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

Re:Yawn

[ihtoit]

there is no accountability because Government is nothing more than puppetry for industry.

You get what you pay for.

FDA == slow progress too

[javilon]

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.

This is clearly the case, and this not only means that some drugs that should not be on the market are approved. It also means, and in my mind this is more important, that the big Pharma are using the FDA as a barrier of entry against startups. Getting a new drug on the market costs an average of $2.558 billion in 2013 dollars.

This days are the early days of the biotech revolution where we will gain enormous control over our health are just starting, and progress is slow due to regulation capture. If some of this money would be given back to researchers instead of lawyers and bureaucrats, we would get better treatments available sooner.

As an example, big pharma companies get old drugs whose patents are about to run out, change their chemical formula and improve them just a bit and then go to market with them so the can reap huge margins with basically the same compound. This is safer business than trying to produce a breakthrough with a completely new compound. And the reason for this is the way the FDA operates. This results in very valuable resources being used with little benefit to the public.

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.

Re:FDA == slow progress too

[Dorianny]

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.

Government bait and switch

[sdinfoserv]

Most government agencies are mere puppets for the owned representatives in office. Like the FDA, the EPA will not protect the interest of the citizens but rather corporate interests. Many victims of fracking where once fertile land has become toxic have found the EPA's sole job is to protect the frrackers, not the land they supposedly steward. Commerce Department is another example. The Commerce Departments job is to protect and secure 'commerce' not individuals but huge corporations. The FBI diligently attacks people who illegally share music - with the same ferocity as mass murders or terrorists.

Net neutrality will become another victim. It will eventually die since It 'burdens' profiteers.

. Our rights as citizens is a veneer. Till we change how campaigns are financed, corporate puppets will continue to operate with impunity sealing more and more wealth from the masses for the benefit of the few.

Don't crucify the FDA. They came out long ago...

[bogaboga]

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.

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:Don't crucify the FDA. They came out long ago..

[Duckman5]

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.

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.