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