An excerpt from Unhinged: The trouble with psychiatry- a doctor’s revelations about a profession in crisis. Copyright © 2010 Daniel Carlat. Excerpted with permission by Free Press, a Division of Simon & Schuster, Inc.
In 1993, the FDA approved Neurontin for the treatment of epilepsy. This should have been a cause for celebration at Warner-Lambert, the drug company that introduced it, but the celebration was muted. The FDA had downgraded the approval, saying that since Neurontin’s data was not strong enough, the drug could only be used as an add-on drug for patients who had failed to respond to a primary epilepsy drug.
This limited indication was a problem for executives at Warner-Lambert, because it meant that Neurontin was unlikely to find its way onto doctors’ prescription pads. The market for such adjunctive epilepsy drugs is small, and the company estimated that it could make no more than about $500 million over the drug’s patented lifetime. That may seem like good money to you and me, but it is positively mediocre for drug companies, which define very successful drugs as those bringing in $1 billion or more in sales per year. Measured by this exalted standard, Neurontin was a turkey.
The executives, therefore, came up with a new marketing plan. A number of small studies and case series had shown that Neurontin might be effective for several other conditions, such as bipolar disorder, migraine headaches, neuropathic pain, and ADHD. The evidence was poor, and it did not meet the FDA’s criteria for proof of effectiveness, but the executives decided to try to convince doctors to prescribe it for these disorders anyway. After all, doctors are free to prescribe medications for anything they want, even if there is no official FDA indication. This is called “off-label” prescribing.
Warner-Lambert was well aware, however, that it is illegal for drug companies to explicitly market their drugs for off-label uses. Nonetheless, according to a series of stories written by New York Times journalist Melody Peterson, such legal technicalities didn’t seem to bother this ethically challenged company. Peterson interviewed David Franklin, a former Warner-Lambert employee-turned whistle blower, who detailed his former company’s systematic off-label marketing campaign for Neurontin. Franklin recounted a meeting at which John Ford, a senior executive, exhorted reps to pitch Neurontin to doctors for a long list of disorders, none of them adequately researched. “That’s where we need to be, holding their hand and whispering in their ear,” Ford said, referring to the doctors, “Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything.” He went further, encouraging reps to get doctors to ramp the dose up higher than FDA’s recommended maximum of 1,800 mg/day: “I don’t want to hear that safety crap either,” he said. “Have you tried Neurontin? Every one of you should take one just to see there is nothing. It’s a great drug.”
Warner-Lambert kept pushing the envelope of ethics to the point that it was eventually torn to shreds. According to Peterson’s reporting, drug reps were explicitly instructed to not leave a paper trail: “Anything you write down can be audited. So don’t write anything down,” they were told by executives who were concerned about future lawsuits.
The company rewarded doctors who prescribed high amounts of Neurontin with free trips, dinners, or cash, essentially bribing doctors to use more of the drug.
The company hired marketing firms to ghost-write articles pushing Neurontin; physicians were paid $1,000 for nothing more than permission to be listed as authors. One memo from this marketing firm read “draft completed. we just need an author.”
The company paid doctors to allow reps to read patient records and to shadow doctors during visits. In some cases, reps convinced doctors to prescribe Neurontin for off-label uses during these so called preceptorships.
These sleazy techniques worked beautifully. The drug became a blockbuster, earning $2.7 billion in 2003 alone. Almost all of that income was from off-label uses; in 2004, experts estimated that 90 percent of Neurontin prescriptions were for disorders not approved by the FDA. Eventually, due partly to David Franklin’s revelations, Pfizer (which had since bought Warner-Lambert) pleaded guilty to criminal charges and agreed to pay $430 million in fines—a pittance in comparison with the billions the drug was earning per year. For Pfizer, it was simply another business expense, and a fairly minor one at that.
Meanwhile, I saw my colleagues in psychiatry continuing to prescribe Neurontin for conditions such as bipolar disorder and anxiety disorders, even though the newest definitive studies found that it worked no better than placebo for either of these conditions. Apparently, doctors had been brainwashed so thoroughly by the Neurontin marketing machine that the data no longer mattered. They were prescribing the drug on autopilot.
Big Pharma was once a proud industry, a scientific crucible that created the first antibiotics, cardiac medications, and chemotherapeutics. But over the last fifteen years, the output of drug companies has gone into a steady decline. A congressional report published in 2007 found that from 1995 to 2004 (the last year for which they had complete figures) the number of novel drugs introduced dropped by 40 percent. They found that most “new” drugs during that time—68 percent—were actually “me-too” drugs, drugs with different names but with the same mechanism of action as older drugs. Bemoaning this trend, Senator Ted Kennedy said, “the report shows that much drug industry research doesn’t translate into real breakthroughs for patients.”
It is unclear exactly why the pipeline began to dry up, but in response, companies changed their business strategies. Marketing and sales divisions were beefed up. And marketing gradually morphed into something different, larger, all-pervasive, and, frankly, uglier than anything that had come before it.
The new marketing strategies are not unique to psychiatry, but they have pervaded psychiatry more than other fields, for various reasons. With little scientific basis to choose one drug over another, psychiatrists are eager for guidance, and drug companies have been only too eager to comply. In order to provide prescribers with evidence to use their products, companies have brought their marketing departments front and center into the research business. When they have had trouble finding legitimate independent researchers to do test treatments, they have designed and funded those tests themselves.
When they haven’t been able to find academics to write up the results, they have hired ghostwriters, and then paid academics to simply put their names on the articles. And when, heaven forbid, they have conducted studies that haven’t shown their drugs to be effective, they have slipped the studies into file drawers, hoping that nobody would ever find out they were conducted.
[Editor's note: Stay tuned for parts 2 and 3 of this excerpt, coming soon.]
Daniel Carlat is a psychiatrist and author of Unhinged: The trouble with psychiatry- a doctor’s revelations about a profession in crisis.
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