Bayer AG recently agreed to take Trasylol off the market after studies showed that it increased death rates in patients. The drug, which has been approved for use by the FDA since 1993, is used to reduce excessive bleeding before heart surgery.
The most recent study was conducted by the Ottawa Health Research Institute and involved 3000 bypass and valve surgery patients. The study was halted when it was determined that although patients receiving it bled less, they were half again as likely to die as those given different drugs.
This is not the first study to indicate problems with Trasylol. Previous studies determined that the drug increased the risk of kidney failure, heart attack and stroke. One study suggested that taking the drug off the market could prevent between 10,000 and 11,000 cases of kidney failure per year and save more than $1 billion on dialysis costs.
Bayer’s own studies have suggested problems with this drug, but the results were not provided to the FDA or to advisory panels examining the safety issue. Bayer’s representatives defended the drug, but did not mention the studies that should have caused concern. The company later stated that this was the result of regrettable human error.
In spite of this the FDA has been reluctant to take action. A panel convened last September decided that the drug could remain on the market. After the Canadian Study, the FDA suggested that Bayer withdraw the drug (notice the use of the term suggest not require, while German authorities demanded that the drug be withdrawn.
This is indicative of a serious problem in the way drugs are approved and monitored. First, drugs are often approved by the FDA not because they are proven to extend life, but rather because they have an effect on a biomarker, such as cholesterol, which may not result in any lasting benefit. Studies are often short-term, and approvals are granted without knowledge of the long-term effects of the drug.
Additionally, the FDA is constantly victimized by its own internal conflict of interest, which is why it is such an uphill battle to remove drugs from the market. In order for a dangerous drug to be taken off the market, the agency must admit that it was wrong, which is difficult for anyone or any group to do.
The obvious solution is to do two things change the drug approval process and split the FDA into two agencies one responsible for drug approvals, and the other one responsible for safety monitoring and having the authority to remove drugs from the market. I am confident that eventually this will take place, as there are more members of Congress that are starting to understand this issue, but in the meantime, medical consumers need to be aware that FDA approved does not mean safe or effective, and that everyone should be responsible for their own investigation as to which drugs and devices to use.