Wednesday, December 03, 2008

Manufacturing Customers

Born With a Statin Deficiency?

By MARTHA ROSENBERG

When Dr. Paul Ridker of Brigham and Women's Hospital in Boston, MA presented the results of the AstraZeneca-funded JUPITER study at the American Heart Association conference in November--JUPITER standing for The Justification for the Use of Statins in Primary Prevention--there were a lot more stenographers than skeptics in the press corps.

How could a drug company-funded study designed to show why the general population should use its drug (Crestor, or rosuvastatin) be objective? Or even newsworthy?

Especially when its lead author is co-inventor on the related patent?

And its authors list 131 financial ties to drug companies? Hello?

But the press didn't let overt conflicts of interest--COIs as pharma calls them because they're so common--ruin the story.

"AstraZeneca's Crestor Cuts Death, Heart Attack," exalted Reuters remembering the PR dictim of getting Name and Company in the headline. "Crestor Study Seen Changing Preventive Treatment!"

"Wider Cholesterol Drug Use May Save Lives," trumpeted other headlines.

"Statins For Everyone!"

"Crestor In The Water?"

Was this the same Crestor which was vilified in a Lancet editorial three months after its 2003 US approval as "inadequately investigated"?

Named as one of the top five most dangerous drugs by the FDA's Dr. David "Vioxx" Graham on Capitol Hill in 2004?

Petitioned for recall by the Washington D.C. based Public Citizen?

Found worthless against chronic heart failure just one month earlier in Lancet?

In the feeder frenzy to cover the self-engineered drug breakthrough, where was press mention of another American Heart Association finding about Crestor in its journal Circulation in 2005? [111:3051-3057]

That Crestor "was significantly more likely to be associated with the composite end point of rhabdomyolysis, proteinuria, nephropathy, or renal failure," than other drugs?

Where was mention of the FDA warning about rhabdomyolysis--the muscle disease that did Bayer's Baycol in--that was added to Crestor in 2005 after a patient death--along with warnings to the physician about Crestor use in Asian patients, people with severe kidney disease and patients taking cyclosporine?

Oops.

But while the gee whiz press focused on the JUPITER study's startling results--the Crestor group had a 54 percent reduction in heart attacks, 48 percent reduction in strokes and 20 percent reduction in death compared to placebo--especially in light of the fact that the study group was free of heart disease and high cholesterol, most doctors wouldn't drink the AstraZeneca Kool-Aid.

The study's 17,802 enrollees may have had normal levels of the bad LDL cholesterol but some were "walking vasculopaths," with abnormal C-reactive protein levels [CRP] which indicate inflammation in the body said Dr. Bernadine Healy, health editor for U.S. News & World Report.

"As a result, the JUPITER trial was riddled with obesity, high blood pressure, prediabetes, and genes predisposing to heart disease," said Healy. "Almost 3,000 enrollees were smokers, a big time CRP elevator, and only 10 percent took aspirin, an inexpensive preventive medicine that protects against both heart disease and stroke. (Aspirin also lowers CRP.) Other study patients were really healthy, free of any known risk factors and yet had elevated CRP for no obvious reason."

While the press bought AstraZeneca's contrivance that the JUPITER study was so conclusive it was ended early, many of the 470 doctors who posted online comments after the study in the New England Journal of Medicine (Nov. 20, 2008) said you ended the trial WHEN?

"It is well established that RCTs [randomized controlled trials] stopped early overestimate benefits significantly," wrote a physician from Rochester, MN.

"It is shocking that this trial was terminated 50% through, based on a small absolute benefit, with real questions about long term risk," said a poster from the Public Health Law Program, LSU Law Center.

"There is no justification for stopping the follow-up, even if the triallists felt it was unethical to recruit new patients," wrote a physician from Yorkshire, UK. "Congratulations to AstraZeneca for selling the results to the uncritical lay media. I feel sorry for all the family doctors who will be pestered by patients for some time to come."

Doctors also balked at the study's ipso facto preference for a pill over lifestyle changes like diet and exercise--including the well known Dr. Dean Ornish of Preventive Medicine Research Institute who noted the nation spent $20 billion on cholesterol-lowering drugs last year.

While cardiologists were soft on the study--except one who assailed the Western "pandemic food addiction and the mirage of immortality in a bottle of pills"--many other doctors detected disease mongering behind JUPITER of the sort that sold HRT and Vioxx to anyone over 50.

Even a medical student wasn't impressed.

"I don't think risking the patient's life by giving him statins is a correct procedure. I would be giving him/her benefits for a disease which has not been diagnosed yet and increasing the odds of developing another disease (Diabetes)," she wrote.

Martha Rosenberg is staff cartoonist on the Evanston Roundtable.

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