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22 Thousand Americans Died Needlessly From Side Effects of Drug. Bayer Concealed Studies from FDA

A shocking news story from Reuters...

The lives of 22,000 patients could have been saved if U.S. regulators had been quicker to remove a Bayer AG drug used to stem bleeding during open heart surgery, according to a medical researcher interviewed by CBS Television's '60 Minutes' program.

The drug Trasylol was withdrawn in November at the request of the FDA after an observational study linked the medicine to kidney failure requiring dialysis and increased death of those patients.

It had been given to as many as a third of all heart bypass patients in the United States at the height of its use over a period of many years, according to the report.

Dr. Dennis Mangano, the study's researcher, said during the program that 22,000 lives could have been saved if Trasylol had been taken off the market when he first published his study in January 2006, according to a CBS News report on its Web site ahead of a broadcast slated for next Sunday.

He said in the broadcast that Bayer failed to disclose to the FDA during an FDA advisory panel meeting in September 2006 -- at which Mangano's negative findings were discussed -- that the German drugmaker had conducted its own research which confirmed the same dangers established by his study.

The chairman of the FDA advisory panel, Dr. William Hiatt, told 60 Minutes he would have voted to remove Trasylol from the market had he been informed about Bayer's study, according to the CBS report.

This isn't the first time that Bayer including Bayer Corp. a USA subsidiary of Bayer AG, part of the Bayer Group of companies based in Germany, has been involved in a case where it acted in a unconscionable manner, in concealing it's own research to the FDA, the Food and Drug Administration, research which demonstrated that patients could have 'fatal side effects' from receiving one of Bayer's pharmaceutical drugs.

There seem to be an established pattern here. Roger Clemens may be a drug cheat, but he isn't in the same league as these reckless corporate drug merchants. One year ago..

Bayer, a global drug and biotechnology company with a turnover of $US35.5 billion in 2005, has agreed to pay $8 million to settle a legal action by 30 U.S. states over its failure to disclose potentially serious consequences of using Baycol, a cholesterol-lowering drug. Baycol was withdrawn from the market in August 2001 due to its "sometimes fatal" side effects. Under the terms of the settlement, Bayer agreed that it failed to adequately warn doctors and patients of the results of clinical studies that demonstrated serious consequences from using the drug. The settlement also requires Bayer to post the results of all future clinical studies on the Internet at the time of the completion.
( a little too late)

And where do the commercial presures come from, that lead to the unintended patient deaths from the administering of these lethal drugs. Here is a glimpse of Bayer's raison d'etre, its crown jewels in the 2006 Annual Report...

From the 2006 shareholder statement by President Werner Wenning,
Chairman of the Board of Management of Bayer AG, 'Schering acquisition crowns a strong year!' a paean, to its takeover and commercial success..His statement is as follows:..

"We want to live up to our mission statement "Bayer: Science For A Better Life". And I'm already sure we can succeed - not least because we can count on an exceptionally dedicated workforce dedicated to the succss of the company," (by blinding or at least blinkering the patients and the medical authorities to the fatal side effects of our drugs).

In these type of concealment cases, 'death merchants' would be a just as an appropriate label for Bayer as 'drug merchants'. Of course, being good citizens and worried about the safety of its citizens, Bayer including its American subsidiary, in order to fight the continuing GOP 'global war on terror' campaign where only a fraction of Americans have died compared to the consequences of Bayer's 'stealth drug' attacks, the company gave $255,000 to federal candidates in the 2006 election through its political action committee - 21% to Democrats and 78% to Republicans.

Bayer spent $3,192,969 for lobbying in 2006 in the U.S. Six lobbying firms were used with most lobbying being done using in-house lobbyists..this in overall drug lobbying operation, pushing prescription drugs which is second to no other industry in influence and spending in Washington.



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Publisher: Kevin Aylward

Editors: Lee Ward, Larkin, Paul S Hooson, and Steve Crickmore

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