case assignment from previous assignment

Part A: Overview of the situation
Merck’s Vioxx crisis and ethical issues
Merck had a reputation of being one of the most reliable and trustworthy firms till 2005.
The company earned much respect not only because of its business strategy but also
for its socially responsible activities. It had demonstrated its competence both in terms
of its operations as well as personnel. Merck had more patented compounds than its
competitors and its personnel had many more scientific papers than other
pharmaceutical companies. In the period spanning from 1995 to 2001, Merck was able
to convert all its 13 submissions into approvals by FDA. And the average review time for
these was just eleven months.
The company‟s blockbuster drug, Vioxx, was able to get an approval within bare six
months. This was an achievement for a company and they could boast of their
compelling research and documentation skills. But there is plethora of information that
shows the other side of the picture. The company claimed Vioxx to be a safe and better
option as a painkiller as compared to other over-the -counter drugs of same category.
It cannot be said Merck was completely off the track on the path of ethics. It did not
come out with misleading interpretations of Vioxx-naproxen study results. They were as
“valid” as any other. When the company realized the naproxen-Vioxx cardiovascular
issue, it started a study called APPROVe to check if Vioxx will lead to a reduction of
colon polyps. If this could be proved, it would give doctors another reason to prescribe
Vioxx. APPROVe compared Vioxx with a placebo instead of another drug and thus was
a truly controlled trial which could provide a more definitive test of whether Vioxx
increased blood vessel risk.
Beyond this, there were some major areas of lax when which is why the safety of the
drug was put to question.
Drug Development and testing
Merck was committed to ongoing clinical research and development and its commitment
was well indicated by $3 billion the company invested in this area. The Food and Drug
Administration (FDA) in US is the authority responsible for keeping a check on
development and testing of drugs. Only after its approval can a drug hit the market. In
1999, the FDA approved Vioxx in record time, which was much less than what it takes
to get an average drug approved.
During the development process, the scientists at Merck were worried about its safety
and efficacy. The proof of this concern is documented in company‟s internal e-mails.
This e-mail was reported in The Wall Street Journal in 1997, and it clearly stated that
there is a possibility of cardiovascular events with the use of the drug which is a cause
of major concern. The question is why was this concern ignored and the drug was put
on the market?
Marketing and advertising
Merck spent a considerable amount in marketing of the drug. The sales representatives
of the company were, on behalf of the company, distributing free samples, offering gifts
in the form of free meals or events sponsorships to develop a good rapport with the
doctors. Merck had spent $ 500 million on advertisement of Vioxx, of which $422 million
were spent advertising to doctors and hospitals alone. Merck‟s sales force did not
clearly resolve doubts raised by doctors about the cardiovascular effects of Vioxx. This
“trained” response was an unethical act on the part of the company.
Relationship with government regulators and policy makers
FDA has its own process of assessment and subsequent approval of the drug submitted
by companies. In case of Vioxx, approval in a span of six months could be taken
negatively on the part of FDA. It should have been more vigilant when it came to drug
approval process. There is some evidence suggesting...