Therapeutics

On July 21, 2004, in Therapeutics
New York cyborgs are reaping substantial benefits from their implanted “brain pacemakers” in the form of
significant relief of Parkinson’s and other tremors. Epileptic cyborgs implanted
with similar technology are proving that thought control of remote objects is
getting closer to becoming a real therapeutic tool.

Even before “telehaptics” (transmitting the sense of touch remotely) becomes
common, physical therapy for
recovering stroke victims is possible via computer games and the Internet.

The field of artificial organs is
not progressing as fast right now as some anticipated, but it is progressing, as
is the growing of replacement
teeth
.

The Bush administration’s arbitrary barriers to stem cell research in the US
have not halted the research completely. One team has successfully created lines
of genetically defective stem cells,
which will aid research into therapies for the diseases they cause.

Leading Alzheimer’s researchers are less confident of quick results from stem
cell therapies than they are of other treatments that will be “much more
effective” than today’s treatments, in “five years, or certainly 10.”

Wyeth says it has 68 drugs in the
pipeline
— some new, and some new uses for old. But a drug does not have to
be very old to find new uses. Rituxan, approved for non-Hodgkin’s
lymphoma, turns out to be quite effective against rheumatoid
arthritis
. We reported in November 2003, however, that an experimental drug
is showing even more promise against lymphoma and could also be effective for
arthritis.

We have previously reported on several initiatives to develop technologies
that record every waking moment, event, communication, and activity of a
person’s life. Microsoft is now applying the concept to help memory-impaired
patients.

“Cyborgs of New York”

Deep-brain stimulation of patients fitted with hair-thin electrodes inserted
into the brain and connected by thin wires to neurostimulators (so-called “brain
pacemakers”) implanted under the skin in the chest or shoulder to control
tremors has resulted in marked improvements in Parkinson’s, essential tremor,
and dystonia patients over several years.

A dystonia sufferer told Steve Ditlea of the New York Daily News:
“[The surgeon] practically hit the switch [following the implant procedure] and
I was better.” A Parkinson’s patient said he could now shave “without
decapitating myself.” The results have been “encouraging enough for similar
treatments to have been given, successfully, to sufferers of Tourette’s
syndrome, epilepsy, migraine, even severe depression,” writes Ditlea; adding
that “The latest clinical wisdom is that treatment should include a brain
implant for each of the body’s sides,” at a cost of US$20,000 per side. The
entire operation can cost $80,000 to $100,000.

Deep-brain stimulation has an even higher success rate for essential tremor
and dystonia than for Parkinson’s, and as clinical experience grows, the
procedure may eventually be offered to patients at earlier stages of their
disease, at least until “things like gene therapy, growth factor infusion or
cellular transplantation, aimed at restoring the neural function that’s lost”
arrive.

Reference: Ditlea, Steve (2004). “Cyborgs
of New York
.” New York Daily News, June 9.

Thought Control

In yet another study of “thought control” via brain chip implants, four
epileptic volunteers were able to control a video game just by thinking. This
study differed from others in that the implants were done on the surface of the
brain rather than deep inside. “It took six minutes of training and they all
achieved control in less than 24 minutes,” one of the researchers told Reuters’
Maggie Fox. “They achieved between 74 and 100 percent accuracy, with one patient
hitting 33 out of 33 targets correctly in a row.”

The researchers centered about 32 electrodes over the sensory motor cortex
and the speech-related Broca’s area. The entire study cost only about
US$20,000.

Reference: Fox, Maggie (2004). “Patients
Control Video with Thought Alone in Study
.” Reuters, June 14.

Technology-assisted Therapy

After two weeks of playing a computer game for up to four hours a day, a
stroke victim with a paralyzed hand “made as much progress as in the previous
two years, regaining the ability to point, grab the handle of a pulley exercise
system, and touch each finger to his thumb,” reports Kimberly Moy in the
Boston Globe.

“Home-based computer therapy programs are now under design across the country
to help stroke victims, people with psychological problems, and disabled
children, among others,” she writes, and patients’ progress can be automatically
assessed via an Internet connection to their doctors.

Besides online physical therapy, online psychotherapy is also predicted to
grow as both patients and therapists grow increasingly web-literate, and as the
cost of hiring a physical therapist or going to an outpatient clinic grows. As
always, however, there are those who caution against a reliance on machines and
insist that human intervention is needed at some point. A point raised by one is
that “if the person is so motivated to go through this Web site and do these
things, they wouldn’t be depressed,” which — it seems to us — could be said
equally of the motivation to visit a therapist.

Reference: Moy, Kimberly W. (2004). “Doctors
assign computer homework
.” Boston Globe, June 22.

Artificial Organs Progress Report

“Why, half a century after the first kidney transplant, have not we developed
a wide range of artificial organs that can be implanted in patients, just as
organs from human donors are?” asks Scott Kirsner in the Boston Globe. An
artificial organ researcher responded: ”If we were talking 10 years ago, I’d
have said that the impact, commercially and medically, of tissue engineering and
organ replacement by 2005 would be significant, . . . we were just overly
optimistic.”

Patience! The field is making progress. Mass. General’s Laboratory for Tissue
Engineering and Organ Fabrication is beginning to implant prototype artificial
livers made up of polymers and living cells into rats. It was built using
semiconductor manufacturing techniques to create microscopic channels through
which blood can flow — which sounds very similar to the “animal on a chip”
reported in our last issue, only in this case the goal is that the biodegradable
polymer will eventually dissolve into the body, to be replaced by regular liver
cells.

Nephros Therapeutics, applying research done at the University of Michigan,
is testing an external artificial kidney* to treat acute renal failure. Nephros
has begun a 12-month clinical trial on 100 patients. After tacking the acute
market, the company intends to improve its device to replace dialysis machines,
and after that, to make an implantable device. Even that will not be the end of
the story: the Holy Grail is a way to get the body, perhaps using stem cells, to
regenerate natural, healthy kidneys.

* See also “Cyborgans” in the August 2003
issue.

Reference: Kirsner, Scott (2004). “Hopes
high for artificial organs, despite slow going
.” Boston Globe, June 7.

Dental Regeneration

A team at King’s College London is one of several teams worldwide attempting
to grow replacement teeth, writes James Randerson in New Scientist. It
combined bone marrow stem cells from young mice with epithelial cells from the
mouths of embryonic mice to create “artificial” tooth primordia which, when
transferred into the kidneys of other mice, grew into intact teeth. “Real”
(non-engineered) primordia taken from embryos have been shown to develop
normally when placed in the jaw of an adult mouse, but the attempt has yet to be
made using the engineered primordial.

As always, getting from mouse to man will not be easy, but the proof of
principle is almost there. A team at the Forsyth Institute in Boston, which was
the first to show that tooth primordia from pigs could develop in the abdomens
of mice, is investigating whether developing engineered teeth can be molded into
the right shape.

Reference: Randerson, James (2004). “Tooth growing
experiments bring smiles
.” New Scientist, June 24.

Mutant Cell Lines Created in US

Presumably (given the Bush administration’s policy against funding research
on stem cells involving all but a handful of aging cell lines) with private
funding, US scientists have created 12 human stem cell lines from genetically
flawed human embryos in hopes of shedding light on diseases and to test new
treatments. It may not be the first to do so, though it is the first to announce
so.

New Scientist,” Shaoni Bhattacharya writes in that magazine, “has
learned that one group in the UK has already created a line for cystic
fibrosis,” and is planning to create one for Huntington’s disease.

The US cell lines were produced from embryos discarded from in-vitro
fertilization procedures when pre-implantation genetic diagnosis revealed they
carried single-gene mutations for two forms of muscular dystrophy that affect
children and adults, thalassemia, Fanconi anemia, Fragile X syndrome, Marfan
syndrome and a type of neurofibromatosis. Scientists will now be better able to
study and test gene therapies and help design new drugs and toxicological
screening technologies for those diseases.

Reference: Bhattacharya, Shaoni (2004). “Mutant human stem
cell lines created
.” New Scientist, June 11.

Reference: Unknown (2004). “Embryos Yield
New Stem Cell Lines
.” Associated Press via Wired News, June 9.

Stem Cell Therapy for Alzheimer’s May Take a
While

The chair of the Medical and Scientific Advisory Council of the Alzheimer’s
Association thinks “everybody feels there are higher priorities for seeking
effective treatments for Alzheimer’s disease and for identifying preventive
strategies” than stem cell therapy research. Such priorities may include efforts
to attack the buildup of amyloid plaque and methods for early diagnosis, which
could pay off within “five or 10 years, earlier than any expected advances from
stem cells,” says an Associated Press article citing the experts.

A vaccine that causes the immune system to attack amyloid produced
encouraging results in animal studies, but failed safety trials in human in
2002. However, work is continuing to make the vaccine safer. Another approach
being pursued by “every major drug company” aims to stop the brain from making
the plaque-forming form of amyloid. Such efforts are resulting in “just enormous
optimism that in five years, or certainly 10 years, we’ll have much more
effective treatments,” said the expert.

Reference: Unknown (2004). “Alzheimer’s:
Beyond Stem Cells
.” Associated Press via Wired News, June 11.

Drugs in the Pipeline

Wyeth Pharmaceuticals is working on 68 drugs, including new molecular
compounds, vaccines, and new uses for existing drugs, reports Linda Loyd in the
Philadelphia Inquirer. Seven potential blockbuster drugs are in late-stage
testing. The company says it “intends to file more applications for new drugs
over the next 21/2 years than it has in any similar period.”

First to market, possibly this year, is Tygacil, an injectable
antibiotic for drug-resistant bacteria. That may be followed next year by
bazedoxifene for osteoporosis. Seven drugs that could be out in 2006 are new
molecular entities, including an antidepressant (DVS-233, intended to
replace Effexor) and bifeprunox for schizophrenia.

Wyeth is also working on new uses for Effexor (to treat panic
disorder); Enbrel (for psoriasis, pulmonary fibrosis and asthma);
Rapamune (for liver transplants); Prevnar (as a pneumonia vaccine
for adults and not just children as now); and ReFacto AF (as an
albumin-free hemophilia drug).

Reference: Loyd, Linda (2004). “Wyeth
tells of a pipeline of its blockbusters-to-be
.” Philadelphia Inquirer, June
3.

Targeting Rheumatoid Arthritis

An international study of rituximab (Rituxan) is hailed by the
president of the Arthritis Foundation as “a pivotal study. . . . opening up a
new era of targeted biologic therapies for rheumatoid arthritis,” reports Jeff
Donn of the Associated Press. After six months, more than 40 percent of patients
who took rituximab combinations were greatly improved. One-third of
patients on rituximab alone were greatly improved. But only 13 percent of
those on the standard drug methotrexate alone improved that much.

However, some doctors, including the study’s authors, said rituximab
needs more testing before any widespread use and noted that other drugs under
development could eventually outperform rituximab.

Reference: Donn, Jeff (2004). “Drug
Appears Effective Against Arthritis
.” Associated Press via Washington Post,
June 16.

A Health Application for LifeLog

Microsoft’s laboratory at Cambridge University is developing a device to
complement therapies for patients with short term memory problems caused by
Alzheimer’s, head injuries, etc. SenseCam will maintain a visual diary of
everything the patient sees and does, enabling the patient to reconstitute a
memory and, it is assumed, thereby improve the quality of life. The device is
about the size of a small camera (and is to be considerably shrunk later) and is
worn around the neck. It contains a wide angle camera activated by infrared,
motion, and light detectors in response to movement, changing light levels, and
the presence of another person or animal.

Reference: Sherriff, Lucy (2004). “Alzheimer’s
patients to trial MS labs life-blog gadget
.” The Register, June 11.

See also previous articles in HFD on:
Nokia’s plan to let camera phone users automatically store and catalog all their
messages, images, videos, and sound clips collaborative agents; AI bots that
help mothers cope with the stresses of caring for cancer-stricken children;
Spyglass spectacles sporting a hidden camera record everything the wearer sees;
DARPA’s now officially abandoned LifeLog; and Thinking Machines that watch
everything you do, learn everything they can about you, and (you hope) help you
in whatever way they can.

 

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