Author:
T Hanbey, Hepatitis C Outreach Project
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Date Posted: Wed, August 13 2003, 1:33:44 PDT
In reply to:
Digestive Diseases Week, May 19-21, 2002
's message, "Five abstracts on Pegasys (Roche)" on Mon, May 20 2002, 8:38:43 PDT
All about interferon therapy
by T Hanbey
The FDA approval process is the mechanism designed to protect the public from dangerous drugs and treatments and to limit the use of certain drugs to specific purposes.
It is very, very important information, much more so than ANY other source.
The approval process is the litmus test for the approval by the FDA to sell the therapy for a specific use. This is called "on label." If a doctor uses a drug for another indication, this is called "off lable."
The very reason it is so important is that here is where the rubber hits the road in terms of what, exactly, the medications are proven to do, what side effects have been noted, how they were noted(depression, for example was a side patients had to bring up, they were not asked about it), when effects occurred, how many deaths or other adverse events occurred and what the circumstance of them were, what patients benefitted, which do not, etc etc.
The drugs are compared and contrasted with other drugs approved already and the manufacturers have to defend all of their data.
At the end of the day, claims heard around the internet, in marketing efforts (which may include sites paid to promote the drugs and/or people paid to post to chat rooms, message boards and the like to promote the treatments to "other patients") and in published articles and studies have no proven reliability if they are not tested by the FDA approval process. Peer reviewed articles have more weight than those that are not peer reviewed, but most are still theory.
The FDA is the one and only place that you can find the bare bones, bold faced truth about what you can, and cannot expect from treatment.
So, the (hepatitis C) treatment are approved for the achievement of a sustained viral response. Questions remain about what that means and answers are given for what it means to those who do, and those who do not, achieve the sustained viral response. Those who do seems to fair much better than those who do not.
What I do not want to do is to interpret the transcript and/or defend it. It speaks for itself for anyone willing to read it.
You can find the transcript here:
http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3909T1.htm
The significance of this is that the FDA process is the highest level of scrutiny for any drug. Approval indications are specific and manufacturers are limited in what they can claim in the literature.
But that does not stop anyone from making any claim they wish anonymously in chat rooms, message boards, and in support groups or anyone from having an opinion about what the data says. I think it is clear enough not to need an interpretaion from me unless I am asked specifically for an opinion. At that point, my opinion is just as good as anyone else's.
The FDA hearing on the approval of Pegaysus talks about the Rebetron therapy, genotypes, and results of many studies across the board. These studies are selected by the manufacturers as their "best foot forward" data. Then, the FDA panel challenges that information.
The result is the only place you can get the real goods on the treatment without "spin."
I admit that some of the information is technical and hard to follow. The question and answer portion is much less so.
My strong advice to anyone considering this treatment is to take a copy to your doctor and insist on having your questions answered to your satisfaction, based on a thorough assessment of your own personal situation.
The Harvard School of Public Health Risk Assessment IS a study. It is a study of the risk vs benefits of interferon therapy for hepatitis C
The particulars of that study were published in The Journal of the American Medical Association (July 2003, Author: Goldie). Abstracts are fine for reference purposes, but the article in its entirely is much more informative. This is a big decision for many.
Every hospital has a medical library and many will allow you to copy articles from publications. I'm guessing, but they all have a copy of JAMA.
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www.hcop.org
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