First Wellstone center in New England and first center in the world to focus exclusively on facioscapulohumeral muscular dystrophy

The U.S. National Institutes of Health (NIH) have awarded $9 million to launch a unique collaboration of researchers, clinicians, patients, government research agencies and pharmaceutical/biomedical companies to study the causes and potential treatments for facioscapulohumeral muscular dystrophy (FSHD), a muscle weakening and disabling disease that affects, at the least, one in 20,000 individuals worldwide. The award will create the first Senator Wellstone Muscular Dystrophy Cooperative Research Center (MD CRC) to focus on FSHD, the award recipients announced today.

Headquartered at the Boston Biomedical Research Institute (BBRI), this center for excellence in muscular dystrophy will be the first ever in New England, and the first of these prestigious centers — named for the late Senator Paul Wellstone — to focus on FSHD, the second most prevalent adult muscular dystrophy. The Wellstone MD CRCs themselves represent a paradigm shift in research because of their intensely collaborative nature and particularly because of their mandate to include the patient advocacy organizations as a full partner in the research process.

“We see this as a unique opportunity to tackle a tough disease in the most efficient way to set the stage for development of therapies,” says Dr. Charles Emerson, director of the new center and president of BBRI. “We have recruited the best minds in basic and clinical research and have an extraordinarily committed patient advocacy group to help us focus on this problem.”

Co-director, Dr. Louis Kunkel, a professor of Genetics and Pediatrics at Harvard Medical School, director of the Genomics Program at Children’s Hospital and an investigator with the Howard Hughes Medical Institute, agrees. “We believe this research center model will bring discoveries from bench to bedside more rapidly than the traditional model, because we already have the full participation of the people with the most at stake in our work — the patients,” he says.

In fact, both Emerson and Kunkel admit that without the advocacy of Daniel Paul Perez, FSHD patient, resident of Bedford, MA, and the founder and CEO of the FSH Society, the new Wellstone Center might not have become a reality. According to the two scientists, Perez has been fighting tirelessly behind the scenes and in front of Congress, the NIH and the scientific community for 20 years for funds, increased research and attention for this disease. “This is a victory for all of us,” says Perez. “It represents decades of work by dedicated researchers, Society leaders and patients to find a research home for this disease.” Perez was diagnosed as a toddler and has been the national leader for patients with FSHD since graduating from college.

Another major collaborator will be Acceleron Pharma, a biotech company that will partner with the Wellstone Center scientists and clinicians to determine the safety and effectiveness of a new class of drugs that enhance muscle mass and strength. The hope is that these drugs will help maintain muscle strength and physical function in patients with FSHD and other dystrophies.

Additionally, Genzyme Corporation will participate in the development of cell-based therapeutic approaches, which also have noteworthy promise.

Economically, the Wellstone Center will have a positive impact, according to Bob Coughlin, president of Massachusetts Biotechnology Council, who believes it is just the kind of program that will strengthen the regional economy and the life science industry in Massachusetts. “The new center at Boston Biomedical Research Institute will be a magnet for drawing talent into the state,” says Coughlin, adding, “we applaud the partners of the Wellstone Center for their commitment to cooperating on this important project, which will expand our understanding of a devastating disease and bring together scientists and industry.”

In a congratulatory letter of support for the Wellstone Center, Senator Edward Kennedy wrote: “Beyond research, this new center will provide future medical health pioneers insight and knowledge into muscular disease treatment as well as promote national cooperation among top leading research centers.”

“Indeed, a major goal of ours is to make the work we do here available to the entire international scientific community,” says Emerson, who sees the center as a resource to help anyone investigating FSHD or similar diseases.

The Wellstone center partners will identify molecular biomarkers to monitor the effectiveness of therapeutics during clinical trials and establish a repository of FSHD-diseased and normal muscle stem cells to provide the international community with the resources critically needed to develop and test new drug and cell-based therapeutics. A key component of the Wellstone Center will be to educate and train the next generation of research and clinical scientists in an outstanding environment for muscle disease research.

Like the five other Wellstone centers established since 2002, the Boston center is the legacy of Senator Paul Wellstone, who was the Congressional champion of muscular dystrophy. Perez and the Senator worked on the original MD Care Act 2001 legislation together before the Senator’s untimely death in a plane crash in 2002.

Facioscapulohumeral muscular dystrophy is the second most common adult-onset muscular dystrophy and currently has no treatment or cure. Perez notes, “The prevalence of FSHD is probably three times higher than previously thought given our increased experience with the disease and improved genetic testing for FSHD.” Its major characteristic is weakening of the skeletal muscles, beginning in the face and slowly progressing to the shoulder and upper-arm muscles and then down to the abdominal and foot-extensor muscles. In the worst cases, all skeletal muscles are lost, hearing and vision are involved, and respiratory insufficiency can cause severe disability and even death.

In addition to Emerson, Kunkel and Perez, the center’s network of collaborators includes Kathryn Wagner, M.D., Ph.D., The Johns Hopkins Hospital; Mayana Zatz, M.Sc., Ph.D., University of Sao Paolo, Brazil; Robert J. Bloch, Ph.D., University of Maryland School of Medicine; Woodring Wright, M.D., Ph.D., University of Texas Southwestern Medical Center; and Jeffery B. Miller, Ph.D., Boston Biomedical Research Institute.

The opening of the new Senator Wellstone Muscular Dystrophy Cooperative Research Center will take place at Boston Biomedical Research Institute at 64 Grove Street in Watertown, MA, from 4:00 to 6:00 pm on Friday, October 10th. The public will be welcome.

The Boston Biomedical Research Institute is a not-for-profit institution dedicated to the understanding, treatment, and prevention of specific human diseases such as muscular dystrophy, cancer, cardiovascular disease, and Alzheimer’s disease. For more information, visit us on the web at www.bbri.org.

The FSH Society, a not-for-profit volunteer health organization founded in 1991, is located at the Boston Biomedical Research Institute and is a comprehensive resource for individuals with FSHD and their families. The FSH Society funds research into this genetic disease that leads to progressive muscle wasting and weakness. The disease affects between 330,000 and one million people worldwide. In addition, the Society provides research grants, advocacy, education and outreach to professionals, patients and advocates on their behalf. For more information on FSHD please see www.fshsociety.org.

Source: Boston Biomedical Research Institute


24-Hour Patient Vigilance System Now Available to Nearly 30 Percent of State’s Population

In a move unparalleled in modern healthcare, Hoana Medical, Inc. and several Hawai’i unions are taking on patient safety by challenging traditional thinking around what benefits will and won’t be covered by insurance companies. Whereas typical healthcare insurers like Blue Cross and Blue Shield, or their franchise in Hawai’i, the Hawai’i Medical Service Association (HMSA), decide what constitutes an eligible insurance benefit, several union health and welfare trust funds have decided that, rather than cut benefits to their members or increase member costs, they will invest in advanced technology that improves patient safety and reduces costs by making the LifeBed(TM) Patient Vigilance System a reimbursable benefit for their members when they enter a hospital.

The State of Hawaii Hawai’i Employer-Union Health Benefits Trust Fund (EUTF), the Health and Welfare Trust Fund of the Teamsters, Hotel and Restaurant Employees Local 5, Carpenters, Laborers, ILWU Hotel Workers, and United Food and Commercial Workers, have chosen to make the LifeBed(TM) Patient Vigilance System (LifeBed) available to their collective member groups statewide. Traditionally, healthcare payors have made these decisions surrounding benefit coverage — and plan members must live with those decisions with little other choice.

Nearly 40 percent of all unexpected hospital deaths occur on the med-surg floor, resulting in a surge of interest in early recognition and patient safety. With healthcare costs at unprecedented levels and rising each year, the union health and welfare trust funds have taken a major step toward improving patient safety by directing their third party insurance payors to reimburse LifeBed costs for their members. Hoana Medical’s LifeBed System identifies patients as they begin to deteriorate and immediately notifies the hospital nursing staff — all invisible to the patient since there is no physical connection to the patient whatsoever.

Now, the LifeBed’s 24-hour continuous vigilance of patients is a paid benefit for all union members, their dependents and retirees. This means that more than 230,000 people will have access to cutting edge, state-of-the-art technology while in the hospital — all paid for by the union health and welfare trust funds, reimbursing hospitals at $18 per day per bed. This improves the quality of patient care while reducing the costs to the unions and their members and dependents — providing a substantial return-on-investment. It’s this type of disruptive approach, coupled with new technology that will ultimately solve the nation’s perplexing healthcare issues. For Hawai’i, this represents nearly 30 percent of the state’s current workforce and showcases the unions’ commitment to partner with technology providers and with hospitals in the growing need for improved patient safety and quality in healthcare, which ultimately reduces costs.

According to the HealthGrades(1) 2006 Report, the State of Hawai’i ranked last in a nationwide survey of patient safety incidents. Patients admitted to hospitals in Hawai’i are more likely to die from a patient safety event than anywhere else in the United States. Hawaiian hospitals were rated the lowest performers in two key mortality indicators including “failure to rescue” and “death in low-mortality DRGs.”

“This looks like an emerging trend in healthcare; we are beginning similar conversations around the rest of the U.S. We hear so much about the problems with healthcare and the unanswered rhetoric question ‘how can we fix healthcare?’ These unions have decided to be part of the solution — their decision to provide the LifeBed technology as a paid benefit is part of a much bigger issue. They are taking responsibility to address this problem for their members, rather than wait for ‘someone to fix the problem.’ It clearly spotlights their commitment to their members,” said Dr. Patrick Sullivan, president of Hawai’i-based Hoana Medical, Inc. “Our experience across the country is that patient safety in hospitals is part of a bigger issue of too much to do and not enough resources to deliver. The complexity of healthcare and hospitals make weighing-in with a solution a daunting task. However, most hospitals universally agree that the simple act of finding a patient in trouble early is enormously helpful, both from a patient outcome standpoint, as well as all the economics of healthcare. The LifeBed delivers a very sophisticated and complex technology in a simple and elegant form — simplicity in a complex chaotic sea. Hospital experience with the LifeBed shows that it reduces falls, decreases mortality, and increases patient and nurse satisfaction. It’s a tool that immediately alerts nurses to patient deterioration — early recognition is the key to saving lives.”

Nurses are a critical element to delivering quality care at the bedside. Nursing shortages are a growing concern in the patient safety arena, with nursing shortages contributing to higher nurse-patient ratios, which results in less patient vigilance on the medical-surgical unit. Currently, there is a shortage of approximately 126,000 nurses nationwide, which is expected to increase to 808,000 by the year 2020(2). The State of Hawai’i has a shortage of approximately 1,211 full-time equivalent nurses or a 14 percent shortfall. By 2020, that number is expected to increase to 2,669 FTE nurses or a 24 percent shortfall(3).

A recent study on nurse-patient ratios showed that ” … each additional patient per nurse (above 4) is associated with a 7 percent increase in both patient mortality and deaths following complications.” Pair this with the current industry standard of four- to eight-hour nurse rounds and patients are left with a large gap in patient monitoring, where sudden or deteriorating negative events can occur unnoticed.

In addition to nursing shortages, recent studies also show that respiratory function is the leading indicator of pending patient distress. Recently the Joint Commission found that “4 – 17 percent of inpatient admissions have critical events such as cardiopulmonary and respiratory arrests and vital sign changes, with warning signs preceding events by an average of 6 – 8 hours” (Joint Commission, 2007). Studies also show a strong correlation with cardiopulmonary trending and patient outcomes. These types of studies have led the Joint Commission to include patient safety as a major focus in its 2009 Patient Safety Goals for all accredited U.S. hospitals, two of which target the reduction of falls and the early recognition of patient decline.

(1) HealthGrades is an independent organization that ranks hospitals across the country.

(2) U.S. Department of Health and Human Services, 2002

(3) Hawai’i State Center for Nursing, 2007

Source: Hoana Medical, Inc.


Webcam MD, the world’s first live 24/7 online visual physical examination site, is poised to change the way patients receive quality medical care around the globe

Remember the days when doctors actually made housecalls?

Well, those days are back, thanks to Webcam MD, a revolutionary new web-based medical technology site.

Two years in the making, this powerful new online technology is designed to provide fast, live access in your home to key medical specialists located anywhere in the world. All users need is an internet link, computer with a webcam, credit card number (or Paypal account), and they can talk to medical professionals, including surgeons, worldwide in mere minutes.

webcamMD

Basically, the site enables users to have a live, visual, physical examination and discussion with a licensed physician, specialist or surgeon.

Webcam MD’s Chief Medical Advisor is Dr. Agostino Cervone, a board-certified surgeon and Chairman of the Department of Surgery at Peconic Bay Medical Center in Riverhead, NY. “This online medical technology is highly beneficial, especially for skin cancer check-ups and post-surgical wound management,” he says. “For example, the technology uses a specialized high-resolution zoom lens to perform skin cancer check-ups. It’s an efficient way to improve the chances of saving lives through early detection.”

Another major benefit will be felt by busy downtown hospitals as the instant, online medical attention that Webcam MD provides will reduce burdens placed on emergency rooms around the world. In remote rural areas where access to healthcare is poor, Webcam MD will provide additional options and reassurance to patients.

“This is a significant improvement over the static, self-diagnosing websites on the internet today,” says Webcam MD’s CEO and Founder, Rob Tayler of Toronto, Ontario. In conjunction with a team of medical and IT specialists, Tayler developed the breakthrough site two years ago. Other sites have tried to mimic his ideas and format, but Webcam MD continues to boast many unique advantages.

“Webcam MD has many benefits over existing sites that use webcams,” says Tayler, “not the least of which is the clarity of the images, the ability to get immediate advice in real time 24/7, and the fact that you get access not just to doctors and specialists worldwide, but to surgeons. You can also take as much time as you need, and the cost is very reasonable at only $50 for each 20-minute session.”

Source: Webcam MD


Results of ThermoSuit(R) System Study Could Benefit Brain Injury Casualties of Iraq War

Life Recovery Systems’ ThermoSuit(R) System, a rapid patient cooling device, has been approved by the U.S. Food and Drug Administration for use in a clinical study of patients with traumatic brain injury. Currently, the ThermoSuit System is used to induce rapid cooling of victims of cardiac arrest and heart attacks.

The study is being conducted under an Investigational Device Exemption by Dr. Guy Clifton and other researchers at the University of Texas Health Science Center in Houston, whose Institutional Review Board has also approved the study.

The study will explore whether the induction of hypothermia to 35 degrees C in two-and-a-half hours after severe traumatic brain injury and reaching 33 degrees C by four hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months and 12 months after injury compared to patients randomized to normothermia. Previous research conducted by the Houston-based researchers indicated that later cooling was ineffective in reducing brain injury. The researchers concluded that more rapid cooling methods are needed to achieve a benefit in these patients.

“If the study proves to be successful, the ThermoSuit System could potentially benefit thousands of patients with traumatic brain injury,” said Milton Frank, Life Recovery Systems’ COO. “Traumatic brain injury is the ‘signature wound’ of the Iraq war, and LRS is hopeful that early cooling will be beneficial to a number of military casualties.”

The ThermoSuit System, a non-invasive cooling technology was adopted for the current study because of its rapid cooling capabilities, safety and ease of use in an emergency department. While other non-invasive cooling methods typically require hours to cool the patient to the target temperatures of this protocol, the ThermoSuit System is able to provide the desired amount of cooling in less than 30 minutes.

The 240-patient study titled, “National Acute Brain Injury Study: Hypothermia IIR” (NABIS:HIIR), is being sponsored by the National Institute of Neurological Disorders and Stroke (NINDS). The study currently includes five participating hospitals in addition to the University of Texas.

Life Recovery Systems developed and markets the ThermoSuit(R) System, the fastest noninvasive hypothermia device. The first products were shipped in February 2007. The system continuously pumps a thin film of ice water around the patient’s body until the temperature reaches a preset level. This unique technology cools patients at a rate of one degree centigrade for every seven minutes of treatment. The duration of cooling treatment required to achieve the target temperature is typically 20 to 30 minutes. Numerous publications support the potential benefits of rapid cooling. After cooling, the patient is removed from the ThermoSuit System and can easily be transported around the hospital for other therapeutic treatments. Patients cooled with the ThermoSuit System typically stay cold for hours with little or no further maintenance cooling required.

For additional information about the NABIS:HIIR study, please go to http://clinicaltrials.gov/ct2/show/NCT00178711?cond=%22Hypothermia%22&rank=22

For additional information about Life Recovery Systems and the ThermoSuit System, go to http://www.life-recovery.com/ .

Source: Life Recovery Systems


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