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Greg Webb
Greg Webb
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$142 Million Award Against Pfizer Stands – What is Off-Label Marketing?

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Giving false hope to people with chronic illnesses is a little like promising Christmas Day to a child and then not delivering.  Similarly, Pfizer Inc. has been sued in civil lawsuits by Kaiser Foundation, Aetna Inc., and other insurers for marketing and promising results for one of its successful drugs, only the drug would not deliver.  At issue is the highly profitable tactic of promoting and selling drugs for “off-label” uses. The motivation, for Pfizer and other drug corporations, is (obviously)financial.  Do not get me wrong, wanting to make a profit is not a bad thing.  It only becomes a bad thing when it is done via representations that are less than accurate, to put it nicely.

Neurontin was developed as an epilepsy drug, but is often prescribed “off-label” for symptoms of Multiple Sclerosis, Lou Gehrig’s disease, restless leg syndrome, attention deficit disorder, and bipolar disorder, among others. When the lawsuit against Pfizer was filed in 2004, it was alleged that the “company encouraged doctors to use Neurontin in patients with bipolar disorder, a psychological condition, even though a study had shown that the medicine was no better than a placebo in treating the disorder.”

Pfizer fought back, taking the case to the higher court. This month the U.S. Supreme Court let stand a $142 million award Pfizer Inc. must pay to Kaiser Foundation’s health plan and hospitals. This decision allows two similar lawsuits against the drug maker for defrauding insurers with its illegal marketing of Neurontin.  A basis for Kaiser’s suit against Pfizer was RICO – Racketeer Influenced and Corrupt Organizations Act.

Pfizer acquired Warner-Lambert in 2000. In its 2004 plea agreement, Warner-Lambert admitted it had promoted Neurontin for off-label uses. Under Warner-Lambert 15% of Neurontin sales were for off-label uses. By 2002, now under Pfizer, that number jumped to 94 percent. The drug’s sales hit $2.3 billion in 2002.

It is important to note that doctors are allowed to prescribe medications for off-label uses and they often do. Federal law prohibits drug manufacturers from marketing a drug for off-label uses, however. The reason for this prohibition is demonstrated well by the lawsuit involving Pfizer and Kaiser Foundation – the alleged fraudulent marketing and conduct by Pfizer.  Thus, this involves business on business litigation (which comprises the vast majority of litigation in the U.S.):  it is the health care providers and insurers who are pursuing Pfizer.

Presumably doctors are acting from sound medical judgment, based on a thorough knowledge of the patient’s history, with the belief that a certain drug presents the best chance of helping that patient’s condition. But drug manufacturers’ marketing likely influences many physicians.  Some physicians have been paid to promote medications and that may have caused them to lose objectivity.  Big Pharma understands the lure of cash.  It creates marketing strategies just to convince doctors, hospitals and insurers that Drug X is the best treatment for whatever ails the patient. In the case of Neurontin, we have an epilepsy drug being promoted to treat bi-polar disorder.

The issue can become complicated when the drug actually does work for some off-label uses.  For example, Neurontin is sometimes prescribed for neuropathic or nerve pain – and it may be effective for some.  Doctors may and can prescribe the medication this way, but the drug cannot be marketed for that off-label use.  The issue becomes one of over-reaching by the drug company, marketing for certain off-label uses when it has clinical studies showing that the drug is or was not effective for that treatment.  And, in the case of Neurontin, Pfizer had clinical tests showing Neurontin was not effective for treating bi-polar disorders, neuropathic pain and migraines.

There is little the consumer can do in the face of the drug industry’s manipulation of the facts, and its incredible marketing complex. We can ask more questions of our doctors. We can also ask about specific prescriptions with the hope of obtaining a better understanding of what medications we are taking, the side effects, the drug’s effectiveness and any options available.  In the end, however, we will need to have faith and trust in our physician(s) and, primarily, the drug industry, because they have superior knowledge and understanding.  Given some of the history of Big Pharma, that can be a scary leap to take.