Nov 08

(NaturalNews) A congressional investigation has revealed that a group of Harvard psychiatrists, instrumental in pushing the diagnosis of bipolar disorder in children and its off-label treatment with antipsychotics, concealed from university officials the millions of dollars they earned in consulting fees for the companies that make those drugs.

Iowa Sen. Charles E. Grassley requested the financial disclosure reports that Drs. Joseph Biederman, Timothy E. Wilens and Thomas Spencer had filed with Harvard University between 2000 and 2007. He then asked a handful of pharmaceutical companies for their own records on how much had been paid to the researchers in that time.

The numbers reported by the drug companies were much higher than those on the researchers’ forms.

“Basically, these forms were a mess,” Grassley said. “Over the last seven years, it looked like they had taken a couple hundred thousand dollars.”

Upon being confronted with the discrepancies, the researchers admitted to having concealed certain consulting fees and upped their estimates. These new numbers still fell short of those reported by the drug companies.

Biederman, for example, originally told Harvard that he had received no money from Johnson & Johnson in 2001. When Grassley asked him to double check, Biederman admitted to receiving $3,500. The drug company’s records, however, recorded payments of $58,169 to Biederman in that year alone.

A more thorough investigation revealed that Biederman and Wilens had received at least $1.6 million from the pharmaceutical industry between 2000 and 2007, while Spencer had received at least $1 million.

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Apr 09

· Anti-psychotics may cause long-term harm, say critics
· Youngsters under 6 being given unlicensed drugs

New evidence has shown children’s lives are being put at risk by a surge in the use of controversial tranquillising drugs which are being prescribed to control their behaviour, the Guardian has learned.

The anti-psychotic drugs are being given to youngsters under the age of six even though the drugs have no licence for use in children except in certain schizophrenia cases, the report says.

The number of children on the drugs has doubled since the early 1990s as the UK begins to follow a trend started in the US, but critics say they are a “chemical cosh” that could cause premature death. Continue reading »

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Apr 09

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.

More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the food and drug agency received reports of at least 50 deaths associated with the drug. Continue reading »

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