Pfizer's new CEO, Jeffrey Kindler, implicitly acknowledged last week, that Pfizer has hit the wall. "Despite the nearly $15 billion it made last year it; despite the fact that it still has the best-selling drug in the world, Lipitor, which generates around $13 billion in annual revenue - its reliable business model had begun to break down", is the assessment of Joe Nocera in an article in the New York Times' business section.

"Jeffrey B. Kindler, announced that Pfizer was going to do some serious retrenching. For starters, it would lay off 7,800 people. Along with a previously announced reduction of 2,200 sales representatives, that meant Pfizer was going to cut 10,000 jobs, about 10 percent of its work force", continues the article.

Vera Hassner Sharav of the Alliance for Human Research Protection has a comment about this:

"Oddly, the New York Times seems to buy industry's efforts to gain even longer patent extensions beyond its current 20 year market exclusivity. What the Times doesn't begin to address is that many of the blockbuster drugs have no proven, demonstrable therapeutic value, but rather a perceived benefit that when the adverse events are added up, the perceived benefit disappears.

By checking the initial FDA-approved label and subsequent changes in the labels of blockbuster drugs provides insight about how risky it is to consume a newly approved drug.

Take Pfizer's blockbuster antidepressant, Zoloft--whose sales in 2005 reached $3.5 billion. In scientific controlled trials, its benefit (82% of its benefit) was matched by placebo--which carries no risks and no cost.

Pfizer's Zoloft label history shows an incremental acknowledgment of previously undisclosed serious risks of harm. The labels do not reflect any commensurate findings of added benefits for those who are exposed to those increased risks of serious harm.

By the time the latest Zoloft label included a black box warning about suicidality in children and adolescents -- its patent protection had almost run out. Even today, the Zoloft label does not yet reflect the evidence that the drug poses a greater than twofold increased risk of suicidality for adults -- as the FDA's latest reported finding (December 2006) show."

This gradually emerging profile of deadly side effects is by no means unique to Pfizer's Zoloft. Other companies and indeed a number of drugs are suffering similar problems. Merck's Cox-2 inhibitor Vioxx was approved in 1999 but after some years, as thousands of deaths among patients could no longer be covered up, the company decided to remove the drug from the market. In 2001, Bayer withdrew its cholesterol-lowering Baycol after it had been linked to more than 50 deaths, later estimated to have been more than a hundred - an ominous sign for Pfizer's blockbuster Lipitor.

When 13 billion dollars out of your total yearly income of 15 billion are from the sales of one fatally flawed drug like Lipitor, you know you are in trouble, despite the size of your company. Despite its apparent success, Lipitor has an appalling side effect profile, and the philosophy behind it - the drug interferes with the liver's natural ability to produce cholesterol - renders the drug both damaging and ineffective.