison, Tradex Foods reports that the current price on fresh atlantic salmon (farmed) in Miami for trimmed fillets is $4.25-$4.30 per pound. In any case, Alaskan fishers should rest easy. The Aquabounty facility in Indiana would produce about 1,200 tons of Atlantic salmon annually. Americans annually consume about 180,000 tons of Atlantic salmon, of which 170,000 tons are imported. Only 2,000 tons of Atlantic salmon are wild-caught. Most of the 105,000 tons of Pacific salmon is wild and is caught in domestic waters. Congress has tied the FDA's hands with respect to the AquAdvantage salmon, but the agency could do a great deal of good by withdrawing the scientifically ridiculous draft regulations meant to govern genomically improved livestock, which the Obama administration issued on its way out of the door in January. Personally, I dislike the flavor of salmon. But I plan to eat an AquAdvantage fillet as soon as I can legally lay hands on one.[...]

Most Drug Expiration Dates Are Bogus, and the FDA Knows It

Mon, 14 Aug 2017 12:35:00 -0400

(image) Hospitals in the U.S. throw away $800 million worth of unused medicine every year, and pharmacies and consumers trash uncounted millions more, all because they didn't use or sell those medicines prior to the date printed on the bottle.

But according to a new report from ProPublica, most of those drugs are safe and effective for years after the expiration date. And the Food and Drug Administration (FDA) knows it.

"It turns out that the FDA, the agency that helps set the dates, has long known the shelf life of some drugs can be extended, sometimes by years," writes ProPublica's Marshall Allen. "In fact, the federal government has saved a fortune by doing this."

Allen explains:

For decades, the federal government has stockpiled massive stashes of medication, antidotes and vaccines in secure locations throughout the country. The drugs are worth tens of billions of dollars and would provide a first line of defense in case of a large-scale emergency.

Each year, drugs from the stockpiles are selected based on their value and pending expiration and analyzed in batches to determine whether their end dates could be safely extended. For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates.

A 2006 study of 122 drugs tested by the program showed that two-thirds of the expired medications were stable every time a lot was tested. Each of them had their expiration dates extended, on average, by more than four years, according to research published in the Journal of Pharmaceutical Sciences.

An official with the Department of Defense, which maintains about $13.6 billion worth of drugs in its stockpile, says that in 2016 it cost $3.1 million to run the extension program, but it saved the department from replacing $2.1 billion in expired drugs. To put the magnitude of that return on investment into everyday terms: It's like spending a dollar to save $677.

I suggest reading ProPublica's entire report, which provides one stunning example after another of bureaucratic cautiousness fueling rational but egregiously wasteful behavior. Hospitals don't dispense perfectly safe but expired drugs because that may expose them to regulatory penalties or lawsuits. Pharmaceutical companies don't push back against the FDA "because regulations make it expensive and time-consuming for manufacturers to extend expiration date." And the FDA won't do anything, because...well, ProPublica doesn't really provide a good explanation. The simplest explanation is that regulatory structures are like weeds: They don't uproot themselves.

There is no top-down fix in sight. The American Medical Association has apparently been drawing attention to this issue for over a decade now, but the FDA has made exceptions only in the case of medicine shortages. But that doesn't mean consumers have to comply.

Crazy Pet Anti-Vaxxers Provoke My Canine Lyme Disease Vaccine Envy

Fri, 04 Aug 2017 13:30:00 -0400

Admittedly it sounds like a spoof or a plot from the TV comedy Portlandia, but the the Brooklyn Paper is reporting that local veterinarians have noticed anti-vax madness has taken hold among Brooklynite hipsters who are refusing to get their dogs and cats inoculated. From the article: Some Brooklynites are refusing to vaccinate their pets against virulent and potentially deadly illnesses — some of which could spread to humans — thanks to a growing movement against the life-saving inoculations, according to borough veterinarians. "We do see a higher number of clients who don't want to vaccinate their animals," said Dr. Amy Ford of the Veterinarian Wellness Center of Boerum Hill. "This may be stemming from the anti-vaccine movement, which people are applying to their pets." ... A Clinton Hill–based veterinarian said she has heard clients suggest the inoculations could give their pups autism, however, echoing the argument of those who oppose vaccinating kids. But even if pooches were susceptible to the condition, their owners probably wouldn't notice, according to the doctor. Let's say it one more time: Numerous studies have debunked the claim that autism is linked to vaccinations. Brooklyn anti-vaxxers should be wary of allowing their pets to romp across the fields and dunes in the Hamptons since the number of Lyme disease carrying ticks has exploded on Long Island this summer. The ticks that latch onto dogs can move along to their owners. The Brooklyn Paper story, however, reminded me pooches do have access to effective vaccinations against Lyme disease while people do not. The one time I was infected from a tick-bite acquired while mowing the grass at my Blue Ridge cabin, I noticed the disease's characteristic bull's-eye rash and immediately got dosed with antibiotics. Looking back, I should have been inoculated with the human version when it was available between 1998 and 2002. Although there were complaints of adverse reactions, follow-on research found that they were no more frequent or dangerous than those associated with other vaccines. Of course, I didn't know then its manufacturer would decide to withdraw the vaccine in the face of a class action lawsuit motivated by anti-vaccine fearmongering. The suit settled in 2003 and the plaintiffs got no compensation. Since the vaccine was withdrawn, the Centers for Disease Control estimates that 300,000 Americans are diagnosed with the disease every year. Thanks a lot, anti-vaxxers! The good news is that the Food and Drug Administration is apparently fast-tracking a new human Lyme disease vaccine from the European biotech company Valneva. It could be approved as early as next year. This time, I won't dilly-dally about getting inoculated.[...]

Will All Seriously Ill Americans Be Granted the ‘Right to Try’ Experimental Meds?

Fri, 04 Aug 2017 13:01:00 -0400

(image) A state-level movement to allow Americans who are seriously and potentially terminally ill to access medication earlier in the approval process may successfully be going national.

The U.S. Senate has approved—by unanimous consent—Senate Bill 204, sponsored by Sen. Ron Johnson (R-Wisconsin) and pushed by the libertarian Arizona-based Goldwater Institute. It mimics legislation in 37 states that allows for people with life-threatening illnesses earlier access to medication being evaluated through the very lengthy Food and Drug Administration (FDA) approval process.

To be clear, this "right to try" legislation does not create a free-for-all when it comes to access to experimental medicine. The bill requires that a person have a life-threatening illness or disease and that the drug in question has already completed the first phase of clinical trials for the FDA.

Furthermore it does not require drug manufacturers or dispensers to provide access if they don't want to, and they cannot be held liable if they refuse (and they can't be held liable if the drug causes harm except in cases of misconduct or negligence). And as a compromise for critics worried about the ethics of letting people access drugs early, drug manufactures who do provide medicine as part of this process will need to report to the government any adverse effects.

The bill now heads to the House of Representatives, where two Republican congressmen have already introduced companion legislation. In a release praising the passage of Johnson's bill, the Goldwater Institute notes how state-level right-to-try laws actually help:

Right to Try is saving lives already. In Texas alone, Dr. Ebrahim Delpassand has helped nearly 100 patients under his state law, providing a treatment that has completed clinical trials but is not yet fully approved for advanced stage neuroendocrine cancer. Many of these patients were told they had only months to live but are still alive a year later, thanks to Right to Try.

Reason has been covering the "Right to Try" movement for years now. Below, watch a ReasonTV explanation video from 2015 about the efforts:

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A Cap on Nicotine in Cigarettes Would Be Hazardous to Health

Wed, 02 Aug 2017 15:20:00 -0400

Robert Proctor, the historian of science who wrote the fascinating 1999 book The Nazi War on Cancer, loves the Food and Drug Administration's idea of "reducing the nicotine in cigarettes to a nonaddictive level." Writing in The New York Times, Proctor, now a professor at Stanford, calls the FDA's proposal "exceptionally good news for tobacco control, and for human health." In fact, he says, "a legal cap on the nicotine in cigarettes could be one of the most important interventions in human health history." I don't think this intervention would work out the way Proctor imagines. His op-ed piece is an excellent example of expecting good intentions to ensure good outcomes, even when experience tells us the policy is bound to backfire. "Cigarettes with nonaddictive nicotine levels would be radically different from what used to be known as 'low tar' or 'light' cigarettes, marketing gimmicks now barred by law," Proctor assures us. "Those cigarettes were advertised as delivering less nicotine and tar into the lungs, even though there was no actual reduction." Although it is by no means clear that "there was no actual reduction," it's true that "light" cigarettes were at best only slightly less harmful than regular cigarettes. But the reason for that casts doubt on the logic of the proposal Proctor is championing. It turned out that smokers who switched to "light" cigarettes tended to engage in "compensatory behavior" that boosted nicotine delivery and moved them closer to their usual dose. They smoked more cigarettes, took more puffs from each one, took bigger puffs, or held the smoke deeper and longer. They even subconsciously covered the tiny filter holes that helped reduce a cigarette's machine-measured tar and nicotine yields. The upshot is that "light" cigarettes did not offer anything like the health advantage implied by those official, government-certified numbers. The problem was that tobacco companies reduced nicotine along with tar, when what they should have done was reduce tar while keeping nicotine the same. E-cigarettes embody the latter approach taken to its logical conclusion: They deliver nicotine with no tar at all, since they do not contain tobacco and do not rely on combustion. To its credit, the FDA has finally begun to recognize the huge potential health benefit of reducing the toxins and carcinogens that smokers absorb along with nicotine. In the case of conventional cigarettes, however, the agency is considering the opposite approach: forcing smokers to absorb more toxins and carcinogens for any given dose of nicotine. The aim, as Proctor says, is to "make addiction virtually impossible," so that "kids might start smoking, but they wouldn't have trouble quitting." But what about the 30 million or so Americans who already smoke cigarettes? Deliberately increasing their exposure to the dangerous compounds generated by burning tobacco is neither ethical nor sensible, even (or especially) from a "public health" perspective. There are other problems with the FDA's proposal, aside from its health-damaging paternalism. Proctor notes that "sales were disappointing" when Philip Morris introduced three brands of nicotine-free cigarettes in the 1980s, "in part because high-nicotine cigarettes remained on the market." But forcing cigarette manufacturers to dramatically reduce nicotine levels would stimulate a black market supplied by smuggled imports and illicitly manufactured smokes. Smokers could dodge the cap on nicotine by turning to the black market, spiking their cigarettes with liquid nicotine, or rolling their own using full-strength tobacco. As longtime British anti-smoking activist Clive Bates notes, it is not even clear that the FDA has the authority to mandate the nearly complete removal of nicotine from cigarettes. The Family Smoking [...]

The FDA Warms to Vaping

Wed, 02 Aug 2017 00:01:00 -0400

On the face of it, the decision that the Food and Drug Administration (FDA) announced on Friday, extending by four years a crucial deadline for e-cigarette manufacturers to seek approval of their products, was no more than a stay of execution. But the FDA also signaled a new receptiveness to vaping as a harm-reducing alternative to smoking, which suggests this reprieve could turn into a commutation. That would be good news for smokers who want to quit and for anyone sincerely interested in helping them. For too long American public health officials have been unreasonably hostile to e-cigarettes, which are far less hazardous than the conventional kind and offer a closer simulation of the real thing than nicotine gum or patches do. Scott Gottlieb, the new FDA commissioner, seems to appreciate the public health potential of this innovation. "The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes," he says. "Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts—and we believe it's vital that we pursue this common ground." Gottlieb's vision of nonaddictive cigarettes involves mandating a gradual reduction in nicotine content, which would increase the risks that smokers face by forcing them to absorb more toxins and carcinogens for the same dose of nicotine. But his interest in less dangerous alternatives to cigarettes is encouraging. The FDA says "a key piece" of its new approach is "demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes." The agency wants to strike "an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes." Toward that end, the FDA is giving e-cigarette companies until August 8, 2022, to apply for permission to keep their products on the market under regulations published last year, rather than the original deadline of November 8, 2018. The agency says it will use the extra time to seek additional public comment and develop clearer guidance for the industry. The 2016 regulations require manufacturers of vaping equipment and e-liquids to demonstrate that approval of their products "would be appropriate for the protection of the public health." It is not clear what that means in practice, but the FDA projected that applications would cost hundreds of thousands of dollars per product, and many observers thought that was an underestimate. To give you a sense of how expensive and burdensome the process was expected to be, the FDA anticipated that it would receive applications for just a tiny percentage of existing products. The implication was that the regulations would drive the vast majority of companies out of business. If the FDA is serious about making "less harmful sources" of nicotine "the cornerstone of our efforts," it will develop transparent, straightforward, and practical criteria for approval of current and new vaping products. Standing between smokers and products that can save their lives is surely not "appropriate for the protection of the public health." Nor is making those products less appealing by arbitrarily restricting flavors. Since supposedly "kid-friendly" e-liquids are very popular among adults who switch from smoking to vaping, it's a bit worrisome that the FDA plans to solicit public comment on regulation of flavors, which it acknowledges may be "helping some smokers switch to potentially less harmful forms of nic[...]

New York City Sued Over Unconstitutional Menu-Labeling Law

Sat, 29 Jul 2017 08:00:00 -0400

Earlier this month, several food-industry groups sued New York City in an effort to halt Mayor Bill de Blasio's plans to begin enforcing the city's mandatory menu-labeling law next month. The National Restaurant Association's Restaurant Law Center—along with the Food Marketing Institute, National Association of Convenience Stores, and New York Association of Convenience Stores—filed suit on July 14 in U.S. District Court in Manhattan. The suit argues the city's menu-labeling law—which I wrote about here in May, before the lawsuit—conflicts with a federal menu-labeling law, passed as part of the Affordable Care Act, even though enforcement of the pertinent portion of that federal law has yet to begin. The plaintiffs contend that under the U.S. Constitution's Supremacy Clause, New York City's "premature enforcement is preempted by federal law." That conflict is very real. The federal law and New York City law are similar but not identical, something the city admits freely. For example, the federal rules apply to restaurants with 20 or more locations nationwide, while the New York City rules apply to restaurants with 15 or more locations nationwide. And, as the lawsuit states, implementation of the federal rules has been delayed several times—most recently until May 2018—while New York City's rules are set to take effect next month. These differences matter. When Congress passed the menu-labeling law as part of Obamacare, notes this month's lawsuit, it "prohibit[ed] any state or locality from imposing any food labeling regulation 'that is not identical to'" the federal law. Nevertheless, Mayor de Blasio announced in May that the city would move ahead with enforcing its rules in part due to perceived federal foot-dragging. "We can no longer wait for federal action, and urge other cities to follow our lead," de Blasio said. The mayor's decision to "lead" means the staggering cost of doing business in New York City will rise even more for an estimated 3,000 restaurants there. Restaurateurs have argued the rules present them with "a legal quandary." Complying with menu-labeling laws is high—up to $1,000 for each menu item, according to the lawsuit. But so too are potential fines for noncompliance. In fact, the lawsuit was filed shortly after Mayor de Blasio announced the city would begin later this summer to issue fines of up to $600 for violations of the rules. Costs are very much at the heart of the debate over mandatory menu labeling. As I've explained before, the National Restaurant Association pushed for federal law as a way of avoiding the prohibitive costs of complying with potentially hundreds of local and state menu-labeling laws. In addition to these costs, the very basis of compulsory menu-labeling laws is flawed. While New York City is the scene of compulsory menu labeling's earliest triumph, it's also the site of many of its most public failures. In 2008, the city, under then-Mayor Michael Bloomberg, became the first in the nation to "to require chain restaurants to post calorie information on menus and menu boards." The purpose of the law was to help consumers choose lower-calorie options. But subsequent research on the menu-labeling law—see here, here, here, and here, for starters—has shown it to be ineffective at best, and counterproductive at worst. Rushing headlong to comply with a federal law that's inherently flawed, still in flux, and which may never take effect—a recent analysis suggests the FDA's delay in implementing the law has called "perhaps its core validity... into public question"—would be foolhardy. But in New York City, the costs of noncompliance with the looming local rules are now an immediate threat. "Plaintiffs' members should not be forced to alter[...]

Embracing Harm Reduction, FDA Gives E-Cigarette Industry a Regulatory Reprieve

Fri, 28 Jul 2017 13:15:00 -0400

Today the Food and Drug Administration (FDA) said it is giving manufacturers of electronic cigarettes until August 8, 2022, to apply for approval of their products under regulations announced last year, which were widely expected to drive most companies out of business. The original deadline was November 8, 2018, and the four-year extension is supposed to provide more time for public comment and industry guidance as part of a "comprehensive regulatory plan" that aims to strike "an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes." The agency says "a key piece of the FDA's approach is demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes." That is music to the ears of harm-reduction advocates who see vaping as a life-saving alternative to smoking and viewed the original FDA rules as misguided, heavy-handed, and potentially deadly meddling that effectively gave conventional cigarettes an advantage over competing sources of nicotine that are much less dangerous. In addition to providing regulatory relief for the e-cigarette industry, the FDA will be investigating the possibility of mandating a gradual reduction in the nicotine levels of combustible cigarettes. The idea is to make cigarettes less addictive for new smokers, but the policy is apt to hurt current smokers by forcing them to absorb more toxins and carcinogens along with their usual dose of nicotine. The FDA "intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes." The FDA's new commissioner, Scott Gottlieb, sees a nicotine-reduction mandate as complementing the agency's new receptivity to harm-reducing cigarette alternatives. "The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes," Gottlieb says. "Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts—and we believe it's vital that we pursue this common ground." The FDA also seems to be contemplating flavor regulations that might favor e-cigarettes over the real thing. It says it will "seek public comment on the role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery." The Family Smoking Prevention and Tobacco Control Act, the law that gave the FDA authority to regulate tobacco products, banned most "characterizing flavors" from cigarettes but made an exception for menthol, by far the most popular one (and, not coincidentally, a big moneymaker for Philip Morris, which supported the law). It sounds like the FDA might be reconsidering that exception, while at the same time recognizing that so-called kid-friendly e-cigarette flavors are in fact very popular with adults who switch from smoking to vaping. The FDA says it will use the reprieve it is giving e-cigarette companies to clarify what will be required to keep their products on the market. The agency also plans to develop product standards that address battery hazards and help keep e-cigarette liquids away from children. Over all, it looks like the FDA under Gottlieb will be taking a much more practical approach to e-cigarette regulation that recognizes the realities of the ex[...]

Helix Launches Online Personal Genomics Testing Marketplace

Tue, 25 Jul 2017 15:05:00 -0400

Helix wants you to become a lifelong repeat customer in its newly launched genomics testing marketplace. For $80 the company will use your saliva sample to sequence all 22,000 protein-coding genes in your exome, along with some additional genetic sequences that its scientists find relevant to human health. The exome (the protein-coding region of the human genome) represents less than 2 percent of the genome but contains about 85 percent of known disease-related genetic variants. The company says it will keep your genetic information securely on file. Customers can now purchase various genetic testing "apps" from about a dozen vendors in Helix's genomics marketplace. Helix will share the relevant sections of your exome with the vendors, who then provide the results of their readouts directly to you. The current options include an ancestry testing app from National Geographic ($69.95); a family planning test from Sema4 ($199) that tells you if you are a carrier of any of 67 different genetic variants that might affect the health of your prospective children; a fitness app from Exploragen ($24.99) that identifies genes that may affect your sleep pattern; a health app from Admera ($124.99) that tests for a genetic predisposition to having high levels of bad cholesterol; and a nutritional app from Everlywell ($249) that tests for food senstivities that may be related to your genetic makeup. There is even a wine explorer entertainment app by Vinome ($29.99), which claims to match your genes to your vintage tastes. Now that Helix has created a genomics marketplace, the company plans to add new validated tests from additional app vendors over time. Once they become available, Helix customers can purchase them and then simply have their online genetic information sent along for analysis. Prior to getting the results from the health apps in the marketplace, customer's health histories are evaluated by physicians from an independent third party network. That part—the evaluation of health app results by independent physicians—is clearly aimed at getting around the Food and Drug Administration's outrageous ban on direct-to-consumer genetic testing. The ban essentially began in 2013, when the agency shut down the personal genomics start-up 23andMe. In April of this year, the agency finally relented somewhat and allowed 23andMe to offer tests to identify genetic variants that contribute to 10 different conditions, including Parkinson's disease, late-onset Alzheimer's disease, and a blood-clotting disorder. But tight restrictions are still in place. When I was an early customer, the company provided me with genetic insights not just about those 10 health risks, but also about 140 others. We will never know how much further along companies, customers, and medical practitioners would be now had the government not hamfistedly stymied the development of direct-to-consumer genetic testing for four years. The good news is that the Helix marketplace model seems designed to work around such regulatory excesses and enable Americans to gain access to their genetic information.[...]