AShatzer BizLaw Assignment 1
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Washington State University *
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Course
210
Subject
Medicine
Date
Dec 6, 2023
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Pages
5
Uploaded by MegaValorMongoose21
Amber Shatzer
B_Law-210
8/27/2023
Ethics Concerning Merck & Co.’s
Involvement with Vioxx
Health Risks Hidden from The Public
1.
Overview of The Medication Vioxx and The Health Risks Involved with Taking the Medication
2.
Lawsuit Brought Against Merck & Co. for Hiding Potential Risks
2.1
When Health Risks Became Known to Merck & Co.
2.2
Trial for Adenomatous Polyp Prevention on Vioxx
2.3
Vioxx Approval By the FDA
2.4
Removal of Vioxx from the Market
2.5
New England Journal of Medicine (NEJM) Announces Dissatisfaction
2.6
Merck & Co. Settles Lawsuit Concerning Vioxx
3.
Conclusion
1. Overview of the Medication Vioxx and the Hidden Risks That Come with Taking It
The Food and Drug Administration (FDA) is the organization tasked with protecting the
American public by providing safety standards that companies must adhere to when providing
products such as medications, medical devices, food, and cosmetics. In 1999, the company
Merck & Co. introduced the drug Vioxx as a better pain relief medication for acute arthritis than
its competitor Celebrex. Vioxx fell into a new class of drugs known as Nonsteroidal Anit-
Inflammatory, or NSAIDs, and was only the second of its kind on the market. Merck presented
the drug as having fewer gastrointestinal side effects than pain medications like ibuprofen but
failed to mention the risks associated with heart attacks and strokes. In testimony given against
Merck & Co., experts said that the drugmaker knew about the potential for cardiovascular issues
involving Vioxx as early as 1999, 5 years before pulling the drug off the market.
2. Lawsuits Brought Against Merck & Co. for Hiding Potential Risks
2.1 When Health Risks Became Known to Merck & Co.
With the successful release of Vioxx, attention was brought to Merck & Co. about the potential
benefits the drug could bring in eliminating polyps in the colon and potentially preventing colon
cancer. Merck’s decision to test the hypothesis did not grant them the results they were looking
for. Merck & Co. had hoped that the study would conclude that three years of using Vioxx would
reduce the risks of adenomatous polyps in patients who had a history of colorectal adenomas. In
the clinical trial called Adenomatous Polyp Prevention on Vioxx (APPROVe), it became apparent
to Merck that the risk for heart attacks and strokes increased when Vioxx was taken for longer
than an 18-month period. The study conducted in 2004 ultimately led to the withdrawal of Vioxx
from the market.
2.2 Trial for Adenomatous Polyp Prevention on Vioxx
In a randomized study conducted by Merck & Co., 2,587 patients were given a sugar-based
placebo or Vioxx to study the effects the drug had on polyps found in the large bowel. The trial
was overseen in 108 centers worldwide between 2000 and 2001. It spanned three years and
uncovered the possibility of cardiovascular occurrences revolving around heart attacks and
strokes. Although the study did show a reduction in the risk of colorectal polyps, it was
terminated early due to the findings related to heart issues.
2.3 Vioxx Approval by the FDA
While the FDA approved Vioxx for public use in 1999, the tests proving the drug to have
positive effects were not thoroughly administered. Trials of the drug did not anticipate that
cardiovascular issues could occur with the use of Vioxx. Although the FDA has the right to force
trials to be conducted, it was never done. In October of 2000, Merck & Co. informed the FDA
that patients did have heart attacks in conjunction with the use of Vioxx. The FDA did not
publish findings on its website until February of 2001 and the drug was not taken off the market
until September of 2004.
2.4 Removal of Vioxx from the Market
After the APPROVe trial revealed the negative side effects of Vioxx leading to heart attacks and
strokes, Merck & Co. voluntarily removed Vioxx from the marketplace. Upwards of 20 million
Americans had taken the drug prior to its withdrawal with 88,00 having heart attacks and 38,000
dying. Merck’s misleading information about Vioxx appearing to be risky in comparison to other
drugs led to lawsuits by shareholders and users.
2.5 New England Journal of Medicine (NEJM) Announces Dissatisfaction
In May of 2000, Merck & Co. submitted the findings of the trials conducted by VIGOR to the
New England Journal of Medicine so they could be published. The information provided failed
to mention three of the twenty heart attacks found to be caused by Vioxx. When the information
was published in November of 2000, it did not include data pertaining to other kinds of cardiac
issues besides heart attacks. In July 2005 the NEJM expressed to the National Public Radio that
they felt deceived by Merck and VIGOR because of the details left out of the materials provided
to them.
2.6 Merck & Co. Settles Lawsuit Concerning Vioxx
Lawsuits brought against Merck & Co. not only by those affected by Vioxx but also by
shareholders began forming in 2005. Shareholders believed Merck misled and influenced them
to make decisions they would not have made had they been given all the information found in
the trials on Vioxx. To regain losses incurred by shareholders in the removal of Vioxx from the
market, a class action lawsuit was formed against Merck. This lawsuit ended with an $830
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million dollar settlement in the shareholder's favor. Although Merck & Co. refuses to admit any
wrongdoing, in 2013, they settled lawsuits brought against them in about 60,000 personal injury
trials with a payout of $4.85 billion.
3. Conclusion
While the FDA is responsible for providing safety measures to consumers, it is the moral and
ethical obligation of organizations providing goods and services to American citizens to supply
clear and accurate information on what they produce. In the case of Merck & Co.’s distribution
of Vioxx, both the organization and the FDA failed our community. While their intent to provide
positive information using trials existed, they failed to include damaging details pertaining to the
risk of heart attacks and strokes when Vioxx was used for longer than 18 months. Through the
deliberate exclusion of key details, Merck & Co. inadvertently caused the deaths of
approximately 38,000 citizens. The elimination of prudent facts also caused shareholders to
invest in a dangerous product which caused disastrous financial losses. Although Merck & Co.
denies any wrongdoing, the omission of information grossly altered the actions of shareholders
and users alike, which caused death and financial destruction in historically profound ways.
Bibliography
Internet Sources
National Library of Medicine, What have we learnt from Vioxx? (Harlan M Krummholz 2007),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1779871/
Union of Concerned Scientists, Merck Manipulated the Science about the Drug Vioxx (2017),
https://www.ucsusa.org/resources/merck-manipulated-science-about-drug-
vioxx#:~:text=In%20fact%2C%20Vioxx%20has%20since,of%20ghostwriting%20of%20scientif
ic%20articles.
Drugwatch, Vioxx (Kristin Compton 2022), https://www.drugwatch.com/vioxx/
Drugwatch, Vioxx Lawsuits (Kristin Compton 2022,
https://www.drugwatch.com/vioxx/lawsuits/#:~:text=The%20company%20finally%20decided%
20to,for%2018%20months%20or%20longer.
The New England Journal of Medicine, Failing the Public Health – Rofecoxib, Merck, and the
FDA (Eric J Topol M.D. 2004),
https://www.nejm.org/doi/full/10.1056/nejmp048286#:~:text=On%20May%2021%2C%201999
%2C%20Merck,to%20market%20rofecoxib%20(Vioxx).
NPR, Vioxx: The Downfall of a Drug (Snigdha Prakash, Vikki Valentine 2007),
https://www.npr.org/2007/11/10/5470430/timeline-the-rise-and-fall-of-
vioxx#:~:text=May%202006%3A%20Outside%20analysis%20of,patients%20started%20taking
%20the%20drug.