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Press Release: 2007-12-04

DRUG SAFETY EXPERTS CALL FOR INCREASED PATIENT INVOLVEMENT

Panel addresses need for improved reporting about drug safety issues

WASHINGTON, D.C. – December 04, 2007 –

Drug safety experts are calling for an improved approach to providing consumers with real time and personalized information about the risks and benefits of drugs on the market.

Representatives from the Center for Medicine in the Public Interest (CMPI) and the Critical Path Institute (CPI) hosted a breakfast briefing today at the National Press Club, to raise awareness about iGuard, a solution to the growing issue of drug safety.

"Medical journals and media reports provide conflicting information that often promote confusion and fear rather than provide guidance. Doctors are finding that their patients—as a result of hearing about a drug risk—are either afraid to start drugs that they need to improve a serious medical condition, or stop taking a medicine altogether, often without telling their physicians," according to Michael Weber, M.D., associate dean and professor of medicine, SUNY Downstate College of Medicine, Brooklyn.

To address this problem, drug safety experts are urging people to take a more active role in understanding the risks and benefits of their medicines through real time updates-something that headline news or research cannot provide today.

"This is a growing public health problem that reinforces the need for improved, immediate and continuing communication with pharmaceutical firms, physicians and patients about the benefits as well as safety of their medications. The current approach-waiting years after a drug is launched to see how it's doing in clinical practice, and even then getting information that is either sensationalized or not specific to individual patients-is not good enough. Patients, just as much as doctors, have a right to objective information that lets them make individualized treatment decisions. iGuard is an important initiative that provides patients, who are the true consumers of drug products, with this needed information about their treatment," Weber said.

With nearly half of all Americans taking a prescription drug and one in six taking three or more medications,i the opportunity for improved health and safer, more effective prescribing is significant. iGuard was developed to meet this gap and provide the personalized safety information patients need to take a more active role in managing their health.

iGuard (http://www.iguard.org), is a new, free online service that provides patients with personalized risk ratings and safety alerts. These tools allow patients to stay informed about the safety of the medications and supplements they take. And, by providing patient-reported feedback to drug safety researchers in a structured manner, iGuard may also shorten the time it takes to identify safety issues.

About CMPI

CMPI is a non-profit institution founded to promote advances in genomics and health information technology that make medicine more predictive, preventive and personalized. CMPI does that through research, outreach and solutions focusing on how to use 21st century science to personalize medicine, improve wellbeing and extend life.

About iGuard

iGuard is the fastest and easiest way for patients to get information and safety updates on the drugs they are taking. This drug safety monitoring program facilitates bi-directional exchange of timely and relevant information, enabling patients to take an active role in managing their health. iGuard maintains an efficient communication channel where patients and health professionals can monitor, evaluate and share information about drug risks and benefits. Registration is free online at www.iguard.org.

About The Critical Path Institute

Based in Tucson, Ariz., with offices in Rockville, MD, The Critical Path Institute (C-Path) was established in 2005 as an independent nonprofit research and education institute to serve as a "trusted third party" for collaborations among scientists from government, industry and academia. C-Path's vision is to help implement the FDA's Critical Path Initiative by developing faster, safer and smarter pathways to new medical products. For more information, visit www.C-Path.org.

i US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics. November 2006 DHHS Publication 2006-1232, p 28

DISCLAIMER: iGuard is not intended to be a substitute for professional medical advice. iGuard cannot and does not take into consideration every possible interaction or account for individual responses to medicine. Different individuals may respond to medication in different ways. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective, or appropriate for any given patient. Always seek the advice of a qualified health provider with any questions you may have before making any changes to your treatment. The use of the iGuard site and its content is at your own risk. The iGuard site and the information contained in it is intended for users in the United States and information in other countries may be different.

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