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Statins Should be Removed from the Market!

I'm not the only one who feels this way. Maryanne Demasi PhD is an investigative journalist who writes for online media and top-tier medical journals. She was a TV presenter for the Australian Broadcasting Corporation (ABC) for over a decade. Her articles are hard-hitting and always on point.

 

I subscribe to her paid substack and recommend you consider doing the same to support her investigative work. Here is an example.



The cholesterol-lowering drug Crestor® (generic name rosuvastatin) was the last of seven statins in the drug class to be approved by the US Food and Drug Administration (FDA), paving the way for other regulators to follow the lead.


With the help of an aggressive marketing campaign, the cholesterol-busting drug quickly rose to prominence in an already crowded market.


In Australia for example, rosuvastatin is now the most prescribed drug, with over 14 million prescriptions written in the 2020/2021 financial year.  Its competitor, atorvastatin, is a close second.




No wonder Australians, a population I considered very independent-minded, rolled over and took the jab in unprecedented numbers. Statins harm the brain, thus impacting rational thought.


 

Early safety issues overlooked

Early testing showed that rosuvastatin was the most potent of all statins (milligram for milligram) at lowering cholesterol. But its higher potency meant greater toxicity.

Even before the FDA approved rosuvastatin, the drug was dogged by safety concerns after trial participants reported developing kidney problems and a rapid muscle-wasting condition called rhabdomyolysis.


In 2003, the FDA presented these findings to its advisory panel - specifically demonstrating rosuvastatin led to dose-dependent increases in proteinuria (abnormal levels of protein in the urine) and haematuria (blood in the urine).



 

The FDA also presented seven cases of rhabdomyolysis - a potentially fatal condition - which developed approximately nine months after subjects began taking 80 mg of rosuvastatin.


This was especially concerning because it was the only statin in the drug class that caused rhabdomyolysis in trial participants before its approval.


Not even cerivastatin, which was eventually banned in 2001 after 52 people died from rhabdomyolysis, had any cases that showed up in the clinical trials before its approval.

After deliberation, the FDA dismissed the concerns, saying that the rhabdomyolysis cases occurred mainly in patients taking the highest dose of rosuvastatin (80 mg), prompting the decision to discontinue manufacturing the higher dose.


In the end, the FDA went ahead and approved rosuvastatin at doses between 5 and 40 mg for the treatment of “primary hyperlipidemia” (elevated lipid levels).


 

Marketing hype

Once approved, the drug manufacturer - AstraZeneca - wasted no time boasting to investors that it would spend over a billion US dollars promoting Crestor® in order to dwarf its competition.


The undisputed market leader then was Lipitor® (Pfizer), with estimated sales of US$7.4 billion in 2002 and commanding a 42% market share in the statin drug class.

AstraZeneca’s then-CEO Tom McKillop vowed to knock Pfizer’s Lipitor out of its top spot, saying he would do whatever it took to persuade doctors to prescribe rosuvastatin.


“We’ve got to drive the momentum…you get one shot at launching a major new product. This is our shot,” he remarked.


It prompted Richard Horton, editor-in-chief of The Lancet to write a scathing editorial demanding that McKillop desist from his “unprincipled campaign.”


Horton labeled it “blatant marketing dressed up as research,” urging physicians to “tell their patients the truth” about rosuvastatin’s inferior evidence base (at the time, the drug had not been shown to reduce heart attacks, only lipid levels).


But McKillop responded by saying that it was “unthinkable” that AstraZeneca would desist from its efforts to make the drug more widely available to the public. 

“I deplore the fact that a respected scientific journal, such as The Lancet, should make such an outrageous critique of a serious, well-studied, and important medicine,” wrote McKillop at the time.


Determined to usurp the statin market, AstraZeneca launched a series of print and TV direct-to-consumer advertisements.


However, the marketing campaign made several false and misleading claims about the drug and caught the regulator's attention.


A TV ad, for example, falsely claimed that rosuvastatin (Crestor) was superior to its biggest competitor, atorvastatin (Lipitor). So, the FDA sent a warning letter to AstraZeneca stating;


The superiority claim was based on a study funded by AstraZeneca, which compared Crestor against other statins in that drug class – while Crestor performed better, it was not statistically significant. Accordingly, your suggestion that Crestor is superior to Lipitor is therefore misleading.

AstraZeneca pulled the ads, but the message had already been widely disseminated.


 

Post-marketing surveillance

After only seven months on the market, the FDA’s Adverse Event Reporting System (FAERS) recorded 18 cases of rhabdomyolysis.


Despite previous assurances by the FDA that rhabdomyolysis cases were confined to the 80 mg dose (which was discontinued), the cases reported to FAERS occurred in people taking much lower doses of rosuvastatin, i.e., 10 to 20mg.


There were also eight reported cases of acute renal failure and four of renal insufficiency in patients on rosuvastatin – again, mostly occurring at the lower dose of 10mg.


Sidney Wolfe, co-founder of Public Citizen’s Health Research Group, petitioned the FDA to ban Crestor after raising concerns about the rhabdomyolysis cases in the population.

However, the FDA denied the petition and blamed the higher rates of reported rhabdomyolysis on the negative media publicity over the withdrawal of cerivastatin (which led to 52 deaths).


“This is absurd,” said Wolfe in a statement then.


Wolfe’s own analysis showed the rate of rhabdomyolysis with rosuvastatin was 6.2 times higher than all statins combined -- and those cases were reported between Oct 2003 – Sept 2004, a time when the reporting of all statins would’ve been affected by the negative media publicity over cerivastatin.


“Once again, when faced with concerns about a drug's safety, the FDA has sided with the drug company AstraZeneca instead of the public….this will represent yet another blow to the agency’s badly tarnished reputation,” said Wolfe.


AstraZeneca - impervious to the criticism - marched ahead and commenced a major clinical trial of rosuvastatin, hoping to show that the drug could reduce cholesterol and heart attacks.


The trial would turn out to be the most controversial study of its time - The JUPITER trial.


Lewis Comment: I know the author of the JUPITER trial - Paul Ridker. You might be interested to know that the trial was designed to show that rosuvastatin (Crestor) reduced inflammation as measured by CRP. Ridker is chair professor of epidemiology at Harvard Medical School at Brigham and Women's Hospital, and he occupied the same building as Dr. Trempe, my mentor. Unsurprisingly, "The Brigham" is named on both the Crestor and CRP patents.


Am I implying a conflict of interest? YES.

 


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