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

Yawn

[g0bshiTe]

So sick of hearing "US knows of wrongdoing, we have proof" yet never ever is there any accountability.

Wake up people it's time to make Washington work and listen to us again!

Re:Yawn

[ihtoit]

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

You get what you pay for.

Easy fix.

[bigfinger76]

The FDA probably just doesn't have enough women.

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

[fermion]

Also the washington post reports a John Oliver story that most pharma companies spend more on marketing than research. A number of stories has come out over the past few years indicated that phramcos essentially pay doctors to prescribe their drugs.

The real issue here is the idea that medical science is in fact a science. It may have elements of science, but if science is to flourish we must root for the null hypothesis, and there is no incentive in medical science to so do.

No, everyone want to believe the snake oil works. The desperate patient who wants to believe the snake oil will magically cure the illness. The doctor who is going to be paid a huge sum of money to promote the drugs. The legislators who need to win the next election. The regulators who want to get a job after they do their government stint.

I would support allowing risky drugs to be used for terminally ill patients, even children. What I don't support is the routine use of drugs we know are dangerous, and then the litigation after the fact, which arguably a major reason drugs are more expensive. Don't put dangerous drugs on the market, and the pharmcos would save billions, if not ten of billions.

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.

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

[rock_climbing_guy]

You could start by putting a stop to the sting ops and SWAT raids on farmers who sell raw milk.

Re:FDA due for reform

[TapeCutter]

A SWAT raid seems a tad excessive but I assume you're posting from the US, so who knows? However, there's good public health reasons for banning the sale of raw milk, nobody is banning foolhardy and ignorant nature nuts drinking it straight from the cow, they are stopping people from profiting from the ignorance of others. Pasteurising milk is simply the act of boiling the milk to kill the nasties (such as tuberculosis), it used to be called "scalding the milk" before anyone figured out why it worked. Homogenised simply means the cream and milk have been mixed in such a way that the cream no longer rises to the top. The problem I have with supermarket milk here in Oz is that virtually every one of the countless different types have something added or removed, ie: it's not milk. It can actually take quite some time to find plain old full cream milk in a supermarket, if it's there at all.

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.

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.

Re:In b4 stupid libertarians

[Anonymous Coward]

Libertarians decry fraud, and view prevention/punishment of same as one of the legitimate functions of government.

I don't know who you've been talking to, but if they're calling what you describe as libertarian, they're lying. (Both Democrats and Republicans would rather nobody understood what Libertarians really stood for, or they'd see their voter bases begin to evaporate.)

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.

Let me see if I can get this straight...

[slew]

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.

He wants the completely-non-influenced-by-big-money legislature to do something about the FDA being co-dependent with big-pharma...

Yeah, that sounds like it's gonna work...

And people wonder...

[PermacultureEngineer]

If anyone, anywhere wonders where the anti-vax movement came from, here you go. I am NOT defending the antivaxxers. Vaccinate your kids, dammit, and yourself too! But is it any wonder that people have come to systematically distrust experts when the institutions of expertise have been shown repeatedly to be corrupt to their core?
I am agnostic as to whether we have more corruption than we used to, or just more public awareness of it. I suspect the latter case, but it doesn't really matter. Getting people to act like good citizens requires trust in public institutions. If that trust has been destroyed, good citizenship goes with it. We can't put the information genie back in the bottle, even if we wanted to, so we'd best figure out how to start building trustworthy public institutions.

This probably starts with NOT cutting their budgets to the bone.

(cue the libertarian clown car, to tell us that public institutions are not necessary, in 3... 2... 1...)

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.

Nice hack job.

[Kludge]

This article reads like the hack job that it is.

So as part of my investigative reporting class at New York University, my students and I ...

Something tells me that these people do not know a lot about science or drug evaluation, but do know a lot about trying to make a big splash with an article that "exposes" wrongdoing.

Here's a small dose of reality: All studies and clinical trials have things wrong with them. Everytime I read a study in JAMA and the NEJM, I can point out half a dozen things that should have been done differently. When evaluating whether a drug or procedure or implant is effective you always have to read these studies with a critical eye, and consider all the evidence (laboratory, clinical, statistical, etc.) when making a decision.

The fact that some "investigative reporting" students found problems with clinical studies is hardly surprising given how many details the federal government regularly documents and records.