Pfizer’s loss – lessons for all of us

Implications:

Implications:

• We can learn from the failure of torcetrapib in clinical trials.
• Drug development is risky and unpredictable, and we need to temper our enthusiasm over news that emerges during this process.
• Hypertension remains an important risk factor for heart disease and requires a renewed commitment by all to detect and treat it properly.
• Torcetrapib-like drugs in development could also run into similar problems.
• We need to know more about mechanisms of diseases and not confuse association with causality.

Analysis: Pfizer’s decision to terminate a clinical trial and development of torcetrapib because of excess deaths occurring during the trial is obviously tragic for the victims and disheartening for many. Nevertheless, we can all learn some lessons from this experience. Bad things can happen anytime during the drug development process and we must remember to cautiously interpret and react to all news, good and bad, during this process. Because it appears the deaths in this trial may have been related to the surprising development of hypertension in patients treated with torcetrapib, we need to remember that hypertension is a significantly more ominous risk factor for atherosclerosis than lipids and we need to renew the commitment to detect and adequately treat hypertension. Pharmaceutical companies have, and should, play a key role in this process. Since the mechanism of the torcetrapib-related deaths is unknown, there has to be concern over other similar drugs in development for the treatment of low levels of so-called “good cholesterol” (HDL-cholesterol). Finally, just because low levels of HDL-cholesterol are associated with increased risk of heart disease, it doesn’t necessarily follow that raising HDL is good, as HDL may just be a “marker” and not a cause of the increased risk.