Thursday, October 14, 2010

Barbara Evans is Right! Sliding scale of regulation.

As the FDA debates what they should do, Barbara Evans at the University of Houston Law School and Amy L. McGuire of the Center for Medical Ethics and Health Policy at Baylor College of Medicine in Houston, also includes, Canadian legal expert Timothy Caulfield and Wylie Burke, M.D., of the University of Washington School of Medicine post some guidelines for regulation of DTCG/LDT genetic testing.

I love this sort of handicapping.

You have absolutely brilliant people posing ideas for regulations. I have read a ton. There are those from industry insiders, Ones from industry "Advisors", Ones from politicians who receive funding from industry, Ones from academic centers that do LDT testing. Ones from bioethicists...

But I have paid attention to the mixed group that includes pragmatist Wylie Burke and Barb Evans

In an article I just read from Science published October 8th. They propose rules for DTCG, but I am certain they also would work for LDT.

What they propose is a "sliding scale of potential harm"

Which is sort of what I had been saying for years, which perhaps is why it rings true.

If this is for earwax type, let it go to market, if it is for medically related decision making, probably needs some regulation.

The proponents for a wild west DTCG (WWDTCG), which BTW includes a "registry" say
"Well, there is no proof of harm or risk"

I say, well, this is not about psychologic risk.

Instead, it is about medically actionable risk.

I say this because recently, Kif6 testing has fallen into question, despite a company promoting these tests to physicians.

The test is marketed as a "Statin response" genetic test.

Can you imagine how many people were started on statins? Well, 250,000 tests had been ordered. Even if 10% were started it would be nearly as many people as DCTG 23andMe have tested.

The real problem here: Pharmacogenomics tests are not something you hide, you ask your doctor to use these results. Unless you are a doctor, you can't use these results to dose medications.......

That is a real risk. Despite what WWDTCG proponents say.

Another risk, BRCA testing. I cringe at the thought that a doctor would use 23andMe results and only those results to infer carrier status of BRCA 1/2
The same goes for CF carrier status.

These DTCG medical tests aren't recreational. These companies added these tests because NO ONE wanted to pay hundreds, hell thousands of dollars to find out these risks.....

In a business decision, they fell short of looking at the medical risks.

So yes, a sliding scale of regulation is likely coming. But not because of Wylie, because of the FDA.

It is obvious. Again, medical testing will be regulated as medical. Ear Wax as ear wax. Will LDT be forced to go through pre-market review? Probably not if they can only be ordered by licensed professionals.....

It's not a form a rent seeking, it is a form of guidance and protection for consumers. That's why physicians are licensed and malpractice covered.

Yes, yes. Someday everyone will have these genomes done and everyone will be educated enough to know what they mean. And all humans will have medical education and we can replace the oligarchy of physicians and the tyrannical healthcare system once and for all........

But until that day, we will have to rely on trained professionals who don't have their retirements tied to their company's new genetic test......

The Sherpa Says: Handicapping of the FDA by the Sherpa. If it has any medical utility it will be regulated as either Class II or III. If only ordered via physician it will more likely be Class II. If not, will need Class III.


Anonymous said...

I agree about risk-based stratification of regulation. But my question is: are you sure that all physicians are sufficiently expert on genetics? Do you think that all MDs have the expertise to deal with these genetics data, with all the statistics behind them? I think that genetic counselling is needed when we speak about high-risk tests, but maybe this counselling could be done also by a properly trained expert who is not a physician.

Keith Robison said...

WRT BRCA testing, I hope you saw this.

Genome Biol. 2010 Oct 7;11(10):404
. [Epub ahead of print]
Do-it-yourself genetic testing.
Salzberg SL, Pertea M.

Center for Bioinformatics and Computational Biology, University of Maryland, College Park, MD 20742, USA.

We developed a computational screen that tests an individual's genome for mutations in the BRCA genes, despite the fact that both are currently protected by patents.

PMID: 2093227

(also note that Salzberg has a pair of blogs
Field of Science
and at

Keith Grimaldi said...

One point about BRCA etc. If someone cannot afford the $000's but can stretch to a few hundred, is knowing the few (but most common) mutations not better than nothing?

Second - this goes beyond just genomics as the recent CFS $650 virus test (through MDs some of whom then prescribe anti-retrovirals... see my blog for more

The harm or risk exists whether DTC or via MD. Pre market review does not really seem to be feasible without destroying 90% of the LDT market just to weed out a few baddies. But - here is where transparency would be helpful, and a registry (for all LDTs?) which would allow at least some "post-market" review by independent experts. mygenomix has a very good point about the availability of real experts, they are very few in number.

In my opinion the transparency is the most important first step before trying to tackle risk-based stratification - the latter will get bogged down in the detail, the transparency (plus registry) will at least make the detail easily accessible and that would help with any next steps in the regulatory efforts

Unknown said...

You can see more policy briefs of interest on our Genomics, Public Policy and Society policy pages at

Between the policy briefs and videos from some our meetings you'll see most of the people you have mentioned.