Society Logo
ME/CFS Australia Ltd

 
Please Click Here To Donate ME/CFS Australia (SA) Inc
 

Facebook
 


  ME/CFS AUSTRALIA (SA) INC

Registered Charity 698

Email:
sacfs@sacfs.asn.au

Mailing address:
PO Box 28,
Hindmarsh,
South Australia 5007

Office:
266 Port Road,
Hindmarsh,
South Australia 5007
Ph: 1300 128 339

Office Hours:
Wednesdays, 10am-3pm


FIBROMYALGIA HELP:
Contact
Fibromyalgia SA
at the
Arthritis Foundation of SA
118 Richmond Road,
Marleston 5033
Ph: (08) 8379 5711

ME/CFS Australia (SA) Inc supports the needs of sufferers of Myalgic Encephalomyelitis, Chronic Fatigue Syndrome and related illnesses. We do this by providing services and information to members.

Disclaimer

ME/CFS Australia (SA) Inc aims to keep members informed of the various research projects, diets, medications, therapies etc. All communication, both verbal and written, is merely to disseminate information and not to make recommendations or directives.

Unless otherwise stated, the views expressed on this Web site are not necessarily the official views of the Society or its Committee and are not simply an endorsement of products or services.

Become a Member
PDF Application Form 2014 (PDF, 243KB)
Why become a member?
 

FBI agent, 19 others vote against Jazz Pharma's drug for Fibromyalgia

Sunday 22 August 2010

Jazz PharmaceuticalsThe Wall Street Journal's Health Blog reports on news from the US that we believe comes under the "Huh?" category:

FBI Agent, 19 Others Vote Against Jazz Pharma’s Drug For Fibromyalgia

By Katherine Hobson

An FDA panel of outside experts — including an FBI agent! — voted against expanding the use of Jazz Pharmaceuticals’ narcolepsy drug to fibromyalgia, in part because of its potential as a street drug.

An illegal form of sodium oxybate is similar to the drug GHB, Dow Jones Newswires reports. As the NPR Shots Blog noted in the run-up to the meeting, GHB gained notoriety for its use as a date rape drug. Right now sodium oxybate is distributed for use against narcolepsy only under heavy restrictions, and while panel members agreed it seemed effective against fibromyalgia symptoms in some patients, they were concerned about the potential for its misuse.

TheStreet.com’s Adam Feuerstein, who live-blogged (and Tweeted) the advisory panel’s meeting, reported that an FBI agent was invited by the FDA to participate in the panel, presumably because of the questions about the drug’s way-way-way-off-label potential. She and 19 others voted no on the critical question of whether the benefits of marketing the drug to treat fibromyalgia outweighed the risks. Two panelists voted yes. (The company, obviously, said at the meeting that it believes the benefits do outweigh the risks, DJN reports.)

The panel didn’t shut the door forever on the drug, saying Jazz should keep working on it as a possible fibromyalgia therapy, DJN says. “While we are disappointed with the recommendation” of the committee, “we plan to work closely with FDA on the continuing review of our new drug application,” said Bruce Cozadd, chairman and CEO of Jazz, in a statement. The company will “carefully consider” the committee’s input as it “seeks to address the needs of fibromyalgia patients for new treatment options in a safe and reasonable way.”

The concerns about potential abuse and misuse were highlighted in the documents the FDA itself released earlier this week, in advance of this meeting. Say it together with feeling, everyone: The FDA usually, but doesn’t always, follows the advice of its advisory panels.

Update: This post has been updated to include a statement from the company.

We believe the news may also fit into the "What???" category.

The article originally appeared here.

 


Arrow right

More Fibromyalgia News

 


 

blog comments powered by Disqus
Previous Previous Page