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Biotech / Medical : MEDX ... anybody following?
MEDX 31.14-0.1%10:04 AM EDT

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To: scaram(o)uche who wrote (2184)6/25/2009 4:02:12 AM
From: tuck1 Recommendation  Read Replies (2) of 2240
 
>>if you can't do science, write about it<<

I don't think Derek Lowe has ever tried to represent himself as someone with deep experience in immunotherapy. Did you do the search on Lowe's career before publicly questioning his productivity? What's your definition of productivity?

>>You didn't attack two PRODUCTIVE (to contrast with Derek) scientists from Mayo.<<

Neither did Derek Lowe, He attacked Mayo as a whole. I grant you, he could have been more precise and attacked the PR dept., where the problem most likely lies. And for some reason, he didn't link the actual Mayo PR. I had to go dig that fluff up myself.

>>if you CAN invest, why not do it instead of blogging?<<

Why not do both if one is so moved? I think he failed when shorting ImClone, but don't know about the rest of his investment track record. So, 1 out of 1, he can't invest and should indeed be blogging.

Whatever. I actually agree with some of what you say.

The investigators' more relevant experience carries more weight.

I sort of agree about the 2 of 2 part, but don't think either one of us believes that after the ipilimumab dose every patient in this trial could have had this result but lost it because of continuation of other parts of the treatment (here's the protocol: clinicaltrials.gov. It would appear the other 51 guys didn't get the drop in PSA count that led to the dropout for surgery decision. The PR makes it clear these two went through the protocol as far as treatment was concerned but dropped out before their endpoint of progression was determined. Treatment prior to surgery was per protocol, ablation then antibody (I can find no info on how closely one followed the other). 2 out of 2? OK, fine. Awfully small data set, though. What about the third guy, who got the same treatment, and had dramatic results but didn't drop out for surgery? 1 out of 52? I see a valid case for ITT to claim a 3/54 with somewhat more confidence because the sample size is larger, and the dropouts are related to outcome.

I agree that it is indeed a physician sponsored trial, and the investigators have the right to talk about these patients. But when they say things like Dr. Kwon's closing comment: "This is one of the holy grails of prostate cancer research," says Dr. Kwon. "We've been looking for this for years," without offering a balanced comment like, "This is anecdotal and preliminary, we don't really know if it's the combo or the antibody or the ablation that led to this response," well, I can't fault Lowe for offering that balance, even if he has nothing else to add. Note again that Lowe doesn't fault the investigators specifically, he faults Mayo. I think that is appropriate. Dr. Kwon's comment was probably taken out of context by the Mayo PR staff.

Susan Perry of the Minnesota Post, actually did get some balance and color -- that Mayo itself did not give in its PR (you read the Mayo PR I linked, right? Here it is, again, just in case you need it handy: mayoclinic.org -- as posted by Erik (my thanks, too, Erik, for all you do here!):

Message 25727420

Including numbers, of a sort. 3/54 with "dramatic results." Not bad for advanced patients, perhaps? Including caveats sorely missing from the Mayo PR. Incidentally, her report is also in blog form. Should we all go check her qualifications and representations? Who has the time for such trivia? Anyhow, I have no problem with her version.

I'd be willing to bet Dr. Kwon supplied the same numbers & caveats he offered to Ms. Perry to his institution's PR dept., and the Mayo PR dept. chose not to mention them. The closest the Mayo PR dept. came to balance is this: "Further research is being planned to understand more about the mechanisms of the antibody and how best to use the approach in practice."

Sorry we got our hackles up over this. It's not Lowe's fault, my fault, the investigators' fault, or your fault. I blame the Mayo PR dept. If they don't like that, they can come out & try to set me straight.

My own feeling (unqualified, unproductive, just from following the company) is that it is a provocative finding, and certainly grounds for cautious optimism. It has seemed to me that normal trial design gives ipilimumab and its ilk short shrift, as it apparently takes longer to really kick in than standard chemo, and the latter's longer track record & more immediate action has led to current protocols. It will take longer and be more difficult and expensive to prove ipilimumab out, at least as monotherapy. This is, of course, not news to you. Perhaps these responses will provide some impetus for that kind of research. In the meantime, I find it interesting that one dose and off the protocol produced this effect. Looking forward to the higher dose version of this trial, but it doesn't start till this fall, so it's going to be a good year before we hear much, I'd guess.

Cheers, Tuck
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