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John W. Whitehead

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

Posted: 05/10/09 03:20 PM ET

In a 2005 article in the Village Voice entitled "Capitalizing on the Flu," James Ridgeway predicted that a "flu pandemic would spark enough fear to make it a greed pandemic." As Ridgeway observed, "With a worldwide market estimated at more than $1 billion, there's big money in a flu plague." In fact, the pharmaceutical industry has gone to great lengths through its lobbying and government contracts to ensure that it will get a good piece of the plague pie. Now with the swine flu set to become a global pandemic, Big Pharma is raking it in.

Responding to the somewhat hysteria-induced demand for drugs to protect against the swine flu, pharmaceutical companies have ramped up production of Tamiflu and Relenza, two anti-viral drugs being touted for their ability to fight the flu. Eleven million doses of the flu-fighting drugs, about one-quarter of what has been stockpiled by the U.S. government, have already been sent to the states.

News media sycophants, in typical fashion, have taken up the hew and cry over Tamiflu's life-saving properties. Yet little is being said about the very real dangers that these drugs, particularly Tamiflu, pose to your health and mental welfare.

First approved by the U.S. Food and Drug Administration (FDA) in 1999, Tamiflu was promoted 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 suit, paying a whopping $58 million in July 2005 for treatments of U.S. troops around the world.

However, problems with Tamiflu had already begun to surface as early as 2004 when it was alleged that the drug 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 others had experienced hallucinations, encephalitis and other symptoms.

Despite these alarming reports, the FDA opted not to issue a warning about the drug's potential for causing abnormal behavior. Instead, the FDA issued a warning about 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 required Roche, the Swiss company that makes the drug, to include a warning label cautioning patients, doctors and parents to look out for strange behavior in anyone taking the drug.

However, Tamiflu is not the only drug to be suspected of having psychiatric side effects. There have been a disconcerting number of drugs which, although cleared by the FDA for use in treating epilepsy, asthma, influenza, obesity and smoking, are now believed to contribute to suicidal behavior.

Thus, there is good reason why the FDA has increasingly been viewed as one of the most corrupt agencies within the U.S. government. The FDA is suspected 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 of its most vocal critics is Dr. David Graham, currently the Associate Director of the FDA's Office of Drug Safety. 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. 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."

The pharmaceutical companies also bear the responsibility -- and the blame -- for unsafe drugs being approved and sold to the American public. "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 2008 report from the Center for Public Integrity, the pharmaceutical industry has spent more than $1 billion on federal lobbying and campaign donations over the past decade. Indeed, Washington is so overrun with drug lobbyists that Sen. Charles E. Grassley (R-Iowa) once remarked, "You can hardly swing a cat by the tail in Washington without hitting a pharmaceutical lobbyist." Furthermore, as CPI pointed out, the drug industry's investments in Washington have paid off handsomely, resulting in a series of favorable laws on Capitol Hill and tens of billions of dollars in additional profits.

"It is by now well-known that the drug companies provide huge sums of cash to politicians -- $133 million to federal candidates since 1998, according to the Center for Public Integrity, with upwards of $1.5 million going to Bush, the top recipient," writes James Ridgeway in the Village Voice. "The industry operates an elaborate lobby in Washington that in 2004 spent $123 million and employed an army of 1,291 lobbyists, more than half of whom were former federal officials." Those numbers have increased dramatically in the past five years. For example, in the first nine months of 2008 alone, the pharmaceutical industry reportedly shelled out $171.1 million on lobbying and was on track to exceed what it had spent the year before.

However, while the drug industry has in the past invested more of its funds on Republican candidates (they received $89.9 million in campaign contributions between 1998 and 2005), its lobbyists have in recent years been working hard to gain favor with the Democrats. As the Washington Post reports, "To strengthen their position, drug firms and their trade groups have been transforming their Washington operations by hiring top Democratic lobbyists to gain access to new committee chairmen, bolstering Democratic political donations and spending millions on public relations campaigns to overcome an image, indicated in recent surveys, that the industry puts profits ahead of patients."

Certainly, this collusion between the pharmaceutical industry and the government should come as no surprise to anyone who keeps up with the news and the rampant corruption in the halls of Congress. But there are dire ramifications from Big Pharma's stranglehold on the U.S. government. As James Ridgeway writes in his recent article in Mother Jones, "Swine Flu: Bringing Home the Bacon," there are "winners as well as losers in every high-profile outbreak of infectious disease. First and foremost among them, of course, is Big Pharma, which can always be counted on to have its hand out wherever human misery presents an opportunity to rake in some cash."

Clearly, Big Pharma are the winners here. Stock prices for pharmaceutical companies involved in the production of Tamiflu and Relenza have already jumped dramatically. And investors are already salivating at the prospect of the government insuring against future outbreaks by increasing its stockpiles of the drugs, as well as spending more on grants and funding for research.

What remains to be seen, however, is who will be the biggest loser.

 
 
 

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