Few actually need antidepressants, study finds

It seems that despite the efforts of big drug companies to mass market their antidepressants -- turning them into blockbuster druggs as they pitch the pills to children and pregnant women -- only the severly depressed actually benefit, a new study says.

The magnitude of benefit of antidepressant medication compared with placebo increases with severity of depression symptoms and may be minimal or nonexistent, on average, in patients with mild or moderate symptoms. For patients with very severe depression, the benefit of medications over placebo is substantial.

Lead researcher Robert J. DeRubeis of the University of Pennsylvania said the study, published in the Journal of the American Medical Association, showed that those with only mild depression seemed to benefit from simply the added attention given to them by doctors during the drug trials -- and points to other ways such people can fight their depression.

“The message for patients with mild to moderate depression,” Dr. DeRubeis said, “is, ‘Look, medications are always an option, but there’s little evidence that they add to other efforts to shake the depression — whether it’s exercise, seeing the doctor, reading about the disorder or going for psychotherapy.’ ”

GlaxoSmithKline, the makers of Paxil, one of the drugs in the study, questioned the findings.

”The studies used for the analysis in the JAMA paper differ methodologically from studies used to support the approval of paroxetine for major depressive disorder, so it is difficult to make direct comparisons between the study results,” Glaxo spokeswoman Claire Brough said.

”Antidepressants are an important option, in addition to counseling and lifestyle changes, for treatment of depression.”

About 70 per cent of those taking such medications have mild enough depression that the medications may be of no use, the study found. The study could change how doctors approach depression with their patients, the New York Times said.

“I think the study could dampen enthusiasm for antidepressant medications a bit, and that may be a good thing,” said Dr. Erick H. Turner, a psychiatrist at Oregon Health and Science University. “People’s expectations for the drugs won’t be so high, and doctors won’t be surprised if they’re not curing every patient they see with medications.”

But Dr. Turner added, “The findings shouldn’t dampen expectations so much that people refuse to even try medication.”

The Star's mental health blogger, Sandy Naiman, also wrote about this study today, saying it "supports the strong contention I have about quick-fix, pill-popping approaches to mental health recovery."

 

 

 

 

A medical writer's perspective on ghostwriting

Montreal-based medical writer Kate Johnson has weighed in on her blog about the ongoing ghostwriting scandal, saying a distinction needs to be made between anonymous writers hired by drug companies, and those hired by the researchers themselves.

It's a fair point, and Johnson goes to lengths to explain how academic journal articles can have several authors, named and unnamed.

Obviously, if four names appear on a paper, it is unlikely that all four people sat down and typed individual sections. As a medical editor I strongly discourage this degree of “co-operation” because of the disjointed and chaotic results. But it is when an additional, unnamed person is responsible for the writing, that the notion of ghostwriting takes shape.

The ghostwriting scandal revealed in August by the New York Times hinges on this type of ghostwriting, but here a further distinction should be made regarding the definition of ghostwriting.

Although the JAMA study does not make this distinction, the Times focuses on ghostwriters who were hired by drug companies to spin the science in favor of their products. This is clearly a corruption of science and an indisputable attempt to mislead doctors and the public.

Few medical academics could see anything except extreme dishonesty in this practice.

The only point I might quibble with Johnson is on her use of the word "obviously" at the beginning of the excerpt. I am not sure this is obvious to most people, but I could be wrong.

She is right, though, that there is a difference between ghostwriters paid by a drug company and those paid by a researcher -- especially since the drug companies have made clear in their internal documents (made public in court cases) that paying ghostwriters is part of their drug marketing strategy. One would expect that ghostwriters hired by the researchers themsleves would be more attuned to the researchers' findings than to the marketing needs of Big Pharma.

Johnson has pointed out before that many top researchers, for all their brilliance and innovation, are not the best writers -- so turn to people like her for help. As a reporter who has had to sift through many scientific reports, I appreciate that contribution.

But I would also like to know that such a contribution has been made. From a reporter's point of view, there's no such thing as too much information when it comes to such things. It also erodes a researcher's credibility if, and when, it is revealed that a ghostwriter has been used and not acknowledged.

Perhaps researchers, when considering how much (if any) credit to give to ghostwriters should ask themselves one simple question: would I accept such behaviour from one of my students?

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.

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.
 

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.

Making academic fraud a crime, have your say

A story in the online version of The Scientist is sparking calls from readers that academic fraud be criminalized, with the journal now polling readers.

The original story documentedsome $23 million (US) in grants handed out to researchers at the University of Alabama at Birmingham who lied about their methodology and falsified data in at least 16 journal articles. The story is based on records from the US Department of Health's Office of Research Integrity.

The scientists, Judith Thomas and Juan Contreras, formerly at the University of Alabama at Birmingham (UAB), falsely reported that they performed double kidney removals on several rhesus macaques in experiments designed to test the effectiveness of two immune suppressing drugs -- Immunotoxin FN18-CRM9 and 15-deoxyspergualin (15-DSG) -- in preventing rejection of the a single transplanted kidney.

The experimental protocol was to remove one intrinsic kidney, replacing it with a transplant and starting the monkeys on immunosuppresants, and then remove the other intrinsic kidney a month later, according to Richard Marchase, UAB's vice president of research. "What occurred in a good number of these animals was that [Contreras and Thomas] never performed the second surgery," Marchase told The Scientist. In a statement emailed to The Scientist Marchase called the misconduct "a very serious offense."

Thomas's and Contreras's research was funded with more than $23 million in grants from the National Institutes of Health. UAB officials learned that Contreras and Thomas had left one native kidney intact in at least 32 animals -- which allowed those animals to live and inflated the apparent effectiveness of the drugs -- on January 27, 2006, when Thomas reported that she found an experimental monkey with one of its native kidneys intact and blamed Contreras for the mistake.

The scale of the fraud and the implications of the falsified results -- patients could have ended up getting dangerously wrong treatment -- led to readers of the original story going onto the Scientist web site to call for criminal fraud charges to be laid, prompting the journal to poll readers for their thoughts.

Feel free to join in.

 

Congrats to me and my blog

I just found out that this Medical Ethics Blog has been put on a list of the Top 25 Healthcare Policy Blogs in the world.

The list is compiled by Medicine 3.0, a blog on a site dedicated to helping nursing students.

Here's what it says:

Are you concerned about health care policies and reform? You can learn more about the direction that health care policies are taking through the blogs listed below. We discovered writers who were doctors, attorneys, journalists and politicians who all lend their perspectives to the volatile and ethical issues surrounding health care reform.

The blogs are listed below in alphabetical order. This method assures our readers that we do not favor one blog over another. All blogs listed, however, are up-to-date and all information is provided by professionals in their fields. ...

Medical Ethics Blog: Stuart Laidlaw has covered faith and ethics for over a decade, and he applies these attributes to a blog that covers health and health policies.

I'm blushing.

Bad news for men -- artificial sperm

A team of British researchers claimed this morning to have developed a method to create sperm from embryonic stem cells.

Researchers at Newcastle University and the NorthEast England Stem Cell Institute say they used a new technique to derive what they described as sperm cells from embryonic stem cells. Stem cells have the potential to become any cell in the body.

Newcastle research leader Karim Nayernia said in a statement Wednesday that the technique would allow researchers to study how sperm develops and possibly help develop treatments for infertile men.

The research was published Wednesday in the journal Stem Cells and Development.

The Independent newspaper immediately wondered if this meant "a world without men." Ethicist John Harris, professor of bioethics at The University of Manchester and editor-in-chief of the Journal of Medical Ethics, said no man would need to be considered infertile again.

Now, if this research is confirmed, all they will need is a very large supply of male stem cells. Might we see the George Clooney stem cell line (assuming he were to consent to it)? I can see no objection. It is no more wrong to choose the genes of your child than your reproductive partner. Indeed, we have always sought to do both, choosing our partners on the basis of our -- sometimes erroneous -- belief about the sort of children likely to result. I see nothing wrong with people exercising that choice using the technology as it becomes available.

If it is not wrong to wish for a bouncing brown-eyed baby girl, why would it become wrong once we had the technology to play Fairy Godmother to ourselves and grant our own wish?

Not all ethicists see it so simply.

"This area has potential powerful clinical applications mixed with people's concerns over embryo research," says Insoo Hyun, a bioethicist at Case Western Reserve University who specializes in stem-cell-related ethical issues. "All the ingredients are there for a really, really lively ethical debate."

Others simply doubt the research.

"I am unconvinced from the data presented in this paper that the cells produced by Professor Nayernia's group from embryonic stem cells can be accurately called 'spermatazoa," said Allan Pacey, a senior lecturer in andrology at the University of Sheffield.

Pacey said in a statement that the sperm created by Nayernia did not have the specific shape, movement and function of real sperm.

Azim Surani, a professor of physiology and reproduction at the University of Cambridge said the sperm produced by the Newcastle team were "a long way from being authentic sperm cells."