Treatment Should Be Decided By Doctors – Not Bureaucrats

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BY DAVID CHARLES, M.D. – In my 15 years as a practicing neurologist, I’ve learned that tailoring medical care for individual patients is challenging. No two people are the same, and small differences can have a major impact.


As my experience has grown, so too has my belief that doctors and patients should be responsible for choosing between different treatments. Unfortunately, there’s a growing trend where insurance companies or government bureaucrats try to get between the patient and doctor and limit what’s approved.

Take Neurontin, a medication originally approved to treat seizures. Patients and doctors soon noticed that it was also very helpful in relieving certain types of pain, including the pain associated with fibromyalgia.

Neurontin isn’t approved by the FDA to treat fibromyalgia, but once doctors found it helped some patients, they started to prescribe it “off label.” By 2004, 90 percent of the drug’s sales were for conditions not FDA-approved.

This trend didn’t sit right with government officials. In 2004 they slapped Neurontin’s manufacturer with a lawsuit for purportedly marketing the drug for unapproved uses. Regulators leaned on doctors to stop prescribing Neurontin “off label,” even though it helped many patients.

In 2005, The FDA approved another drug for seizures called Lyrica. And two years later, Lyrica became the first drug approved for fibromyalgia.

Today, Lyrica is one of the most popular treatments for fibromyalgia. Given the government’s crackdown on “off label” use of  Neurontin and that Lyrica is FDA approved, you’re probably figuring government regulators are happy.

If so, you’re wrong. Government bureaucrats for Medicare and Medicaid – along with some insurers – are now considering requiring physicians to start fibromyalgia patients on Neurontin.

This is called a “fail first” policy, and it’s intended to cut costs. Because Neurontin’s patent has expired, it’s available as a less expensive generic drug and isn’t FDA approved for fibromyalgia. Lyrica is FDA approved for fibromyalgia and is more expensive because it remains on-patent. Only if  a patient continues to suffer and fails with Neurontin would the doctor be allowed to prescribe Lyrica, a drug that’s actually FDA approved to treat the condition.

Doctors and patients are well positioned to make appropriate medical choices. Distant bureaucrats are not. Both drugs should be options — and doctors and patients should have the freedom to choose.

Unfortunately, this example seems to be just the start of a campaign to dictate treatments.

Lucentis, for example, is FDA approved for age-related, “wet” macular degeneration, an eye disease that can cause blindness and especially affects seniors. Like many advanced treatments, Lucentis is expensive, costing about $2,000 per injection.

The National Institutes of Health is now supporting a head-to-head study between Lucentis and Avastin, a cancer drug which has also shown promise in the treatment of macular degeneration. Because Avastin costs about $50 per injection, some are concerned that the government appears to be supporting the study to simply show that these drugs are similarly effective, so that bureaucrats could try and force doctors to make patients first suffer through failing Avastin before allowing Lucentis.

Different medicines have different effects on different patients. A policy that always forces doctors and patients to the least expensive treatment ignores the complexities of the human body and will doubtlessly fail – because the policy’s first step is a bureaucrat that’s okay with a patient continuing to suffer.

Dr. David Charles is Chairman of the Alliance for Patient Access and Chief Medical Officer of the Vanderbilt Neuroscience Institute.