Brain, spinal cord injury patients in Alberta test devices to restore movement

People with brain or spinal cord injuries in Alberta are testing new technologies designed to improve their lives by restoring movement.

Scientists, biomedical engineers, physicians and nurses from Edmonton and Calgary who are working to make paralyzed muscles move will receive $5 million over the next five years from the Alberta Heritage Foundation and the province.

On Monday, Darryl Steeles, who has multiple sclerosis, used a device that works with a leg brace to help him to walk. Electrodes in the device kick his nervous system back into high gear after nine years of destruction from the disease.

"I don't want to get a wheelchair," Steeles said. "I want to walk as far as I can walk when I can walk."

Researchers are working on improving the device, said Prof. Richard Stein, a neuroscientist at the University of Alberta.

"Come back in a couple of years, and we'll be able to get the upper part of the leg working as well," said Stein.

Preventing bedsores

A second device affectionately called "smart underwear" is designed to help prevent pressure ulcers, also known as bedsores, in people with spinal cord injuries. The ulcers cost the health-care system $3.5 billion in Canada, including $475 million in Alberta.

"We sit in front of our computers the whole day and we do not develop a pressure ulcer," explained Prof. Vivian Mushahwar, a specialist in cell biology. "And the reason for that is because we do dynamic relief of pressure by fidgeting."

For Warren Fleury, who can't fidget because of a spinal cord injury he suffered 20 years ago, the smart underwear makes the movements for him.

The computerized device detects when muscles need stimulating. A red light indicates pressure on his buttocks as Fleury sits in a wheelchair, but when the underwear is turned on, the pressure eases.

"I've been trying it, and it seems to be doing pretty good for me right now," said Fleury. "I also have chronic pain with my injury and it also helps kinda [offer] relief for that too, I'm finding."

Researchers hope to take the device to clinical partners next year. More tests are needed, but when the product is ready for consumers, it will sell for $500 to $1,000.

The team is also focused on a research project that aims to create a system that will stimulate small regions of the spinal cord and brain to restore walking, a sense of touch, and the sensations of pressure, movement, temperature and pain for people with injuries, Parkinson's, multiple sclerosis, or other degenerative diseases.

The Madoff of medicine?

A doctor in the United States is accused of faking data in 21 published studies linked to painkillers such as Vioxx and Celebrex.

There's been so much about corruption in the news lately whether it's on Wall Street or from bugs in cyberspace or scam artists looking to steal our money, our privacy and even our identities. Now there's news of fraud of another kind.

In what has been described as the longest and most wide-ranging case of scientific fraud, Dr. Scott Reuben, a renowned Massachusetts anesthesiologist, has been accused of fabricating data (and in some cases even inventing patients out of thin air) from 1996 to 2008 in 21 published studies. The fraud has rocked the medical community with Scientific American calling Reuben the medical equivalent of Bernard Madoff, the former NASDAQ chairman who is awaiting sentencing for his admitted $65-billion fraud.

Reuben, who is currently on leave from the Baystate Medical Center (located on one of the campuses of Tufts University School of Medicine), studied the use of several drugs to relieve pain and speed recovery after surgery. The hospital has since asked the journals who had published Reuben's work to retract the studies, some of which reported favorable results from Pfizer Inc.'s Bextra, Celebrex and Lyrica and Merck & Co. Inc.'s Vioxx. His research also claimed Wyeth's antidepressant Effexor could be used as a painkiller.

"Dr. Reuben deeply regrets that this happened," his attorney, Ingrid Martin, told the Associated Press. "Dr. Reuben cooperated fully with the peer review committee. There were extenuating circumstances that the committee fairly and justly considered."

While Dr. Reuben's research was not included with the clinical trials that led the US Food and Drug Administration to approve Celebrex and Lyrica, his work was considered widely influential on how doctors treat surgery patients for pain.

"Doctors have been using (his) findings very widely," said Dr. Steven Shafer, editor of Anesthesia and Analgesia. "His findings had a huge impact on the field."

As a result of Dr. Reuben's fabricated studies, Shafer said researchers would need to re-examine the literature and may be forced to repeat clinical trials.

Critics condemn 'marketing studies'

According to media reports, Pfizer gave Reuben five research grants between 2002 and 2007, and he was also a paid member of the company's speakers bureau, giving talks about Pfizer drugs to colleagues.

Pfizer said in a statement that it was not involved in the conduct of any of these independent studies or in the interpretation or publication of the study results.

"Independent clinical research advances disease treatments and improves the lives of patients," Raymond F. Kerins Jr., a Pfizer spokesman, told The New York Times. "As part of such research, we count on independent researchers to be truthful and motivated by a desire to advance care for patients. It is very disappointing to learn about Dr. Scott Reuben's alleged actions."

Pharmaceutical companies routinely hire physicians to conduct studies of drugs that are already approved. Companies say these studies are legitimate preliminary investigations of new uses for their products. But critics allege that drug companies often underwrite studies of little scientific merit in hopes of persuading doctors to prescribe the medicines more often.

As a result of the Reuben fraud, some critics are calling for a crackdown on the use of small scientific studies for ‘marketing purposes'.