Medical ghostwriting scandal: doctors sign their names to drug company marketing lies

I had to go have a little lie-down after I read the The New York Times story this week about the scandalous practice of medical ghostwriting. Here’s how Danish researcher Dr. Peter Gøtzsche describes medical ghostwriting: “Ghostwriting occurs when someone makes substantial contributions to a manuscript without attribution or disclosure. It is considered bad publication practice in the medical sciences, and some argue it is scientific misconduct. At its extreme, medical ghostwriting involves pharmaceutical companies hiring professional writers to produce papers promoting their products –  but hiding those contributions and instead naming academic physicians or scientists as the authors.”

Here’s an extreme example of extreme medical ghostwriting. The New York Times has outlined recent court documents revealing that ghostwriters paid by drug giant Wyeth Pharmaceuticals played a major role in producing 26 scientific papers published in medical journals that backed the use of hormone replacement therapy in women. That supposed medical consensus benefited Wyeth directly, as sales of its HRT drugs Premarin and Prempro soared to nearly $2 billion by 2001.

Wyeth paid Design Write, a New Jersey medical communications firm, to draft these papers that were then published in medical journals between 1998 and 2005.  They emphasized the benefits and de-emphasized the risks of HRT to protect against conditions like aging skin, heart disease and dementia.

But in 2002, independent  researchers pulled the plug three years early on the Women’s Health Initiative, a large-scale, federally funded study of  HRT. They had found that the therapy actually produced an increased risk of breast cancer, heart attack, stroke and blood clots.

Wyeth now faces over 8,400 lawsuits* from women who claim that the company’s hormone replacement therapy drugs caused them to develop illnesses. Twenty-eight of the 31 cases that had been set for trial have been settled out of court; other cases are on appeal. Wyeth claims that they have changed their policy and now require these physician and academic ‘authors’ to actually participate in the medical research.  That’s the power of 8,400 lawsuits.

“It’s almost like steroids and baseball,” according to Dr. Joseph Ross at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting.

“You don’t know who was using and who wasn’t; now you don’t know which articles are tainted and which aren’t.”

In North American medicine, doctors’ links to industry are often hidden from public view. And critics justifiably argue that such relationships can taint the integrity of medical research and patient care. A truly brilliant marketing scam.

Because physicians rely on medical literature, the concern about ghostwriting is that doctors might change their clinical prescribing habits after reading certain articles, unaware they were commissioned by a drug company.

And what about the medical journals that agree to publish these ghostwritten papers?  Their editors cannot possibly be ignorant of the widespread unethical practice of ghostwriting. The Public Library of Science Medicine journal ran an editorial this week with these recommendations:

• Medical journal editors need to decide whether they want to roll over and just join the marketing departments of pharmaceutical companies
• Authors who put their names to such papers need to consider whether doing so is more important than having medical literature that can be believed in
• Politicians need to consider the harm done by an environment that incites companies into insane races for profit rather than for medical need
• Companies need to consider whether the arms race they have started will in the end benefit anyone. After all, even drug company employees get sick; do they trust ghost authors?

Dr. James H. Stein, professor of cardiology at the University of Wisconsin School of Medicine adds:

“Just three days ago, I got a request to be the ‘author’ of a ghostwritten article about the effectiveness of a cholesterol-lowering drug. This happens all the time.”

He declined to attach his name to the paper.

Thankfully, other physicians like Dr. Stein have also refused to get into bed with Big Pharma. Dr. Charlotte Thompson, of the University of California at San Diego Medical School – and a practicing physician for 50 years – adds this question:

“How can a professor in a medical school allow his or her name to be used on an article ghostwritten for a drug company? What has happened to their ethics? One professor (in the New York Times article) was quoted that it would take her too long to do the necessary research for the article. As a salaried medical school professor, I can’t imagine what she was thinking!”

Well, what the too-busy professor was thinking was likely the old axiom of academia: publish or perish.

Dr. Carl Elliott of the Centre for Bioethics at the University of Minnesota asks:

“How long does this have to go on before it actually is stopped? One way to stop it would be if the real authors were punished in some way. But the academics who are complicit in it all never seem to be punished at all.”

Here’s a suggestion, if ethical physicians and academics are truly serious about stopping this appalling practice: let’s start by publicizing the names of  all professionals who have agreed to lend their names to industry-sponsored marketing scams.  Oops, I meant “scientific research”.

And here’s an example:  the Toronto Star has revealed that psychology professor Dr. Barbara Sherwin of McGill University claimed at first to be the sole author of a Wyeth-funded, Design Write-created paper published in the Journal of the American Geriatic Society. She’s now offering a version of this stupefyingly preposterous defense to the media:

“Who knew that a drug company was paying my ghostwriters?”

According to the Star, this paper “examined treatments for memory loss in aging patients. It favoured hormone replacement therapy, saying the hormones could also help prevent cardiovascular disease in postmenopausal women.”  Which happens to be a lie, by the way.

Independent (i.e. not bought and paid for by Big Pharma) randomized control studies instead have shown an increase in the risk of heart attack or death due to heart disease in the first year of HRT, and an approximate three-fold increase in the risk of blood clots. McGill University reports that it is now investigating Dr. Sherwin.

By the way, if you’re a science writer interested in making a lot more money than you’re earning right now doing legitimate writing, consider that Design Write charges $25,000 a pop to ghostwrite scientific papers. Tinker Ready, senior writer at Boston Health News, wrote recently in a column:

“I went to a session at a science writers’ meeting a few years back on how to make a six-figure income. The session leader talked about getting  jobs from drug companies to write articles. They’ll give you all the medical studies you need. The pay, at the time, was exponentially higher than any other science writing work.  ‘But you can’t include any other studies?’  No.  ‘And a doctor’s name goes on it, not yours?’  Yes.  A few people in the room said they made a good living that way. The session then turned into a tense debate about the ethics of this kind of work.”

Read this week’s New York Times article, or the Public Library of Science Medicine journal.

Read more about medical ghostwriting at The Ethical Nag, or at:

• Doctors On The Take: How To Read the Fine Print in Cardiac Research Reports
• What if Everybody Starting Telling the Truth About Medical Ghostwriting?

 

 

* NEWS UPDATE

 

December 15, 2011 (via Bloomberg Business Week): 

 

Pfizer, the world’s largest drugmaker, and its Wyeth and Pharmacia & Upjohn units, have settled almost half of the lawsuits over its menopause drugs and increased the funds set aside to resolve the cases, the company said in a regulatory filing. The suits claimed the companies’ hormone-replacement medicines, including Prempro and Premarin, caused breast cancer, according to the Securities and Exchange Commission filing. Pfizer said it added $68 million to the $772 million it already reserved for the cases.

 

 More than 6 million women took Prempro and related menopause drugs to treat symptoms including hot flashes and mood swings before a 2002 study highlighted their links to cancer. Wyeth’s sales of the medicines, which are still on the market, exceeded $2 billion before the release of the Women’s Health Initiative study sponsored by the National Institutes of Health.

 

At the height of the litigation, Pfizer faced more than 10,000 claims that its menopause drugs caused breast cancer, according to lawyers for former users.

 

Earlier this month, a Philadelphia jury ordered the Pfizer units to pay $72.6 million in compensatory damages to three women who blamed the drugs for their breast cancers. Pfizer agreed to settle the case before jurors were asked to decide whether the company should face punitive damages. Terms of the settlements weren’t released.