THE pharmaceutical giant which threatened to ‘destroy’ doctors
expressing concerns about one of its drugs is in court again for
allegedly lying about the efficacy of its measles, mumps, and rubella
vaccine.
Merck ranks third on the list of most-fined drug manufacturers with $10.7bn fines to date, and by 2009, had paid over £2billion compensation to 44,000 US citizens because its arthritis drug Vioxx increased
the risk of heart attacks. Now, in a shocking case brought under the
False Claims Act, a 200-year-old law introduced to protect the US
government from fraud, it admits falsifying data relating to the mumps
component of its measles, mumps, and rubella (MMR) vaccination.
Merck*, which annually sells $100million (£78million) MMR doses in
the US, told the Centers for Disease Control (CDC), the US public health
body who purchase it, and the Food and Drug Administration, (FDA) who
licensed it, that it provided children with 95 per cent protection
against mumps. That figure could be as low as 50 per cent or even zero.
From 2000, increasing mumps outbreaks amongst the fully vaccinated
and boosted prompted the FDA to instruct Merck to prove the 95 per cent
protection claim, otherwise they would lose their licence. Merck re-ran
the numbers and fell way short. They designed a test to measure
effectiveness – Protocol 7 – that included rabbit’s blood in the hope it
would falsely enhance the sensitivity of it. They also swapped the wild
measles virus for the weakened vaccine strain in the test. Nothing
improved the figures enough and they stood to lose millions in revenue.
Investigating the alleged fraud, Dr Andy Wakefield said: ‘At that stage
they simply decided to cross out the numbers and change them for numbers
that gave them the result they wanted.’
Despite overwhelming evidence, first highlighted in 2010 by Merck
whistleblowers, virologists Stephen Krahling and Joan Wlochowski, last
July Judge Chad F Kenney ruled in favour of the drugs giant who claimed
that doctoring the data did not matter because the US government knew
and continued to buy their MMR jab anyway. The government’s defence was
that they had no choice as they had to protect children against measles.
Merck hold the US monopoly for MMR, and measles was targeted for global
eradication using the vaccine. An appeal is expected to be heard next
month.
The convoluted case is the subject of an award-winning feature film Protocol 7, being
premiered today. It follows the story of a mother and lawyer, played by
Rachel Whittle, who discovers the fraud while trying to find reasons
for her adopted son’s autism. Actors Matthew Marsden and Eric Roberts
(Julia Roberts’s brother) also star.
It is directed by Andy Wakefield,
the much-maligned British doctor struck off after he raised concerns
about the MMR vaccine’s links to bowel disease and autism. Dr Wakefield,
who has read thousands of pages from court documents relating to the
mumps scandal, said: ‘The judge did not rule in favour of Merck on the
basis of fraud. Merck have not effectively denied the efficacy problems.
‘Merck’s lawyers argued that the government went on purchasing the
vaccine and if the evidence about the mumps component was valid, they
would have stopped. Lawyers for the whistleblowers said number one, the
CDC as the purchaser of the vaccine was defrauded, and they did not know
what Merck had been up to. Number two, because it is a triple vaccine,
they had to go on providing children with immunisation against measles
and rubella. There was no choice.
‘You would think they were pretty sound arguments, but the judge
still ruled that because the government went on purchasing it that the
issue of materiality won the day.’ (The legal term ‘materiality’ means
important or significant.)
Protocol 7’s legal adviser Jim Moody said: ‘There are many
studies that show the mumps component doesn’t work at all to around 50
per cent of the time. It’s a plain vanilla false claims case like if
you’re selling a defective piece of hardware to the military.’
The terrible irony is that the US did not want the mumps component,
developed by American vaccinologist Maurice Hilleman in the 1960s.
Dr Wakefield said: ‘Somehow it got on to the market. Merck combined
it with measles and rubella because they own mumps and put all their
measles competitors out of business.
‘Measles was the market because it was targeted for global
eradication using the vaccine. That’s where the money was. Suddenly
Merck owned the monopoly in the US on MMR and measles.’
Millions of children have potentially been harmed because of the
alleged fraud. Dr Wakefield said: ‘Mumps as a child is trivial. Mumps as
a teenager and beyond puberty is not trivial; there’s a much higher
rate of testicular inflammation and sterility, ovarian inflammation and
meningitis. So, a vaccine that does not work makes a trivial disease a
more serious disease. That’s why safety and efficacy are inextricably
linked with the mumps vaccine. The vaccine failed or wore off and
children became susceptible when they were far more vulnerable to
permanent damage. Merck knew this, they knew they were dealing with a
potential timebomb.’
The MMR was introduced in the US in 1971 (1988 in the UK) but most infectious disease had declined by 98 per cent before any vaccinations were introduced. Mumps cases rose again in 2006,
most of them in vaccinated children or adults. The CDC admitted that as
many as 94 per cent of those who contracted the illness had been
vaccinated. They failed to recall the jab, patients were not warned, and
Merck failed to mention that although they claimed their product had a
24-month shelf life, the mumps component only lasted only 12 months.
Merck are known to play rough, and their dirty tricks first came to
light in 2009. During the Australian Vioxx trial, emails showed they had
made a ‘hit list’ of
doctors criticising them and their drug Vioxx. Their communications
used words such as ‘neutralise’ and ‘discredit’ next to the names of
various doctors. One particularly shocking memo said: ‘We may need to
seek them out and destroy them where they live.’
Dr Wakefield’s career was destroyed for questioning the MMR. A senior
lecturer, liver transplant surgeon, and paediatric gastroenterologist
at the Royal Free Hospital in north London, his case study series,
published in the Lancet in 1998, looked at 12 children with
bowel disease and autism, eight of whom developed both issues after
receiving the MMR, their parents said. The study concluded they needed
further investigation to prove the link. This never happened as the
following furore saw Dr Wakefield struck off the medical register by the General Medical Council (GMC) in 2010.
He was immediately cancelled by the British media, which served as a
warning to all doctors and scientists questioning vaccines. He said:
‘It’s a very different world now, everybody understands cancel culture,
but then there was just me. I don’t mean that to sound poor old Andy
Wakefield, it’s just a historical fact of life. We didn’t have the
systems in place to take people down: the prototype was developed
through my experience.’
Covid vaccines and the resulting deaths and injuries have changed many doctors’ opinions of him, as Dr Ahmad Malik’s podcast
discusses. The public’s experience of covid vaccines, capable of
causing permanent disability and death, have made them wonder if
childhood vaccines can also cause considerable harm.
Dr Wakefield agrees. He said: ‘The whole covid saga will turn out to
be one of the greatest mistakes that science and experts and
carpetbaggers and the pharmaceutical industry have ever made. It has led
to almost a complete loss of trust in public health and the
pharmaceutical industry.
‘This is why these films are so important. You can provide a series of facts that make people think. There is a silver lining.’
Merck, the CDC, the FDA and GlaxoSmithKline were all contacted for comment. None has been received.
NOTE: If the whistleblowers’ appeal is successful the likelihood is
that Merck will settle out of court, not with any children or adults
damaged by their product but with the US government. Mr Moody said:
‘These kinds of cases always settle because the damages are too big,
three times the size of the purchase. They’ll probably end up settling
for $100million or more. Merck will never risk a jury.’
*NOTE: GlaxoSmithKline sell the MMR jab in the UK.
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