Archive for Julia Belluz

Lawsuits are shedding light on dubious relationship between medical researchers and pharmaceutical companies

Photograph by Flickr user striatic

When Barbara Sherwin, a McGill University psychology professor, became embroiled in a ghostwriting case in 2009, many wondered how an esteemed academic—one who dedicated her life to researching the relationship between hormones and cognition—could be accused of attaching her name to an article she didn’t write.

Her alleged transgression came to light in a class-action suit involving 8,400 women against the drug company Wyeth (now part of Pfizer). Lawyers representing the women, who claim they were harmed by their hormone replacement therapy (HRT) drugs, discovered that scientific research papers extolling the virtues of the treatment while downplaying potential harm appeared to have been written, not by the academics who signed their name to the papers, but by writers hired by the pharmaceutical company.

According to court documents filed by the plaintiffs, Wyeth paid the Princeton, New Jersey-based medical communications company DesignWrite to produce articles on HRT for publication in academic journals between 1997 and 2003. DesignWrite would write the papers, then approach leading academics to claim authorship for them.

Sherwin’s name appeared in the court documents in the form of DesignWrite correspondence and internal meeting notes. She has, until now, remained silent about her side of the story. But the topic has stayed in the news, as similar cases continue to reveal apparent conflicts of interest between academia and pharmaceutical companies.

Sherwin’s relationship with the pharmaceutical company started innocently enough. In the early 1990s, she was invited to give a presentation about her work on androgens and psychological functioning in women. There, she met a woman named Karen Mittleman during the lunch break. Mittleman introduced herself as a PhD and a former academic who worked in medical communications. The pair hit it off, and kept in touch. “I liked her, and considered her a casual friend,” Sherwin told Maclean’s over the phone from her office at McGill.

Several years later, in 1998, Mittleman called Sherwin to ask if she wanted to write a paper for the Journal of the American Geriatrics Society at the invitation of the journal’s editor. The subject was pharmacological treatment options for age-associated memory loss. Sherwin, an expert on hormones and how they influence memory and mood in people, had just completed a grant proposal on the subject, and said she’d be happy to write the article.

“[Mittleman] told me she would provide support by typing the manuscript and formatting it in the style of that particular journal,” explains Sherwin. The work itself would be based on Sherwin’s notes. In return, Mittleman, a senior writer at DesignWrite, promised to send Sherwin typed drafts for editing, and hard copies of references the professor requested. “I was completely under the impression that [Mittleman] was working for the journal, that it was the journal who hired her.”

What Mittleman never revealed was that her employer, DesignWrite, had a business relationship with Wyeth and other pharmaceutical companies. The ensuing article, which was peer-reviewed and listed Sherwin as its sole author, appeared in the April 2000 edition of the Journal of the American Geriatrics Society. Sherwin says the work was her own, and that Mittleman had no input on the content beyond typing and formatting Sherwin’s notes. She also says she had no reason to believe there was any problem with the paper—until 2009, when Sherwin became the only Canadian researcher embroiled in the ongoing scandal in the US involving the class-action suit against Wyeth.

A 2009 study found that 7.8 per cent of articles published the previous year in six leading medical journals had at least one ghostwriter. Paul Hebert, editor-in-chief of the Canadian Medical Association Journal, estimates he rejects between five and 10 manuscripts per year because they were ghostwritten in collaboration with pharmaceutical companies. Blockbuster drugs such as the painkiller Vioxx (pulled from the market in 2004 after it was linked to heart problems), and the antidepressants Paxil and Zoloft, continue to come under scrutiny for citing ghostwritten articles that promote their use. Similarly, in 2004, it was found that the manufacturer of Neurontin used a ghostwriting campaign to market off-label uses.

Sherwin says, “If you’re approached by someone who is the head of marketing for Wyeth, then you know. I got a phone call from Karen saying the journal invited this paper, do you want to write it? This was a person I had known for several years.”

Sherwin says she was ultimately cleared by McGill after an eight-month investigation she describes as “emotionally devastating.” (The university has never formally released the results of its investigation.) The Quebec Order of Psychologists also investigated the allegations against Sherwin, and told Maclean’s “no disciplinary actions were taken.”

Richard Janda, a McGill law professor who became Sherwin’s advisor during the ordeal, says the university concluded no one but Sherwin had any input on the article. McGill also found that Sherwin had no way of knowing Wyeth was involved in the publication, and that the paper did not favour Wyeth’s drugs. (It had one section on estrogen and looked at seven other classes of non-hormonal drugs that might benefit mild cognitive impairment. Sherwin and Janda estimate that just over one per cent of the 163 references in the paper cite studies involving Wyeth products.)

Sherwin was, however, reprimanded for not acknowledging the “editorial assistance” she received. She says she offered to credit Mittleman, who declined, saying, “You did all the work.” Maclean’s tried to contact Mittleman, but she did not respond. In her 2006 court deposition, she claimed that a DesignWrite medical writer wrote the Journal of the American Geriatrics Society paper, but that Sherwin appeared as the author.

When the news of Sherwin’s involvement with DesignWrite broke, the McGill professor released a statement (which she now says was penned by the univsersity’s public relations department) defending her work while admitting, “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.”

Newspaper articles at the time questioned the statement, noting that court documents appeared to reveal that Sherwin had worked with DesignWrite again on another article that appeared in the journal Endocrine Reviews in 2003.“I never published anything in conjunction with DesignWrite after [2000],” Sherwin told Maclean’s via email. “I had told Karen (as a friend) that I had been invited to write a review for another journal in 2000. She volunteered help, which I forcefully declined. She nonetheless sent some unsolicited text to me, which I destroyed upon receipt and never spoke to her again.”

Sherwin also added that the allegation of DesignWrite’s involvement in a second paper was dismissed by McGill. “DesignWrite had clearly tried (and failed) to appropriate my second review,” she wrote to Maclean’s. Sherwin believes the hope was that the first article would lead to more collaboration, and incrementally, more influence on her work.

In a written statement to Maclean’s, DesignWrite defended its collaboration with academics, saying it had never promoted bad science and that it was simply trying to help advance worthwhile research. “It is perfectly normal, acceptable, and ethical for physicians to have substantial assistance in drafting articles,” the statement reads. “The exact amount of that assistance can vary, but as long as the physician author has control over the final product and final approval over the article, the exact amount of assistance provided is not an issue.”

At a University of Toronto conference on ghostwriting held earlier this week, a former ghostwriter, Linda Logdberg, says it was not usual for her to approach academics on behalf of drug companies and withhold information about her relationship with the industry. “I was asked to identify myself as a writer for the medical education company,” she says, adding that her range of involvement with a researcher could be anything from editing a manuscript, to writing the entire thing under a researcher’s byline.

Though the Wyeth ghostwriting cases go back a decade, those who study the problem say it persists. Trudo Lemmens, the University of Toronto law professor who hosted the conference, says biomedical ghostwriting is a public health issue in need of serious attention. “We know that erroneous or wrong use of pharmaceuticals is a leading cause of hospitalization in both the U.S. and Canada, so if ghost-authored publications contribute to that, particularly if they do not accurately represent the evidence, and over-emphasize positive studies, physicians who give their names [to these articles] are indirectly responsible for the prescriptions that are handed out.”

Lemmens is looking at the legal tools that can be used to fight the practice of ghostwriting and hold academics legally and professionally accountable. Ghostwriting is difficult to detect outside of legal discovery during class-action suits against drug companies, he says, and universities are often slow to reprimand their own researchers, who bring prestige and large research grants to their institutions.

In the world of journals, PLoS Medicine has been leading the effort to curb ghostwriting. It found that only 13 of the top 50 medical schools in the U.S. have a policy that prohibits ghostwriting, which Jocalyn Clark, senior editor of the journal, says is similar to the picture here in Canada.

Clark explains that that policies in place at PLoS Medicine now require that all authors must declare their competing interests and all the sources of funding for their work. “Many of the leading medical journals now have competing interest policies,” she says, “but the large bulk of medical and science journals in the world do not have that standard.”

For now, Sherwin’s story reveals just how complex, sophisticated, and murky the relationship between industry and the academy can be. “There’s a certain amount of deviousness that went on here,” she says. “DesignWrite had a publication plan, they were working with pharma. I spent my life staying away from pharmaceutical companies. If [Mittleman] had said there would be an honourarium, if she had mentioned Wyeth’s name, I could have known.”

The generation now entering university is the most anxious since the 1930s

By the time Victoria Ciciretto left her family’s home in Kleinburg, Ont., to live and study at the University of Toronto, the 18-year-old was already a seasoned world traveller. “I’d gone away for a month in Europe for summer school in Grade 10,” she says. “I took a Grade 12 course in Greece,” she adds. “And the year before last, I studied English in England.”

Presumably, moving 40 km away from home would be easy, but instead the arts and science student was filled with anxiety. “For my first week, I was like, ‘Oh my god, why would people say this is the most amazing time of your life?’ ”

She was nervous about living in a dorm, about classes and homework, about what major to choose and if she would make friends. There was a reason she could handle summers overseas, but was scared of university. “I had really good friends with me when I went travelling,” she says. “When I went to university, I didn’t know anybody.”

Ciciretto’s concerns are not unusual. For some, anxiety is a normal reaction to stress and loneliness. For others, it’s a serious mental health issue—one that afflicts university-aged students more than any other age group.

Statistics Canada’s 2006 Community Health Survey of Mental Health and Well-being revealed that people aged 15 to 24 are most likely to experience anxiety disorders, with 6.5 per cent reporting an anxiety disorder in the past year. Studies in Canada and the U.S. have also shown that about 30 per cent of post-secondary students suffer from a mental health or substance abuse issue, compared to 18 per cent of the general population. Researchers from Case Western Reserve University in Cleveland found today’s college students suffer from anxiety and depression at a higher rate than every generation since the 1930s.

Why all this stress during what’s supposed to be the most exciting time of life? Michael Van Ameringen, a professor in the department of psychiatry at McMaster University, explains that it may be timing. The co-director of the anxiety disorders clinic on campus since 1985 says students are at the peak age of susceptibility. “The university cohort is entering the age of risk for onset of psychological disorders,” he says. The first episodes of clinical depression, panic disorders and generalized anxiety typically manifest in the late teens or early twenties. That risk, paired with normal stress about the whole university or college experience, makes it the most vulnerable time.

Novelist Patricia Pearson swam through her undergraduate degree in her hometown of Toronto, but generalized anxiety disorder hit her during grad school, when she found herself alone in Chicago at the age of 23. In her book, A Brief History of Anxiety: Yours and Mine, she concludes that anxiety is more often a product of culture and circumstance (like loneliness) than something written in our biology. “There is data on the fact that in a country like Mexico, where there’s less onus on the individual and it’s more collective, anxiety doesn’t last as long,” she says.

The Mexican example and other cross-national psychological literature revealed that tight-knit communities with collective rituals in place—say churchgoing or fiestas—tended to be healthier. “You don’t feel as isolated and you don’t feel like it’s all about you,” she says. But university, Pearson points out, is often all about you; it’s a period of isolation from social supports.

In Generation Me, Jean Twenge, a professor of psychology at San Diego State University, attributes anxiety to the individualism that characterizes the group born after the 1970s and she links it to unrealistic optimism. Yes, according to Twenge, there is such a thing as too much optimism: young people (“Generation Me”) have been brought up with unrealistic expectations about how their lives will turn out. “When things don’t happen the way they expect, they can hit anxiety and depression,” she says.

In other words, they have less access to the traditional social connections that promote mental health, such as closeness to family, stable relationships and a strong sense of community, so they’re more likely to experience anxiety disorders. If anxiety becomes disruptive, Twenge suggests students should pay a visit to the university counselling service, or talk to elders who have life experience. “But these rough periods can be a learning experience, too,” she says. “Things don’t have to be perfect all the time.”

Canada’s oldest English-language university celebrates its 225th year

This school year marks the 225th anniversary of the University of New Brunswick, Canada’s oldest English-language university (only Laval, founded in 1663, trumps it), currently renowned for its engineering, science, and computer programs. Eddy Campbell, UNB president and vice chancellor, says this milestone is just the right opportunity for the university to boast about its considerable accomplishments and rich legacy. “Universities in Atlantic Canada probably don’t receive the national distinction they deserve,” says Campbell. “Canadians are a modest bunch and maybe we don’t take sufficient time to celebrate our success and blow our own horn.”

Related: Honourary degrees awarded at UNB’s 225th

So the school has planned a series of events that will do just that. First, there’s an honorary degree night at Koerner Hall in Toronto on Sept. 23 that will showcase talented alumni, including Anne Murray and Frank McKenna, as well as five Canadians that the university feels have made an enormous contribution to Canada. The honourees are Carolyn Acker (pioneer in poverty reduction), Purdy Crawford (business leader and dean emeritus of Canada’s corporate bar), Phil Fontaine (former National Chief of the Assembly of First Nations), Clara Hughes (Olympic champion and philanthropist) and Alan MacGibbon (UNB alumnus, global strategist, and corporate visionary).

In October, homecoming at UNB will be bigger and splashier than usual, and the history of the university will be documented in a new book about architecture on campus. The university was founded in 1785 by Loyalists who had fled the American Revolution. (A second campus was established in Saint John, N.B., in 1964.) The Fredericton campus houses the oldest university building in the country that is still in regular use for school operations.

The university’s history is also entwined with the legacy of Max Aitken, or Lord Beaverbrook. He was the first modern day chancellor at UNB, a patron of the university, and of course, a towering historical figure who became a press baron and sat on the war cabinet of Winston Churchill. To pay homage to their great benefactor, a “Beaverbrook Celebration” will take place on campus in November.

As Campbell says, “UNB is a great university and it does not always enjoy the kind of reputation it should given its quality.” He adds: “This event is a good opportunity for us to go to Toronto, make a splash, celebrate our accomplishments, and start pointing out to people what great universities we have out here on the east coast.”

Photo: Sir Howard Douglas Hall (Old Arts Building) at the UNB Fredericton Campus; the oldest university building in Canada. Courtesy of the University of New Brunswick.

Technical geeks? Hardly. Today’s new breed of financial engineers take the lead as global innovators.

When Sukrit Ganguly finished his undergraduate degree in chemical engineering and applied science, he set out on a traditional career track in oil and gas consulting. “The job was very technical,” says the 27-year-old, “and required me to work on models all day long.” Bored after a year, Ganguly wanted to try something new. So he returned to the University of Toronto to do a master’s of applied science, this time focusing on applied engineering in banking and setting his sights on Bay Street. “I wanted a job that looked at the bigger picture, and in finance you have to follow what’s going on all over the world,” he says.

The chemical engineer is now working on the trading floor for equity derivatives at TD Securities—on Bay Street. Instead of modelling pipelines and heat exchangers like many of his former classmates, he spends his days structuring financial products, reading international market commentary, and researching the activities of TD’s competitors. And he says an engineering degree was the best possible training for the job. “As an engineer, you’re taught how to solve programs. The finance part I could learn on the fly.”

Indeed, as more students flock to the field of engineering (at last count, enrolment in accredited undergraduate engineering programs grew by 11 per cent between 2006 and 2009), universities across the country are advancing the concept of the “global engineer” and broadening the educational experience offering courses—such as finance or entrepreneurial studies—outside of traditional engineering disciplines. “The idea now is that engineers are no longer just technical geeks,” says David Wilkinson, McMaster University’s dean of engineering. “They need to be able to solve global problems and answer complex open-ended questions.”

At Ganguly’s alma mater, the University of Toronto, students in the faculty of applied science and engineering can now enroll in a financial engineering major, the first undergraduate program of its kind in Canada. The inaugural participants in the course this fall will learn financial modelling and theory, while also getting a strong engineering science foundation that they can apply to work in financial institutions and investment banking. The university will also launch a new minor in engineering business in 2011.

These courses were born out of the realization that “our students are being hired by Bay Street and Wall Street,” says the faculty’s dean, Cristina Amon. “It’s their ability to address problems and the analytical skills engineers gather during their education that is very attractive for the i-banking and financial services industry,” she says, adding that “this recent phenomenon” has already registered in the U.S., where finance and business course options have been offered to engineering students at prestigious schools like Princeton and Columbia for several years.

At Queen’s University, the faculty of engineering and applied science is developing a program with the Queen’s School of Business called innovation and global leadership, which will bring engineering and commerce students together. “We decided to design this now because of a need for engineers and commerce students to contribute to the knowledge economy,” explains Kimberly Woodhouse, dean of the faculty of engineering and applied science. “In order for them to do that, they’re going to need to be innovators.”

While Woodhouse says she’s seen “a huge demand in finance for engineers,” the program— anticipated to start in fall 2011—is focused on teaching business and engineering students to collaborate. “As an engineer, you now need to understand the business world, and commerce students need to understand the impact of technology on business.”