Autism and snake oil

For me, one of the most interesting things about the retraction last week by the Lancet of its discredited 1998 study linking vaccines and autism was the consensus that those who have believed the study will continue to have faith in it, despite the retraction.

That's why, with the help of Star health reporter Megan Ogilvie, who wrote the paper's original story on the retraction, I began asking around why people clung to scientific studies long after they have been discredited. The result was a story in Tuesday's paper.

I spoke with Jeanette Holden, a geneticist at Queen's University specializing in autism and whose brother is autistic.

As a scientist, Holden knows every rational reason why a discredited 1998 study, by Andrew Wakefield of London's Royal Free Hospital, linking autism to vaccines is poor science – vaccines have no connection to autism, she says – but can find little fault in the families of autistic children who remain loyal to it.

"This does provide some sort of an answer," she says.

I also spoke with Paul Offit, a Philadelphia pediatrician whose book Autism's False Prophets takes aim at the anti- vaccination movement, who said that people such as Wakefield offers patients and their families the glimmer of something he and other scientists so far cannot: hope.

And hope can be a powerful thing. "They love him because he offers them something," Offit says.

The story has generated some e-mails to Ogilvie and I, with one reader from the United States this morning passionately defending Wakefield and assailing his critics.

Offit, he says, has a conflict of interest because he created a vaccine and stands to lose financially if vaccines are shown to cause autism. However, Wakefield had his own conflicts of interest, having been paid by a law firm suing vaccine makers to conduct the study. The firm also provided some of the research subjects.

Wakefield was the lead author of the report. He wrote that the parents of eight of the 12 children blamed MMR: they said symptoms of autism had set in within days of vaccination. The Sunday Times has now established that four, probably five, of these children were covered by the legal aid study. And Wakefield himself had been awarded up to £55,000 to assist their case by finding scientific evidence of the link.

Wakefield did not tell his colleagues or medical authorities of this conflict of interest either during or after the research.The children were subjected to a battery of invasive procedures, including colonoscopies and lumbar punctures.

In the months that followed the examination of the first children, many more were channelled through the hospital. The parents of many were clients of one solicitor, Richard Barr, of King's Lynn, Norfolk, who was leading the legal attack and had organised Wakefield's funding from the Legal Aid Board (now the Legal Services Commission).

The writer also disputes the description in the story that autism as "relatively rare," pointing out that diagnoses of the condition have been increasing rapidly. I have no way of knowing, however, if that's due to more cases, or better diagnostics. The write ends the e-mail by saying that parents love Wakefiled because he listens to them, which is essentially what Holden and Offit said.

Holden said the only way such family members might finally break with the vaccine study is if Wakefield himself disavows it. She doesn't, however, expect that to happen.

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.

Only one-quarter of U.S. medical centres ban ghostwriting

A new study released today shows only 26 per cent of top American medical centres have a ban on the use of ghostwriters by their researchers.

The study, released today by PLoS Medicine, surveyed 50 top medical centres across the United States, and found that 10 schools ban ghostwriting by name, while another three ban the practice without using the words "ghostwriting" or "ghostwriter."

Authors Jeffrey R. Lacasse and Jonathan Leo called ghostwriting a dangerous practice.

Medical ghostwriting, the practice of pharmaceutical companies secretly authoring journal articles published under the byline of academic researchers, is a troubling phenomenon because it is dangerous to public health. For example, ghostwritten articles on rofecoxib probably contributed to “…lasting injury and even deaths as a result of prescribers and patients being misinformed about risks”. Study 329, a randomized controlled trial of paroxetine in adolescents, was ghostwritten to claim that paroxetine is “generally well tolerated and effective for major depression in adolescents”, although data made available through legal proceedings show that “Study 329 was negative for efficacy on all 8 protocol specified outcomes and positive for harm”. Even beyond frank misrepresentation of data, commercially driven ghostwritten articles shape the medical literature in subtler but important ways, affecting how health conditions and treatments are perceived by clinicians. The ability of industry to exercise clandestine influence over the peer-reviewed medical literature is thus a serious threat to public health.

In 2009, the Institute of Medicine recommended that US-based academic medical centers enact policies that prohibit ghostwriting by their faculties. However, to date, there has been no systematic assessment of ghostwriting policies at academic medical centers. Since US-based academic medical centers generate biomedical research for a worldwide audience, we chose to conduct the first such investigation on elite US-based academic medical centers.

... When a pharmaceutical salesperson hands a clinician an article reprint, the name of the institution on the front page of the reprint serves as a stamp of approval. The article is not viewed as an advertisement, but as scientific research; the reprint is an effective marketing tool because peer-reviewed journal articles generated in academia are perceived to be the result of unbiased scientific inquiry. Deception regarding authorship prevents a discriminating audience from properly assessing the impact of bias in the published article. Importantly, this deception is impossible without the cooperation of faculty employed by academic medical centers. The practice of ghostwriting explicitly violates the usual norms of academia. We are not aware of any other academic fields where it is acceptable for professors to allow themselves to be listed as authors on research papers they did not write, or to purposefully conceal the contributions of industry coauthors in order to mislead readers.

The authors offer a possible wording for a ban on ghostwriting that they urge medical centres to adopt.

“All listed authors on a publication must meet the authorship criteria set by the International Committee of Medical Journal Editors. Making minor revisions to a manuscript does not qualify as authorship. Participating in the creation of ghost-authored manuscripts is not permitted. A ghost author is defined as someone who makes substantial contributions to writing a publication but is not listed as an author. All individuals who have made a substantial contribution to the manuscript must be listed as authors. Accurately reporting authorship is essential for maintaining research integrity, and violating any of these rules is considered research misconduct akin to plagiarism or falsification of data.”

No similar survey has been condiucted in Canada.