Discussion in 'Active Clinical Studies' started by mojoey, Nov 3, 2010.
Excellent, excellent questions.
Does anyone want to take a stab at trying to answer them?
Dr. Bateman's clinic is likely to be posting a form soon, with estimates of the costs and details of the required arrangements - pre-trial testing, some conditions of agreeing to participate, etc. They fully appreciate how difficult (impossible?) it would be for most people (nearly everyone?) to participate in such a trial but they are very sympathetic to the limited number of options available to ME/CFS patients and they didn't want to reject the idea of a cost-recovery study out of hand. They need to know how many people would seriously consider participating given the challenges of such a study. If a minimum number of people are serious they would likely move forward with a trial but they would need a minimum number to do so.
Keep an eye for the release of the form here on PR (and I am sure on the www.OFFERUTAH.org web page).
The real solution here seems to be to try and convince Hemispherx to do a proper phase III trial and if they aren't will to do so soon, then they ought to sell their rights to someone who is interested in making this available to everyone who could benefit.
I would change the "very likely' to "you would be wise to move to the city." All the physicians I've spoken to that have done the trial say the benefits and negated when you need to commute to receive the drug
In Canada, clinical trials are free for cancer patients. I wonder if cancer patients in the US pay to enter a clinical trial? Of course we are second class patients with a shameful disease.
It is unreal to fathom that patients got to pay for a drug that hasn't yet been approved, but yet holds lots of hope for all of us.
No locations have been names despite the title of this thread. I am not holding any hopes that Canada would be involved in this trial. They still think this is in our head.
Another question I have is... does anyone know why the patients that have a positive ANA are excluded from the study?
Hemispherx say they intend to do a proper Phase III. From the last conference call in October: They have done a retrospective on their AMP516 phase III data with help from WPI and they have identified an XMRV+ sub-group. See slide 13 here: http://www.wsw.com/webcast/rrshq18/heb/ They said they intend on meeting with the FDA next January or February - much of the delay has been due to PCR and blood culture testing of the 516 and waiting for the XMRV controversy to sort itself out. I think the Lo/Alter study satisfied them as far as xmrv is concerned. It is my opinion, and my opinion only, that these new trial centers will offer the new Phase III trial once it is approved by the FDA. It only makes sense. But they cannot say anything about a 516 type trial until the FDA approves it. Hemispherx is conducting a conference call next Tuesday: http://finance.yahoo.com/news/Hemispherx-Biopharma-Inc-to-pz-673267569.html?x=0&.v=1 to discuss recent developments. They may have more recent information on the new Phase III trial. If anyone is interested in their ampligen trials, you should follow their SEC filings and their conference calls.
Joey - you say all the drs you've talked to who have done the study - who have you spoken to? Peterson, Bateman, Lapp? Anybody else? It just sounds from your post that you've spoken to several.
Also, from your conversations, what is considered a commute? 30 minutes? 1 hour? 3 hours?
I should amend that statement to physicians, their research teams, and patients that have done the trial. Peterson, several Peterson patients that have done the drug, Bateman's research team, Dr. Ferre's research team in Orange County, another patient that did ampligen with neither peterson, lapp, nor bateman.
I can't recall if Kelvin Lord mentioned anything about commuting, but I'm almost 100% sure he doesn't live very far from Dr. Lapp
I'm not sure what the cut-off point for a commute is, but I know when I was considering doing the trial with Peterson, they advised me that the drive from Reno to Incline was too long.
Would 12 months on ampligen be enough time to cure cfs or is it a drug that u have to keep taking to keep getting benefits from it. A definate diagnosis is whats required i guess, that might be the reason for past treatment failures.
This is some great info JohnnyD Thank you for posting it along with the links that was very thoughtful. The "new trial centers" you are refering to would be the ones proposed by the NIH at CFSAC that followed along the IMAPP model? That would make sense.
[quoteThis is some great info JohnnyD Thank you for posting it along with the links that was very thoughtful. The "new trial centers" you are refering to would be the ones proposed by the NIH at CFSAC that followed along the IMAPP model? That would make sense.[/quote]
Hi George, no, different animals. The 'trial centers' discussed at the CFSAC/NIH meeting are govt funded research and treatment centers for ME/CFS sufferers. Hemispherx 'trial locations' have to do with running an FDA sanctioned Phase III trial in order for Hemispherx to gain approval for commercialization.
Ah. . .Thanks for the clarification.
I just heard from Dr. Bateman's office that they are going ahead with the open-label trial. Anyone who is interested: please contact them directly.
I skimmed the thread for this info, but may have missed it --
How often is treatment administered? If a patient had to travel a long distance, weekly infusions wouldn't be feasible.
Are there limits on the sickness level of patients; that is, are they only taking patients who are houseboud, for example?
I'm guessing this trial is not feasible for anyone who does not live within an hour or so of SLC. Either the travel cost or the cost to live temporarily in SLC plus the $20k for treatment would be prohibitive. Am I missing something?
BTW, as a reference pt: Valcyte treatment for two people in my family costs us in excess of $100k, all told. Insurance does cover part of that, fortunately. Still, in comparison, $20k per patient (if you didn't have to travel) doesn't sound that bad.
I'd move to SLC in a flash for Ampligen, but couldn't afford to maintain two households.
A few answers
Just thought I'd clarify a few of the issues that have been raised in this thread:
- the cost of Ampligen + the physician cost to infuse the drug is about $30K per year, cost of moving/living in the area would be additional
- the reason that they are conducting the open label study is primarily to offer the drug on a "compassionate care" basis to patients that are desperate, it is a cost recovery program. According to HEB, they are not able to financially cover the cost of this drug, they are just a small pharma
- patients are definitely discouraged from traveling for infusions, my guess is anything over 2 -3 hours is too much
- the infusions are given twice per week
- someone referred to Ampligen as a "cure", it is far from it, at its best it will allow significant improvement but you will still be sick and will have to continue to rest, pace, etc.
- Phase III has been delayed because of the XMRV news, they are re-working the design of the trial in order to include XMRV testing/tracking etc. I think this is a moving target as news continues to break with XMRV. As I understand, if they had the deep pockets of a big pharma this would probably be moving at a faster pace.
- patients do not have to be housebound to try Ampligen, but you would want to be pretty sick given the considerable expense and inconvenience
Thank you Kristina for that balanced post. That all sounds accurate to me, although I think the "wanting to be pretty sick given the considerable expense and inconvenience" is relative and up to the individual depending on their financial considerations.
I would definitely agree that it is far from a cure, and patients that, say, have 30k left and are wondering if this is the best investment to get them back to full-time work should understand that many do relapse after coming off the drug. If I knew I had 30k/year to spend for several years before proper XMRV treatment is established , I would probably jump in.
Thanks, Kristina, that answered my questions. No Ampligen for us.
I agree with mojoey that different people will have different criteria for when they're willing to spring for the cost of Ampligen. My daughter and I have both moved up 2pts on Dr Lerner's scale taking Valcyte and the quality of life improvement for both of us is huge. For my daughter it was the difference between being not being able to go to college and being a successful engineering student. She's not cured, by any means, but the improvement is worth the cost, especially for someone her age.
Ampligen is not a cure. Neither is Valcyte (IMO). But we have no cure, and may never have a cure -- there's no cure for HIV or HTLV -- so quality of life improvements are important. I think we all have to consider the possibility that weakening whatever is infecting us may prevent or slow down long-term damage to our bodies. We don't know much about this illness, sadly, so I think we need to at least think about the longer term implications of NOT treating.
This illness sucks SO MUCH. We know so little about it, we can't even make many intelligent guesses about the right path for staying as healthy as possible........
Sickofcfs - I am so happy for you and your daughter's improvement - that is huge that she can go to college! Congratulations on weathering the storm, I wish you both continued success. I couldn't agree more that we are all groping around in the dark making guesses and taking calculated risks, forced to be our own doctors and educate ourselves. It is madness.
Can I ask what infections you each had? HHV-6, EBV, etc. Did blood tests show improvement as you got better?
For myself, I do believe in taking some risk with treatment in hopes of improvement and of strengthening the body until a cure is found. I am a huge believer in Ampligen, it definitely does help a subset of people with CFS, I look at it as a band-aid that may hold us together until there is something better to be had. Same goes for AVs.
Also, sometimes trying a treatment protocol gives us renewed promise, a reason to keep fighting, and sometimes that is what we need most.
Thanks, Kristen, for your kind wishes! We're thrilled with my daughter's improvement(mine too, of course). I was heartbroken when she took a major turn for the worse (after a chicken pox booster) in her last semester of high school.
We both have active HHV-6 infections, but nothing else (not tested for XMRV). I think my EBV titre was borderline. Unfortunately, the lab changed it's scale since our original tests, so it's hard to know for sure if our HHV-6 titres changed or not. Next round of tests should be more informative.
I'm with you 100% on treatment, and although I'd never thought of it that way, I think you're absolutely right -- sometimes what we need most is a reason to keep fighting.
Mojoey, can u clarify this? I thought one negative to the trial (even cost recovery) was that once the year/trial was done so was your access to Ampligen. Are you saying once you're in the trial you could, say wean off slooooowly or come back in for "top up's?"
There is no specified time limit on open label trial, unlike phase 3's. For example the Peterson trial has been ongoing for years. Of course if they decide to pull the trial, you will likely be without the drug although Hemispherx has made exceptions for this in the past, not without some major arm twisting of course
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