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.

 

Healthcare for all called an ethical issue

A professional association of U.S. bioethcists has come out in favour of President Barack Obama's plans to make public health insurance available to the 50 million Americans currently uninsured.

Collegiate bioethicists waded into the health-care reform debate Tuesday, declaring that "the current state of health care is unethical" and branding as false criticisms that congressional proposals would threaten patient choice or deny older Americans medical treatment.

"We felt we needed to speak up. The tenor of the debate has become quite strained and full of misinformation," said Jeffrey Kahn, president of the new, 60-member Association of Bioethics Program Directors. Kahn also heads the Center for Bioethics at the University of Minnesota.

"There is no morally defensible reason why some Americans get excellent medical care at costs they can afford and other Americans lose their homes or go into bankruptcy attempting to secure treatment for a seriously ill loved one," a statement from the group said.

"The current proposals being debated in Congress all go a long way toward making health care in America more just," it said. The group disputed what it called "the top three myths" about the proposals: that they would prevent individual control over health decisions, that costs would be cut by prohibiting costly treatments and that older people would be denied end-of-life care.

"This [end-of-life argument] may be the most pernicious myth of all," the statement said. Instead, a provision would pay doctors to spend time with dying patients and their families as they describe the care they want. The statement is on the group's website, www.bioethics directors.org.

The bioethcists have posted a fact sheet disputing the claims made by critics of the healthcare plan.

Letter calls for Lancet to be sold

A letter to the editor -- sparked by revleations in this blog, in The Scientist online and the American Journal of Bioethics blog -- calls on medical publishing company Elsevier to either divest of its respected journal The Lancet, or its pharmaceutical services division, which helps drug companies promote their products.

"Although the relationship between medical publishing and service to the pharmaceutical industry is not unique to Elsevier, we question the compatibility of these two roles," wrote Jon Jureidini, a psychiatry and paediatrics researcher at Australia's University of Adelaide, and Robyn Clothier, a staffer at the non-profit Healthy SKepticism, which Jureidini heads.

Elsevier wrote a response letter, saying specialty publications are okay as long as they come with full disclosure.

We believe that high standards for disclosure are appropriate and necessary to ensure that the purpose and sponsorship of any publication are clear to the reader, and we are confident the disclosure policies in place at Excerpta Medica meet this standard.

More medical conflicts revealed

Working with medical companies whose products they are supposed to be testing can make a doctor a millionaire, according to reports surfacing in the United States this summer. 

The latest revelations come from Minnesota, where documents released by the offices of Iowa Senator Charles Grassley show that University of Minnesota researcher Dr. David Polly billed Medtronic for reviewing one of its products at the request of a local non-profit group.  

Back in 2005, Dr. David Polly participated in a review of a new technology in spine surgery by an influential nonprofit group. After he concluded the work, the University of Minnesota expert submitted a bill for some of his time to Fridley-based Medtronic.

Four years later, leaders of the nonprofit group — the Bloomington-based Institute for Clinical Systems, or ICSI — say they wouldn't have let Polly participate in the review had they known about the billing arrangement. Technology reviews by ICSI are supposed to be impartial, they say, and a Medtronic device was among those being evaluated.

"I was shocked," said John Sakowski, the chief operating officer at ICSI, who learned of Polly's bill with the recent release of Polly's records by Sen. Charles Grassley, R-Iowa.

Although surprised, Sakowski said ICSI is not accusing Polly of wrongdoing in the matter. The nonprofit group didn't specifically ask whether the surgeon was billing an interested party for working on the review, and ICSI said the results generated by the group were solid — even with the apparent conflict of interest.

Medical ethicists say they have questions about how both ICSI and Polly acted during the episode, but they conclude that the moral of the story goes to a much broader point: Disclosure requirements throughout the health care industry have been woefully lacking.

"More independent control of financial relations is needed, clear conflict-of-interest rules are needed, and investigators have to receive proper education about conflicts of interest," said Trudo Lemmens, a medical ethicist at the University of Toronto. ...

Polly's bill for working on the ICSI review was just one of several hundred items in billing records released last month by Grassley. The senator has been probing the financial ties between doctors and medical companies for several years and has introduced federal legislation that would require more public disclosure.

The records released last month showed how Polly accumulated nearly $1.2 million in consulting bills to Medtronic between 2003 and 2007. Compared with the grand total, the bill for work at ICSI was a drop in the bucket.

It's not the first time Grassley's office has revealed payments to doctors and researchers. Last June, a Wisconsin newspaper used documents from his office to detail millions in payments to 11 doctors with the University of Wisconsin School of Medicine and Public Health.

Topping the list of those receiving large sums from medical companies was a group of UW orthopedic surgeons. They include:

• Paul Anderson, a professor of orthopedic surgery, who got $150,000 for eight days of work as a consultant from medical device-maker Medtronic. Anderson, who could not be reached for comment, also earned a UW salary of $755,000 in 2007.

• Ben Graf, an associate professor of orthopedic surgery, who got $770,000 in royalties from device company Smith & Nephew. Graf, who could not be reached for comment, also earned a UW salary of $591,000 in 2007.

• Clifford Tribus, an associate professor orthopedic surgery, who got $310,000 for 15 days of work as a speaker and consultant and from royalties from device company Stryker Spine. Tribus also earned a UW salary of $618,000 in 2007.

 

Wyeth hired ghostwriters to push HRT

Once again, a class action lawsuit has served to unveil the extent of ghostwriting in top medical journals.

In a story published this morning in the New York Times, drug giant Wyeth was found to have paid for more than two-doxen articles favourable to hormone replacement therapy over a seven-year period. For almost half that time, HRT was coming under scrutiny as independent tests linked the controversial treatment to breast cancer, hear disease and stroke.

Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known. 

The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.

But the seeming consensus fell apart in 2002 when a huge federal study on hormone therapy was stopped after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer, heart disease and stroke. A later study found that hormones increased the risk of dementia in older patients. 

The ghostwritten papers were typically review articles, in which an author weighs a large body of medical research and offers a bottom-line judgment about how to treat a particular ailment. The articles appeared in 18 medical journals, including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology. 

The articles did not disclose Wyeth’s role in initiating and paying for the work. Elsevier, the publisher of some of the journals, said it was disturbed by the allegations of ghostwriting and would investigate.

The documents on ghostwriting were uncovered by lawyers suing Wyeth and were made public after a request in court from PLoS Medicine, a medical journal from the Public Library of Science, and The New York Times.

A spokesman for Wyeth said that the articles were scientifically accurate and that pharmaceutical companies routinely hired medical writing companies to assist authors in drafting manuscripts.

The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs from other pharmaceutical companies.

The company hired to write the studies, as well as one of the academics credited for writing one of them, stood by the work.

In response to a query from a reporter, Michael Platt, the president of DesignWrite, wrote that the company “has not, and will not, participate in the publication of any material in which it does not have complete confidence in the scientific validity of the content, based upon the best available data.” 

The problem is, even if the science itself is not damaged by the connection to the company benefitting from it, its credibility can be. 
 

The ethics of birth and death

A couple of interesting stories in the Toronto Star this morning, looking at two medical ethics issues. I was out of town, so didn't write either.

The first looked at when a woman is too old to have a baby, sparked by the death of Maria del Carmen Bousada, who gave birth to twins in December 2006 at age 66.

When it comes to motherhood, how old is too old?

Fertility experts and ethicists re-examined that question yesterday after hearing that a 69-year-old Spanish mother died Saturday, leaving behind 2-year-old twins conceived with a younger woman's eggs and donated sperm.

Maria del Carmen Bousada is believed to have been the world's oldest new mother. She gave birth in December 2006, shortly before her 67th birthday, after telling a clinic in Los Angeles she was 55, the facility's maximum age for single women receiving in-vitro fertilization.

The story goes on to outline the medical reasons for most in-vitro clinics to refuse the treatment to older patients -- the children have more health problrms -- and concluded with Margaret Somerville of McGill questioning whether medical science should be used to do things that are impossible in nature, rather than just stepping in when nature fails.

The other story looked at the other end of the spectrum. Pegged to the assisted suicide death of British conductor Edward Downes and his wife, Joan, at a Swiss clinic it asked whether more countries, including Canada, should allow assisted suicide.

"Whenever it's in the news, we know this comes up again and again," said Olga Krassioukova-Enns, executive director of the Winnipeg-based Canadian Centre for Disability Issues. "This issue, this question, affects people with disabilities and seniors and anyone part of a family."

In May, Bloc Québécois MP Francine Lalonde of Montreal reintroduced a private members' bill to amend the Criminal Code to allow assisted suicide. A similar one she introduced in 2005 failed.

A number of high-profile cases in Quebec recently drove her to try to get the bill passed again.

"We need to have this in order to allow people to make their own choice under certain conditions when the time is right for them to die," said Lalonde yesterday.

Last year, a Quebec man was acquitted after he was charged with helping his disabled uncle commit suicide. A Vancouver man was charged in May with giving his friend a loaded shotgun and a demonstration on how to use the weapon to commit suicide.

Alex Schadenberg, founder of Euthanasia Prevention Coalition, said Canadians want better end-of-life care. The mindset that older people and those with disabilities don't want to live as long as possible is a misconception, he said.