Glaxo defends Avandia in hearings on drug’s safety

By Reuters
Posted July 13, 2010 at 10:03 a.m.

GlaxoSmithKline Plc insisted its diabetes pill Avandia was safe as U.S. advisers began a two-day meeting to consider whether the medicine is too dangerous to stay on the market.

The scientific experts assembled by the Food and Drug Administration are sorting through sharply conflicting data on whether Avandia causes heart attacks.
“Follow the science where it leads and the rest will fall into place,” urged FDA Commissioner Margaret Hamburg in opening the meeting held in a packed hotel ballroom, acknowledging that the advisers had a difficult job.

The recommendations of the panel, with 33 voting members, are expected to weigh heavily on the FDA in making its final decision in the coming months.

British-based Glaxo, which could face a new wave of lawsuits if the drug comes off the market, said diabetes was a serious disease that needed multiple treatment options to control blood sugar and prevent devastating complications including amputations and blindness.

“When used appropriately, (Avandia) has a positive benefit/risk profile and should remain a treatment for Type 2 diabetes,” said Dr. Murray Stewart, a Glaxo vice president for drug research and development.

The pill was once Glaxo’s second-biggest drug but its sales have plunged since safety fears erupted three years ago. Revenue totaled $1.16 billion in 2009, equivalent to 2.7 percent of Glaxo’s group sales.

Added pressure is coming from the European Medicines Agency, which has launched a new review into Avandia’s risks and benefits.

For the FDA, the case is seen as a test of how the agency will handle major controversies under Democratic President Barack Obama. Officials are facing heavy pressure from consumer groups and some lawmakers who say the FDA fumbled in past administrations and failed to protect the public.

Shares of Glaxo were up almost 1 percent in both London and New York trading, amid a broad rally in stocks.

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One comment:

  1. Philip July 13, 2010 at 7:22 pm

    There are a few interesting related write-ups to this at the Skeptic’s Health Journal club. Avandia and Earwax
    provides the background of what the Senate funded investigation into Avandia found. David Graham and the tragedy of Vioxx parts I and II discuss in part I, some of the culture at FDA and in part II the specifics of what occured with the withdrawal of Vioxx. If anyone is interested those may be accessed here.

    Yes Avandia needs to be recalled, the risk/benefit ratio is not there for a me-too diabetes drug and how strange and sad that a senator had to use his own staff resources to research and bring attention to this issue, something FDA should have done on its own.