Which is More Dangerous to Your Health - the Flu or the FDA?_ Whitehead

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Excellent editorial - in my opinion, it gets to the core of the problem.

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

By 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. 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. "

Constitutional attorney and author W. Whitehead is founder and president of

The Rutherford Institute. He can be contacted at johnw@... .

Information about The Rutherford Institute is available atwww.rutherford.org