Readers: I just took down a comment posted by "James" in response to the recent posting on the Whitaker book. James was asking for assistance in coming off a psychiatric drug that he has been taking for many years.
I wish James all the best for his future health. But I must remind all readers that this blog is about ethics and health policy. It is not designed to offer anyone personal medical advice and it would be highly irresponsible to interpret anything said on this blog as personal medical advice. You must consult the appropriate health professional to get personal medical advice. Everything discussed on this blog is general background information and cannot be applied to any specific individual's care without expert interpretation.
Tuesday, May 25, 2010
Sunday, May 23, 2010
Whitaker's Anatomy of an Epidemic: A Fundamental Challenge to Psychopharmacology
In the course of writing HOOKED and then doing this blog, I thought I was pretty much up on all the misinformation that had been spread about psychiatric drugs. As we've seen in previous posts, we are aware of the lack of evidence to show that mental illnesses result from specific chemical imbalances in the brain, or that psychiatric drugs are targeted to fix those imbalances. We are aware that drugs touted as almost free of serious side effects actually have an array of serious side effects. We have seen that drugs advertised as non-habit-forming in fact pose serious withdrawal risks.
I have just finished reading Robert Whitaker's Anatomy of an Epidemic, and have concluded that we don't yet know the half of it.
Whitaker's message is such a fundamental challenge to today's practice of psychiatry that I went searching on the web for any evidence that he's connected with Scientology or any of its fellow travelers. I found no such evidence (and will mention later how Whitaker's assertions part company with the wacko claims of the anti-psychiatry groups). Whitaker is a journalist and author of a previous book, Mad in America.
I have to explain first Whitaker's assertions about psychotropic drugs, and then his claims about the role of Pharma and psychiatry in misleading us about them.
Whitaker starts off with an epidemiological question. If you go back about 60 years, you discover that relatively few people in the US were diagnosed with mental illness, and that they often recovered and went back to leading normal lives in the vast majority of cases. A tiny percentage made up the chronically mentally ill that were warehoused in state hospitals. Then came the psychopharmacology revolution and the discovery of all the modern classes of psychotropic drugs. We have been told that these drugs revolutionized psychiatry and allowed those "warehoused" people to come out of the hospital and into the community. But when we look at the numbers we see a surprising thing. Not only are many more times the old number of people being diagnosed today with mental illness, but their long term prognosis seems to be abysmal, with a great many ending up on disability. If these new drugs do such a great job, how come we have so many more mentally ill and they do so much worse?
Whitaker then offers an answer, in terms of both basic biological mechanisms and actual patient outcome data. The mechanism answer is a great embarrassment to me personally because I never thought of it, despite having had what I thought was a good biology education in college and even writing papers about systems biology. The standard psychiatric theory, which seems correct, says that the new drugs alter the levels of neurotransmitters in the synapses between brain cells. Anyone with an ounce of knowledge of biology ought then to ask--and what happens next? Just about the fourth or fifth word we learned in biology class is homeostasis. If something comes along from the outside and disrupts any body system, the body almost always has a built-in regulator that seeks to restore the prior state of balance. And indeed, Whitaker tells us, scientists who have gone looking have found the homeostatic responses to these drugs. If the drug results in(say) an increase in dopamine in the synapse, the brain down-regulates its dopamine system, by putting out less dopamine from the first neuron, or by shutting down some of the dopamine receptor sites in the second neuron. In short, the drug, that was supposed to be correcting a disorder (which was actually not the cause of any mental illness anyway according to the best current evidence) has actually now induced a brain disorder.
Homeostasis works for a while, but if you stay on the drug long term, homeostasis eventually poops out. So what happens to people on the drug long-term may look quite different from what happens in the short-term. In any event we have mechanisms that can explain why you actually might induce a brain disorder from using these medications, rather than relieving an existing disorder.
That's at the mechanism level; what about with real people? Whitaker marshals a good deal of evidence from legitimate scientific studies to show that indeed, what the mechanism hints at is what happens. A regular refrain in the book is that there remains about 20% of patients who seem to need the medications and who do much better with them than without them. (That seems clearly to me to show that Whitaker has no truck with the Scientology line.) What about the other 80%? These people may have less symptoms for the first 6-8 weeks or so of treatment, and indeed most controlled trials confirm that advantage. However, after that initial response, the advantage seems to disappear. People treated with medication initially tend to do markedly worse at 1, 2, 5, and 10 years out from initiation of treatment compared to the few patients who somehow escape drug treatment. The standard psychiatric theory is that we see many more people today with bipolar disorder than in the past because when they go into the depression phase of the disorder, psychiatrists treat them with antidepressants, and they then develop symptoms suggestive of mania, meaning that the antidepressants have "unmasked" the true, underlying disease. Whitaker reviews data suggesting that it is much more likely that the antidepressants caused the manic reaction, and that a person who becomes bipolar following medication use cycles more rapidly in and out of mania and depression, and ultimately has a much poorer prognosis, than the classic bipolar patient of days gone by.
How good are the data Whitaker cites? Not knowing the psychiatric literature as a whole, I cannot exclude the possibility that he has carefully cherry-picked a set of studies that happen to confirm his thesis while ignoring a much larger body of studies that disprove it. I tried to get some input from psychiatrist friends but none had as yet read the book. So I remain open to being shown the error of my ways on that point.
Whitaker thus paints a picture by which the standard psychiatric practice has helped a few but has greatly harmed many others. He claims this has happened becaue we as a society have been systematically lied to about the data. The next question is how that set of lies came about.
(A brief detour here to do the "don't try this at home" disclaimer. If you are taking psychotropic drugs and read Whitaker's book, the first thing that crosses your mind is to stop taking the drugs. Do not do that. Quite apart from the fact that you might be among the 20% who do better with the drugs, a quick withdrawal will almost guarantee worsening and a greater dependency on drugs in the future. (Indeed, the standard belief system of psychiatry holds that we know psychiatric drugs do good, precisely because withdrawal worsening is so common.) Only slow, cautious drug withdrawal seems to work for most people.)
In writing HOOKED, I had a standard model of the medicine-Pharma relationship that I thought was based on historical research and fact. I assumed that the heavy financial entanglement between docs and drug companies today was a very slow, almost imperceptible process that occurred throughout the 20th century. The gradual nature of the entanglement explained why docs seemed to have developed no moral compass to guide them when things got seriously out of kilter.
Whitaker paints quite a different picture of the situation with psychiatry. He reminds us first how beleagured the field felt itself to be back in the late 1960s and early 1970s. First, internally, a pitched battle was beign fought among three camps--the newer drug-oriented shrinks; the traditional Freudians who sneered at drugs; and the emerging cadre of social psychiatrists who thought that environmental factors were more important in both causing and treating mental illness. From the outside, psychiatry was threatened with losing all its business as psychologists, psychiatric social workers, and other non-physician counselors set up shop and offered psychotherapy at lower rates. Finally, in academic circles, psychiatry was under attack from the anti-psychiatry movement of folks like Thomas Szasz (The Myth of Mental Illness), R.D. Laing, and, in popular culture, the film One Flew Over the Cuckoo's Nest.
The American Psychiatric Association responded to all this with what looks, for all intents and purposes, like a PR and marketing effort worthy of Toyota's recent efforts to restore America's confidence in its vehicles. Far from any "incremental" change, the dates at which all this happened can be readily determined, says Whitaker. It was in 1974 that the APA formed a task force to explore the possibility that the field could benefit from a large influx of Pharma dollars; and it was in 1980 that the APA adopted a new policy of encouraging drug companies to sponsor "scientific" talks at APA conventions.
Thus, says Whitaker, was formed an alliance unified to get the message out about the goodness of psychotropic drugs and the "chemical imbalance" view of mental illness. The APA and the drug companies both did their part in PR and public "education," and in suppressing as much as possible the dissemination of research results that did not hew to the party line. The NIMH joined forces by deciding that it should be a cheerleader for psychiatry; NIMH officials who harbored doubts about long term efficacy of drugs were forced out and few studies looking at dangers of drugs long-term, or nondrug treatment alternatives, could get funding. Finally, NAMI (National Alliance on Mental Illness), the grass-roots organization of patients and relatives, bought the claim that anyone who doubted the chemical-imbalance theory was denying that mental illness existed and telling NAMI members that your kid did not have a real mental illness, so it must be instead that you're just a bad parent. And of course the drug companies made sure generously to fund NAMI. (In light of this history the recent moves of the APA to distance itself from Pharma funding are even more noteworthy.)
Whitaker notes that the conventional party line has been so successful that he has had a great deal of trouble finding working examples of how mental illness, in his view, actually ought to be treated. He cites a handful of programs in Finland and the U.S. that do it the right way, starting off with nondrug approaches that stress human engagement with and human regard for the patient, and that resort of drugs only in the minority of cases that do not respond to repeated nondrug efforts. (The programs then try hard to get the patients off drugs after the initial symptoms resolve.) Again, to me, the recommendations he offers for solutions clearly put distance between him and disreputable sources such as Scientology.
Botton line-- this book poses serious challenges to many of our presuppositions. I await more insights from others as to its reliability.
Whitaker R. Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America. New York: Crown, 2010.
I have just finished reading Robert Whitaker's Anatomy of an Epidemic, and have concluded that we don't yet know the half of it.
Whitaker's message is such a fundamental challenge to today's practice of psychiatry that I went searching on the web for any evidence that he's connected with Scientology or any of its fellow travelers. I found no such evidence (and will mention later how Whitaker's assertions part company with the wacko claims of the anti-psychiatry groups). Whitaker is a journalist and author of a previous book, Mad in America.
I have to explain first Whitaker's assertions about psychotropic drugs, and then his claims about the role of Pharma and psychiatry in misleading us about them.
Whitaker starts off with an epidemiological question. If you go back about 60 years, you discover that relatively few people in the US were diagnosed with mental illness, and that they often recovered and went back to leading normal lives in the vast majority of cases. A tiny percentage made up the chronically mentally ill that were warehoused in state hospitals. Then came the psychopharmacology revolution and the discovery of all the modern classes of psychotropic drugs. We have been told that these drugs revolutionized psychiatry and allowed those "warehoused" people to come out of the hospital and into the community. But when we look at the numbers we see a surprising thing. Not only are many more times the old number of people being diagnosed today with mental illness, but their long term prognosis seems to be abysmal, with a great many ending up on disability. If these new drugs do such a great job, how come we have so many more mentally ill and they do so much worse?
Whitaker then offers an answer, in terms of both basic biological mechanisms and actual patient outcome data. The mechanism answer is a great embarrassment to me personally because I never thought of it, despite having had what I thought was a good biology education in college and even writing papers about systems biology. The standard psychiatric theory, which seems correct, says that the new drugs alter the levels of neurotransmitters in the synapses between brain cells. Anyone with an ounce of knowledge of biology ought then to ask--and what happens next? Just about the fourth or fifth word we learned in biology class is homeostasis. If something comes along from the outside and disrupts any body system, the body almost always has a built-in regulator that seeks to restore the prior state of balance. And indeed, Whitaker tells us, scientists who have gone looking have found the homeostatic responses to these drugs. If the drug results in(say) an increase in dopamine in the synapse, the brain down-regulates its dopamine system, by putting out less dopamine from the first neuron, or by shutting down some of the dopamine receptor sites in the second neuron. In short, the drug, that was supposed to be correcting a disorder (which was actually not the cause of any mental illness anyway according to the best current evidence) has actually now induced a brain disorder.
Homeostasis works for a while, but if you stay on the drug long term, homeostasis eventually poops out. So what happens to people on the drug long-term may look quite different from what happens in the short-term. In any event we have mechanisms that can explain why you actually might induce a brain disorder from using these medications, rather than relieving an existing disorder.
That's at the mechanism level; what about with real people? Whitaker marshals a good deal of evidence from legitimate scientific studies to show that indeed, what the mechanism hints at is what happens. A regular refrain in the book is that there remains about 20% of patients who seem to need the medications and who do much better with them than without them. (That seems clearly to me to show that Whitaker has no truck with the Scientology line.) What about the other 80%? These people may have less symptoms for the first 6-8 weeks or so of treatment, and indeed most controlled trials confirm that advantage. However, after that initial response, the advantage seems to disappear. People treated with medication initially tend to do markedly worse at 1, 2, 5, and 10 years out from initiation of treatment compared to the few patients who somehow escape drug treatment. The standard psychiatric theory is that we see many more people today with bipolar disorder than in the past because when they go into the depression phase of the disorder, psychiatrists treat them with antidepressants, and they then develop symptoms suggestive of mania, meaning that the antidepressants have "unmasked" the true, underlying disease. Whitaker reviews data suggesting that it is much more likely that the antidepressants caused the manic reaction, and that a person who becomes bipolar following medication use cycles more rapidly in and out of mania and depression, and ultimately has a much poorer prognosis, than the classic bipolar patient of days gone by.
How good are the data Whitaker cites? Not knowing the psychiatric literature as a whole, I cannot exclude the possibility that he has carefully cherry-picked a set of studies that happen to confirm his thesis while ignoring a much larger body of studies that disprove it. I tried to get some input from psychiatrist friends but none had as yet read the book. So I remain open to being shown the error of my ways on that point.
Whitaker thus paints a picture by which the standard psychiatric practice has helped a few but has greatly harmed many others. He claims this has happened becaue we as a society have been systematically lied to about the data. The next question is how that set of lies came about.
(A brief detour here to do the "don't try this at home" disclaimer. If you are taking psychotropic drugs and read Whitaker's book, the first thing that crosses your mind is to stop taking the drugs. Do not do that. Quite apart from the fact that you might be among the 20% who do better with the drugs, a quick withdrawal will almost guarantee worsening and a greater dependency on drugs in the future. (Indeed, the standard belief system of psychiatry holds that we know psychiatric drugs do good, precisely because withdrawal worsening is so common.) Only slow, cautious drug withdrawal seems to work for most people.)
In writing HOOKED, I had a standard model of the medicine-Pharma relationship that I thought was based on historical research and fact. I assumed that the heavy financial entanglement between docs and drug companies today was a very slow, almost imperceptible process that occurred throughout the 20th century. The gradual nature of the entanglement explained why docs seemed to have developed no moral compass to guide them when things got seriously out of kilter.
Whitaker paints quite a different picture of the situation with psychiatry. He reminds us first how beleagured the field felt itself to be back in the late 1960s and early 1970s. First, internally, a pitched battle was beign fought among three camps--the newer drug-oriented shrinks; the traditional Freudians who sneered at drugs; and the emerging cadre of social psychiatrists who thought that environmental factors were more important in both causing and treating mental illness. From the outside, psychiatry was threatened with losing all its business as psychologists, psychiatric social workers, and other non-physician counselors set up shop and offered psychotherapy at lower rates. Finally, in academic circles, psychiatry was under attack from the anti-psychiatry movement of folks like Thomas Szasz (The Myth of Mental Illness), R.D. Laing, and, in popular culture, the film One Flew Over the Cuckoo's Nest.
The American Psychiatric Association responded to all this with what looks, for all intents and purposes, like a PR and marketing effort worthy of Toyota's recent efforts to restore America's confidence in its vehicles. Far from any "incremental" change, the dates at which all this happened can be readily determined, says Whitaker. It was in 1974 that the APA formed a task force to explore the possibility that the field could benefit from a large influx of Pharma dollars; and it was in 1980 that the APA adopted a new policy of encouraging drug companies to sponsor "scientific" talks at APA conventions.
Thus, says Whitaker, was formed an alliance unified to get the message out about the goodness of psychotropic drugs and the "chemical imbalance" view of mental illness. The APA and the drug companies both did their part in PR and public "education," and in suppressing as much as possible the dissemination of research results that did not hew to the party line. The NIMH joined forces by deciding that it should be a cheerleader for psychiatry; NIMH officials who harbored doubts about long term efficacy of drugs were forced out and few studies looking at dangers of drugs long-term, or nondrug treatment alternatives, could get funding. Finally, NAMI (National Alliance on Mental Illness), the grass-roots organization of patients and relatives, bought the claim that anyone who doubted the chemical-imbalance theory was denying that mental illness existed and telling NAMI members that your kid did not have a real mental illness, so it must be instead that you're just a bad parent. And of course the drug companies made sure generously to fund NAMI. (In light of this history the recent moves of the APA to distance itself from Pharma funding are even more noteworthy.)
Whitaker notes that the conventional party line has been so successful that he has had a great deal of trouble finding working examples of how mental illness, in his view, actually ought to be treated. He cites a handful of programs in Finland and the U.S. that do it the right way, starting off with nondrug approaches that stress human engagement with and human regard for the patient, and that resort of drugs only in the minority of cases that do not respond to repeated nondrug efforts. (The programs then try hard to get the patients off drugs after the initial symptoms resolve.) Again, to me, the recommendations he offers for solutions clearly put distance between him and disreputable sources such as Scientology.
Botton line-- this book poses serious challenges to many of our presuppositions. I await more insights from others as to its reliability.
Whitaker R. Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America. New York: Crown, 2010.
Thursday, May 6, 2010
Are We Seeing the New FDA Emerge?
According to a New York Times editorial--
http://www.nytimes.com/2010/05/05/opinion/05wed3.html
--there may be positive changes in the air at the FDA, consistent with the more-hard-nosed team that the Obama administration had appointed to replace the generally pro-business folks of the previous regime. According to the Times:
The Times continues to hope that there will be less need for disclosure and no conflicts of interest, but also agrees these are all positive steps.
http://www.nytimes.com/2010/05/05/opinion/05wed3.html
--there may be positive changes in the air at the FDA, consistent with the more-hard-nosed team that the Obama administration had appointed to replace the generally pro-business folks of the previous regime. According to the Times:
- The percentage of members of advisory boards granted waivers due to conflicts of interest has been reduced from 15 to 5 since 2007
- Commissioner Margaret Hamburg has issued a letter to staff that any future proposed waivers have to be justified by descriptions of how hard the staff worked to try to find a neutral expert first
- FDA will now release the name of the company involved in the conflict, and a rough dollar amount of the conflict, if a waiver is granted, as part of increased disclosure
The Times continues to hope that there will be less need for disclosure and no conflicts of interest, but also agrees these are all positive steps.
Upcoming Conference: Industry-Funded CME
Message from our esteemed colleague, Dr. Adriane Fugh-Berman of PharmedOut fame:
Please help us publicize our conference, "Prescription for Conflict:
Should Industry Fund Continuing Medical Education?" This is an issue that is critical to patients, providers and health care systems. While our primary audience is physicians, nurses, and other health care providers (6 CEU credits are available, and 5 CME credits are pending), it will be of interest to diverse groups, including educators, regulators, policymakers, ethicists, consumer activists, and students.
Our conference website for has just been updated. We have a new flyer , suitable for posting, available at http://www.pharmedout.org/RxforConflictFlyer1pg.pdf ; the updated agenda is at http://www.pharmedout.org/conferenceagenda.htm.
Thank you!
--
Adriane Fugh-Berman MD
Department of Physiology and Biophysics
Georgetown University Medical Center
Box 571460
Washington DC 20057-1460
Please help us publicize our conference, "Prescription for Conflict:
Should Industry Fund Continuing Medical Education?" This is an issue that is critical to patients, providers and health care systems. While our primary audience is physicians, nurses, and other health care providers (6 CEU credits are available, and 5 CME credits are pending), it will be of interest to diverse groups, including educators, regulators, policymakers, ethicists, consumer activists, and students.
Our conference website for has just been updated. We have a new flyer , suitable for posting, available at http://www.pharmedout.org/RxforConflictFlyer1pg.pdf ; the updated agenda is at http://www.pharmedout.org/conferenceagenda.htm.
Thank you!
--
Adriane Fugh-Berman MD
Department of Physiology and Biophysics
Georgetown University Medical Center
Box 571460
Washington DC 20057-1460
Sunday, May 2, 2010
You Read It Here Second: Drug Giant Buys Belgium
Fortunately, this is just for laughs--this time:
http://www.newsbiscuit.com/2010/04/29/glaxo-smith-kline-buys-belguim/
(Thanks to our good friends at the Healthy Skepticism listserv for this tip.)
http://www.newsbiscuit.com/2010/04/29/glaxo-smith-kline-buys-belguim/
(Thanks to our good friends at the Healthy Skepticism listserv for this tip.)
Friday, April 30, 2010
Should Drug Companies Censor Medical Journals?
I have previously addressed the debate over the safety of the diabetes drug Avandia (rosiglitazone) between Steve Nissen, head of cardiology at the Cleveland Clinic, and GlaxoSmithKline, the drug's manufacturer:
http://brodyhooked.blogspot.com/2010/04/more-on-avandia-saga.html
http://brodyhooked.blogspot.com/2010/02/secret-avandia-tapes-comedy-or-smoking.html
http://brodyhooked.blogspot.com/2010/02/avandia-story-failures-of-regulation.html
So a further round of fisticuffs between these worthy opponents in the European Heart Journal (subscription required) might seem like old news--were it not for the bit of interest GSK added by calling on the journal to censor Dr. Nissen's previous editorial.
Dr. Nissen had written his editorial, "The Rise and Fall of Rosiglitazone," giving his take on the whole matter. The journal had published the editorial on line but it had not yet appeared in the print edition. GSK, in the person of Moncef Slaoui, Chair of Research & Development, wrote a long letter to the editor of the journal disputing Nissen's account point by point, and including the statement: "We strongly disagree with several key points...most importantly those which imply misconduct on the part of GSK... On this basis GSK believes that it is necessary for the journal to withdraw this editorial from the website and refrain from publishing it in hard copy, until the journal has investigated these inaccuracies and unsubstantiated allegations."
Nissen responded with his own point by point refutation of GSK's point by point refutation. He introduced his letter: "Pharmaceutical companies have abundant resources for delivering their messages to physicians and the public. Physician-scientists essentially have only medical journals through which we communicate... If we allow a pharmaceutical company to control what we are allowed to publish, scientific discussion and debate would suffer irreparable harm. This demand from GSK constitutes an unacceptable attempt to interfere with the editorial decisions of a major medical journal."
The EHJ editors chimed in, "Scientists know what a good argument is and will consider its merits and evidence...However, we cannot suppress concerns, data or divergent opinions--we must consider them and argue with data, numbers and plausibility. Only through such a discourse can progress evolve."
As a side matter, one of the Nissen accusations at which GSK took the greatest umbrage was that they "stole" a copy of the manuscript of Nissen's meta-analysis while it was still under review with the New England Journal. To defend their counterclaim that they were essentially innocent bystanders who received a faxed copy of the manuscript that they had never requested, they cited an earlier publication that I did not realize existed, in which the leak of the manuscript was reported as a news item in Nature by Brian Vastag about 7 months after the event occurred. Vastag offered an interview with the leaker, Dr. Steven Haffner of the University of Texas-San Antonio. At that time, and apparently later as well, the New England Journal declined to say anything about what had been done with Haffner, though they added that routinely such an offense would lead to a future ban from reviewing and from contributing editorials and review articles. Vastag quoted Haffner about his decision to fax the copy of the manuscript to a former resarch collaborator who worked for GSK, "Why I sent it is a mystery...I really don't understand it. I wasn't feeling well. It was a bad judgment." He went on to say--this is apparently the part that GSK liked and why they cited Vastag's article in their reply to Nissen--that his collaborator at GSK had not requested the manuscript (how could he if the manuscript was presumably under confidential editorial review at the time) and was "probably a bystander." No further comment.
Nissen SE. The rise and fall of rosiglitazone [editorial]. European Heart Journal 31:773-776, 2010.
Slaoui M. The rise and fall of rosiglitazone: reply [letter to editor]. European Heart Journal (advance access e-published April 23, 2010).
Nissen SE. The painful truth [letter to editor]. European Heart Journal (advance access e-published April 23, 2010).
Luscher TF, Landmesser U, Ruschitzka F. Standing firm: the European Heart Journal, scientific controversies and the industry [editorial]. European Heart Journal doi:10.1093/eurheartj/ehq127 (advance access e-published April 23, 2010).
Vastag B. Reviewer leaked Avandia study to drug firm. Nature 451:509, 2008.
http://brodyhooked.blogspot.com/2010/04/more-on-avandia-saga.html
http://brodyhooked.blogspot.com/2010/02/secret-avandia-tapes-comedy-or-smoking.html
http://brodyhooked.blogspot.com/2010/02/avandia-story-failures-of-regulation.html
So a further round of fisticuffs between these worthy opponents in the European Heart Journal (subscription required) might seem like old news--were it not for the bit of interest GSK added by calling on the journal to censor Dr. Nissen's previous editorial.
Dr. Nissen had written his editorial, "The Rise and Fall of Rosiglitazone," giving his take on the whole matter. The journal had published the editorial on line but it had not yet appeared in the print edition. GSK, in the person of Moncef Slaoui, Chair of Research & Development, wrote a long letter to the editor of the journal disputing Nissen's account point by point, and including the statement: "We strongly disagree with several key points...most importantly those which imply misconduct on the part of GSK... On this basis GSK believes that it is necessary for the journal to withdraw this editorial from the website and refrain from publishing it in hard copy, until the journal has investigated these inaccuracies and unsubstantiated allegations."
Nissen responded with his own point by point refutation of GSK's point by point refutation. He introduced his letter: "Pharmaceutical companies have abundant resources for delivering their messages to physicians and the public. Physician-scientists essentially have only medical journals through which we communicate... If we allow a pharmaceutical company to control what we are allowed to publish, scientific discussion and debate would suffer irreparable harm. This demand from GSK constitutes an unacceptable attempt to interfere with the editorial decisions of a major medical journal."
The EHJ editors chimed in, "Scientists know what a good argument is and will consider its merits and evidence...However, we cannot suppress concerns, data or divergent opinions--we must consider them and argue with data, numbers and plausibility. Only through such a discourse can progress evolve."
As a side matter, one of the Nissen accusations at which GSK took the greatest umbrage was that they "stole" a copy of the manuscript of Nissen's meta-analysis while it was still under review with the New England Journal. To defend their counterclaim that they were essentially innocent bystanders who received a faxed copy of the manuscript that they had never requested, they cited an earlier publication that I did not realize existed, in which the leak of the manuscript was reported as a news item in Nature by Brian Vastag about 7 months after the event occurred. Vastag offered an interview with the leaker, Dr. Steven Haffner of the University of Texas-San Antonio. At that time, and apparently later as well, the New England Journal declined to say anything about what had been done with Haffner, though they added that routinely such an offense would lead to a future ban from reviewing and from contributing editorials and review articles. Vastag quoted Haffner about his decision to fax the copy of the manuscript to a former resarch collaborator who worked for GSK, "Why I sent it is a mystery...I really don't understand it. I wasn't feeling well. It was a bad judgment." He went on to say--this is apparently the part that GSK liked and why they cited Vastag's article in their reply to Nissen--that his collaborator at GSK had not requested the manuscript (how could he if the manuscript was presumably under confidential editorial review at the time) and was "probably a bystander." No further comment.
Nissen SE. The rise and fall of rosiglitazone [editorial]. European Heart Journal 31:773-776, 2010.
Slaoui M. The rise and fall of rosiglitazone: reply [letter to editor]. European Heart Journal (advance access e-published April 23, 2010).
Nissen SE. The painful truth [letter to editor]. European Heart Journal (advance access e-published April 23, 2010).
Luscher TF, Landmesser U, Ruschitzka F. Standing firm: the European Heart Journal, scientific controversies and the industry [editorial]. European Heart Journal doi:10.1093/eurheartj/ehq127 (advance access e-published April 23, 2010).
Vastag B. Reviewer leaked Avandia study to drug firm. Nature 451:509, 2008.
What Do Patients Think of Docs' Financial Ties?
Adam Licurse, leading a team primarily from Yale, has contributed to our understanding of patient attitudes toward physicians having financial ties to industry (subscription required). Licurse et al. attempted a systematic review of the available literature on this subject. They identified 20 studies, most of decent or better quality, that addressed their questions. Let me quote their key conclusion: "When asked about the importance of disclosing certain [financial ties], patients and research participants largely want to know about physician and researcher [financial ties]. In clinical care, many patients believed that industry gifts of a personal nature to physicians are unacceptable, whereas fewer found professional gifts to be unacceptable. Patients are concerned that these gifts affect the cost and quality of care and that these gifts influence clinical judgment." The situation seemed less clear in research; most studies wanted to know whether people would be less likely to participate as subjects in research if they knew that the investigator had financial ties, but several studies seemed to indicate that this would not be a very big factor.
People coming at the subject from my own bias would tend to wish that the research would show massive distrust of physicians if patients found out about financial ties. The research that is available hardly shows that univocal or extreme an answer. However, neither does it support a claim one now hears from our friends the pharmapologists-- that there are simply no compelling data that the issue of financial ties and disclosure has anything to do with public trust in medicine at all. For example, here is Dr. Thomas Huddle, replying to his critics in a January article that I blogged about previously (http://brodyhooked.blogspot.com/2010/02/what-would-it-take-to-prove-harm-from.html): "Surveys have repeatedly shown that large majorities of patients do not regard the promotional items and food involved in typical detailing to be ethically problematic."
Dr. Huddle is strictly correct, but his assessment tells only a piece of the story. Plus he cites only three sources for his claim, all published before 2000. The Licurse review includes several surveys conducted within the last decade. One of them, by Jastifer and Roberts, notes in passing that more recent reviews appear to show patients as more critical of financial ties than surveys done in the 1990s (as would be very reasonable given recent publicity, and findings in some early studies that few patients were even aware of the nature of these ties).
Here is how I would summarize the Licurse et al. review: There is sufficient evidence to believe that a significant number of patients are concerned about financial ties between physicians and industry, in ways that implicate public trust in medicine.
Licurse A, Barber E, Joffe S, Gross C. The impact of disclosing financial ties in research and clinical care. Archives of Internal Medicine 170:675-82, April 26, 2010.
Jastifer J, Roberts S. Patients' awareness of and attitudes toward gifts from pharmaceutical companies to physicians. International Journal of Health Services 39:405-14, 2009.
People coming at the subject from my own bias would tend to wish that the research would show massive distrust of physicians if patients found out about financial ties. The research that is available hardly shows that univocal or extreme an answer. However, neither does it support a claim one now hears from our friends the pharmapologists-- that there are simply no compelling data that the issue of financial ties and disclosure has anything to do with public trust in medicine at all. For example, here is Dr. Thomas Huddle, replying to his critics in a January article that I blogged about previously (http://brodyhooked.blogspot.com/2010/02/what-would-it-take-to-prove-harm-from.html): "Surveys have repeatedly shown that large majorities of patients do not regard the promotional items and food involved in typical detailing to be ethically problematic."
Dr. Huddle is strictly correct, but his assessment tells only a piece of the story. Plus he cites only three sources for his claim, all published before 2000. The Licurse review includes several surveys conducted within the last decade. One of them, by Jastifer and Roberts, notes in passing that more recent reviews appear to show patients as more critical of financial ties than surveys done in the 1990s (as would be very reasonable given recent publicity, and findings in some early studies that few patients were even aware of the nature of these ties).
Here is how I would summarize the Licurse et al. review: There is sufficient evidence to believe that a significant number of patients are concerned about financial ties between physicians and industry, in ways that implicate public trust in medicine.
Licurse A, Barber E, Joffe S, Gross C. The impact of disclosing financial ties in research and clinical care. Archives of Internal Medicine 170:675-82, April 26, 2010.
Jastifer J, Roberts S. Patients' awareness of and attitudes toward gifts from pharmaceutical companies to physicians. International Journal of Health Services 39:405-14, 2009.
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