FDA Orders 23andMe Off The Market; Apparently Concerned That People Are Too Stupid To Understand Their Own DNA

from the regulatory-overreach? dept

Soon after 23andme launched, there had been regulatory questions about whether it can market its simple DNA test without first getting regulatory approval. There hadn't been much news on that for a few years, so I had been under the assumption that the company had worked through all the regulatory hurdles. However, according to the FDA, the company has actually failed to meet the regulatory hurdles to make the product legal, and they're demanding that the company stop offering its product immediately, and fix problems within 15 working days, or face "regulatory action."

The FDA seems mainly worried that 23andMe's offering may overstate what it can do, and fail to inform people properly of the possibilities of false positives, which could create significant problems:

Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by International Normalized Ratio (INR) management under a physician’s care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.

The FDA further notes that it's been talking to the company for quite some time about this, including: "more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications" during which it claims to have given the company very specific information and suggestions for how to meet the necessary regulatory hurdles. I certainly recognize the value of the FDA making sure that companies aren't out there promoting quack medicine, which could create very real harms. But there is also something in all of this that suggests a compliance-by-the-numbers approach of trying to fit a square peg into a round hole by the FDA in trying to classify 23andMe as something that it's not. Most people I've known who use 23andMe don't use it as the final word on something, but rather as a simple and cheap way of figuring out where they might want to investigate for a more thorough analysis.

It will be interesting to see how the company responds to the FDA, as this has all the hallmarks of a company doing something unique, new and valuable, where the regulatory systems are simply unable to process. It's entirely possible that there is, in fact, problems with how 23andMe markets its products, but we'll reserve judgment until more details are available. From a basic informational standpoint, however, we have trouble believing that providing individuals with more information about their own genes should be heavily regulated. A more informed populace is a good thing and should be supported. The idea that people are too stupid to understand what information 23andMe provides seems insulting to the public, and it further perpetuates the myth that the public can't be responsible for understanding health and medical issues. Keeping the public less informed and more reliant on traditional (read: insanely expensive) healthcare options seems like the wrong choice. The FDA, if anything, should be encouraging more efforts to better educate the public.

Update: A petition has already been set up, by TechFreedom, asking the FDA not to ban home genomics kits and to reconsider:

We haven’t all used 23andMe yet, but those of us who have know the real problem is that doctors themselves are behind the curve. When 23andMe sent us our results, we followed their advice: we asked our doctor to talk about them. Most doctors didn’t know where to begin. But the more of us ask, the more the medical profession is catching up: brushing up on genomics, taking the time to understand the site, and talking to us about our results and what, if anything, to do about them. By prompting such dialogue, 23andMe has sparked a revolution in how the medical profession uses genetic information.

We urge you not to short-circuit this revolution. Please trust us — and our doctors — to make responsible use of our own genetic information. Instead of banning new technologies, the FDA should focus on educating doctors and patients about the benefits, and limitations, of genetic testing.

Filed Under: fda, genetic testing, genomics, regulations
Companies: 23andme

DailyDirt: Safe Until Proven Harmful

from the urls-we-dig-up dept

It seems like every other day we hear about yet another chemical in our food supply that's bad for our health. Maybe it's because the Toxic Substances Control Act of 1976, which is supposed to help regulate the use of chemicals in consumer products, has failed us with its assumption that "chemicals are safe until proven harmful," and has turned us into unwitting human guinea pigs. Phthalates in vinyl, perfluorinated chemicals in non-stick cookware, brominated flame retardants in electronics, polychlorinated biphenyls (PCBs) in coolant/dielectric fluids, and dichlorodiphenyltrichloroethane (DDT) in insecticides -- these are just a few chemicals that, over the years, have been discovered to be unsafe, long after they were introduced in consumer products. Here are a few more:

• The FDA will likely ban trans fats in foods. Trans fats, typically found in partially hydrogenated oils, help increase the shelf life of processed foods and make deep-frying oils last longer. However, the FDA has now concluded that the negative health effects of trans fats -- they raise LDL (bad) cholesterol and lower HDL (good) cholesterol -- far outweigh their benefits. [url]
• The FDA is now warning people to reduce their consumption of acrylamide, which tends to form when starch-rich foods are cooked at high temperatures, like in frying or baking. Acrylamide, in high doses, can cause cancer in animals and likely also in humans. So, in every humanly possible way, avoid eating tasty things like fries, chips, toasted bread, and even coffee. [url]
• The FDA is keeping an eye on bisphenol A (BPA). While there have been a ton of fear-mongering media reports on BPA, the FDA has concluded that at this time, there is no strong evidence that BPA is unsafe at the very low levels we get exposed to through our diet. However, it will continue to study BPA and recommends that people who want to reduce their exposure to BPA should: avoid using plastics with recycle codes 3 or 7; never put hot liquids in containers made with BPA; and throw away scratched plastic bottles. [url]

If you'd like to read more awesome and interesting stuff, check out this unrelated (but not entirely random!) Techdirt post via StumbleUpon.

Filed Under: acrylamide, bpa, chemicals, ddt, fda, food, pcbs, pfcs, phthalates, trans fats, tsca

Just Because You Don't Like What People Say About You, Doesn't Mean You Get To Sue For Defamation

from the nuisance dept

We've written plenty of times about public interest organization Public Citizen, mainly concerning efforts by its litigation group to protect those who have been sued in bogus lawsuits that would impact the internet's openness. However, every so often Public Citizen itself gets sued. Late last week, it revealed all of the details of a defamation lawsuit filed against it, concerning its letter to the FDA arguing that a certain product -- the LipoTron -- was being illegally marketed and promoted.

One of the organizations mentioned in the letter took exception to the claims in the letter and discussion on the web, and sent a cease-and-desist arguing that the claims were defamatory. In response, Public Citizen sent back a long letter backing up all of its claims (and also noting that they had never named the principal in the company, Mark Durante, so having him claim defamation personally didn't make much sense). This is the point where it makes sense to give up, but Durante's company, Advanced Aesthetic Concepts LP, sued anyway for libel, and asked the court for a temporary restraining order (TRO). When Public Citizen signed up a top local lawyer in Texas, pointed to Texas' new anti-SLAPP law (which would allow them to seek lawyers' fees), and told the lawyer that they were prepared to show up in court to contest the TRO, they were told that the case against them would be dropped.

At the very least, this yet again highlights the value of good anti-SLAPP laws in protecting those who are sued. But, once again we're amazed at how many people seem to think that filing defamation lawsuits in situations like this could possibly bring about a good result. In this case, all it's serving to do is call significantly more attention to the original claims that Public Citizen made in its original letter to the FDA (and then backed up in the legal filings).

Filed Under: defamation, fda, lipotron, marketing, medical devices, nuisance
Companies: advanced aesthetic concepts, public citizen

DailyDirt: Thank You For Not Smoking

from the urls-we-dig-up dept

People have been smoking tobacco for centuries (if not longer), but the health problems associated with tobacco have only been shifting from correlation to causation over the last decade or so. As usual, technology might be able to help... by improving how tobacco is used -- with various kinds of smokeless delivery mechanisms or with better treatments for addiction/cancer/etc. So the trend of a shrinking population of smokers might slow down or reverse course if there's a breakthrough in tobacco tech someday. But don't hold your breath.

• Smokers in the US could be extinct by 2046 -- not from dying, but because fewer and fewer people are smoking and a simple extrapolation points to about 34 years from now. A Citibank report has a few other linear predictions for the end of smoking: the UK in 2040, France in 2118, Germany in 2280... [url]
• In 2000, Philip Morris commissioned an infamous study in the Czech Republic on the impact of smoking -- which found that the cost "benefits" of smokers' early mortality along with cigarette-tax revenue outweighed the economic drawbacks of the healthcare costs for smokers. Live fast, die young... and help the national debt/deficit. [url]
• The FDA is looking at dissolvable, smokeless tobacco products that look a lot like candy. Chocolate, peanut butter and nicotine -- three great tastes that taste great together. [url]

If you'd like to read more awesome and interesting stuff, check out this unrelated (but not entirely random!) Techdirt post.

Filed Under: fda, healthcare, nicotine, predictions, smoking, tobacco
Companies: citibank, philip morris

FDA Spied On Emails To Try To Silence Critics

from the and-it-may-have-just-made-new-critics dept

We've discussed how the government often seems much more focused on silencing leaks of information, rather than recognizing that those leaks are often highlighting serious misconduct. The latest example involves the Food and Drug Administration (FDA), who apparently started trying to find the source of a leak, but in the end started collecting thousands of emails to try to stifle all sorts of criticism of the FDA, as revealed by the NY Times over the weekend.

What began as a narrow investigation into the possible leaking of confidential agency information by five scientists quickly grew in mid-2010 into a much broader campaign to counter outside critics of the agency’s medical review process, according to the cache of more than 80,000 pages of computer documents generated by the surveillance effort.

Moving to quell what one memorandum called the “collaboration” of the F.D.A.’s opponents, the surveillance operation identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and “defamatory” information about the agency.

The details show that the FDA installed key logger software on the computers of their own scientists, tracked the personal emails they wrote to others, and tracked documents they copied to key drives. Now, you can make a reasonable argument that since these were work laptops, the FDA has every right to track the usage, but it seems pretty clear that the FDA went really far here, and it wasn't just about stopping leaks, but about trying to stifle criticism and whistleblowing.

In fact, much of the evidence suggests that this absolutely was an attempt to blow the whistle on faulty review procedures by the FDA, that resulted in the approval of medical imaging devices that weren't actually safe. And, apparently, the complaints by the whistleblowers were convincing enough that there's now a Congressional investigation into "a substantial and specific danger to public safety" from this activity.

If the FDA were functioning as it was supposed to, it would have seen these complaints as a reason to investigate its own activities. Instead, in the supposed attempt to "stop leaks," the FDA used this info to try to squelch the attempt to have its own practices investigated.

Filed Under: fda, key logger, leak, whistleblower

OxyContin Being Tested On Kids... So Drugmaker Can Get 6 More Months Of Patent Protection

from the skewed-priorities dept

Want a sense of just how screwed up the incentives of our patent system are today? Purdue Pharma, the makers of the highly addictive painkiller OxyContin, is now running clinical tests to get the FDA to approve its use for kids as young as 6-years-old. Why? Because the Federal Food, Drug, and Cosmetic Act section 505A includes a little "gift": if drugmakers conduct clinical studies for their drugs with kids, they can get six more months of patent protection. So even if they don't even sell OxyContin to six year olds, just securing the extended patent, thanks to the massive monopoly rents given to drugs still on patent, Purdue is likely to profit massively. Lots of people are reasonably troubled by this:

“They are doing (the pediatric trial) for patent exclusivity, there’s no doubt about it in my mind — not out of largesse,” said Dr. Elliot Krane, director of pain management at Lucile Packard Children’s Hospital at Stanford University in Palo Alto, Calif. “That’s important for their bottom line.”

Of course, some will argue that if this provides better drug availability to kids, and those drugs really help the kids, then perhaps this isn't a bad thing. But, no matter what, the incentives here are highly questionable.

Filed Under: clinical trials, drug patents, fda, oxycontin
Companies: purdue pharma

How Extending Patent Protection For Antibiotics Creates Perverse Incentives To Render Them Useless

from the monopolizing-ourselves-to-death dept

We take antibiotics and their ability to kill practically all bacteria for granted. But scientists are increasingly warning that we may be about to leave what might come to be seen as a golden age for anti-bacterial drugs, and enter a post-antibiotic era. As the World Health Organization’s Director-General said, quoted in an article on the Citizen Vox site:

"A post-antibiotic era means, in effect, an end to modern medicine as we know it. Things as common as strep throat or a child’s scratched knee could once again kill."

The problem arises from natural selection. The more we use an antibiotic -- especially if we use it carelessly, failing to complete the full course -- the more we select for bacteria that are partially resistant to it. Over time, those bacteria thrive, displacing bacteria that are unable to withstand the antibiotic. Eventually, bacteria that are completely resistant to that particular drug are likely to evolve -- a situation that can have dire consequences. For example, even five years ago, methicillin-resistant Staphylococcus Aureus (MRSA) was killing more people in the US annually than AIDS.

The obvious way to mitigate this problem is to reduce the use of antibiotics, saving them for truly life-threatening situations, and that's what's happening to a certain extent in Europe:

To preserve the effectiveness of antibiotics for human use, Europe banned feeding antibiotics to livestock for growth promotion in 2006. In Denmark, where such use of antibiotics had been phased out more than a decade ago, drug-resistant pathogens in livestock are down while industry output is up.

As the Citizen Vox article notes, a similar proposal to restrict the use of antibiotics has not gone very far in the US, partly because an alternative approach has found far more favor, for evident reasons:

the Generating Antibiotic Incentives Now, or GAIN, Act has piggybacked into the FDA bill reauthorizing user fees for drug approval. GAIN would provide five more years of monopoly protections for new antibiotics. Already receiving three to seven years of exclusivity, some antibiotics may receive up to 10 years of protection after market approval. This measure defies both the economics and biology of antibiotic resistance.

The reason for that comes down to the nature of patents. Since they are time-limited, their owners have a natural incentive to exploit them as fully as possible during their entire term, when they can charge elevated monopoly prices. For other kinds of patents, that might be regrettable from an economic viewpoint, but it's hardly a matter of life or death. For antibiotics it's more problematic.

The more holders of patents for antibiotics seek to maximize their profits by boosting production and selling them as widely as possible, the more antibiotic resistance is likely to develop -- especially if they are given to livestock as well as humans. That growing resistance is a classic negative externality -- it's not something the pharma company needs to worry about, since the cost will come later and be borne by the general population in the form of increased medical expenses, longer stays in hospital, more serious infections and higher mortality rates.

Antibiotics are perhaps the clearest example of how the interests of patent holders are not only misaligned with those of the public, but are diametrically opposed to them in some cases. Although, in the short term, patents may encourage more antibiotics to be developed, in the long term they undermine their effectiveness. Even more than for drugs in general, antibiotics are an area where we need different kinds of incentives to stimulate development of new drugs -- government-funded prizes, perhaps.

Follow me @glynmoody on Twitter or identi.ca, and on Google+

Filed Under: aids, antibiotics, denmark, europe, fda, world health organization

Protected To Death: How Medical Privacy Laws Helped Kill 25,000 People

from the still-feeling-safe? dept

Privacy. Everybody talks about it. Grandstanding politicians make plenty of loud noises in the general direction of the internet, disparaging it for turning your perusal of Kim Kardashian-related articles into targeted ads for breast enhancement surgery and Kanye West tickets. Of course, while these politicians are making all this noise about your privacy, they're quietly signing off on efforts allowing them to sneak in the backdoor and raid your browser history.

Putting the government in charge of your privacy has never been a great idea. When HIPAA was enacted, its privacy requirements greatly affected the medical community. Like many regulatory acts, HIPAA both raised costs (additional paperwork and other compliance factors) and lowered quality (negatively affecting retrospective research and curtailing proactive follow up care).

The true cost of all this additional paperwork, regulation and privacy is now coming to light. Via The Volokh Conspiracy comes the news that HIPAA's privacy requirements may have hampered research efforts that could have prevented an estimated 90,000 unnecessary heart attacks and 25,000 deaths.

Vioxx, the non-steroidal anti-inflammatory drug once prescribed for arthritis, was on the market for over five years before it was withdrawn from the market in 2004. Though a group of small-scale studies had found a correlation between Vioxx and increased risk of heart attack, the FDA did not have convincing evidence until it completed its own analysis of 1.4 million Kaiser Permanente HMO members. By the time Vioxx was pulled, it had caused between 88,000 and 139,000 unnecessary heart attacks, and 27,000-55,000 avoidable deaths.

Even the government's own regulators were stymied by HIPAA's privacy requirements, as was pointed out by Dr. Richard Platt, a drug risk researcher for the FDA:

The Vioxx debacle is a haunting illustration of the importance of large-scale data research. If researchers had had access to 7 million longitudinal patient record, a statistically significant relationship between Vioxx and heart attack would have been revealed in under three years. If researchers had had access to 100 million longitudinal patient records, the relationship would have been discovered in just three months. Of course, if public health researchers did post-market studies that looked for everything all the time, many of the results that look significant would be the product of random noise. But even if it took six months or one year to become confident in the results from a nation-wide health research database, tens of thousands of deaths may have been averted.

At least as troubling as the fact that several thousand deaths could have been prevented if HIPAA's restrictions and terms had not been so limiting is the fact that the privacy stipulations were put into place based on a faulty premise and the Dept. of Health and Human Services' misplaced confidence in the erroneous results.

The premise, as demonstrated by Massachusetts graduate student Latayna Sweeney, was that patient reidentification was possible using only voter registration records and Massachusetts Group Insurance Commission's (GIC) anonymized records. Sweeney was able to reidentify Governor Weld using voter record information, including birth date, name, address, zip code and sex and cross-referencing it with GIC's data. But, as Info/Law points out, Sweeney made a couple of errors, not the least of which was conflating two different terms:

Latanya Sweeney used census data to estimate that 87% of the population has a unique combination of 5-digit zip code, birthdate, and gender, and implied that the same sort of attack, using voter registration records or other public files. Phillip Golle's replication corrected the figure to 63%, though that's hardly comforting. But these uniqueness statistics are rather misleading. There is an important difference between distinguishability and identifiability. Distinguishability is a necessary condition to conduct the sort of matching attack that Ohm describes, but it is not sufficient. Latanya Sweeney conflated the two when she suggested that a unique individual can be identified by linking the unique combination of attributes to public records-voter registration records, e.g.. But public records are never complete. We know, for example, that a significant portion of the population is not registered to vote. How was Sweeney so sure that there was not another man who shared Gov. Weld's birth date and zip code who was not registered to vote?

Not only was the data set incomplete, but it was overly simplistic and off by a large margin:

Daniel Barth-Jones has recently uploaded a fascinating new article that revisits the famous Gov. Weld reidentification. To start with, Sweeney's estimate of the Cambridge population is way off. There were nearly 100,000 people living in Cambridge at the time of the William Weld attack. This should have been the first hint that Sweeney's methodology was overly simple. She reported a population of 54,000 because that is the number of Cambridge residents who were registered to vote. Sweeney used these records as if they described the entire population.

By comparing Sweeney's count of Cambridge voter registrants with U.S. Census records, Barth-Jones confirmed that many voting-age adults in Cambridge (about 35%) were not registered to vote. In William Weld's case, the census data show that approximately 174 men living in Weld's zip code were Weld's age. We don't know their precise birth dates, but we can calculate that the chance another man living in Weld's zip code shared his birthdate was about 35%. This is quite important all on its own to illustrate the difference between identifiability and distinguishability. Most of those 174 men had a unique combination of birth date, gender, and zip code, but each one of them was quite likely-35% likely-to be non-unique.

Sweeney presumably used the voter registration records to rule out the possibility that some of these 174 Cambridge men shared Gov. Weld's birth date. But even if Sweeney did indeed confirm that no other registered voter shared Weld's gender, zip, and birth date, she could not have been sure about the 50 or so Cambridge residents who were Weld's age and were not registered to vote. Thus, at best, Weld's chance of having a unique birth date, zip code, and gender combination is 87%. Put differently, the chance that Latanya Sweeney's matching attack would have been wrong using these three variables alone was 13%- much worse than traditional 5% statistical confidence.

Despite these erroneous assumptions based on incomplete data, the Dept. of Health and Human Services stated the study had shown that "97 percent of the individuals in Cambridge whose data appeared in a database which contained only their nine digit ZIP code and birth date could be identified with certainty." This completely ignores the fact that over a third of the population wouldn't even show up on the list.

But bad data and faulty research have never stopped governmental "progress." The threat of reidentification is low and any attacks remain purely speculative. But while bad regulations have a tendency to be able to weather even the toughest criticism without making the slightest concessions, HIPAA has one thing most bad regulations don't, as Info/Law points out: "a body count."

Filed Under: fda, hipaa, hmo, medicine

DailyDirt: Caffeine In Everything

from the urls-we-dig-up dept

No one likes feeling drowsy when they want to be awake and alert. For centuries, folks have been self-medicating by drinking various beverages with caffeine (and Coca-cola originally had a more potent drug in it). We've come a long way from just boiling tea leaves in water, and here are just a few more ways caffeine is spreading into our lives.

• Inhalable caffeine isn't really meant to be absorbed by the lungs, despite its name. Caffeine doesn't really seem like a dietary supplement, either. [url]
• The Caffeine Zone app is supposed to help optimize when a person should ingest caffeine for maximal effects. But this simple app doesn't take into account personal metabolisms -- it just predicts how much caffeine will be left in your bloodstream after you enter in how much you drank, when and how fast. [url]
• The CDC and FDA have several warnings against caffeinated alcoholic beverages. But where are the warnings for a rum and Coke? [url]
• To discover more food-related links, check out what's floating around in StumbleUpon. [url]  

By the way, StumbleUpon can also recommend some good Techdirt articles, too.

Filed Under: caffeine, cdc, fda, metabolism, rum and coke
Companies: coca-cola