The FDA, apparently tarred by the anti-science brush of the Bush
administration, gagged the public
testimony of its own expert on antidepressants. The administration seems to
have less of a problem with hardware and software than with bioware, and the
former FDA director — now CMS director — is pushing for the adoption of EMRs and RFID
in healthcare.

There is further evidence of the potential harmful health and
environmental effects of nanomaterials.

The US healthcare system, says US senator and former first Lady Hillary
Clinton in a long article for New York Times Magazine, is in worse shape
today than it was in 1994 when she led the last attempt to modernize it. That
attempt was defeated by a political system that forces those (like Mrs. Clinton)
who would do the right thing to resort (like her opponents) to untruths. For
example, she writes: ” . . . we have to begin applying American ingenuity and
resolve or watch the best health care system in the world deteriorate.”

To anyone who has read with an open and rational mind the studies showing
consistently over time that all other first world and not a few second world
countries have far better health systems in terms of what really matters to the
people (not just to the rich people) — affordable access to basic and
preventive care, and better mortality and morbidity rates — the United States
has one of the worst healthcare systems in the world. That is a
demonstrated fact, and to deny it has consequences, such as well over 40 million
American citizens unable to afford healthcare.

Although, writes senator Clinton, “Medical advances have the potential to
overwhelm the health care system top to bottom,” America’s “antiquated”
healthcare system (“best in the world,” remember) is “ill equipped to deliver
the fruits of that progress,” and it puts American businesses and workers at a
disadvantage against foreign rivals that benefit from tax-funded national health
systems rather than the voluntary employer-based American model.

“If all we had to do was face [the] tremendous changes” induced by
technological advances and globalization, “that would be daunting enough. But
many of the systemic problems we have struggled with for decades — like high
costs and the uninsured — are simply getting worse,” she writes. And all this
is despite the fact that “health spending in the United States is 50 percent
higher than the second-highest-spending country: Switzerland. If we spend so
much, even after administrative costs, why does the United States rank behind 47
other countries in life expectancy and 42nd in infant mortality?” Her answer:
“our ailing health care system is plagued with underuse, overuse and misuse. In
a fundamental way, we pay far more for less than citizens in other advanced
economies get.” Still, it is the best healthcare system in the world, is
it not?

Those of the “let the cold and uncaring free market take care of the people”
mentality and morality will and do find everything to disagree with in any
suggestion of universal care, but there is one ray of hope in that people of all
political, religious, and moral persuasions appear to be in no disagreement
about the need for and value of patient-controlled electronic medical records.
President Bush, senator Clinton, senator Ted Kennedy, and former House Speaker
Newt Gingrich, appear all to be on the same page with respect to this issue at
least, because whether the system is financed by employers or government, EMRs
will reduce the level of financing required and raise quality at the same time.

“All that we have learned in the last decade confirms that our goal should
continue to be what every other industrialized nation has achieved — health
care that’s always there for every citizen.” “Insurance should be about sharing
risk and responsibility — pooling resources and risk to protect ourselves from
the devastating cost of illness or injury” and not about excluding bad risks,
“especially as we enter the genomic age,” when our individual genetic
predispositions to disease will be an open book.

“The nexus of globalization, the revolution in medical technology and the
seismic pressures imposed by the contradictions in our current health care
system will force radical changes whether we choose them or not. . . . The
present system is unsustainable. The only question is whether we will master the
change or it will master us.”

The first step toward recovery is to admit that one has a problem. Americans
policymakers, including senator Clinton, must stop telling the American people,
and themselves, that they have the best healthcare in the world. It is not true,
and perpetuating the myth only serves as a barrier to making it come true.

Reference: Clinton, Hillary Rodham (2004). “Now
Can We Talk About Health Care?” New York Times Magazine, April 18.

Cloning Debate

President Bush’s Council on Bioethics has released a report on therapeutic
and reproductive cloning, titled “Reproduction and Responsibility: The
Regulation of New Biotechnologies.” It recommends legislation limiting
reproduction to “the union of egg and sperm,” which would exclude reproductive
cloning and any other methods that do not involve such a union.

On the separate issue of therapeutic cloning, the Council recommends allowing
researchers to use embryos for research if they have developed for no more than
14 days after fertilization, which is an advance on what the more strident
opponents of research using embryonic material would like.

In personal statements of Council members, included in an appendix, some
criticized President Bush’s stem cell policy prohibiting the use of federal
funds for embryonic stem-cell research on any stem cell lines other than a
handful of pre-existing lines specifically approved for the purpose. Some
Council members interpret the report as reaffirming the council’s earlier
majority recommendation to place a four-year moratorium on all cloning for
biomedical research. In short, mild and cautious as it appears to try to be, the
report is being interpreted differently by different perspectives and
interests.

While America argues itself out of the stem cell therapy business, the
Australian government has issued licenses to two IVF clinics to use excess human
embryos in research, provided the embryos are no longer required for IVF
procedures and the couples concerned have given their consent.

Reference: Philipkoski, Kristen (2004). “Bioethics Panel
Nudges Lawmakers.” WIred News, April 1.

Reference: Unknown (2004). “Embryo research set to
begin.” ABC (Australian Broadcasting Corporation) News Online, April
16.

Ethics and the FDA

US Food and Drug Administration officials Robert Temple, Mark Avigan, and
Anne Trontell have admitted that they prevented their own expert from testifying
publicly that antidepressants cause some children to become suicidal because
they did not share his opinion or the findings of studies supporting that
opinion. The press was similarly denied access to the expert by the agency. Two
Republican senators are investigating the officials’ behavior, which on its face
represents bad science and bad public policy and is a further stain on the FDA’s
character following other instances of malfeasance.

Reference: Harris, Gardiner (2004). “Expert Kept
From Speaking at Antidepressant Hearing.” New York Times, April 16.

Focus on EMRs, RFID

The new head of the Centers for Medicare and Medicaid Services (CMS), the US
federal government agency that provides some health insurance for the elderly
and oversees it for some of the rapidly growing number of poor in the United
States, wants to accelerate what he regards as the inevitable widespread
adoption of electronic medical records and prescriptions. As head of the Food
and Drug Administration (FDA) before taking over at CMS, he encouraged the
pharmaceutical industry to adopt radio-frequency identification (RFID) tags into
drug packaging by 2007, to help stem drug counterfeiting.

Reference: Whiting, Rick (2004). “Focusing
On E-Payments At Medicare, Medicaid.” InformationWeek, April 5.

Nanomaterials and Health

We reported last
month that fish exposed to nanoparticles suffered brain damage; a finding
that has environmentalists calling for a moratorium on the commercial production
of nanoparticles until the environmental and health implications are better
understood. Nanoparticles are already manufactured and in use in fabrics,
sunscreens, cosmetics, and even a bowling ball.

Two other recent studies have documented lung damage in animals after they
inhaled a type of nanoparticle similar to the one used in the bowling ball.
Nanoparticles can penetrate the blood-brain barrier in humans and can penetrate
the nucleus of bacteria, many of which are essential to a healthy ecosystem.

Meanwhile, nanotechnology is already described as “business as usual” at
Intel, whose chips are fabricated with nanoscale components, reports Reuters’
Dane Hamilton. The same is true of General Electric, 3M, IBM, Hewlett-Packard,
and many other companies today, leading Merrill Lynch to create an American
Stock Exchange quoted index of 25 companies that have “a significant percent of
their future profits” in nanotech. The number of US nanotech start-ups nearly
doubled to 430 since 2001.

Reference: Leahy, Stephen (2004). “Big Concern for
Very Small Things.” Wired News, April 7.

Reference: Hamilton, Dane (2004). “Nanotech
Looms Big in Tech Companies; Not Wall Street.” Reuters, April 1.