[quote="better2gether"].
FDA Drug-Approval Process: Is Criticism of It Fair?
May 20, 2005
By Harold J. DeMonaco, M.S.
Massachusetts General Hospital
.... Multiple sclerosis can vary in severity, with the relapsing-remitting type being especially debilitating.
.... I disagree; the FDA is doing its job. And there is nothing wrong with the approval process. What is missing is an understanding of the nature of discovery.
Harold J. DeMonaco, M.S., is senior clinical associate in the Decision Support and Quality Management Unit at the Massachusetts General Hospital and is currently a Visiting Scholar at the MIT Sloan School of Management. He is author of over 20 publications in the pharmacy and medical literature and routinely reviews manuscript submissions for eight medical journals.
What I think is missing is someone who knows enough about the disease not to make a notably misleading statement about the forms of the disease that are, in fact, most debilitating--not relapsing- remittiing, but rather primary and secondary progressive as well as the so-called fulminating variety. Perhaps someone at Mass General Hospital or at MIT could give Mr. DeMonaco a tutorial on the subject.
Tysabri info
Unbelievable!!!!!
Heres a copy of an email I just fired of to Inteliheath:
"Multiple sclerosis can vary in severity, with the relapsing-remitting type being especially debilitating."
This quote from Mr. DeMonacos article has, in the online MS community, been a great source of laughter, disdain and out right disbelief.
To publish an article with such an absurd statement in it, renders his whole article laughable.
If Mr. DeMonaco knows anything whatsoever about MS and its varying degrees, he surely should know that RRMS is the LEAST debilitating form of the disease.
And the fact that your website claims that medical content is reviewed by the Harvard school of medicine is another laugher. Reviewed for what? Punctuation???
Publishing such inaccuracies just shows how those of us with MS are misunderstood. Even by those who supposedly have glowing credentials.
In the future I would hope Mr. DeMonaco would brush up on MS 101 before another feeble attempt at writing for your web site.
And I'm resonably sure most MS'ers out there who have read this piece won't be back here. As I won't.
I Y'am What I Y'am - Popeye
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HarryZ
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John,
I'm afraid I am going to have to withdraw my recommendation for the MS Sucks website which I advised is a very controlled site. After being in the center of a very heated thread involving a posting on that site which involved new information on Tysabri and PML, I have been denied any further access over there. The reason doesn't stem from the thread itself but from a related number of private messages between myself and the moderator. What started off very positively turned very nasty when he made a sarcastic, demeaning reply to my attempt at telling him that my intention in a previous message was not what he thought. Since he holds all the cards and didn't like it when I responded back to him in the same manner, he pulled the plug on me.....something I knew he would do.
That moderator can't come close to the professional level that we enjoy with Arron over here.
Harry
I'm afraid I am going to have to withdraw my recommendation for the MS Sucks website which I advised is a very controlled site. After being in the center of a very heated thread involving a posting on that site which involved new information on Tysabri and PML, I have been denied any further access over there. The reason doesn't stem from the thread itself but from a related number of private messages between myself and the moderator. What started off very positively turned very nasty when he made a sarcastic, demeaning reply to my attempt at telling him that my intention in a previous message was not what he thought. Since he holds all the cards and didn't like it when I responded back to him in the same manner, he pulled the plug on me.....something I knew he would do.
That moderator can't come close to the professional level that we enjoy with Arron over here.
Harry
HarryZ,
It might be a good idea if you were also barred from this site. I've never seen anything positive in your posts and you seem to have a limitless supply of rumours / bad news relating to Tysabri. The withdrawal of Tysabri was a real blow to many with ms but your 'I told you so' attitude never seems to appreciate the loss of hope felt by many.
An enforced break from these sites will do you no harm.
Enjoy yourself.
Bromley
It might be a good idea if you were also barred from this site. I've never seen anything positive in your posts and you seem to have a limitless supply of rumours / bad news relating to Tysabri. The withdrawal of Tysabri was a real blow to many with ms but your 'I told you so' attitude never seems to appreciate the loss of hope felt by many.
An enforced break from these sites will do you no harm.
Enjoy yourself.
Bromley
You know I kind of like Harry. At least he's not in the "main stream". He's not like the many sheep who follow what garbage the pharmas toss out to us. Read the article above by Harold DeMonaco. Smell it?? The tie to Biogen I mean.
Don't blame Harry for what happened. My wifes Neuro would'nt even discuss Tysabri when we brought it up. He felt it was way to early to make a judgement on the drug. And you what? He was right. He's a wise and cautous man.
Harry can have his opinion if he wants. I'm old enough and smart enough to either agree or disagree with him. And I'm much to thick skinned to let what strangers on the internet say bother me.
If we start banning evryone we disagree with pretty soon you have no message board at all.
And if you have not read anything positive that Harry has written, you have not looked very hard.
Don't blame Harry for what happened. My wifes Neuro would'nt even discuss Tysabri when we brought it up. He felt it was way to early to make a judgement on the drug. And you what? He was right. He's a wise and cautous man.
Harry can have his opinion if he wants. I'm old enough and smart enough to either agree or disagree with him. And I'm much to thick skinned to let what strangers on the internet say bother me.
If we start banning evryone we disagree with pretty soon you have no message board at all.
And if you have not read anything positive that Harry has written, you have not looked very hard.
I Y'am What I Y'am - Popeye
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SarahLonglands
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HarryZ
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Bromley,
Everyone is entitled to their opinion. As you have probably read by now in this thread, not everyone happens to agree with yours.
I can remember in the early Tysabri threads how people loved to really go after me for all the "nasty rumors" on Tysabri. Spreading false information, getting everyone upset is what some said when that's all I tried to do was warn everyone about the dangers of this drug that I was told about by some pretty clever people involved with MS. And you know what has upset me the most about Tysabri and Biogen....the end result that hurt and caused more frustration in MS patients than I can imagine. That's what my original fear was when Biogen started to go into over-drive with this drug. I have seen so many people suffer from MS over the past 40 years that at times now, it really wears me down.
And when those "rumors" became true some people now get angry with me and accuse me of the "I told you so" syndrome! I guess it will never end because I'm sure around the next corner, there will be another accusation labeled against me for something.
But you know, I use my real name on every MS site that I visit, I regularly post my personal e-mail on these forums whenever someone wants it and I have never used an alias. I can't be any more open.
But like one reader who sent me a private message suggested, maybe you should join the MS Sucks website and feel more comfortable. From a post of one of those members just the other day, he didn't have too much nice to say about the members of ThisIsMs. Then again, he got banned from this site so that was expected.
Harry
Everyone is entitled to their opinion. As you have probably read by now in this thread, not everyone happens to agree with yours.
I can remember in the early Tysabri threads how people loved to really go after me for all the "nasty rumors" on Tysabri. Spreading false information, getting everyone upset is what some said when that's all I tried to do was warn everyone about the dangers of this drug that I was told about by some pretty clever people involved with MS. And you know what has upset me the most about Tysabri and Biogen....the end result that hurt and caused more frustration in MS patients than I can imagine. That's what my original fear was when Biogen started to go into over-drive with this drug. I have seen so many people suffer from MS over the past 40 years that at times now, it really wears me down.
And when those "rumors" became true some people now get angry with me and accuse me of the "I told you so" syndrome! I guess it will never end because I'm sure around the next corner, there will be another accusation labeled against me for something.
But you know, I use my real name on every MS site that I visit, I regularly post my personal e-mail on these forums whenever someone wants it and I have never used an alias. I can't be any more open.
But like one reader who sent me a private message suggested, maybe you should join the MS Sucks website and feel more comfortable. From a post of one of those members just the other day, he didn't have too much nice to say about the members of ThisIsMs. Then again, he got banned from this site so that was expected.
Harry
Sorry, time to leave the board.
-finn
-finn
Last edited by finn on Sun Aug 28, 2005 1:30 pm, edited 1 time in total.
HarryZ,
I don't really want to see you barred - I was just being a bit cheeky.
I know that you have a lot of knowledge about ms and participate in a number of ms websites. It would just be nice to get some postings from you on other ms issues that you know about / come across - the Tysabri postings often come across as flogging a dead horse. My recent posts have been on neuro-protection, gene therapy and stem cells. These all look like possible areas where better treatements for ms sufferers may result.
Ian
I don't really want to see you barred - I was just being a bit cheeky.
I know that you have a lot of knowledge about ms and participate in a number of ms websites. It would just be nice to get some postings from you on other ms issues that you know about / come across - the Tysabri postings often come across as flogging a dead horse. My recent posts have been on neuro-protection, gene therapy and stem cells. These all look like possible areas where better treatements for ms sufferers may result.
Ian
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HarryZ
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Finn,
Thank you for your opinion which of course I value.
Out of curiosity, you mentioned that I should have got my facts straight about that quote that Cherie posted on MS Sucks. The source of information on that quote came from a doctor who attended the recent AAN conference. That was eventually made known on BT....in fact that entire quote was eventually posted on BT by another member of MS Sucks. Are you saying that the facts were wrong or that it should have never been posted over there because it wasn't verified?
I will certainly agree with you re: ThisIsMs vs BT. And yes, the Histamine board can be very questionable but I believe most of their readers are MS patients who have tried the conventional MS treatment route with total failure. It isn't surprising that they have chosen another path.
Harry
Thank you for your opinion which of course I value.
Out of curiosity, you mentioned that I should have got my facts straight about that quote that Cherie posted on MS Sucks. The source of information on that quote came from a doctor who attended the recent AAN conference. That was eventually made known on BT....in fact that entire quote was eventually posted on BT by another member of MS Sucks. Are you saying that the facts were wrong or that it should have never been posted over there because it wasn't verified?
Without going back and re-reading the BT thread, I believe it was stated that this information was subject to verification. Since it came from a doc who attended the AAN conference and Cherie felt it credible enough to post, I believed that it had more than a vague rumor status. Obviously many people felt otherwise.Rumors just aren't enough, especially the ones originally told on another board by a nick like "Clinical1".
Of course there are but Behan's paper really went out on the limb against pretty much most of the previous, conservative based theories and comments about MS research. And then you look at where we are with MS today after decades of work (no cause, no cure and extremely limited effects of current medications) you have to wonder just how right he may be.es, there are also other critical research papers, not just the one by P. O. Behan.
I will certainly agree with you re: ThisIsMs vs BT. And yes, the Histamine board can be very questionable but I believe most of their readers are MS patients who have tried the conventional MS treatment route with total failure. It isn't surprising that they have chosen another path.
Harry
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HarryZ
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Ian,
Thank you for the clarifcation but like I've said many times, getting the correct intention from written posts can sometimes be difficult. And don't I know that after the past week or so! What would have been great in your first post would have been to place a
at the end of your comment and that would have clearly indicated your meaning.
Harry
.I don't really want to see you barred - I was just being a bit cheeky
Thank you for the clarifcation but like I've said many times, getting the correct intention from written posts can sometimes be difficult. And don't I know that after the past week or so! What would have been great in your first post would have been to place a
at the end of your comment and that would have clearly indicated your meaning.Perhaps not on this forum but I do post many messages that have nothing to do with Tysabri on other MS forums....family relationship issues, choosing docs and recently a thread here involving college grads discussing other possible causes of MS. I follow several MS Forums (8 at last count) which have varied topics so I do indeed get involved with far more than just Tysabri. (although it may be hard to believe if you follow the Tysabri threads here.)I know that you have a lot of knowledge about ms and participate in a number of ms websites. It would just be nice to get some postings from you on other ms issues that you know about / come across - the Tysabri postings often come across as flogging a dead horse. My recent posts have been on neuro-protection, gene therapy and stem cells. These all look like possible areas where better treatements for ms sufferers may result.
Harry
Sorry, time to leave the board.
-finn
-finn
Last edited by finn on Sun Aug 28, 2005 1:31 pm, edited 1 time in total.
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HarryZ
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Finn,
In the past I have trusted Cherie's information because on many occasions, her information proves to be quite accurate. (although others would debate that) But I can assure you that I wasn't looking for entertainment or as one person on MS Sucks said, I relished in the "scoop" nature of the information. Hec, the information had already been posted by someone else on that forum so there wasn't any "scoop" at all!
Take care.
Harry
Yes, your are correct in stating that I copied part of the information from MS Sucks and posted it on BT. Knowing how info from Cherie in the past has made its way to other forums on the net, my feeling was that info would be making out sooner rather than later. In retrospect, and to avoid the resulting wrath, I probably should have left it alone and waited for someone else to announce it.Well, it was your decision to spread the rumour. You seem to trust the way Cherie interprets the information she receives. I don't mind, it makes reading the forums quite entertaining
In the past I have trusted Cherie's information because on many occasions, her information proves to be quite accurate. (although others would debate that) But I can assure you that I wasn't looking for entertainment or as one person on MS Sucks said, I relished in the "scoop" nature of the information. Hec, the information had already been posted by someone else on that forum so there wasn't any "scoop" at all!
You are quite correct over that gap but I think one of the big reasons for that is the nature of MS information itself. MS patients have been waiting decades for some kind real advancement but it hasn't really happened. And now we are hearing some huge differences in opinion on the nature and cause of MS and that is slowly coming from the MS research community. When that situation exists, it only acts as a catalyst for alternative theories which can't be proven or at this point, disproved either.Yes, it is understandable. What really worries me sometimes is the growing gap between "MS theories" presented on different discussion forums and evidence/knowledge based science. On forums like this anybody can write anything, and nobody is in responsible for the consequenses.
Yes, his views may very well be closer to the truth...at least that is the way that I have been leaning for a few years now. Prineas and Barrett have certainly opened a few eyes with their autopsy info. Perhaps looking in another direction may get the cure sooner than later. Who knows.Btw, you are right. Behan's point of view may be closer to the truth than the consensus opinion. But there are also other researchers that don't accept the current theory of MS being primarily an autoimmune disease.
Take care.
Harry