Today's Houston Chronicle features a hard-hitting editorial--
http://www.chron.com/disp/story.mpl/editorial/6859351.html
--detailing a number of important facts about recent increases in drug prices. (While the cost of drugs, and the doings of the drug industry that do not directly affect relationships with the medical profession, are generally beyond the purview of this blog--to be brief, industry-bashing is not what I try to be about--there are times when the issues overlap and when we need an update about general industry behavior.)
Specifically, the Chronicle states that if there ever was any perception that the drug industry was stepping up by agreeing to support health reform and to agree to moderate future price increases as its contribution to the need to cut medical costs, that posture has been revealed as an empty facade. The figues are: proposed future savings of $8B annually; recent runups in drug prices in advance of any future savings due to possible health reform, $10B annually; net result, $2B annual extra profits for Pharma rather than any real reductions in the price of drugs.
The editorial continues by noting that Congress is increasingly exasperated with this game and is now proposing to add legislation that will limit "pay-for-delay," the industry practice by which the brand-name company pays off the generic company to postpone the arrival of a lower-cost generic on the scene once a drug patent expires. (Ending this practice, says the FTC, could save consumers $35B over the next decade.) In response, the industry is now threatening to withdraw completely from its support for health reform. Sounds like they want the entire $10B a year, rather than having to pay back the $8B they promised.
Wednesday, February 10, 2010
Tuesday, February 9, 2010
What Would It Take to Prove Harm from Detailing?
I hope to do a few posts about a recent exchange in the American Journal of Bioethics centering on a paper by Dr. Thomas S. Huddle, a general internist at Universityof Alabama-Birmingham. Dr. Huddle objects to the recent report by the AAMC, "Industry Funding of Medical Education" (see http://brodyhooked.blogspot.com/2008/04/aamc-has-spoken-more-or-less-pharm-free.html). AJOB ran 10 peer commentaries in response to Dr. Huddle's paper, one by yours truly, to which Huddle then replied.
In this post I want to focus on only one point Huddle raised. He takes issue with the AAMC for trying to turn the presence of drug detailing on an academic medical campus into an ethical issue. So far as he is concerned, it ought to be treated strictly in prudential terms: does it cause more good vs. harm or vice versa? And in both of his commentaries he regards the record as straightforward--there is some substantial evidence that good results from drug detailing, and no reliable evidence whatever of harm having resulted, so prudential considerations require that detailing be allowed.
I am struck by this "on what planet do you live?" disagreement between those of us who take the perspective usually represented on this blog-where just about every post is about some harm that presumably has resulted from today's system of drug marketing--and those people we have labeled as pharmapologists, and who have now formed the organization ACRE (though I see no clear link between Dr. Huddle and that organization). The latter group has dismissed as merely anecdotal all the evidence that the former group believes to be overwhelming. By way of trying to tease out the presumptions underlying that radical difference in worldview, I will address here what would count as a truly definitive study of harms resulting from drug detailing.
We would have to select a cohort of entering medical students and randomly assign them to two groups. The first group would be encouraged to maximize their contact with, and acceptance of gifts from, the pharmaceutical indistry, while the second group would be absolutely prohibited from any such contacts or goodies. We would follow both groups through medical school and residency and into practice. After each group had been in practice for (let's say) five years, we would do an in-depth health assessment of all their patients. If we could demonstrate worse health outcomes among the patients of the maximum-contact group, compared to those of the no-contact group, then we would have proven that drug detailing is harmful. Absent that result, we'd have no reliable evidence on the matter.
I used to say that we'd have to examine the prescribing patterns of the two groups of docs and prove that according to some set of objective criteria for "rational" prescribing, there was more irrational prescribing among the maximum-contact group. But that would not do the trick, because the buzzword in evidence-based medicine today (to which I try my best to adhere) is patient-oriented outcomes. Even if drug detailing caused physicians to prescribe irrationally, it would mean nothing unless that irrational prescribing caused worse health among the patients.
It seems to me that folks like Dr. Huddle can say with a straight face that we have no evidence that docs' hanging out with drug reps leads to any harmful consequences for patients only so long as they adhere to this sort of standard for what would count as good evidence. I trust it's clear that no such study could or will ever be done, and so it is a foregone conclusion that there will never be evidence that meets the criteria set forth by the pharmapologists.
Do us pharmascolds then simply abandon the field? There are many areas of medicine where we can show that the ideal randomized controlled trial cannot practically be done, and evidence-based medicine requires then that we consult the best available evidence, not some ideal evidence that will never exist. I believe that websites such as Drug Promotion Database and Healthy Skepticism have done an excellent job of compiling the best available evidence. What is striking to me about that evidence is its univocal nature. We do not see some studies saying that detailing provides benefits and others that detailing causes harm. Virtually every study shows some sort of negative outcome as a result of drug marketing to physicians, and the sorts of harm shown in one study are usually replicated in similar studies. So I take the evidence (as I attempted to summarize in HOOKED, and which has only grown since that book was published in 2007) as quite clear in raising serious concerns about the consequences of drug marketing to physicians in the form of standard detailing practices.
I continue to believe that the best statement of the current evidence is the formula generally employed by our colleagues at Healthy Skepticism--we currently know of no way for physicians to receive either benefits or information from representatives of the pharmaceutical industry, in such a way that the exchange results in more good than harm for patients.
Huddle TS. The pitfalls of deducing ethics from economics: why the Association of American Medical Colleges is wrong about pharmaceutical detailing. Am J Bioethics 10(1):1-8, 2010.
Huddle TS. Response to open peer commentaries on "The pitfalls of deducing ethics from economics: why the Association of American Medical Colleges is wrong about pharmaceutical detailing." Am J Bioethics 10(1):W1-3, 2010.
In this post I want to focus on only one point Huddle raised. He takes issue with the AAMC for trying to turn the presence of drug detailing on an academic medical campus into an ethical issue. So far as he is concerned, it ought to be treated strictly in prudential terms: does it cause more good vs. harm or vice versa? And in both of his commentaries he regards the record as straightforward--there is some substantial evidence that good results from drug detailing, and no reliable evidence whatever of harm having resulted, so prudential considerations require that detailing be allowed.
I am struck by this "on what planet do you live?" disagreement between those of us who take the perspective usually represented on this blog-where just about every post is about some harm that presumably has resulted from today's system of drug marketing--and those people we have labeled as pharmapologists, and who have now formed the organization ACRE (though I see no clear link between Dr. Huddle and that organization). The latter group has dismissed as merely anecdotal all the evidence that the former group believes to be overwhelming. By way of trying to tease out the presumptions underlying that radical difference in worldview, I will address here what would count as a truly definitive study of harms resulting from drug detailing.
We would have to select a cohort of entering medical students and randomly assign them to two groups. The first group would be encouraged to maximize their contact with, and acceptance of gifts from, the pharmaceutical indistry, while the second group would be absolutely prohibited from any such contacts or goodies. We would follow both groups through medical school and residency and into practice. After each group had been in practice for (let's say) five years, we would do an in-depth health assessment of all their patients. If we could demonstrate worse health outcomes among the patients of the maximum-contact group, compared to those of the no-contact group, then we would have proven that drug detailing is harmful. Absent that result, we'd have no reliable evidence on the matter.
I used to say that we'd have to examine the prescribing patterns of the two groups of docs and prove that according to some set of objective criteria for "rational" prescribing, there was more irrational prescribing among the maximum-contact group. But that would not do the trick, because the buzzword in evidence-based medicine today (to which I try my best to adhere) is patient-oriented outcomes. Even if drug detailing caused physicians to prescribe irrationally, it would mean nothing unless that irrational prescribing caused worse health among the patients.
It seems to me that folks like Dr. Huddle can say with a straight face that we have no evidence that docs' hanging out with drug reps leads to any harmful consequences for patients only so long as they adhere to this sort of standard for what would count as good evidence. I trust it's clear that no such study could or will ever be done, and so it is a foregone conclusion that there will never be evidence that meets the criteria set forth by the pharmapologists.
Do us pharmascolds then simply abandon the field? There are many areas of medicine where we can show that the ideal randomized controlled trial cannot practically be done, and evidence-based medicine requires then that we consult the best available evidence, not some ideal evidence that will never exist. I believe that websites such as Drug Promotion Database and Healthy Skepticism have done an excellent job of compiling the best available evidence. What is striking to me about that evidence is its univocal nature. We do not see some studies saying that detailing provides benefits and others that detailing causes harm. Virtually every study shows some sort of negative outcome as a result of drug marketing to physicians, and the sorts of harm shown in one study are usually replicated in similar studies. So I take the evidence (as I attempted to summarize in HOOKED, and which has only grown since that book was published in 2007) as quite clear in raising serious concerns about the consequences of drug marketing to physicians in the form of standard detailing practices.
I continue to believe that the best statement of the current evidence is the formula generally employed by our colleagues at Healthy Skepticism--we currently know of no way for physicians to receive either benefits or information from representatives of the pharmaceutical industry, in such a way that the exchange results in more good than harm for patients.
Huddle TS. The pitfalls of deducing ethics from economics: why the Association of American Medical Colleges is wrong about pharmaceutical detailing. Am J Bioethics 10(1):1-8, 2010.
Huddle TS. Response to open peer commentaries on "The pitfalls of deducing ethics from economics: why the Association of American Medical Colleges is wrong about pharmaceutical detailing." Am J Bioethics 10(1):W1-3, 2010.
Some Quick News Updates
During the last two weeks when I was away on vacation and blessedly mostly out of e-mail range, a number of news items occurred, some of which were even good news. For instance:
http://www.nytimes.com/2010/02/01/business/01wrinkle.html
The New York Times business page warned that the FDA might be getting serious about slapping down cosmetic doctors who play fast and loose with unapproved indications for drugs in their marketing messages. Perhaps a sign that under the present administration, the FDA may have returned to its mission of regulating the drug industry, instead of just making nice?
http://seattletimes.nwsource.com/cgi-bin/PrintStory.pl?document_id=2010961355&zsection_id=2003960373&slug=apusglaxoceoqa&date=20100202
An AP business interview with the new CEO of Glaxo, Andrew Witty, who has a couple of pretty radical ideas--first that his company has an obligation to address health concerns in the developing world even among populations that cannot afford to pay top dollar for brand-name drugs; and second, that maybe to properly discover useful new drugs, you actually needs teams of scientists with brains, rather than machines on autopilot that screen thousands of molecules per hour.
http://www.nytimes.com/2010/02/01/business/01wrinkle.html
The New York Times business page warned that the FDA might be getting serious about slapping down cosmetic doctors who play fast and loose with unapproved indications for drugs in their marketing messages. Perhaps a sign that under the present administration, the FDA may have returned to its mission of regulating the drug industry, instead of just making nice?
http://seattletimes.nwsource.com/cgi-bin/PrintStory.pl?document_id=2010961355&zsection_id=2003960373&slug=apusglaxoceoqa&date=20100202
An AP business interview with the new CEO of Glaxo, Andrew Witty, who has a couple of pretty radical ideas--first that his company has an obligation to address health concerns in the developing world even among populations that cannot afford to pay top dollar for brand-name drugs; and second, that maybe to properly discover useful new drugs, you actually needs teams of scientists with brains, rather than machines on autopilot that screen thousands of molecules per hour.
Another County Heard From: An ACRE Perspective on Conflict of Interest and 'Political Correctness'
On a few occasions I have mentioned my colleague Dr. Avi Markowitz, chief of medical oncology at our medical center. Dr. Markowitz recently presented a Cancer Center Grand Rounds on “Academia and Industry.” As he’s a member of the Board of Directors of the Association of Clinical Researchers and Educators (ACRE), this talk promised to be a good summation of the position that I have opposed in this blog. I thought that a good way to present the ideas is to try to restrain myself and give Dr. Markowitz’s point of view as much as possible, perhaps then devoting a subsequent post to a rebuttal of specific points if need be. Where I was unable to stifle my responses, they appear below [in square brackets].
Suitable for a talk that vigorously defended, among other things, allowing industry to buy us lunch, there was free pizza and soda provided, courtesy of Fisher Scientific, a firm that primarily sells lab equipment; and the Fisher rep gave a short sales pitch before the grand rounds. This lunch was in line with the official UTMB policy, so far as I can gather, because the grant was prominently labeled as an “unrestricted educational” grant from the company to support the grand rounds.
Dr. Markowitz also started with his disclosure slide listing the 41 commercial firms he’s been associated with in his career, also accompanied by a statement of pride in all of those associations.
The subtitle of the talk (which I was not fast enough to write down in toto) prominently used the term “political correctness,” and in keeping with much ACRE material, AM returned regularly to this term. [As I do have a comment about the appropriateness of the ‘PC’ term, that will be the main issue I’ll take up briefly at the end.]
AM proceeded to a list of allegations that he finds offensive [suggesting thereby that these are the statements that his opponents actually make]—that physicians are for sale for a pen or a slice of pizza, that physicians would harm people for a fee, that physicians are too stupid to know if we are being biased, that if industry pays for it, it’s bad, that being a member of a company speakers bureau is bad, that being on an industry advisory board is bad, and that taking stuff from industry, including food, is bad. He alluded to data showing that delays in uptake of useful medicines by practitioners is a real problem, so therefore anything that interferes with industry marketing that might speed uptake potentially injures patients. He stated here that so long as a drug has gotten FDA approval, we can presume that it’s safe and effective, so there is then really no excuse not to promote its use. He added that in today’s world, if the industry did not pay top dollar, it could not get “real expertise” on pharmaceutical and scientific matters, so the amount paid for consultants, etc. should not be second-guessed.
In defense of providing food, AM mentioned the circumstances that arose here in Galveston following Hurricane Ike in September, 2008. The hospital was basically shut down, including the food services. Let me try to get the gist of his quote: “While a lot of staff were sitting at home collecting their paychecks, some of us, like me and my fellows, were here trying to get our clinic operations restarted. Some drug companies offered to send us food since we could not get anything to eat otherwise. I was told by a bureaucrat, one of the staff staying at home and collecting a paycheck, that this would be a violation of UTMB policy and so we had to refuse the food.”
That led to a long discussion of conflict of interest (COI). AM asserted that there is no generally accepted definition that measurably distinguishes benign from malignant forms of COI, so the term COI therefore becomes, with its negative connotation, a type of “insinuendo.” He reminded us that COI is ubiquitous in academics, where we all want to get raises and keep our jobs in addition to doing good science and patient care; hence “overlapping interests” and not COI would generally be the more accurate term. The legal principle should apply—innocent till proven guilty—whereas COI tends to label one as guilty until proven innocent.
AM then put up a slide that gave the definition of COI contained in the most recent IOM report on medicine and the pharmaceutical industry. He did not, however, discuss or analyze that definition. Instead, he noted that the IOM admitted that they could identify no data that showed that physicians and patients, themselves, view COI as a problem. This was a frank admission that the definition could not be data-based, and AM apparently felt that justified dismissing the definition out of hand for that reason. [AM asserted that there were data to show that patients, when asked if they were concerned about financial COI involving their physicians, denied any concern, and that the IOM ignored these data. On his side he denied that any data exist showing that patients are concerned about COI. I reviewed some of the data showing patient concern in HOOKED. I am aware of one study of cancer patients showing an apparent don’t-care attitude, but hardly believe that’s the totality of the data that exists.] “In science you are not allowed to reason without data,” AM said, [suggesting apparently that defining COI was a matter of science, and not, say, of ethics or policy.]
After some other comments AM turned to the Vioxx debate. While admitting that Vioxx was outside of his area of expertise, he cited several papers condemning the activities of Merck in that case, all written by physicians who admitted to having been paid by plaintiffs’ attorneys in anti-Merck lawsuits. AM then suggested that there was a double standard at play if some demand that those paid by Pharma disclose their conflicts, whereas there is no problem if others take more than $1M from plaintiffs’ lawyers. [The reasoning here seemed fallacious on several counts. By citing only those papers written by physicians with legal-fee conflicts, AM hinted that only people who were thus conflicted wrote papers critical of Merck. In fact there is a huge literature condemning what happened with Vioxx and the papers written by those physicians are only a small sampling. Second, there is a reason that these physicians wrote the few papers they did—as a result of the access to the legal documents, these physicians had evidence of ghostwriting and other things disclosed only as a result of access to internal company documents. The few papers that AM cited specifically dealt with company documents released as a result of legal discovery. Finally, there was no double standard. It is routine for journals to demand that authors list who pays them that could constitute a COI, but it is not usual to demand that the exact dollar amount be revealed. The plaintiffs’ lawyers’ advisors followed these same rules.]
AM mentioned that ACRE recently went toe to toe with the Council on Ethical and Judicial Affairs of the AMA and was pleased that they forced the draft on ethics and relationships with drug companies back to committee for the 3rd time. Who, we asked, is suited to determine our integrity for us? “Who is clean enough that they’re without sin?” [By this logic, no one could sit on a jury, because no one is so clean as to be without sin.] Among agencies that AM viewed as too conflicted themselves to be entrusted to tell the rest of us what integrity requires, he included the FDA, [apparently having forgotten that a few minutes previously, he had listed FDA approval of a drug as proof positive that the drug was both safe and effective.]
AM next asserted, “The real scandals in medicine have come not out of Pharma but out of academia.” He did not elaborate on this beyond an anecdote, of how he was involved once in a federally funded cooperative cancer trial, and a fellow mistakenly changed a drug dose in a way prohibited by protocol (due to a confusion as to what part of the protocol applied to the case). It took 8 months, AM reported, for the overseers of the trial to identify the protocol violation and notify him, by which time it was far too late to make any clinical changes (fortunately the patient was not harmed in any way by the minor dose change). By contrast, he stated from his experience commercially sponsored trials, had that been a company funded trial, the call would have come in 3 days.
AM next listed a set of truisms, including “the truth always comes out,” which he seemed to suggest meant that no company had any real incentive to conceal negative data. He proceeded to list advantages of partnering with industry: money, especially given limited federal research support; flexibility; scientific support; goal oriented; close monitoring; educational/CME support. “How do you develop a profitable drug? You invent something that works.”
In defense of industry’s making a profit, AM asserted that it’s the industry and not the government that develops new drugs—a point that he “proved” by listing how much money industry vs. government spends on clinical drug trials. [He did not address several studies claiming to show that a majority of drugs in important areas like cancer have their start in federally funded academic labs, not in industry.] He denied that drug companies make “excessive” profits by flashing a graph showing (I think) the net profit margins of a number of industries. Drug companies were near the top of the chart, but one of the handful of industries that were higher was brewers. AM then said that since the profit margin of the drug industry was slightly less than that of the beer industry, it could not be the case that drug companies earned excessive profits. He repeated the industry claims that if they did not charge the high prices they do today, they’d have no money to reinvest in R&D.
AM ended by listing Constitutional issues that he worries about due to the “moral bullying” in academia by the “politically correct” crowd, including violations of the First Amendment and of freedom of assembly (if people cannot gather for a company sponsored lunch). He used up all but 4 minutes of his hour giving the talk, and there were no audience questions in the brief time remaining.
[Had there been more time for questions, the one I would have asked AM would have been, “Please define ‘political correctness.’” I admit that there are some contexts where this term makes good sense. However, I think it is easy to misuse or overuse the term. In general, people use the term when they cannot think of a substantive ethical consideration to defeat their opponents’ case. Supposing that I support the rights of a minority group to do a certain thing. People who disagree with me, if they could think of a flaw in my ethical argument, would surely refute me by pointing out that flaw. So when the only thing they can say in opposition to my defense of minority rights is that I am being “politically correct,” it seems they are admitting that they have no substantive rebuttal. If that is so, then all “PC” can count as is an ad hominem argument—that is, being unable to attack my logic, they attack my motives instead. As AM objected to what he took to be the “insinuendo” aspect of COI, it was interesting that he saw nothing “insinuendo” about PC.]
***
I sent Dr. Markowitz a copy of the above text some time back and he did not reply to two offers to suggest amendments or initial reactive comments; so I have to assume that he will choose to comment on this post in the usual way if he wishes to.
Suitable for a talk that vigorously defended, among other things, allowing industry to buy us lunch, there was free pizza and soda provided, courtesy of Fisher Scientific, a firm that primarily sells lab equipment; and the Fisher rep gave a short sales pitch before the grand rounds. This lunch was in line with the official UTMB policy, so far as I can gather, because the grant was prominently labeled as an “unrestricted educational” grant from the company to support the grand rounds.
Dr. Markowitz also started with his disclosure slide listing the 41 commercial firms he’s been associated with in his career, also accompanied by a statement of pride in all of those associations.
The subtitle of the talk (which I was not fast enough to write down in toto) prominently used the term “political correctness,” and in keeping with much ACRE material, AM returned regularly to this term. [As I do have a comment about the appropriateness of the ‘PC’ term, that will be the main issue I’ll take up briefly at the end.]
AM proceeded to a list of allegations that he finds offensive [suggesting thereby that these are the statements that his opponents actually make]—that physicians are for sale for a pen or a slice of pizza, that physicians would harm people for a fee, that physicians are too stupid to know if we are being biased, that if industry pays for it, it’s bad, that being a member of a company speakers bureau is bad, that being on an industry advisory board is bad, and that taking stuff from industry, including food, is bad. He alluded to data showing that delays in uptake of useful medicines by practitioners is a real problem, so therefore anything that interferes with industry marketing that might speed uptake potentially injures patients. He stated here that so long as a drug has gotten FDA approval, we can presume that it’s safe and effective, so there is then really no excuse not to promote its use. He added that in today’s world, if the industry did not pay top dollar, it could not get “real expertise” on pharmaceutical and scientific matters, so the amount paid for consultants, etc. should not be second-guessed.
In defense of providing food, AM mentioned the circumstances that arose here in Galveston following Hurricane Ike in September, 2008. The hospital was basically shut down, including the food services. Let me try to get the gist of his quote: “While a lot of staff were sitting at home collecting their paychecks, some of us, like me and my fellows, were here trying to get our clinic operations restarted. Some drug companies offered to send us food since we could not get anything to eat otherwise. I was told by a bureaucrat, one of the staff staying at home and collecting a paycheck, that this would be a violation of UTMB policy and so we had to refuse the food.”
That led to a long discussion of conflict of interest (COI). AM asserted that there is no generally accepted definition that measurably distinguishes benign from malignant forms of COI, so the term COI therefore becomes, with its negative connotation, a type of “insinuendo.” He reminded us that COI is ubiquitous in academics, where we all want to get raises and keep our jobs in addition to doing good science and patient care; hence “overlapping interests” and not COI would generally be the more accurate term. The legal principle should apply—innocent till proven guilty—whereas COI tends to label one as guilty until proven innocent.
AM then put up a slide that gave the definition of COI contained in the most recent IOM report on medicine and the pharmaceutical industry. He did not, however, discuss or analyze that definition. Instead, he noted that the IOM admitted that they could identify no data that showed that physicians and patients, themselves, view COI as a problem. This was a frank admission that the definition could not be data-based, and AM apparently felt that justified dismissing the definition out of hand for that reason. [AM asserted that there were data to show that patients, when asked if they were concerned about financial COI involving their physicians, denied any concern, and that the IOM ignored these data. On his side he denied that any data exist showing that patients are concerned about COI. I reviewed some of the data showing patient concern in HOOKED. I am aware of one study of cancer patients showing an apparent don’t-care attitude, but hardly believe that’s the totality of the data that exists.] “In science you are not allowed to reason without data,” AM said, [suggesting apparently that defining COI was a matter of science, and not, say, of ethics or policy.]
After some other comments AM turned to the Vioxx debate. While admitting that Vioxx was outside of his area of expertise, he cited several papers condemning the activities of Merck in that case, all written by physicians who admitted to having been paid by plaintiffs’ attorneys in anti-Merck lawsuits. AM then suggested that there was a double standard at play if some demand that those paid by Pharma disclose their conflicts, whereas there is no problem if others take more than $1M from plaintiffs’ lawyers. [The reasoning here seemed fallacious on several counts. By citing only those papers written by physicians with legal-fee conflicts, AM hinted that only people who were thus conflicted wrote papers critical of Merck. In fact there is a huge literature condemning what happened with Vioxx and the papers written by those physicians are only a small sampling. Second, there is a reason that these physicians wrote the few papers they did—as a result of the access to the legal documents, these physicians had evidence of ghostwriting and other things disclosed only as a result of access to internal company documents. The few papers that AM cited specifically dealt with company documents released as a result of legal discovery. Finally, there was no double standard. It is routine for journals to demand that authors list who pays them that could constitute a COI, but it is not usual to demand that the exact dollar amount be revealed. The plaintiffs’ lawyers’ advisors followed these same rules.]
AM mentioned that ACRE recently went toe to toe with the Council on Ethical and Judicial Affairs of the AMA and was pleased that they forced the draft on ethics and relationships with drug companies back to committee for the 3rd time. Who, we asked, is suited to determine our integrity for us? “Who is clean enough that they’re without sin?” [By this logic, no one could sit on a jury, because no one is so clean as to be without sin.] Among agencies that AM viewed as too conflicted themselves to be entrusted to tell the rest of us what integrity requires, he included the FDA, [apparently having forgotten that a few minutes previously, he had listed FDA approval of a drug as proof positive that the drug was both safe and effective.]
AM next asserted, “The real scandals in medicine have come not out of Pharma but out of academia.” He did not elaborate on this beyond an anecdote, of how he was involved once in a federally funded cooperative cancer trial, and a fellow mistakenly changed a drug dose in a way prohibited by protocol (due to a confusion as to what part of the protocol applied to the case). It took 8 months, AM reported, for the overseers of the trial to identify the protocol violation and notify him, by which time it was far too late to make any clinical changes (fortunately the patient was not harmed in any way by the minor dose change). By contrast, he stated from his experience commercially sponsored trials, had that been a company funded trial, the call would have come in 3 days.
AM next listed a set of truisms, including “the truth always comes out,” which he seemed to suggest meant that no company had any real incentive to conceal negative data. He proceeded to list advantages of partnering with industry: money, especially given limited federal research support; flexibility; scientific support; goal oriented; close monitoring; educational/CME support. “How do you develop a profitable drug? You invent something that works.”
In defense of industry’s making a profit, AM asserted that it’s the industry and not the government that develops new drugs—a point that he “proved” by listing how much money industry vs. government spends on clinical drug trials. [He did not address several studies claiming to show that a majority of drugs in important areas like cancer have their start in federally funded academic labs, not in industry.] He denied that drug companies make “excessive” profits by flashing a graph showing (I think) the net profit margins of a number of industries. Drug companies were near the top of the chart, but one of the handful of industries that were higher was brewers. AM then said that since the profit margin of the drug industry was slightly less than that of the beer industry, it could not be the case that drug companies earned excessive profits. He repeated the industry claims that if they did not charge the high prices they do today, they’d have no money to reinvest in R&D.
AM ended by listing Constitutional issues that he worries about due to the “moral bullying” in academia by the “politically correct” crowd, including violations of the First Amendment and of freedom of assembly (if people cannot gather for a company sponsored lunch). He used up all but 4 minutes of his hour giving the talk, and there were no audience questions in the brief time remaining.
[Had there been more time for questions, the one I would have asked AM would have been, “Please define ‘political correctness.’” I admit that there are some contexts where this term makes good sense. However, I think it is easy to misuse or overuse the term. In general, people use the term when they cannot think of a substantive ethical consideration to defeat their opponents’ case. Supposing that I support the rights of a minority group to do a certain thing. People who disagree with me, if they could think of a flaw in my ethical argument, would surely refute me by pointing out that flaw. So when the only thing they can say in opposition to my defense of minority rights is that I am being “politically correct,” it seems they are admitting that they have no substantive rebuttal. If that is so, then all “PC” can count as is an ad hominem argument—that is, being unable to attack my logic, they attack my motives instead. As AM objected to what he took to be the “insinuendo” aspect of COI, it was interesting that he saw nothing “insinuendo” about PC.]
***
I sent Dr. Markowitz a copy of the above text some time back and he did not reply to two offers to suggest amendments or initial reactive comments; so I have to assume that he will choose to comment on this post in the usual way if he wishes to.
Ghostwriting: Academic Medical Centers Need to Step Up
In HOOKED I referred to ghostwriting of medical journal articles as "a particularly egregious ethical violation" but said little about what should be done about it. Our friends Jeffrey Lacasse and Jonathan Leo have made up the deficiency nicely:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000230
Lacasse and Leo began by searching the on-line policies (and contacting staff at the medical school if policies were unavailable on line) for the 50 highest ranking medical schools in the US according to US News and World Report. They were able to identify policies explicitly banning ghostwriting, or else authorship policies that effectively banned ghostwriting without naming it, at only 13 of these schools. They then argued that even some of the schools that had policies seem to lack critical elements of an enforcement mechanism. They conclude their paper with their own suggested academic policy to prohibit ghostwriting and to bring real consequences upon the heads of academics who allow their names to be attached to ghostwritten articles.
A number of solid observations in this piece:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000230
Lacasse and Leo began by searching the on-line policies (and contacting staff at the medical school if policies were unavailable on line) for the 50 highest ranking medical schools in the US according to US News and World Report. They were able to identify policies explicitly banning ghostwriting, or else authorship policies that effectively banned ghostwriting without naming it, at only 13 of these schools. They then argued that even some of the schools that had policies seem to lack critical elements of an enforcement mechanism. They conclude their paper with their own suggested academic policy to prohibit ghostwriting and to bring real consequences upon the heads of academics who allow their names to be attached to ghostwritten articles.
A number of solid observations in this piece:
- L&L note that academics in non-medical fields are (appropriately) shocked and outraged when they come to learn the degree to which ghostwriting has been implicitly tolerated in medicine. They list in their endnotes specific documentation of cases where ghostwriting has been proven and yet no action was taken against the putative academic authors.
- L&L as a policy matter call for a period of amnesty--they would allow academics who have participated in ghostwriting to come forward, identify the offending articles for potential later journal retraction, and essentially apologize and promise never to do it again, without penalty. I recommended something similar on a more general basis in HOOKED. Basically we need to recognize that a generation of academic physicians have grown up in an era when certain practices were widely accepted as the norm, that today we are belatedly coming to criticize and condemn. While we can take strong issue with those of our colleagues who try to defend the old practices as ethically acceptable, we must have some mercy on well-meaning colleagues who simply went along with the crowd and now are willing to acknowledge their previous errors.
- L&L reinforce the basic point that I also alluded to in HOOKED, that unless bad behavior has real consequences for the individual directly involved, we can expect it to continue, at least so long as it pays. I am still at a loss to provide any list of names of academic physicians who have been found allowing their names to be attached to ghostwritten articles, and who have suffered any ill effects to their careers as a result.
Sunday, February 7, 2010
HOOKED among Top 50 Public Health Blogs
I am posting this link to an article listing the Top 50 blogs on public health not just to brag about this blog making the list, but also since readers might be interested to know what other blogs are available on these important topics:
http://mastersinhealthscience.com/2010/top-50-public-health-blogs/
http://mastersinhealthscience.com/2010/top-50-public-health-blogs/
Monday, January 25, 2010
India on Gifts to Docs: Just Say No
The following item came my way courtesy of the Healthy Skepticism list-serv and as the material itself is labeled for public release, I asume I have permission to post it here. It suggests yet a further way in which India may be ahead of the U.S. I have bolded what I take to be the key messages below.
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The following editorial will appear in the Monthly Index of Medical Specialities, New Delhi, India in its January 31, 2010 issue. Released in advance for public information.
Indian Medical Council Defines Do's and Don'ts for Doctors
Extensive media coverage of the unethical, "you-scratch-my-back-I-scratch yours" nexus between most doctors and drug companies has spurred the Medical Council of India (MCI) to take action. In a notification issued last month, MCI has banned all relationships that can potentially harm the patients and bring medical practice to ridicule. The new rules cover both individual doctors and professional associations. Some examples:
Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied health care industry. Since there is no mention of any monetary ceiling, even small value items are not permitted.
Travel: Any travel facility inside or outside the country for self and/or family members even for attending conferences, seminars, workshops, CME programme etc is not permitted. In the past drug manufacturers and doctors used to argue that such facilities were meant to advance the scientific knowledge and hence not improper. MCI has rejected this self-serving logic.
Hospitality: Any hospitality like hotel accommodation for self and family members under any pretext stands prohibited.
Cash or monetary grants: Receiving funds by doctors under any pretext has been banned. Funding for medical research, study etc. can only be received through approved institutions by modalities laid down by law / rules / guidelines adopted by such approved institutions. Such funding is to be publicly disclosed.
Medical research: Doctors are allowed to carry out research projects funded by pharmaceutical and allied healthcare industries under certain specific conditions such as after prior permission from the competent authorities including the Drugs Controller General, India (DCGI), relevant Hospital Ethics Committee, provision of proper facilities to human volunteers, public disclosure of the source and amount of funding at the beginning of the research itself. Above all the medical practitioner must have the freedom to publish the results of the research by inserting such a clause in the agreement or any other document before accepting such assignment.
Most drug companies routinely prohibit the publication of clinical trial results by individual investigators/hospitals under one pretext or the other. In such a scenario, there is an in-built risk of concealing unfavourable results of drug and medical devices trials to the detriment of patients.
Endorsement: of any commercial product by doctors was already banned in the year 2002. Two important additions have been made to his rule. Firstly, the professional associations of doctors are also barred from endorsements and secondly, any study conducted on the efficacy or otherwise of such products shall be presented to and/or through appropriate scientific bodies or published in appropriate scientific journals only. Thus doctors should not permit the use of results of such studies for any purpose by interested companies.
Violation of any of the MCI directives is considered "Misconduct" and therefore can invite penalties in the form of suspension or cancellation of registration to practice.
While the new rules deserve appreciation and applause, the real test will be the level and extent of implementation. Stronger and sharper teeth can be added to MCI regulations by amending relevant sections of the Income Tax Rules. All facilities with monetary value received by medical professionals from healthcare industry should be deemed to be perquisites in the hands of recipients and hence taxable. Similarly all expenses incurred by drug, medical devices and other healthcare companies in violation of MCI rules should be disallowed by amending income tax rules.
Dr. Chandra M. Gulhati,
Editor, Monthly Index of Medical Specialities, New Delhi, India.
Chandra Gulhati
****
The following editorial will appear in the Monthly Index of Medical Specialities, New Delhi, India in its January 31, 2010 issue. Released in advance for public information.
Indian Medical Council Defines Do's and Don'ts for Doctors
Extensive media coverage of the unethical, "you-scratch-my-back-I-scratch yours" nexus between most doctors and drug companies has spurred the Medical Council of India (MCI) to take action. In a notification issued last month, MCI has banned all relationships that can potentially harm the patients and bring medical practice to ridicule. The new rules cover both individual doctors and professional associations. Some examples:
Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied health care industry. Since there is no mention of any monetary ceiling, even small value items are not permitted.
Travel: Any travel facility inside or outside the country for self and/or family members even for attending conferences, seminars, workshops, CME programme etc is not permitted. In the past drug manufacturers and doctors used to argue that such facilities were meant to advance the scientific knowledge and hence not improper. MCI has rejected this self-serving logic.
Hospitality: Any hospitality like hotel accommodation for self and family members under any pretext stands prohibited.
Cash or monetary grants: Receiving funds by doctors under any pretext has been banned. Funding for medical research, study etc. can only be received through approved institutions by modalities laid down by law / rules / guidelines adopted by such approved institutions. Such funding is to be publicly disclosed.
Medical research: Doctors are allowed to carry out research projects funded by pharmaceutical and allied healthcare industries under certain specific conditions such as after prior permission from the competent authorities including the Drugs Controller General, India (DCGI), relevant Hospital Ethics Committee, provision of proper facilities to human volunteers, public disclosure of the source and amount of funding at the beginning of the research itself. Above all the medical practitioner must have the freedom to publish the results of the research by inserting such a clause in the agreement or any other document before accepting such assignment.
Most drug companies routinely prohibit the publication of clinical trial results by individual investigators/hospitals under one pretext or the other. In such a scenario, there is an in-built risk of concealing unfavourable results of drug and medical devices trials to the detriment of patients.
Endorsement: of any commercial product by doctors was already banned in the year 2002. Two important additions have been made to his rule. Firstly, the professional associations of doctors are also barred from endorsements and secondly, any study conducted on the efficacy or otherwise of such products shall be presented to and/or through appropriate scientific bodies or published in appropriate scientific journals only. Thus doctors should not permit the use of results of such studies for any purpose by interested companies.
Violation of any of the MCI directives is considered "Misconduct" and therefore can invite penalties in the form of suspension or cancellation of registration to practice.
While the new rules deserve appreciation and applause, the real test will be the level and extent of implementation. Stronger and sharper teeth can be added to MCI regulations by amending relevant sections of the Income Tax Rules. All facilities with monetary value received by medical professionals from healthcare industry should be deemed to be perquisites in the hands of recipients and hence taxable. Similarly all expenses incurred by drug, medical devices and other healthcare companies in violation of MCI rules should be disallowed by amending income tax rules.
Dr. Chandra M. Gulhati,
Editor, Monthly Index of Medical Specialities, New Delhi, India.
Chandra Gulhati
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