Tag Archive | merck

Remember the time Merck was sued for falsifying vaccine data?

Now someone else has been caught out at it.

On the 25th of June, NBC reported that “Iowa State University laboratory manager Dong-Pyou Han has confessed to spiking samples of rabbit blood with human antibodies to make an experimental HIV vaccine appear to have great promise. Responding to a major case of research misconduct, federal prosecutors have taken the rare step of filing charges against a scientist after he admitted falsifying data that led to millions in grants and hopes of a breakthrough in AIDS vaccine research.

Han was indicted last week on four counts of making false statements, each of which carries up to five years in prison.

“It’s an important case because it is extremely rare for scientists found to have committed fraud to be held accountable by the actual criminal justice system,” said Ivan Oransky, co-founder of Retraction Watch, which tracks research misconduct.“

 

Some might remember the Merck story, as reported by Courthouse News Service in 2012. See the original court document here .

“PHILADELPHIA (CN) – Merck has known for a decade that its mumps vaccine is “far less effective” than it tells the government, and it falsified test results and sold millions of doses of “questionable efficacy,” flooding and monopolizing the market, a primary caregiver claims in a federal antitrust class action. Alabama-based Chatom Primary Care sued Merck on Monday, the week after the unsealing of a False Claims Act complaint two relators filed in 2010.

Those relators, Stephen Krahling and Joan Wlochowski, were Merck virologists who claim in their unsealed complaint that they “witnessed firsthand the improper testing and data falsification in which Merck engaged to artificially inflate the vaccine’s efficacy findings.” Krahling and Wlochowski claimed Merck’s scheme caused the United States to pay “hundreds of millions of dollars for a vaccine that does not provide adequate immunization.”

Merck is the only manufacturer licensed by the FDA to sell the mumps vaccine in United States, and if it could not show that the vaccine was 95 percent effective, it risked losing its lucrative monopoly, according to the complaint. That’s why Merck found it critically important to keep claiming such a high efficacy rate, the complaint states.

Merck also added animal antibodies to blood samples to achieve more favorable test results, though it knew that the human immune system would never produce such antibodies, and that the antibodies created a laboratory testing scenario that “did not in any way correspond to, correlate with, or represent real life … virus neutralization in vaccinated people,” according to the complaint. Chatom claims that the falsification of test results occurred “with the knowledge, authority and approval of Merck’s senior management.”

 

Only the truly foolish would believe that these are the only two instances of dishonest manipulation of vaccine science

 

Pharmaceutical companies will do anything to bolster their coffers. We often hear from people that “There’s no money in vaccination”. The profit may not be up there with that raked in by some other misery-causing pharmaceutical products, but $36 billion a year can hardly be called “no money”. Make no mistake – this is big business.

Someone once told me that vaccines are free, and told me that I was a liar for saying pharmaceutical companies make money from them. Yes, some people truly are that thick and blinkered. I daresay that person will be the first in line to roll up their sleeve for the 200 new vaccines that are in the pipeline at the moment. No matter what it is, just stick it in because the government tells you to.

 

That figure of 200 comes directly from the International Federation of Pharmaceutical Manufacturers & Associations. Apparently, a quarter of these vaccines are for supposed protection against life-threatening illnesses. See the list here.
Among the vaccines in the pipeline is one for multiple sclerosis. Is this some kind of sick joke? Sick being the operative word. If anyone cares to check out the Database of Adverse Event Notifications at the Department of Health Therapeutic Goods Administration site, they can see for themselves instances of multiple sclerosis that have been directly caused by vaccination. Find the TGA here, type DAEN into the search box and go looking.

 

So they are developing a vaccine to prevent a disease that has been caused, in some instances, by a vaccine? Unbelievable.

 

Science for Sale

By the by, I have in my possession Science for Sale by whistleblower, David Lewis. I’m very much looking forward to reading it.

Here’s a Barnes and Noble overview of the book:

“When Speaker Newt Gingrich greeted Dr. David Lewis in his office overlooking the National Mall, he looked at Dr. Lewis and said: “You know you’re going to be fired for this, don’t you?” “I know,” Dr. Lewis replied, “I just hope to stay out of prison.” Gingrich had just read Dr. Lewis’s commentary in Nature, titled “EPA Science: Casualty of Election Politics.” Three years later, and thirty years after Dr. Lewis began working at EPA, he was back in Washington to receive a Science Achievement Award from Administrator Carol Browner for his second article in Nature. By then, EPA had transferred Dr. Lewis to the University of Georgia to await termination—the Agency’s only scientist to ever be lead author on papers published in Nature and Lancet.

The government hires scientists to support its policies; industry hires them to support its business; and universities hire them to bring in grants that are handed out to support government policies and industry practices. Organizations dealing with scientific integrity are designed only to weed out those who commit fraud behind the backs of the institutions where they work. The greatest threat of all is the purposeful corruption of the scientific enterprise by the institutions themselves. The science they create is often only an illusion, designed to deceive; and the scientists they destroy to protect that illusion are often our best. This book is about both, beginning with Dr. Lewis’s experience, and ending with the story of Dr. Andrew Wakefield.”

There’s an interview with David Lewis here, if anyone would care to listen.

 

In the two instances of corruption I’ve mentioned today, rabbit antibodies were used. And we are certainly dumb bunnies if we, without question, let our bodies be corrupted with products foisted upon us by governments that rely on pharmaceutical companies for their information.

science for sale

 

 

Will Gardasil become the greatest medical scandal of all time?

Gardasil, approved by the FDA (Food and Drug Administration) in 2006, is a Merck vaccine intended to prevent some strains of human papilloma virus.

Dr Bernard Dalbergue, formerly of Merck, predicts in the April 2014 issue of Principes de Santé (Health Principles) that “Gardasil will become the greatest medical scandal of all time because at some point in time, the evidence will add up to prove that this vaccine, technical and scientific feat that it may be, has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers.”

 

Time will tell.

 

Anyone with even a cursory interest in the subject of Gardasil, will be aware that the Japanese government withdrew its recommendation for cervical cancer vaccines after adverse events were suffered by young Japanese girls.

As reported in The Japan Times, “According to Dr. Sotaro Sato, who has examined many cervical vaccine victims, the convulsions, inability to walk, and involuntary hand and toe movements are being caused by encephalomyelitis, or the inflammation of the brain and spinal cord.

“Cervical cancer vaccines, which are chemically bound to special types of adjuvants, often trigger encephalomyelitis,” he said.

“Since the vaccines cause autoantibodies against the brain’s neuronal fibers to be produced in many cases, they have triggered demyelinating disorders,” he said, adding they have also induced many cases of cerebral vasculitis.

Cerebral vasculitis causes the body’s immune system to attack blood vessels in the brain, often leading to hemorrhaging, said Sato, who runs a hospital in Osaki, Miyagi Prefecture.”

 

It’s hard to imagine that any of this would be news to Dr Diane Harper, the principal investigator in the Gardasil trials.

“Diane M. Harper, MD, MS, MPH Director of the Gynecologic Cancer Prevention Research Group and Professor of Obstetrics and Gynecology, Community and family Medicine, and Informatics and Personalized Medicine at the University of Missouri–Kansas City School of Medicine. Dr. Harper reports that she has served as a speaker and advisor for Merck and GlaxoSmithKline, and that the institutions at which she conducted HPV vaccination trials have received funding from Merck and GlaxoSmithKline.”

During this discussion  Dr Harper mentions that there is the potential for “ serious adverse events, including demyelinating diseases that cause blindness, paralysis, and death…”.

Dr Harper also states that “In the United States, the same women could choose a lifetime of Pap screening and be afforded the same protection against cervical cancer as they would get from vaccination.”

 

Something to consider

 

There are more than 100 types of HPV. At least 13 of these types of HPV are cancer-causing, according to the World Health Organisation. Gardasil contains only 2 of these – types 16 and 18 (along with types 6 and 11 for warts).

 

Dr Harper also made some very interesting points when interviewed by Marcia G. Yerman in 2009. (See full story here)

“Many vaccinated women have returned to me in clinic with more abnormal Pap tests and more HPV disease. They are tremendously disappointed when told that Gardasil does not protect against all types of HPV, and that they are still at risk for cervical cancer.

There is a real risk that cervical cancer will increase in the U.S. if those women getting Gardasil do not realize that:

• Gardasil will not protect them for life

• They can get other HPV infections that lead to cancer that are not covered by Gardasil

• They need to continue to have Pap tests throughout their lifetime.

 

Recent reports state that Gardasil may have triggered MS (Multiple Sclerosis) in some girls receiving the vaccine. What are your thoughts on this? 

“Neurologists at the American Neurological Association have indeed concluded that Gardasil is temporally associated with autoimmune attacks on the neurologic system. The range of neurologic disorders is unknown.”

Do you believe that the Gardasil vaccine, as it currently stands, could present more risks to a young girl or woman than the possibility of cervical cancer?

“Pap smears have never killed anyone. Pap smears are an effective screening tool to prevent cervical cancer. Pap smears alone prevent more cervical cancers than can the vaccines alone.

Gardasil is associated with serious adverse events, including death. If Gardasil is given to 11 year olds, and the vaccine does not last at least fifteen years, then there is no benefit – and only risk – for the young girl. Vaccinating will not reduce the population incidence of cervical cancer if the woman continues to get Pap screening throughout her life.”

Has the original Gardasil marketing campaign of “one less” muddied the waters and misinformed the public, who heretofore believed that a Pap smear was sufficient to protect them from cervical cancer?

“If women were participating in Pap screening, or if as a parent you educated your daughter to seek Pap screening at the appropriate age (21 years) for her entire life, then she would have been very unlikely to be at risk for being “one” and would not be “one less.” She would not have been “one” to begin with!

Yes, the marketing campaign was designed to incite the greatest fear possible in parents, so that there would be uptake of the vaccine. If parents and girls were told the benefits and harms of Pap screening and HPV vaccines as described above, an informed and valued decision would have been able to be made. Many may have chosen to continue with a lifetime of Pap screening and forgo the vaccines, with the unknowns of duration of efficacy and safety unable to be answered for many more years.”

Can you point out specific “misstatements” that Merck has promulgated about the Gardasil vaccine?

“Less misstatements, than incomplete statements. For instance, the cumulative incidence of HPV infections for women in the U.S. through the age of 50 years old is 80%. That statement is true. That statement infers that nearly everyone is infected with HPV at least one point in their life.

What is left out is that 95% of all HPV infections are cleared spontaneously by the body’s immune system. The remaining 5% progress to cancer precursors. Cancer precursors, specifically CIN 3, progresses to invasive cancer in the following proportions: 20% of women with CIN 3 progress to invasive cervical cancer in five years; 40% progress to cervical cancer in thirty years. There is ample time to detect and treat the early precancers and early stage cancers for 100% cure.

Other examples include inferences that Gardasil will last a lifetime, with no mention of boosters or limited protection possible. Regarding wart protection promotion, there is no mention that the data showed protection against genital warts in men for only a 2.4-year period of time.

Gardasil is not really a cervical cancer vaccine. The vaccine prevents HPV infection, not the development of cervical cancer.”

 

 

Something else to consider

 

The Australian National Cervical Cancer Screening program information here indicates that “The biggest risk factor in cervical cancer is not being screened every two years, and that 3 out of 4 women who develop cervical cancer have either  never had a Pap smear or haven’t had one in the past 5 years.”

It would seem that the real focus should be on further encouraging women to have their regular Pap tests, rather than encouraging a false sense of security in a vaccine covering only a couple of types of HPV.

 

 

Who yet knows whether Dr Bernard Dalbergue is correct when he says that Gardasil will be the greatest medical scandal of all time. What I do know is that if I check the Australian Therapeutic Goods Administration Database of Adverse Event Notifications, I can see that over 2,500 reports have been made about Gardasil so far in this country - and they include 9 cases of multiple sclerosis and 1 of blindness. As such sites as the TGA rely on passive surveillance, it is variously estimated that as few as 1-2%, or maybe up to 10% of cases are ever reported.

Would it even faze Merck if Gardasil did become the greatest medical scandal of all time? They will have surely by this time recouped their Vioxx scandal losses.

In my opinion, what definitely is a scandal at this current time is the way that children are being lined up like sheep to be given this vaccine at school in this country. The parents are provided with very little information – certainly no information that would allow them to make a true, informed choice. In my opinion, not only is that a scandal, it’s nothing short of an utter disgrace. In fact, it really gets to me.

 

needle