MCVC Notifies Maine CDC on the Merck Mumps False Claims Act Lawsuit

Subject: Merck Mumps False Claims Act Lawsuit
Date: Mon, 01 Jun 2015 17:51:21 -0400
From: Ginger Taylor <ginger@mainevaxchoice.org>
To: Albert, Kenneth <Kenneth.Albert@maine.gov>
CC: Tonya Philbrick <Tonya.Philbrick@maine.gov>, Holly Lusk <Holly.E.Lusk@maine.gov>, Eric Brakey <sen.eric.brakey@gmail.com>, Gattine, Drew <drew.gattine@legislature.maine.gov>, David.Burns@legislature.maine.gov, Kevin Flanigan <kevin.flanigan@maine.gov>, Martins, John A <John.a.Martins@maine.gov>, Wolanski, Lori <Lori.Wolanski@maine.gov>, Mary Holland <mary.holland@nyu.edu>

Mr. Albert,

Congratulations on your new role as Director of Maine CDC.

Our organization has discussed this matter in person with your predecessor, and with Ms. Lusk who represents Governor LePage, but wanted to take this opportunity to bring US v. Merck/Chatom v. Merck to your attention.  This email is meant both to serve as a formal notification of the matter to Maine DHHS, and to bring our concerns arising from the case to your attention.

In 2000, Merck was required to submit efficacy data to the FDA for reapproval of their MMR II vaccine (the only vaccine for measles, mumps or rubella used in the US).  According to two of their scientists tasked with doing the research, Merck found that the mumps component of the vaccine was ineffective, and yet submitted fraudulent efficacy data to federal health authorities in order to keep the vaccine on the market.  The researchers have filed suit against the company, and others have joined in.  (initial filing attached)

We do not yet know how ineffective the mumps vaccine is, but those close to the case say that it may be as low as 0% effective against the circulating strain of mumps.  Our understanding is that the case is currently in the discovery process, so we will have to wait for the specifics to be made public before we will know just how bad the fraud might be, and how high a risk Mainers are at catching the disease.

We bring this matter to your attention for several reasons:

1.  We are strongly encouraging the state of Maine to join the suit.  We have had mumps circulating in Maine among the vaccinated, and believe that Merck should be footing the bill for all costs associated with the development of the illness in those who received the vaccine since 2000 if fraud is proven.

2.  We believe that the Maine CDC should be looking to the FDA and CDC for guidance on these matters, but we also believe that the Maine CDC should not depend on the FDA and CDC for guidance on these matters.  Recent events have shown that federal health authorities have serious conflicts of interest on vaccination, and have been at best negligent and at worst culpable in vaccine safety and efficacy failures.  Should HHS not see this as a matter to be taken seriously, we encourage Maine to investigate and address potential risks arising from this accused malfeasance independent of federal health authorities.

3.  As the we have seen recent mumps outbreaks in colleges and in the National Hockey League, it is reasonable to assume that underage Mainers and those in their early adulthood have lower resistance to the disease than we have assumed, and in fact may not be immunized from mumps at all.  If this turns out to be the case, and we reach a critical mass of unimmunized Mainers, it is reasonable to expect a widespread outbreak of the disease for which we will have no effective vaccine available.  We believe that it is the responsibility of the Maine CDC to begin discussing plans to accurately assess the risk of this occurring and formulating an approach to handle such an outbreak by means other than vaccination.  The length of time that has elapsed between the alleged breach and the public disclosure of the probable vaccine failure has allowed those who received the possibly ineffective vaccine to pass through puberty and well into adulthood, where the complications from mumps increase dramatically, and include meningitis, pancreatitis, miscarriage in women, sterility in men and death.  Maine parents who have chosen to have the MMR II delivered to their children should know that their children may be at higher risk for the disease than they had believed so they can take appropriate measures to protect their children’s health.

4.  We are concerned that future mumps outbreaks will be blamed on those who have chosen not to receive the MMR II vaccine or deliver it to their children, as often happens with pertussis outbreaks, rather than the failure of the vaccine itself.  Even though both federal and Maine CDC officials have been clear that the pertussis outbreaks we have seen are to be blamed on a vaccine that does not work as well as other shots, media and vaccine interests continue to try to shift blame to vaccine resistant families.  Families who are choosing to opt out of one or more vaccines often do so because of serious adverse reactions and even disability of a family member following vaccination, and to attack them unjustly for product failures (especially for those arising from corporate fraud) is not ok.  It is our expectation that if and when there are more mumps outbreaks in Maine, the Maine DHHS will be open with the public that the reason for the outbreak may be that Merck committed a massive fraud on the American people, and not that the members of our organization are to blame.

As always, we are happy to make ourselves available to assist your department in any way we can to improve the health and functioning of Mainers.

Sincerely,
Ginger Taylor, MS
Director Maine Coalition for Vaccine Choice
207-200-8469

 

Subject: Reuters report: Merck Stonewalling in Mumps False Claims Act Lawsuit
Date: Fri, 05 Jun 2015 11:18:19 -0400
From: Ginger Taylor <ginger@mainevaxchoice.org>
To: Albert, Kenneth <Kenneth.Albert@maine.gov>
CC: Tonya Philbrick <Tonya.Philbrick@maine.gov>, Holly Lusk <Holly.E.Lusk@maine.gov>, Eric Brakey <sen.eric.brakey@gmail.com>, Gattine, Drew <drew.gattine@legislature.maine.gov>, David.Burns@legislature.maine.gov, Kevin Flanigan <kevin.flanigan@maine.gov>, Martins, John A <John.a.Martins@maine.gov>, Wolanski, Lori <Lori.Wolanski@maine.gov>, Mary Holland <mary.holland@nyu.edu>

Mr.  Albert,

Yesterday Reuters published an update on the Merck mumps lawsuit, reporting that Merck is stonewalling the court, and will not report the efficacy data on mumps component of the MMR vaccine.  This supports the claim that Maine children are receiving a vaccine for mumps that may not work for them, and that we should be preparing for a mumps outbreak in light of this likely fraud perpetrated on our state.

This action by Merck is typical of the stonewalling on vital vaccine questions that parents who want real data experience on a daily basis.

We hope that Maine CDC will begin address this and other vaccine safety and efficacy matters with the seriousness they deserve.  Stonewalling only further erodes faith in the vaccine program and threatens the doctor patient relationship and the health of Maine children.

Ginger Taylor, MS
Director
Maine Coalition for Vaccine Choice
207-200-8469

 

Merck accused of stonewalling in mumps vaccine antitrust lawsuit
BY BRENDAN PIERSON
Thu Jun 4, 2015 10:06am EDT

Two former Merck & Co Inc scientists accusing the drugmaker of falsifying tests of its exclusive mumps vaccine said in a court filing on Monday that Merck is refusing to respond to questions about the efficacy of the vaccine.

Attorneys at Constantine Cannon, who represent the scientists, asked U.S. Magistrate Judge Lynne Sitarski of the Eastern District of Pennsylvania to compel Merck to respond to their discovery request, which asks the company to give the efficacy of the vaccine as a percentage.

Instead of answering the question, the letter said, Merck has been consistently evasive, using “cut-and-paste” answers saying it cannot run a new clinical trial to determine the current efficacy, and providing only data from 50 years ago.

“Merck should not be permitted to raise as one of its principal defenses that its vaccine has a high efficacy, which is accurately represented on the product’s label, but then refuse to answer what it claims that efficacy actually is,” the letter said.

A representative of Merck could not immediately be reached for comment.

The two scientists, Stephen Krahling and Joan Wlochowski, filed their whistleblower lawsuit in 2010 claiming Merck, the only company licensed by the Food and Drug Administration to sell a mumps vaccine in the United States, skewed tests of the vaccine by adding animal antibodies to blood samples.

As a result, they said, Merck was able to produce test results showing that the vaccine was 95 percent effective, even though more accurate tests would have shown a lower success rate. The plaintiffs said these false results kept competitors from trying to produce their own mumps vaccines, since they were unable to match the effectiveness Merck claimed.

In 2012, Alabama-based Chatom Primary Care and two individual doctors, all purchasers of the vaccine, filed a proposed antitrust class action based on the allegations in the whistleblower suit. The two suits are now being coordinated before U.S. District Judge C. Darnell Jones and Magistrate Judge Sitarski.

The case is United States ex rel Krahling et al v. Merck & Co Inc, U.S. District Court, Eastern District of Pennsylvania, No. 10-4374.

For whistleblowers: Gordon Schnell of Constantine Cannon

For Merck: Lisa Dykstra of Morgan Lewis & Bockius

 

 

Subject: RE: Reuters report: Merck Stonewalling in Mumps False Claims Act Lawsuit
Date: Fri, 5 Jun 2015 17:18:53 +0000
From: Albert, Kenneth <Kenneth.Albert@maine.gov>
To: ‘Ginger Taylor’ <ginger@mainevaxchoice.org>
CC: Philbrick, Tonya <Tonya.Philbrick@maine.gov>, Lusk, Holly E <Holly.E.Lusk@maine.gov>, Eric Brakey <sen.eric.brakey@gmail.com>, Gattine, Drew <drew.gattine@legislature.maine.gov>, David.Burns@legislature.maine.gov <David.Burns@legislature.maine.gov>, Flanigan, Kevin <Kevin.Flanigan@maine.gov>, Martins, John A <John.A.Martins@maine.gov>, Wolanski, Lori <Lori.Wolanski@maine.gov>, Mary Holland <mary.holland@nyu.edu>

Ms. Taylor – Please be assured that Maine CDC will be monitoring this litigation closely.

Kenneth J. Albert RN, Esq.
Director and Chief Operating Officer
Maine Center for Disease Control and Prevention

 

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