Maryland Injury and Disability Law : Washington DC Metro Injury & Disability Lawyer & Attorney : Greenberg & Bederman : Accidents, Falls, Medical Malpractice : Maryland, DC, Virginia

Another aspect of the CDER’s testing and safety process is that the same scientists, statisticians, doctors and pharmacologists who approve a drug as safe for consumption are the same ones who are in charge of handling safety concerns after the drug has been on the market. This has led to real problems in the past.

In 1999, the FDA approved a drug called Vioxx, which was developed and initially tested by Merck. Vioxx was marketed as a nonsteroidal anti-inflammatory drug (NSAID,) which was meant to provide non-narcotic pain relief for sufferers of arthritis. This pill was basically known as a “super-aspirin,” mainly because Merck claimed it was able to not only provide better pain relief than traditional over the counter analgesics, but was able to do so without causing upset stomachs, which is a common side effect of aspirin and acetaminophen.

The drug was a huge success, with an estimated 80 million people taking the drug worldwide. But almost immediately, there began to be some real problems. Within months, there were reports of people suffering severe heart attacks. However, the very nature of Vioxx actually provided Merck with some protection from FDA fallout. After all, Vioxx was a drug for the treatment of arthritis, and arthritis sufferers are generally elderly. The elderly are statistically more likely to have heart attacks than any other demographic. The fact that Vioxx was a common link with these victims was discounted by the FDA:

“There were 14 cardiovascular deaths, (nine and five in rofecoxib and naproxen groups,

respectively). Most of the cardiovascular deaths were in patients with known

cardiovascular risks.”

Obviously, Merck was not going to admit that there was anything wrong, considering that they had spent millions on both developing and marketing the drug, and they were making money hand over fist. And the problems and delays with the FDA were due to the fact that the people in charge of reviewing Vioxx complaints were the same people who approved the drug in the first place.

There were two things very wrong with this scenario. In the first place, if the same FDA workers who approved Vioxx came out publically and said that they were wrong to do so, that would essentially be admitting that they didn’t do their jobs properly. Secondly, aside from regular FDA workers reviewing the drug, it was also reviewed by what was called an “independent advisory board,” which wasn’t really “independent” at all.

In 2005, when it became clear that there was a severe problem with Vioxx that could no longer be ignored by the FDA, the advisory board met to discuss not only Vioxx, but also the similar NSAID drugs that were either on the market or were close to being put into production by all the other pharmaceutical companies. The advisory board voted to keep these drugs on the market, despite the estimated 27,000 deaths that had occurred since their introduction. A group called the Center for Science in the Public Interest looked into who was serving on this board, and found that of the 32 experts serving on the panel, 23 of them were either receiving consulting fees from the drug companies themselves or owned a considerable amount of stock in drug companies that were either marketing NSAID’s or were about to introduce one of their own.

So between rank and file FDA members who were hesitant to publically correct their own mistakes and outside advisory boards that were staffed with people who were practically pharmaceutical company employees, the environment for fast action on a dangerous drug did not exist.

To its credit, the FDA did in fact alter the rules of its advisory panels, so that in order to serve on one you couldn’t have a financial stake higher than $50,000. But the rules regarding in-house review of dangers at the FDA have not changed:

Agency officials have made some changes to drug oversight, according to a Government Accountability Office report, but the FDA continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market.

This was one of the two major factors in Vioxx being allowed to stay on the market for so long, and this worries us because right now a popular drug is posing a serious danger to the health of women who have been using it.

Bayer’s line of birth control pills, which are marketed under the names Yaz, Yasmin and Oscella, have been linked to thousands of hospitalizations all over the world, and more than a few deaths. The active ingredient in these pills is a synthetic variation of progestin called Drispirenone, which has been shown to raise the potassium levels of women who use it. Elevated potassium levels can raise the risk of deep vein thrombosis, which is the formation of blood clots in the legs. These clots can break apart and travel, which can and does cause strokes, heart attacks, and pulmonary embolisms.

Bayer has been arguing that these dangerous side effects are not out of the statistical norm, and that the victims are mostly women who smoke or were over the age of thirty. But we and other attorneys like us have read about enough cases of perfectly healthy women ending up hospitalized after taking these pills disagree with Bayer.

With FDA culture being what it is, it isn’t very surprising that the only real problems they have had with Bayer so far is over their advertising. The rest of it, the strokes, the heart attacks, the elevated levels of potassium, well…that’s still under review. Perhaps by the exact same people who approved this drug in the first place?

Greenberg and Bederman is a Washington, D.C. area law firm that is currently offering legal help for women who have been injured due to the use of Yaz, Yasmin or Oscella. If you or a loved one has been injured or hospitalized due to the use of these birth control pills, contact our yaz stroke lawyer, Andy Bederman, for a free yaz legal consultation.