by: Jeff S. Gibson, Attorney
Is it possible for a drug or medical device manufacturer to conduct a study on the efficacy of its product without showing bias? Consider a study to compare three different branded drugs that are used for the treatment of a disease. If Company A sponsors the drug trial, will there be bias present to show that drug A is more effective?
Bias in clinical trials can be a very bad thing. A lot of money goes into the research and development of new drugs and medical devices. When the product reaches the clinical trial phase, a lot is riding on the results. If a drug does not prove to be more effective than other products on the market, more money and time will need to be invested in order to make a profit. When a company puts profits ahead of its customers, bad things happen. Products that are intended to improve the quality of life can have the opposite effect by causing severe injury or death.
The Washington Post recently reported about the presence of bias in clinical trials that were funded by the pharmaceutical industry. The story noted that in some instances these industry-funded studies were published in reputable medical journals such as the New England Journal of Medicine. Readers most likely assume that studies found in these journals are independent and reflect statistically valid results. However, the example in the article discusses a study in which all 11 authors of the study received money from the drug manufacturer. Some were academic experts who received grants or consultant fees, and others were employees who held company stock. The study indicated that the drug sold by the manufacturer who sponsored the study performed the best in comparison to other drugs on the market. The drug in question was Avandia. It was later determined that this drug raised the risk of heart attack in patients. Further data suggests that Avandia contributed to more than 80,000 heart attacks and deaths.
The Cochrane group, an industry leader in providing primary research for the health care industry, previously determined that pharmaceutical industry sponsored drug trials did show bias in favor of a manufacturer’s product. These researchers recently conducted an analysis of medical device studies to determine if the same bias that was present in clinical drug trials also appeared in these trials. It should come as no surprise that the same bias was observed.
The key takeaway for consumers is to be their own healthcare advocate. When a doctor or medical professional prescribes a treatment, consumers need to educate themselves. Ask your doctor for additional materials that explain what the drug or medical device can do in the treatment of your medical issue. By arming yourself with information, you will be able to make an informed decision regarding your medical care.
People who have been injured by dangerous drugs or defective medical devices should contact a product liability/personal injury attorney to discuss their legal rights and options in obtaining compensation for their injuries. My practice is focused on these matters. I have helped people who have suffered serious personal injury litigate claims against drug and medical device manufacturers.
(photo credit: SLU Madrid Campus via photopin cc)
Industry Sponsorship of Drug and Device Trials Shows Bias
by: Jeff S. Gibson, Attorney