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"Over the years, thousands of people taking or withdrawing from Paxil or other psychiatric drugs have committed violent acts, including suicide, experts said, t

by petra 11y ago

"Over the years, thousands of people taking or withdrawing from Paxil or other psychiatric drugs have committed violent acts, including suicide, experts said, though no firm statistics are available. Because many factors could have contributed to that behavior, it is still far from clear who is at risk — and for whom the drugs are protective."[1] So we have a case where thousands of people we're put at a big risk,with clearly illegal practices , and nobody is going to jail ? and on the other hand, no major systemic change has happened - like taking the responsibility for clinical testing , and drug advertising out of drug developer's hands ? How will anybody learn ? [1]http://www.nytimes.com/2015/09/17/health/antidepressant-paxil-is-unsafe-for-teenagers-new-analysis-says.html?ref=health&_r=0 http://www.nytimes.com/2015/09/17/health/antidepressant-paxi...

danso 11y ago
Not playing devil's advocate here, but just to point out why things that seem obviously black-and-white don't seem to be nipped in the bud. Drug companies are not allowed to advertise drugs for any reason than what they were officially approved for. However, doctors are allowed to have discretion in this matter...for example, if they know a certain drug prescribed only for, say, hair loss, is also good for erectile dysfunction, and they've read enough of the literature to prescribe this confidently...then they don't have to go strictly by FDA regulations. This freedom is not a bad thing in itself...I mean, it reflects the reality that have effects (good and bad) that are independent of a regulatory process. One extreme case that I can remember is when Avastin -- originally prescribed to fight cancer -- was found to be as effective for treating eye disease at $50 a pop as a drug that cost $1,950 [1]...and so there was controversy over whether doctors should be allowed to prescribe Avastin before it was officially approved by the FDA for this usage. So it became obvious to drug companies that if they advertise/befriend doctors, they could influence them to prescribe drugs for these off-label uses. Maybe some of those uses were completely legitimate (and profitable). Some obviously should not have been pushed for off-label use, such as highly-addictive painkillers approved only for use by the most serious cancer afflictions being prescribed to people with migraines. When you consider that highly competitive pharma sales reps had the ability to basically know exactly how much each doctor prescribed on a weekly (daily?) basis, and thus, how much to visit and chat them up...you basically have a bunch of not-technically-illegal-things that were maybe fine on their own, but added up, eventually, to what the Justice Dept. considered to be fraudulent activity. [1] http://www.wsj.com/articles/SB10001424052702304868004577376310954390608 http://www.wsj.com/articles/SB100014240527023048680045773763...

by petra 11y ago

danso 11y ago

Not playing devil's advocate here, but just to point out why things that seem obviously black-and-white don't seem to be nipped in the bud. Drug companies are not allowed to advertise drugs for any reason than what they were officially approved for. However, doctors are allowed to have discretion in this matter...for example, if they know a certain drug prescribed only for, say, hair loss, is also good for erectile dysfunction, and they've read enough of the literature to prescribe this confidently...then they don't have to go strictly by FDA regulations. This freedom is not a bad thing in itself...I mean, it reflects the reality that have effects (good and bad) that are independent of a regulatory process. One extreme case that I can remember is when Avastin -- originally prescribed to fight cancer -- was found to be as effective for treating eye disease at $50 a pop as a drug that cost $1,950 [1]...and so there was controversy over whether doctors should be allowed to prescribe Avastin before it was officially approved by the FDA for this usage. So it became obvious to drug companies that if they advertise/befriend doctors, they could influence them to prescribe drugs for these off-label uses. Maybe some of those uses were completely legitimate (and profitable). Some obviously should not have been pushed for off-label use, such as highly-addictive painkillers approved only for use by the most serious cancer afflictions being prescribed to people with migraines. When you consider that highly competitive pharma sales reps had the ability to basically know exactly how much each doctor prescribed on a weekly (daily?) basis, and thus, how much to visit and chat them up...you basically have a bunch of not-technically-illegal-things that were maybe fine on their own, but added up, eventually, to what the Justice Dept. considered to be fraudulent activity. [1] http://www.wsj.com/articles/SB10001424052702304868004577376310954390608 http://www.wsj.com/articles/SB100014240527023048680045773763...