Unit #1 – Ethics
1) Introduction of Vioxx
a) Introduction in 1999
b) Withdrawal of the drug in 2004 due to heart attacks c) Merck’s knowledge of the effects of Vioxx and unethical decision to continue to sell the drug 2) Vigor Study
d) Vioxx lessened stomach bleeding
e) Results also showed higher risk of heart attacks
f) Merck blamed naproxen for skewing the results against Vioxx 3) New England Journal of Medicine Omission
g) Merck omits three heart attacks from article submission h) Inclusion of omitted data caused a significantly greater result 4) FDA Reaction
i) Letter regarding downplay of risks
j) Addition of warning label to Vioxx
k) Additional study results
5) Approve Study
l) Results with placebo group cause Merck to recall drug 6) Trials
m) Challenge of showing causation
n) 18 month defense
7) Settlement
o) $4.85 Billion Settlement
p) Admission of guilt
8) Merck’s Choices
q) Merck made choices that showed clear wrongdoing
Introduction of Vioxx
In May of 1999, the FDA approved the use of rofecoxib. Marketed under the name of Vioxx, rofecoxib was manufactured and distributed by Merck, a large pharmaceutical company. Doctors prescribed the drug as a non-steroidal anti-inflammatory and prescription painkiller. Five years after its release, rofecoxib was withdrawn because of a study that showed the drug more than doubled the risk of heart attack or stroke. Because of Merck’s ongoing and increasing knowledge of the dangerous effects of the drug while continuing to distribute rofecoxib, Merck should be held accountable for acting unethically. Vigor Study
The Essay on Drug Study Clinton Tuskegee
As President Bill Clinton said in his Apology Speech for the Study done in Tuskegee, It was a time when our nation failed to live up to its ideals, when our nation broke the trust with our people that is the very foundation of our democracy. And the third reason I believe it affected our society, is that of course, we have to live with the shame of having harmed in some ways a culture of our own. ...
Less than a year after the drug’s release, a study named Vigor was completed. The study’s intent was to compare Vioxx and naproxen and the drugs’ effects on the gastrointestinal system. Results from the study showed Vioxx lessened internal bleeding but the study also found a higher incidence of heart attacks. Rather than focus on the negative effects identified during the Vigor study, Merck claimed the higher incidence of heart attacks was due to naproxen’s heart protective benefits. New England Journal of Medicine Omission
When Merck submitted the results to the New England Journal of Medicine in November, 2000, their data omitted three out of twenty heart attacks even though Merck had notified the FDA about them the month prior. When cardiologists reanalyzed the data in 2001 with the complete data available on the FDA website, the results became increasingly significant with the addition of the 3 heart attacks. FDA Reaction
In 2001, the FDA wrote a warning letter to Merck stating the company was not disclosing potential heart problems that could be caused by Vioxx. In response, Merck added a warning label in April, 2002 regarding possible heart risks. Along with the Vigor study results, other studies were finding links between Vioxx and heart attacks. A report in the Archives of Internal Medicine stated studies as of 2001 indicated Vioxx increased the risk of heart problems by 35%. Merck continued to sell Vioxx. Approve Study
In early 2000, Merck had started a study named Approve that examined Vioxx and a possible effect in reducing colon polyps. It was the results from this study that prompted Merck to withdraw the drug. Because the study involved a group taking placebo medication, Merck couldn’t avoid the connection between Vioxx and cardiovascular events. Trials
As lawsuits developed, Merck chose to take the claims to court, rather than settle. Plaintiffs had a difficult challenge in proving that Vioxx was the main cause of heart attacks, rather than other contributing factors. In 2005, Merck defended its position stating Vioxx was only a danger if taken for more than 18 months. This claim was based on the results of the Approve study and was a key component of Merck’s defense, as many of the plaintiffs had taken Vioxx for less than 18 months. The following year, Merck reported their original finding was incorrect and admitted to an error in analyzing the results. Settlement and Admission of Guilt
The Research paper on Merck Case Study
Merck was established in 1891 to improve human and animal health through the development of innovative products. Merck currently has two reportable segments, the Pharmaceutical Segment and the Vaccines and Infectious Diseases Segment. Merck sells products through several channels including wholesalers, retailers, hospitals, clinics, government and managed health services providers. In the 1980’s ...
Despite winning 11 of 16 cases that had gone to trial, Merck offered a settlement in 2007 to close out a large number of cases. Part of the settlement included a provision that Merck’s payout would have a limit of $4.85 billion. In 2011, Merck pled guilty to a misdemeanor charge for promoting usage of Vioxx for rheumatoid arthritis prior to FDA approval. The punishment included $950 million in fines and settlements. Merck’s Choices
With the Vigor study, Merck made the choice to blame the positive effects of the comparison drug, naproxen. When the results were published, Merck omitted data that showed the danger of Vioxx. As more and more studies continued to find links between Vioxx and heart attacks, Merck waited until they couldn’t argue with results and had to withdraw Vioxx. It is these choices that Merck made over five years that show Merck had an intention of wrongdoing.
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[ 1 ]. The Associated Press, Timeline of Events Surrounding Vioxx and Other Painkillers, http://www.nytimes.com/2005/11/03/business/vioxx-timeline.html (November 2005).
[ 2 ]. Snigdha Prakash, Conflicted Safety Panel Let Vioxx Study Continue, http://www.npr.org/templates/story/story.php?storyId=5462419 (June 2006) [ 3 ]. Snigdha Prakash and Vikki Valentine, Timeline: The Rise and Fall of Vioxx, http://www.npr.org/templates/story/story.php?storyId=5470430 (November 2007).
[ 4 ]. Jonathan D. Rockhoff, Analysis Finds Vioxx’s Heart Attack Risk in 2001, http://online.wsj.com/article/SB10001424052748704779704574554071807123380.html (November 2009).
[ 5 ]. Aaron Smith, Merck’s Fight Looks Tougher in NJ, http://money.cnn.com/2006/02/27/news/companies/vioxx/index.htm (February
