Early this month Pfizer Inc., world's largest pharmaceutical company, came out with a devastating announcement: It is abandoning the clinical development of its highly promising cholesterol drug, torcetrapib. The decision follows the recommendation of an independent board monitoring the study of the cholesterol drug on account of an unacceptable number of deaths among the trial subjects. A total of 82 people died during the trials at various centres and Pfizer directed more than 100 trial investigators to stop giving the drug to the patients. Higher death rate was among patients taking a combination of torcetrapib and Lipitor, Pfizer's $12 billion cholesterol drug. Torcetrapib was one of the biggest blockbuster drugs in the giant's pipeline and Pfizer had already spent $800m developing torcetrapib for over a decade. The company had undertaken perhaps the most comprehensive clinical trial development programme ever for this drug involving 25,000 patients at hundreds of trial centres worldwide. Torcetrapib was designed to raise HDL levels of what's commonly known as good cholesterol. Pfizer has two other products in early development to raise HDL and it is possible that suspension of torcetrapib trials could affect the development of these two products too. A consolation, however, to Pfizer is that the torcetrapib-related deaths occurred during the clinical trials and before the drug reached the market. Otherwise, it would have faced numerous product liability lawsuits costing several billions of dollars as in the case of Merck over its painkiller, Vioxx. Merck withdrew Vioxx from the market two years ago after evidence indicating that it could cause strokes and heart attacks.
Pfizer is in the midst of a serious crisis for some time now on account of lower sales, profitability and a poor product pipeline. And it was mainly counting on torcetrapib to change its fortunes in the coming years as Lipitor, contributing almost 25 per cent to its sales, is to lose the patent by 2010. Apart from the untimely demise of torcetrapib, Pfizer is also facing quite a few patent expirations in the next five years. All these are going to hurt the company quite badly. The crisis that is being faced by Pfizer is only part of a major dilemma confronted by the world pharmaceutical industry. Despite an average 18 per cent expenditure on R&D, pharmaceutical giants are finding it difficult to get blockbusters for some years. Pfizer, despite its annual spend of $7 billion on research, its near-term pipeline of new drugs is almost empty. Worldwide, the rate of new drug launches has dropped from an average of 1.5 product per year from the top 20 companies during the last decade to less than one new product per year since 2000. This is quite alarming. As per the latest US FDA figures, new product launches by pharmaceutical industry fell to a low of 21 molecules in 2003 from 36 in 2002. Whereas, the global pharmaceutical industry had the largest number of 53 approvals in 1996. Increasing number of failures in development stages of drugs are putting tremendous pressure on pharmaceutical companies and it is quite possible that they may push riskier compounds into later stages of development in order to somehow get the next best seller. This is a dangerous situation for the patient community and it calls for a stringent regulatory vigilance on new drug approval process.