Should Pharma Companies Disclose Failed, not just Successful, Studies?
One aspect of the labeling deserves special mention. The [report] not only describes the clinical trials providing evidence of citalopram’s antidepressant effects, but make mention of adequate and well-controlled clinical studies that failed to do so… The Office Director is inclined toward the view that the provision of such information is of no practical value to either the patient or prescriber. I disagree. I believe it is useful for the prescriber, patient, and 3rd-party payer to know, without having to gain access to official FDA review documents, that citalopram’s antidepressants effects were not detected in every controlled clinical trial intended to demonstrate those effects. I am aware that clinical studies often fail to document the efficacy of effective drugs, but I doubt that the public, or even the majority of the medical community, is aware of this fact. I am persuaded that they not only have a right to know but that they should know. Moreover, I believe that labeling that selectively describes positive studies and excludes mention of negative ones can be viewed as potentially “false and misleading.” (Leber, May 4, 1998).
|
2
points
1
point
I'm not against this but...? Disclose where? Are you talking about a webpage with the FDA or are you talking phone call to the nightly news? Because only a small fraction of stuff that enters clinical trials will make it to market. Do you really want to hear about 100 failures for every 1 success? And whom does that even serve? If the 1 success genuinely works then scaring people with the other 99 does a disservice to society. Disclose at what level? Because there are studies in the test tube, studies in small animals, studies in big animals, studies in humans. Do you really want to know if an experiment not yet involving a living thing went poorly? Or what if something with mice failed? Finally, what do you think you're going to learn? Do you think somehow this is going to incriminate companies? Not at all. Conducting a study as long as done properly is completely legal. Finding out a study fails is all part of the scientific method. And when one thing fails another different thing may get studied which moves ahead. The success of the different thing shouldn't be tarnished at all by the failure of the attempts which preceded it. 1
point
Drugs that get approved by the FDA need only a certain number of successful studies. It could have any number of studies showing minimal efficacy, if any, or even negative effects. All it needs is those few success stories to root out the bad stuff, and when a company has spent a billion dollars in R&D;, they are going to work hard to get those success stories. Even if not patients (though I believe patients, too, have a right to know all the scientific data available regarding what they put into their bodies voluntarily or otherwise, especially when there are negative data), at least doctors should be given access to such information so that they might make an informed decision regarding what they prescribe to their patients. Are you talking about a webpage with the FDA That works. Because only a small fraction of stuff that enters clinical trials will make it to market. I'm talking about the drugs that get approved. If they don't get approved, there is no reason to disclose any information whatsoever on them. Do you think somehow this is going to incriminate companies? Not at all. Conducting a study as long as done properly is completely legal. The only incrimination (social, not legal) I see is deceptive marketing practices, as Leber (and Irving Kirsch, from which the quote above originates) argue. I can't see the value of it. What I would REALLY like to see is the actual cost of development and production divided into the amount we are forced to pay, and how long it will take to recover the costs. Most. I believe, would be paid for and producing indecent profits for them in MONTHS! At 2-300 (or more) times the actual cost of the product, it can't take long! I am having laser surgery for the next few weeks. Eye drop bottles (3) half the size of my thumb .... $400 (If I didn't have insurance). But then, add the cost of that insurance and BOTH the Drug and Insurance company are taking FAR more of my (and everyone else's ) money than they should! |
