Back to the drawing board for Pfizer, et al

Drug giant Pfizer is in a panic after its new generation heart drug - designed to raise 'good' HDL cholesterol - was blamed for the deaths of 82 participants in a pre-licensing trial.

Pfizer is desperate to find a replacement for its statin drug Lipitor, which is the world's best-selling drug with annual revenues of around $10bn. The drug loses its patent protection in 2010, when it becomes open season for other manufacturers to produce 'me too' generic copies.

As with all statins, Lipitor lowers the 'bad' LDL cholesterol in the blood - but Pfizer researchers reckoned they could reduce heart deaths more dramatically if they instead raised the levels of HDL cholesterol.

The new drug, called torcetrapib, was due to be licensed for approval next year, and was undergoing $800m trials. Researchers running the trial recommended an immediate halt following the deaths of 82 participants who were taking the new drug in combination with Lipitor.

It's thought that the participants may have died from raised blood pressure, an effect that was reported early on, but one that Pfizer chose to ignore.

Interestingly, 51 participants who were taking only Lipitor also died. This may be as equally surprising to Pfizer as the torcetrapib results. According to the drug company, Lipitor causes a little bloating and gas. Many patients suffer many more serious side effects, including muscle wasting, and according to the latest Pfizer trial, death.
(Source: The Guardian, 5 December 2006).

and here is what the BMJ has to say about STATINS -

STATINS: Heart patients get them after op, but doctors don't know why

It's extraordinary just how frequently medicine works with myth rather than fact. One example is the use of cholesterol- lowering statin drugs, which have become one of medicine's holy grails for patients with coronary heart disease.

Heart specialists are convinced that statins are a vital part of patient care, especially after high-risk surgery.

But scratch the surface and you discover that this post-operative medical practice, conducted in every heart unit in the West for decades, is based on just 16 observational studies - which means they're not even properly regulated trials - and on two small studies.

Researchers from the University of Alberta made the discovery when they sifted through 2,373 references for statins. But these reduced down to just the handful of observational studies that provided any meaningful data.

The truth is, the researchers conclude, we just don't know if statins are helping heart patients after surgery.

So what to do? Well, it might be an idea to test the theory once and for all and discover if the statins are helping - or possibly harming - the patient.

(Source: British Medical Journal, 2006; 333: 1149-52).