Pharma news

PARIS: One tiny brain cell is all it
takes to restore voluntary movement of paralysed muscles, scientists in the
United States reported.

In experiments pointing to new treatments
for paralysis caused by spinal cord injury or stroke, monkeys learned within
minutes to harness the power of a single neuron to activate muscles immobilised
by drugs.

There are some 100 billion neurons in the human brain, and
the study suggests an unsuspected degree of flexibility in the kinds of tasks
they can perform.

“Nearly every neuron we tested could be used
to control this type of stimulation,” Chet Moritz, lead author and a
researcher at the University of Washington, told journalists in a conference
call on Wednesday.

If a monkey can do it, a human should be able to
do it even better, he said.

 The 20th annual conference of The MacLean Center for Clinical Medical Ethics at the University of Chicago will honor the Center’s founder and director, Mark Siegler, MD, and examine his work and influence on the field. The conference will be held at the University of Chicago Law School, 1111 E. 60th Street, on Fri., Nov 14 from 1 to 5 pm, and Sat., Nov. 15, from 7:30 am to 5:15 pm.

The conference will be a “festschrift” - a European tradition in which a scholar’s colleagues and trainees honor him with a discussion of his work.

The conference is organized around 16 of Sielger’s elegant and opinionated writings on the doctor-patient relationship, the development of the field of clinical medical ethics, improved end-of-life care for patients, and new ethical approaches to innovations in surgical cancer care.

The Lindy Bergman Distinguished Service Professor of Medicine at the University, Siegler has written and spoken extensively on decision-making in complex medical situations, such as intensive care, end-of-life decision making and living-donor organ transplantation. These stressful situations serve as “clinical probes,” he said. “They can help us understand the process by which patients and doctors reach everyday decisions.”

Siegler founded The MacLean Center in 1984. It quickly became the country’s leading center for teaching clinicians about patient-centered medical ethics. Since 1984, nearly 250 fellows - most of them physicians, but also nurses, legal scholars, theologians, and philosophers - have trained at the Center in a one- or two-year fellowship program.

Former MacLean fellows, many of who will speak at the conference, have published more than 60 books in the field. More than 30 have directed ethics programs in hospitals and research centers in the United States, Canada and Europe. More than 25 are now full professors at leading academic institutions and about a dozen hold endowed university professorships.

Although there is no fee for this conference, the organizers ask that attendees register online at http://ethics.bsd.uchicago.edu/events/2008conference.

CONFERENCE SCHEDULE

DAY ONE: Friday, November 14, 2008
The MacLean Center and its Role in the Development of Clinical Ethics

1:00 pm Opening Remarks and Welcome
Lainie Ross and Mary Ann MacLean

1:10-1:45 pm The MacLean Center Then and Now
THEN: Al Tarlov, Ann Dudley Goldblatt and Joel Howell*
NOW: Skip Garcia, Jim Madara and Lainie Ross

1:45-2:45 pm Clinical Ethics: The Field Then and Now
THEN: Ed Pellegrino, Paper #1: “Clinical Medical Ethics.” 1990.
NOW: Peter Singer*, Paper #2: “Clinical Ethics Revisited.”

3:00-4:30 pm Shared Decision Making and the Doctor-Patient Relationship
Paper #3: “The Nature and Limits of Clinical Medicine” 1979.
Paper #4: “Searching for Moral Certainty in Medicine: A Proposal for a New Model of the Doctor-Patient Encounter.” 1981.
Speakers: Bob Levine, Jack Wennberg, Peter Ubel*

4:30-5:30 pm Futility and Hope
Paper #5: “Pascal’s Wager and the Hanging of Crepe.” 1975
Paper #6: “The Illusion of Futility in Clinical Practice.” 1989.
Paper #7: “The Rise and Fall of the Futility Movement.” 2000.
Speakers: William May, John Lantos* Caleb Alexander

DAY TWO: Saturday, November 15, 2008
Clinical Medical Ethics Chair: John Lantos*

Morning Session: The Impact of Clinical Ethics on Patient Care 8:30-9:15 am The MacLean Center as Part of the University of Chicago
Speakers: Arthur Rubenstein (Medicine) Richard Epstein (Law) Ed Laumann (Sociology) Ed Lawlor (The Harris School and SSA)

9:15-10:15 am Clinical Ethics and Patient Care
Paper #8: “The Contributions of Clinical Ethics to Patient Care.” 1997.
Paper #9: “Confidentiality in Medicine - A Decrepit Concept.” 1982.
Speakers: Jim Childress, Daniel Sulmasy

10:45-12 pm Clinical Ethics Consultation and End of Life Care
Paper #10: “An Ethics Consultation Service in a Teaching Hospital: Utilization and Evaluation.” 1988.
Paper #11: “A Medicine of Strangers or a Medicine of Intimates: The Two Legacies of Karen Ann Quinlan.” 1992.
Speakers: Susan Tolle* Paul Helft* Woody Moss* Annette Dula*

Afternoon Session: The Three Pillars of Academic Medicine: Research, Teaching and Patient Care
1:30-2:45 pm Clinical Ethics Research and Research Ethics Consultation
Paper #12: “Perceptions of Cancer Patients and Their Physicians Involved in Phase I Trials.” 1995
Paper #13: “Learning from Our Patients: One Participant’s Impact on Clinical Trial Research and Informed Consent.” 1997.
Speakers: Al Jonsen, Carol Stocking, Rick Kodish* Chris Daugherty*

2:45-3:30 pm Teaching Ethics
Paper #14: “A Legacy of Osler: Teaching Clinical Ethics at the Bedside.” 1978.
Speakers: Jordan Cohen, Laura Roberts*

3:45-5 pm Ethical Issues in Surgery and Organ Transplantation
Paper #15: “Identifying the Ethical Aspects of Clinical Practice.” 1996.
Paper #16: “Ethics of Liver Transplantation with Living Donors.” 1989.
Speakers: C. Rollins Hanlon, Peter Angelos* Ira Kodner* Charles Bosk 5-5:15pm Looking Back, Looking Ahead Mark Siegler

* Speaker is a former MacLean Center Ethics Fellow.

Source: John Easton

University of Chicago Medical Center

 A new study indicates that educational literature can influence young women’s use of indoor tanning, not by raising their fear of skin cancer but by changing their attitudes about indoor tanning and promoting healthier alternatives for changing appearance. The study is published in the December 1, 2008 issue of CANCER, a peer-reviewed journal of the American Cancer Society.

Each year there are more than 1.3 million skin cancer diagnoses in the U.S., resulting in more than 10,000 deaths. A variety of efforts have attempted to get young people to alter their sun exposure behaviors, with limited success. For the new study, researchers led by Dr. Joel Hillhouse of the School of Public Health at East Tennessee State University designed a large, randomized, controlled study on an educational-based intervention meant to reduce indoor tanning, which is related to an increased risk of melanoma in young women.

The researchers included approximately 430 female university students aged 17 to 21 years, 200 of whom received a booklet on the effects of indoor tanning. The booklet, which focused on the appearance damaging effects of tanning, provided information on the history of tanning and tanning norms in society. It also presented the effects of ultraviolet radiation, specifically related to indoor tanning on the skin’s appearance. The booklet also offered guidelines emphasizing tanning abstinence and recommended healthier alternatives to improve appearance including exercise, choosing fashion that does not require a complimentary tan and sunless tanning products.

All participants were assessed at the start of the study to determine their tanning practices over the previous year. Six months after the booklets were distributed, the subjects were asked questions related to recent indoor tanning frequency and their intentions to tan indoors in the future. The survey also explored attitudes toward indoor tanning, alternatives to indoor tanning, and beliefs about indoor tanning (e.g. whether it was relaxing or reduced stress). The test also assessed participants’ thoughts on tanning’s negative effects on physical appearance and risk of developing skin cancer.

The investigators found that indoor tanning was reduced by approximately 35 percent in women who received the booklets compared with women who received no intervention. Similar changes were noted for future intentions to tan. The intervention also reduced positive attitudes toward indoor tanning and improved attitudes toward using sunless tanning and fashion to enhance appearance. However, the investigators found no impact on participants’ perceptions on susceptibility to skin damage or skin cancer from indoor tanning.

The study revealed that “a simple message delivery method, a booklet, was able to achieve clinically significant reductions in ultraviolet exposure behavior,” the authors wrote. They concluded that their clinical trial “supports the use of… intervention messages to change young people’s ultraviolet risky behaviors and ultimately reduce skin cancer morbidity and mortality.”

Article: “A randomized controlled trial of an appearance-focused intervention to prevent skin cancer.” Joel Hillhouse, Rob Turrisi, Jerod Stapleton, and June Robinson. CANCER; Published Online: October 20, 2008 (DOI: 10.1002/cncr.23922); Print Issue Date: December 1, 2008.

Source: David Sampson

American Cancer Society

An E. coli outbreak in Ontario’s Niagara-on-the-Lake region has sickened five people, health authorities confirmed over the weekend.

Health officials haven’t been able to pinpoint the cause of the outbreak, but they noted that people in two of the confirmed cases and two suspected cases ate at the Little Red Rooster Restaurant. Samples have been taken from the restaurant for testing.

Dr. Robin Williams, the local medical officer of health, called on people to report any symptoms.

“We are conducting enhanced surveillance in order to identify the source of this food-borne illness,” Williams said in a statement released Saturday.

In a separate outbreak, 209 people reported experiencing symptoms of E. coli poisoning in northern Ontario and Quebec. Health officials have linked the outbreak with a Harvey’s restaurant, though they continue to search for the source of the bacteria. On Oct. 12, health officials ordered the Harvey’s restaurant to close.

E. coli, short for Escherichia coli, is a type of bacteria commonly found in the intestines of animals and humans. There are hundreds of strains of the bacterium, some of which are dangerous to people.

 
Health experts in Thailand are calling for a review of the country’s national program to prevent mother-to-child HIV transmission, which follows World Health Organization guidelines, the Bangkok Post reports. According to Manoon Leechanwengwong, president of the Thai AIDS Society, Thailand’s current PMTCT program could lead to increased drug resistance among HIV-positive pregnant women.

According to the Post, the WHO guidelines — which involve administering the antiretroviral zidovudine beginning in the 34th week of pregnancy and the antiretroviral nevirapine during delivery — could help reduce MTCT to 4%. However, HIV-positive women with CD4+ T cell counts between 500 and 1,500 could develop drug resistance to nevirapine, the Post reports. In contrast, the NIH-recommended regimen to prevent MTCT calls for the administration of a combination antiretroviral in the 14th week of pregnancy through the 34th week. The NIH recommendation also calls for the administration of a combination of the antiretrovirals zidovudine and lamivudine three to seven days after birth to reduce the risk of resistance to nevirapine.

According to Manoon, studies of the NIH regimen have found it could reduce MTCT to 1%. Manoon called for the Thai government to revise and improve the existing PMTCT program to follow NIH recommendations. About 7,000 to 8,000 HIV-positive women become pregnant annually in Thailand, and the number of infants born with HIV could increase to between 1,800 and 2,000 annually without improved MTCT measures, according to Thailand’s Ministry of Public Health (Apiradee, Bangkok Post, 9/22).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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 Elevation Biotech, a start-up biotechnology company funded by LIFElab, an agency of the South African Department of Science and Technology, and the International AIDS Vaccine Initiative (IAVI), the world’s only global non-profit organization dedicated solely to AIDS vaccine development, have partnered to develop the next generation of AIDS vaccine candidates.

“An AIDS vaccine remains our best hope for ending AIDS. While we have made progress in developing a vaccine, we still have a long road ahead of us,” said Professor Salim Abdool Karim of the Centre for the AIDS Programme of Research in South Africa and member of IAVI’s Scientific Advisory Committee. “South Africa has the research infrastructure and scientific capacity to help make an AIDS vaccine a reality. IAVI’s partnership with Elevation Biotech marks an important step in this direction. I am confident that we will begin to see more North-South collaborations in the future and am proud to see Africans playing an important role in finding a solution to a disease that is decimating our continent.”

Getting the human immune system to generate antibodies capable of neutralizing HIV remains one of the greatest challenges in the field of AIDS vaccine research and development. IAVI has awarded Elevation Biotech a one-year grant to develop and test novel HIV antigens that elicit HIV-specific broadly cross-neutralizing antibodies - or antibodies that will neutralize a wide range of HIV isolates. Using a proprietary technology, Elevation Biotech aims to design antigens that deliver one of the stabilized forms of HIV envelope protein to the immune system in a way that mimics its natural conformation. Presented to the immune system in this way, the antigens have a better chance of producing neutralizing antibodies that might protect against HIV infection. To create these antigens, Elevation will generate stabilized HIV envelope and antibody immune complexes. The goal of this collaboration will be to test whether this stabilized HIV envelope immune complex is better at eliciting broadly neutralizing HIV antibodies than other immunogens tested to date.

“We are thrilled to partner with IAVI to help solve one of the toughest challenges facing AIDS vaccine researchers today,” said Grant Napier, Managing Director of Elevation. “To date, South Africa has played a significant role in the clinical testing of promising AIDS vaccine candidates. This new partnership demonstrates that South African scientists can also make important contributions to discovery efforts for new AIDS vaccine candidates to help bring an end to this devastating pandemic.”

South Africa is one of the areas hardest hit by the AIDS pandemic. “I am proud to lead a team of South African researchers who can help to play a role in rolling back the epidemic in our region,” said Professor Wendy Stevens, the Principal Investigator for the project at the University of the Witwatersrand and the South African National Health Laboratory Service, who have partnered with Elevation in this research. “If Elevation’s technology can produce an antigen that will induce the production of HIV neutralizing antibodies in humans, it will revolutionize HIV vaccine development.”

“Our investment in South African biotechnology is starting to pay off,” said Derek Hanekom, Deputy Minister of Science and Technology. “This is an exciting development and proves the international stature of South African innovation.” Blessed Okole, CEO of LIFElab said that “AIDS is the most pressing health crisis we face in South Africa today. And a vaccine will be indispensable to curbing the epidemic. IAVI’s award is a big boost to South African AIDS vaccine research efforts and one that we hope will also encourage young researchers to enter the field.”

Nearly all of the AIDS vaccine candidates currently in clinical trials are designed to stimulate cell-mediated immune responses. Most licensed vaccines against other diseases, however, work primarily by provoking antibody immune responses. But eliciting antibodies to HIV has proven exceptionally difficult. “More resources must be dedicated to overcoming the neutralizing antibody problem. Our partnership with Elevation Biotech aims to explore a novel way of stimulating the production of antibodies against HIV by creating and testing antigens that resemble the shape of the HIV envelope protein during natural infection,” said Dr. Wayne Koff, Senior Vice President of Research and Development at IAVI. “Although IAVI has invested in solving the neutralizing antibody problem since 2002, we have not to date tried this approach.”

IAVI’s Innovation Fund is a new seed capital fund designed to bring novel, early-stage technologies to the field of AIDS vaccine research. To help diversify the existing AIDS vaccine pipeline, IAVI created the Innovation Fund to develop new partnerships and draw from new disciplines - including cancer immunology, monoclonal antibody engineering and drug development - to advance AIDS vaccine research. IAVI hopes to apply technologies from leading biotechnology companies to help overcome some of the technical and scientific barriers currently facing researchers, which in turn could ultimately lead to the development of more promising candidates for human testing. This grant represents the sixth award made by IAVI through the Innovation Fund to support research with the goal of enhancing human antibody responses to AIDS.

About IAVI

The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996 and operational in 24 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI’s financial and in-kind supporters include the Alfred P. Sloan Foundation, the Bill & Melinda Gates Foundation, the Foundation for the National Institutes of Health, The John D. Evans Foundation, The New York Community Trust, the James B. Pendleton Charitable Trust, The Rockefeller Foundation, The Starr Foundation, The William and Flora Hewlett Foundation; the Governments of Canada, Denmark, India, Ireland, The Netherlands, Norway, Spain, Sweden, the United Kingdom, and the United States, the Basque Autonomous Government as well as the European Union; multilateral organizations such as The World Bank; corporate donors including BD (Becton, Dickinson & Co.), Bristol-Myers Squibb, Continental Airlines, Google Inc., Henry Schein, Inc., Merck & Co., Inc., Pfizer Inc and Thermo Fisher Scientific Inc.; leading AIDS charities such as Broadway Cares/Equity Fights AIDS and Until There’s A Cure Foundation; other private donors such as The Haas Trusts; and many generous individuals from around the world. For more information, see http://www.iavi.org/.

About Elevation Biotech

Elevation Biotech (Pty) Ltd. is an HIV therapy and vaccine discovery research company founded in 2006 on technology initially discovered by the University of the Witwatersrand and the South African National Health Laboratory Service. The first round investment in Elevation was made by LIFElab, a trust established by the South African government’s Department of Science and Technology. Elevation has developed a core technology that allows specific, high affinity attachment of peptides, proteins and other molecules to a structurally conserved region of HIV envelope proteins. Elevation’s technology has application in a number of area’s including antiretroviral drug therapy, HIV therapeutic and preventative vaccines and HIV diagnostics.

Source: Rachel Steinhardt

International AIDS Vaccine Initiative

People with medical conditions such as obesity and high blood pressure may experience a delay in being diagnosed with multiple sclerosis, and the disease may be more severe once it is diagnosed, a new study suggests.

In Wednesday’s issue of the journal Neurology, researchers in Manitoba reported that it took one to 10 years longer for people who were obese, smoked, or had physical or mental health conditions to be diagnosed with MS compared with people without such conditions.

“The balance is not on automatically assuming everything is due to an existing [condition] because that leads to delays, but balancing that against assuming that everything new that happens requires the million-dollar work-up,” study author Dr. Ruth Ann Marrie of the University of Manitoba in Winnipeg suggested for doctors.

“Let’s pause for a second and think about this carefully when somebody has a new symptom and they have an existing health condition, so you can make a well-thought decision about it,” she added in a telephone interview.

Studies suggest that for some diseases, such as cancer, patients may run to their doctor sooner than average. But in other cases, patients may chalk up new symptoms such as numbness and tingling to an existing condition, potentially leading to delays in an MS diagnosis. Delays on the order of months are not a problem, but years could be, Marrie noted.

Differences in severity of disease found

In the study, Marrie and her colleagues examined records of 2,375 MS patients in the U.S. who filled in questionnaires about their pre-existing health conditions as well as weight and smoking status.

It took between one to 10 years longer for people who were obese, smoked or had physical or mental health conditions to be diagnosed with MS compared with people without those conditions, the researchers found.

“People with multiple medical problems on top of MS may need more health-care resources or might respond differently to medication,” Marrie said. “This needs more study.”

The more medical problems someone with MS had, the more severe the disease became by the time they were diagnosed, the researchers found.

People who had a mental disorder or any muscle or joint problem along with MS were nearly two times more likely to be severely disabled when diagnosed compared with those with a mild disability, according to the study.

Those with vascular problems such as diabetes, high blood pressure or high cholesterol, were about 1.5 times more likely to be moderately disabled when diagnosed compared with people who had MS but no heart or weight problems.

This study was supported by the National Institutes of Health and the National Institute of Child Health and Human Development and Consortium of MS Centers.

Some of the study’s authors reported receiving research support or working as consultants for pharmaceutical companies.

Caitlin Carey, 17, says her bouts with anxiety began when she was 6 and were not just a matter of being “a nervous Nelly.”

“Since I’ve had medication it has helped so much, and since I have had treatment,” she said. “But anxiety is very rough because it is always in the back of your mind and sometimes it creeps into the forefront of your mind. You are always afraid of something.”

Caitlin is not the only one. Childhood anxieties are incredibly prevalent, and at times far more severe than the monster under the bed. Overwhelming and debilitating anxieties affect an estimated 10 to 20 percent of children, according to the American Academy of Child and Adolescent Psychiatry. Even at the low end of that range, the upshot is that more children may suffer from severe anxiety than with attention-deficit hyperactivity disorder, or ADHD.

But how to best treat those children is a difficult question, and little has been published about how well therapy and medication work together.

A study unveiled today that will be published in the New England Journal of Medicine, aims to provide answers. It finds that the combination of cognitive behavioral therapy and the medication sertraline, known as Zoloft, was more effective than either method on its own, and fared far better than giving kids a placebo.

“Both cognitive behavioral therapy and sertraline reduced the severity of anxiety in children with anxiety disorders,” the report concluded. “A combination of the two therapies had a superior response rate.”

 The International Diabetes Federation (IDF) announced today that Ms Ann Keeling has joined the organization as Chief Executive Officer/Executive Director.

The International Diabetes Federation, headquartered in Brussels, Belgium, is an umbrella organization of over 200 diabetes associations worldwide. It is the global advocate for the more than 250 million people with diabetes, their families, and healthcare providers.

Ms Keeling takes the helm of the Federation at a time when the diabetes pandemic is growing fast and placing unrelenting strain on global healthcare resources. She will help steer the response of the Federation as it broadens its efforts to increase awareness and encourage action. IDF leads the World Diabetes Day (14 November) campaign and the Unite for Diabetes campaign, which resulted in a UN Resolution on diabetes. The organization will hold its flagship World Diabetes Congress in Montreal, Canada next year.

For over 50 years, the Federation has been at the vanguard of global diabetes advocacy. It is an NGO in official relations with the World Health Organization and the Pan American Health Organization (PAHO), and an associated NGO with the United Nations Department of Public Information. IDF is committed to raising global awareness of diabetes, promoting appropriate diabetes care and prevention, and encouraging activities towards finding a cure.

“Diabetes is often thought to be a disease of the rich. Yet the world is in the grip of a global diabetes epidemic that affects rich and poor countries alike. In many countries, diabetes threatens to overwhelm health systems. I want the International Diabetes Federation to be the place for people everywhere to learn more about diabetes. A place to join the global diabetes community and help turn back the tide of this disease. The landmark UN Resolution on diabetes gives us our mandate,” said Ms Keeling.

Ann Keeling joins the Federation from the Government of the United Kingdom, where she was a senior civil servant in the Government Equalities Office. She has global experience, having lived in the Pacific, Caribbean and Asia working for the United Nations and the Governments of Papua New Guinea, Pakistan and Great Britain. She has also undertaken short assignments in Africa, Eastern Europe, the Middle East and Latin America. Her work has centred on policy reform and programme delivery in health, education and poverty reduction.

Previously, Ann Keeling served as Director Social Transformation Programmes Division (leading on health, education and gender) in the Commonwealth Secretariat supporting the 53 countries of the Commonwealth. In that capacity she worked with the Federation on the UN Resolution on Diabetes and was a member of the Global Health Worker Advisory Council convened by Mary Robinson and the Global Health Workforce Alliance.

Dr Martin Silink, President of the International Diabetes Federation described Keeling as an incredibly gifted and experienced leader. He considers her the ideal choice to lead the Federation at such an important time.

“Ms Keeling’s appointment is of major significance to the continued development of the International Diabetes Federation. Her appointment has the full support of the Executive Board. We are extremely pleased to have her onboard to help steer the future of the Federation,” said Dr Silink.

International Diabetes Federation (IDF)