FDA endorses masking placebos as proven drugs as a get-rich-quick scheme

That's not really what the FDA said but based on the shameful actions unearthed by ProPublica and reported by Scientific American here, one would think one can get away with this scam.

Three years ago, the FDA busted a Houston lab (based on a whistleblower report) that fabricated loads of research studies that were used by the FDA to approve about 100 drugs. Eighty-percent of those drugs were generic drugs that the lab supposedly proved as (bio)equivalent to the brand-name counterparts.

Three years later, the FDA has only reviewed new research on 21 of those drugs. The agency has refused to provide any information about the names of the drugs that have been fraudulently approved, nor provided any information about how they were reevaluating these drugs. The excuse is "confidential commercial information".

To date, the FDA has not pulled any of the drugs from the market. (Some are off the market because the pharma pulled them.) Even pharmacists do not know that those drugs are under a cloud of suspicion and continue to sell them. Some drugs still carry labels that reference the discredited studies. Some peer-reviewed articles continue to be available with no reference to the controversy (not too surprising).

The FDA claimed that so far, no harm has been reported from any of the suspicious drugs.

This leads me to my scam: if I create an injection of saline and market it as equivalent to a cancer-treating drug, I will do no harm; in fact, I may even do some good based on the placebo effect. I will make loads of money based on the belief (mislabeling) that my drug can treat cancer. The FDA seems to be saying I can do this so long as my "drug" does no harm.

The article makes no mention that anyone is being prosecuted for the fraud. The lab director does not appear to be in legal trouble. The pharmaceuticals who made a lot of money selling these drugs are portrayed as peripheral players. The chemists who faked data apparently have been fired. There is also no mention of whether the FDA personnel who approved the fraudulent research are being cited for professional negligence and failing their duty of care.

***

The biggest revelation is in the last page of this long article. Former FDA agent was cited:

There are thousands of bioequivalence studies done every year, he pointed out, with each study generating thousands of pages of paper records. "Do you really think we're going to look at 100 percent of them? We're going to look at maybe 5 percent if we're lucky," he said. "Sometimes 1 percent."

So, he's saying that most drugs are approved without any oversight.

This makes me angry, and it should make you angry, too.

 

Comments

[Ken]

You are being a bit hard on the FDA. These drugs are the same chemical, in the same or similar binder materials, and would already have had chemical tests. They allow plus or minus 20% bio-availability, so it would be very surprising if they weren't found equivalent. Some of the more radical changes such as changes between oral and injectable are more difficult but there would already be a lot of data guiding the required ratio between the two delivery methods. Also a lot of this equivalence testing is a waste of time, as doses don't matter or can be titrated anyway.

[Kaiser]

Ken: Thanks for the comment. I think there are two separate issues here: you're arguing that most of the bioequivalence testing is pointless, which may be true; and if the margin of error is allowed to be 20%, it in fact may just be a public relations vehicle. Separately, though, given that a policy has been established in which such testing is required to gain approval, I still find it revolting that the entire process seemed to have been usurped and turned into a farce.

[Ken]

Yes, I had thought that the FDA policy would be that anyone caught cheating should have a prison sentence.

My assumption is that the FDA would have based it's decision on there being some data, just not as much as they thought, that it is not strictly necessary for generics which are identical compounds, and the drugs were already on the market. Regulators have a bad habit of expecting to see tests that they didn't really need.

The requirement for bio-equivalence which is 80-125%, is actually a bit more strict because it is the 90% CI that must lie within those values. It does mean that individuals can have ratios well outside. The only one I did, there were some subjects where the absorption of the generic was much lower, probably due to diet and the generic not having the same physical properties. The average was still within the limits so it was OK. It had actually got through he regulatory process, somehow, but the question was raised about equivalence because of pricing. A cheap drug isn't so cheap if you need more of it.

[Drug Test Friend]

This doesn't surprise me at all. The FDA has always worked in the best interest of the big pharmaceutical companies.