Hi, Joe - Please allow me to ramble a bit, here...I know this stuff must bore the hell out of the jaded old-timers.
"I also believe Dr. Pugen has had results, using WF10 on his patients, that can be attributed to more than chance or random possibility. I don't believe the system in Canada is anywhere near the US in terms of litigiousness, but one has to think that prescribing a treatment that is yet unapproved, and available only through HC's Emergency Drug Release program, could result in some serious consequences for the physician if it resulted in adverse clinical reactions. Those consequences could vary from law suits to serious reprimands from the College of Physicians and Surgeons."
Yes, that's it exactly. One has to look at the risks for the physician - even in a best-case scenario, risk never disappears.
My impression of Dr. Pugen is "outstanding". Believe it or not, that opinion wouldn't change if I didn't own DMX. While it's easy enough to say that he's treating people who have exhausted all other possibilities, it's also apparently true that he has witnessed remarkable success with WF10 therapy, for an extended period of time.
I have seen this sort of debate around therapies before, and never paid much attention. To be honest, I've usually categorized such events as crank medicine, or bad data. I've tended to side with the orthodox view. So I approached this question with considerable scepticism.
Recalling the spillover from Burroughs-Wellcome (now Glaxo) and AZT, and others such as INC, there is a legacy of mistrust around such drugs, and therapies.
Even without any attempt to distort data, anecdotal information is dangerous; the patient population is not randomized, no control, etc., etc.
My point here is that in addition to the obvious risks (ethical, professional, medical) there is the risk in perceptions.
"It's one thing to stick your neck out for a drug that is unpopular, but still approved. However, to stick your neck out for an unapproved, unorthodox and unheard of drug, would suggest that you are pretty confident in its safety and efficacy. Granted, there is likely profit in there somewhere for him, as the treatment is not currently cheap, however I don't know if the profit outweighs the potential risks associated with something going wrong."
This is the source of "outstanding". I personally believe that the risks far outweigh the rewards. My sense is that this guy is advocating a therapy for his patients on the basis of efficacy, motivated by a desire to see the patients return to health: what's good for them, not him. This is of course, an ethical call of the highest order, and one that most physicians would simply not be bothered to attempt: too dangerous, too unorthodox.
That's my impression. The present risks far outweigh the possible gains. Personal gain must, of course, be figured into the equation. My take on it (especially in comparison to the norms) is that the patient is first, personal gain is second, though not absent - and why should it be?
Put it another way; if there were no possibility of personal gain from WF10 therapy for him, would Dr. Pugen continue to advocate and use WF10? My impression? Yes.
"I've heard first hand myself from WF10 patients, and I've heard nothing but great things. So much like Pennsaid, the people who have actually used it, swear by it. I've yet to hear even a rumour of somebody who had a bad experience. If there were bad clinical experiences with WF10, I'm sure HC would have taken the drug off its program already."
I wondered whether anyone in Vancouver has received WF10 therapy (I know St. Paul's is part of P3; I'm thinking more in terms of another "Dr. Pugen" out here) - but the question of how to approach the matter has defeated me. I also wish I had a better sense of why WF10 has failed, when it has failed.
There is no evidence that SAE's have been a problem, and the FDA visits, permitting the continuance of P3, support that conclusion.
"Those are just my thoughts Jim. I'm not trying to convince anyone one way or the other."
Just so. IMO, that is the purpose of these threads. Neither am I trying to convince anyone - I'm simply looking to discuss the matter with informed people, to expand and qualify my understanding.
Thanks for your thoughts, Joe.
Best regards,
Jim |
