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FDA Prioritizes Hepatitis C

December 28, 2010

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In order for our society to overcome the burden of Hepatitis C, we must prioritize efforts to increase its awareness, detection and treatment. Moving along those lines, the FDA makes an important step in that direction.

by Nicole Cutler, L.Ac.

The pharmaceutical industry has identified the tremendous gap between effective Hepatitis C treatment and adequacy of the currently approved Hepatitis C antiviral drugs. Improvements in training, research and drug development are getting closer to narrowing the gap in eliminating the Hepatitis C virus, but an equally intensive effort for approving medications is warranted. Progress in Hepatitis C awareness has not yet sufficiently infiltrated the public health sector. However, the U.S. Food and Drug Administration (FDA) has recently taken a monumental step in acknowledging that specialized education and greater funding is required to aid the plight of advancements in Hepatitis C therapy.

More on Hepatitis C
Hepatitis C infects an estimated four to five million American adults, statistics that dwarf the number of Americans living with HIV - the virus that causes AIDS. Because symptoms of this infection go relatively unnoticed until it has progressed to advanced liver disease, many people don't know that Hepatitis C resides in their liver. An undiagnosed Hepatitis C infection can lead to cirrhosis, liver failure or liver cancer, a fact that renders such an oversight to be dangerous.

Even for those who know they are infected with Hepatitis C, treatment is not guaranteed to help. Sadly, even knowing that you have Hepatitis C and diligently receiving treatment may not rid you of this virus. Since the currently approved treatment for Hepatitis C is only about 50 percent effective in individuals with the most common strain of the virus, the need for better treatment options is blatant.

Government Involvement
As a testament to the government support needed, the National Viral Hepatitis Roundtable (NVHR) took an official stand on Hepatitis C education last year. The NVHR urged Congress to move quickly on bipartisan legislation advocating new Hepatitis C state-based detection, research and surveillance efforts. Their urging followed the publication of a study in the December 2009 edition of Hepatology where University of Michigan investigators found:

· Fewer than 20 percent of Americans with chronic Hepatitis C received antiviral therapy between 2002 and 2007.

· Treatment rates are sub-par, because only about 50 percent of those with Hepatitis C know they are infected.

· Barriers to Hepatitis C screening include the absence of health insurance coverage, limited access to standard medical care and lower priority of Hepatitis C testing by primary care physicians.

Without a doubt, increased public health efforts are needed to improve awareness, testing and access to Hepatitis C antiviral therapy. The Michigan researchers also recommended further research of health services delivery and quality of care for Hepatitis C patients.

Hooray FDA
Government support to improve Hepatitis C detection, research and surveillance is important, but it is not the only type of aid needed. Addressing another portion of government support, the U.S. Food and Drug Administration recently announced its search looking for new members of its Antiviral Drugs Advisory Committee.

As a group of individuals who consider evidence from clinical trials and make recommendations about whether new drugs should be approved or denied, the FDA is now looking for qualified medical and/or scientific consultants who have medical expertise and experience in Hepatitis C. More specifically, the FDA wants new members who:

1. are hepatologists or another type of medical doctor who treat a substantial number of Hepatitis C patients

2. can interpret and analyze detailed scientific data

3. comprehend the magnitude new Hepatitis C drugs pose to public health

In order to keep the motivations of the new committee members honest, the FDA is considering any ties to a pharmaceutical company to be a conflict of interest. Since the first of the next generation of Hepatitis C drugs are expected to be up for approval in 2011, strengthening the Hepatitis C-knowledgeable contingent in the FDA's Antiviral Drugs Advisory Committee is a great step forward in fighting this illness.

Just about everyone personally affected by chronic Hepatitis C infection recognizes the need to improve mass education and medical advances for this disease. When it comes to comprehending the prevalence and health implications of Hepatitis C, public health campaigns have a great deal more progress to make. On the other hand, drug companies are well aware that Hepatitis C represents a major health crisis capable of crippling our current healthcare system. Now, the branch of the government that approves medications is finally joining the pharmaceutical industry in realizing that our community needs and deserves a commitment towards improving the future of Hepatitis C treatment.

References:

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm222191.htm, What is an FDA Advisory Committee?, Retrieved December 12, 2010, US Food and Drug Administration, 2010.

http://www.fda.gov/AdvisoryCommittees/default.htm, Advisory Committees, Retrieved December 12, 2010, US Food and Drug Administration, 2010.

http://www.prnewswire.com/news-releases/nvhr-new-data-finding-fewer-than-1-in-5-hepatitis-c-patients-receiving-antiviral-therapy-is-wake-up-call-for-washington-72130697.html, NVHR: New Data Finding Fewer than 1 in 5 Hepatitis C Patients Receiving Antiviral Therapy is 'Wake-Up Call' for Washington, Retrieved December 12, 2010, PR Newswire Association LLC, 2010.

http://www.hivandhepatitis.com/hep_c/news/2010/1210_2010_a.html, Hepatitis C Experts Sought for FDA Advisory Committee, Retrieved December 12, 2010, hivandhepatitis.com, 2010.

Posted by Editors at December 28, 2010 11:01 AM

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