Navigation Links
FDA Panel Recommends Against 1st Drug for Chronic Fatigue Syndrome
Date:12/21/2012

By Steven Reinberg
HealthDay Reporter

FRIDAY, Dec. 21 (HealthDay News) -- A U.S. Food and Drug Administration advisory committee on Thursday recommended against approval of the first proposed drug to treat chronic fatigue syndrome.

The advisors weighed the risks and benefits associated with the intravenous drug rintatolimod (suggested brand name Ampligen). The drug's maker, Hemispherx Biopharma of Philadelphia, also failed to win FDA approval in 2009 because of concerns about the methodology of clinical trials used to study the drug.

In Thursday's 8-to-5 vote, the advisory panel said the company hadn't provided enough data to support the approval of Ampligen. Although the FDA isn't bound to follow the recommendations of its advisory committees it usually does so.

The central issue Thursday was whether Ampligen works and is safe. The FDA said there wasn't sufficient data in clinical trials to determine the drug's safety. Possible concerns include infections and liver problems, The Wall Street Journal reported.

Several panel members said they struggled with their decisions because it seems the drug works in some patients, the newspaper reported.

Experts have said they would welcome a treatment for chronic fatigue syndrome, a disabling condition that affects as many as 4 million Americans, mostly women. There is no cure, but Ampligen appears to reduce symptoms for some patients.

"It does seem to help at least a subset of patients significantly. For others, there isn't a significant response," said K. Kimberly McCleary, president of the Chronic Fatigue and Immune Dysfunction Syndrome Association of America.

"This drug has been studied in chronic fatigue syndrome since the late 1980s, so it's been around for a while," McCleary added.

Dr. Nancy Klimas, professor of medicine at Nova Southeastern University College of Osteopathic Medicine in Fort Lauderdale, Fla., who is part of an ongoing trial of the drug, said some of her patients have benefitted from the drug. Now there needs to be a way to identify which patients would do well on the drug, she added.

According to the drug company, Ampligen is a new type of drug called a nucleic acid compound, which uses specially made RNA to target a variety of diseases. Hemispherx believes the drug has the potential to fight HIV, kidney cancer and melanoma in addition to chronic fatigue syndrome.

The drug is said to work by modulating the immune and antiviral functions in diseased cells.

One drawback of the treatment is that it needs to be infused twice a week, Klimas said. It also is very expensive, she said.

The maker of the drug couldn't estimate the retail cost but said the manufacturing cost is about $1,000 a month per patient.

The FDA denied approval for Ampligen in November 2009 because of concerns about the way two studies were conducted -- too few patients, a protocol change and an early end to one study.

Some experts think chronic fatigue syndrome is caused by a virus; others believe it is linked to a bacteria. It can begin after an illness from which a patient doesn't quite recover, or the symptoms can appear almost overnight, McCleary said.

Symptoms often include flu-like weakness. The one common thread is the inability to do almost anything without becoming exhausted, McCleary said. Even simple tasks like reading a magazine can set off a cascade of symptoms that last for days or weeks, she said.

"It's a bone-crushing exhaustion," McCleary said. "There is pain in the muscles and joints that can move from one body part to another, sore throat, headaches like migraines, and trouble falling asleep or staying asleep."

There are mental symptoms as well, including difficulty processing information and a "big problem" with short-term memory, McCleary noted.

More information

For more on chronic fatigue syndrome, visit the U.S. National Library of Medicine.

SOURCES: K. Kimberly McCleary, president, Chronic Fatigue and Immune Dysfunction Syndrome Association of America; Nancy Klimas, M.D., professor, medicine, and director, Institute for Neuroimmune Medicine, Nova Southeastern University of Osteopathic Medicine, Fort Lauderdale, Fla.; Wall Street Journal


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. FDA Panel Considers 1st Drug for Chronic Fatigue Syndrome
2. CDC Panel: All Pregnant Women Should Get Whooping Cough Shot
3. U.S. Panel Rejects Ovarian Cancer Screens for Low-Risk Women
4. Expert panel calls for new research approach to prevent youth violence
5. Expert Panel Suggests PSA Test May Benefit Some Men
6. Few Patients Should Get Metal-on-Metal Hip Implants, FDA Panel Says
7. Screen All Adults for Obesity: U.S. Panel
8. FDA Panel Backs At-Home HIV Test
9. FDA Panel to Consider At-Home HIV Test
10. FDA Panel Gives Blessing to New Weight-Loss Drug
11. U.S. Panel Rejects Ovarian Cancer Screening
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2017)... TN (PRWEB) , ... May 24, 2017 , ... ... the addition of ExtraHop to its solutions portfolio. ExtraHop delivers an analytics-first approach, ... security of every IT system, from the datacenter to the cloud to the ...
(Date:5/24/2017)... ... May 24, 2017 , ... Rob Lowe is a sought ... for Public Television. “Informed” brings the public important topics from all aspects of life, ... the feet and issues surrounding feet and ankles. , Podiatry is essential to people’s ...
(Date:5/24/2017)... ... May 24, 2017 , ... Technique, technique, technique – with a dash ... weights for strength training and exercise or simply lifting heavy objects, advises Dr. Kaliq ... is everything,” Dr. Chang says. “Improper technique in lifting anything heavy or an attempt ...
(Date:5/23/2017)... ... 23, 2017 , ... Axiad IDS , a leading provider of trusted ... named the company a “Top 25 Cybersecurity Companies 2017.” Axiad IDS received ... simply and proactively address potential cybersecurity threats before they happen. The annual ...
(Date:5/23/2017)... ... May 23, 2017 , ... Cambridge, MA, ... steady since 2009, according to a Workers Compensation Research Institute (WCRI) study, a ... the North Carolina System: CompScope™ Benchmarks, 17th Edition looks at indemnity and ...
Breaking Medicine News(10 mins):
(Date:5/22/2017)... MAITLAND, Fla. , May 22, 2017 /PRNewswire/ ... industry as a whole continue to make the ... evidence becomes increasingly important for ensuring positive patient ... Key industry stakeholders are shifting focus away from ... results and effects of long-term specialty drug therapy ...
(Date:5/15/2017)... Enterin Inc., a privately-held CNS pharmaceutical company based ... to treat Parkinson,s disease (PD), has enrolled the first patient ... randomized, controlled, multicenter study involving patients with PD and taking ... over a 9-to-12-month period. The first stage is open label ... Participating sites include Denver , ...
(Date:5/10/2017)... -- Global Health Intelligence (GHI), the leading healthcare ... published its 2017 ranking of the Best-Equipped Hospitals in ... analysis from GHI,s hospitals database for Latin America , ... The GHI database covers 86% of the hospitals in ... points for each institution in key areas such as beds, ...
Breaking Medicine Technology: