Medical "breakthrough" - cholesterol therapy for people with low cholesterol

New Era

Treatment for people who don’t need treatment. What a concept! This just might be the dawn of a new era in medicine.

And doctors everywhere must be kicking themselves and asking, “Why didn’t someone think of this sooner?”

Comforting the unafflicted

Big news from the New England Journal of Medicine: People with low cholesterol levels who took Crestor, a cholesterol-lowering statin drug, “significantly reduced the incidence of major cardiovascular events.”

Of course, not everyone has the same definition for “significant.”

According to the Associated Press, the research is being “hailed as a watershed event in heart disease prevention.” And yet, the study suggests that if 120 people with low cholesterol take Crestor for two years, only one heart attack, stroke, or death will be prevented over that two-year period.

Those 120 theoretical consumers will each spend more than $1,200 per year on Crestor, so it’s sort of like playing a very expensive lottery with no way to find out if you’re the one and only winner. You have to take that on faith. And in this case your faith would be based on this single study, sponsored by AstraZeneca, the maker of Crestor.

Ah, but the guys at AZ didn’t stop there. Of the 14 researchers who conducted the study, 10 received either “consulting fees” or individual grant support from AstraZeneca.

Now imagine if a dietary supplement study showed heart protection benefits, and the supplement’s maker had sponsored the study. Please. The mainstream media would lead off with that caveat, basically dismissing the study results.

So how did the AP handle the sponsorship issue? That little detail was quietly buried in paragraph 20.

Reading the fine print

The AP also mentioned (but didn’t explore) one glaring detail that doesn’t quite pass the smell test.

The Crestor intervention period was designed to last five years, but “independent monitors” stopped the study after about two years because “those taking Crestor were faring better than the others.”

Okay…but they weren’t fairing THAT much better. Why not let the study continue so we could judge Crestor’s true long-range effects?

Could a healthy fear of side effects have something to do with the cancellation?

Amid all the chirpy optimistic talk of Crestor reducing heart risks, far less attention was given to this result: New cases of diabetes and elevated blood sugar levels were markedly higher in the Crestor group compared to placebo.

On top of that, Crestor has a history of other serious side effects.

In 2004, Sidney M. Wolfe, M.D. (director of Public Citizen’s Health Research Group) sent a letter to the FDA, requesting the drug be taken off the market. Dr. Wolfe wrote, “We based our opposition to the approval of this drug on its unique renal toxicity and on the higher rate of life-threatening rhabdomyolysis (destruction of muscle) than had been seen with other statins in pre-approval clinical trials. As of August 26, 2004, there had been 65 U.S. reports of rhabdomyolysis among patients taking Crestor in less than the first full year of its availability in this country…”

In other words, perfectly healthy people who take Crestor might (MIGHT) reduce heart risks, but they’ll also open the door to plenty of other potential problems.

It’s all right there in the fine print, but don’t expect to get much of that from the AP or other media outlets.

Sources:
“Rosuvastatin to Prevent Vascular Events in Men and Women with elevated C-Reactive Protein” New England Journal of Medicine, Published online 11/9/08, content.nejm.org
“Study: Wider Cholesterol Drug Use May Save Lives” Marilynn Marchione, Associated Press, 11/9/08, ap.org

Letter to FDA from Sidney M. Wolfe, M.D., Director, Public Citizen’s Health Research Group, 10/29/04, citizen.org