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"I have a plane to catch"

Discussion in 'General ME/CFS News' started by silicon, Dec 24, 2012.

  1. silicon

    silicon Senior Member

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    http://thoughtsaboutme.com/2012/12/24/i-have-a-plane-to-catch/

    "There is much to say about the meeting, but one of several things that stood out were the distressing votes cast by one of the few ME community’s specialist physicians, Dr. Anthony Komaroff of Harvard University. Dr. Komaroff voted “no” on all four questions, even on the one question that the majority of the committee voted “yes” on! Throughout the meeting, Dr. Komaroff was hostile and dismissive towards Hemispherx, the sponsor of Ampligen. Still, his vote came as a shock to patients many of whom had pegged him as being on our team. Make sense, right?! Unlike some of the other committee member who obviously knew nothing about the illness, Dr. Komaroff is familiar with the disease, probably more through his research than through clinical work, but nevertheless. Why would somebody like him sell out the patients he is studying?"
    Nielk likes this.
  2. joshualevy

    joshualevy

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    I tend to view this in the exact opposite way that you: the fact that the most knowledgeable committee member voted no, while the relatively less knowledgeable ones voted yes, shows that there was even less there than we thought.

    The data presented by HEB was obviously not enough for the majority of the people voting. But their excuse/rational for approval was that there was something there in a small subgroup or some limited benefit for some people (and ME/CFS has a lot of subgroups and a lot of uncertainty). By Dr. Komaroff was in the best possible place to evaluate that kind of argument. He knows about the uncertainty and the subgroups and all that stuff, and he still voted no.

    It seem pretty clear to me: the more you know, the more you "no".

    Joshua (not Jay!) Levy
  3. Nielk

    Nielk

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    Dr. Komaroff has no personal experience with Ampligen. He is not one of the CFS specialist who have gone out of their way to make this drug available to the patients for whom this is a miracle treatment. These patients are willing to shell out of their pocket thousands of dollars each month because it is worthwhile for them.

    In my eye, it is a cop out for a doctor who should understand how severely some of these CFS patients are affected and to just blow this chance away for them IN SUCH A CASUAL WAY is not something that I respect.

    What I don't understand is why none of the doctors who have experience treating patients with Ampligen appeared on the panel. They, and only they, have the best current information to really judge the efficacy and safety of Ampligen.

    "The more you know the more you no" I don't think applies here. It is so much harder to say yes. Komaroff might have better knowledge than the others on the panel about our illness but, he doesn't have any "inside information" about Hemispherx and their Ampligen study.
    ukxmrv likes this.
  4. Hope123

    Hope123 Senior Member

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    I would not assume that Dr. Komaroff has no experience with Ampligen. It might not be personal but he's seen a lot of people, medications, and ideas about this illness over the last 30 years. Looking through some other stuff, I found out he used to sit on the the board of Hemispherix (not sure if he does now) so for him to reverse his decision says something to me.

    One reason why the doctors currently treating people with Ampligen are not on the board is that FDA and other governmental agencies likely have conflict of interest policies about who can sit on such a panel. Those rules are there for very good reasons. The policies can vary -- e.g. it's not uncommon to have some stock in companies but "substantial holdings" (and that can be defined variously) can exclude someone from sitting on such a panel. The general public may not know this and I agree that doctors should get paid for their work but in most studies, physicians are paid a "finder's fee" for each patient enrolled. That fee can be reasonable or not and when physicians recommend the patients they follow regularly for trials, it can set up a conflict between treating the patient as a patient (which would mean withdrawing a patient early from a trial if the patient doesn't feel well) vs. as a research subject (which would mean encouraging someone to stay in a trial as long as possible even with side effects). What if MDs are being paid for encouraging patients to complete a trial? This doesn't mean that physicians should not participate in clinical trials but patients and physicians should be aware of these issues when they consider participating in clinical trials. It might be interesting to ask physicians if they are being paid a fee and how much. This applies not only to randomized controlled trials but also other types, like the open label trial of Ampligen. When in doubt, ask questions.

    Skimming through some of the current FDA documents that are publicly available, I was surprised to not see a disclosure statement (either affiliated with Hemispherix of other commericial enterprises) from everyone who was on the panel. It's possible FDA screened everyone but it's not publicly displayed or it's somewhere I haven't looked yet.

    I actually believe it was courageous of Komaroff to say "no." Of the people on that panel, he's the only one that sees CFS patients on a regular basis and likely will face flack directly from patients and advocates for his decision. But I believe he has good reasons for doing so. I believe Ampligen likely has beneficial effects for some people with CFS but approving it might have meant putting 1-4 million people at risk for undefined side effects. The panel was not making decisions for a few people but for all people with CFS. Hemispherix was not applying for approval for the drug for a subset of CFS patients but for all CFS patients.
    Persimmon likes this.
  5. dannybex

    dannybex Senior Member

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    I was wondering about that too. Dr. Enlander said on Facebook that he had offered (or was willing) to go, but got no response from the FDA folks. But where was Dr. Daniel Peterson?

    Hope123 -- Interesting that you say Komaroff used to sit on the board of Hemispherx. Perhaps he knows a lot more about the drug and/or the company...?
  6. ggingues

    ggingues $10 gift code at iHerb GAS343 of $40

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    Wouldn't this be like conflict of interest?

    GG
  7. Snow Leopard

    Snow Leopard Senior Member

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    It's disappointing really. Love it or hate it, approval of Ampligen would open up the floodgates for drug development for CFS.
    Kati likes this.
  8. Stukindawski

    Stukindawski

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    Personally, I don't think patients should want researchers 'on their team' at all.

    The very idea of some complicit patient-researcher relationship rather damages the credibility of any research produced. I don't think it's a line that helps anyone.

    I don't know why Komaroff said no, I may never have the intelligence or expertise to understand why he said no, so I wont rush to any sort of judgement. I know a lot of patients wanted Ampligen to succeed and even supported the efforts of those patients. So it sucks, especially for those patients who are adamant they are responding to this treatment.

    But really, people need to think long and hard before they start binning people off, or striking them off the 'team' which they should never have been on.
  9. Persimmon

    Persimmon Senior Member

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    I would have been thrilled to see the first drug approved for ME/CFS, but still have faith in Professor Komaroff.

    If you look at the videos of him in action, and read his publications, it seems to me that he is quite a conservative physician. That conclusion pertains to the therapies his patients receive, to the forms of research he conducts, and to the judgements he makes. This sort of conservatism has pluses and minuses.

    On the one hand, he doesn't make many rash comments - I wonder if there are any public comments he's made that look foolish with the benefit of hindsight. When a third party hears what he has to say, they can trust that he isn't deliberately guilding the lilly, nor inadvertently expressing optimism as if it were fact. Also, being cautious has presumably been critical to his career success - to earn a named chair at a university like Harvard, without being a superstar (like Lipkin), I image that he has relied upon being impeccably solid and reliable.

    On the other hand, conservative physicians aren't typically the ones you go to if you want to try experimental therapies; nor if you want endorsement of research that isn't compelling.

    I think our cause needs experimenters like Dan Peterson and conservatives like Tony Komaroff. At the risk of over-simplifying, Peterson comes up with great new ideas; Komaroff applies intellectual discipline and lends credibility to our plight. Personally, it has helped me to be able to refer people to videos by Komaroff: they see a trustworthy sort of chap, speaking in measured words and carrying the authority of Harvard. It's hard to simply dismiss that sort of message.

    I think we've been extremely lucky that Komaroff took up our illness, and that he's stuck with it. Maybe we've been unlucky that more prestigious academics haven't taken up our cause, but I'm still appreciative of any who do so.
  10. Nielk

    Nielk

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    http://www.hemispherx.net/content/investor/default.asp?goto=189

    Philadelphia, PA, Thursday, October 16, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today the appointment of Anthony L. Komaroff, M.D., to its Scientific Advisory Board. Dr. Komaroff, one of the world’s experts on Chronic Fatigue Syndrome (CFS), is Professor of Medicine at Harvard Medical School, the Senior Physician at Brigham and Women’s Hospital in Boston, and the Editor-in-Chief of Harvard Health Publications.

    How is it that there was no conflict of interest regarding Dr. Komaroff's past ties with Hemispherx as far as serving on this advisory board?
  11. Hope123

    Hope123 Senior Member

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    Past ties are usually not considered in the same vein as present ties and the fact that he is making the decision opposing Ampligen with possibly "inside knowledge" about the drug and company is actually a positive in my mind.

    In regards to "superstars" in science and medicine, who the public regards as "stars" are not necessarily the same people that physicians and scientists regard as 'stars'. Usually, whom the public knows are the people who are the most publicized; popularity doesn't equate necessarily to impact in the long run. This has been proven over and over again in history of science. How many people here know of Ada Lovelace or Alan Turing? Without them, we would not be communicating today via Internet; both pioneers in the field of computer science. And even I wouldn't have known them except my mother early on studied computer programming.

    In my mind, from what I have read by Komaroff inside and outside of CFS and having had the chance to interact briefly on a professional level, my impression is he is a very smart, practical, sympathetic physician. Komaroff ran the general internal medicine service at one of the top hospitals in the country for 15 years, started one of the best medicine review journals out there (JournalWatch), and is head editor of Harvard Health publications. He was also involved in the Lipkin studies for XMRV. In the "diffusion of innovation" theory, while Komaroff may not be an "innovator," he strikes me also as not a "late majority" or "laggard" either; I would put him at "early adopter" but even "early adopter" physicians/ scientists need proof beyond patient anecdotes (as important as they are) and studies with major flaws.

    [http://en.wikipedia.org/wiki/Diffusion_of_innovations]
  12. Dolphin

    Dolphin Senior Member

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    FWIW, somebody once told me Dr. Komaroff wasn't really interested in treating ME/CFS in patients with the condition i.e. who came to see him.
  13. ukxmrv

    ukxmrv Senior Member

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    What treatments has Dr K been offering (either in the past or current)?

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