Dr. David Franklin鈥檚 conscience was bothering him. At first, the job he had secured in 1996 with Parke-Davis, a division of the Warner-Lambert pharmaceutical company, seemed ideal. Armed with a PhD in microbiology and three years of research experience at the prestigious Dana Farber Cancer Institute, he felt ready to take on the challenge of acting as a 鈥渕edical liaison鈥� with physicians. He would not be a drug salesman, the company told him, but would answer physicians鈥� questions about medications so that they could practice the best medicine that science allowed. One of the drugs that Franklin was responsible for was gabapentin which is more familiar by its brand name, Neurontin. The drug had been designed as an analogue of the neurotransmitter gamma-aminobutyric acid (GABA) with an aim of crossing the blood-brain barrier more easily. It had been approved in 1993 by the FDA for the treatment of epileptic seizures when used in conjunction with another medication. Approval of course is based on scientific studies showing efficacy and indeed Neurontin proved useful in the treatment of epileptics. But there was a problem. The epileptic market was too small and the drug wasn鈥檛 generating enough of a profit.聽
Based on Neurontin鈥檚 mechanism of action and some preliminary studies, company researchers theorized that the drug could also be useful in treating pain, bipolar disorder, Lou Gehrig鈥檚 Disease, attention deficit disorder, migraine, seizures due to drug or alcohol withdrawal, restless leg syndrome and that it could also control epileptic seizures without having to be combined with other drugs. These were reasonable scientific assumptions, but there was not enough evidence to secure FDA approval, so Parke-Davis could not advertise the drug for these conditions. Another approach was needed.聽聽聽
Since direct advertising was out, the company decided that physicians could be educated about these potential uses for Neurontin through one-on one sales pitches, seminars for physicians on vacations paid for by the company and the use of 鈥渕edical liaisons,鈥� such as Dr. Franklin. He was encouraged not only to answer questions, but to actively promote the drug for off-label prescriptions. Once a drug is approved, physicians can prescribe it for any condition they deem appropriate.聽聽聽
Franklin began to be bothered when he realized that some of the information he was asked to dispense was on rather thin ice. While there was some evidence for pain relief and migraines, studies on bipolar disease had been disappointing. Yet he was asked to push physicians to prescribe for this condition. Finally, Dr. Franklin had enough, he could not continue with what he thought was an illegal activity. Just four months into the job he abruptly quit and filed a lawsuit charging the company with violations of the U.S. False Claims Act. The suit was finally settled in 2004 for the staggering sum of 430 million dollars by the pharmaceutical giant Pfizer, the pharmaceutical company that聽聽had acquired Warner-Lambert four year earlier. Pfizer agreed to stop promoting Neurontin for off-label uses and Dr. Franklin himself received 24 million dollars as part of the settlement. 聽
Gabapentin, now available generically is a good drug when used appropriately and may work for some of the conditions for which it was promoted off-label. It is now approved for the pain of shingles and nerve damage caused by diabetes. However, off-label prescribing is still extensive with physicians writing numerous scripts for anxiety, sleep disorders, migraine and chronic pain, conditions for which there is at least some evidence. It is also commonly prescribed off-label for bipolar disorder despite studies that have shown it works no better than placebo. 聽
With the 2004 settlement, Pfizer promised to desist from off-label promotion, yet in 2009, charges were again brought against the company for the same offense. This time the drug in question was Bextra, approved for arthritis and menstrual problems, but promoted for the treatment of acute pain of all kinds to physicians who had been enticed to presentations at resorts with cash payments. Pfizer ended up paying a $1.19 billion fine, the largest in U.S. history, for illegal promotion of Bextra, a drug that was taken off the market in 2005 because of possible cardiac complications. Since 2004, Pfizer paid a total of $2.75 billion for off-label promotion, a drop in the bucket compared with annual sales which for 2023 were around $70 billion. Since 2004, seven major pharmaceutical companies have paid a total of $7 billion in fines for promoting unapproved drug use. They all promised to never do it again. Sure.聽
Obviously, there are skeletons in the closets of Big Pharma. But pharmaceutical companies have produced numerous drugs that effectively treat pain, mental illness, diabetes, cancer, heart disease and infections. So, let鈥檚 not throw the baby out with the bathwater.聽
