Health Alert 114
I once went to see the Miami Dolphins at Joe Robby Stadium in style. Pfizer bought me box seats complete with all I could eat and drink. So of course, I ate and drank a lot. But I felt a little guilty and I’ve never done it again. I worried that I might be influenced to write for their drug (they were promoting Viagra) because of their gift.
You probably know that drug companies do this with doctors every day. But, you may be shocked to learn that drug company influence over doctors can be much more calculating. And, there is evidence that it has tainted the medical research on which your health care depends.
In this letter, I’ll give you the recent details of one of the most damaging pharmaceutical scandals of our time. And I’ll help you recognize real valid medical research.
* A Whistleblower Tells All *
“I was trained to deceive, to lie to doctors,” said scientist David Franklin.1 Franklin worked as a medical liaison for Parke-Davis. They manufacture the drug Neurontin. The FDA approved Neurontin for treating seizures. But Parke-Davis had their sights on a broader market.
Franklin revealed he was part of a coordinated strategy to deceive and entice doctors to prescribe Neurontin for a wider range of conditions. Some of these “off-label” uses include chronic pain, attention deficit disorder, depression, alcoholism, and drug addiction. Even though he now claims there was no scientific basis for any of these uses.
This marketing strategy is illegal but it was wildly successful. It generated over $2 billion in sales. Even now after Franklin blew the whistle, more than three quarters of Neurontin sales are from off-label uses.
How did they do it? They persuaded doctors with cash, trips, gifts and their own bogus research. The level of deception was highly organized.
Parke-Davis used a company called Medical Education Systems of Philadelphia (MES). They hired them to put together a series of articles on off-label uses of Neurontin. MES would hire physicians selected by Parke-Davis to author the articles. Doctors who “authored” these articles received fees up to $1,000 a piece.
In some cases MES completely wrote the articles, and added the doctor’s name later. As one MES status report notes: “MES draft completed — we just need an author.”2
Parke-Davis hired Ph.D.s like Franklin as medical liaisons. They posed as medical experts and called on doctors in their offices and at medical conferences. Their job was to convince them that Neurontin was effective for whatever condition their patients had. Franklin said he was little more than a salesman.
He said he received incredible pressure to sell. Realizing this was illegal, he began to record voice mails left by his superiors. The following is a quote from a senior Warner-Lambert executive on a conference call:
“I want you out there every day selling Neurontin… holding their hand,
whispering in their ear — Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything….”3
Another part of the marketing strategy was to wine and dine doctors. Parke-Davis gave cruises, Yankee games, and golfing trips. Their only price was to listen to Neurontin presentations featuring their bogus research.
As a result, Parke-Davis made $55 million from doctors using Neurontin for bipolar disorder. Bipolar causes the mood to cycle through episodes of mania and depression. There is no research supporting the use of Neurontin in bipolar. In fact there are two independent double-blind studies that refute it. One bipolar patient had the worse manic episode of her life while on Neurontin. She tried to kill herself and was hospitalization.
After four months, Franklin’s conscience led him to resign. He has filed a whistleblower lawsuit against Parke-Davis. The company faces charges of violating the U. S. False Claims Act. They are also under investigation for Medicaid fraud. The lawsuit is still pending.
* Question Any New Drug Therapy *
It is legal for a doctor to prescribe a medication to you for a use not approved by the FDA. Medical breakthroughs may come this way. But what is not legal is for a drug company to exaggerate or fabricate reports to doctors as a way to get them to prescribe their drugs.
If you receive a prescription for an off-label use:
• Ask your doctor to explain why he thinks this drug is a good choice.
• Think about getting a second opinion.
• Verify the drug company did not sponsor the research.
• Don’t rely on “one-study proof”.
• Remember, it is your right to refuse any prescription.
Al Sears, MD
1. NBC, Dateline, “Drug Giant Accused of False Claims” July 11, 2003. http://www.msnbc.com/news/937302.asp