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Drug company push on doctors disclosed
By Liz Kowalczyk, Globe Staff, 5/19/2002
Newly unsealed court files provide an inside view into how one of the largest pharmaceutical companies sought to influence doctors - many of them prominent Massachusetts physicians - into prescribing a key drug, a strategy that included ghost-writing journal articles for doctors and rewarding the largest potential prescribers with seaside trips.

The files, hundreds of pages of internal company memos, voicemail messages, and records on individual physicians are part of a civil lawsuit brought by a former company sales representative turned whistleblower against Pfizer Inc. and Parke-Davis, which merged two years ago. The civil lawsuit and a parallel criminal investigation by the US attorney in Boston seek to prove that Parke-Davis and its parent company, Warner-Lambert, illegally influenced and paid kickbacks to doctors to prescribe the antiseizure drug Neurontin for a range of medical problems for which the drug was never approved.
One company memo in March 1996 directs sales representatives to ''target neurologists with the greatest potential'' for an all-expenses paid weekend at the Jupiter Beach Resort in Florida that included a honorarium for each physician. To do so, the company generated a list of the top prescribers of antiepileptic drugs for sales representatives and said ''it is essential that the invitees are from this list.''
In a memo after the April conference, the Neurontin marketing team wrote that doctors who attended ''were delivered a hard-hitting message'' about the drug. The company included charts for each physician and told sales representatives to tally their prescriptions before and after the trip.
Many drug companies have used such strategies for years to increase sales of their drugs. But federal and state prosecutors, angry over the soaring costs of prescription drugs to state Medicaid programs, are increasingly investigating and bringing charges against companies that market drugs illegally.
A key issue is whether pharmaceutical companies are promoting their drugs for conditions not approved by the US Food and Drug Administration - an illegal practice. It is not illegal for doctors to prescribe drugs for ''off-label'' uses. Neurontin is approved only as combination therapy for seizures. But in one undated transcript of a voice mail message, the whistle-blower, Dr. David Franklin, said he recorded a manager telling company medical liaisons: ''When we get out there, we want to kick some ass. We want to sell Neurontin on pain. All right?''
In Massachusetts alone, Medicaid spending on Neurontin grew from $1.1 million in 1996 to .1 million in 2000, the height of the Parke-Davis marketing campaign. Two years ago, about three-quarters of Neurontin prescriptions were written for off-label uses, pushing sales to $1.75 billion last year.
The American Medical Association responded to the government investigations by launching an ethics-education campaign with the pharmaceutical industry for doctors and sales representatives last year. The organization's ethical guidelines - which generally prohibit physicians from accepting trips unless they are conference speakers - have been in place since 1992. But the AMA contends that many doctors remain unfamiliar with them. Doctors who violate AMA guidelines can get expelled from the organization, but the guidelines don't carry the force of law.
Both the AMA and medical journals, including the Journal of the American Medical Association, have guidelines on authorship of articles that require doctors to have made significant intellectual contributions to articles on which their names appear and the disclosure of others who have provided substantial assistance in research or writing. JAMA editors would not comment on whether they had reviewed the authorship of Neurontin articles.
Doctors say they're
savvy to sales pitch
In talking to doctors Parke-Davis courted, it's clear that some marketing practices are well established in the medical community and that many physicians don't believe that drug company gifts and trips influence what medications they offer patients. Many doctors assert that they see through exaggerated drug company claims. Sales people from competing companies bombard them with so much information, physicians say, that messages essentially cancel each other out.
''Each time we go for a talk, the expert is spinning it for the company sponsoring the talk - we all know that,'' said Dr. Alan Kurland, a neurologist at Norwood Hospital who attended the Florida meeting, called Advances in Anticonvulsants. ''I've got people walking into my office every day giving me a hard sell. But this is not all of the information I'm receiving. I'm also looking at articles and talking to other doctors I respect about using the drug. The bottom line here is that I did not feel unduly influenced or coerced to try anything that's inappropriate.''
Company hires firms
to draft articles
Pfizer, which is now the world's largest drug company, defends itself against Franklin's allegations in the court filings. Company spokeswoman Mariann Caprino said she could not comment on pending litigation specifically. But she said that the allegations against Parke-Davis were made up to six years ago, before the merger with Pfizer.
''It's firm and established policy at Pfizer that our representatives do not promote off-label use of our medicines under any circumstances,'' she said.
The court documents, unsealed by US District Judge Patti Saris in Boston on April 23, also describe how Parke-Davis hired Medical Education Systems of Philadelphia to draft 12 articles and opinion letters on antiepileptic drug therapy. According to company memos, MES compiled a list of topics, such as the use of antiepileptics for pain and psychiatric illnesses, and proposed physicians to act as authors. The company paid the doctors $1,000 each to review and revise drafts written by MES and lend their names to the articles, some published in prestigious journals, including the Annals of Internal Medicine and JAMA.
In an Oct. 29, 1997, memo, MES told Parke-Davis that it still was trying to track down Dr. John Pellock of the Medical College of Virginia for an article about pediatric seizure disorders: ''Author interested; still playing phone tag. MES HAS DRAFT COMPLETED, WE JUST NEED AN AUTHOR.'' Pellock did not return a telephone call to his office.
Parke-Davis also hired another company, AMM/Adelphi, to draft articles. In a November 1996 memo, the company wrote ''these physicians are clinicians rather than academicians or researchers, making them less than accessible scientific authors.'' The company said it ''input data'' on 100 patients who'd taken Neurontin or a placebo for restless leg syndrome for Dr. Bruce Ehrenberg. The company returned the data to Ehrenberg, a neurologist at New England Medical Center, for review.
In an interview, Ehrenberg said he was not concerned that the company would distort the data because he randomly checked them and analyzed the results himself. Entering the data into a computer spreadsheet was busy work, he said, and his department had no secretarial support at the time. But, he said, a later experience with another company that confused some study data convinced him to stop using outside firms for this purpose.
The court documents also describe a shadowing program involving 75 to 100 doctors in the Northeast; they were paid or more each day they allowed sales representatives to watch as they examined patients.
Ethical guidelines
difficult to enforce
Prosecutors have targeted drug companies more than doctors in their investigations. Franklin's lawsuit, brought by Boston lawyer Thomas Greene, does not name any physicians as defendants. And medical boards have not been aggressive about disciplining doctors for their dealings with drug companies - few even have policies covering these relationships.
Drug companies have millions of dollars to pay large fines, and law enforcement officials often count on doctors as witnesses to win large settlements. And while doctors cannot accept plane tickets and hotel rooms from drug companies under AMA guidelines, it is far more difficult to prove this behavior is actually a crime. In other words, did the doctor specifically take the gifts as a kickback in return for prescribing the company's drugs?
Several doctors interviewed about drug company trips said that there are never any such agreements and that speakers often present information about drugs made by several companies - even those not sponsoring the conference.
In October, the US attorney in Boston forced TAP Pharmaceuticals of Illinois to pay a record million to settle civil and criminal charges over its best-selling prostate cancer drug, Lupron. Four doctors pleaded guilty in the case, for billing insurance companies for free Lupron samples, and a fifth was indicted. None of these doctors has lost his license.
In the TAP case, doctors chose between Lupron and a competing drug, Zolodex, which were equally effective for cancer patients, said Dr. Frank Riddick, chairman of the AMA Council on Ethical and Judicial Affairs. ''This was a choice of product A or product B; they do essentially the same thing,'' he said. ''That's not as bad from the patient's standpoint as if a physician was convinced to use a worse product.''
''The enforcement of ethical guidelines is more or less hit and miss,'' he said. ''There is probably no physician in the US that hasn't violated in spirit or in fact some aspect of these guidelines. But given the new focus on this, some of these abuses will probably disappear over the next few years.''
This story ran on page A1 of the Boston Globe on 5/19/2002.
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