A Senate inquiry found that the Food and Drug Administration (FDA) “isn’t keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it’s the FDA’s job to enforce that law,” Sen. Charles Grassley, R-Iowa said in a statement. “As a result, drug makers aren’t being held accountable for promoting unapproved use of medicine and patient safety is diminished.”
The report from the Government Accountability Office delves into a gray area of medical practice and federal oversight: the use of medications to treat conditions other than the ones the drugs were approved for, a practice known as “off-label” prescribing. The Wall Street Journal reports that studies have found off-label use accounted for 40% to 50% of all prescriptions.
Drug companies are forbidden to promote medications for uses that have not been validated by the FDA on evidence from clinical trials. Doctors, however, can use independent judgment in prescribing medicines. Also, under guidance proposed by the FDA this year, drug companies could distribute to doctors “scientific articles” that suggest new and unapproved uses for medications
The review that Grassley requested by the investigative arm of Congress found that the FDA is ill-equipped to catch even blatant marketing abuses by drug companies. The agency does not have any staff exclusively assigned to monitor whether companies are following the rule against marketing drugs for unapproved uses. Although widely accepted, off-label prescribing can amount to an uncontrolled experiment. Many people have been harmed by unexpected side effects.
The study found that it takes FDA an average of seven months to issue a warning, according to a draft report by congressional investigators. It typically takes four more months for the company to fix the problem. During the ensuing 11 months, a lot of prescriptions can be written.
From 2003-2007, the office issued only 42 notices of possible violations, which usually (but not always) prompted the drug maker to drop its promotional claims.
Why does this matter to me as a chiropractor? One word: Neurontin.
Neurontin is a controversial anti-seizure drug approved for epilepsy, which was widely and illegally promoted by Pfizer for pain. Pfizer also illegally promoted the drug for bi-polar disorder and anxiety disorder.
In 2004, Pfizer pleaded guilty to criminal fraud in the promotion of Neurontin, and agreed to pay $430 million. Neurontin was approved for limited use as a supplemental anti-seizure treatment for epilepsy, but was promoted by Lambert-Warner (now Pfizer) and a consortium of paid physicians who promoted and prescribed the drug for everything from ADHD, mental illnesses to a variety of pain conditions, including migraine headaches. The Wall Street Journal reported in 2004: “use of Neurontin for unapproved uses – estimated to account for 90% of the $2.7 billion in sales last year – continues to rise despite stepped up prosecutorial efforts aimed at curbing the practice. At the same time, studies show that much of the unapproved use of Neurontin isn’t even effective.”
The commercially successful marketing “miracle” of Neurontin was achieved through a collaborative effort of the company and leading physicians who were given financial incentives to encourage their colleagues–under the pretext of providing “continuing medical education”–to prescribe a largely ineffective drug for unapproved, diverse and unrelated conditions. Essentially physicians were “educated” to use their prescribing license to increase profits rather than to improve their patients’ health.
Neurontin and its successor Lyrica work by depressing the central nerve system. They are widely prescribed for “neuropathy”, “peripheral neuropathy” or “nerve pain”. The pharmaceutical answer to the subluxation is as follows: if there is a problem with the signals being transmitted over the nerve system, chemically shut down the transmission network.
The marketing for these chemicals include statements such as: “Peripheral Neuropathy is one of the most common diseases most people have never heard of…and yet, upwards of 20 million Americans have it. Peripheral neuropathy is caused by damage to your body’s peripheral nerves. This damage disrupts the body’s ability to communicate with its muscles, skin, joints, or internal organs. It is like the body’s wiring system breaking down.” They go on to explain that the nerve interference can be caused by: “compression, drugs and toxins, or of unknown psychological causes”.
Sound familiar to anyone? Improper communication between the brain and the muscles, skin, joints, or internal organs caused by physical, chemical or emotional stressors.
Drugs that chemically shut down the nerve system are raking in billions of dollars for drug companies who are promoting them as the only solution for “neuropathy”, which literally means “changes in the pathology of the nerve”. But wait, it gets worse.
Neurontin has been documented to cause potential side effects of depression, aggression and suicide. There are currently over 100 lawsuits pending in federal court from suicides that are allegedly tied to Neurontin. A researcher involved in the clinical trials that preceded Neurontin’s approval testified last month that the company was aware of the side effects as early as 1995.
In June 2008, the FDA officially announced that Neurontin, Lyrica and nine other epilepsy drugs are associated with a higher risk of suicidal thoughts and behavior. They are working, as you read this, on requiring that patients finally be warned of the associated risks with a “black box” warning, the FDA’s strongest safety notice.
In the mean time, millions of unsuspecting consumers are taking these potentially lethal chemicals to treat “nerve interference” causing back pain, neck pain, headaches or any other nerve related pain.
One more thing, Lyrica is the world’s first drug ever approved by the FDA to treat fibromyalgia. The time is now to stand up and have your voice heard. If you don’t do it, who will?