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Which is More Dangerous to Your Health: The Flu or the FDA?

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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