sábado, 20 de agosto de 2016

BioEdge: Bioethicist alleges “publication bias” at NEJM

BioEdge: Bioethicist alleges “publication bias” at NEJM

Bioethicist alleges “publication bias” at NEJM
For a fascinating behind-the-scenes view of how a major medical journal can stifle heterodox views, it is hard to beat Ruth Macklin’s saga in the Indian Journal of Medical Ethics (IJME).

Dr Macklin, a prominent bioethicist at Albert Einstein College of Medicine, in New York, disagreed strongly with a battery of articles published in the New England Journal of Medicine about treatments for extremely premature newborns.

The medical issue is complex. Basically the so-called SUPPORT study compared oxygen levels given to newborns in order to determine the optimal level. A lot is at stake; wrong levels can result in blindness and death. One vocal critic of the SUPPORT study, Peter Aleff, has a brain-damaged and blind son whose disabilities he attributes to problematic oxygen levels. He has described the SUPPORT study as “even more unethical than the syphilis studies in Guatemala and Tuskegee”.

After the results of the SUPPORT study were published in the NEJM in 2010, the Office of Human Research Protections (OHRP) rebuked the University of Alabama for the inadequacy of its informed consent forms. The NEJM came out with all guns blazing in defense of its editorial judgement and launched four counter-attacks on OHRP: an article by two leading bioethicists; an editorial by the NEJM editor, Jeffrey M. Drazen; a long letter signed by 46 bioethicists and paediatricians; and an article by three officials at the National Institutes of Health, including its head, Francis S. Collins.

Dr Macklin and two colleagues studied the forms at the centre of this controversy. In their view, OHRP was right: “They failed to disclose the foreseeable risks of the study that the parents of the premature infants should have been told about before deciding to enter their babies in the study.” They composed a letter with 45 signatories questioning the regnant orthodoxy at the NEJM.

To Dr Macklin’s surprise, Dr Drazen refused to publish it, except in a very condensed form. After much negotiation, a version of the letter on this important topic appeared in 2013, but only online. Her correspondence with him is the centrepiece of her article in the IJME -- a duel between two sharp and powerful minds. Dr Macklin concludes:

“[All this] raises the question of a reputed journal's ability to bias its readers by the sheer number of publications on one side of a controversial issue. … Although this sort of potential bias does not constitute a direct conflict of interest, it may very well fall into another ethically suspect category: publication bias.”
This is not the only controversy in which the NEJM and Dr Drazen have become embroiled. “They basically have a view that . . . they don’t need to change or adapt. It’s their way or the highway,” Dr. Eric Topol, director of the Scripps Translational Science Institute, told the Boston Globe earlier this year. “Most people are afraid to say anything about the New England Journal because they’re afraid they won’t get something published there.”

Dr Drazen brushed off criticism in an interview with the Globe. “If there’s anything that I have a passion for, it’s getting it right,” he said. “We work very hard at that. We’re not arrogant. We’re not dismissive.”
- See more at: http://www.bioedge.org/bioethics/bioethicist-alleges-publication-bias-at-nejm/11965#sthash.aZMf1sH3.dpuf


Costa Rica is a small Central American republic of about 4.5 million people which is remarkably stable, compared to other countries in the region. It is one of the few countries in the world without a standing army. Its democratic institutions are robust. A higher proportion of people turn out to vote than in the US. The percentage of seats in parliament held by women is nearly double that of the US – about one-third.

Yet Costa Rica has been dragooned by an international court into enacting legislation which violates its Constitution. In 2000 it became the only country in the world to ban IVF, based on a Supreme Court ruling that this violated a constitutional guarantee to the right to life for the unborn. Last year, after many legal battles, Costa Rica was ordered by the Inter-American Court of Human Rights to enact legislation enabling IVF -- against the will of its legislature and Supreme Court. “Seven foreigners are making decisions about human life in Costa Rica,” said one deputy bitterly. After more legal tussles, clinics began offering IVF procedures last month.
Regardless of where one stands on the ethics of IVF, this seems like a low point for respect for democracy. An article in Nature crowed over the victory and said that the next goal must be the legalization of abortion. There’s something quite cynical about this. If the Inter-American Court of Human Rights struck down the death penalty in the US, all Americans would be united in their outrage. Voters in the UK supported Brexit because EU courts were suborning UK legislation, amongst other issues. Yet no one is defending Costa Rica’s right to make up its own mind on controversial bioethical problems.
This is The Mouse That Roared with an unhappy ending.  

Michael Cook



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