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By allowing Big Pharma to suppress negative results on clinical trials, the New York attorney-general claims, the Food and Drug Administration has failed the industry and failed patients.
Flushed with his “success” in bringing GlaxoSmithKline to book over its development and marketing of Seroxat, an anti-depressant which was found to spark suicidal tendencies among adolescent patients, Mr Spitzer is widening his investigation.
Pfizer is helping Spitzer’s team with their inquiries into the development and subsequent marketing of no less than six different medicines in its portfolio. Merck is under a similar investigation amid charges that it continued to sell Vioxx for five years despite evidence to suggest that the pain killer might cause serious heart problems.
Spitzer’s campaign is as much about stirring a sleepy FDA into life as it is about improving the safety of new drugs under development. He is not seeking new legislation to push through an overhaul of the rule book, but rather, he is trying to push the FDA to take a greater lead in encouraging transparency of drugs data — good or bad.
His comments echo similar concerns in the UK, where MPs are considering whether to strip the Department of Health of its dual role as both champion and regulator of Britain’s pharmaceuticals industry. Unlike America’s Health and Human Services department, which ultimately oversees the work of the FDA, Britain’s Department of Health has at least been quick to react.
Rules this week severing the close links between the pharmaceuticals industry and the Medicines and Healthcare Regulatory Agency, which approves new drugs on behalf of the health department, will certainly improve transparency.
But if regulators are to play a greater role in the way new drugs come to the market, then they must demonstrate a willingness to balance the risks new drugs may carry with the benefits they promise to deliver. To settle for less would be to consign world beating research to the laboratory floor.
Question for the ECB
IN A memorable broadside last autumn, Ken Rogoff, the then chief economist of the International Monetary Fund, said that if Europe wanted to see an economic recovery it would have to watch it on television.
Since then, the eurozone has seen a real, if modest, revival.
Sadly, however, yesterday’s bleak growth figures suggest that this is proving to be as fleeting as a flicker on a television screen. When eurozone finance ministers meet to contemplate their plight on Monday, they will take solace that they find themselves in the same boat as Japan. It, too, has seen its recovery undercut by soaring oil prices and faltering world demand. The ministers would be better advised, though, to consider the differences between their predicament and that of Japan, where growth looks set to be supported by resurgent consumer demand. In Europe, domestic demand stays elusive, although, it could be rekindled by a cut in interest rates. Perhaps the ministers might ask the European Central Bank what it will do to help.
THE corporate governance police claim that executive use of a private jet is tantamount to shareholder robbery. Warren Buffett himself, the world’s savviest investor, calls his aircraft “The Indefensible”.
Then there are those who argue that a private aircraft is an essential business tool, saving time and boosting productivity.
Whoever is right, the rise in private jet sales is a certain indicator that business confidence is on the increase after years in the doldrums of corporate scandal.
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