Comments for Postscript http://postscript.communitycatalyst.org A Blog by Community Catalyst Thu, 27 Dec 2012 17:22:20 +0000 hourly 1 http://wordpress.org/?v=3.3.1 Comment on Say Anything: Does 2nd Circuit Ruling in Caronia Protect All Off-Label Marketing? by Michael Silver http://postscript.communitycatalyst.org/?p=3254&cpage=1#comment-19356 Michael Silver Thu, 27 Dec 2012 17:22:20 +0000 http://postscript.communitycatalyst.org/?p=3254#comment-19356 That is not to say that the court ruling makes any sense at all. A salesperson operating on behalf of a drug company is making factual claims about a drug when they endorse an off-label use of that drug, even if there isn't evidence for that use. It's not a free speech issue, but a consumer fraud issue. A salesperson, in this realm, is acting as an advertisement. With advertisements, especially with pharma advertisements there are strict rules on claims that can and can't be made. It boggles my mind that the court felt that a drug rep is not acting as a walking advertisement when they make claims about a drug. That is not to say that the court ruling makes any sense at all. A salesperson operating on behalf of a drug company is making factual claims about a drug when they endorse an off-label use of that drug, even if there isn’t evidence for that use. It’s not a free speech issue, but a consumer fraud issue.

A salesperson, in this realm, is acting as an advertisement. With advertisements, especially with pharma advertisements there are strict rules on claims that can and can’t be made.

It boggles my mind that the court felt that a drug rep is not acting as a walking advertisement when they make claims about a drug.

]]> Comment on Say Anything: Does 2nd Circuit Ruling in Caronia Protect All Off-Label Marketing? by Michael Silver http://postscript.communitycatalyst.org/?p=3254&cpage=1#comment-19355 Michael Silver Thu, 27 Dec 2012 16:45:24 +0000 http://postscript.communitycatalyst.org/?p=3254#comment-19355 In reading this I begin to wonder how a drug becomes used off-label? There are many drugs whose off-label use is necessary. I know that I have family members who had IBS, for instance, and were prescribed SSRIs. Obviously there is no indication, according the FDA, for this use, but they found these drugs helpful. I think that we enter a bit of a conundrum: It's very difficult for a pharma company to get a drug approved for a second indication and many off-label uses of drugs are helpful (not all, but a lot). If the suggestion for these uses doesn't come from the pharma company then aren't we relying on the doctors to figure this out for themselves? and is it realistic that it would happen? I'm torn:off-label use of drugs are often a good thing, but a Pharma company marketing said use should very much be forbidden. Clear conflict of interest. But then how to we get drugs to be used safely and off-label? Even having a physician do research on a drug to see if it works off-label would require a IND (Investigational New Drug)? I think. In reading this I begin to wonder how a drug becomes used off-label? There are many drugs whose off-label use is necessary. I know that I have family members who had IBS, for instance, and were prescribed SSRIs. Obviously there is no indication, according the FDA, for this use, but they found these drugs helpful.

I think that we enter a bit of a conundrum: It’s very difficult for a pharma company to get a drug approved for a second indication and many off-label uses of drugs are helpful (not all, but a lot). If the suggestion for these uses doesn’t come from the pharma company then aren’t we relying on the doctors to figure this out for themselves? and is it realistic that it would happen?

I’m torn:off-label use of drugs are often a good thing, but a Pharma company marketing said use should very much be forbidden. Clear conflict of interest. But then how to we get drugs to be used safely and off-label?

Even having a physician do research on a drug to see if it works off-label would require a IND (Investigational New Drug)? I think.

]]> Comment on Say Anything: Does 2nd Circuit Ruling in Caronia Protect All Off-Label Marketing? by Lynn Parry, M.D. http://postscript.communitycatalyst.org/?p=3254&cpage=1#comment-19187 Lynn Parry, M.D. Sat, 22 Dec 2012 00:37:20 +0000 http://postscript.communitycatalyst.org/?p=3254#comment-19187 First amendment legal arguments have no place in health care. This continual application of business ethics, "buyer beware" policies and "free-speech" arguments are inappropriate in a system with the substantial knowledge gap that exists in medicine. Patient safety depends on trust that providers will base recommendations on truthful evidence. Providers, in turn, expect PhRMA reps to provide valid "education". The fact that reps only market with half or no-truths will never be understood unless all aspects of health care are held to the same standard and misrepresentation is fully prosecuted. First amendment legal arguments have no place in health care. This continual application of business ethics, “buyer beware” policies and “free-speech” arguments are inappropriate in a system with the substantial knowledge gap that exists in medicine. Patient safety depends on trust that providers will base recommendations on truthful evidence. Providers, in turn, expect PhRMA reps to provide valid “education”. The fact that reps only market with half or no-truths will never be understood unless all aspects of health care are held to the same standard and misrepresentation is fully prosecuted.

]]> Comment on DPH Revives Pharma-Funded Meals in Massachusetts and Guts Disclosure Law by Lynn Parry, M.D. http://postscript.communitycatalyst.org/?p=3236&cpage=1#comment-18726 Lynn Parry, M.D. Wed, 26 Sep 2012 02:09:50 +0000 http://postscript.communitycatalyst.org/?p=3236#comment-18726 This is horrifying. This is a move in which there is bipartisan participation (unfortunately)--it is guided by the cries from Business that regulation of any kind discourages investment, loses jobs, is bad for the economy, etc. etc. Patient safety and protection of the public take a back seat. This is horrifying. This is a move in which there is bipartisan participation (unfortunately)–it is guided by the cries from Business that regulation of any kind discourages investment, loses jobs, is bad for the economy, etc. etc.

Patient safety and protection of the public take a back seat.

]]> Comment on Protecting seniors from Abbott’s abuses – the Depakote saga by More Drugmakers Pay More Big Fines | health professions http://postscript.communitycatalyst.org/?p=3222&cpage=1#comment-18086 More Drugmakers Pay More Big Fines | health professions Sun, 10 Jun 2012 04:19:00 +0000 http://postscript.communitycatalyst.org/?p=3222#comment-18086 [...] More Drugmakers Pay More Big Fines Keeping up with our friends over at PostScript/Community Catalyst:http://postscript.communitycatalyst.org/?p=3222http://postscript.communitycatalyst.org/?p=3221 [...] [...] More Drugmakers Pay More Big Fines Keeping up with our friends over at PostScript/Community Catalyst:http://postscript.communitycatalyst.org/?p=3222http://postscript.communitycatalyst.org/?p=3221 [...]

]]> Comment on Anti-fraud efforts by Attorneys-General and the Department of Justice are reaping billions more than expected by Alex http://postscript.communitycatalyst.org/?p=3213&cpage=1#comment-17984 Alex Wed, 30 May 2012 15:50:12 +0000 http://postscript.communitycatalyst.org/?p=3213#comment-17984 Until execs of the offending companies face the prospect of some real jail time, ain't nothing gonna change in how these companies do businesses. The ROI is just too great and too tempting. Indictments now! Until execs of the offending companies face the prospect of some real jail time, ain’t nothing gonna change in how these companies do businesses. The ROI is just too great and too tempting. Indictments now!

]]> Comment on Anti-fraud efforts by Attorneys-General and the Department of Justice are reaping billions more than expected by SJ Johnson http://postscript.communitycatalyst.org/?p=3213&cpage=1#comment-17960 SJ Johnson Fri, 25 May 2012 17:24:31 +0000 http://postscript.communitycatalyst.org/?p=3213#comment-17960 Maybe if management were jailed for fraud and putting public health at risk they would stop this immediately. Maybe if management were jailed for fraud and putting public health at risk they would stop this immediately.

]]> Comment on Anti-fraud efforts by Attorneys-General and the Department of Justice are reaping billions more than expected by Sarah http://postscript.communitycatalyst.org/?p=3213&cpage=1#comment-17959 Sarah Fri, 25 May 2012 16:33:36 +0000 http://postscript.communitycatalyst.org/?p=3213#comment-17959 It is good that the DOJ is using these enforcement techniques, but it would be much better if at least some of the financial gains went into efforts to strengthen prescription drug safety. Because this is not happening, the moneys can be considered ill-gotten in some ways: The fines represent egregious behavior that has resulted in thousands of deaths. Would that the DOJ would use the stronger powers it has; namely, indicting individuals within the pharmaceutical industry who are hiding the raw data from clinical trials and marketing drugs with dangerous, hidden, lethal side effects for the purposes of the bottom line. At stake here is our public health. It is good that the DOJ is using these enforcement techniques, but it would be much better if at least some of the financial gains went into efforts to strengthen prescription drug safety. Because this is not happening, the moneys can be considered ill-gotten in some ways: The fines represent egregious behavior that has resulted in thousands of deaths.

Would that the DOJ would use the stronger powers it has; namely, indicting individuals within the pharmaceutical industry who are hiding the raw data from clinical trials and marketing drugs with dangerous, hidden, lethal side effects for the purposes of the bottom line. At stake here is our public health.

]]> Comment on U.S. Medical Schools make great strides in quest for professionalism of tomorrow’s doctors by Med Schools Improving Their Grades, Students Say | health professions http://postscript.communitycatalyst.org/?p=3202&cpage=1#comment-17331 Med Schools Improving Their Grades, Students Say | health professions Wed, 14 Mar 2012 04:03:28 +0000 http://postscript.communitycatalyst.org/?p=3202#comment-17331 [...] Schools Improving Their Grades, Students Say PostScript at Community Catalyst:http://postscript.communitycatalyst.org/?p=3202–informs us that medical schools continue to improve on the scores they receive from the [...] [...] Schools Improving Their Grades, Students Say PostScript at Community Catalyst:http://postscript.communitycatalyst.org/?p=3202–informs us that medical schools continue to improve on the scores they receive from the [...]

]]> Comment on AMSA, RxP Scorecard: One-fifth of med schools improved their grades by Postscript » Blog Archive » How’s your doctor’s alma mater doing? Scorecard measures progress of academic medical institutions http://postscript.communitycatalyst.org/?p=666&cpage=1#comment-17276 Postscript » Blog Archive » How’s your doctor’s alma mater doing? Scorecard measures progress of academic medical institutions Mon, 12 Mar 2012 19:51:29 +0000 http://blog.prescriptionproject.org/?p=666#comment-17276 [...] 2009, 45 institutions received an A or B, and one-fifth of the schools improved their policies over the [...] [...] 2009, 45 institutions received an A or B, and one-fifth of the schools improved their policies over the [...]

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