23andMe vs. F.D.A.

Tuesday, November 26, 2013

The F.D.A. warned genetic testing company 23andMe to stop marketing their product, as they need more approvals from the agency. Alice ParkTime magazine staff writer covering health, shares on the latest.

Any 23andMe users? Call us and tell us what you've done with your results and how you feel about the company's marketing promises.


Alice Park

Comments [19]

Martin Chuzzlewit from Manhattan

The important part of this story is how scary the Obama administration and its death panel-type regulators can be - they see a burden here to the health cost structure of Obamacare and they will steamroll anything that might add expensive medical tests because people have a certain vulnerability and might want to be screened.
This is your life under Big Government.

Nov. 26 2013 01:36 PM
BK from Hoboken

Unfortunately, most people refuse to do the alternatives. I don't argue your point about there being non-pharma alternatives. For instance, almost every diabetes drug, heart disease drugs, etc all are approved as an adjunct to diet and exercise. Most doctors will sit a patient down and tell them they need to lose weight, get their blood sugar down, BP down, LDL down, etc. The dr will go over diet changes, execercises tht are safe for the patient, etc. Then the patient comes back 6 months later 5 pounds heavier! Lazy Americans just want a pill.

Nov. 26 2013 12:38 PM
Taher from Croton on Hudson

@BK from Hoboken,
you don’t get it. The medical professional has been Stockholm syndromed by pharm in the US. The only solution to ailments, for the medical profession, is pharmaceutical compounds to the exclusion of all else.

Nov. 26 2013 12:23 PM

I am a customer of 23 and Me as are 5 of my relatives.
I have a DNA Match with hundreds of people throughout the world.
Matching genomes, it's amazing.
I also have a health profile with 23 & Me.
I think it is a very useful service.
Why should only medical professionals have access to this service?

Through and GedMatch, using my DNA profile obtained
via 23 and Me, I have a lot more matches.

I find it fascinating.

I would not have biological children without knowing the results of
my significant other's 23 and me results.

I would want to know about their health profile and also
if I want to have children with their particular ancestry profile.

Nov. 26 2013 12:19 PM
BK from Hoboken

Don't you know that wnyc can't discuss an even tangentially related story involving pharma without all of the crazies coming out of the woodwork? Lets discuss warfarin- a drug that was developed first to be rat poison. The therapeutic window for this drug is so incredibly narrow. Yes it requires constant PT INR testing (a measure of how quickly your blood clots), as even a change in diet exercise levels and other behaviors can alter the appropriate dose. And yes there are newer anti-coagulants that are much safer and don't require constant monitoring. And yes they are more expensive, but they really are a revelation to doctors and patients who have had to deal with warfarin for several decades (it's an ancient long-generic drug). Bit this doesn't work with the big pharma is corrupt stories they love around here.

Nov. 26 2013 12:15 PM
Taher from Croton on Hudson

@BK from Hoboken
Incompetent medical doctors and the use of pharmaceutical drugs murdered members of my family.
It has been discovered that Tylenol can seriously damage children and adults liver leading to death.
It has been known that the over use of anti-biotic has lead to super bugs. So tell me more about how all of this is not connected to the need for higher profits? And how much more drugs a day we need to take? You are either a patsy or a shill.

Nov. 26 2013 12:11 PM

There is variable expressivity of traits between people with the same genotype; there are epigenetic factors that determine when, how much and whether or not a gene is expressed; there are environmental factors, and there is the obvious factor of body weight that should be considered when considering, say, use and dosage of a drug. Genetics is one (really, really cool!) factor, and should be considered with the other informing factors listed above. In the same way, it might be incomplete to decide to use a cholesterol drug based on one blood test, esp. if you didn't fast and had shellfish the night before! That's what I believe, and I should probably get my 23&Me done before they take the opportunity away from me because' I can't handle it'!

Nov. 26 2013 11:42 AM
BK from Hoboken

I wil assume that you dont pop Tylenol for a headache, won't take a statins when you get older and your cholesterol goes up, won't take antihistamine for your seasonal allergies, won't take an antibiotic when you have an infection...
Yes big pharma are all criminals. You have no clue how much you and your loved ones have been helped by big pharma. Get a clue.

Nov. 26 2013 11:39 AM
Amy from Manhattan

hjs11211, don't you remember the pet food from China that poisoned many pets a few years ago? I *want* the *Food and Drug* administration to regulate pet food! And a lot of their problem w/enforcement has to do w/having had their funding cut.

Nov. 26 2013 11:36 AM
Jack from Manhattan

Once again Lehrer, a man who hasn't seen a conspiracy he doesn't love, is way off base when it comes to the drug Warfarin. Certain populations metabolize this drug differently depending on their genetic profile. This is why every competent physician prescribing Warfarin has their patient's blood levels routinely monitored. Big pharma's liability has nothing to do with it. If a patient determines their genetic background with respect to Warfarin metabolism via 23 & Me or by some other method is of interest, however the standard of care is to routinely monitor Warfarin concentration. In fact, a patient knowing their relative ability to metabolize Warfarin might be inclined to request from their doctor the newer, more expensive, [Read more profits for drug companies, Brian.] alternative drugs.

Nov. 26 2013 11:35 AM
Taher from Croton on Hudson

chantal from ny /dc, right you are. The higher supervisors in the FDA get no show jobs at pharmaceutical companies after retirement.
Payola for their corrupt work on behave of pharma.

Nov. 26 2013 11:35 AM
Jo from NYC

Coincidently, just yesterday put my saliva in the tube and sealed the box to return to 23 & Me. My primary interest is for "infotainment", as I'm curious about my ancestry. I started to think about how much information do I really want and haven't mailed it yet.

Nov. 26 2013 11:35 AM
Amy from Manhattan

The anticoagulant (blood thinner) that Ms. Park mentioned, warfarin, is better known by its brand name, coumadin. I hope doctors are aware of the gene test for high sensitivity to it & mention it to their patients.

Nov. 26 2013 11:31 AM
MeAgain from Bayonne

This doesn't make sense. People won't take medication on their own or have operation without talking to doctor. And no doctor will perform operation solely based on the test.

Nov. 26 2013 11:24 AM
chantal from ny / dc

I was thinking the same thing as James as well! And now I'm convinced the only reason for this move by the FDA is the pharmaceutical lobby.

Nov. 26 2013 11:23 AM
Taher from Croton on Hudson

That corrupt agency known as the FDA is shutting down the public’s ability to find information.
Making it safe for pharma to make and sale more toxic drugs. Added is a medical profession- medical schools, doctors- that work hand in clove with aiding and abetting criminal phrama.

Nov. 26 2013 11:21 AM
Karen from NYC

My son and I were both tested by 23 and Me. We did so out of curiosity, not as a diagnostic or predictive tool. For example, I tested negative for the "breast cancer gene," but would have confirmed a positive result with additional tests my doctor.

I doubt that anyone would have surgery, or that a doctor would perform surgery, based solely on a test by 23 and Me. On the other hand, my son and I had fun with the genetic results. I learned that I was 10% Ashkenazi -- "Shaalom!" -- something I'd always suspected based on family stories of the "old country."

So what's the problem?

Nov. 26 2013 11:13 AM
Catie from New York

I just checked the 23andme site as I recently sent in my saliva kit that I did in RI because I wasn't allowed collect my own saliva in NYC. I haven't received the result yet. I requested it for genealogy but also curious about health issues. Their site has no mention of FDA nor did they email me as a 'customer' re same.

Nov. 26 2013 11:11 AM

What's up with THIS power grab? The FDA also wants to regulate pet food. Doesn't our government have enough to do already? What they are in control of they do a bad job so maybe they shouldn't take on more.

Nov. 26 2013 10:52 AM

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