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Friday, Apr 18th

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Big Pharma May be Handed Blanket Immunity for All Drug Side Effects, Deaths

The Supreme Court may rule that pharmaceutical companies cannot be sued for dangerous or even deadly side effects from their drugs if those side effects arise from an FDA-approved use.

Under a legal argument known as "pre-emption," the FDA's approval of a drug absolves companies of any responsibility if that drug later turns out to be dangerous, even if information was concealed from the FDA during the approval process. While courts have rejected this argument for decades, the winds appear to be shifting.

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Stem-cell technique may end need for heart donors

Growing human organs in the laboratory has moved a step closer with the development of a biodegradable material forming a non-living "scaffold" on which beating heart muscle can be grown from stem cells.

The aim is to make three-dimensional organs from scratch, although in the shorter-term scientists will be happy to be able to seed the scaffolding with stem cells in order to mend broken hearts in situ rather than relying on a transplant operation.

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FDA Panel Accepts Findings On BPA Despite Mistakes

The Food and Drug Administration made mistakes when determining that a widely used chemical found in baby bottles and other plastics was harmless and the agency should redo its risk assessment, an FDA advisory panel ruled yesterday.

But the report's authors told the Science Board advisory panel that they could not say whether BPA was harmful or whether it should be banned in food and beverage containers. They left that to FDA Commissioner Andrew von Eschenbach to decide.

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Adequate pain care sorely lacking for patients

Medical science has learned a great deal about the causes of pain and ways to relieve it, pain experts say, but for a host of reasons, the treatment of pain and suffering has improved hardly at all in recent years.

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F.D.A. Criticized for Assurances on Chemical in Plastic

A scientific panel has issued a blistering report against the Food and Drug Administration, saying the agency ignored important evidence in reassuring consumers about the safety of the controversial chemical bisphenol-A.

The panel, in a report issued this week, did not draw any conclusions about the safety of the chemical, known as BPA. But it criticized the F.D.A. for ignoring crucial studies and using what it said were flawed methods in reaching its conclusions. 

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How Merck Made a Killing

Stockmarket pressure to find "blockbuster" drugs has forced drug companies to push products to market ever more aggressively. In the case of Merck's painkiller Vioxx, this had disastrous and lethal results.

There are two remarkable things about the painkiller Vioxx. One was its disastrous impact on those who took it. Before it was pulled from the market in September 2004, Vioxx probably did more harm than any other modern prescription medicine. Critics of the drug have estimated that up to 140,000 Americans suffered heart attacks or strokes and about a third died as a result of taking it—and that is not counting those who died in the other countries where the drug was sold. It was as if a full jumbo jet dropped from the sky every week for five years, yet no one noticed. 

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Media lift lid on secret reports on drug side-effects

Adverse reactions to medication is the fifth most common cause of death in hospitals according to the European Commission, but EU agencies and national governments have until now kept secret pharmaceutical companies' reports on side-effects.

The PSURs for example detail how doctors in various countries suspect that teenagers grow suicidal when taking a certain medication against pimples, or that a diet product could lead to a stroke and what industry has to say about the medical fears.

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