Wednesday, January 31, 2007

Creator of "Bionic Ear" Working to Help Paraplegics

The creator of the bionic ear is about to start tests on a new spinal cord implant, which could help paraplegics walk again.

The Bionic Ear Institute's Professor Graeme Clark is working with scientists from the Australian Research Centre to develop the technology.

Patients would have an implant inserted near their spinal injury and receive a controlled hormone release to stimulate new nerve growth.

Professor Clark says testing is about to start on animals, but it could be some time before it is ready for human use.

"I would say if the animal tests are successful - [it could be ready] within a few years," he said.

"I don't mean three - it could be four, it could be five, then that's time to do some preliminary studies a couple of years later on patients."
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Tuesday, January 23, 2007

Insurers Often Cap Coverage for the Latest Spinal Cord Injury Treatments

New technologies and more aggressive approaches to treating spinal cord injuries pioneered in Detroit are giving patients new independence and improved mobility.

But the innovations come at a big price at the very time insurers are trying to hold down rising health costs. While some advocates see progress in getting insurance to cover the treatment, patients are finding that insurers are willing to pay only so much for only so long.

Bob Smith of Harrison Township, injured in a diving accident on July 4, 1999, learned in December that Health Alliance Plan no longer would pay for his therapy at the Rehabilitation Institute of Michigan in Detroit, as it had for 2 1/2 years.

In 2003, Smith became the first American to go to China for experimental surgery to repair his spinal cord. The health plan told Smith that his gains had plateaued, and it no longer would pay for his rehabilitation.

"I'm worried I won't be able to maintain the strength and health I have," said Smith, a former Chevy salesman. Though he can't walk unassisted, he has gained considerable strength, has improved bladder function and hand movement and even has begun to feel sensation in his toes, he said in early January.

Insurers say that physical therapy is an extra health benefit that companies and individuals must purchase. Once people exceed the lifetime cap on those benefits, the expense far exceeds the cost of the policy.

"We try to do the right thing," said Dr. Mumtaz Ibrahim, senior associate medical director at HAP, noting that he could not talk specifically about Smith's case without Smith's consent. He said coverage decisions are reviewed by two levels of physicians and a board of directors committee.

"This is a huge issue," said Erica Nader of Bloomfield Hills, who was injured in a 2001 auto accident. She has been undergoing intensive therapies since, and in March 2003, she became the first American to undergo experimental stem-cell surgery in Portugal.

For five years, her therapy at the Rehabilitation Institute of Michigan has been paid for through her auto insurance.

"This isn't a six-month to 12-month rehab process. Look at Mike Utley," she said, referring to the former Detroit Lions player paralyzed from the middle of his chest down during a game in 1991. "We need long-term aggressive therapies that make us less dependent."

Intensive physical therapy for spinal cord injury is most associated with the late actor Christopher Reeve, the one-time movie Superman who became a champion for a cure after being paralyzed in a 1995 horse-riding accident.

Advanced treatments costly

Now, all over the United States -- and particularly in metro Detroit, where the Rehabilitation Institute of Michigan has become a world leader in intensive therapies -- patients once told they'd never walk again are participating in rigorous regimens, three times a week, three hours at a time.

They use high-tech braces, upright walking devices and other machines to build strength, coax paralyzed muscles to move, stand upright without falling and even walk with help from trainers or equipment.

Many health plans offer companies options to purchase physical therapy coverage, but a typical plan limits lifetime benefits to about 60 hours.

A decade ago, that was sufficient for many patients who never expected to walk again. Now, some patients want long-term therapy.

"This is becoming a whole new way to treat people with neurological injuries," said Polly Swingle, director of the Recovery Project, a Livonia-based intensive-therapy program. "There's so much more research out there to support the importance of being upright."

Conventional physical therapy costs about $75 an hour, compared to $325 for three hours of intensive therapy at the Recovery Project, Swingle said.

That's nearly $1,000 a week for three days of therapy, or more than $50,000 a year.

Willingness to pay is growing

Michigan has no-fault auto insurance that establishes a fund to pay the medical bills of people injured in auto accidents. The coverage may pay for operations abroad, intensive therapies three times a week, home accommodations, high-tech power wheelchairs and more.

By comparison, someone without that coverage may get as little as three weeks of outpatient therapy after an accident, a basic wheelchair and little or no accommodations at home, said Cathy Lysack, associate professor of occupational therapy at Wayne State University. She has a $1.1-million grant from the National Institutes of Health to understand how people can return to independent lives after a catastrophic injury.

She sees setbacks, not progress, as insurers seek "to compete and remain profitable."

Paula Denison, administrative director of specialty services at the Rehabilitation Institute, has seen health plans show more willingness to pay.

She estimates that 85% of the institute's patients receive some insurance reimbursement, up from 25% to 30% two or three years ago. Laura Kling, a case management worker with Robert B. Ancell and Associates in Southfield who works with auto insurance companies, said the key to getting insurance companies to pay for therapy is a physician's prescription and documentation of progress. "As long as it can be explained, and you provide them with the reasons, the insurance companies can be reasonable."

Jim Nugent, director of reimbursement for the American Physical Therapy Association, a 65,000-member organization based in Alexandria, Va., said health care workers and insurers must find new ways to pay for therapies as patients live longer.

"If you step back, it's a wonderful thing," he said. "But it's surely not time to dust off our hands. There's lots more work to be done."

By: PATRICIA ANSTETT
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Wednesday, January 17, 2007

Surgery Gives Quadriplegic Ability to Breathe on His Own

Bob Blair bears an uncanny facial resemblance to Christopher Reeve and on top of that, he, like Reeve, was paralysed in a horse-riding accident.

But the similarities don't end there as Blair has now had an experimental operation ? just like Reeve did in 2003 ? which will also rid of him of mechanical ventilation for the first time since his injury four years ago.

That's where the coincidences with the late actor end, as Blair, an Alberta farmer, is the first patient to have the procedure in Canada, at Vancouver General Hospital.
The surgery was developed by Dr. Raymond Onders and engineers at a Case Western Reserve University spinoff company called Synapse Biomedical Inc.

VGH is the only Canadian hospital to participate in a clinical trial in which surgeons implant electrodes that stimulate the phrenic nerves in the diaphragm to make it contract and relax so that breathing in and out in paralysed individuals is not dependent on respirator tubing and machinery.
The technology means such patients can breathe through their nose instead of getting air through a hole in their throats.

A 29-year old Vancouver man named Daniel Leblanc had the surgery done in Cleveland last year.
Leblanc still has the tracheostomy in his throat so that if he ever needs backup mechanical breathing support, the tubing can be quickly attached. He became a quadriplegic just over two years ago in a dirt biking accident.

"I can smell again and taste. It's changed my life in a good way. I feel more free and a little more natural," said Leblanc, noting that he also likes the fact that he doesn't have to hear the ventilator's constant humming noise anymore.
During a joint interview Monday, Blair and Leblanc spoke of the quality of life improvements the technology brings.

Blair said he feels fortunate he's had the opportunity to meet another high level quadriplegic (with a severe high cervical area spinal cord injury) who has already undergone the process. Blair had the electrodes implanted a week ago and he is now in what is called the conditioning period, the interim time in which he undergoes exercises to retrain the diaphragm before the mechanical tubes are disconnected in a few weeks and the external pack paces his breathing full time.
Doctors in Cleveland have now implanted the electrodes into 46 patients in the past five years, (with only one reported failure) and are getting closer to final Food and Drug Administration approval.

Dr. John Yee, a VGH thoracic specialist, went to Cleveland to learn the technique, and accompanied Leblanc when he went there for the surgery.

Yee said the clinical trial is an example of "how advances in the basic science of muscle physiology can be combined with biomedical engineering and minimally invasive surgery to bring practical solutions" to improve patient's lives.

Blair said one of the things he's looking forward to the most when he banishes his mechanical ventilator is breathing "the fresh country air where I live" in through his nose for the first time since his accident.

"Also, my voice will be much clearer and I will be able to speak stronger," said the 61-year old.

Dr. Jeremy Road, a VGH respirologist, is principal investigator of the Canadian trial. Road said there are patients from across Canada being considered for inclusion in the trial.

Patients must meet certain criteria, including having a diaphragm which still has preserved nerves so that the electrodes can stimulate them. Health Canada has granted permission for 10 surgeries in the clinical trial at VGH and spinal cord injury patients who are ventilator dependent from across Canada will be considered for inclusion.

By Pamela Fayerman
Vancouver Sun
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Thursday, January 11, 2007

Bill on Embryonic Stem-Cell Research Clears the House

The only bill that President Bush vetoed so far, in July 2006, probably a record of sorts for any presidency, was on federal funding for new stem-cell research. But following the result of the November 2006 election, the impact of emotional statements from actor Michael J. Fox and others suffering from intractable diseases, the House of Representatives considered the bill once again on January 11, 2007 now renamed "Stem Cell Research Enhancement Act of 2007" and voted to approve it.

Similarly, there is likely to be majority support in the Senate, the body that moves with less frenetic pace, or some would say, with plodding efficiency and with the possibility of adding amendments to this bill. But whenever a unified House-Senate bill reaches the President, will he veto it again? And, as in the case of some previous President-Congress tussles, observers wait with bated breath to see if there are the necessary votes to override the veto -- the Constitution specifies 2/3 majority in both the House and Senate to override a presidential veto.

In this bill, consideration is given to research on stem cells derived from human embryos that have been donated from in vitro fertilization clinics, and were created for fertility treatment, and were in excess of the clinical needs of individuals seeking such treatment; and also that they were slated to be discarded, never to be implanted, and donated with informed written consent without any financial or other incentive.

What are stem cells? In any growing embryo, stem cells differentiate into the various specialized tissues in the body. There are some 200 different cell types in the body, and they all owe their origins to the embryo. Adult stem cells function as a repair system for the body. Sources of stem cells include the umbilical cord blood, bone marrow, amniotic fluid, and embryos destined to be discarded. At this time, private and philanthropic funding is legal in the US for new embryonic stem cell line research. Only Federal funding is prohibited, and the purpose of the bill is to enable new embryonic stem cell lines to be eligible for Federal funding as well.

Stem cell research is racing ahead in several countries, ranging from the UK to Singapore, threatening America's preeminent position in biomedical R&D. Even a senior executive branch official confided to me, privately, that in the case of stem cells "science lost and politics won."

Hopes were raised that science could serve to circumvent the entrenched dueling positions by providing another source of stem cells that may be as potentially useful as embryonic stem cells. Indeed, some in the minority appeared to be grasping at that, hoping to avoid the wrath of a booming aging population that is yearning for cures for Parkinson's, Alzheimer's, spinal cord injuries, cancers, diabetes and other diseases for which stem-cells hold promise. This was through the publication in the journal Nature Biotechnology of the scientific paper "Isolation of amniotic stem cell lines with potential for therapy " by De Coppi et. al. Senior author Anthony Atala of Wake Forest University was all over the airwaves in interview after interview, clearly the media were hoping that the newly published research might help to avoid the emotional, morally and scientifically-charged fight that almost everyone wants to avoid so that R&D progress can occur within the bounds of societal, ethical and funding approval. But this newly publicized amniotic fluid source cannot yet be a definitive future supply of all types of tissues because it is still so early in the research cycle. The paper reveals that only about 1% of the cells derived from amniocentesis for prenatal genetic diagnosis comprise stem cells (technically, those cells that express the surface antigen indicating the receptor for stem cell factor).

The Debate

Rep. Barney Frank (D-MA) chaired the debate. The bill was co-sponsored by Rep Diana DeGette, Democrat from Colorado, Chief Deputy Whip of the Majority in the House of Representatives, and Rep Michael Castle, Republican from Delaware. Rep. James Langevin (D-Rhode Island) a pro-life congressman who is paraplegic because of spinal cord injury made a powerful impact with his speech urging support for the bill delivered from a wheelchair on the House floor. At the age of sixteen, Congressman Langevin was injured while working with the local Police Department in the Boy Scouts Explorer program. A gun accidentally discharged and a bullet struck, leaving him paralyzed. Rep. Jason Altmire (D-Pennsylvania) said that he was supporting the bill as a pro-life democrat because stem cells have the potential of preserving and enhancing life for those suffering from serious debilitating diseases. He mentioned his prior work-experience at a tertiary academic medical center to where patients with the most serious illnesses are referred. Rep. Anna Eshoo (D-California) who represents Silicon Valley pointed out that the only type of stem cell research lacking federal support is the embryonic, and urged a reversal of that ban. Rep. Joe Barton (R-Texas) Ranking Member of the House Energy and Commerce Committee, with a strong pro-life record, supported the bill stating that the issue was a choice between medical waste or medical research. Rep. Hilda Solis (D-California), health chair of the Congressional Hispanic Caucus, pointed out that Hispanic-Americans suffer from a range of debilitating diseases, bringing into focus the parallel issue of health insurance, cost of care, and access to treatment, all factors that add to the problem of the absence of break-through medical treatments for certain chronic diseases. Rep. Stephanie Tubbs Jones spoke about her father, now suffering dementia, who she said was a baggage handler for many years for United Airlines, and now can only barely recognize her. She hoped that stem cell research could offer some hope for her and others like her. Rep. Eliot Engel (D-NY) stated that there are an estimated 400,000 frozen embryos, many of which may be discarded over time.

For the opposition, Rep. Michael Burgess (R-Texas) an Obstetrics and Gynaecology physician, along with Minority Leader John Boehner (R-Ohio) and Rep. Christopher Smith (R-New Jersey) led the attempts to defeat the bill with the claim that any use of embryonic stem cells for research and development is objectionable and that in effect throwing them away is preferable. They made a series of assertions that stem cells from bone marrow, cord blood, amniotic fluid and placenta are sufficient because they do not involve "destruction of life" and that embryonic stem cells are tumorigenic. These are scientific and ethical controversies that presumably will be thoroughly vetted in Senate committee hearings in the coming months. So, the acrimony likely will continue for some more time.

There was a procedural maneuver by Rep. Burgess to recommit the bill to a committee hearing, but that attempt was defeated. At the end of the voting, Speaker Nancy Pelosi announced that the bill passed the House by a vote of 253 in favor and 174 against. So it is now on to the Senate.

By: Sunil Chacko
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Thursday, January 04, 2007

Uric Acid May Aid in Spinal Cord Injury Treatment

Uric acid is commonly associated with the excruciatingly painful joint disease known as gout, but it can also play a crucial role in the treatment of spinal cord injury and other central nervous system disorders, such as stroke, multiple sclerosis and Parkinson's disease, according to Rutgers' Bonnie Firestein.

Firestein, an associate professor of cell biology and neuroscience at Rutgers, The State University of New Jersey, and her laboratory team have reported their discovery in the Early View (online in advance of print) version of the journal Glia.

"In spinal cord injury, as well as stroke, two kinds of damage can occur," Firestein explained. "First there is the physical damage, but this is followed by secondary chemical damage to neurons [nerve cells] by compounds released in response to the trauma. We have found that uric acid can promote an early intervention step in combating this chemical damage through its action on astroglial cells."

Astroglial cells or astrocytes are specialized cells that support neuron function with nutrients and protective buffering.
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