What happened to the FDA campaign that was just started and aborted?

[RivkaRivka]

== What happened to the FDA campaign that was just started and aborted? ==

This was written by me (Rivka) alone. I am only speaking for myself here.

1) FDA CAMPAIGN

In terms of this December 2010 FDA campaign targeting the Blood Working Group and Blood Products Advisory Committee, organized by Rivka and a 3 other patients who wish to remain anonymous:

What I can say about this, and why the FDA campaign was aborted 7 hours after it was started, is that we are still learning as we go with all this advocacy, including who to target and what to ask for (what to demand). Because not all information is available to us patients, we make calculated decisions on the information that IS available to us. But there may be things we do not know. For example, we are still learning who is on our side and who is not (both individuals and groups).

Just a few hours after publicizing the FDA campaign (making it public, starting it) I was asked by Dr. Judy Mikovits to to stop it. (She has now agreed that I may state this publicly.) Seeking clarification, I was told that our campaign was not helpful (to put it gently) to the work they were feverishing pursuing. We patients who worked on this FDA campaign worked hard on it and had thought it could have a good impact. Believe me when I tell you, we did not want to abort the mission unless we had good reason. And being asked by Judy Mikovits, hero to many of us, to stop it seemed like a darn good reason.

2) NIH CAMPAIGN

Since folks have asked about this campaign, too. Here is my reply...

In terms of the fall 2010 "Time For Action" campaign of a daily email/call/fax to the NIH:

This NIH campaign was stopped a couple of weeks after it started, and only after it yielded some successes, not like the December FDA campaign that was aborted before it really got going.

Personally, I actually do feel we stopped that NIH campaign too early. But there were others in my trio who worked on that campaign with me who attended the CFSAC meeting (I did not) who felt strongly that we should stop it.

There are pros and cons to working with a group, in this case, a trio. One of the pros is that more gets done in a group. And one of the cons is that it can be hard to reach consensus. And sometimes you can't. Yet I still felt it was important to act as a team. So I signed on to the decision to stop that NIH campaign. I regretted the decision immediately after we stopped the campaign, even before the publication went out. I am new at this. I made a mistake. I should have not signed on to that decision and instead should have graciously bowed out of adding my name to that decision. Live and learn. After that decision, I pulled out of working in that trio, as it was clear we had/have different views on advocacy strategies and priorities. I parted from the trio respectfully and amicably.

FINAL THOUGHT
I am learning-as-I-go how to fight for ME/CFS issues. So either I can *not* take any action -- which means not take any risks and thus not make any mistakes -- or I can take action and thus take the risk of making mistakes. I have chosen the latter. So I will likely make more mistakes, but with luck, less and less as I go.

I hope others will join me in taking more risks and doing more actions, including public actions (for those who are able), in putting themselves out there, even at the risk of making mistakes. I mean, nothing will change unless we do just that.

So come on board, everyone, get on the TAKE A RISK train for ME/CFS advocacy and activism. If we all get on board, maybe we can finally get clinical trials, treatments, a vaccine and who knows, maybe a cure!

With great respect for the ME/CFS community,
Rivka

 

[George]

Pissed Puppy

I know most of you will disagree with what I'm about to say, that's no problem, I understand right up front. That said here's my rant, feel free to skip or hit ignore.

I'm pretty pissed right now and want to get this off my chest. First let me say how much I appreciate all the hard work that all of patients do in getting these campaigns off the ground and flying. It's real heroics to crawl out of bed on your hands and knees some days to send an e-mail to let "your" government know what you need. What you need, in order to become, someday, a productive, tax paying, voting, hard working member of the world. Something that has been taken from most of us and that we would walk across hot coals to have back, that we would crawl out of bed and send e-mails for.

So when I hear that it's "not helpful" for these poor smuks to have to deal with the inconvenience of a couple of hundred e-mails a day. My response is BITE ME.

Try having to tie yourself to the stove so you don't wander off and burn your dinner then come and talk to me about "inconvenience". Try not being able to drive, or having to rest for an entire day when you do laundry, or being denied the pleasure of eating toast because of gut problems, then come back and whine to me about having to deal with some e-mails!

The e-mails are such a horrible inconvenience that these people might just have to ***gasp*** use the phone for a couple of days ***horror of horror's***

Or ***WOW*** here's a thought from the brain dead xombie to the hard working terribly inconvenienced people, put a web site on line and talk to your flipping patient population.

That's all we are asking for is the respect of information! But obviously that's "tooooo harrrrdddd".

As for the BS about how hard they are working for us, how they are our friends! I'm not seeing any of this hard work, friendship, transparency, caring about the patient population. All I've seen is a media answer when we've poured on the pressure. I've seen a lot of whiny people with PH.D's who want the patient population to sit down and shut up and wait till they have things in order on their time line and we get to know when the rest of the world get's to know. And as for trust, They are 3 decades late and pile of milk bones short to expect that.

Heck I get this kind of arrogance and disrespect from my own doctor, now I get it from yet more people I pay. What's up with that??? I have to say I'm really tired of giving my money to people who think only about themselves.

As for using Dr. Mikovits as the weapon to shut us up. I'm not surprised. It seems to me like even the WPI has decided to straighten up and fly within the NIH guidelines. Where is all the advocacy the WPI was so engaged in in the beginning? Why did they hire Dr. Donnica and then not use her to help push for the information sharing that was going on in the beginning? It seems to me like the moment Andrea started to get better Annette no longer needed the patient population.

I know you guys think these people are hero's and I understand. I'm sorry but I've never been one to put anyone on a pedestal. Folks are folks they protect their own interest first. The Science paper was a team effort, it was Silvermans discovery, Frank Ruscetti's design, Sandra Ruscetti's assays, Lombardi's lab and Judy was the spokes person. The team did great work but the people are just people and I don't think any of them have my interest at heart. I'll get what I get when it's convenient for them to provided and be grateful that I get anything at all.

But I don't plan to stop "Acting Now" just cause someone tells me too, not even if that someone is Dr. Mikovits.

End of Rant, and you are now returned to your regularly scheduled program.

 

[alice1]

I love what you wrote George.
HIV/AIDS men and women were able to achieve what they did because they had ONE BIG VOICE!!
The sick,the families and friends all said ENOUGH IS ENOUGH!
I've had 3 cancers since being ill and I'm not looking for a 4th.
So,what is going on??

 

[Ernie]

The FDA meeting is for the BWG to report back their findings to see what the next step should be. We can't change whatever these findings may be with e-mails. And that's if they have even completed the study.

 

[George]

Depends are we asking them to change the results? Or are we asking them to communicate with us and not keep us in the dark? Do we get a web cast?? A web site with updates about the things that effect the rest of our lives??? The FDA meeting is for the FDA to make a choice based on "RECOMMEDATIONS" of patients, BWG, and Scientist currently working in this field to determine if

1-XMRV is a threat to the blood supply
2-People with Prostate Cancer and/or ME/CFS pose a threat to the blood supply

My bitch isn't with the process. I'm tired of these people whining about how an e-mail campaign inconveniences them. People who can still work, still shop and buy things that they want, eat what they want, people who have a working brain are inconvenienced because they are too lazy to set up a system to talk to the patient community and let us know what's going on. People who have placed the patient community in the position of needing to do e-mail campaign's and take out ad's with their own money, time and energy as well issue press releases because these same people want to keep things on the low down, god forbid the public find out about it before they are ready for a press release ***GASP***

So sorry, I do have a really bad attitude about the entire mess. Using Dr. Mikovits to stop the campaign's is just dirty fighting in my view and while I understand she has a career of working on this to think about I'm not please that she caved to the request. Considering the Patient community would lay down on broken glass so that her sole of her shoes would not have to become dirty.

We can sit back and wait like good girls and boys or we can demand to be treated with respect, dignity and transparency. I deserve all three.

 

[floydguy]

Depends are we asking them to change the results? Or are we asking them to communicate with us and not keep us in the dark? Do we get a web cast?? A web site with updates about the things that effect the rest of our lives??? The FDA meeting is for the FDA to make a choice based on "RECOMMEDATIONS" of patients, BWG, and Scientist currently working in this field to determine if

1-XMRV is a threat to the blood supply
2-People with Prostate Cancer and/or ME/CFS pose a threat to the blood supply

My bitch isn't with the process. I'm tired of these people whining about how an e-mail campaign inconveniences them. People who can still work, still shop and buy things that they want, eat what they want, people who have a working brain are inconvenienced because they are too lazy to set up a system to talk to the patient community and let us know what's going on. People who have placed the patient community in the position of needing to do e-mail campaign's and take out ad's with their own money, time and energy as well issue press releases because these same people want to keep things on the low down, god forbid the public find out about it before they are ready for a press release ***GASP***

So sorry, I do have a really bad attitude about the entire mess. Using Dr. Mikovits to stop the campaign's is just dirty fighting in my view and while I understand she has a career of working on this to think about I'm not please that she caved to the request. Considering the Patient community would lay down on broken glass so that her sole of her shoes would not have to become dirty.

We can sit back and wait like good girls and boys or we can demand to be treated with respect, dignity and transparency. I deserve all three.

Yes, information is very, very thin. I think things will and should get very ugly if there isn't some good information next week. It's too bad that if Dr. Mikovits is allowing her name to be used to encourage a cease and desist, she isn't providing more info as to why now is not the time to put pressure on.

 

[Ernie]

How can the FDA do anything at this point when they don't have the results yet from the BWG. That is what this meeting is for. Dr. Lo is also from the FDA and is presenting at this meeting. The FDA has never webcast these meetings. They are taped and then a CD can be purchased later like the last meeting. Maybe just maybe Dr. Mikovits doesn't want the patients to exhaust themselves because they can confirm "again" and prove that XMRV and MLV's do exist and are a possible threat to the blood supply. Dr. Hansen is also presenter.

 

[RivkaRivka]

i understand george's anger, i really do. more later. i'm really exhausted and beat and fried and wacked out and and and and

 

[CBS]

Hey George,

Nothing wrong with a little bit of scrutiny and sunlight (pressure!) to keep folks honest and moving forward. As a patient community the one thing we can inject is a sense of urgency (and in government speak that means resources - $).

I hear your frustration and second it.

"Sunlight is said to be the best of disinfectants (now shut up and do something!*)." - Louis D. Brandeis

* my edit

 

[Ernie]

I think the fight would be better directed at getting ME/CFS put back into NIAID and to target the NIH to get research grants approved. That is where the hold up is. How many XMRV or MLV research grants have you seen approved for anyone?

 

[Sean]

It seems to me like even the WPI has decided to straighten up and fly within the NIH guidelines.

WPI is really only after one thing right now. Getting mainstream medical science to properly test the XMRV-CFS link. Which is what is happening at the moment, so there is no need for WPI to rock the boat, for now at least.

Serious funding can only come from the NIH. If WPI want NIH money - and they sure need it - then they can't piss the NIH off too much.

I believe right now is a time to be giving XMRV researchers a little breathing space. This is new science, and new science never unfolds nice and neatly at the best of times. The XMRV question is not going to be resolved overnight. Being constantly on the backs of the researchers is not going to help our cause. They already have plenty of technical and political problems to deal with.

If Mikovits is asking patients to cool it on the email campaign, I think we should pay heed.

 

[urbantravels]

I'm willing to reserve judgment until we hear whatever we're going to hear next week.

And there is one type of contact we should ALL be making without any fear that we're 'bothering' them - our ELECTED REPRESENTATIVES. Whose job it is to hear and directly respond to our complaints and issues, and who are charged with allocating funds to the NIH and other public agencies. Those are OUR dollars, US citizens, that they're spending (or failing to spend) to protect the public health.

 

[Sean]

Agree with that, UT. The political class are fair game for sustained campaigns.

 

[Recovery Soon]

when I hear that it's "not helpful" for these poor smuks to have to deal with the inconvenience of a couple of hundred e-mails a day. My response is BITE ME.

I didn't necessarily agree with every single point in this post. But God that's funny.

 

[WillowJ]

I think the fight would be better directed at getting ME/CFS put back into NIAID and to target the NIH to get research grants approved. That is where the hold up is. How many XMRV or MLV research grants have you seen approved for anyone?

Very good point.

WPI is really only after one thing right now. Getting mainstream medical science to properly test the XMRV-CFS link. Which is what is happening at the moment, so there is no need for WPI to rock the boat, for now at least.

Serious funding can only come from the NIH. If WPI want NIH money - and they sure need it - then they can't piss the NIH off too much.

I believe right now is a time to be giving XMRV researchers a little breathing space. This is new science, and new science never unfolds nice and neatly at the best of times. The XMRV question is not going to be resolved overnight. Being constantly on the backs of the researchers is not going to help our cause. They already have plenty of technical and political problems to deal with.

If Mikovits is asking patients to cool it on the email campaign, I think we should pay heed.

True, that (the italics, especially; having studied science myself I can attest to that).

I'm willing to reserve judgment until we hear whatever we're going to hear next week.

And there is one type of contact we should ALL be making without any fear that we're 'bothering' them - our ELECTED REPRESENTATIVES. Whose job it is to hear and directly respond to our complaints and issues, and who are charged with allocating funds to the NIH and other public agencies. Those are OUR dollars, US citizens, that they're spending (or failing to spend) to protect the public health.

Yes! They really do need to be putting more oversight into this! Send them MCWPA's press release with the ad, and CAA's statement on how the CDC has been spending its money lately, and whatever other documents and research studies you have handy (feel free to send me a PM with your email if you need help with this).

the press release (link to ad on page)
http://www.prnewswire.com/news-rele...ever-ad-in-the-washington-post-111363234.html

CAA's statement on how the CDC chooses to use scarce money:
http://www.cfids.org/pdf/response-110810-study.pdf
(even if you don't happen to like CAA, this is a pretty good response and will look impressive to your legislators, coming from "the Department of Health and Human Services CFS Advisory Committee" and making several very good arguments against the CDC's tactics)

If you can, make a phone call, or send a fax or postal letter to your representatives rather than using email (email is counted as a less serious form of contact to them), or use the "get help with a federal agency" link on your representative's page.

 

[WillowJ]

here is my response to the OP:

Thanks, Rikva, very much, for the post and for being one to think of these actions.

I agreed with the decision to stop lobbying NIH, for now, because all that was doing was to flood Mangan's inbox and he was already paying attention (new name, new-- presumably science-based--website under development; the name [without a definition change and without dropping CFS] is a token but the website has huge potential to reach physicians and change how we are viewed and treated by them).

However, I think we should continue that campaign at HHS and CDC, as well as the Senate. Just cut out NIH, or change to other NIH officials to people who aren't Mangan's direct supervisors who think they've done their part by forwarding emails to Mangan. We need someone to increase funding, and I think NIH is responsible for that.

And we need radical change at the CDC. HHS and Senate should effect that if CDC is unwilling or unable to do this themselves.

And we need either a lawsuit or congressional hearings to expose the malfeasance so that this injustice ends here, now. Epilepsy, multiple sclerosis, autism, myalgic encephalomyelitis, chronic lyme... how many others?

 

[Roy S]

i'm really exhausted and beat and fried and wacked out and and and and

been there. done that. rest rest, RivkaRivka

 

[Tuha]

Rivka, greeting from the other side of the ocean. I think what you do is great. There will be always a lot of opinions how to do advocacy but without people like you we will never move forward. I share your opinion - I think advocacy has to be strong, sometimes we can also do a lot of mistakes but how you say its also because of the lack of the informations whats going behind the scene. So please continue to do your advocacy - you have great ideas, you are able to coordinate other patients and the patients follow your campaigns. not so many people have these competences - so we need everyone.

to do advocacy it doesnt mean to be nice - if we will be nice we will never get attention - so I think its good to hear that they are annoyed of our mails - good sign. but without continuing these campaigns - they will forget their promisses soon. We cannot be glad from the promisses - we have to check the results. I ask - did we see an increase of cfs funding, did we get more informations - I think the answer is "no" - so we cannot stop the campaigns just because of some "cheap" promisses. we are too weak to do demonstrations - so these email campaigns are the only way how to get attention.

I also think that in WPI they found out that if they will continue to do the advocacy - they will have a lot of problems with funding from federal grants. But I think its ok if they will not do advocacy - they are researchers. its the patients time to do more advocacy.

george, i understand your feelings and I think in a short time we will see if our advocacy was efficace.

 

[Merry]

Letters I've written to Kathleen Sibelius and Francis Collins have been passed on to Dennis Mangan. Dr. Mangan strikes me as a conscientious public servant who is genuinely sympathetic to ME/CFS patients. I've been satisfied with his responses and for the time being don't see a reason to write to him or anyone else at HHS or NIH.

urbantravel's suggestion to keep writing to elected representatives is a good one.

 

[WillowJ]

Merry,

So you're saying everyone at HHS and NIH is passing the buck to Mangan? Right up to the Cabinet? I like Mangan and I agree with you that he seems genuine and conscientious. I just wasn't sure his upline was conscientious or genuine. (Mangan doesn't have the power to do certain things that they should be doing, like change the definition and increase funding, and simply passing all their letters to Mangan doesn't remove from them the obligation to do these sorts of things. However if they are thoughtless enough to think they are doing their part by passing all their letters to Mangan, I'm not sure what we can do to change their minds except continue to lobby Congress and try to engage the media.)

I do think the new website is a serious result and until it's online for evaluation, we shouldn't pester Mangan (or pester anyone who will redirect all the letters to Magan) or think we haven't been heard. The website has tremendous potential to influence and educate physicians (as well as social services, the media, and the public in general), which is one of our key goals.

Speaking of Dr. Mangan, has his email changed? I emailed him and didn't hear back. (Just because I'm not in favor of pestering him frequently doesn't mean we shouldn't email him on occasion about new problems we encounter as we try to get appropriate medical care, or other concerns that come up from time to time.) This is uncharacteristic for him. I thought he was just gone for Thanksgiving but I still didn't hear back. Does anyone know his current email?

Willow