FDA: Watchdog or Agent of Death?

The FDA was formed in 1906 and has the job of ensuring the safety of all dietary supplements and foods processed and sold in the United States. This agency is supposed to act as a watchdog over food and drug manufacturers in the United States.

Here’s the official mission statement from their website:

“The Food and Drug Administration is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The Food and Drug Administration is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”

Does the FDA Protect the Public?

In some cases, no. The Food and Drug Administration has a division, the Center for Drug Evaluation and Research (CDER) which is supposed to “independently” review drug applications and clinical trial results from pharmaceutical companies and then rule “objectively” on the safety of each drug.

By law, for each drug review application, the pharmaceutical companies pay the FDA $300,000 dollars. In addition, many FDA scientists receive consulting fees from pharmaceutical companies whose drugs they review. Conflicts of interest are built right into the drug approval process.

In multiple cases, the Food and Drug Administration’s CDER division approved drugs that were KNOWN to have deadly side effects. David Willman, a Pulitzer Prize-winning reporter with the Los Angeles Times, writes about this in a 2003 article:

Seven drugs approved since 1993 have been withdrawn after reports of deaths and severe side effects. A two-year Los Angeles Times investigation has found that the FDA approved each of those drugs while disregarding danger signs or blunt warnings from its own specialists. Then, after receiving reports of significant harm to patients, the agency was slow to seek withdrawals.

Here’s a quick look at some of The Food and Drug Administration’s approved but deadly drugs, with thanks to Mr. Willman:

  • 2000: Lotronex, manufactured by Glaxo, Inc. CDER medical officer, Dr. John R. Senior, discovered during the review that four Lotronex patients in clinical studies had suffered a potentially life-threatening complication called ischemic colitis, which results from inadequate blood flow to the colon. Senior found other troubling results. He warned that 27% of the patients who took Lotronex in Glaxo’s studies experienced constipation. He noted that not a single patient who took a placebo pill developed ischemic colitis and that only 5% of the placebo patients got constipated. Glaxo representatives denied that Lotronex had caused the cases of ischemic colitis and said any risks could be adequately managed. But Senior warned of the potential for Lotronex patients to suffer debilitating bowel injuries or death.

    In February of 2000, a Food and Drug Administration advisory committee, whose participants included a paid consultant to Glaxo, unanimously recommended approval, despite Senior’s warnings. By October 2000, 49 cases of ischemic colitis in Lotronex patients had been reported. Five people died. Records show that no fewer than 91 patients were hospitalized, many with severe constipation. Several bowel surgeries, including the removal of a patient’s colon, were performed. Source

  • 2000: Propulsid, manufactured by Janssen Pharmaceutica, a Johnson & Johnson Co. subsidiary. In mid-1993, CDER officials were reviewing Propulsid, a drug that eased nighttime heartburn. Food and Drug Administration medical officer Andre Dubois was assigned even though he normally approved gastrointestinal drugs for the FDA. Dubois noted that 48 out of 1,993, or 2.4%, of the patients who took Propulsid in U.S. studies, experienced “heart rate and rhythm disorders.” In addition, eight children under the age of 6 who were given Propulsid had died. Dubois found that the drug’s chemical makeup could disturb cardiac function, but he agreed with the drugmaker that the deaths in the studies were attributable to other causes. The Food and Drug Administration approved the drug in July 1993, without ever having a cardiac specialist review the application. Even though they were aware of the deaths attributed to Propulsid, it wasn’t until July 2000 that the FDA pulled Propulsid off the market because of scores of confirmed heart-rhythm deaths. Overall, Propulsid has been cited as a suspect in 302 deaths, many of them infants and children. Source
  • 1997: Duract, manufactured by Wyeth-Ayerst Laboratories. This painkiller was approved in July 1997 despite FDA medical officers’ repeated warnings of the drug’s liver toxicity. Senior officials sided with the manufacturer in softening the label’s warning of the liver threat. The drug was withdrawn almost a year later. By late 1998, the Food and Drug Administration had received voluntary reports citing Duract as a suspect in 68 deaths, including 17 that involved liver failure. Source

FDA Employees are Staging a Revolt

In early 2009, Food and Drug Administration scientists in the medical device division sent a letter to President-elect Obama urging him to restructure the FDA, saying that “managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law.”

Now, I’d say that when scientists are willing to risk their reputations and their jobs in a precarious economy, that’s pretty strong evidence that the FDA is not working in the best interests of the American people. Here’s hoping these employees and the America public get the changes wanted and needed. You can read the story here.

Further Reading

For additional reading on the other approved but deadly drugs:

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