In “what may be one of the biggest medical deceptions in history,” NBC Dateline recently examined the story of a doctor who blew the whistle on the sales practices of a large drug company. But this doctor wasn’t on the receiving end of a sales pitch, he was doing the pitching; helping salespeople promote a particular drug for off-label usesuntil his conscience got the better of him.
This is a case I first told you about last year in “The Whistle Blower” (6/6/03). At that time, the revelations were astonishing – nothing less than a drug company caught holding a smoking gun. In this new report, additional details emerge that reveal even uglier evidence of what happens when corporate greed is placed way ahead of patient safety.
Hear that lonesome whistle blow
In 1997, Dr. David P. Franklin contacted a lawyer to file suit against his employer, the pharmaceutical company, Warner-Lambert (W-L). Dr. Franklin told the New York Times last year, “I was terrified.” Executives at Warner-Lambert had threatened to make him a scapegoat if he went public with his concerns about certain company practices that Dr. Franklin describes as “an illegal marketing scheme that put patients at risk.”
Throughout most of the ’90s Warner-Lambert (acquired by Pfizer in 2000) manufactured a prescription drug called Neurontin, approved by the FDA for the very specific use of helping to control epileptic seizures for patients already taking another epilepsy drug. But the marketing geniuses at W-L had much bigger plans for Neurontin. So they enlisted people like Dr. Franklin to help drug salespeople convince doctors that Neurontin was useful for a wide range of health problems. (It’s not illegal for a doctor to prescribe a drug for conditions it hasn’t been approved for, but it is illegal for drug companies to promote off-label use where there’s no evidence that the drug is safe or effective for that alternate use.)
In a voice-mail message that’s now entered as evidence in Dr. Franklin’s lawsuit, a W-L executive told sales reps that in order to make Neurontin profitable they would have to promote it for a variety of off-label uses, such as pain relief, bipolar disorder, and other psychiatric uses, including ADHD for children.
But independent researchers say that Neurontin simply doesn’t work for some of those conditions. For instance, when NBC asked a doctor who specializes in bipolar treatment if treating a bipolar patient with Neurontin meant that they were “essentially untreated,” the doctor replied, “I think that’s a fair assumption.” Furthermore, if used inappropriately, Neurontin can cause serious adverse reactions. (The Dateline report tells of one bipolar patient whose doctor simply kept upping the dosage when the patient didn’t respond. After becoming uncharacteristically hostile and eventually attempting suicide, she was taken off the Neurontin.)
Little details like that, however, didn’t slow down the gung-ho W-L sales team. After Dr. Franklin became convinced that what he was being asked to do was illegal, he began taping phone conversations and messages, one of which caught this stunning quote from a W-L senior executive: “I don’t want to hear that safety crap either it’s a great drug.”
This tunnel-vision sales policy seems to have paid off. Since its introduction 10 years ago, Neurontin has become a bonanza, bringing in more than $2 billion each year. Pfizer estimates that off-label use makes up over 75 percent of Neurontin sales.
Is there an ethic in the house?
Part of Neurontin’s success may be attributed to the fact that many of the W-L sales reps went much further than simply encouraging doctors to prescribe the drug for off-label use. They crossed the line, and they crossed it arm in arm with quite a few doctors who did something completely unprofessional and inexcusable.
In a so-called “shadowing program,” W-L paid 75 to 100 doctors for allowing sales reps to sit in during patient exams. This invasion of privacy, condoned by doctors who were trusted by their patients, is nothing less than deplorable.
At the conclusion of the exams the sales reps gave “recommendations” on what medicines to prescribe. The doctors were paid $350 or more for each day the sales people were allowed to spend in the exam rooms. Hundreds of patients were affected by this program, but whether or not any of them knew that the person sitting in for their exam was a pharmaceutical salesperson is unclear.
More than one out of three doctors
Can it get any worse? Sure it can.
Court documents accuse Warner-Lambert of hiring a marketing firm to write medical journal articles that would place Neurontin in a positive light. W-L is said to have paid $12,000 for each article, as well as an additional $1,000 to various doctors who agreed to allow their names to be listed as “authors.” Salespeople were then able to distribute the not-quite-kosher articles to doctors to help persuade them that Neurontin was safe and effective for off-label uses.
Dr. Franklin’s case also shows that doctors who prescribed high volumes of Neurontin were rewarded with additional payments for “consulting” or “speaking” fees.
As I’ve noted in previous e-Alerts, these sorts of sales tactics have become business as usual for the giant drug companies that spend billions of dollars encouraging physicians to prescribe certain products. In fact, 37 percent of the doctors who participated in a 2002 Maryland survey said they had accepted compensation from drug companies in return for prescribing their drugs.
And guess who helped pay for many of those prescriptions? Dr. Franklin’s lawsuit has led to a federal investigation claiming that Medicaid paid tens of millions of dollars for Neurontin prescriptions written for untested uses. Those were our tax dollars at work for Warner-Lambert!
Profiting ugly
Today, Dr. Franklin – a former research fellow at Harvard Medical School – is the director of market research at Boston Scientific, a company that develops medical devices. Reflecting on his time at Warner-Lambert, he says the thing that was most troubling was the pressure they put on him to encourage doctors to prescribe Neurontin in much higher doses than it was approved for. He told the New York Times, “I recognized that my actions may be putting people in harm’s way.”
And Pfizer, through a spokesperson, offers this defense of the ongoing legal mess: “The actions that allegedly occurred took place well before Pfizer completed its merger with Warner-Lambert. It is firm and established Pfizer policy not to allow our sales representatives to make inappropriate claims or encourage off-label use of any of our medicines.”
So are we really supposed to believe that Warner-Lambert’s sales policy for Neurontin was just an isolated case in an industry that’s otherwise honest and has our best interests in mind? The answer to that depends on who you choose to believe: an international drug company spokesperson, or a whistle blower who saw from the inside just how ugly the business of selling prescription drugs can be.
To Your Good Health,
Jenny Thompson
Health Sciences Institute
Sources:
“Drug Giant Accused of False Claims” NBC Dateline, 7/11/03, msnbc.com
“Suit Says Company Promoted Drug in Exam Rooms” The New York Times, 5/15/02, nytimes.com
