Ghostwriting: 'What's the harm?'

Ever since the Toronto Star broke the story of a McGill University professor's involvment with ghostwriters, there has been a growing debate across Canada about the practice.

In an unsigned editorial put online this morning, the Montreal Gazette asks, "What's the harm?" Afterall, it says, there's no evidence Sherwin intended to deceive anyone and the article in question was in line with the rest of her scholarship.

It's an important question. Across the country in Victoria, BC, the Time Colonist offers an answer:

Why is that important? First, DesignWrite is paid by pharmaceutical giant Wyeth to promote its drugs. But there was no mention of those co-authors in the article. That could mislead readers into believing the report was independent, when it was not.

Second, the article concluded that estrogen therapy helps prevent memory loss. But Wyeth is a producer of estrogen-based medications. In the research field, such an obvious conflict of interest could invalidate the findings, if it were known.

The danger, in other words, isn't just that bad science gets portrayed as good, but that good science gets dismissed as tainted. Both outcomes are dangerous to public health.

The Gazette seems to understand this, too, concluding its editorial with a discussion of the importance of the issue and a comparison to politicians -- who rarely write the speeches they give.

And this is different from writing speeches for politicians. The people who do that are usually partisans who share the views of their employer and who, in fact, might well be part of the team developing both policy and political strategy. In other words, both writer and reader share essentially the same goal.

That is very much not the case with a drug-company employee and a scientist. The aims they serve are quite different and often opposed. And maintaining that difference is often quite literally a matter of life and death. Sherwin's "error" suggests that at the very least, academics need to update and clarify the ethics that guide them.

McGill bioethicist Margaret Somerville joins in the debate, as well, in a column in the Gazzette. She questions whether we can judge researchers who used ghostwriters a decade (or less) ago based on the ethics of today, quoting British Lord Denning saying that "you can't look at 1956 events with 1964 glasses."

Just as the law evolves and science evolves, so too ethics evolves and something we now rightly regard as unethical might not have been so characterized in the past.

Much has changed in the last few years with respect to the ethics of academic publishing. Practices that were considered normal just a few years ago, such as placing on research articles the names of people who did not participate directly in the research (for instance, a principal investigator whose only connection with the research was that his research grant supported it) are now considered unethical.

She does not, however, make the case that using drug company paid ghostwriters was considered acceptable in 2000 when Sherwin's article appeared -- or in 1964, for that matter.

Meanwhile, the medical freelancers whose ranks make up the anonymous ghostwriters, have begun to speak up. One, Kate Johnson of Montreal, cautions in her blog about "throwing the baby out with the bathwater" by letting the ghostwriting scandal end the practice of researchers using editors to smooth out their prose.

As a medical editor, I help researchers with their writing - enabling them to communicate the results of their studies to the wider medical community.

This is not ghostwriting.

But in their haste to distance themselves from this ghostwriting exposé of the pharmaceutical industry, medical schools and academic journals may intimidate researchers from seeking the appropriate help of professional writers and editors.

In doing so they risk losing a great deal of valuable research done by brilliant investigators who can’t write.

No reporter would discount the role of a good editor. Any story that appears in a newspaper has been edited two or three or more times before it appears in print. Johnson is right, this is not ghostwriting.

Ghostwriting happens when an anonymous writer prepares an article that is edited by a respected researcher in the field. The editor's name then appears on the paper as author. 

No newspaper I know assigns bylines that way.

In a letter to the Boston Globe in response to an editorial about ghostwriting, medical freelancer Judith Pepin likewise sees nothing wrong with researchers getting help with their writing -- a skill she says many don't have.

I agree wholeheartedly that ghostwriting (undisclosed drafting of a manuscript) is a clear violation of ethics. However, acknowledged medical writing help is not ghostwriting.

In addition to assistance with writing, editing, and fact-finding, the medical writer lends valuable expertise to the lead author in the stylistic requirements of the many scientific journals to which manuscripts are submitted for publication.

This is a collaborative effort between the writer and the authors, and in no way, should be lumped in the category of “ghostwriting.’’

Also a good point. Editing is not the same as ghostwriting.

But it can still be wrong if the editor is getting money from the people whose products are being written about.

Collaboration is at the heart of good science. More people involved in the writing of a scientific article is can be a good thing, if it ensures that more facts and possiblities are brought to the table, discussed and presented to the reader. 

It only becomes an issue when some of those at the table have a possible conflict of interest, and it isn't diclosed.

Conflicts of interest can hurt business

The chief executive of medical device maker Medtronic Inc. was forced during the company's annual meeting yesterday to defend his company's million-dollar deals with university professors and other researchers hired as consultants.

Medtronic is at the centre of a growing scandal over the close ties between medical and pharmaceutical companies and the researchers who are supposed to be testing their products.

At the annual shareholder meeting of Medtronic Inc. Thursday, CEO Bill Hawkins defended the company's longstanding practice of collaborating with physicians, although he acknowledged these paid relationships could pose a conflict of interest.

Working with doctors to improve devices and commercialize inventions is crucial to advancing medical technology, Hawkins said before a crowd of about 400 people at the company's Fridley headquarters.

Yet these relationships have triggered inquiries by Congress and the Department of Justice, prompting a pointed question from one shareholder who said he was shocked at the amount of money paid to Medtronic's doctor consultants.

Recent reports have focused on the consulting relationship between Medtronic and Dr. David Polly, the head of spine surgery at the University of Minnesota. Between 2003 and 2007, Medtronic paid Polly $1.2 million for consulting, expenses and honoraria.

The shareholder, 77-year-old John Burbidge of Edina, Minnesota, said that while he understood the need for input from physician consultants, he was "taken aback" by the sums of money involved.

Is it really necessary to pay that kind of money to doctors in order to get good information?" he asked.

"Can you rely on information that you pay that much money for?" added Burbidge, who said he is a longtime Medtronic shareholder.

"Obviously, nobody is going to want to tell you anything you don't want to hear and jeopardize his relationship with the company."

The university of Minnesota is investigating Polly's links to Medtronic to see if they violate school policy.

Meanwhile, it would seem that quarterly profits at the company dropped almost 40 per cent do to leagal costs, and the price of its shares fell.

Ghostwriting -- why they do it

A prominent hormone replacement therapy researcher exposed by the New York Times last December to have put his name on ghostwritten studies for estrogen drug company Wyeth Pharmaceuticals has broken his silence to say he's sorry.

Seattle blogger William Heisel, a former award-winning health reporter for the LA Times, managed to reach Australisn researcher John Eden by e-mail, where others had failed.

He was surprisingly forthcoming and said he regrets the decision.

"We academics are under some pressure to 'publish or perish,'" Eden wrote. "Performance evaluation of at least Australian academics includes the number and quality of publications per year. In retrospect, I was probably naïve and I wouldn't do it now."

His comments cut to the heart of what observers have said is at the heart of ghostwriting -- professors are under pressure to publish papers, and to publish often, or see their careers suffer. So when someone comes along to help them get more publishing credits to their name, they agree.

In a column by Peggy Curran, the Montreal Gazette wondered if the pressure to publish was behind the involvment with ghostwriters by McGill University professor Barbara Sherwin.

In a written statement last weekend, Sherwin said she “made an error in agreeing to have my name attributed to that article without making it clear that others contributed to it.” Sherwin said she was not paid for the article, and believes the article reflected “sound and thorough scholarship.”

So was Sherwin duped or simply sloppy, so desperately keen to publish she was willing to blur the lines of ethical conduct? If, as she says, the article went through a peer review, why didn’t she mention the other authors? How often do academics, under pressure to deliver on deadline, rely on a ghost for hire?

Jocalyn Clark, a University of Toronto assistant professor of medicine and a senior editor at PLoS, says universities have a responsiblity to get tough on ghostwriting. PLoS, along with the New York Times, managed to get 1,500 court documents on ghostwriting made public, and then put them online.

Canadian named in ghostwriting, part 2, and what can be done

In a story in this morning's Toronto Star, I explore the ties between McGill University professor Barbara Sherwin, alleged in court documents to have used a ghostwriter for an April 2000 study, and New Jersey ghostwriting firm on a second study published three years later.

Sherwin vehemently denies there was any ghostwriting involved in the 2003 article.

Here is her complete statement to the Star on the matter:

"Concerning the article in question, published in Endocrine Reviews in April 2003, I had refused to submit material offered by DesignWrite personnel. The article eventually published in Endocrine Reviews was entirely my own work. I cannot emmphasize that strongly enough."

"In my previous statement, I maintained that I had never - either prior to or following the publication of an article in the Journal of the American Geriatric Society in April 2000 - submitted work other than my own. I stand by that statement."

McGill continues to investigate. Here is the university's complete statement yesterday from provost Anthony C. Masi:

"As I said last week, McGill University takes academic integrity very seriously. We have policies and procedures in place that require us to investigate serious allegations of academic misconduct."

Jocalyn Clark, a Toronto-based senior editor for PLoS Medicine, which last month managed with the New York Times to get the court documents released to the public. says universities need take the lead in stamping out ghostwriting.

Academic institutions, she says, use a professor’s publishing record as the basis for promotions, grants and deciding who gets tenure – so have a responsibility to ensure those records are beyond reproach.

“Publications are the main currency in academic institutions,” Clark, an assistant professor at the Unviersity of Toronto medical school, said in an interview.

As such, the schools need to send a clear message that using ghostwriters will hurt an academic’s career, not help.

“Stamping out ghostwriting will only happen when academic institutions, their medical schools and their faculty declare that this is not acceptable,” she says.

PLoS, which in a recent editorial referred to ghostwriting as "the dirty little secret of medical publishing," has also called on medical journals to retract all ghostwritten articles, to notify the universities where the authors of the articles work and to ban those authors from publishing with that journal again.

Such measures, Clark says, could damage a researcher’s career. At that, she hopes, would be a powerful incentive for them to stay away from ghostwriters. 

PLoS has also made the court documents available online.
 

Ghostwriting documents a wealth of information

Court documents put online last week by PLoS Medicine give the public an unprecedented look into the world of academic publishing and the extent to which big drug companies used ghostwriters to market their products.

The 1,500 documents -- internal memos, meeting agendas and minutes, project tracking report, faxes, cover letters, draft manuscripts and more -- detail the efforts by Wyeth Pharmaceuticals to use top academic journals as marketing tools for its hormone replacement therapy drugs, and to enlist top researchers from around the world to be "authors" of the studies.

The documents were made public last month after PLoS and the New York Times convinced a US court ot unseal documents in a lawsuit to release them to the public. PLoS put them all online last Friday.

Toronto-based senior editor told me yesterday that the public needs access to these document so they can see for themselves what happened.

"The thing that strikes me about the documents is how the campaign is so co-ordinated, so deliberate," Jocalyn Clark says. "Which implies it is a normal course of business."

One document, a May 15, 1997 proposal by DesignWrite to produce ghostwritten articles for Wyeth, bluntly states three main goals for the partnership: boost physician awareness of HRT, “diminish the negative perceptions associated with estrogens and cancer” and lessen the competitive threat of another company’s similar drug.

The proposal, which won DesignWrite a seven-year contract to produce up to 30 articles at up to $25,000 per article, offers Wyeth (referred to as “the client”), full control over the content of the articles.

“After the client has reviewed and released the manuscript for submission, DesignWrite will see it through the necessary production stages – creating camera-ready figures and tables and the text according to journal guidelines and submit the package (manuscript, art cover letter, and any required forms and checklists) to the appropriate journal editor.”

Depositions by several DesignWrite and Wyeth executives are also among the doucments available.

In one such deposition, Karen Mittleman, senior medical writer at DesignWrite, explains the general process for ghostwriting: Wyeth sends data to DesignWrite to be used in a ghostwritten article. An outline is prepared by DesignWrite and sent to Wyeth for review. It then goes back to DesignWrite to prepare a first draft, which takes between four to eight weeks. The draft is sent to Wyeth for review and to a respected researcher in the field, who will also review it and attach his or her name as author.

In many of the documents, a distinction is drawn between “writers,” the anonymous people who pen the articles, and “authors,” the academics who lend their names and reputations to the finished product.

Beyond ghostwriting, the documents indicate, DesignWrite was also hired by Wyeth produced PowerPoint slides to be used by academics when making presentations at industry conferences. Wyeth paid $10,000 for this service.

Trudo Lemmens, a professor of law and medical ethics, has said such help with presentations is often the beginning of the slippery slope drawing academics into a pharmaceutical company’s sphere.

DesignWrite also wrote articles for academic journal supplements at $25,000 apiece, the court documents indicate. Wyeth could then by up multiple copies of the supplements for distribution to doctors’ offices and to give to its sales force to use as evidence of the effectiveness and safety of hormone replacement therapy.

The firm was also instrumental in putting together a patient information handout for doctors to give their patients if they had questions about HRT. The 2001 handout, written by DesignWrite writer Bernadette Janas and sent to Wyeth for approval, reassured women that “HRT does not increase breast cancer risk.”

No mention was made of the role DesgnWrite or Wyeth played in putting the handout together.

Canadian named in ghostwriting

Writing in the Toronto Star this morning, I look at the case of a McGill University psychology professor, Barbara Sherwin, whose name appeared atop an article prepared by ghostwriting firm DesignWrite as part of its contract to promote Wyeth Pharmaceutical's HRT drugs.

A top Canadian researcher studying hormone replacement therapy was part of a ghostwriting scheme paid for by drug giant Wyeth Pharmaceuticals to promote its products, court documents obtained by the Toronto Star indicate. 
The article in question appeared in the April 2000 edition of the Journal of the American Geriatrics Society and listed McGill University psychology professor Barbara Sherwin as author. 
It argued that estrogen could help treat memory loss in older patients, while offering other benefits. 
Sherwin is the first Canadian implicated in an ongoing scandal in the United States, where court documents – unsealed recently after a successful motion by The New York Times and the journal PLoS Medicine – have lifted the veil on the extent of ghostwriting in the pharmaceutical industry. 
The university is investigating. 
"McGill University is committed to the highest standards of honesty and integrity in research and scholarship and takes substantiated allegations of research misconduct very seriously," said provost Anthony C. Masi in a statement yesterday.
"The university has an established process for investigating and dealing with such allegations, (and) will look into this matter and take appropriate action." 

Sherwin's article examined treatments for memory loss in aging patients. It favoured estrogen, used in hormone replacement therapy, saying the hormone could also help prevent cardiovascular disease and osteoporosis, as well as reduce the risk of colorectal cancer and "all-cause mortality in postmenopausal women." 

"Since estrogen has been used for nearly 60 years, its effective dosages, side effects, and influences on other organ systems are well known," the study says, describing estrogen as "relatively safe." The study, a copy of which remains in the stacks of the University of Toronto's medical school library, lists Sherwin as the sole author. 

But court documents now indicate that New Jersey ghostwriting firm DesignWrite, hired by Wyeth to promote its products, actually penned the article. 

The danger of ghostwriting, said James Szaller, a Cleveland lawyer leading a large class-action suit against Wyeth, is that doctors rely on such articles when caring for their patients. 
"It puts patients at risk, and doctors are relying on marketing materials and not truly clinical studies or unbiased reviews of the medical literature," he said. "It's insane."

Sherwin declined comment, but issued a statement regretting her work with DesignWrite.

"I wrote a portion of the article, but not all of it, although only my name was listed as its author. Other parts of that article were written with the assistance of DesignWrite, a firm which, it turns out, was employed by a pharmaceutical manufacturer to assist in the development of academic articles," she said in the email statement. 
"I made an error in agreeing to have my name attached to that article without having it made clear that others contributed to it. It is an error I regret and which had never occurred before or since. I received no remuneration for the article in question. I believe the article, which was peer-reviewed, represented sound and thorough scholarship and in no way could be construed as promotion for any particular product or company." 
Szaller, who for four years has sifted through internal DesignWrite documents, said Sherwin seems to have offered "a fair amount of editing" suggestions to the writers, compared with others working with DesignWrite. 
"There are some who simply seemed to glance at it and make one- or two-word changes," he said.

Ghostwriting documents put online

PLoS Medicine, the medical journal that paired up with the New York Times last month to convince a US court ot unseal documents in a class action suit against Wyeth, put the court documents online this morning. These are raw documents, and so numerous they're tough to sort through.

The documents include internal correspondence, reports, and tracking documents relating to interactions between the pharmaceutical company Wyeth and a medical communications firm, to promote Wyeth’s hormone drugs. These documents show in considerable detail a coordinated and carefully monitored campaign of “ghostwriting” by Wyeth and medical writing companies for a number of products marketed by the company.

Ghostwriting, which involves using medical writers to produce articles that are then nominally authored by an academic not substantially involved in the writing process, has been condemned as an unacceptable practice by medical journals and editors. Nonetheless, the practice appears to persist and by placing all the documents for scrutiny in the public domain, the editors of PLoS Medicine hope that they will help guide the way to identifying reforms that will eventually stamp ghostwriting out.

In order to make these documents available, PLoS Medicine, represented by public interest law firm, Public Justice (http://www.publicjustice.net), and The New York Times intervened in an ongoing court case in which women were suing Wyeth, the manufacturers of Prempro, a hormone replacement therapy. During the discovery process for this case, one of the lawyers representing injured women in the litigation, Jim Szaller of Cleveland, Ohio, had become aware of many documents that laid out in detail the company’s (mostly successful) attempts to publish papers written by unacknowledged professional medical writers in which the message, tone, and content had been determined by the company but the paper was subsequently nominally “authored” by respected academics.

In an accompanying editorial to be published in the September issue of PLoS Medicine, but put online today, PLoS condemns ghostwriting as medical publishing's "dirty little secret" and calls on journals to immediate retract any ghostwritten articles and to ban the authors involved from future publication. Universities are urged to investigate any professor implicated "as a matter of urgency. Shareholders should worry about whether the companies they are invested in could be in for a financil hit.

But more than that, it says, much soul searching is also needed.

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 a 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. And 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?

Glaxo implicated in ghostwriting scandal

Court documents uncovered in a California lawsuit against GlaxoSmithKline over its antidepressant Paxil show that the big pharmaceutical company made extensive use of ghostwriters to promote its drug, later found to be highly addictive and to cause suicidal thoughts in some cases, the Associated Press reports.

WASHINGTON — Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.

An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.

Known as the CASPPER program, the paper explains how the company can help physicians with everything from "developing a topic," to "submitting the manuscript for publication."

The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.

A spokeswoman for London-based Glaxo said the published articles noted any assistance to the main authors.

"The program was not heavily used and was discontinued a number of years ago," said Mary Anne Rhyne.

According to the memo, which dates from April 2000, the CASPPER program was designed to "strengthen the product positioning and overcome competitive issues."

The stroy says Glaxo played a big role in preparing articles for publication.

According to ghostwriting expert Dr. Leemon McHenry, Glaxo's program was unusually intertwined with its internal sales and marketing department.

"We know that GSK has engaged in ghostwriting for many years," said McHenry, who works as a research consultant for Baum Hedlund. "But to create an internal ghostwriting program and have the gall to name it after a cartoon ghost demonstrates their juvenile attitude and careless disregard for patients."

The story draws Glaxo into a scandal that has focused most recently on Wyeth's use of ghostwriters to promote its hormone replacement therapy drug Premarin. There have been several Wyeth stories of late, thanks to a court motion by the New York Times and PLoS Medicine to unseal boxes of court documents.

Meanwhile, Iowa Senator Charles Grassley has asked his country respected National Institutes of Health to explain what it's doing to address ghostwriting.

 

Senator's ghostwriting campaign gaining attention

The efforts of an Republican senator from Iowa to lift the veil on the secretive world of academic publishing and the ties between doctors, researchers and big medical companies is gaining increased attention, with stories this week in the Washington Post and the New York Times.

The Milwaukee Journal Sentinal and the Minneapolis Star Tribune have also got in on the action, writing about the ties to medical supply compnies and big pharma of local doctors and researchers at their local universities.

What all these stories have in common is the work of Iowa Senator Charles Grassley, who is putting his post on the Senate Finance Committee to to use by looking into the ties between doctors and researchers and the big companies behind medical and pharmaceutical advances.

Also key in this whole thing is a stack of duments made public recently, thanks to a successful court motion by the New York Times and PLoS Medicine to unseal boxes and boxes of internal company documents from ghostwriting firm, DesignWrite.

The ties include researchers being hired as paid consultants for the companies whose prodcuts theya re supposed to be testing -- with some getting more than $1 million US in fees, and medical schools themselves receiving millions in research money from the companies -- and a surpirisingly widespread use of ghostwriters by academics (who, under most schools' academic policies would have to fail any of their students who did the same thing). The ghostwriters are paid $25,000 by the companies whose products they are writing about.

The result is a growing distrust of medical research and the medical profession, as the Washington Post writes:

You may not be able to trust your mortgage broker, your car salesman or your congressman, but you can trust your doctor.

Can't you?

Patients might well ask themselves this question when they learn that 94 percent of physicians have "a relationship" with the pharmaceutical, medical device or other related industries, according to a national survey of physicians published two years ago in the New England Journal of Medicine.

It is unclear how much those businesses spend on marketing overall, but Integrated Medical Systems, a research firm, estimates that pharmaceutical companies spend more than $20 billion annually marketing directly to doctors.

It does seem clear, however, that many patients want a better sense of the links their doctors have with industry.

A consumer survey last year by the Pew Prescription Project, an initiative to help eliminate conflicts of interest in prescribing, showed that 68 per cent of respondents supported legislation that would require public disclosure of financial relationships between physicians and industry. Seventy-eight per cent believed that accepting gifts from the pharmaceutical industry influences their doctors' prescribing habits, but only 34 per cent said they would be likely to ask their doctors about potentially troubling financial ties.

Such ties are dangerous. They not only lead to bad research being portrayed as good, but it taints good research which might be able to to people some good.

Ghostwriting called bad medicine

Over the weekend, I had a story in the Toronto Star looking at ghostwriting in medical journal, beginning with the case of a woman diagnosed with breast cancer after two decades of using hormone replacement therapy.

Jackie Smith thought she was doing the right thing.

With an asthmatic 4-year-old boy at home and a sick father a world away in Australia, she had no room in her life for osteoporosis or early menopause. It was 20 years ago, and when her gynecologist suggested hormone replacement therapy to stave off the effects of aging, she agreed.

"I was having these awful hot flashes," the 62-year-old recalls. "I found it really hard to deal with. There was a lot of stress in my life."

It's a moment she is revisiting now, with news that the company behind her treatment used ghostwriters to promote HRT in academic journals and play down any health threats, including breast cancer and stroke.

Last month, Smith, who was on HRT for 13 years, was told she has breast cancer. "The hardest part was telling my son," she says, adding that her boy, now living in British Columbia, flew home immediately.

News of ghostwriting has been seeping out for years, with lawsuits in the U.S. forcing drug companies to admit to the practice.

But a lawsuit against HRT manufacturer Wyeth Pharmaceuticals has gone further, finally pulling back the veil on the shadowy world of academic publishing and laying out how ghostwriting works.

In the story, I compare ghostwriting to students who hire essay-writing companies to prepare their term papers -- except the money involved is a lot bigger, and the professors get promoted for having more articles published, while students get expelled.

It hardly seems fair.In fact, Smith says she would fail any student who uses such a service.