Avandia, once the best-selling diabetes drug in the world, is set to become a heavily restricted niche product, plastered with scary warnings, writes Matthew Herper at Forbes.com
While the majority of a panel of experts told the Food and Drug Administration that GlaxoSmithKline’s diabetes drug Avandia should remain on the market, they said it should have the most severe restrictions possible.
Several panelists blasted GlaxoSmithKline for not conducting better safety trials of its drug, forcing experts to grapple with uncertainty for two days. Many panelists said they did not trust the results of the company’s main study defending the drug and expressed exasperation at the way the company analyzed its studies. “Why isn’t there better data at this point?” said Lewis Nelson, an emergency physician at New York University Medical Center.
Remember, Glaxo has a track record of hiding negative clinical trial data that would knock sales of its drugs – the story of Seroxat and Study 329 is truly shocking.
Read more about Seroxat here:
More on Paxil and suicide – “Glaxo was aware of this risk, and hid it”
Let down by the MHRA… again
Back at the Avandia panel, overall, 22 of 33 panelists voted to either withdraw the drug completely or to heavily restrict its use. Seven merely wanted more warnings. Only three thought that no additional warnings were needed beyond what is already on the drug’s label.
In a long discussion period after the vote, it was clear that most panelists wanted to keep the drug around mainly for patients who can’t tolerate a rival medicine, Actos, that appears safe for the heart. “I don’t see why this drug needs to be on the market anymore,” said Morrie Schambelan, a professor of medicine at UC-San Francisco.
Many panelists had grave concerns about the main safety study that Glaxo had done to evaluate Avandia’s risk, called Record. Marvin Konstam, a veteran Tufts clinical trialist who became one of the sternest Avandia critics, said he didn’t think he could use the data from the study at all. “I’m very disturbed by the Record trial and the audit,” echoed Clifford Rosen, a diabetes expert at the Jackson Laboratory in Bar Harbor, Maine.
And this from the London Evening Standard:
GlaxoSmithKline today swallowed a £1.57 billion charge to settle legal wrangles including litigation over its blockbuster diabetes drug Avandia, after winning a reprieve over a potentially reputation-ruining safety scandal.
Britain’s biggest drugs firm said the fee would cover the “substantial majority” of settlements with Avandia patients as well as “the vast majority” of product liability lawsuits against Paxil, an anti-depressant which patients allege has links to suicidal behaviour and birth defects.
And then of course there is the soon to start action against Glaxo in the High Court in London regarding Seroxat (Paxil) and the withdrawal problems associated with it.
Ultimately Glaxo does not care – even though it settles these claims for huge sums of money, those sums are dwarfed by the profits its dangerous drugs have made over the years they have been prescribed.
It matters little to Glaxo that patients suffer and even die as a direct result of taking its dangerous drugs – after all even after all the fines and the legal settlements have been taken into account there is still a healthy profit being made.