FDA Review Criticizes Avandia Trial for Downplaying Reports of Injuries
GlaxoSmithKline received a major setback to its anti-type II diabetes drug Avandia this week. A researcher at the Food and Drug Administration released a scathing report that had strong criticism for a major clinical trial the company has been conducting into Avandia benefits.
According to the New York Times, the researcher, Dr. Thomas Marciniak wrote in his report that there were a number of instances that suggest that adverse incidents from the use of Avandia were not included in the clinical trial. At least one patient who took Avandia for diabetes was hospitalized for 67 days after suffering a serious stroke, but the Avandia trial report made no mention of this incident. In another case, a patient died after suffering a serious heart problem, but heart disease was not listed as having anything to do with his death. In fact, Dr. Marciniak says that far from proving that Avandia is safe for use, the clinical trial called Record actually shows that the drug increases the risk of suffering heart disease and cardiovascular disease among users.
The link between Avandia use and the development of heart disease has been contested strongly by Glaxo Smith Kline. The company says that there isn’t enough conclusive evidence to prove that its type II diabetes drug increases the risk of suffering a heart attack and heart failure among patients. This is in spite of the fact that there have been several recorded reports of patients suffering heart disease after continued use of Avandia. Some studies have even compared the risk of heart disease among Avandia users compared to users of another diabetes drug, Actos. That study found that not only did Avandia not have major benefits over its competition in controlling diabetes, but that it could also actually increase the patient’s risk of suffering heart disease.
Glaxo has depended heavily on the conclusions of the Record study to prove its contention that Avandia is safe for users. The release of this report by a prominent Food and Drug Administration official definitely impacts the company’s position. The report couldn’t come at a worse time. The company is expected to come up before a panel of experts that has been convened to determine whether Avandia should be pulled from market or have restrictions placed on its use.
The decisions of the panel will have a major impact not just on GlaxoSmithKline and Avandia sales, but also on how the Food And Drug Administration approves pharmaceutical drugs in the future. Currently, the agency relies too heavily on pharmaceutical companies to conduct their own trials into their own products. This kind of approach has been heavily criticized by California pharmaceutical liability lawyers, who believe that it gives the pharmaceutical companies too much power to determine whether their own product is safe to use. It’s too much like the fox guarding the henhouse for there to be any serious protection of patients’ rights.
The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of pharmaceutical liability. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.
The Reeves Law Group is not representing any party in the matters discussed in this posting.