Open the mail, see cancer doctors say they must control costs

The drumbeat is growing among prominent, thoughtful cancer physicians to the effect that they are not only concerned about the costs of the care they give, but that they must be more active in reducing those costs.  I know at least some of the publicly-quoted doctors personally, and while I don’t know for sure the details of where they stand, for example, on physician-assisted suicide, I know that they are concerned about taking care of people with cancer, helping them get better or limiting the effects of their illness, and getting new and better ways to treat them.  In other words, and to be admittedly crass about it, they can’t be accused of being “death panel” types.  These are good doctors.

Some of the recent mail:

  • My ASCO Post (newsletter from the American Society of Clinical Oncology) reports that senior doctors at Memorial Sloan-Kettering will not prescribe a certain new treatment for colon cancer that is intended to be an improvement on Roche’s Avastin—at twice the price—but is little or no better, based on the data.  These doctors wrote a New York Times op-ed to that effect—after which, the ASCO Post says, the manufacturer cut the price of the new drug in half;
  • I open my email to several MedScape Top 10 oncology stories, and one of them is, “Physicians ‘Hit the Barricades’ over Cancer Costs.”  Read it, and concerns are raised about the high cost of today’s new, cutting-edge drugs, with a particular disgust for those that simply don’t work very well.  But as worrisome to the doctors here is how much money is spent on highfalutin’ scans, like PET scans, to watch for cancers to recur, when there is no evidence that a close surveillance strategy helps, or when there might even be reasonably clear evidence that it doesn’t.  The word “rationing” gets used, but drill down on that, and what is really being discussed is a combination of push-back on pharmaceutical industry pricing plus a concern about prioritizing payments for treatments and practices that work the best.
  • But look at the next two headlines and one sees:
    • “New ALK inhibitor ‘Fantastically Active’”—new drugs designed to treat the 5% of people with lung cancer whose tumors have a particular genetic abnormality work very well for them, probably at high cost once the drugs are launched; and
    • “How Insurance Exchanges Will Affect Doctors’ Incomes,” in which we learn that oncology practices may be forced, under the terms of the Affordable Care Act when implemented, to take on an unlimited number of patients whose insurance—and payments under that—are reminiscent of the low rates that prevail for Medicaid.  And there’s not much doctors can do about that.

So, I think some of the directions we are going are getting clearer:

  • There will be some active price negotiation/price setting, similar to the current regimes in continental Europe or the U.K., to limit the prices of some new drugs.  As free-market oriented as I am, I have to admit that I am coming to see this as desirable as well as necessary.
  • Also, marginally effective drugs will lose pricing power.  In accordance with what I have written on this blog in the past, amen to that when it happens.
  • This may affect the availability of some of these, as well as the amount of effort spent on finding new treatments in the first place.  That may not be as bad as one might think, but the trip may be bumpy.
  • Efforts—led, I hope, by doctors taking care of patients—will continue to define ‘best practices’ and thereby limit at least some ineffective or inefficient practices.  Even then, the experts will wrangle about what the data mean and what conclusions to draw.
  • Those efficiencies will not be enough to keep overall costs down, and there may well be a strongly perceived need, fairly soon (10 years or so) frankly to deny some effective treatments to some people, solely on cost.   For example, the same ASCO Post reports that there may be some drug regimens that prolong life for people with lung cancer who generally are too sick to benefit from chemotherapy and who, by the emerging conventional wisdom, should not receive chemotherapy at all.
  • Some, perhaps many, middle-class people who are currently willing and able to pay a bit more for insurance that gives them a choice of which doctor to see or which clinic or hospital to go to, may lose that option as insurers drop those coverages and more people are in practice “nudged” into “Medicaid for all” type exchanges that limit the hospitals you may visit and the doctors you may see.  Some of the “best” academic centers and doctors may, I read, be excluded from those exchanges.  Does that violate the principle of justice?  I would argue that it unjustly limits autonomy (to hedge my Belmontian bets), but if everyone (or almost everyone) is in the same boat, how can anyone cry, “unfair?”  But maybe that’s a policy matter, not an ethical one, and maybe the fans of the British NHS are essentially correct.  Or not.

Paying for oocyte donation—California’s governor vetoes AB 926

On July 18, I wrote at length on this blog about AB 926, which had passed both houses of California’s legislature.  I was pleased to learn that California’s Governor Jerry Brown vetoed it on August 13.  Governor Brown, a progressive Democrat, can hardly be considered a pro-life conservative.

He based his reasoning on the issues of informed consent that I (and others) have described.  In my opinion, the key graph of his veto message is:

“In medical procedures of this kind, genuinely informed consent is difficult because the long-term risks are not adequately known.  Putting thousands of dollars on the table only compounds the problem.”

This of course keeps the reasoning fully focused on autonomy, and does not address the other major moral issues at stake.  But the governor’s decision is still the correct one, and wise.  At a minimum, it slows the freight train a bit.

You can read the entire concise veto message here.

Privacy and Henrietta Lacks

News comes today that, in a settlement of a dispute, two descendants of Henrietta Lacks, whose cancer cells were used to establish the famous “HeLa” cancer cell line, will sit on a committee that will decide which scientists get access to the gene sequence from the cells.

The scientists want to sequence the cell’s genes so that they can understand them better and interpret experiments in light of what is known about genes and cancer.  Frequently, that information can be more relevant than more general information about the cells—for example, what sort of cancer they are supposed to represent.  In fact, the latter sort of judgment, which has been the order of the day until recently, is often wrong.  Cells believed to be, for example, breast cancer cells can turn out to be something else, like melanoma cells.  Cell lines are commonly shared among scientists, and somebody puts a label on them that serial recipients simply accept without checking, and before long, a cell has a reputation for being something that it in fact is not.

Ms. Lacks’ descendants are concerned that genetic information from the cells might be associated with members of the family, and create invasions of privacy, possibilities for discrimination, or health alarms, accurate or not.  These are understandable concerns, although one should note that the Genetic Information Nondiscrimination Act (GINA) prohibits discrimination for some things (hiring, for example) based on genetic information, and employers are not even permitted to ask questions about, or otherwise seek, genetic information about actual or prospective employees.

In a sense, though, the concerns seem a bit misplaced.  For one, immortalized cell lines change—often dramatically—over time.  I would guess that the current gene sequence of HeLa cells is not what it was when the cells were first obtained.  Even areas of accuracy would not necessarily apply to currently living descendants a couple of generations later.  For another, I would also guess that medical decisions for a living person would better be based on direct testing of that person.

In general, it appears that genetic information online is anonymous, except when it isn’t.  As I posted on this blog a while back, if someone posts genetic information with personally-identifying information, it is possible for hackers to infer that person’s representation in an otherwise anonymous, open-source gene database.  The most important first step is to keep one’s own genetic information separate from their personal information.  The most secure way to do that is probably physical sequestration under good old fashioned lock and key, with very limited access to the key.  People concerned with privacy and confidentiality in human subject research recognize that when it comes to data entered and stored online, subjects must be told that there can be no absolute protection against some breach, from hackers or elsewhere.  Modern data security methods certainly help, but are not considered entirely foolproof.

All the more so if, as will be the case for HeLa cells, the data will be freely shared in the scientific community.  Then again, the Lacks family has at least an online presence, although perhaps not including too much truly personal information.  Their concerns are reasonably placed, but perhaps the practical consequences are limited.

For the near future, I’m at least as troubled by news reports that there may be no meaningful protection of personal data in the upcoming Obamacare online exchange portals, and the assertion that the HHS has moved to exempt Obamacare from the provisions of the Privacy Act.  In a world where it also appears at least possible that government may disclose private information for political purposes (see, the IRS), this sort of privacy concern looks much more immediate, and ominous, to me.

Not that there is necessarily anything we can do about it…

Euthanasia this week—in case you didn’t see it

Two developments—“hat tip” to Wesley Smith’s Human Exceptionalism blog for posting about these:

1)      In April, the World Medical Association (WMA) reaffirmed its past statements opposing euthanasia and physician-assisted suicide.   Their resolution:

 

“The World Medical Association reaffirms its strong belief that euthanasia is in conflict with basic ethical principles of medical practice, and

 

“The World Medical Association strongly encourages all National Medical Associations and physicians to refrain from participating in euthanasia, even if national law allows it or decriminalizes it under certain conditions.”

 

The WMA similarly holds that physician-assisted suicide “is unethical and must be condemned by the medical profession.”

The American Medical Association’s position on euthanasia dates from 1996.  From the AMA website, it reads in part:

“It is understandable, though tragic, that some patients in extreme duress–such as those suffering from a terminal, painful, debilitating illness–may come to decide that death is preferable to life. However, permitting physicians to engage in euthanasia would ultimately cause more harm than good. Euthanasia is fundamentally incompatible with the physician’s role as healer, would be difficult or impossible to control, and would pose serious societal risks.

“The involvement of physicians in euthanasia heightens the significance of its ethical prohibition. The physician who performs euthanasia assumes unique responsibility for the act of ending the patient’s life. Euthanasia could also readily be extended to incompetent patients and other vulnerable populations.

“Instead of engaging in euthanasia, physicians must aggressively respond to the needs of patients at the end of life. Patients should not be abandoned once it is determined that cure is impossible. Patients near the end of life must continue to receive emotional support, comfort care, adequate pain control, respect for patient autonomy, and good communication.”

Substitute “physician-assisted suicide” for “euthanasia” in the above and you essentially have the AMA’s current statement on physician-assisted suicide.

2)    In Britain, an appeals court upheld a law against euthanasia.  Two men had argued that their human rights under the European Convention on Human Rights were violated by not allowing a physician to kill them.  The court agreed that the ban on euthanasia did conflict with this human right, but that permitting euthanasia is a matter that should be decided politically, not in the courts:

“In a unanimous ruling, the judges said the two men had ‘permanent and catastrophic physical disabilities’ but said the issue of euthanasia ‘raises profoundly sensitive questions about the nature of our society.’ The judges wrote that ‘Parliament represents the conscience of the nation’ and said the court had no jurisdiction to challenge the legal ban on euthanasia.”

I am cheered by this decision, but it’s sort of “lukewarm comfort” (as opposed to “cold comfort”), in that the statement above underscores how the most critical ethical matters are changeable on a majority vote, in Western democracies.  Also, the news report cited and linked to here states that an appeal to the UK Supreme Court is likely in the offing, so we’ll see what they say.  And a separate case is proceeding to clarify who in the UK is allowed to assist someone’s suicide; doctors and nurses, it is reported, are prohibited from doing so, but the authorities often look the other way and decline to prosecute family or close friends who assist a loved one’s travel abroad to commit suicide, “if they act in good faith.”

Remember Margaret Mead:  “[S]ociety is always attempting to make the physician into a killer—to kill the defective child at birth, to leave the sleeping pills beside the bed of the cancer patient.  [It is] the duty of society to protect the physician from such requests.”

Potpourri about recent stories about abortion

It will hardly be news to readers of this blog that many states are enacting laws to restrict later-term abortions.  Formally, states cannot restrict access to abortion before a fetus is “viable.”  Practically, abortion proceeds largely unrestricted, at the sole decision of the woman requesting the abortion, in consultation with her physician.  (I will try not to revisit well-plowed territory here.)  The Gosnell case, having grabbed the attention of anyone willing to pay attention, seems to be a reminder that it is reasonable to take the step of protecting, in law, the lives of unborn children as they approach the point at which our best current medical efforts are capable of giving them a chance at life.   I am a bit reluctant to try to adjudicate too precisely the 20-week cutoff point in the recent Texas bill and others—legislating medical details is unavoidably problematic—but the impulse to establish a zone beyond which we agree we will not venture is appropriate, I think.

Such a step is a small one.  If I have the statistics straight, a distinct minority of abortions—about 1.5% out of a total of about 1.2 million annually in the U.S.—currently occurs after 20 weeks.  So it seems to me that in practice the “restriction” on abortion that we are talking about here would be limited indeed.

A new Wall Street Journal/NBC News poll indicates that a plurality (44% vs 37%, with 19% undecided) favor this small step.  Interesting.

Perhaps more problematic is the move to require that all abortions be done in facilities that meet more stringent regulatory requirements, such as those for outpatient surgery facilities.  I’ve been emailing with Susan Haack about this, and she points out that one might encounter a type of “slippery slope” in which other standard medical office procedures—that are similar in methods but do NOT involve terminating a nascent human life—become over-regulated.   So the counter argument, to the effect that these new regulations by some states constitute, in a sense, an over-reaction to the Gosnells of the world, is not entirely unreasonable.  (Again, however, the fundamental motive and stance behind abortion by choice must be unequivocally challenged.)  The regulatory provisions looked appropriate to me at first blush, but maybe that’s because I spend my efforts in the highly regulated arena of pharmaceutical clinical research.

Finally, perhaps you have read of the recent dust-up (to put it mildly) between the Center for Bio-ethical Reform (CBR) and Biola University, over a student’s insistence to pursue the former’s agenda of aggressively displaying graphic images of abortion, and the University’s response.   Again, I will not attempt to weigh in on the details of that confrontation, but just offer my 2 cents:

  • Visit the CBR website and you are immediately confronted a graphic abortion video that turned my stomach—and I’m an M.D. who generally can stand the sight of blood.  I think it is good that I had that reaction.
  • I think that anyone in the medical field, especially someone contemplating performing abortions in any way, must confront images like this.
  • I am ready to grant that there is a place, from time to time, for insisting that people deal with revoltingly immoral practices on a sensory level.  (Consider William Wilberforce’s “dinner cruise” scene, past the slave ships, in the movie Amazing Grace.)
  • Still, there is a time and a place and a way.  Parading or posting revolting images in public, in general, can backfire, raising resistance in some who are otherwise sympathetic to the message, or communicating condemnation to individuals who, at that point in time, are better addressed more gently.
  • Yes, images of abortion are revolting.  So is watching an amputation.  So is draining a liter of pus from an infected chest.  So are a lot of things in medicine that must be done for the good of the patient.   At issue is not the picture, but the underlying moral judgment.

Paying for oocyte donation—update from California

A number of concerned groups in California are encouraging citizens to urge Governor Jerry Brown to veto AB 926, which has passed both houses of the state legislature.   AB 926 would repeal a provision in the California Health and Safety Code that prohibits compensating women who donate their oocytes (eggs) for research purposes.   Wesley Smith has blogged against it, arguing that it would “permit Big Biotech to buy eggs from poor women to conduct human cloning and other experiments.”  One Leah Campbell, a past egg donor and author of a book entitled Single Infertile Female and an eponymous blog and website, writes in the San Diego Union-Tribune that AB926 “aims to turn women’s bodies and ovaries into an assembly line.”

What is going on?  It merits some unwinding.

In 2004, California passed Proposition 71, which established and provided $3 billion in bond funding for the California Institute for Regenerative Medicine (CIRM), to support basic and translational stem cell research.  The proposition explicitly cited human embryonic stem cell research as a major priority.  (In fairness, CIRM funds all things stem-cell, including somatic, or “adult,” stem cell research, and research with induced pluripotential cells [iPSC’s].)

As the California Senate’s analysis of the bill (available here) points out, at the request of the CIRM the Institute of Medicine (IOM) issued a 2007 report assessing the medical risks of oocyte donation for research.  Those risks included ovarian hyperstimulation syndrome (OHSS) which can have serious medical consequences in 1-2 of every 1000 stimulation cycles; risks of the procedures involved; psychological risks; and unknown but potential increased risk of some cancers.  The IOM pointed out that the stimulatory treatments needed for oocyte donation, when used in fertility treatments, are largely self-regulated by the medical specialty society involved, the American Society of Reproductive Medicine (ASRM), and the associated Society for Assisted Reproductive Technology.  Further, there is no ongoing registry of oocyte donors in place to observe women systematically, over time, for medical outcomes.  (This in the age of “evidence-based medicine.”)

Accordingly, in California law: “No human oocyte or embryo shall be acquired, sold, offered for sale, received, or otherwise transferred for valuable consideration for the purposes of medical research or development of medical therapies. For purposes of this section, ‘valuable consideration’ does not include reasonable payment for the removal, processing, disposal, preservation, quality control, and storage of oocytes or embryos” (Section 125350 of the California Health and Safety Code).  AB 926 would not change that part of the law.

However, in accordance with the sorts of concerns identified by the IOM, California law has prohibited paying egg donors more than the actual direct costs of the procedures (the “removal, processing, etc.”).  That is, women should not be charged for the medical and research procedures involved, but they shouldn’t be paid extra for their time and trouble, out of concern that such extra payment would constitute an unacceptable inducement to donate, and amount to impermissible exploitation.  This is what Ms. Campbell (and Mr. Smith, and to be candid, I) am concerned about.

Now, AB would repeal this specific prohibition, and allow this extra compensation of women who donate their eggs for research.  There are a couple of wrinkles:

First, as noted, the language prohibiting payment for the oocytes per se (or for an embryo) would not change, and new wording is provided to put a fine point on that.

Second, the bill tries to distinguish between donation specifically for research and donation for infertility treatment.  How?  To begin with, the rationale for the bill is that we already accept compensation for subjects of medical research, particularly for early clinical trials of experimental drugs given to healthy volunteers.  Such compensation can reach well into four figures per study, leading the phenomenon of the “professional research subject” who serially volunteers for these studies and tries to make a living off the compensation for participating.  Such compensation is for the subject’s time and inconvenience, and the consent form usually says so in so many words.  This is standard practice in research ethics, and there is a substantial body of literature (and ongoing debate) around the merits or harms associated with this practice.  The argument for AB 926 is that it would just treat women who donate their eggs for research like other research volunteers.  Further, without the compensation, people won’t volunteer.  (That is a safe assumption, based on the experience with drug studies in healthy volunteers.)  And, since much of the research is sponsored by industry, Wesley Smith is, in a sense, correct:  industry is not paying for the eggs proper, but they are paying for enhanced research participation.  I leave it to you to judge whether this is a distinction without a difference.

How much compensation is too much?  That is for Independent Review Boards (IRBs) to decide.  AB 926 affirms that the IRB must make this judgment in the case of compensation for women who donate their eggs for research.

But what about women who donate eggs for infertility treatment?  AB 926 tries not to be about them.  But if there are “extra” eggs—eggs that an infertile woman deems, with her doctor, she doesn’t need for her attempts to have a baby—then, if the clinic harvesting the eggs belongs to the Society for Assisted Reproductive Technology, then the IRB “shall disregard” the matter of compensation.

Got that?  The further wrinkle is that, according the California Senate’s analysis and the IOM report, while ASRM endorsed this sort of compensation for women who donate eggs for infertility treatment, it said that “total payments to donors in excess of $5000 require justification, and sums above $10,000 are not appropriate.”  Yet it is common knowledge that these payments can be much greater than that.  But in that case, AB 926 tells IRBs, “never you mind.”

Ms. Campbell (see the Union-Tribune link above) wrote that the aftermath of her egg donation included severe pain from endometriosis related to the ovarian stimulation, and, in a cruel irony, now she is herself infertile.  Her story reminds one of “Eggsploitation.”

So what to say of all this?

  • A decade after Prop 71, the commodification of the egg donation process, in the name of supporting research with created embryos, is a reality.
  • If I were on an IRB evaluating a proposal, it would be a lively meeting:
    • The egg donation is likely primae facie unethical because it supports the fundamentally unethical act to create or destroy human embryos solely for research purposes;
    • Compensation to the donor would have to at least fall within the ASRM dollar limits as described above; higher amounts should be viewed as an unacceptable inducement;
    • The required description of risks to the donor in the consent form must make the risks of severe complications of OHSS, and the lack of data on long-term risks, starkly evident;
    • I would argue strenuously that two basic requirements of IRB approval of the research—that risks are minimized and that they are commensurate with the benefits of the research—could never be met.

This one had flown under my radar, and I now need to send a letter to the governor.

“Presumed,” or “implied” consent for organ donation

The issue of whether explicit advance consent for organ donation should be required, as it is in most places, or “presumed,” is back in the news.  Lawmakers in Wales overwhelmingly enacted presumed consent in a recent vote.  What that means is that, when someone dies, that person will be assumed to consent to having his or her organs harvested for transplantation, unless the person has, while alive, explicitly signed on to a roll objecting to such donation.  This presumed, or implied, consent will be legally binding; one’s relatives cannot block it.   Although it is said that, in practice, survivors will have the opportunity to voice objections, how one could legally follow those rather than enforce the presumed consent is hard for me to envision.  (Spain is said to have such a “soft” approach to presumed consent, while the Austrians take a harder line and permit no exceptions.)

Supporters say that most people, when polled, say they would be willing to donate organs at the time of death, and that, in the face of truly severe shortages of available organs to transplant, presumed consent for organ donation is not only permissible, but ethically preferable if not demanded.  There is even a web site devoted to the topic.   Admittedly, there is a strong intuitive “tug” toward presumed consent.

We accept implied consent—albeit, not without some controversy—in other contexts; e.g., the implied consent to breath alcohol testing when the cop puts down his donut and pulls you over (I couldn’t resist the cheap shot), or for emergency medical treatment.

When it comes to biomedical research, US regulations and Good Clinical Practice guidelines speak not of “implied” or “presumed” consent, but to carefully limited criteria in which a waiver of informed consent is permitted.  Such waivers are, indeed, generally reserved for experimentation on an emergency basis, where there is a clear prospect for direct benefit to the person involved (not just indirect benefit to someone else), and where alternative treatments or opportunities to obtain consent are limited.  And even then, one must go back, after the fact, and obtain consent in retrospect where possible.

Certainly, the willingness to donate one’s organ to benefit someone else in need—indeed, in critical need—is praiseworthy.  Still, presumed consent for organ donation gives me cooties.  To begin with, negative check-offs are widely illegal in less urgent contexts.  (Consider, for example, the outfit trying to sell you something by mail unless you specifically opt-out.)  If not illegal, they are prominently flagged, and people are actively reminded of the option and implications of a negative check-off.  (Think about the last time you signed up for employer-sponsored health insurance and had to specifically sign off if you didn’t want part of it.)  Here, they slip by without a moment’s notice.

And, personally, I am suspicious of aggressive protocols to declare death to enhance the likelihood of harvesting an organ that will succeed when transplanted.   I think that a regime of affirmative consent is more likely to prevent people from being, as it were, used as means to the ends of transplantation medicine.  Even checking an organ donor card—which, as I understand it, has the force of a legally binding document—is an inferior approach, in my mind, to discussing my desires in advance with my loved ones and leaving them with the flexibility to apply those considerations to unpredictable end-of-life events, when they arise.  By all means, encourage these conversations, but don’t presume on the consent of strangers.

Mama, encourage your kids to grow up to be journalists

Once again, we are being treated to the blind spots (or bias, take your pick) of much of what is called “reporting” these days, in the coverage of the Texas legislature’s attempt to pass a bill restricting late-term abortions.  A “heroic” Texas state Democrat wore a back brace to keep herself upright for a “courageous” 11-hour filibuster, only to be “silenced” by fellow senators who were “pro-life extremists.”  (Never mind the rather vociferous champions of “choice” in the gallery who shouted down the proceedings, preventing a vote before the end of the session, prompting, in turn, the governor to call an extra session to complete the work properly.)  Oh, those knee-walking, knuckle-dragging troglodyte stumblebums of the apocalypse.  It was duly reported that advocates for abortion choice pronounce the bill “anti-woman.”

From some reporting, you would never know about the role of the throng in the gallery, and some reports I saw on CNBC left the impression the shouting spectators supported the bill and were shouting down the filibustering Democrat—the exact opposite of the truth.

Never mind that states are increasingly moving to restrict abortion of otherwise viable babies who are at or near the point where modern neonatal care can give them a chance at life.  We didn’t hear that.  Nor did we hear that public opinion polls increasingly show strong support for restricting abortion after the first trimester.

We also heard that this draconian bill would shut down many abortion clinics in Texas by holding them too much too high a standard of medical/surgical care.  But we hold every other medical/surgical care venue to high standards, do we not?  Or is abortion some sort of lower-tier medical service?  And never mind that the drafters of the Texas bill apparently took their cues from—where?—the Philadelphia grand jury indictment of the subsequently-convicted baby murderer Kermit Gosnell.  “Oh, that was an aberration, we don’t need to think about that.”  Pay no attention to that provider behind the curtain!

Oh, I forgot—most of the media didn’t report on the Gosnell trial.  The media chairs in the courtroom were empty.  The Grey Lady buried what stories it did carry on, let’s see, about page 12, while leading with the Keeling curve of global CO2 levels.   Surely climate change is more important.  Then again, if one of the overarching lessons of climate change is that there are just too many people in the world….  (I actually am hearing that one recently.)

Whether it’s the Texas bill, or the Gosnell trial, or getting it right w/r/t what actually is an embryo (cf. the recent posts on this blog), or reporting on euthanasia and infanticide, the conceits of the educated elite have gotten insufferable.  (Goodness, it makes me nostalgic for Spiro Agnew—I can’t help but thinking that, in general, he was right—apart from the self-serving purpose to which he spoke.)

We need more Christians committed to human dignity in journalism.  Educate them classically.  Please be sure they learn some real science.  And help them understand, as Ben Mitchell put it so nicely in a recent issue of Ethics in Medicine, that bioethics is about adopting a virtuous stance toward life, not just about ethical conundrums.

I confess—my paintbrush is broad.  There are good Christian journalists out there.  For example, I think of solid, clearly left-of-center commentators like Bob Beckel and Kirsten Powers, both of whom have confessed Christian faith on camera.  I thank God for them.

And I thank God for Marvin Olasky and World magazine.  If you don’t get that, go to www.worldmag.com and subscribe.  Or do someone else a favor and give a gift subscription.

In praise of the Myriad Genetics decision—as far as it goes

The U.S. Supreme Court has recently been handing down a series of controversial decisions (as if you hadn’t noticed).  But a less contentious decision, nonetheless meaningful in bioethics, was the unanimous decision two weeks ago in Association for Molecular Pathology et.al. v. Myriad Genetics, Inc., et.al. 

Myriad Genetics has marketed a test for the cancer susceptibility genes BRCA1 and BRCA2, certain mutations of which greatly increase the risks of breast and ovarian cancer in women.  Their patent included the full sequence of these genes, as found in nature.  Enforcing that patent meant that any other company or lab—including a university lab or independent lab—was guilty of infringement if they attempted to test a woman for mutations of these genes in the course of her medical care, regardless of the method of testing used.  That in turn meant that in practice the Myriad Genetics test, along with its high price, had to be used.  The patents were challenged in court.

Myriad Genetics had discovered the naturally occurring gene sequences and claimed them in their patents.  The court held this part of the company’s patents invalid; one may not patent a discovery from nature, without creating a new substance or a new method of using that substance in an invention.  This opens the door for competing tests.  In “bumper sticker” terms, “life,” as it is encountered in nature, is not patentable.

What may be patented, among many other things in biotechnology, is something that Myriad Genetics and many other scientists and companies create from naturally occurring genes; namely, complementary DNA, or “cDNA.”  cDNA is the sequence of coding regions of a gene, with the non-coding regions spliced out, that is “complementary” to that gene’s messenger RNA (mRNA).  (In nature, a gene’s coding regions, called “exons,” are interrupted by noncoding regions called “introns.”  The introns are spiced out in the course of transcription, or reading, of the DNA to form mRNA.)  This part of the ruling limits the overall impact on the patent estates of biotechnology firms, which in turn means that the ruling is unlikely to impair the discovery and development of new treatments or diagnostic tests.  Similarly, the methods used in such discovery and development also may still be patented.

Something else that may still be patented is a genetically engineered organism—for example, a bacterium with a gene inserted so that it will produce a protein of interest that it would not naturally produce.  This represents a lot of activity; many such organisms are patented, including microbes and genetically altered higher animals like mice created for specific experimentation.

What of the future?  Could human tissues, made from adult stem cells for an alternative to organ transplant, be patented?  I would think that they could.  At a minimum, the procedures for growing such tissues could be patented.  If some future human embryo were enhanced with a gene to improve vision, what could be patented then?  My guess is that the process could be, but the actual person could not be.  This seems commonsense but of course one would need to see the actual cases, if and when they arise.

Commodification of life, including human life, remains an urgent concern, but it seems that, even if some altered organisms are patentable, it is unlikely that people, though they may be “made,” could be considered to be “invented.”  My guess is that this decision would help set a limit.  In any event, I think the court got this one right.

Connecting the dots on euthanasia

Last weekend’s Wall Street Journal—ever the source of interesting reading—carried a page 1 article under the headline, “For Belgium’s Tormented Souls, Euthanasia-Made-Easy Beckons.”  The main anecdote was of a pair of identical, deaf twins who had a “genetic disorder” that was making them blind.  Belgium’s euthanasia law allows one to request active euthanasia—i.e., performed by a physician—for suffering that need not be related to physical discomfort or terminal illness.  Apparently, about 1% of Belgian deaths each year are from euthanasia.  Some prominent Belgians have exited earthly existence in this way, and their cases are portrayed as positive, dignity-affirming choices, with loved ones at their side for an event described as a “party.”  Sometimes, a person requesting euthanasia doesn’t tell her family, and demands that the doctor not tell, and the doctor, not surprisingly, honors that insistence, so the news comes as a bit of shock to the euthanized person’s survivors.  Belgian doctors interviewed for the story insist that people are not and cannot be buffaloed into being euthanized, but must request it and “really be desperate,” or words to that effect.  People wanting euthanasia sometimes have to doctor-shop; the Catholic physicians won’t do it.  It’s not clear to me what sort of documentation, or consent process, is required of a person’s decision for euthanasia.

But get this—liberalization of the law is being considered by the Belgian parliament.  One change would allow minors with a “capacity for discernment” to request euthanasia, if their parents agree.  Another would let patients with early Alzheimer’s disease request, in writing, to be euthanized at a future date when a doctor determines that they are no longer interacting with the outside world.

And the article describes how euthanasia is being mainstreamed into the entertainment culture of the West.  In Britain, a TV series called “Way to Go” is planned.  It is described as “a black comedy about three ordinary guys who find themselves forced by an extraordinary set of circumstances into setting up an assisted-suicide business.”  (And the merry mix-ups that occur when a depressed girlfriend asks to be a customer, I suppose.  Yuk-yuk.) “Forced by an extraordinary set of circumstances????”  (“Oh, but it’s only assisted suicide, not euthanasia.”)  Goodness!  What sort of imagination conjures up such a premise?

Where is this headed?  Let me count the ways.  But I’ll just mention a couple:

For one, making assisted suicide and euthanasia a matter of a sitcom is to trivialize human life, quite simply.  We must encourage our youth, in particular, and people entering the arts and entertainment industry, to develop better, more godly, imaginations—and we must turn our hearts, thoughts, and eyes (and entertainment dollars) away from more deranged projects.

An advance directive for euthanasia will be seen as mirroring other discussions surrounding advance directives.

Euthanasia for minors will press the issue of informed consent.  I can imagine that this will be framed substantially like the decision to forgo life-prolonging treatment, with older children having a recognized autonomy interest in making their own call, and the process and documentation will follow current regulations for informed consent by minors who are considered candidates for human subject research; i.e., parental consent will be required with a less-detailed “assent” form, varying by age range of the child, presented to and in some way executed by the child.  Even in our world, euthanasia of minors without parental consent, much less notification, seems like it would be a bridge too far even for our sick world.  (Anyone who objects to my use of “sick” in that sentence should just read the epigraph of Paul Tournier’s The Whole Person in a Broken World.)  I can’t begin to guess how many lives will be prematurely foreclosed.

And performance of euthanasia, wherever the practice is accepted at all in the West, will eventually be considered just one more medical procedure which physicians are bound to agree to perform as a condition of being allowed to practice medicine at all.  At least, that’s what our wiser-than-thou philosophers, who pooh-pooh issues of conscience in medicine, will insist on.

And I think it’s obvious that all neo-Hippocratic physicians, and those who stand with them, must tell our neighbors with a strong voice, “We must not,” and if pressed to participate, “We shall not.”

Finally, let us all memorize the statement by the great anthropologist Margaret Mead, cited by Nigel Cameron in The New Medicine: Life and Death After Hippocrates:

[With Hippocrates, “f]or the first time in our tradition there was a complete separation between killing and curing.  Throughout the primitive world the doctor and the sorcerer tended to be the same person.  He with the power to kill had power to cure…He who had power to cure would necessarily also be able to kill.  With the Greeks, the distinction was made clear.  One profession…were to be dedicated completely to life under all circumstances, regardless of rank, age, or intellect—the life of a slave, the life of the Emperor, the life of a foreign man, the life of a defective child…but society is always attempting to make the physician into a killer—to kill the defective child at birth, to leave the sleeping pills beside the bed of the cancer patient.  [It is] the duty of society to protect the physician from such requests.”