Collecting Thoughts on the FDA vs. 23andMe


Lantern Slides: Heritance of Clefting

I’ve been reading many of the news articles and blogposts about the 23andMe / FDA controversy, and marking interesting points, agreements and disagreements, various perspectives. These are some of my favorite bits from the pieces that have come out so far. I have a distinct personal bias regarding this extremely complicated topic, but also have good friends on “the other side,” as well as having a professional commitment to attempt to be unbiased. In this collection of quotes and highlights, I try to not let my own bias interfere too much, and to fairly represent opinions both pro-FDA and pro-23andMe. Please note that, on both sides, there are extremists, who I found typically didn’t clearly express the complexity of the issues, thus most of the quotes excerpted below are from more moderate authors.


Pic of the Day - PGen
Thoughts on the FDA

“The Food and Drug Administration’s recent directive to the company 23andMe to stop marketing its genetic tests directly to consumers is a shortsighted, heavy-handed, double-standard act of paternalism.”

Marchant, Gary. The FDA Could Set Personal Genetics Rights Back Decades. Slate Nov. 26 2013 12:39 PM. http://www.slate.com/articles/technology/future_tense/2013/11/_23andme_fda_letter_premarket_approval_requirement_could_kill_at_home_genetic.html

“I am deeply frustrated by the simplistic narrative of OMG FDA BIG GUBBERMINT SILENCING DARING ENTREPRENEUR. It’s not that simple.”

Wilbanks, John. FDA’s Culture Is Mendelian Dominant Over 23andme’s Business Model. DEL-FI November 30, 2013. http://del-fi.org/post/68560843111/fdas-culture-is-mendelian-dominant-over-23andmes

“The outrage over the FDA’s treatment of 23andMe is the wrong response. We should be holding 23andMe accountable for the claims they make in marketing their product. Even a product with such great potential should have to support its claims with valid evidence.”

Curtiss, Chase. Here’s what health entrepreneurs can learn from 23andMe. The Verge Beat November 29, 2013 5:11 PM. http://venturebeat.com/2013/11/29/heres-what-health-entrepreneurs-can-learn-from-23andme/

“This incident highlights the tension between the paternalistic medical establishment that arose to deal with the dangers of 19th-century quack medicine, and a “techno-populist” element of American society pioneering personal health assessment and decision-making by leveraging new information technologies.”

Khan, Razib. The FDA’s Battle With 23andMe Won’t Mean Anything in the Long Run. Slate Nov. 25 2013 2:46 PM. http://www.slate.com/blogs/future_tense/2013/11/25/fda_letter_to_23andme_won_t_mean_anything_in_the_long_run.html

“If the F.D.A. indeed insists on making 23andMe prove beyond doubt the validity of every single correlation, no genetic-testing service will be able to economically deliver medically relevant genetic information directly to consumers. It will destroy the industry and leave medical genetics in the hands of a medical establishment that has already failed to give people an easy way to obtain and use the elemental information in their own spit.”

Dobbs, David. The F.D.A. vs. Personal Genetic Testing. New Yorker November 27, 2013. http://www.newyorker.com/online/blogs/elements/2013/11/the-fda-vs-personal-genetic-testing.html

“Years ago, the FDA used the same argument against selling blood glucose meters to patients with diabetes. I believe that the FDA is wrong in saying that data in the hands of patients will do damage.”

Bartlett, Ann. Genetic Testing and the FDA. Health Central Wednesday, November 27, 2013. http://www.healthcentral.com/diabetes/c/9993/164554/genetic-testing-fda?ap=2008

“FDA acted properly in view of 23andMe’s cavalier attitude toward its regulatory obligations and its failure to meet past commitments. However, it would be a setback for science if 23andMe were not allowed to proceed. For its research model to deliver, it needs more people, far more people in its database. A campaign to sign up a million customers is a good start, and not losing momentum is essential. Perhaps 23andMe and FDA can find an accommodation — such as a consent order — that allows 23andMe to move forward while catching up on its overdue obligations, under threat of financial penalties or even perhaps the licensing of its database.”

Munos, Bernard. 23andMe: A Fumbling Gene In Its Corporate DNA? Forbes 11/29/2013 @ 10:19AM. http://www.forbes.com/sites/bernardmunos/2013/11/29/23andme-a-fumbling-gene-in-its-corporate-dna/

“It reads like the letter of a jilted lover,” Misha Angrist, a former genetic counsellor who writes about personal genomics and teaches at Duke University, said. “ ‘We went on fourteen dates! We exchanged all these e-mails! We held hands in the park! Now you’re telling me, “F*** you,” and kicking me to the curb.’ ”

Dobbs, David. The F.D.A. vs. Personal Genetic Testing. New Yorker November 27, 2013. http://www.newyorker.com/online/blogs/elements/2013/11/the-fda-vs-personal-genetic-testing.html

“Though the FDA talks up progress, there is a risk that it may slow it down. The agency is weighing regulations on test kits sold directly to consumers, laboratory tests and software that analyses raw genetic data. It is clear that 23andMe is not the only testing firm in its sights.”

And the FDA: A regulator brings a genetics company to a halt. Economist Nov 30th 2013. http://www.economist.com/news/business/21590941-regulator-brings-genetics-company-halt-and-fda

“Is the FDA and the rest of the medical establishment too conservative about innovation and health data that consumers can get directly? Well… is the Pope Catholic?”

MacManus, Richard. Thoughts On 23andMe & The FDA. November 27, 2013. http://ricm.ac/2013/11/27/thoughts-on-23andme-the-fda/

“I asked Dr. Hamburg if she were to have any power that FDA currently lacks, what would it be? The central thesis of her reply was: “I also think we need to find a way – maybe it’s just completely unrealistic – where we can have more flexibility in the system so that every time there’s a crisis or a recognition of a need to do more…we don’t have to go through the process of seeking new legislation.””

Kroll, David. Why The FDA Can’t Be Flexible With 23andMe, By Law. Forbes 11/28/2013 @ 8:45AM. http://www.forbes.com/sites/davidkroll/2013/11/28/why-the-fda-cant-be-flexible-with-23andme-by-law/


PGEN, Take 2
Thoughts about 23andMe

“Either 23andMe is deliberately trying to force a battle with the FDA, which I think would potentially win points for the movement the company represents but kill the company itself, or it is simply guilty of the single dumbest regulatory strategy I have seen in 13 years of covering the Food and Drug Administration.”

Herper, Matthew. 23andStupid: Is 23andMe Self-Destructing? Forbes 11/25/2013 @ 3:51PM. http://www.forbes.com/sites/matthewherper/2013/11/25/23andstupid-is-23andme-self-destructing/

“On the Twitterz, I wrote that 23andMe’s attorneys should be disbarred for letting things reach this point. Interestingly, it appears that General Counsel left the company several weeks ago (and no replacement has been found). I’m not always a big fan of the FDA (they still haven’t really figured out how to approve new antibiotics), but the reality is that the FDA is like those humongous tractors used to move space rockets: they’re slow, but crush everything in their path. You can’t bullshit these guys–they just keep coming.”

Mike. Some Thoughts on the FDA Action Against 23andMe.com. Mike the Mad Biologist November 26, 2013. http://mikethemadbiologist.com/2013/11/26/some-thoughts-on-the-fda-action-against-23andme-com/

“The consequences of mistakes by 23andMe can be deadly serious. If it reports a “false positive” for a major disease, that can alter someone’s whole life (though I’m rather sure that any medical professional would obtain results from another service to confirm positive results).”

Khan, Razib. The FDA’s Battle With 23andMe Won’t Mean Anything in the Long Run. Slate Nov. 25 2013 2:46 PM. http://www.slate.com/blogs/future_tense/2013/11/25/fda_letter_to_23andme_won_t_mean_anything_in_the_long_run.html

“But as the FDA frets about the accuracy of 23andMe’s tests, it is missing their true function, and consequently the agency has no clue about the real dangers they pose. The Personal Genome Service isn’t primarily intended to be a medical device. It is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public.”

Seife, Charles. 23andMe Is Terrifying, But Not for the Reasons the FDA Thinks. Scientific American November 27, 2013. http://www.scientificamerican.com/article.cfm?id=23andme-is-terrifying-but-not-for-reasons-fda

“Some experts claim that the risk of ailments like Type 2 diabetes can only be partially calculated based on genetic information. A credible diagnosis would require understanding a lot more about the person’s lifestyle and health history. Promoting a do-it-yourself culture when talking about serious health concerns like cancer and heart disease might have major downsides. However, the opinion in favor of 23andMe is that a dangerous double standard is at work. Today a doctor can sell many types of genetic tests to a patient, at a much higher cost. Only a few have received FDA approval. So why penalize the direct-to-consumer model?”

Kaushik, Preetam. FDA vs. 23andMe: The DNA of a disagreement. All Voices Nov 29, 2013 at 8:35 PM PST. http://www.allvoices.com/contributed-news/16062954-fda-vs-23andme-the-dna-of-a-disagreement

“However, according to one expert, the accuracy of the test is not the biggest issue. The company’s testing methods have been found to meet federal standards for lab testing, called Clinical Laboratory Improvement Amendments (CLIA), said Amy Sturm, a genetic counselor at The Ohio State University Wexner Medical Center. A greater problem is that the results provide “a very incomplete view” of a person’s risk for a given disease, Sturm said.”

Rettner, Rachel. 23andMe: What’s Really Wrong with Personal Genetic Tests. November 26, 2013 01:55pm ET. http://www.livescience.com/41534-23andme-direct-to-consumer-genetic-test-shortcomings.html

“Unfortunately, due to all the complex interactions between the markers, this full unravelling is impossible. The number of interactions is probably so high that every patient will have his or her own unique complex cause of disease. And what has never happened cannot be identified or predicted by big data. Advances in genome science will improve what tests offer, but these improvements will be small. While the hope is based on big data, the reality is that most diseases are simply not genetic enough. Other risk factors such as diet, body weight, smoking, exercise and stress are too important. And big data cannot change the biology of diseases – it will not make them more genetic.”

Janssens, Cecile. It is game over for 23andMe, and rightly so. Pando Daily November 27, 2013. http://pando.com/2013/11/27/it-is-game-over-for-23andme-and-rightly-so/

“It’s not all 23andMe’s fault. In my book research, I’ve read a lot about personal genomics. And the more I read up on genetics, epigenetics, etc., the more I see that the scientific community still has very little clue about what actually causes disease.”

MacManus, Richard. Thoughts On 23andMe & The FDA. November 27, 2013. http://ricm.ac/2013/11/27/thoughts-on-23andme-the-fda/

“THAT is the future. The DTC SNP chip era is ending. 23andMe’s two main competitors, Navigenics and deCODEme, already left the market. 23andMe’s SNP chips are slipping rapidly into the past. And 23andMe knows it.”

Greely, Hank. The FDA Drops an Anvil on 23andMe – Now What? Stanford Law School Blog November 25, 2013 http://blogs.law.stanford.edu/lawandbiosciences/2013/11/25/the-fda-drops-an-anvil-on-23andme-%E2%80%93-now-what/

“As to what will happen now is actually very simple. 23&Me will have to either file as a diagnostic and go through medical approval (which will cost millions of dollars) or start to only offer their service through a medical practitioner, more than likely through a clinical geneticist that can walk a patient through the intricacies of genetics and disease. The problem though is that according to the US News, there are only 358 clinical geneticists currently practicing in the United States. Measure the knowledge dissemination of a clinical geneticist, who usually only sees patients through referral, to the marketing power of a Google backed company like 23&Me, that was gearing up for a television marketing campaign: the outcome is a nail in the proverbial coffin for recreational genomics. As for 23&Me, its problems will only worsen as it will struggle to validate itself through the FDA since genomics is still in its infancy, thus: RIP the only viable, scalable consumer genetics company in the world.”

Pablo, Juan. What is next for Direct to Consumer Genetics. 1EQ Nov. 27, 2013. http://1eq.me/blog/?p=182

“We’re ignoring the bigger issue! The real reason 23andMe can’t test for my mutation is the company who formerly held a patent on BRCA1 and BRCA2 still has a proprietary database of our genetic mutations, and they aren’t sharing it with anyone! We need to fix THIS. We need for the government to help us figure out how data can be shared rather than be treated as a trade secret.”

Andrea. FDA B*tchslap of 23andMe: A BRCA Previvor’s Perspective. Brave Bosom November 26, 2013. http://www.bravebosom.com/fda-btchslap-of-23andme-a-brca-previvors-perspective/

“23andMe is simply doing what the Internet does best: forcing old dogs to learn new tricks. That’s what the fight between Uber and taxicab commissions is about. Same for AirBnB and hotel regulators. The only profession slower to change how they do things than doctors is bureaucrats. So the FDA’s reaction is understandable — but misguided.”

Szoka, Berin. FDA Just Banned 23andMe’s DNA Testing Kits, and Users Are Fighting Back. Huffington Post 11/26/2013 7:46 pm. http://www.huffingtonpost.com/berin-szoka/fda-just-banned-23andmes-_b_4339182.html


23andMe Celiac Disease Risk Markers
Thoughts about Regulation of Personal Genetic/Genomic Services

“We need DTC screening. It helped me. It’ll help many others. But until the FDA learns how to deal with Bayes’s rule and its discomforts – and until DTC companies figure out a business model that isn’t based on massive loss leadership – we’re going to keep coming back to this clash of culture and business models. Both sides need to make some changes if we’re going to avoid doing this over, and over, and over.”

Wilbanks, John. FDA’s Culture Is Mendelian Dominant Over 23andme’s Business Model. DEL-FI November 30, 2013. http://del-fi.org/post/68560843111/fdas-culture-is-mendelian-dominant-over-23andmes

“23andMe embodies a generation preoccupied with itself. Our right to know has superseded our ability to understand. Empowerment has evolved as data, information, knowledge and wisdom are almost seen as one in the same. Whether 23andMe’s reporting is actionable is to miss the point. When you’ve got your data, what more do you need, really? Epigenetics…what epigenetics?”

Vartabedian, Bryan. 23andMe – Why Our Big Government is Right. 33 Charts November 28, 2013. http://33charts.com/2013/11/23andme-government-is-right.html

“As a citizen, I expect corporate transparency for any new health product. As a patient, I think the risks of taking the test outweigh the benefits for my health. As a doctor, I have my concerns for people with distress or misinformation from results of an unproven genomic test. As a human being, I worry about misuse and unintended social consequences of our genetic heritage.”

Matthew Katz on 23andMe: “Return to Sender, Genome Unknown: Seven Reasons I Will Return My Personal Genome Kit.” e-patients.net December 3, 2013. http://e-patients.net/archives/2013/12/matthew-katz-on-23andme-return-to-sender-genome-unknown-seven-reasons-i-will-return-my-personal-genome-kit.html#!

“Our society has increasing information and public access to information. While it is difficult for me to think that this isn’t a good thing overall, we have to thoughtfully consider the possible unintended negative consequences. This case is part of a larger pattern of sacrificing quality-control filters for the sake of open access. This increasingly puts the burden on the public to make sense of sometimes complex and technical information. Everyone, now, can be their own geneticist.”

Novella, Steven. The FDA and Personalized Genetic Testing. Science Based Medicine November 27, 2013. http://www.sciencebasedmedicine.org/the_fda_and_personalized_genetic_testing/

“Community forums and news sites across the web exploded with debate, with most people rallying to 23andMe’s defense. The company’s ample support-base claims that the Food and Drug Administration is over-regulating, and is stifling innovation. However, the majority of geneticists and medical professionals I’ve spoke with have sided with the Food and Drug Administration, arguing that many patients require genetic counseling after receiving DNA test results that point to a high risk of cancer and other life-threatening conditions.”

Farr, Christina. Here’s why the FDA is targeting 23andMe. MedCityNews November 26, 2013 10:00 am http://medcitynews.com/2013/11/heres-fda-targeting-23andme/

“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 about 23andMe, the more the medical profession is catching up. Slowly but surely, they’re 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.”

Szoka, Berin. FDA Just Banned 23andMe’s DNA Testing Kits, and Users Are Fighting Back. Huffington Post 11/26/2013 7:46 pm. http://www.huffingtonpost.com/berin-szoka/fda-just-banned-23andmes-_b_4339182.html

“If you scare somebody into believing they’re high risk, they could take actions that hurt their health,” says Gutierrez. Not only is the data on some genetic links inconclusive, he adds, it’s well-chronicled that patients can push their doctors into authorizing unnecessary procedures. “Doctors do a lot of double mastectomies because of fear.”

Brady, Diane. Do Genetic Tests Need Doctors? FDA Defends Its Challenge to 23andMe. Business Week November 27, 2013. http://www.businessweek.com/articles/2013-11-27/do-genetic-tests-need-doctors-fda-defends-its-challenge-to-23andme#r=hp-lst

“Should this third party be a doctor, as some (mostly doctors) are arguing? There are certainly doctors out there who have a great grasp of human genetics. But there aren’t a lot of them. And even the doctors who do know the world of human genetics inside and out aren’t in a position to help people navigate every nook and cranny of their genome. This is a job for software, not for people.”

Eisen, Michael. FDA vs. 23andMe: How do we want genetic testing to be regulated? November 26, 2013. http://www.michaeleisen.org/blog/?p=1480

“This is a broad cautionary tale,” says Quackenbush. “We need to be careful about how we define phenotypes, such as whether a patient is likely to respond to a drug or have an adverse event, because if we don’t do it well, we’re not going to have good tools for advancing personalized medicine.”

Hayden, Erika Check. Personalized cancer treatments suffer setback. NATURE 27 November 2013. http://www.nature.com/news/personalized-cancer-treatments-suffer-setback-1.14238


OTHER COLLECTIONS

Alexander, Lindsey. Six smart takes on the 23andMe FDA standoff. MedCityNews November 27, 2013 11:58 am. http://medcitynews.com/2013/11/smart-takes-23andme-fda-standoff/

Dobbs, David. I Got Your 23andMe – FDA Food Fight Links Right Here. Neuron Culture November 30, 2013. http://daviddobbs.net/smoothpebbles/i-got-your-23andme-v-fda-links-right-here/

2 responses to “Collecting Thoughts on the FDA vs. 23andMe

  1. Two more collections, if you will:
    The inevitable: class action lawsuit against 23andMe http://telecareaware.com/inevitable-class-action-23-and-me/
    FDA tells 23andMe genomic test to stop marketing http://telecareaware.com/fda-tells-23andme-genomic-test-to-stop-marketing-us/

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