In 1988, the AIDS activist group ACT UP staged a protest that led to a dramatic change in the US Food and Drug Adminstration (FDA) drug approval process. Previously, the drug approval process was slow, bureaucratic and unresponsive to patients who were desperately ill and might not live to see a drug approved. By 1995, the process became streamlined and dying patients with no other options were given early access to promising medications. Drugs that were granted “priority review” status saw the approval times drop from just under three years to as little as six months.
This makes perfects sense for terminal patients and for catastrophic diseases such as AIDS and cancer, however this streamlining process has allowed drugs to be approved before proper testing has been completed. Vioxx, which may have caused up to 100,000 heart attack and stroke related deaths, is a direct result of prioritizing speed over safety. And, studies have shown that drug makers are spending almost twice as much on marketing a drug than they are on research and development.
A dangerous by-product of this streamlined approval process is weaker standards. The arguments made for fatal diseases such as AIDS and cancer were then extrapolated to other less serious conditions. In 1999, Vioxx was approved under these diluted standards and only after millions of people have taken it was research made public showing that high doses of Vioxx increased the risk of heart attack by a factor of 5 compared to a similar painkiller, naproxen (Aleve).
So, what can you do to protect yourself? Be an informed consumer and research any drugs you are taking for any potential safety risks. Some drugs, like Darvon and Darvocet have been found to be no more effective than aspirin, and they may cause heart damage.
1. Oxycodone Prescription opiod painkiller 5548 deaths 1998 – 2005
2. Fentanyl Prescription opiod painkiller 3545 deaths 1998 – 2005
3. Clozapine Anitpsychotic 3277 deaths 1998 – 2005
4. Morphine Prescription opiod painkiller 1616 deaths 1998 – 2005
5. Acetaminophen Over-the-counter painkiller 1393 deaths 1998 – 2005
6. Methadone Prescription opiod painkiller 1258 deaths 1998 – 2005
7. Infliximab Immune-system modulating drug 1228 deaths 1998 – 2005
8. Interferon beta Immune-system modulating drug 1178 deaths 1998 – 2005
9. Risperidone Antipsychotic 1093 deaths 1998 – 2005
10. Etanercept Immune-system modulating drug 1034 deaths 1998 – 2005