You spoke negatively of Ampligen, as experimental. If this was outside of a clinical trial, then I would agree with your tone. If it was in a clinical trial, then, yes, it was experimental; but if not for clinical trials, we wouldn't have drug approval, would we? Every drug that's come through the approval process has been considered experimental prior to approval, so I think your characterization is kind of out of context.
If Ampligen has ever been used outside of a clinical trial, I'm curious about it. Unlike Rituximab, Ampligen has not received approval for anything, so the loophole of 'off-label' use would not apply. Correct?
There is one major issue that doesn't get mentioned enough: we hear calls for more research on so many seemingly promising findings...but, as we know, ME/CFS doesn't get much funding. Now, I don't view Ampligen approval as being a simple yes or no issue; it doesn't work for a lot of people, and the CDC tells us there are as many as 4 million people with "CFS." So, if Ampligen is approved, that's a signal to doctors who know nothing about ME to consider prescribing what would be, with much fanfare, the only drug approved to treat this "CFS" condition. Unless I'm mistaken, this drug is seen to be effective in a subgroup of a fairly strict criteria such as CCC. Broaden that criteria to Fukuda, and that's a whole other conversation. Make it 'Revised Fukuda' or 'Empirical' or whatever it was the CDC used to come up with the 2.54% number, and...I can't get behind that. I do think Hemispherix was fairly strict about the cohorts in the trials, but who knows what could happen later.
On the other hand, I have seen an ME patient in a major crash during a period where they had come off of Ampligen...and the same patient not long afterward having come back to life. This patient is of course not the only one who responds well to this drug. What happens to these patients? Will they even be allowed access under 'compassionate use' or some such?
The larger point, though, is, who's going to fund this research? Maybe Fluge & Mella get funded...maybe they don't. We sure heard a lot immediately following publication about how the companies that owned the rights to the drugs were not interested in funding a trial (and nobody else has seen fit to, yet, either). The FDA panel wants to see more research on Ampligen? This is hardly an unreasonable position, but...what research? There was no funding for Ampligen to begin with. The NIH? I don't expect to see them fund trials for Ampligen or Rituximab. Maybe someday they will, but now? No.
It's easy for medical authorities to call for 'more research.' It's especially easy because it is the correct call. But in this case the correct call is not necessarily the right thing to do.
I will not argue against the issues raised with these drugs. I will say that it is quite unreasonable to expect people who have been waiting for decades to continue waiting for research that is unlikely to be funded anytime soon. If Kogelnik is prescribing off-label, and that muddies the waters, makes it difficult to interpret research later on...what research. When?
No research. Not anytime soon. I suggest that letting people suffer indefinitely is a far worse outcome than experimenting with a drug off-label.
If Ampligen has ever been used outside of a clinical trial, I'm curious about it. Unlike Rituximab, Ampligen has not received approval for anything, so the loophole of 'off-label' use would not apply. Correct?
There is one major issue that doesn't get mentioned enough: we hear calls for more research on so many seemingly promising findings...but, as we know, ME/CFS doesn't get much funding. Now, I don't view Ampligen approval as being a simple yes or no issue; it doesn't work for a lot of people, and the CDC tells us there are as many as 4 million people with "CFS." So, if Ampligen is approved, that's a signal to doctors who know nothing about ME to consider prescribing what would be, with much fanfare, the only drug approved to treat this "CFS" condition. Unless I'm mistaken, this drug is seen to be effective in a subgroup of a fairly strict criteria such as CCC. Broaden that criteria to Fukuda, and that's a whole other conversation. Make it 'Revised Fukuda' or 'Empirical' or whatever it was the CDC used to come up with the 2.54% number, and...I can't get behind that. I do think Hemispherix was fairly strict about the cohorts in the trials, but who knows what could happen later.
On the other hand, I have seen an ME patient in a major crash during a period where they had come off of Ampligen...and the same patient not long afterward having come back to life. This patient is of course not the only one who responds well to this drug. What happens to these patients? Will they even be allowed access under 'compassionate use' or some such?
The larger point, though, is, who's going to fund this research? Maybe Fluge & Mella get funded...maybe they don't. We sure heard a lot immediately following publication about how the companies that owned the rights to the drugs were not interested in funding a trial (and nobody else has seen fit to, yet, either). The FDA panel wants to see more research on Ampligen? This is hardly an unreasonable position, but...what research? There was no funding for Ampligen to begin with. The NIH? I don't expect to see them fund trials for Ampligen or Rituximab. Maybe someday they will, but now? No.
It's easy for medical authorities to call for 'more research.' It's especially easy because it is the correct call. But in this case the correct call is not necessarily the right thing to do.
I will not argue against the issues raised with these drugs. I will say that it is quite unreasonable to expect people who have been waiting for decades to continue waiting for research that is unlikely to be funded anytime soon. If Kogelnik is prescribing off-label, and that muddies the waters, makes it difficult to interpret research later on...what research. When?
No research. Not anytime soon. I suggest that letting people suffer indefinitely is a far worse outcome than experimenting with a drug off-label.