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

 

Thanks Cort.

 

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 agree with "justinreilly" as it may ruffle the right feathers. I don't think it still hurts to reming them os of the massive funding that was stolen fron CFS researh years ago age had that not not happened there very well may not be 4 million people walking around in the US with this disease, there may not be 10 million walking around (i'm geussing at numbers here) the world with a disease that has not been proven that is not contagious. Also, out of the 4 million in US and 10 million worldwide approxiamately 20% of these are disabled (again , I do not know these numbers), which accounts for an enormous amount of money.

If even a cause and, especially if a cure may have been discovered due the enormous amount of funds had not ben squandered in the earlier years. Most of the disabled are bed-bound or at least house-bound and the financial burden imposed on society is astronomical in these times of economic turmoil. I feel very positive the perecent of disability cases that are being approved are increasing substancially with new test being developed proving their disability status will only continue to devaste the economical status of these programs at a time when they are struggling.

If God would bless us with a cure through the hands of the researchers that are devoted to bringing and end to this horrible disease, while some archaic doctors and researchers who wish to ignore their oath of office, but instead they bow down to the money of the pharmaceutical and insurance industry. We can still stand so that approriate funding will be provided so that treaments can be developed which may help some and maybe all of the disabled people of this disease become members of society and help it prosper again and contribute to the well being of the economy, instead of hurting it as we have in the past. The financial impact of this disease alone is staggering to the sum of (somebody could probably fill in this amount closely) annually. I doubt these numbers include people with CFS, such as myself that have had to live on food stamps for years and medicaid, while waiting for Social Security Disability comes through if and when it does, but my doctor will not give me clearance to return to to work due to the high probability of hurting someone and inability to concentrate adequately to perform any job. Medicaid, food stamps, Family Indepependance cost the country more than Social Security does bacause of the amount of people employeed to administer these programs.

As time goes on the chance of CFS becoming contagious could become greater. We just don't know! I beleive history is bearing this out that CFS and/or it's subsets are becoming more prevalent in society, just as Autism is!!

 

Here was my email...

My name is Cort Johnson and I'm writing you to request that the FDA hold a Stakeholder meeting to discuss treatments opportunities for Chronic Fatigue Syndrome (also called Myalgic Encephalomyelitis or ME/CFS).

CFS is costly both to the families of those who have it and to the country in the terms of the high economic losses (estimated at @20 billions a year) yet those patients needs have been almost completely ignored; there are validated treatment options and precious little research ($6/year per patient.) An A student in college, I've had CFS for over thirty years and regularly saw physicians until my reduced income made that impossible for the last 20 years.

The FDA can assist patients in the getting the treatments they need by meeting with stakeholders to produce results, yet CFS 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 a decade.

This disorder demands real and significant action today. I request that FDA hold a Stakeholder meeting, including Dr.Woodcock, Dr. Lee, expert ME/CFS clinicians, patients, product sponsor and other key stakeholders, to explore opportunities to accelerate approval of treatments. Approval of a drug is critical to changing the face of this disease.

Robert Miller, a ME/CFS patient/advocate, will contact you in two weeks to confirm scheduling of this meeting.

As patients and family, we cannot allow our lives to be destroyed any longer. This meeting must happen to advance science for all ME/CFS patients!

Sincerely,

Cort Johnson
1657 Rockcrest Hills Ave.
Las Vegas, NV 89052

292 341 7536

 

Remember one email a day until May 2nd when Bob will meet with them to discuss a meeting...

 

I just sent my letters. Thank you so much for having all the info ready for us and making this very easy!

 

Question :

Is there anyway to include ones senators and congressperson, w/o filling out a form on their website ? thanks

 

Question :

Is there anyway to include ones senators and congressperson, w/o filling out a form on their website ? thanks

Beaker,
Not that I know of unless you happen to know their email addresses or the address of one of their aides. Unfortunately, I've never seen a list online anywhere of their email addresses.

Thank you for sending a letter!

 

Thank you Justin, But

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."

Thank you Justin, But we need emails sent Daily. Please send the same email by clicking on reply to all and erase your email address in the To: Box, DHHS is telling patients to STOP sending emails, which means we are accomplishing our Goal...To get their attention to ACT and set up a meeting. Please spread the word to keep sending emails Daily thru May 2nd.

Thank you Again,

Robert Miller

 

Done. Have emailed and will send again tomorrow. sorry I wasn't able to do it sooner. Thanks for doing this....

 

ps I live in the UK, but sent it when I read you think it would be worthwhile for non American citizens to also e mail

 

This was my latest:

Keep emailing!

My name is Cort Johnson.

Federal studies suggest that Chronic fatigue syndrome costs the US economy approximately 20 billion dollars a year...yet the NIH spends less than $6 million dollars a year on it and there are no federally approved drugs. One drug, Ampligen, produced by a small company has been in the FDA's pipeline for 15 years. The FDA must take notice of the million Americans with this disorder and produce a stakeholders meeting that results in accelerated drug approval for CFS drugs.

I personally know of people who's lives have been saved by that drug and the FDA recently approved a drug, Benylstra, which was not better than placebo after a long term trial but which did markedly help a subset of the patients. Why? Because lupus has not had a drug approved for it in over 50 years...Well CFS has never had a drug approved for it. Its time for the federal government to recognize that a million ill Americans do deserve adequate research as well as treatment options..

I request that FDA hold a Stakeholder meeting, including Dr.Woodcock, Dr. Lee, expert ME/CFS clinicians, patients, product sponsor and other key stakeholders, to explore opportunities to accelerate approval of treatments. Approval of a drug is critical to changing the face of this disease.

Robert Miller, a ME/CFS patient/advocate, will contact you in two weeks to confirm scheduling of this meeting.

As patients and family, we cannot allow our lives to be destroyed any longer. This meeting must happen to advance science for all ME/CFS patients!

Sincerely,

Cort Johnson
1657 Rockcrest Hills Avenue
Henderson, NV, 89052

 

A reminder to send letters for the FDA Call To Action by tomorrow!

Have you already sent your letter to Secretary of Health Kathleen Sebelius asking for a meeting for ME/CFS to push the FDA to approve new drugs for ME/CFS?

If yes, YEAH! If not, remember - INTENSE LOBBYING is how AIDS/HIV got put on the government's map. AIDS/HIV now gets $3 BILLION a year for research from the NIH (National Institutes of Health); CFS gets $6 million. AIDS/HIV sufferers now have multiple drugs to fight the disease. We have none. Dr. Nancy Klimas has said, "...My HIV patients for the most part are hale and hearty thanks to three decades of intense and excellent research and billions of dollars invested. Many of my CFS patients, on the other hand, are terribly ill and unable to work or participate in the care of their families. I split my clinical time between the two illnesses, and I can tell you, if I had to choose between the two illnesses, I would rather have HIV...." (NYTimes, 10/15/09)

WE MUST STAND UP FOR OURSELVES, and ask our family and friends to do the same, or our situation will NEVER change. Please write. It is only by inundating these government officials with letters that we will get any action to research and approve treatments. Many other, much lesser-impact diseases get FDA approvals for drugs. We must insist that we be listened to!

IF YOU HAVE NOT SENT IN A LETTER YET, PLEASE DO SO NOW. It is not too late. Please send in your letter and ask your relatives and friends to do the same - ideally by the end of the day tomorrow (May 2) if possible but otherwise as soon as you can. The letter, email addresses and instructions can be found on Co-Cure and Phoenix Rising

Thank you to everyone for calling for Secretary Sebelius and Dr. Hamburg to hold this meeting!

 

Chronic fatigue syndrome is probably the only large disorder in the US without a single medical treatment approved for it. Dr. Woodcock at the FDA has said she is committed to examining treatments for the chronically ill where few or no treatments exist.

Here's one FDA response: Fatigue supplements are actually misbranded drugs: FDA (http://www.chicagotribune.com/featu...ts-illegal-drugs-fda-20120504,0,5706746.story).