It is a worry if a drug company is able to find some way of stopping publication of the results of a study Dr Michael Wilks, BMA ----->http://news.bbc.co.uk/2/hi/health/2352839.stm;o)
Delighted,How DO you manage to get my goat so often? I should have a small herd of them so you could borrow one as you please and return it when you're done with it. The article is inflammatory even though it raises several valid points.But it is stilted against the pharma/med community all the same; we both know how carefully chosen words can turn a "suspect" into a "murderer".As a case study, an Army buddy of mine volunteered for a study. Military folks are choice meat for healthy-patient trial phases because they're periodically tested for AIDS, are (generally) in the top 5% of the US population for fitness, and they're desparate for money.He came home (we shared a house along with a wonderful Australian sheepdog and a Golden Retriever From Hell) one day to say he signed up for a trial. He'd get $1400. Already my skin was crawling. The "Are you INSANE?" was chomped down on my tongue."Uh, for what?" 'Oh, some experimental drug for AIDS along with some other drug, they want to see if they interact."Well, Drug X was probably one of the protease inhibitors; NO GRAPEFRUIT ANYTHING was a hint; the other was Rifampin.All of it was uneventful. Thankfully.But I saw the stuff he had to sign, and I do wonder whether he fully understood what he was getting into.On the other hand, my mother in nursing school was part of a cadre to test whether BCG (Bacillus Calmette Guerin) was a vaccine for tuberculosis. Oddly, after decades, nobody is still sure one way or the other. Except God help you if you get a Tine or Mantoux test after BCG vaccination.What is the right, proper, ethical framework for testing drugs and biologicals and even medical devices?Pulling a study because it is flawed, I don't have a problem with; pulling it because you don't like the answers showing up, that's a problem.Actually, no study should ever be pulled; just like medical charts, errors "are lined out with one line of indelible red ink, and the correction or amendment is placed underneath the correcton, along with the reason for it". It worked then, it works now.Honesty and integrity and diligence, whatever it is you do, are intrinsically appropriate. And as we have seen too vividly, failure to adhere to basic core values have led to enormous consequences.RSH.
RSHHave no intention of getting your goat---just posting things i find interesting and valid for the most part.The only drug i ever had a very bad reaction to was Enkaid.Shortly thereafter it was pulled off the American market.http://www.drugs.com/xq/cfm/pageID_0/htm_202212/type_cons/bn_Enkaid/micr_medex/qx/index.htm;o)
RSHHave no intention of getting your goat---just posting things i find interesting and valid for the most part.The only drug i ever had a very bad reaction to was Enkaid.Shortly thereafter it was pulled off the American market.http://www.drugs.com/xq/cfm/pageID_0/htm_202212/type_cons/bn_Enkaid/micr_medex/qx/index.htm;o) You can borrow one of my goats anytime you find it necessary.Elsewhere, somewhere on TMF, either here or in biotech you;ll read a lot I wrote about antiarrythmics.I suspect that Enkaid (what a rotten link you gave me this time) is related to flecainamide; if I am not further mistaken, your drug was part of the same massive CAST study. (Go look for my damn notes, my back hurts and I'm cranky.) I got up and looked up Tambocor, just for you. Riker/3M makes that and that was the other drug in the CAST study.The bottom line is they are all risky, especially depending on the Class. And unless electrolytes, blood gases, and other supportive measures are used, they can all be very deadly.A leading cardiologist once told me "Yeah, they work, sometimes, we think. Maybe. We just don't know. We do every test that exists, and use our best judgement, and we still don't know for sure which patient will do better with or without these new drugs, or the old ones. A post MI patient, well, you do your best."Thank you very much, I'm glad all I need at present are antihistamines and pain killers.The CAST study was terminated early because more treated patients were having poor outcomes than placebo patients. It was probably the most extensive study of antiarrythmics in post-MI patients ever conducted.To hear years after the results, "Well, you just never know, really" from someone going to head a major cardiology unit made me wonder.RSH.
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