Opinion: Is Lipitor Worth the Risk? Who Should Decide?

Who Should Decide

More than 800 lawsuits that claim that Lipitor has caused Type 2 diabetes are pending in the U.S. District Court of South Carolina in a federal multidistrict litigation (MDL).

That is more than three times the number of federal Lipitor complaints that had been filed when the MDL panel consolidated the claims in February. Considering that Lipitor is the No. 1 prescription drug of all times, taken by more than 29 million Americans, the total of Lipitor-diabetes lawsuits is expected to quickly climb into the thousands.

Plaintiffs claim that taking Lipitor caused them to contract Type 2 diabetes, a life-changing and sometimes debilitating illness. Their claims are backed by several research studies. In 2012, the FDA required manufacturers of high-dose statins, including Pfizer, which manufactures Lipitor, to include information about the risk of Type 2 diabetes in their warning labels.

But don’t the positive effects of Lipitor and other statins outweigh the risk of contracting diabetes?

Lipitor is so popular because it is sometimes effective in lowering cholesterol, which may reduce the possibility of heart attack, stroke and heart disease. The hundreds of plaintiffs who have filed lawsuits may have contracted diabetes, but perhaps they have avoided heart attacks and heart disease. Doesn’t all the good that Lipitor does outweigh the risks?

The issue is not as simple as that question suggests. The answer is different for each patient. Here’s what I want to ask: Who should decide whether Lipitor’s positive effects justify its risks?

Each patient should decide for oneself, with the informed advice of one’s doctor. That it is why it is essential for a manufacturer to make all information about its pharmaceutical products available to the public.

The hundreds of pending Lipitor lawsuits claim not only that Lipitor caused Type 2 diabetes, but that Pfizer knew it. The petitions allege Pfizer knew that Lipitor was affecting blood sugar levels, but the company failed to make the information known to the people taking their drug and to the doctors who were prescribing it.

If that is proved to be true, Pfizer was clearly in the wrong. When a manufacturer becomes aware of a prescription drug’s link to increased health risks, it is not up to the manufacturer to decide whether the risk is too low or whether the benefits of the drug outweigh the risks. The manufacturer has an obvious vested interest and is unable to evaluate that question objectively.

That is why it is a pharmaceutical company’s moral and legal obligation to make all product-related risks public knowledge, so each patient can make an informed decision.

Many factors go into the decision each patient must make. When patients and their doctors are made aware that Lipitor increases the likelihood of diabetes, they have several options to consider, including:

  • Trying a lower dose statin rather than a high-potency statin such as Lipitor.
  • Trying a non-pharmaceutical solution to high cholesterol, such as diet and exercise.
  • If the patient already has other indicators of high risk for diabetes, that should be considered.
  • If the patient is post-menopausal, she should consider the research that shows that she is particularly vulnerable.

Even if a patient knows the risk and still decides to take Lipitor, knowledge of the drug’s link to diabetes may suggest monitoring one’s blood glucose levels while taking the drug, so any adverse effect can be detected early on.

If Pfizer knew that Lipitor increased the chances of Type 2 diabetes, but did not tell the public, it robbed millions of patients of the opportunity to correctly weigh the benefits and the risks.

Lipitor may do a lot of good for a lot of people. The number of Lipitor patients who contract diabetes from taking the drug may be a relatively small percentage. But with millions of people taking Lipitor, that small percentage represents tens of thousands of people, as well as the hundreds of thousands of people whose lives are intertwined with those Lipitor patients.

The question is not about percentages. The question is: Who should decide? When a pharmaceutical company gives its customers false information or deprives them of correct information they need to make an informed decision, that is a breach that calls for taking the matter to court, as hundreds of Lipitor patients are now doing.