Drug Safety and Clinical Trial Fraud

Drug Safety and Clinical Trial Fraud | Pintas & Mullins Law Firm

We recently reported on how and why drug companies hide the negative studies linked to their drugs and medical devices. It has recently come to light that the FDA, too, has a hand in concealing evidence of fraud in medical studies. Our team of dangerous drug lawyers details this new report and how the practice is harming the public.

The Food and Drug Administration (FDA) is responsible for regulating, approving, and overseeing the incredible amount of prescription drugs in this country. A recent report published in Slate found that the FDA habitually hides scientific fraud and misconduct from the medical community and the public. The agency actually has a long-term record of burying the details of scientific misconduct.

Because of this concealment, no one – even doctors, nutritionists and scientists – know which studies, drugs and data is of quality or simply bogus. When drug companies submit a drug to the FDA for approval, they must provide long-term, in-depth data on its side effects, efficacy, and safety. The FDA is then tasked with going through every page of this data to determine whether or not it is safe for the public.

The problem is that this data is not available to anyone else except the FDA and the drug companies – even congressional panels are unable to get the data they need when investigating dangerous drugs. In the Slate report, authored by a professor at New York University, researchers looked into FDA documents relating to about 600 clinical trials.

These 600 trials were chosen because they all were run by researchers who failed an FDA inspection. Although there was a plethora of documents available from these trials, much of the most important parts were blacked out or redacted. So much so, that only in about 1 out of every 6 trials were the NYU researchers able to figure out which study, which drug, and which drug maker were involved.

As mentioned earlier, the problem here is not that the FDA is concealing some information from public knowledge; the problem is that the agency conceals so much critically important data from doctors and other researchers.

The FDA is aware of countless scientific papers that includes questionable or unproven data and does nothing about it. No wonder unsuspecting doctors are prescribing dangerous medications, using defective medical devices, and patients do not understand how to handle their own health.

Xarelto As Prime Example

The NYU researchers offer a perfect example of how seriously this is harming us. The blood thinner Xarelto was approved for market based on a study called RECORD 4, which involved thousands of patients. The FDA inspected or audited 16 of the clinical sites used in RECORD 4, finding falsified data, systemic discarding of medical records, misconduct fraud, and other suspect behavior.

The RECORD 4 practices were so bad that the FDA declared it unreliable and its data worthless. Yet, still even today, the results of RECORD 4 remain in established medical journals (such as The Lancet) without any mention of its fraud. In researching what blood thinners to prescribe to patients, then, doctors are basing their decisions on a study that was dangerous and falsified.

Consequently, just a few years after its release, reports started emerging on Xarelto’s extraordinary danger. The drug can cause fatal internal bleeding, strokes, heart attacks, and other life-threatening side effects. Xarelto has and continues to kill masses of patients, who were as unaware of the drug’s dangers as their doctors. 

Xarelto wrongful death lawsuits are multiplying throughout the country. The FDA has yet to release a statement on it. Even its own advisory committees, which help determine whether or not drugs stay on market, are not told of the true extent of the trials’ issues.

Our team of dangerous drug lawyers has been fighting on behalf of injured victims for over 30 years. We know exactly how harmful prescription drugs and medical devices are in the United States and how little the FDA does to prevent it. If you or someone you love has been injured by a drug or medical device, contact our firm immediately. Our case reviews are always free, confidential, and available to concerned patients nationwide.