The FDA Does Its’ Best

In order to make sure that  harmful products do not go the people, organizations such as the FDA-also known as the Food and Drug Administration-place very rigid requirements. However, regulatory associations such as the FDA are simply not enough to keep the influence of drug companies away from scientific studies.

Petter Hutt’s paper, “Untangling the Vioxx-Celebrex Controversy: A Story about Responsibility.” on the controversy describes the exact context on how the FDA approves a drug.  The FDA first requires what is known as an NDA or new drug application. The new drug then undergoes the Investigation New Drug, or IND, and three Phases. The IND test to see if the production and analyzation had, “protection of the human research project, animal studies completed and analyzed, scientific merit, and qualifications of the investigator.” From the IND, the drug then undergoes Phase I, II, and III. Phase I tests the drug on one subject to check for adverse side effects, which moves on to phase II if successful. Phase II administers the drug multiple times on a small group,, which will move on to phase III. In this phase the drug is given to thousands of patients with many different methodologies in order to check for drug interactions/reactions. It is estimated that this entire process takes around 7 to 13 years before the application is finished. After the application is submitted, the FDA then makes a committee to push the new drug and either authorize the drug or stop the process there.

This very methodical authorization system should be able to handle drug after numerous checks. However,the unreliability of the FDA is completely exposed with the Vioxx controversy. DrugWatch, in the web article “Vioxx Recall – Merck and FDA,” discusses the painkiller Vioxx and how it was spread to many different doctors with the primary goal of giving the drug to as many patients as possible. However, in only 5 years ,this seemingly harmless drug was found to more the double the risk of heart attacks and death. Eventually, in 2004 Merck recalled Vioxx after being put in the spotlight for their drug. DrugWatch described the havoc Vioxx  caused, with over 38,000 deaths, as potentially, “ the worst drug disaster in history”

The drug went through the entire rigid appeal process of the FDA and was approved in 1999. Not once did the FDA stop the drug until the symptoms the heart issues started to appear and an anylazation was made. But by the time the FDA caught on, Vioxx already damaged thousands of lives. The reason why this disaster even occurred was due manipulating data. In order for the Merck scientists to show that the drug was safe enough for use, they omitted the detrimental data pertaining to patients with heart complications or else the drug couldn’t have been released.  In fact Hutt stated that, “the General Accounting Office found that of 198 drugs approved by the FDA between 1976-1985, about half had serious post-approval problems.”

Not only that, but this controversy also shed light on corruption of the FDA. It was noted that Merck persuaded the FDA to remove warning labels for digestive issue with Vioxx even before the drug was approved. The FDA also ignored the doctors claims of patients’ hearts problem until in 2002 a study that showed the relationship between heart complications and Vioxx. When that integral piece of information came out, all the FDA did was simply add a label.

The FDA had numerous times to prevent a disaster from happening and the organization was built to do just that. However, the bias that Merck was push forward to push their product slipped through, which means shows even the FDA struggles to mitigate the effect of bias in scientific studies.

Works Cited:

Hutt, Peter Barton. “Untangling the Vioxx-Celebrex Controversy: A Story about Responsibility.”Tran, Lan. N.p., 4 May 2005. Web. 18 Nov. 2016.

“Vioxx Recall – Merck and FDA.” DrugWatch. N.p., n.d. Web. 18 Nov. 2016.