Tuesday, January 31, 2006
What seems to be at issue in this debate is commodification. "Commodification" refers to the association of a thing or a practice with attitudes and behaviors that accompany typical market transactions. Today there are commercial and non-commercial markets for human blood, sperm, organs, and other body parts. But for the idea of there being a market for ova, human embryos and fetal material is repugnant to many. This reaction is supported by a belief that there are certain kinds of things that should never be commodities or treated like commodities.
The issue is not a quibble about price. If we put a price, any price, on bits of the human body, the worry is that in so doing we are saying that it is acceptable to treat some persons (the donors/vendors) in the same manner that all manufactured objects are treated. So fertile women who exchange ova for money would be treated like toasters and laundry detergent.
Human tissue, like ova, is needed to continue stem cell research. And stem cell research promises to be a therapy to treat for all sorts of horrible diseases. So ova have more than intrinsic value. They have the potential to be really good for other things, like helping people. Because of this, and the toaster concern, people claim that exchange of human tissue should be motivated by altruism and given in the form of a gift. Thus, embryos and fetal tissue, ova and sperm, (as well sex and surrogacy) may be given to others, for others, but only if the giver does not get paid for it. The exchange is this: a woman gives her ova freely and in exchange she get the satisfaction that she is helping the greater good.
But these tissues are extremely valuable for other reasons besides the greater good. They are market commodities. Their value derives from what researchers and companies are willing to pay for the development of therapies, the potential profit to be made from the products derived from the tissue, and from the patents that that biotechnology companies and universities can obtain on these tissues.
According to Curtis Naser and Sheri Albert, “[t]he use of human tissues and cells is …the foundation upon which much of the current biotechnological revolution has been based.” The interests of the person supplying the tissue and of researchers or firms may conflict. This potential conflict is usually put forward as conflict between the interests of the individual tissue supplier and those of scientific progress, of “researchers in freely pursuing scientific knowledge.” To be sure, new breakthroughs have the potential in principle to benefit all humankind, but it is not outrageous to point out that the medical biotechnological industry has a great financial incentive for developing therapies and products.
And here is my concern for the exploitation of women if they are not paid for ova: To be forced to give something away for free and not even to have a say as to where it goes when others make significant profit from it is to grossly exploit the giver. This for-profit part of the picture is missing from the current debate over ova donation.
Curtis Naser and Sheri Albert, “Genetic Information, Ethics, Ethical Issues in Tissue Banking and Human Subject research in Stored Tissues,” Encyclopedia of Biotechnology, Volume 1 Thomas H. Murray and Maxwell J. Mehlman, eds. (New York: Thomas Wiley, 1999): 363-389.
Monday, January 30, 2006
Now what is pharmacogenetics? Pharmocogentics emerged in 1950’s when it was noticed drug reactions run in families and researchers started to correlate genetic variation with response to specific meds. It was thought that if a physician would use a genetic test to predict how each patient would respond to the drug before prescribing it, she could tailor make a pharmaceutical regimen that would work best for that particular person; work best would mean that the drug would not harm (reduce side effects) and the drug would help. The goal of pharmacogenetics is personalized drug therapy based on diagnostic tests to predict patient’s response to specific drugs based on genetic profile
Closely related to pharmacogenetics is pharamogenomics. It combines pharmacogenetics with genomic studies. This research started when it was realized that people vary in response to prescribed meds and people vary in response to getting certain diseases. Research studies in pharmacogenomics aim to reveal how different drugs interact with multiple gene populations. Matching drug candidates with patient populations by pharmacogenomic screening will reduce time and cost involved in drug discovery. Lots of money is to be saved by pharmaceutical companies here.
Pharmaceutical industry people say that, “This [pharmacogenetics] is not a fad," (Gualberto Ruano, CEO of Genaissance Pharmaceuticals); "It's a major tidal wave changing the entire pattern of health care."
However, a major report recently offered by The Royal Society (UK), “Personalized Medicine: Hopes and Realities”, says that the impact of personalized medicine is at least 15 years away. The three objectives of PGx combined are to : 1) Reduce drug side effects and improve drug efficacy; 2) Lead to prevention strategies by estimating risk of getting disease; 3) Reduce cost and time of drug development process. The technological, clinical, and ethical obstacles, however, are great.
There is no cheap single molecule DNA test in existence. Recently, however, J. Craig Venter, the genomics entrepreneur who paced the U.S. government to the completion of the Human Genome Project, announced that he hopes to offer $10 million as a prize (he originally pledged $500,000) for automated DNA sequencing technology that can decode a human genome for $1,000. Clinical and ethical challenges include: What level of knowledge is adequate for the patient and the physician to go ahead with the procedure? How will this potential treatment affect other treatment choices? A physician may think that a novel, expensive drug treatment not appropriate, and the health insurance company may not pay for it. But a patient who is dying may think it is worth taking for the slight chance it offers. Who should decide? Who will administer the genetic test, where will the genetic information on the patient be stored, and who will have access to it? As we well know, the nature of data is that it is pervasive and permanent. In order for informed consent to be realized, a patient will have to understand among other things the relationship between DNA and disease, will we have enough genetic counselors trained to do the job? What about the issue of returning benefits to persons or communities whose genotypes made the drug development possible? For more see the World Health Organization (WHO) Human Genetic Programme: Review of Ethical Issues in Medical Genetics.
But even if we had the an adequate knowledge of the genome, a cheap DNA test, a battalion of trained at the graduate level people to explain tests and their meaning to patients, and effective laws in place to secure privacy, what this information means at a diagnostic level is still open. According to Technology Review, while several new genetic diagnostic tests have hit the market in the past two years, doctors will need to learn how to incorporate them into their clinical practices, and scientists will have to figure out what kind of guidelines doctors need to do this properly.
The problems with such legislation are numerous: First of all, patients are a captive audience, a vulnerable population. An individual who feels that they need the protection of the law because t because they don't want to engage in some healthcare practice that they find morally repugnant, is saying 'my rights supercede the rights of the patient'. In healthcare, where the healthcare provider is put in a position of power and trust and the relationship is inherently unequal, this is an abuse of power. R. Alto Charo, bioethicist at the University of Wisconsin, gives a good example in the Post article: Doctors opposed to fetal tissue research, for example, could refuse to notify parents that their child was due for a chicken pox inoculation because the vaccine was originally produced using fetal tissue cell cultures, and be immune from state disciplinary action and malpractice suits.
Could you imagine? A doctor refusing to treat an AIDS patient because she/he finds that the patient's lifestyle is 'morally repugnant'. The American Medical Association has addressed this in its Principles of Medical Ethics: “the physician has an ethical obligation to help the patient make choices from among the therapeutic alternatives consistent with good medical practice” (Opinion E-8.08, “Informed Consent”).
From a legal standpoint, this legislation could be challenged on a variety of levels: Aside from affecting an employers unfettered right to hire someone 'at will', this legislation is attempting to create a protected class when there is none – you can’t give more rights to one group by taking away rights from another group (particularly a captive audience or vulnerable population).
On a constitutional level, other challenges include violation of the interstate commerce clause, and denial of individual liberties (a possible 42 USC section 1983 action, based on the state nexus of licensing boards.)
Currently, employers are dealing with the issue on a case-by-case basis -- does the heavy hand of the law have a place in this?
[Updated Feb 16, 2006] Check out what our partner blog, Business Ethics, has to say about this and Walmart.
Friday, January 27, 2006
Here's a great opportunity for women who are no longer comfortable wearing their furs -- donate them to the Women's Bioethics Project . The WBP will make them into keepsake items like fur-lined wooden jewelry boxes and sell those items to support women's research.
Thursday, January 26, 2006
Wednesday, January 25, 2006
"The fact that EPA allows pesticide testing of any kind on the most vulnerable, including abused and neglected children, is simply astonishing," Boxer said.
To be continued....
Monday, January 23, 2006
Ouch -- what a commentary on the status of women. Will this change as the sex ratio shifts? Reports are that they already have. Some argue that this will make a women a precious commodity and lead to the abduction and trafficking of women in prostitution.
The restrictions on the use of ultrasound for the purposes of termination of pregnancy based sex selection don't seem to be working; making abortion illegal won't turn things around either -- especially since female infanticide is not uncommon. Aside from the obvious answer of "education", I'd really like to hear and learn about what can be done to stop this devaluation of women.
Wednesday, January 18, 2006
No one is saying that this will be easy, but I agree that this is an important process to pursue -- to engage in respectful discussion and to find common concerns and values -- that is the moral high ground.
In the case of Ayotte, Attorney General of New Hampshire vs Planned Parenthood of Northern New England, soon to be retiring Justice Sandra Day O'Connor writes (emphasis added):
"As the case comes to this Court, three propositions are established. First, States have the right to require parental involvement when a minor considers terminating her pregnancy. Second, a State may not restrict access to abortions that are “ ‘necessary, in appropriate medical judgment for preservation of the life or health of the mother.’ ” Planned Parenthood of Southeastern Pa. v. Casey, 505 U.S. 833, 879 (plurality opinion). Third, New Hampshire has not taken issue with the case’s factual basis: In a very small percentage of cases, pregnant minors need immediate abortions to avert serious and often irreversible damage to their health. New Hampshire has conceded that, under this Court’s cases, it would be unconstitutional to apply the Act in a manner that subjects minors to significant health risks."
And so the court remanded the case to the lower court, holding that "If enforcing a statute that regulates access to abortion would be unconstitutional in medical emergencies, invalidating the statute entirely is not always necessary or justified, for lower courts may be able to render narrower declaratory and injunctive relief."
In a manner akin to Edward A. Langerak's essay Listening to the Middle, this decision is a reflection of the delicate balancing act that the US Supremes are trying to accomplish in listening to the middle. In a similar vein, more pro-life activists are going for gentle persuasion, foregoing politics for quiet talk.
Despite sometimes harsh rhetoric from both sides, it's important to remember that that is there is common ground and that the dialogue must continue for any progress to be made.
According to the Washington Post, conservatives reacted angrily to the ruling. Jay Sekulow, chief counsel of the American Center for Law and Justice, a nonprofit litigation group founded by Pat Robertson, called it "a disturbing and dangerous decision that can only lessen the value of protecting human life." But assisted-suicide initiatives have not fared well in recent years: State referendums and proposed legislation supporting assisted suicide have failed in California, Maine, Maryland, Michigan and Washington.
From a more legal viewpoint, the case presents an interesting tension between the philosophical approaches in strict constructionalism vs interpretationalism. Traditionally, conservatives favor strict constructionalism, but in this case the Bush administration argued for a more expansive, liberal interpretation of the federal Controlled Substances Act (CSA). The majority opinion, written by Justice Kennedy, looks to the text and structure of the CSA:
" The Government does not suggest that its interpretation turns on any difference between the statutory and regulatory language. The CSA allows prescription of drugs only if they have a “currently accepted medical use,” 21 U.S.C. § 812(b); requires a “medical purpose” for dispensing the least controlled substances of those on the schedules, §829(c); and, in its reporting provision, defines a “valid prescription” as one “issued for a legitimate medical purpose,” §830(b)(3)(A)(ii). Similarly, physicians are considered to be acting as practitioners under the statute if they dispense controlled substances “in the course of professional practice.” §802(21). The regulation uses the terms “legitimate medical purpose” and “the course of professional practice,” ibid., but this just repeats two statutory phrases and attempts to summarize the others. It gives little or no instruction on a central issue in this case: Who decides whether a particular activity is in “the course of professional practice” or done for a “legitimate medical purpose”? Since the regulation gives no indication how to decide this issue, the Attorney General’s effort to decide it now cannot be considered an interpretation of the regulation. Simply put, the existence of a parroting regulation does not change the fact that the question here is not the meaning of the regulation but the meaning of the statute. An agency does not acquire special authority to interpret its own words when, instead of using its expertise and experience to formulate a regulation, it has elected merely to paraphrase the statutory language."
Does anyone else see the irony in this?
Tuesday, January 17, 2006
Justice Anthony Kennedy, writing the majority opinion said that the federal government does have the authority to go after drug dealers and pass rules for health and safety, but power was not intended to extend to the Oregon law. Kennedy said the "authority claimed by the attorney general is both beyond his expertise and incongruous with the statutory purposes and design."The majority opinion included retiring Justice Sandra Day O'Connor and Justices John Paul Stevens, David Souter, and Ruth Bader Ginsburg, and Stephen Breyer.
Roberts and Justices Clarence Thomas and Antonin Scalia dissented. Scalia commented that the court's ruling "is perhaps driven by a feeling that the subject of assisted suicide is none of the federal government's business. It is easy to sympathize with that position."
More on the court's reasoning as soon as the bench opinion becomes available.
Monday, January 16, 2006
As I watched the confirmation hearings for the Supreme Court nominee Samuel Alito on C-Span, it struck me that this was a man who would confirm the philosophy that law operates by looking through the rear-view mirror -- and everyone knows it's hard to move forward when you're only looking in a rear-view mirror. He is, by most accounts, a strict constructionist --In legal circles, this term refers to a philosophy of judicial restraint that calls on judges to interpret laws according to their original meanings. Strict constructionists don't want to meddle with theories of evolving community morals, divine natural law, or seek out "penumbrae." Theirs is a code of strict adherence to the words on the page. Never mind at looking at the spirit of the law. Justice or doing what's right be damned. What's law is law, and what isn't law -- well, get back to us after you've had it enacted by your local legislature.
The problem with strict constructionism is that it leads to decisions like the Dredd Scott case . And for someone like me, who has been promoting "evolving notions of personhood" (since emerging technologies will challenge our traditional notions of personhood) and trying to forge a path between pro-choice and pro-life activists, this is not good.
The question, as I see it, is do we want to see the U.S. Constitution as an empowering document or as a limiting document? So with confirmation of Alito are we really preparing to face the difficulties emerging technologies present (ranging from privacy of our own thoughts to the artificial womb to new life forms) or are we beating a hasty retreat to feel safe and snug in our straightjackets?
Sunday, January 15, 2006
"Of all the forms of inequality, injustice in health care is the most shocking and inhumane." - Martin Luther King, Jr.
A large scale clinical study has shown that patients admininstered Femara showed a 27% reduction in the risk of distant recurrence (metastases) with Femara as compared with tamoxifen. Both of these drugs have been effective in treatment of Estrogen-receptor-positive tumors (tumors that grow in the presence of estrogen).
Femara is a potent member of a new class of drugs called aromatase inhibitors; these drugs almost totally shut down the body's ability to make estrogen. But each drug carries the risk of side effects: Women taking Femara had higher cholesterol and a higher incidence of heart trouble than women taking tamoxifen. (It's not clear whether this is due to a side effect of Femara or a possible protective effect of tamoxifen). But at least there are some more choices for women.
Saturday, January 14, 2006
You can preorder the book on their website (and there's a nifty 25% discount available right now).
Thursday, January 12, 2006
While Europeans interested in medical research have, ventured into
While it may not be for outsiders to judge the significance of such sums to South Asia’s impoverished, many, including Philpott, who cautions that individuals may not even realize they are being coerced, worry that the testing borders on exploitation. Pharmaceutical companies conducting research have come under criticism before. In 2004, before the anti-generic drug rules were enacted, two India-based drug companies, Shantha Biotech and Biocon came under scrutiny for conducting illegal clinical trials without proper consent, actions that led to eight deaths.
To read more, click here.
Monday, January 09, 2006
The Times article points out that there is an underappreciated truth about disease: it will harm you even if you never get it. Disease reverberates outward, and if the illness gets big enough, it brushes everyone. Diabetes is big enough.
Predicting the path of a disease is always speculative, but without bold intervention diabetes threatens to hamper some of society's most basic functions.
For instance, no one with diabetes can join the military, though service members whose disease is diagnosed after enlisting can sometimes stay. No insulin-dependent diabetic can become a commercial pilot.
As more women contract diabetes in their reproductive years, more babies will be born with birth defects. Those needy babies will be raised by parents increasingly crippled by their diabetes. Needless to say, this would be a tremendous drain on Medicare and Medicaid.
Stopping this epidemic is obviously something our government and policy leaders need to make a priority.
Saturday, January 07, 2006
Women can now be tested to determine whether they have the genetic mutations in BRCA1 and BRCA2 that are known to increase the risk of breast cancer. This testing isn't currently recommended for the general population--clinical breast exams and mammography are the standard screening recommended for the general population--but it might make sense for women who have a family history of breast and/or ovarian cancer. But some women do get tested and, upon finding out that they do have a very high risk of developing cancer, choose to have their breasts surgically removed. Some may also choose to have their ovaries removed, as the same genetic mutations that cause breast cancer can also cause ovarian cancer.
Random thoughts this rainy Saturday: Are there circumstances under which we could all agree that prophylactic mastectomy/oophorectomy makes sense? Would we base our decisions on clinical criteria, or other reasons? And are there other situations in which we would contemplate removing a body part because it could become diseased in the future?
Say we do agree: there are times it's a good idea to remove a so-far-healthy breast or two. What if a person finds out that she *doesn't* have an increased genetic risk, but is so frightened of breast cancer that she wants a mastectomy anyway? Should a surgeon refuse to do the procedure? If the surgeon refuses, and the woman later develops breast cancer, does she have a case against the surgeon?
Should insurance pay for the surgery in an average-risk woman? Could insurance require the surgery in high-risk patients? Could they say that a high-risk patient who refused surgery would be dropped from the plan? Might they say that if a high-risk patient opted not to have the mastectomy (which the insurer would pay for), and then developed breast cancer, it wouldn't pay for treatment?
As we move more and more toward a "personal responsibility" view of healthcare in the United States, we need to remain cognizant of the bigger picture. Today, the view that people are responsible for the unhealthy choices they make (smoking, drinking, using drugs, etc.) and should bear the burdens of their decisions is becoming more and more popular. It may turn out that when we began to think about this issue in terms of "health problems you choose for yourself," we may unwittingly have opened the door to such ideas as mandatory (if you want to stay insured) mastectomy.