Visions of Sugarplums On paper it was golden: Combine the world's best selling drug (the LDL cholesterol lowering Lipitor) with a second drug that promised to raise HDL cholesterol.
Not only would this drug combo balance the cholesterol therapy picture (up with the good - down with the bad), but it would also ensure that Pfizer (the maker of Lipitor) would remain the dominant player in cholesterol drug therapy.
Ah, but visions of sugarplums have a way of vanishing when the sun rises and the aroma of fresh brewed reality fills the house.
Deadly imbalance
You may have heard the news this past weekend: Pfizer abruptly ended a major clinical trial of torcetrapib - a drug designed to raise HDL - because of an "imbalance of mortality and cardiovascular events." That quote, from a press release posted on the Pfizer web site, is a corporate-speak way of saying that too many subjects were having heart attacks and dying, although specific details about what caused the deaths have not been revealed.
The press release includes a statement by Pfizer's CEO Jeffrey Kindler who called the sudden turn of events, "surprising and disappointing."
Disappointing? I'll buy that. But surprising? Not so much.
HSI members may recall that I first told you about torcetrapib more than two years ago ("Beef 'n' Butter" 4/20/04). And in a follow up e-Alert I sent you last year, I noted that preliminary trials suggested there were hypertension concerns with higher doses of torcetrapib. Not exactly what you're looking for in a drug designed to PREVENT heart disease.
This choice of words - from a 2004 Forbes magazine article - has a chilling effect today: "Doctors working on the clinical trials seem to think the high blood pressure side effect will not kill the product."
Unfortunately, they didn't seem to think about whether it might kill the patients.
Not the one, not the only
According to Bloomberg, Pfizer devoted $1 billion dollars to the development of torcetrapib. Yes, you read that correctly: one billion. But that's small potatoes compared to the projected sales of $20 billion PER YEAR the new drug was expected to generate.
The Bloomberg article also offers this quote from Steven Nissen, the head of cardiology at the Cleveland Clinic, "I'm terribly disappointed on behalf of our patients."
But Steven! Why so glum, chum? As a prominent cardiologist you must be aware that torcetrapib wasn't the one and only HDL-boosting option available to your patients.
For instance, in several e-Alerts and HSI Members Alerts we've told you how some people enjoy a double heart-healthy benefit from supplements of niacin (vitamin B-3), which raises HDL while also lowering triglycerides.
And in the e-Alert "To Lower, or Not to Lower…" (9/9/03), I told you about a trial that tested policosanol (a compound of fatty alcohols) on more than 240 women with high cholesterol. Over six months, the supplement lowered LDL levels by more than 25 percent, lowered total cholesterol by more than 16 percent, and raised HDL by nearly 30 percent. And in a 2002 issue of his Nutrition & Healing newsletter, Jonathan V. Wright, M.D., notes that some patients may experience LOWER blood pressure when taking policosanol.
And then, of course, there's always the old fashioned way to raise HDL: exercise and diet. In 2003, two University of Pennsylvania studies showed that subjects on the Atkins low-carb diet raised HDL significantly more than subjects on a "normal" diet. Subjects in the Atkins group also had greater triglyceride reduction and increased insulin sensitivity (lowering the risk of type 2 diabetes).
So let's not shed too many crocodile tears over the loss of torcetrapib. There are plenty of heart-health options that are actually healthy…without that pesky side effect of death. |
