By Vera Hassner Sharav
February 25, 2008
CBS-60 Minutes expose (Feb. 17) of the marketing of a lethal drug (Trasylol) underscored the need for Congressional action. The evidence presented clearly showed that the FDA fails to protect the public health: "A renowned researcher estimates that 22,000 patients could have been saved if the Food and Drug Administration removed the heart surgery drug Trasylol two years
That number includes only the preventable casualties since 2006. The drug has been marketed for 14 years--over four and a half million patients were exposed- one third Americans.
What conflicts of interest prevent Congress from taking action to protect the American public from being exposed to dozens of lethal drugs bearing the U.S Government seal of approval?
60 Minutes revealed something the Supreme Court clearly did not consider in its deliberations: FDA approval standards have drastically veered away from the agency's legal mandate. The FDA is approving drugs whose safety has NOT been proven.
CBS Reporter asked Dr. Dennis Mangano, an eminent medical researcher: "Doesn't a drug have to be proven safe before the FDA allows it on the market?"
"No. The trials that are constructed before a drug is marketed and given approval to be marketed generally address effectiveness of the studies."
Reporter: "Make sure I understand. If the FDA is not certifying a drug as safe, before it goes on the market, what is it doing?"
Dr. Mangano: "It's certifying that the drug is effective and that within the small numbers studied, relatively small, it doesn't appear to be unsafe."
The FDA approved Trasylol for patients at high risk of bleeding and it noted kidney toxicity was a problem. Despite the noted risk, the FDA expanded its approval in 1998, to cover all heart bypass patients. That expanded approval was not backed by evidence of safety, but was driven to promote increased profits not public health: by 2005, Trasylol sales hit $300 million, the
next year, $750 million was projected.
Dr. Dennis Mangano conducted a study that had followed 5,065 patients in 17 countries. His alarming findings were reported in the January, 2006 issue of The New England Journal of Medicine. The study "showed an important association between Trasylol use and kidney failure requiring dialysis. And it showed a trend toward increased death in hospital in these patients."
Trasylol increased the risk of stroke by 181%; Trasylol increased the risk of heart attack by 48%; Trasylol increased heart failure by 109%
Why would the FDA merely issue an advisory to the medical community, rather than withdraw a lethal drug--especially since safe and inexpensive alternative drugs existed?
Dr. Mangano's study findings were confirmed by Dr. Alexander Walker of Harvard who was hired by Bayer. But Dr. Walker's findings were concealed from the FDA advisory committee.
60 Minutes reported that as early as the 1980's a researcher in Germany reported to Bayer that Trasyslol caused severe kidney failure in animals. But, he told 60 Minutes that the company was not interested. In 1992, a US study found that 13 of 20 patients exposed to the drug developed problems with kidney function. But neither the company nor the FDA paid attention.
Physicians such as Dr. Mangano and Dr. Walker deserve high praise for blowing the whistle on wrongdoing. Companies such as Bayer and FDA officials who failed to remove a lethal drug from the market should be held accountable.
Dr. Mangano is credited with improving the health of millions. He was one of the researchers who discovered that aspirin reduces the risk of heart attack. His non-profit institute studies drug safety and how generic drugs can lower health care costs.
A Feb. 19, 2008, press release (below) from the Coalition Against Bayer Dangers, announces that an Argentinean court has awarded damages to a claimant harmed by Bayer's other lethal drug, Baycol. After taking the cholesterol-lowering drug, Carlos Potocnik, suffered from a breakdown of muscle fibres which led to severe kidney damage and permanent disability. In previous court cases Bayer had managed to reach out of court settlements.
Baycol gives rise to a serious muscle-wasting condition known as rhabdomyolysis that in some cases can lead to life-threatening kidney failure. The judge, Sylvia Aramberri, noted the fact that Bayer knew about Baycol's serious side effects but knowingly put it on the market. More than 100 patients died. The damages of 160 000 Peso (barely 40 000 Euro) consist
of compensation, court costs and lost earnings. Potocnik originally demanded 570 000 Peso in damages.
Today's Supreme Court Decision effectively provides medical device manufacturers with immunity from liability:
Unless and until Congress takes action to criminalize concealment of lethal side effects of prescription drugs, tens of thousands of Americans will die unnecessarily.
Contact: Vera Hassner Sharav
CBS-- 60 MINUTES
One Thousand Lives A Month