Peering over the edge into assisted suicide

In today's Toronto Star, I address the issue of assisted suicide -- and the argument that euthanasia is practiced so often in hospitals in all but name, that we should consider simply legalizing it.

Starving to death in a hospital bed is a horrible way to die, says an expert on the ethics of death, and it may be time to allow more overt ways of ending the lives of the terminally ill.

Wayne Sumner, a University of Toronto philosophy professor writing a book on assisted suicide, says while euthanasia is illegal in Canada, terminally ill patients or their families can refuse food, water and life-sustaining treatment.

"We tip-toe up to the barrier," says Wayne Sumner, who will speak about assisted suicide at UofT's Joint Centre for Bioethics on Wednesday afternoon.

"We peer over the edge, but seem reluctant to take that next step."

Sumner says there is no practical difference between letting someone starve to death, as is now done when feeding tubes are removed, and the more overt act of instructing a doctor to inject a lethal dose of medication to hasten death.

"If someone is refusing food and water, it's hard to see that the intention is anything but death," he says.

As such, he says, Canada should consider taking euthanasia out of the Criminal Code.

The peg for the story is a seminar to be given this afternoon by the University of Toronto's Joint Centre for Bioethics at their new home at 155 College St., Ste. 754, in Toronto. The centre often webcasts its seminars. Sumner will outline how he came to his conclusions, by addressing the agruments against allowing assisted suicide. Dr. Lawrence Librach of the Temmy Latner Centre for Palliative Care at Mount Sinai Hospital will provide commentary.

Moira McQueen, director of the Canadian Catholic Bioethics Institute, does not agree with Sumner that taking the next step to allow euthanasia would be the compassionate thing to do, as a way of alleviating suffering for both patients and family under the current system.

Every patient, she says,  has the right to refuse treatment or food, and let nature take its course.

"With euthanasia, you're not letting anything take its course," she says.

It is too big a leap to say that because people can refuse treatment or nourishment, they should actively take their own lives, she says.

"We all want to be compassionate, but we want to make sure we're doing the right thing, too."

A private member's bill by Bloc Quebecois MP Francine Lalonde to allow doctor-assisted suicide is currently before Parliament. Assisted suicide is allowed in three U.S. states – Oregon, Montana and Washington state – and in Belgium, Luxemburg, the Netherlands and Switzerland.

A Swiss clinic, Dignitas, has become a destination for people around the world seeking physician-assisted suicide, with more than 1,000 people travelling to Zurich since the clinic opened 12 years ago – including 10 from Canada. The Swiss government is now considering restricting suicides by foreigners, with Justice Minister Eveline Widmer-Schlumpf saying last October, "As a country, we aren't interested in attracting suicide tourism."

Sumner said the move could put political pressure on other governments to allow assisted suicide, since people will soon no longer have the option of flying out of the country for the procedure.

More on salami slicing -- Cymbalta ads ordered pulled

Today, I had a story in the Toronto Star about an issue I touched on in this blog last week: Salami slicing, or the re-use of clinical trial data in more than one journal study.

I spoke to Glen Spielmans, who wrote a study on the practice after looking into claims made in TV ads by Eli Lilly about its antidepressant Cymbalta.

As he went through every study he could find on Cymbalta – which is also known by its generic name, duloxetine – Spielmans began feeling as if he was reading the same study over and over again, sort of an academic déjà vu.

"There just aren't that many data to do all these secondary analyses on," Spielmans said in an interview. "That raised a flag for me."

I also spoke to a cancer researcher that while salami slicing does happen, it's worth remembering that trials are often designed so the data can be sliced up later.

"I would be careful of anything that's given a folksy name," says Dr. Ralph Meyer, director of the National Cancer Institute of Canada's Clinical Trials Group at Queen's University. ...

"Clinical trials are a lot of work. They're a lot of expense," he says.

Trials that Meyer has run, for instance, have looked at such standard questions as the safety and effectiveness of a new treatment but have also used the opportunity to examine the cost-effectiveness of the procedure or the treatment's impact on a patient's quality of life. 

Jocalyn Clark, a researcher at the University of Toronto and an editor at the journal PLoS Medicine, says top journals like hers require all authors to declare if any part of the underlying research has been – or soon will be – published elsewhere.

She said universities and hospitals need to tell their researchers that slami slicing is not acceptable, and that academics taking part in the practice risk ruining their reputations with the journals they count on to publish their studies. In a part of the stroy that had to be cut for length, she equated the practice to ghostwriting, in that academics slicing up their data are not being fully honest with readers.

Meanwhile, the Food and Drug Administration in the U.S. has sent a letter to Eli Lilly ordering to pull its "misleading" print ads for Cymbalta.

Promotional materials are misleading if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. The Print Ad is misleading because it presents various efficacy claims for Cymbalta, but fails to communicate any risk information in the main part of the ad.




 

Who best to regulate -- doctors or drug companies?

A move by New Jersey to become the first state in the US to regulate the relationship of doctors to drug companies is sparking a debate over the best way to counter the power of Big Pharma.

Last month, NJ Attorney General Anne Milgram released a 22-page report limiting the gifts doctors can accept from drug companies -- among other things saying they can no longer accept free lunches, gifts worth more than $200 (US) and banning them from putting their name on ghostwritten articles. It also calls for tighter controls on doctors' financial disclosure and limits on drug companies paying for doctor retraining.

All are methods used by drug companies to market their products to the doctors who write the prescriptions. New Jersey has one of the highest concentrations of drug companies in the U.S.

The Medical Society of New Jersey, however, says doctors should not be targeted.

Spokesman Daniel Klim said the task force's time could have been better spent on other issues.

"We don't believe that pharmaceutical gifts influence medical decision-making as much as, say, a patient's insurance plan," he said. Klim said that physicians follow a code of ethics and that real conflicts were rare.

"I think in any industry you could find negativity," he said.

Milgram defended the report, saying the state has greater jurisdiction over doctors. "It really is, at the end of the day, each individual doctor's conflict of interest as much as it is the industry's."

Other states, such as Massachusetts and Vermont, put the reporting onus on industry instead of physicians.

Daniel Hoffman, president of the consulting firm Pharmaceutical Business Research Associates in Glenmoore, Pa., supported the restrictions, saying small gifts lead to bigger benefits, such as free education courses.

"It's sort of the opening gambit to a one-hand-washes-the-other relationship that I think has to be broken, to which this kind of ban can be useful," he said.

Industry groups agreed with Klim, however.

Dave Knowlton, president of the nonprofit New Jersey Health Care Quality Institute, said the state should be wary of putting new regulations on doctors who already have too many hoops to jump through.

"I really think that we should be diligent about saying, 'Let's not put another hassle on them unless we really think there's a need for it,' " he said.

Knowlton was on the task force and said he was frustrated that he and other members were left out of much of the process.

He wanted proof that the regulations were needed, arguing that many of the abuses of years past had been remedied through voluntary actions by manufacturers and federal regulations controlling such things as payments to physicians during drug and product trials.

The US federal government is working on regulations governing the drug companies, but Milgram said action is needed now: "To me, the argument of 'please just wait [for a federal plan]' isn't fair to the consumer, because people go to the doctor's every day."

The report makes 22 recommendations in all.

 

 

Pfizer conflict controversy continues

The controversial appointment of Pfizer Canada executive Bernard Prigent to the Canadian Institutes of Health Research was the lead item on the CBC's national morning radio show, The Current.

A podcast of the show is available.

In the show, Francoise Baylis, Canada Research Chair in bioethics at Dalhousie University, says it is impossible for Prigent to avoid a conflict of interest in the new posting because his job as a Pfizer vice president is to sell as many drugs as possible. The job of the CIHR, however, is to ensure public safety. The two are not always the same thing, she said.

Dr. Jean Rouleau, dean of medicine at the University of Montreal and a member of the CIFR's governing council told the CBC's Anna Maria Tremonti that the group needs to hear from people in the pharmaceutical industry.

Baylis said such input, when needed, could be had by calling Prigent and other industry executives to make submission to the CIHR, without giving them a voice in the decisions made by the group.

Meanwhile, a former member of the CIHR, Saskatchewan researcher Steven Lewis lashed out at the appointment, citing the industry's past marketing scandals and saying the appointment gives Pfizer a competitive advantage over other companies.

"The industry's greatest innovations have occurred outside the lab," he wrote. "Expensive junkets for docs-for-hire to shill for their products to their peers; the purchase of previously distinguished academics to affix their names to ghostwritten papers; the suppression of unfriendly clinical trials and adverse effects data; the publication of the same data in different journals to bias systematic reviews and meta-analyses; etc. ad infinitum."

Lewis said it is "hardly irrelevant that the company to which Dr. Prigent owes his livelihood and his allegiance has owned up to sleaze that stands out even among its shady peers."

Since 2004, Pfizer, the world's largest drug company, has paid $2.75 billion in criminal fines and penalties, Lewis said. "Most recently (Pfizer paid) a whopping $2.3 billion for fraudulently marketing Bextra, a painkiller withdrawn from the market in 2005, and three other drugs."

He questioned how Prigent would respond if the council were asked to support research showing a Pfizer drug is dangerous or identifies the massive public subsidies that flow to drug companies.

As a member of the governing council, Lewis said Prigent will have access to information that his competitors do not and "he can exert a steering effect where they cannot."

CIHR president Dr. Alain Beaudet, who recommended Prigent for the appointment, has said he will bring a private-sector voice to the council and help ensure wise spending.

An online petition against the appointment has now collected almost 4,000 names.

 

 

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.

 

Researchers ask NIH to fund ethics research

In the wake of growing scandals over conflicts of interest and ghostwriting in medical research, more than 100 top researchers from around the world -- including several from Canada -- wrote to the U.S. National Institutes of Health this morning asking it to fund ethics research.

We are writing to ask NIH to fund studies on medical ethics, conflicts of interest in medicine and research, and prescribing behavior. NIH funds a substantial portion of the generation and dissemination of evidence, but the uptake of that evidence and its translation into clinical practice is strongly affected by the complex web of relationships that exists among industry, academicians, medical educators and clinicians.

There is growing evidence that each strand of this web is compromised by ethical lapses and financial conflicts of interest. The recent disclosure of ghostwritten articles, physician payoffs, and the use of academic opinion leaders to increase markets for FDA-regulated products indicate that ethical lapses may permeate biomedical research. A PLoS Medicine editorial in September called ghostwriting “The dirty little secret of medical publishing” and notes “the systematic manipulation and abuse of scholarly publishing by the pharmaceutical industry and its commercial partners in their attempt to influence the health care decisions of physicians and the general public.” An October 1 editorial in the Boston Globe called for a ban on industry speaker fees to physicians. Last month, a commentary in JAMA called for physicians to pay for continuing medical education (CME), citing a recent Institute of Medicine report4 that criticized physicians’ reliance on industry-funded education.

The letter to NIH director Francis Collins says the NIH "is the best place to launch and support a scientifically rigorous inquiry into the state of research ethics, industry-academic relationships, and the effect of these relationships on human health."

It notes, however, that there is currently no mechanism in place for the NIH to conduct such a study, but asks to meet face-to-face with Collins to discuss the issue.

The 10-page footnoted letter co-ordinated by PharmedIOut, a physician-run organization researching conflicts of interest, contains more than eight pages of signatures from top medical and ethics researchers from around the world.

Signatories include several Canadians, including Sharon Batt of Dalhousie University, Pierre Biron of the Université de Montréal, Alan Cassels of the University of Victoria, Carol Kushner a health policy consultant in Toronto, Joel Lexchin at York University, Barbara Mintzes at the University of British Columbia, David L. Sackett at McMaster University and Sergio Sismondo at Queen's University.

 

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.