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.”