Chicago Injury Law Blog

As uncertainty surrounds the safety of the popular diabetes drug Avandia, federal health officials are prohibiting new patients from enrolling in a safety study of the prescription medication because of the associated risks. The TIDE study is designed to give a definite answer to whether or not Avandia holds more risk for heart problems than similar drugs. The Federal Food and Drug Administration (FDA) issued a “partial clinical hold” on the TIDE trial, which Avandia’s manufacturer GlaxoSmithKline agreed to conduct when the drug’s safety was first questioned in 2007. However, patients who are already participating are permitted to continue.

A panel of experts recently voted that although Avandia seems to increase the risk of heart problems, the majority voted to leave it on the market.  Some health professionals are  arguing that the TIDE trial is unethical since there is enough evidence to prove that the drug is more dangerous. Other health professionals have speculated that Avandia will be pulled off the market soon.

It was recently reported by the Wall Street Journal that one of the members of the government advisory panel who voted to back Avandia last week was on GlaxoSmithKline’s payroll. More specifically, endocrinologist David Capuzzi is a paid speaker for the drug manufacturer.

Avandia, a diabetes drug, has carried the Federal Food and Drug Administration’s (“FDA’s”) strongest warning, a black box warning, regarding its risk for heart problems since 2007.  Last week, a FDA advisory panel met to consider further restrictions on the drug in the wake of new information indicating it to be more harmful than previously thought.  During the meeting of 33 panel members, 12 voted Avandia should be withdrawn; 10 voted its sales should be restricted and warning labels enhanced; 7 voted solely for enhanced warning labels; and 3 voted to keep Avandia on the market with no changes to its warnings.  Because of the lack of unity, it is difficult to predict what the FDA will do with regard to the drug.

According to the Wall Street Journal, Dr. Capuzzi was one of the three panel members who voted to keep Avandia on the market with no changes to its warnings, and defended the drug during the two-day panel meeting.  Dr. Capuzzi has received almost $15,000 in speaking fees from GlaxoSmithKline, but has denied previously speaking about Avandia. The controversy surrounding Dr. Capuzzi and Avandia highlights a problem in the FDA’s regulations: the disclosure form for outside experts who advise the FDA on risky drugs only requires them to list fees from speaking or writing for a drug company for the previous 12 months or that are under negotiation. This is typically too short a period of time to catch most conflicts in the pharmaceuticals business. In Dr. Capuzzi’s case, the FDA’s current requirement would not have captured the majority of GlaxoSmithKline’s payments to him.  

As a follow-up to our previous blog on the current controversy surrounding the popular diabetes drug Avandia, it was recently reported that Avandia’s manufacturer GlaxoSmithCline hid a 1999 study that indicated the drug’s danger.

In the fall of 1999, the manufacturer secretly began a study to test if Avandia was better and safer in terms of heart problem risks than the competing drug Actos. The study showed that Avandia was not better than Actos, and was in fact riskier for the heart. The company did not share these results, but instead tried to cover them up, likely due to fear of lost profits. In most cases, the law requires posting the results in a public forum or submitting them to federal drug regulators. In fact, GlaxoSmithKline has not only hid valuable data regarding Avandia’s safety, it has also manipulated data to make the drug appear less risky.

Avandia went on to become one of the most popular drugs in the world, earning GlaxoSmithKline hundreds of millions in profits.  It was not until May 2007 when a cardiologist at the Cleveland Clinic  disclosed a study that showed an increase risk of heart attacks  associated with Avandia.  Currently, the FDA is debating whether or not to allow a further clinical trial to test the safety risks of the drug proceed.

Contact an Experienced Drug Litigation Attorney

The attorneys at the Pintas & Mullins Law Firm have extensive experience with drug litigation cases.  If you or a loved one has suffered heart problems as a result of taking Avandia, contact us for a free no-obligation consultation to find out about your legal rights.  You can also visit our website to learn more about Avandia.

On May 21, 2007 the FDA issued an alert warning people with underlying heart disease are at an increased risk of heart attack or stroke while taking Avandia. On July 30, 2007, the FDA’s advisory committee concluded that the use of Avandia for treatment of Type 2 diabetes was associated with a greater risk of cardiovascular problems compared to a placebo. The FDA is now requiring GlaxoSmithKline, the maker of Avandia, to conduct a cardiovascular outcome trial on Avandia to provide a definitive answer to whether Avandia poses an unacceptable risk of cardiovascular disease.

Avandia has also been associated with other health risks including a greater risk of fractures in women as well as a higher risk for macular edema (swelling in the retina). In addition, Public Citizen, a consumer advocacy organization, has identified 14 cases of liver failure induced by Avandia, including 12 deaths.  

The FDA has not recalled Avandia, but has required the drug to include a black box warning as of November 14, 2007. The warning states that people with underlying heart disease should be monitored closely while taking Avandia. If you believe you or a family member have  suffered heart problems or a stroke while taking  Avandia, please contact the Pintas Firm immediately. Consult your physician before discontinuing your medications.