As others have mentioned here and elsewhere, the FDA is in a tough spot. On the one hand some people feel that too many flawed products are allowed to be marketed (e.g. Avandia or Vioxx) and on the other, people feel the FDA is just obstructionist and prevents them from doing or getting what they want (e.g. Abigail Alliance; much of the dietary supplement industry, much discourse here). Is the FDA way too lax or way too strict? I think good people work there and are trying to steer a reasonable path through this mess. I don’t think the FDA as an institution (or in its officers) is evil or incompetent or conspiring with the AMA.

The biggest problem is that the American people are not of one mind on these questions — not at all. I rarely talk to or read somebody angry about “obstructionist FDA” considering arguments made by an old man who believes that “Avandia killed my wife and it’s the FDA’s fault” nor vice versa. It would be interesting to see the FD&C Act debated today in Congress. I wonder what kind of regulatory regime Congress could agree on… whether this massive divide could somehow be bridged in a way that made sense to most everybody.

My initial posting that Razib posted above was a reaction to his angry and really one-sided posting of March 9. There is much other even handed discussion here, from Razib and others. I should not have reacted so strongly. I apologize for that!

In the case of Labcorp’s Ovasure (FDA letter is here: http://tinyurl.com/3ff8xpx) the issue was that nobody had proved that the test was useful for “high risk women who might have ovarian cancer” — which is how Labcorp was marketing it. The issue was the marketing of the test.

From the FDA’s point of view it doesn’t matter if the diagnostic is a genetic test marketed DTC or a protein panel marketed to doctors – what matters is whether the medical claims with which the products are marketed, are valid. (Although I will grant that the FDA is probably more concerned about any medical product that is marketed DTC – the bar for safety and efficacy is generally much higher for DTC). But that is the point the FDA officers were making — that claims made in the marketing of medical products must rest on solid support, and if they do not, the FDA’s job is to step in and shut that marketing down. This has been their job from day 1.

Instead, I interpreted it to mean evidence-based medicine, which (in theory at least) represents a distillation of the best available knowledge compiled by practitioners in a field and filtered by a panel of distinguished experts.

I would hope never to be in a position where the physician treating me was unaware or, worse, willfully ignoring these guidelines.

A number of studies have documented the extent of non-FDA-approved (off-label) prescribing in a variety of medical fields. According to a study by the U.S. General Accounting Office, 56 percent of cancer patients have been given non-FDA-approved prescriptions, and 33 percent of all prescriptions in cancer treatment were off-label (General Accounting Office [GAO] 1991). Another survey, of AIDS patients, found that 81 percent of patients received at least one drug off-label, and 40 percent of all reported drug use was off-label (Brosgart and others 1996). Experts have estimated that nearly all pediatric patients (80 to 90 percent) are prescribed drugs off-label (Jaffe 1994; Kauffman 1996; Goldberg 1996).

…
In summary, off-label prescribing is common in every field of medicine, and in a large number of fields most patients are prescribed at least one drug off-label. It is clear that if the FDA were to attempt to prohibit doctors from prescribing off-label, current practices would have to change significantly.1

Why Physicians Prescribe Off-Label

Off-label prescribing is common for at least three reasons. First, new discoveries change the “best practice” standard of care much more rapidly than the FDA ap- proves new uses for existing drugs. Second, it is an ineluctable fact that in many cases. best practices fail to stem a patient’s disease. When best practices fail, patients demand innovation. Patients with terminal diseases rationally demand new approaches, despite possible dangers and low odds of success, because they face low costs of experiment- ing with new therapies. Third, getting the FDA to approve a new use for an old drug is an expensive and lengthy process. In many cases, the costs of the required testing exceed the benefits of FDA approval. Each of these reasons for off-label prescribing merits additional discussion.

Medical practice moves far faster than the FDA and often in surprising ways. For almost a century, for example, doctors thought that stomach ulcers were caused by diet and emotional stress. In 1982, Barry Marshall and Robin Warren discovered in the stomachs of ulcer suffers a new bacterium, Helicobacter pylori, which they hypoth- esized was the cause of the ulcer. Their theory was initially highly controversial, but it is now believed that most stomach ulcers (perhaps 90 percent or more) are caused by Helicobacter pylori.2 Using antibiotics such as amoxicillin and tetracycline, these ulcers can now be cured. Although hundreds of thousands of prescriptions have been writ- ten to this effect, all have been off-label. Neither amoxicillin nor tetracycline is ap- proved for use in the treatment of stomach ulcers.

What is scary is the realization that the FDA is safety theater. Doctors just use the FDA as a very basic safety evaluation. Which demonstrably does not require $500 million dollars per drug!

So all this effort and time on FDA approval is just this kabuki dance, a safety theater similar to the TSA screening process. Because literally millions of patients would suffer if doctors substituted the FDA’s judgment for their own.

The scary part is the idea that we could even think of bottlenecking the determination of all biological and medical truth through a group of unelected bureaucrats.

more than 30% of prescriptions are for “off label” uses of drugs, where an MD substitutes the distributed judgment of the medical and scientific community over whether a drug approved for one purpose is safe/effective for another purpose.

That’s scary.

If the person writing this was actually fit to be a doctor, he would know this:

The FDA DOES NOT regulate the practice of medicine, so it does not have prima facie authority over all “medical claims”!

1. It cannot tell doctors what to say or do. This is why more than 30% of prescriptions are for “off label” uses of drugs, where an MD substitutes the distributed judgment of the medical and scientific community over whether a drug approved for one purpose is safe/effective for another purpose.

2. It cannot regulate surgeons, which is part of the reason that automated surgery has not progressed as fast as it should (because error prone humans are unregulated, but devices are regulated).

3. It cannot regulate pharmacists, as it lost a lawsuit that attempted to ban compounding pharmacies. It has resorted to a negative PR campaign against pharmacists to spread FUD: (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM238592.pdf).

4. It does not — and likely will not — have the ability to regulate pathologists. CAP is gearing up for a battle royale with the FDA next month over its attempt to take over regulation of 200,000 clinical laboratory from another agency.

5. It cannot regulate professors and researchers who make medical claims in papers.

6. It cannot regulate websites such as WebMD or the Mayo Clinic who make medical claims on the internet.

Etcetera, etcetera, etcetera.

The WHOLE POINT of the discussion is that in order to annotate the genome, no one centralized agency is going to be fit for the task of aggregating all these “medical claims”. You simply cannot bottleneck something which is the common property of all humanity through someone as mendacious, ignorant, and power-hungry as Jeffrey Shuren!

tl;dr: jytdog is just a moron who doesn’t understand (a) what the FDA’s jurisdiction actually is and (b) doesn’t understand why so many people (including doctors!) have long fought to keep the FDA from having the ability to regulate all “medical claims”.

http://www.asianews.it/news-en/Hong-Kong-becoming-a-leading-centre-for-genomic-research-20379.html

I might find out something worrying from a DTC test? Like a BRCA mutation. Or I might find something worrying after reading WebMD after it tells me to check for lumps under my armpits. Whatever, the next steps will involve an MD since it would now be appropriate.

It’s not doing medicine vs. not doing medicine, the measure is does it do harm? So far, no -and certainly many have been looking very, very hard, so hard that people like Gutierrez of the FDA had to invent a horror story about ovary removal (http://bit.ly/huau07)

Your average MD will not be able to offer a genetic diagnostic interpretation for the next decade, if not beyond.

Anyway, as Razib points out, it’s case of trying to lock the barn after the stampede : this is the internet age. Information circulates worldwide in a matter of seconds. It’s one thing to regulate a person-to-person service or sale of physical goods, where you do have the possibility of acting. It’s completely absurd to try to regulate the diffusion of information; we’re not in the realm of counterfeit pharmacy.

The FDA’s range of options is rather narrow : the only thing the FDA can adequately regulate and monitor are the companies themselves, to insure they provide quality diagnostics.

Oh, they can attempt to make illegal for an american company to provide analysis direct to people. Trying to “outlaw” the diagnostics is simply going to make every chinese entrepreneur very, very happy to sell his unfettered – and cheap – access to DNA interpretations.

If you are not a doctor, please say what you are, so readers can know the context for your statements. It would also show some integrity.

What motive did Shuren have for lying, and what motive did the FDA have for trying to cover it up?

Why the need for the patronising tone and insults?

These are not rhetorical questions.

1) chill on the tone, you might not know what’s gone on before you showed up

2) follow genomics law report, genomes unzipped, genetic future. that’s where the real action is

to take away my own inflammatory language — my point:

The regulatory difference between providing sequence information, and providing medical information, is enormous.

The FDA’s job is to regulate medical treatments and diagnostics marketed to consumers.

If you want to offer people a service, sequencing their genomes, you will get no hassle from the FDA as you are not in their domain. But start to sell people medical information based on their sequences… now you are squarely in the FDA’s domain.

Keep it straight, oh hipsters! Save your rage for real issues.