Posting in Design
The FDA thinks the consumer-to-direct DNA tests are medical devices that need to be regulated. What do you think?
In 2007, back when I got my DNA tested by 23andMe, Navigenics, and deCODEme, all you had to do was harbor curiosity about your genetic makeup and actually purchase the test online. I treated the results as an experiment and therefore didn't use them to make any medical decisions.
Not surprisingly, as these companies have become more mainstream over the last couple of years, the Food and Drug Administration has become more critical of the genetic tests.
Lately, DNA testing has gotten a bad rap. My SmartPlanet colleague Deborah Gage wrote about 23andMe's recent sample mix up, which affected as many as 96 consumers. Now Congress is on the case and has requested all communication pertaining to the mistake, as well as the company's policy for handling errors and any other documentation that could reveal previous accidental swaps.
And when Pathway Genomics announced their plans to sell DNA tests at Walgreens, it certainly struck a nerve with the already-squeamish FDA -- as it should.
DNA tests aren't the same as selling a pregnancy test over-the-counter. There is no simple "yes" or "no" answer that you will receive, and the meaning of results are often much more complicated than that.
In the latest brouhaha, the FDA sent letters to the five major DNA companies — 23andMe, deCODEme, Knome, Navigenics, and Illumina — to air concerns about "medical devices" (that is, DNA tests) that it believes should be approved before they can be marketed.
Pathway Genomics was not included because a previous FDA letter made the company rethink their plan to market their tests directly to consumers.
Dan Vorhaus wrote the following about the situation at Genomics Law Report:
Supporters of the move argue that these [direct-to-consumer] products are medical in nature and require more stringent regulatory controls. Critics, including at least one of the companies receiving a letter (23andMe), fault the FDA for adopting a paternalistic stance to personal genetic information and imposing unnecessary regulatory controls.
If you look at 23andMe's Terms of Service agreement, it's not surprising they think the FDA approval is unnecessary.
You should always seek the advice of your physician or other appropriate healthcare professional with any questions you may have regarding diagnosis, cure, treatment, mitigation, or prevention of any disease or other medical condition or impairment or the status of your health.
Basically, any information I learned through the 23andMe service was at my own risk.
Frustration over mounds of genetic information never making it out of genetic research cliques is understandable, but I had my own frustration to address. You get the best results if you are of European descent. I told the founders I was an Asian-European mix, and when I clicked on the different options on the Web site, I got conflicting results. I wanted to know why. "Research needs to go a significant step further," Wojcicki admitted. "23andMe’s goal is to advance genetics research in this area. So 12 months from now, when you’re logging on to the site every day, we hope the data is more reflective of your [ethnic] background."
Forcing companies to get FDA approval for genetic tests would, in effect, further validate them as medical tests — giving consumers the impression that the tests can diagnose disease.
The problem is that these tests were never designed to be used as medical tests in the first place. Unlike a blood test, the results of a genetic test indicate nothing concrete. Gene mutations can't absolutely predict disease outcomes.
If anything, the tests ought to come with a huge warning label on them: "Genetic risks for disease implied by the results of this test is not a replacement for the medical advice of a licensed physician."
Newsweek interviewed Alberto Gutierrez, FDA director of its Office of In Vitro Diagnostics, about why the tests are considered medical devices years after they have been sold.
Well, the claims [made by the companies] have changed constantly. The original claims from three years ago were very, very vague. For example, the claims they’re making now for the different drugs and how they’re metabolized, those weren’t being made previously. Even some of the health claims in terms of risk of chronic disease, those just started coming online about a year ago.
In a report published last week, Andrew Pollack of the New York Times added the following:
But the letters stop short of saying the tests must be taken off the market until they are approved. Dr. Gutierrez said in an interview that it would be unfair to remove the tests from the market because the agency had not clearly told the companies that the devices needed approval.
The answer is clear: as long as these companies continue to sell their tests directly to consumers, the issue will remain a sticky one.
Should the FDA regulate this industry before personalized medicine matures?
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Jun 15, 2010
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Jeff, who says that one can not, or should not, go through Medical Doctors for Genome Testing? Everybody should have the freedom of choice. True, at present some discourage going through doctors; and most often they are the very medical doctors who, because of at the time of their training could have zero education on postmodern genomics on one hand - and can not afford the many-many hours necessary for genome analysis and interpretation without suitable software. It is pricewise totally prohibitive both for the doctor and for the patient. Yet, the choice, in theory, is there, and I suggest should stay there. True, "if these DNA kits had to go through doctors' offices, the costs would like increase 5 to 10 fold, not including the cost of the doctor's visit". IMHO a free choice of a consumer can simply depend on the kind of testing - as it already is, e.g. with pregnancy tests. One may opt to see a doctor right away, pay $$$ - or get a kit from e.g. Walgreen's for less than twenty bucks and next morning, reading "not pregnant" can safely forget about scheduling an expensive doctor's visit. It is just totally untrue that DTC tests provide only for "rare" and/or "severe" conditions. A lot of people (most notably James Watson) live up their eighties with abdominal discomfort, though these days anyone can get a rather strong signal from DTC SNP-testing e.g. is one is prone to lactose and/or gluten intolerance. How "rare" is lactose intolerance? About 80% of the global population is lactose intolerant! It is not an exceptionally severe condition, but uncomfortable enough to warrant a quick and reasonably priced test to flag predilection. Does one have to be "in doubt" or "contemplate suicide" if e.g. one or the other (or both...) of these predilections are signaled by DTC? Absolutely not. One can easily test if the marker signaled veritable "lactose" and/or "gluten" intolerance. Go drink a glass of milk. Go eat half a loaf of wheat bread (not simultaneously). Your body will verify/falsify the warning flag - as Dr. Watson, upon learning that he was all through his life partially lactose intolerant, at the tender age of 80 switched from dairy to soy-based products - and his abdominal discomforts are gone! Pellionisz_at_JunkDNA.com
Continued progress in the sequencing and understanding of the Human Genome promises to make DNA testing EVENTUALLY likely be about as foolproof a way to predict and prevent many genetically-linked diseases as the invention of the transistor a half century ago led to the computers we're all using today. That's a certainty. The problem is -- as any REASONABLE person knows -- that with our current understanding THE BEST anyone can do with a DNA profile is say that XX% of people with your genetic tendencies on THIS chromosome or THAT chromosome have an XX% chance of developing this cancer or that blood disease, or Parkinsons, or Alzheimers -- or whatever the ailment is -- in their lifetime. And IF you happen to have one of the very few RARE genetic markers which is a HIGH PROBABILTITY marker for something, a doctor MAY be able to start you on some preventive treatment, or recommend you avoid or eat certain foods, do certain exercises, put you on certain drugs, etc. The PROBLEM is that since these tests can be and ARE BEING sold to any Tom, Dick or Harriet with the $$$ to buy one -- including any too-smart, highly neurotic hypochondriac with too much money and time on their hands -- when the results come back, they come back with the indicators saying you have that XX% chance for THIS or THAT, and it doesn't matter HOW BIG any warning label(s) is/are, or how many times people are advised to SEE THEIR DOCTORS before going off half-cocked, there are literally MILLIONS of people who will, regardless, do literally stupid and crazy things based on reports they could be interpreting WAYYYYYYY out of perspective or even totally incorrectly. One really easy example to think of is the already-existing fact that many young, attractive, HEALTHY women in families where mothers, aunts, cousins and/or sisters have died from breast cancer with completely HEALTHY breasts have been, for a good many years, now, having double-radical mastectomies done as a precautionary preventive measure to "ward off" the risk of dying from a cancer they may never even get... And this was BEFORE DNA testing was even available! With DNA tests widely available, if a test says you have a 25% chance of getting gout in your feet as you get older, do you have your feet amputated? What if it says you have a decent risk of contracting some incurable terminal disease, such as Amytrophic Lateral Sclerosis or Alzheimer's, even though you're, say, 35 and in perfect health with no problems? Even if you actually ARE going to get one of those diseases it may not have appeared for another 30 years or more, during which you'd have lived a presumably healthy, happy life. But NOW (assuming you're the neurotic hypchondriac I'm referencing), you'll spend every day the rest of your life worrying about it, NEVER enjoy another day again, ALWAYS think you're feeling "phantom symptoms," and possibly even commit suicide at an early age as your OWN "preventive measure" to avoid the long pain and suffering you anticipate is "right around the corner." This is an extreme example, and certainly not many folks would do such things. But I can guarantee you some would, and likely will, once "the genie is out of the bottle." The old anecdote that "a little information is a dangerous thing" is never more true than when you give people just enough information about their health to scare the living daylights out of them, but they're too ignorant or stubborn to actually follow up with proper medical care and actually see what SHOULD be done. Worse, yet, quite a few (I know folks like this) will see a doctor -- or a dozen -- and if they don't massage their neuroses they'll just continue to obsess anyway and do whatever they were going to do without seeing a doctor (the "Laetrile crowd," so to speak). Every bottle of aspirin or Tylenol made says to take two tablets every four hours (or whatever the dosage is). But there are ALWAYS people who are CERTAIN "more is better," and for those folks, NOBODY can convince them otherwise. When they have liver failure from too much Tylenol, or get an ulcer from too much Aspirin, then suddenly they'll want to sue Johnson & Johnson or Bayer, or somebody, claiming total ignorance, or that the warning label should have been bigger, or that they couldn't read, or SOMETHING. Of course if we make DNA tests available ONLY through a doctor's office visit (so you CAN'T get the results without proper interpretation and sensible recommendations), there's a definite downside to THAT, as well, as ANYTHING done only THAT WAY these days without REALLY paying through the nose. My insurance changed the first of the year, and when I went to my doctor I gave them my new information, but they forgot to give it to their blood lab when they drew my blood to do 6-month routine labs to check my lipid levels, cholesterol, and most other major metabolites... I'm still trying to get the bill straight, but in the meantime I'm learning just HOW MUCH that would be if it was out of pocket -- $403 for a SINGLE test tube of blood that was tested for about a dozen different metabolites by an independent lab that operates as a separate company inside the doctor's office! Highway ROBBERY, I say! If these DNA kits had to go through doctors' offices, the costs would like increase 5 to 10 fold, not including the cost of the doctor's visit! All the same, at least until people get better educated about their own health and we learn more about DNA and the science gets better settled, that might be the best route to take. Jeff Hayes Spartanburg, SC
It seems to be quite clear from the ending of Gutierrez' video-interview (see in http://www.junkdna.com/holgentech/blog_news.html#fda_did_not ) that the present FDA, with an 1976 mandate, was not rushing to regulate genome testing in part because the field in the last 3 years was more in the "5' clock morning news" stage (certainly not in "prime time") - in part because the definition of "medical device" a generation ago just did not factor in postmodern genomics of our time; e.g. related "medical devices" to "diagnosis". However, diagnosis originates from the ancient Greek of learning - and now we know (a bit like post-Heisenberg' "principle of uncertainty") that epigenomics a priori makes "learning our destiny" impossible from our genome. ("The genome is NOT our destiny" - some like George Church proclaim). Genome-based prevention of certain proclivities is just as tentative as any good mother's advice "eat more veggies" - only getting to be science-based, and computer-assisted, both in a hyper-escalated manner. FDA is like the police department, they enforce the law - Congress is supposed to make laws! The process is now driven by an announced Congressional Investigation, where in the driver's seat (providing expert testimonies) we'll see Francis Collins, George Church, Jay Flatley - maybe even Sergey Brin both as an expert in "regulating software" (China-size...) and someone with 20-80% elevated proclivity for Parkinson's - established by scientific principles of uncertainty that Anne Wojcicki's 23andMe must rely upon. - Pellionisz_at_JunkDNA.com