Policy

On July 21, 2004, in Policy
A well-known technologist has rebuked President Bush’s “Stalinization” of science in America, drawing provocative
parallels between presidential science adviser John Marburger and Stalin’s
science lap-dog Viktor Lysenko. The comparison is no doubt over the top in many
respects, and seems intended to shock a complacent scientific community into
joining the 20 Nobel laureates who recently called for a return to fundamental
scientific principles uncorrupted by politics.

Disturbing signs of corrupt health policy making (in this case, mental health policy) continue to
dog the Bush administration, and the perception of corruption is not helped by
the administration’s secrecy in approving applications for “pharming” operations. Meanwhile, possible
corruption scandals at the US National
Institutes of Health go from bad to worse, and a US$5.6 billion government plan
to create and stockpile drugs for
use in a bioterror attack
seems like . . . well . . . a government plan.

Healthcare cost increases have
slowed over the past three years, but remain very high. And when you multiply the price of modern cancer drugs by the
growing number of boomers likely to benefit from them the result is patently
unsupportable. Technology makes such drugs possible, and technology must now be
brought to bear on making them affordable as well. The social consequences of
failure to do so will be incalculably bad.

A UK plan to clone human embryos to treat diabetes
has been attacked as “unfeasible.”

Bush Science Goes Soviet?

A well-known technologist has delivered a stinging rebuke to President Bush’s
“Stalinization” of science in America, drawing parallels between presidential
science adviser John Marburger and Stalin’s science lap-dog Viktor Lysenko.

In a wry reversal of Stalinization, the Russian lab that produced “the most
dangerous pathogens on Earth” during the Cold War is now a biomedical facility
working for the US government. One of its researchers discovered 46,000
different ways in which HIV could mutate in order to evade a vaccine, and then
developed a vaccine that has overcome that problem in rabbits. “The [US] State
Department,” writes Kristen Philipkoski in Wired, “will support further
tests.” In the process of developing a vaccine for the human respiratory
papilloma virus (HPV), another Russian lab invented a whole new technology for
making vaccines stronger.

Reference: Sterling, Bruce (2004). “Suicide by
Pseudoscience
.” Wired, issue 12.06, June.

Reference: Philipkoski, Kristen (2004). “Weapons Makers
Turn to Medicine
.” Wired News, June 8.

Politics Gone Mad?

Following a nearly two-years-long study of the US mental health service
delivery system, the Bush administration plans to integrate mentally ill
patients fully into the community by providing “services in the community,
rather than institutions.”* Opponents say it is more of a handout of public
funds to the drug companies than a genuinely beneficial public health
initiative, suggests Jeanne Lenzer in the British Medical Journal.

The president’s commission recommends comprehensive mental health screening
for “consumers of all ages,” including preschool children, to be followed by
treatment modeled on the Texas Medication Algorithm Project (TMAP), which
promotes the use of newer, more expensive antidepressants and antipsychotic
drugs. TMAP was founded by individuals from the pharmaceutical industry, the
University of Texas, and the Texas departments of mental health and corrections,
and funded by the Robert Wood Johnson foundation and several drug companies.

A Pennsylvania whistleblower was fired recently after revealing that state
officials with influence over the medication plan received money and perks from
drug companies with a stake in it. Other experts note that US and UK studies
suggest that using older drugs first makes more sense, clinically as well as
financially, than using the new, very expensive, and relatively untested drugs.
Drug companies have fared exceedingly well under the Bush administration, notes
one.

Case in point: Eli Lilly’s top selling antipsychotic Olanzapine (
Zyprexa) grossed US$4.28 billion worldwide in 2003, some 70 percent of
that paid for by government agencies. George Bush Sr. was a member of Lilly’s
board of directors and Bush Jr. appointed Lilly’s chief executive officer to the
Homeland Security Council, while “Lilly made $1.6m in political contributions in
2000 – 82% of which went to Bush and the Republican Party,” writes Lenzer. While
identifying and treating mentally ill children at an earlier age is a laudable
goal, exorbitant and possibly unnecessary spending on new drugs “robs from other
forms of care such as job training and shelter programs,” as one of Lenzer’s
correspondents put it.

*See the March 2004 progress report entitled
New Freedom Initiative.

Reference: Lenzer, Jeanne (2004). “Bush plans to
screen whole US population for mental illness
.” British Medical Journal,
June 19.

Down on the Pharm

The Center for Science in the Public Interest has criticized the Bush
administration’s secrecy about its approval process for growing crops
genetically modified to produce drugs. Although the US Department of Agriculture
says the process will be made more open, “activist groups are skeptical,” writed
Kristen Philipkoski in Wired. A senior scientist with the Center for Food
Safety complains that “We’ve seen no public risk assessment of any kind about
what the potential hazards are.”

Details such as where the “pharms” are located, their acreage, their intended
products, and the potential hazards are not disclosed to the public. The
“pharmers” have a legitimate concern about vandalism and sabotage, but that must
be weighed against the wider public health interest.

Reference: Philipkoski, Kristen (2004). “How Tough Are
the Crop Cops
?” Wired News, June 2.

NIH Ethics

Scandal involving ethics at the US National Institutes of Health gets worse,
indicates an article by Rick Weiss in the Washington Post. The agency’s
top legal and ethics officials are already under fire for allowing researchers
to strike lucrative consulting deals with pharmaceutical and biotech companies;
now, it turns out that some researchers (including one who received US$517,000)
didn’t even bother to ask permission, that one who swore he had suspended a
suspect deal turns out to have continued receiving largesse, and that he and
others appear to have illegally used federal resources for personal gain.

The revelations have led NIH Director Elias A. Zerhouni to conclude that
“drastic changes are needed,” and the House subcommittee investigating the
issues to widen its probe to include 15 other federal agencies.

Reference: Weiss, Rick (2004). “NIH
Scientists Broke Rules, Panel Says: Deals With Companies Went Unreported, Probe
of Potential Conflicts of Interest Finds
.” Washington Post, June 23.

Bioterror Drugs

The US government is proposing to spend US$5.6 billion over the coming decade
for manufacturing and stockpiling bioterrorism drugs. However, points out
Wired‘s Randy Dotinga, “a single cholesterol drug — Lipitor — rakes in
$9 billion in revenue each year,” so the government plan seems somewhat
underfunded.

The so-called BioShield bill, which authorizes the spending, could become law
soon. It also allows waivers to let drug companies to bypass years of testing if
there is a national emergency. One problem is that drugs to treat chronic
conditions are much more profitable than drugs that treat acute ones. BioShield
will indemnify manufacturers, meaning the government would be on the hook if
something goes wrong, and would pay companies even if no one ever needs to take
one of their new drugs, vaccines or antitoxins.

But analysts point out that government is not likely to compete successfully
against a market handsomely funding biotech development for potential
blockbusters.

Reference: Dotinga, Randy (2004). “Wanted: Drugs to
Fight Bioterror
.” Wired News, June 2.

Health Care Costs Slowing

US healthcare spending per privately insured person increased 7.4 percent in
2003, down from a 9.5 percent rise in 2002 and 10 percent gain in 2001,
according to a report by the Center for Studying Health System Change. Though
falling, the growth rate remains historically high, notes Theresa Agovino of the
Associated Press, and is much higher than inflation (1.9 percent in 2003). In
short, healthcare is still very hard to afford.

Spending on hospital outpatient centers rose 11 percent in 2003, compared to
12.9 percent in 2002; but again, the increase — which the Center attributes to
technology — is still very high.

Reference: Agovino, Theresa (2004). “Growth
in Health Care Spending Again Drops
.” Associated Press via Washington Post,
June 9.

Costs of the War on Cancer

“Ten years ago,” writes Matthew Herper in Forbes, “doctors could
extend the life of a patient who had failed to respond to chemotherapy several
times by an average 11.5 months using a combination of drugs that cost $500 in
today’s dollars. Now, new medicines such as Avastin and Eloxatin can extend
survival to 22.5 months, but at a total cost of $250,000. And that doesn’t
include pharmacy markups, salaries for doctors and nurses, and the cost of
infusing the drugs into patients in the hospital.”

At those prices, there is absolutely no way society can afford to treat
cancer as a chronic disease, yet doctors and the pharmaceutical industry have no
choice but to move in that direction. It might be more affordable if
pharmacogenomics could determine exactly who will and will not benefit from
specific drugs, but we are not there yet.

In the meantime, one expert told Herper, “We’re going to have to stop taking
the stance that every patient has to get every last shot at survival. The days
of developing drugs and not worrying what they cost are over.”

Reference: Herper, Matthew (2004). “Cancer’s
Cost Crisis
.” Forbes, June 8.

UK Asked to Approve Cloning for Stem Cell
Research

The British government’s Human Fertilisation and Embryology Authority has met
to consider the first application to clone human embryos. Newcastle University
researchers have applied for permission to clone human embryos in order to
harvest embryonic stem cells for diabetes therapy.

Therapeutic cloning is legal in the UK but only, reports Ian Sample in the
Guardian, on condition that the work meets at least one of three tests:
that it will increase our understanding of how embryos develop, improve our
knowledge of serious disease, or enable the development of treatments for
serious disease. In addition, the embryos must be destroyed before they are 14
days old, “when they are a ball of cells no larger than a pinhead.”

The Newcastle team intends to replace the genetic material in unfertilized
eggs (obtained as surplus from IVF clinics) with genetic material from the skin
cells of diabetics. After six to eight days, the eggs develop into a ball of
around 100 embryonic stem cells, which will then be treated with growth
promoters to turn them into insulin-producing pancreas cells for implantation
into the diabetic patient. Since their genetic material comes from the patient
in the first place, there is no risk of rejection.

Detractors told Sample: “It’s . . . giving diabetics false hopes. You would
need around 35m human eggs to treat everyone in the UK with diabetes. It’s
totally unfeasible,” and “It is very unlikely to produce anything medically
useful.”

Reference: Sample, Ian (2004). “Human
embryo research plan is first of its kind
.” Guardian, June 17.

 

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