Bioethics, healthcare policy, and related issues.
The recent South Dakota law banning almost all abortions is clearly intended as a strategic move in an effort to allow and newly-anti-choice Supreme Court to overturn Roe v. Wade; the content of the law or its supposed justification are almost beside the point, and its backers have hardly pretended otherwise. It is still somewhat startling, however, to read the actual words of the rube who wrote this law. The gasping scientific ignorance, legal confusion, and sheer dunderheadedness they betray is almost as dismaying as the law itself.
I posted earlier about the spreading fear among women and their supporters that the right wing’s drive to roll back women’s rights through the courts is reaching fruition with the Bush nominees. What is increasingly apparent is that the right wing also thinks its time has come.
You come alert on a subway train in a bleak part of town you’ve never seen before. You don’t know why you’re there or how you got there. Thinking about it some more you realize you can’t recall anything that’s happened to you recently, or in fact anything that has ever happened to you, or what your own name is. You’re carrying a backpack; you open it up and it contains no ID or money, nothing with your name on it. It holds only a few cryptic items, a set of keys you don’t recognize, and a scrap of paper with a name and phone number you also don’t remember. The train stops. You’re at Coney Island, early in the morning, and you don’t know why you’re there, or who you are.
Now what?
(more…)
Much hangs on the upcoming Supreme Court decisions on the dilation-and-extraction ban and the no-doubt-to-be-challenged South Dakota abortion ban. Everybody is watching to see which way the court breaks with its two new stealth-anti-choice Justices now seated. Just the fact that they granted cert in Carhart is ominous, given the law’s obvious extremism and the fact that it has now been held unconstitutional in five federal courts and three federal appellate courts. The South Dakota law is, of course, a deliberate attempt to provoke the court into overturning Roe entirely, by giving them a test case that violates virtually every remaining vestige of that decision. The results in these two cases will probably paint the full picture of abortion jurisprudence under the current Court.
The suspense is killing us - in some cases literally. “Back-alley” abortions have been reported even throughout the period of legal abortion, and in almost every case they are prompted by fears that a legal abortion would be unobtainable or bring repercussions from the violation of the patient’s confidentiality. With the possibility that abortion will be even more severely restricted than it now is, and on a nationwide basis, women are beginning to imagine what a post-autonomy world would look like.
One sign: the realistic consideration of the need for an “abortion underground” again. Women on the Waves offers detailed advice (with plenty of safety warnings) on how to self-administer a medical abortion with misoprostol (one of the ingredients of RU-486) up to the 9th week of pregnancy. Molly, of Molly Saves the Day, attempts to fill the need for a new “Jane“-style abortion network by providing detailed instructions for D&Cs by non-professional caregivers. (CAUTION: These instructions are not vetted by professional review, and in some places lack considerable detail. For instance, it instructs operators to “don’t be afraid to scrape [the uterus] fairly hard”, but nowhere at all does it mention the possibility of perforation - still less how to recognize it or what to do about it.)
I appreciate these women’s concerns, and the service they are providing to other women. However, I would much prefer to see hands-on training by professionals of non-professionals in a one-to-one setting before people blithely set out doing this on their own. At some point, experienced non-professionals could then start mentoring others, as the Jane network did, but the thought of somebody reading sketchy instructions off a Web site and then setting up as an abortion provider is exactly the reason we need abortion to remain legal! But women know this, of course. They prefer to get healthcare openly, without denial of services or deliberate misinformation, with respect for their autonomy, and from trained professionals backed by a non-punitive healthcare system. They prefer their healthcare professionals to care for women’s freedom and women’s bodily security. They prefer abortion to remain legal. The fact that they are willing to seek other avenues to preserving their freedom - and are doing so already - merely underscores how far the assault on women’s independence has already undermined their sense of security - not to mention the actual availability of healthcare services.
Just how bad things are going to get - they are surely going to get worse, whatever happens - remains to be seen. We will know much of what we need to know in weeks or a few months. But the fact that women are now planning to find the least unsafe method to preserve control of their bodies and their lives is testimony to the climate of fear the right wing has created, aside from actual practical inroads it has made on sexual freedom. This fear is one of the tools they use to control women - it’s part of the reason they seek to ban procedures that are safer than the alternatives, why they oppose realistic contraception education and access, and why, increasingly, they seek restrictions on abortion that make no exception even for direct threats to a woman’s health. The more dangerous pregnancy and abortion are, the more women are punished for their sexual activity (and, it is claimed, the less likely they are to choose to be sexually active, though the empirical facts demonstrate that this is not the case).
“Fear Up” is the name for one of the torture strategies used at Abu Ghraib - a method of breaking the enemy by threatening the most grievous bodily harms (accompanied with some physical abuse, lasting injury, and the occasional death). It appears to be the strategy adopted by the anti-sex right toward women’s autonomy, and it appears to be working.
Hat tip: Amanda at Pandagon.
I hesitate to mention it, but . . . Sufficient Scruples has been nominated for Koufax Awards in the following categories:
Best Post (twice! - for this and this)
and
Most Deserving of Wider Recognition
Thanks, Mom!
(Seriously, thanks to whoever did the nominating. I’m very flattered that one [or more] of you thinks that highly of the blog, and honored to be in the company of some really great blogs among the nominees. You read me! You really, really read me!)
Wampum, who run the awards, are doing their usual great job, and at considerable expense. (Apparently they’ve had to pay for computer repairs, at least one of them has taken a whole week off to coordinate the awards this year, and last year bandwidth alone during the awards season ran them over 4 figures.) Please consider dropping them a dime through the PayPal link on their awards page. And please peruse the categories and the nominees, and vote for the most deserving. Polls open soon, and there are a lot of great candidates to choose from. Recognition really makes a blogger’s day.
Thanks again.
Almost a year ago, Art Caplan waded into the prenatal genetic testing arena with this variation on an old trope: “Would you allow Bill Gates to be born?” I’m a bit slow on these things, so I’m just getting around to answering him. (And my answer is: given how screwed up my Windows computer system is, I’d abort Gates right now if I had the chance.)
Caplan muses:
If you could go back in time and stop the birth of the world’s most famous nerd, would you?
You probably answered my question with a “no.” Whatever Gates’ sins may be, he is the father of a computer revolution that has brought much good to many people throughout the world. Add to that achievement his current generous philanthropic activities supporting some very worthy causes, such as vaccine research and a center for autism research in Seattle, and the case for having Bill with us becomes pretty persuasive. . . .
But what if I told you it’s possible that Gates has a medical condition that accounts, in part, for both his tremendous achievements and for his “nerdiness?” Gates is widely reported to display many personality traits characteristic of a condition known as Asperger’s syndrome. Asperger’s is a mild version of autism, a more serious condition that renders many children unable to talk, be touched, communicate or socialize. While I certainly do not know if Gates has Asperger’s, his difficulties in social settings are nearly as legendary as his genius, so it’s possible. . . .
The drive for more genetic tests continues unabated. Undoubtedly the genes for autism and Asperger’s will soon be found. When they are, my question — would you have stopped Bill Gates from existing? — will take on a very real meaning.
Fewer geniuses?
There are many in the autism and Asperger’s community, like the newly formed Aspies for Freedom, who worry that the minute a genetic test appears, it will spell the end for a lot of future geniuses, like Gates. Maybe there will be fewer Thomas Jeffersons or Lewis Carrolls — remarkable thinkers who also fit the profile for Asperger’s.
(First, let me say that I am both wary of and uncomfortable with this business of “diagnosing” psychological or medical conditions in famous figures on the basis of a few imagined personality traits. I don’t think there is any reliable evidence to base a claim that Gates has Asperger Syndrome - observations about his “difficult personality” are no more than long-distance stereotyping. I also think it’s an abuse of professional insight to broadcast such claims, whether or not reliable. I have no great sympathy for Gates, but it’s still rude and insensitive to make remarks like this, and in some circumstances - public figures, for instance - it can be quite dangerous.)
I find it odd to see Caplan endorsing this line of reasoning. It’s an old one, most commonly found in anti-abortion arguments, and notoriously weak; Caplan should know better. To put it simply, if the argument against preventing certain births (by abortion, IVF embryo culling, genetic engineering, or what have you) is the utilitarian one that some people with the target condition could turn out to be great geniuses, the counterargument is that they could just as well turn out to be great villains. Medical testing does not give us diagnostic precognition (and if it did, we would undoubtedly choose to abort only the villians - making the case for doing so even stronger). Since there is no way to know that certain births will turn out to be greatly utilitarian for the world, there is no weight to an argument that we should not prevent them for that reason. (Another implication of this argument is that we should not practice birth control, and in fact should attempt to have as many children as biologically possible - since any child not conceived could be a lost genius just as much as any embryo not gestated. Unless we think we are really obligated to become desperate breeding machines seeking the inventor/entrepreneur jackpot that is the apparent raison d’etre of human reproduction, we are entitled to not to have any child we choose.)
Another problem is that this argument ties the anti-[whatever] stance to the utility of the births in question (something that even most Utilitarians - autonomy-loving libertines that they are - would not do). Thus it seems to imply that it is OK to systematically prevent births that are socially disadvantageous - perhaps not in cases of Down Syndrome, or Aspberger Syndrome, or what have you, but in other more severe cases. This is almost invariably not what the “anti-’s” have in mind, and apparently not what Caplan has in mind in raising fears of genetic euthanasia.
The “anti-” argument has got to be made on other grounds. The strongest argument is the pro-autonomy one: that the lives of people with [whatever condition] are just as rich and valuable to them as the lives of people without it; there is no reason to deprive them of life for their own good (that justification virtually never works, since virtually nobody would prefer the alternative for their own good), and you may not deprive someone of life purely for someone else’s good, so they may as well live. (To put that more simply: the lives of people with “disabilities” - however we may conceive that term - are almost always a net positive benefit to them - they do still want to live; thus, the only reason not to let them live would be to benefit someone else, which we normally say we cannot do.) This argument falters when you consider that the lives that are going to be ended are not those of persons with the condition in question, but of embryonic non-persons who have no interests to take into account. Ending the life of an adult person with [whatever condition] who still wants to live would be a grave injustice, but ending the life of an embryo that is not a person, and wants nothing at all because it has no consciousness, is no harm at all, and so is permissible. The response to this argument is that systematically eliminating all births with the chosen condition is tantamount to genocide - to casting the existing generation with that condition adrift by not letting any new members of their “community” arrive - essentially declaring war on people with that condition not by attacking them directly but by genetically cutting them off as a barren community. And, finally, the response to that argument is that there is no obligation on the part of prospective parents to have any particular type of child simply so that others like that child will have a thriving community. (There we will have to let the argument stand for now. It’s a vital topic, but not for this post.)
Whether or not there is a good “anti-” argument against systematic elimination of embryos with a given “disability”, the point is that doing so directly harms no living person. Harms to imaginary future persons, in the sense that they do not come into existence, are of no moment. (An embryo that is aborted “suffers” just as much as one that was never conceived, or one - say, the hypothetical offspring of Benjamin Franklin and Britney Spears - that never could have been conceived. We are not morally obligated to any of these non-persons.) And so I am puzzled to imagine what Caplan - or the many who share his fears - are upset about. The “future genius” argument that Caplan foregrounds is absurd, and the “discrimination” argument makes no sense - not least because, at the early-embryo stage, there is no one there to be discriminated against.
We may well worry about the world we create in seizing domination over our own genetics, but the problems to be feared come not from the fact that certain imaginary people will not come into being. The real problems are the familiar dysutopian scenarios - clone armies, Delta-minus worker slaves, complacent feudal drudges, raving military savages, universal genetic conformism, loss of hybrid vigor - that threaten from attempting to manage a planned genetic economy. These are possibilities to be considered, and avoided by proper planning. (How do you avoid the danger of a clone army? Don’t make one!) But that is something we can do - something that does not depend on diagnostic precognition to prevent us aborting hypothetical geniuses, or equates not having a child with a given condition to killing another person with the same condition.
Mediagirl has an outstanding survey of this issue from many angles.
Once again, I couldn’t say it better, so I didn’t. Go look.
Iocaste, guest-blogging at Majikthise, quotes the below Wall Street Journal Op-Ed at length:
“The belief that there are such things as witches is so essential a part of the faith that obstinately to maintain the opposite opinion manifestly savors of heresy.” So begins “Malleus Maleficarum” (”The Hammer of Witches”), a book commissioned by Pope Innocent VIII and published in 1484. For three centuries “The Hammer” was the principal reference for witch hunters determined to punish sorcerers and rid them of the world.
A no less sweeping manifesto recently appeared in the Journal of the American Medical Association (JAMA). It called for total extermination of contemporary witchery — “financial conflicts of interest” — caused by the malign influence of pharmaceutical and device manufacturers in academic health centers. It argues that these companies pervert altruism, misinform physician education and cause breaches of scientific integrity in medical research. . . .
The [American Board of Internal Medicine] Foundation, like the medieval church, liberally taxes without consent [by charging certification fees] to fund its crusade against “profit-seeking in medicine.” . . .
In their zeal, both “The Hammer” and the JAMA cited scripture selectively. “The Hammer” trolled the Bible and ecclesiastical works for references to support the existence of witches and witchcraft, which remained uncontested until the retraction of anti-witch doctrines centuries later. The JAMA article baldly states that “a systematic review of the medical literature on [industry] gifting . . . found that an overwhelming majority of [commercial] interactions had negative results on patient care,” although the source it cites explicitly says: “No study used patient outcome measures.” The JAMA piece reminds us that industry marketing influences the prescribing habits of physicians. But it repeatedly neglects documented evidence that physicians frequently fail to prescribe appropriate drugs according to evidence-based guidelines for nearly all diseases.
WSJ scores a minor point by noting that the studies mentioned in the editorial did not include clinical data. But they engage in apparently deliberate equivocation by using that point to discredit the actual claim made, regarding the much broader concept of “negative results on patient care” - which can easily be demonstrable without clinical outcome data (though would be better demonstrated with it). The point about sub-optimal prescription patterns is simple misdirection - the (well-documented, and much-criticized) fact that most doctors write the same prescriptions over and over, without close adherence to best-practices standards, will hardly be improved on if they shift to letting perky former college cheerleaders tell them what to prescribe in exchange for a paltry bribe.
What’s really interesting about this, though, is its place in the growing anti-science stance of the right wing. The Bush administration’s outright medievalism on scientific questions is well-documented, as is their wholesale dismissal and distortion of data on science-related policy issues, in favor of positions dictated by their religious or corporate supporters. But it is important to recognize this as a characteristic tactic of the right wing in general, not just the Bush fringe.
The basic position of the right wing on scientific issues that cut across their religious or economic interests is that nothing is ever believable. Distorting the honorable scientific position of keeping all questions open to new data, the right holds that this means nothing science tells us is ever true, or should ever be accepted. The fact that a question can be raised about a given scientific claim means that that claim is “controversial” - whether or not the question raised has actually been answered in a way that implicates the prevailing consensus, or answered at all, or even has any data whatsoever behind it. (Cf. William Hurlbut’s imaginary “altered nuclear transfer” cells, or “intelligent design”, for examples.) Thus every scientific question is controversial, since science allows that challenges can always be raised. Thus, it is always true to say that “science hasn’t proven _____”, and never proper to regard a scientific claim as reliable; for the right wing, “proven” means necessarily true (a category philosophers generally regard as populated only by purely logical constructs), while “reliable” means “proven”. (In clinical-ethics terms, right wingers are in “clinical equipoise” about every scientific fact ever discovered, where the alternative is anything they want it to be no matter what. Now that’s keeping an open mind!)
Thus, the great thing about being a right-wing critic of scientific consensus is that you never have to back up your own claims. To support their points, those advocating for change, or for the adoption of any new policy of any kind, must “prove” (in the right-wing’s impossible sense) whatever they are claiming, while those opposed to change merely have to repeat, after every new study, “it still isn’t ‘proven’”. Conservatism being defined as opposition to change, this is a strategy that works perfectly for conservatives, and has the bonus of making them sound like sophisticated philosophers of science while requiring absolutely no scientific knowledge at all.
From there, it’s simply a matter of putting the rhetorical touches on it. Creationists like to claim science is infected with “a naturalistic bias”; WSJ prefers the historical analogy of equating science with witch-hunting. Since factual claims have no meaning, none of this has to make sense; still, the arrogance of it is breathtaking. The JAMA editorialists cite studies showing impact on patient treatment from the non-patient-directed interference of pharmaceutical advertising; WSJ admits that the advertising is actually effective in distoring doctors’ treatment patterns, then calls this fact-based criticism a witch-hunt. (The alleged reason is that the studies could have been made stronger with more data - a point that makes little difference since WSJ conceded the main point anyway.) Witches, of course, don’t exist. WSJ is not merely calling for more data (and more data, and more data . . . remember how much data it takes to “prove” anything to the right wing?): they are claiming that there is no such thing as deleterious interference with doctors’ prescribing decisions. (But they said the advertising was effective . . .)
This is true in the same sense that there is no such thing as global warming, evolution, or tobacco-caused cancer. Only in the latter case have corporate shills been this shameless in declaring science irrelevant to science policy. That level of intellect, and discourse, is now the conservative standard for evidence-based decisionmaking. It’s going to hurt if we let them get away with it.
PowerBlog has this collection of ultimata from the previous Pope regarding an “objectively so profoundly unlawful” crime that, well, you just better not, that’s all. It is, of course, the unlawful, the unspeakable, the profound crime of . . . using a Jimmy Hat on your Johnson when you do the Wild Thing.
On September 17, 1983, Pope John Paul II told a group of priests that “contraception is to be judged objectively so profoundly unlawful as never to be, for any reason, justified. To think or to say the contrary is equal to maintaining that, in human life, situations may arise in which it is lawful not to recognize God as God.”
On June 5, 1987, the Holy Father warned clergy and theologians of their grave obligation to faithfully transmit the Church’s teaching on this subject: “. . . The Church’s teaching on contraception does not belong to the category of matter open to free discussion among theologians. Teaching the contrary amounts to leading the moral consciences of spouses into error.”
Pope John Paul II also explained that contraception contradicts and is opposed to true love: “Thus the innate language that expresses the total reciprocal self-giving of husband and wife is overlaid, through contraception, by an objectively contradictory language, namely, that of not giving oneself totally to the other. This leads not only to a positive refusal to be open to life but also to a falsification of the inner truth of conjugal love, which is called upon to give itself in personal totality.” (Familiaris Consortio, #32)
The Holy Father has explained that when contraception is used, the marital act ceases to be an act of love: “. . . [When using contraception} the conjugal act, deprived of its interior truth because it is artificially deprived of its procreative capacity, ceases also to be an act of love.” (General Audience of August 22, 1984)
The constant teaching of the Church was again stated on March 1, 1997 when the Vatican’s Pontifical Council for the Family issued a Vade Mecum for Confessors Concerning Some Aspects of the Morality of Conjugal Life. Included in this document is the following statement: “The Church has always taught the intrinsic evil of contraception, that is, of every marital act intentionally rendered unfruitful. This teaching is to be held as definitive and irreformable. Contraception is gravely opposed to marital chastity; it is contrary to the good of the transmission of life (the procreative aspect of matrimony) and to the reciprocal self-giving of the spouses (the unitive aspect of matrimony); it harms true love and denies the sovereign role of God in the transmission of life (n. 24).”
As Pope John Paul II has stated, “The heart has become a battlefield between love and lust. The more lust dominates the heart, the less the heart experiences the nuptial meaning of the body. It becomes less sensitive to the gift of the person, which expresses that meaning in the mutual relations of the man and woman.” (General audience of July 23, 1980)
OK - I’ll say it: this is insane.
The basic cultural conflicts of our time are at heart conflicts between moral visions grounded on incompatible values (and to some extent incompatible factual beliefs). It is difficult to criticize values from a neutral standpoint, but we can at least notice the weird ends some of them lead us to - and that’s as good a reason for rejecting them as any. Nonsense like the above is just nutty - that’s all. People who think like this are nutty, and there’s no reason to take them, or their beliefs, seriously. Aquinas’s Five-Fold Proof be damned - all we need to know is this: a religion that is grounded on a profound disgust for humanity in its simplest and most definitive expressions of itself isn’t worth taking seriously, and a religion that is this perversely hysterical over sex is . . . well, nutty.
Commenting on a story about moves to allow pharmacists to prescribe emergency contraception, the editor of CovenantNews.com offers the following:
Editor asks, What does the future hold for a nation possessed by the Spirit of Murder? With each expansion of death comes escalation. Local churches hold silent prayer vigils outside Eckerd Drugs? Anti-abortion protest at local drug stores? Drug Store ‘Escorts’ volunteer at CVS Pharmacies? Off duty cops moonlight at abortion-drug stores? Local Right to Life director opposes protesters and graphic pro-life signs at drug stores? Operation Rescue holds sit-in at abortion-drug store? Court creates ‘Buffer Zones’ around abortion-drug stores? U.S. Congress adds ‘Pharmacies’ to the Freedom of Accsess to Clinic Enterance Act, President said he will sign bill into law? Fire guts local drug store, FBI suspects arson? Pharmacist is keynote speaker at NARAL fund raiser? Pharmacists wear bulletproof vests?
That’s interesting.
Why would a “pro-life” blogger imagine that providing safe and legal contraceptive services would result in protests, blockades, security details, harassment, sit-ins, arsons, and shootings? We were told over and over that those tactics - rampant at abortion clinics, with deadly results - are not representative of the anti-choice movement, that they (in their thousands, over and over, year after year) were each and every time spontaneous aberrations caused by a few “bad apples”. Now “pro-lifers” themselves are predicting “escalation” of the characteristic violence of the anti-choice religious right in response to the newest reproductive-health technology.
I suspect many supporters of women’s rights have the same expectation, but it would sound accusatory if we said it. I think we should take “pro-lifers” at their word - and prepare for the worst.
Here’s another story of politically-appointed FDA brass overruling the overwhelming consensus of its own scientific board to make a scientifically dubious decision on approval of a marketing application. The best-known - and previously unique - example of behavior of this kind was the bizarre saga of Plan B emergency contraception; now another case has surfaced involving experimental therapeutic usage of a surgical-implant device that FDA reviewers say - on the basis of the manufacturer’s own data showing no statistical difference between the experimental and control groups - is worthless. The division Director unilaterally approved the device anyway.
If “two data points is a trend”, this establishes a very puzzling and very disturbing trend at the FDA. It is fast squandering its reputation as “the world’s most reliable medical safety agency”.
A top federal medical official overruled the unanimous opinion of his scientific staff when he decided last year to approve a pacemaker-like device to treat persistent depression, a Senate committee reported Thursday.
The device, the surgically implanted vagus nerve stimulator, had not proved effective against depression in its only clinical trial for treatment of that illness. As a result, scientists at the Food and Drug Administration repeatedly and unanimously recommended rejecting the application of its maker, Cyberonics Inc., to sell it as such a treatment, said the report, written by the staff of the Senate Finance Committee.
But Dr. Daniel G. Schultz, director of the Center for Devices and Radiological Health at the agency, kept moving the application along and eventually decided to approve it, the report said.
That approval did follow the backing of a divided F.D.A. advisory committee. Still, the Senate committee, which for two years has been investigating the decision-making processes at the F.D.A., could find no previous instance in which the director of the center had approved a device in the face of unanimous opposition from staff scientists and administrators beneath him, the report said.
There is no explanation what the “divided advisory committee” refers to. It is clear that the actual scientific review committee was unanimously against the device, and it’s not hard to see why:
The vagus nerve stimulator is surgically implanted in the upper chest, and its wires are threaded into the neck. Batteries in the device stimulate a nerve leading to the brain.
The nerve stimulator has been approved since 1997 for the treatment of epilepsy in some patients. Common side effects include voice alteration, increased cough, shortness of breath, neck pain and difficulty swallowing. The device has also been linked to rare reports of death, heart problems and vocal cord paralysis.
When some epilepsy patients reported that their moods had changed after receiving the devices, Cyberonics, based in Houston, implanted them in 235 depressed patients and turned the machines on in half of them. After three months, the two groups were equally depressed. The trial had failed.
Cyberonics then turned the devices on in all 235 patients and determined that 30 percent showed significant improvement after six months or more. Without a control group, however, it was impossible to determine if the device had caused the improvement.
Cyberonics is now defending the device as “the only safe and effective treatment option ever specifically developed, studied, F.D.A.-approved and fully informatively labeled for the treatment of chronic or recurrent treatment-resistant depression.”
This is shocking. If the description above is correct, the company not only failed to demonstrate any therapeutic effect from their device, they actively manipulated the trial to obscure disconfirmatory data and then claimed a positive result based on an uncontrolled trial which they had purposefully initiated after the controlled trial failed. This goes beyond a merely questionable device: based on this news report (which may not be reliable, it is important to remember), this appears to be deliberate scientific fraud.
The company’s behavior is absurd: they deliberately eliminated the control group and then claimed a positive result that was only apparent in the trial group when no control group was available for comparison - doing so after the controlled trial demonstrated no distinct effectiveness in the experimental group! This is just outrageous. And their claimed “benefit” is laughable - famously, about one-third of untreated psychiatric patients show improvement over time, and at any rate you would expect some percentage of the experimental group to get at least somewhat better after 6-9 months; to openly embrace the post hoc fallacy by claiming it was due to your device simply because something happened (as if nothing would have happened without the device - when we know patients change naturally), is nonsense. (Based on the company’s reasoning, it would be equally valid to claim that the device prevents improvement in 70% of patients!) Again, this is indistinguishable from fraud.
Even ignoring the company’s outrageous behavior, however, that an FDA Director overruled the scientific panel, and in such an egregiously obvious case!, is worse yet. It’s hard to tell what motivation this Director would have had - it doesn’t appear to be a case of pandering to the right wing, as with Plan B - and there is yet no reported evidence of payoffs or conflicts of interest. But clearly something went very wrong on this case, and clearly, too, the FDA has become the kind of organization at which such things can and do happen.
Once that would have been unthinkable. Under the current administration - anti-science, pro-business, and with a conviction that truth is what you say it is - it appears to have become policy.
Kathryn Hinsch makes a good point at the Women’s Bioethics Project blog:
Much of the “assisted death” debate gets reduced to two questions: “Do people have a right to commit suicide?” and “Should we allow physicians to assist in hastening death?” But before we tangle with those tough public policy questions, it is important to ask “how might people’s different life circumstances impact the issue?”
Looking at these questions from a gender perspective will be imperative as we move forward in crafting new laws. There are some key facts that make a woman’s end-of-life decision quite different from a man’s—women on average live longer than men. Additionally, women are more likely to be impoverished, receive inferior health care, experience poorer pain relief, and are two times as likely to suffer from depression as men. Women, who have often lost their life partner by the time they face debilitating disease, may feel a stronger cultural pressure not to be a burden on their families. All these factors must be considered when crafting a policy to allow “physician assisted death.”
Looking at gender implications is just one step in a thorough public policy analysis of this issue. We also must look at the implications of physician assisted death for disabled, poor, and minority populations. From some groups, the fear that death with dignity could quickly lead to duty to die is not an unfounded fear and something we must be vigilant to prevent.
She’s right that it’s traditional to boil bioethics issues down into clashes of abstract principles. Feminist philosophers in particular have been invaluable in demanding “thick descriptions” of cases, to situate them in a fuller human context and identify the systematic inequities and pressures that impinge on the people affected. Just as career opportunities turned into the double burden of a full-time job plus sole responsibility for homemaking, for many women, the “empowerment” of autonomy may merely mean the reduction of support systems in the healthcare setting if the real burdens people face are not kept in mind.
As someone who is partial both to strong autonomy rights and to the “airy principlist” approach to ethical problems, this is a useful reminder that principles do not play out in real lives the same way for everyone. The practical impact of general principles must always be the touchstone for practical policymaking.
I have here a “blast fax” - one of those spam fax that spew out of your own fax machine overnight at your expense. This one is from some no-name stock market tout, puffing the latest greatest thing. Normally it would be trash, but just as I was crumpling it up I happened to notice some of the buzzwords. You don’t get a whole lot of bioethics stock recommendations.
Stem Cell Research Without All the Controversy! . . .
It seems like for every positive application scientists believe will come from [stem cell] research, moral issues counter them. If only there was some way to bypass the moral issues and allow this life-saving research to continue . . .
That’s precisely what [Worthless Biotech Company] offers. [Worthless Biotech Company] is the emerging leader in a radical new process of collecting, processing and storing of stem cells from something called cord blood. . . .
Stem-cell research could lead to treatments for two-dozen degenerative diseases such as cancer, heart disease, Alzheimer’s and Parkinson’s disease. . . . [Worthless Biotech Company] is at the forefront of saving lives - which translates naturally to a healthy profit. . . .
And so on. Excitingly, the “analyst” is predicting a 500% increase in stock price over the next year!
The overhype is familiar to both the worlds of stem-cell research and penny-stock flogging (in particular, Alzheimer’s is widely agreed to be a poor candidate for stem cell therapy, but repeatedly comes up in discussion, even from people who should know better). And the casual observation that “saving lives . . . translates naturally to a healthy profit” says volumes about biotech as a business. This may be the first time I’ve seen ethical controversy cited as a distinct investment factor, however.
Looking further into this subject, though, I found almost exactly the same comment made by a more respectable analyst. Indeed, it’s hard to deny that public agitation surrounding a company’s technology would be a factor investors would be concerned about - it’s not unreasonable to base investment decisions on the presence or absence of such controversy. (Doing so can even be a form of activism, as witness the “divestment” campaigns aimed at various reprehensible governments.) But to see issues of great moral import appearing as line-items on an investment analysis summary somehow seems as startling as the equation of lifesaving and profit. What this tout sheet seems to imply is that there are investors scouring the biotech stocks for companies that occupy some specific niche at the intersection of new technology and low moral controversy - a form of “technical analysis” that even the most dizzy-eyed day trader has probably not considered.
I don’t know that I have any great moral lesson to draw from this. Seems odd, though.
It just occurred to me what it means to take some of the right wing’s wackier policies literally.
Among their most visceral phobias are gay marriage and “illicit” sex.
Across the nation, “abstinence only” policies are increasingly mandatory, and they are the official policy of the George Bush administration (beginning with his term as governor of Texas). Christian groups are increasingly outspoken against sex of whatever form - outside lifelong monogamous heterosexual marriage, that is. (Among other crusades, “abstinence” is the major part of the administration’s official policy on AIDS in Africa: they believe it is their business to tell adult Africans whether they may or may not have sex, not just legal minors in the US public school system. There is also some sort of weird vengeance movement afoot to nullify Michael Schiavo’s Catholic marriage to his long-time fiance, apparently as revenge for having thwarted the right wing’s designs on his late wife’s healthcare.) The point is clear enough: nobody falls outside their authority to dictate - mostly to prohibit - sexual behavior, and only religiously-defined marriages within the conceptual purview of their understanding of the “meaning” of those marriages is a valid context for sex.
And, of course, gay marriage is right out - no way, nohow, no circumstances.
Add them up and it means that the official policy on sexual relationships for adult gays - throughout their entire lives, no matter the circumstances or the relationships in which they find themselves - held by the evangelistic right wing is identical with that held by the Catholic church hierarchy: no sexual behavior of any kind whatsoever at any point in one’s life is allowable or deserving of respect or protection. (Note that this is Scalia’s position as a matter of Constitutional law.) You can only have sex if you are married, and gays may not get married - in both cases because the right wing wants it that way.
Aside from the perverse psycho-sexual discomfort and simple bigotry this betrays, its arrogance is breathtaking. It is astounding to imagine that other people’s most personal life choices are regarded as fair game for intrusive and coercive policymaking based upon nothing more than one’s own personal preference. Of course I realize how naive it is to say this - this is exactly the way policy has been made for decades, if not centuries, in the areas of heterosexual sex, birth control, abortion, gay sex, inter-racial sex or marriage, and on any number of other issues. It is obvious how much “irrational animus” drives the anti-marriage movement. It is surely no discovery of mine to carry those policies to their logical conclusions.
But when you consider the breadth of breathless Nosey-Parkerism the right wing considers its god-given mandate, the results can sometimes leave you reeling. The United States of America has, as its official foreign policy on one of the most significant international crises the world has ever faced, the position that adult Africans must be encouraged not to have sex? The US has any policy on whether adult citizens of other countries should or should not have sex? Who dreams up this crap? Who goes into foreign policy with the intent of regulating the sex lives of adult citizens of other nations? And finally, is there not a hint of “sex-crazed African savages” stereotyping caught up in this policy? At the same time, why is it the government’s business whether its gay citizens have sex or not? Why is it the government’s business, at all, whether or how anyone has sex? Is this an appropriate exercise of constitutional democracy in a liberty-loving country? Should we not ask why the functionaries of our government - in the midst of a budgetary crisis of their own making, a looming Social Security shortfall they are actively deepening, and the never-ending quagmire of what they persist in calling a “war” - are spending time and money dictating people’s sex lives?
One of the anti-abortion groups mentioned by MediaGirl (see post below) is CareNet of Texas. Their Web site offers a check-off box online screening test for “post-abortion syndrome” - you check any feelings or issues you may be having after having had an abortion, and they tell you your risk of exhibiting this “syndrome”.
Aside from the dubious professionalism of offering an anonymous, online questionaire of vaguely-worded generic items as a real pyschological exam, it is especially odd to see a screening test for a “condition” that doesn’t actually exist. The “post-abortion syndrome” nonsense has been floating around for decades now, repeatedly debunked, but never eliminated from the armamentarium of the quacks and propagandists who seem to gravitate to the anti-choice brigades. Famously, Surgeon General C. Everett Koop stated decisively that there was no such “syndrome” detectable in the clinical literature after President Ronald Reagan practically ordered him to find one. The American Psychiatric Society’s official policy position is that abortion rights are an important aspect of mental health; even a splinter group of psychiatrists opposed to abortion officially holds that it is simply not an issue for psychiatry, not that it is psychologically dangerous. The American Psychological Association has officially published a book on the sociology and psychology of the abortion conflict that concludes - citing recent research - that abortion is not a mental health threat.
But why heed longstanding and documented research results? Apparently, if you really, really believe something, you can just claim it is true - even down to the level of naming and testing for psychological illnesses that no one but your ideological compatriots even believes exists.
And the test?
The “Post-Abortion Stress Test” consists of a panel of 42 check-boxes labeled with a grab-bag of feelings, behaviors, or things you might “feel unc0mfortable with”, including such highly specific diagnostic predictors as “guilt”, “disappointment”, “trouble sleeping”, “helplessness”, “hopelessness”, “avoiding sex”, “having multiple sex partners”, “weight gain/loss”, and “crying” (as well as a host of more specific “symptoms” specifying various terrors of having an abortion, such as “fear of harming my other children” and “fear of God’s punishment”). Apparently, you’re crazy after having an abortion unless you are neither hopeless nor helpless, have neither gained nor lost weight, and have had sex with exactly the right number of people (whatever number that might be); you might still, of course, go whacko and kill all your kids, or God might do it for you, so you’d better watch out for those just in case.
Having checked off whatever among this list of common feelings you personally might have experienced (no timeframe is specified), you can click a button to “Take the test” and receive your diagnostic score: a pop-up box appears telling you how many of the checkboxes you marked, and what the mental health implications of this might be. In every case, the box reads:
You have checked X symptoms, and may have a ______ form of post-abortion stress.
The “X” corresponds to the number of your check-marks, and the blank is filled - in every single case - with either “mild”, “moderate”, or “severe”. Checking even a single box prompts the “diagnosis” that you “may have a mild form of post-abortion stress.” Checking anywhere up to 5 boxes gives the same result; check 6-15, inclusive, and you are told you may have a “moderate” form of post-abortion stress; anything over 15 puts you in the “severe” category. (The different “symptoms” do not appear to be weighted for relative seriousness.)
Of course, some people have no adverse effects at all following abortion. Surely having no symptoms would be a sign of health, right? What if you leave all the boxes blank and just push the “Take the test” button?
You have not checked any symptoms, but may still have a mild form of post-abortion stress.
Yes, post-abortion stress syndrome is stranger than you thought! It’s not just a non-existent illness - it’s a non-existent illness that it’s impossible not to have! (And why not? In view of the crying, sleeplessness, helplessness, and completely unsatisfactory sex life, it’s obvious that I have post-abortion trauma syndrome, certain disconfirmatory biological pre-requisites notwithstanding.)
To be fair, these “diagnoses” are, strictly speaking, accurate: you may have almost any condition, so I suppose you may have this one too (if we indulge a bit of metaphysical stretching to imagine that you may be the subject of a predicate that doesn’t actually apply to anyone). But if we are to take this diagnostic nonsense seriously - if we are to take these CareNet people as seriously as they ask us to - we can’t believe this is anything but the most idiotic manipulation. And that of course is precisely what it is - the continued insistence on bogus “psychology” that has been repeatedly denounced even by anti-choicers, the pseudo-scientific “screening test”, the absurdly vague “symptoms” and a diagnostic standard that it is impossible not to meet, coupled with the pervasive stereotypically anti-choice language (”child”, “baby”, “victim”, and repeatedly negative images of abortion, sex, and non-motherhood) makes it clear that this is no more than a propaganda tool intended to create discomfort with abortion. After diagnosing every person who takes the “test” as mentally disturbed, the pop-up boxes in every case give the phone number of the anti-choice center, for further information. The test is simply a recruiting tool for their real anti-choice suasive pressure - but they never drop the guise of actual psychological legitimacy.
This is a compounded fraud - fraudulent information packaged in a fraudulent professional setting for misleadingly manipulative purposes. So much anti-choice information is of this kind, but there seems to be no accountability for it.
Mediagirl does an excellent job surveying ongoing coordinated campaigns to propagandize against abortion, and the links many of them have to aggressively proselytizing Christian groups (often taking advantage of federal funding).
I don’t usually do “link only” posts, but this is an important topic and she covers it better than I could. Go look.
The FDA has instituted a much-publicized “voluntary” program, involving manufacturers, doctors, and - whether they like it or not - patients, aimed at preventing birth defects resulting from use of Accutae (isotretinoin ) for severe acne.
[A]s of the beginning of this year, the companies that make isotretinoin, together with the Food and Drug Administration, have imposed mandatory prescribing rules. Any woman of childbearing age who is given the drug must meet several requirements. Before starting the medication she must have negative pregnancy tests two months in a row. While taking it, she must either promise in writing to abstain from sex with a man or else use two forms of contraception, one of which must be a highly effective kind like birth control pills or the injectable Depo-Provera. Each month during her treatment (usually five months) she must take a pregnancy test. And she must document every step she takes by logging onto iPledge, a national online database.
The new rules are meant to prevent isotretinoin-related birth defects once and for all. But the rules are so strict, some doctors say, they might discourage or even prevent many patients from using the drug, the only treatment that can erase severe acne. Many dermatologists say the iPledge program is overkill.
“It’s one of the worst things that’s happened to our specialty,” said Dr. Ranella Hirsch, a Boston dermatologist who is the vice president of the American Society of Cosmetic Dermatology & Aesthetic Surgery. “We’re taking a very good drug that is for many people the only real choice out of reasonable access.”
The risk is real: first-trimester fetal isotretinoin exposure often causes a suite of severe birth defects including hydrocephaly, microcephaly, cleft palate, mental retardation, and developmental abnormalities; it often causes spontaneous abortion or infant death. Prior to the “iPledge” registration program, Accutane access was controlled through an aggressive patient-education program that involved repeated pregnancy testing and a sticky label placed on prescriptions to indicate to pharmacists that testing had been done and the patient was not pregnant. The program significantly reduced pregnancy rates among the user cohort, but not to zero. Mama’s Health has a good summary of the best available study on the matter:
Shortly after the Pregnancy Prevention Program began, Roche sponsored a survey of women taking Accutane to assess compliance with the program, and the company encouraged doctors to enroll patients. Run by the Slone Epidemiology Unit at Boston University’s School of Public Health, the survey set out to track pregnancy rates and outcomes, patients’ awareness of risks, and patient and physician behavior.
Of the 500,000 women enrolled in the Slone survey from 1989 to 1998, there have been 958 pregnancies, 834 of which were terminations (either elective, spontaneous or due to ectopic pregnancies), 110 that resulted in live births, and 14 patients that had unknown outcomes. Of the 60 infants with available medical records, eight had congenital abnormalities. Since Accutane’s approval, Roche has received close to 2,000 reports of Accutane-exposed pregnancies, 70 percent of which occurred after the PPP began.
According to FDA, exactly how well the PPP has worked is unclear. Experts say the PPP is a significant program that has prevented many pregnancies and is the first of its kind initiated by a pharmaceutical company. Roche has made extraordinary efforts to educate patients that they must not become pregnant while taking Accutane, says a Roche spokesperson.
At a September 2000 meeting of FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee, a Roche representative reported that from the company’s perspective, pregnancy rates have declined. Amarilys Vega, MD, an FDA medical officer, agreed. However, because use of the product has increased over the years, the actual number of pregnancies occurring while taking Accutane has not declined. One limitation is that the survey is voluntary and only captures about 30 to 40 percent of all patients on Accutane. So there’s no way to know exactly how many pregnancy exposures there have been, according to FDA experts.
The FDA makes the point that compliance rates among women who did not respond to the survey may not be the same as among those who did (meaning you cannot simply extrapolate from the 30 - 40% response rate to get a total figure). This is a good point, but, still, as a ballpark we are looking at something like 3,000 pregnancies, and maybe 50 congenital birth defects, over a 10-year period under the voluntary-compliance regimen. Double those numbers and they’re still small.
For comparison purposes, we can look at Trisomy 13, a (usually) spontaneous chromosomal abnormality with clinical results very similar to those of Accutane teratogenicity. The CDC estimates its prevalence is 1.3 per 10,000 live births, and the annual number of cases is about 530. This prevalence is vastly lower than that of Accutane-linked birth defects (about half of live births), but only because the latter are so commonly aborted. In absolute numbers, the prevalence is something like 100 times as high - yet we almost never hear anything about Trisomy 13. (It’s #17 on the CDC’s list of the 18 most-common sources of birth defects - not all of which are life-threatening.)
Obviously, the two situations are not comparable, because there is no easy way to prevent trisomies, and there is no situation in which it is known that they are particularly likely to occur. Thus, imposing heavy-handed preventive regimens on women “at risk” for that condition is not an option. But it is interesting that a nation-wide, mandatory, sexual-behavior-registration program is being imposed for a potential condition that results in so vanishingly few cases, compared with the natural rates of birth defects that are not even visible as national health problems.
Whenever women’s sexuality enters the health-policy picture, under the current administration and under this FDA, we are forced to consider ulterior motives as likely policy drivers. The utterly bizarre history of OTC emergency-contraceptive approval is all the proof needed. In that light it is suspcicious - in a way it might not be under a more rational and professional regulatory regime - how perfectly a number of hot-button ideological factors line up on this issue:
Speaking somewhat cynically, it’s as if they mixed up the worst aspects of abortion restrictions, “conscience clauses”, Taliban-style denial of women’s healthcare, Margaret Atwood-style sexual slavery, and “for the children” emotionalism into a slurry of rejectionist thinking about women’s sexuality and women’s healthcare. The Web site and multiple stages of sexual monitoring look uncomfortably like a slut registry, while their persistent touching faith in abstinence vows as a guaranteed prevention for pregnancy continues unabated. The total absence of any sense of proportionality - the idea that any level of birth defects, no matter how small, is worth a persistent, painful infection resulting in disfiguring scarring for tens of thousands of women per year - further betrays the ideology that makes such policies seem reasonable: the ideology that holds that no benefit to any number of women is worth any harm to even one fetus.
It is hard not to think that the issue of abortion creeps into this decision as well. Given the almost immeasurably-small level of birth defects recorded during the monitoring program, it is possible to suspect that what this program really aims to prevent is not the 5 birth defects per year but the 250 abortions. It is not clear how many of those were elective, but no doubt a large fraction were. And it is a certainty as well that those incidents were regarded not as adjunct therapies serving to further reduce the incidence of birth defect from Accutane, but as added “tragedies” swelling the death toll from the drug. So the apparent purpose of this policy - as we cannot avoid suspecting - is not simply to prevent women from conceiving fetuses with some probability of birth defects, but rather to prevent women from conceiving fetuses they would then be likely to abort.
Perhaps this is too cynical. Perhaps the crafters of this policy sincerely felt that reducing birth defects from 5 per year to something closer to zero was justification enough to impose an extensive and intrusive monitoring regimen on up to 100,000 women per year - even if likely driving significant numbers of them away from the only drug that can cure their ongoing infections and prevent life-long scarring. Perhaps this was “for the children” thinking in its more benign aspect, and not by way of using children as a weapon against the women who bear them. And perhaps the program will even work - most women will choose to comply, pregnancy rates will drop near zero among Accutane users, and the slut registry will not be breached or misused. But I find it curious that it is so easy, and so readily seized upon as policy, to make the most onerous inroads on women’s health whenever they are found engaged in “non-approved” sex, or whenever a (potential or even imaginary) fetus raises its tiny head.
As the Olympics near, the question of performance-enhancing procedures for athletes gains social salience. MSNBC has run two articles recently on the ethics of performance enhancement, one by venerable mediagenic bioethicist Art Caplan, and the other addressing biotech advances that may allow new forms of enhancement.
The biotech article really caught my attention. It discusses the possibility of somatic-cell genetic engineering as a means of performance enhancement - perhaps to boost operation of erythropoietin-making genes (to increase oxygen-carrying capacity of the blood), or to provide other, unspecified advantages. According to the article, experts believe the scenarios are closer on the horizon than I had imagined:
In March of 2002, the World Anti-Doping Agency (WADA) . . . met with genetic scientists to ask if athletes and their handlers would soon be altering their very genomes in an effort to soup up their performance. Was the age of the genetically-enhanced athlete upon us?
The meeting resulted in a good deal of speculation and public fretting, both by pundits and by WADA. But much of that fretting, said experts in genetic science, was misplaced. Using genes to enhance athletic prowess was still far away.
The second meeting to assess the future of genetic tinkering in sport was held in December in Stockholm, but now, says Theodore Friedmann, one of the world’s leading experts on gene therapy to treat disease and the chairman of WADA’s gene-doping panel, “I’m not so sanguine as I was that this is far off in the future.” Scientists studying genetics, Friedmann reports, “often say they are approached frequently by athletes, trainers, entourage-type people asking what is available.”
Still, all that proves is that athletes are motivated. But is the technology really ready?
Probably not, but, says Larry Bowers, the senior managing director of technical and information resources for the United States Anti-Doping Agency (USADA), the sports world has its eye on the Beijing summer games. “By 2008 there may be tempting possibilities. That might be the time we really need to be more concerned.”
2008 sounds pretty damn close to me. Recognize, also, that there is at this time not one single somatic-cell genetic therapy in clinical use, even against seemingly-tractable conditions such as sickle-cell anemia or cystic fibrosis. The few therapies that have been tried have shown limited results and often came with horrendous side effects. If they are seriously talking about potential performance-enhancing technologies in less than two years - presumably procedures that have gotten far less research attention than have cures for genetic diseases - that suggests remarkable breakthroughs very close to completion. But whenever it happens, it will surely happen. The question is what to do about it.
For obvious reasons, genetic enhancements are being treated as a form of illegal “doping” - the “drugs” in question apparently being the poly-peptide products of engineered genes. The real parallel, of course, is the common theme of “tinkering” with the body to increase the performance available from the inborn “hardware” alone. If blood-doping or erythropoietin injections are illegal - using substances naturally occurring in the body, or even produced by that athlete’s own body - then it is not so far a stretch to suggest that taking advantage of proteins produced by and remaining within the body should also be illegal, where those proteins are the direct product of technological interventions far more intrusive than mere blood transfusion.
However, I think we are entering territory in which we are forced to split hairs more and more finely. What if - to take a hypothetical, and likely impossible, example - an athlete has a naturally-inherited genetic condition that produces a certain substance when and only when (as in the case of PKU) the athlete eats a certain diet, and this substance happens to be highly performance-enhancing? Would the athlete be prohibited from eating that diet? What if it was a very strange diet that no one would likely eat, and that has no nutritional benefit, other than in the case of possessing this enhancing allele - would the athlete then be allowed to engage in a practice that clearly serves only to provide a unique genetic benefit?
The MSNBC story recounts the history of Eero Mantyra, a Finn who owned Olympic cross-country skiiing in the 1960s; he had a genetic mutation of his erythropoietin gene that gave him a much higher-than-normal red cell count. No one questions that he was entitled to compete and win his medals; in fact, the mutation story laid to rest rumors that he had been blood-doping. But that is the oddest fact of all: he was entitled to compete with an abnormally high hematocrit resulting from a natural genetic mutation, but would have been severely punished for competing with the same hematocrit resulting from a transfusion of his own blood; now, apparently anyone else will be prohibited from competing after using genetic engineering to acquire the same genetic mutation Mantyra had