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Discussion Starter · #1 ·
Today's Boston Globe has an interview with Dr. Jeffrey Drazen, the editor-in-chief of the New England Journal of Medicine, regarding the public registration and publication of all drug trial information -- not just the favorable ones that we typically see now. It's a small step but a step in the right direction.Here's the gist of the interview:
quote: Q. What long-term impacts will the trial registry have?For one thing, drug companies will think three times before they initiate a frivolous clinical trial, such as a ''seeding" trial in which the scientific hypothesis is marginal, but it gets the drug into the hands of a lot of physicians. Research shows that if a doctor has been an investigator, they're more likely to prescribe the drug in the future. This is really marketing disguised as research, and it will be diminished, which is a good thing. The second thing is this will enforce a discipline that hasn't existed in clinical trials. If you have to post your hoped-for outcomes at the start of a trial, you can't fudge it when the data come back. Sometimes researchers change what they look at, or focus on a subgroup or a slightly different endpoint. It's called outcome creep.Q. Why are these changes important?Clinical research in which drug companies develop a new drug is different from any other kind of research. You have altruistic patients who put themselves at risk because they believe it will lead to improved health for others. Currently, they're being treated just like mice: the data are a commodity, the drug company keeps the data secret, the drug company tells you what it wants when it wants. But because people are putting their health on the line to volunteer for trials, this needs to be a card game that is played with all the cards face up.
Here's the link for the full interview: Q&A Dr. Jeffrey M. Drazen on drug trial results
 

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This IS great news. Really great article. Thanks(again)
Finally, people are beginning to hold the FDA & incredibly powerful drug companies accountable.Here's another sign of positive change~"Members of Congress blast FDA, drug makers"Friday, September 10, 2004 http://www.cnn.com/2004/HEALTH/conditions/...n.ap/index.html But of course the FDA & some companies claim "too much information would confuse us." Grrrr.
 

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This IS great news. Really great article. Thanks(again)
Finally, people are beginning to hold the FDA & incredibly powerful drug companies accountable.Here's another sign of positive change~"Members of Congress blast FDA, drug makers"Friday, September 10, 2004 http://www.cnn.com/2004/HEALTH/conditions/...n.ap/index.html But of course the FDA & some companies claim "too much information would confuse us." Grrrr.
 

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Talissa,do you live in a bunker?
IVAN is a MONSTER!!!80% of the home in a island are destroyed.
 

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Talissa,do you live in a bunker?
IVAN is a MONSTER!!!80% of the home in a island are destroyed.
 

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LOL!!! You're THE BEST Spasman.Like K said, we're not too close to the islands Ivan's barreled through--feeling extremely lucky about that too. Knock on wood.The only thing we got from Ivan was some wave action. Didn't feel anything at all from Frances.Just dumb luck so far.We're contributing to a canned food drive for the folks in Grenada--they are so bad off right now. Will probably be doing the same for those in Jamaica & Grand Caymen. This Ivan is such a monster, very scary.T-
 

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LOL!!! You're THE BEST Spasman.Like K said, we're not too close to the islands Ivan's barreled through--feeling extremely lucky about that too. Knock on wood.The only thing we got from Ivan was some wave action. Didn't feel anything at all from Frances.Just dumb luck so far.We're contributing to a canned food drive for the folks in Grenada--they are so bad off right now. Will probably be doing the same for those in Jamaica & Grand Caymen. This Ivan is such a monster, very scary.T-
 

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Discussion Starter · #10 ·
quote: But of course the FDA & some companies claim "too much information would confuse us." Grrrr.
I think it is totally disgraceful. One drug company argument is that drug trial documents can exceed 400,000 pages. IMHO, a 399,999 page
For any drug trial, I only need a one page summary that explains the overall safety and efficacy of the tested drug. I just want to know if anyone died or was made ill from it and did it significantly improve their symptoms (or cure what it was meant to cure). I would think this info would be in any executive summary prepared for decision makers. I would be very surprised if it was not on page 1 of the final report. Right now, the bar that big pharma has to leap over is pretty darn low. They only need to show that some new drug works better than a sugar pill. I'd love to see this standard raised significantly higher than it is now.One of the spearheads for this effort is Marcia Angell (MD, Harvard Professor, former editor-in-chief of the New England Journal of Medicine). Her book was just published recently. I have only read excerpts but she makes a compelling case: The Truth About the Drug Companies Of course, she is not without her detractors: The Truth About Marcia Angell
 

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Discussion Starter · #11 ·
quote: But of course the FDA & some companies claim "too much information would confuse us." Grrrr.
I think it is totally disgraceful. One drug company argument is that drug trial documents can exceed 400,000 pages. IMHO, a 399,999 page
For any drug trial, I only need a one page summary that explains the overall safety and efficacy of the tested drug. I just want to know if anyone died or was made ill from it and did it significantly improve their symptoms (or cure what it was meant to cure). I would think this info would be in any executive summary prepared for decision makers. I would be very surprised if it was not on page 1 of the final report. Right now, the bar that big pharma has to leap over is pretty darn low. They only need to show that some new drug works better than a sugar pill. I'd love to see this standard raised significantly higher than it is now.One of the spearheads for this effort is Marcia Angell (MD, Harvard Professor, former editor-in-chief of the New England Journal of Medicine). Her book was just published recently. I have only read excerpts but she makes a compelling case: The Truth About the Drug Companies Of course, she is not without her detractors: The Truth About Marcia Angell
 

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T-Q-LOL!!! You're THE BEST Spasman.I know,that's what my ex-wife told me.
 

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T-Q-LOL!!! You're THE BEST Spasman.I know,that's what my ex-wife told me.
 
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