GlaxoSmithKline faces several new issues over its drug rosiglitazone (Avandia) and possible cardiovascular problems.
The company has had to answer reports that it had asked the European Heart Journal not to publish in print an online editorial that was critical of the drug. It was also reported to have settled lawsuits relating to rosiglitazone and has faced calls for the US Food and Drug Administration to stop an international trial and demands from members of Congress asking why the drug had not been recalled.
The company denied charges, first reported at www.cardiobrief.org, that it had tried to prevent the European Heart Journal from publishing in its print edition an online editorial, "The rise and fall of rosiglitazone," by Steven Nissen of the Cleveland Clinic (2010;31;773-6, doi:10.1093/eurheartj/ehq016). In 2007 Dr Nissen raised the issue of possible cardiovascular problems with rosiglitazone in a paper in the New England Journal of Medicine (2007;356:2457-71).
GlaxoSmithKline’s head of research and development, Moncef Slaoui, wrote to the European Heart Journal saying that Dr Nissen’s online editorial was "rife with inaccurate representations and speculation that fall well outside the realm of accepted scientific debate. We strongly disagree with several key points within the editorial, most importantly those which imply misconduct on the part of GSK." He asked the journal to withdraw the editorial from its website and not to print it in the journal’s hardcopy edition.
The European Heart Journal posted both Dr Slaoui’s letter (doi:10.1093/eurheartj/ehq118) and Dr Nissen’s reply (doi.10.1093/eurheartj/ehq126) online, together with an editorial.
A GlaxoSmithKline spokeswoman told the BMJ: "There was absolutely no attempt to suppress [Dr Nissen’s editorial]. As Glaxo’s chairman of research and development [Dr Slaoui] states in his letter, we saw inaccuracies and considered them serious enough to warrant correction before being repeated. We requested that the journal address these inaccuracies."
The Bloomberg news service reported that GlaxoSmithKline had agreed to pay about $60m (£42m;
50m) to settle about 700 of the thousands of lawsuits relating to rosiglitazone for type 2 diabetes (www.bloomberg.com, 11 May, "Glaxo said to pay $60 million in Avandia settlements").The drug firm faces at least 4000 lawsuits over rosiglitazone from people who alleged that their heart attacks and strokes were caused by the drug. As many as 9000 more lawsuits may be filed, Bloomberg reported. A group of these lawsuits will go to trial in Pennsylvania in July.
The GlaxoSmithKline spokeswoman said that the company had no comment on the reported settlements but that it stood by rosiglitazone and believed that "the facts will support our position" when courts and juries looked at the clinical data, the company’s communications with the FDA and doctors, and "our openness in posting studies on our website."
On July 13 and 14 an FDA advisory committee will review rosiglitazone’s safety.
Meanwhile, the US consumer group Public Citizen has asked the FDA to stop a trial comparing rosiglitazone with another thiazolidinedione, Takeda’s pioglitazone, on the grounds that it is unethical. The thiazolidinedione intervention in vitamin D evaluation (TIDE) trial is estimated to include about 16 000 people at 137 sites in 14 countries and is due to be completed in 2015. Previously, in October 2008, Public Citizen had asked the FDA to take rosiglitazone off the market.
Sidney Wolfe, director of Public Citizen’s health research arm, and David Juurlink, head of the division of clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre in Toronto, said in a letter to the FDA’s commissioner, Margaret Hamburg, that many of the new sites added to the trial were in developing countries. The letter said that their request to stop the trial "was based on accumulating evidence of the increased dangers of rosiglitazone (Avandia) relative to pioglitazone (Actos) and in comparison to older, standard treatments for diabetes."
Senators and representatives speaking at a meeting of the House of Representatives agriculture appropriations subcommittee on 28 April asked why rosiglitazone had not been recalled, given the reports of problems with the drug.
In a response to Public Citizen’s letter GlaxoSmithKline said that the TIDE trial had been required by the FDA, which had specified a comparison of rosiglitazone and pioglitazone in addition to comparing rosiglitazone with placebo. The company said that the trial had been approved by institutional review boards and ethics committees around the world and that an independent data monitoring committee is monitoring the safety of patients.
The company responded to the House of Representatives subcommittee by entering a statement into testimony. It said that the company "welcomes additional scientific information that could help guide decisions around clinical trials and ultimately patient safety." It repeated that the TIDE trial design was directed by the FDA and had approval from institutional review boards. It added that the American Heart Association and the American College of Cardiology Foundation had said that "insufficient data exist to support the choice of pioglitazone over rosiglitazone."
Cite this as: BMJ 2010;340:c2654
1 comment:
I doubt that this is the first, or last time big pharma have tried this.
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