I am still working through all the emotions triggered by the highly anticipated December 20, 2012 FDA Arthritis Advisory Committee meeting about the approval of Ampligen, an immune-modulatory drug that has been very successful in treating a sub-group of myalgic encephalomyelitis patients, a devastating disease that has no FDA-approved treatment. The meeting was held at the FDA White Oak Campus in Silver Spring, just outside of Washington, D.C. The purpose of the meeting was to make a recommendation to the FDA regarding whether or not to approve Ampligen. The FDA’s decision is due by February 2, 2013.
Before I dive into giving my impression of the meeting, I should mention that it was often hard to know who on the panel was talking because the meeting room was large and the public was seated at a bit of a distance from the committee. It was also challenging to hear everything that was said at times, as the sound system wasn’t always working that well. Ironically, the members of Hemispherx’s team were frequently admonished for not stating their name before every comment even though they were standing at the podium and everybody could seem them very well. Not so for the members of the committee who were sitting at a u-shaped table (thus hard to make out), but they were not required to state their name before speaking. So, often the public had no idea who was speaking.
After the long and exhausting trip, several very short nights and finding out that a good friend of mine had passed away unexpectedly just hours before the meeting, I didn’t have it in me to take notes. So, this is all from memory, which has been refreshed several times by discussing the meeting with other attendees.
I went to the meting fully aware that the chances for a recommendation to approve Amplgien were maybe better than ever, but probably not particularly good. But I definitely felt like the drug and, thus, the ME community, had a chance here. Maybe the FDA was finally ready to stop the neglect of ME. At least that’s what the agency was claiming, right? After all, there are no FDA-approved treatments for ME and none are on the horizon for years, if not decades.
In light of this huge opportunity, if I wanted to be able to feel like I had done all I could to support the approval of Ampligen, I just had to travel from Incline Village to D.C. to give my three-minute testimony at the meeting in person together with about 30 other patients and their relatives, Kim McCleary of the CAA and Dr. Sidney Wolfe, physician and director of Public Citizen’s Health Research Group.
I have improved so much on Ampligen that I felt I could handle the trip from Incline Village. It wouldn’t be easy and it wasn’t, but when is it ever easy when you are flying United? All three flights I booked on United during the last 2 months were canceled! But consider this: A few months ago, I couldn’t even handle a one-hour flight to the Bay Area to see my family. Now, I was able to tolerate a 27-hour trip to D.C., a day-long meeting and a 12-hour return trip. I have come a long way. All due to Ampligen. And I know in my gut that I am not done improving since I am still relatively early in the treatment.
What I hadn’t accounted for in my attempt to predict the outcome of the meeting was that at least some (maybe many) of the 14 committee members would know close to nothing about either the disease or the drug. I realize that the committee members are probably not paid much for preparing for, and attending, the meeting. These things are mainly a resume builder. But given the stakes for hundreds of thousands of patients plus their families, it boggles the mind that some of those panel members felt comfortable being involved in deciding the future of Ampligen.
Two cases in point: One panel member opined that cognitive-behavioral therapy should be an effective treatment for ME. I am not going to dignify that statement with a comment. Another panel member asked whether Ampligen is available to patients now. What?! I just about fell off my chair when I heard this. This one member (and who knows how many more) was completely unaware of the fact that the only way to get Ampligen right now is to be part of the open-label trial, which means paying for the expensive drug out of pocket and moving to one of the few Ampligen locations and either uprooting one’s family or leaving one’s family behind. The sacrifices patients are making to get access to Ampligen are enormous. How did these guys, who were clearly unqualified to be involved, get on the committee? And why would they want to be on the committee given the unfamiliarity with the disease and the drug? There were two votes right there that we lost. Well, we didn’t lose them. We never had a chance of getting them in the first place. One thing you can’t argue with is ignorance.
What I also hadn’t taken into account was the fact that not everybody on the panel would have a grasp of the magnitude of their responsibility in casting their vote. There was little understanding among many panel members of how immense the suffering is in the ME community, how great the need for hope is among patients, how truly pivotal this decision was and how devastating a “no” vote would be. Quite frankly, I believe that some of the panel members who voted “no” simply have no idea what they have done.
The Public Testimony
The public testimony of patients was truly moving. More than once did it bring me and others to tears. To hear the details of so much suffering, back to back, was emotionally challenging, but so important.
The public was separated from the committee by a literal red tape and was not allowed to go beyond that line. Only Kim McCleary of the CAA and Dr. Wolfe of Public Citizen’s Health Research Group were allowed to “cross over” that line. Robert Miller’s wife, Courtney, was expressly refused access to the cordoned off area when she tried to speak to committee members after the meeting had ended.
The three-minute time limit per person was strictly enforced. The microphone was turned off at the 3-minute mark. I understand the need to keep a meeting agenda on track. Nothing is more painful than to waste time at an already long meeting. But I would have sworn that the FDA was allowed to go beyond their allotted time slot to make their case against Ampligen. They were not even reminded of the fact that they had gone over. It became very clear who the top dog was at the meeting. It certainly wasn’t the patients.
One big surprise was the testimony of Sidney Wolfe, of Public Citizen’s Health Research Group. Dr. Wolfe was originally slated for an earlier slot during the public testimony, but he somehow managed to change the order of speakers and be the last one—for maximum impact. He read from prepared slides, which all quoted the FDA, trashing Ampligen. I kept wondering what his big “but” would be, as I was sure he was there in the interest of the patients. Naïve, I know. When his three minutes were up, there was no “but.” Dr. Wolfe strongly urged the committee not to recommend approving Ampligen. I was flabbergasted. Dr. Wolfe does not know Ampligen. He does not understand ME. But he clearly believes that he was chosen to protect patients who’ve gone through hell for years and have no other options or prospects for treatment from themselves. Simply astounding!
When it came time to vote on the safety issue, Dr. Buckley, the Acting Chairperson of the AAC, pushed really hard to skip the discussion that was supposed to precede the vote on each question. This was obviously driven by time concerns, as the meeting was running behind schedule and it was getting close to dinner time and to the plane departure times for some committee members. But the patient advocate, Alaine Perry, who did an outstanding job in representing us and really came through for the patient community throughout the meeting, pushed back even harder saying that she felt uncomfortable to have a vote on this important issue without any discussion. I’d like to add that it would also seem highly inappropriate and unusual to skip the discussion, but maybe not so much to somebody who pretty much knew what the outcome of the vote would be—with or without discussion. Reluctantly, Dr. Buckley gave in. The discussion was being had. The vote was “no.”
In the end, the committee overwhelmingly voted to recommend to the FDA not to approve Ampligen by casting a vote on four questions. The vote was “no” on three out of the four questions (9 to 4 and 8 to 5 respectively, so not close). I will list the four questions that were being voted on as well as the names of all committee members at the end of this post. It was abundantly clear to everybody in the room that the whole meeting was just a formality. Members of the committee had their minds made up before they ever entered the meeting room that morning. I understand that there are rules for the FDA on these matters and that an advisory committee meeting is probably required. But seriously, how cruel to put patients through the agony of such arduous travel when the decision was made already!
One member of the committee, Dr. Robert Lahita, was not present for voting. No explanation was given for his absence. The audience was merely told that he had left the room. This seems most unusual for such an important vote, not that it would have changed the outcome even if he had voted “yes.” I presume an emergency was the reason for his leaving, as no other explanation would be acceptable. But what seemed equally as unacceptable was the lack of explanation of his absence.
There is much to say about the meeting, but one of several things that stood out were the distressing votes cast by one of the few ME community’s specialist physicians, Dr. Anthony Kamaroff of Harvard University. Dr. Komaroff voted “no” on all four questions, even on the one question that the majority of the committee voted “yes” on! Throughout the meeting, Dr. Komaroff was hostile and dismissive towards Hemispherx, the sponsor of Ampligen. Still, his vote came as a shock to patients many of whom had pegged him as being on our team. Makes sense, right?! Unlike some of the other committee members who obviously knew nothing about the illness, Dr. Komaroff is familiar with the disease, probably more through his research than through clinical work, but nevertheless. Why would somebody like him sell out the patients he is studying?
I am sure that Dr. Komaroff has rationalized his decision. The data isn’t there. The drug’s efficacy hasn’t been proven. The drug’s safety hasn’t been proven. Hemispherx is not trustworthy. The problem with that line of arguing is that the data is open to interpretation. And that is exactly how some, though not enough, other committee members voted “yes.” Also, if one enters into the equation the fact that there is no other approved treatment for ME patients as a result of a scandalous neglect and abuse of this patient group by medical and scientific professionals and the government as well as the fact that the suffering is seemingly never-ending, I find it simply impossible to comprehend how somebody who knows this disease and understands the great suffering would reject Ampligen, a drug that has been given to patients for 24 years with no fatality and no serious side effects that can be definitively traced back to Ampligen.
I understand physicians who decide that they are not comfortable with providing Ampligen to their patients. The drug’s mechanism is not totally understood. The administrative burden that comes with prescribing it, as part of Hemispherx’s open-label trial, is a nightmare. The guidelines for shipping and storing the drug have to be meticulously followed. Infusion reactions do happen, including infiltrations, which are painful and potentially dangerous, although—based on patient reports—maybe less so than originally thought. Not wanting to get involved with Ampligen, even as an “ME doctor,” is a reasonable decision. But why torpedo the drug by keeping it out of the hands of those who are willing to help those who are suffering and therefore keeping it from patients altogether?
If “our” specialists do not help us, we are doomed. If I had to take a guess, I would bet that Dr. Komaroff didn’t bother to pick up the phone and call those physicians who, unlike him, actually know the drug: first and foremost Dr. Peterson, but also Dr. Bateman, Dr. Lapp, Dr. Klimas, Dr. Enlander. I would also bet that he never talked to a patient about his or her experience with Ampligen. Wouldn’t want to risk having to revise one’s opinion once made up. The dangers of the academic ivory tower!
After the meeting was over, Dr. Komaroff was chatting with Dr. Wolfe; two kindred souls who were clearly pleased with themselves. Dr. Komaroff had a huge smile on his face until I started taking pictures of him. It might have occurred to him that that was a bit inappropriate, as patients were crying and utterly devastated. Better not to provide any lasting evidence of such insensitivity to the patients.
Patient advocate, Anita Patton, approached Dr. Komaroff to remind him of his Hippocratic Oath and to let him know that he had done some real harm to patients with his vote. Dr. Komaroff’s response was, “I have a plane to catch.” He then moved away from Ms. Patton who, as a member of the public, wasn’t allowed behind the red tape and he proceeded to chat with somebody else in the area off-limits for patients.
Blowing off Ms. Patton that way was so undignified and he was, by his own admission, more concerned about catching his plane than the consequences of his actions. So, I couldn’t stop my self from saying, “I hope you’ll miss your flight.” I regret saying that. That wasn’t professional of me. And it was pointless, as I am sure Dr. Komaroff slept very well that night.
Dr. Unger of the CDC voted “no” on three out of the four questions. Mindy Kitei summed up very well, in her piece, “The Oxford Definition, It’s Baaack,” how many patients feel about that. Mindy said, “In my view, Beth Unger—who should know the suffering that millions experience with ME better than most FDA committee members—would vote for Ampligen approval when pigs fly.” I have nothing to add.
I haven’t always gotten a good vibe from Dr. Gailen Marshall at the CFSAC meetings. For example, his reaction at the last CFSAC meeting after a patient testified about the consideration of suicide seemed totally inadequate and inappropriate. To suggest, as he did, that only patients who are not informed about all the exciting research being conducted (yeah, right!) would commit suicide was so off the mark. It can be more depressing to know about the research projects underway right now (not many!) than to be blissfully unaware of how neglected this illness still is and how small the chances are that there will be a treatment in one’s lifetime. But I must say that Dr. Marshall was as true champion for the ME community at the AAC meeting. He voted “yes” on all four questions. I wanted to give him a really big hug after the meeting. That’s how grateful I felt to him and still do. But I wasn’t going to risk getting arrested for breaking through the red tape.
The FDA presentation consisted of a complete destruction of Ampligen. In all fairness, Hemispherx didn’t have all their ducks in a row and that was very unfortunate, but we have no other approved treatment, no prospect of one in the foreseeable future and no hope whatsoever. That didn’t seem to enter the equation for the FDA at all. Nor did the fact that Hemishpherx is a small drug company and, unlike the big pharma hitters, doesn’t have unlimited financial resources to conduct another 300 patient placebo-controlled, double-blind, randomized study, as the FDA wants them to do.
The FDA struggled hugely to distinguish side effects of the drug from typical symptoms of the disease. Seriously, abdominal pain? Show me an ME patient who doesn’t have that symptom as a result of having ME! And infections? Infections are one of the hallmark features of ME. Flu-like symptoms, headaches, fevers, pain, chills, diarrhea, depression, suicides, suicide attempts: all part of everyday living of an ME patient not on Ampligen.
Like a physician friend of mine pointed out to me: Could it be that there was a patient on Ampligen who had deep vein thrombosis because ME patients just can’t move much because they are too ill? And counting an incident of cancer as a side effect of the drug despite the fact that the cancer had been a pre-existing condition prior to starting Ampligen treatment, as had been determined after the cancer was detected, really makes you wonder.
Interestingly, the FDA didn’t consider the data of the ongoing open-label trial in terms of efficacy, which would have been a slam dunk in favor of the drug, but they did hold the side effects experienced by patients in that trial against the drug. I call that cherry picking.
Hemispherx was denied the opportunity for a rebuttal on the side-effects issue by Dr. Buckley, the AAC acting chairperson.
Another point the FDA kept making was that they were not convinced that Ampligen provides sustained relief, i.e., is a cure. In that spirit, I think the FDA should consider pulling insulin off the market, as it requires ongoing injections to treat diabetes. How about blood pressure medications, thyroid medications, cholesterol medications, etc.?
The FDA has approved more dangerous drugs for conditions less serious than ME, a serious and life-threatening disease, more than once.
There is no doubt in my mind that Ampligen would have received a favorable recommendation had it been developed by big pharma or if it were a treatment for most other diseases, even those less serious that ME. It would have received such recommendation even if it had more serious side effects. There is a clear bias against ME and against Hemispherx, the drug maker. Maybe the bigger problem is the complete lack of understanding of how serious this disease is. Without that, the risk-benefit analysis is bound to be completely off.
I had a short conversation with Dr. Michele, Clinical Team leader of the FDA, after the meeting. Dr. Michele, whom I found very personable, said that the FDA has yet to vote on the application. In other words, not all is lost. The reality is that the agency does not usually, if ever, approve a drug that has been recommended for denial. That conversation just added insult to injury and I couldn’t resist remarking that my growing up in East Germany has not bestowed a high level of confidence in me that a government would do the right thing.
But I have to hand it to the FDA in one respect: They have become excellent at paying lip service. Several times during the meeting were we assured that the agency is aware of the seriousness of the disease. A “sincere” appreciation of the large number of patients taking an interest in the matter was expressed numerous times. There was obviously some good public-relations briefing before the meeting.
The FDA received about 750 written patient comments before the meeting and that seemed to have left an impression on the agency, which remarked that they hadn’t seen so many written comments and so many patients in attendance in a long time at a meeting. They are starting to get the idea that we are not going to let up. They are starting to feel the heat. It may too late for patients my age and older. But we will still fight for the generations that come after us.
The timing of the meeting, right before the holiday weekend, was disastrous for patients in attendance. Here is one example: One patient from Reno flew from Washington, D.C., to San Francisco where her plane to Reno was delayed by 6 hours only to be canceled after that. (You guessed it: United). She was unable to book another flight until after the holidays despite trying all airlines servicing Reno from the Bay Area because, well, it’s the holidays! So after getting up at 4 am Eastern on Friday, she rented a car at the San Francisco airport and drove, though a heavy rain storm for 6 hours, all the way to Incline Village that night, arriving at 2 am Pacific on Saturday (25 hours after getting up the prior morning) to stay there with a friend to receive her Ampligen infusion—which she would have normally gotten on Thursday had the meeting not been scheduled on that infusion day—at Dr. Peterson’s office later that day. She then got stuck in Incline Village until Sunday afternoon because of a heavy snowstorm affecting Mt. Rose highway, the road between Incline Village and Reno. Her kids who were home from college and whom she doesn’t see that often had been waiting for her in Reno since Friday afternoon when she was scheduled to arrive at home.
Scheduling the meeting right before the holidays also meant that patients had to pay higher airfare, were mostly unable to upgrade their tickets using miles to have a less painful flight and will be less functional throughout the holidays, as they recover from their trip. I myself have been stuck in Incline Village because of the heavy snow. I had planned on going home on Saturday to be with my 2-year old daughter and my husband for Christmas. I will attempt to fly out on Monday now. In case it’s still snowing too much then, I have a back-up ticket for midday Tuesday, Christmas Day!
Many patients have complained that the live streaming of the meeting was basically not working. They lost connection as soon as they had logged on. Some said that the webcast problem forced them to continually reboot their computers in addition to having to keep signing back on to the meeting. Many patients were not able to follow the meeting because of these technical issues. Some set up Skype meetings with fellow patients who were successful in logging on, but missed a good part of the meeting because of the technical issues.
I found these reports extremely surprising. The building the meeting was held in seemed to be very new and the technology looked state of the art. There were lots of cameras built in the high the walls. There was also a camera set up in the back of the room specifically for the meeting with a live cameraman.
The degree of disability and/or resulting poverty of many patients made it impossible for them to attend in person. The sub-par quality of the webcast also prevented them from attending via the Internet.
It seems that this was no isolated incident and that the FDA is well aware of its technical issues. The meeting notice contained this disclaimer regarding the webcast: “While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible.”
In the year 2012, I can think of no excuse not to provide a quality live streaming of an event that is expected to create a lot of interest in people who are too sick to attend in person.
Here are the 14 members of the AAC:
Larry Borish, MD
Lenore Buckley, MD, MPH
Ralph B. D’Agostino, Sr., PhD
Jacqueline Gardner, MPH, PhD
Lisa Gualtieri, PhD, ScM
Sean Hennessy, PhamD, PhD
Anthony Komaroff, MD, MA
Robert Lahita, MD, PhD
Gailenn Marshall, Jr., MD, PhD
Alaine Perry, MPH
Matthew Rudorfer, MD
Irwin J. Russel, MD, PhD
Elizabeth Unger, PhD, MD
James H. Ware, PhD
The Four Questions
Here are the four questions the committee voted on:
1. Considering the totality of the data, is there substantial evidence of efficacy for Ampligen for the treatment of patients with chronic fatigue syndrome (CFS)?
Yes: 4 (Borish, Marshall, Perry, Rudorfer)
Not Voting: 1
2. Has the safety of Ampligen been adequately assessed and characterized for the treatment of chronic fatigue syndrome (CFS)?
Yes: 4 (Marshall, Perry, Rudorfer, Perry)
Not Voting: 1
3. Is the safety profile of Ampigen adequate for approval for the treatment of CFS?
Yes: 8 (Borish, Gardner, Hennessy, Marshall, Perry, Rudorfer, Russel, Unger)
Not Voting: 1
I admit to being confused by the difference between question 3 and 4. I think, but don’t know for sure, that question #3 was a vote on whether the committee thinks that Hemispherx was being truthful when it provided the safety information regarding the two Ampligen trials.
4. Based on the information included in the briefing materials and presentations, has the applicant provided sufficient efficacy and safety data to support marketing of Ampligen for the treatment of chronic fatigue syndrome (CFS)?
Yes: 5 (Borish, Hennessy, Marshall, Perry, Rudorfer)
Not Voting: 1
Thanks for this detailed summary of what went on at the AAC meeting. It would be shocking except that I am not shocked at anything the FDA or its advisory committees do or don’t do. I’ve seen too many absurdities happen.
You did a terrific job of writing all of this up, and that you sustained this ordeal and rigorous schedule shows that the Ampligen is helping you. I don’t know that precise next steps, but the pressure must be kept up on the FDA.
I often think we should take on the tactics of the AIDS community when ACT-UP took action and carried out civil disobedience protests, which got results with medications and treatment. I wish we had enough energy to do this.
Jeannette, thank you for your efforts on our behalf in traveling to the meeting and giving your excellent testimony. You have the satisfaction, at least, of knowing you did all you could. Thank you, too, for this detailed summary of the FDA meeting. It clarifies issues for me that were confused as I watched the webstream of the meeting.
Quote: One panel member opined that cognitive-behavioral therapy should be an effective treatment for ME. I am not going to dignify that statement with a comment. Another panel member asked whether Ampligen is available to patients now. What?! I just about fell off my chair when I heard this.
I noticed this when he said that during the meeting too, and I commented on it in the notes I was posting on mecfsforums. My opinion of it was perhaps a bit more cynical than yours. When I heard this man recommending CBT for us, I wondered whether he did know something about the disease and whether he was a “plant” there to push the psychologists’ “it’s-all-in-your-head” version of M.E.
Quote: Quite frankly, I believe that some of the panel members who voted “no” simply have no idea what they have done.
I agree with you; I think most of them do not know about the illness at all, and have no idea what their “no” votes meant to patients.
The public was separated from the committee by a literal red tape and was not allowed to go beyond that line. Only Kim McCleary of the CAA and Dr. Wolfe of Public Citizen’s Health Research Group were allowed to “cross over” that line.
Here we go again. We have Kim McCleary as our spokesperson. You are aware, are you not, that prior to the meeting, McCleary described Ampligen to the press this way: “It does seem to help at least a subset of patients significantly. For others, there isn’t a significant response.” http://www.drugs.com/news/fda-panel-recommends-against-first-chronic-fatigue-syndrome-42195.html
Of course, McCleary had access to the Committee members. McCleary is using her influence as our patient spokesperson to keep us quiet so the government agencies do not have to admit that they are denying patients real research and effective treatment. Government agencies and committees would naturally give her every access because she tells everyone–media and government alike–that she speaks for patients. And all the time she is selling out the interests of patients.
While patients allow the CFIDS Assn of America to misrepresent us and do not protest this, there is no chance that M.E. will be treated as the scourge that it is. This illness takes lives, both in the biological sense and in the sense of destroying all quality of life for patients. Until we have someone to speak for us who will say so in no uncertain terms, we will not be treated with respect by the media or by the government.
This refusal to allow M.E. patients Ampligen is a clear statement from both our “patient” organizations and the US government that they are not going to help; they intend to hide this illness from view and understanding by the public for as long as they can. How much longer will patients and those who love them allow this to happen?
I can’t figure out what they decided at all. And 3 and 4 sound like the same thing. And I don’t understand the disparity between the answers for 1 and 2 with #3.
You did a fantastic job of summing everything up–thank you! And your testimony was really good.
I’m surprised that CFS advocates and some doctors painted such a positive picture of the prospects for approval.
Admiral Kweder, deputy director of the FDA, could not have been more clear in her CFSAC briefing. .
Without an “agreed upon definition” the means for testing of efficacy of any drug does not even exist.
By refusing to agree on a definition that represents the actual disease, the CDC/NIH and DHHS had ensured that this was a “non starter”. Not even a possibility.
But to satisfy the patients desire to be heard, they had to go through the charade of holding a hearing anyway.
Hi Jeannette, this was great writing , thank you so much for sharing. i feel quite bitter about what has transpired at the FDa meting, and Komaroff has certainly more than disappointed, amongst other people.
I hope you can make it to SFO on time for Christmas, best wishes to you, and family.
I am just sickened by the results of this meeting. Why am I not surprised that it was voted down when we should all know by now that big Pharma and big $$ control the medical industrial complex in this country. Neither the government, nor insurance companies want to take on another expensive illness.
I think the only real chance for meaningful change is to take the approach that AIDS patients took to finally get some recognition of the seriousness of their disease. Only problem is, we don’t have the energy for this kind of undertaking. Some how, some way, we simply must do this.
I was so hoping to be able to get the drug here in Houston. Now, I must rethink what I am going to do re moving to Incline…….that is, if the drug will still be available on a cost recovery basis.
I know you are trying to get home for Christmas, but just had to write and thank you for your efforts on behalf of all of us with this dreadful illness. Thank you, thank you, thank you.
I will be back with you after the holidays with some questions, until then
Sent from my iPad.
For some reason, my name keeps popping up as anonymous, but it’s Kathy D. who wrote the above comment. Hope that you and your family are able to enjoy the holidays.
I think at this point it is fair to ask the question of “CFS/ME” patients, “Why has this disease been so difficult to understand from a clinical and research standpoint?” After all, the etiology of AIDS — which has many times been described as the mirror illness of “CFS” — was unravelled in short order after it’s initial appearance in the US in the early 1980’s.
In response, I would like to suggest the answer to this can be found in the form of another question. If a public health issue presented a significant enough threat to potentially bankrupt the economic interests of the industrial elements that so clearly are now controlling the federal bureaucracy, what would the policy and public relations response look like?
If you politically deconstruct the history of “CFS”, I think you would have your answer. I suspect the causative element of this disease is known, and has been for quite some time.
Jonathan Lee wright, Hello, found this late so I dont know if any will respond, I’m not quite grasping what your saying, but feel there is signifagence to your statment. How can we, being weak, bring down or scare the public enough to force a bring down of a financial institution. We have to somehow band together, this illness could bring down a nation, that should be reason enough for hysteria. Thank you
HI Jeanette, somehow my name, Kathy D., turned up as Anonymous above.
Wishing you and your family holiday fun and joy.
Thanks for everybody’s comments! I will write some more about this, hopefully very soon. There is lots more to say.
lucewriter, i couldn’t agree more. i am trained in understanding weirdly worded language, but these questions are drafted so poorly that i have no idea how they relate to each other. this was not explained to the public and we were not allowed to ask questions of the committee. in fact, we were not allowed to speak at all, unless we were registered to speak for 3 minutes. but the public-testimony section happened before the the voting and before the questions were discussed. so, there was no chance for us to clarify what was going on. The drug company was also not allowed to speak or comment (after their presentation in the morning), unless they were asked a question by the committee. That is why they never got a chance to rebut the side-effects accusations, which I still find quite stunning (among many other things that seemed unusual to say the least).
i suspect that the drug needed an affirmative vote on all four questions to receive a favorable recommendation, but quite frankly, i am not sure. Maybe just the last question needed a “yes” vote. Who knows.
transparency was not a concern at the meeting, quite obviously.
and one more thing: we are not done fighting. quite the opposite. many patients and patient advocates are really fired up over this now. i know i am. this will not go away as easily as the FDA has been hoping.
“Oh, she got both feet on the ground
And she’s burning it down
Oh, she got her head in the clouds
And she’s not backing down
This girl is on fire”
To reiterate a comment I left at CFS central:
Same as with the Mikovits “HGRV”-fraud, people should heed any criticism coming from “our side” – it was a big mistake to vilify all the people who criticized Mikovits for her shoddy work.
If Komaroff voted against Ampligen in that meeting, I would guess he had his reasons – when Komaroff does or says something, he usually has put some considerable thought into it, and I will expect the same with his vote. Have you considered asking him what his reasons were? Any criticism of Ampligen by Komaroff should be well heeded. Ask him about his reasons like you would ask a friend, when he has a different opinion. You might learn something, if only how to better convince him.
I would be very interested in hearing Dr. Komaroff’s reasons. He made it very clear after the meeting though that he had no interest in talking to patients. That’s his right and I respect that decision. But I don’t have to like his vote.
PS: “respect the decision” as in “honor it.” not as in “respect him for it.”
I also agree Jeannette. I don’t think it’s good form not to talk to patients who came from very far just for this meeting.
On Tony’s comment, i agreed that many vilified other scientists who did not agree with her. i am one who has been bullied because I was supporting other scientists who wanted to research us. (Dusty Miller),
It would certainly be nice to hear what Komaroff has to say.
I wonder if the February decision will have any impact on the current phase 3 open label trial, and whether the class action against Hemispherx will be interfering?
i’d say it’s par for the course for many in the medical community. i wasn’t very surprised, actually. i just find it ironic to be called on not considering talking to komaroff.
i certainly wish physicians left their egos and conflicts of interests at the door. And cconsidering that some of the members voting didn’t even know about our disease, one would wonder how easy it would have been for them to get convinced to vote no.
Well said Tony, I agree.
Sorry, but I agree with Jeanette here. Doctors who are actively working on a disease, helping people with it, trying to find out causes, biomarkers, treatments, should be open to talking to people with the disease and answering questions. All of this behind-closed-doors maneuvering and secrecy and probably pre-ordained voting should be the opposite of what scientific discussions are about. All of the scientists, doctors and governmental agencies that deal with ME/CFS should be open about what they think — and have scientific reasons for their decisions, votes, opinions one way or the other. And sick people should be able to ask whatever they want to ask.
To not do so is treating them like they’re royalty who are above the discussions and far removed from those who suffer from this disease — and the first priority should be to listen to the patient community and be responsive. Governmental agencies should be responsive to the population of those affected by their decision no matter what.
Otherwise, where are our rights in this?
That is dynamite Alicia Keys! Love it, will bookmark it.
I am totally aware that this is Jeannette’s blog here, and want to make clear that
I respect Jeannette and what she writes.
i want to make it clear that I was agreeing to what Tony wrote in respect to Dr Mikovits’s situation.
The participatory model of medicine should be practiced especially in the context of such a neglected and stigmatized disease as ME. The problem comes with how scientists get rewarded (publication and ability to publish, getting grants, etc). There is also lots of problem with the medical system, insurance and conflicts of interest as well. it is far too complicated for me to even attempt something legible.
In this instance, after the meeting, what are patients in the capacity to do? should be what we ask ourselves.
Best regards, and thank you Jeannette for writing.
I was sickened by the news of the dog and pony show . Thank you for this write up that makes me so angry I could scream, if I had the stamina to scream. What are we to do? This illness feels like a prolonged death with no end in sight and no help on the horizon. Meanwhile, life continues as if we do not exist.
Again, somehow I’m anonymous, but it’s Kathy D. I wish we had the energy to ACT-UP. They got results. Boldness paid off.
the time is running, just a couple of days!
You need public interest urgently very fast!
Maybe after a bad decision Hemispherx think about to stop the program for CFS because the money is running out. They have some other expensive programs and its hard to collect more money for new CFS-trails when you tried to get an approval over two decades with no positive return.
Here is an link to an petition, maybe it can help a little bit, its just a sign.
But without public interest / pressure the CFS-patients loose in February, thats for sure!
I have no CFS, but I read a lot in the last couple of years.
Maybe Hemispherx get the money and start new trails, that means minimum 2-3 maybe 4 or 5 years more and then starts the same games with the FDA, maybe with the same votings.
It’s now been a few days since I read the post. 1) I’m still literally sick to my stomach – it’s stuck in my throat after reading who did what and how it all happened; 2) I’m still impressed with your abilities to sum it all up and grateful to you for going on our behalf; 3) Kamaroff: may he rot! “Turncoat” is the best I can say of him. I’m thoroughly disgusted and devastated by all that has transpired, though there is absolutely no way I, personally, could have benefited from anything taking place (I’ve been sick for 38 years). I’m horrified that a third generation is getting sick. I also see now that we cannot trust any of these specialists. Was Kamaroff afraid of losing his ivory-tower Harvard position? (Rhetorical question.) I know someone who used to go to him back in the late 90’s and I can see where he’d turn: he was already doling out his patients to his peons then. Sorry to sound so harsh but they all deserve so much more! If you feel like I’ve been too harsh, don’t let this comment through. I would really like to say so much more, more forcefully…this is me restrained!
“Patient advocate, Anita Patton, approached Dr. Komaroff to remind him of his Hippocratic Oath and to let him know that he had done some real harm to patients with his vote.” And you seriously wonder why Dr. Komaroff made a polite excuse and walked off? I give him full credit for understanding how upset she was and not blistering her in return.
An FDA meeting is not the Twilight saga with teams. Members of the committee are expected to be scientists not advocates for either patients or companies. If patients are not sure how FDA meetings go in general it might help to observe webcasts of other FDA hearings and educate themselves as to the criteria expected and the procedures to be followed. That patients are upset is very understandable, but no one should be expected to tolerate insulting, rude or abusive comments regardless of how high feelings are running.
Dr. Komaroff, Dr. Unger, other committee members, Ms. McCleary didn’t do patients harm – Hemispherx Biopharma did. They knew that they would be expected to do another trial months ago. That they were sloppy with their trials and don’t subgroup patients is on them not patients, not the FDA, not clinicians or patient advocacy organizations.
Hemispherx Biopharma needs to meet the same requirements that every other company does because patients are severely ill and desperately need effective treatments.
That other companies have gotten other drugs through that later turned out to have safety issues is a argument for strengthening the FDA clinical trial requirements not the opposite.
the drug has gone through 5 different departments at the FDA all of which have asked HEB to comply with different requirements, which HEB mostly did (except a new multimillion dollar trial, which it doesn’t have the money for). The FDA has, in all these years, not raised any of the safety concerns it raised last week. this seems unusual to me, but maybe it is, as you imply, standard practice. HEB was not given a chance to reply to the new side-effects accusations. If this was a big pharma company or a “real disease,” is there any chance the FDA would actually make an effort to work with HEB to do whatever it takes to get this approved, kind of like they did with AZT and AIDS? nobody has died from Ampligen in 24 years with over 94,000 doses administered! show me a drug, any drug (let alone one that treats a serious and life-threatening illness), with that kind of safety record.
the FDA folks were definitely antagonistic. it was clear to everybody in the room that THEY viewed this as being “on separate teams.”
as far as dr. komaroff is concerned, everybody is free not to engage with patients. like i said above, it’s pretty standard practice among medical doctors. when I politely questioned the medical advice of a physician recently (who basically said that dr. peterson doesn’t know what he is talking about), he replied with, “I have two PhDs!” that was his response. no attempt to convince me with good arguments. it’s not at all unusual or surprising to be dismissed as a patient, but in light of the magnitude of this decision, i am baffled to think that there is anybody who feels like dr. komaroff didn’t owe patients an explanation. i think it’s quite reasonable for patients who have been given their lives back by Ampligen and who will return to a vegetative state without the drug to confront those who are withholding it from them and to ask them for an explanation. obviously, opinions differ on that.
I’m with you all the way, Jeannette, and thank you for this clear review of the meeting. My audio was on and off constantly and I couldn’t get full sentences from the meeting. Shame on the FDA for apparently doing nothing to correct the problem all day long. It is true that the fault has always been with the sloppiness of Hemispherix, and we want an FDA that makes decisions based on the data. The only difference here from other drugs is that we have additional data – the unprecidented patient experience of improvement from a devastating disease – that should create an exception in this case to allow this data into the decision. I fully support the Act Up model, as I see so much patient effort being expended on “meetings” with government officials which are designed to keep us quiet. If we don’t address CDC’s denial, we cannot expect other government agencies or our doctors or anyone to believe us. If all our effort were directed to blatantly opposing CDC,we would start to make progress. Look where twenty five years of “cooperation” has gotten us….
case in point, bob: the FDA held it against HEB that there is no clear definition for the illness and there are no clear end points for treatment or no clear sub-groups. it’s so ironic, as the CDC has done an outstanding job in coming up with harmful definitions over the years and making it impossible to get any meaningful research done.
mindy kitei talks about this in detail in her recent post:
i agree with everybody who has said that we need to ACT UP.
“They recommended yet another large and prolonged study of Ampligen, which has undergone at least 8 different studies in the past 24 years already!”–Dr. Lapp
thanks so much for this blog post. very helpful to get your insider’s view of the meeting (as in inside the room). i was one who watched on the live webstream and was able to catch some of it, but the delay meant missing whole sentences at a time, and even half sentences — making it hard to catch it all. anyway, i, too, was shocked at komarof’s seemingly disregard for the patients he has treated for 2 decades. i assume he’s votes were all about protecting his position at harvard. made me very sad. and unger? jeeeesh. she has learned nothing from talking to the patients this past year. (or she never planned to learn anything all along!) we may as well give up on her and demand we talk to her bosses. IT IS SURE TIME TO ACT UP, FOLKS, IT IS THE ONLY WAY TO GET THE ATTENTION AND THE RESULTS WE NEED TO SAVE OUR LIVES. one simple thing we can do is make compelling videos from our beds, telling our (short) story of our illness and daily struggle, and then email these videos en mass to Sebelius, Fauci, Collins and others. i did just this a few years back, and called for others to join me in the effort. i don’t know of anyone who did. maybe we can try it again!? (http://www.youtube.com/watch?v=8t1Xqp1LDxM) — rivka
Great ideas every one! We have to ACT UP, do whatever we can. Sick people should take priority in all this. Being in ivy covered halls of academia separated from human suffering is not a good thing. Where is the humanity in this? Doctors and researchers should be accountable to people with ME/CFS, as with other serious diseases.
audio recording of the meeting webcast.
Please everybody, sign this petition for Ampligen’s approval. Thanks!
Definitely signed and shared.
Happy New Year 2013, best wishes Jeannette, Ed and Aimee
and same to you! may the next year bring some breakthroughs for us!
I do not understand why cognitive behavioral therapy cannot be considered a potential treatment for this condition. Also, you seem like a thoughtful, intelligent person who understands science. Yet your post doesn’t really discuss the possibility that the perceived benefits seen in the open-label trial and anecdotally by patients such as yourself might be due to the placebo effect.
sure, i am all for CBT as complimentary treatment with a qualified therapist who knows the illness and his or her limitations in being helpful to patients. learning about coping mechanisms can be helpful in ME to the same degree it is in other chronic and/or serious illnesses. but would you seriously consider offering CBT to cancer, AIDS, MS etc. patients instead of a drug treatment? If not, why suggest that for ME patients? We need a an effective treatment of the symptoms (not even asking for a cure here), which CBT does not provide, and not just ways to cope with them. why would any patient argue otherwise?
as far as the placebo effect is concerned, when you get a 70-80% response rate (as Dr. Peterson is), i think you’ll find yourself way out of placebo territory.
this is not directed at you, Sarah, but it seems to me that there are lots of hidden agendas when it comes to ampligen. and maybe that makes sense for people who are not patients: financial investors, psychiatrists, academics who can’t stand the thought of potentially being wrong, etc. but i can’t, for the life of me, figure out why a patient would not want this drug approved even if he or she isn’t comfortable taking it. give those who are access to it. that’s all we are asking.
Would you use CBT as a treatment for cancer? Yes, it could help in dealing with having a chronic illness, but it’s not treatment.
Having gone through the double-blind placebo-controlled Ampligen trial myself, I could see a big difference in those of us on the drug and those not. Shouldn’t we all have benefitted from the placebo effect equally if that’s all it was?
May Ampligen continue to be available to you. You are a force to be reckoned with. Thank you for your efforts.
please promote this E-Mail action, the time is running fast!
URGENT: Email the FDA about Ampligen now and daily – final decision is imminent
January 6, 2013
The FDA will announce its final decision on Ampligen some time around 2 February but could make the decision much earlier.
“There comes a point in human suffering when acceptable risk is most appropriately determined for oneself, not by government.”
“Now, with the FDA in decision-making mode let’s make their decision as a difficult a one as can be.
We are a force to be reckoned with.
We deserve access to this drug.
We know it works.
We know every doctor that has used it for the past ten years strongly supports it.
Let’s bring Ampligen home for the ME/CFS Community. Please support this action.”
We are missing something in all this. It is so unreasonable of the FDA to not pass Ampligen, a drug they approved 20 yrs ago as an orphan drug. So the FDA thinks it is okay for the people who can afford it to have the treatments, but not for those who cannot afford it? Why were the do tots and psychologists so adversarial on 12/20/2012? I see that dr. Komaroff used to work for Hemispherx, and he presented as hostile at the forum in Dec. He’s an idiot.
It appears the FDA has their OWN agenda but it has nothing to do with the suffering that CFS victims experience.
Perhaps this has to do with greed, or money, or another simple sinister character trait?
Also, this Dr. Lapp is buddies with Dr. Komaroff. These men are against victims getting relief.
Dr. Lapp has signed the petition, I think.
What my problem is, where is the fight from more than one million sufferers,
where are the signatures from families and friends?
Maybe two weeks and we get an decision, I can not see the pressure, just 2300 signatures and maybe Bob Miller collected some hundreds E-Mails.
Thats not enough, for sure!
The patients gave up to fight, before they really start.
Why its not possible to mobilize more patients with friends and families?
2300 signatures, this is an drop in the ocean.
Until 02.02. we have about 3400, thats a joke for the FDA.
Last chance is to get a huge public interest with TV and Radio.
Send letters or E-Mails, patients testimonies to radio and TV-Stations!
Or maybe somebody have a friend with a TV – Station, a little help to big sucess!
PLEASE, PLEASE HELP!
Millions of people should know what CFS/ME really means for the patients for the families.
Millions of people must known how long the patients are waiting for an treatment and how long it takes to do another study and then to fight with the same Adcom.
Millions of people must known what that means to waiting another couple of years with a NO from the FDA.
They will delete thousands years of lifetime with a NO.
A NO means a shock for all the patients worldwide.
The patients had a lot of hope until the 20 December, now a black hole in the sky.
Millions of people must known about the opinion from Klimas, Bateman, Enlander and especially the sucess from Peterson.
This is maybe the final call, we have just two weeks!
DONT GIVE UP !
“What my problem is, where is the fight from more than one million sufferers, where are the signatures from families and friends?”
i am struggling with that a lot myself right now. i am trying to keep a positive attitude because that’s the only way to deal with it that works for me, but it is challenging not to wonder. very disheartening.
“Millions of people must known what that means to waiting another couple of years with a NO from the FDA.”
i am afraid it will be a lot longer than 2 more years if they deny us ampligen again. we are talking more like a decade or more. this may be the most pivotal moment this patient population has ever seen. and most likely our best shot for a very long time. and we don’t have a very good shot right now, particularly without the support we desperately need.
I agree that its hard to see the numbers so small in a petition that we think might make some difference for us. If only we had enough? What would be enough? The reality is they(FDA) don’t have a clue as to what kind of energy it takes to get out of bed, much less get the thought process together to get on line and sign a petition. Plus, how many people don’t even know what we know, they just listen to their doctors tell them over and over, everthings “Normal”. They know nothing of Ampligen. If the FDA doesnt pass Ampligen this time, I am with the previous person Alfie, there is a different agenda, and no matter how many signatures we get, it won’t change. To be honest I’m tired of begging them, pleading, we have nothing, and watching all the patients testify on Dec. 20, confirms that it does in fact work, and if the FDA does not approve Ampligen, its on them. We have done all we are physically able to do. This will not be our failure, it will be theres.
i am not blaming the patients for the FDA’s bias. Ampligen should be approved without the need for any patient input at all. But given that we are up against an agenda to keep Ampligen off the market, we need to rally. What gets to me more than patients not signing is family and friends not caring one bit. If their lives were at stake and we couldn’t be bothered to spend less than a minute on an online petition, they might find that heartless and selfish and really just totally incomprehensible. trying to get people to care by just “sacrificing” a minute of their time (and maybe 10 more minutes by convincing their spouses/partners and friends to sign) has not endeared me to the human race.
Jeannette, trust me I am on your side, and agree that patients, family, friends, all should be fighting the fight. I am saying that people are not able, the reality is that people are going to have to give up their own lives to fight for the sick. Every day, signs on Washington, email, blogs, media, radio, a constant bombardment to the senses of Washington. This disease is the Perfect Storm of an illness. We haven’t the strength to fight, at least not for long. I have suffered for over ten years, and it was about one and half years ago that I had the energy to even surf the net, and before I ever saw the word Ampligen. Part of it is, family tend to just believe the doctors, we have all grown up hearing “Go to the Dr.” They will fix you. Even though I am on my coffin couch most of the time, my daughter still thinks Why can’t you come go do things with me? They don’t get it. Period. I mean if Cher has this, why hasn’t she rallied the people. I am losing faith in the “System”.
“Part of it is, family tend to just believe the doctors …”
that’s what i am having a hard time with. when my friends or family members do not believe me, then there is a huge problem with the relationship.
on a positive note, this exercise has really shown me whom i can rely on. our nanny got 152 (!) signatures!!! talk about love! a good friend of mine has spent quite some energy on getting more than just her own signature. that’s really where it’s at. because, like you said, we are too sick to do this ourselves. i got a few hundred signatures, but i am in bad shape as a result of that.
I know, its hard when facing the doctors that don’t believe. With family/friends, they do believe, but just feel helpless. I had been emailing the fda every day last week, then I got an email from an actual person, not automated, the response was from someone at the FDA, they had recevied my email, but, it was the wrong department, and she wanted to let me know that she wasn’t allowed to forward it to the correct department, and she wanted to make sure they got it. Genuine concern from her, she read it, and thought it important enough to email me. I wish all of the FDA thought it was as important as that person that read my story thought it was. Energy is a precious commodity for us, I am having a up week now, don’t know why? Never do. Hope your energy soon returns.
…..particularly without the support we desperately need.
Again and again, I wrote this everywhere.
We/You need to have the public interest, the power of million people.
Radio or TV – Stations on your side, then you get the right power.
It must be possible to find patients with connections to a big TV-station.
Tell the world whats wrong with this illness / the government since two decades!!!
Obama gave a promise, what happend?
The Adcom was a farce, hit in the face of every patient worldwide!
people are working on the media angle. it is so incredibly hard to get anything on this published/aired.
hey, on a lighter note (i need that tonight b/c it’s been an awful day): are you from germany? the “adcom” gave it away 😉
Ja aus Deutschland… point for you
and I am thinking we both had the same schoolsystem.
I had read your conversation with Teri about your Nanny and your friend.
Good for you, you get great support. These guys know this illness, so they will support you, whereever they can.
Here is the main reason, the biggest problem, how much people in the world are known what CFS/ME really means? Maybe 1% not more. The most are thinking they have no power, because of to much work.
A sample like me, I know nobody personally with these illness, I know nobody who knows what CFS/ME really means. A couple of years ago I know nothing about CFS/ME, I thought Its the same like burnout.
Then I read and learned a lot in the last couple of years about this illness, lot of heartbreaking storys. And Iam was wondering, that so much people are living in the shade of life.
When I find the petition and the E-Mail action I decide to help.
Every evening I was looking for some organisation and send a lot of E-Mails to all over the world, most of them in Europe……PLEASE SUPPORT THESE ACTIONS….
Sometimes I am very sad, because its so hard to motivate some peopleto do something. So much E-Mails to a lot of ME-Organisations and I got 2 of them an answer.
I can’t see really progress. It’s not enough to send E-Mails to sign petitions over and over again. Who cares?????????????????
Thats the reason I am strong believe, only helpful is the public interest, the pressure of ten- maybe hundret thousand people or better millions.
I think the petition and the E-Mail Action will end with the decision, what will happen after that?
A big black hole?
I dont hope so!
You need the TV / Radio, big Stations and a good promotion / moderation.
Under this pressure the FDA must give some hands in direction of the patients.
I think HIV/AIDS have got the biggest interest after the movie Philadelphia and some others good movies.
After that the whole world was interested and decide to help whereever they can.
PLEASE, IF SOMEBODY READ THIS, WITH GOOD CONNECTIONS, HELP TO SPREAD THE SAD STORYS, THE WHOLE TRUTH ABOUT THE FIGHT OVER TWO DECADES WITH THE GOVERNMENT, WITH DOCTORS, WITH PREJUDICE AND WITH A LOT OF PAIN!
PLEASE HELP TO FIGHT AGAINST THE STUBBORN FDA, TO FIGHT AGAINST THE LOBBYISM, TO FIGHT FOR THE RIGHT FOR A BETTER LIFE!
Viel Glück Jeannette und natürlich auch allen anderen!
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Anyone hear about ampligen?
Jeannette, thanks for responding, while everyone prepares for their Super bowl party, I sit here waiting on the FDA response regarding Ampligen. Hoping that maybe next year I will be able to (Health Wise) be at a Super bowl party.
Yeah, lots of folks are pulling their hair out right now.
OMG, Really? Could the delay be a good sign on the Ampligen decision?
Jeannette, Robert Miller continues his hunger strike, would this be something we could possibly make bigger in the media if more people started hunger strikes with him? If they, of course were able.
bob made it very clear that he doesn’t want other patients to go down this route. it’s really so dangerous for us. having said that, i have considered it.
we are working on getting more media coverage for bob’s hunger strike.
Please support Bob,
send E-Mails also Cc to Bob Miller — email@example.com —
… and this ! ! !
Hey Jeannette, just wanted to drop you a line about the Natures Bounty Charity Contest, the 1,2,3, place winners get money. Its at http://www.SHARETHEBOUNTY.ca. The National ME/FM Action network is in second place behind a animal charity. It would be nice to see that $20,000. go for ME RESEARCH. We can vote every day through March 29. Please pass it on, its a little money, and brings awareness. Thanks, hope all is going okay.
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