FDA intruding itself between doctors and their patients

For what gain?

U.S. health officials unveiled Tuesday a new plan to try to curb misuse of extended-release and long-acting opioid pain killers such as OxyContin, morphine and methadone.

The new Risk Evaluation and Mitigation Strategy (REMS) is part of a larger multi-agency initiative announced Tuesday by the White House to reduce overall prescription drug abuse in the United States.

"This new REMS will provide tools to doctors and other prescribers for appropriate pain management to reduce risks and at the same time preserve access for patients and appropriate management of pain for those suffering from moderate to severe pain," said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, the agency that launched the new program.

For now, the initiative will be limited to extended-release and long-acting products, which, Woodcock said, "have a much greater risk than immediate-release because they contain more medicine." She did not rule out the possibility that the approach could be expanded to include immediate-release drugs in the future.

Right now, the action affects 16 companies that make both branded and generic products. The products affected are known under their generic names as hydromorphone, methadone, morphine, oxycodone, oxymorphone, transdermal fentanyl and transdermal buprenorphine.

According to Woodcock, about 23 million prescriptions are dispensed each year for extended-release and long-acting opioids, which represented about 10% of the opioid market in 2009. But, abuse and misuse is also extensive, with the FDA estimating that 33 million Americans aged 12 and older used such a drug for non-medical purposes in 2007, up from 29 million people in 2002.
Some 50,000 emergency room visits in 2006 were related to opioids, officials said.

"This is a large and growing problem and, despite a number of efforts over the years, it continues to grow," Woodcock said. "It's clear we have a huge problem on our hands."

One of the main components of the new FDA program will be educating doctors and other prescribers on proper ways to prescribe opioids, as well as how to identify appropriate patients for these drugs.

"If a prescriber has a concern that a patient might unintentionally or intentionally misuse the drug, they need to know how to spot these individuals," Woodcock said. Doctors will also get materials on how to educate their patients, not only on proper use of opioids but also on proper storage and disposal.

Manufacturers will be required to use one central system to provide these educational materials, Woodcock said. And the FDA will monitor company-generated literature to make sure it isn't promotional but is effective, she added.

Companies have 120 days to issue a draft REMS and Woodcock hoped matters will be completed by early 2012.

"In the meantime, doctors should be prescribing opioids as they have been doing and we hope they thoroughly discuss risks and benefits with their patients," Woodcock said. "People taking opioids should continue to take them as directed and, if they have concerns, should consult a health-care professional."

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Lithium 'slows development of Alzheimer's'

A small study but encouraging. Does a remnote bureaucrat know better than your doctor what you need?

Lithium, used for decades to treat mania and depression, could also help slow the advance of Alzheimer's disease, according to a study published today

A trial of 41 people over 60 years of age with mild cognitive impairment, a condition that often leads to full-blown Alzheimer's, found that the rate of mental decline was lower in the half given 150mg of lithium daily, compared to those given a placebo.

While all participants showed a decline in memory function and attention tasks over the year, the rate of decline among those on lithium was significantly less. Levels of a biomarker for Alzheimer's disease called phospho-tau concentrations also rose more slowly in those on lithium.

Psychiatrists believe this is because it "may hamper mechanisms that lead to the formation of amyloid plaques and neurofibrillary tangles", microscopic brain structures linked to the most common form of dementia.

Dr Orestes Forlenza, who led the research, published in the British Journal of Psychiatry, said: "This study supports the idea that giving lithium to a person who is at risk of Alzheimer’s disease may have a protective effect, and slow down the progression of memory loss to dementia."

Professor Allan Young, a psychiatrist from Imperial College London, described the study as "encouraging" - and particularly interesting because no pharmaceutical company has a patent on lithium, meaning it is very cheap to prescribe.

He added: "This trial adds to the increasing evidence that lithium may have beneficial effects on the brain and begs to be replicated in further randomised trials."

But Rebecca Wood, chief executive of Alzheimer’s Research UK, said it was "too soon to draw any firm conclusions" because of the small study size.

Dr Anne Corbett, research manager at the Alzheimer's Society, said: "We need more, larger clinical trials to test existing drugs like lithium if we are to find better treatments for people with Alzheimer’s.

"Yet such trials are very expensive. We need greater investment in this area in order to help us develop better treatments for people with this devastating condition."

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