[Ip-health] Whistle blowers alledge Merck lied about Mumps vaccine efficacy, to deter entry by competitors

Jamie Love james.love at keionline.org
Tue Sep 9 17:15:38 PDT 2014


* Merck maintained that the mumps vaccine had a 95-percent efficacy rate,
even during epidemic mumps outbreaks of 2006 and 2009 in highly vaccinated
populations—a rate reportedly attained by basing efficacy tests not on wild
mumps but rather on Merck's own vaccine strain of the disease.

* The first suit, a whistleblower case, was filed in Pennsylvania in 2010
but sealed until 2012, and had been brought under the False Claims Act by
two Merck virologists, Joan Wlochowski and Stephen Krahling. The second
suit is a class action filed mere days after the unsealing of the
whistleblower case and maintains that Merck violated the Sherman Anti-Trust
Act by falsifying the efficacy of its mumps vaccine, one of the claims of
that case being that such actions discouraged or prevented other companies
from bringing rival mumps vaccines to market.


http://www.ddn-news.com/news?newsarticle=8768

AUGUST 2014 | VOL. 10 | NO. 8
Drug Discovery News

Antitrust and some other mumps claims against Merck proceed
09-08-2014
by Jeffrey Bouley

ALLENTOWN, Pa.—In an issue of the mumps portion of Merck’s MMR vaccine
being “good” but not “good enough”—or, more specifically, perhaps not being
nearly as good as the company has maintained over the years—the pharma
giant now faces a threat to its control of the mumps vaccination market
after a federal court ruling Sept. 5.

Issuing a single opinion in two related suits—United States v. Merck & Co.
and Chatom Primary Care v. Merck & Co.—a judge in the U.S. District Court
for the Eastern District of Pennsylvania has upheld antitrust claims
brought against Merck in a qui tam suit and related class action over the
company's testing and government sales of its mumps vaccine. The Friday
ruling overcomes Merck’s motions to dismiss and will allow claims against
it to proceed to trial.

The first suit, a whistleblower case, was filed in Pennsylvania in 2010 but
sealed until 2012, and had been brought under the False Claims Act by two
Merck virologists, Joan Wlochowski and Stephen Krahling. The second suit is
a class action filed mere days after the unsealing of the whistleblower
case and maintains that Merck violated the Sherman Anti-Trust Act by
falsifying the efficacy of its mumps vaccine, one of the claims of that
case being that such actions discouraged or prevented other companies from
bringing rival mumps vaccines to market.

U.S. District Judge C. Darnell Jones II found with regard to the first
case, the qui tam action, that a fraud-on-the-FDA theory through a False
Claims Act suit can proceed, noting, “Plaintiffs have argued sufficient
facts to sustain a claim for proximate causation, detailing the significant
barriers that other companies would face to enter the mumps vaccine market.”

His opinion on the second case, the class action suit, was more favorable
to Merck, though, in that he dismissed the class action's claims under the
laws of 22 states which were filed, except for some of involving New York
and New Jersey law.

A spokesperson for law firm Robins, Kaplan, Miller & Ciresi L.L.P.—one of
the firms involved with suing Merck—contacted DDNews via email on the day
of Jones’ ruling to point out that “there have been two historic mumps
outbreaks in the U.S. among vaccinated populations in just the last decade.
With a third mumps outbreak currently underway in the U.S. … Robins,
Kaplan, Miller & Ciresi L.L.P. today achieved a significant victory against
pharmaceutical stalwart Merck. The U.S. District Court for the Eastern
District of Pennsylvania upheld the firm’s federal antitrust claims, and
state consumer protection claims, against Merck for falsifying test data
and misrepresenting the efficacy of its mumps vaccine, ultimately
discouraging other providers from entering the market with competing
products and breaking up Merck’s monopoly.

“Plaintiffs in the case allege that Merck fraudulently represented that its
mumps vaccine has an efficacy rate of 95 percent or higher, when in truth,
Merck has taken affirmative steps to conceal—by using improper testing
techniques and falsifying test data—that the efficacy rate of its mumps
vaccine is significantly lower than 95 percent.”

Kellie Lerner, a partner at Robins, Kaplan, Miller & Ciresi, who serves as
co-lead counsel on behalf of direct purchasers of the mumps vaccine, added
in an email statement, “We are pleased that the court has upheld our
federal antitrust claim in this important case. While Merck has enjoyed an
exclusive monopoly on the sale of mumps vaccine in the United States, mumps
outbreaks continue to occur because, as we allege in our lawsuit, Merck has
misled the public about the vaccine’s efficacy.  This decision brings us
one step closer to shining a light on Merck’s deceptive business practices
so that new and more effective vaccines will ultimately be developed in the
future.”

So far, Merck has been quiet on the latest ruling, though presumably it
still maintains its innocence, and in 2012, the company said the qui tam
lawsuit was “without merit and the company intends to vigorously defend
itself in court.” Merck has claimed that the vaccine’s ability to prevent
disease remains the same, and said that “MMR-II continues to be recommended
for routine administration to childen by public health authorities around
the world … Nothing is more important to Merck than the safety and
effectiveness of our vaccines and medicines and the people who use them.
It’s important to understand that none of the allegations in the complaint
relate to the safety of MMR-II, and we remain confident that MMR-II helps
protect against measles, mumps and rubella as described in the labeling for
the vaccine.”

The whistleblowers who gave rise to the antitrust case claim to have
witnessed Merck management give instructions to staff to withhold
information about failure rates regarding the mumps portion of the MMR
vaccine before selling it to the U.S. government. Merck maintained that the
mumps vaccine had a 95-percent efficacy rate, even during epidemic mumps
outbreaks of 2006 and 2009 in highly vaccinated populations—a rate
reportedly attained by basing efficacy tests not on wild mumps but rather
on Merck's own vaccine strain of the disease.

On its website page outlining its history and legacy with regard to
vaccines, Merck quotes Dr. Julie Gerberding, president of Merck Vaccines
and former director of the U.S. Centers for Disease Control and Prevention
as saying, “Vaccines are a powerful force of health and health development,
and their globalization is not just a business necessity but a public
health obligation. Merck is on a mission to ensure that more people can
access our vaccines, regardless of where they live or their financial
circumstances."


-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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