Glaxo's Avandia Should Be Pulled From U.K. Market, BMJ Chief Editor Says
Glaxo’s Avandia Should Be Pulled From U.K.
JB Reed/Bloomberg
The European Medicines Agency will hold a meeting on Sept. 8 to discuss the “ongoing benefit-risk review” of Avandia.
The European Medicines Agency will hold a meeting on Sept. 8 to discuss the “ongoing benefit-risk review” of Avandia. Photographer: JB Reed/Bloomberg
GlaxoSmithKline Plc’s Avandia diabetes treatment should be withdrawn from the market and never should have been approved, the British Medical Journal’s Editor- in-Chief Fiona Godlee wrote as European regulators prepare to review the drug’s safety.
The Commission on Human Medicines advised the U.K. drug regulator in July that Avandia should be pulled because the product’s risks outweigh its benefits, according to the journal, which today published an investigation of the drug with an editorial from Godlee.
“We need to be absolutely certain that our long-term treatments for type 2 diabetes are not causing the very harm they are meant to prevent,” John Yudkin of University College London said in the BMJ report. “And if the regulatory bodies do not insist on clear evidence of greater benefit than harm, they are failing in their basic purpose.”
The European Medicines Agency will hold a meeting on Sept. 8 to discuss the “ongoing benefit-risk review” of Avandia, after research linked the drug, also known as rosiglitazone, to higher rates of heart disease. The Medicines and Healthcare products Regulatory Agency, the U.K. regulator, said July 26 that doctors should consider alternative treatments “where appropriate.” The MHRA said today that Avandia “no longer has a place on the U.K. market,” based on the commission’s advice.
‘Extensive Research’
“We reject any suggestion that there is a lack of publicly available trial results related to rosiglitazone for independent scientific scrutiny,” London-based Glaxo, the U.K.’s biggest drugmaker, said in an e-mail. The company “has carried out an extensive research program involving more than 50,000 patients to analyze the safety and benefits of rosiglitazone. No other diabetes medicine introduced in the last 10 years has such an extensive safety database.”
Avandia’s sales have fallen since a study published in the New England Journal of Medicine in 2007 showed a 43 percent increased risk of heart attacks from the drug. Avandia last year garnered revenue of 462 million pounds ($710 million), down from 1.4 billion pounds in 2006. Actos, from Takeda Pharmaceutical Co., is the world’s best-selling diabetes medicine, generating 387 billion yen ($4.6 billion) in the year ended March 31, according to the Osaka, Japan-based company’s annual report.
Glaxo fell 1.5 percent to 1,249 pence at 4:35 p.m. in London trading. The stock has fallen 5.3 percent so far in 2010, after climbing in the past two years. Takeda added 1.2 percent to 3,975 yen at the 3 p.m. close in Tokyo trading, taking its gain to 3.8 percent this year.
Nissen’s Recording
Glaxo posted on its website a recording of a meeting between company scientists and Steven Nissen, the Cleveland Clinic cardiologist who wrote the 2007 analysis that appeared in the New England Journal of Medicine. Nissen made the recording of the May 10, 2007, meeting, which took place before his study was published, without the company’s knowledge, Glaxo said. The drugmaker said it obtained a copy of the recording on Sept. 3 following a legal request to Nissen.
Nissen had previously shared the contents of the recording with The New York Times. The company said it expects the British Broadcasting Corp. to release the recording on its Panorama program later today. Glaxo said it hasn’t seen the program.
“We regret if any comments made by GSK during this meeting might be misinterpreted as seeking to stifle an independent view of the science around Avandia,” Glaxo said. “Patients concerned by the program should seek advice from their doctor and not stop their medication.”
Avandia’s Approval
Avandia was approved in the U.S. in 1999. The EMA had initially rejected the drug in October 1999, and then approved it in July 2000 “in the absence of new evidence,” wrote Deborah Cohen, the BMJ’s features editor, in the journal’s report. Advisers to the European agency commented on the lack of scientific data during the approval process, Cohen wrote, citing documents obtained by the journal.
The World Health Organization sent Glaxo an alert about heart disease and Avandia in 2004, the BMJ said. The company conducted an analysis that confirmed an increase in cardiac events to U.S. and European regulators in 2006, and the drug’s label was changed in Europe to reflect those findings, the BMJ said. The data remained confidential, according to the BMJ.
In an assessment report on the EMA website, the agency said that Glaxo provided additional information on increased duration of exposure to Avandia, rather that data on new patients or a new study. The updated database included more than 1,000 patients receiving the drug for at least two years and 2,000 treated for at least one year.
Safety Data
Safety data had shown Avandia plus insulin was linked to an increased incidence of congestive heart failure, according to the EMA report. The reviewers found no increased cardiovascular risk in the short term, based on Glaxo’s research, and said data were “insufficient” to determine long-term risk, the EMA report said.
Monika Benstetter, a spokeswoman for the EMA, said she couldn’t comment on the BMJ report because she hadn’t seen it.
To contact the reporter on this story: Kristen Hallam in London at khallam@bloomberg.net.
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