What is behind the Lipitor curtain?

Pfizer Suit May Open Skeleton-Filled Closet on Side Effects of Cholesterol Drug Lipitor

By Jim Edwards | Feb 12, 2010

Jesse Polansky’s whistleblower suit against Pfizer (PFE), his former employer, over its best-selling cholesterol drug Lipitor, contains a small section about the drug’s alleged side effects — muscle weakness, memory loss, fatigue and strokes — that Pfizer will doubtless like to see get as little publicity as possible.

Lipitor is a hugely popular drug taken by millions of middle-aged and elderly Americans. It generated $11.4 billion in sales for Pfizer last year — just over 20 percent of the company’s entire revenue. The drug has a gold-standard reputation for safety. However, so many people take it that even a small rate of side effects still adds up to thousands, possibly millions, of patients affected. And that means lawsuits.

In short, side effects on Lipitor are like a closet that may or may not contain skeletons, and no one has yet gotten the door open to look at them.

The suit will no doubt be eagerly read by plaintiffs who have already sued Pfizer over Lipitor’s side effects. (Pfizer has previously described the suits as “baseless.”) Polansky, a former outcomes manager for Lipitor, claims:

… one issue not yet fully explored is aching muscles (“myopathy”), one of the leading side effects of statin use. Sen.Charles Grassley recently wrote the FDA asking whether the agency has sufficiently considered potential problems caused by statins, in particular myopathy.

BusinessWeek reported in September:

Grassley’s investigators were struck by the number of people who have come to them with tales of serious side effects and long-lasting injuries after taking the drugs. The most common side effect of statins is muscle pain. The aches usually go away if people stop taking the drugs, but there’s growing evidence that pain—and worse—can continue for years afterward.

Polansky’s suit contains this anecdote about Pfizer’s interest in muscle pain and weakness issues:

Dr. Paul Phillips is Director of Interventional Cardiology at Scripps Memorial Hospital in San Diego, California, is a specialist in statin myopathy who was scheduled to speak at a Pfizer national research meeting in or around 2003. His presentation was summarily canceled the day before because Pfizer “did not want to hear too much about muscle toxicity.”

Pfizer has previously opposed Polansky’s suit and had it dismissed at least once.

The other issue is strokes. Pfizer advertises Lipitor as lowering patients’ risk for a stroke, but some researchers have found that incertain patient subgroups risk of stroke actually increases.

Bottom line: Lipitor’s patent expires in 2010, which will cause Pfizer some financial problems. But we’ll be hearing about the legal problems for years after that.



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