Once again our good friends, in this case Dr. Roy Poses, over at Health Care Renewal provide grist for our mill:
http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html
This instructive post first notes how Mr. Bill Weldon, CEO of Johnson & Johnson, was one of eight business leaders invited by President Obama to the White House to give advice in the economy and in particular, to tell the Administration how it could restore their confidence. The remainder of the post is a litany of all the illegal behavior that has earned J&J fines and censure in the past several years, and how Mr. Weldom has been given hefty annual raises despite presiding over this string of disasters. Dr. Poses naturally asks why any Administration would want to gain such a person's confidence.
We could dig into this a little deeper and ask whether this interest on the part of the White House in making nice with big business--potential source of huge piles of campaign cash as the 2012 election looms--has anything at all to do with the Feds doing a one-eighty on some "get tough" conflict of interest provisions, as we discussed recently:
http://brodyhooked.blogspot.com/2011/08/integrity-in-government-forget-about-it.html
http://brodyhooked.blogspot.com/2011/08/nih-conflict-of-interest-rules-weakened.html
We could also ask about the timing of this sudden desire to regain the "confidence" of big business. It seemed to come right after the Democrats took a whupping in the 2010 elections. From a purely political point of view that timing may have made sense. From a policy point of view it is hard to get away from the fact that we were, in 2010, in the middle of a very deep recession, brought about by the irresponsible behavior of that same big-business community--who continue to tell us that the best way toward future economic prosperity is the same set of policies that got us into that recession--that is, shrink big government, don't regulate business, and above all else don't tax the rich. And, as Charles Ferguson showed dramatically in his brilliant documentary, Inside Job--
http://www.insidejob.com/
--Obama proceeded to appoint to his own economic team almost all of the major architects of the previous disaster.
Monday, August 29, 2011
Saturday, August 27, 2011
More on the Effects of Samples in the Doctor's Office
It's nice to be able to come back to a topic we have not addressed in a while, the good ol' down home matter of the doctor's office sample cupboard. Dr. Richard G. Pinckney and colleagues from the University of Vermont (subscription required to access article) noted that previous attitude surveys about how samples impacted on prescribing practices had usually been restricted to just a few office sites and so set out to do a broader survey, taking advantage of a Vermont statewide primary care database. Now you could immediately object that if you had to survey docs in any state of the US, Vermont might well be the greatest outlier, especially since they are now considering something akin to a single-payer system. Be that as it may, in Vermont they had their database and in Vermont they did their study, which got in the end a 35% response rate, fairly typical for today's world.
Along they way they cited a Kaiser Family Foundation poll that showed that 92% of US physicians reported that at least once in their careers, they'd received samples from a drug rep. I interpret that to mean that 8% of physicians are either liars or have rotten memories.
Pinckney and friends found in this particular instance that about 3/4 of their responding docs had samples in their offices, and they proceeded to compare that group with the remainder who did not. They provided two vignettes involving patients with no insurance and with hypertension and depression, respectively. The majority of docs got the right answer--use a cheap and effective thiazide diuretic for the first-pass treatment of the hypertension, and if the depressed patient needs drug therapy, pick a cheap generic. But there were significant differences between their two groups. Only 70% of the sample-docs picked the thiazide while 91% of the no-sample-docs did, and while 91% of the sample-docs went for the generic antidepressant, every single one of the no-sample-docs did.
They also asked those folks about attitudes toward samples, and again not surprisingly, the sample-docs were significantly more likely to believe that samples expedite treatment, make patients happy, help the indigent, and allow the docs to check out which meds work best. The no-sample-docs were more likely to believe that samples distort treatment plans, increase the costs of care, and lead to overuse. Pinckney et al. noted that actually a majority in both groups agreed that samples increase the costs of care and can affect physicians' prescribing habits.
What's cart and what's horse? It could be of course that docs who have certain attitudes are more likely to elect to dispense with the traditional sample cupboard, or that docs who have samples around all the time end up getting certain attitudes, or a bit of each. From such a study one can only hypothesize associates and not causes. Still this is just a bit more support for the already-fairly-well-documented idea that "free" samples in the office do more harm than good.
(Hat tip to Primary Care Medical Abstracts for the citation.)
Pinckney RG, Helminski AS, Kennedy AG, et al. The effect of medication samples on self-reported prescribing practices: a statewide, cross-sectional survey. Journal of General Internal Medicine 26:40-44, January 2011.
Along they way they cited a Kaiser Family Foundation poll that showed that 92% of US physicians reported that at least once in their careers, they'd received samples from a drug rep. I interpret that to mean that 8% of physicians are either liars or have rotten memories.
Pinckney and friends found in this particular instance that about 3/4 of their responding docs had samples in their offices, and they proceeded to compare that group with the remainder who did not. They provided two vignettes involving patients with no insurance and with hypertension and depression, respectively. The majority of docs got the right answer--use a cheap and effective thiazide diuretic for the first-pass treatment of the hypertension, and if the depressed patient needs drug therapy, pick a cheap generic. But there were significant differences between their two groups. Only 70% of the sample-docs picked the thiazide while 91% of the no-sample-docs did, and while 91% of the sample-docs went for the generic antidepressant, every single one of the no-sample-docs did.
They also asked those folks about attitudes toward samples, and again not surprisingly, the sample-docs were significantly more likely to believe that samples expedite treatment, make patients happy, help the indigent, and allow the docs to check out which meds work best. The no-sample-docs were more likely to believe that samples distort treatment plans, increase the costs of care, and lead to overuse. Pinckney et al. noted that actually a majority in both groups agreed that samples increase the costs of care and can affect physicians' prescribing habits.
What's cart and what's horse? It could be of course that docs who have certain attitudes are more likely to elect to dispense with the traditional sample cupboard, or that docs who have samples around all the time end up getting certain attitudes, or a bit of each. From such a study one can only hypothesize associates and not causes. Still this is just a bit more support for the already-fairly-well-documented idea that "free" samples in the office do more harm than good.
(Hat tip to Primary Care Medical Abstracts for the citation.)
Pinckney RG, Helminski AS, Kennedy AG, et al. The effect of medication samples on self-reported prescribing practices: a statewide, cross-sectional survey. Journal of General Internal Medicine 26:40-44, January 2011.
Maybe Starting to Get It: Neurosurgeons on COI in Research
An article and accompanying editorial in the Journal of Neurosurgery back in January are instructive in regard to our present level of understanding of the threats to medical research integrity posed by conflicts of interest.
Dr. Alpesh A. Patel and co-authors, a group of academic orthopedists:
http://thejns.org/doi/full/10.3171/2010.8.JNS091834
--discuss various recent cases of conflicts of interest in medical research and publication, many of which we've addressed here. They start off with this list of problems raised by these instances:
Dr. Joseph H. Piatt, Jr., a Delaware neurosurgeon, takes up in the accompanying editorial--
http://thejns.org/doi/full/10.3171/2010.1.JNS10152
--the prevarication in tone in Patel et al's paper. He's stronger about the extent of the problem: "By corrupting the scientific method, commercial bias contaminates our knowledge base and deflects us from the objective best interests of our patients." He then scolds the other authors for placing so much emphasis in professional self-regulation when it has failed thus far to solve the problem: "The challenge of commercial bias in clinical research is not new, and the profession has made sincere but largely toothless attempts to contain it over the years. Patel and coauthors do well to exhort us neurosurgeons to take ownership, but none of their suggestions are game-changing. Look for expanded governmental control of the clinical evaluation and marketing of new medical technologies, particularly as the imperative for the containment of the growth of health care spending by any and all means becomes more acutely felt in the next decade." (The editorial includes a reply from Patel et al. who basically don't disagree with anything that Piatt says.)
What's the take-home message? I propose that we can see the slow evolution of attitudes within academic medicine, in specialties like neurosurgery and orthopedics that have not historically been at the very forefront of ethical advances (if I may express my bias):
(Note: I'm grateful to Rick Bukata and Jerry Hoffman of Primary Care Medical Abstracts for alerting me to this paper, though what I say above is a slightly more sympathetic take on the article than suggested in Jerry's recorded commentary.)
Dr. Alpesh A. Patel and co-authors, a group of academic orthopedists:
http://thejns.org/doi/full/10.3171/2010.8.JNS091834
--discuss various recent cases of conflicts of interest in medical research and publication, many of which we've addressed here. They start off with this list of problems raised by these instances:
- Calling into question the ethics and motives of the involved individuals
- Creating public distrust of science
- Calling into question academic medicine's "honor code"
- Disrupting relationships with patients
- "They offer salacious opportunities for the lay press to decry the rampant corruption in health care"
- "Lastly, and most ominously, they draw the attention and scrutiny of the government and politicians"
Dr. Joseph H. Piatt, Jr., a Delaware neurosurgeon, takes up in the accompanying editorial--
http://thejns.org/doi/full/10.3171/2010.1.JNS10152
--the prevarication in tone in Patel et al's paper. He's stronger about the extent of the problem: "By corrupting the scientific method, commercial bias contaminates our knowledge base and deflects us from the objective best interests of our patients." He then scolds the other authors for placing so much emphasis in professional self-regulation when it has failed thus far to solve the problem: "The challenge of commercial bias in clinical research is not new, and the profession has made sincere but largely toothless attempts to contain it over the years. Patel and coauthors do well to exhort us neurosurgeons to take ownership, but none of their suggestions are game-changing. Look for expanded governmental control of the clinical evaluation and marketing of new medical technologies, particularly as the imperative for the containment of the growth of health care spending by any and all means becomes more acutely felt in the next decade." (The editorial includes a reply from Patel et al. who basically don't disagree with anything that Piatt says.)
What's the take-home message? I propose that we can see the slow evolution of attitudes within academic medicine, in specialties like neurosurgery and orthopedics that have not historically been at the very forefront of ethical advances (if I may express my bias):
- COI is not a problem.
- COI is a minor problem and we can easily manage it with a few tweaks.
- COI is a serious problem and we had better do more to eliminate it, else the dreaded government will take over and tell us what to do.
- COI is a serious problem, we had our chance to eliminate it and we failed, so we might as well make up our minds that the dreaded government is going to have to come in and fix it, even though there is still much we could do ourselves if we'd grow a bit of backbone.
(Note: I'm grateful to Rick Bukata and Jerry Hoffman of Primary Care Medical Abstracts for alerting me to this paper, though what I say above is a slightly more sympathetic take on the article than suggested in Jerry's recorded commentary.)
Thursday, August 25, 2011
Controlling the Channels: Pushing the Pharma-Friendly Model of Diabetes
In keeping with my lazy habit of letting others write this blog for me, I will talk about a couple of commentaries included in the July, 2011 edition of Primary Care Medical Abstracts by my friends Rick Bukata and Jerry Hoffman. The first, I will argue, illustrates the concept previously blogged about by the anthropologist, Kalman Applbaum, on the idea of drug "channels" and how drug company marketing works to control these channels effectively. The take-home message in each case is how medical journals have been harnessed to the cause of selling drugs, despite lack of sound evidence, in ways that are usually opaque to the average reader.
Exhibit A for this commentary is a so-called expert consensus panel (McInnes et al., subscription required) on diabetic foot care, published in the British journal Diabetic Medicine. The panel appears to be what evidence-based gurus call BOGSAT, or "bunch of old guys sitting around talking," rather than a systematic evidence-based review with proper methods. The funding for the "old guys" came from a firm called SSL International, which has since been bought out by another firm, which makes a variety of health-related products, mostly for nonprescription home use. I don't see offhand that they make any diabetes drugs. Nothing is said in the article about conflicts of interest, or lack of same, among the authors.
The authors set out to answer the question of what kind of foot care should be provided for diabetics considered to be at relatively low risk. I was puzzled because the article does not say whether they are talking about Type 1 or Type 2 diabetes, so I have to imagine they mean both. It is therefore important to keep in mind that about 90 percent of patients seen by adult practitioners have Type 2 (adult onset) diabetes. As we have discussed in several previous posts, there is at present no compelling evidence that tight control of blood sugar levels (trying to get the hemoglobin A1c blood test within normal limits) effectively prevents the major complications of Type 2 diabetes, in particular diabetic neuropathy which is the cause of most foot problems.
So the "old guys" list four things that they think physicians should advise patients as part of good diabetic foot care. The second is: "maintaining adequate glycaemic control." They proceed to explain: "Numerous clinical studies have demonstrated the positive relationship between reductions in HbA1c and reduced risk of microvascular complications of diabetes, including neuropathy and foot ulcers." Now, this is sort of half right. Numerous studies have shown that if you have two groups of diabetics, one with high levels of A1c (poor control) and others with low A1c (good control), the first group will have many fewer complications. What has never been shown is that giving medicines in Type 2 diabetes to lower A1c reduces the incidence of complications.
So what evidence do these "old guys" cite to prove their point about better control leading to fewer complications, especially in the feet? They mention two references. The first, as Jerry pointed out in his commentary on the paper, was to the DCCT trial published in 1993, which showed that tight control reduced complications in Type 1 diabetics--that is, irrelevant to the vast majority of adult diabetics. The second reference is a paper by Boyko et al. in 2006. This paper has nothing to do with diabetes treatment or the prevention of complications. Rather it is the development of a prediction tool to show which diabetic patients are most likely to develop foot ulcers. Not surprisingly, one of the risk predictors is elevated HbA1c--though interestingly enough, this single factor increases one's risk of foot ulcers by only 10% above baseline, while other predictive facts double or triple the risk. But the Boyko et al. paper says nothing whatever about whether better glycemic control will prevent neuropathy or ulcers.
So what we have here in this journal is a supposed "expert consensus" on preventing foot complications in diabetics, claiming that better blood sugar control is a critical component of this prevention, but unable to cite a single clinical trial showing this to be true for the most common type of diabetes. So long as physicians think that the best way to prevent the complications of Type 2 diabetes is to lower HbA1c, they will write a lot of prescriptions for expensive medications, making the drug companies richer--but doing very little actually to prevent diabetes complications. In this way even an article that seems to be not at all about drug therapy manages to convey a drug-industry-friendly message--and the evidence be damned.
McInnes A, Jeffcote W, Vileikyte L, et al. Foot care education in patients with diabetes at low risk of complications: a consensus statement. Diabetic Medicine 28:162-167, 2011.
Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. New England Journal of Medicine 329:977-986, 1993.
Boyko EJ, Ahroni JH, Cohen V, et al. Prediction of diabetic foot ulcer occurrence using commonly available clinical information: the Seattle Diabetic Foot Study. Diabetes Care 29:1202-1207, 2006.
Exhibit A for this commentary is a so-called expert consensus panel (McInnes et al., subscription required) on diabetic foot care, published in the British journal Diabetic Medicine. The panel appears to be what evidence-based gurus call BOGSAT, or "bunch of old guys sitting around talking," rather than a systematic evidence-based review with proper methods. The funding for the "old guys" came from a firm called SSL International, which has since been bought out by another firm, which makes a variety of health-related products, mostly for nonprescription home use. I don't see offhand that they make any diabetes drugs. Nothing is said in the article about conflicts of interest, or lack of same, among the authors.
The authors set out to answer the question of what kind of foot care should be provided for diabetics considered to be at relatively low risk. I was puzzled because the article does not say whether they are talking about Type 1 or Type 2 diabetes, so I have to imagine they mean both. It is therefore important to keep in mind that about 90 percent of patients seen by adult practitioners have Type 2 (adult onset) diabetes. As we have discussed in several previous posts, there is at present no compelling evidence that tight control of blood sugar levels (trying to get the hemoglobin A1c blood test within normal limits) effectively prevents the major complications of Type 2 diabetes, in particular diabetic neuropathy which is the cause of most foot problems.
So the "old guys" list four things that they think physicians should advise patients as part of good diabetic foot care. The second is: "maintaining adequate glycaemic control." They proceed to explain: "Numerous clinical studies have demonstrated the positive relationship between reductions in HbA1c and reduced risk of microvascular complications of diabetes, including neuropathy and foot ulcers." Now, this is sort of half right. Numerous studies have shown that if you have two groups of diabetics, one with high levels of A1c (poor control) and others with low A1c (good control), the first group will have many fewer complications. What has never been shown is that giving medicines in Type 2 diabetes to lower A1c reduces the incidence of complications.
So what evidence do these "old guys" cite to prove their point about better control leading to fewer complications, especially in the feet? They mention two references. The first, as Jerry pointed out in his commentary on the paper, was to the DCCT trial published in 1993, which showed that tight control reduced complications in Type 1 diabetics--that is, irrelevant to the vast majority of adult diabetics. The second reference is a paper by Boyko et al. in 2006. This paper has nothing to do with diabetes treatment or the prevention of complications. Rather it is the development of a prediction tool to show which diabetic patients are most likely to develop foot ulcers. Not surprisingly, one of the risk predictors is elevated HbA1c--though interestingly enough, this single factor increases one's risk of foot ulcers by only 10% above baseline, while other predictive facts double or triple the risk. But the Boyko et al. paper says nothing whatever about whether better glycemic control will prevent neuropathy or ulcers.
So what we have here in this journal is a supposed "expert consensus" on preventing foot complications in diabetics, claiming that better blood sugar control is a critical component of this prevention, but unable to cite a single clinical trial showing this to be true for the most common type of diabetes. So long as physicians think that the best way to prevent the complications of Type 2 diabetes is to lower HbA1c, they will write a lot of prescriptions for expensive medications, making the drug companies richer--but doing very little actually to prevent diabetes complications. In this way even an article that seems to be not at all about drug therapy manages to convey a drug-industry-friendly message--and the evidence be damned.
McInnes A, Jeffcote W, Vileikyte L, et al. Foot care education in patients with diabetes at low risk of complications: a consensus statement. Diabetic Medicine 28:162-167, 2011.
Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. New England Journal of Medicine 329:977-986, 1993.
Boyko EJ, Ahroni JH, Cohen V, et al. Prediction of diabetic foot ulcer occurrence using commonly available clinical information: the Seattle Diabetic Foot Study. Diabetes Care 29:1202-1207, 2006.
Tuesday, August 23, 2011
Want to Wreck Things and Rake In Millions? Become a Pfizer CEO
Let me tell you a little story, that has very broad implications about national economic policy, and eventually get around to saying something that relates to the pharmaceutical industry.
Andrew Carnegie, who in his day was sort of Bill Gates and Warren Buffett wrapped into one, wrote an essay called "The Gospel of Wealth." As rich guys go Carnegie was not a bad sort; he believed that the rich should give away most of their wealth to community charities such as libraries and museums. But Carnegie also had pretty strict views about why you should not give direct charity to the poor. He described an instance in which a philanthropist he knew gave a quarter to a beggar. Carnegie was outraged, and insisted that that single stupid act was bad enough to undo all the good work this philanthropist had achieved over a lifetime. First, he was quite sure that the beggar would use that quarter for some immoral purpose--and those were the days when a quarter would actually buy something. But more important, Carnegie was sure that giving assistance to a poor person was a sure way to sap that individual's sense of responsibility, and lead inexorably to what today people would term the "culture of poverty," always waiting around for a handout and doing nothing to pull oneself up by those proverbial bootstraps.
I don't think that Carnegie had a name for this phenomenon, but when conservative economists started creating the theories that led to Reaganism and supply-side policies in the late 1970s, somebody came up with the term "moral hazard." The basic idea is that if people are in unfortunate straits and you give them some sort of aid, all you do is increase the rewards for being in those straits and make that behavior even more attractive in the future, which works directly against the unfortunate bettering themselves. So basically any federal program to help the needy in any way is a bad idea.
Okay, now back to Pharma. Dr. Roy Poses over at Health Care Renewal--http://hcrenewal.blogspot.com/2011/08/what-pfizer-iii-enormous-pay-for-poor.html--
in turn drawing on a report in Fortune magazine/CNN Money--http://hcrenewal.blogspot.com/2011/08/what-pfizer-iii-enormous-pay-for-poor.html--
tells us about the deeds and reimbursement of the most recent crop of CEOs at Pfizer. The basic bottom line is that the investigation viewed their performance as abysmal; their annual pay was in each case in excess of $10M; and during the time they were doing their best to ruin the company, they were actually granted annual raises. One former CEO, "Hank" McKinnell, more or less threw up his hands and declared his job impossible in 2002. He then sort of went missing and left a power vacuum that created severe headaches in the upper reaches of the company until he finally was forced to "retire" in 2006. He was paid $10.7M in 2003, $11.3M in 2004, and $12.8M in 2005.
This says something about bloated CEO pay throughout US corporations. This also says something about ineffective leadership at some large drug firms. But the particular lesson I wish to draw is about moral hazard. Notice that according to the gurus of our economy, if you give a poor man a quarter, you will probably ruin him for life and incidentally cause the collapse of Western civilization. If you pay a CEO extra millions of dollars every year for destroying his company, however, you are apparently following good economic principles; no "moral hazard"
here.
In other words, there are rules for the rich and rules for the poor. And the rich are in charge. And don't you forget it.
Andrew Carnegie, who in his day was sort of Bill Gates and Warren Buffett wrapped into one, wrote an essay called "The Gospel of Wealth." As rich guys go Carnegie was not a bad sort; he believed that the rich should give away most of their wealth to community charities such as libraries and museums. But Carnegie also had pretty strict views about why you should not give direct charity to the poor. He described an instance in which a philanthropist he knew gave a quarter to a beggar. Carnegie was outraged, and insisted that that single stupid act was bad enough to undo all the good work this philanthropist had achieved over a lifetime. First, he was quite sure that the beggar would use that quarter for some immoral purpose--and those were the days when a quarter would actually buy something. But more important, Carnegie was sure that giving assistance to a poor person was a sure way to sap that individual's sense of responsibility, and lead inexorably to what today people would term the "culture of poverty," always waiting around for a handout and doing nothing to pull oneself up by those proverbial bootstraps.
I don't think that Carnegie had a name for this phenomenon, but when conservative economists started creating the theories that led to Reaganism and supply-side policies in the late 1970s, somebody came up with the term "moral hazard." The basic idea is that if people are in unfortunate straits and you give them some sort of aid, all you do is increase the rewards for being in those straits and make that behavior even more attractive in the future, which works directly against the unfortunate bettering themselves. So basically any federal program to help the needy in any way is a bad idea.
Okay, now back to Pharma. Dr. Roy Poses over at Health Care Renewal--http://hcrenewal.blogspot.com/2011/08/what-pfizer-iii-enormous-pay-for-poor.html--
in turn drawing on a report in Fortune magazine/CNN Money--http://hcrenewal.blogspot.com/2011/08/what-pfizer-iii-enormous-pay-for-poor.html--
tells us about the deeds and reimbursement of the most recent crop of CEOs at Pfizer. The basic bottom line is that the investigation viewed their performance as abysmal; their annual pay was in each case in excess of $10M; and during the time they were doing their best to ruin the company, they were actually granted annual raises. One former CEO, "Hank" McKinnell, more or less threw up his hands and declared his job impossible in 2002. He then sort of went missing and left a power vacuum that created severe headaches in the upper reaches of the company until he finally was forced to "retire" in 2006. He was paid $10.7M in 2003, $11.3M in 2004, and $12.8M in 2005.
This says something about bloated CEO pay throughout US corporations. This also says something about ineffective leadership at some large drug firms. But the particular lesson I wish to draw is about moral hazard. Notice that according to the gurus of our economy, if you give a poor man a quarter, you will probably ruin him for life and incidentally cause the collapse of Western civilization. If you pay a CEO extra millions of dollars every year for destroying his company, however, you are apparently following good economic principles; no "moral hazard"
here.
In other words, there are rules for the rich and rules for the poor. And the rich are in charge. And don't you forget it.
NIH Conflict of Interest Rules: Weakened
I recently recapped fears that "get tough" moves at NIH, FDA and DHHS/DOJ regarding conflicts of interest were all being retracted or watered down. I then described some pushback on the FDA front, but according to our friend Dr. Bernard Carroll writing for Health Care Renewal:http://hcrenewal.blogspot.com/2011/08/quis-custodiet-ipsos-custodes-redux.html, the announcement from NIH earlier today on their new COI rules leaves considerable disappointment.
Dr. Carroll notes two major issues. One, that I summarized in my earlier post--http://brodyhooked.blogspot.com/2011/08/integrity-in-government-forget-about-it.html--is that universities are no longer required to post information about investigators' conflicts of interest in an easily accessible public website. (If you want you can write the university a letter and they are supposed to reply within 5 days.) The second is that the loophole that allows a conflicted investigator who was sanctioned at one institution simply to jump ship to another bottom-feeder university and start applying for NIH grants again right away, remains more or less wide open.
Dr. Carroll notes two major issues. One, that I summarized in my earlier post--http://brodyhooked.blogspot.com/2011/08/integrity-in-government-forget-about-it.html--is that universities are no longer required to post information about investigators' conflicts of interest in an easily accessible public website. (If you want you can write the university a letter and they are supposed to reply within 5 days.) The second is that the loophole that allows a conflicted investigator who was sanctioned at one institution simply to jump ship to another bottom-feeder university and start applying for NIH grants again right away, remains more or less wide open.
Monday, August 22, 2011
Pressure Builds on FDA to Maintain New COI Rules
In the previous post, I discussed briefly the FDA's apparent desire to retreat from the tough new conflict of interest rules it had earlier announced, particularly, excluding "experts" funded by industry from its advisory committees. Numerous examples have occurred where industry-supported votes made the difference between keeping a dangerous drug on the market and pulling it, for example. But the FDA is now claiming that it simply can't find any real experts who are not in the pay of the industry.
Enter our old friends, journalists Shannon Brownlee and Jeanne Lenzer. Jeanne authored a news item in last week's BMJ (subscription required) highlighting the entry of our other friends, the National Physicians Alliance, into the fray. The main point raised by Brownlee, Lenzer and the NPA is that they had worked hard a little while ago to compile a list of expert physicians who take no industry cash. They were able to come up with a list of over 100 such individuals (full disclosure: I'm on the list, though just what I am an expert in remains to be determined). The NPA and the journalists objected that despite their having been supplied with this list, there's no evidence that anyone at the FDA made any effort to contact any of those physicians. How, then, said the FDA's critics, can anyone claim that these experts are too hard to find?
There is some tentative evidence that the FDA may be backpedalling on their backpedalling, so stay tuned for further exciting adventures.
Lenzer J. Doctors join protest over change to FDA rules on conflicts of interest. BMJ 2011; 343:d5269.
Enter our old friends, journalists Shannon Brownlee and Jeanne Lenzer. Jeanne authored a news item in last week's BMJ (subscription required) highlighting the entry of our other friends, the National Physicians Alliance, into the fray. The main point raised by Brownlee, Lenzer and the NPA is that they had worked hard a little while ago to compile a list of expert physicians who take no industry cash. They were able to come up with a list of over 100 such individuals (full disclosure: I'm on the list, though just what I am an expert in remains to be determined). The NPA and the journalists objected that despite their having been supplied with this list, there's no evidence that anyone at the FDA made any effort to contact any of those physicians. How, then, said the FDA's critics, can anyone claim that these experts are too hard to find?
There is some tentative evidence that the FDA may be backpedalling on their backpedalling, so stay tuned for further exciting adventures.
Lenzer J. Doctors join protest over change to FDA rules on conflicts of interest. BMJ 2011; 343:d5269.
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