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Mon, 11 Aug 2003 12:49:02 -0500

HSI - Jenny Thompson

How Much is that Doctor in the Window?

 

How Much is that Doctor in the Window?

 

Health Sciences Institute e-Alert

 

August 11, 2003

 

**************************************************************

 

Dear Reader,

 

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 uses... until 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.

 

**************************************************************

 

... and another thing

 

It's sticky and steamy in London.

 

Last week, I received an e-mail from a colleague named

Rachael in HSI's London office. Rachael wrote to tell me

about, " a ludicrous report from a leading UK newspaper (The

Times), which warns that the Atkins diet is unsafe to follow

in hot weather (there's currently a heat wave in the UK...

makes a change!!) "

 

Rachael kindly included the Times article, which quoted Dr.

Sarah Schenker, a dietician and spokesman for the British

Nutrition Foundation. Dr. Schenker told the Times, " The body

has to work harder to metabolise protein than other food

types. This means that on a really hot day, people on the

protein-based diet who are facing, say, the Underground could

have problems. My advice would be avoid the Atkins diet in

hot weather. "

 

Dr. Schenker seems to be unaware that the Atkins diet is not

simply one plate of T-bones and pork chops after another. In

fact, many fruits and vegetables are low in carbohydrates and

can be eaten while following the Atkins plan.

 

Meanwhile, we've seen how a heavy intake of carbohydrates can

contribute to obesity. And it's quite obvious that obese

people have a very hard time of it during extremely hot

weather. If Dr. Schenker has any warm weather menu

suggestions for the obese or anyone else, she didn't share

them with the Times. I guess she just showed up to bash

Atkins, and then took off to find the nearest air conditioner

and a heaping plate of pasta.

 

If you're wondering how popular the Atkins diet is in the UK,

here's a good indicator: The only book that " Dr. Atkins' New

Diet Revolution " is currently NOT outselling is the new Harry

Potter.

 

I wonder if J.K. Rowling has considered writing a Harry

Potter diet book? She might end up with an even bigger

following than Dr. Atkins.

 

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

" Health Warning to Atkins Dieters as the Heat Goes on " Sam

Coates and Patrick Barkham, The Times of London, 8/7/03,

timesonline.co.uk

 

Copyright ©1997-2003 by www.hsibaltimore.com, L.L.C.

The e-Alert may not be posted on commercial sites without

written permission.

 

**************************************************************

Before you hit reply to send us a question or request, please

click here http://www.hsibaltimore.com/ealert/questions.html

 

**************************************************************

If you'd like to participate in the HSI Forum, search past

e-Alerts and products or you're an HSI member and would like

to search past articles, visit http://www.hsibaltimore.com

 

**************************************************************

To learn more about HSI, call (203) 699-4416 or visit

http://www.agora-inc.com/reports/HSI/WHSID618/home.cfm.

 

**************************************************************

 

 

 

 

 

 

 

 

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