Nielk
Senior Member
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- 6,970
1) People should not assume that the data that is availabel publicly is ALL the data that is available. FDA can request data from the drug companies but by business laws concerning confidentiality/ patents/ etc., neither FDA nor drug companies are required to release all information to the public. There have been some big scandals in recent years with drug companies witholding data on adverse effects, the drug being approved, and lots of patients being harmed. Some drugs have been pulled off the market or had a big warning label slapped on them because of this.
As a healthcare professional, I used to get mailings almost every week from pharma about new side effects, indications, warnings, etc. These were from drug companies and required by FDA when something new came up.
2) One thought is Hemispherix could have looked at who responded to Ampligen and then work backwards to see what, if any, of their blood tests were different from the people who did not respond. I believe they did a fair amount of bloodwork to screen who qualified for the drug initially and to rule out other causes of disease.
3) An Immunovir study would likely be much les expensive than an Ampligen study. partly because the drug is orally taken, doesn't need a lot of safety monitoring (decades long good safety profile), and is not overly expensive ($100/ month US currently vs. $2,000 or more for Ampligen, not counting infusion cost).
As far as #2, I would think that Hemispherx who have had so much at stake, would have done this. My only thought is that they could not find any definitive markers to identify the responders.