Monday, October 31, 2011

One-fifth of Major Journal Articles Have Misattributed Authorship

Here's a sobering article from BMJ. The authors (all senior editors from JAMA) surveyed in 2009 hundreds of corresponding authors on pieces that had published in high-impact medical journals in 2008. (The journals were Annals of Internal Medicine, JAMA, Lancet, Nature Medicine, New England Journal of Medicine, and PLoS Medicine). The surveyed authors self-reported 21% rates of ghost authorship and/or honorary authorship! ("Honorary" authors are listed authors whose actual contribution to the paper should not merit authorship under the International Committee of Medical Journal Editors criteria. "Ghost" authors are those who meet the criteria and aren't listed, or whom the corresponding author mentioned as participating in writing the article, but who remained unnamed.) Overall incidence of honorary authorship was largely unchanged since a similar survey was conducted in 1996, though ghost authorship was down to 7.9% from 11.5%. Fully a quarter of all original research articles in these top-notch journals had honorary authors--as did 15% of reviews and 11.2% of editorials. 11.9% of research articles, 6% of reviews and 5.3% of editorials had ghost authors. Of course, these numbers may overlap, because a ghost-written article can be signed by an honorary author.

This looks terrible, especially since one might expect under-reporting of bad behavior in surveys of this kind. Of course, we needn't think that all of the honorary authorships were the extreme case of people signing onto something they didn't work on; most probably fell into the category of people who contributed a lot to the piece but not enough to merit full authorship--they were made authors, in other words, when they should merely have been mentioned in an acknowledgement footnote. Still: a fifth of all articles, and a quarter of original research articles, gave the wrong kind of credit to the wrong people, and 8% failed to acknowledge the right people. And people wonder why NIH is requiring Responsible Conduct of Research training....

Brief Technical Post


Sunday, October 30, 2011

NHS Permits "Caesarian on Maternal Demand"

An update of a new guidance document being developed by the UK's National Institute for Health and Clinical Excellenct ("NICE") would permit caesarian section on maternal request, even when there are no medical indications for the procedure. In the US context, I'm skeptical even of the language of "maternal request" or "maternal demand," since I believe that there is significant evidence that physician preferences and reimbursement drive our sky-high c-section rates here in the US, and elsewhere (such as Brazil); and also that physician preferences and conversations can end up driving what is later called "maternal demand". The new guidelines make me worry that the official availability of c-section on maternal request in the UK will lead to some non-medically-indicated c-sections being performed for reasons other than "maternal request," like physician scheduling convenience. But it may work differently in the NHS; and anyway, the NICE guidelines include a number of steps to be taken before acquiescing in mom's request for CS, like counseling on fear of childbirth, and proper discussion of the comparative risks of CS and vaginal birth. Let's see what happens to the overall CS rate, and how many maternal requests for CS crop up, after the new guidelines are finalized.

Bioethics Hall of Fame, Henry K. Beecher Edition

My second nomination to the notional Bioethics Hall of Fame is Henry K. Beecher. Beecher, an distinguished anaesthesiologist, wrote a highly influential 1955 paper on the placebo effect; wrote a then-controversial 1966 paper which served as the single most important goad to regulation of research on human subjects; was one of the cast of all-star contributors to the American Academy of Arts and Sciences influential 1969 book, "Experimentation with Human Subjects" (Paul Freund, ed.); and chaired the Harvard Medical School ad hoc committee whose report supplied the first generally accepted criteria for brain death. Less well-known is Beecher's post-war work on LSD and mind-control, some of which was done on unconsenting subjects. Indeed, it may have been this military and CIA-sponsored work which led him, shortly thereafter, to embrace the necessity of informed consent.

Friday, October 28, 2011

Friday Frivolity, Side Effects of Big Pharma Edition

Ah, an oldie but a goodie! Enjoy!

Black Market Kidney Conviction in US

A man pled guilty yesterday to multiple counts of illegal trafficking in human kidneys. This is the first conviction under federal law banning the sale of human organs. The defendant took payments of $120,000 or more for each of three kidneys which he purchased from donors in Israel for $10,000 each. He was caught in a government sting operation, attempting to sell an organ to a federal agent. His attorneys argued that the resultant transplants worked, relieving the American buyers from the burdens of kidney disease and dialysis; that the organ recipients had sought him out and not vice-versa; that the donors in each case were aware of what they were doing; and that the surgeries were conducted by reputable and skilled transplant surgeons in well-known (but unnamed) American hospitals. The money, they argued, was used for "expenses associated with the procedures"--though it's not clear from the coverage what that's supposed to mean. Federal prosecutors were rightly unimpressed, noting that black-market organ sales pose a public health danger, and are also unfair, since they result in preferential allocation of organs to the rich (and corrupt).

Breach of Confidentiality on Social Media

An extensive new report from Big Brother Watch (a UK privacy organization) documents hundreds of breaches of patient confidentiality by the UK's National Health Service. A press release on the report notes that the over 800 breaches of privacy included:

23 incidents of patient information being posted on social networking sites
91 incidents of NHS staff looking up details of colleagues
24 NHS Trusts saw confidential information stolen, lost or left behind by staff

These numbers are low, too, because 44 NHS trusts failed to respond to Big Brother Watch's Freedom of Information request and 55 Trusts refused to release all of the information requested.

I want to draw particular attention to the social networking site posts. A lot of physician groups, hospital units, etc., are using Facebook and similar sites to create a sense of community with and among their patients. Some physicians and nurses "friend" their patients, and others face "friend" requests from their patients or their families which they find difficult to turn down. Still others simply have their own social media sites on which they discuss their private and work lives. All of these uses of social media risk breaches of patient confidentiality; there are also risks of offending or shocking patients or their families with posted personal or work-related information. Patients routinely Google their caregivers. Medical groups, wards, clinics and hospitals should all be thinking about the limits of social media use, and developing policies and guidance for caregivers, patients and families.

Thursday, October 27, 2011

Lesser Theories of Bioethics

Here's a gem from MK Czerwiec, alias Comic Nurse:
There's a larger version here. Thanks, Comic Nurse!

That's waaay more than "surrogacy"

Wow. This BioEdge article, somewhat tamely titled "Surrogacy thrives in China, despite illegality," includes the following shocker: "[One s]urrogacy agency promised an undercover reporter posing as a customer that for 1 million yuan (US$150,000), the company would enlist 5-7 surrogate mothers and impregnate them with the customer’s sperm all at once, solely to ensure that at least one baby is a boy...[F]emale foetuses who are not wanted are aborted. If all babies are girls, the mothers have to keep getting pregnant after abortions....In the more likely situation that two or more babies are male, the customer chooses a mother to carry the foetus to term, and the other babies are aborted." I'm generally pro-choice and pro-surrogacy. But this industrial-model combination of bodily commodification and the callous routinization of abortion as a form of manufacturing quality control (where "quality" is maleness) is just evil.

Vaccine Trouble

An October study in Pediatrics shows that 13% of parents follow a non-standard vaccination schedule for their children, by refusing particular vaccines, delaying certain vaccines, or (in about 2% of all cases) refusing all vaccines. More disturbing is the fact that many parents who are currently using the recommended schedule are at risk of departing from it in the future: 22% of them disagreed that the expert-recommended schedule they were following was the best one to use, and 28% of them thought delaying vaccination would be safer for their children. This is the legacy, I think, of Andrew Wakefield's fraud and the misguided activism of RFK Jr., Jenny McCarthy, and others. Meanwhile, a paper presented at last week's meeting of the Infectious Disease Society of America showed that younger doctors have less faith in vaccines than older doctors. In a WebMD interview, one of the authors stated that while there was generally strong support among all doctors for vaccination, every increase of five years in year of graduation was associated with a 20% reduced likelihood that the doctor believed that vaccines were very safe, and with a 20% increased likelihood of agreement with the statement that "children get more immunizations than are good for them." Why would younger doctors have less faith in vaccines? This, too, may be partly a legacy of the recent controversies surrounding HPV vaccination, the alleged vaccine/autism link, and so on. But there may also be something else at work: younger doctors have no experience of the devastating effects of childhood diseases. Indeed, many young physicians are more apt to have seen an adverse reaction to a vaccine than a case of polio or whooping cough or rubella. Vaccines, in other words, may partly be victims of their own success.

Tuesday, October 25, 2011

Bioethicsy Stuff at Yale

A couple of things for folks who might be in New Haven: The Bioethics Center's sister-institution, the Forum on Religion and Ecology at Yale, is screening "Green Fire," a film on the life of environmentalist Aldo Leopold (author of "A Sand County Almanac"), tonight at 6. There'll be a reception and what looks to be a very fine panel discussion. Details are here. The event is being hosted by the Yale School of Forestry & Environmental Studies (from which Leopold graduated in '09), with cosponsorship from the Yale Forum on Religion and Ecology, the Interdisciplinary Center for Bioethics, the Yale Divinity School, the Environmental Film Festival at Yale, and the Center for Humans and Nature. Another sister institution, the Program for Biomedical Ethics at Yale Medical School, is hosting an event on Transplant Ethics on Wednesday evening; details here. And finally, look at our front page to find out about Hal Herzog's Oct. 27 address to our Animal Ethics group on "Moral Inconsistency, Psychology, and Animal Ethics," and David Chalmers' November 4 talk to our Technology and Ethics group on "The Singularity: A Philosophical Analysis."

Human Subjects Protection, Unintended Consequences Edition

The New York Times has a story here (oddly printed in the Arts section) dealing with some unintended consequences of the proposed changes to the Common Rule, which protects human subjects of research. One of the major proposed changes (which I earlier mentioned here) is to implement HIPAA-like privacy and security standards to protect the data gathered in human-subjects research. The idea is to relieve IRBs from having to consider "informational risks" when they evaluate studies (risks related to subjects' having their personal data leaked out into the world). The Times article notes that the actual HIPAA standards prevent data collected for one purpose from being released to researchers for another. This means that studies-about-studies (like the recent work of Susan Reverby, which uncovered unethical US research in Guatemala) could be much more difficult to conduct. Jerry Menikoff of OHRP has said that the government will work on the problem, based on the comments received from historians and social scientists. This is an example of a good feature of our administrative law system: federal regulations are always released in draft form with a comment period, precisely so that problems like this can be pointed out by interested parties and addressed before the rules become final. The rub is that regulators are not as responsive to comments as we'd sometimes like them to be. But in this case, researchers have in Jerry Menikoff a former academic bioethicist with real expertise in this area. He'll take all the comments seriously.

This Year in Bioethics, Sperm Donor Edition

The second of my top stories in bioethics for 2011 is the story about the sperm donor who's been discovered to have 150 or more children. (The first "top story," on pending reforms to the Common Rule protecting human subjects of research, is here.) This is only the largest reported instance of many large groups of half-siblings. This raises the issue of how to control problems of consanguinity: children of donors are naturally afraid that they'll meet and fall in love with someone who is, unbeknownst to them, their half-brother or -sister. This, in turn, raises the issue of why it is that we permit sperm donors to remain anonymous. If they weren't anonymous, the consanguinity issue would be easy to handle. The case for donor anonymity is not, in my view, terribly strong. The main claim made in favor of anonymity is that without it, the number of sperm donors would decrease drastically. But donor registration numbers have not been drastically affected in countries that have abandoned anonymity, such as Sweden and, more recently, the UK. A second argument is that donors need anonymity to protect them from paternity suits; but while there have been a couple of isolated cases of such suits succeeding in the U.S., abolishing liability seems a more direct way to treat the problem than preserving donor anonymity. Some clinics may prefer anonymity because it relieves them of the duty to keep updated information on file for many years; and some recipient couples may want anonymity because they think their family lives will be simpler if the sperm donor is completely and permanently out of the picture. But the children of gamete donation often turn out to want information about their biological parents, just as in the case of adoption; and it seems odd to privilege the convenience of parents over the interests of children. Some US clinics already offer only non-anonymous donation. Some try to take a middle-ground position, offering a sheaf of the donor's genetic and anonymized family-history information, so that children of the donors can make use of relevant medical information and satisfy some of their curiosity about their roots without actually learning the identity of the donor parent. But this doesn't solve the consanguinity problem. In my view, donor anonymity ought to be abolished, donor liability eliminated, and the number of families to which a given donor can donate sharply limited.

Friday, October 21, 2011

Thursday, October 20, 2011

Paying Gamete Donors in the UK

The UK's Human Fertilization and Embryology Authority has just approved a major change in gamete-donor compensation policy. Previously, sperm and egg donors could be compensated up to £61.28 per day in lost earnings, with an overall cap of £250 for each donation. They could also be reimbursed for reasonable expenses, such as travel costs. Under the new regime, donors will instead receive fixed sums: £35 per donation for sperm donors, £750 per donation for egg donors. Donors who incur "excessive expenses" by, e.g., traveling long distances, will be eligible for additional reimbursement, but such expense-based reimbursement will no longer be the norm. Donors from other countries won't be eligible for travel expenses. The HFEA announcement is here. BioNews has some nice coverage. Note: these are donors for reproductive purposes. The UK doesn't pay people who donate gametes for research purposes, though a recent report from the Nuffield Council on Bioethics recommends that research egg donors be paid.

Wednesday, October 19, 2011

Gostin on HPV Vaccination

The current issue of JAMA contains a brief commentary (subscription required) by Larry Gostin, public-health law-professor extraordinaire, on the politics and history of mandatory vaccination for human papillomavirus ("HPV"). HPV is a sexually-transmitted virus which is responsible for much cervical cancer in women, for a large portion of oral cancers, and for some forms of genital warts. Gostin clearly seems to favor mandatory HPV vaccination, though--given the political heat that's surrounded the HPV vaccination because of its relationship to adolescent sexuality--he's willing to give publicity and public funding a shot at upping the vaccination rates before pushing the mandates. I agree that HPV vaccination would be good for public health, but I worry that an HPV mandate will move some parents (e.g., those who are offended at the state's implication that their child is or will be sexually active) to make serious efforts to exempt their children from all publicly-mandated vaccinations. In other words, an anti-HPV backlash could translate into an anti-vaccine backlash of the sort earlier associated with the vaccine/autism scare.

Bioethics Web Resource of the Week

The European Society of Human Reproduction and Embryology has a great page, here, summarizing a number of European countries' policies on human reproduction, especially embryo research and the currently hot question of gamete donor anonymity. And while we're looking at assisted reproduction, check out the Global IVF map here; and the IVF insurance-status information here.

European Court: No Patents on Human Embryonic Stem-Cell Products

The European Court of Justice ("ECJ") has held that scientists cannot patent products developed from any research which involves the destruction of the human embryo. The Court's full opinion is here. Greenpeace (!) began the case in 2004 by suing to block a Bonn researcher's patent on a technique for deriving neural cells from human embryonic stem cells. European law has banned patenting in connection with the "uses of human embryos for industrial or commercial purposes" since 1998, and German law includes similar language. The Greenpeace case turned on whether a blastocyst destroyed in creating a stem-cell line counts as an "embryo;" whether "industrial or commercial purposes" includes university-based research; and whether the European patent-exclusion law applies to research that is conducted significantly downstream from the act of embryonic destruction (for example, on stem cell lines produced many years ago, and purchased by German researchers from researchers in other countries). The German court's 2006 ruling in favor of Greenpeace was appealed to the German supreme court, who referred it to the ECJ for clarity on the meaning and application of the various terms. Earlier this year the ECJ's advocate-general recommended that the court uphold the patent ban, so yesterday's opinion was widely expected. The court held, first, that the term "embryo" includes any fertilized egg, any product of "research cloning" (in which an unfertilized egg has introduced into it a nucleus from a mature cell), and any parthenote (an unfertilized egg whose division and development have been artificially stimulated by researchers). (This last holding is surprising to me, since parthenotes aren't capable of developing into babies.) Next, the court held that scientific research is included within the legal restriction from patentability concerning the use of embryos "for industrial or commercial purposes". Finally, the court found that the patent restriction applies no matter how distant the research or patent is from the original act of embryonic destruction, and even if the patent itself makes no mention of embryos (referring, for example, only to particular cell-lines originally derived from embryos). There's a fine technical overview of the opinion here.

Tuesday, October 18, 2011

Upcoming Bioethicsy Stuff at Yale

Two things to put on the calendar: First, Hal Herzog (Psychology, Western Carolina University) will speak to our Animal Ethics Working Group at 1 p.m. on Thursday the 27th at the Bioethics Center; his topic will be "Moral Inconsistency, Psychology, and Animal Ethics." Second (though it's a day earlier, I'm just writing this backwards), our sister organization, Yale Medical Schoo'ls Program on Biomedical Ethics, will host a conference on Transplantation Ethics on Wednesday the 26th, 5 p.m., in the Beaumont Room of Yale Med's Sterling Hall, above the medical library. Speakers will be Robert Truog and Norm Fost. Should be wonderful!

French Parliament at Yale

Jean-Sebastien Vialatte and and Alain Claeys, members of the French Parliament, visited the Yale Interdisciplinary Center for Bioethics this week. They're in the US, visiting Boston, New York and Los Angeles (and Yale!) to find out what American scientists and bioethicists think about the ethics of neuroimaging. They came to us courtesy of Wendell Wallach, who runs our Technology and Ethics Working Group. (They'd originally hoped to meet with James Hughes and members of his Institute for Ethics and Emerging Technologies (IEET). James was out of the country, and graciously recommended they speak to Wendell, instead.) They arrived, together with a translator, a member of the Parliamentary office of Science and Technology, the Science and Technology rep from the French Consulate to the US, and at least two other staff, for a morning meeting with Wendell, myself, Carol Pollard and Mike Treder, Managing Director of the IEET. We had a wide-ranging and serious discussion about the ethics of imaging, the ethics of brain technologies more generally, the current political situation in the US around several bioethics issues from stem cell research to genetic medicine, the political status of the transhumanism movement, and more. All of which blew my mind, because I couldn't imagine the analogous US Congressional delegation to France, or anywhere else. To my admittedly rather amateur eye, our Congressional delegations to foreign destinations seem to be political events (chances to be seen and heard) rather than genuine investigations (chances to listen). Who in our Congress would actually ask, "I wonder what scientists and academics in France (or Germany or Sweden or Japan or the UK) think about this important issue?" And who, then, would actually go and ask, and listen?

This Year in Bioethics: Common Rule Edition

So, fall is (finally) in the air, and 2011 is winding down. It's not too early (is it?) to start thinking about what this year's top bioethics stories were. I think anybody's list has to start with the massive proposed changes to the Common Rule. Proposed changes include 1) beefing up data security standards in order to relieve IRBs from having to review protocols for informational risks; 2) eliminating continuing IRB review requirements for protocols past their active stages, and for all protocols originally subject only to expedited review; 3) expanding the category of exempt studies and reducing oversight of such studies; 4) permitting blanket prospective written consent for research on biospecimens; 5) expanding the category of studies subject only to expedited review, and streamlining of oversight for such studies; and 6) permitting single-IRB approval of protocols for multi-site studies. For a quick overview, look at this Emanuel/Menikoff article in NEJM. Here's the full text of the advance notice of proposed rulemaking. You can submit your own comments here, until October 26!

Friday, October 14, 2011

Another approach to organ donation...

Bioethics Hall of Fame: Paul Ramsey Edition

Over at, Summer McGee has asked, "Who would you put in the bioethics hall of fame?"

So here's my first of many nominees: Paul Ramsey, author of Fabricated Man, Ethics at the Edges of Life, and The Patient as Person. He was one of the first-generation bioethicists who came, mostly, from moral theology backgrounds. Himself a Methodist, he is credited with having brought the Catholic doctrine of just war theory to the attention of mainstream Protestant ethicists. He is not, frankly, the easiest person to read; but his essays still repay careful attention, even when--or perhaps especially when--they wrestle with subjects about which most contemporary bioethicists have already reached consensus, e.g., cessation of life-sustaining treatment.

Bioethics Web Resource of the Week

And speaking of the Nuffield Council on Bioethics, why not name their collection of excellent, free, downloadable reports on a wide variety of bioethics issues as the first of my planned weekly "Bioethics Web Resources" posts? Here you'll find material on the bioethics of dementia, biofuels, the use of animals as research subjects, GM crops, personalized medicine, stem-cell research and more.

Nuffield on Bodily Donation

The Nuffield Council on Bioethics has posted a new report on donation of human bodies and body parts for medicine and research. It covers a wide range of topics: live and cadaveric organ donation for transplant, gamete donation for reproduction, use of healthy volunteers in first-in-human trials, blood and cord blood, tissue donation, and more. It's a huge and far-reaching report, and I haven't had time to read it deeply, yet, but it appears that the most controversial of its recommendations is to create a pilot program under which women would be paid for donating eggs for research.