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The whistle blower

Greed…corruption…invasions of medical privacy

Sounds like a chapter out of a John Grisham novel – or a Congressional hearing. But it isn’t. It’s the latest scandal brought to us by the big drug companies. And it may already have passed through a town near you.

It comes from a New York Times article that delivers plenty of dark drama: drug company greed, unscrupulous sales tactics, corrupt doctors, misuse of a popular FDA-approved drug, a whistle blower, a federal investigation, and even a few “smoking guns.”
On the inside

Dateline: Boston 1997. Dr. David P. Franklin contacts a lawyer to file suit against his employer, the pharmaceutical company, Warner-Lambert. Dr. Franklin admits, “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, which brings us to the first two smoking guns.

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 market Neurontin effectively they would have to promote it to fight pain, as well as bipolar and other psychiatric uses, in addition to epilepsy. But independent researchers say that Neurontin simply doesn’t work for some of those uses and, if used inappropriately, it can cause serious adverse reactions. Dr. Franklin even has internal company documents showing that sales reps encouraged doctors to “experiment” by prescribing Neurontin to treat attention deficit disorder in children. (Yes, you read that right, they are experimenting on our children!)

But the sales reps went much further than simple encouragement. They crossed the line.
Dark shadows

Unfortunately they crossed the line with the help of 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 truly shocking.
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.

The highest bidders

Can it get any worse? Oh, we’re just getting started. Court documents show that doctors who prescribed high volumes of Neurontin were rewarded with additional payments for “consulting” or “speaking” fees. Unfortunately, this sort of practice between doctors and drug companies is not uncommon. For instance, in an unrelated case, a doctor in California allowed a sales rep to attend an exam of a breast cancer patient who was not told at the time that the man was a drug company employee. The doctor was paid $500. (The patient later sued both her doctor and the drug company and the case was settled out of court.)

These sorts of sales tactics have become business as usual for the giant drug companies who spend billions of dollars in their attempts to encourage physicians to prescribe their products. In fact, 37 percent of the doctors who participated in a recent Maryland survey said they had accepted compensation from drug companies in return for prescriptions of their drugs.

Now – want to know how you helped pay for some 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!

Publish or perish

As if all of that weren’t enough, Dr. Franklin’s case also reveals that Warner-Lambert attempted to influence doctors to prescribe Neurontin by paying them to write medical journal articles that would place Neurontin in a positive light. Offering yet another “smoking gun,” W-L internal memos reveal that a marketing firm often wrote the first drafts of articles that were then reviewed by W-L executives before being sent to medical journals for publication.

Court papers show that W-L paid the marketing firm $12,000 to write each article, then paid $1,000 to the doctors who agreed to serve as “authors.” This ghost writing, which is an insidious and dishonest form of marketing, is quite common among drug companies.
Old dog, old tricks

So what’s going on today with the principals in this drama?

Dr. Franklin – a former research fellow at Harvard Medical School – is currently 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 says, “It was untried ground. 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.”

Why am I not convinced? Is this really 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’s seen the dark labyrinth from the inside.

To Your Good Health,

Jenny Thompson
Health Sciences Institute

Sources:
“Suit Says Company Promoted Drug in Exam Rooms” New York Times, May 15, 2002

Copyright 1997-2002 by Institute of Health Sciences, L.L.C.

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