Drug companies regularly hide the results of bad clinical trials that may have a negative impact on their medications and attempt to only publish studies that show their products in a positive light, according to a new international study.
Researchers from Canada, France and Britain, working with the Ottawa Hospital Research Institute, found that pharmaceutical companies are routinely conducting tests without disclosure that the drug trials are underway, allowing them to cancel studies that may reveal problems with their medications.
According to standard practices for clinical trials, researchers are supposed to announce when any trial is underway and provide information on what the goals are, the researchers pointed out in the Ottawa Citizen.
The examination into drug company practices found that only 50% of drug trials were publicly announced in an appropriate manner, and medical journals are not consistently insisting that the trials first be published on a public register. The researchers concluded that there was a prevalent amount of “selective outcome” reporting of trial results.
Drug companies use two ways to report only positive drug trial results in medical journals, according to the researchers. The first method is to simply not mention tests which did not generate favorable results for a particular drug. The other method is to “cherry pick” data from a drug trial; playing up positive results, and downplaying or simply not mentioning negative findings that were part of the same study.
After a 2004 lawsuit against GlaxoSmithKline PLC resulted in the company admitting that it hid negative information on the antidepressant Paxil, the International Committee of Medical Journal Editors decided that it would only publish the results of clinical trials that had first been publicly announced. However, researchers in the new study said that many of the journals do not have the staff to confirm that the studies have been properly registered and that authors adhered to acceptable reporting standards.
As part of the settlement of the lawsuit filed by New York State over their failure to disclose data from clinical trials into side effects of Paxil in children, GlaxoSmithKline agreed to publicly disclose data from all clinical trials.
As a result of data released by Glaxo from dozens of clinical studies for their popular diabetes drug Avandia, independent researchers performed a meta-analysis that was published in the New England Journal of Medicine in May 2007, showing that the popular drug increased the risk of heart attacks and death.
This independent study ultimately led to a “black box” warning about the risk of Avandia heart side effects, and thousands of Avandia lawsuits have been filed on behalf of users who suffered a heart attack or other injury. The complaints allege that Glaxo failed to warn the public about the risk of heart problems, which some estimates suggest could have resulted in 83,000 heart attacks since the drug was approved in 1999.
According to the international researchers with the Ottawa Hospital Research Institute, medical journals need to insist that all clinical trials are publicly announced or refuse to publish them. They also suggested hospital and university ethic committees need to go after authors who use deceptive reporting practices.