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Avandia News
University of Miami Miller School of Medicine and Humana Launch Drug Safety Surveillance Program
August 22, 2007 - MIAMI--(BUSINESS WIRE)--The University of Miami Miller School of Medicine and Humana Inc. (NYSE: HUM) today announced the launch of a new Pharmacovigilance Initiative at the University’s medical campus in Miami. The new program will focus on prescription drug safety -- in particular, the science of detecting and understanding adverse drug events.
“It is estimated that about 2 million people in this country experience a serious adverse drug reaction each year,” said University of Miami President Donna E. Shalala. “Clearly, something in our system is not working properly, and this new program will track the problem and offer solutions based on good science and research.”
The new Pharmacovigilance Initiative will be undertaken by the University of Miami-Humana Health Services Research Center, a public-private partnership established in 2005 to focus on health services and health behavior research with an emphasis on improving health outcomes for individual patients.
“Pharmacovigilance represents yet another area where the University and Humana have a unique opportunity to bridge the research gap between the bench and the bedside and give consumers a real time, transparent view into the health care system,” said Jonathan Lord, M.D., Humana’s Chief Innovation Officer.
Although the Center works with a number of entities today to design and produce cutting edge research on conditions like metabolic syndrome, obesity, heart disease and diabetes, the new Pharmacovigilance Initiative will be an independent pursuit aimed at protecting the health and safety of the public, supporting better clinician decision making through reporting on the comparative effectiveness of pharmaceuticals, and contributing to the ongoing dialogue in Washington around drug safety.
“Right now, the reporting of adverse drug events to the U.S. Food and Drug Administration is strictly voluntary, and the recent drug recalls and stepped-up black box warnings would suggest something more needs to be done to protect patient safety,” said Pascal J. Goldschmidt, M.D., senior vice president for medical affairs and dean of the Miller School of Medicine. “This new initiative between the Miller School of Medicine and Humana is the right thing to do for the patient, at the right time.”
Further complicating the risks of adverse drug events, roughly 21 percent of all medications are prescribed “off label,” or for uses other than what they were approved for by the FDA. Little is known about clinical and cost impacts of off-label use.
“We will be looking at a wide range of medications to track trends in side effects and potential adverse events,” said William J. O’Neill, M.D., executive dean for clinical affairs and medical director of the Pharmacovigilance Initiative. “For example, we are analyzing the outcomes of 41,000 diabetics in Humana’s population, including Avandia users.”
Avandia is the diabetes drug that recently came under fire because of a reported increase in heart attack risk.
The Center will be appointing a multi-disciplinary Advisory Board, including a medical ethicist, to provide guidance on the clinical domains of exploration and communicating findings to the public. Beyond Avandia and several other targeted analyses, the University of Miami and Humana expect the Pharmacovigilance Initiative to begin communicating through public releases and a consumer Website a large volume of research findings in early 2008.
About Humana
Humana Inc., headquartered in Louisville, Kentucky, is one of the nation’s largest publicly traded health benefits companies, with approximately 11.3 million medical members. Humana offers a diversified portfolio of health insurance products and related services – through traditional and consumer-choice plans – to employer groups, government-sponsored plans, and individuals.
Humana is one of Florida’s leading health benefits companies with nearly 1 million medical members statewide, and is the University of Miami’s health benefits provider.
Over its 46-year history, Humana has consistently seized opportunities to meet changing customer needs. Today, the company is a leader in consumer engagement, providing guidance that leads to lower costs and a better health plan experience throughout its diversified customer portfolio.
More information regarding Humana is available to investors via the Investor Relations page of the company’s Web site at http://www.humana.com.
Contacts
Humana Corporate Communications
Mitch Lubitz, 813-732-0386
mlubitz@humana.com
or
University of Miami Miller School of Medicine
Media Relations
Jeanne Antol Krull, 305-243-4853
jkrull@med.miami.edu
Doctors welcome decision to make Avandia available
By Nina Muslim, Staff Reporter
August 05, 2007 - Dubai: Physicians in the country heaved a sigh of relief following an announcement that popular diabetes drug Avandia will remain available, albeit with stronger warnings for increased heart risks, following a recommendation from the US drug authority.
A panel of external experts recommended to the US Food and Drug Administration (FDA) on Monday that Avandia, or rosiglitazone maleate, continue to be available with stronger warning.
FDA is not bound to follow the panel recommendations but adopts them frequently.
Journal report
The safety of the GlaxoSmithKline (GSK) drug was called into question in May with the publication of an analytical study in the New England Journal of Medicine, which contended that Avandia increased heart failure risks by 43 per cent.
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Dr Abdul Razzak Al Madani, president of Emirates Diabetes Society, told Gulf News physicians should now be careful to explain the risks of the drug, used to treat Type II diabetes.
"There is not enough evidence of the risks compared to other drugs. But we have to explain to the patient and leave the decision to him," he said.
"If it's working fine and there are [no serious side effects], there is no good reason to discontinue it. Unless, of course, the patient requests it," he added.
He stressed that the drug safety scare highlighted the importance of preventing diabetes as "there are no medicines without side effects".
Dr V.J. Sebastian, head of cardiology at Welcare Hospital, told Gulf News he was relieved that the drug remained available although he would be prescribing it less.
"I'm happy because it is a very good drug for patients with insulin resistance," he said. "[But] we will now have to be very careful in selecting patients [to prescribe the drug] and carefully monitor them for heart failure and fluid retention," he added.
He said he used to prescribe Avandia to 40 per cent of his patients. Now, he plans to prescribe to about 30 per cent of patients.
The Health Ministry will not take immediate action on the FDA panel's recommendation of stronger warnings on Avandia.
'No immediate action'
Dr Fatima Ali Abdullah, deputy director of drug control at the ministry, told Gulf News they need time to peruse the recommendation and weigh the risks against the benefits.
In a press release, GSK stated they were happy with the advisory committee's decision.
"We welcome the decision as positive for patients. This was the first opportunity for these scientific experts to review the full data behind Avandia," said Dr Ronald Krall, the company's chief medical officer.
The UAE has the second highest rate of diabetes, according to the International Diabetes Federation.
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