Merck Company-Vioxx

MERCK
COMPANY- VIOXX
MADE BY- MAYANK SINGHLA (ERP-O221MBA010)
SABREEN KAUR (ERP-0221MBA011)
VANSHIKA MAHESHVARI (0221MBA036)
GARIMA NAUTIYAL (ERP-0221MBA026)
AMISHA CHAURASIYA (ERP-0221MBA058)
MERCK INRODUCTION
 Merck & Co., Inc. is an American multinational pharmaceutical company headquartered

in Rahway, New Jersey, and is named for Merck Group, founded in Germany in 1668, of
whom it was once the American arm.
 The company does business as Merck Sharp & Dohme or MSD outside the United
States and Canada.
 It is one of the largest pharmaceutical companies in the world, generally ranking in the
global top five by revenue.Merck develops and produces medicines, vaccines, biologic
therapies and animal health products.
 It has multiple blockbuster drugs or products each with 2020 revenues including cancer
immunotherapy, anti-diabetic medication and vaccines against HPV and chickenpox.
MERCK HISTORY
 Merck & Co. founded- Merck & Co. was founded in the U.S. on January 1, 1891. George Merck, age 23, established the
company to distribute fine chemicals throughout New York City and the neighbouring areas. Merck & Co. traces its origins to
its former German parent company Merck Group, which was established by the Merck family in 1668 when
Friedrich Jacob Merck purchased a drug store in Darmstadt. In 1827, Merck Group evolved from a pharmacy to a
drug manufacturer company with the commercial manufacture of morphine.] Merck perfected the chemical process of
deriving morphine from opium and later introduced cocaine, used to treat sinus problems and to add to beverages to
boost energy levels.[28]
 In 1887 a German-born, long-time Merck employee, Theodore Weicker, went to the United States to represent Merck
Group.
 The Angel Pharmacy in Darmstadt, the beginning of the Merck Group

VIOXX
• In 1999, Merck and company Created vioxx , a drug used as a painkiller for conditions such as osteoarthritis.
However, before its initial release to the market,Merck conducted a series of common evaluations to ensure that
this drug was safe for use.
• In 1998 study 090, an internal trial conducted on 978 patients, showed that Vioxx users had an increased chance
of developing cardiovascular problems such as a heart attack or a stroke. When provided with this information,
Merck deemed that the findings of the study were insignificant because the sample size tested was too small.
• In 1999, the company received approval from the Food and Drug Administration (FDA) to release the drug on
the market. However, Based on research conducted, the most common side effects of Vioxx were high blood
pressure, nausea, diarrhea and respiratory infections such as sore throat, sneezing, cough and so on. Vioxx was
so profitable that Merck received approximately $661million in sales in the first quarter of 2004 as it was sold in
both international and domestic markets.
VIGOR STUDY
As a part of their research and development, in 1999 Merck conducted Vioxx Gastro intestinal
Outcomes Research Study (VIGOR), on whether or not Vioxx caused less damage to the stomach
than naproxen. Naproxen is an anti-inflammatory drug targeting the same problem as Vioxx
(Durbin,2021). The study, which included 8,000 patients, discovered that naproxen caused
gastrointestinal side effects such as diarrhea, heartburn, and abdominal pain. It also revealed that
while Vioxx caused fewer upper-respiratory problems than naproxen, it increased the risk of a heart
attack by five times. Despite these findings, Merck’s executives continued to promote Vioxx in 2000
and 2001, believing that the increase in heart attacks was due to naproxen's capability to protect the
heart rather than any flaws in Vioxx. These findings were published in the New England Journal of
Medicine in 2000, and in 2001 Merck was warned by the FDA for falsely advertising the safety of
Vioxx through dismissing the cardiovascular risks associated with its use.
LAWSUITS AGAINST VIOXX
 The first VIOXX lawsuit, was a wrongful death case heard in a Texas
courtroom. The jury decided by 10-2 vote on August 19, 2005, that
Merck was liable and awarded $253.4 million to the widow of Robert
Ernst.
 Under Texas law the amount is expected to be reduced to $26.1
million.
 Merck eventually settled the lawsuits out of court for $4.85 billion.
 The legal defense for Merck cost them $1.2billion.
LAWSUITS AGAINST VIOXX
 This agreement settled 27,000 lawsuits for 47,000 plaintiffs.
 The plaintiff's attorneys will receive almost $2billion in fees.
 The average plaintiff will receive just over $100,000 before fees and
expenses, which usually run between 30-50%.
 Merck has also had to settle with unions and insurers for $80 million.
 Shareholders of Merck filed suit against the officers of Merck on
behalf of the company and came to an agreement that the officers
would pay $12.5 million in legal fees.
Ethical issues of Merck
 It is, in fact, the question of trust, mistrust, information, and misinformation which is the central
theme of the ethical analysis of this affair. Thus, it is of interest to attempt to delineate any
difference of individual moral agency in the medical versus the business milieu.
 Disclosure of information- Early suspicion of cardiovascular risk- Since the early development of
rofecoxib, some scientists at Merck were concerned that the drug might adversely affect the
cardiovascular system by altering the ratio of prostacyclin to thromboxane, which act in
opposition, balancing blood flow and clotting
 Honesty- The company suffered a major blow last November when Gilmartin called a halt to
clinical trials involving four of the company’s most high-profile new drugs, damaging the
company’s credibility on Wall Street, followed by a 7 percent cut in the company’s workforce,
which damaged morale.
 New research suggesting a correlation between high doses of Vioxx and increased risk of heart
attack was first presented at a medical conference in August, and an Food & Drug Administration
study led one of the agency’s lead scientists to recommend still stronger warnings on the label.
Merck, meanwhile, was conducting its own clinical trial intended to determine whether Vioxx
could prevent a recurrence of precancerous growths in the colon. Instead, the trial showed that
people taking a low dose of Vioxx (25 milligrams), for more than 18 months were twice as likely
to have a heart attack or stroke as patients taking a placebo.
• Merck disagreed with the various medical studies that indicated cardiovascular risks until its own
internal study indicated the risk. Finally, in September 2004, Vioxx was recalled from the market.
• Another way we believe the FDA can improve the process of approving drugs for the market
would be to have a similar set up as financial statement auditing. We believe all test conducted
on the drugs should be performed by an independent firm; we do not think that companies who
are introducing the drug should have the final say on the test results of their drugs. By bringing
in an independent firm to conduct the testing of the drugs, a more credible non-biased opinion
would then result.
27/04/2023
The Lessons of Vioxx — Drug
Safety and Sales
In October UK patients who had cardiovascular events while taking rofecoxib lost the
right to fight Merck in the US for compensation. But researchers and journals can still
benefit from this case if they learn from the mistakes, write Harlan Krumholz and
colleagues
Rofecoxib (Vioxx) was introduced by Merck in 1999 as an effective, safer alternative
to non-steroidal anti-inflammatory drugs for the treatment of pain associated with
osteoarthritis. It was subsequently found to increase the risk of cardiovascular disease
and withdrawn from the worldwide market. Merck now faces legal claims from
nearly 30 000 people who had cardiovascular events while taking the drug. 1 The
company has stated that it will fight each case, denying liability. 2 Our recent
participation in litigation at the request of plaintiffs provided a unique opportunity to
thoroughly examine and reflect on much of the accumulated court documents,
research, and other evidence. This story offers important lessons about how best to
promote constructive collaboration between academic medicine and industry
27/04/2023
This finding of a significant increase in the risk of myocardial infarction was an early
signal of a potentially serious safety problem with rofecoxib. Nonetheless, sales remained
robust. By the time of rofecoxib's withdrawal from the market in September 2004, after a
placebo-controlled study confirmed its cardiovascular risk, more than 100 million
prescriptions had been filled in the United States. 1Tens of millions of these prescriptions
were written for persons who had a low or very low risk of gastrointestinal problems. 2
27/04/2023

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MERCK

 Merck & Co., Inc. is an American multinational pharmaceutical company headquartered

 The Angel Pharmacy in Darmstadt, the beginning of the Merck Group

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