Other developments in therapeutics:

• The discovery of cancer stem cellshas led to promising research into ways to eliminate them. 

   

• The artificial bloodsubstitute PolyHeme has received federal funding to complete clinical trials. 

   

• A potential cancer “vaccine”attracts an additional US$50 million in investment capital. Is this a case of having more money than sense? A high-stakes gamble? Pure philanthropy? Might the investor know something we don’t? Whatever; the important thing is it’s a goodly sum that will at least lead to the resolution of several questions. 

   

• The market for implantable neurostimulators to manage chronic painappears to be growing rapidly, and may come at the expense of the pharmaceutical industry, whose drugs are not up to the task. 

   

• A number of drugs under active clinical trials appear to have a good shot at eliminatinga very large number of cardiovascular and peripheral vascular procedures. Perhaps these drugs will once and for all resolve the turf wars between interventional cardiologists, radiologists, and vascular surgeons. 

   

• Plaque-shaving and cryoplastyhave shown early promise over angioplasty, stenting, and leg bypass procedures for treating peripheral arterial disease. 

   

• The future of medicine may lie in unlocking the secrets of self-healing. All the medicine we need is already inside us. We just don’t know how to unlock it. 

   

• Toronto researchers appear to have made a breakthrough in functional electrical stimulationto help paralyzed patients regain limb movement. 

   

• Toothpaste giant Colgate hopes to deliver genetic therapy in a mouthwash.

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Surgeons in France have performed the first face transplant, on a 38-year-old woman who lost her nose, lips, and chin after being savaged by a dog. The microsurgical techniques necessary for the procedure have been available for some years, but ethical concerns and concerns relating to immunosuppression, psychological impact, and the consequence of technical failure held things up.

Among the ethical and moral issues is the need to obtain the transplant from a beating heart donor, whose face has to be removed before the ventilator is switched off and who could conceivably self-resuscitate afterwards.

Targeting Cancer Stem Cells

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The University of Michigan has patented a method that targets proteins on the outside of cancer stem cells. The patent, worth “possibly millions of dollars” in royalties according to an article in the Detroit Free Press, is apparently being shared with a company part-owned by the director of the university’s Comprehensive Cancer Center.

The company says it could produce a drug ready for clinical studies in solid tumors by next year; however, a leading cancer researcher cautioned that while “this probably is a concept that’s real,” human applications of the research might be years away.

The Free Press article notes that a study targeting stem cells in multiple myeloma, a “liquid tumor,” is already under way at the university. It is not clear whether the newly patented method is related.

Artificial Blood Still in the Game

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Northfield Laboratories has been awarded US$3.5 million in federal military funding to continue final-stage clinical trials of its blood substitute PolyHeme at 32 trauma centers across the country. PolyHeme requires no blood-typing and, unlike saline, transports oxygen. It has a shelf life of more than 12 months, compared to 42 days for stored blood.

About 720 trauma patients, including some at Loyola University Medical Center in Maywood and the Brooke Army Medical Center in Texas, have received with the blood substitute with favorable results, the company says.

Cancer Vaccines

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A German billionaire is investing a further US$50 million (on top of his previous investments totaling sunk $94 million) in Therion Biologics Corp., a small US company working on what the Boston Globe‘s Stephen Heuser calls “the first-ever therapeutic vaccine for cancer.”* Panvac-VF, as it is called, is an injectable drug that fights pancreatic cancer.

Unlike a traditional vaccine given to healthy people to prevent a disease from taking hold later, Panvac is designed to prevent the growth and spread of pancreatic cancer in people who already have it, by getting the patient’s immune system to recognize and attack the cancer as it tries to grow and spread. It works by identifying two proteins common in pancreatic cancer cells but rare in the rest of the body. The genes that encode for those proteins are inserted into harmless viruses which, when injected into the patient, alert the immune system to those particular proteins, which in theory triggers an attack on the cancer without hurting other tissue.

In early tests, Panvac extended the lives of patients with late-stage pancreatic cancer. Results from a larger trial on 250 patients are anticipated early this year.

* That honor would seem to belong to Merck’s Gardasil, a vaccine against human papillomavirus (HPV) — the leading cause of cervical cancer. See http://hfd.dmc.org/issuetopic.pl?issuetopicid=96&issueid=200511#Vaccines

Devices vs. Drugs

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The “neuromodulation” or neurostimulation market has already surpassed US$1 billion and may be headed much higher, reports Reuters’ Susan Kelly. The growth potential exists because neurostimulation technology can be broadly applied to treat pain from multiple chronic diseases that are drug-resistant today. Drugs can’t compete with implantable neurostimulators for management of pain from bad backs, aging joints, and migraine headaches, medical device makers believe.

Implantable neurostimulators to treat chronic back pain, epilepsy, severe depression. obesity, Alzheimer’s disease and a host of other conditions are available or in the works. A device that stimulates the Vagus nerve to treat depression and epilepsy has been on the US market since last September. A spinal cord stimulation device is also available to treat severe back pain.

Drugs vs. Surgery for Blocked Arteries

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Several drugs and non-surgical methods are under development to clear congested arteries, rather like Drano clears a blocked drainpipe, according to Steve Sternberg in USA Today. Most work by boosting “good” HDL cholesterol. They include:

• Pfizer’s torceptrapib
• The protein apoA-1 Milano
• A synthetic form of apoA-1 Milano that’s simpler to make
• D-4F, a simulated apoA-1 in tablet form made by Bruin Pharmaceuticals and licensed to Novartis, undergoing clinical trials at the University of Pennsylvania hospital
• Roche’s JTT-705 (first discovered by the Japan Tobacco Co.)
• Lipid Sciences’ method for extracting cholesterol from HDL so that the empty molecule can be reinfused into the bloodstream and reused
• Merck’s niacin, which currently has unwanted side effects
• PPAR and LXR agonists to pump cholesterol out of artery walls

Sternberg notes that many clinical trials of these methods will use intravascular ultrasound (IVUS) to measure the growth or shrinkage of deposits on artery walls.

Plaque Shaver, Cryoplasty

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The latest therapy for removing plaque in the peripheral arteries, particularly in the legs, is to shave it off with a tiny razor called the SilverHawk. It is threaded in a catheter through the artery to the site of a blockage, where the blade emerges and shaves the plaque, collecting the shavings in the device’s tip for extraction. Of 335 patients tracked for a year as of last October, 79 percent needed no further treatment.

Another fairly new therapy shows similar success in treating peripheral artery disease. It is variant of angioplasty, which pushes aside the plaque with a balloon, called cryoplasty, in which the balloon is inflated with freezing nitrous oxide. Cryoplasty inhibits scar tissue formation and also makes the plaque easier to push aside. Of 102 patients tracked for three years following cryoplasty, 73.5 percent needed no further treatment.

Neither new therapy has yet been directly compared to the older treatments — regular angioplasty, stenting, and arterial bypass — to determine comparative durability over the long term.

Placebo Therapy

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Placebos such as sugar pills, saline injections, and sham surgery have been found in some patients to ameliorate depression, anxiety, Parkinson’s tremors, high blood pressure, asthma, and even arthritis and angina pain. Some researchers now think it is possible to offer placebos openly to some patients, on the grounds that “The response to placebo is not just a response to an inactive pill, it’s a response to the entire treatment situation,” as a Brown University psychiatrist explained it to Emily Singer of the Los Angeles Times. “It’s everything: going to an expert, talking about the problem, getting a diagnosis and a plausible treatment.”

Not everyone will agree. “Some scientists argue that the placebo effect doesn’t exist or has been greatly exaggerated,” writes Singer; while others “suggest . . . that the placebo’s clout can be impressively strong.

Better imaging and understanding of the brain and its physiochemistry may settle the debate. For example, one recent study at the University of Michigan showed that sham injections of pain medicine blocked pain by activating endorphins, the brain’s natural painkillers. For another example: In 2001, Parkinson’s patients given a fake treatment (and who experienced improvements in tremors and other symptoms) exhibited a change similar to that seen with drugs used to treat the condition: an increase in the brain chemical dopamine.

Nobody yet knows how it works. One Pavlov-like theory holds that “our bodies may respond to a specific pain medication by releasing molecules — such as endorphins in the brain. But as we begin to associate the pill or doctor with that analgesic response, our brains may learn to respond to these factors rather than to the medication,” says Singer.

Lack of agreement and understanding notwithstanding, placebos are prescribed in routine care more commonly than is perhaps realized, at least outside the US. Singer cites an Israeli survey published in the British Medical Journal last year which found that 60 percent of doctors surveyed used placebos, with 30 percent of those prescribing placebos once a month or more; and another survey which found that nearly half of all doctors in Denmark regularly used placebos.

Singer also notes that alternative medicine therapies such as acupuncture could also be equivalent to placebo medicine. A large-scale trial of acupuncture for migraines published in May in the Journal of the American Medical Association showed, she writes, that “real and sham acupuncture treatments both could cut migraine pain as much as popular drugs, implying that the key to the treatment’s successes doesn’t depend on the precise placement of a needle — or perhaps on any needle at all.”

A federally funded study is underway at UCLA to measure the effect of doctor-patient interaction in self-healing among 140 patients with major depression. Among other rigorous aspects of the study, their brains will be scanned and monitored for changes. “The goal will be to find out whether merely visiting the clinic makes a patient feel better and, if so, how much of a contribution it makes.” In the meantime, based on research findings so far, it seems there are some things doctors could do now to take advantage of the apparent placebo effect. They include:

• Accentuate the many elements that make a visit to a doctor special and powerful-seeming — such as the knowledge that one is visiting a recognized healing authority, the careful discussion of ailments, and all those medical office accouterments such as the white coat, stethoscope, weigh scales, medical diplomas and busy nurses bustling down hallways.
• Write down patient instructions (say, to exercise regularly) on a prescription pad instead of plain paper. The patient is more likely to follow a directive written on a prescription pad.
• Give simple diagnostic tests in addition to merely discussing symptoms with patients with unspecific chest pain. They will tend to do better.
• Give patients “an appropriate and optimistic expectation about their treatment. . . . For example, say, ‘This is a powerful painkiller’ rather than ‘This may help.'”
• Be honest about but do not overemphasize possible side effects. Cancer patients who expect to suffer nausea with chemotherapy are more likely to experience it.

SCI Rehab

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A functional electrical stimulation (FES) device called “Compex Motion” developed at the University of Toronto may improve grip in quadriplegics and help stroke patients recover lost muscle function. It sends pulses of electricity through the skin to the muscles, causing them to contract, but uniquely it teaches patients “how to trigger their muscles independently so they can gradually wean off the device and walk on their own,” according to a UPI wire story. The device is “relatively” simple, non-specific to a narrow condition, easy to implement, and “will be” cost-effective,” one of its developers said.

In tests with five spinal-cord-injured patients who had some residual sensory or motor function (from two to 25 years after the injury) but were not expected to improve, FES was administered two to five times a week for 18 weeks. The patients also walked on treadmills and gradually increased their step frequency, stride length, and overall walking speed, and finally were helped to make their leg muscles work without the help of the machine. All five patients improved significantly during the trial, and although their walking skills had decreased 10 weeks after the treatment concluded, they were all still doing considerably better than they had been before they received FES therapy. Further studies are underway and there is no immediate plan to commercialize the device.

Gene Therapy in Mouthwash

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Colgate-Palmolive is spending US$20 million on a 9.7 percent stake in Introgen Therapeutics, whose method of inserting tumor suppressor genes into head and neck cancer cells to stop tumor growth is in late-stage clinical trials. Colgate intends to incorporate the gene therapy into its mouthwashes, gels, and other oral products to treat leukoplakia, a precancerous condition characterized by lesions on the cheeks, gums or tongue, and thereby prevent oral cancers.

Introgen’s current method is to inject viruses containing the desired gene directly into tumors. Colgate is already in early stages of human testing of a mouthwash containing a tumor-suppressor gene.