Unearthing Fraud In Medical Trials

An anonymous reader writes: The U.S. Food and Drug Administration holds a position of trust among citizens that few government agencies share. So when NYU professor Charles Seife found out the FDA is not forthcoming about misconduct in the scientific trials it oversees, he and his class set out to bring it to light. "For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn't get forthright answers." Seife suggests the FDA is trapped in a co-dependent relationship with the pharmaceutical industry, and needs strong legislative support to end its bad behavior.

Comments

FDA due for reform

[jd.schmidt]

The FDA should have it's scope limited somewhat, focusing more on purity of things is regulates and less on effectiveness and uses. I have heard of various cases of outside influence and political pressure in the past. I think a more open source/wiki approach to medication effectiveness might be better. There is always a big danger of misuse when so much is relying on one organization with no outside checks.

Re:FDA due for reform

[Rockoon]

The FDA should have it's scope limited somewhat, focusing more on purity of things is regulates and less on effectiveness and uses.

Prior to 1962 the FDA only required proof of safety before a drug could be sold and marketed. The mandate was changed in 1962 to include efficacy, and the excuse for doing so were the birth defects caused by thalidomide in Europe. Note that thalidomide was quite effective, but not safe, which is why the FDA already didn't allow it to be marketed or sold in the United States. The FDA pounded its own chest and asked congress for more control even though it didn't need it to prevent thalidomide birth defects in the States, and thus congress passed the Kefauver-Harris Drug Amendment.

Thats it right there. Before 1962 the FDA didn't care about efficacy. After 1962 it did, and all because the FDA's safety mandate was good enough.

If you are competent in drug development ...

[BoRegardless]

Do you work for the FDA for a government civil servant wage reviewing other company's work or do you go to work for industry and earn the wage you trained for?

Same thing at the US Patent & Trademark office. Patent examiners come in, learn the ropes and go out to become patent attorneys in the private sector.

Same thing happens at the IRS.

Government doesn't keep the brightest bulbs because of pay and bureaucracy.

Re:FDA == slow progress too

[rock_climbing_guy]

A million times this. I recently heard some news about a new medical discovery. It is a treatment for a chronic illness called "cluster headache", which reportedly causes such severe pain that people literally kill themselves to stop the pain.

A CH sufferer serendipitously discovered that using LSD recreationally stopped his pain. Word quickly spread among CH sufferers, but as you can imagine, they were worried about being busted by the man who wears the badge.

A medical researcher got wind of this and did some rudimentary research on a drug that is chemically similar to LSD, but does not cause a "high"; in other words, it has no abuse potential. He made a remarkable discovery: many of the patients he studied reported that taking just THREE DOSES PER YEAR stopped the pain.

The problem then, is that the illness is rare enough that you could never make back $2.5 billion dollars selling three pills per year to patients, so no big pharma company would want to go thru all the red tape to get it approved by the FDA. As a result, there remains no effective FDA-approved treatment for CH.

Many of these patients continue to self-medicate with old-fashioned LSD while looking over their shoulder for "The Man". How sad....

Profit indeed comes before people, but I had no idea how abusive the system could be. And for the record, I do not have CH.