The FDA: Whatever Happened To Due Dilligence?

A cardiologist from Cleveland recently published a report in which he linked the diabetes drug Avandia with an increased likelihood of heart attacks for those that were taking the drug. This isn’t a minor spike in probability. This is a statistically enormous 43% increase in risk.

Glasko Smith Kline is denying the accuracy of the report, and is standing by the safety of its product. The Food and Drug Administration issued a public safety bulletin advising anyone taking the drug to consult with their doctors about any possible cardiovascular dangers.

While the FDA should be commended for prompt action in the face of possible threats to public safety, the Avandia situation and several others like it in recent years causes us to question how the FDA is doing its job. One question of importance is this: Why is it that so many of the recent discoveries about the harmful effects of so many drugs are coming from independent research and whistleblowers instead of the FDA itself?

This is, verbatim, the mission statement of the FDA:

The FDA 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 FDA 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.

In terms of “assuring the safety” of the drugs consumed by the public, the following calamities have occurred under the FDA’s watch.

Vioxx: On September 30, 2004, the arthritis medication Vioxx was pulled from the shelves by its manufacturer, Merck, after a study showed that the drug significantly raised the risk of strokes and heart attacks. This study was not the first to provide the public with this information. In fact, the FDA had seen reports that said the exact same thing as early as 2000. Their reaction was to simply add more lines to the warning label on the packaging, which meant that hundreds of thousands of Americans continued to take a drug that could have killed them for four additional years.

Ortho Evra Birth Control Patch: This patch, which was supposed to revolutionize birth control, exposed its users to enormous levels of estrogen, which was pumped almost continuously into the body. While it certainly was an effective method of birth control, it also caused random clots to form in the bloodstreams of the women that used it. In 2004, about a dozen women died due to the clotting, and several others suffered from strokes or heart attacks. The FDA’s response was, again, to simply add more lines to the warning label. The patch is still on sale to this day.

OxyContin: This opioid pain medication has been Purdue Pharma’s biggest seller since they put it on the market. While it contains the same essential painkilling ingredient (oxycodone) as other painkillers such as Percocet or Percodan, the amount in OxyContin is significantly larger. Initially meant to be for patients who were in chronic, severe pain, Purdue Pharma wrote in its marketing literature that the drug was “thought to be less addictive” than any other drug containing Oxycodone. The FDA allowed this ambiguous statement to go unchallenged, and as a result Purdue Pharma’s sales force used this conjecture as fact when marketing the drug. As a result, doctors began prescribing OxyContin for injuries that were much less severe. The end result was that OxyContin, which was just as powerful and just as addictive as heroin, became the new designer drug of choice for thousands of addicted Americans.

It is the FDA’s job to do more than simply add lines to warning labels on products that they know are detrimental to the health of those who take the drug. Sometime over the past ten years, the FDA has become more of a reactive government agency, biding their time and waiting for something bad to happen before they take any action. Sitting on reports and waiting is what got American consumers killed.

What is needed is reform. The Food and Drug Administration needs to do thorough investigations of every drug that gets submitted for approval, and these investigations need to be independent and completely removed from the influence of scientists and lobbyists. While the pharmaceutical industry wields enormous influence on Capital Hill, and while their products have added a great deal to the quality of our lives, this does not give them the right to circumvent the safeguards that are in place to protect us. The Food and Drug Administration should be reminded of this, and should make the necessary changes in its testing and approval procedures so there won’t be another Vioxx, OxyContin, or birth control patch.

Charles E. Boyk Law Offices, LLC