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Author: joshbk Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: of 24967  
Subject: Hemispherix, CFS, and politics Date: 7/17/2008 12:04 AM
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I think it's time to reassess Hemispherix, whose new drug application for Ampligen (their only) drug, was recently accepted for FDA review.

I also want to address some of the issues that made Fools skeptical about Hemispherix in the past. Ampligen is primarily intended to treat Chronic Fatigue Syndeom (CFS), so a large portion of the discussion involves background on CFS, trends in relevant research, and the role of the FDA. Hey at the least it all makes an interesting story.

Firstly, there are two different camps in CFS research - (a) government research primarily from the CDC (and also NIH) and (b) a strong network of primary care physicians who treat CFS (often with Fibromyalgia) and have transitioned into research. The former primarily investigate the psychological and cognitive aspects of CFS, while the latter have been digging for physical causes. If the total research picture seems inconsistent, it's often due to discrepancies between these 2 camps, which go so far as to use vastly different research definitions of CFS. Nonetheless, if you follow strands from individual groups of researchers who use the same criteria for CFS, then the picture is not quite so hazy.

Secondly, many doctors in the physician camp view Ampligen as a solid cure for CFS, which at the least will work wonders in a substantial subset of patients. You can easily find websites and articles by/about these physicians, some top names include Daniel Peterson, Paul Cheney, and David Bell. Among these doctors, Ampligen is not seen as a risky, fringe, or even "experimental" drug. They don't have financial ties to Ampligen, they're simply genuine concerned doctors, who were flung into this mess when people in their town started coming down with CFS. Peterson and Cheney, who were the first physicians to treat CFS in an "outbreak" in the 80's, actually proclaimed that Ampligen was the cure, as far as they were concerned. But there was another twist: The FDA demanded more research.

The delay in approving Ampligen (20 years and counting) is due to politics and research surrounding CFS, not to Hemispherix's efforts. When the FDA initially reviewed the drug, many government scientists were still questioning the validity of CFS as a disease, and there was (and still is) bias towards framing it as a psychological illness. In fact, many of the symptoms that the FDA deemed side effects form Ampligen - flu-like symptoms, heart-related symptoms, and occasional elevated liver enzymes, and others - are actually classic symptoms of CFS. CFS is so impairing that other deemed "side-effects" really don't hold a torch to it. However, the FDA deemed that these were side-effects of the drug because of debate over the core physical symptoms of CFS - a decision which cut the last ties between expert CFS physicians and governmental research efforts 20 years ago.

As it stands currently, the FDA is still being stingy regarding Ampligen. I recently heard a speech by an FDA spokesperson who said that wee need to find a biomarker for CFS in order to facilitate Ampligen's approval. Once again, though, non-governmental researchers have found many biomarkers when using more solid research definitions of CFS. And moreover, the FDA doesn't require a biomarker for most of their drug-approvals. Nonetheless, pressure has steadily continued to approve Ampligen since it was created; and furthermore they recently approved the first drug for Fibromyalgia (Lyrica), which a disease often seen with CFS, and filled with similar political controversy.

Of course, these are all just opinions, but trust me they're shared by many other people as well (see the book Osler's Web for much more detail).

However, since they're not mainstream, you won't see them in a typical analysis of Hemispherix.

Ampligen will be approved some day, it's just a matter of time - hopefully, by now, it'll be a question of years and not decades.

As for the financial strength of Hermispherix - and their ability to profit off their only drug - I was curious about what other Fools have to say.
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