Breaking: Congress to Investigate DTC Genetic Testing
The United States House of Representatives Committee on Energy and Commerce today launched an investigation into direct-to-consumer (DTC) genetic testing, sending letters to three prominent DTC companies: 23andMe, Pathway Genomics and Navigenics. Here is the announcement from the Committee:
Today Chairman Henry A. Waxman, Ranking Member Joe Barton, Subcommittee Chairman Bart Stupak, and Subcommittee Ranking Member Michael C. Burgess sent letters to 23andMe, Inc., Navigenics, and Pathway Genomics Corporation in light of recent reports that at least one of the companies is seeking to sell personal genetic testing kits in retail locations, despite concern from the scientific community regarding the accuracy of test results.
The Committee is requesting information from the companies on several aspects of the tests: How the companies analyze test results to determine consumers’ risk for any conditions, diseases, drug responses, and adverse reactions; the ability of the companies’ genetic testing products to accurately identify any genetic risks; and the companies’ policies for the collection, storage, and processing of individual genetic samples collected from consumers.
Signed by the Chairman and Ranking Member of both the full Committee (Henry Waxman and Joe Barton) and its Subcommitee on Oversight and Investigations (Bart Stupak and Michael Burgess), the three letters (23andMe, Pathway Genomics, Navigenics) appear to be substantively identical.
The Committee appears to be interested in gathering information. Lots and lots of information. The letters are impressively broad in their scope, which is unsurprising given that this is the first publicly reported Congressional investigation into the current generation of DTC genetic testing companies. (A previous investigation into several companies offering nutrigenetic testing culminated in this GAO report to Congress.) The Committee is seeking the following information for each DTC company:
(1) description of available tests, including which conditions, diseases, drug responses, etc. are tested;
(2) policies with respect to the involvement or availability of genetic counselors and/or physicians in conjunction with its tests;
(3) scientific support for the accuracy of its tests (including proficiency testing) and validity of its reported associations;
(4) policies for processing and use of DNA samples, including privacy protections and third party use; and
(5) compliance with the Federal Food, Drug, and Cosmetic Act (FFDCA) and FDA regulations.
The DTC genetic testing landscape has certainly shifted dramatically. This time last week, Walgreens and CVS were still planning to offer DTC genetic tests from Pathway Genomics on drugstore shelves nationwide. Since then, first the FDA and now Congress have launched investigations into DTC genetic testing.
As for what happens next, that’s anybody’s guess. The FDA, in its letter last week to Pathway, gave the company until May 25th to demonstrate that it has proper FDA approval or to explain why such approval is not necessary. Congress is proving slightly more generous, giving the three companies until June 4th to respond to its information request. Rest assured that nobody at any DTC genetic testing company, including those not currently targeted by either the FDA or Congress, of which there are plenty, is going to be getting much sleep over the next few weeks.
The Genomics Law Report will have more on this story, and the future of DTC genetic testing and regulation, as developments occur.
I decided to give 23andMe a try when they were running their $99 DNA Day special a few weeks ago. I sent them an email a few minutes ago asking if this investigation would delay the results of my test. Their automated response is below. Coincidence?
Hello,
Thank you for writing to the 23andMe Team. We are currently experiencing high email volumes and the expected response time is 5-7 business days. Our apologies for any inconvenience.
Your case number is 000XXXXX.
Best Wishes,
The 23andMe Team
I know not everyone will agree with me, but I think it’s about time (overdue!) that regulatory and/or government bodies started taking a closer look at this issue. Not that I think we need to be a complete nanny state, but someone should be making sure that these tests are clinically valid, not just analytically valid.
In any event, I’m guessing 23andme and navgenics are pretty pi**ed at Pathway right now.
Well, I don’t think this is Pathway’s fault. What you have is one of 3 things.
1. Bad legal advice
2. Bad VC advice
3. A set of revolutionary millionaires hell bent on the reshaping of healthcare into “Google yourself care”
Take your pick of the 3. These companies are merely pawns in the bigger game between government and the silicon valley over human life and death.
Rest assured, the government is going to take this punchbowl away pretty quickly. Despite having waited for 2 years to “study” it, they are now going to act very swiftly here.
Hate to say I told you so, but I think I started telling everyone so back in 2007…….
-Steve
http://www.thegenesherpa.blogspot.com
Waxman may have bitten off more than he can chew on this one.
The FDA is usually portrayed as a neutral arbiter but Congresscritters are known to be political actors. The press regularly labels them as “grandstanding for the cameras” or “blowhards” at these kinds of events.
Pathway has to be thanking their lucky stars that they got Navigenics and 23andme pulled into this. Let’s remember that between Google and Kleiner, those two have some JUICE in Washington.
“Al Gore Helps Navigenics Launch Personal Genomics Service”
http://www.bio-itworld.com/BioIT_Article.aspx?id=74584
“Obama personally entertaining Google”
http://www.youtube.com/watch?v=m4yVlPqeZwo
“Sergey on Google & Government’s shared vision”
http://www.youtube.com/watch?v=lfg0YymBUF0
“Eric is a member of President Obama’s Council of Advisors on Science and Technology. ”
http://www.google.com/corporate/execs.html#eric
Whoever turned this into a political fight from a regulatory fight has made a bit of a miscalculation.
In a regulatory fight there is the presumption of guilt because people don’t understand that the FDA is a political actor (“With Obama, Regulation is Back in Fashion”: http://www.nytimes.com/2010/05/13/us/politics/13rules.html).
But in a political fight you can hit back.
I think Gore and Obama are going to get involved.
Obama needs the votes of the business community for the fall and this out-of-the-blue persecution will get technological swing voters recognizing that new economy business aren’t any more immune to the triple team of govt. + media + regulator persecution than those “bad” old economy industries like oil and banking.
Waxman may well get backhanded and go quietly scampering back to the corner to look for smaller prey just like he did with AT&T (“Waxman cancels AT&T hearing”, http://www.businessweek.com/news/2010-04-14/waxman-cancels-health-hearing-with-at-t-deere-ceos-update1-.html).
Well done, Dan. Despite believing that most congressional investigations, and especially hearings, belong under the big tent, I think this House committee deserves some credit for the same reason FDA deserves criticism.
Unlike the FDA, Waxman’s merry bunch has provided the three DTC companies with a relatively narrow list of the points it intends to investigate (and that you list nicely). Although the last one — to show how the tests are in compliance with FDA regulations — is a bit cheeky because the companies have been operating openly under the belief that their tests do not require any kind of regulatory approval.
@Martin,
You may be right. We’ll see.
I seems to me that as long as you include the age-old adage “This product is not intended to diagnose, treat, cure or prevent any disease” then you can sell any product that you like and not have any worries from the FDA. This is an exaggeration of course but I think my point has come across. Why then is the FDA concentrating on the DTC genomics market?
Likely because they ARE intending to diagnose, prevent, and cure diseases. It seems to me to be fairly straightforward to have these companies subject to FDA regulation when their intents are to directly tell a potential patient what diseases they are susceptible to and how they might react to prospective treatments. I will admit that the timing of this does stink a bit. If not earlier then why now? Politics, son…politics.
But that’s not my point. Or if it is, here is my counterpoint. Instead of Congress focusing so much on what these companies are doing and if they are or are not in compliance with FDA regulations (which is nothing more than a paper trail), perhaps Joe Barton, Bart Stupak, and Michael Burgess should focus their attention onto the more pressing matter, educating the public on the benefits and dangers of DTC genetic testing. The questions that we should be asking is not WHETHER we should be doing these tests but rather WHAT are we going to do with the information derived from them.
For example, you send your DNA to your favorite DTC company and they send you a SNP list and perhaps traits associated with those specific SNPs. Fantastic. Say you have a SNP which predisposes you to lung cancer and a SNP which dictates whether or not you will respond to Propecia. Information is power and it is now up to you to determine what you do with this power. I suppose it is Congress’ assertion that we are all too ignorant to properly process this information and that we need the gub-ment to decide for us what to do with this knowledge. Surely, I have digressed (and don’t call me Shirley). People need to be educated on what exactly these associations mean. In our example we had a pateint who has a SNP associated with lung cancer. An uneducated person might say to him/herself OMG!!! I’m going to die!!!!! Bald too!!!!! !He/she then proceeds to bankrupt their nest-egg on pricey dinners and exotic cruises (or hookers and blow) only to discover that they are going to live a long and fruitful 97. I do not think that your average consumer purchasing a test off of the Walgreen’s shelf can comprehend the information that they will receive. This is where we should have Congress focus, not on this silly business. Just let the FDA do it’s job says I to the distinguished gentleman from Califor-regulating-a.
@Jason Schultz,
Well Said
Personalized Medicine is Medicine. When you have a terms of service which says “Not to be used for medicine” How can you be a part of personalized medicine?
1. These tests can be used for medicine, some of them at least.
2. There is clearly a Political Play here, I am just not sure which one yet.
3. DTC will end up losing what little trust they have with the public now, unless they start becoming medicine.
@Kirell,
It is not cheeky, it is designed to discredit. Once a meeting of the IOM asked the CEO of a DTC company, “Do you consider yourself to be medicine? If not, why not.” I think congress will ask the same. How is a BRCA mutation from 23andMe not medicine? How could anyone seriously say it wasn’t?
-Steve
http://news.cnet.com/8301-13578_3-20005458-38.html
Politics? Most certainly now.
As for Mr. Gore,
You mean the guy who hyped Global Warming to make millions, I guess that may be the same guy to hype genome scans to make another million…..
@Steven: Wow. You’re bringing that here? Please don’t. This was a good comment thread.
Ok fine. I will let it drop. But if I were a tea partier……
I could not agree more with FDA and U.S. Congress. It was long time overdue. ASHG and ACMG have long time now expressed major concerns on DTC SNP testing. Please, see ASHG’s news release on this topic, http://www.ashg.org/pages/statement_5_13_10.shtml. On the other hand, whole genome or exome analysis research is ongoing with very promising results so far, please see http://www.nytimes.com/2010/03/11/health/research/11gene.html for more information.
In my opinion and in view of this international new DNA era in medicine, a medical genetics evaluation and counseling in collaboration with the primary care practitioner and/or family medicine specialist, is highly recommended before any kind of genetic testing and especially any DTC DNA testing.
I ordered two tests on that sale, and a week has been the standard time it has taken them to actually answer e-mails on anything, even the billing problem. I don’t know if I’ve ever had a phone message returned, or if that happened once but that took a week as well.
In the two months since I ordered those tests, I ‘ve developed some issues with 23andMe. They did me a couple of invaluable services for that $200 bucks (for two tests).
First, that was a relatively inexpensive way to pin down my paternal lineages’s Y DNA subclade. We probably couldn’t have done it otherwise. This is proven technology.
Second, we got valuable information on our genetic risk for type 2 diabetes. But I say that with some important caveats. 23andMe does a mickey mouse report on odds of developing type 2 diabetes, based on a handful of the more important genes for the condition, but they left out alot of important genes, and in fact, there are over 50 known genes for type 2 diabetes. The sad fact is that scientists find it so hard to predict with the current state of knowledge who will develop type 2 diabetes given their genes, that the risk of “average” in a family where nearly everyone gets diabetes was representative of what I got looking at more genes. The research, and a careful look at our genes, supports thinking that actually, diet, weight control and exercise matter more than the genes – and 23andMe does not counsel that, though it does advise that the condtion is only a third heritable, which is both possibly true, and contrary to current scientific wisdom that it is 67% heritable.
I am bright adn well educated enough to research the genes on my own. Because 23andMe is involved in medical research and gets a certain amount of its funding by participating in medical research, its raw data, which its customers have access to, does actually contain a number of alleles of most of the genes for type 2 diabetes that are currently under study.
Most people couldn’t do this research. I learned invaluable things about how type 2 diabetes deveops and how to avoid it that are actually at the forefront of the field at this time. I learned to understand my problem with first stage insulin release. I learned how to change my diet to get my gut to make more of a key hormone that I particularly have trouble responding to.
Most people couldn’t ahve extracted this knowledge from their 23andMe results, and neither could my doctor.
Most people would have misunderstood 23andMe’s statement that I have a very high odds ratio for type I diabetes, a condition that infrequently strikes people with a number of very common genes for it.
23andMe offers no help whatever understanding our genetic results, beyond its report.
Two things I’ve experienced at 23andMe particularly bother me. One is that 23andMe offers “relative finding” based on autosomal DNA testing, which is NOT a proven science, and which I have real doubts about. 23andMe also has a Facebook like basic setup. People on the forums try to bully other people into socializing with them because 23andMe said we’re cousins – even in the absence of any reason to think they’re distant cousnis. “So what if we don’t share the same name”, someone wrote. Maybe we’ll be related in the future! Of four people who responded to my invitations to “share genomes” with me, only one provided me with the information necessary to determine that instead of fifth cousins, we’re eight times 10th cousins from 17th century Connecticut. Everyone else insisted to me that if 23andMe says we’re cousins, we’re cousins. In one case, I thought that probably we are 4th or 5th cousins, because someone with a very rare name that is on on her surname list married into one of my lines that far back, but I couldn’t get any more information out of her.
The other thing is that 23andMe just had a major data mixup. They claim it affected 96 people, occurred on June 1, and was straightened out by June 2. However, very upset people were posting on June 2 that they’d gotten no response from 23andMe, and some said that the mixup was a few days old at that point. By June 4, a couple of people reported getting an e-mail saying that some peoples’ data didn’t meet control quality standards and was pulled, and others were getting all their information from each other on the forums. One woman posted that her whole family was extremely upset and her son couldnt’ get out of bed, because they’d been told he wasn’t her son, but the son of an African American woman. Another reported that she’d called her family to get them to explain to her how come she wasn’t their child. Now, keep in mind that 23andMe doesn’t reven read any e-mail you send customer service for a week. How did they even know something was wrong.
I’m outright disturbed at the notion of Walgreen and CVS selling DNA kits. They aren’t even going to test for more than a couple of genes for complex genetic medical conditions, and they aren’t going to have any quality control, or any genuine customer service.
I’ve been threatened with having my posting privileges pulled for saying the same thing repetitively on the forums.
@DoraSmith I see absolutely no evidence of bullying from 23andme that people communicate because they are on Relative Finder. In fact, I see evidence that people clearly understand that sharing DNA can mean anything from close relative to an ancestor 400 years ago.
I did see you announcing before you got your results that you would only accept invites from people that passed certain requirements and emailed you personally and that you were not interested in a social forum. If there is bullying, I have seen it from you in choosing terms of your own on how and with whom you will communicate. You are the only person on there that has done that. No one else thinks this is FB like and I have been on there for a while before you.
You seem to have misunderstood a lot, including a problem that you have blown out of proportion and misstated. The woman in question you describe is African American – so she certainly wasn’t afraid her son was African American.
And despite the fact that everyone was contacted including a family member of mine, you insist on saying it never happened. My family has always been happy with the response from 23andme. But maybe it is because we don’t overwhelm them and ask nicely.
That you don’t like 23andme is obvious. That you get the facts wrong on many issues about them is also obvious. The one thing they are clear about is the role of epigenetics. Complaining that the studies they report are not the whole truth is irrelevant. They already know this and report it. Maybe complain to the peer reviewed journals they come from.
There was a very sweet window of opportunity which i see closing. It isn’t only because of your misrepresentation of facts but I am sure it helped.
The paternalism of the medical community which thinks more highly of itself than it should will also bring down genetics testing. What a pity this is.