Case of Justina Pelletier Spawns Dubious Legislation

The intersection of science and politics is a very murky area. While science can and should inform policy and legislation, those who try to legislate science can easily find themselves on shaky ground. To say that politicians ought to exercise great care when introducing legislation that affects the scientific enterprise is, perhaps, a slight understatement. That is especially true when they start trying to dictate what science is and is not allowed. It's even worse when the individual politicians behind the legislation have demonstrated by past behavior that they are, shall we say, science-averse.

That's the case with a recent bill that has been introduced into the House of Representatives by Minnesota's Rep. Michele Bachmann. I won't go so far as to say that Bachmann is crazy or insane, as I'm no psychologist and there's no need to pathologize her particular brand of nonsense, but she certainly has shown that she does not understand science and her conception of the world differs quite profoundly from reality. Whether it's on the subject of evolution, climate change, or vaccines, Bachmann regularly gets the facts wrong. Now she's wading into policy governing research by introducing a bill nicknamed "Justina's Law". In a related vein, Rep. Steve Stockman has introduced what he's calling the "Parental Protection Act". Both bills are vague and stand to do more harm than good.

A while back, I wrote about a bit of a to-do involving a young woman named Justina Pelletier, noting that much of the media coverage lacked an appropriate degree of nuance, with most reporting being very one-sided. While a judge ruled that she was to remain in state custody, she was eventually returned to her home state of Connecticut and her family after her parents finally agreed to her treatment plan. Her parents allege that while she was in the care of Boston Children's Hospital, she was being experimented on. That is a very serious allegation, and one for which I have not seen any evidence beyond Lou Pelletier's assertions that was the case. BCH has denied the claim, as reported by the Hartford Courant:

"At no time did Boston Children's conduct research on the patient in question," said Rob Graham, spokesman for Boston Children's Hospital, in a written statement Thursday. "The allegations that research was conducted on the patient are baseless and patently false."

As with much of the reporting on Justina Pelletier's experiences, we have little more than assertions and stories, and certainly no hard evidence. But that has not stopped the Pelletiers and a number of politicians from moving forward with legislation aimed at preventing such alleged experimentation on children who become wards of the state.

H.R. 4989  - "Justina's Law"

Rep. Michele Bachmann (R-MN)

Rep. Bachmann introduced H.R. 4989, a bill "To prohibit Federal funding of any treatment or research in which a ward of the State is subjected to greater than minimal risk to the individual's health with no or minimal prospect of direct benefit." A number of legislators have signed on to co-sponsor the bill, including such fellow scientifically-challenged representatives as Bill Posey and Darrell Issa. Justina and her family are also reportedly lobbying in Washington, D.C., to get it passed. What, precisely, would this bill accomplish? Certainly nothing that benefits children or promotes responsible medical research. The bill states:

No Federal funds may be used to conduct or support treatment or research in which a patient or subject is--
            (1) a ward of the State; and
            (2) subjected to greater than minimal risk to the patient or subject's health with no or minimal prospect of direct benefit.

The goal is to protect children who become wards of the state from being used as human guinea pigs. It's a good goal, but this bill does a poor job and jeopardizes the advancement of knowledge to help children. It also is not necessary.

Lets' start with the last bit first. Current human subjects regulations already address the issue of wards of the state. As the text states, federal funds would be denied for any research involving greater than minimal risks with no or minimal prospect of benefit to a ward who is a subject in the research. Yet wards are already protected by regulations governing human subjects research (see 45 CFR 46, Subpart D).

First off, there are the regulations that apply to all children, whether they are wards of the state or under the care of their parents:

§46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.

HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if the IRB finds that:

 (a) The risk represents a minor increase over minimal risk;

 (b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

 (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and

 (d) Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians, as set forth in §46.408.

§46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

HHS will conduct or fund research that the IRB does not believe meets the requirements of §46.404, §46.405, or §46.406 only if:

 (a) the IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and

 (b) the Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either:

     (1) that the research in fact satisfies the conditions of §46.404, §46.405, or §46.406, as applicable, or (2) the following:

     (i) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;

     (ii) the research will be conducted in accordance with sound ethical principles;

     (iii) adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in §46.408.

Any research that poses greater than minimal risk with little or no direct benefit to the subject must satisfy all of the requirements of either §46.406 or §46.407, as appropriate. But protections for wards go even further:

§46.409 Wards.

 (a) Children who are wards of the state or any other agency, institution, or entity can be included in research approved under §46.406 or §46.407 only if such research is:

     (1) Related to their status as wards; or

     (2) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.

 (b) If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.

Not only would any research targeted by this bill already need to meet the requirements that apply to all research involving children, but that research must also have particular bearing on children who are wards or take place in a setting where wards do not carry an undue burden. Furthermore, an advocate for the child must be appointed who is completely independent of the research and the organization(s) conducting the research. Violation of these regulations can lead to loss of federal funding or even revocation of authorization to conduct any research.

In addition to being unnecessary due to already existing protections, the bill threatens research that would benefit wards. By being overly broad in scope, federal funding for research into topics of particular interest to wards could be denied. Every effort should be taken to minimize, as much as possible, the risks to study subjects, especially when those subjects are from vulnerable populations. However, there are times when such risks are unavoidable if we want to improve the conditions or treatments available to wards. Especially when we are exploring new areas, the knowledge gained may benefit future generations, even if the subjects themselves derive no direct benefit. This bill would hamper such research efforts and potentially delay improvements in the lot of wards.

But research is not the only area in which this bill oversteps its bounds. Bachmann also targets treatments. While much, though not all, research can be conducted without resorting to enrolling wards, this bill poses a particular threat to their well-being in terms of treatment options. There are medical conditions for which few treatment options exist, and some of those can be a long-shot. For instance, some cancer treatments may have "minimal prospect of direct benefit" for the patient, yet are still the only option available. HR 4989 would prohibit, for example, Medicare/Medicaid coverage for those treatments, leaving the full cost of the treatment to the guardian. If the guardian cannot afford the medical bills, then the child may go without the medical care that they require.

H.R. 4518 - "Parental Protection Act"

Rep. Steve Stockman (R-TX)

Similar to Bachmann's ill-conceived bill, Rep. Steve Stockman was also moved by Justina's case to introduce equally bad legsilation. On his government web site, he discusses his motivation and goal. In doing so, he makes a number of mistakes. Let me address those before I get to his bill. First off, he writes:

Federal regulations prohibit medical experiments on humans that present greater than minimal risk with no prospect of direct benefit for the research subject.

This is not true. Federal regulations do permit human subjects research that presents greater than minimal risk without direct benefit for the research subject. If it did not, very little medical research would be done in this country and we would advance very slowly, indeed, in improving medical treatments. The regulations do establish certain requirements when the research does pose greater than minimal risk, but it does not prohibit it.

Next, he writes:

If a child is deemed a ward of the state, however, that legal protection does not apply.  The government is taking legal protections away from the very children declared most in need of legal protection.

Federal regulations governing human subjects research (45 CFR 46), as I noted above, actually puts more protections in place for children and even more on top of those for children who are wards of the state. I can't tell if Rep. Stockman just didn't bother reading the regulations before writing this or is deliberately lying in order to garner public support. Whatever is going on inside his head, he's wrong and ought to know better.

Now, on to the text of his bill, H.R. 4518 (his page has a typo, listing the bill as H.R. 4158):

The Department of Health and Human Services shall withhold all
monies from State agencies or entities, hospitals, and medical
facilities that--
            (1) allow research presenting greater than minimal risk to
        minors, juveniles, or wards of the State;
            (2) deny Fourteenth Amendment rights to the parents or
        child; or
            (3) investigate parents or charge them with medical
        neglect, or remove children from the parents' custody when in
        disagreement with a subjective diagnosis involving psychotropic
        drugs.

If anything, Stockman's bill is perhaps even worse than Bachmann's. Where Bachmann at least makes note of direct benefit to the subjects, HR 4518 focuses only on risk and expands the scope to all children, rather than only wards of the state. His first clause would ensure that medical research involving treatments for children stagnates, especially for rare diseases and conditions. Just about any new drug would pose greater than minimal risk and so, under HR 4518, would not be able to be studied.

His third clause is also bad news for children. Suppose a hospital or Child Protective Services suspects medical neglect or abuse. If they simply investigate the parents to find out if the suspicions are accurate or not, Stockman's bill would mean that the agency would no longer receive funds from the Department of Health and Human Services. For agencies where funding is already insufficient to provide for adequate staffing, that doesn't sound like a good idea. And that threat of decreased funding may very well mean that children who actually are being abused by their parents are not protected from their abusers. For hospitals, if I'm reading the legislation correctly, that would also mean the suspension of Medicaid/Medicare payments across the board. It doesn't make a distinction between Federal money used for a particular patient or treatment. If an organization violates this bill, all Federal funds would be withheld. That means the hospital doesn't get paid for the services they provide to their patients covered by Medicaid or Medicare. The money would then either come out of their operating budgets, with cuts to other services, or they would have to increase their prices, leading to a greater burden on their patients. Rising costs for health care are already a problem plaguing communities around the nation. Stockman's bill would just make that worse. As with Bachmann, Rep. Stockman takes far too broad a scope, actually jeopardizing protections for children and wards of the state and doing little with regard to parental rights. Indeed, he seems to care more about imagined assaults on parental rights than he does about the real rights of children. Much of what I said about HR 4989 also applies to HR 4518.

Justina Pelletier's case has generated a great deal of moral outrage from the public and politicians alike. Much of it has been fueled by speculation and hearsay, rather than by any actual evidence. And while I can understand what Bachmann and Stockman are trying to accomplish, they stand to do far more harm than good. What is worse is that these bills are built upon a potentially false premise: that Justina was subjected to unethical research, a claim for which no evidence has been presented.

Children are a particularly vulnerable population, and we should strive to have the best protections in place for them while still allowing the advancement of knowledge that can also help them or those who come after them. Current regulations do provide a great deal of protection for the health and well-being of children. While there is likely room for improvement in those regulations, these two bills are not the way to go about it. They are far too vague and have far-reaching negative consequences that may well be worse than the (real or imagined) problem they're trying to fix. They are not good for science. They are not good for medicine. They are not good for children.