Preface
Seventy million Americans and over two hundred million people worldwide
are taking a deadly drug called statins. How did this happen? Whose fault is
it?
The record reads like an Edgar Allen Poe novel. It did not start
with some grand conspiracy. It became one.
It was an insidious creeping cancer, a combination of events and
history. It was capitalism running amuck. It was the rise to power of one true
believer. It was competition and greed. It was corruption of good science and
good scientists. It was deregulation of the FDA. It was pride and prejudice and
the residual of WWII.
It was a poison so tiny it went unnoticed. It crept into the
culture in the name of good and infected everyone it touched with evil.
By 1930, cardiovascular disease (CVD) had become the leading cause
of death of Americans. It was an enemy to be stopped.
In 1913, a Russian scientist named Nicolay Anitschkow released a study
that grass-eating rabbits developed CVD when force-fed an all-cholesterol diet.
The evil seed was planted.
When WWII broke out the “Japs” became America’s archenemy. Movies,
news articles and newsreels portrayed them as diabolical “slant-eyed” demons.
It was a national agenda: “Beat the Japs”. The residual prejudice of that war
would play into the development and widespread acceptance of statins.
In 1948, the largest tax-paid study ever mounted on heart disease
began in a small town called Framingham. The cost of it would eventually amount
to hundreds of millions of dollars. It was established on a flawed agenda. It
set out to prove the relationship of high LDL cholesterol to heart disease (the
lipid theory). It failed. But millions of taxpayer dollars had been
spent and reputations and jobs were on the line; it had to succeed.
The evil began to grow.
The Framingham study proved that if you were male, between the
ages of 28 and 45, lived in Framingham and had high LDL cholesterol levels, you
had a 2% greater chance of dying from a heart attack or stroke than the
national average. On that one statistic a national health agenda began: stamp
out high LDL cholesterol in everyone. The lower the better.
The evil began to spread.
In 1957, a young Japanese scientist named Akira Endo graduated from
Tokyo Noko University and joined Sankyo – a Japanese drug company. His part in
the coming travesty would not be known until much later.
In 1959, the William S. Merrell Company pushed through the FDA, in
record time, a drug called triparanol (MER/29). It lowered cholesterol by
blocking the same biochemical path as statins.
Cataracts, skin lesions, hair loss, impotence and neuropathy began
to develop in the patients. Whistle-blowers came forward. Merrell Co. had lied
and withheld information pertinent to approval. Heads rolled, people were
convicted, lawsuits abounded and the drug was withdrawn in 1962.
MER/29 was a hugely profitable and popular drug.
Enter Daniel Steinberg MD, PHD, NIH investigator, egomaniac and
true believer. He led the science team that dismantled MER/29 and had advised
the FDA against approval. His stature rose far beyond that of a public servant
just doing his job. In time, he became an NIH chief with far-reaching
influence. In third-person language of a narcissist, he would later publicize
himself as a hero in structuring FDA’s approval of statins: “Daniel Steinberg
did this. Daniel Steinberg did that.”
Steinberg hails Nikolai Anitschkow as the first lipid theorist worthy of the Nobel
Prize – having supposedly first proved that LDL cholesterol is the cause of
heart disease. He would spend hundreds of millions of taxpayer dollars on the
CPPT (Coronary Primary Prevention Trial). It failed.
Undaunted, he would manipulate the statistics to be right
regardless the true results. That had already been done with the Framingham
study. He perverted an absolute statistic of less than two percent in the CPPT
study into a 19% relative statistic. He then declared the cholesterol wars over
and the lipid theory factual science. He gathered like-minded true believers
and formed the NIH “consensus panel” on cholesterol.
In 1980, statin development came to a screeching halt due to
cancer in Sankyo’s lab animals. Daniel Steinberg and Akira Endo would resurrect
its development.
In 1981, Endo published the results of clandestine human studies
in Japan. Steinberg consulted Merck and the FDA, discredited Sankyo’s findings
of cancer in more than half their statin-fed dogs and helped pave the way for starting
human trials in the U.S. so as to beat Japan in a “knock-down drag-out race” –
an ugly leftover from WWII.
In 1982, human studies began on Merck’s lovastatin at a university
in Dallas using NIH grant funds. The taxpayers would pay for Merck’s trials.
In February 1987, Daniel Steinberg, the former NIH chief turned
Merck’s advisor, would be the first speaker at the FDA advisory committee meeting
on statins, held at the NIH.
In August 1987, the FDA approved lovastatin.
In October of 1987, the National Heart, Lung and Blood Institute
(of the NIH) launched the largest free advertising program ever devised: the
National Cholesterol Education Program (NCEP). Steinberg again led the way. At
taxpayer expense, Americans were screened and 25% prescribed statins to take
the rest of their lives. The taxpayers would pay another 150 million dollars to
advertise for Merck. Steinberg would brag of his involvement in his later
writings.
The evil had overcome the land like the creeping vines of Japanese
kudzu had swept over southern farmlands and immersed them in a tangled
impenetrable web.
Even leeches and bloodletting have proved more useful and safe
than statins.
Never in the history of medical science has one man and his followers
done so much harm to so many. Steinberg
et al. have been beating a dead horse.
The myopia of their dead science and findings have harmed and killed too many
to count.
Akira Endo is another dangerous and driven man.
There
was only one thing certain about Anitschkow’s rabbits: they are natural vegetarians that do not
normally suffer cardiovascular disease. The cholesterol they were fed was never
the enemy. The quantum leap that even Anitschkow did not make linking cholesterol
to heart disease was not just bad science.
It was,
and remains, insane.
James and Hannah Yoseph
March 12, 2012
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