Articles and Publications
Perspectives on Drug and Medical Device Development: 2007
The development of new therapies for epilepsy is a long and complicated process. We have asked experts with interests and concerns to write about issues that affect the different perspectives on drug development. This is a new series that we recently started and we very much invite your participation. / The Editors
By Zach Lynch
Emerging tools to treat the brain and the nervous system have the potential to transform nearly every aspect of our lives. There’s no mistaking the progress. Neurotechnology — the tools to treat and understand the brain and nervous system — will also revolutionize our concept of the human mind. It is now time for public policy to catch up to the science. Imagine walking into a doctor’s office where an advanced brain scanning system can detect cellular-level changes that signal the onset of epilepsy, before any symptoms begin. The quality of life for you and your loved ones might be extended by decades with a treatment plan personalized to your specific case. To read more, go to: http://professionals.epilepsy.com/page/ar_1193760406.html
Zack Lynch is Executive Director, Neurotechnology Industry Organization (NIO). The Neurotechnology Industry Organization (NIO) is the trade association representing companies involved in commercial neuroscience (drugs, devices and diagnostics), brain research centers, and advocacy groups across the world. NIO is based in San Francisco with offices in Washington DC. www.neurotechindustry.org
By Joyce A. Cramer
Medical scientists, including epilepsy researchers, were stunned to learn recently that the overall NIH budget for fiscal year 2007-08 would be less than the previous year. Focusing on the National Institute of Neurological Disorders and Stroke (NINDS), which oversees epilepsy research, this cut will result in even fewer new grant awards than in 2006. This is bad news for people with epilepsy who need new therapies.
Part of the growth of NIH and NINDS research funding occurred during the years 1998-2003 when very large increases more than doubled the budget. This will be the fourth year that the NIH budget has not kept pace with inflation. Each NIH agency sets aside part of the total budget for annual renewals of previously awarded grants (individual R01 and Program-Project or Center P50, P60 grants). That means that the larger number of grants awarded in the past now absorb 75% of the NINDS budget. Read more at: http://professionals.epilepsy.com/page/ar_1187905182.html
Joyce A. Cramer is President of the Epilepsy Therapy Project (ETP), a non-profit organization advancing new therapies for people living with epilepsy, and Associate Research Scientist at Yale University School of Medicine, New Haven, CT.
By Michael Losow
Perhaps the most significant issue Congress is working on is one that will not even register on the radar screen of the people who should care the most – patients and physicians. That issue is patent reform. Every patient advocacy organization and medical specialty group has its top legislative priorities -- from NIH funding to medical malpractice reform. So why should a change in patent laws mean anything to the practice of medicine or the treatment of one’s disease? First let me explain the significance of patents to the biotechnology industry. For more, please go to: http://www.epilepsy.com/articles/ar_1183476354
Michael Losow is an attorney who joined the Biotechnology Industry Organization (BIO) in 1996. He has more than 20 years experience in public policy and government relations, 15 spent as a health and disability consumer advocate, and 13 spent at the National Multiple Sclerosis Society where he established its government relations program.
By Robert S. Fisher, MD, PhD
Throughout the world medications have different names. We may find it daunting and confusing, but nations maintain the right to approve or not approve marketing of pharmaceuticals in their own country. As physicians, however, we are often called upon to prescribe or help find medications for patients from other countries, particularly travelers. As such, at epilepsy.com we have an International AED database to help out.
When patients become frustrated as to why there are so many names, there are no simple answers. But here are a few key reasons. . . Regulatory agencies in one country may consider a drug useful and in another country not so useful, depending upon whether or not they are available in each country. Industry may have gone to the effort and expense of documenting safety and efficacy of a drug in one country, but not in another. Find out more about this perplexing issue at: http://professionals.epilepsy.com/page/ar_1180557801.html
Dr. Fisher is Maslah Saul MD Professor of Neurology and Director of the Stanford Comprehensive Epilepsy Center. He received his PhD in the Neurosciences in 1976 and a MD in 1977, from Stanford University.
By Richard Barker, PhD
Life is about decision-making, weighing the risks and benefits. And when it comes to medication, most of us ask the same question – will the benefits justify the risks, any side-effects, any “adverse reactions” as they are called? The making of a medication is a long journey. It begins with a process of discovery. It is first tested on experimental animals and then typically on small numbers of healthy volunteers. Then it is tested on a small group of patients and before it moves to a larger group, until thousands of patients may have received it. And each time the benefit – the efficacy, as we call it – is weighed against any side-effects that might appear. Learn more about the process at: http://www.epilepsy.com/articles/ar_1177687008
Richard Barker, PhD, is Director General of the Association of the British Pharmaceutical Industry. In this capacity he is also a board member of EFPIA (the European industry association) and council member of IFPMA (the International equivalent).
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