Friday, December 10, 2004

Keeping Teenagers Out Of Clinics

Jordan Barab, who apparently knows exactly what it takes to get me frothing at the mouth in incoherent fury, called my attention to this Effect Measure post about Texas laws limiting adolescents' access to reproductive health care.
Some teenagers tell their parents everything. Some tell them nothing. They want none of that in Texas. In an effort to discourage adolescent sexual activity, Texas lawmakers have passed a law that requires parental consent for girls under 18 to receive prescription contraceptives. There is more. Health care providers must report to law enforcement officials the identity of patients 17 and under who seek reproductive health care services since sexual contact with a person of this age is illegal in Texas.

Only someone brain dead would expect such a policy to have much effect on teenage sexual activity but you can be pretty sure it will have an effect on care seeking behavior in this age group.
My first reaction, after all the swearing, was, "Why the hell haven't I heard anything about those laws?" And my shock deepened when I learned that the laws date to 2003 (for the contraceptive prohibition) and 2001 (for the mandated reporting of adolescent sexual activity). I did discover, at least, that the law mandating reporting of sexual activity only applies when the partners are at least three years apart in age.

The Guttmacher Institute has released two excellent reports examining the issue of parental consent for minors seeking health services. Most states exempt reproductive health services from parental consent laws based on the assumption that it may discourage minors from seeking needed treatment. And research suggests that it does - a 1999 study published in the Journal of the American Medical Association found that a substantial percentage of adolescents have avoided seeking health care because of confidentiality concerns, and a 2002 study found that 47% of adolescents receiving reproductive health care services at public clinics stated that they would no longer seek health care if their parents were notified. (A much, much, much smaller minority said that they would stop having sex.)

A recent Texas study attempts to put a price tag on the public health costs that would result from adolescent girls abandoning reproductive health services as a result of the changes to Texas law. They estimate that approximately 37% of girls currently receiving care would no longer do so, and report:
This would result in an additional 11.45 pregnancies, 7.44 births and 2.29 abortions per 100 teenagers, costing approximately $61,000 per 100 girls.

Also, the estimated increase in sexually transmitted diseases would cost $980 per 100 teens.

The projected overall cost is approximately $43.6 million per year, Franzini's team reports. Even so, that figure underestimates "the true costs to society because they include only direct medical costs,"
Even the direct-cost estimates seem low to me, actually, because they don't figure in increased costs from pregnant adolescents avoiding prenatal care. Lack of prenatal care is strongly related to an increased risk of birth complications and poor infant health outcomes - and yet, if you're a pregnant 16-year-old who knows the obstetrician will be required to report you to the police for getting pregnant, those distant health outcomes probably aren't as much on your mind as the hell that will break loose at home if the police show up at your door.

Texas isn't alone in its use of statutory rape laws to discourage consensual sexual activity by minors: in 2003, the Attorney General of Kansas issued an opinion that health care providers must report to law enforcement anyone under the age of 16 who seeks an abortion, prenatal care, birth control, or STD treatment. Fortunately, the Center for Reproductive Rights has been able to secure an injunction preventing the Kansas directive from going into effect while a challenge works its way through the courts.

There's no doubt that some teenaged girls are preyed upon by much older partners. Research indicates that the younger a girl is when she first has sex, the higher the likelihood that her partner is not another adolescent, but an adult. One study found that, among pregnant 15-year-olds, 40% had been impregnated by a man who was at least 20 years old. (Age gaps tend to be significantly smaller for older teenagers.) Age of consent laws, when applied with careful discretion, can be an important tool in protecting girls from exploitation by adult men. And there have been a few shocking, high-profile cases in which reproductive health clinics failed to protect girls who quite obviously needed help. For example, in 1998, an Illinois clinic failed to report a 37-year-old teacher who brought his 14-year-old student and sexual partner in for birth control.

But the Texas law and the proposed Kansas legal interpretation leave no room for discretion. The result is actually less protection for exploited minors, not more:
Peggy Romberg, CEO of the Women's Health and Family Planning Association of Texas, notes that statutory rape reporting among family planning providers has gone up substantially because of changes to Texas law. As a result, law enforcement agencies have been inundated with reports, with most ending up in file drawers with no action taken. "Historically, we [family planning providers] have been the partners of law enforcement agencies in identifying and reporting actual sexual abuse of teens, including by inappropriate adult partners. When we filed a report, law enforcement agencies took it seriously. Now that we are no longer allowed to exercise our discretion, there is a lot more reporting going on, but the police are ignoring most."
In 1977, the Supreme Court affirmed minors' rights to access contraception and other reproductive health services in Carey v. Population Services International. The majority ruled that
(a) The right to privacy in connection with decisions affecting procreation extends to minors as well as to adults, and since a State may not impose a blanket prohibition, or even a blanket requirement of parental consent, on the choice of a minor to terminate her pregnancy, Planned Parenthood of Missouri v. Danforth, 428 U.S. 52, the constitutionality of a blanket prohibition of the distribution of contraceptives to minors is a fortiori foreclosed. Pp. 693-694.

(b) The argument that sexual activity may be deterred by increasing the hazards attendant on it has been rejected by the Court as a justification for restrictions on the freedom to choose whether to bear or beget a child. Eisenstadt v. Baird, 405 U.S. 438, 448; Roe v. Wade, 410 U.S. 113, 148. Moreover, there is substantial doubt whether limiting access to contraceptives will, in fact, substantially discourage early sexual behavior. When a State, as here, burdens the exercise of a fundamental right, its attempt to justify that burden as a rational means for the accomplishment of some state policy requires more than the unsupported assertion (appellants here having conceded that there is no evidence that teenage extramarital sexual activity increases in proportion to the availability of contraceptives) that the burden is connected to such a policy.
The Supreme Court has repeatedly ruled (for example, in Belloti v. Baird and Ohio v. Akron Center for Reproductive Health) that parental notification or consent requirements for minors seeking abortions must be accompanied by a judicial bypass procedure through which minors can avoid involving their parents. The Texas birth control law includes no such bypass; as such, given Carey v. Population Services International, it is probably unconstitutional. Right now, Texas reproductive health care providers are getting around the law by directing all of their federal family planning funds (also known as Title X funds) towards services for adolescents. Title X services have confidentiality mandated by federal law and cannot be superceded or restricted by state laws. Still, that's only a temporary solution. The confidentiality of Title X services is constantly under threat; efforts to undermine Title X are a common pet project of social conservatives. So hopefully, a Supreme Court challenge of the Texas law is underway. Fast. Before Bush gets a chance to put anyone on the Supreme Court.

Tuesday, December 07, 2004

Playing Connect-The-Dots

It's funny how news stories look completely different, sometimes, when you string them together in a line.

Garance Franke-Ruta brought my attention to a David Brooks column in which he waxes rhapsodic about a phenomenon he calls "natalism," in which white people move to the suburbs and have babies. (As Slacktivist points out, this is supposed to be a novel phenomenon?) It turns out, from what I can gather from Brooks's column, that only white suburbanites really find parenthood "enriching and elevating" in a spiritual sense. Seriously: Brooks makes it clear that he's only talking approvingly about higher white fertility rates. (Garance did the work of tracking down the white supremacist Brooks cites, so, mercifully, I don't have to.)

It also turns out that these white suburban "natalists" tend to vote Republican. Brooks suggests that this is because, when people become parents, they are driven to protect their children from pernicious influences like Janet Jackson's boob and the First Amendment.

But I got to thinking about another interpretation, based on a chart I'd seen at Daily Kos, just yesterday. It turns out that, in addition to carrying "the 19 states with the highest white fertility rates, and 25 of the top 26," Bush also just happened to carry 20 of the top 21 states with the highest teen pregnancy rates. And in addition to winning the "16 states with the lowest [white] fertility rates," John Kerry also won 14 of the 16 states with the lowest teen pregnancy rates. Hmm. Suddenly Red-State "natalism" seems a lot less desirable.

(And why is the teenage birthrate so high in the Bible Belt? Maybe because of the questionable things they're learning in those popular Red State abstinence-only sex ed classes.)

But the mention of classes reminds me of yet another well-known difference between Red States and Blue States. (See what I mean about how these news stories cascade, in my head?) Kerry mostly took the 10 states placing the highest value on education, while Bush took most of the bottom 10. We know that women who are more highly educated have fewer children than women with less education. In fact, worldwide, the education and empowerment of women is one of the strongest predictors of fertility rates. Put simply, women who have more options, more freedom, and more social power have fewer children.

(What's the moral pointed out in that abstinence-only curriculum, again? "Occasional suggestions and assistance may be alright, but too much of it will lessen a man's confidence or even turn him away from his princess." Because, apparently, if you're going to keep the birth rate up, you've got to keep the women down.)

My research also came up with the grisly statistic that infant mortality is 57% higher in Red States than Blue States. I don't think I want to poke at that one any more closely, except to say that high infant mortality rates and higher fertility tend to co-occur.

So the more I poke at Brooks's assumption that higher fertility rates, excuse me, higher white fertility rates say something good about Bush states, the less justified it seems. I'm not saying that I've got the definitive explanation for why birth rates are higher in Bush country, but it does seem likely that it involves something less sweet and simple than a starry-eyed belief in parenthood as "enriching and elevating."

But that may just be me: barefoot, pregnant, and hanging my Ph.D. diploma on the wall of an urban Blue State home. What do I know about natalism?

Monday, December 06, 2004

Roz Kaveny shares a heartening story today. Apparently, a prominent conversion ministry and "ex-gay" organization in Britain has had a radical change of heart:
Our non-negotiable view regarding homosexuality, promoted the belief that ‘the answer’ was either to be found through the possibility of change-’to become heterosexual as God intended’, if this was the heart’s desire of the person seeking help, or at the very least to live a celibate life. We believed such objectives could be realised through a lifestyle of ongoing repentance, devotion to Christ and a willingness ‘to deal with the deeper issues’ (e.g. abuse, rejection, lack of bonding to the same-sex parent, etc.). [...]

After ten years, however, six spent running residential discipleship courses, followed by years of weekly group meetings, it was increasingly clear that however repentant people were, and however much dedication and effort they put into seeking change, none were really ‘successful’ in the long term in ‘dealing with the deeper issues’. This is not to say that people gained no benefit! Many matured greatly. A few married (though their same-sex attractions remain an ongoing issue for them). But the kind of change everyone really hoped for – to re-orientate and reach a point where their struggle with being gay was over – remained elusive. We never saw the fruit we longed for. [...]

Clearly the sense of alienation from God (and from themselves) that many lesbian and gay people have experienced, also the guilt and shame, has contributed nothing to godly living, never mind healing. So how can we, with any integrity, proclaim a message of ‘healing’ from homosexuality if God is not supporting it? Moreover, I do not see what scriptural basis we have for doggedly insisting that any and every form of erotic expression outside monogamous heterosexual marriage is sinful.

Everyone needs to know the unconditional love of Christ; gay people are no exception. While it may be argued that pursuit of ‘casual sex’ calls for repentance, from years of persistent prayer and Bible study, I’ve concluded that there is scope in scripture for acceptance of committed, intimate same-sex relationships. This is not an ‘anything goes’ approach-anyone seeking to be Christ-centred will naturally yearn to find a basic moral framework and ethos for gay and lesbian relationships.

By the year 2000, it had become clear that God was requiring of our ministry a marked change of attitude, outlook and policy.
As a psychotherapist and as a person of faith, one of the things that keeps me from despair is my belief that change is always possible - that no matter how hopeless a situation appears to be, the people within it can change. Some days it's easy to believe that. Some days it's harder.

These folks prayed for a healing change, and it came to them in a form that was utterly unexpected. They had the courage to embrace it anyway - even knowing that it would separate them from some of their strongest supporters. Good for them! They restore my faith in human possibility.

Saturday, December 04, 2004

More Human Guinea Pigs

Several people (for example, here) have criticized my last post as paying insufficient attention to the charge that children were being removed from parental custody if parents declined to participate in research. Re-reading my original post, I can see how it might be read by someone who doesn't know me as, "AIDS clinical trials are good, so it's okay that people were forced into them." Of course that's not what I meant to convey at all.

Take a look at the full transcript of the documentary. I read it through, trying to find an example of a parent or guardian who lost custody for refusing experimental participation. There are two candidates: the story of the guardians of a child named Garfield, presented in the first five minutes, and the story of the nurse Jacklyn Hoerger, which is covered at length in the second half of the documentary. Let's look at both of them closely, plus a third story in one of the Liam Scheff pieces that served as source materials for the documentary.

According to the transcript, Garfield's aunt and grandmother had concerns about side effects of his prescribed medications, so they stopped the meds. At the urging of his doctor, meds were re-started. When the family asked the doctor if they had any other options, he suggested that they could enroll in a clinical trial. They refused, and (again, according to the transcript):
Regina’s daughter took Garfield off all medication. Almost immediately his health improved. Then there was a knock on the door.
In other words, this family didn't lose custody for refusing to participate in the clinical trial, they lost custody for refusing to provide Garfield with any medical treatment whatsoever for HIV. The family says "his health improved" off meds, but anyone familiar with the course of HIV knows that labwork tells the true story. If the child's CD4+ cell (T-cell) count were declining rapidly, for example, then it would be perfectly reasonable for his physicians to believe that withholding all treatment constituted medical neglect - and to report it to the state authorities.

The Liam Scheff article carries a similar story about a great-aunt who withheld all conventional medical treatment from her HIV-positive wards, instead taking them to a naturopath. Again, this was not a case in which she lost custody for refusing to participate in clinical trials, it was a case of refusing all conventional, approved, treatments for HIV. (She says she refused "AZT, Nevirapine, Epivir, Zerit," the latest of which was approved in 1996. The children were taken from her custody four years ago.) One of the children subsequently participated in a clinical trial at Incarnation Children's Center, but no details are given as to the nature of the study. Participation in a clinical trial might involve an experimental drug or combination, but it also might involve something as trivial as a change in dosage times - for example, testing the efficacy of once-a-day Epivir over twice-a-day Epivir. In any case, there is no suggestion whatsoever that she lost custody for refusing participation in clinical trials. She lost custody for refusing to treat the children with any approved HIV medications at all.

Jacklyn Hoerger's story takes up almost half of the BBC documentary, and more details are given in a Liam Scheff profile. The profile makes it clear that Hoerger also stopped all medications for the children in her care. Not experimental medications - the only drugs she mentions by name are Nevirapine and AZT, both FDA-approved before the children came to live with her in 1996 - but all medications:
I was looking for answers, so I went to a lecture on HIV by Philip Incao, an MD with a background in Holistic Medicine. He talked about problems with the HIV diagnosis, the toxicity of the drugs and their effect on the immune system. What he said made me feel angry and threatened.

I confronted him after the lecture. I said, “I have two HIV positive children in my home right now, and you’re recommending that I take them off the drugs?” He said “Yes” “The drugs are too toxic for children.” He said that he had a better way to treat them and to strengthen their immune systems. He told me to read the book “What If Everything You Thought You Knew About AIDS Was Wrong,” by Christine Maggiore.

I read the book, and I spoke with medical professionals who all advised me that the drugs were harmful. I researched the drugs myself and reached the same conclusion. And for a good number of months, I struggled. I knew that Catholic Home Bureau and ICC wouldn’t support this, even if it was the best thing for the children’s health and survival. I had long consultations with Dr. Incao about what complementary and holistic medications to give the girls to support their immune systems. And after a great deal of research and thought, I took them off the drugs.
Although Hoerger had begun the adoption application process, at the time that she stopped all treatment, she had not legally adopted the children - they were in foster care with her. That made the state their legal guardians, not Hoerger. So this case has nothing whatsoever to do with parental rights. The state had the legal responsibility to make sure those children got adequate medical care, because they were still wards of the state. It's hardly surprising that they wound up deciding that HIV-positive children should be cared for by people with mainstream beliefs about HIV. Consider the liability the state would be under - legal and moral - if the children had died from having FDA-approved HIV treatments withheld.

There seems to be no evidence that parents or guardians are losing custody of their children for refusing to participate in clinical trials. There is evidence that parents and guardians may lose custody for refusing all mainstream HIV care for their minor children. Again, as I said in my first post, one could have a legitimate discussion about the circumstances in which parents have the right to refuse medical treatment for children in their care. But it's simply inaccurate to say that these examples amount to children being taken away for the refusal to be "guinea pigs." Scheff and the BBC filmmakers have produced no evidence of that.

Friday, December 03, 2004

"Human Guinea Pigs?"

Apparently, on Tuesday night the BBC aired a documentary claiming that HIV+ children in foster care were used in horrific drug-testing experiments without the consent of their parents. The blogosphere is understandably aghast, hearing echoes of the Tuskeegee syphillis study or - worse - Nazi "medical experiments" involving the often-fatal torture of helpless victims.

I read the BBC article a couple of days ago, and it didn't sound right to me. Too much is missing - including anything that could be used to check the veracity of the story, such as the names of the experimental drug compounds or the names of scientists running the trials. Another detail that didn't ring true: the drugs were "supplied by major drug manufacturers including Glaxo SmithKline." Glaxo SmithKline is a major manufacturer of HIV drugs - I have several of their pens - but why the lack of specificity?

The language used in the BBC piece also seemed familiar. A vocal contingent of people oppose HIV medications, and they favor certain turns of phrase. "Human guinea pigs." "Experimental." "Toxic." They focus on side effects and subjective sensations to the exclusion of clinical or lab data. It's hard to pin down exactly, but when you've read enough of their writings you begin to recognize the tone. I heard that tone in the BBC article.

The story also broke my plausibility meter. Severely. I do research with human subjects for a living, and I have an excellent sense of the regulatory tangles and layers of oversight surrounding any research with human beings. For "protected classes" of research subjects, including children and institutionalized people, the rules are even more stringent. What happens when research protections are violated? Banner headlines and regulatory Armageddon. When a single research subject died at Johns Hopkins because of faulty study protections, the federal government didn't hesitate to shut down all human research of every kind at one of the foremost research institutions in the world. Gene therapy research was essentially halted nationwide for years because of a patient death which was linked to inadequate monitoring of research-related adverse events. Both incidents were widely covered in national news outlets, and they were everywhere in news sites for health research professionals. And yet there was not a word about the BBC documentary and its shocking allegations in Medscape or any of the other HIV sites I follow. That didn't seem plausible at all.

So I did some poking around, and instantly hit pay dirt. The documentary filmmakers state that:
We asked Dr David Rasnick, visiting scholar at the University of Berkeley, for his opinion on some of the experiments.

He said: "We're talking about serious, serious side-effects. These children are going to be absolutely miserable. They're going to have cramps, diarrhoea and their joints are going to swell up. They're going to roll around the ground and you can't touch them."

He went on to describe some of the drugs - supplied by major drug manufacturers including Glaxo SmithKline - as "lethal".
Dr. David Rasnick is an AIDS denialist. He doesn't believe that HIV causes AIDS. He doesn't believe that AIDS is contagious or sexually transmitted. He doesn't believe in protease inhibitors, the class of drugs which, since 1997, have caused a dramatic decline in AIDS diagnoses and deaths in the developed world. He thinks HIV drugs are the problem, not the solution.

The Guerrilla News Nework led me to some articles by a guy named Liam Scheff, which the BBC filmmakers purportedly used as the basis for their research. The GNN reprinted the BBC piece with a prefacing paragraph that listed some of the compounds in question: "chemotherapy drugs such as AZT, and potent cell-killing drugs like Nevirapine." (Perhaps those drugs weren't listed in the BBC piece because they would have diminished its shock value; AZT and nevirapine are well-established, FDA-approved HIV medications.) Scheff's articles make it clear that he's been talking exclusively to AIDS denialists like Christine Maggiore; he promotes the theory that HIV tests are wildly inaccurate and that naturopathic treatment is sufficient to prevent illness in HIV-positive individuals. Shocked by HIV drugs' potential for serious toxicities, he blames the medications for all the ills suffered by persons with HIV rather than balancing the risks of medication against the risks of untreated HIV. So there are gory color photos of Stevens-Johnson Syndrome, a rare but very serious medication side effect, but no pictures of untreated end-stage AIDS patients in Africa or from the pre-drug 1980s. There is no mention of the decline in death rates since protease inhibitors were introduced in 1997.

Scheff did document that children at the Incarnation Childrens Center participate in clinical trials, as large numbers of HIV patients do. There is nothing inherently wrong with conducting medical research with children - in fact, it is necessary. Medications proven to work in adults may not work the same way in children, so children need their own clinical trials. The law requires that children cannot be subjected to research-associated risks unless the potential benefit to the child far outweighs the level of risk involved. In other words, the vast majority of children who participate in potentially risky medical research are dying and otherwise out of treatment options.

That was particularly true in the late 90s, when many of these disputed studies apparently took place. At that time, participation in clinical trials was the only way to access new life-saving treatments like protease inhibitors. The existing treatments in the late 90s were highly toxic and largely ineffective, as you can deduce from the death-rate table I linked above. For many people, getting into a clinical trial rather than waiting for the protease inhibitors to be approved for release represented the difference between life and death. So, in that context, there's nothing inherently sinister about these children's guardians (the child protection authorities) allowing them to take part in clinical trials.

In summary, the BBC documentary appears to uncritically embrace the theories of AIDS denialists who believe that all HIV treatments are toxic. Their primary sources of information have no scientific or medical credibility. Neither the BBC piece nor the set of Scheff articles upon which the documentary was apparently based cite any mainstream experts in HIV or human subjects research - no appeal to the FDA, no experts from the National Institutes of Allergies and Infectious Diseases. They're not credible.

There is definitely a place for thoughtful argument about whether parents have the unrestricted right to withhold medical treatment from their children. There is a place for thoughtful argument about how to balance concerns about quality of life and treatment-related toxicity with the need for HIV treatment. But the BBC documentary and its source articles hardly provide that kind of thoughtful argument. Don't get sucked in.