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Bob Miller wants your ideas for the spring FDA Stakeholders Meeting

Discussion in 'Action Alerts and Advocacy' started by Sasha, Feb 9, 2013.

  1. Sasha

    Sasha Fine, thank you

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    Bob wrote on another thread:

    We need to prepare for the upcoming StakeHolders meeting. I would ask everyone to stop all emails and phone calls to the Health agencies as we now want their attention on the StakeHolder meeting and you have all done such a great job of slamming them, they have been unable to do anything else. [...]​

    I would ask all patients who can, to do some homework on who and what we should have at the meeting. Such as the expert clinicians in the world of ME/CFS, Pharma companies (we can select a few and begin writing to them to attend) Insurance Co's. and more.​

    We as patients need to be prepared and educated for the best possible meeting. So please take a rest and then begin doing the Homework. [...]​

    And again my humble thank you to the patients for your support.​

    Bob asked me to set up a new thread for discussion so here it is but I must confess to knowing zippo about such meetings (I'm just a Brit!) and I'm assuming Bob will be having a bit of a lie down and then a steak dinner. :) I'm hoping someone knowledgeable will step in and say something about the meeting's scope, when it is (if we know) and so forth.
  2. SpecialK82

    SpecialK82 Senior Member

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    Ok, I guess I will start this off by just a broad idea.

    I think that we should set up some SMART goals. SMART is an acronym that means that the goals for the meeting or meeting outcome should be:

    S - Specific
    M - Measureable
    A - Attainable (action-focused)
    R - Releavant (Results-based, Realistic)
    T- Timely (TIme-oriented, Trackable)

    So for example, if we would like to ask the FDA to do something, let's make sure that it fits all the criteria above. For example, is it something attainable by the FDA or would another agency have to do it?? If so, can we get the other agency invited?

    I think these same criteria should be used to set-up sepecifc goals for the CFSAC (and it's member agencies) to accomplish. And then to ask for these goals to be met through our patient representatives and to hammer on them during the testimonies.

    We want to be able to track and measure their outcomes on a regular basis, and when we see that it is stalling we can protest, etc. I am tired of hearing agencies report out during the CFSAC and hearing that not much of anything has changed since the last meeting.
    taniaaust1, SOC, BEG and 1 other person like this.
  3. Sasha

    Sasha Fine, thank you

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    Bob posted this video on his Facebook page - also on Youtube, which allows me to give a direct link to it:



    He's looking and sounding much better, which I am relieved about!
    BEG likes this.
  4. Tuha

    Tuha Senior Member

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    What do we need? The answer is simple - money, money, money. So I would ask a significant amount of money for ME research and clinical trials - there are already ME research studies and clinical trials which need money (Rhituximab, Ampligen clinical trial, Open medicin Institut research, Simmaron research,...). So a lot of possible work but no money.
    I dont know how much money I would ask - I think the comparable amount like the other simmilar diseases like MS. I think this is 120 mil USD/ yer - this I would ask to achieve in the periode of 3 years - so maybe this year 40 mil., next yer 80 mil and the next one 120 mil. So on the stakeholders meeting I would ask to fund immediatelly Rhituximab and Ampligen research trials and funding some other research studies till 40 mil.

    Remember we need to ask them exact things and to do schedule for the promisses because then you can controle them and confront them. If they will not keep the promisses I would start immediatelly another email campaign till they will not keep their promisses. This campaign I wouldnt stop before money will arrive. We can see that they are only promissing - how did we move the last years? did we get some research money? Did they found some clinical trials? No, No, No - so it´s the time for strong advocacy. I think it was amazing what robert did but till I will not see that money on our account we didnt achive anything.

    So to make exact demands and schedule for these demands and then strong "agresive" advocacy
  5. JohnnyD

    JohnnyD Senior Member

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    (cross-posted from another thread)
    Hi Roland,

    You make a good point. The FDA has so far paid lip service to CFS being a serious and life threatening disease, now they need to produce an action that, at the very least, moves ampligen and other drug development to a near term possibility. However, IMO, I don't think they are going to approve ampligen on an appeal, - I think they will want one more trial. There must be a better fit for Hemispherx, other than a large, expensive, long drawn out phase III. Here are some questions I'd like to know the answer to before the spring stakeholders meeting.

    The FDA has a new policy named: Enrichment Strategies for Clinical Trials to Support Approval

    How can Enrichment Strategies help Hemispherx?
    http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM332181.pdf

    The FDA met last week to discuss a New Pathway To Approval for Serious and Life Threatening diseases. The idea is to focus smaller and quicker trials for quikcer approval on the most serious afflicted and then expand to the labeling later to include the not as serious afficted.

    If passed, how can the New Pathway to Approval, if passed, help Hemispherx?

    In the September 13 Stakeholders meeting, the FDA touted the new FDASIA statute as a possible fit for Ampligen and Hemispherx. Is FDASIA still a possibility for Hemispherx and if not, why not?

    In the September 13 Stakeholders meeting, the FDA stated that they had some other drugs under consideration but when pressed, these turned out only to be Supplements. Why is the FDA considering supplements for a serious and life threatening disease, when real and effective therapeutics are needed? And why, in the 20 years that Hemispherx has been developing Ampligen, there are no other drug makers developing real and effective therapeutics for this disease?

    There should probably be some separate thread to start building a case for the Spring Stakeholders meeting. And I mean build a strong case.
    taniaaust1, SpecialK82 and Sasha like this.
  6. Mark

    Mark Acting CEO

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    This is the kind of job that we want to build an Advocacy Team for. Open forum discussions play an important part in building such a case, but they rarely if ever produce the end-product, probably because the group contributing is too large and diverse to remain focused. To achieve that end-product requires a smaller, focused team, with clear goals, using richer collaboration solutions which we can provide. It also requires that the team be networked with the resources of the wider group of advocates beyond Phoenix Rising. If anybody is interested in taking part in building such a case, please contact me to register your interest in joining the Advocacy Team.
    Sasha likes this.
  7. Kati

    Kati Patient in training

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    i echo Tuha's idea, we need serious money injected into the projects of our experts. Dr Kogelnik has a listful of clinical trials he'd like to do, in collaboration with OMI-Merit, which includes most if not all of the experts in the field plus auto-immunity researchers.

    This is worthy of getting support.

    The NIH needs to be involved -what happened to the thinktank meeting (State ofthe knowedge) from a couple years back? no ripples, no funding, no nothing, business as usual. Tis has gotto change. 32 billions is spent in health research in the US, 6millions for CFS. It's a disgrace.
    WillowJ and Sasha like this.
  8. SpecialK82

    SpecialK82 Senior Member

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    I agree that more money needs to be spent, research etc. but I think we have to give them more specific ideas of what to fund and take them through a thought out plan of action.

    I think that we should come up with as many non-monetary requests as we can (these will be easier for them to agree to) and then also some monetary requests, for example:

    - make a committment across agencies to set-up regular meetings with patient advocates. I would love to see a monthly meeting but at best we can probably hope for only every other month. I think giving them short windows of time between meetings would yield better results. I am tired of only the bi-annual CFSAC, where it seems sometimes that much of the agency work was done right before the meeting. I'm not blaming anyone, I think it's human nature to put off accomplishing goals when you have 6 months to get it done.

    - this next request is not necessarily FDA, but whichever agencies will be involved with Obama's new healthcare plan and setting guidelines for doctor reimbursement. Right now, most all good ME/CFS doctors do not take insurance. This is because a normal ME/CFS office visit can easily take 1 -2 hours or more. Insurance companies only understand how to reimburse doctors for short visits, 15 minutes or so, and consequently won't reimburse an ME/CFS doctor for actual time spent. THIS HAS GOT TO CHANGE!! We need to get the government to write the rules now so that ME/CFS docs can get the money that they deserve and so patients can afford to see doctors. This would help the community greatly and would even encourage more physicians to start treating our illness.

    Both of these ideas may have some costs, but are minimal or at least indirect (down the line).

    Mark - I agree that a working group across advocates inside and outside of Phoenix Rising is a good idea
    taniaaust1, WillowJ and Sasha like this.
  9. Sasha

    Sasha Fine, thank you

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    OMI-MERIT has a prioritised list of projects agreed by ME specialists - it wouldn't cost the NIH much to implement the entire programme: $13.5 million, peanuts for the NIH in comparison to what it spends annually on other diseases:

    http://openmedicineinstitute.org/research-initiatives/mecfs-merit/

    Can that programme be fast-tracked?
    taniaaust1, WillowJ and Kati like this.
  10. Sasha

    Sasha Fine, thank you

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    Could people join the Advocacy Team specifically for this project, even if they didn't feel willing/able to join the team on a longer-term or broader basis?

    Not talking about myself here! Just thinking that more people may be willing to commit to a specific project than to an ongoing and broader commitment.

    I like the idea that the forums help generate ideas and an Advocacy Team can generate further ideas and take the best of everything and make a focused, actionable thing out of it.
  11. Mark

    Mark Acting CEO

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    Yes. I expect the 'Advocacy Team' project will involve the formation of subgroups on specific projects.

    Exactly how this will work in practice will evolve, but as I see it there will be no expectation or requirement for members of the team to commit to anything specific; everyone will just do as much as they want or are able to do. Really, I see it as a distillation of the advocacy discussion and work that already goes on in the forums into a team with a bit more focus on practical outcomes, with support from PR behind the scenes to help them achieve that. I'd hope that everyone who already contributes to advocacy discussions on the forums would become a member of this group.


    I agree. I think some people may feel reluctant about committing to such work, but the way I see it they are already doing this kind of work on the forum threads! The question is: do any of those conversations ever go anywhere? Do they end up producing a document, a position statement? This is often suggested, discussions often get to the point of "we should do something about this" but then nothing seems to happen. In other areas, we have found that this problem can be solved by forming a subgroup - like you would form a subcommittee with a specific job - and providing that subgroup with a bit of structure and some tools. These more closed threads have more focus and less distractions, while remaining connected to the wider forum. The aim of this model, as I see it, is to produce something like a 'position statement', a document or letter that the PR board could approve, the members could vote to approve (or indicate approval like a petition). That model could turn the advocacy discussions into concrete action. That's my vision for this concept in a nutshell. It will depend on who gets involved as to how it turns out in practice. We have a few good members who've indicated their interest already, so I'm quite optimistic it will work out well.
    Blue and Sasha like this.
  12. WillowJ

    WillowJ Senior Member

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    I agree with what you have said, Tuha. Very well said.

    About the amount, I think MS gets $144 million, and it's said we have twice as many patients (I would need to check on this). According to the usual rules of disease burden, we 'should' be getting $280, if we compare to MS. MS is sort of a good comparison because it's debilitating and does not have as good treatments as needed, or as good biomarkers as needed.

    It's sort of similar in that it's escaping from treatment as if a personal problem of the patient, but this probably means that MS is underfunded (which makes a less good comparison). This could contribute to why they don't have as good understanding and treatments as we would like for MS. The main biomarker for MS is lesions, but this doesn't seem to correlate to clinical status (even though there is obvious tissue damage, which would be a negative outcome).

    I have a friend with MS and he says the way they tell if his treatment is correct is: they try a mix of several medications and he comes back in a year and gets another MRI. If there are no more lesions, they figure the medication regime is correct. Obviously there are problems with this approach. (but why then are we asked to prove which patients a medicine will work in? don't we need options just as much as these other patients?)

    Also, these medicines are expensive. My friend's medicines get paid for by the MS foundations.

    Anyway, comparable to MS is probably a rational starting point, but it will not be enough to solve it in the end. Both diseases will need more funding from somewhere.
    taniaaust1 likes this.
  13. WillowJ

    WillowJ Senior Member

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    I really love this idea!
    SpecialK82 and taniaaust1 like this.
  14. WillowJ

    WillowJ Senior Member

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    FDA can consider only the medicines which are submitted to it. So it cannot consider, for instance, valcyte or famvir for ME/CFS because no one has made that application. If someone makes an application for supplements, they will (and must) consider those.

    FWIW, supplements are used for the classic (and fatal) mitochondrial diseases. Supplements aren't necessarily ineffective; it's just that in most cases no one has bothered to actually try for FDA approval (usually because the cost recovery potential isn't deemed to be there) so there isn't usually a sufficient evidence base to be sure what does or doesn't work, and if it does work, in what dose it should be used.

    FDA seems to have had a personnel change for the people involved with ME/CFS. The people there now think the barriers to drug development (ignoring misperception) are that there are not agreed targets for proving that a drug works. They say they want to change this. Hopefully they are serious about that. Cross talk between agencies is a good starting point, and they say they want to do this.

    However they say they are not announcing the meeting date for "a few weeks"; Spring is coming up fast and it seems they will be about as short notice as CFSAC. This doesn't give us a lot of time for inviting experts and out-of-community advocates. I think this sort of short notice is substandard; jspotila or CBS do you know the answer to that?
    JohnnyD, Sasha and taniaaust1 like this.
  15. alex3619

    alex3619 Senior Member

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    Asking for more research money is only half the issue. Sure we have a wish list, but where are they going to send the money? Any advance in funding requires something more specific. For example, we could go to Simmaron or Klimas or whoever and ask how much would be required to do project X, Y, or Z. That would at least tell us what is feasible and potentially fundable. It doesn't matter what project you are aiming for, you need a project to direct funds at.

    Which brings us to the next issue. We would also require a formal project application.

    This is all NIH too, not FDA. As WillowJ says, the FDA can only approve drugs for which applications have been received. I am not sure about repurposing existing drugs though: there will undoubtably be specific requirements.

    So what is needed, at least, at the FDA stakeholders meeting is to set up liaisons so that we can get these questions answered. At the first such meeting (and there should be more) we need to find out information and ask questions more than we need to make demands.

    We will have to find the projects. We will have to support the researchers with making an application to the NIH. We will then have to support FDA approval. All this means we need to know the mechanisms necessary to do this. Its boring bureaucratic stuff, but necessary.

    The big question to me is how can we organize the NIH to actually take the initiative instead of reacting (poorly). Is this possible? How would we do this? There is probably a role for having the FDA involved, so that such research meets their needs at the planning stages and we don't find out a project was unsuitable five or ten years later.

    Maybe we should be looking at other successful drug repurposing applications, and aim at creating a general blueprint? The FDA can help us with that.
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  16. taniaaust1

    taniaaust1 Senior Member

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    I too think its no good asking for more funding if it isnt going to be being put into good studies eg we dont need more funding going into psych studies!!.
    An Ampligen study may not turn out good at all for Ampligen if they used the Wessely type of CFS group. We need good studies with subgrouping and comparing how different ME/CFS subgroups compare with things.

    It is about time ME/CFS gets the funding it should do compared to other illnesses rather then the current biased towards us funding our studies. There is NO EXCUSE if a gov is recognising that this illness is a serious one.. for them to fund in a biased way.

    I think the funding issue and what and how studies should be being done.. should be a priority thing to be sorted out.

    Whatever happens at this meeting.. there needs to be ongoing meetings with updates on everything and plans of action set in place with regular checking that things are being followed up and progressing forward. Rather then just all the lip service we get now. TIME FOR ACTION, NOT FOR TALK FOR ME (cfs).

    ALL relevant gov agencies need to be at such a meeting or otherwise there will be issues with agencies trying to pass on blame or issues to other agencies saying "its not up to our dept to deal with that". (no matter where you are in the world they just LOVE to do that and can delay all the time in the world otherwise). So get them all together, get them talking and making commitments and get them to give time dates of when agreed things will be happening or moving forward. Meetings I personally think should be happening every 3mths until a lot of the ME/CFS mess is sorted out.
  17. WillowJ

    WillowJ Senior Member

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    That is probably a smart approach
  18. JohnnyD

    JohnnyD Senior Member

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    I agree with the idea of trying to get the gov't agencies to meet, through a liaison or whatever, more often than every 6 months. It's long passed time to ask specific questions and attempt to get answers that lead to action. Somehow a sense of urgency needs to be instilled and I think more frequent meetings would help.

    Thanks for you thoughtful reply and education about supplements. I remain jaundiced, I'm sure there are some, but it is hard for me to imagine supplements that have not already been tried!

    Something happened last summer that brought about a change. After 20+ years the FDA declares CFS a serious disease. CFS is incredibly challenging. Folks have broken immune systems, a variety of co-morbidites, and are on a variety of drugs and supplements and they are just now figuring out that a target for a drug company might be difficult? (sorry, my jadedness abounds). I'm speculating here, but this may be the reason that Hemispherx cannot find a partner and not other companies have managed to get a trial going.

    I agree that it is the time for action, something specific needs to now come from the gov't agencies - they have finally, after 20+ years, recognized CFS as a serious and life threatening disease. People have suffered too long. I see no reason why it cannot be demanded. The FDA is under statutory mandate to proved the tools and help necessary to expedite treatment options for serious and life threatening diseases regardless at what stage of development drugs are in. The FDA knows the current laws are not addressing this adequately - thus last weeks public seminar on a "New Pathway to Approval" targeting the most seriously afflicted of serious and life threatening diseases. If Hemispherx needs to do another trial, let the FDA help them do a small, quick trial that takes into account the enormous difficulty of running trials for the CFS population. Hemispherx has taken CFS seriously for 20 years, the FDA for 5 months. If FDASIA is not appropriate, or cannot be made appropriate - tell us why not and why it was touted at the Sept 13 Stakeholders meeting? What other tracks would be appropriate? What about a Special Protocol Assessment... so that drug companies and the FDA can decide on endpoints and protocols beforehand and stop this petty bickering? What about Enriched Trials (which were mentioned at the Sept 13 stakeholders meeting)? When might the New Pathway to Approval, now in planning, be authorized? Why weren't CFS representatives at the table? (<- which might be a public comment as that group is taking public comments until February 28th).

    Instead of continually putting up roadblocks, now is the time for the NIH/FDA to take some responsibility for this disease, one they have ignored for 20+ years, and come up with some positive action that makes an impact on the lives of people with CFS in the NEAR term.
    WillowJ, alex3619, Kati and 1 other person like this.
  19. Ember

    Ember Senior Member

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    Dr. Sandra Kweder agrees with you. She concluded her FDA presentation to CFSAC in October saying, “A research definition is needed so that we cam begin to study things.... Clinical therapeutics are not going to be developed until this is done:”
    In the subsequent discussion, Dr. Kweder pointed out that subgroups need to be identified upfront in clinical trials involving heterogeneous conditions:
    The FDA's “Alternative Approval Pathway” proposes studying a drug's safety and effectiveness “in a smaller subpopulation of patients with more serious manifestations of a condition. Such a pathway could involve smaller and more rapid clinical trials than would occur if the drug were studied in a broader group of patients with a wide range of clinical manifestations.”

    In its clinical trials, Hemispherx used the Holmes (1988) definition of CFS and required both acute onset or sub-acute onset and a Karnofsky score of 40 – 60 upon entry. It re-analyzed its data using a subset of patients with lower disease duration (1-10 years).

    It sounds now as though the FDA expects clinical therapeutics to be on hold for us pending completion of the CDC's new definition. Since Dr. Unger has repeatedly promised an umbrella definition with severity scales, it isn't clear that the CDC is up to the task.

    Meanwhile, the ICC identifies an ME subpopulation with more serious manifestations of our condition, but it languished on the sidelines, along with its optional subgroups:”
    According to Dr. Peterson (2011), the CCC, a clinical definition, is used in most clinical trials.
    The ICC should be used once its International Consensus Symptom Scale is published.
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  20. BobM

    BobM

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    Based on the AZT Model described below, the NIH could do the same with Ampligen's
    sponsor.
    For those who are not familiar with the background on
    the development of AZT, the following letter from
    Dr. Samuel Broder and others to the New York Times
    on September 28,1989 may be of interest.

    In this letter five scientists from NIH and Duke
    University took issue with Burroughs Wellcome's
    efforts to take excessive credit from the development
    of AZT. The letter provides a concise description
    of the government's role in the development of this
    important AIDS drug.



    New York Times, September 28, 1989

    Credit Government Scientists With Developing Anti-AIDS Drug

    To the Editor:

    The Sept. 16 letter from T.E. Haigler Jr., president of the
    Burroughs Wellcome Company, was astonishing in both substance and
    tone. Mr. Haigler asserts that azidothymidine, or AZT, was
    essentially discovered and developed entirely by Burroughs
    Wellcome with no substantive role from Government scientists and
    Government-supported research. This will be a surprise to the
    many men and women who have devoted their lives to working for
    the viral cancer program and developmental therapeutics program
    of the National Institutes of Health over the last 25 years.

    We (associated with the National Cancer Institute and Duke
    University) make this statement as co-authors of the first
    publications describing AZT as a drug for treatment of acquired
    immune deficiency syndrome (Mitsuya, et al., Proceedings of the
    National Academy of Sciences, 1985, and Yarchoan, et al., The
    Lancet, 1986). There are few drugs now approved in this country
    that owe more to Government-sponsored research. In the interest
    of brevity, perhaps this point can be summarized most efficiently
    by stating what Mr. Haigler's company did not do.

    - The company did not perform the first synthesis of AZT. This
    was done by Dr. Jerome Horowitz at the Michigan Cancer
    Foundation in 1964, using a Government grant.

    - The company did not conceive or provide the first
    demonstration of an effect against animal retroviruses. This
    was done by Wolfram Ostertag at the Max Planck Institute in
    1974, using a mouse retrovirus in a test tube. Mr. Haigler's
    implication that his staff discovered" the antiretroviral
    potential of AZT in 1984 is noteworthy. What he did not say
    was that his staff repeated the Ostertag mouse experiments.
    You cannot discover" something published by someone else 10
    years earlier.

    - The company specifically did not develop or provide the first
    application of the technology for determining whether a drug
    like AZT can suppress live AIDS virus in human cells, nor did
    it develop the technology to determine at what concentration
    such an effect might be achieved in humans. Moreover, it was
    not first to administer AZT to a human being with AIDS, nor
    did it perform the first clinical pharmacology studies in
    patients. It also did not perform the immunological and
    virological studies necessary to infer that the drug might
    work, and was therefore worth pursuing in further studies.

    All of these were accomplished by the staff of the National
    Cancer Institute working with staff at Duke University. These
    scientists did not work for the Burroughs Wellcome Company. They
    were doing investigator-initiated research, which required
    resources and reprogramming from other important projects, in
    response to a public health emergency.

    Indeed, one of the key obstacles to the development of AZT was
    that Burroughs Wellcome did not work with live AIDS virus nor
    wish to receive samples from AIDS patients.

    In a number of specific ways, Government scientists made it
    possible to take a drug in the public domain with no medical use
    and make it a practical reality as a new therapy for AIDS. It is
    unlikely that any drug company could have found a better partner
    than the Government in developing a new product. We believe that
    the development of this drug in a record two years, start to
    finish, would have been impossible without the substantive
    commitment of Government scientists and Government technology. It
    does not serve anyone's interests to nullify the importance of
    Government-sponsored research in solving problems of American
    public health.

    HIROAKI MITSUYA, M.D.
    KENT WEINHOLD
    ROBERT YARCHOAN, M.D.
    DANI BOLOGNESI
    SAMUEL BRODER, M.D.
    Bethesda, Md., Sept. 20, 1989

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