Pfizer Canada facing two conflict fights

Drug giant Pfizer Canada finds itself at the centre of two conflict of interest controversies after one of its executives was appointed to the Canadian Institutes of Health Research and it signed a deal to provide $780,000 for the Canadian Medical Association to set up educational programs for doctors.

The controversies have also touched the Canadian Medical Association, which is coming under fire for taking $780,000 from Pfizer to set up the education programs.

“My feeling is that the pharmaceutical industry has no business at all educating doctors,” said Arnold Relman, professor emeritus at Harvard Medical School and former editor of the New England Journal of Medicine. “There's no question that if you're paying the piper, you influence the tune that the piper is going to play.”

Heather Bisset, Pfizer Canada's manager of corporate communications, said it simply wants to “improve education that's provided for doctors across Canada.”

Meanwhile, as of this writing, more than 3,100 people had signed an online petition against the appointment of Dr. Bernard Prigent, vice president and medical director of Pfizer Canada, to the governing council of CIHR.

Francoise Baylis, Canada Research Chair in bioethics at Dalhousie University calls Prigent's appointment "an intractable conflict of interest."

To quote from one of the signatories, “You don’t put the rooster in charge of the hen house.” The duty of pharmaceutical companies (e.g., Pfizer) is to make money for their shareholders. The duty of CIHR is to promote the public interest. The interests of shareholders and the interests of Canadians are not one and the same.

CIHR was created in 2000 as an arms-length federal agency responsible for funding health research in Canada. The 2009-2010 total budget for CIHR was just under a billion dollars. This is a lot of money and it is important that Canadians understand how their tax dollars are being spent.

CIHR president Alain Beaudet said Prigent's experience in innovation and commercialization will “fill a major expertise gap” on the board.

 

The fingerprints of ghostwriting

At a conference of journal editors last week, the head of one publication said the electronic fingerprints left on documents as they pass from one use to the next can help weed out ghostwritten articles.

It's called metadata, a feature of Microsoft Word that identifies each person who uses and changes a document as it is transferred from one person to the next.

Frederic Curtiss, editor-in-chief of the Journal of Managed Care Pharmacy, told Reuters Health that data attached to documents by Word has allowed him to discover undisclosed contributors. In one case, for instance, a revised manuscript arrived at his office with four named authors, but when he examined the metadata, he discovered an additional author was making substantial contributions.  

When documents are saved in Word, the software attaches additional information, called metadata, which identifies the creator of the document. During the editing process, changes made by additional authors are also sometimes labeled with authors' names. Curtiss estimates that every third manuscript he receives has metadata that doesn't match listed authors, which can subsequently result in contributors being added to the acknowledgments, or, rarely, as additional authors.

That one-third is much higher than the 12 per cent figure released in a study released at the Sixth International Congress of Peer Review and Biomedical Publication in Vancouver where Curtiss was speaking. That study, however, relied on researchers admitting they used a ghostwriter. Other studies have pegged the rate of ghostwriting at more than half the articles in major journals.

As for the metadata, Curtiss said ghostwriters, and the researchers using them, are catching on.

Unfortunately, says Curtiss, he is losing the lead in the battle against ghostwriting. Sometimes, the metadata includes only the word "Author" or a number. "Now people are savvy about it," Curtiss says. "We are getting manuscripts where they have purposely removed data from the identification box."

In other words, this is no silver bullet.

Authors admit to ghostwriting

A study released this morning has found a high level of ghostwriting among the world's top medical journals, the New York Times is reporting.

Six of the top medical journals published a significant number of ghostwritten articles in 2008, according to the study by a researcher and editors at the Journal of the American Medical Association.

Among authors of 630 articles who responded to an online questionnaire designed by the researchers, 7.8 per cent acknowledged contributions to their articles by people whose work should have qualified them to be named as authors on the papers but who were not listed.

The prestigious New England Journal of Medicine had the highest rate, at 10.9 per cent. The Journal of the American Medical Association had a ghostwriting rate of 7.9 per cent, according to the study, released in Vancouver as journal editors gather to discuss ghostwriting.

Past studies have estimated much-higher ghostwriting rates, with some researchers saying their independent research foudn that more than half of the articles in some journals are ghostwritten. Today's study, however, relied on authors responding to an online survey, rather than a random sampling of researchers typically used in surveys, the Times points out.

Still, the researchers behind it said they hoped that the study will push journals to address the issue.

“These journals are the top of the medical field,” Joseph S. Wislar, the lead author of the study, said in a phone interview Tuesday.

He recommended that medical journals take more action to require that all contributors be listed in acknowledgments if they are not named as authors.

“Journals are really just starting to dig into that, and we’re hoping that’s going to help,” Mr. Wislar said. “We haven’t seen that help yet.”

Medical journal examines ghostwriting

Canada's top medical journal, the Canadian Medical Association Journal, takes a look today at the risks involved with ghostwriting, following up on the case of McGill researcher Barbara Sherwin.

The Toronto Star last month revealed that Sherwin was listed as the sole author on a 2000 article on hormone replacement therapy, without revealing that she had been helped by ghostwriting firm DesignWrite. The firm had been hired by drug company Wyeth to promote its HRT products. She also worked with the company three years later, though she denies she used any of its contribution in the 2003 article.

In its article today, the CMAJ says the revelations were the tip of the iceberg.

Somewhere between 50% and 100% of articles on drugs that appear in journals are ghostwritten,” says Dr. David Healy, a psychiatrist at the University of Cardiff in Wales, United Kingdom, and a critic of the drug industry's influence on physicians’ drug prescribing habits.

Healy says that ghostwriting “crept up on” the medical profession and became so common by the mid-90s that even senior researchers came to accept it as an ethical practice. Other critics of the practice agree, claiming that many researchers will put their name on a document as primary author even if they just edited it — or only read it and made no changes.

“If you have people like me who say they can’t do this, the pharmaceutical industry can easily go elsewhere and find a person who will,” says Healy.

Ghostwriting has been able to spread, the article says, because all three groups involved -- drug companies, academics and medical journals -- benefit.

Transparency advocates say ghostwriting has become commonplace because it provides substantial benefits to three parties: drug companies, researchers and medical journals. By managing the publication of articles about their products, it is easier for drug companies to spread positive results and bury negative results. This often provides a big boost to drug sales. Having the name of a “key opinion leader” on a study is even better, ghostwriting critics say, because it gives the study an air of independence and respectability.

Many academics show little reluctance in lending their names to articles someone else wrote because it pads their resumes, which tends to help them bring in more money on the lecture circuit, says Arthur Schafer, director of the Centre for Professional and Applied Ethics at the University of Manitoba in Winnipeg.

“They sold their credentials for false credit and money,” says Schafer.

As for medical journals, they benefit by gaining access to papers on the latest clinical trials for new drug products. Some even accuse medical journals of pandering to the pharmaceutical industry, including turning a blind eye to ghostwriting, so they can publish clinical trial results.

 The article quotes critics calling for more transparency in who writes journal articles and details of their contributions, but does not say what CMAJ will do. As the CMAJ notes, ghostwriting will be a major topic at a meeting of journal editors next weekend in Vancouver.
 

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.