Patients interested in participating in an open-label trial for the experimental ME/CFS drug Ampligen should contact Ali Allen or Kristin Pierce at Dr. Lucinda Bateman's office in Salt Lake City, Utah, for more information. Depending in part upon patient response, Bateman may elect to conduct a trial in 2011. With an open-label trial, all patients receive the investigative drug.
The drug cost will be approximately $6,700 for the first six months, which will include extensive testing to determine eligibility, and $7,200 for each additional six-month period. In addition, there will be procedure expenses (infusion costs, bloodwork, X rays, EKGs and other testing) of approximately $6,900 every six months, plus administrative costs of approximately $1,500 every six months. For six months, expect to shell out more than $15,000 to participate in the study, plus housing costs if you're not from the area.
The drug cost will be approximately $6,700 for the first six months, which will include extensive testing to determine eligibility, and $7,200 for each additional six-month period. In addition, there will be procedure expenses (infusion costs, bloodwork, X rays, EKGs and other testing) of approximately $6,900 every six months, plus administrative costs of approximately $1,500 every six months. For six months, expect to shell out more than $15,000 to participate in the study, plus housing costs if you're not from the area.
To qualify for the study, patients must be able to visit the clinic up to six times during the first 10 weeks for baseline testing before receiving the intravenous drug Ampligen. Once you begin the drug, you must reside in the Salt Lake City area and visit the clinic at least twice each week, for one- to two-hour visits, for at least six months.
Ali Allen: ali@fcclinic.com
Kristin Pierce: kristinp@fcclinic.com
1-801-532-8311
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I am absolutely astonished at the cost of this clinical trial. It appears health is divided between the rich and the poor in the United States. How insulting after all the years of negelct of diasabled patients...
ReplyDeleteMaybe we should campiagn for equal access to research and treatment for ME patients around the world. I am so depressed by the inequality built into this trial I can't be happy about the possible benefits of the research.
Clinical trials are free in Canada. That is especially if you are a cancer patient, a HIV or arthritis patient. Otherwise, there is nothing for CFS. Not even a doctor.
ReplyDeleteHas the formula for ampligen been changed?
ReplyDeleteThe cost is disappointing but remember this is a trial and lots of people don't get to take part in trials for all sorts of reasons (no researchers in my area).
ReplyDeleteBut with enough results, perhaps treatments may become more widely available.
Trials may be free in Canada but there is no Ampligen trial there that I know of - a trial like this is better than none on some sort of "principle". A bit like the UK: lots of free health care there but no Ampligen trials.
The staff at the FCC realizes that the cost is prohibitive for nearly all CFS patients. In blinded studies (as opposed to open-label studies) the pharmaceutical company picks up the cost of the trial and compensates the researcher. Hemispheryx dose not appear to be covering any of the costs in this "trial."
ReplyDeleteAs of last week, the FCC had yet to determine whether or not there was enough interest in participating - under the current limitations - to make conducting the trial practical for them. Appreciating the inequity of the finances, they still felt that it was not serving patients to simply rule out the possibility of providing Ampligen through an open-label trial without first determining the level of potential interest amongst those fortunate enough to have the resources to participate.
The FCC felt that the bet way to treat patients with the respect they deserve was to be upfront about the costs of what their clinic could offer under the circumstances.
A lot of thought went into how to approach the possibility of an open-label trial.
Personally, I feel that the best way to voice your very reasonable concerns and frustrations about cost and access for all CFS patients is contact the entity setting the rules - the pharmaceutical company itself - Hemispheryx.
Well, given the dodgy business practices at Biospherx, it would seem that having human guinea pigs bear the costs of an experimental treatment would help the company provide even higher unwarranted bonuses to its executives.
DeleteAs it turns out though, even a large profitable company, La Roche/Genentech, has the same set for their Rituxan open label trials. Well, if things go badly we can take some comfort in the knowledge that the ranks of the 1% will be thinned.
who can afford that?
ReplyDeleteI had no idea subjects ever had to pay for the meds in clinical trials. I'm glad the research is moving forward, but ... wow.
ReplyDeleteBesides the Prohibitive cost. If a patient that has me/cfs and is disabled how and the... are they going to be able to keep up with this schedule. Wow, is all i can say. My wife sleeps 16- 22 hrs a day and physically gets sick if not given that. I think its great somebody is trying something. Unfortunately due to my wife's totally devastating disease ME/CFS we have lost almost everything, and could in not afford this trial. I also have developed many of the symptoms.
ReplyDeleteBest wishes to those of you that have this option.
This study has such huge energy requirements- they will never include the sickest of us. Such a schedule would probably literally kill me.
ReplyDeleteI take 10,000 mcg of b12 for energy... its like a b12 shot
ReplyDelete1 b100 vitamin ..... b's for health and immune support
D-Ribose powder to help mitochondrial function 5grams 3x before meals
Acety-l-carnitine 1000 mg free form 2x daily for increased memory function
120 mg co-q-10 2x daily for joint pain
I do better with these vitamins by 30% I would say.
I have found a doctor to prescribe Raltegrarvir and I feel so much better. That Raltegrarvir adds another 40% functionality for me and if I was to raw myself on the KPS scale I would have to say that I am between 70-80. More than functional. There is an adjustment period for Raltegrarvir of about 1 month but its great after a couple of days of migraines and stomach pain which will disappear. It's an anti-retroviral. I'm sure you have heard about XMRV.
I am happy that Dr. Bateman is looking into the option of providing Ampligen. It gets the drug to those who can afford it and accumulates more data that will hopefully lead to FDA approval some day. we've been waiting for how many decades? I wish it were offered in Colorado. If it were I would pay.
ReplyDeletei would not touch that drug with a 10 foot pole...they use patients and then they dump them...a very untrustworthy company...i hope they never ever get to market...nancy kaiser was first cfids patient on it and she is dead today...also the inventor of the fax machine was one of the biggest investors in ampligen who had cancer and used the drug...he also is dead today...ampligen is a waste of time...besides dr. yomamoto with GcMAF will put all of these useless pharma companies completely out of business...www.watercure.com www.watercure2.org P.S. azt causes aids and the last thing anyone wants is a year later for your cfs specialist to say 'sorry you do not have cfs anymore but full blown aids'...sincerely and always speak the full truth, aidan walsh southampton, u.k.
ReplyDeleteThe drugs is quite expensive then there are other cost that we have to pay
ReplyDeleteThe big name doctors are joining the trial of Ampligen.
ReplyDeleteDr Charles Lapp in Carolina, Dr Derek Enlander in New York, Dr Lucinda Bateman in Salt Lake City, Dr Klimas in Miami, and Dr Peterson in Reno.
After spending $6,000 for useless therapy at the FATIGUE CENTER in Connecticut I am joining this trial. The Fatigue Center made me pay $6,000 upfront for ineffective drips on a Teitlebaum protocol, no insurance accepted.
If I can go back to work this Ampligen trial will be more than worthwhile
Joan
Those of us who truly need this drug are the severely ill who are on disability and who cannot possibly afford to participate in this trial, never mind the time it requires!!!
ReplyDeleteGina
Ridiculous price.
ReplyDeleteI went to the Fatigue Center yesterday. Yes, their cost is $6,000, plus another $2,000 in meds, as they mentioned. I was debating whether I should sign up until I read your post.
Mickey
Hey guys. I can tell you that I also went to the Fibro & Fatigue Center in Stamford (by the way they are closed now). I went 3 years ago when you could pay-as-you-went. However, when they asked me for $6,000 my questions was "but you've already got me on a protocol which I see the doctor every six months so why more?" Then a a few months later they closed their doors. Tietlebaum is retired, living in Hawaii (which I'm all for), however he is exploiting the patients with these centers. IF you read his books you'll get the info they give you at the center. Don't waste your money on the centers.
ReplyDeleteHi I agree that the costs of the Ampligen trial are high and many people who would like to try it will miss out HOWEVER we will all benefit from the research and information gained by those who can afford to trialling this drug.
ReplyDeletePatients enrolled in the trial are paying a portion of the actual cost of the drug. I do not believe that this small drug company is trying to take advantage of the patients enrolled in the trial- quite the contrary. The big pharma companies could afford a free trial, but this is a very small company asking patients to help offset the cost. My son is enrolled in the trial- we are glad to have the opportunity to help him get better- he has severe CFS.
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