Hidden FDA Agenda for Avandia Meeting?

Hidden FDA Agenda for Avandia Meeting?

May 23rd, 2013 // 3:24 pm @

Latest FDA and cGMP Compliance News

In June, FDA is going to have a two day meeting to talk about clinical trial results for the Avandia diabetes drug, which comes three years after FDA majorly restricted the use of the pill. Steve Nissan, who was the co-author of a meta analysis that found higher heart risks with the GSK drug, thinks FDA has a secret agenda for having this meeting.

Nissan stated in Forbes this week that he thinks that the leadership of CDER wants to duck accountability for the agency’s role in the Avandia mess. Nissan is a top chief of cardiology at the famed Cleveland Clinic.

The meeting is going to have a reassessment of a clinical trial that was the focus of an FDA panel meeting in 2010 that was held to go over the safety record of Avandia. At that time, Avandia and the agency were under pressure from the public regarding safety and clinical data disclosure.

June 12 – Quality Agreement Essentials

Nissen writes in his Forbes article that GSK did a secret analysis from 2005 to 2006. It concluded that the pill boosted heart attack risk by 30 percent. GSK did not give this data to FDA, but it did tell the agency about it. In 2007, Nissen’s meta-analysis was released, and this caused a great deal of embarrassment at FDA, he maintains.

Since 2006, FDA has spent a lot of taxpayer money to absolve the agency of any responsibility for this major lapse in judgement that cost an untold number of lives. CDER and GSK in 2010 saw a chance to clear Avandia of any heart hazards and booked an advisory committee meeting to clear the drug’s name.

GSK was widely blasted for how it handled the clinical trial. Some scientists at the agency stated that the study had many flaws and seriously undercounted cardiovascular problems The US Senate Finance Committee and the Journal of the AMA also criticized GSK for trying to undermine its steering committee on science and also for trying to suppress bad results in clinical trials.

The largest event at the meeting was a presentation by an FDA reviewer who talked about how the clinical trial was biased. He noted that the trial was unblinded, which means that the doctors and patients knew which drug each person was taking, and GSK knew, too.

When the study site reported any type of clinical event, GSK and its CRO knew which drug the person was getting. The review showed that adverse events that were happening in trial subjects were either deleted or changed. This happened sometimes months after they should have been reported. The clinical trial was entirely unreliable.

FDA still told GSK to have an independent group of experts to review the clinical trial. FDA stated that the independent review was needed to get more clarity about the trial findings.FDA also announced a REMs , where the patients must enroll in an access program for Avandia, and the pill would only be available by mail from certain pharmacies.

Nissen claims in his article that the meeting that is coming up is just an effort to save face at FDA. CDER leadership would not accept the conclusions of experts around the world that Avandia is dangerous. These FDA officials want to show that the clinical trial actually did prove that the drug is safe.

He notes that GSK was able to prepare materials for the trial reanalysis, which was done by scientists at Duke. This undermines the process and its independence, he says. CDER leadership ignored the health hazards of Avandia, and the new meeting is an attempt to white wash the entire scandal, he claims.

Nissen tried to get a chance to speak at the meeting, but FDA denied it.



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