Lipitor Lawsuits Question Safety Of Statins

"The Takedown" slogan ironically may be on Lipitor this time

This Washington Post story about two men who have sued the manufacturer of the commonly prescribed cholesterol-lowering drug Lipitor because it caused irreparable damage to their muscles is the first in what will likely be a long line of lawsuits to come questioning the safety and even the need for statin medications.

Former Atlanta insurance executive Charles M. Wilson as well as New York City criminal trial lawyer Michael Mazzariello each filed separate lawsuits in Manhatten State Supreme Court on Wednesday alleging that the drug Lipitor caused them to experience intense pain in their muscles and joints, overall weakness and even trouble remembering simple tasks.

Wilson, 67, said he took Lipitor for nearly one and a half years from 2002-2003 and now he has a series of irreversible health problems, including peripheral nervous system damage (peripheral neuropathy), inflammatory demyelinating polyneuropathy, and memory loss. He alleges in his lawsuit that although he has been off the drug for about three years, he still has trouble keeping his balance, has a constant burning sensation in the hands and feet, and is always fighting off fatigue. Wilson said he had to go into early retirement as a result of the injuries he sustained while taking Lipitor.

Meanwhile, Mazzariello, 47, said he had to be hospitalized several times while he took Lipitor and even started walking with a cane while not being able to enjoy his favorite activities such as gardening and playing with his 1-year-old child. Also, he said there was a noticable amount of memory loss that he attributes directly with his use of a statin drug that was prescribed to him by his doctor.

"[Lipitor] ruined my life," Mazzariello said.

Interestingly, Mazzariello added that the side effects of Lipitor that he experienced have subsided somewhat after he stopped taking the medication but noted in a news conference on Thursday that he still has pain, a sense of tiredness and even tingling in his extremities that has not gone away.

At that same news conference even more anecdotal evidence about the dangers of statin drug use was presented, including a woman named Susan Nelson from Washington state, who said her teenage son Jacob began taking Lipitor in 2001 on the advice of his doctor to lower his cholesterol. Nelson said her son was a gifted gymnast and in great physical shape until she noticed he started battling with severe depression and violent nightmares while he was taking Lipitor. The nightmares became so vivid and real to Jacob that they forced him own life in 2003, Nelson said.

"It is very clear to me that the culprit of the depressions ... and suicide of my son is due to the side effects of the cholesterol-lowering drugs Mevacor and Lipitor," Nelson said in a statement. "Had I known that the nightmares, lack of concentration, and depression ... could have been warning signs for side effects of these medications, the doctors, my husband, son and I could have taken another course and gotten [him] off these supposed wonder drugs! There is no doubt my son Jake would be alive today had I been warned."

Pfizer, the manufacturer of what is expected to be $13 billion in sales this year for the #1 selling drug in the world, Lipitor, predictably responded to the lawsuits saying they will proven in court to be frivolous and scaremongering among a dissident few.

"Pfizer intends to vigorously challenge in court all the baseless claims made in these lawsuits," they said in a statement.

A spokesman for Pfizer named Dr. Michael Berelowitz said he is shocked and dismayed that anyone would question the veracity of a product that has been taken by nearly 22 million patients since 2001.

"To create undue concern and doubt about Lipitor is a real disservice to health-care professionals who prescribe Lipitor and the patients who depend on Lipitor to reduce heart disease, which is the leading cause of death in the United States and around the world," Dr. Berelowitz exclaimed.

At the same time, Pfizer noted that Lipitor has been through 400 trials with 80,000 patients to study the side effects of Lipitor and found it to be completely safe for use among most people. They also schedule regular physician "education" sessions to help doctors understand why the drug works in an effort to convince them to prescribe higher and higher doses to their patients.

"This is a drug that has been on the market for 10 years. It is one of the most studied cholesterol lowering medications in the world," another Pfizer spokesman contended.

However, Pfizer does admit on Lipitor's packaging as well as in the marketing of the drug that less than one percent of the people who take Lipitor may experience muscle pain and weakness. What they fail to mention is that still translates into hundreds of thousands of patients annually who suffer from the potentially harmful or deadly side effects that come from statin drug usage.

In their defense, Pfizer reminds their critics that it has been warning people on their web site to "tell your doctor if you feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects."

Finally, responding to claims that Lipitor causes mental damage as alleged by the plaintiffs in the lawsuit as well as Nelson who said her son committed suicide because he was taking the statin drug, Pfizer countered that there is "no causal relationship" between Lipitor and dementia or peripheral neuropathy.

The attorney who filed the lawsuit on behalf of Wilson and Mazzariello said Pfizer must now bear the responsibility of causing personal injury to his clients because they haven't done an effective enough job of marketing the known side effects to the hundreds of thousands of people who can and do get hurt by taking Lipitor.

"Pfizer has aggressively promoted Lipitor to consumers as a safe drug with manageable and limited side effects despite apparently knowing and fraudulently concealing the serious health risks associated with statins," contended attorney Mark Jay Krum. "The complaints allege that the company has negligently misled both physicians and patients and is apparently more concerned with driving sales of Lipitor than with the safety of its users."

Krum said Pfizer received two letters of concern in just the past five years from the Food & Drug Administration about their desire to see the side effects of Lipitor being clearly advertised in their marketing efforts. Instead, Krum added, Pfizer has been promoting Lipitor as a drug with virtually zero symptoms as evidenced by statements like the following that appear on their web site.

"In fact, in some clinical studies, Lipitor has been proven to be as safe as taking a sugar pill."

A class-action lawsuit has not been announced at this time, but is very likely to happen against other drug companies that produce statin drugs if more sufferers come forward about their pain and discomfort while taking any of the popular statins , including AstraZeneca's Crestor, Bristol Myer Squibb's Pravachol, and Merck's Zocor, just to name a few.

Cholesterol-lowering statin drugs are big business, a multi-billion industry that takes full advantage of a problem that may or may not even exist. While health professionals, including many doctors and cardiologists, stand by their endorsement of these potentially dangerous medications for the sake of improving public health, the rate of heart disease and death have not been shown any decrease since the introduction of these drugs into society.

Dr. Peter Langsjoen, a noted cardiologist from Texas, said at the news conference on Thursday that the unsuspecting public needs to understand that statin drugs are not about public health, but rather profiteering by the pharmaceutical companies under the guise of preventing heart disease.

"Statin drugs make enormous amounts of money for the pharmaceutical industry, the power and influence of which should not be underestimated," said Dr. Langsjoen. "By lowering cholesterol they give doctors and their patients a false sense of security by treating 'cholesterol neurosis,' but statin adverse effects are insidious and are often delayed for several years."

These concerns over Lipitor and other statin drugs side effects were also expressed to members of the Senate Finance Committee on Capitol Hill on Friday as these anti-statin advocates asked Congress to enact federal health warnings regarding the hazards of statin usage. While cholesterol numbers may have dropped because of statins, the question remains at what cost to public health has this come.

Something tells me that Anthony Colpo has got a big smile on his face today at the news of these lawsuits.

6-12-06 UPDATE: Speaking of Anthony Colpo, here was his reaction to the Lipitor lawsuits that he sent to me in an e-mail today.

The drug companies have had a dream run with statins. They've screwed up so many people and made bilions in the process. It would be nice to see them finally have to start paying for their greed and malice.

Amen, brother! And I think this is only just the beginning of a long line of legal backlash against "The Great Cholesterol Con" you talk about in your book. One of these days history will look back on this period of life and give people like you the credit you deserve for having the courage to stand up for the truth.