Merck, the FDA, and Vioxx
Summary of Facts –
* Merck gave patent of streptomycin to a university foundation.
* Merck’s core values are said to be: medicine is for the people and not for profits.
* In 2000, Merck spent $3 billion annually on research.
* September 30th, 2004, Merck recalled Vioxx as it doubled the risk of heart attack and stroke for users.
* The recall decision was expected to cost Merck $2.5 billion in revenues as it was their second largest selling drug.
* Vioxx was the fastest selling drug in Merck’s product portfolio.
* Merck disagreed with all the reports until their own internal study (APPROVe) suggested cardiovascular risks ...view middle of the document...
Patients on high dosage of Vioxx, had three times the rate of heart attacks than those patients on Celebrex. This lead to Merck discounting this finding saying the studies were less reliable than double blind clinical studies.
Responses to questions –
1. Do you believe Merck acted in a socially responsible and ethical manner with regard to Vioxx? Address the company’s drug development and testing, marketing, advertising, relationships with government and policymakers, and handling of the recall.
In regards to whether Merck acted in a socially responsible or ethical manner is difficult to determine without covering every bit of information presented. A case could be made that the Prescription Drug Free User Act (PDUFA) could have led to an increase in prescription drugs being looked at with less scrutiny. As shown, after Congress granted the Food and Drug Administration the authority to begin charging a mandatory “user fee” in order to review new proposed medicines; this allowed the FDA to shorten the approval time for new drugs from 27 months in 1993 to 14 months in 2001, nearly cutting the time in half. Was it socially responsible or ethical to grant to FDA the authority to begin collecting mandatory revenue for new medicines? An argument has and could be made to the contrary as stated in an article published in the Journal of the American Medical Association (JAMA) in December of 2004 stated, “It is unreasonable to expect that the same agency that was responsible for the approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong (i.e., that the decision to approve the product was subsequently shown to be incorrect)”. During the development process, there is evidence to suggest that Merck was aware of the risks involved relating to cardiac episodes in patients. With the VIGOR test conducted internally to compare the risks of cardiac episodes in patients taking Vioxx and others taking Aleve, the results showed a clear 7.3 per thousand person-years in Vioxx to 1.7 per thousand person-years. After the evidence of the VIGOR test, Merck conducted a similar test dubbed APPROVe in which enrolled patients were studied to determine the likelihood of patients suffering from a heart attack or stroke while on Vioxx as opposed to taking a placebo. After 18 months of study, it was shown that patients taking Vioxx we twice as likely to suffer from a heart attack or stroke as opposed to those taking the placebo. What is most alarming is that both of these studies were conducted after Vioxx was released to the general public.
Speculation can be made as to the intended purpose of pharmaceutical companies establishing stealth PAC’s in order to make anonymous political donations. Given that Merck spent $40.7 million on lobbying between 1998 and 2004 is interesting to note, however, Merck ultimately made the decision to recall Vioxx in 2004 after extensive studies and research determining...