Zeke Emanuel and Jeffrey Liebman are predicting that health insurance companies will vanish by 2020, to be replaced by the Accountable Care Organizations (ACOs) being called into being by President Obama's Affordable Care Act. ACOs, they predict, will practice more efficient medicine than the current fee-for-service system can generate, and will also replace insurance companies' risk-spreading function by pooling the risks of their higher- and lower-cost patients.
I can't share their optimism. Data from the five-year Medicare Physician Group Practice demonstration project casts doubt on the ability of ACOs to extract major savings from care-coordination. This Health Affairs Health Policy Brief on ACOs raises that question, and others as well: will ACOs form only in wealthier regions of the country, thus worsening already-existing health disparities? Could alliances among healthcare providers result in higher prices? Will ACOs run afoul of antitrust laws?
Of course we should do a better job of coordinating care; of course we should incentivize our doctors and hospitals to work on keeping people well rather than on intervening with expensive procedures after they're sick; of course we should use our better information technology to cut costs without cutting quality. Can ACOs do all of that? I sincerely hope so. But I'm not willing to bet that they'll be so successful as to make private health insurance obsolete in the next eight years.
Tuesday, January 31, 2012
Friday Frivolity, Vegetative Teens Edition
Yeah, I know, it's only Tuesday. But this is just too good to wait for.
Brain-Dead Teen, Only Capable Of Rolling Eyes And Texting, To Be Euthanized
Brain-Dead Teen, Only Capable Of Rolling Eyes And Texting, To Be Euthanized
Affordable Malaria Medicine in Nigeria
Here's a heartening article about a coalition that has just completed negotiations which will permit antimalarial medication to be sold in five Nigerian states (together containing about one-fifth of the population) for as little as N60.00 per dose (that's about 27 cents). Previously, Artemisinin-based Combination Therapies had sold for anywhere between N800.00 and N2000.00. The Partnership for Transforming Health Systems, PATHS2, is a program of the United Kingdom Department for International Development. The initiative is a collaboration of PATHS2 with the Clinton Health Access Initiative, Nigeria's Federal Ministry of Health, and some pharmaceutical manufacturing firms, working through the Affordable Medicines Facility for malaria (AMFm) initiative. More details on the funding mechanism are here. Malaria accounts for 70% of all disease incidence in Nigeria; in 2008 there were 57,506,430 reported cases, of which 225,424 were fatal.
Monday, January 30, 2012
Council of Europe on Euthanasia
The Parliamentary Assembly of the Council of Europe ("PACE") has issued a non-binding declaration (mainly aimed at getting member states to beef up their laws governing living wills and advance directives) in which it opines that "[e]uthanasia, in the sense of the intentional killing by act or omission of a dependent human being for his or her alleged benefit, must always be prohibited."
A number of different publications are mistakenly alleging that PACE has called for a permanent ban on assisted suicide. The resolution explicitly says that it "is not intended to deal with the issues of euthanasia or assisted suicide," and while it goes on to condemn euthanasia, it says nothing additional about assisted suicide.
The PACE declaration may indeed have some political effect on movements within Europe toward legalization of euthanasia. But it's a mistake to report it as a condemnation of assisted suicide, or to anticipate that it will have strong effect on pending cases involving assisted suicide. The European Court of Human Rights, for example, has repeatedly recognized the distinction between assisted suicide and euthanasia, and has held that Article 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms protects the individual's choice to avoid a painful and undignified death.
A number of different publications are mistakenly alleging that PACE has called for a permanent ban on assisted suicide. The resolution explicitly says that it "is not intended to deal with the issues of euthanasia or assisted suicide," and while it goes on to condemn euthanasia, it says nothing additional about assisted suicide.
The PACE declaration may indeed have some political effect on movements within Europe toward legalization of euthanasia. But it's a mistake to report it as a condemnation of assisted suicide, or to anticipate that it will have strong effect on pending cases involving assisted suicide. The European Court of Human Rights, for example, has repeatedly recognized the distinction between assisted suicide and euthanasia, and has held that Article 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms protects the individual's choice to avoid a painful and undignified death.
No Fetuses in Food!
Oklahoma Senate Bill 1418, introduced by State Sen. Ralph Shortey, would prevent anyone from manufacturing or selling food "which contains aborted human fetuses in the ingredients or which used aborted human fetuses in the research or development of any of the ingredients." The concern behind the bill, apparently, is with food companies which are in fact using tissue derived from aborted fetuses in research on the development of new product flavorings. (This is of course different from saying that such cells are being used as ingredients in food!)
The Onion, America's finest news source, has gathered some informed opinions on the issue.
The Onion, America's finest news source, has gathered some informed opinions on the issue.
Gingrich Would Ban Stem Cell Research, Regulate IVF
Newt Gingrich is telling conservative audiences in Florida that, if elected, he will ban all human embryonic stem-cell research, including research done on excess embryos from fertility clinics. He regards embryonic stem-cell research as "the use of science to desensitize society over the killing of babies." This is a reversal of positions he took in two different interviews in 2001, in which he expressed support for federally funding research on leftover fertility-clinic embryos which would otherwise be discarded. Over this weekend Gingrich also indicated that he would create a commission to look into the ethics of IVF: “I believe life begins at conception, and the question I was raising was what happens to embryos in fertility clinics, and I would favor a commission to look seriously at the ethics of how we manage fertility clinics....If you have in vitro fertilization, you are creating life; therefore, we should look seriously at what the rules should be for clinics that are doing that, because they are creating life.”
The roughly $125 million saved by cutting all of NIH's human embryonic stem-cell research funding could presumably be used to help offset some of the billions and billions of dollars required to create the new moon-base Gingrich says he wants by the end of his second term.
The roughly $125 million saved by cutting all of NIH's human embryonic stem-cell research funding could presumably be used to help offset some of the billions and billions of dollars required to create the new moon-base Gingrich says he wants by the end of his second term.
Friday, January 13, 2012
Bioethics Poetry, Sylvia Plath Edition
Morning Song
Love set you going like a fat gold watch.
The midwife slapped your footsoles, and your bald cry
Took its place among the elements.
Our voices echo, magnifying your arrival. New statue.
In a drafty museum, your nakedness
Shadows our safety. We stand round blankly as walls.
I'm no more your mother
Than the cloud that distills a mirror to reflect its own slow
Effacement at the wind's hand.
All night your moth-breath
Flickers among the flat pink roses. I wake to listen:
A far sea moves in my ear.
One cry, and I stumble from bed, cow-heavy and floral
In my Victorian nightgown.
Your mouth opens clean as a cat's. The window square
Whitens and swallows its dull stars. And now you try
Your handful of notes;
The clear vowels rise like balloons.
Sylvia Plath
Love set you going like a fat gold watch.
The midwife slapped your footsoles, and your bald cry
Took its place among the elements.
Our voices echo, magnifying your arrival. New statue.
In a drafty museum, your nakedness
Shadows our safety. We stand round blankly as walls.
I'm no more your mother
Than the cloud that distills a mirror to reflect its own slow
Effacement at the wind's hand.
All night your moth-breath
Flickers among the flat pink roses. I wake to listen:
A far sea moves in my ear.
One cry, and I stumble from bed, cow-heavy and floral
In my Victorian nightgown.
Your mouth opens clean as a cat's. The window square
Whitens and swallows its dull stars. And now you try
Your handful of notes;
The clear vowels rise like balloons.
Sylvia Plath
Research Misconduct and Red Wine
Dipak Das of the University of Connecticut has been found by a special review board to have committed 145 separate counts of data falsification and fabrication in his studies of the effects on the heart of red-wine consumption (and specifically of the compound resveratrol, found in red wine). A summary the board's findings is here. The research misconduct is said to affect 26 articles in as many as 11 journals. Retraction Watch is following the case, and has printed some responses from Das, who is alleging ethnic bias, conspiracy and mistreatment by UConn.
Harvard's David Sinclair (a booster of resveratrol) was quoted in the New York Times as saying that there will be little fallout for the general field of resveratrol study around the world. "Today I had to look up who he is. His papers are mostly in specialty journals,” he said. Ouch! But Science 2.0 (which is skeptical about resveratrol) notes an earlier connection between Sinclair and Das, and a sort-of retraction by Sinclair of his NYT comment. Curioser and curioser!
Harvard's David Sinclair (a booster of resveratrol) was quoted in the New York Times as saying that there will be little fallout for the general field of resveratrol study around the world. "Today I had to look up who he is. His papers are mostly in specialty journals,” he said. Ouch! But Science 2.0 (which is skeptical about resveratrol) notes an earlier connection between Sinclair and Das, and a sort-of retraction by Sinclair of his NYT comment. Curioser and curioser!
Pharma and Phraud
Here's a report from Public Citizen summarizing the recent trend in payments by the pharmaceutical industry of civil and criminal monetary penalties. It seems that pharma has now eclipsed the defense industry as the leading defrauder of the US government under the False Claims Act. Some of the report's findings:
In the last twenty years, pharma firms have made 165 settlements for $19.8 billion in penalties. Three-quarters of these (both in terms of numbers of settlements and in terms of fines paid) have occurred in the last five years. GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough accounted, together, for more than half of the twenty years' penalties. Illegal off-label promotion of drugs has triggered the largest number of federal fines. Overcharging state Medicaid programs triggered the largest state-level fines. Actions initiated by industry whistleblowers gave rise to 67 percent of payouts over the last decade.
The report concludes that fines are probably not sufficient motivation to get high-profit-margin firms to behave. It recommends the application of the "Park Doctrine" to pharma executives--a doctrine under which individual executives can be convicted of criminal misdemeanors based on corporate misbehavior, even if they weren't personally aware of the problem. The doctrine is designed to motivate executives to become pro-active in preventing their firms from engaging in criminal misconduct.
The report's call for the FDA to revive the long-neglected Park Doctrine in fact follows recent signals from the FDA that it intends to do just that. The law firm of Hyman, Phelps and McNamara has an informative powerpoint presentation on the FDA's past and future use of the Park doctrine, here. The clear message from the FDA has been, "Expect some prosecutions of pharma executives soon!"
In the last twenty years, pharma firms have made 165 settlements for $19.8 billion in penalties. Three-quarters of these (both in terms of numbers of settlements and in terms of fines paid) have occurred in the last five years. GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough accounted, together, for more than half of the twenty years' penalties. Illegal off-label promotion of drugs has triggered the largest number of federal fines. Overcharging state Medicaid programs triggered the largest state-level fines. Actions initiated by industry whistleblowers gave rise to 67 percent of payouts over the last decade.
The report concludes that fines are probably not sufficient motivation to get high-profit-margin firms to behave. It recommends the application of the "Park Doctrine" to pharma executives--a doctrine under which individual executives can be convicted of criminal misdemeanors based on corporate misbehavior, even if they weren't personally aware of the problem. The doctrine is designed to motivate executives to become pro-active in preventing their firms from engaging in criminal misconduct.
The report's call for the FDA to revive the long-neglected Park Doctrine in fact follows recent signals from the FDA that it intends to do just that. The law firm of Hyman, Phelps and McNamara has an informative powerpoint presentation on the FDA's past and future use of the Park doctrine, here. The clear message from the FDA has been, "Expect some prosecutions of pharma executives soon!"
Tuesday, January 10, 2012
Lesbian Couple's Parental Rights
A lesbian couple in Florida had a child. One of the couple was the child's birth-mother and the other its genetic (egg-providing) mother. (The genetic father was a sperm donor, not involved in the case.) After years of jointly rearing the child, the two mothers split up. Genetic mom sought parental rights to the child, and birth-mom resisted, claiming that 1) Florida common law recognizes only birth-mothers as mothers; 2) since Florida doesn't permit adoption by gay couples, it has prohibited lesbian couples from sharing custody of children; 3) the genetic mother was an "egg donor," required under Florida gamete-donation law to relinquish parental rights; and 4) the biological mother had relinquished her parental rights contractually, in the text of her agreement with the fertility clinic which helped the couple create the child. In this opinion, the Fifth District of Florida finds 1) that Florida in fact has no common law recognizing exclusive parental rights in birth mothers--particularly in a case like this, where the birth mother is not the genetic mother; 2) that if Florida law prevents gay couples from sharing parental responsibility for a jointly-conceived child for whom they cared as mothers for years, then that law is unconstitutional under both the US and the Florida constitutions; 3) that a biological mother who provided her lesbian partner with an egg for purposes of fertilizing and implanting it in her partner and then raising the resultant child together, is not an "egg donor" under Florida law; and 4) that the provisions of the standard pre-printed form used by the fertility clinic did not apply to the facts in the case and could not operate to vitiate the genetic mother's parental rights. This is big news, because it appears to establish a fundamental, constitutionally-protected right to procreate--even for gay couples who, under current Florida law, can neither marry nor adopt.
ABC reports that birth-mom intends to appeal the case to the Florida Supreme Court.
ABC reports that birth-mom intends to appeal the case to the Florida Supreme Court.
Addiction, Philosophy--and Science
A number of bioethics twitterers were calling attention to this piece on addiction and philosophy from the New York Times's online Opinionator page. I enjoyed it, but thought that at its core it was more the application of a metaphor drawn from philosophy to the problem of addiction, rather than a philosophical treatment of the problem of addiction. So I googled around for a philosophical treatment of addiction and found this piece by Piers Benn. It is a genuinely philosophical treatment of the issue, but one which fails for lack of familiarity with contemporary addiction science.
In the piece, Benn asks whether addiction is properly termed a disease. (He speaks mostly about alcohol addiction, and so shall I.) Benn entertains and rejects four reasons why we might consider it a disease. The first is people sometimes argue that it would be more humane for us to talk about it that way, and thus to relieve addicts from blame and stigma. But Benn rejects that argument, favoring a "tough love" approach. (In another portion of the essay, he rejects the idea that addicts can't control themselves, essentially by pointing to the fact that some addicts can and do.) The second reason he considers for the disease model is that "the disease model seemingly gains support from genetics;" on this point, he cites a study from 1973 that showed that children of alcoholics, raised by non-alcoholic parents, are more likely to become alcoholic. Benn rejects this on grounds that genetic predispositions to drink don't actually force anyone to drink, and don't keep everyone from quitting. The third justification for the disease model is that addicts often talk about their own experience of powerlessness--inability to quit their habit even though they want to; Benn rejects this as self-deception. Addicts, he implies, aren't powerless, they just think they are. The fourth reason is that ordinary language often describes addiction in terms of irresistible forces and compulsions; Benn recommends that we simply think about addiction differently, as involving powerful forces, but not irresistible ones.
The underlying theme seems to be that addiction can only be a disease if it implies complete lack of control and therefore supplies addicts with a moral excuse for their conduct. If some addicts can control their behavior, then addiction doesn't imply complete lack of control, and therefore isn't a disease, and therefore supplies no moral excuse.
This won't do. First, it implicitly regards "addiction" as uniform, such that the ability of one person to kick an addiction is proof that all others could have done so as well, but for their weakness of will. Second, as Benn comes close to admitting at the close of the essay, the whole essay maps the idea of disease onto an idea of powerlessness which doesn't make sense. Some Type II diabetics can bring their insulin and blood-glucose under control with diet and exercise. Does this imply that the others aren't really sick?
Most unfortunate, though, is the fact that the whole article proceeds without any investigation into the current science of addiction. Scores of studies since 1973 have confirmed genetic predispositions to addiction, not only in humans but also in rats and monkeys. And contemporary brain-scan science has firmly established that the brain's reward-triggers are physically altered by substance use among addicts, in a way that they are not among mere "social users" of the same substances. (These results, too, have been duplicated in other species.) Recent brain-imaging studies have show that addicted alcoholics, unlike social drinkers, drink less for pleasure than for stress-relief; and that alcohol abuse among those with the correct genetic predisposition sensitizes the brains to stressors. This sensitization lasts well after detoxification, both in humans and in other species, and may help explain high rates of relapse. And finally, it's been shown that judgment centers of the brain (in the prefrontal cortex) are physically inhibited by alcohol intake, so that when (as Benn puts it) the tenth drink seems "highly alluring" to the alcoholic, that is not because (as Benn argues) the alcoholic is being akratic, and lacks the resolution to act on his better judgment, but because the portion of the brain which might normally supply better judgment has literally been shut down.
Someone, somewhere, might mount a philosophical argument against the disease model of addiction. But such an argument cannot be based only on armchair reflections about how we use language, about the Greek view of weakness of will, or about whether medicalization of addiction would or would not be kind. It must, also, deal with the science of the last four decades.
In the piece, Benn asks whether addiction is properly termed a disease. (He speaks mostly about alcohol addiction, and so shall I.) Benn entertains and rejects four reasons why we might consider it a disease. The first is people sometimes argue that it would be more humane for us to talk about it that way, and thus to relieve addicts from blame and stigma. But Benn rejects that argument, favoring a "tough love" approach. (In another portion of the essay, he rejects the idea that addicts can't control themselves, essentially by pointing to the fact that some addicts can and do.) The second reason he considers for the disease model is that "the disease model seemingly gains support from genetics;" on this point, he cites a study from 1973 that showed that children of alcoholics, raised by non-alcoholic parents, are more likely to become alcoholic. Benn rejects this on grounds that genetic predispositions to drink don't actually force anyone to drink, and don't keep everyone from quitting. The third justification for the disease model is that addicts often talk about their own experience of powerlessness--inability to quit their habit even though they want to; Benn rejects this as self-deception. Addicts, he implies, aren't powerless, they just think they are. The fourth reason is that ordinary language often describes addiction in terms of irresistible forces and compulsions; Benn recommends that we simply think about addiction differently, as involving powerful forces, but not irresistible ones.
The underlying theme seems to be that addiction can only be a disease if it implies complete lack of control and therefore supplies addicts with a moral excuse for their conduct. If some addicts can control their behavior, then addiction doesn't imply complete lack of control, and therefore isn't a disease, and therefore supplies no moral excuse.
This won't do. First, it implicitly regards "addiction" as uniform, such that the ability of one person to kick an addiction is proof that all others could have done so as well, but for their weakness of will. Second, as Benn comes close to admitting at the close of the essay, the whole essay maps the idea of disease onto an idea of powerlessness which doesn't make sense. Some Type II diabetics can bring their insulin and blood-glucose under control with diet and exercise. Does this imply that the others aren't really sick?
Most unfortunate, though, is the fact that the whole article proceeds without any investigation into the current science of addiction. Scores of studies since 1973 have confirmed genetic predispositions to addiction, not only in humans but also in rats and monkeys. And contemporary brain-scan science has firmly established that the brain's reward-triggers are physically altered by substance use among addicts, in a way that they are not among mere "social users" of the same substances. (These results, too, have been duplicated in other species.) Recent brain-imaging studies have show that addicted alcoholics, unlike social drinkers, drink less for pleasure than for stress-relief; and that alcohol abuse among those with the correct genetic predisposition sensitizes the brains to stressors. This sensitization lasts well after detoxification, both in humans and in other species, and may help explain high rates of relapse. And finally, it's been shown that judgment centers of the brain (in the prefrontal cortex) are physically inhibited by alcohol intake, so that when (as Benn puts it) the tenth drink seems "highly alluring" to the alcoholic, that is not because (as Benn argues) the alcoholic is being akratic, and lacks the resolution to act on his better judgment, but because the portion of the brain which might normally supply better judgment has literally been shut down.
Someone, somewhere, might mount a philosophical argument against the disease model of addiction. But such an argument cannot be based only on armchair reflections about how we use language, about the Greek view of weakness of will, or about whether medicalization of addiction would or would not be kind. It must, also, deal with the science of the last four decades.
Monday, January 9, 2012
Chimeric Monkeys, Mice and Stem Cells
Shoukhrat Mitalipov of the Oregon National Primate Research Center has created chimeric rhesus monkeys, each of whose bodies combines tissues with up to six different genetic identities. The chimera creation was part of research which showed that--unlike in the case of mice--chimeras cannot be formed by injecting rhesus embryonic stem cells into blastocysts. Chimera formation was instead achieved by aggregating several four-cell embryos (a result never achieved in mice). The research hints at some important limitations of using mouse embryonic stem cell models to predict experience in primates, including humans.
The Onion has gathered some on-the-street comments on the research, including from Mr. Bobo.
The Onion has gathered some on-the-street comments on the research, including from Mr. Bobo.
Online Advance Directives
Virginia has recently decided to create an advance directives registry which, when it goes live sometime this spring, will permit patients to upload their own living wills. The plan is eventually to integrate the advance directives information into the state's health information exchange, so that physicians will be able to access their patients' documents without needing to know their login information. The hope is that physicians will then be able to act on their patients' previously-expressed wishes without having to locate and contact surrogate decision makers.
Saturday, January 7, 2012
Bioethics Poetry, Emily Dickinson Edition
Death is a Dialogue between
Death is a Dialogue between
The Spirit and the Dust.
"Dissolve" says Death -- The Spirit "Sir
I have another Trust" --
Death doubts it -- Argues from the Ground --
The Spirit turns away
Just laying off for evidence
An Overcoat of Clay.
Emily Dickinson
(Mary M. Scott Morton, RIP)
Death is a Dialogue between
The Spirit and the Dust.
"Dissolve" says Death -- The Spirit "Sir
I have another Trust" --
Death doubts it -- Argues from the Ground --
The Spirit turns away
Just laying off for evidence
An Overcoat of Clay.
Emily Dickinson
(Mary M. Scott Morton, RIP)
86% of Medical Error Goes Unreported
Hospital incident reporting systems were informed of only 14% of errors that harmed Medicare patients, according to this report on a recent survey undertaken by the Department of Health and Human Services Office of Inspector General. Hospital staff didn't perceive 61% of adverse events as reportable. Another 25% were classified as of a type commonly reported, but somehow not reported this time.
Remember what the Institute of Medicine told us, back in 1999, about how we ought to be dealing with medical errors? We're supposed to report them all, in a blame-free atmosphere, in order to gather information that will help us change the systems which give rise to them. The idea was that we'd make more progress by reporting error in this blame-neutral way than by either a) covering the error up or b) blaming error on particular human beings. The basic assumption was that most medical error resulted from flawed systems (training systems, oversight systems, information systems, and so on) which put hospital staff at predictable and preventable risk of making mistakes.
Some progress has been made. But this latest report shows how very far we have to go. A 14% reporting rate is absolutely dreadful, particularly because this is the report-rate for events that actually harmed Medicare patients. The IOM's goal was that not only harmful errors, but also "near-misses"--events that could have harmed patients, but luckily didn't--should be reported.
The Inspector General recommends that the government establish a list of reportable events, so that there's clarity about what needs to be reported and what doesn't; and that CMS (the Medicare agency) cooperate with accrediting bodies like the Joint Commission to establish review of hospital reporting procedures. Accrediting bodies currently tend to concentrate on what's done with reported information, rather than on the accuracy and breadth of the reporting process itself. That clearly needs to change.
Remember what the Institute of Medicine told us, back in 1999, about how we ought to be dealing with medical errors? We're supposed to report them all, in a blame-free atmosphere, in order to gather information that will help us change the systems which give rise to them. The idea was that we'd make more progress by reporting error in this blame-neutral way than by either a) covering the error up or b) blaming error on particular human beings. The basic assumption was that most medical error resulted from flawed systems (training systems, oversight systems, information systems, and so on) which put hospital staff at predictable and preventable risk of making mistakes.
Some progress has been made. But this latest report shows how very far we have to go. A 14% reporting rate is absolutely dreadful, particularly because this is the report-rate for events that actually harmed Medicare patients. The IOM's goal was that not only harmful errors, but also "near-misses"--events that could have harmed patients, but luckily didn't--should be reported.
The Inspector General recommends that the government establish a list of reportable events, so that there's clarity about what needs to be reported and what doesn't; and that CMS (the Medicare agency) cooperate with accrediting bodies like the Joint Commission to establish review of hospital reporting procedures. Accrediting bodies currently tend to concentrate on what's done with reported information, rather than on the accuracy and breadth of the reporting process itself. That clearly needs to change.
Friday, January 6, 2012
Regulation, War, and Face Transplants
These proposed regulations from the US Department of Health and Human Services would subject vascularized composite allographs (VCA) to the rules currently governing solid organ procurement and transplantation. VCA involves transplanting multiple tissue-types as a single functional unit. The highest-profile VCA procedures are face and hand transplants, but VCA procedures around the world have included limb transplants, abdominal wall transplants, finger transplants, and transplants of penises and uteruses. What the procedures have in common is the need for re-vascularization via surgical connection of blood vessels to the transplanted tissue. Bringing these procedures under the existing organ procurement and transplantation rules will rationalize the supply and distribution of transplantable tissue, and permit medical teams to find better matches for their patients.
Recent successes in face-transplantation have captured a great deal of media attention. But another reason for this move is the medical aftermath of the US military presence in Iraq and Afghanistan. More than 1,000 military personnel have lost an arm or a leg in these conflicts; one fifth of those have lost two or more limbs. In the summer of 2010 there were an estimated 200 soldiers who might be eligible for partial or full face transplant, and an additional 50 who could use hand or forearm transplants. The US Departments of Defense and of Veterans Affairs have been leading funders of research on limb and face transplantation. The proposed regulation of VCA is in part aimed at permitting more veterans to get the procedures they need, with the best available material.
Recent successes in face-transplantation have captured a great deal of media attention. But another reason for this move is the medical aftermath of the US military presence in Iraq and Afghanistan. More than 1,000 military personnel have lost an arm or a leg in these conflicts; one fifth of those have lost two or more limbs. In the summer of 2010 there were an estimated 200 soldiers who might be eligible for partial or full face transplant, and an additional 50 who could use hand or forearm transplants. The US Departments of Defense and of Veterans Affairs have been leading funders of research on limb and face transplantation. The proposed regulation of VCA is in part aimed at permitting more veterans to get the procedures they need, with the best available material.
Thursday, January 5, 2012
Hepatitis C Vaccine Success and Chimpanzees
This article from Science Translational Medicine shows excellent results in a phase-1 trial of a new hepatitis C vaccine. This is a huge deal: hepatitis C infects 170 million globally, and causes a great deal of the world's liver damage. It kills more people in the US annually than HIV/AIDS.
The new vaccine was developed using chimpanzees as research subjects. I submit that this is exactly the sort of research for which the IOM's recent report on use of chimps in research left room. But I submit, also, that there aren't many more examples of this sort.
The new vaccine was developed using chimpanzees as research subjects. I submit that this is exactly the sort of research for which the IOM's recent report on use of chimps in research left room. But I submit, also, that there aren't many more examples of this sort.
Wakefield Sues BMJ Editor for Defamation
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.
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.
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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