Pfizer and torcetrapib

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Category : Medical Rants

At the risk of redundancy, I will comment on the torcetrapib decision. For those who do not know what torcetrapib is – read this NY Times article – End of Drug Trial Is a Big Loss for Pfizer. Torcetrapib (trying saying that quickly) raised HDL levels. Many investigators think that raising HDL is the next frontier in secondary prevention of coronary artery disease.

Prior to getting FDA approval, drug companies must do clinical trials to demonstrate efficacy and safety. Unfortunately, torcetrapib failed the safety test.

The news came to Pfizer’s chief scientist, Dr. John L. LaMattina, as he was showering at 7 a.m. Saturday: the company’s most promising experimental drug, intended to treat heart disease, actually caused an increase in deaths and heart problems. Eighty-two people had died so far in a clinical trial, versus 51 people in the same trial who had not taken it.

Within hours, Pfizer, the world’s largest drug maker, told more than 100 trial investigators to stop giving patients the drug, called torcetrapib. Shortly after 9 p.m. Saturday, Pfizer announced that it had pulled the plug on the medicine entirely, turning the company’s nearly $1 billion investment in it into a total loss.

The abrupt decision to discontinue torcetrapib was a shocking disappointment for Pfizer and for people who suffer from heart disease. The drug, which has been in development since the early 1990s, raises so-called good cholesterol, and cardiologists had hoped it would reduce the buildup of plaques in blood vessels that can cause heart attacks. Just last Thursday, Pfizer’s chief executive, Jeffrey B. Kindler, said publicly that the drug could be among the most important new developments for heart disease in decades and that the company hoped to get Food and Drug Administration approval for it in 2007.

“I’m terribly disappointed,” said Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and lead investigator of an earlier torcetrapib clinical trial. “This drug, if it worked, would probably have been the largest-selling pharmaceutical in history.”

For people with heart disease, torcetrapib’s failure means that progress may be slowing after two decades of substantial advances against the disease. Medicines to lower blood pressure and bad cholesterol are already effective and widely used, yet heart disease remains the biggest cause of death in the United States, killing 911,000 people in 2003, according to the American Heart Association.

Heart disease patients do so much better in 2006 then 30 years ago. While a drug to increase HDL might help patients (obviously an unproven hypothesis), we actually have better ways available. Unfortunately, many patients would rather have a magic pill than to engage in the appropriate lifestyle changes.

The number one preventive measure remains smoking cessation. This totally trumps all drug therapy Weight reduction (for the obese) and exercise probably do as much as most drugs.

The problem with lifestyle changes is that they require patients to actively change their lives. Too many patients would rather search for that magic pill rather than confront the correctable lifestyle choices which they make daily.

The Food and Drug Administration said it endorsed Pfizer’s decision to end the trial and believed the company had acted properly. Torcetrapib’s failure is disappointing, but developing new drugs is risky and difficult, said Dr. Robert Meyer, director of the agency’s office of drug evaluation.

“Research is research,” Dr. Meyer said. “If you knew the answer, you wouldn’t be doing it.”

We should never forget that great theories do not always produce great results. We need randomized controlled trials to test theories. We should never skip that step.

Withdrawing this drug is a victory for patients, although we mourn those who died prematurely participating in this study. These studies are a victory for careful research and independent monitoring boards.

KevinMD has linked to a large number of blogs who have commented on this issue – Kevin MD on The torcetrapib disaster: Blogosphere response

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Comments (4)

I wish it was as simple as lifestyle changes. My total cholesterol level wasn’t ever very high and yet I still needed bypass surgery for 95% blockages at age 56. My main risk factor was a congenitally low HDL level, that never went up no matter what diet/exercises changes were made. This is a disappointment for many of us.

The time has come to realise that a legitimate hypothesis should have been laid to rest decades ago, but has been kept alive by the enormous revenues generated by statins.
People with low Total C can have heart attacks, people with high Total C often have none. That ought to have killed the whole cholestreol lowering fiasco stone dead.

The compliance rate for adherence to life-style changes / TLC [weight loss, dietary modification & exercise] is horrible. Wosre than ANY drug therapy. Dr Wm Castelli himself said in his recent Am J Cardiol interview with the editor,..”..the guideline writers obviously necer treat patients every day,.. if hey did they would see it [TLC] DOESN`T GET DONE !! They have to take the drugs !!’ In the same artcle he mentioned stains in a few paragraphs,.. no mention of fibrates,.. did mention fish oil,.. and spent a page & a half praising niacin. Hmmmmm. It is ALL in the fractions & ratios. Read the article,.. it is still cutting edge since our current myopia has kept us focused solely on LDL for over 20 years & not the global picture. See the video on Bradley Bale re GOOGLE to find it. 3800 patients followed for 10 years: ONE MI, no deaths. 89% statins, 83% ASA/Plavix, 74% ACE / ARB, 66% Rx Niacin, 53% TZD`s / Metformin.

Yes it IS in the cholesterol,..but it`s like a city,.. some good, some evil, some horribly dangerous [Lp(a)]. To quote Castelli [who sees similar results to Dr Bales`,.. “..They HAVE to taker the drugs !!..”

For the gentleman with severe [?] hypo-alphalipoproteinemia most common phenotype, yet NO fredrickson`s classification; 74% of all patients tested via ultracentrifuge/ VAp have low HDL2 & 30% that is the ONLY defect marked,.. low HDL2 [see Framingham data]. Niacin works slow,.. so do NOT be in a hurry. Start with carlson Labs 50 mg TID, titrate very slowuntil tachyphyaxis of the flush has occurred. Convert if Dr agrees to simpler Rx-ER-Niacin, after the TID “bolus” exceeeds 300 mg [900 mg/day]. ASA 325 & a fiber snack during titration. Castelli swears by Alka-Seltzer,.. I do as well. Your HDL2 will rise slowly, but it WILL rise:
113% at the 1st year on treatent with 1 gm daily. ~200% with 2 gms/daily. There IS NOTHING ELSE. Exercise, etOH, etc., are all ineffective on HDL2 and hat is the “game”. Again, ask Castelli, or sme one who actually knows,.. not merely the “holder of an opinion”. That is far too common. Most critiques of HDL treatment & niacin tx, are just that:
Observers, ‘opine-ers’ & NOT experienced clinicians. Anyone with 30% or more [Brad Bale, Castelli, Ziajka, Varveris, Taylor, etc.] of their dyslipidemic patients on 1-2 gms/daily niacin, have earned the right to profer an opinion.

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