Slashdot Mirror
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.
Didn't they agree to this long ago? What do you expect anyway?
From the piece, authored more than half a decade go, "The FDA now admits that Americans are suffering and dying because the FDA does not have the scientific ability to ascertain if new drugs are safe or effective or to evaluate scientific claims." (Bold mine).
What troubles me though, is that most Americans believe our country has the "best" medicine or healthcare one can find anywhere on planet earth.
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.
Under U.S law rare diseases are designated as "orphan disease" and the FDA can give " orphan drug" status to drugs specifically targeting the rare disease. The law gives tax incentives, enhanced patent protection and even subsidizes clinical research. In the U.S there is more than 300 orphan designated drugs under clinical trial process. The problem with your LSD like chemical is that it is likely so similar that you are in dubious legal ground with regard to anti-drug legislation. That is not the fault of either the FDA or the pharmaceutical industry.
Are you kidding me? Did you read where that came from? It's reposted from Mercola.com. The guy is a anti-vaxx quack with a minor history of battling with the fda. Not only that, but those extra regulations on supplements threaten his livelihood.
Does any of that mean that the FDA is perfect? No. The structure of the FDA is retarded. They require a whole series of clinical trials, have the evidence presented to their advisory team (composed of actual scientist and medical professionals) who make a recommendation, then a group of people (who have no legal requirement to know ANYTHING about medicine) vote on whether to approve the drug or not. That's how you end up with stupid garbage like Aricept 23mg getting regulatory approval (Over 2x the side effects with almost negligible gain on Mini Metal Status Exam compared to the 10mg dose? Yay! Put Grandpa on it today!)
The FDA is also only allowed to look at safety and efficacy data. They can't deny something on the basis of utility. Companies like this one make a killing on it. I'm not aware of a single novel medication that company makes. All they do is take stuff that has been on the market for decades, make it a gel instead of a cream or combine two products (so convenient), sell it for 10 or 20 times the generic price, and send an army of sales reps to convince gullible dermatologists to prescribe their products.
It would be crazy if it weren't true. There are some serious problems with the FDA that need to resolved. The ability to assess whether something is safe/effective or not is not one of them. The testing process is sound. The requirement to listen to the people who CAN assess the results, however, needs to be changed. Just for crying out loud, don't use Mercola as a source. His scientific reasoning ability is clearly questionable.