One-Third of Drugs Approved Using Single Study

One-Third of Drugs Approved Using Single Study | Pintas & Mullins Law Firm

A study recently published in the esteemed Journal of the American Medical Association (JAMA) found that one-third of all drugs were approved by the FDA based on one clinical trial. This is incredibly important, as Americans are seriously injured and killed every day from unknown effects of pharmaceuticals and medical devices, while medical companies reap the profits. Dangerous drug attorneys at Pintas & Mullins Law Firm take a closer look at the JAMA study.

Researchers identified 188 new drugs approved by the FDA between 2005 and 2012, ranging from cancer treatments to drugs for cardiovascular diseases. About 37% of these drugs were approved based on a single clinical trial, despite clear federal rules that require at least two pivotal trials before approval.

So what is the difference between drugs that are studied in-depth and those that only require preliminary evidence of efficacy and safety? In the case of medical devices, many cardiovascular products, such as defibrillators, are approved without ever being tested in humans. This is possible through a specific FDA program that allows devices that are similar to other, older devices to be quickly approved.

Surveillance Programs not Enough

In a statement, the FDA asserted that it tailors approval requirements for each individual drug and disease area, and that it has a strict surveillance program in place to monitor new drugs and devices after market release. This practice is backwards and dangerous, placing American lives at risk.

Nowhere is this more evident than in the recent recalls of two cardiac defibrillators, the Riata from St. Jude Medical and the Medtronic Sprint Fidelis. These devices are implanted in patients with irregular heartbeats and shock the heart with electrical wires if an irregularity occurs. They were approved through the accelerated FDA process because they were similar in design to previously-approved devices. These defibrillators have caused dozens of deaths due to bad wiring and other defective parts.

Having a “strong” surveillance program does nothing to protect innocent patients who are being used as little more than guinea pigs for Big Pharma’s latest development. In fact, most follow-up studies requested by the FDA are never even conducted. Of all the follow-up studies requested in 2008, only 31% had been carried out by 2013.

In effort to remedy this, JAMA researchers urged the FDA to place statements on drugs’ labels that clearly define what type – and how much – evidence went into the approval of the drug. A novel and admirable concept, but not one I see happening anytime soon.

The goal of rushing drugs onto the market, for some ailments, makes sense. Patients fighting cancer do not have time to wait for three clinical trials to be completed before they can start taking a promising new drug. That makes sense. But for ailments like type 2 diabetes or osteoporosis, for which there are already dozens of drugs on market, accelerated approval does not make sense and is causing great harm.

Further compounding the problem, only about 34% of all new drug approvals are based on studies that last longer than six months. This is unacceptable for many reasons, most importantly because patients blindly trust the FDA to approve drugs that are extremely effective and do not carry any serious side effects. It is impossible for medical researchers to determine the true risks of a prescription drug after only six months of use. For most drugs, the actual long-term risks are not known until years, even decades after initial approval. 

With this knowledge it is not surprising that so many drugs in the U.S. are causing serious injury and premature death. What is surprising is how little is being done about it. Certain programs through the Affordable Care Act are taking on these issues, but more needs to be done to inform the general public about how pharmaceuticals are actually studied and approved.

Much of this responsibility lies on the physicians who prescribe medications. Doctors need to clearly explain the full spectrum of information about a drug before a patient agrees to start taking it. This is especially true for serious ailments, like cancer, that require very expensive drug treatments.

Our team of dangerous drug attorneys works frequently with victims of negligently-approved drugs and medical devices, and we know first-hand how devastating the consequences can be. If you have any questions about injuries suffered while taking a medication or using a medical device, contact our firm immediately. We provide free legal case reviews to injured patients nationwide.