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Action alert: Bob Miller calls for email campaign to request hearing on Ampligen

Sasha

Fine, thank you
Messages
17,863
Location
UK
As we all know, the IOM and P2P reports, and the Hornig/Lipkin cytokine paper, give us weapons with which to press for funding, treatment, and respect for our long-neglected disease.

On Health Rising, Bob Miller has made the first call to action off the back of these important events. He's calling for mass action to pressure the government on Ampligen. This is an advocacy action that has been in the pipeline for a while and is now ready to go.

Bob says that another advocacy campaign - to pressure the NIH for more research funding off the back of these important events - will begin soon.

Here are details of how to take part in the Ampligen campaign. I've impertinently given Bob's instructions a light edit and have broken up the text for ease of reading.

Bob Miller on Health Rising said:
To all ME/CFS/SEID patients, family and friends,

As most patients know, the IOM and NIH P2P have released some positive findings in our disease. While there is debate about the new name, SEID, there is no debate at all that we need treatments.

(From the recent Hornig et al. study: “If replicated in longitudinal studies, these data may provide a basis for early immuno-modulatory intervention to prevent long-term, recalcitrant illness”. In fact we already have an immuno-modulatory drug that’s proven to help with ME/CFS: it’s called Ampligen.)

The FDA admitted prior to and during the Advisory Committee meeting for the approval of Ampligen, that they did not fully understand this disease. They have agreed that it is a serious disease – but they’re not treating it like one.

Consider:
(1) that the FDA Advisory Committee voted 8 to 5 that Ampligen is safe for this patient population;
(2) that the FDA has stated it has no safety concerns regarding Ampligen;
(3) that the FDA has stated ME/CFS is a serious disease and that ME/CFS patients urgently need treatment options;
(4) that two recent federally funded reports (IOM and P2P) underscore the immense need for treatment options for the million Americans with this disease; and
(5) that the FDA has done nothing to alleviate the suffering of people with ME/CFS … but it could.

It’s clear that Ampligen presents minimal risks and large potential rewards for a large, drastically underserved community.

The recent IOM Report from the National Academy of Sciences and the NIH’s P2P findings give us our best opportunity yet to push for FDA approval of Ampligen. That‘s why we are asking patients, family and friends to email the below request to our representatives in Washington DC and at the Department of Health and Human Services (DHHS).

This is step one of many to finally get a treatment approved for ME/CFS. With approval will come insurance coverage for all, and more treatments as other companies see the potential for profits.

There is a template email below to follow if needed and you can copy and paste for ease. It is only a template or guide; use your own voice and let your voice be heard. Please send in your email ASAP.

Thank you for taking action for yourself and for those unable to do so.

Kindly,
The FDA Action Team

Instructions
Please cut and paste these addresses (for staff of Congress members, and for Dr. Woodcock at the FDA and Dr. Lee at the HHS) into your email "TO" box: monica.volante@mail.house.gov; sarah.curtis@mail.house.gov; Elizabeth.brown@mail.house.gov; dennis.sills@mail.house.gov; mark.ratner@mail.house.gov; james.paluskiewicz@mail.house.gov; scott.dziengelski@mail.house.gov; thomas.power@mail.house.gov ; janet.woodcock@fda.hhs.gov; Nancy.Lee@hhs.gov

Cut and paste into the SUBJECT LINE: Hearing request for treatment denial

Cut and paste into the EMAIL MESSAGE:

To: The Honorable Congressman Joseph Pitts Chairman, Energy and Commerce, Subcommittee on Health
To: Representatives Reid, Kennedy, Castor, Butterfield, Upton, Burgess, Murphy, Bilirakis
Cc: Janet Woodcock, Director, Center for Drug Evaluation and Research, Nancy Lee HHS

REQUEST: A hearing/adjudication to examine the failure to provide treatment that has the potential to positively impact 40% of the population living with ME/CFS.

You may have recently seen the report issued by the Institute of Medicine (Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness, 2015) which stated that Chronic Fatigue Syndrome is a legitimate disease that needs diagnosis and treatment.

We have been calling on the government for decades to support ME/CFS. While we are grateful for the IOM report, until the spirit of the report is acted on – and approved treatments exist – the report is simply more words to a community that has been hearing nothing but words for decades. Until approved treatments for ME/CFS exist, the million people with ME/CFS will continue to suffer – many of them needlessly.

We, therefore, request that you call a hearing to examine a treatment that has shown promise for 20 years. Experts agree that between 20-40% of patients see improvement and without a doubt it would open the gate for greatly needed biomedical research and innovation.

Your oversight powers enable you to ensure that drugs receive a just and fair review based on an appropriate risk-benefit assessment. We don’t believe this has happened with Ampligen and we’re not surprised, given the FDA’s public statement that they do not understand this disease.

We therefore ask that you bring experts in who do understand this disorder, in order to conduct an open and objective hearing on the pro’s and cons of Ampligen approval for ME/CFS.

Cost Estimates: Using ME/CFS prevalence data of 0.42% and indirect cost estimates from Reynolds et al. (2004), the direct and indirect cost of ME/CFS to society in the US is estimated to be $18,677,912,000 for the community sample and $23,972,300,000 for the tertiary sample. These findings indicate that ME/CFS imposes substantial economic costs to the US economy, that many are suffering and all deserve to have valid treatment options.

NIH currently spends $5 million annually on a disease that costs the US economy over 20 billion dollars a year.

Sincerely,
Your name HERE
Number of years of life lost to CFS HERE
 

Jonathan Edwards

"Gibberish"
Messages
5,256
Dear Sasha,
This is an interesting proposal. Let me be devil's advocate, though.

One complaint is that the FDA admitted it did not fully understand this disease. So that makes quite a few of us - is this really a helpful introduction - seems not to me.

The proposer says that approval would bring 'insurance coverage for all'. I found a blog that said that the cost of ampligen at their clinic was $2000 per month. So if a million Americans took ampligen that would cost $24 billion straight off. Is this the best way to spend the notional cost (almost to the penny) of ME? There would be nothing left for research.

It seems that ampligen is fairly safe but what I am unclear about is convincing evidence of efficacy. For me that would be clinched by a double blind RCT of at least three doses so that we knew we had roughly the right dose, rather than maybe four times the right dose or a quarter the right dose. That is basic testing if you are thinking cost-effectiveness. Do we have anything of that sort?

If we do not have anything of that sort then maybe what PWME should be pressing for is not a reimbursement cheque for $24 billion but a government run trial of the sort above, which ought to cost about $2.4 million - one ten thousandth of the cost of approval without proper testing.

The problem we have in the UK is that the government simply does not see it as its job to test drugs owned by commercial interests. NICE is not interested in whether a drug works, only in whether a company has shown convincingly that it does. This was a big problem for RA treatments. If ampligen is coming out of patent maybe things could be easier. And if so maybe what PWME should be petitioning for is a decent trial of ampligen rather than spending ten thousand times as much money on something that might not work after all or which might work at a quarter the recommended dose.

Edit: actually over ten years it would be a hundred thousand times as much - isn't this bonkers?
 
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A.B.

Senior Member
Messages
3,780
Isn't the point of Ampligen to increase NK cell function? Aren't there cheaper alternatives to do a proper trial with? Nancy Klimas mentioned Immunovir.
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
Only too happy for devil's advocates to discuss this whole issue, @Jonathan Edwards!

There's quite a history to this Ampligen question, which is not included in Bob's article, but my understanding is that the US govt is legally prevented from running a trial because of Ampligen's legal status (can't remember the issue) and its parent company, Hemispherx, can't afford to trial it further than it already has.
 

Jonathan Edwards

"Gibberish"
Messages
5,256
Only too happy for devil's advocates to discuss this whole issue, @Jonathan Edwards!

There's quite a history to this Ampligen question, which is not included in Bob's article, but my understanding is that the US govt is legally prevented from running a trial because of Ampligen's legal status (can't remember the issue) and its parent company, Hemispherx, can't afford to trial it further than it already has.

I guess that shows just how dumb capitalism is?
 

Kati

Patient in training
Messages
5,497
Dear Sasha,
This is an interesting proposal. Let me be devil's advocate, though.

One complaint is that the FDA admitted it did not fully understand this disease. So that makes quite a few of us - is this really a helpful introduction - seems not to me.

The proposer says that approval would bring 'insurance coverage for all'. I found a blog that said that the cost of ampligen at their clinic was $2000 per month. So if a million Americans took ampligen that would cost $24 billion straight off. Is this the best way to spend the notional cost (almost to the penny) of ME? There would be nothing left for research.

It seems that ampligen is fairly safe but what I am unclear about is convincing evidence of efficacy. For me that would be clinched by a double blind RCT of at least three doses so that we knew we had roughly the right dose, rather than maybe four times the right dose or a quarter the right dose. That is basic testing if you are thinking cost-effectiveness. Do we have anything of that sort?

If we do not have anything of that sort then maybe what PWME should be pressing for is not a reimbursement cheque for $24 billion but a government run trial of the sort above, which ought to cost about $2.4 million - one ten thousandth of the cost of approval without proper testing.

The problem we have in the UK is that the government simply does not see it as its job to test drugs owned by commercial interests. NICE is not interested in whether a drug works, only in whether a company has shown convincingly that it does. This was a big problem for RA treatments. If ampligen is coming out of patent maybe things could be easier. And if so maybe what PWME should be petitioning for is a decent trial of ampligen rather than spending ten thousand times as much money on something that might not work after all or which might work at a quarter the recommended dose.

Edit: actually over ten years it would be a hundred thousand times as much - isn't this bonkers?
On one side we have many patients who say that Ampligen works for them and should they be refused access to it they would be confined to their house or their bed.

And on the other hand we have the FDA which has a responsibility to the public for safety of drugs one the market. Safety in this case was not deemed the problem. Efficacy was the problem, due to the the fact that it is difficult to have end points.

The problem that many patients find is the double standard that FDA seems to have, when riskier drugs for other diseases are approved and fast-tracked but Ampligen has been stuck in phase 3 for 2 long decades.

Patients need and deserve a few lines of treatments. We know that it would be really rare that a drug is 100% effective on everyone. However if 25% of us respond to Ampligen and another 25% to Rituximab and 50% to Valcyte or other antivirals, we then already have 3 options for treatments. Giving patient hope in an era where many have given up and taken their own lives should be made a priority.
 
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Jonathan Edwards

"Gibberish"
Messages
5,256
Isn't the point of Ampligen to increase NK cell function? Aren't there cheaper alternatives to do a proper trial with? Nancy Klimas mentioned Immunovir.

If people think ampligen helps I suspect that is a more useful starting point than any theory about why it might work. Lots of drugs that work turn out to work for unexpected reasons. If the idea is that ampligen ought to be available if it works then $2 million would probably be justified.
 

Kati

Patient in training
Messages
5,497
If people think ampligen helps I suspect that is a more useful starting point than any theory about why it might work. Lots of drugs that work turn out to work for unexpected reasons. If the idea is that ampligen ought to be available if it works then $2 million would probably be justified.
i think one of the reasons why Dr Peterson is so successful with Ampligen is because he handpicks his patients, on what criterias I don't know.
 

oceiv

Senior Member
Messages
259
I agree with @Kati's assessment of the Ampligen situation. In addition IMHO, if this medication has helped 25% of ME/CFS patients, it should be made available. There was a recent study on Ampligen. It gives some updated info on Ampligen. The FDA is slow-walking Ampligen because it and other agencies still don't believe this disease is real, not because of efficacy or safety.

The proposer says that approval would bring 'insurance coverage for all'. I found a blog that said that the cost of ampligen at their clinic was $2000 per month. So if a million Americans took ampligen that would cost $24 billion straight off. Is this the best way to spend the notional cost (almost to the penny) of ME? There would be nothing left for research.


If we do not have anything of that sort then maybe what PWME should be pressing for is not a reimbursement cheque for $24 billion but a government run trial of the sort above, which ought to cost about $2.4 million - one ten thousandth of the cost of approval without proper testing.

The problem we have in the UK is that the government simply does not see it as its job to test drugs owned by commercial interests. NICE is not interested in whether a drug works, only in whether a company has shown convincingly that it does. This was a big problem for RA treatments. If ampligen is coming out of patent maybe things could be easier. And if so maybe what PWME should be petitioning for is a decent trial of ampligen rather than spending ten thousand times as much money on something that might not work after all or which might work at a quarter the recommended dose.

Edit: actually over ten years it would be a hundred thousand times as much - isn't this bonkers?

@Jonathan Edwards It is bonkers. The cost calculations for what Ampligen coverage would cost the U.S. government are different than calculations for a country with universal, government-provided healthcare. Most U.S. citizens who have medical insurance get their insurance from private, non-governmental insurance companies. These private insurers are allowed to negotiate for better prices for their customers on any given medication, treatment, doctor service or procedure. Therefore, an MRI, for example, can cost anywhere from under $1000 to thousands of dollars depending on your insurer. The same type of wide price variations exists with medications. Depending on how good a person's coverage is, the insured person could have to pay none, some or all of that negotiated price.

Unfortunately, by law, the government can't negotiate prices on any medications. The drug lobbies have been very successful in protecting their high profits. Many medications cost more for the government than they do for private insurers. I don't know the percentages on how many ME/CFS patients are insured vs. uninsured. But for the uninsured patients, the Ampligen costs would be born solely by the patients, not the government. Many other Americans are underinsured (often in what's called "catastrophic coverage plans."). These people would probably also bear the whole Ampligen cost. More on U.S. health insurance coverage.

But, even though the U.S. government would not bear all of the Ampligen costs were it to be approved, the U.S. government would bear many of the costs of patients who would be well on Ampligen, but are completely disabled without it. From loss in tax revenue to loss from SSA disability to medicare and medicaid costs.
 
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Jonathan Edwards

"Gibberish"
Messages
5,256
On one side we have many patients who say that Ampligen works for them and should they be refused access to it they would be confined to their house or their bed.

And on the other hand we have the FDA which has a responsibility to the public for safety of drugs one the market. Safety in this case was not deemed the problem. Efficacy was the problem, due to the the fact that it is difficult to have end points.

The problem that many patients find is the double standard that FDA seems to have, when riskier drugs for other diseases are approved and fast-tracked but Ampligen has been stuck in phase 3 for 2 long decades.

Patients need and deserve a few lines of treatments. We know that it would be really rare that a drug is 100% effective on everyone. However if 25% of us respond to Ampligen and another 25% to Rituximab and 50% to Valcyte or other antivirals, we then already have 3 options for treatments. Giving patient hope in an era where many have given up and taken their own lives should be made a priority.

Dear Kati,
I agree that giving people hope is crucial but I have yet to be convinced that the FDA is applying double standards. I am quite convinced that ME has a biological basis and needs higher priority so by being 'devil's advocate' I guess I am saying that if you want to convince the FDA then try to convince me first, because it should be easier.

The role of a medical control agency like FDA is presumably more complicated than just safety. I do not know their charter but I suspect that part of their role is to adjudicate on whether or not claims of efficacy are reasonable. I see that as a bit like the old Trade Descriptions Act which says that you cannot sell something and claim it does something unless you can show that it does. It is easy to get your money back on a microwave oven that does not cook but health care is more complex - you may not have the chance to go back and try the thing that did actually work - so most countries have a system for evaluating claims of efficacy.

And as far as I can see this is in practice what this is about. People can get ampligen but approval from the FDA would change things in terms of reimbursement from insurance companies. Insurance companies get their money from ordinary people so effectively the FDA is saying 'We are not convinced that every man woman and child in the USA should pay another $100 on their health insurance so that people can get free ampligen because it may not work. If we approved drugs like this without good evidence of efficacy then the same would apply for another nine common diseases and everyone's bill would go up $1000.)

I agree that the US health insurance system is different from that in the UK but it is largely a matter of how it is administered. It is ordinary people that pay - in the UK into a state run insurance system. Politicians get voted in or out according to whether they manage health insurance sensibly - whether in terms of value for money for tax or what you have to pay to get private health insurance.

So the bottom line is that approval means that the ordinary US citizen should foot the bill. Would PWME be happy to pay another $900 a year for drugs for the other nine common diseases that might not work?

I had a close look at the study the ampligen people quote a while back. My impression was that the results are presented in a form that is hard to interpret. They say there is a 21% improvement in activity but the bare figures suggest it is 10% and that does not seem very much. To my mind this sort of average figure is not what is wanted. We want some sort of figure indicating how many people were usefully better in each group - a bit like the Haukeland study. I fully appreciate the problem of outcome assessment for trials but if a study is properly blinded I think there are ways of assessing useful improvement that ought to stand up.

So I would go with the FDA at present. And I would come back to the point that there should be a minimum dose (dose response) assessment. Otherwise people may be paying for four times as much drug as in needed. We actually have that problem for rituximab because nobody insisted on a minimum dose assessment. Work on a similar drug suggests that minimum effective dose may be somewhere between 100 and 1000 mg per infusion but we may well be spending twice as much on rituximab as is needed (as someone flagged up in a study somewhere else).

The real problem seems to be the crazy rules designed to protect private commercial interests. I personally do not think there should be such things as patents in health care products. When you see the money wasted on company premises and parties in Hawaii it makes you weep.
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
Is there a way to get more info on The FDA Action Team and/or to contact them?

Hi oceiv - Bob Miller has a Facebook page:

https://www.facebook.com/HungerStrikeForAmpligen

The title refers to the fact that he went on hunger strike at one point to put pressure on the FDA to approve Ampligen - a very distressing thing to see...

Cort Johnson may be able to put you in more direct touch with him, and you can contact Cort via Health Rising:

http://www.cortjohnson.org/contact-us/
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
if you want to convince the FDA then try to convince me first, because it should be easier.

Once again, thanks for engaging in this kind of discussion! We need these things thought through critically.

People can get ampligen but approval from the FDA would change things in terms of reimbursement from insurance companies.

That's just it - my understanding is that people can't get Ampligen unless they're in some weird scheme. Bob Miller was getting it because his doctor was in that special scheme with Hemisperx - he had to move himself and his whole family so he could be near to that doctor to get the infusions administered. I'm not sure if that scheme was stopped - if my memory serves, the clinicians were getting Ampligen under some special arrangement to do with research. I wonder if it was to provide safety data or something.

Insurance companies get their money from ordinary people so effectively the FDA is saying 'We are not convinced that every man woman and child in the USA should pay another $100 on their health insurance so that people can get free ampligen because it may not work. If we approved drugs like this without good evidence of efficacy then the same would apply for another nine common diseases and everyone's bill would go up $1000.)

Bob (and Cort, I think) claim that the FDA is approving drugs with a similar safety/efficacy state of evidence as Ampligen for other conditions; there certainly seems to be a lot of weirdness about how the FDA do things and my understanding is that the FDA is seen by many in the US as being in the pharma industry's pocket.

So the bottom line is that approval means that the ordinary US citizen should foot the bill. Would PWME be happy to pay another $900 a year for drugs for the other nine common diseases that might not work?

I'm not sure about your cost calculations on this. An estimated 90% of US PWME don't have a diagnosis, so we're only talking about 100,000 patients at this point (though that could change if the IoM recommendations are rolled out); not all doctors are going to prescribe it; and it may become apparent quite quickly what subset of patients benefit. So the real figure could be more like $50/year maximum; and one would hope that some patients would do so well on Ampligen that they wouldn't need to stay on it.

In terms of whether I'd be happy to pay $X (whatever X is) for drugs of questionable efficacy for other common conditions, I think that would depend on whether those conditions already have any kind of treatment available: ours doesn't.

I had a close look at the study the ampligen people quote a while back. My impression was that the results are presented in a form that is hard to interpret. They say there is a 21% improvement in activity but the bare figures suggest it is 10% and that does not seem very much. To my mind this sort of average figure is not what is wanted. We want some sort of figure indicating how many people were usefully better in each group - a bit like the Haukeland study. I fully appreciate the problem of outcome assessment for trials but if a study is properly blinded I think there are ways of assessing useful improvement that ought to stand up.

People were disappointed, I think, at the time about how Hemispherx presented their data. If they presented it the way you've been suggesting (scatterplots of individual patient data) that would be useful.

So I would go with the FDA at present. And I would come back to the point that there should be a minimum dose (dose response) assessment.

I think I'm sounding like some sort of major apologist for this campaign because I posted it and then bumped it so that the Ampligen afficionadoes here on PR would be aware of the campaign. But I'm aware that the data as presented by Hemispherx aren't as strong as they might be and I agree that in a sensible world, the next thing to happen should be further, high-quality trialling of Ampligen and the dose-assessment that you're suggesting.

But that doesn't seem to be an option: the US govt agencies are legally barred from trialling Ampligen (as I understand it) and Hemispherx are too small a company to be able to afford to do it (article on that here by Cort - who is very pro-Ampligen).

That leaves people like Bob Miller with only one option, it seems to me: to campaign for the FDA to approve Ampligen as is.

If you were Bob, what would you do?

How else can he move the Ampligen issue forward?
 

Jonathan Edwards

"Gibberish"
Messages
5,256
That's just it - my understanding is that people can't get Ampligen unless they're in some weird scheme. ... I'm not sure if that scheme was stopped - if my memory serves, the clinicians were getting Ampligen under some special arrangement to do with research. I wonder if it was to provide safety data or something.

I take that point. But my understanding is that several thousand doses have been given - so quite a lot of people have got it. So there is another possible argument - that people should be able to buy ampligen treatment if they can afford it. But how many PWME can afford $24,000 p.a. indefinitely? And should they if we do not know it works - or even that a quarter dose might be as good?

Bob (and Cort, I think) claim that the FDA is approving drugs with a similar safety/efficacy state of evidence as Ampligen for other conditions; there certainly seems to be a lot of weirdness about how the FDA do things and my understanding is that the FDA is seen by many in the US as being in the pharma industry's pocket.

I entirely agree that the FDA and the UK MCA and NICE make some very dodgy decisions. PWME have grounds for protest - but it is best to protest on sound grounds. I have spent thirty years developing drugs that work well and drugs that people would like to work well but don;t do much. From what I see ampligen looks rather like a 'don't do much' to me. I would like to be proved wrong but we want evidence. And the FDA is not in the pharma industry's pocket - it IS the pharma industry's pocket - the one with the wallet in, accessed by 'revolving zippers'.

I'm not sure about your cost calculations on this. An estimated 90% of US PWME don't have a diagnosis, so we're only talking about 100,000 patients at this point (though that could change if the IoM recommendations are rolled out); not all doctors are going to prescribe it; and it may become apparent quite quickly what subset of patients benefit. So the real figure could be more like $50/year maximum; and one would hope that some patients would do so well on Ampligen that they wouldn't need to stay on it.

My cost calculations are suspect, I agree. But they may not be unrealistic. You cannot argue that the undiagnosed people do not deserve ampligen - so I think that won't wash. Of course not everyone with ME would go on ampligen. However, the general point is that if you approve ampligen you have to approve anything similar that comes along that has not really been tested properly. In RA there are now at least six drugs that cost thousands of dollars a year. If you do not have one you can have another. Health insurance for RA is probably now costing everyone in the UK £50 per annum.

In terms of whether I'd be happy to pay $X (whatever X is) for drugs of questionable efficacy for other common conditions, I think that would depend on whether those conditions already have any kind of treatment available: ours doesn't.

I am not sure that 'any kind of treatment available' is really what matters. There are treatments for MS but the reality is that they do not solve the problem. People with MS are just as stuck as PWME.

But that doesn't seem to be an option: the US govt agencies are legally barred from trialling Ampligen (as I understand it) and Hemispherx are too small a company to be able to afford to do it (article on that here by Cort - who is very pro-Ampligen).

Then maybe the campaign should be to make laws on testing drugs more in the interest of the consumers and less in the interest of venture capital people. It seems to me the people who at fault here are to some extent the American public who have voted for politicians who think the current laws are ethical. I don't buy the bit about Hemispherx being too small. When I have come across situations like this before with drugs in the pipeline, if the data in house look promising to independent scientific advisors like me then the company usually has trouble fighting off the overtures from big companies to buy them out. The people in the small company sell out and live the life of Riley.

That leaves people like Bob Miller with only one option, it seems to me: to campaign for the FDA to approve Ampligen as is.

If you were Bob, what would you do?

How else can he move the Ampligen issue forward?

I don't think the FDA is going to respond - it would be opening the floodgates to hundreds of billions of increase in insurance premiums. I think the law needs changing. Governments support vaccine programs - I bet the law as it stands could be interpreted so that a trial could be done. I think it is the NIH that needs lobbying.
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
I think you're making a lot of good points there, @Jonathan Edwards, and I don't think I've got any particularly good answers. I wish Bob Miller would come to PR and discuss his campaign rationale but this doesn't seem to be his environment.

Interesting point about Hemispherx. I just don't know enough about the history there.

I don't understand the US system well enough to know whether it's the NIH that needs targeting, exactly what we should ask for from them, or how well they're likely to respond to a bunch of PWME. We've had zero success for years in getting increased funding from them.

But if there's a better campaign there, perhaps we should be thinking about it.

It's at this kind of point that I hit a bit of a brick wall, I must admit. There are clearly issues to be discussed if it's the NIH that should be targeted, but this is a US problem and needs US advocates to take the lead on first having a discussion, and then leading a campaign on it.