Pfizer reported that Lyrica benefited patients with Restless Legs Syndrome in a late-stage clinical study of more than 700 patients. Lyrica, which is one of Pfizer’s top-selling products, is approved to treat diabetic nerve pain, pain after shingles, and fibromyalgia, among other conditions. Pfizer said it does not have plans at this time to seek regulatory approval for Lyrica to address Restless Legs Syndrome.
FDA advisers suggest revising popular birth control labels
U.S. health advisers recommended a revision of labels for the new generation of widely used birth control pills that contain the compound drospirenone (i.e., Yaz, Yasmin). Although all common birth control pills increase women’s chances of getting blood clots, data has been mounting that reveals a higher risk linked with these newer pills. Outside experts advising the Food and Drug Administration agreed that the current, rather complex label does not adequately help women and doctors understand the risks and benefits of such pills. “[The label] is incredibly hard for physicians to read and if we think that patients are reading these and understanding these before making their decisions, we’re delusional,” said panel member Dr. Peter Kaboli, associate professor of internal medicine at the University of Iowa Caver College of Medicine. An FDA study conducted in 2011 found that women taking Yasmin were about twice as likely to develop venous or arterial thrombotic events (VTEs and ATEs) than women on older birth control. This study also estimated that 10 in 10,000 women taking the newer drug would get a blood clot per year, compared with about six in 10,000 women taking older contraceptives.
Generic version of Plavix® will save the Canadian healthcare system over one billion dollars
The Federal Court of Canada recently ruled in favour of Apotex, clearing the way to deliver their generic version of Plavix®, Apo-Clopidogrel, to the Canadian market. Apotex challenged the Sanofi-aventis Plavix® patents for over eight years,through two FederalCourtsystemsandmultiplelevels of judicial review, including the Supreme Court of Canada. “Apotex is proud to have been the only generic company in Canada to have successfully taken on enormous risk and lead the legal pursuit to deliver a cost saving alternative to Plavix® for Canadians” stated Mr. Jack Kay, Apotex President. The Clopidogrel market in Canada is valued at over $300 million in annual brand sales.Apotex’s successful litigation of the Plavix® patents comes seven years prior to all patents expiring and this represents an accumulative savings of an estimated one billion dollars to the Canadian healthcare system.
CMA releases social media guidelines for doctors
The Canadian Medical Association (CMA) Board of Directors has approved Canada’s first-ever national social media guidelines to help doctors safely, effectively, and responsibly use tools such as Facebook, Twitter, and other forms of social media as they care for patients. The CMA’s document Social media and Canadian physicians – Issues and rules of engagement (http://www.cma.ca/socialmedia) provides practical considerations and outlines the potential benefits and drawbacks of social media for physicians. The document states “The reality is that individual doctors and medical organizations have to consciously decide if, why and how to use the various social media platforms.”
Study reveals that many surgeons do not discuss end-of-life care
A new survey published in the Annals of Surgery reveals that many surgeons fail to discuss their patients’ wishes in case a risky operation goes awry and even more surgeons would not operate if patients limited what could be done to keep them alive. Margaret Schwarze, an assistant professor at the University of Wisconsin School of Medicine and Public Health, and her colleagues asked 912 surgeons who regularly perform risky operations 14 questions on how they discuss a patient’s advance directives. More than four out of every five surgeons discussed which forms of life support the patients would like to limit but only about half asked specifically about the patient’s advance directive, which can include restricting the use of feeding tubes and ventilators. More than half of the surgeons surveyed reported that they would not operate if an advance directive limited what could be done to keep a patient alive after surgery. The researchers said such instructions can cause tension between the surgeon and the patient because it shows the patient may be unwilling to accept the therapies that come with high-risk operations. Ann Surg. 2011 Dec 1. PMID: 22167006
Canadian researchers to test the safety of a new HIV vaccine
Many researchers have tried and failed to create an HIV vaccination but researchers from the University of Western Ontario have been working on a vaccine, dubbed SAV001 that takes a different approach. Developed by Dr. Chil-Yong Kang and his team over the last ten years, this vaccine uses the whole HIV virus that has been genetically engineered to be non-pathogenic. The idea is that the vaccine will prime the body’s T-cells to destroy any cells that might become infected with HIV. This vaccine has been shown to stimulate a strong immune response in preliminary animal toxicology tests but it will be several years before researchers will know whether it is effective in humans. The research team announced that they have received approval from regulators with the U.S. Food and Drug Administration to begin testing the experimental vaccine on humans. The Phase I clinical trial will involve 40 volunteers with HIV to test the safety of the vaccine. If reported to be safe, the next phases of study would test whether the vaccine is actually effective. The vaccine was developed with support from Sumagen Canada, a biotech company established in 2008 specifically to support clinical development of Kang’s vaccine.
Harper government invests in suicide prevention
On January 12, 2012, Leona Aglukkaq, Minister of Health, and Peter Penashue, Minister of Intergovernmental Affairs, announced funding for an initiative that aims to prevent suicide by rapidly gathering the best research on suicide prevention and making it available to community members and leaders who can put this information swiftly into action. The initiative is being carried out through the Evidence on Tap program by the Canadian Institutes of Health Research (CIHR). Through a competitive, peer-reviewed process, CIHR will support teams of researchers that will review and analyze research evidence from across the globe on suicide prevention. Teams will be asked to specifically examine research on school and community-based approaches to suicide prevention, the role of media in preventing suicide, and interventions that focus on people at high risk for suicide. The teams will have six months to carry their work. They will be required to submit a report to CIHR and to hold a workshop to share their findings with stakeholders.
Atrium Innovations announces continued growth and record results in 2011
Atrium Innovations Inc., a globally recognized leader in the development, manufacturing, and commercialization of innovative, science-based dietary supplements, released its 2011 revenue results. For the fiscal year ended December 31, 2011, Atrium recorded revenues of $414.7 million representing an increase of 16.3% compared to revenues of $356.6 million in 2010. This increase is mainly attributable to the acquisition of Seroyal, as well as to organic growth of North American branded business and to the favorable impact of exchange rates. “2011 proved to be a year of important changes for Atrium. After completing a series of strategic acquisitions in the last few years, the time was right to alter our management structure and thereby optimize our business platform with increased emphasis on organic growth. We appointed a Head of Operations in both North America and Europe, and welcomed new corporate executives. This team will provide us with a structure precisely tailored to maximize our synergies and build an effective platform. Atrium’s new ERP system implementation will be central to the new platform in North America. In this era of enhanced regulation, Atrium is advantageously positioned to reap the benefits of an industry which is increasingly gaining legitimacy and credibility,” said President and Chief Executive Officer, Pierre Fitzgibbon.
CMCC and UOIT create new professional pathway for qualified students
A new articulation agreement between the Canadian Memorial Chiropractic College (CMCC) and the University of Ontario Institute of Technology (UOIT) will enable qualified students to complete a Bachelor of Health Sciences (Honours) in Kinesiology degree and a Doctor of Chiropractic degree in seven years, instead of eight. For individuals who identify their career path early, this agreement seamlessly bridges a foundational degree into a professional degree in chiropractic. “UOIT and CMCC share a commitment to innovation in education,” said UOIT President Tim McTiernan, PhD. “This accelerated pathway will enable our students to further their education in less time so they can take an active role in helping others. In addition, cross appointments between our two institutions will enable the sharing of expertise and knowledge resources, allowing us to fully leverage the academic excellence resident at both institutions.” Acceptance into the CMCC-UOIT Bridging Program will begin in September 2012.
Harper government invests in personalized medicine
The Harper Government announced an important investment that will help Canadians receive more effective treatments and make the healthcare system more sustainable through personalized medicine. Healthcare will evolve from a reactive “one-size-fits-all” system towards a system of predictive, preventive, and precision care. Areas in which personalized approaches are particularly promising include oncology, cardiovascular diseases, neurodegenerative diseases, psychiatric disorders, diabetes and obesity, arthritis, pain, and Alzheimer’s disease. In all of these fields, and others, a personalized molecular medicine approach is expected to lead to better health outcomes, improved treatments, and reduction in toxicity due to variable or adverse drug responses. In addition to saving on the costs of expensive drug treatments, this personalized treatment would prevent a great deal of suffering, while identifying and initiating earlier treatments that would be more effective.animal data indicates AFN-1252 has mg/ kg efficacy that is significantly improved compared to linezolid; and both single and multiple dose Phase 1 data indicate an excellent safety and tolerability profile. We are confident that the Phase 2 trial will confirm AFN-1252 as a potent and well tolerated anti-Staph antibiotic” commented Dr. Hafkin, Chief Medical Officer of Affinium Pharmaceuticals.









