The FDA is in a very delicate position. On one hand, critics are saying that the FDA is taking too long to release new, potentially life-saving drugs to the public, and critics on the other side are arguing that the FDA is pushing drugs through too quickly, resulting in unnecessary deaths from medications that have yet to be tested properly. Even though the FDA says that the amount of drugs being taken off the market has remained steady over the years, a balance between these two positions is almost impossible to obtain and the FDA will never be able to solve this dilemma. The fact is, this is not a problem they can solve. The health care industry in our country is in shambles and nothing short of a complete overhaul will effect positive change. (Meadows)
Groups such as The Abigail Alliance are pushing to get new drugs approved much faster with the hopes that these experimental drugs may hold the key to curing many different illnesses. The FDA however, is hesitant to allow such speedy approval. With the recent court case involving patient deaths caused by the drug Vioxx, and the fact that the number of warnings placed on drug labels has increased dramatically over the last couple years, it is easy to see why the FDA would want to slow the approval of the drugs to better test their safety and effectiveness. (Leaf)
Some individuals, including Don Berry who is the head of biostatistics at M.D. Anderson Cancer Center in Houston, have recommended a new way of analyzing the effectiveness and safety of drugs. The technique, known as Bayesian analysis, allows the testing of drugs to take a more humanistic approach; instead of the standard technique of testing, which locks the researchers into the hypothesis made at the beginning of the study, Bayesian analysis allows for flexibility depending on the patients reactions to the drug. According to some, this process of testing the drug, if implemented, would speed up the approval process and disallow many dangerous drugs to ever reach the hands of consumers. (Leaf)
There are others who feel that we need to understand that some people are going to react negatively to a drug, and when they do, the consequences of taking the drug off the market may be worse than keeping it on; one need look no further than the vaccine RotaShield to see how this could be so.(Leaf)
When children were given RotaShield, they became vaccinated from the rotavirus-a virus that could cause life threatening diarrhea. However, once more than a million children had received the vaccine, they noticed some of those children would develop another condition and decided to pull it off the shelf. Eventually other pharmaceutical companies developed a new, safer form of the vaccine. But critics argue, what was the cost of completely pulling RotaShield off the market? How many more children came down with the rotavirus than needed to? (Leaf)
According to a Washington Post article, the amount of money spent on healthcare in this country is about $5,540 a year for year person in the United States. That is 15 percent of the nation’s income, more than any other advanced country. It is a profitable business for the pharmaceutical industries. And to make highest profit, they assume a shotgun strategy to healthcare; make as many types of drugs as possible and one of them is bound to be profitable. This is one of the reasons the FDA is having a hard time keeping up with and being able to accurately identify which drugs are useful and which harmful. Nationalization of the healthcare industry would take profit out of medicine and lead to better healthcare for everyone. (Broder)
Broder, David S. “Our Broken Healthcare System.” Washington Post 15 July 2004. 09 Apr 2006 <http://www.washingtonpost.com/wp-dyn/articles/A50500-2004Jul14.html>.
Leaf, Clifton. “Deadly Caution: How our national obsession with drug safety is killing people-and what we can do about it..” Fortune Magazine 9 Feb 2006. 09 Apr 2006 <http://money.cnn.com/magazines/fortune/fortune_archive/2006/02/20/8369155/index.htm>.
Meadows, Michelle. “Why Drugs Get Pulled off the Market.” FDA Consumer Magazine. Jan-Feb 2002. FDA. 09 Apr. 2006 <http://www.fda.gov/fdac/features/2002/102_drug.html>.