“Protocol 007”: Merck Scientists Accuse Company of Mumps Vaccine Fraud that Endangers Public Health
By Dan Olmsted and Mark Blaxill
At its core, the 55-page whistleblower lawsuit unsealed Friday in U.S. District Court in Philadelphia makes one stunning allegation – that pharmaceutical giant Merck traded children’s health to protect monopoly profits, and engaged in a systematic, elaborate, and ongoing fraud to do so.
If the charges – which Merck denies – are true, a 12-month-old child getting a recommended shot containing the mumps vaccine at their pediatrician’s office this morning would not be adequately protected from the disease, and could face serious health complications down the road as a result.
The alleged fraud: a multi-year effort to hide the fact that the mumps vaccine is no longer anywhere near as effective as Merck claims. The project was widely known and approved within the company’s vaccine division and even had a name, Protocol 007, according to the two former Merck scientists who filed the suit more than two years ago under the federal whistleblower statute. Virologists Stephen A. Krahling and Joan A. Wlochowski claim they witnessed the fraud firsthand when they worked at the Merck vaccine laboratory in West Point, Pennsylvania, between 1999 and 2002, and were pressured to participate.
They describe a supervisor manually changing test results that showed the vaccine wasn’t working; hurriedly destroying garbage-bags full of evidence to keep the fraud from being exposed; and lying to FDA regulators who came to the lab after being alerted by the whistleblowers. A top Merck vaccine official told Krahling the matter was a “business decision,” the suit says, and he was twice told the company would make sure he went to jail if he told federal regulators the truth.
The alleged fraud occurred because, in order to maintain its license for the mumps-measles-rubella vaccine, known as the MMRII, Merck needed to show that the mumps vaccine was still as potent as when originally approved in 1967 as a single vaccine, able to induce immunity in 95 percent of those vaccinated. That number, according to vaccine authorities, is crucial because it leads to “herd immunity,” protective against outbreaks even among unvaccinated people. The problem with the mumps vaccine lay in the fact that by the late 1990s, after decades of producing it with the original strain of mumps virus, the vaccine’s effectiveness had steadily declined, the suit says.
Merck is the only company licensed in the United States to produce the individual mumps vaccine, as well as the MMRII and a newer shot called the MMRV or ProQuad, which also contains the chickenpox vaccine. That gives Merck an effective monopoly on the product line, which by our estimate has brought the company as much as $10 billion in business since 2000. The complaint conservatively estimates MMRII purchases by the Centers for Disease Control and Prevention at $750 million.
If tests showed the mumps vaccine is ineffective -- or far less so than promised -- the door would be opened to any number of adverse events for Merck, from federal regulators pulling the licenses for all of its mumps-vaccine-containing products, to intensified competition from other manufacturers if they became aware of the problem.
What’s more, weak efficacy could be triggering real-time, real-world health problems here and abroad, where a version of the MMRII is also used. Mumps outbreaks unexpectedly occurred in the United States in 2006 and in 2009-10, reflecting the three-year cycle in which younger children become exposed. A total of 6,500 cases were reported in a highly vaccinated population in the Midwest in 2006, according to the suit, and another 5,000 cases in 2009; in the years leading up to the first outbreak, the annual average had been 265 cases.
If that pattern holds true, another outbreak might be due as early as this summer.
Additionally, poor vaccine efficacy has the effect of pushing some cases of mumps to a later age, when mumps is a more dangerous disease that can induce sterility in males. One intriguing implication is that no vaccine at all might have been better than the one Merck currently produces.
The suit claims that as a result of the fraud, the U.S. government has been cheated out of millions of dollars paid by the CDC to buy the vaccine for its immunization program. It says the agency, and other government bodies, were wrongly deprived of the knowledge they needed to make proper use of taxpayer money and sound medical decisions. (The CDC predicted several years ago that mumps would be eradicated in the United States by 2010, an outcome predicated on the idea that the vaccine worked.)
The suit describes Merck’s allegedly no-holds-barred effort to protect its market position. “Merck set out to conduct testing of its mumps vaccine that would support its original efficacy finding. In performing this testing, Merck’s objective was to report efficacy of 95 percent or higher regardless of the vaccine’s true efficacy. The only way Merck could accomplish this was through manipulating its testing procedures and falsifying the test results. … Krahling and Wlochowski participated on the Merck team that conducted this testing and witnessed firsthand the fraud in which Merck engaged to reach its desired results. Merck internally referred to the testing as Protocol 007.”
The suit says testing began in 1999, led by Senior Investigator David Krah and his second-in-command, Mary Yagodich. Merck’s Executive Director of Vaccine Research, Alan Shaw, approved the testing methodology, the suit says. Krahling said he complained about the fraud to Emilio Emini, Vice President of Merck’s Vaccine Research Division, and brought “actual testing samples and plaque counting sheets to demonstrate to Emini the fraudulent data that Krah was directing. Emini agreed that Krah had falsified the data,” the suit said, but defended some aspects of the work.
“Emini promised to conduct an ‘internal audit’ of the mumps testing. … Emini ordered Krahling not to call the FDA. Immediately after the meeting [a Human Resources representative] approached Krahling and again threatened that he would be put in jail if he contacted the FDA.” Shortly thereafter, Krahling was transferred to another lab, and soon left the company; Wlochowski was also transferred and left the next year. (In 2005, Emini became Executive Vice President of Vaccine Research and Development at Wyeth Pharmaceuticals. He is now Senior Vice President and Chief Scientific Officer of Vaccine Research at Pfizer.)
The suit describes how Merck scientists allegedly engaged in a number of techniques in order to claim that the vaccine remained effective, from essentially testing the vaccine against itself – using the weakened vaccine virus rather than the more virulent “wild” type to which children are exposed in the real world -- to adding animal antibodies that increased potency in lab tests; to, when all else failed, simply changing the data accurately recorded by Krahling, Wlochowski, and other virologists.
While many of the details of the alleged fraud are technical, one internal Merck document clearly describes the nature of the mission, according to the suit. It was titled: “Objective: Identify a mumps neutralization assay format [testing procedure] that permits measurement of a greater than or equal to 95% seroconversion rate in MMRII vaccines.”
Merck responded Friday that the suit is “completely without merit” and said the company will “vigorously defend” itself – presumably by quickly filing a motion to have the suit dismissed. Merck pointedly noted that, to date, the U.S. Department of Justice has not joined the suit.
Under the federal whistleblower statute, anyone can bring a whistleblower suit alleging that a business they worked for defrauded the United States government and, by extension, taxpayers. Such a suit remains sealed while the company has a chance to review it, and Department of Justice (DOJ) attorneys decide whether to join as plaintiffs, throwing the government’s weight behind the whistleblower’s claim that it was defrauded.
In this case the DOJ did not reach its decision on whether to join as a plaintiff quickly or definitively. The lengthy period between the filing of the suit by Krah and Wlochowski, on April 27, 2010, and the department’s decision not to intervene for the time being, on April 27, 2012, required the DOJ to request multiple six-month extensions, according to the civil docket for the case, filed in the Eastern District of Pennsylvania. In its statement declining to intervene, the department asked that if either side wants to settle or dismiss the case, “the court solicit the written consent of the United States before ruling or granting its approval.”
The mumps component of the combination measles-mumps-rubella (MMR) vaccine has long been a source of controversy. Merck was first to market in the category introducing a vaccine named MMR in 1971, using a strain of mumps taken from the throat of a Merck scientist’s daughter named “Jeryl Lynn.” (In 1979, Merck replaced the MMR’s rubella component due to safety concerns and named the reformulated vaccine MMRII). Starting in 1986, the first serious competitors to Merck’s vaccine began to emerge based on a different mumps component: the so-called Urabe strain, which was first licensed by Japan’s Biken Institute in 1979. Urabe-based vaccines were licensed in countries all over the world, including Canada, Japan, and the United Kingdom, to name just a few. For many years, however, Merck was able maintained its advantage in the category by outpacing the performance of Urabe-based MMR vaccines.
Merck’s main advantage came from its superior safety reputation. One of the most troublesome adverse events for MMR vaccines, aseptic meningitis, is a serious and potentially fatal side effect of vaccination. According to a major textbook on vaccines, “the Urabe strain has been linked with aseptic meningitis wherever adverse reactions have been studied.” By contrast, according to another review cited in the complaint, “aseptic meningitis, the Achilles heel of mumps vaccines, has never been documented to be caused by Jeryl Lynn.” In country after country, introduction of Urabe-based MMR vaccines have spawned outbreaks of aseptic meningitis and prompted withdrawal of the suspect MMR vaccine. In several of these cases, Merck’s MMRII has been the primary beneficiary.
Some researchers have argued, however, that the superior safety profile of MMRII comes at the expense of reduced efficacy. According to the authors above, “a mathematical model using the Urabe or Jeryl Lynn strains, suggested that … the greater apparent safety … associated with the Jeryl Lynn strain is offset by the potentially greater effectiveness associated with the Urabe strain.”
In light of these competitive threats to its highly successful MMRII franchise, it’s not surprising that asking Merck scientists to oversee testing of the efficacy of its own mumps vaccine would create a conflict of interest, not to mention an incentive to cheat on the test, if the underlying efficacy of the vaccine was weak.
The DOJ’s decision also points to another unavoidable but potentially troubling conflict of interest – the department is part of the same Executive Branch of government as the FDA and CDC. Under the Department of Health and Human Services, the FDA and CDC approve, recommend, and monitor vaccines, and they have repeatedly certified mumps-containing vaccines as effective. Allowing an alleged fraud to go on under their noses, involving a vaccine to which they are strongly committed, might not be something they would care to acknoweldge.
The fate of the lawsuit notwithstanding, serious new questions about children’s health are now in the public domain. It will be worth watching whether regulators or legislators here or abroad ask Merck for convincing, current evidence that the mumps vaccine is working as promised, and that the public's health remains protected.
--
Dan Olmsted is Editor and Mark Blaxill is Editor at Large of AgeofAutism.com. They are co-authors of The Age of Autism – Mercury, Medicine, and a Man-made Epidemic, published in 2010 by Thomas Dunne Books.
Mumps outbreak at Ohio State
http://www.dispatch.com/content/stories/local/2014/03/06/Health-officials-say-7-OSU-students-might-have-mumps.html
Posted by: Andrea | March 07, 2014 at 07:31 AM
The article I quoted in an earlier post claimed that the mumps virus had mutated (because of bad parents who didn't vaccinate) and that's why the mumps vaccine didn't work any longer. But in reading the amended complaint, the plaintiffs say that the vaccine was tested against the *attenuated* Jeryl Lynn virus, the same virus in the vaccine, not a wild type virus, not even the original Jeryl Lynn virus. And even with this manipulation, they had to phony up the results, eventually abandoning this test altogether because they couldn't get the number they wanted.
Posted by: Carol | July 03, 2012 at 12:12 PM
The article links to the amended complaint. I think this is the original complaint: http://www.courthousenews.com/2012/06/27/MerckUnsealed.pdf
Posted by: Carol | June 30, 2012 at 11:40 AM
Just a couple of comments on this case (you can see them in my article here:http://ruleof6ix.fieldofscience.com/2012/06/mercks-mumps-vaccine-is-good-but-not.html?showComment=1341062704733#c4852737695980086528) : although it's a bit premature considering it hasn't gone to court yet but we will se what happens.
No matter what Merck has done with their 'in-house' vaccine testing I can tell you that this has little to do with what is happening across the world in vaccinated people.
We do not know how we are immune to mumps. This makes it difficult to determine whether or not a vaccine works by just looking at antibody responses (like what Merck does and is being sued over forging). A better way to do it is to measure how many people get mumps who are vaccinated and who are not. This allows us to calculate the vaccine efficacy (VE). If you look at the VE levels for the mumps component of MMR you can see that is pretty effective (between 70 - 95%).
You end: "serious new questions about children’s health are now in the public domain" - there is your answer. The vaccine is working to protect our children. But evidently it could be better and new vaccines are being developed to expand on and improve Merck's already gold-standard, effective and safe Jeryl-Lynn vaccine.
Posted by: Connor Bamford (@cggbamford) | June 30, 2012 at 09:36 AM
Dr Andrew J Wakefield and Dr John Walker Smith from the UK published a peer reviewed article in the Lancet exposing the risks of the Mumps vaccine using the Urabe strain AM9. This SKB manufactured vaccine caused large outbreaks of Aseptic Meningitis in Canada causing the health authorities to withdraw it. SKB simply changed the name in order to get a license in UK. The result was large outbreaks of Aseptic Meningitis in UK which forced health authorities to withdraw the SKB vaccine using Urabe strain AM9 and switch to the Merck vaccine using Jeryl Lynn strain. SKB simply changed vaccine name and sold it to Brazil. The UK GMC viciously attacked Drs Wakefield and Smith using forged evidence and libelous testimony by journalist Brian Deer. When UK Justice Mitting reviewed the appeal he quashed all charges and restored the integrity and medical license and charged the GMC of a coverup.
Posted by: William Hewitt | June 28, 2012 at 12:52 PM
Jen,
I didn't always feel this way, but I can honestly say that i no longer fear the so called "vaccine preventable" diseases. What I now fear, are the vaccines which supposedly prevent them.
They're hard to find, but the following link offers an amazingly honest viewpoint from a doctor who really grasps the issue
http://www.vaccinationcouncil.org/2011/12/27/new-video-from-gary-null-dr-humphries-there-will-never-be-a-safe-vaccine/
I agree with just about everything she says here, excluding the view that all this vaccine damage is not intentional. I know I'm a broken record on this, but I honestly believe that vaccines create severely corrupted immune systems, by design.
We need only look at who generates the vaccines, and who profits so enormously from the damage they create. It's the same industry.
Posted by: Barry | June 28, 2012 at 07:14 AM
Barry;
This is a big problem!
Dang, simple easy, and now complicated and in more danger than when we had no vaccine.
Posted by: Benedetta | June 27, 2012 at 09:26 PM
Barry, I hear you. I honestly don't know what to think about the mumps issue. My son has only had one MMR and of course I can get titers done. I really don't want to give another MMR and we don't have single mumps vaccine in Canada. AND, now it's not even very effective. I feel really pissed off that the choice to have mumps as a relatively benign illness has been taken from us all.
Posted by: Jen | June 27, 2012 at 08:01 PM
If they offered single dose, I might bite, because my male child is getting older.
**********
Vaccines injured my child in ways that I'll probably never fully understand
One thing i do understand though, is that it takes a special kind of poison to do that. And I really don't know if the damage was caused by too many too soon... or just one out of all of them was solely responsible for the damage.
In my humble opinion, to give my sone even one more vaccine, would be to re-enagae in the same dangerous game that severely injured him once already.
Posted by: Barry | June 26, 2012 at 09:50 PM
This really pisses me off. This should be an automatic call to re-instituting single mumps vaccine- now that they have taken away mumps as a CHILDHOOD illness (when it would cause less complications rather having adult males be more vulnerable when getting it later). If they offered single dose, I might bite, because my male child is getting older. They have really messed with nature too much!
Posted by: Jen | June 26, 2012 at 02:17 PM
WOW. I have said it here before, "Truth and Time". I can only pray that all of us are alive the day this entire thing blows up.
At a recent family reunion, someone was a HUGE Alex Jones follower(he's a radio host/conspiracy theorist). Well, this person started talking about how Alex Jones believes that the government is creating diseases and situations that will lessen our population in the future because we are way too overpopulated. He was VERY detailed about how the government/pharma is doing all of this, but never mentioned autism.
When I mentioned how I believed that a few years down the line MOST of our men and some women will be "disabled" due to autism and not able to protect our country via military, police, fire, etc...much less procreate, they were stunned. We suddenly stood there with a massive connection on two very different levels. It was extremely frightening to say the least.
The evil that is going on between all these bed-buddies is beyond explanation. We are now a "what's in it for me" society rather than a "children are our future" one. UGH.
Posted by: antoinette f. | June 26, 2012 at 12:02 PM
@cmo: "Perhaps Merck could hire this "award winning journalist and vaccine expert" [Brian Deer] to investigate "the science" of this matter...
Excellent suggestion. If Brian Deer is too busy working on uncovering another vaccine truth, I nominate Trine Tsouderos to look into this, as we know no grain of truth or unsavoury ingredient can escape her trained baking eye.
Posted by: Natasa | June 26, 2012 at 06:50 AM
From Ed Yazbak's post regarding the European Programme for Intervention Epidemiology Training (EPIET), European Centre for Disease Prevention and Control (ECDC), Stockholm, Sweden.
These organisations monitor the efficacy of vaccination programmes, by analysing data submitted to them about outbreaks of diseases occurring in vaccinated poulations.(See also my post below regarding the Oban, Scotland Mumps outbreak Dec 2010-Feb 2011).
"Preventing outbreaks and controlling mumps probably requires several elements, including high-coverage vaccination programmes with MMR vaccine with 4-8 years between doses."
God Forbid!! MMR vaccinations every 4 years?? Don't these idiots realise that viruses evolve to 'get round' vaccinations and that animal immune systems also evolve to 'get round' the 'wild' viruses.
Maybe mumps in infancy was not such a bad thing after all. I am sure most of those young men rendered sterile because the MMR vaccine failed to protect them from Mumps long term, would have preferred a few childhood days with sore swollen necks and subsequent conferred lifelong immunity.
Posted by: Jenny Allan | June 26, 2012 at 03:07 AM
Damn this company. My grandson received Proquad (Kaiser no longer uses) at his 12 month visit. At 14 months he should of been hospitalized his lymphocytes were at 96% and his neutrophils were at 3%. He was crashing and Kaiser did nothing did not even alert his parents to the horror that was taking place. Left them in the dark about what all this meant. He was sick and they left him with these disastrous numbers. The crime was done and the criminals screen themselves from their crimes. Viruses plaque him now Measles, mumps, rubella, CMV, HHV6 titers are monstrous and that damn varicella component(Ten times the amount of a normal vaccine!) shows no titer at all.
Posted by: Nora | June 26, 2012 at 02:05 AM
Sorry Carol. Thanks for clarifying. That went right over my head :)
Posted by: DrSuzanne | June 26, 2012 at 12:17 AM
The same people who develop the vaccines do the safety and efficacy testing also,this is a HORRENDOUS MISTAKE.
They need to bring in the independent scientists ASAP, completely separate from big-pHarma to do all safety and efficacy testing that is required to PROTECT OUR CHILDREN.
Those manufacturers who do not understand that vaccine safety come FIRST above all,need to get out of the vaccine business.They should not prioritize vaccine policy over
vaccine safety.A great thank you to Lucija Tomljenovic - an other medical hero - for standing up for what is right and protecting our children.
Posted by: oneVoice | June 25, 2012 at 10:40 PM
Vaccines have never prevented a disease of any kind, because they were never actually designed to do that.
Vaccine efficacy is a complete myth, that's exists as part of a larger strategy designed to scare people into lining up to receive them.
Pharmaceutical companies make enormous profits treating symptoms of our sabotaged immune systems. Vaccines are the saboteurs weapon of choice, which have actually been designed to corrupt our healthy immune systems.
It's kinda hard not to notice, that pharmaceutical companies sell them both.
Posted by: Barry | June 25, 2012 at 09:26 PM
Merck cares about $$$ and our kids are paying the price.
Posted by: 4Bobby | June 25, 2012 at 08:05 PM
Perhaps Merck could hire this "award winning journalist and vaccine expert" to investigate "the science" of this matter...
UK Murdoch news reporter Brian Deer
http://www.youtube.com/watch?v=AX2Rq1jM0mU
Mr. Deer "strikes fear" into any renegade Dr. or Phd...
Posted by: cmo | June 25, 2012 at 07:55 PM
DrSuzanne,
*I* wasn't making the argument. The article quoted was making the argument.
I'm a strong supporter of Andrew Wakefield.
Posted by: Carol | June 25, 2012 at 07:37 PM
The US government tends to be soft in prosecuting Big Pharma. I saw the prosecutor in a Pfizer case awhile back quoted as saying, in explanation, that because the company did so much good, consumers would ultimately suffer if the penalties against Pfizer were too big. In the Vioxx debacle, Merck got off relatively light. Put the criminals behind bars, I say.
Posted by: Christina Waldman | June 25, 2012 at 07:34 PM
It sounds like these self-styled wizards have not even considered how much more needs to be learned about cellular resistance to infection, and its evolution since the beginning of life on earth. Their presumption that they can control “herd immunity” is as insane as efforts in the last century to purify the human race through eugenics. These are the tyrants of today’s world.
Posted by: Eileen Nicole Simon | June 25, 2012 at 07:33 PM
Additional information, particularly about the connivance of the FDA in the cover up, in Hilary Butler's Beyond Conformity blog:
http://www.beyondconformity.co.nz/_blog/Hilary's_Desk/post/Former_Merck_Scientists_File_Suit_Against_Merck_Under_the_False_Claims_Act_/
Posted by: John Stone | June 25, 2012 at 07:23 PM
One must wonder how the following recently published results of years of mumps serosurveillance in Europe were ignored.
Epidemiol Infect. 2012 Jun 12:1-16. [Epub ahead of print]
Seroepidemiology of mumps in Europe (1996-2008): why do outbreaks occur in highly vaccinated populations?
Eriksen J, Davidkin I, Kafatos G, Andrews N, Barbara C, Cohen D, Duks A, Griskevicius A, Johansen K, Bartha K, Kriz B, Mitis G, Mossong J, Nardone A, O'Flanagan D, DE Ory F, Pistol A, Theeten H, Prosenc K, Slacikova M, Pebody R.
Source
European Programme for Intervention Epidemiology Training (EPIET), European Centre for Disease Prevention and Control (ECDC), Stockholm, Sweden.
Abstract
SUMMARY Mumps outbreaks have recently been recorded in a number of highly vaccinated populations. We related seroprevalence, epidemiological and vaccination data from 18 European countries participating in The European Sero-Epidemiology Network (ESEN) to their risk of mumps outbreaks in order to inform vaccination strategies. Samples from national population serum banks were collected, tested for mumps IgG antibodies and standardized for international comparisons. A comparative analysis between countries was undertaken using age-specific mumps seroprevalence data and information on reported mumps incidence, vaccine strains, vaccination programmes and vaccine coverage 5-12 years after sera collection. Mean geometric mumps antibody titres were lower in mumps outbreak countries [odds ratio (OR) 0•09, 95% confidence interval (CI) 0•01-0•71)]. MMR1 vaccine coverage ⩾95% remained protective in a multivariable model (P<0•001), as did an interval of 4-8 years between doses (OR 0•08, 95% CI 0•01-0•85). Preventing outbreaks and controlling mumps probably requires several elements, including high-coverage vaccination programmes with MMR vaccine with 4-8 years between doses.
PMID: 22687578
Posted by: Ed Yazbak | June 25, 2012 at 06:51 PM
I think Pamela has good questions. If whistle-blowers from an industry so merged with government, as the pharmaceutical industry and our federal agencies are, have to wait upon that entity to essentially take action against itself, then I think it would be helpful to be able to at least knowledgeably point out the lack of consequences in the current system while attempting to make this case go viral.
Posted by: Jeannette Bishop | June 25, 2012 at 05:58 PM
Merck quadrupled the mumps component of its MMR Trivalent vaccine in the late 80s, because it wasnt working well enough
The mumps component is made with fetal human DNA
Posted by: TicTocDoc | June 25, 2012 at 05:45 PM
Carol, the vaccine did not mutate by going into unvaccinated. The company and the complaint are well aware that "passaging" the virus in the vaccine manufacture is what causes mutation and weakened the antigenic activity. If you look at recent outbreaks, you will also see that the vast majority, as in 86% of those infected and symptomatic are those who were up to date on the vaccine. In addition you can find in medical literature that shows how the mumps vaccine infects people with vaccine strain virus http://www.ncbi.nlm.nih.gov/pubmed/21983359. So your argument doesn't hold water. And you obviously have done no independent reading on Andrew Wakefield.
Posted by: DrSuzanne | June 25, 2012 at 05:14 PM
Especially troubling is the fact the former head of the CDC .. Dr. Julie Gerberding .. is presently head of Merck's global vaccine program.
Either way you look at it .. public health officials and Merck .. were either IGNORANT of the diminished efficiency of their Mumps vaccines .. or .. more likely .. they were INDIFFERENT to that diminished efficience.
Posted by: Bob Moffitt | June 25, 2012 at 05:10 PM
What? You mean that the scaremongers actually knowingly GAVE inadequate amounts of mump antigen? I thought that they were so concerned about measles and mumps epidemics?
This explains the recent news article from UGA indicating NIH is giving mega grant bucks to a university professor (of animals of course) to create a new mumps vaccine...the blame of course was not that the vaccine doesnt work because they "watered it down" but because andrew wakefield caused a mutation in the strain by scaring parents :)
They are drowning in their own lies...but there are so many of them that the only thing they can do is keep trying to hide behind others skeletons
Looks like perhaps they better go back to single vaccines eh? Hmmmm
Posted by: single vaccines | June 25, 2012 at 04:15 PM
Defending fraud charges is just part of the cost of doing business for Merck who has paid $1.6 billion in fines since 2008. Those fines were for defrauding Medicare. (The biggest drugmakers have paid $8 billion in fines for defrauding Medicare and Medicaid in the last decade.)
This will continue due to the $200 million per year annual lobbying efforts of pharma.
I hope this story receives the media coverage it deserves.
Posted by: Madvocate | June 25, 2012 at 03:39 PM
Despicable that a company would make a "business decision" to falsify data and defraud the public. In my opinion this will ultimately prove to be a positive development if it contributes to bringing down the vaccine machine as it exists today. I saw a call for a special prosecutor and I heartily agree. We need someone free of bias who will pursue the truth in this matter.
Posted by: Janet Levatin | June 25, 2012 at 02:46 PM
"Fate of the lawsuit not withstanding".....I would love to know more about what hte DOJ's decision means for the lawsuit. What are the possible scenarios?
Given the main charge is defrauding the gov't, can a suit go forward if the injured party is not interested in pursuing it? Might it go forward with only seeking remedy to the individual plaintiffs without seeking remedy to the gov't?
Is a jury trial even possible at this point?
Obviously, I am not an attorney but I am certainly interested in understanding where this might go from here.
Posted by: Pamela | June 25, 2012 at 02:43 PM
"There is great dishonesty about autism." Donald Trump
And there is great dishonesty about vaccines in general. It is great to see these Whistleblowers coming out. More will follow because: it's the right thing to do.
Posted by: The Truth Shall Set You Free | June 25, 2012 at 02:08 PM
It couldn't read the complaint without a lot of pausing to regain composure so my impression may be disjointed, but it did seem like Governmerck has a lot to answer for on both mission "fronts," "disease prevention" and "regulation."
Posted by: Jeannette Bishop | June 25, 2012 at 01:39 PM
I guess no matter the size of the fraud or its effects on public health, it would be pretty awkward for DOJ to accuse the same vax manufacturers that they get paid to defend in vaccine court. Talk about a conflict of interest! DOJ are nothing more than mob lawyers. How about asking for a special prosecutor, folks?
Posted by: Garbo | June 25, 2012 at 01:14 PM
on a related subject:
http://www.nytimes.com/2012/06/25/health/in-documents-on-pain-drug-celebrex-signs-of-doubt-and-deception.html?hp
Posted by: ottoschnaut | June 25, 2012 at 12:31 PM
Dan, Mark I was wondering if you could comment on the following, and maybe provide links to info:
“The immune system is driven by cells and not antibodies. The stem cells in the myeloid tissue (bone marrow) produce all the cells that differentiate and protect us - dendritic cells, mast cells, monocytes, macrophages, B cells, T cells, NK cells, that do the job of protecting the body. Antibodies are not the first-line nor even second-line defense - they are 'tags' used to identify the dead after the battle. To use antibody production as a signal of vaccine effectiveness is as valid as stating that a black eye is proof that a punch in the face is good for you”
Posted by: AutismDad | June 25, 2012 at 12:03 PM
wonder if this is related to the new attempt to silence those who work in the health field and exempt them from whistle blower rights.
maurine
Posted by: Maurine Meleck | June 25, 2012 at 11:37 AM
Guys;
You know this probably means that the company will now put out a more dangerous product; to cover thier behinds.
We can't win here.
Mumps vaccine don't work at lower doses, but the higher doses causes severe autoimmune reactions.
Posted by: Benedetta | June 25, 2012 at 11:21 AM
Is anyone surprised that a company that doesn't care about vaccine safety doesn't care about efficacy either? I'm not.
Anne Dachel, Media
Posted by: Anne McElroy Dachel | June 25, 2012 at 10:32 AM
Well, well, well. The second bad news story for MMR vaccine. The other one being the Italian court's decision to award parents damages and name the MMR as the reason their son descended into irreversible brain damage. So when is Anderson Cooper or Matt Lauer or Dr. Snyderman going to report on these? It's getting more obvious by the minute that they are paid to ignore information and be biased. I hope they can live with themselves; I couldn't.
Posted by: Jen | June 25, 2012 at 10:28 AM
This is off-topic but this line caught my eye: "Under the federal whistleblower statute, anyone can bring a whistleblower suit alleging that a business they worked for defrauded the United States government and, by extension, taxpayers."
Does this mean that a teacher,or any school employee, who has knowledge that a child's (or children's) IEP is not being followed can blow the whistle on their own school district? The federal government partially funds special education. Would this amount to fraud?
Posted by: Sue Keller | June 25, 2012 at 10:13 AM
I'm sure this is just one story of many in Merck's laboratories and statistical analysis units.
I'm also sure the same applies to Merck's competitors - GSK, Pfizer, Sanofi, etc.
If one company cheats the others must also do so in order to compete.
They are all doing this, I'm sure.
Posted by: vaccine.explorer | June 25, 2012 at 09:41 AM
AoA readers will not be surprised that the parties at fault are Andrew Wakefield and people who failed to vaccinate their children:
"But vaccination rates dropped, particularly in Great Britain, after British scientist Andrew Wakefield reported a link between the MMR vaccine and autism.
Wakefield’s research later was proven faulty, though the damage was already done, He said. Parents thought their children might develop autism and stopped getting the MMR vaccine.
'Many people in the (United Kingdom) stopped vaccinating their kids, so the mumps came back in the U.K.,' he said.
The virus likely mutated in the unvaccinated population and then appeared in outbreaks of hundreds, then thousands, of Americans in 2006 and 2010 in Iowa, New Jersey and New York, He said.
Researchers discovered that American patients had a virus that could bypass the old vaccine, and its RNA matched that of viruses tested in Great Britain, according to the Centers for Disease Control and Prevention."
http://onlineathens.com/local-news/2012-06-17/uga-researcher-works-vaccine-new-version-mumps
Posted by: Carol | June 25, 2012 at 08:53 AM
"If that pattern holds true, another outbreak might be due as early as this summer."
Well, I am sure Merck was all prepared for that: release media campaigns showing that parent refusing the MMR for their children are responsible for new mumps outbreaks.
In this way they would have taken advantage of their own fraud and product weaknesses, to attack their adversaries, put the blame of the parents, and put even more pressure on selling more of their (defective) product.
Use your own weaknesses to strengthen your empire.
Posted by: Karin | June 25, 2012 at 08:22 AM
FYI.........
M-M-R® II
(MEASLES, MUMPS, and
RUBELLA VIRUS VACCINE LIVE)
DESCRIPTION
M-M-R* II (Measles, Mumps, and Rubella Virus Vaccine Live) is a live virus vaccine for vaccination
against measles (rubeola), mumps, and rubella (German measles).
M-M-R II is a sterile lyophilized preparation of (1) ATTENUVAX* (Measles Virus Vaccine Live), a more
attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in
chick embryo cell culture; (2) MUMPSVAX* (Mumps Virus Vaccine Live), the Jeryl Lynn** (B level) strain
of mumps virus propagated in chick embryo cell culture; and (3) MERUVAX* II (Rubella Virus Vaccine
Live), the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung
fibroblasts.1,2
The growth medium for measles and mumps is Medium 199 (a buffered salt solution containing
vitamins and amino acids and supplemented with fetal bovine serum) containing SPGA (sucrose,
phosphate, glutamate, and recombinant human albumin) as stabilizer and neomycin.
The growth medium for rubella is Minimum Essential Medium (MEM) [a buffered salt solution
containing vitamins and amino acids and supplemented with fetal bovine serum] containing recombinant
human albumin and neomycin. Sorbitol and hydrolyzed gelatin stabilizer are added to the individual virus
harvests.
The cells, virus pools, and fetal bovine serum are all screened for the absence of adventitious agents.
The reconstituted vaccine is for subcutaneous administration. Each 0.5 mL dose contains not less
than 1,000 TCID50 (tissue culture infectious doses) of measles virus; 12,500 TCID50 of mumps virus; and
1,000 TCID50 of rubella virus. Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium
phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), recombinant human albumin
(≤0.3 mg), fetal bovine serum (<1 ppm), other buffer and media ingredients and approximately 25 mcg of
neomycin. The product contains no preservative.
Before reconstitution, the lyophilized vaccine is a light yellow compact crystalline plug. M-M-R II, when
reconstituted as directed, is clear yellow.
http://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf
Posted by: Raymond Gallup | June 25, 2012 at 08:19 AM
Mumps outbreak hits Oban Scotland January 2011:-
http://www.bbc.co.uk/news/uk-scotland-glasgow-west-12184237
13-01-11
BBC NEWS:-
"NHS Highland said about 50 cases had been identified, mainly among teenagers and those in their early 20s.
It is believed returning students and increased social events over the festive period may have contributed to the spread of the virus.
Mumps is spread through saliva and is transmitted by coughs and sneezes
Symptoms include swelling on the angle of the jaw on one or both sides of the face.
Often there are several days of earlier symptoms, which could include fever, headache, tiredness, muscle aches and loss of appetite.
Doctors have said that teenagers in Oban who have not had all their MMR jabs should make sure they are up to date with vaccination."
http://www.pressandjournal.co.uk/Article.aspx/2201876?UserKey=
"Immunity fears after probe into Oban mumps outbreak
The investigation shows that of the 140 cases recorded during the outbreak between December and February, 44% had received two doses of MMR, 28% had received one dose and 25% had not been immunised with MMR.
The figures will be discussed at the NHS Highland Board meeting in Inverness next Tuesday.
A report to the board states: “This suggests some waning mumps immunity from MMR vaccine. Our work has now been published in Eurosurveillance (the European scientific journal devoted to the epidemiology, surveillance, prevention and control of communicable diseases).”
“It is of interest and concern to everyone, not just the locality of Oban. This is something which would be looked into across the whole of the UK and also the world really."
Posted by: Jenny Allan | June 25, 2012 at 08:04 AM
FYI..........
Meruvax I Mumps Vaccine Ingredients
Meruvax I is the trade name for the Mumps vaccine manufactured by Merck & co. The Meruvax I mumps vaccine ingredients include the mumps live virus, the antibiotic neomycin, the chemical Sorbitol and the animal by product hydrolyzed gelatin.
The Mumps live virus is the active ingredient to the mumps vaccine. My opposition to injecting any virus into the body is you are by passing the first line of defense, the respiratory system, thereby tricking the immune system into fighting the virus. The issue I have with this is the potential of tricking the immune system into fighting similar proteins as well, including those that are a natural part of the body. Vaccines have been used in some countries to fight population growth via sterilization by tricking the body into fighting against pregnancy hormones. You can read my article on vaccines used to sterilize girls.
The antibiotic neomycin is a very strong antibiotic with allergenic potential to harm those allergic to this family of antibiotics. Neomycin is Nephrotoxic and can damage the kidneys. When ingested in pill form, most of the neomycin is passed through the system and is not absorbed, when injected the intestinal system is by passed therefore the body has no option to pass this potentially toxic antibiotic. Neomycin also has the potential to deplete the body of Vitamin B6 and if the body is too short on B6 it can lead to mental retardation or a form of epilepsy.
The chemical Sorbitol is a sugar alcohol that is used medically for urinary irrigation. At Drugs.com under the warnings, the first warning is, not for injection. Sorbitol can cause potential side effects of Nausea, gas, diarrhea, stomach cramps or anal irritation, acidosis, diuresis, lack of urination, edema, cardiovascular/pulmonary disorders, convulsions, back ache and more, and can be harmful or fatal to those with fructose, intolerance.
The animal by product hydrolyzed gelatin is a potential allergenic. Those who have allergies to Jello and other gelatin based food products may suffer anaphylaxsis. Animal by products can also be carriers of additional viral or bacterial hitch hikers.
Resources:
http://www.informedchoice.info/cocktail.html
http://www.drugs.com/pro/sorbitol.html
http://www.drugs.com/mtm/neomycin.html
http://www.whale.to/v/antibiotics.html
http://en.wikipedia.org/wiki/Gelatin
http://www.sciencelab.com/xMSDS-Gelatin_Powder-9924120
Disclaimer: This article, "Meruvax I Mumps Vaccine Ingredients", is not intended to give medical advice. It is a call to educate yourself about disease and vaccines so that in making a decision where your child is concerned, you should take an active role in learning all you can from medical experts on both sides of the fence, then make an educated decision. we did not make an informed decision until one son got Leukemia and another developed Autism immediately after receiving his MMR vaccine. This has sent us on a quest to inform ourselves and others to seriously question what kind of toxic soups are being injected with the vaccines. Odds are if your child is injured by a vaccine, you have little or no recompense against the industry.
http://voices.yahoo.com/meruvax-mumps-vaccine-ingredients-1864356.html?cat=70
Posted by: Raymond Gallup | June 25, 2012 at 07:58 AM
A friend was also pointing out to me that early on the UK authorities were favourng the GSK vaccine Pluserix with the Urabe strain (although they were using the Merck vaccine as well) because it was more "reactogenic" . This is documented on p.8 of Lucija Tomljenovic's epochal paper 'The vaccination policy and Code of Practice of the Joint Committee on Vaccination and Immunisation: are they at odds?'
http://www.ecomed.org.uk/wp-content/uploads/2011/09/3-tomljenovic.pdf
Posted by: John Stone | June 25, 2012 at 07:52 AM
This highlights the more general issue that once you start to play around with immunity you can create all sorts of other problems. With mumps vaccines these problems were identified and why in the UK we had a 20 year history of not using them prior to the introduction of MMR in 1988. MMR in its various forms was introduced in the UK as a matter of political expedience despite the fact that it was known that this would be the result. Another way of describing it in UK parlance is "shambolic".
Posted by: John Stone | June 25, 2012 at 07:11 AM
Gee, maybe that is why when I checked my son's titers after his autism regression and our decision he no longer receive vaccinations (after the 18 months set) he is NOT immune to mumps. Here I thought it was just because of his body. Such crooks. I can think of a lot harsher words, but seeing as how this is a family based online publication... I hope they (the Merck executives) all rot in jail (and hell). What really sucks is my son received this vaccine in 2003. Had Merck been honest about what they knew about their vaccine, it might have been pulled and then maybe he would never have received it at all...which would have made our lives so much different.
Posted by: MelissaD | June 25, 2012 at 06:57 AM