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Healthy Skepticism Library item: 18962

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Publication type: news

Kresge N
Obesity Drug Risks Prompt New EU Drug Data Disclosure Rule
Bloomberg News 2010 Nov 19

Full text:

Europe’s drug regulator will make thousands of pages of clinical trial reports public next week after pressure from drug-safety activists because of suicide risks linked to Sanofi-Aventis SA’s failed diet pill Acomplia.

The European Medicines Agency will from next week provide data on request for every drug it has reviewed, Sabine Haubenreisser, an EMA spokeswoman, said Nov. 17. The agency aims to publish the reports on its website within five years, Executive Director Thomas Loenngren said.

“We are becoming more transparent,” Loenngren said in an interview in London this month. “We also have a huge pressure on us to be more transparent. This is a challenge for all of us in the future.”

The prompt release of full trial reports for every drug approved or rejected would be a more aggressive policy than that in the U.S., Sidney Wolfe, head of health research at Washington-based consumer group Public Citizen, said in a telephone interview. U.S. law requires summary results of trials under way by September 2007 to be reported for products approved by the FDA.

Quicker release of data in Europe would be “great news for the entire world,” Wolfe said. “Once things are made public there, everyone can get their hands on it.”

The EMA won’t require drugmakers to disclose data deemed commercial or confidential such as manufacturing information, Loenngren said. A separate online registry of clinical trials conducted in Europe is set to go public next year, he said.

New Policy

The new disclosure policy follows a request from researchers at the Copenhagen-based Nordic Cochrane Centre for clinical trial reports on three obesity drugs: Roche Holding AG’s Xenical, Abbott Laboratories’ Meridia and Sanofi’s Acomplia. The institute wanted to see if the published data matched up with the more detailed reports submitted to the regulators, Anders Joergesen, a researcher at the center, said in a telephone interview yesterday.

“It’s a very detailed report describing the benefits and harms, more detail than is available for example in medical journals,” Joergesen said. “The medical journal’s report is about 10-15 pages, maybe less, and these consist of 100, 200, 300 pages per trial.”

The Danish researchers asked for the reports on June 29, 2007, three weeks after the FDA said Acomplia might raise the risk of suicide and suicidal thoughts. Abbott’s Meridia had been linked to increased blood pressure and heart rate, while sales of Roche’s Xenical had been hampered by embarrassing side effects such as some patients’ inability to control bowel movements. All three drugs were already being sold in Europe.


The researchers were able to get information about Meridia from Danish health authorities, Joergesen said. The EMA rejected their request for information on the other two drugs, and the researchers appealed to Nikiforos Diamandouros, the Strasbourg, France-based European ombudsman responsible for investigating complaints about EU institutions.

The regulator said it wanted to protect the drugmakers’ commercial interests, Diamandouros wrote in a May report. The ombudsman rejected that argument after inspecting portions of the trial data, saying they don’t contain trade secrets, and called on the agency to release the reports. The EMA was reworking its policy and took Diamandouros’s comments into account, Haubenreisser said.

Pulled From Market

Abbott, based in Abbott Park, Illinois, agreed to take Meridia off the U.S. market in October. The EMA halted sales of the 13-year-old diet pill in January. Acomplia was never approved in the U.S., and the European regulator pulled the drug from the market in October 2008. The EMA agreed in 2008 to let GlaxoSmithKline Plc sell the 12-year-old Xenical’s active ingredient, orlistat, as the non-prescription diet pill Alli.

Sanofi forecast sales of more than $3 billion a year if Acomplia had won U.S. approval. Roche’s Xenical generated sales of 397 million Swiss francs ($398.1 million) last year, less than the annual revenue of more than $1 billion some analysts had predicted.

Joergesen said he expects the Danish research team will get the reports on the diet pills by Dec. 5.

“Their interpretation before was that nobody should have access to these,” the researcher said. “Let’s see what we get, because it may be fully redacted and a blank sheet.”

Annette Walz, a spokeswoman at Roche, and Scott Davies, a spokesman at Abbott, both said that requests for comment should be directed to the European Federation of Pharmaceutical Industries and Associations. A telephone message and e-mail to the Efpia weren’t immediately returned. Marisol Peron, a spokeswoman at Sanofi, didn’t immediately comment.


After watching the three-year debate over a link to heart disease discovered in unpublished studies of Glaxo’s diabetes drug Avandia, the European agency is also considering whether to hold public hearings as the U.S. Food and Drug Administration does, Loenngren said.

Once the world’s best-selling diabetes medicine, Avandia was withdrawn from the European market and restricted in the U.S. in September. Glaxo is “absolutely committed” to openness and research, Claire Brough, a spokeswoman for the London-based company, said in a telephone interview.

“There’s a lesson learned from that experience,” Loenngren said. “All kinds of secrecy are leading to suspicion that things aren’t right and are leading to lack of confidence. So why shouldn’t you be open?”


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