But it continues to take ethical missteps. While it may be no surprise to
learn that a member of the US Congress appears to be a participant in
pharmaceutical industry corruption, it is a shock to learn that a respected medical journal has got with the
program, too.

When a major academy offers exclusivity to a device
maker, competition and patient choice (not to mention academic objectivity) may
be casualties. On the other hand, if they don’t, perhaps the business world will
simply create and finance its own
academies.

The creation by Korean scientists of human clone embryos and the extraction
from them of stem cells for therapeutic purposes keeps the spotlight on the Bush
administration’s foot-dragging on the issue, which now extends beyond therapy to
the question of declining US leadership in medical science and technology, and
perhaps in medical ethics as well. Given the Bush restrictions, two states are putting their own money into
stem cell research. The Bush administration is under further attack by a phalanx
of Nobel laureates and other leading scientists for its alleged abrogation of the fundamental
scientific principle of objectivity.

The apparent fact that industrial robots are becoming a commodity may
partially explain the current US jobless recovery. As for industrial
robots in healthcare, mounting evidence of the beneficial outcomes of robot-assisted surgeries prompts one surgeon
to predict their adoption for most basic procedures in five years. On the other
hand, at more than a million US dollars each and absent competition, today’s
monopoly surgical robot, the da Vinci,
may not become a commodity any time soon, unlike pharmacy robots and
(potentially) lab robots.

“It seems obvious,” a healthcare economist told the Memphis Business
Journal‘s David Royer, “that the aging of the baby boomers will cause the
demand [for hospital beds] to outstrip supply . . . if technology remains
constant.” The economist warns, writes Royer, that “simply looking at a
population-based model is too simple,” and that advances in medical technology
constitute a wild card. This is almost the point we keep hammering in the
Digest: Predictions (such as a 2003 American Hospital Association study
claiming that the boomers will increase the average hospital stay by seven
percent over ten years) are suspect if they do not take account of future
technologies. The technologies are a wild card only to the extent they are not
understood and their likely impacts not seriously studied.

A hospital executive also told Royer that technological advances were crucial
to keeping up with demand, and suggested a way hospitals could finance the
acquisition of new technologies: “If we reduce length of stay by half a day, we
free up 25 extra beds. Instead of building beds, we can use that money to buy
technology.”

Reference: Royer, David (2004). “Despite
longer hospital stays, number of beds shrinking.” Memphis Business Journal,
February 13.

Drug Discovery Costs and Technology

The Digest‘s confidence that technology has led and will continue,
exponentially, to lead to breakthroughs in healthcare was somewhat shaken by a
recent Wall Street Journal article presenting evidence that the promise
of faster, better, more prolific drug discovery using “lab chips,” robots, and
combinatorial chemistry has not, in fact, been kept; and that this failure at
least partly accounts for the drop in the number of new drugs approved by the
FDA since the pharmaceutical industry began installing automation.

The reasons Peter Landers cites for the failure — machines’ inability to
spot the serendipitous side effect (as Fleming spotted penicillin), chemists’
tendency to become “fixated” on the quantity of experiments facilitated by
automation rather than on their quality, and limitations on the machines’
ability to handle water-soluble chemicals — are clearly valid, or have been
valid. But they are not likely to be show-stoppers. Inadequacies in the
technologies will be addressed and overcome, and quality will improve. The
abilities of the intelligent robot chemist reported elsewhere in this issue
attests to that.

Those most opposed to combinatorial chemistry and high-throughput screening
believe it eliminates chances for serendipity, writes Landers. He quotes a Nobel
laureate in medicine: “That is what the modern pharmaceutical industry throws
out: intuition and intellectual creativity. It replaces intellectual creativity
with a robot — a highly sophisticated robot, admittedly — but a robot can
never have intuition.” The articles in this month’s Robotics section
would seem to us, with the greatest respect, to suggest that “never” may be an
incautious word.

According to a senior vice president at Pfizer’s research labs, recent data
on throughput suggests that their efforts to improve the technology is working.
“The proof of the pudding will be in 10 years’ time,” he told Landers, adding
“We’re very confident.” His equivalent at Bristol-Myers is equally confident: “I
anticipate that we will see a renaissance of new compounds coming onto the
marketplace. It took a while to learn how to use all these new
technologies.”

Some note that other factors may also be responsible for the drought in new
drugs; for example, the difficulty of testing complex human diseases such as
AIDS and Alzheimer’s in mice, and higher FDA safety and efficacy standards than
before. Still, we think Landers has analyzed the situation well, that the
technology does need to improve, and that it will.

The Wall Street Journal‘s Julia Flynn sees “seismic” shifts in the
pharmaceutical industry stemming from megamergers and technological advances in
drug discovery. For one thing, technology has helped make it “much harder for an
individual scientist to hit a home run.” She compares and contrasts the
experience of the man who discovered Valium after years of mixing compounds by
hand in enamel kettles and testing them on himself. His footsteps-following son
uses combinatorial chemistry, “rational drug design,” and robotic systems to do
the mixing and screening.

“Drugs came to market much faster before 1963, when a law requiring more
rigorous testing took effect. Before that, the clinical phase of testing took an
average of 2.8 years . . . . Now, it takes six or more years, and far more drugs
drop out during trials. Chemists can toil a lifetime without producing a
marketable medicine,” writes Flynn.

Reference: Landers, Peter (2004). “Drug
Industry’s Big Push Into Technology Falls Short: Testing Machines Were Built To
Streamline Research — But May Be Stifling It.” Wall Street Journal,
February 24.

Reference: Flynn, Julia (2004). “In Two
Generations, Drug Research Sees a Big Shift.” Wall Street Journal, February
11.

Ethics

During a talk I gave to a group of pharmaceutical sales executives in 2001
about the impact of technology trends on their business, one of them asked:
“What should be keeping us awake at night?” Given what I had read about the
state of ethics in their profession, my answer should have been, but to my shame
was not, “Your consciences.” Perhaps because folks like me have been too
concerned about our own careers to risk speaking out, unethical practices
persist in organizations that sell to the healthcare industry. They include even
research journals, which we usually think of as august, dignified, and
incorruptible entities.

The Washington Post recently reported that a marketing executive at a
journal whose parent company was beholden to a drug maker for revenues from
advertising had prevented the journal’s editors from publishing a scientific
paper questioning the safety of a kidney drug on which Medicare was on the verge
of spending maybe a hundred million dollars more year. Greatly to his credit, an
editor at the journal spoke out; but if scientific progress has to depend on
whistleblowers willing to risk their jobs and careers, then we are in bad shape.

“Even the most jaded of eyebrows,” says a Los Angeles Times reporter,
are raised when the pharmaceutical industry bribes the people’s representatives.
A cases in point was an offer to Louisiana congressman Billy Tauzin to become
the extremely well-paid head of the Pharmaceutical Research and Manufacturers of
America (PhRMA), in which capacity he would lobby on issues that he has overseen
as chairman of the House Energy and Commerce Committee. Worse, it appears that
negotiations on the offer were underway for some time while Rep. Tauzin was
helping to write prescription drug coverage provisions in the new Medicare bill,
decried by its critics as a taxpayer handout to the pharmaceutical industry.
Only two months prior to this flap, says the LA Times report, the Bush
administration’s top Medicare official, Tom Scully, resigned to join a law firm
specializing in healthcare; and these cases are just the tip of an iceberg of
congressional members and staffers parlaying their knowledge, expertise, and
relationships into lucrative corporate jobs.

While there is some anger in Congress about the Tauzin case, it seems
directed more at the blatancy than at the substance of the corruption.

Reference: Vedantam, Shankar (2004). “Business,
Science Clash at Medical Journal.” Washington Post, February 7.

Reference: Hook, Janet (2004). “Lobbyist
Offers Make Jaws Drop.” LA Times, February 9.

Privatization of Academic Medical
Schools

The Indianapolis Star reports that Johns Hopkins University School of
Medicine will be “home to the Zimmer Institute teaching facility. Zimmer
Holdings Inc., a producer of orthopedic implants and surgical products,
announced a partnership with the university, in which orthopedic surgeons will
be trained to use Zimmer technologies and participate in product refinement
projects.”

One hopes this will not be to the detriment of competition in such devices,
or to the availability of the best orthopedic technologies to surgeons and their
patients. One can see the mutual benefits of vendors providing technology to
institutions for training, provided it is inclusive of all vendors.

Reference: Unknown (2004). “Zimmer’s teaching
facility to be at Johns Hopkins.” Indianapolis Star, February 4.

Corporate Research

A businessman has invested US$50 million over the past seven years in an
“unorthodox” team of researchers pursuing therapeutic cloning, stem cell
medicine, genetic engineering, and other leading edge medical technologies. A
surmised endowment of his $3 billion fortune would provide upwards of $150
million a year to the team.

The investor also owns an upscale clinic, labs, and a pharmacy, giving the
wealthy patients at his clinic “one-stop-shop” access presumably to the fruits
of a slew of biotech, agricultural biotech, stem cells, livestock cloning,
“regenerative medicine” companies, and a non-profit longevity research institute
also acquired or established by him.

The institute is engineering a long-lived supermouse as a first step in its
“Manhattan Project” to increase the human lifespan. The investor, says
Wired‘s Brian Alexander, “is freelancing biology on an unprecedented
scale. He doesn’t answer to a government agency or a board of directors — just
his own bank account. He’s free to say whatever he chooses.” And among the
things he chooses to say is that issues like therapeutic cloning and stem cells
“became a philosophical construct with George Bush’s election, [who] decided to
impose a fundamentalist Christian ethic on the scientific community.”

Reference: Alexander, Brian (2004). “John Sperling
Wants You to Live Forever: And he’s Promising $3 billion to make it so.”
Wired, Issue 12.02, February.

Therapeutic and Research Cloning

Perhaps the biggest health futures-related news last month, if media response
(including no fewer than three articles by Wired‘s Kristen Philipkoski)
was that Korean researchers have created a human clone and derived stem cells
from it. We reported a similar
achievement by Advanced Cell Technology, in January, but ACT did not extract
and grow a stem cell line as the Koreans have done.

“The United States is supposed to be the most scientifically and
technologically advanced country in the world,” one expert told Philipkoski, so
how come it was South Korean and not American scientists, who were first to
develop cells “that could lead to the biggest revolution medicine has ever
seen?” One reason, she notes, is the lack of support from the federal
government. President Bush’s moratorium on spending federal funds to develop new
embryonic stem-cell lines and his apparent support for a ban on all cloning
research, including therapeutic cloning, is favored by some religious and
anti-abortion groups. The Koreans have a different ethic: “Our inspiration is to
treat incurable diseases,” said one of the team. “As scientists, we believe that
this study is our responsibility and moral obligation.”

On the other hand, according to Rick Weiss of the Washington Post,
many scientists say that therapeutic cloning is far down the list of reasons
they want to clone human embryos.” They are more interested in cloning (in part
because of the US government’s foot-dragging on therapeutic applications) as a
technique to aid basic research into diseases, which could speed the development
of drug therapies without the need to break new technical and regulatory ground.

The idea is to clone embryos from patients with a disease, harvest stem cells
from the clone embryo, and differentiate them into the cells of interest,
thereby giving researchers “an unprecedented opportunity to watch the disease
unfold outside a person, and to test whether certain classes of chemicals or
drugs might slow or prevent the process.” They could inject the cloned cells
into mice and watch how the cells develop and respond to drugs, and “study them
not only in a dish but in the context of the kind of organ in which they
normally find themselves,” according to a senior Stanford researcher. They could
also tinker with the genetic structure of the cloned cells to find a genetic
cure. Not least, they could expose the cells to hypothesized environmental
determinants of disease such as pollutants and stress hormones to see exactly
how they contribute. “This use of clones has been totally missed by the public
but is of extreme importance to really understand the molecular basis of
disease,” said the Stanford researcher.

Such experiments are specifically allowed in the UK despite an otherwise
broad ban on cloning research, but are not allowed in the US if federal funds
are involved. The federal ban and public controversy may be having a chilling
effect, as well, on private sector-funded research in the US, guaranteeing that
many future advances in healthcare will come from abroad.

Reference: Philipkoski, Kristen (2004) “Human Clone
Produces Stem Cells.” Wired News, February 11.

Reference: Philipkoski, Kristen (2004) “The Truth Behind
Fear and Cloning.” Wired News, February 12.

Reference: Philipkoski, Kristen (2004) “Why Cloning Didn’t
Happen in U.S.” Wired News, February 13.

Reference: Weiss, Rick (2004). “Cloned
Embryos Could Help Explain Basis for Diseases: Scientists Expect to Determine
Causes, Develop Therapies by Watching Progress of Illness in Cells Implanted in
Mice.” Washington Post, February 23.

New Jersey to Finance Stem Cell Research

The state of New Jersey will spend $6.5 million on a new stem-cell research
institute, according to the New York Times, and a further $50 million
over the next five years on human embryonic stem cell research. A California
ballot initiative also proposes to spend state money — $3 billion over ten
years — on stem-cell research.

Reference: Associated Press (2004). “New Jersey to
Research Stem Cells.” Wired News, February 22.

Science and the Public Interest

Some 60 scientists, including 20 Nobel laureates, say that in order to
justify policy decisions on the environment, health, biomedical research, and
nuclear weapons, the Bush administration has deliberately undermined science,
distorted and suppressed scientific findings, stacked scientific review panels
with politically biased, venal, and underqualified scientists, and eliminated
some advisory committees altogether. A report issued by the Union of Concerned
Scientists presents evidence in support of its accusations. President Bush’s
science adviser, though troubled that some very prestigious scientists signed
the statement, maintains it is they who are biased, according to Wired‘s
Kristen Philipkoski.

Earlier in the month, Philipkoski also wrote about a Bush administration
proposal to extend the scientific peer-review process uniformly through federal

agencies, that would allow the government to stack peer-review panels for
federally-funded projects with scientists beholden to government and industry
(according to its critics) and would eliminate the top experts in a given field
from participation in the panels.

Because it would also require many reports to undergo peer review that
currently do not, it could also “dangerously slow down the process of warning
the public about health dangers,” said a regulatory affairs counsel for Public
Citizen. “This is explicitly taking control over when the public health and
environmental agencies can make an announcement to the public. . . . You would
have to go through peer review before disseminating that information to the
public unless peer review is waived.”

Industry groups such as the Gas Appliance Manufacturers Association and the
Industrial Minerals Association favor the Bush proposal. Scientific and
environmental groups including the American Academy for the Advancement of
Science, the National Academy of Sciences, and the Natural Resources Defense
Council oppose it.

This controversy follows close on the heels of controversy over President
Bush’s Council on Bioethics report “Beyond Therapy.” To many critics —
including this writer, who has studied it — that report shows signs of
ideological and religious bias.

Reference: Philipkoski, Kristen (2004). “Stacking the Deck
Against Science.” Wired News, February 3.

Reference: Philipkoski, Kristen (2004). “Scientists: Bush
Distorts Science.” Wired News, February 18.

Jobless Recovery

New orders for industrial robots were up 28 percent to 10,382 in the first
three quarters of 2003, writes Rick Barrett in the Milwaukee Journal
Sentinel, citing the (US) Robotics Industries Association, which opined
further that the rising cost of employee health insurance is among factors
driving manufacturers to buy new or used robots or retrofit their existing older
robots.

“Once you get a company’s management to buy into robots,” said an RIA
executive, “they become believers. They don’t have fears about getting a second
system.” Industrial robots are now “almost . . . a commodity,” ubiquitous enough
that a handful of engineers left well-paid jobs at a major industrial robotics
company, Sweden’s ABB, to found their own small robot repair business when ABB
moved a US operation from Wisconsin to Michigan.

Reference: Barrett, Rick (2004). “Robotics, and home,
their thing: Trio begins fixing robots in New Berlin after employer moves.”
Milwaukee Journal Sentinel, February 1.

Robotic Surgery To Become the Norm

The Mayo Clinic has achieved positive results using robot-assisted
laparoscopic sacrocolpopexy to correct the vaginal vault prolapse that sometimes
follows hysterectomy. The procedure is “markedly less painful,” makes “a strong
repair,” requires only an overnight hospital stay, is less likely to result in a
recurrence of the prolapse, and has a fast recovery time. In contrast,
traditional surgery requires a four- to five-day hospital stay, a sizable
abdominal incision, and a recovery period of about six weeks. With the robot,
the surgeon has a better 3-D view, more maneuverability, and more control over
tremor.

The University of Michigan has found similar benefits for robot-assisted
surgeries to repair abnormally-formed blood vessels or to insert a pacemaker in
children, who spent less time in hospital and suffered reduced complications. At
present, however, the size of the robot probes precludes their use on children
under about a year old. The robot operations took longer, but some children in
the study returned home in a much shorter time than children undergoing the same
procedure with open chest techniques. A surgeon involved in the study said: “In
five or so years, perhaps we’ll perform most of the basic procedures with the
robot’s help,” reports the BBC.

Reference: Mayo Clinic (2004). “Robot
does quick fix on post-hysterectomy, sagging vagina.” Science Blog, February
22.

Reference: Unknown (2004). “Robot op
‘shortens hospital stay’.” BBC News, February 1.

Robot Costs

Sales of the four-year-old, US$1.2 million da Vinci surgical robot took off
last year, writes Bernard Wysocki in the Wall Street Journal. Just over
200 have been sold world-wide, 61 of them last year. But even surgeons wowed by
its ability to let them perform minimally invasive procedures complain about its
price. Since patients are becoming savvy enough to ask for it, and its maker
bought its chief rival last year, the maker has no competitive incentive to
lower the price.

Besides the cost of the hardware, doctors and staff need to be trained,
procedures often take longer than traditional surgeries, and more medical
personnel are needed in the operating room. Against this, faster recovery from
robotic surgery lowers postoperative costs such as nursing care.

Reference: Wysocki, Bernard (2004). “Robots
Assist Heart Surgeons.” Wall Street Journal, February 26.

Robotic Pharmacies Take Off

A US robotic pharmacy dispensing unit manufacturer currently has fewer than
20 of its machines installed in retail pharmacies — but has orders in hand for
400 more and by year’s end expects to sell 1,200 more. The US$185,000 machines
automatically dispense, cap, label, and alphabetically sort 240 prescriptions an
hour. Pharmacy workers, take note.

Reference: Fisher, Jean P. (2004). “Parata
Systems reports fast growth.” News & Observer, February 20.

Hospital Installs Automated Lab

Florida’s Martin Memorial Health Systems has installed a US$1.2 million
robotic lab to test patient blood and fluid samples and virtually eliminate
human error at the same time. “It’s going to save us dollars and improve patient
care. It’s a huge deal,” the hospital’s president told Susan Port of the Palm
Beach Post.

The German-built system can perform at least 10,000 tests a day and has
eliminated two of the three technicians who used to staff the lab. Lab
technicians, take note.

Reference: Port, Susan (2004). “Martin
Memorial gets automated lab.” Palm Beach Post, February 26.