Defective Pharmaceuticals Could cause Terrorism Risk
If the prospect of contaminated Heparin and injuries from Avandia were not disturbing enough, an eminent cardiologist has now warned of the danger of a biological threat if the FDA does not get its act together, and fast.
Dr. Steven Nissen, a prominent Cleveland Clinic cardiologist and medical researcher, was one of the first to bring the risk of Avandia injuries caused by Glaxo's anti-diabetes drug into the spotlight. This man has a reputation for being straight forward and honest and has never shied away from calling out pharmaceutical companies and the FDA for their negligence. He has also been named a possible contender for FDA chief. Big pharmaceutical companies have always been wary of his announcements and the FDA has frequently been the target of Dr. Nissen's criticism.
So, when Dr. Nissen raises concerns that terrorist organizations, like Al-Qaeda, could use the FDA's scant oversight of foreign pharmaceutical plants to mount a biological attack on the U.S., we are inclined to pay attention. Dr. Nissen insists that he is not trying to stir up paranoia. Recent instances of the FDA’s somnambular conduct of its drug safety processes, especially at foreign plants, do raise concerns that the facilities could be used by those who seek to harm Americans. China, for instance, is growing to be a significant source of drugs manufactured for Americans. Last year's heparin scandal was traced to batches of contaminated Heparin injections manufactured in China. The Heparin contamination, it is believed, came from adding a synthetic, cheaper compound in place of the original ingredient in a possible effort to cut costs. Since then, we have found that the FDA has not conducted a single inspection of the Chinese plant since it received approval several years ago. The FDA now has an inspection office in China to handle inspections of food and drug plants supplying the U.S. It seems like a reassuring first step, until you realize that the total staff strength at the Chinese FDA office is 8.
The FDA admitted that it has been unable to adapt to growing changes brought about by globalization. In a scenario where a growing number of drugs are sourced from Chinese plants, there may be reason to worry about whether a lack of FDA inspections, combined with poor regulatory standards in China could lead to the first major biological terrorist attack on the U.S. Of course, the chances of terrorists infiltrating a Chinese pharmaceutical plant and contaminating drugs meant for American consumers may seem far fetched now, but we never imagined that a group of zealots would drive aircrafts into the heart of New York City either.
Medical Injury Lawyers
The FDA's poor oversight of drug makers and poor regulatory practices, combined with pharmaceutical companies' negligence, have time and again placed American consumers at risk of tainted or defective pharmaceutical drugs. If you have been injured as a result of using a dangerous drug or defective medical device, you will need the help of a medical injury lawyer to recover the compensation you deserve.
To get the help you need contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.
