Merck the Fda and Vioxx

Due: 8/4/14

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 if Vioxx was used for more than 18 months.

* Merck tried to demonstrate that Vioxx helps patients with colon polyps.

* Results unexpectedly show an 84% increase in relative risk of cardiovascular events from taking Vioxx.

* FDA claims its original data on Vioxx displayed on increased risk of heart problems.

* Vioxx received a six month priority review due to its fewer gastrointestinal side effects.

* Complaints of Vioxx’s quick approval and lack of adequate action after various studies.

* Earnings have been in decline since 2001.

* In 2003, Merck saw one of its worst financial years. Net income decreased for the second straight year with a decline of 4.5%.

Problem identification and evidence of the problem –

In early development of Vioxx, cardio vascular risks were a worry, and this was not fully addressed like it should have been. Merck financed a research to compare Naproxen and Vioxx which resulted in finding that people taking Vioxx had nearly five times as many heart attacks than Naproxen users. Merck said that these findings were due to the heart protective effect on Naproxen instead of any defect on Vioxx. Merck then considered reformulating Vioxx but never actually did. Patients on high dosage of Vioxx, had three times the rate of...