| Bioethics Council’s View of the Future
Last month, the President’s Council on Bioethics issued its first major
report, Beyond Therapy: Biotechnology and the Pursuit of Happiness. The
document’s 300+ pages examine the ethical implications of drugs and devices that
don’t just restore health but take normal health and enhance it (what Health
Futures Digest calls “superhealth.”) It covers such topics as
pre-implantation genetic screening of embryos to select for sex or other
attributes, physical and mental performance-enhancing drugs, and elixirs of
youth. The report is intended to be a basis for future policy recommendations.
We are in the process of conducting an in-depth review of the
document, which seems at first reading to represent a conservative
standpoint that abhors any further change in the natural order of things. It
does not, in our view, adequately take into account the relentless acceleration
of medical and other technologies toward a future in which the natural order of
things is what a race of enhanced human beings — the next step in evolution —
makes it. We will make our review available to regular Health Futures
Digest subscribers.
References: Wade, Nicholas (2003). “Bush’s Advisers on
Biotechnology Express Concern on Its Use.” New York Times, October 17;
President’s Council on Bioethics (2003). “Beyond Therapy:
Biotechnology and the Pursuit of Happiness.”
Longevity
An American born in 1900 lived, on average, 48 years; now the average life
span is 78. Today there are more than 40,000 centenarians in the United States.
In 1950 there were only 2,300. The number of centenarians in many industrialized
nations is reported to be doubling every decade. If the trendline continues, the
average life span in industrialized countries in 2150 will be 122.5, and
150-year-olds will be not uncommon.
Technology was directly responsible for much of the quantum improvement in
public health between 1900 and 1950. The resulting sharp increase in average
life expectancy was not because old people were given a handful of extra years,
but because children were given an entire lifetime, saved by technology
from the deadly childhood diseases endemic through all of human history until
the 20th century. But by mid-century the childhood mortality rate had fallen,
statistically-speaking, to a negligible level. Any further gains in average
human life expectancy would have to come from the other end of the spectrum —
by extending the lives of older people. And while medical technology has begun
to do just that, most notably with respect to heart disease, it can add only a
few months or years to an individual life and barely dent the actuarial tables.
Some researchers therefore conclude that we cannot expect to see truly dramatic
rises in life expectancy.
But others say this view fails to take into account the potentially explosive
result of understanding the process of aging at the molecular level, and being
able to interfere directly in that process. Curing heart disease or cancer will
not be nearly as big a deal (statistically) as delaying the onset of old age
itself. We have done that, quite dramatically in some cases, for mice, fruit
flies, yeast, and nematode worms, and the discoveries of age-delaying methods
are accelerating. Only last month we reported on resveratrol,
a chemical found in red wine, that extends the lifespan of yeast cells by 70
percent. Even that is nothing compared to the 600 percent increase in nematode
lifespan achieved in the lab by making a single genetic modification.
Researchers seem to agree that there is no fundamental biological reason why
humans should not live very much longer lives, at least beyond 150. Evolutionary
biology shows that species survival and procreation are the proximate
determinants of longevity. Members of all species except our own live only as
long as is necessary to bear and nurture the next generation and keep the
species, rather than the individual, going. Human control over the environment
plus our sociocultural capabilities have given us an evolutionary advantage and
enabled us to postpone what, for other species, is an evolutionary imperative.
But they don’t eliminate it. That task may fall to direct human control over
human genes, through molecular genetic engineering and medicine.
Reference: Wright, Karen (2003). “Staying Alive.”
Discover, Vol. 24 No. 11, November.
Superhealth
UCLA professor Gregory Stock, who contributed testimony before the
President’s Bioethics Council in connection with its recent report, Beyond
Therapy*, notes that the trend to superhealth “officially” began in the
United States with the Food and Drug Administration’s July 25 approval of human
growth hormone (hGh) injections for healthy children who have normal levels of
hGh but fall within the bottom 1.2 percent of below-average height. Unofficial
— but legal — “off-label” use of hGh for treating shorter-than-average
children (or, who knows, to turn tall children into even taller children) has
been going on for some time, for parents able to pay up to US$200,000 out of
their own pockets, since insurance will not cover it. FDA approval will put
pressure on the insurance companies to do so.
The FDA has created a new pediatric indication, “non-growth hormone-deficient
short stature,” which Stock suggests is a (benign) cover-up for enhancement, not
therapy. The FDA, he says, is “inventing short stature to disguise its
acceptance of enhancement,” and he hopes to see more such approvals, especially
in the area of youth-enhancing treatments. “The core issue,” he writes in
Wired, “is not whether enhancement is a good idea, but when we’ll have
interventions worth making…. The biggest risk isn’t that we’ll make mistakes
or create a race of superhumans. It’s that we’ll proceed too cautiously with
health enhancements that would benefit us all.”
*See “Bioethics Council’s View of the Future,”
this section.
Reference: Stock, Gregory (2003). “Stamping Out
Short People: Growth hormone is just the start of human enhancement.” Wired,
11.11, November.
Reproductive Technology
Chinese researchers have succeeded in making a woman pregnant with a fetus
created using nuclear transfer, a process also used in cloning. She did not,
however, carry to term — none of the five zygotes (impregnated eggs) implanted
into her womb survived to term, though one survived for 29 weeks.
The researchers took eggs from the patient and from a fertile donor, and
injected them all with sperm. They then replaced the nuclei from the fertile
woman’s zygotes with the nuclei from the infertile patient’s zygotes. This is
similar to the way Dolly the sheep was cloned, with the nucleus from an adult
cell being transferred into an egg. But in the Chinese woman’s case, the
transplanted nuclei were embryonic, not adult, avoiding the medical
complications now known to ensue in the latter case, but not the ethical
complications of using a cloning -related procedure.
Even the Chinese government appears to have since grown a little nervous,
introducing regulations that will “hamper,” though not halt, reproductive
experiments. In fact, the technique has been successfully used for years in
mice, and the resulting offspring are not clones. Had a healthy child been born,
and the false comparison with cloning debunked, the experiment might have been
welcomed as a breakthrough for women with mitochondrial defects in their eggs.
Reference: Unknown (2003). “Not
cloning: New embryo research has sparked controversy.” The Economist,
October 16.
Genetic Discrimination
A bill forbidding insurers from using genetic information to deny health
coverage or increase premiums, and employers from using it in hiring, firing, or
promotion decisions, has passed the U.S. Senate. The American Medical
Association supports the bill, and the U.S. Chamber of Commerce and the Health
Insurance Association of America (HIAA) oppose it, even while HIAA dismisses it
as redundant, since “health insurers do not currently use genetic information in
determining coverage or in setting premiums, nor do they plan to do so in the
future.”
Opposition stems from the bill’s definition of genetic information to include
not just the results from DNA and chromosomal testing, but also “the occurrence
of a disease or disorder in family members of the individual.”
Where to draw the line is a central issue, reports Forbes‘ Ira
Carnahan, who quotes a congressional staffer as testifying that “Prohibiting use
of predictive genetic information…provides a hidden subsidy to any individual
who might be discriminated against for genetic risk reasons….” Why, they ask,
would a consumer who knows s/he has a potentially costly genetic condition
not take advantage of the insurance underwriter, and thereby raise the
cost of insurance for all?
An unselfish, caring, and wealthy civilized society might be expected to ask
why the consumer should not “take advantage” to save their own or a loved
one’s life. Supporters point out that the fear of discrimination may deter
individuals from getting genetic tests that could reveal a life-threatening but
preventable condition.
Meanwhile, reports the Wall Street Journal‘s Laurie McGinley, the U.S.
House Republican leadership is lukewarm at best about the bill.
References: Carnahan, Ira (2003). “Gene
Policy.” Forbes, October 22; McGinley, Laurie (2003). “Senate Is
Ready To Pass Measure On Genetic Bias.” Wall Street Journal, October 3.
Biogenerics
The United States has no regulatory process allowing the manufacture of
generic versions of biotech drugs such as interferon, human growth hormone,
red-blood-cell enhancers, and targeted antibodies, even after the patents
expire. However, the Food & Drug Administration now appears ready to tackle
the issue, and the pharmaceuticals industry is preparing for war against
regulation, the generics industry, and consumer advocates.
That is to be expected. The Wall Street Journal points to potentially
billion-dollar consequences for Amgen, if generics are allowed when the patents
on Epogen and Aranesp (red-blood-cell enhancers for anemia; $2.7
billion in sales last year) begin expiring in 2004; and for Genentech, whose
Rituxan (antibody treatment for lymphoma) generated $1.2 billion in 2002.
Novartis, whose generic-drug unit is seeking European regulatory approval to
market a generic human growth hormone (Omnitrop) next year, seems to have
a foot in both camps.
Although biotech drugs are more difficult to manufacture than traditional
pharmaceuticals, that is not stopping two of the world’s biggest generic-drug
makers from building new biotech drug manufacturing facilities. One of them,
Teva, appears to be on a buying spree of small biotech product makers.
“Generic knockoffs are coming,” writes BusinessWeek‘s Amy Tsao, ” —
it’s just a matter of how soon. The seemingly endless skyrocketing of
health-care costs will only speed the day.”
Reference: Tsao, Amy (2003). “Seeking
a Prescription for Biogenerics.” BusinessWeek, October 24.
Gingrich on HIT
Former U.S. House speaker Newt Gingrich believes “the best way” not just to
continue the level of healthcare service seniors have grown to expect but even
to improve upon it is by harnessing the power of information technology. He is
talking the familiar (but no less valid for that) refrain that healthcare’s
failure to harness that power is costing lives, suffering, and money.
He calls for congressional funding of a nationwide EMR system incorporating
AI-based expert systems in doctor’s offices that would check a patient’s
eligibility for insurance coverage, file claims instantly, email a prescription
to the patient’s pharmacist, and print out an “Explanation of Benefits” with
clear information about what is being charged for and who is paying what. “All
of which would reduce the number of clerical people the doctor and insurance
company need to employ.”
But Mr. Gingrich has no suggestions for what to do with the resulting
unemployed. Perhaps now would be a good time to consider an “Employment Impact
Statement,’ modeled after the Environmental Impact Statement legislation, for
any large-scale technology-based infrastructure project. We can’t halt the
progress of technology, but surely we can mitigate misery.
Reference: Gingrich, Newt (2003). “The Cure for What Ails
Us.” CIO Magazine, Fall/Winter.
NIH Funding for Med Tech Innovation
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is
the newest of now 27 institutes at the U.S. National Institutes of Health. It
was created in 2000 in response to the actual and anticipated impacts of imaging
technologies on the practice of medicine.
Much of the science and technology behind CT, MRI, and other advanced imaging
devices originated in Europe. NIBIB hopes to wrest the lead through its research
on MRI magnets that will work at room temperatures instead of requiring liquid
helium cooling; deep brain stimulator implants to control Parkinson’s tremors;
3-D imaging of brain aneurysms enabling surgical repaired using
magnet-controlled catheters; thought-controlled artificial limbs; and other
breakthrough technologies.
Reference: Hathaway, William (2003). “BEACON
Shines On Medical Advances.” Hartford Courant, October 23.
Affording Med Tech
Automated polymerase chain reaction (PCR) processors are an invaluable DNA
amplification tool enabling quick, non-invasive, and relatively inexpensive
detection of pathogens, but they are priced far too high for Third World
healthcare systems. The Sustainable Sciences Institute promotes a low-cost way
to replicate PCR: First, by substituting hobbyists’ ceramic dust (US$20 for a
five pound bag) for the silica particles (US$100 for a few milliliters) normally
used; and Second, by replacing US$10,000 agitators (which mechanically agitate
multiple test tubes containing DNA at various temperatures within the machine)
with three water baths heated to the required temperatures and manually swishing
the test tubes around in the water. All that’s needed is a fire, a glass of ice
water, a glass of hot water, and a thermometer.
Meanwhile, some First World countries have medical technology cost problems
of their own. The commissioner of the U.S. Federal Drug Administration has
expressed concern for drug and medical device companies apparently struggling to
meet the costs of post-research development of products. “There are a lot of
research breakthroughs sitting on the shelf” (because of these costs), he said.
The FDA is considering making available to such companies the massive amounts of
data it has collected from clinical trials, and is working on simpler and faster
guidelines and standards and on the use of genomic data to reduce the size of
clinical trials.
Medtronic’s CEO complains that many of his company’s available products have
reached less than 20 percent of the patients who might be helped by them. He
attributes the shortfall partly to a failure to “communicate” with (market to)
consumers, and partly to the focus on costs at the expense of focus on benefits.
Abbott Laboratories’ CEO echoed this sentiment, saying the industry needed to
shift the discussion from the cost of its products to their value. Like any good
sales pitch, these contain elements of truth. Drugs and devices have indeed
brought major benefits to heart disease and AIDS patients and many more.
While confident that pharmacogenomics and gene-targeted drugs will be
commonplace within ten years, the head of the National Human Genome Research
Institute worries about the transfer of publicly-funded research and patents to
private interests. He seems to imply that the resulting monopoly pricing adds to
the cost of development without adding benefit to the public.
References: Dreifus, Claudia (2003). “A Conversation With
Eva Harris: How the Simple Side of High-Tech Makes the Developing World
Better.” New York Times, September 30; Herper, Matthew (2003). “Medicine’s
Big Bottleneck.” Forbes, October 8.
Robotics, Education, and the End of
Work
MIT economist Lester Thurow recently told audiences in India that “30 or 50
years from now . . . you will have robots to do what an illiterate does now.”
Then he essentially contradicted himself, as to the timeline, by adding: “Today,
I can get a robot that can mow my lawn and does not cost more than an ordinary
lawn mower. Very soon they will be cleaning the house and doing other household
chores.” In point of fact, tens of thousands already are cleaning house
(see “Accelerating Adoption” and “Vacuum Review” in the Robotics section
of this issue.)
His central argument is that menial jobs are under threat from robotics,
leaving only work that has “a big knowledge component” — in other words, only
jobs that can be done by educated workers. Literacy, he concludes, is a crucial
competitive factor in the global economy. (Apparently, he then cites Cuba as
“the best educated country in Latin America,” but — as far as one can gather
from Hariharan’s report of Thurow’s India speeches in Technology Review)
— he does not bother to explain why, that being so, Cuba’s economy is in the
toilet.)
A general argument of job loss to automation seems to us correct but
insufficient. Given the serious social, political, and economic ramifications of
growing chronic unemployment, rather more rigor in assessing the timeline
(taking into account the acceleration of robotics and of AI-based automation
that increasingly encroaches on knowledge-work jobs, too) would seem important
and urgent.
Reference: Hariharan, Venkatesh (2003). “Message
to India: Globalize Or Be Left Behind.” Technology Review, October 29.
Self Care
The U.S. Surgeon General has partnered with pharmacy and consumer groups in a
media campaign called “Be MedWise” to teach consumers how to provide their own
healthcare safely and effectively. Over-the-counter, non-prescription drug use
is increasing, and with it the chance of complications from inappropriate use.
Among other things, the campaign urges consumers to consult with their
pharmacists.
The campaign signals official recognition, if not approbation, of the trend
to patient self-care, and comes at the expense of the doctors who will likely be
consulted less. To the extent the campaign succeeds in educating the uninsured
public in medicine, the sick benefit along with the pharmacies; but to the
extent it does not — or, worse, that it gives patients a false sense of medical
competence (a little knowledge is a dangerous thing, perhaps nowhere more so
than in medicine) — the problem of providing access to quality care to all
Americans could remain or grow even worse.
Reference: Neergaard, Lauran (2003). “Group
Counsels Patients on Self-Treatment.” AP/Yahoo, October 6. |
