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January 2010

FDA Urges Drug Companies to Focus on Abuse Potential

FDA Urges Drug Companies to Focus on Abuse Potential
January 29, 2010

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News Summary

New voluntary guidelines issued by the U.S. Food and Drug Administration (FDA) direct pharmaceutical companies to more closely examine the abuse potential of new drugs and help determine if and how they should be listed under the Controlled Substances Act, the Baltimore Sun reported Jan. 27.

The FDA guidance says that drugmakers should look beyond addictiveness to also consider other ways that drugs could be abused. Michael Klein, director of FDA's controlled substances program, noted that the anesthetic propofol -- one of the drugs that killed pop star Michael Jackson -- is not a controlled substance but has reported abuse potential.

"They're expanding this idea that abusable drugs aren't just the ones that are addictive," said Scott Fishman, chief of pain medicine at the University of California at Davis' School of Medicine.

FDA is currently gathering public comments on the proposed guidance (


Rules on Addiction and Mental Health Parity Issued by Obama Administration

Rules on Addiction and Mental Health Parity Issued by Obama Administration
January 29, 2010

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News Feature
By Bob Curley

New rules for implementing the addiction and mental-health parity law passed by Congress in 2008 are being hailed by advocates, despite their issuance three months after the law actually went into effect.

The interim final regulations (PDF) unveiled on Jan. 29 included detailed guidelines and guidance on implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA), which took effect in October 2009. "The rules we are issuing today will, for the first time, help assure that those diagnosed with these debilitating and sometimes life-threatening disorders will not suffer needless or arbitrary limits on their care," said U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius.

The final rules will go into effect on April 5, and will be applicable to insurance plan years that begin on or after July 1. Rep. Patrick Kennedy (D-R.I.), who along with former Rep. Jim Ramstad (R-Minn


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Scott Kelley LCDC     

Switching Off Hunger Hormone Affects Desire To Drink

A Faculty of 1000 evaluation examines how a stomach-produced hormone that influences the desire to eat and consume alcohol could be switched off to control drinking problems.

The study, carried out by Jerlhag et al. at the University of Gothenburg in Sweden, showed that the hormone ghrelin, typically released by the stomach and known to promote appetite and therefore the intake of food, also influences the consumption of alcohol.

The results, published in The Proceedings of the National Academy of Sciences of the USA, showed that mice injected with ghrelin and then given the choice of alcohol or water to drink, were more likely to choose alcohol. At the same time, mice treated with ghrelin antagonists, as well as knockout mice (mice with the hormone's receptor removed), proved resistant to the effects of alcohol.

Faculty of 1000 Biology reviewer Kent Berridge of the University of Michigan says the ghrelin-injected mice showed more than a typical appetite for calories in choosing alcohol and the findings might influence treatment strategies for alcoholism.

Professor Berridge says, "These results seem to suggest a role for the effects of ghrelin on the brain in the motivation for alcohol consumption."

Kent Berridge, Faculty Member for f1000 Biology, is James Olds Collegiate Professor of Psychology and Neuroscience at the University of Michigan.

The full text of the evaluation of is available free for 90 days here.

An abstract of the original paper by Jerlhag et al. (Requirement Of Central Ghrelin Signaling For Alcohol Reward) is available here.

Steve Pogonowski
Faculty of 1000: Biology and Medicine


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