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INTERVIEW-Avandia-type crisis could hit other drugs -Hassan

Mon Jun 4, 2007 1:31pm EDT

By Ben Hirschler, European Pharmaceuticals Correspondent

LONDON, June 4 (Reuters) - Safety scares like the one now engulfing GlaxoSmithKline Plc (GSK.L) diabetes drug Avandia could easily hit other medicines, Schering-Plough Corp. SGP.N Chief Executive Fred Hassan said on Monday.

Hassan, who is also president of the International Federation of Pharmaceutical Manufacturers and Associations, said the decision by companies to post their clinical trial results on the Internet increased the scope for sometimes questionable third-party analysis.

"This was always a concern, and unfortunately it's now being borne out," he said in a telephone interview. "This kind of thing could happen to many, many other drugs as well."

The world's leading pharmaceutical companies, responding to widespread demands for greater openness, recently started posting most clinical studies on a series of Web sites.

Hassan said the move was good for transparency but increased the risk of potentially misleading analysis, including the pooling of results of various studies in what is known as meta analysis, which was always "very dangerous territory".

Concerns about Avandia were sparked last month by a meta analysis published in the New England Journal of Medicine by top U.S. cardiologist Steven Nissen, which concluded Avandia increased the risk of heart attack by 43 percent.

Glaxo said it strongly disagreed with this conclusion, but confidence in Avandia, Glaxo's second-biggest seller, was hit. Shares in Europe's biggest drugmaker have tumbled around 10 percent.

The episode also put the spotlight on the U.S. Food and Drug Administration. Some politicians questioned whether its officials did enough to ensure patient safety. A congressional committee will probe the issue on June 6.

Hassan said the furore could further weaken the drug agency, which has faced intense criticism since the withdrawal of Merck & Co. Inc.'s (MRK.N) painkiller Vioxx in 2004.

"The FDA is going through a prolonged cycle, post Vioxx, of being under pressure, and morale at the FDA is not very good," he said.

"The FDA used to be the gold standard. It is still the gold standard, but in some ways the EMEA (European Medicines Agency) is emerging as a much stronger science-oriented body, because they are less vulnerable to political pressures," he added.

((Reporting by Ben Hirschler; editing by Jane Baird; email: ben.hirschler@reuters.com; Reuters Messaging: ben.hirschler.reuters.com@reuters.net; +44 20 7542 5082)) Keywords: GLAXO AVANDIA/HASSAN

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