Article: Accelerating Treatments For ME/CFS: A Call to Action for the FDA

You can view the page at http://forums.phoenixrising.me/content.php?557-Accelerating-Treatments-For-ME-CFS-A-Call-to-Action-for-the-FDA

 

Great! Thanks to John Smith, Robert Miller and Cort for this very important initiative! I have emailed mine. I'd like to request a change to the text: I believe that Ampligen has been in the FDA process since 1990 (Osler's Web p. 371); so I suggest the last sentence of the fourth paragraph be changed to read:
"Yet, ME/CFS patients continue to suffer terribly while ME/CFS as a disease has been moved through six different divisions at the FDA and the only treatment for ME/CFS has been stuck in the FDA process for over two decades."

 

I think even treatments used now like antivirals etc should be approved as well, not just prescribed off label, as i think this would also help legitimise cfs/me as well as help encourage more research and development into cfs/me.

cheers!!!

 

Is there anything non-US patients and advocates can do to help this very worthwhile cause?
OTH

 

Cort,

First of all thank you for all the work that has gone into preparing this Call to Action advocacy campaign. I have a couple of comments/suggestions about additional individuals who these letters can be sent to and a suggestion for another area that may be ripe for a similar campaign.

1) Suggestions for additional people where this letter can be sent.

a) President Obama, who ultimately oversees the agencies and departments within the United States government;
b) Both the majority/minority leaders in the Senate and the House of Representatives;
c) The Governor of the sender's home State and,
d) The elected officials in the sender's home State legislature.


2) Suggestion for an additional call to action letter.

It appears that comments made by CDC official, Dr. Elizabeth Unger, regarding the government's recent functional MRI studies, which showed decreased blood flow to the brains of ME/CFS patients, might be worthy of an additional call to action letter. See Dr. Ungers statements at http://health.yahoo.net/news/s/hsn/new-clues-to-chronic-fatigue-syndrome.

"We don't know if these changes are involved in causing CFS or are found as a result of CFS," said study author Dr. Elizabeth Unger, chief of the chronic viral diseases branch of the U.S. Centers for Disease Control and Prevention. "Every carefully controlled scientific study on CFS helps raise the credibility of this very complex illness. Even though our findings are preliminary . . . they do support a biologic [theory] about this illness."

"A strength of the study is that we used some of the newest technology available to look at the function of regions of the brain that may be involved with CFS," she said. "We hope the impact of our study will be to encourage further basic science investigation of CFS."

According to Dr. Ungers statements, there appears to be continuing confusion within this agency (and the NIH) that research, using some of the newest technology available" at that time, had not already been conducted and made known to the federal government over 25 years ago. Specifically, there was considerable clinical research conducted, which appeared to identify abnormal physiological changes to the brains of ME/CFS patients (physicians/researchers who were involved in this research - Drs. Peterson, Cheney*, Komaroff, Handelman, Goldstein). See, Hillary Johnsons (amazing!!!) book Osler's Web at pages 75-80, 126, 173, 307-321, and 687-690 - http://www.oslersweb.com/. It may be worth an investment to supply copies of this book with select passages marked to entice interest in the historical perspective of this illness.

Perhaps the U.S. government may now be receiving sufficient encouragement from its own Public Health Agencies, its citizens and citizens throughout the world, to immediately begin funding and conducting more basic and sophisticated science investigation into the diagnosis, treatment and possible cure for this devastating illness.

Wally

(*Note, I could not locate the published reference to Dr. Cheney taking patients MRI scans to the CDC or NIH for review and finding out later that the government used MRI scanners with a lower resolution to investigate the Cheney MRI scan findings. Maybe someone with a better memory or research skills than mine will help me find a reference to this information? Could this have been discussed in one of the old televised news reports from the 1980s or 1990s???)

 

I think this is a wonderful initiative. Will work on letters.

I do disagree with the statement cort wrote : Ampligen, the only drug currently under review at the FDA, has been shown to be effective (see PlosOne study) and hundreds of patients over the past ten years have shown that its safe. and with justin's suggestion to specifically mention ampligen.

maybe hundreds have used it safely. But it has also caused serious problems for others. ( I have personally used this med)
Do I think it should be approved? probably. I think the potential benefit outweighs the risks. BUT patients should be properly screened and realize if it works, it is probably not a long term asnwer, and that it could make them sicker. much much sicker. That's true, of course, of all meds -- some more than others. I would hate to see approval and it prescribed just b/c there is nothing else and have it used incorrectly. I guess that's what all the prescribing information is for.

I have a friend who had a strong negative response and b/c of decline triggered by this, is no longer on this earth.
I also have friends who have been immensely helped during time they had access to the drug. ( relapse after stopping)
Me? unpleasant side effects and no benefit. (no lasting negatives that I know of, either. )
It's a mix like everything else.

Of course, those doing the approval, probably don't understand the serious nature of this plague, and therefore don't understand the risks are for many, worth taking. Just as those risks are accessed for other meds approval for many other serious disabling illness. I think that is a problem with meds for ME/CFS.

Can't really put all the asterisks in the letter though ;- )
I just personally wouldn't single out ampligen in the letter.

 

Just now got myself organized (finally!), personalized the template, and sent out the email. Thanks, Cort, and thanks to Denise, Bob and others who initiated the call to action.

A reminder to anyone else interested in participating: This has to be done before 2 May.

 

This really is great! Thanks Cort! I have sent my letter to Secetary Sebilus and others yesterday evening. I haven't found the e-mail for my Vermont Senator Sanders. He has great power and is behind the people. He is Independant. If anybody has a template for a Senator letter it would help due to my brain fog. Cut and paste I can do.!

If we could rally 1/2 of the ME CFS patients in this USA and send all our e-mails at once on a given day that "MIGHT" get some attention. Again....this is fantastic. Thanks!

 

Xandoff Letter to Rep. Sanders

This really is great! Thanks Cort! I have sent my letter to Secetary Sebilus and others yesterday evening. I haven't found the e-mail for my Vermont Senator Sanders. He has great power and is behind the people. He is Independant. If anybody has a template for a Senator letter it would help due to my brain fog. Cut and paste I can do.!

If we could rally 1/2 of the ME CFS patients in this USA and send all our e-mails at once on a given day that "MIGHT" get some attention. Again....this is fantastic. Thanks!

Xandoff,
Thank you for taking part in this Action. As for Bernie Sanders, just fill out the form and do a copy & paste into the form area. Bernie Sanders is a great Rep. and having you send a contact email would be of great Help. http://www.sanders.senate.gov/services/casework/

Thank you,

Bob Miller

 

Cort,

Thank you for posting this Action, I would ask those taking part to send the Action Email Daily until May 2nd. Fill their Mail-Boxes before we make contact after the May 2nd, Date.

We thank All those taking part in their Recovery.
Bob Miller

 

Why Mention Ampligen

I think this is a wonderful initiative. Will work on letters.

I do disagree with the statement cort wrote : Ampligen, the only drug currently under review at the FDA, has been shown to be effective (see PlosOne study) and hundreds of patients over the past ten years have shown that its safe. and with justin's suggestion to specifically mention ampligen.

maybe hundreds have used it safely. But it has also caused serious problems for others. ( I have personally used this med)
Do I think it should be approved? probably. I think the potential benefit outweighs the risks. BUT patients should be properly screened and realize if it works, it is probably not a long term asnwer, and that it could make them sicker. much much sicker. That's true, of course, of all meds -- some more than others. I would hate to see approval and it prescribed just b/c there is nothing else and have it used incorrectly. I guess that's what all the prescribing information is for.

I have a friend who had a strong negative response and b/c of decline triggered by this, is no longer on this earth.
I also have friends who have been immensely helped during time they had access to the drug. ( relapse after stopping)
Me? unpleasant side effects and no benefit. (no lasting negatives that I know of, either. )
It's a mix like everything else.

Of course, those doing the approval, probably don't understand the serious nature of this plague, and therefore don't understand the risks are for many, worth taking. Just as those risks are accessed for other meds approval for many other serious disabling illness. I think that is a problem with meds for ME/CFS.

Can't really put all the asterisks in the letter though ;- )
I just personally wouldn't single out ampligen in the letter.

Hi Beaker,

As you know Ampligen is no different than any other drug re: Patient response. Just like aspirin, some patients can tolerate it and respond well and some do not. It is the only drug specific for ME/CFS treatment in clinical trials at the FDA. We want the FDA to have a roadmap in place for approving any promising drug treatments for ME/CFS, that is why we want a Stakeholders meeting. We want a plan in place, so if a drug like Rituxan proves to be another treatment for patients, it does not get lost at the FDA for 20 plus years. I agree with you that those doing the approval don't understand the serious nature of this illness, another reason why we want the meeting. I am sorry for your loss and hope for better health days ahead.

Kindly,
Bob Miller

 

Bob Miller,

Thanks for the e-mail info for Senator Bernie Sanders. I just sent my letter to him. I see him in Lyndonville VT every July at the Stars and Stripes Festival. Keep this energy going folks!

 

Cort,
Thanks for posting, Cort and thanks to everyone for participating in this action.

OverTheHills,
You asked what non-US patients and advocates could do to help...

The lack of progress on treatments for ME/CFS affects all patients, not just those in the U.S. Getting the U.S. to foster development and accelerate approval of treatments for ME/CFS will affect us all in the same way that Norway's actions regarding Rituximab affect us all.

I think Dr. Sebelius should hear about how this also affects others like you in other countries.

 

Great! Thanks to John Smith, Robert Miller and Cort for this very important initiative! I have emailed mine. I'd like to request a change to the text: I believe that Ampligen has been in the FDA process since 1990 (Osler's Web p. 371); so I suggest the last sentence of the fourth paragraph be changed to read:
"Yet, ME/CFS patients continue to suffer terribly while ME/CFS as a disease has been moved through six different divisions at the FDA and the only treatment for ME/CFS has been stuck in the FDA process for over two decades."

I'm not clear about this technically. I'm foggy on this but I think they started the process over 2 decades ago, kind of relinquished it as some point and then began it again around 1997. I could be wrong but I think that's about when the current application started. In any case its been a long, long time for a drug that really helps some very ill people.

 

This is a big deal for CFS. Ampligen has been moved around to five different sections as the FDA has tried to figure out what to do with CFS. We need the FDA to get together with the stakeholders, chart out a path for ME/CFS drugs that get them to the patients as quickly as possible. The FDA says they are willing to do that for disorders with unmet needs and with regards the FDA NONE of the ME/CFSs have been met; there is not one drug or other approved treatment optionThe FDA should recognize that CFS is a priority and do everything it can to get drugs to patients..

Rituximab or another drug like it if the next study results are good may be next.(We should note that the NIH states its a partner for drug approval not an overlord and they should be engaged in the beginning to find ways that Rituximab like drugs can be quickly studied, and if found to be safe given accelerated approval. That gets the drugs out to patients and allows companies to raise money for larger effectiveness trials.

The CAAs Biovista project may very well uncover a suite of drugs that never been tried in ME/CFS. If its does getting the FDA on board now should speed things up there as well.

 

I think everybody might want to consider one more thingI looked at published treatment trials for the first part of this year; 6 CBT/GET type trials and one none CBT/GET trial (Ampligen). CBT has an astonishing hold on treatment trials in CFS that appears to getting stronger over time

Getting drugs for CFS accelerated approval means giving Ampligen a chance and giving drug companies the incentive to create similar drugs. Ampligen and its effects would boost research and Hemispherx would have the money to complete the studies the FDA wants(It doesnt have the $)

 

done! sent my email in. hope others do, too.

 

Thanks for the template.

I sent to everyone on the To and CC email list, both my senators, my congressman and posted only the first paragraph and email addresses on FB so my friends can cut and paste quickly and easily as May 2 is not far away.

I also sent to Al Franken even though I live in Florida due to the fact he is on one of the sub-committees. I have found that sometimes an influx of emails on the day before one needs to make a statement can have a greater impact possibly than even your own state's reps The people on the Sub-committeess have more stake in this endeavor and will need to respond to the public. Also, Al's site asks if you want to follow the results. Yes, I do.

 

done! sent my email in. hope others do, too.

Cool

 

Thanks for the template.

I sent to everyone on the To and CC email list, both my senators, my congressman and posted only the first paragraph and email addresses on FB so my friends can cut and paste quickly and easily as May 2 is not far away.

.

Perfect - love viral messaging...Just think if Ampligen could get conditional approval! That would be amazing. Think how many hundreds if not 1,000's of people could be helped.......Hemispherx will have the money to do their big studies and they'll learn lots about the immune system and that will pave the way for more research and new drugs .......it would be one of the key events in ME/CFS history....maybe even a game-changer.