Thursday, December 12, 2013

FDA – A Bump in the Genomic Road to the Future?

This week I received two detailed reports from 23andMe (23andMe.com), the genomic organization I wrote about in an earlier blog. They sent a LOT of information, and I am still working through. The first report was about strengths and weaknesses in my health plus information about how my body might respond to various medications. The second report related more to ancestry and genealogy.
Three days later there was an email announcement, apparently sent to all 23andMe customers. 23andMe, in response to a letter from the Food and Drug Administration;
If you are a customer whose kit was purchased before November 22, 2013, your 23andMe experience will not change. You will be able to access both ancestry and health-related information as you always have.

 23andMe has complied with the FDA's directive and stopped offering new consumers access to health-related genetic results while the company moves forward with the agency's regulatory review processes. Be sure to refer to our 23andMe blog for updates.

I beat the deadline and received the complete reports and will (I understand) continue to receive updates. Apparently customers of 23andMe who ordered after November 22 will receive the genetic results relating to health and medications, but without the helpful interpretations provided by 23andMe.

 My first reaction was hostile to the FDA. I had received what I believe is valuable information and the government doesn’t want me to know what’s going on in my own genome! Then I saw Mathew Herper’s article in Forbes- “23andStupid: Is 23andMe Self Destructing?” Herper pointed out that the FDA letter stated that 23andMe had stopped communication with the FDA in May!

Here’s part of the FDA letter, with link:
"Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA." (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm37629...)

But enough of legal and political maneuvering. What about the future of personal genomics? Frankly, I was impressed with the reports I received. Impressed enough that I planned to order 23andMe kits for our children and grandchildren.

To be specific, the 23andMe “drug response” report showed an “Increased” response to Warfarin. Coincidentally, my cardiologist had recently started me on a standard dose of blood thinner, then quickly reduced the dosage. He may have had similar information.
The Drug Response report was the report I was most interested in when I ordered the 23andMe kit, as I have family members who are over-responsive to multiple medications and feel this is an area that should be of greater concern in the medical community, as “standard” dosages can be way too much, or too little. The only problem I have had (so far) has been with beta blockers. Reading the report and the postings from other people revealed that a lot of people have trouble with standard dosages of beta blockers.

In the “Health Risks” report, my first three risks were Gout, Atrial Fibrillation, and Prostate Cancer. No problems with gout and my doctor been monitoring PSA and other tests for years, so no surprises there. But I had no clue, no education, no preparation for Atrial Fibrillation, so my education came from a team of doctors at the foot of my bed after a long night in the emergency room. A few years advance notice from a report like this would have been very valuable.

When I ordered the 23andMe kit, I didn’t expect many surprises. I’m 78, so I’ve already experienced most of the conditions that a genomic report would reveal, but I wanted to learn what genome testing can do for individuals. As I said earlier, I am impressed by the information I received. This is helpful information on many fronts, and we are still very early in the game—only 10 years since Dr. Collins report to Congress. Still a lot to learn about the human genome that will be added to future reports. Imagine what new information will be available over the next ten years!

But what about the FDA’s stated concern that individuals will “self-manage” their medications. Might knowledge and awareness of medical risks also help patients to better communicate with their physicians about their responses to medication? Do some physicians hesitate to vary from “normal” dosages because of legal risks? It would seem that an informed patient is the best solution to many potential problems.

And what about the problem between the FDA and 23andMe? Is this politics, bureaucracy, lobbying or something else at work? Or is this a legal challenge to the FDA? How will this play out? Lots of possible scenarios for this new industry. Some clues may come from a new book by Peter W. Huber, The Cure in the Code (reviewed in the December 4 Wall Street Journal by Ronald Bailey).
I have to believe that there is far more going on in this interaction between this young business and federal regulators than is apparent yet. We’ll have to wait for the next chapter!

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