Wow. Author of the a now-discredited Lancet article which started a vaccine scare by falsely linking MMR vaccination to autism onset, Andrew Wakefield is suing BMJ's editor, Fiona Godlee, and British investigative journalist Brian Deer, for defamation of his character. The complaint, filed in Travis County, Texas, is here. It focuses fairly narrowly on statements by Godlee and Deer to the effect that Wakefield manipulated or falsified data in the study.
The UK's General Medical Council, after the longest hearing in its history, found Wakefield guilty of serious professional misconduct in connection with the conduct of the research underlying the article, and erased him from its rolls. But they didn't specifically find that he altered data in the study; their main complaint about the article itself was that it mischaracterized the children under study--especially the means by which, and purpose for which, they were recruited. The GMC's findings spoke mainly to other forms of research and clinical misconduct. To review, the GMC found that Wakefield violated the limits of his appointment as an Honorary Consultant in a "breach of trust of patients and employers alike," and mismanaged funds, and failed to disclose "matters which could legitimately give rise to a perception of a conflict of interest," and conducted research on vulnerable children without required ethics review, and concealed that fact, and repeatedly breached "fundamental principles of research medicine," and acted contrary to the clinical interests of 9 of the 12 children mentioned in the article, and violated his duties as a senior author, and failed to correct his mistakes when given the chance, and made "dishonest and irresponsible" statements to the GMC board itself.
Of course, the fact that Wakefield was unprofessional in a bunch of different ways doesn't mean that he was unprofessional in all of the ways that Godlee or Deer have, at one time or another, alleged. It's just possible that one or the other of them has said something factually wrong by accusing Wakefield of some specific kind of scumbaggery that he didn't actually engage in. If so, may the damages found be very, very small.
Because the damage caused by Wakefield hasn't been small. The publicity around his unethical research likely caused children to die of completely preventable childhood diseases, and is certainly still causing misguided parents to fail to vaccinate their children. It is depressing to note that here, the Autism Action Network is already trumpeting Wakefield's suit against Deer and a woman whom they call "Fiona Godley." Their view is that Wakefield and his co-author John Walker-Smith "had their medical licenses suspended for their refusal to recant their hypothesis." They don't mention the actual GMC findings against Wakefield, nor those against Walker-Smith (which you can read here), nor the fact that in 2004, six years before the GMC acted, Walker-Smith and nine of Wakefield's other co-authors specifically retracted the portion of the paper that posited a link of MMR with autism.
Thursday, January 5, 2012
Egg Donors and Stem Cell Research
This piece from the Atlantic (summarizing this article from Fertility and Sterility) says that most fertility clinics which accept donor eggs for fertility treatments, and which donate at least some "excess" embryos for research, fail to inform egg donors of the possibility that their eggs might be used in stem-cell research. Most of the surveyed clinics told donors that they would not have control over the future uses of their eggs or the embryos made from them, and 30% mentioned the possibility of research use, but very few mentioned stem-cell research by name. This ought to be remedied. I doubt that most women who are willing to donate eggs for fertility treatment have serious opposition to the use of their eggs in fertility research or in stem-cell research, but a few might. They should be given the information.
Commission Report on Assisted Dying in UK
Here is the final report of the UK's Commission on Assisted Dying. The private commission was funded by author-turned-end-of-life activist Terry Pratchett, who suffers from Alzheimer's disease and founded the UK's Dignity in Dying organization. It was led by Lord Falconer, a vocal proponent of liberalization of laws prohibiting assisted suicide. No one expected the Commission to come out with anything other than a pro-assisted-suicide view, Falconer's protestations of independence and neutrality notwithstanding. The Church of England has condemned the report, as have many (sometimes predictable) others.
But it is perhaps interesting to notice what the Commission actually ends up recommending: a relatively modest assisted suicide program rather similar to those in place in the US states of Oregon and Washington. The proposed program would help only competent adults with terminal diagnoses verified by two physicians. ("Terminal" means under a year to live, as opposed to the 6-month requirement in place in Oregon and Washington.) The patient's decision would have to be voluntary, not subject to undue influence, and not the result of a treatable mental condition such as depression. All requesting patients would be told about available social services and about other end-of-life treatment options such as palliative care. And the program would be open only to patients who are physically capable of taking the lethal medication themselves.
The report doesn't advocate euthanasia, though Falconer is often condemned by the other side as "pro-euthanasia." The program it recommends won't help Mr. Pratchett, whose Alzheimer's will likely render him incompetent before he has the report's recommended 12-month terminal diagnosis. Nor, as the Guardian points out, would the recommended program help Debbie Purdy, whose litigation forced prosecutorial authorities in England and Wales to issue guidelines backing away from criminal prosecution of those who assist their loved ones to die. Purdy has MS--a chronic, rather than a terminal, illness, and one that will likely make it impossible for her to take her own lethal medication within a year of her forecast death.
But it is perhaps interesting to notice what the Commission actually ends up recommending: a relatively modest assisted suicide program rather similar to those in place in the US states of Oregon and Washington. The proposed program would help only competent adults with terminal diagnoses verified by two physicians. ("Terminal" means under a year to live, as opposed to the 6-month requirement in place in Oregon and Washington.) The patient's decision would have to be voluntary, not subject to undue influence, and not the result of a treatable mental condition such as depression. All requesting patients would be told about available social services and about other end-of-life treatment options such as palliative care. And the program would be open only to patients who are physically capable of taking the lethal medication themselves.
The report doesn't advocate euthanasia, though Falconer is often condemned by the other side as "pro-euthanasia." The program it recommends won't help Mr. Pratchett, whose Alzheimer's will likely render him incompetent before he has the report's recommended 12-month terminal diagnosis. Nor, as the Guardian points out, would the recommended program help Debbie Purdy, whose litigation forced prosecutorial authorities in England and Wales to issue guidelines backing away from criminal prosecution of those who assist their loved ones to die. Purdy has MS--a chronic, rather than a terminal, illness, and one that will likely make it impossible for her to take her own lethal medication within a year of her forecast death.
Drug Research on Non-Representative Populations
A while back I had my eyes opened by this review by Alex John London of Adriana Petryna's wonderful book, When Experiments Travel: Clinical Trials and the Global Search for Human Subjects. One of Petryna's important points is that when drug-trials are conducted in the developing world, the populations on whom drugs are tested are not very similar to the populations to whom the drug companies expect, eventually, to sell most of their drugs. Not only that, but the drug companies know this, and can work to choose populations with particular characteristics favorable to good trial results. Of course, they can do that at home, too, using inclusion and exclusion criteria for drug trials. A letter in last week's JAMA drives the point home: hardly any drug studies in high-impact journals include patients with multiple chronic conditions--this, in spite of the fact that 28% of Americans, and 2 of 3 three seniors, have multiple chronic conditions; and treatment of multiple chronic conditions accounts for 66% of overall US healthcare expenditure, and 95% of Medicare expenditure. The letter's sobering conclusion: "Given the possible drug-to-drug, drug-to-disease, and disease-to-disease interactions that remain unexamined, most of the evidence gathered to date by [clinical trials] is of limited value to guide decisions about medication use by patients with multiple chronic diseases."
Mouse Sperm Grown in Culture, Press Overreacts
This article from the Asian Journal of Andrology reveals that a German/Israeli team of researchers has been able to grow murine testicular cells in a soft agar culture system, and differentiate them to the point where they appear like morphologically normal spermatozoa. That is: they can take pre-sperm cells from mouse testes and grow them until they look like real, functional sperm cells. This is amazing news, but not as amazing as some journalists have made it seem. The Daily Mirror and the Telegraph said this could lead to in-lab production of human sperm "soon." Well, okay--depending on what you mean by "soon." JotZoom went with the present tense: "The latest news reports reveal more details about sperm grown in laboratory as a real scientific breakthrough. Infertile men are no longer deprived of the unique experience of becoming the father of a child using their own sperms." And the Times of India headlined the story, "Way to beat male infertility found." CBS used the Telegraph's reporting to do a more careful story, here. NHS splashes some appropriate cold water here.
US Restricts Antibiotics in Animals
From the "it's about time" department: the New York Times reports that the FDA is restricting the use of cephalosporins in livestock feed, in order to slow down the development of antibiotic-resistant bacteria. (Recent studies have shown that such resistant bacteria are indeed passed from feed animals to human beings.) Cephalosporins are a class of antibiotic widely used to treat strep, pneumonia, UTIs, skin infections and childhood bacterial infections. Europe banned the use of several antibiotics important in human medicine in 1998; banned the use of all antibiotics for growth-enhancement of livestock in 2006; and has recently moved to ban all prophylactic use of antibiotics in feed animals.
Bioethicsy Stuff at Yale
Here are a few upcoming bioethical events at Yale, all of which are open to the public:
Our Jerome Medalie End-of-Life Issues group will hear Kenneth Goodman, PhD, FACMI, Bioethics Program Director and Co-Director University of Miami Ethics Programs, on January 10 at 5:30. Details here.
Our sister institution, Yale Med's Program for Biomedical Ethics, will hear Carl Elliott, M.D., Ph.D., Professor, Center for Bioethics, University of Minnesota, on "Fear and Loathing in Medical Research: How to Exploit the Poor," on January 10 at 5p.m. Details here.
Our Biotechnology in Agriculture group will hear Scott Deeter, President and CEO of Ventria Bioscience, on "Global Human Health Innovations From Plant Biotechnology" on January 12 at 4pm. Details here.
Our Perspectives on Aging group will hear Dr. Marianthe Grammas, Clinical Fellow, Internal Medicine/Geriatrics, Yale School of Medicine on January 12 at 9 a.m. Details here.
Our Jerome Medalie End-of-Life Issues group will hear Kenneth Goodman, PhD, FACMI, Bioethics Program Director and Co-Director University of Miami Ethics Programs, on January 10 at 5:30. Details here.
Our sister institution, Yale Med's Program for Biomedical Ethics, will hear Carl Elliott, M.D., Ph.D., Professor, Center for Bioethics, University of Minnesota, on "Fear and Loathing in Medical Research: How to Exploit the Poor," on January 10 at 5p.m. Details here.
Our Biotechnology in Agriculture group will hear Scott Deeter, President and CEO of Ventria Bioscience, on "Global Human Health Innovations From Plant Biotechnology" on January 12 at 4pm. Details here.
Our Perspectives on Aging group will hear Dr. Marianthe Grammas, Clinical Fellow, Internal Medicine/Geriatrics, Yale School of Medicine on January 12 at 9 a.m. Details here.
Blogging Hiatus Ends
Just goes to show you: I take a seasonal holiday from the blog (any my own daily blog-reading) and miss the one day when Andrew Sullivan's The Dish sends hundreds of page-views my way.
Anyway, holiday's over. Time to make the donuts. Andrew, Patrick, Chris, Zoe, Maisie, Zack: come back anytime, and bring your readers!
Anyway, holiday's over. Time to make the donuts. Andrew, Patrick, Chris, Zoe, Maisie, Zack: come back anytime, and bring your readers!
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