Back in 2008 I was pleased to blog about the new law in Massachusetts that imposed one of the most stringent restrictions on Pharma gifts to docs, in the name of constraining health care costs by eliminating commercial influence: http://imh.utmb.edu/docs/electives-and-selectives-info/mh-track-introduction.pdf?sfvrsn=0
More recently, I had to report that the law was in jeopardy:
http://brodyhooked.blogspot.com/2011/05/massachusetts-gift-ban-and-reporting.html
Now we learn from the good folks at Pharmalot:
http://www.pharmalot.com/2012/06/massachusetts-docs-may-get-free-lunches/
--that the Mass. legislature has approved the amended bill that allows more free lunches, in particular, and that the Gov is poised to approve, though organizations like the National Physicians Alliance is writing to urge that he withhold his signature and the American Medical Student Association is also griping.
As to what arguments seemed most powerful in swaying the legislature, the most forceful lobbying seems to have been a combo of the restaurant and the medical device makers, both claiming that the ban was killing jobs and driving business to other states-- for instance, as Pharmalot tells us:
“The gift ban has been devastating to restaurants and thousands of middle-class employees,” according to a statement on the Massachusetts Restaurant Association web site ... However, state tax receipts on meals increased last year and the same trend continued through the first five months of this year, according to the state Blue Book ....
State coffers aside, some eateries maintain the ban has had real consequences. The Chocolate Truffle, for instance, is not selling as many chocolate shoes, a popular corporate gift, since the ban took effect. “We have closed a store in Lynnfield, we have drastically cut the number of employees we have,” Erin Calvo-Bacci told a Boston television station last week .... “If that gift ban was gone then we could increase our production.”
What I had said in the past holds: It is really interesting to see how the drug and device industries will give up a lot of marketing tools under pressure, such as jettisoning the previously ubiquitous drug logo pens--but free meals really must work because they'll fight tooth and nail to keep them. And it is really interesting how much total restaurant revenue seems to ride on these junkets. (So much for them being the "modest" meals we hear about in the language opf the law and in the PhRMA code of conduct).
Friday, June 29, 2012
Monday, June 25, 2012
How COI Poisons Academic Medicine: UC-Davis
Thanks once again to our friend Dr. Roy Poses over at Health Care Renewal--
http://hcrenewal.blogspot.com/2012/06/administrators-at-pepper-spray-u-found.html
--for filling in the backstory on a recent event at UC-Davis med school. I had not initially blogged about this incident because it had little to do directly with the pharmaeutical industry, and because the two principals, Drs. Michael Wilkes and Jerry Hoffman, are personal friends (Jerry being half of the Rick Bukata-Jerry Hoffman team that does Primary Care Medical Abstracts, whose reviews of the medical literature I often rely on here). But Dr. Poses helps highlight why the incident is of more general concern regarding conflicts of interest at the interface between industry and academic medicine.
What happened: Drs Wilkes and Hoffman had the effrontery to write an op-ed for the San Francisco Chronicle in thich they did two things. First, they pointed out the evidence that prostate screening by means of the PSA blood test is not a very useful thing--no news here as the US Preventive Services Task Force has recently said the same thing even more strongly. Second, they noted that UC-Davis, where Dr. Wilkes is on the faculty, has a program that aggressively promotes PSA testing, and wondered if that was linked to the money the university receives for the increased number of procedures and cancer treatments (mostly unnecessary) that PSA screening reliably generates. The program, Dr. Roses adds, was supported by the urologists' foundation, which in turn receives big bucks from the various device makers who profit from prostate surgery. (The urologists as a group continue to throw evidence to the winds and to attack the USPSTF viciously for advising men to consider carefully whether to have a PSA test.)
Dr. Wilkes was then contacted by UC-Davis lawyers, and was informed that he was being terminated as the head of several academic programs that he was responsible for, including programs on professional practice and global health. These were accompanied by threats that he'd be sued for defamation for what he said about Davis in the op-ed.
Dr. Wilkes filed an internal complaint. The current Hwealth Care Renewal post is occasioned by the results of that investigation (see post for link), in which Dr. Wilkes was found to have been unfairly treated and subjected to unjust reprisals for exercising his academic freedom to speak out on medical issues of public concern. Dr. Poses adds that given the past record of UC-Davis in suppressing dissent among students, it's not surprising they'd treat a faculty member this way. (By the way, if the Davis leadership has apologized or in any way made it up to Dr. Wilkes for their outrageous treatment of him, it has yet to be reported.)
Dr. Poses has hit the nail on the head by addresing the past track record of UC-Davis and its leaders. When the people who run academic medical centers start to think of what they do as a business, and when they see industries that make profits off questionable patient care as lucrative sources of funding, they naturally start to think of their physician and scientist faculty members as their sales force that is supposed to roll up their sleeves and sell the Davis "product." When a faculty member adheres to his academic responsibilities and puts the truth over the UCF-Davis "brand," the leadership becomes outraged at this treasonous behavior. Which is why conflicts of interest in academic medicine, especially at the institutional level, need to be vigorously rooted out--and why we need leadership in health care and academic medicine that understands the difference between a business and a profession.
http://hcrenewal.blogspot.com/2012/06/administrators-at-pepper-spray-u-found.html
--for filling in the backstory on a recent event at UC-Davis med school. I had not initially blogged about this incident because it had little to do directly with the pharmaeutical industry, and because the two principals, Drs. Michael Wilkes and Jerry Hoffman, are personal friends (Jerry being half of the Rick Bukata-Jerry Hoffman team that does Primary Care Medical Abstracts, whose reviews of the medical literature I often rely on here). But Dr. Poses helps highlight why the incident is of more general concern regarding conflicts of interest at the interface between industry and academic medicine.
What happened: Drs Wilkes and Hoffman had the effrontery to write an op-ed for the San Francisco Chronicle in thich they did two things. First, they pointed out the evidence that prostate screening by means of the PSA blood test is not a very useful thing--no news here as the US Preventive Services Task Force has recently said the same thing even more strongly. Second, they noted that UC-Davis, where Dr. Wilkes is on the faculty, has a program that aggressively promotes PSA testing, and wondered if that was linked to the money the university receives for the increased number of procedures and cancer treatments (mostly unnecessary) that PSA screening reliably generates. The program, Dr. Roses adds, was supported by the urologists' foundation, which in turn receives big bucks from the various device makers who profit from prostate surgery. (The urologists as a group continue to throw evidence to the winds and to attack the USPSTF viciously for advising men to consider carefully whether to have a PSA test.)
Dr. Wilkes was then contacted by UC-Davis lawyers, and was informed that he was being terminated as the head of several academic programs that he was responsible for, including programs on professional practice and global health. These were accompanied by threats that he'd be sued for defamation for what he said about Davis in the op-ed.
Dr. Wilkes filed an internal complaint. The current Hwealth Care Renewal post is occasioned by the results of that investigation (see post for link), in which Dr. Wilkes was found to have been unfairly treated and subjected to unjust reprisals for exercising his academic freedom to speak out on medical issues of public concern. Dr. Poses adds that given the past record of UC-Davis in suppressing dissent among students, it's not surprising they'd treat a faculty member this way. (By the way, if the Davis leadership has apologized or in any way made it up to Dr. Wilkes for their outrageous treatment of him, it has yet to be reported.)
Dr. Poses has hit the nail on the head by addresing the past track record of UC-Davis and its leaders. When the people who run academic medical centers start to think of what they do as a business, and when they see industries that make profits off questionable patient care as lucrative sources of funding, they naturally start to think of their physician and scientist faculty members as their sales force that is supposed to roll up their sleeves and sell the Davis "product." When a faculty member adheres to his academic responsibilities and puts the truth over the UCF-Davis "brand," the leadership becomes outraged at this treasonous behavior. Which is why conflicts of interest in academic medicine, especially at the institutional level, need to be vigorously rooted out--and why we need leadership in health care and academic medicine that understands the difference between a business and a profession.
Saturday, June 23, 2012
Those Persistent Ghosts: The Key Loophole
Our old friends Jonathan Leo and Jeff Lacasse are at it again, this time in the Pharmalot blog:
http://www.pharmalot.com/2012/06/ghosts-in-the-pharma-attic-jon-jeff-explain/
--on the subject of ghostwriting. As we've detailed in many previous posts, there has been a great deal of huffing and puffing over the evils of ghostwriting, where a hired hand for the drug industry writes almost all the article, academic experts then affix their names to the author byline, and the hired gun disappears into obscurity when the paper appears in a journal. Yet there's no good evidence that the practice has diminished, and indeed defenders of the medical communications firms that employ the ghostwriters have become even more brazen in defending these practices, insisting that it's not ghostwriting at all. What Drs. Leo and Lacasse add in this more recent post is a clue as to the large loophole that people jump through to keep ghostwriting alive and well.
The ICMJE, the International Committee of Medical Journal Editors, has been forceful (it would seem) in moving against ghostwriting and similarly unethical practices by formulating a set of criteria for authorship that are now widely adopted as authoritative. They say that to be an author you must:
The common practice now is that a hired-gun medical writer will write the crucial first draft of the paper, making sure to organize and spin the paper in a way favorable for drug marketing. The academic guest authors (who meet the first criteria by having been involved in conducting the research) then meet the second criteria by doing some edits--often really minor and trivial, but enough so that they can claim that they had something to do with the manuscript. The hired gun then turns the manuscript over to the academics, who approve the final version. The hired gun is named in an acknowledgement as having provided writing or editorial "assistance." In this scenario, the ICMJE guidelines have been followed, and the hired gun cannot be listed as an author because he/she did not meet the 3rd criterion.
What has changed as a result of this is that the old practice of eliminating all mention of the ghostwriter has given way to the newer practice of listing the ghostwriter in an acknowledgement. No doubt the drug firm preferred the old way, keeping all of its involvement in writing the paper hidden. But the new way works well enough, as the actual key role of the ghostwriter in shaping the paper the way the company wants it is still quite well concealed, and no one who doesn't read the fine print at the end of the article knows of the ghostwriter's existence.
Drs. Leo and Lacasse note that if either medical journals or academic medical centers truly wanted to police this practice, they could do so. As an example of a journal that has adoped more stringent standards than ICMJE, they cite Neurology, that has cut to the chase to ask the really key question, "who influenced the content?" When other bodies continue to swear by the ICMJE criteria, despite widely published accounts of their limitations, we can only conclude that people don't really want to get rid of ghostwriting-- which is highly lucrative for the medical journals through sales of reprints, and also for academic centers, as those faculty who are asked to be ghostwriters in all probability bring in hefty funding from Pharma.
As I explained in HOOKED and in many previous posts, ghostwriting, despite recent efforts to sanitize it, has to be the most egregious case of unethical practice at the medicine-Pharma interface. If you cannot believe that the listed authors actually wrote an article, what can you believe? Maybe in the world of celebrity kiss-and-tell memoirs, no one is shocked to discover that the celebrity "author" really did no writing at all (and more than likely couldn't if he tried), and some hired hack writer churned out the text. But the entire system of trust in science is built on the reader's confidence that the authors, with their academic reputations, are vouching for the results stated in the article and especially for the interpretation they attach to those results. If academic medicine cannot put a stop to this, it is time to call in Senator Grassley and his troops and turn the control of academic medicine over to Congress or some other outside agency, because we've failed.
http://www.pharmalot.com/2012/06/ghosts-in-the-pharma-attic-jon-jeff-explain/
--on the subject of ghostwriting. As we've detailed in many previous posts, there has been a great deal of huffing and puffing over the evils of ghostwriting, where a hired hand for the drug industry writes almost all the article, academic experts then affix their names to the author byline, and the hired gun disappears into obscurity when the paper appears in a journal. Yet there's no good evidence that the practice has diminished, and indeed defenders of the medical communications firms that employ the ghostwriters have become even more brazen in defending these practices, insisting that it's not ghostwriting at all. What Drs. Leo and Lacasse add in this more recent post is a clue as to the large loophole that people jump through to keep ghostwriting alive and well.
The ICMJE, the International Committee of Medical Journal Editors, has been forceful (it would seem) in moving against ghostwriting and similarly unethical practices by formulating a set of criteria for authorship that are now widely adopted as authoritative. They say that to be an author you must:
- Make substantive contributions to the research work
- Draft the article or revise it critically
- Give final approval to the version to be published
The common practice now is that a hired-gun medical writer will write the crucial first draft of the paper, making sure to organize and spin the paper in a way favorable for drug marketing. The academic guest authors (who meet the first criteria by having been involved in conducting the research) then meet the second criteria by doing some edits--often really minor and trivial, but enough so that they can claim that they had something to do with the manuscript. The hired gun then turns the manuscript over to the academics, who approve the final version. The hired gun is named in an acknowledgement as having provided writing or editorial "assistance." In this scenario, the ICMJE guidelines have been followed, and the hired gun cannot be listed as an author because he/she did not meet the 3rd criterion.
What has changed as a result of this is that the old practice of eliminating all mention of the ghostwriter has given way to the newer practice of listing the ghostwriter in an acknowledgement. No doubt the drug firm preferred the old way, keeping all of its involvement in writing the paper hidden. But the new way works well enough, as the actual key role of the ghostwriter in shaping the paper the way the company wants it is still quite well concealed, and no one who doesn't read the fine print at the end of the article knows of the ghostwriter's existence.
Drs. Leo and Lacasse note that if either medical journals or academic medical centers truly wanted to police this practice, they could do so. As an example of a journal that has adoped more stringent standards than ICMJE, they cite Neurology, that has cut to the chase to ask the really key question, "who influenced the content?" When other bodies continue to swear by the ICMJE criteria, despite widely published accounts of their limitations, we can only conclude that people don't really want to get rid of ghostwriting-- which is highly lucrative for the medical journals through sales of reprints, and also for academic centers, as those faculty who are asked to be ghostwriters in all probability bring in hefty funding from Pharma.
As I explained in HOOKED and in many previous posts, ghostwriting, despite recent efforts to sanitize it, has to be the most egregious case of unethical practice at the medicine-Pharma interface. If you cannot believe that the listed authors actually wrote an article, what can you believe? Maybe in the world of celebrity kiss-and-tell memoirs, no one is shocked to discover that the celebrity "author" really did no writing at all (and more than likely couldn't if he tried), and some hired hack writer churned out the text. But the entire system of trust in science is built on the reader's confidence that the authors, with their academic reputations, are vouching for the results stated in the article and especially for the interpretation they attach to those results. If academic medicine cannot put a stop to this, it is time to call in Senator Grassley and his troops and turn the control of academic medicine over to Congress or some other outside agency, because we've failed.
Sunday, June 17, 2012
The Word from Pakistan: Bioethics, for Sale to the Highest Bidder
Dr. Farhat Moazam is a most impressive Pakistani physician. She became interested in organ transplant issues in her native country and eventually came to the US to study for a PhD in ethics. Her book, Bioethics and Organ Transplantation in a Muslim Society, is a superb example both of an ethical investigation of organ transplantation, and a comparative treartment of modes of ethical thought in different cultures.
I was therefore delighted to see her views on Pharma influence in Pakistan posted on the PharmaGossip blog:
http://pharmagossip.blogspot.com/2012/06/pharma-in-pakistan-farhat-moazam-writes.html
She recounts the usual sorts of skullduggery of academic physicians seeking Pharma money and doing the bidding of the industry while fondly imagining that they're not influenced. But perhaps most worrisome, especially to somebody like me whose day job includes bioethics, are these observations:
Another particularly egregious development is the increasing financial support of multinationals for bioethics centres, staff and programmes. Carl Elliot of the Centre for Bioethics, University of Minnesota, who follows this phenomenon in the US, reports a $100,000 grant established by a leading drug manufacturer for a Fellowship in Bioethics, meant to allow researchers to explore “conflicts of interest”.
The irony of this is inescapable if one recalls that not too long ago this company was involved in a deadly drug research scandal involving Nigerian children with meningitis and, according to Elliot, made to pay the largest criminal fine in 2009.
This year, another two more pharmaceuticals are to fund a “crash course in bioethics” in China which will include “meetings” with “pharma folks … expats who work for large drugmakers”. The University of Pennsylvania faculty member that is organising this course admits that he has worked “in big pharma for many years” with the key objective to “develop academic-industry collaborations”. One of the companies was cited last year for interfering in the approval of generic alternatives to its blood-thinning drug.
When US physicians eat out of Pharma's hands, one can object among other things that we ought to have enough money floating about in our bloated health care system to pay for whatever is needed without going begging to the drug industry--especially when what's at stake is not a grant to run a research project, but the funds to sponsor a luxurious dinner or reception at a swank hotel. By contrast, in a country like Pakistan, it's easier to argue that the poverty of the medical system in general leaves physicians with no options but to seek funding wherever they can. It's therefore impressive that Dr. Moazam (who directs the Centre of Biomedical Ethics and Culture at the Sindh Institute of Urology and Transplantation) is having none of that. She quite rightly demands ethical accountability and scrutiny of all such transactions--and real ethical scrutiny, not bioethics-for-hire. If she can insist on this in Pakistan, how much more are we in wealthier nations obligated to follow her example?
(Hat tip to Dr. Barney Carroll for alerting me to this post.)
I was therefore delighted to see her views on Pharma influence in Pakistan posted on the PharmaGossip blog:
http://pharmagossip.blogspot.com/2012/06/pharma-in-pakistan-farhat-moazam-writes.html
She recounts the usual sorts of skullduggery of academic physicians seeking Pharma money and doing the bidding of the industry while fondly imagining that they're not influenced. But perhaps most worrisome, especially to somebody like me whose day job includes bioethics, are these observations:
Another particularly egregious development is the increasing financial support of multinationals for bioethics centres, staff and programmes. Carl Elliot of the Centre for Bioethics, University of Minnesota, who follows this phenomenon in the US, reports a $100,000 grant established by a leading drug manufacturer for a Fellowship in Bioethics, meant to allow researchers to explore “conflicts of interest”.
The irony of this is inescapable if one recalls that not too long ago this company was involved in a deadly drug research scandal involving Nigerian children with meningitis and, according to Elliot, made to pay the largest criminal fine in 2009.
This year, another two more pharmaceuticals are to fund a “crash course in bioethics” in China which will include “meetings” with “pharma folks … expats who work for large drugmakers”. The University of Pennsylvania faculty member that is organising this course admits that he has worked “in big pharma for many years” with the key objective to “develop academic-industry collaborations”. One of the companies was cited last year for interfering in the approval of generic alternatives to its blood-thinning drug.
When US physicians eat out of Pharma's hands, one can object among other things that we ought to have enough money floating about in our bloated health care system to pay for whatever is needed without going begging to the drug industry--especially when what's at stake is not a grant to run a research project, but the funds to sponsor a luxurious dinner or reception at a swank hotel. By contrast, in a country like Pakistan, it's easier to argue that the poverty of the medical system in general leaves physicians with no options but to seek funding wherever they can. It's therefore impressive that Dr. Moazam (who directs the Centre of Biomedical Ethics and Culture at the Sindh Institute of Urology and Transplantation) is having none of that. She quite rightly demands ethical accountability and scrutiny of all such transactions--and real ethical scrutiny, not bioethics-for-hire. If she can insist on this in Pakistan, how much more are we in wealthier nations obligated to follow her example?
(Hat tip to Dr. Barney Carroll for alerting me to this post.)
Monday, June 11, 2012
Treating Stroke: Pharma Influence, Medical Zealotry, or Both?
I recently had occasion: http://brodyhooked.blogspot.com/2012/05/statins-in-water-supply-continued-why.html
--to call attention to the excellent blog that Dr. David Newman runs over at Mt. Sinai--he calls it "SMART EM" which stands for "Scientific Medicine and Research Translation [in Emergency Medicine]." I'm going to pay a return visit to his blog, even though the issue he discusses is perhaps of peripheral concern to our topic of ethics and the pharmaceutical industry. It does relate to how Americans end up being seriously overtreated without any resulting health benefits. (It's also very discouraging for those of us Anglophiles who had imagined that the Brits had things better figured out.)
Dr. Newman takes aim at a recent study in Lancet:
http://smartem.org/content/delusions-benefit-international-stroke-trial
I need to provide some general background, review what Dr. Newman says, and then add some commentary.
Background: Dr. Newman quickly reviews the reasons why I had decided long ago that even though I am not into tattoos, if I were to have something tattooed on my chest, it would be "No tPA in case of stroke." Stroke care has been taken over by the group I cynically call the "brain attack mafia" who argue that we should go into crisis mode when a stroke patient rolls into the ER just like we do when a heart attack victim arrives. Their problem: We have proven things to do to save lives in acute heart attack, but what do we have to offer for acute stroke? The logic of the disease suggests that dissolving the clot in the brain artery quickly would save brain tissue, function, and ultimately lives. Sadly, as often happens, logic and scientific outcomes fail to match. The clot buster usually recommended, tPA, has been shown in numerous trials either to have no benefit, or to have a very small benefit which you can only find by tying knots in the statistics, while posing risks of major bleeding.
So now there's a new international trial of tPA in acute stroke, IST-3, just published on line in Lancet (subscription required), that Dr. Newman thoughtfully dissects. Their primary endpoint was death or dependence at 6 months. The study data were clear--no difference in either outcome between the tPA and the control group.
But of course the Mafia would not be satisfied with that negative outcome, so the authors then went back and had to play around with the statistics, and they came up with a new, secondary measure that they claim offered a very slight benefit for the tPA group. So, in what Dr. Newman terms as "breathtaking" evidence of going "stark, raving mad," the authors claim that the study was actually a success for tPA. Not only did Lancet aid and abet the insanity by publishing the paper with this obvious lying-with-statistics, but even added an editorial strongly favoring widespread use of tPA based on this supposed "success."
Commentary: Two main things to note about all this. First, is this obviously biased result due to drug company or industry influence? Well, no and yes, apparently. I looked at the Lancet paper for the usual Pharma footprints. The study was funded by what appears to be a consortium of government health research agencies with no obvious industry money. The authors on the other hand have a long list of ties to industry.
What to make of this? My best guess on the Brain Attack Mafia" is that this is at root genuine therapeutic zealotry among a group of neurologists who are tired of seeing stroke dissed as an "oh well" diagnosis that you just have to take care of and cannot attack with all guns blazing. Folks like this may be biased advocates for relatively useless therapies even when no Pharma money is on the table. But when any industry funding shows up, it's naturally this group that is the greatest ally of the industry that wants to push the drug or the test in question.
Now, second main thing to note. As Dr. Newman points out, even if you believe the crazy statistical gymnasics of IST-3, you are still looking at a miniscule benefit from tPA with a big risk of harm. So an obvious question is: Do we have anything better to offer a patient who has just suffered an acute stroke? And the answer is: Yes.
The literature is now full of studies showing over and over what happens when such a patient is admitted to an acute stroke unit, or the care of a dedicated stroke team, or basically a group of nurses, physical therapists, and other staff in the hospital who wear t-shirts that say "Strokes R Us." It hardly matters if there are any docs involved. What has to happen is that the patient gets care from a team that does stroke all day and every day and has a system not to forget all the little details of care. There's no rocket science, it's just painstakling use of known, beneficial aspects of nursing care, physical therapy, prevention of blood clots in the legs, etc. etc.
What hapens? Here's just one observational study, ironically also published in Lancet:
http://www.sciencedirect.com/science/article/pii/S0140673607601524
This Italian study followed 11,572 acute stroke patients. Those admitted to the right sort of stroke unit had a 28% long term mortality rate compared to 36% in the controls. Those too disabled to live at home at the end of follow-up were 43% of the controls vs. 35% for the stroke unit. (You don't like observational studies? There are also controlled studies in the literature showing the same results, which have now been widely replicated.)
So we are talking here about absolute differences (not relative) of around 8 percentage points, which is hugely superior to results seen in any study of tPA. So why, you might ask, is the Brain Attack Mafia so insistent that we have to give every eligible patient tPA, and so unconcerned about whether each hospital that cares for stroke patients has a good stroke team or unit?
Dr. Newman has the answer in a term he calls "scienciness." We in medicine love scienciness. We often don't like science, because it shows us that stuff that we devoutly believe in (like busting clots with tPA) doesn't really benefit patients. Stroke units and teams are extremely unsexy and unexciting (good nursing care??? Give me a break) but are solid science. Clot-busting with tPA is scienciness.
The IST-3 Collaborative Group. The benefits and harms of intravenous thrombolysis with recombinant tissue plasminogen activator within 6 h of acute ischaemic stroke (the third international stroke trial [IST-3]): a randomised controlled trial. Lancet, 23 May 2012,
http://dx.doi.org/10.1016/S0140-6736(12)60768-5
--to call attention to the excellent blog that Dr. David Newman runs over at Mt. Sinai--he calls it "SMART EM" which stands for "Scientific Medicine and Research Translation [in Emergency Medicine]." I'm going to pay a return visit to his blog, even though the issue he discusses is perhaps of peripheral concern to our topic of ethics and the pharmaceutical industry. It does relate to how Americans end up being seriously overtreated without any resulting health benefits. (It's also very discouraging for those of us Anglophiles who had imagined that the Brits had things better figured out.)
Dr. Newman takes aim at a recent study in Lancet:
http://smartem.org/content/delusions-benefit-international-stroke-trial
I need to provide some general background, review what Dr. Newman says, and then add some commentary.
Background: Dr. Newman quickly reviews the reasons why I had decided long ago that even though I am not into tattoos, if I were to have something tattooed on my chest, it would be "No tPA in case of stroke." Stroke care has been taken over by the group I cynically call the "brain attack mafia" who argue that we should go into crisis mode when a stroke patient rolls into the ER just like we do when a heart attack victim arrives. Their problem: We have proven things to do to save lives in acute heart attack, but what do we have to offer for acute stroke? The logic of the disease suggests that dissolving the clot in the brain artery quickly would save brain tissue, function, and ultimately lives. Sadly, as often happens, logic and scientific outcomes fail to match. The clot buster usually recommended, tPA, has been shown in numerous trials either to have no benefit, or to have a very small benefit which you can only find by tying knots in the statistics, while posing risks of major bleeding.
So now there's a new international trial of tPA in acute stroke, IST-3, just published on line in Lancet (subscription required), that Dr. Newman thoughtfully dissects. Their primary endpoint was death or dependence at 6 months. The study data were clear--no difference in either outcome between the tPA and the control group.
But of course the Mafia would not be satisfied with that negative outcome, so the authors then went back and had to play around with the statistics, and they came up with a new, secondary measure that they claim offered a very slight benefit for the tPA group. So, in what Dr. Newman terms as "breathtaking" evidence of going "stark, raving mad," the authors claim that the study was actually a success for tPA. Not only did Lancet aid and abet the insanity by publishing the paper with this obvious lying-with-statistics, but even added an editorial strongly favoring widespread use of tPA based on this supposed "success."
Commentary: Two main things to note about all this. First, is this obviously biased result due to drug company or industry influence? Well, no and yes, apparently. I looked at the Lancet paper for the usual Pharma footprints. The study was funded by what appears to be a consortium of government health research agencies with no obvious industry money. The authors on the other hand have a long list of ties to industry.
What to make of this? My best guess on the Brain Attack Mafia" is that this is at root genuine therapeutic zealotry among a group of neurologists who are tired of seeing stroke dissed as an "oh well" diagnosis that you just have to take care of and cannot attack with all guns blazing. Folks like this may be biased advocates for relatively useless therapies even when no Pharma money is on the table. But when any industry funding shows up, it's naturally this group that is the greatest ally of the industry that wants to push the drug or the test in question.
Now, second main thing to note. As Dr. Newman points out, even if you believe the crazy statistical gymnasics of IST-3, you are still looking at a miniscule benefit from tPA with a big risk of harm. So an obvious question is: Do we have anything better to offer a patient who has just suffered an acute stroke? And the answer is: Yes.
The literature is now full of studies showing over and over what happens when such a patient is admitted to an acute stroke unit, or the care of a dedicated stroke team, or basically a group of nurses, physical therapists, and other staff in the hospital who wear t-shirts that say "Strokes R Us." It hardly matters if there are any docs involved. What has to happen is that the patient gets care from a team that does stroke all day and every day and has a system not to forget all the little details of care. There's no rocket science, it's just painstakling use of known, beneficial aspects of nursing care, physical therapy, prevention of blood clots in the legs, etc. etc.
What hapens? Here's just one observational study, ironically also published in Lancet:
http://www.sciencedirect.com/science/article/pii/S0140673607601524
This Italian study followed 11,572 acute stroke patients. Those admitted to the right sort of stroke unit had a 28% long term mortality rate compared to 36% in the controls. Those too disabled to live at home at the end of follow-up were 43% of the controls vs. 35% for the stroke unit. (You don't like observational studies? There are also controlled studies in the literature showing the same results, which have now been widely replicated.)
So we are talking here about absolute differences (not relative) of around 8 percentage points, which is hugely superior to results seen in any study of tPA. So why, you might ask, is the Brain Attack Mafia so insistent that we have to give every eligible patient tPA, and so unconcerned about whether each hospital that cares for stroke patients has a good stroke team or unit?
Dr. Newman has the answer in a term he calls "scienciness." We in medicine love scienciness. We often don't like science, because it shows us that stuff that we devoutly believe in (like busting clots with tPA) doesn't really benefit patients. Stroke units and teams are extremely unsexy and unexciting (good nursing care??? Give me a break) but are solid science. Clot-busting with tPA is scienciness.
The IST-3 Collaborative Group. The benefits and harms of intravenous thrombolysis with recombinant tissue plasminogen activator within 6 h of acute ischaemic stroke (the third international stroke trial [IST-3]): a randomised controlled trial. Lancet, 23 May 2012,
Friday, June 8, 2012
Worshiping at the Altar of Innovation (a.k.a. Profits)
Catching up on some older literature, I see that British sociologist John Abraham (last blogged about: http://brodyhooked.blogspot.com/2011/11/emergent-patient-industry-complex-and.html) and his associate Courtney Davis have produced an interesting paper comparing the drug regulation systems in the U.S. and the European Union, using diabetes as a case study-- specifically, the class of drugs called the glitazones.
They review the story of the approval process in each system for the drugs rosiglitazone (Avandia) and pioglitazone (Actos). Their principal conclusion is that what drove the regulatory approval process in the U.S., and to a somewhat lesser extent in Europe, was the "innovation" factor--that the glitazones were a new class of diabetes drugs and worked by a new chemical mechanism. This led the regulators to take their eye off what should have been the ball--the question of whether these drugs were safe and effective for patients with diabetes.
The FDA approved Avandia and Actos in 1999. Davis and Abraham tell us, "By 2007, the FDA had reached the uncomfortable conclusion that their medical optimism about the glitazones’ ‘wonderful’ and ‘unique’ mechanism had been little more than wishful thinking." They go on to suggest that such an outcome "is consistent with an ideology that mistakes technological novelty for public health benefit."
While the EU was to some extent driven by the same love affair with "innovation," the Europeans eventually became more hard-nosed than the Americans, demanding to see evidence of improved outcomes in diabetes (that is, longer life, or fewer major cardiovascular events) in comparison with existing drugs, while the US FDA was happy to require the companies merely to prove that their drugs did a better job than placebo at lowering blood sugar. Davis and Abraham explain, "The FDA justified its more permissive approach on the grounds that once efficacy is established, albeit against placebo, the drugs should be approved to find their place in the ‘market’ where doctors can judge which drugs are best for their patients." Conveniently left out of this FDA equation is how physicians are supposed to be able to "judge" when the industry gets to design all the studies of the new drugs and can avoid asking any of the hard scientific questions that might threaten drug sales--and when the FDA refuses to use its regulatory clout to force the companies to do the studies that would really prove that the drugs have a worthy role in therapy.
Moreover, "The glitazones highlight the ideological nature of the FDA’s expectations in relation to rational drug use because the hypothesized clinical benefits associated with the drugs’ innovative mechanism, on the one hand, and the comparative clinical evidence actually available, on the other, implied diametrically opposed clinical use. On the clinical trial evidence that the glitazones were less effective than existing drugs at lowering blood-glucose, glitazone use would be recommended after those other drugs had failed .... By contrast, the hypothesized benefits from the glitazones’ innovative mechanism implied that the drugs should be used early in therapy to prevent disease progression. The contradiction of the FDA’s approach is that to suggest such potential benefits from an innovative mechanism underlines the need for good comparative efficacy data because it is all the more important that information about the glitazones’ most effective use is available."
So, where does this worship of innovation come from? It is hard to blame industry fully. Physicians are always excited to hear that a new class of drugs has been discovered. Scientists are intrigued by novel mechanisms. These discoveries make the evening news and get patient-advocacy groups all in a lather about the latest "cure" or "miracle." But despite those other contributing factors, we cannot deny that it serves industry's interests to get the regulators to pay more attention to "innovation" than to actual patient outcome data: "Our case-study of ‘innovative’ pharmaceuticals suggest that even if ... the expectations of medical innovation are rarely proportionate to future therapeutic results, sales ‘results’ can prosper for years after because of immense promotional efforts by manufacturers and the ideological sway of the idea of innovation within neo-liberal regulation..."
Now, one interesting feature of this analysis is that Davis and Abraham don't really tell the whole glitazone story. They dismiss with one sentence what happened to the predecessor of both Actos and Avandia, troglitazone (Rezulin)--a drug that I found worthy of three pages of discussion in HOOKED. The first drug to be marketed in this class had to be withdrawn from the market due to liver failure. The British regulators took Rezulin off the market more than 2 years before the FDA did, and 63 people had to die in the US before the FDA finally took action. The love affair with "innovation" therefore claimed even more lives than David and Abraham indicate.
Since Rezulin had done its dirty work via the liver, the FDA thought ot was home free when it could see that neither Actos or Avandia caused similar liver problems. That distracted the agency from the real problem with Avandia, causing excess cases of heart failure. But you could argue that the FDA was even more distracted from the real issue, which is whether these drugs have any significant role at all in the treatment of diabetes--in the absence of any clinical data showing superior outcomes to the many other drugs already in use for diabetes.
A background assumption in most of the FDA actions taken on these drugs is that when a company goes to the trouble of actually discovering a branbd-new drug--instead of just making yet another me-too drug--it somehow deserves a reward for these efforts. This raises two questions. First, how low has the bar become for what counts as exemplary behavior by a drug company? Second, if the company deserves some sort of pat on the back for their work of scientific discovery, how does that translate into subjecting patients to a new drug that may be unsafe and that has not been shown to make them better?
Hat tip (again) to Primary Care Medical Abstracts for alerting me to this paper.
Davis C, Abraham J. The socio-political roots of pharmaceutical uncertainty in the evaluation of 'innovative' diabetes drugs in the European Union and the US. Social Science and Medicine 72:1574-1581, 2011.
They review the story of the approval process in each system for the drugs rosiglitazone (Avandia) and pioglitazone (Actos). Their principal conclusion is that what drove the regulatory approval process in the U.S., and to a somewhat lesser extent in Europe, was the "innovation" factor--that the glitazones were a new class of diabetes drugs and worked by a new chemical mechanism. This led the regulators to take their eye off what should have been the ball--the question of whether these drugs were safe and effective for patients with diabetes.
The FDA approved Avandia and Actos in 1999. Davis and Abraham tell us, "By 2007, the FDA had reached the uncomfortable conclusion that their medical optimism about the glitazones’ ‘wonderful’ and ‘unique’ mechanism had been little more than wishful thinking." They go on to suggest that such an outcome "is consistent with an ideology that mistakes technological novelty for public health benefit."
While the EU was to some extent driven by the same love affair with "innovation," the Europeans eventually became more hard-nosed than the Americans, demanding to see evidence of improved outcomes in diabetes (that is, longer life, or fewer major cardiovascular events) in comparison with existing drugs, while the US FDA was happy to require the companies merely to prove that their drugs did a better job than placebo at lowering blood sugar. Davis and Abraham explain, "The FDA justified its more permissive approach on the grounds that once efficacy is established, albeit against placebo, the drugs should be approved to find their place in the ‘market’ where doctors can judge which drugs are best for their patients." Conveniently left out of this FDA equation is how physicians are supposed to be able to "judge" when the industry gets to design all the studies of the new drugs and can avoid asking any of the hard scientific questions that might threaten drug sales--and when the FDA refuses to use its regulatory clout to force the companies to do the studies that would really prove that the drugs have a worthy role in therapy.
Moreover, "The glitazones highlight the ideological nature of the FDA’s expectations in relation to rational drug use because the hypothesized clinical benefits associated with the drugs’ innovative mechanism, on the one hand, and the comparative clinical evidence actually available, on the other, implied diametrically opposed clinical use. On the clinical trial evidence that the glitazones were less effective than existing drugs at lowering blood-glucose, glitazone use would be recommended after those other drugs had failed .... By contrast, the hypothesized benefits from the glitazones’ innovative mechanism implied that the drugs should be used early in therapy to prevent disease progression. The contradiction of the FDA’s approach is that to suggest such potential benefits from an innovative mechanism underlines the need for good comparative efficacy data because it is all the more important that information about the glitazones’ most effective use is available."
So, where does this worship of innovation come from? It is hard to blame industry fully. Physicians are always excited to hear that a new class of drugs has been discovered. Scientists are intrigued by novel mechanisms. These discoveries make the evening news and get patient-advocacy groups all in a lather about the latest "cure" or "miracle." But despite those other contributing factors, we cannot deny that it serves industry's interests to get the regulators to pay more attention to "innovation" than to actual patient outcome data: "Our case-study of ‘innovative’ pharmaceuticals suggest that even if ... the expectations of medical innovation are rarely proportionate to future therapeutic results, sales ‘results’ can prosper for years after because of immense promotional efforts by manufacturers and the ideological sway of the idea of innovation within neo-liberal regulation..."
Now, one interesting feature of this analysis is that Davis and Abraham don't really tell the whole glitazone story. They dismiss with one sentence what happened to the predecessor of both Actos and Avandia, troglitazone (Rezulin)--a drug that I found worthy of three pages of discussion in HOOKED. The first drug to be marketed in this class had to be withdrawn from the market due to liver failure. The British regulators took Rezulin off the market more than 2 years before the FDA did, and 63 people had to die in the US before the FDA finally took action. The love affair with "innovation" therefore claimed even more lives than David and Abraham indicate.
Since Rezulin had done its dirty work via the liver, the FDA thought ot was home free when it could see that neither Actos or Avandia caused similar liver problems. That distracted the agency from the real problem with Avandia, causing excess cases of heart failure. But you could argue that the FDA was even more distracted from the real issue, which is whether these drugs have any significant role at all in the treatment of diabetes--in the absence of any clinical data showing superior outcomes to the many other drugs already in use for diabetes.
A background assumption in most of the FDA actions taken on these drugs is that when a company goes to the trouble of actually discovering a branbd-new drug--instead of just making yet another me-too drug--it somehow deserves a reward for these efforts. This raises two questions. First, how low has the bar become for what counts as exemplary behavior by a drug company? Second, if the company deserves some sort of pat on the back for their work of scientific discovery, how does that translate into subjecting patients to a new drug that may be unsafe and that has not been shown to make them better?
Hat tip (again) to Primary Care Medical Abstracts for alerting me to this paper.
Davis C, Abraham J. The socio-political roots of pharmaceutical uncertainty in the evaluation of 'innovative' diabetes drugs in the European Union and the US. Social Science and Medicine 72:1574-1581, 2011.
How About a Little Exercise?
In the previous post I talked about new evidence of how many serious injuries and deaths are caused by American medicine's love affair with treating every possible patient malady with prescription drugs. By way of illustrating what might make more sense, let me again thank Drs. Rick Bukata and Jerry Hoffman's Primary Care Medical Abstracts program, whose May 2012 issue just happened to include this reference:
http://www.sciencedirect.com/science/article/pii/S0140673611607496
This Taiwanese group of investigators report a prospective study that involved 416,175 healthy people with a mean follow-up of 8 years, which most people would regard as a sufficiently large sample to draw some reasonable conclusions.
They wanted to explore the conventional wisdom that you need at least 30 minutes of exercise a day to show any health advantage. They did in fact find that if you did 30 minutes of exercise a day, you had a 20% relative reduction in all-cause mortality, and a 15% reduction in cancer mortality. But the good news was that they also found that even 15 minutes a day led to 14% and 10% risk reductions, respectively, which is not all that shabby. There was a nice dose-response curve with added exercise leading to increased health benefits. So the authors conclude that it makes excellent sense to recommend even minimal exercise as a way to get patients some health benefits and hopefully they might find they can increase it over time.
Now I go into all this because in this blog we've seen example after example of a "wonder" drug that alters mortality rates by maybe 1% or 2% at best; and that's rare compared to drugs that change surrogate markers but have no impact on mortality at all; or then the drugs that reduce disease-specific mortality but not all-cause mortality. In short, the effects seen with even 15 minutes of exercise in this study are vastly superior to results shown with the majority of prescription drugs that are commonly used in "preventive" merdicine.
I used to joke about John Abramson's great book, Overdo$ed America, that my esteemed colleague must be in the pay of the exercise industry, because his entire book could be seen as one long appeal, "go get some exercise and forget all this other garbage." Well, he was right. And if American physicians spent half the time counseling patients about exercise as they do reaching for the prescription pad (or the computer equivalent) imagine how much healthier we'd be. (Then we could talk about health disparities and how exercise recommendations increase disparities between groups, but that's another discussion.)
http://www.sciencedirect.com/science/article/pii/S0140673611607496
This Taiwanese group of investigators report a prospective study that involved 416,175 healthy people with a mean follow-up of 8 years, which most people would regard as a sufficiently large sample to draw some reasonable conclusions.
They wanted to explore the conventional wisdom that you need at least 30 minutes of exercise a day to show any health advantage. They did in fact find that if you did 30 minutes of exercise a day, you had a 20% relative reduction in all-cause mortality, and a 15% reduction in cancer mortality. But the good news was that they also found that even 15 minutes a day led to 14% and 10% risk reductions, respectively, which is not all that shabby. There was a nice dose-response curve with added exercise leading to increased health benefits. So the authors conclude that it makes excellent sense to recommend even minimal exercise as a way to get patients some health benefits and hopefully they might find they can increase it over time.
Now I go into all this because in this blog we've seen example after example of a "wonder" drug that alters mortality rates by maybe 1% or 2% at best; and that's rare compared to drugs that change surrogate markers but have no impact on mortality at all; or then the drugs that reduce disease-specific mortality but not all-cause mortality. In short, the effects seen with even 15 minutes of exercise in this study are vastly superior to results shown with the majority of prescription drugs that are commonly used in "preventive" merdicine.
I used to joke about John Abramson's great book, Overdo$ed America, that my esteemed colleague must be in the pay of the exercise industry, because his entire book could be seen as one long appeal, "go get some exercise and forget all this other garbage." Well, he was right. And if American physicians spent half the time counseling patients about exercise as they do reaching for the prescription pad (or the computer equivalent) imagine how much healthier we'd be. (Then we could talk about health disparities and how exercise recommendations increase disparities between groups, but that's another discussion.)
Prescription Drugs: Even More Deadly?
In the past I have blogged about Donald Light's important work on the risks of prescription drugs:
http://brodyhooked.blogspot.com/2011/12/back-to-risks-of-prescription-drugs.html
Now, here's journalist Jeanne Lenzer on the same issue in the BMJ (I am not sure if this link provides free access to non-subscribers):
http://www.bmj.com/content/344/bmj.e3989
Ms. Lenzer cites a new study that uses the FDA adverse reactions report database to calculate the estimates that in 2011, between 2 and 4 milion Americans suffered some sort of serious reaction of prescription drugs taken properly and in the correct dose, and 128,000 died. The latter estimate fits well with Don Light's earlier work that the annual death toll is conservatively estimated at 100,000, making it the 4th largest cause of death in the US. The new study also shows that 11% of the US population is taking 5 or more drugs, which every physician knows is a setup for dangerous drug interactions.
The top troublemakers on this list were anticoagulant drugs that caused dangerous bleeding. One was warfarin, which is an old generic and is not marketed by any company. But the other is one of the new kids on the block, dabigatran (Pradaxa), which is being heavily marketed because it's a new agent and supposedly a lot safer. Another big problem drug in this review is the antibiotic levofloxacin (Levaquin) which is so widely used in hospital as well as outpatient medicine that it's often jokingly referred to as "Vitamin L."
So why is this important? Well, we might ask the American Enterprise Institute. This conservative think tank recently announced a conference:
http://www.aei.org/events/2012/06/21/muzzle-pharma-harm-patients-the-dangers-of-anti-industry-bias/
The idea behind this appears to be that regulations and restrictions are hampering drug reps' access to docs. This is of course bad because these drug reps are a wonderful source of up-to-date, accurate information. So it will no doubt seriously harm patients if these reps can't do their good deeds.
So we have to set up a scale to weigh the pros and cons accurately. On the one side we have to put the possibility that because industry marketing cannot reach some physicians, patients might suffer harm--despite many previous studies that all show that drug reps, when they interact with docs, always tend to downplay any risks of drugs. On the other side of the scale we can put 128,000 deaths per year due to our crazy, overboard overprescribing practices, much of it fed by industry marketing.
You can make guesses as to which way the scale will tip.
http://brodyhooked.blogspot.com/2011/12/back-to-risks-of-prescription-drugs.html
Now, here's journalist Jeanne Lenzer on the same issue in the BMJ (I am not sure if this link provides free access to non-subscribers):
http://www.bmj.com/content/344/bmj.e3989
Ms. Lenzer cites a new study that uses the FDA adverse reactions report database to calculate the estimates that in 2011, between 2 and 4 milion Americans suffered some sort of serious reaction of prescription drugs taken properly and in the correct dose, and 128,000 died. The latter estimate fits well with Don Light's earlier work that the annual death toll is conservatively estimated at 100,000, making it the 4th largest cause of death in the US. The new study also shows that 11% of the US population is taking 5 or more drugs, which every physician knows is a setup for dangerous drug interactions.
The top troublemakers on this list were anticoagulant drugs that caused dangerous bleeding. One was warfarin, which is an old generic and is not marketed by any company. But the other is one of the new kids on the block, dabigatran (Pradaxa), which is being heavily marketed because it's a new agent and supposedly a lot safer. Another big problem drug in this review is the antibiotic levofloxacin (Levaquin) which is so widely used in hospital as well as outpatient medicine that it's often jokingly referred to as "Vitamin L."
So why is this important? Well, we might ask the American Enterprise Institute. This conservative think tank recently announced a conference:
http://www.aei.org/events/2012/06/21/muzzle-pharma-harm-patients-the-dangers-of-anti-industry-bias/
The idea behind this appears to be that regulations and restrictions are hampering drug reps' access to docs. This is of course bad because these drug reps are a wonderful source of up-to-date, accurate information. So it will no doubt seriously harm patients if these reps can't do their good deeds.
So we have to set up a scale to weigh the pros and cons accurately. On the one side we have to put the possibility that because industry marketing cannot reach some physicians, patients might suffer harm--despite many previous studies that all show that drug reps, when they interact with docs, always tend to downplay any risks of drugs. On the other side of the scale we can put 128,000 deaths per year due to our crazy, overboard overprescribing practices, much of it fed by industry marketing.
You can make guesses as to which way the scale will tip.
More Drugmakers Pay More Big Fines
Keeping up with our friends over at PostScript/Community Catalyst:
http://postscript.communitycatalyst.org/?p=3222
http://postscript.communitycatalyst.org/?p=3221
These posts tell us about two recent judgments against drug companies that I have not previously mentioned here--first, Abbott paying $1.5B to settle claims of off-label marketing of the anti-seizure medication, Depakote (valproic acid) for nursing home patients with dementia; and second, Johnson& Johnson being fined $1.19B for off label marketing of Risperdal (risperidone). (I did blog about the latter case when the suit was first filed: http://brodyhooked.blogspot.com/2010/01/doj-johnson-and-johnson-paid-big.html
In the PostScript blog posts, attorney Wells Wilkinson notes that each of these cases represents egregious misuse of medical evidence, putting patients at risk in the name of higher profits. Both cases also represent a particular misuse of medication, basically, telling harried nursing home staff that if your demented patient is making a fuss, no problem, just medicate them with our drug. (More on that later.)
In the J&J settlement, Mr. Wilkinson is happy that the proceeds go to the Arkansas Medicaid fund--noting the justice that if bad drug marketing ends up costing the taxpayers money, the proceeds of the suit should go to making it right. But his lament in each case is that some of the money should have been devoted to a specific re-education campaign to better inform those caring for the elderly of the dangers of these medications, and to undo the damage done by industry marketing misinformation.
Now as to the nursing home patient who's demented and making a fuss that upsets the staff--a group in Norway looked at 352 nursing home residents who were moderately to severely demented and displaying behavioral problems. They decided--maybe these people are in pain, and the reason they are acting up is because they hurt, but they can't tell us. So they tried pain management, beginning with acetaminophen and progressing to stronger measures if needed. For the majority of their patients, just putting them on acetaminophen made the behavior problem go away and created no adverse consequences.
So maybe for at least some of this group of patients, what we need is better pain management with cheap genetric drugs.
Husebo BS, Ballard C, Sandvik R, et al. Efficacy of treating pain to reduce behavioural disturbances in residents of nursing homes with dementia: cluster randomised clinical trial. BMJ 2011 Jul 15;343:d4065.
http://postscript.communitycatalyst.org/?p=3222
http://postscript.communitycatalyst.org/?p=3221
These posts tell us about two recent judgments against drug companies that I have not previously mentioned here--first, Abbott paying $1.5B to settle claims of off-label marketing of the anti-seizure medication, Depakote (valproic acid) for nursing home patients with dementia; and second, Johnson& Johnson being fined $1.19B for off label marketing of Risperdal (risperidone). (I did blog about the latter case when the suit was first filed: http://brodyhooked.blogspot.com/2010/01/doj-johnson-and-johnson-paid-big.html
In the PostScript blog posts, attorney Wells Wilkinson notes that each of these cases represents egregious misuse of medical evidence, putting patients at risk in the name of higher profits. Both cases also represent a particular misuse of medication, basically, telling harried nursing home staff that if your demented patient is making a fuss, no problem, just medicate them with our drug. (More on that later.)
In the J&J settlement, Mr. Wilkinson is happy that the proceeds go to the Arkansas Medicaid fund--noting the justice that if bad drug marketing ends up costing the taxpayers money, the proceeds of the suit should go to making it right. But his lament in each case is that some of the money should have been devoted to a specific re-education campaign to better inform those caring for the elderly of the dangers of these medications, and to undo the damage done by industry marketing misinformation.
Now as to the nursing home patient who's demented and making a fuss that upsets the staff--a group in Norway looked at 352 nursing home residents who were moderately to severely demented and displaying behavioral problems. They decided--maybe these people are in pain, and the reason they are acting up is because they hurt, but they can't tell us. So they tried pain management, beginning with acetaminophen and progressing to stronger measures if needed. For the majority of their patients, just putting them on acetaminophen made the behavior problem go away and created no adverse consequences.
So maybe for at least some of this group of patients, what we need is better pain management with cheap genetric drugs.
Husebo BS, Ballard C, Sandvik R, et al. Efficacy of treating pain to reduce behavioural disturbances in residents of nursing homes with dementia: cluster randomised clinical trial. BMJ 2011 Jul 15;343:d4065.
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