Evidence already suggests that the US
is losing its lead in scientific research as a result of policies that
concentrate research funding on military applications while discounting
education and basic science. Another sign is that good “old” Europe, which
managed to shed and keep off its feudal heritage, is forging ahead with
an artificial intelligence
project reflecting a deep recognition at the policy level of the
revolutionary potential of technologies likely to emerge in the next decade, and
seeking to understand and control rather than ban them.

Meantime, the Bioethics Council has wasted no time since Blackburn’s ouster
in using its unified voice to put a damper on IVF procedures and genetic
screening of embryos, and to forestall any research involving the mixing of
human and animal embryonic/gestational components.

Still, an unfettered free market can be trusted to find a way around
government regulation, even if government were to enforce its regulations, which
it appears not to do in the case of “entertainment ultrasound” clinics
that provide potentially dangerous photographic services to expectant parents
and their unborn children. The US biotech industry, finding even less regulation
in former communist countries than it does at home, is at least acknowledging
that an ethical issue exists with
regard to providing affordable drugs to the impoverished patients who take the
ultimate risk in testing them.

The far from impoverished patients who can afford to pay for so-called VIP, concierge, or boutique medicine seem to
be part of a US regression to a class-based system of healthcare reminiscent of
feudal times. And those relatively few but far from impoverished physicians who
can afford to buy their own MRI and
other scanners appear to have a stronger tendency to dip into the public purse
than their less well-equipped colleagues, with considerable impact on healthcare
costs.

The private sector is also looking to the public purse in asking the US
government to fund the provision of in-home
medical devices. But here there may be a genuine benefit to the public
purse, by reducing the need for expensive hospital and institutional care. The
public purse could certainly use some help. Spending on biotech drugs, already going through
the roof, could go stratospheric when the hundreds now in the pipeline
emerge.

In February, a week after 60 prominent scientists accused the president of
the United States of subverting science for partisan political ends, Elizabeth
Blackburn, a distinguished cell biologist, was summarily dismissed from the
President’s Council on Bioethics. No reason was given, but she had been
sometimes critical of the Bush administration’s restrictive policies on
embryonic stem cell (ESC) research. She has accused Bush of “stacking the
council with the compliant.”

Farhad Manjoo suggests in Salon that “this simple story line is almost
certainly wrong,” citing Blackburn’s absence from half the council’s meetings as
the probable cause of her ouster. On the other hand, notes Kristen Philipkoski
in Wired, Blackburn and another council member who left (though for
personal reasons) were thorns in the council’s side, preventing it from reaching
consensus opinion in the four reports published by the council while she was a
member. “She had the gumption to speak her mind.” For all we know, it may have
been Blackburn’s strong stance that forced the council to present a balanced
view — and led to her replacement by pro-Bush people, whose openly “Christian
right” views have been published in the press and are cited by Philipkoski.

Manjoo also questions criticism of the work of the council, which he says
“has done some fascinating and admirable work — and rather than letting the
president off the hook, the council’s report on stem cell research actually
highlights the unsustainability of Bush’s policy,” which limits federally-funded
ESC research to a handful of decaying cell lines. It shows, he suggests, that
the president has (unrepentantly) painted himself — and US biomedical research
— into a corner. If that is true, it may be attributable to Blackburn’s
contribution to maintaining a balance in the council.

While the council’s report does not reach or advocate a moral conclusion
about the status of embryos, the president does. He decided that no federal
money would go to fund any stem cells harvested from embryos destroyed after his
speech of August 9, 2001. The White House touted this as a compromise, but it
was not much of one, given the paucity and deterioration of stem cell lines
taken from embryos before that date. Although many more cell lines have been
produced with private or foreign funds, Bush cannot — and has made very clear
he will not under any circumstances — allow their use in federally funded
research, having decided they go against what he sees as the will of God. We are
all, therefore, hostage to President Bush’s religious beliefs.

What, asks Manjoo, are the costs of Bush’s stance? There is no doubt it
significantly hampers ESC research by denying federal funds. More subtly, it may
also keep new researchers away from the field — “young ambitious scientists are
leery about getting into work that isn’t funded by the government,” a former NIH
director told him. Scientists are not even sure that any actual therapies can be
derived from the so-called “presidential” (approved) lines, which do not
represent the diversity of the population and which have been maintained and
possibly tainted with outdated biology. It is true, Manjoo points out, that
private funds can be — and are being — used to conduct ESC research, but the
work is “much impeded without the help of the federal government.”

Reference: Manjoo, Farhad (2004). “Thou
shalt not make scientific progress.” Salon, March 25.

Reference: Philipkoski, Kristen (2004). “Bioethics Shuffle
Ignites Outcry.” Wired News, March 2.

US Losing Technology War

In 1992, the US exported about US$35 billion more in high-tech equipment and
goods than it imported. By 2002, it was importing $54 billion more than it
exported. The decline coincided with a ten percent drop in US tech employment
from 2000 to 2002.

BusinessWeek‘s Alex Salkever details the fall of US global dominance
in technology that has contributed to this deficit. He points as examples to
Nordic dominance in cell phones, Israeli prowess in information-security
technology, Japanese leadership in optical electronics, robotics, and
semiconductor-making equipment, and Airbus’s imminent overtaking of Boeing in
commercial aircraft market share (once the United States’ largest foreign
exchange earner).

Among the reasons for the decline are the industrial development policies of
foreign governments (especially in East and Southeast Asia) that target
strategic industries and provide support to domestic companies in those
industries; and a decline, relative to other countries, in per capita spending
on R&D. Defense, the primary beneficiary of US budget increases, spends most
of its funds on weapons development, not research, according to the American
Association for the Advancement of Science. Craig Mundie, Microsoft’s chief
technology officer adds: “To some extent the country has significantly
diminished its investment in fundamental, long-term research. I think this is
producing a long-term weakening in the [scientific base] of the U.S.”

The Bush Administration, in the person of John Marburger, director of the
White House Office of Science & Technology Policy, does not seem to agree.
“I think a close look at how the money is being spent will reassure people who
feel that research has been deflected into defense,” he says, somewhat less than
reassuringly in the context of Salkever’s close look, not to mention in light of
the heavy preponderance of technologies — reported in Health Futures
Digest — that arise from Defense Department projects. (See, for example,
“US Government Pushing Robotics” in the Robotics section of this
issue.)

Science education may be another factor in the decline. Salkever reports that
according to the National Science Foundation, American universities awarded
fewer bachelor degrees in science and technology in 1999 than either China or
India which, two decades ago, were awarding only a fraction of the US number,
and whose lead will widen as the percentage of Asian domestic college students
rises over the next two decades from a current 4.6 percent to rival the US
figure of 32 percent. The trend is further reflected in a percentage decline in
foreign graduate students in US universities, who can now stay home and still
get a first-rate education, although the post-9/11 visa restrictions are also a
factor. While other nations are ramping up their spending on education, the
Brookings Institution reports that state appropriations for higher education
fell from 7.3 percent of total spending in 1977 to 5.3 percent in 2000. Which
may help explain, says Salkever, the finding by Thomson ISI that in 1999
European Union scientists surpassed US scientists in total number of papers
published in leading scientific journals. (Perhaps, though, the expansion of the
EU had something to do with it.)

Given globalization in the post-Cold War era, the US decline relative to
other countries is not really surprising. Optimists maintain that the US still
leads in conceptual thinking, which may or may not be true (see “Europe and
Japan Push for Machine Autonomy” in this section for an example that suggests it
may not be), and even if it is, that is of little comfort to the ordinary
American out of a job. It is true that threats to the US economy in the past —
most notably, the Japanese challenge in the 1980s — “have yet to deliver
on the doomsday scenarios that were painted at those times,” notes Salkever.
Emphasis added.

Reference: Salkever, Alex (2004). “Gunning
for the U.S. in Technology.” BusinessWeek Online, March 16.

Europe and Japan Push for Machine
Autonomy

The European Commission is funding an approximately US$5 million project
called “ECAgents” to develop concepts, tools, and models for creating “embodied
agents” enabling mobile phones, robots, and other devices to interact and
communicate, without human intervention, with the physical world. Top-notch
scientists from nine European countries and Japan who have worked in robotics
and the computer, communication, cognitive, and complex systems sciences will
participate. They will draw on evolutionary theory, information theory, game
theory, network theory, and dynamical systems theory to create the agents.

The project appears to reflect a deep recognition in Europe and Japan of the
revolutionary potential of technologies likely to emerge in the next decade, and
seems to us a laudable and necessary attempt to come to grips with them.

Reference: Unknown (2003). “FP6
funds new generation of robots.” Cordis News, March 23.

Designer Babies Legislation

President Bush’s Council on Bioethics has recommended that the US government
monitor the long-term health of IVF babies and the health effects of related
techniques such as genetic screening. It also recommends that Congress ban:

• the transfer of a human embryo to a woman’s uterus for any purpose other
  than to produce a live-born child;
• attempts to conceive “by any means other than the union of egg and sperm;”
• production of human-animal hybrids or the transfer, for any purpose, of a
  human embryo into an animal’s womb.

It further recommends that the government require better reporting of the
frequency of use of different IVF procedures and genetic embryo screening/gender
selection at infertility clinics, and of costs, including the total cost of the
multiple attempts usually required for a successful pregnancy.

An American Infertility Association spokeswoman worried that the “egg and
sperm” qualification could disqualify new IVF techniques that combine the DNA
from an older mother’s egg with supporting material from a younger donor egg.

Reference: Unknown (2004). “Bioethics Group
Speaks Out.” Associated Press via Wired News, March 30.

Consumer Medical Electronics

For about US$200, more and more prospective parents are having their unborn
babies’ pictures taken at illegal yet unregulated ultrasound centers that have
sprouted in shopping malls throughout the United States, with names like Fetal
Fotos, Prenatal Peek, and Womb With A View, reports the AP’s Martha Mendoza.
They are equipped with $100,000 high-density “4-D” (3-D plus motion) ultrasound
machines many doctors would die for.

According to Mendoza, the US Food and Drug Administration (FDA) shut down
several “entertainment ultrasound” studios about a decade ago, but neither the
FDA nor state medical boards seem to have done much if anything since. The
agency says it is illegal to administer ultrasound without a prescription or to
promote the device for nonmedical use, and under some state laws the operators
may be practicing medicine without a license. Those owned and run by doctors
claim to be operating legally; some perform initial “limited medical” scans
before the family snapshot sessions begin; and some have gotten doctors to issue
a blanket prescription for their machine (we are not quite sure what that
means).

GE Medical Systems told the Associated Press that it “does not support the
use of the 4D equipment for nonmedical purposes,” but Mendoza notes that GE’s
ads play upon its machines’ emotional rather than medical value. The Society of
Medical Diagnostic Sonography, the Society of Maternal-Fetal Medicine, and the
American College of Obstetrics and Gynecology stress that ultrasound is a
medical procedure, writes Mendoza, not a photo op. “What if,” she asks, “an
untrained, unregulated scanner finds a malformation? What if uninsured women
depend on ultrasound centers rather than doctors?” and, in so many words, what
if there are biological effects from these scans, which tend to be longer, use
more energy, and are more frequent than scans performed in regular medical
practices?

Reference: Mendoza, Martha (2004). “FDA
Warns Against Nonmedical Sonograms.” Associated Press via Yahoo News, March
26.

Ethics of Outsourcing Clinical Trials

American biotech firms test many of their products in poor countries,
especially the former communist countries of eastern and central Europe, where
testing is often easier, faster, and cheaper. But few share their successful
drugs with the patients in the countries where they were tested, or even with
the patients on whom they were tested. “It’s not that we are lacking
compassion,” the president of the Biotechnology Industry Organization told Gina
Kolata of the New York Times, “but the economics are tough.”

At least, it appears, the conscience of the industry is awake to the issue of
“compassionate use.” There is no question it is expensive to set up and run a
compassionate use program, and the economics are clearly harder for small
companies than for large companies. With the exception of AIDS drugs, notes
Kolata, there is no industry consensus about what to do, but the issue grows
more pressing as more companies conduct international studies.

On the other hand, there is some collateral benefit to the countries
involved, if not to the patients. The doctors there — well trained but poorly
paid — earn extra money as clinical trial investigators and even as study
monitors, who, in the United States, would usually be nurses. They also benefit
from the advanced medical equipment often supplied by the drug companies for the
trials.

A US ethicist thought that while drug companies should not be seen as “the
deep pocket that helps everyone,” there was nevertheless (in Kolata’s words)
“something troubling about ‘parachute research,’ in which a company drops into a
country, conducts its research and then leaves. . . . The participants in a
study take a risk to help a company determine if its drug is safe and effective,
and ‘it seems to [the ethicist] that there is an ethical obligation to give
back.'”

Reference: Kolata, Gina (2004). “Companies Facing
Ethical Issue as Drugs Are Tested Overseas.” New York Times, March
5.

Back to the Health Future

As health futures in a civilized society go, a medieval system where barons
and rich burghers and their children get better healthcare than serfs and their
children would seem unconscionable. Yet this is not a future; it is a reality
today in the United States, judging by an article by Bill Brubaker in the
Washington Post, who writes that in America there is always a new,
better, and usually more expensive way of doing things — and people willing and
able to pay for it. Lease a private jet instead of hanging around airline desks.
Hire a personal trainer instead of hanging around crowded gyms. Go to a VIP
medical center instead of slumming it next to Medicaid patients.

“The pricey alternatives,” writes Brubaker, “look best when the services
they’re intended to replace are in crisis. So it will shock no one to hear that
there is a whole unfolding world of VIP medical care, . . . a parallel universe
of medicine fueled by frustrations among patients and doctors who feel that
mainstream American health care — with its slashed physicians’ fees and rushed
office visits — simply isn’t adequate anymore.”

A $10,000 initiation fee and $5,000 annual dues buys you and your family a
“silver” membership in Pinnacle Care International, which promises fast access
to top doctors and hospitals, day-long annual physicals, and chauffeur-driven
limousines to appointments. And it delivers on that promise, according to one
satisfied patient.

A small and slowly growing number of physicians nationwide — estimated at
200, according to Brubaker — are setting up VIP, a.k.a. “concierge,” a.k.a.
“boutique” practices of their own, promising “24-hour-a-day access and, in some
cases, home visits.” For retainer fees ranging from several hundred to several
thousand dollars a year, they get “one- or two-hour annual physical exams,
tailor-made preventive health care plans and the promise of on-time
appointments. Beyond that, patients must pay — in cash or through their
insurance plans — for any medical services provided.”

“It’s worth every nickel, every single nickel,” a retired police detective
told Brubaker. The doctors who founded the concierge clinic he attends say the
financial depredations of managed care forced them to it. They would have gone
out of business otherwise, they said, and even this was “not an easy road . . .
not get-rich-quick.”

Why are people willing to pay a premium? “They want to have somebody manage
their health. It’s a convenience for people who have accountants and asset
managers and other such things. This is just another convenience for them.” The
American Medical Association has decided there are no ethical issues provided
VIP services are not “promoted as a promise for more or better diagnostic and
therapeutic services,” even though (it seems to us) that is patently what is in
fact being sold. The sometimes
ethically-challenged AMA seems to have missed, or discounted, the bigger
ethical issue of equal access to care for society’s sick.

One doctor told Brubaker: “We have [a two-tier healthcare system with] people
with health insurance and people without insurance or who have government
assistance like Medicaid. What we’re heading toward rapidly is a three-tier
system, with affluent people who have insurance and who also can afford to join
an exclusive club.” One US lawmaker, concerned about the impact of VIP practices
on Medicare, said: “For basic, quality treatment, we are now setting up
different levels of care. And the majority of seniors cannot afford to go into
these boutique practices.”

Reference: Brubaker, Bill (2004). “Doctoring
At Your Service: VIP Medical Care Promises Fast Access, For a Few Bucks
More.” Washington Post, March 21.

Scanner Costs

By 2005, diagnostic imaging expenditures in the United States will have grown
by 28 percent since 2000, according to an AP newswire. The growth is attributed
not just to the natural professional desire of doctors (radiologists, orthopedic
surgeons, cardiologists, neurologists, and others) to avail themselves of the
diagnostic benefit scanners provide, but also partly to their desire to make
money, since reimbursements are high and patients are increasingly willing to
pay out of pocket for diagnostic scans.

Physicians who refer patients to their own scanners are the most inclined to
succumb to the lure of money. Such “self-referring” physicians order between two
and eight times as many scans as other doctors, according to some studies.

Reference: Unknown (2004). “Panel:
New Technology Affects Health Costs.” Associated Press via Yahoo News, March
25.

Elder Tech Funding

American medical device manufacturers are asking the US Congress to fund
technologies (such as the RFID-tagged devices discussed in “Elder Care” in the
Devices section) that help caregivers monitor people’s health at home.
The argument is that the cost of providing in-home devices would be less than
the cost of providing hospital or institutional care, especially in the face of
an impending baby boomer explosion.

Reference: Ustinova, Anastasia (2004). “New
technologies poised to monitor health of seniors.” Miami Herald, March 18.

Reference: Broder, Caroline (2004.) “Technology
Holds Potential to Help Care for Seniors.” iHealthBeat, March 31.

Medicare Costs

Medicare and social security will eventually cost more than twice as much as
previously estimated and that the total shortfall will be nearly $50 trillion
over the next 75 years, writes Edmund Andrews in the New York Times. An
economist and former Medicare trustee said she had little confidence in such
long-range projections. We agree, and we reiterate our contention that
long-range healthcare cost and budget projections fail to take adequately into
account the impact of emerging technologies.

Case in point: Americans spent almost US$30 billion on specialty drugs in
2002, or 18 percent of US spending on all prescription drugs that year, reports
the Baltimore Sun‘s Cyril Zaneski, citing a pharmacy benefit management
firm. The spending is growing at between 20 percent and 25 percent a year, about
double the projected rate for conventional pharmaceuticals, but even that may
seem tame when the Medicare prescription benefit takes effect in 2006 and as the
Food and Drug Administration approves more and more biotech drugs, of which
there were more than 900 in development for about 200 diseases in 2001. As these
drugs are approved for the treatment of more and more chronic diseases over the
next decade, and as people live longer and take them for longer and longer
periods, costs will explode if nothing else changes. The thing is, other things
will change.

Reference: Andrews, Edmund L., and Robert Pear
(2004). “Entitlement Costs
Are Expected to Soar.” New York Times, March 19.

Reference: Zaneski, Cyril T. (2004). “‘Miracle’
biotech drugs growing in use and cost.” Baltimore Sun, March 16.