Drug Development
By: Cohen, Placitella & Roth @ Mar 15, 2016
As we have seen lately with the Volkswagen scandal, big companies sometimes rig safety tests in order for their products to be quickly approved.. Unfortunately, the pharmaceutical industry is not immune to this sort of gamesmanship.
FDA Approval
Before a new drug goes on the market, it must first be approved by the Food and Drug Administration. The FDA is supposed to have high standards in order to protect the public safety. But sometimes, drug companies manipulate study results to make drugs look safer or more effective than they are, and thus obtain FDA approval. Some of the dubious tactics used by pharmaceutical companies include:
- Drawing random samples from pools of patients that do not include higher-risk groups such as the elderly, women, and those with other health problems;
- Administering high doses of medication in short periods to quickly obtain positive results, before negative side effects have the chance to occur; or
- Running multiple trials for the same drug simultaneously, and later publicizing only the most favorable.
When a new drug is going through the FDA’s approval process, the pharmaceutical company first conducts its own tests, and then the company pays the FDA to conduct its tests. These combinations of potentially biased tests often mean that dangerous or ineffective drugs are approved.
Hundreds of thousands of people are injured by dangerous drugs every year. The FDA is certainly not wholly unaware of the behaviors of drug companies who manipulate trials to obtain favorable results. But it has not taken the appropriate steps to correct the problem and promote consumer safety.
Tracking Systems
Approximately 20 percent of all FDA-approved drugs are eventually discovered to be dangerous to users. And 90 percent of the drugs that receive FDA approval have few or no advantages for patients over other drugs currently on the market, and often have more severe side effects.
The FDA has not provided a tracking system by which physicians and patients can look up how dangerous an FDA-approved drug has proved to users. But there are public groups that track the dangers of various medications. Patients should seek out these independent trackers and evaluations.
Call for Regulation
The U.S. needs better drug development regulation. Every day, people suffered needless injury as a result of dangerous medications that should never have been approved. The system needs to be reformed. Congress should investigate the FDA’s awareness of manipulated trials that result in drugs being falsely found to be safe, and once the source of the problem is located, steps must be taken to fix it.
The branch of the FDA that approves drugs is the same body that conducts investigations of alleged harm caused by these drugs. We need an independent group to act as a whistleblower for the FDA and to ensure that the agency’s opposing interests do not influence each other.
Finally, the FDA needs to be funded by taxpayers only, so that it is not in the pockets of the pharmaceutical industry, whose multi-million dollar payments may have a prejudicial effect on the agency’s testing.
Contact an Attorney
If you or a loved one has been injured because of a defective drug, please call a pharmaceutical litigation attorney at Cohen, Placitella & Roth, P.C. to schedule an initial consultation.
