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发帖数: 789 | 1 by John W. Whitehead
December 21, 2006
The flu season is here once again. During the last flu season, doctors
reportedly wrote more prescriptions for the drug Tamiflu than any other flu
treatment. But after recent reports about the Food and Drug Administration's
reluctance to issue a warning about certain possible dangers of using
Tamiflu, one has to wonder which is more dangerous--the flu or the FDA?
First approved by the FDA in 1999, Tamiflu was touted as a drug that could
significantly reduce the length and severity of influenza. These claims even
prompted the U.S. government to purchase 20 million doses of Tamiflu--at a
cost of $2 billion--in the event that a bird flu pandemic occurred. The
Pentagon followed, paying a whopping $58 million in July 2005 for treatments
of U.S. troops around the world.
However, problems with Tamiflu began to surface in 2004. It was thought that
the drug, which has been used by over 30 million people worldwide, was
causing some of its users to manifest very unusual behavior. For example,
during the 2004 and 2005 flu seasons, two teenage boys committed suicide
within hours of taking Tamiflu. The 17-year-old jumped in front of a large
truck on a busy road after walking outside his house barefoot and in pajamas
during a snowstorm. The 14-year-old jumped to his death from the balcony of
a ninth-floor flat. Later, a teenage girl was narrowly prevented from
jumping to her death from a window within days of starting a course of the
flu drug. By November 2005, it had been reported that 12 Japanese children
had died while on the drug and that others had experienced hallucinations,
encephalitis and other symptoms.
Despite these alarming reports, the FDA voted not to issue a warning about
the drug's potential for causing abnormal behavior. Instead, the FDA chose
to warn of Tamiflu's potential for producing skin rashes. It wasn't until
reports surfaced of more than 100 new cases of delirium, hallucinations and
other abnormal psychiatric behavior in children treated with Tamiflu that
the FDA changed course and added a warning label in November 2006.
Over the years, the FDA has been accused of causing high drug prices,
keeping life-saving drugs off the market, allowing unsafe drugs on the
market because of pressure from pharmaceutical companies and censoring
health information about nutritional supplements and foods.
One such critic is Dr. David Graham, Associate Director for Science and
Medicine and a senior drug safety researcher at the U.S. Food and Drug
Administration. In his estimation, the FDA is "responsible for 140,000 heart
attacks and 60,000 dead Americans. That's as many people as were killed in
the Vietnam War." His words offer an insider's perspective on the fatal role
he believes the FDA played in thousands of heart attacks and deaths caused
by the pain medication Vioxx--a medication the FDA approved and initially
failed to warn of its potential effects. Indeed, the Vioxx debacle was
brought to America's attention when Congress was presented with evidence
showing that among the estimated 20 million users of Vioxx, hundreds of
thousands had died or suffered heart attacks as a result of taking the drug.
Other drugs approved by the FDA and later found to cause harm include
dexfenfluramine, a diet drug whose post-marketing data indicated an
increased risk of pulmonary hypertension, and troglitazone, a diabetes drug
that carried with it the risk of liver failure and was later pulled from the
market. Yet as Graham has pointed out, "Rarely will they keep a drug from
being marketed or pull a drug off the market." The delays in taking action
on problematic drugs was addressed by Dr. Sidney Wolfe, director of the
Public Citizen's Health Research Group, in a statement before the Institute
of Medicine Committee in January 2006: "In too many instances, serious post-
marketing safety problems identified by the Office of Drug Safety have not
been acted upon because of resistance from FDA management and from the
review division that originally approved the drug."
But the pharmaceutical companies also bear the responsibility--and the blame
--for unsafe drugs being approved and put out on the market. "The FDA
assumes the drug is safe and now it's up to the company to prove that the
drug isn't safe," remarked Graham. "Well, that's a no-brainer. What company
on earth is going to try to prove that the drug isn't safe?"
It should come as no surprise that the pharmaceutical companies have the
federal government in their hip pocket. According to a 2005 report from the
Center for Public Integrity, "The pharmaceutical and health products
industry has spent more than $800 million in federal lobbying and campaign
donations at the federal and state levels in the past seven years." In fact,
no other industry has spent more money to sway public policy during that
period. The report continues, "The drug industry's huge investments in
Washington--though meager compared to the profits they make--have paid off
handsomely, resulting in a series of favorable laws on Capitol Hill and tens
of billions of dollars in additional profits."
With an estimated 200,000-plus people dying every year from prescription
drugs, Graham believes "Americans and Congress should be screaming bloody
murder. They should be beating on the doors of the FDA demanding change." |
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