The FDA has somehow missed the fact that Dr. Daniel Peterson is an ME/CFS expert clinician/researcher. For over 30 years now, Dr. Peterson has been treating ME/CFS patients in Incline Village, Nevada, with a variety of treatments. Earlier today ME/CFS patients were told that FDA has not invited Dr. Daniel Peterson, because they state “he only uses/researches Ampligen” to treat ME/CFS patients.
The FDA’s misconception regarding Dr. Peterson suggests they’re not doing their homework…and that the Workshop may miss the experience of a physician uniquely focused on immune dysfunctional patients.
This is incorrect. Dr.Peterson uses a large variety of treatments for ME/CFS including Vistide, Valcyte, Anti-virals, Amino Acids, IV fluids as needed, beta-blockers, Ampligen and other secondary treatments he has found to be of benefit over a 30 year period of treating ME/CFS. It is why he has such a high success rate with ME/CFS patients.
Dr. Peterson brings more than experience with a wide variety of drugs to the table, though. With his focus on natural killer cell (NKC) deficient patients Dr. Peterson would also bring a unique perspective to the Workshop. The FDA acknowledges the need to parse out subsets; indeed, the subset question played a key role in Ampligen’s denial yet they’re ignoring the one physician who has focused on a particular subset of patients. (Ampligen was thought to be effective for a subset of patients.)
Besides, the statement that Dr. Peterson ‘only uses Ampligen’ is startlingly ignorant and suggests the FDA is not doing the homework they need to do to find the most relevant experts. How many people do not know that Dr. Peterson focuses on immune dysfunctional patients? How could the FDA not know this?
All it takes is a phone call, and, if the FDA needs Dr. Peterson’s number – here it is (775-832-0989 call 8:00 am to 5:00 pm PST.)
If the FDA isn’t doing enough homework to know even the fundamentals of Dr. Peterson’s approach, it’s clear the patient community is going to have to be on top of them all the way to the meeting. As someone who’s benefited from Dr. Peterson after failing to do so with other practitioners (and many of his patients will say the same), I believe the FDA needs Dr. Peterson at the Workshop to fully understand the many different treatment options for this disorder.
If you believe the same then please “ACT NOW” by making Phone Calls to FDA’s Mary Gross at (301)-796-3519 and by Doing Daily emails (Mary.Gross@fda.hhs.gov)
Please Explain to Mary Gross that FDA has it Wrong and that the ME/CFS FDA Workshop needs his attendance to be comprehensive.
FDA has been polite when calling them, so please be polite as well.
FDA is supposed to be about facts and science, they have missed both regarding Dr. Peterson.
Thank you All,
Bob Miller & Team
Thanks Bob…
I’m shocked at both the FDA’s lack of basic knowledge regarding one of our foremost practitioners (where are they getting their information from? Are they talking to anyone?) and the idea that they don’t feel this unique doctor should be at the Workshop…I worry that the FDA is not interested in anyone who’s up on Ampligen; I suspect they don’t want to open that subject at the Workshop.
As I remember, Corinne is talking Valcyte, Epocrit, Saline, a prescription probiotic, IVIG…..and not Ampligen! 🙂
I believe this is exactly the reason why the FDA has not invited Dr. Petersen to the meeting, many of these treatments have been shown to have no benefit in the treatment of CFS. As I stated before if we want someone versed in CFS we would be far better off trying to get someone like Dr. Klimas to attend with her Academic background. As a doctor with the same medical background as and 20 years of clinical experience, I am often quite skeptical of the practices of Dr. Petersen.
You have even questioned the efficacy of Valcyte, studies are not coming out because it just so rarely works, the “recovery” scale is a joke!
Epocrit, I’m pretty sure the FDA has said it doesn’t work so why would they want someone there butting heads about that one.
So much snake oil in this disease, let’s stick to Academia, Montoya, Lipkin, Klimas, big names!
Greg
It would be interesting to compare success rates amongst physicians. In fact Health Rising is working on a Practitioner Review program that will hopefully be out fairly soon that will help in that area. (Donations are welcome :))
I imagine that no one has a sterling recovery rate and I imagine that many of our top docs have good improvement rates. Still, I’ve met several people who’ve been around and swear by Dr. Peterson and I hope that he can get in there.
Cort,
Success rate vs. recovery rate? Dorlands Medical Dictionary (the Bible) defines recovery as the return to health from disease. Everyone that comes from a non-caring, uneducated doctor to one of our “chosen ones” is going to be happier. Seeing Montoya however I was not cured. I do know one of his “cures” was a Doctor, sick less than a year, didn’t respond to Valcyte until round 2 when it was discovered elsewhere she was hypothyroid. When talking true recovery you will find no one has better than 5% of true CFS patients “recover”. Heck I had a “CFS” client go to an electro cardiologist after 8 years who found a 3rd degree heart block- pacemaker- cured!
Again, I’m just saying the FDA has spelled out very clearly why Ampligen failed, they cheated on their study. We need to find some other way around that($), and make this meeting about future drugs, CMX001, Rutuximib etc.,.
Get someone they respect, Montoya is the head of the NIH Toxoplasmosis Task Force (for example).
Greg
Greg, Dr. Klimas’s approach to diagnosing and treating ME/CFS is very similar to Dr. Peterson’s. Out of all the treating ME/CFS experts these two experts match up the best. The treatments you mention, Epo and Valcyte have both been used by Dr. Klimas as well. This is not a one pill fixes all patients, that is why we need all the experts attending and participating, as few as there are, they all need to be there sharing their experience and knowledge. Dr. Lipkin’s lead co-researcher Dr. Mady Hornig was a name I submitted early on. She agreed to attend if FDA invited her, thus far no invitation. Montoya, Kogelnik and others were requested to be invited by several patient groups and patients. No invites thus far. So who are they(FDA) bringing to the party??? I am guessing here, but I believe you will hear words at the ME/CFS FDA Stakeholder Workshop like, New Views, New Blood, Fresh Ideas and more. And we will get some of those to attend, but when all those Newbies work for months submitting grants for funding for ME/CFS and they repeatedly get turned down, they will just move on, just as it has been for many years. Once the smoke clears and the Newbies are gone, you will see our top experts still standing there treating their patients, Saying here we are just ask us we are willing and able…
Bob Miller
Greg,
Unless you have been properly screened by an expert ME/CFS clinician who knows how to screen for placing a patient on Ampligen, giving a patient Ampligen is useless. FDA does Not know that Ampligen falied, they assume it does not work, remember most of the panel members stated they all saw a siganl in patients. Dr. Klimas has a near 40% responder rate, Dr. Peterson nearly 70%. These two clinicians are doing something different when selecting patients. FDA and all the other Federal health agencies along with other clinicians & researchers need to know what and how they are doing this. It subgroups the patients and could help with creating a clearer case and clinical definition.
As for your comment about cheating on the study, have you been on Ampligen at one of the study sites? Do you know how the results get reported, do you know who reports them? The Ampligen patients do, so when you say they cheated, you are saying the Ampligen patients cheated. It was our reporting and our testing that was submitted to the company from each participating clinician’s site, by a site director who has been constantly reviewed by FDA and a local IRB. So your comment is offensive to the Ampligen patients, FDA reviewers, expert clinicians, site directors and the IRB’s at several different sites. Could the company have done a better job, of course. But claiming FDA is right because they said so, is not proof. Patients regaining some piece of their lives along with improved immunological testing, that is proof. Having T cells go from 300’s to over 1000 is proof, then returning to 300 again when off ampligen is proof. Viral loads also improve as well. But FDA did not allow for these results to be submitted with the application. Hope this helps you to understand the divide between FDA and the sponsor. This should be about the patients best interest, Not FDA or the sponsor.
Bob Miller
Bob,
What I’m saying is that as a doctor I’ve worked on two NIH grants having to do with cancer drugs. Both failed because they failed to prove what they were written to prove, within statistical parameters,p values(science).Studies are all about statistics! If either study were “stopped” before the written statement, that’s not even a question, it’s all over- that’s what I’m talking about cheating. You can’t change the study in midstream, just won’t fly with these agencies.
Now the FDA is saying, go back, use your knowledge, select your patients, show that the NK cells are statistically altered, come back with that data.
What I’m saying is I don’t think this meeting is about AMPLIGEN! They feel they have fully dealt with this issue.
I agree they said there would be transparency, and there’s not. I think the way to change that is not through them but through our representatives-we have a written statement that there will be transparency- let’s hold them to it! Let’s work on our representatives!
Best,
Greg
Greg,
Thanks for clearing up the comment re: cheating. I appreciate your input. As for the meeting being about Ampligen, I think all real treatments need to be on the table and our experts should be sharing what they use and why. I assume they will be coming prepared to share that type of information and FDA will be willing to listen to it. If we have Pharma companies attend that have done or are doing work related to ME/CFS such as Chimerix and they are willing to discuss cmx 001 then we now have the beginings of a Stakeholder workshop, we know patients will attend and submit input.
As for Transparency, I am concerned. What I and the other original members of the first group who initiated this Stakeholder meeting were told during our first call with top FDA officials was this would have to be an open process. Our group(lets call us the Stkhlder team) offered up an idea to have ME/CFS groups,organizations, websites & blogs post a request for patient input for this meeting, we were told No, it had to be an open process where all would have input directly to FDA. I thought Ok, fair enough. What has happened is you now have a very few patient reps. directing FDA on who to invite. Not the process promised. It is why I and others have been pushing for all the ME/CFS experts to be invited as panel members. And then who do you want representing you as a patient sitting at the table ? I want this meeting to mean something for the patients and to move drug treatments forward.
Kindly,
Bob
Great article both of you, and I am also shocked at their lack of *interest* in getting up to speed on research, causes, patient suffering, and treatment options. They have NO CLUE how sick we are and how urgent our pleas are just for them to PAY ATTENTION and take ACTION. I am frustrated!!
I agree with the prior comments and am also shocked at the lack of knowledge and interest. What else can we do to help them understand how sick we are? As a Dr. Peterson patient I have taken Valcyte for one year and subsequently received Vistide infusions for five months.
I believe that we patients must continue to educate our Federal Health Agencies and the entire Health Care System about ME/CFS. We hear the words that they understand our frustration and pain, if that were true, HHS would lead an all out attack on ME/CFS in the same manner they address Cancer, HIV, MS and other severe chronic and life-threatening, life-stealing illnesses. Praising that they spent $ 11 Million dollars in 2011 is proof, they just do not get it. The illnesses I listed get at least $ 120 Million Dollars annually and they all have several FDA approved medications. This is not about asking HHS to cut funding to any other illness, it is about Basic Mathmatics. ME/CFS costs the U.S. between $ 20 to $50 Billion Dollars annually, As President Obama told my wife Courtney at the Reno Town Hall Meeting ” God gave us brains to figure things out”, well you do not need to be Einstien to figure out that spending $11 million dollars on a $ 20 to $ 50 Billion dollar problem is just not smart math. So, HHS spend what you must to get us treated and back into society, working and paying taxes again. That would be using your” brains to figure things out”.
There are too many patients suffering every hour of every day, every day of every week, every week of every month, every month of every year, every year of each of the past several decades. So, as hard as it is at times, we the patients must also be the teachers and the leaders. A Saint once said ” Fools Argue, Wise Men Discuss”, So let us discuss ME/CFS with all who will listen.
This is the email I sent to Mary
Dear Mary,
I know of several people personally who had seen doctor after doctor who improved tremendously with Dr. Peterson. Dr. Peterson is not your run of the mill ME/CFS physician; he focuses on the large subset of patients who have natural killer cell dysfunction. Dr. Peterson’s decades of work on this particular subset of patients makes his presence, I believe, important at a Workshop of a disorder that everyone believes is characterized by numerous subsets.
The statement that Dr Peterson only uses Ampligen to treat his patients was appallingly misinformed and obviously raised questions how seriously the FDA is taking the ME/CFS workshop. If the FDA gets fundamental facts about this prominent physician so wrong, how can we trust that they are doing their due diligence in other areas?
I am good friends with a patient of Dr. Peterson who is taking valcyte, Epocrit, saline, IVIG, klonopin and prescription probiotics… and has taken xafaxin and other drugs in the past. She is not taking Ampligen!
I request that you invite Dr. Peterson to participate in the FDA Stakeholder Workshop.
Thanks for your time,
Yours truly,
Cort Johnson
Dear Ms Gross,
I believe, as a patient, RN, author and authority on fibromyalgia, the goal of medicine, including drugs is improved patient outcome. How can the FDA know patient outcome without the input from one of the leading clinicians and researchers regarding treatments for ME/CFS, one of those being Ampligen. Physicians can give an aspect that none others on your panel can do. Leaving him out is like leaving out the power saw at a construction site.
The government would fair better in matters of health if they would include physicians on the front line as part of the task force. I ask, in combat would you put your greatest marksmen at the rear, or maybe as in the case, all get rid of him/her all together?
Please reevaluate your position on including Dr. Daniel Peterson in this matter.
Dear Cort,
I am assuming the above email is addressing me, or perhaps Mary Schweitzer? She is currently on the Ampligen, and has been under the care of Dr. Peterson in the somewhat recent past. I was a patient of Dr. Charles Lapp, and received the Ampligen 11 years ago.
I have been very ill this past few weeks, on round two of an antibiotic(doubled strength now) by my local internist. I am watching and waiting for the correct time to address these governmental associates. Having bronchitis and taking antibiotics has taken precedence. Since it is now the weekend, I will have emails or faxes prepared on Monday to address this situation. I will cc you, as well as Bob. I think holding off and seeing the behavior displayed by the FDA is a common sense conclusion. They would not approve the Ampligen because of ‘lack of information’ and questions of the efficacy and safety of the drug. Although I was reactive in the beginning of the Ampligen (hives, etc.), I DID have a very good response in the end. My existence became tolerable, then rewarding as I felt so much better! I had many other treatments from Dr. Lapp over almost a 20 year period.
I think what is the sense of this meeting if we cannot be open and honest about what has helped us the most as chronic M.E./CFS patients? Why are they not inviting the most knowledgeable physicians in this country? Why do we, as patients, have to convince the FDA personnel of what they already know? There are other specialists who have provided care to the ME/CFS community for many, many years. Are they willing to become involved, and can they set up communication with us right now? There has to be a planned approach to be of true and valuable outcome. Sorry, I have not acted quick enough, but it does not mean I won’t. Trying to see who else is going to speak out about this, with safety and efficacy.
To better health,
Mary Silvey, RN
VP, Medical Professionals with M.E. (Yes, we are still in existence, and are aware of what is happening. Please be considerate that we lost Anita Burgess 18 months ago, and Gail is bedbound. But she can listen and talk to me, as I update her. I have her full permission to speak as a member of this group, and plan to do so. We have not lost our true commitment to having M.E. recognized and understood.)
Mary,
I believe Cort’s post was what he sent to Mary Gross of the FDA not to you or Mary S.
Bob
I also want to know why I should bother Dr. Peterson, when he is fully aware of what is going on? I have never known him, but will write to him (insteadof?) despite no forthcoming invitation from Bethesda. Where is Mr. Reid, Bob? We need him and other valued governmental representatives.
This is an exercise of futility if they will not invite the doctors who have carried us through so many years of treatment. Klimas is coming? Who else, please? Thanks, Mary (Yet, I will be rude and invite Dr. Peterson without the FDA doing so, first…They are rude,as well, in my opinion.)
The FDA is not on the side of the consumer, so they select who they work with according to an agenda which usually involves drug companies. We have a huge amount of evidence of this. Why would their actions surprise anyone? Those looking for discovery and discussion invite everyone to the table.
Celia,
That is exactly my point, invite all the ME/CFS experts, clinicians, the researchers, Pharma, NIH, CDC, HHS, Medicare, Insurance, Patients, CFSAC, Political Reps. Lets get them all to attend and discuss how we move forward.
Bob
Bob,
I completely agree that we need as many ME/CFS experts, clinicians, reasearchers, Pharma, govt’ agencies, Insurance, Political reps to attend. They are all crucial in figuring out our path forward. As I understand from a posting by the CAA, at least two ME/CFS clinicians have been invited that have administered Ampligen in the past. I also understand from other sources that Pharma has been invited.
I’m a bit confused on your position. You have asked for letters that Dr. Peterson be invited. Are you changing your stance and now asking for all of the above parties that you have mentioned to be invited or have I mis-understood your intention? I agree that Dr. Peterson is indeed a star in our community but at the same time, he is not the only one that can represent us well.
I agree that this should all be transparent, and as patients we should have some input on panel members ahead of time. As always, I am deeply grateful for your continuing efforts for our illness.
Kristina,
Several of the ME/CFS experts could represent this patient population well. But Dr.Peterson has been committed to the patients, he is very involved with the research side and no matter whether it is a drug company or any federal health agency, his first and last thought is for the patients. I have watched him for 15 years now as a patient, he will do whatever it takes to help a patient’s health improve. That includes sending his patients to other clinicians who may have more expertise in other areas of medical specialities. I would hope that FDA invite all ME/CFS experts, but if I could only select one it would be Dr. Peterson, due to his knowledge clinically and in research, his experience, committment and compassion sets him apart from the rest. And I have a lot of respect for several of the other ME/CFS experts.
Thank you for further clarifying your position Bob. Dr. Peterson is not only an outstanding physician but more importantly a quality indvidual. We would be lost without these heros in our medical community, and am thankful for their sacrifice to us every day. I am looking forward to the FDA meeting with great hope and promise.
Thanks Bob!
The FDA can and will manipulate the stakeholder meeting in the direction they want. Like in the advisory committee the FDA will chair the meeting and can easily stop unliked participants / messages.
Unless we can fix the agenda points upfront:
– Are the results of the AMP-511 und AMP-516 trials sufficient to approve Ampligen?
– What post-approval studies still must be done with Ampligen?
Ampligen will be prevented by the FDA from being discussed or conclusions to be drawn.
I thought Dr. Wanda Jones committed herself after Bob’s hunger strike to help us. Is she involved? Can we demand that she is chairing the meeting and fixing the agenda?
do we have any idea who *is* coming?
The draft roster is up and it’s looking good for Mr Miller IMHO:
Lucinda Bateman, MD
Lisa Corbin, MD
Lily Chu, MD, MHSH (patient)
Jordan Dimitrakoff, MD, PhD
Nancy Klimas, MD
Dennis Mangan, PhD
Robert Miller (patient)
José Montoya, MD
Bernard Munos, PhD
Peter Rowe, MD
Christopher Snell, PhD
Jennie Spotila, JD (patient)
Elizabeth Unger, MD, PhD
Suzanne Vernon, PhD
Christine Williams, MEd
I don’t see Dr. Peterson listed (yet) but congrats to Bob for getting on the list and having a pretty strong squad (Klimas et al) to back him up.
Indeed John – Too bad Dr. Peterson isn’t on there but otherwise very good roster…Glad Bob is on there (if anyone should have been on there, he should have). Dennis Mangan in there and really just about everybody else. Great to have Montoya, Klimas, Bateman, Rowe…I would have liked to have seen Lapp on there; that guy is just so up on drugs and really everything…He’s a walking information resource…All the patient reps are really good – both Lily and Jennie are as smart as they come and both good advocates…
I don’t know Munros or Corbin…
From what I’ve read Corbin works in CAM and lifestyle therapies. All I can find on Munos is that he is some sort of advisor for corporate strategy for Eli Lilly.
Thanks – do you know about Demit……? I think he’s an OI guy???
Dimitrakoff is a biomarker guy; I think he specializes in chronic pelvic pain syndrome.
He is on the CFSAC commitee (?) – I found this presentation that he put together:
http://www.hhs.gov/advcomcfs/meetings/presentations/biomarkers.pdf
Should we still send the daily emails?
We all have to understand that we have a 20th Century medical infrastructure in a 21st Century world. USFDA and NIH have been covering their butts for the last decade. The research is proving that papilloma infection are systemic in the body, the virus is in the blood, and they cause deadly diseases.
Watch the international research particulary in Spain and Australia. Research is almost non-existent or a joke in the US. An example is Dr. John Corbett’s recent diabeties studies. On one hand he spouts the old school jargon that adult onset diabeties is caused by bad diet, then in his mouse studies he is INJECTING MICE WITH PAPILLOMA VIRUS TO CREATE DIABETIC MICE so he can go on to study diabeties. I’m not making this up. Google him yourself. For pitty sake, the man can’t see the forest through the trees. It’s the VIRUS, stupid!
The reason that FDA cannot accept this fact is that a core group of physicians clearly stated several years ago “papilloma does not survive in the blood” and “we don’t need to test donated blood” end of argument. If papilloma (including herpes) was in the blood, it was obvious that it should be screened for when donating plasma. We now know that herpes is in the plasma, we will simply have to wait for a lot of old coots to retire before we get any action. There are a lot of important medical career’s at stake. Those careers are a lot more important than our patient’s lives.
I’m hearing stories every day about doctor’s nearly killing thier patients with simple procedures like epidurals. The patient comes back to emergency a week later with cerebral edema. It then turns out to be HSE. Then they go back and test the blood and its full of herpes virus. The herpes was transfered to the spinal fluid during the spinal stick. In most cases the lab will not be skilled enough to diagnose HSE in time, nobody will ever know because they will never look.
We may eventually come to understand that papilloma infection, herpes, CFS, insulin resistant diabeties, pacreatitis and cancer are just variants and stages of one disease family. At that point I wonder if Dr. Peterson will be consider one of the founders of 21st century medicine?