Published: Sun, 23 Apr 2017 00:00:00 -0400
Last Build Date: Sun, 23 Apr 2017 15:38:35 -0400
Sat, 22 Apr 2017 08:00:00 -0400FDA enforcement of its absurd rules governing mandatory calorie menu labeling, passed in 2010 as part of Obamacare, is set to begin on May 5, after years of delays. In 2015, the FDA delayed implementing the rules until December 2016, after the presidential election. At the time, The Hill speculated that a new "Republican president could choose to scrap the rule altogether." That hasn't happened. Yet. But in December 2016 the FDA delayed enforcing the rules until May 5, 2017, which is the deadline that now looms. The FDA interprets its menu-labeling rules as requiring mandatory calorie labeling of most foods sold by "restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, offering for sale substantially the same menu items and offering for sale restaurant-type foods." Owners of more than twenty vending machines must also comply with the rules. The rules would be a disaster. They'll cost at least $1 billion. And if they're grounded in science, that science is shoddy. The purpose of menu-labeling rules in general is to help consumers make smarter (read: lower-calorie) choices. But the very premise that mandatory menu labeling accomplishes this is flawed. Research demonstrates that menu labeling doesn't improve consumer food choices. That's something I first noted here in 2011, and which subsequent reports have also shown (see, for example, here, here, here, and here). So can the rules be stopped? Yes. Congress could act by repealing or amending the menu-labeling rules. Or food sellers whose First Amendment rights would be violated by rules that compel speech for no constitutionally supported reason could ask a court to halt implementation of the rules. Or the FDA could delay the rules from taking effect. Each of these is possible. But how likely are these outcomes? While the clock is ticking, furious efforts are underway to halt the rules. Earlier this year, Congress introduced a bill supported by the American Pizza Community, an advocacy group that includes pizza companies like Domino's and Pizza Hut. The bill, the Common Sense Nutrition Disclosure Act, would exempt most pizza-delivery companies and delay implementation of the menu-labeling rules by at least two years. A comparable bill passed out of the House last year but died in the Senate. While pizza makers are working in Congress, two other groups that oppose the law, the National Grocers Association and National Association of Convenience Stores, petitioned the FDA this month in an effort to delay or halt implementation of the rules. The petitioners argue compliance with the "unworkable" rules is impossible; that the costs of complying are exorbitant and far exceed FDA estimates; that the FDA exceeded its authority in adopting the rules; that the rules run afoul of the First Amendment; and that the rules are "inconsistent with the [Trump] Administration's agenda to alleviate unnecessary regulatory burdens on business." Pushing back against these efforts is the voice of the restaurant industry—the National Restaurant Association—a staunch supporter of the FDA menu-labeling rules. That stance might surprise some—if for no other reason than that it's got some basis beyond rent-seeking. "With more and more states adopting their own menu-labeling rules, the National Restaurant Association... sought a shield against this death by 1,000 cuts by pushing for one uniform national menu-labeling rule," I explained in a 2013 column. Will one or more of the aforementioned approaches succeed in stymying the rules from taking effect on May 5? Repeal seems like something Congress won't stomach. Consider that the GOP's ham-fisted attempts to repeal, replace, or rename (or whatever) the Affordable Care Act completely ignored the ACA's menu-labeling provisions. Amending the rules via the Common Sense Nutrition Disclosure Act seems a more likely path. "[T]here's now been so much time and money sunk into the process that none of the major lobbying groups are trying to get rid of the mandate as part [...]
Fri, 21 Apr 2017 13:00:00 -0400As a neonatologist, I worry about patients with pulmonary hypertension. This unforgiving disease, sometimes seen after premature birth, can end with sudden death from constricting blood vessels in the lungs. One minute a baby in the neonatal ICU may be sleeping comfortably; moments later, doctors and nurses are giving chest compressions and rescue medications. A pulmonary hypertension crisis, as these frightening episodes are called, starts with a drop in the blood oxygen level. That drop triggers a monitor to beep. It's up to the nurse to hear the sound, come to the bedside and take action. The first and most effective step in stopping a pulmonary hypertension crisis is simple: Give oxygen. But a nurse caring for another patient might be delayed for 30 seconds, and the loss of that time can lead to brain injury or death. In an age of self-driving cars and 400-ton airplanes that can land themselves in blinding fog, it makes no sense that hospitalized patients are surrounded by lifesaving machinery that can be activated only by a person pressing a button or turning a knob. Modern transportation augments human judgment and reaction times with a computer's superior ability to continuously respond to dozens of fluctuating variables. Yet in medicine, safety remains stubbornly reliant on human intervention. FDA regulation impedes innovation My patients with pulmonary hypertension are often attached to a respirator with adjustable oxygen settings. The respirator sits inches below the monitor that indicates how much oxygen is in the blood. But the two machines can't communicate with each other. If they could, it would be possible to increase the flow of oxygen automatically the moment a crisis is detected. In 2009, engineers developed just this kind of closed-loop respirator and introduced it in several hospitals as part of a feasibility study. It increased the time premature babies spent at a safe oxygen level by more than two hours per day. But no biotechnology company has marketed the idea. There are other examples of automated systems with unrealized potential to save lives, and not just in the neonatal ICU. Software that scans an ECG for subtle heartbeat variability can identify patterns—undetectable to the human eye—that indicate an elevated risk of heart attack. Hospital beds that play audible feedback during an emergency promote more effective CPR. Yet patients are not benefiting because neither of these tools has been commercialized. Why haven't these innovations attracted the industry backing necessary to make them widely available? One reason is that the process of getting FDA approval for new devices—particularly those deemed "life-sustaining"—is often even more complicated and expensive than getting approval for drugs. In the Journal of Public Economics, Harvard Business School professor Ariel Dora Stern recently described how FDA hurdles discourage companies from investing in innovation. Often, the more profitable strategy is to wait for someone else to spend the time and money required to get approval for a new device, and then enter the market later with something similar that will face less scrutiny. Dr. Stern estimates that regulatory obstacles add an average of US$6.7 million to the cost of introducing a new medical device. For a company developing an ICU monitor, for instance, that will ultimately sell for less than $35,000 per unit, this up-front commitment can be prohibitive. A consequence is that small biotechnology firms (with annual revenue less than $500 million) rarely gamble on getting new inventions approved. Dr. Stern's paper notes that less than 17 percent of novel device applications to the FDA come from small companies. This is different from new drug applications, the majority of which originate at smaller firms. What's behind this discrepancy? Research has shown that while companies pay a steep price for pioneering new medical devices, the first firm to market a new type of drug often gets favorable treatment from the FDA. This raises the incentive for pharma[...]
Thu, 06 Apr 2017 14:40:00 -0400
(image) Back in 2013 the regulators at the Food and Drug Administration basically shut down the burgeoning field of direct-to-consumer personal genomics when it ordered the genotype screening company 23andMe to stop testing new consumers for genetic health risks. Why? Because the regulators had ginned up some speculative scenarios in which, for example, a woman who tested positive for a deleterious BRCA breast cancer variant would run to her kitchen, grab a butcher knife, and lop off her breasts (I exaggerate slightly.) As a long time and happy 23andMe customer, I was particularly irked by the FDA's nonsensical decision to keep people in the dark about their genetic makeup.
Before the FDA brought its hammer down, 23andMe was developing a wonderful explanatory interface to help customers understand their genetic information. The company provided some insights on more than 200 health risks, drug responses, and inherited traits - and was adding more all of the time.
After 2013, the company was allowed to tell folks what their genes suggested about their ancestry and traits like dry earwax or the likelihood that their second toes are longer than their big toes. (As if anyone needs genetic tests to discern that information.) In their "wellness" reports, the company could inform customers about how their genes affect the speed with which they metabolize caffeine or their tolerance for milk.
Today, the company is announcing that the FDA is loosening its noose a bit and permitting it to tell customers some genetic risk information for ten different conditions, including late-onset Alzheimer's disease, Parkinson's disease, celiac disease and hereditary thrombophilia (harmful blood clots). As an early customer, the company had already provided me with some genetic insights with regard to all of these health risks, plus about 140 others.
Here's hoping that the Trump administration will roll back these unnecessary regulations and free up personal genome companies like 23andMe to provide Americans with access to their genetic information.
To find out what's genetically wrong with me, click over to SNPedia where I have posted the results of my 23andMe genotype screening tests for all to see.
Tue, 21 Mar 2017 17:02:00 -0400
(image) The anaesthetic ketamine has been a popular party drug for decades due to its ability to put users in a blissful mood. Earlier this month, the American Psychiatric Association released a consensus statement acknowledging that the drug might also be a breakthrough treatment for severe depression.
The statement authors write that seven studies--all placebo-controlled, double-blind, and randomized--provide evidence that ketamine therapy is a "rapid and robust, albeit transient" response to severe clinical depression. The treatment is effective within hours, while conventional antidepressants generally take weeks to work. The transient nature of the drug, meanwhile, suggest it works best with twice-weekly dosing.
Ketamine hasn't been approved for treating depression, but Yale psychiatrist Gerard Sanacora succinctly explained to NPR why the drug's off-label status hasn't deterred him:
Sanacora says other doctors sometimes ask him, "How can you be offering this to patients based on the limited amount of information that's out there and not knowing the potential long-term risk?"
Sanacora has a simple answer.
"If you have patients that are likely to seriously injure themselves or kill themselves within a short period of time, and they've tried the standard treatments, how do you not offer this treatment?"
It certainly seems that the long-term risks of ketamine therapy, regardless of how severe they may be, are preferable to the short-term risk of a successful suicide attempt.
The APA paper closes with the hunch that "economic factors make it unlikely that large-scale, pivotal phase 3 clinical trials of racemic ketamine will ever be completed," which means patients with treatment-resistant depression who'd like to give ketamine a shot will need an appointment at one of a handful of clinics offering ketamine treatment. Or, they can apply for enrollment in a philanthropic or federally funded ketamine study, of which there don't appear to be many.
This is a rather strange fate for a drug that the APA says has "generated much excitement and hope for patients with refractory mood disorders and the clinicians who treat them," but it's also an indictment of the Food and Drug Administration's regulatory process. Ketamine is off patent, which means no pharmaceutical company is going to spend several million dollars per phase to get approval for a drug formulation that any company could turn around and sell, no matter how many lives it might save.
Mon, 13 Mar 2017 14:32:00 -0400Products regulated by the Food and Drug Administration (FDA) account for about 20 cents of every dollar of annual spending by U.S. consumers, amounting to more than $2.4 trillion in annual consumption that includes medical products, food and tobacco. The agency regulates medicines, diagnostic tests, medical devices, food safety including those made from modern biotech crops and livestock, food labeling, and tobacco and nicotine products. What the agency's bureaucrats decide has signifcant impact on U.S. economic growth and the livelihoods of Americans. President Donald Trump has nominated physician and American Enterprise Institute scholar Scott Gottlieb to become commissioner of the agency. Gottlieb earlier served as deputy commissioner during the Bush administration. Gottlieb has long been a critic of FDA's increasingly risk-averse culture that is slowing down the approval of new medicines. Defenders of the agency often cite data suggesting that the agency approves new medicines faster than other drug approval agencies abroad. That is true if only the period of time after a drug maker has submitted its New Drug Application (NDA) for approval is taken into account. More consequentially, increasing FDA requirements for longer and more extensive clinical trials before the NDA is submitted has substantially lengthened the periods and raised the costs of getting new treatments from petri dishes to patients' bedsides. Consider that researchers at the Tufts University Center for the Study of Drug Development have estimated that in 1991 it cost $412 million (2013 dollars) to develop and obtain approval for a new pharmaceutical. Last year, they calculated that it now takes more than $2.5 billion, a six-fold increase. Gottlieb, who has been associated with venture capital side of medical innovation, will seek to change the agency's culture from the current highly precautionary approach to one that more readily recognizes that benefits always come with risks. Under his direction, the agency would likely exercise a lighter regulatory hand over the development of new medical apps and diagnostics while seeking to work out the best way to speed up the approval of novel therapeutics based on stem cells and gene-edting technologies like CRISPR. Gottlieb is keen to get generic drugs approved quickly in order to bring down prices for consumers. In an August 2016 op-ed in the Wall Street Journal, he noted it now takes more than 2 years for the agency to approve a generic drug application and that the costs had risen from $1 million in 2003 to over $15 million now. He added, "This means that a drug may not face brisk generic competition until it exceeds $25 million in annual revenue. Thanks to these changes, infrequently used generics—such as clomipramine for major depression—may now have only one competitor and cost as much as branded drugs." Gottlieb also cited research that estimated the FDA's proposed generic labeling rule would expose generic drug manufacturers, who supply 84 percent of all prescriptions, to failure-to-warn product liability lawsuits, costing more than $5 billion in 2017. That rule is supposed to be finalized in April. As commissioner, Gottlieb might be able to halt it. While not a radical reformer, Gottlieb clearly has a good understanding of how over-regulation has been slowing down innovation in medicines and foods.[...]
Mon, 13 Mar 2017 13:45:00 -0400src="https://www.youtube.com/embed/9fMN80wkYvM" allowfullscreen="allowfullscreen" width="560" height="340" frameborder="0"> Josiah Zayner is a scientist and entrepreneur who quit his government job in a NASA lab to start The Odin, a synthetic biology company run out of his garage. For $150, anyone can now purchase the cutting-edge "gene editing" tool CRISPR (Clustered regularly interspaced short palindromic repeats) through The Odin's online shop. Zayner champions do-it-yourself "biohacking" as the future of science and often draws comparisons between his work and that of the computer scientists and hackers of the '80s and '90s who eventually become the titans of Silicon Valley. "I think [genetic engineering] is really going to become a consumer industry," says Zayner. "Consumers drive a lot of technological advancement." Biohackers like Zayner, much like their computer hacker forebears, prefer asking for forgiveness rather than permission. And so far, Zayner hasn't had to do either. But the launch of a new product that allows users to engineer fluorescent yeast by inserting a gene from a bio-luminescent jellyfish drew the attention of the Food and Drug Administration (FDA) after officials learned that breweries were using the product to create glowing beer. They called up Zayner to discuss potential regulatory pitfalls. Officials on the call, which Zayner recorded and posted on his YouTube channel, sound hesitant to make any hard-and-fast declarations about Zayner's work, but they do clearly express the opinion that the yeast modification constitutes a "food color additive," which is subject to pre-market approval by the agency. They instruct him that he should change the language on his website so that nobody construes the yeast as a food product. Zayner then asks them what will happen if he doesn't change anything, to which one of the officials replies, "Well, there's a number of things that we could do, from a warning letter...to, where, if it got to the point where we would, you know, seize material." They also tell him to keep track of who is buying the yeast kit and suggest that he could face "trouble" if breweries continue to use the product, even if he changes the marketing language. "This is who I'm dealing with, a bunch of bullies," says Zayner. "Bullying people into doing what they want, not for scientific reasons, not for the betterment of the public...just because." Zayner is not the only one in the genetics industry burdened with regulatory uncertainty. Another such case is that of Antony Evans at TAXA, a San Francisco-based synthetic biology company that aims to engineer plants to supplement or replace common household items. They currently have a glowing plant in development, which Evans envisions as an alternative to nighttime lighting, and fragrant moss that could act as an organic air freshener. He's had products jammed up by the FDA and the Environmental Protection Agency (EPA) in the past. "If you're an entrepreneur creating a regulated article, the cost to getting that product to market is extremely high," says Evans. "That's why a lot of entrepreneurs are starting in the edges." Evans believes that it's the pre-market approval process that stymies innovation among small, lean startups, which cannot afford to wait years and spend hundreds of thousands or millions of dollars to take a product to market. The FDA does allow products that only contain substances Generally Recognized as Safe (GRAS) to go straight to market, but Zayner and Evans both believe the list of GRAS substances is far too limited and the process for approval needlessly burdensome and time-consuming. "We have no idea how much we are inhibiting [innovation], but we just know that we are because it's almost impossible to launch a plant GMO company." Watch the full video above. Produced by Zach Weissmueller by Alexis Garcia. Camera by Alex Manning and Weissmueller. Music by Jon Luc Hefferman. Subsc[...]
Mon, 13 Mar 2017 12:00:00 -0400Josiah Zayner is a scientist and entrepreneur who quit his government job in a NASA lab to start The Odin, a synthetic biology company run out of his garage. For $150, anyone can now purchase the cutting-edge "gene editing" tool CRISPR (Clustered regularly interspaced short palindromic repeats) through The Odin's online shop. Zayner champions do-it-yourself "biohacking" as the future of science and often draws comparisons between his work and that of the computer scientists and hackers of the '80s and '90s who eventually become the titans of Silicon Valley. "I think [genetic engineering] is really going to become a consumer industry," says Zayner. "Consumers drive a lot of technological advancement." Biohackers like Zayner, much like their computer hacker forebears, prefer asking for forgiveness rather than permission. And so far, Zayner hasn't had to do either. But the launch of a new product that allows users to engineer fluorescent yeast by inserting a gene from a bio-luminescent jellyfish drew the attention of the Food and Drug Administration (FDA) after officials learned that breweries were using the product to create glowing beer. They called up Zayner to discuss potential regulatory pitfalls. Officials on the call, which Zayner recorded and posted on his YouTube channel, sound hesitant to make any hard-and-fast declarations about Zayner's work, but they do clearly express the opinion that the yeast modification constitutes a "food color additive," which is subject to pre-market approval by the agency. They instruct him that he should change the language on his website so that nobody construes the yeast as a food product. Zayner then asks them what will happen if he doesn't change anything, to which one of the officials replies, "Well, there's a number of things that we could do, from a warning letter...to, where, if it got to the point where we would, you know, seize material." They also tell him to keep track of who is buying the yeast kit and suggest that he could face "trouble" if breweries continue to use the product, even if he changes the marketing language. "This is who I'm dealing with, a bunch of bullies," says Zayner. "Bullying people into doing what they want, not for scientific reasons, not for the betterment of the public...just because." Zayner is not the only one in the genetics industry burdened with regulatory uncertainty. Another such case is that of Antony Evans at TAXA, a San Francisco-based synthetic biology company that aims to engineer plants to supplement or replace common household items. They currently have a glowing plant in development, which Evans envisions as an alternative to nighttime lighting, and fragrant moss that could act as an organic air freshener. He's had products jammed up by the FDA and the Environmental Protection Agency (EPA) in the past. "If you're an entrepreneur creating a regulated article, the cost to getting that product to market is extremely high," says Evans. "That's why a lot of entrepreneurs are starting in the edges." Evans believes that it's the pre-market approval process that stymies innovation among small, lean startups, which cannot afford to wait years and spend hundreds of thousands or millions of dollars to take a product to market. The FDA does allow products that only contain substances Generally Recognized as Safe (GRAS) to go straight to market, but Zayner and Evans both believe the list of GRAS substances is far too limited and the process for approval needlessly burdensome and time-consuming. "We have no idea how much we are inhibiting [innovation], but we just know that we are because it's almost impossible to launch a plant GMO company." Watch the full video above. Produced by Zach Weissmueller by Alexis Garcia. Camera by Alex Manning and Weissmueller. Music by Jon Luc Hefferman. Subscribe to our YouTube channel. Like us on Facebook. Follow us on Twitter. Subscribe to our podcast a[...]
Mon, 06 Mar 2017 14:49:00 -0500
(image) Every now and then I like to get soy milk in my coffee instead of the usual skim milk. I have no misconceptions about the product's origins or nutritional value, yet the dairy industry is so worried that consumers like me are being misled by alternatives such as soy, almond, or rice "milk" that it wants the Food and Drug Administration (FDA) to crack down on non-dairy milk substitutes, the Associated Press reports.
"Standards of identity" for food are requirements mandated by the FDA regarding what specifications a food product must meet in order to use a certain label. These regulations are justified as necessary to protect the consumer.
The standard of identity for milk is rather extensive, but in short, it requires that it be "obtained by the complete milking of one or more healthy cows." As Jim Mulhern, president of the National Milk Producers Federation (NMPF), insisted in the AP report, "Mammals produce milk, plants don't."
The group has for decades asked the FDA to do something about this problem. Now, the NMPF might finally get its wish. A bill was recently introduced to the Senate that would require the FDA to enforce the standard of identity rule. The bill, coyly titled the Defending Against Imitations and Replacements of Yogurt, Milk, and Cheese To Promote Regular Intake of Dairy Everyday Act (or the DAIRY PRIDE Act, for short), was unsurprisingly sponsored by Sen. Tammy Baldwin, a Democrat hailing from Wisconsin. A similar bill has been introduced to the U.S. House by Reps. Peter Welch (D-Vt.), Mike Simpson (R-Idaho), and Sean Duffy (R-Wisc.).
Supporters of the DAIRY PRIDE Act claim that over 80 percent of Americans are not meeting the recommended daily dairy intake, and say imitation dairy products do not have the same nutritional value as their "authentic" counterpart. Furthermore, the NMPF complains in a press release that the FDA's lax enforcement "hurts dairy farmers that work tirelessly to ensure their dairy products meet FDA standards and provide the public with nutritious food."
In a letter dated February 2000, NMPF Vice President of Regulatory Affairs Robert D. Byrne decried that soy products were actively competing against the dairy industry. "In many instances, these soy-based beverage products are positioned on the grocery shelf alongside milk and other dairy products in a clear attempt to compete with dairy products as a beverage," he wrote. "In addition, the labeling of soy beverages and accompanying marketing language attempt to portray to consumers that these products are, in fact, dairy-like products by using the term 'milk' on the label."
At least he was honest about the motivations for this push.
Fri, 03 Mar 2017 14:48:00 -0500If President Donald Trump is serious about reforming how the Food and Drug Administration operates, he could start by requiring the agency to use common sense when regulating alternatives to smoking. Alternatives like snus, for example. The Swedish-made tobacco product consists of a small packet, similar to a tea bag, that's filled with tobacco powder and placed in the upper lip. It delivers a jolt of nicotine but doesn't come with the same health risks as smoking or using chewing tobacco. But you wouldn't know that by looking at the label. Swedish Match, the company that makes snus, has been trying since 2014 to get permission from the FDA to identify its product as a safer alternative to smoking. In Sweden, where snus is marketed that way, its popularity is credited with cratering smoking rates and associated diseases, and Swedish Match executives believe they could reshape the American tobacco market (and improve smokers' health) in much the same way. In December, the FDA ruled that snus would have to continue carrying a warning about the potential for causing tooth decay and gum disease, but punted on the more important question: whether snus could be marketed in the U.S. as less dangerous than cigarettes. "Because there is already a warning label, they're not inclined to remove it no matter how much evidence we present," says Jim Solyst, vice president for federal regulatory affairs for Swedish Match, in an interview published by Tobacco Reporter, a trade publication. That's where Trump enters the picture. In his address to a joint session of Congress on Tuesday, the president specifically identified the FDA as a target for his administration's regulatory reform effort. The FDA's "slow and burdensome approval process," Trump said, prevents too too many advances from reaching those in need. He was talking specifically about the FDA's approval process for new drugs—an area where FDA foot-dragging can literally cost lives, as Reason's Ron Bailey pointed out earlier this week—but the same logic makes a case for changing how the administration regulates tobacco, with an eye towards improving Americans' health. Slow and burdensome certainly describes what Swedish Match has gone through. The company has filed more than 130,000 pages of applications with the FDA since May 2014, according to Tobacco Reporter, in trying to become the first product to gain the coveted "modified-risk tobacco product" designation. "We think that telling smokers that these products are 97 percent safer than similar products is the key message; this message is getting lost," Solyst told the trade publication. Swedish Match sees the obvious marketing benefit of earning that designation, but that doesn't cancel out the very real public health benefits that could be realized if snus was more widely used. The research continues to pile up. A peer-reviewed study published in Tobacco Control found that snus "does not appear to cause cancer or respiratory diseases" and cardiovascular risks from using snus were lower than with smoking. A study conducted in Norway and published in Nicotine and Tobacco Research found that using snus was much more effective at getting smokers to quit using cigarettes than nicotine replacement products like patches and gum. Snus-ers were three times as likely to quit smoking as smokers using nicotine gum, the researchers found. They believed snus was so effective because it delivered a nose of nicotine that was almost the same as cigarettes and provided a "sensory effect that medicinal nicotine products perhaps lack" because snus smells and tastes like tobacco. Researchers at the University of Alabama at Birmingham reported in 2007 that 200,000 smoking-related deaths per year could be prevented if tobacco uses across the whole of the European Union adopted snus at the same level as Swedes. While there hasn'[...]
Wed, 01 Mar 2017 15:15:00 -0500President Donald Trump described the Food and Drug Administration's drug approval process as "slow and burdensome" in his speech to a joint session of Congress on Tuesday. He observed that the FDA process "keeps too many advances... from reaching those in need." His solution is to "slash the restraints" at the FDA to speed new drugs to the bedsides of patients. To illustrate his criticisms Trump pointed to Megan Crowley in the gallery, a young woman who has survived Pompe disease which is caused by a genetic glitch that prevents her cells from properly processing glycogen. After she and her younger brother was diagnosed with the disease in 1998, her father John Crowley co-founded the biotech company Novazyme to develoop a treatment. Megan and her brother began taking the recombinate enzyme replacement therapy in 2003. The enzyme treatment was tested on several dozen patients and submitted to the FDA in 2005. The agency took only 9 months to approve the drug in 2006. That may not seem particularly slow and burdensome, but a new Tufts University study reports more typically that getting a new drug from development through the FDA process takes more than a decade and costs about $2.6 billion. As it happens, Crowley is head of Amicus Therapeutics which has developed an enzyme replacement treatment for Fabry Disease. In November, the FDA rejected its initial submission for approval and ordered the company to conduct further clinical trials. Interestingly, the Amicus' new drug was approved by European Union drug regulators in May, 2016. Another way to think about the development of the Pompe treatment is that it took three years for the drug to get FDA approval after Crowley had begun dosing his children with it. If they had had to wait an extra three years for FDA approval, Megan and her brother might well have succumbed to their illness. As I have argued, the FDA should be modernized so that new treatments become available to patients once they have made it through the Phase II safety testing. Patients who choose the new treatments would essentially be enrolled in Phase III efficacy trials. This would drastically cut the time and the expense it takes to get new medicines to people. I am not alone in urging this reform of the drug approval process. In a February 14, 2012 Wall Street Journal op-ed, former FDA Commissioner Andrew von Eschenbach argued that "after proof of concept and safety testing, the [new therapeutic] product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies." Elsewhere von Eschenbach pointed out this FDA reform would mean that new drugs could ... ...come to market after promising early-stage research in targeted patients, with appropriate post-marketing studies required. Payers and patients would be the ultimate judge about the quality of the product, and companies could learn from the experience to develop superior products if needed. Companies would still be liable for unforeseen side effects, but patients and doctors would be warned -- through the drug's labeling -- that the product had been approved based on promising but provisional research. Gradually replacing or reducing dependence on Phase 3 trials with smaller, faster adaptive trials and post-market surveillance would have a positive impact on medical innovation and the U.S. economy.... To head the FDA, Trump is reportedly thinking of nominating venture capitalist Jim O'Neill who argued in 2014: "We should reform [the] FDA so there is approving drugs after their sponsors have demonstrated safety—and let people start using them, at their own risk. Let's prove efficacy after they've been legalized." Sounds good to me.[...]
Wed, 08 Feb 2017 00:01:00 -0500Oh, no! I did it again. It was a foolish mistake. But I slipped. I read The New York Times. This is bad for my health, because I get so mad at the smug socialist spin, but how can I not read it? It's my hometown paper. My wife wakes me up with indignant questions like, "How can you say government is too big? The Times says ..." Aargh! Nearly every day brings a new Times outrage. Saturday, a front-page story smeared Labor Secretary nominee Andy Puzder. The story begins, "Decades before President Trump nominated him ... Puzder went to battle with federal labor regulators ..." Wait a second. "Decades before"? They went back decades to criticize him? Actually, three decades—to 1983, when as a young lawyer, Puzder represented a client whom the Labor Department accused of squandering union money. The Times went on to say: "He has repeatedly argued that economic regulations stifle economic growth." Puzder "argued" that? Regulations obviously stifle growth. That's their purpose—to protect workers by putting limits on businesses' pursuit of profit. Regulation is a big reason this post-recession recovery has been so weak. In just the last 10 years, the Department of Labor added regulations that require another 70 million hours of paperwork. Monday: "Trump's FDA Pick Could Undo Decades of Drug Safeguards." Oh, no! Trump will poison America with unsafe drugs! President Trump hasn't actually made his Food and Drug Administration pick yet, but the Times worries "his push for deregulation might put consumers at risk." The reporter cites thalidomide, which, 60 years ago, "caused severe birth defects in babies whose mothers had taken the drug in pregnancy. Since then, the FDA has come to be viewed as the world's leading watchdog for protecting the safety of food and drugs, a gold standard..." Fool's gold. The FDA protected American babies from thalidomide not by being smart, but by being so slow. By the time thalidomide neared approval, its bad effects were visible in Europe. The Times eagerly reports damage done by drugs: "Drug safety watchdogs point to examples like the painkiller Vioxx, which was withdrawn from the market ... " But "invoking Vioxx as the icon for such looseness is itself ignorant looseness," says my medical researcher brother, Tom. "FDA approvals are tradeoffs between benefits and risks. The FDA knew about Vioxx's risks. It was the company, not the FDA, that withdrew the painkiller. Many doctors now say it was an ill-advised move that deprives patients of a good alternative. Vioxx's risks are no greater than painkillers like Motrin sold over the counter. The Times avoids detailing just how onerous today's regulation is. The reporter says, "The agency sets a 10-month goal for approving standard drugs." Gee, goals are nice, but does the agency honor them? The Times doesn't say. It also doesn't mention that the 10-month goal only applies to the final step of regulation—after all trials are done. The entire process takes an average 16 years and $2.6 billion. Americans want protection from bad drugs, but how many of us suffer needless pain, or die, while waiting those 16 years? How many die because a drug's developers cannot raise $2.6 billion? One more smear: "President Trump's pick to lead the Federal Communications Commission, Ajit Pai, has aggressively moved to roll back consumer protection regulations." Consumer protection? No. Socialist idiocy. The Times says Pai "stopped nine companies from providing discounted high-speed internet service to low-income individuals." No, he stopped a $9.25/month government subsidy for high-speed internet. "He withdrew an effort to keep prison phone rates down," says the Times. No, he stopped FCC lawyers from fighting about in-state phone calls because the FCC has no constitutional authority there. Utterly rea[...]
Tue, 07 Feb 2017 08:30:00 -0500There seem to be embarrassing new "Internet of Things" failures every week now. Sometimes, they are on the humorous side, like when a "smart toilet" was hacked to randomly flush at startled bathroom-goers. Other times, they can be disturbing, as in case of critical vulnerabilities in St. Jude's implantable cardiac devices that could put users' lives in the hands of hackers. But in all cases, these failures tend to grab headlines and inflame calls for government regulation. It's not hard to see why. When faced with some kind of public dilemma, many people immediately assume that the government alone can solve the problem. And when you throw in futuristic fears about losing control of everyday things around us, the prospect of a savior from above seems all the more necessary. But we must take care that such "solutions" don't create more problems than they supposedly solve. Such would almost certainly be the case with one recent proposal: a "Department of Technology Policy." A 'World-Size Robot' Recently, Bruce Schneier, a veteran in information-security studies and leading voice in technology policy, penned a long article for the New Yorker in which he argues for the creation of a new federal agency—the "Department of Technology Policy"—that would consolidate control of technological regulations into a single body. Schneier explains how the incredible rate of "smart"-device adoption has created some new and unprecedented security challenges. Few people realize just how quickly IOT devices have saturated the world around them. This will only accelerate—Schneier likens the rise of IOT technologies to building a "world-size robot," with all of the sensors, commands, and computations to match. And with an expanded connected reality comes an expanded digital threat set. Computer bugs and software vulnerabilities no longer merely endanger personal data and hardware, they can potentially shut down connected home devices or hijack moving cars and even cause us physical harm. Indeed, there have been considerable security problems with connected devices. Often, the issues are theoretical: Security researchers warn the public at conferences and in journals of major vulnerabilities they discover in popular consumer routers or printers or security cameras—vulnerabilities which may or may not end up getting patched. But sometimes these vulnerabilities are actually exploited. Last October, some of the Internet's most popular websites—Twitter, Amazon, GitHub, Reddit—were knocked offline thanks to insecure IOT devices. Some malicious actor was able to infect an army of DVRs, cameras, baby monitors, and printers with a malware called Mirai, directing these devices to launch a distributed-denial-of-service (DDOS) attack on those websites' hosting provider, Dyn. While the attack was short, and the fallout was mostly limited to inconvenience and loss of sales, it was a major warning signal for security researchers who envisioned how such an attack could have been much more devastating. The main problem, as Schneier sees it, is that many companies developing and selling connected devices do not have the right security chops to make sure that they are safe before people buy them. Technology companies like Google and Apple have large dedicated teams to locate and patch software vulnerabilities as soon as possible—and even this process is imperfect. Now, companies who have no such software experience may put IOT products out to market without the necessary testing, which could create major unexpected problems down the road. And the home consumers who buy such devices are seldom equipped to evaluate the security settings on their own. Whose Failure? While Schneier's essay does an excellent job of describing the new security challenges that[...]
Wed, 01 Feb 2017 09:30:00 -0500If President Donald Trump is looking for an easy way to bring American jobs back—without imposing tariffs, building walls, or imposing other big government policies that will cost American consumers more in the long run—and ease regulations on American businesses, he could start by repealing new regulations for electronic cigarettes approved in August by the Food and Drug Administration. Those regulations for electronic cigarettes adopted by the FDA during the final year of the Obama administration could, if left on the books, effectively wipe out large swaths of the vaping industry. The Smoke-Free Alternatives Trade Association, an e-cigarette industry group, believes as much as 99 percent of all vaping products could be affected. That costs jobs, of course, but it also curtails the potential health benefits from getting Americans to switch from smoking to vaping. A new report released this week by the R Street Institute, a Washington, D.C.-based free market think tank, argues that the Trump administration should take immediate steps to overturn the FDA deeming rule and other federal impediments to the growth of vaping. "Perverse tobacco policy is failing the American public and will soon destroy thousands of small and medium-sized businesses that are part of the solution, not part of the problem," write Clive Bates, former director of the United Kingdom's Action on Smoking and Health; Eli Lehrer, president of the R Street Institute; and David Sweanor, a professor at the University of Ottawa's Center for Health Law, the three authors of the R Street report. Among the eight recommendations in the report, the most important is probably wiping away the 2016 reinterpretation of a 2009 law giving the FDA authority to regulate electronic cigarettes and e-liquid by the same standards as tobacco products like cigarettes—yes, even though there is no tobacco in e-cigarettes. As Reason's Jacob Sullum has written, this is essentially a slow-motion ban on many vaping products. The FDA's application process will cost as much as $1 million and a separate application will be required for each and every product. Smaller manufacturers unable to afford the costly application process will likely be driven out of the market, or will be bought up by larger businesses. Any product that has been introduced since 2009 is subject to the new rules and manufacturers have until later this year to either pull their products off shelves, or pay up and get approved. So far, there have been no signals from the Trump administration on whether it will continue with Obama-era policies on e-cigarettes or move in a new direction. It's unlikely that there will be any major policy announcements until Trump chooses a new FDA commissioner—something that he's unlikely to do until after his pick to run the U.S. Department of Health and Human Services, Congressman Tom Price (R-Georgia) is confirmed by the Senate. Jim O'Neill, a managing director at Mithril Capital, an investment firm co-launched by Peter Thiel, has been rumored to be on Trump's shortlist to run the FDA. Vaping businesses are hoping to see quick action from the new administration. "We believe something needs to be done to protect the thousands of businesses that are a crucial player in the global tobacco harm reduction strategy, and help those who are eager to quit smoking have easy access to vaping products," said Patricia Kovacevic, general counsel for Nicopure Labs, a Florida-based manufacturer of e-cigarette fluid that has launched a lawsuit challenging the FDA's deeming rule. Another major change recommended in the R Street report is allowing vaping products to be advertised as what they are: healthier than traditional cigarettes. The authors note that vaping isn[...]
Fri, 27 Jan 2017 12:06:00 -0500The state of Texas—hell bent on procuring banned drugs to be used in lethal injection executions—nearly completed a deal with five party drug dealers in India before the men were arrested. According to an absolutely bonkers report in Buzzfeed, Indian court documents reveal Provizer Pharma—the company equally owned by five Indian men in their twentires—was selling "psychotropic drugs and opioids illegally to people in the US and Europe," but also had a deal in principle with Texas' Department of Criminal Justice (TDCJ) to sell the agency sodium thiopental, a drug used in lethal injections. The TDCJ wrote in a statement, "The agency has not engaged in any transaction with this company," which would technically be true, because the five men from Provinzer Pharma were arrested by India's Narcotics Control Bureau while picking up returned packages loaded with illegal drugs at a FedEx store in Surat before Provinzer's sale of sodium thiopental to the state of Texas could be completed. But per a Drug Enforcement Agency (DEA) report obtained by Buzzfeed, the TDCJ tipped off the DEA of the planned purchase, and even named Provinzer Pharma as the vendor. Buzzfeed adds, "It's unclear how the Texas Department of Criminal Justice found this small company in India that made the rounds on Internet message boards for teens and 20-somethings looking to buy drugs without a prescription," but an American named Chris Harris ended up replacing Provinzer Pharma as Texas' drug supplier. Harris has made sales of death penalty drugs to four states—earning over $100,000—but each time the drugs have been detained by the Food and Drug Administration (FDA). As we've reported at Reason, death penalty states have had a hell of a time in recent years trying to get their hands on drugs used in executions, partially due to a European Union (EU) ban on the sale of such drugs to state governments that allow capital punishment, but also due to public backlash over the many executions which were botched because of drugs of questionable provenance and quality. The final status of the FDA-impounded shipments of sodium thiopental from India is still unsettled. The U.S.'s lone manufacturer of the drug stopped producing it because of its use in executions, and for a time, the Obama administration's FDA allowed states to import the drug, but the agency was eventually ordered by a federal court that it had "a mandatory obligation" to keep the "the misbranded and unapproved drug, thiopental" out of the U.S. That ruling came down in 2012, and has served as the FDA's go-to reasoning for refusing to release the detained shipments of drugs paid for by certain states' dollars. Earlier this month, the Texas Department of Criminal Justice filed suit against the FDA, demanding the release of the drugs. Ars Technica reports Texas Attorney General Ken Paxton accused the FDA of "gross incompetence or willful obstruction" in refusing to make a final decision on the fate of the impounded drugs. Paxton's main argument is that the state has a "responsibility to carry out its law enforcement duties"—which includes executions—and thus should be granted a "law enforcement exemption" and be permitted to import sodium thiopental. President Donald Trump might be the most enthusiastic proponent of capital punishment ever to inhabit the White House. It's one of the few policy positions on which he has never wavered, having taken a full-page ad in four major New York newspapers back in 1989 demanding "BRING BACK THE DEATH PENALTY", as well as writing in his 1997 book Trump: The Art of the Comeback, "I believe in an eye for an eye." In 2010, Trump said the punishment for WikiLeaks' publishing of classified documents provided b[...]
Wed, 25 Jan 2017 12:45:00 -0500The Food and Drug Administration issued, just two days before the end of the Obama administration, draft guidance on how the agency proposes to regulate genomically altered food animals. The FDA claims authority to regulate livestock and their products developed using the fantastically precise and versatile new genome editing techniques like CRISPR. Ultimately, the FDA's guidance document is rife with scientific nonsense. First, the overreaching agency claims it has the authority to regulate genetically improved livestock as a "new animal drug." As the agency points out all new animal drugs are "deemed unsafe" unless it has approved a new animal drug application. Treating each version of new improved livestock as a drug is really bad news for developers and consumers, since it takes years for a new drug to get through the FDA process at an average cost of more than $1 billion. Consider that it took the agency 20 years to approve the Aquabounty salmon that was genetically engineered simply to grow faster. The new FDA proposal is also ridiculously bad science. In fact, the regulation of modern biotech crops has been based on bad science for nearly three decades. Researchers have pleaded for years that regulation, if needed, be based on whether the end product poses novel risks, not on the method by which it is created. Under the new idiotic FDA guidance, any intentional change to a single-nucleotide base pair would make the entire animal a regulated drug. Let's put this into perspective. DNA, the chemicals that make up genes, are safe to eat. Unless you are eating only things like processed pure sugars and some minerals (in which case you'd be dead by now), nearly everything you eat contains DNA. In fact, by one estimate you eat more than 100 trillion genes that are in your food every day. Eating the DNA that specifies the production of snake venom is no more dangerous than eating any other DNA (even eating snake venom isn't necessarily dangerous, but I personally wouldn't advise it). Genetically improved livestock like hornless Holstein dairy cows are now in the FDA regulators' crosshairs. Researchers at the University of California, Davis used precise genomic editing to change the horn gene in Holstein dairy cattle to match the hornless gene found in Angus beef cattle. Most dairy cattle are dehorned as a way to keep them from harming farmers. As someone who has dehorned both calves and cattle, I can tell you that the animals don't enjoy the experience. This gene editing actually advances animal welfare. Since it is safe to eat hornless Angus cows, it is also safe to eat and consume dairy products from now hornless Holstein cows. Yet, the proposed FDA guidance wants the developers to go through its whole new drug regulatory rigamarole before products from these genetically improved animals can be offered to the public. This is on top the the FDA regulations that have stymied biotech advances in crop agriculture for decades. As Alison van Eenennaam, one of the researchers who developed the hornless Holsteins tells Gizmodo: "If DNA is a drug, then all life on Earth is high." She adds, "We have equivalent products with the same risks. Human intention isn't where risk lies. Who would say a Holstein is a drug? It's a bull without horns. There's no normal person that would think that's a drug." The FDA guidance blandly observes: In general, FDA's guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in Agency guidances means t[...]