Date: Fri, 17 May 2002 00:08:21 -0400
To: (Recipient list suppressed)
From: Norman Bauman
Subject: Jobs on this list: Ethical issues

This message discusses ethical controversies about some of the jobs on this list.

I send out medical writing jobs on this list. I don't take those jobs myself for any of several reasons. Sometimes I don't have the time, or the qualifications. Sometimes I don't want the job for ethical reasons. I say "ethical" not as a pejorative, and not to set myself as morally superior to the people who do the work, but simply because I've made a personal and business decision not to do it.

Because some people on this list don't understand ethical conflicts of medical marketing, and don't understand how some of these jobs are actually a back-door way of violating FDA regulations, I want to spell it out.

Many medical writers read with concern the story in yesterday's New York Times about the role of medical writers in the illegal marketing of Neurontin (gabapentin, Pfizer). Suit Says Company Promoted Drug in Exam Rooms, Melody Petersen, 15 May, 2002; earlier story, Whistle-Blower Says Marketers Broke the Rules to Push a Drug, Melody Petersen, NYT, 14 March 2002

Some of the jobs I turn down, and put on this list, are for medical writers to do exactly the same thing.

Typically, a pharmaceutical company will hire a PR firm to find a writer who will go to a medical meeting, hear a doctor report on a new indication for a drug, write a story about the meeting, and place the story in the trade press to promote an unapproved indication that the pharmaceutical company couldn't promote directly. That's why they pay writers so much money. In addition, the writer may or may not disclose the pharmaceutical company payment to the editor, and many doctors (i.e. readers) and medical editors feel that a writer is ethically required to disclose such payments.

(Most of the jobs on my list are not like this. But some of them are -- and when they talk about "placement," that's often what they mean. Sometimes a pharmaceutical company wants a writer to go to a meeting and simply write a report for the company's own benefit in keeping up with current research. That's the kind of work I like. There's enough work around that writers can hold to a reasonable ethical standard and still usually make a living.)

Illegal promotion of Neurontin

As Petersen explained, Warner-Lambert, which was acquired by Pfizer in 2000, got FDA approval to market Neurontin as an add-on drug for treating epilepsy when the first drug doesn't work well enough. Warner-Lambert's alleged illegal activity was to promote Neurontin for other indications that were not approved by the FDA. And that illegal activity included hiring medical writers. That is, it was illegal for Warner-Lambert to hire the writers -- it wasn't illegal for the writers to do what they did.

(Once a drug is approved for any indication, doctors may prescribe it for any other indication they want, although if the treatment is inappropriate, they can be sued in state civil court for malpractice or be subject to state sanctions for the incompetent practice of medicine. However, FDA regulations forbid drug companies from promoting their drugs for unapproved indications, although those regulations are generally enforced with token punishments.)

In 1996, Warner Lambert hired David P. Franklin, PhD, a research fellow at Harvard Medical School, as a medical liaison with doctors who call the company with questions about Neurontin. Medical writers often say that you have to understand the "culture" of pharmaceutical companies. Franklin was shocked to hear Warner tell its consultants to promote Neurontin for indications which were not approved by the FDA, and which in some cases the drug was no better than placebo in randomized controlled studies. Those indications included attention deficit disorder in children, neurological pain, bipolar disorder, migraines, drug and alcohol withdrawal seizures, and restless leg syndrome. As a result, sales of Neurontin were $1.7 billion and growing, which makes it one of the top-selling drugs, and 78% of prescriptions are for indications other than epilepsy.

Pfizer filed data from clinical studies with the FDA to get approval for Neurontin for pain. But according to Petersen, drug companies don't like to get additional FDA approval for additional indications, because by that time the drug is at the end of its patent protection.

Franklin, who tape-recorded conversations and copied internal documents, resigned, and went public with his concerns. He has filed a lawsuit against Warner-Lambert, which revealed more documents.

Part of the illegal marketing of Neurontin involved getting medical writers to ghost-write articles for publication in medical journals. According to Petersen's 15 May article:

For a more detailed and uncharitable account of Warner-Lambert's promotional activities, see Public Citizen, May 2002, "Neurontin (GABAPENTIN)--The Illegal Corporate Creation of a Blockbuster Drug"

Is it wrong?

Is it wrong? And if so, why? Yes. First, it's wrong to cause a patient direct harm. As MJ Friedrich, a reporter for JAMA Medical News & Perspectives, said in a book review (JAMA 287:2151), "Getting the facts straight in medical stories is crucial because this information affects peoples' lives." If I encourage a doctor to prescribe Neurontin to a patient for depression or bipolar disorder, when it's not effective, I'm causing that patient needless suffering and risk of death. Second, it's wrong to conceal financial support. If I write an article with pharmaceutical company money, virtually every editor of every major peer-reviewed journal would agree that I am ethically required to disclose that funding, which is virtually never done in placement work. So it's wrong because it can harm patients, and it violates widely-accepted financial disclosure guidelines.

If it's wrong, am I wrong to distribute these jobs? Am I part of a conspiracy to harm patients? It's a tough call, but it's my call. My decision is no and no.

First, I'm a journalist, and I regard these jobs as news. Journalists from McGraw-Hill to the Wall Street Journal have told me: when a journalist finds out something interesting, he *has* to tell everybody. We often decide that it's our job is to get the truth out, even when the immediate consequences might seem harmful. If I report the business news that a PR firm is looking for a writer, maybe to promote an unapproved indication, that's news. As a journalist, it's my call to print the news.

Second, the National Association of Science Writers has a job list (which, unlike my list, charges money). The NASW job list recently ran a job like this, provoking an angry debate on the email list, in which many members insisted that the NASW should no longer accept such ads. The NASW board of directors considered the question, and decided that they would not judge or reject such ads. If the NASW can do it, so can I.

(And The New York Times prints classified help-wanted ads for these same PR agencies. If the Times can do it, so can I.)

Third, I've discussed this with friends who are good journalists, whose ethics I respect, and they told me that they don't think I'm wrong to pass on these jobs. So that encourages me to believe that my judgment call is right.

But other parties are involved. The blame is not entirely with the drug companies. You'd think doctors would be smart enough and responsible enough to ask a drug company rep for published, randomized controlled studies before they hand out pills as if they were candy.

You'd think citizens in a democracy would be smart enough to be concerned that their president deregulated the pharmaceutical industry so much that new drugs started killing people and had to be withdrawn, that drug companies are contributing money to politicians just as they contribute money to doctors -- you'd think they'd be concerned with this rather than squander the national forum with salacious interest in the president's sex life.

And finally, the FDA regulations on drug promotions are a bad compromise, influenced more by drug company campaign contributions than by the interest of patient health. In some ways the FDA is too lenient, and in other ways too harsh. There are patients who say that Neurontin is the only thing that has relieved their pain. It's difficult to get reliable information on off-label indications. Our government has utterly failed its responsibility to provide the reliable medical information that the public expects.

In contrast, the U.K. National Health Service has created web sites for doctors and patients, like the NHS Centre for Reviews and Dissemination at the University of York.

Living in the real world

As I write this I am listening to Bertold Brecht's Threepenny Opera, in which Jeremiah Peachum says, "Be good, sure, what's to disagree? But circumstances do not permit it." (The circumstances, Brecht would say, of capitalism.) We are living in the real world. Everyone has to make compromises to make a living. Marcia Angell, the editor of the NEJM, is among the most vigorous critics of drug company promotion (and I basically agree with her), but the NEJM was filled with drug company ads that paid her salary and the printer's bill. Gloria Steinem touted Ms. magazine as a force for women's health, but Ms. magazine was filled with cigarette ads, which under Ms.' ad acceptability policy constituted an endorsement, and Ms. never printed a word about the health effects of tobacco, which now kills more women than breast cancer.

I do have certain limits, and I'm rethinking them. I wouldn't help a PR firm find a writer to promote tobacco. I'm uncomfortable with off-label promotions. I wouldn't forward a job to promote a drug for an indication that I *knew* was harmful to patients.

But these are dilemmas that I can't easily resolve. Last week, I was discussing an ethical quandary with another medical writer who summed it up, "You have to make a living."

I want to meet reasonable ethical standards, but I can't be perfect in a world of compromise. For example, a Google search for "gabapentin" led me to New York Online Access to Health (NOAH), a highly-praised medical web site. At that link you will see a page with the name, New York Weill Cornell Center Columbia Presbyterian Center, although it doesn't explicitly say that the center endorses the information on the page. This page has a "Fact Sheet" on Gabapentin (Neurontin), which asks, "What Illnesses are Treated with Neurontin?": and answers, "Seizure disorders ... Bipolar disorder (Manic-Depressive Illness) ... Major Depression," the last 2 of which are life-threatening and *not* FDA-approved. The NOAH page says, "For information or referral, call 1-888-694-5700." When I called that number, I got a woman who said it was the "front door" of New York Presbyterian services, where among other things I could get a referral. I couldn't find anyone at that number who would understand what I meant if I asked them why they were promoting unapproved uses of Neurontin.

So if you're looking for ethical purity, you won't find it easily, and maybe not at all. NOAH is endorsed and promoted by several New York libraries as a reliable layman's guide to medical information. In reality, they don't have enough money and independence to create an objective, reliable, useful web site, so they have to make commercial deals with institutions like New York Presbyterian whose financial motivation compromises the librarian's responsibility to their readers. These are the ways that public services are compromised by commercial sponsorship.

In the old days of television, they used to say, "Most chinchilla farmers are honest, hard-working businessmen, but our broadcast exposes the small number of corrupt operators who give the industry a bad name." The jobs I tell you about run the entire spectrum (although I sometimes clip off the obvious frauds), and this message concerns only the ones in a certain (well-paid) gray area of ethical ambiguity. As I always say, it's your responsibility to evaluate them, for creditworthiness, ethics, and everything else.

Sorry to write such a long message; I didn't have time for a short one.

I will continue to post jobs that involve meeting coverage with placement, even about non-approved indications. But now you know the issues involved and you can make your own decisions about whether to take them. Extra credit (for my journalism students). Call NOAH, ask a few questions, and let me know what they say.

Why they are promoting Neurontin for the life-threatening conditions of depression and bipolar disorder, when that indication is not approved by the FDA, and Public Citizen says there was no data to support it? Is there any current data to show that Neurontin is effective in depression and bipolar disorder? (Their answer will probably be that they turned their responsibility over to New York Presbyterian.)

They don't list any corporate sponsors -- do they have any? Are there any sponsors drug companies, and if so, does NOAH suggest any off-label indications of their sponsor's drugs?

--Norman Bauman


Further reading: Ghostwriting shocker. Articles in the UK Guardian on medical ghostwriting.

I said I'm sorry, I can't do this
Sarah Boseley, health editor
07 February 2002
Marilynn Larkin is a self-employed writer and contributing editor to the Lancet, one of the most prestigious medical journals in Britain. While looking for work earlier in her career she agreed to ghostwrite a scientific paper for a medical communication...

It said the drug was the best thing since sliced bread. I don't think it is
David Healy, director of the north Wales department of psychological medicine, was approached by a communications agency working for Pierre Fabre, makers of the antidepressant milnacipran.

Scandal of scientists who take money for papers ghostwritten by drug companies
Scientists are accepting large sums of money from drug companies to put their names to articles endorsing new medicines that they have not written - a growing practice that some fear is putting scientific integrity in jeopardy.

Subsequent articles from the New York Times:

Madison Ave. Plays Growing Role in Drug Research
Melody Petersen
22 November 2002
Ghostwriter Linda Logdberg, PhD, quit medical writing after 12 years to teach high school biology, because she decided she was writing advertising disguised as science. And she blew the whistle to the New York Times.

Sounding Board: Buying Editorials, Brennan T. A. N Engl J Med 1994; 331:673-675, Sep 8, 1994. Buying Editorials: A Response, Richard J. Rothstein et al. Letters. Troyan Brennan, a naive medical ethicist, was "surprised to receive a call from a representative of Edelman Medical Communications, a public-relations firm in New York, asking whether I would be interested in writing an editorial for a medical journal.... The caller said that I would not really have to do much work on this project. I would discuss the matter with them, and they would then have a professional writer compose the editorial, which I could modify as I saw fit. I would earn $2,500 for what was estimated to be several hours of work." The entire project would be funded by a pharmaceutical company.

Ghost with a chance in publishing undergrowth. Lancet. 1993 Dec 18-25;342(8886-8887):1498-9.