While I have been getting behind in my posting, our friends at Health Care Renewal have been on a tear, including this useful piece:
http://hcrenewal.blogspot.com/2012/11/what-if-institute-of-medicine-wrote.html
The post summarizes (and also links to) a recent study showing that the majority of clinical practice guidelines fall woefully short of the standards recently recommended by an Institute of Medicine report. I should add here that what the IOM did was not exactly rocket science; they pretty much summarized earlier thoughtful recommendations. So no one could claim that the IOM report came from out of the blue with a bunch of wild and crazy criteria.
What HCR is especially concerned about, suitable for our own purposes in this blog as well, is the frequency of conflicts of interest among guideline writers and chairs of panels, and the general failure of the guideline-sponsoring societies to police or even to disclose such conflicts.
As usual the HCR post makes a number of good points, but I would add a comment on what needs to be done about all this. HCR bemoans the fact that right now, no one has any interest in cleaning up the mess; everyone involved is looking for a way to use guidelines to make a buck. As my friend Dr. Jerry Hoffman of Primary Care Medical Abstracts likes to say, our current fetish for pay-for-performance makes the job of the drug companies and their ilk easy. They used to have to find a way to bribe 800,000 docs to write prescriptions for their pills. Now all they have to do is find a way to bribe about 1000 docs--the ones charged with writing the practice guidelines. Then the P4P folks will tell the rest of the 800,000 that they won't get paid unless they follow the guidelines, and the industry can laugh all the way to the bank.
So what to do if no one has an interest in cleaning up the mess? We have to turn back the clock a bit and recall the history of the Federal agency now called the Agency for Healthcare Research and Quality (AHRQ) which in olden days was the Agency for Health Care Policy and Research (AHCPR). In its AHCPR days, the agency gained a reputation for writing the best clinical practice guidelines around. They usually spent $10M per guideline and the result was highly respected by experts.
One result, however, was not highly respected by one group. The lower back pain guideline that said that surgery was hardly ever warranted as treatment upset a few well-heeled orthopedists, and these guys just happened to have some good friends in Congress. Thanks to that cabal, the next thing you knew, there was an action in Congress to eliminate all funding for AHCPR. AHCPR just barely squeaked by and survived with a major budget cut. But as part of that whole deal, they agreed to stop writing practice guidelines.
AHRQ is now the host of www.guidelines.gov, a central respository where you can find just about any clinical practice guideline written by any group for any disease. Also, if you look at the inclusion criteria at http://www.guidelines.gov/about/inclusion-criteria.aspx, you'll see that AHRQ exercises virtually no editorial control whatever over the content of the guidelines. So long as some document is the guideline equivalent of a warm body that has a pulse, it goes on the site. And that makes good political sense if you don't want some other influential group of rich docs, who think you're robbing them of their cash cow, lobbying Congress to revoke your funding.
What has to happen, given the widespread promulgation of guidelines that fall abysmally short of any decent standard of quality? Somebody in government has to run interference for AHRQ and have the spinal fortitude to assign them the task of applying all the IOM criteria to each guideline. Now, so far as I care, www.guidelines.gov can stay as it is and collect all guidelines in one handy location; but there then needs to be an inner circle of the real guidelines that actually meet a reasonable subset of IOM quality criteria. The guidelines with the seal of approval have to be carefully labeled and distinguished from the rest. Then maybe the other players in the game, especially the medical specialty societies which are currently among the worst offenders, will finally have an incentive to produce quality products instead of the current drek.
Full disclosure department: I am a member of IOM and spent the year 1993-94 as a visiting scholar at AHCPR.
Saturday, December 8, 2012
Minimizing Side Effects at Merck--the Old Paycheck Effect
One of the more enthusiastic members of my very small fan club kindly sent me this link:
http://www.alternet.org/drugs/big-pharma-company-mocked-patients-who-got-jawbone-death-drug-ma-toot-hurts-so-bad
Now, I don't want to make too much of this post from a clearly biased source, and the incendiary part of the post is obviously the idea that the big drug company would not only cause terrible side effects in patients who take their drugs, but then proceed to heap scorn on the patients who report the side effects. But what seems mainly to come through loud and clear is the simple refusal on the part of supposed scientists working for the company even to see the link between the drug (alendronate) and the adverse reaction (destruction of the jawbone following dental procedures), despite a large accumulation of both animal and human data pointing toward the connection. So somehow, if you give an animal that drug and you see jawbone destruction, suddenly that animal is no longer a reliable experimental model and the results don't count.
If you ever had occasion to doubt if author Upton Sinclair was on to something when he wrote, "It is difficult to get a man to understand something when his salary depends upon his not understanding it," this little anecdote about Merck staffers might shed some light.
http://www.alternet.org/drugs/big-pharma-company-mocked-patients-who-got-jawbone-death-drug-ma-toot-hurts-so-bad
Now, I don't want to make too much of this post from a clearly biased source, and the incendiary part of the post is obviously the idea that the big drug company would not only cause terrible side effects in patients who take their drugs, but then proceed to heap scorn on the patients who report the side effects. But what seems mainly to come through loud and clear is the simple refusal on the part of supposed scientists working for the company even to see the link between the drug (alendronate) and the adverse reaction (destruction of the jawbone following dental procedures), despite a large accumulation of both animal and human data pointing toward the connection. So somehow, if you give an animal that drug and you see jawbone destruction, suddenly that animal is no longer a reliable experimental model and the results don't count.
If you ever had occasion to doubt if author Upton Sinclair was on to something when he wrote, "It is difficult to get a man to understand something when his salary depends upon his not understanding it," this little anecdote about Merck staffers might shed some light.
Friday, December 7, 2012
US Appeals Court: It's Free Speech, Not Off-Label Marketing
I've been out and about lately and have gotten behind on posting, but before addressing any backlog I have to refer to today's news:
http://www.nytimes.com/2012/12/04/business/ruling-backs-drug-industry-on-off-label-marketing.html?_r=1&
A 2-1 majority of ta panel of the 2nd Circuit Court of Appeals (Manhattan) dismissed the conviction of a drug rep for off-label marketing on the grounds that he was simply exercising his free speech rights. The government will appeal, first to the entire Appeals court, and next to the Supreme Court if that is unsuccessful.
If you have been following our numerous posts about criminal settlements of big drug companies with the Feds in recent years--most recent example: http://brodyhooked.blogspot.com/2012/11/lets-do-it-again-latest-federal.html
--then you know that when the Feds manage to catch the companies doing shady marketing, almost always the regulation that's violated has to do with off-label marketing. We have long had the apparent paradox that while physicians can legally prescribe any drug for whatever purpose, despite what the official FDA-approved label says, companies can only legally market the drug for approved uses. This has become the principal tool by which the regulators can rein in the excesses of the industry. So if this ruling were to stand, the entire landscape of drug regulation in the USD would shift radically.
As the one dissenting judge stated the obvious, the ruling undermines the entire system of FDA regulation, since if companies can freely market drugs for off-label uses, they have no reason to go to the FDA to seek approval for any use except the most minimal required to get the drug onto the market at all. That means no need to submit any data to show that the drug is safe and effective for its various recommended uses.
As somebody concerned about ethics and logic I can say what I think of this ruling, quite apart from how it stands as a bit of legal reasoning based on case law and precedent. The logic part comes in when we ask how drug reps are trained by the companies and assigned to their jobs. Last I heard, the companies spend a lot of time and money to assure that their reps don't speak freely. They are trained to be consistent, reliable mouthpieces for the industry marketing message. Now, if a drug rep had been fired by industry for telling docs that a drug made by his company was unsafe or ineffective, and he sued to keep his job, and the court had ruled that he should keep his job because the company decision violated his free speech rights, then I might believe that the court was perhaps really serious about applying the doctrine of free speech to the relationship between drug rep and doctor. As it stands, to put what the drug rep did in this case by telling a doc (apparently one wearing a wire as a Federal informant) about off-label uses of the drug under the category of "free speech" is simply a bad joke.
http://www.nytimes.com/2012/12/04/business/ruling-backs-drug-industry-on-off-label-marketing.html?_r=1&
A 2-1 majority of ta panel of the 2nd Circuit Court of Appeals (Manhattan) dismissed the conviction of a drug rep for off-label marketing on the grounds that he was simply exercising his free speech rights. The government will appeal, first to the entire Appeals court, and next to the Supreme Court if that is unsuccessful.
If you have been following our numerous posts about criminal settlements of big drug companies with the Feds in recent years--most recent example: http://brodyhooked.blogspot.com/2012/11/lets-do-it-again-latest-federal.html
--then you know that when the Feds manage to catch the companies doing shady marketing, almost always the regulation that's violated has to do with off-label marketing. We have long had the apparent paradox that while physicians can legally prescribe any drug for whatever purpose, despite what the official FDA-approved label says, companies can only legally market the drug for approved uses. This has become the principal tool by which the regulators can rein in the excesses of the industry. So if this ruling were to stand, the entire landscape of drug regulation in the USD would shift radically.
As the one dissenting judge stated the obvious, the ruling undermines the entire system of FDA regulation, since if companies can freely market drugs for off-label uses, they have no reason to go to the FDA to seek approval for any use except the most minimal required to get the drug onto the market at all. That means no need to submit any data to show that the drug is safe and effective for its various recommended uses.
As somebody concerned about ethics and logic I can say what I think of this ruling, quite apart from how it stands as a bit of legal reasoning based on case law and precedent. The logic part comes in when we ask how drug reps are trained by the companies and assigned to their jobs. Last I heard, the companies spend a lot of time and money to assure that their reps don't speak freely. They are trained to be consistent, reliable mouthpieces for the industry marketing message. Now, if a drug rep had been fired by industry for telling docs that a drug made by his company was unsafe or ineffective, and he sued to keep his job, and the court had ruled that he should keep his job because the company decision violated his free speech rights, then I might believe that the court was perhaps really serious about applying the doctrine of free speech to the relationship between drug rep and doctor. As it stands, to put what the drug rep did in this case by telling a doc (apparently one wearing a wire as a Federal informant) about off-label uses of the drug under the category of "free speech" is simply a bad joke.
Monday, November 12, 2012
Corporate Integrity? Professionalism? Give Us a Break
"The rich are different from you and me."
"Yes, they have less integrity."
I'll return at the end to this exchange that never happened between F. Scott Fitzgerald and Ernest Hemingway. The thread begins, however, with this post by our friend Dr. Roy Poses on Health Care Renewal: http://hcrenewal.blogspot.com/2012/11/phony-consulting-and-royalty-agreements.html
Dr. Poses reviews the recent legal difficulties of the firm Orthofix, which seems to be headquartered down in my neck of the woods, in Lewisville, TX. Orthofix makes stuff that orthopedists implant in patients and so getting surgeons to choose their products over competitors' is huge for Orthofix profits. Some of the wrongdoing occurred in a subsidiary company, Blackstone Medical, which Orthofix bought out in 2006.
Some of the legal issues, in four separate legal actions, are summarized in a Bloomberg News release:
http://www.bloomberg.com/news/2012-11-02/orthofix-will-pay-u-s-30-million-to-settle-kickbacks.html
Others came from an SEC news release that Dr. Poses quotes.
Not to get overly fancy about which legal action is which, basically Orthofix was implicated in all of the following:
What do we mean by "egregious"? Well, even if you are now jaded by all the repeated accounts of company wrongdoing, this stuff may get your attention. Here's the partial rundown:
That brings us back to the non-quote with which I began. We would like to talk about corporate integrity, on the industry side, and professionalism on the physicians' side. What does corporate integrity mean when companies act in the way that Orthofix has--apparently as a standard business arrangement? What does professionalism mean when a company offers strippers and prostitutes as well as funny money to surgeons, and expects that this will gain them points with their customers, instead of enraging and offending the surgeons? ("We've already established what you are; we're just haggling over the price"?) And what does professionalism mean when a company assumes that surgeons will find these offers attractive and acceptable--and the surgeons, in fact, do accept them, eagerly?
Well, it turns out that one problem we may be facing here is that both the corporate leaders and their surgeon-customers are wealthy. And going back to Health Care Renewal again:
http://hcrenewal.blogspot.com/2012/07/quantitating-corruption-of-finance.html
--we're reminded that there is starting to be a body of experimental and survey literature that documents a general trend of rich folks to be less honest and more likely to feel entitled to bend the rules in their favor than average people.
This is the opposite of what the popular political discourse proclaims. When we hear mention of "entitlement programs," we are not likely to think of corporate welfare for the rich, but rather of programs that aid the poor and middle class, and make those nasty people into bad folks who feel "entitled" to things they did not properly earn. But the available research suggests that it's rather those who grew up under privilege that somehow are conditioned to believe that they earned every bit of that advantage and that they can expect it to keep rolling in. (Which is what F. Scott Fitzgerald, in the legitimate quote, actually did say about the rich.)
So I conclude that for some corporations to develop integrity, and for some physicians to develop professionalism, would require a dose of anti-entitlement pills. The drug company that seeks to market that particular product might get my blessing.
"Yes, they have less integrity."
I'll return at the end to this exchange that never happened between F. Scott Fitzgerald and Ernest Hemingway. The thread begins, however, with this post by our friend Dr. Roy Poses on Health Care Renewal: http://hcrenewal.blogspot.com/2012/11/phony-consulting-and-royalty-agreements.html
Dr. Poses reviews the recent legal difficulties of the firm Orthofix, which seems to be headquartered down in my neck of the woods, in Lewisville, TX. Orthofix makes stuff that orthopedists implant in patients and so getting surgeons to choose their products over competitors' is huge for Orthofix profits. Some of the wrongdoing occurred in a subsidiary company, Blackstone Medical, which Orthofix bought out in 2006.
Some of the legal issues, in four separate legal actions, are summarized in a Bloomberg News release:
http://www.bloomberg.com/news/2012-11-02/orthofix-will-pay-u-s-30-million-to-settle-kickbacks.html
Others came from an SEC news release that Dr. Poses quotes.
Not to get overly fancy about which legal action is which, basically Orthofix was implicated in all of the following:
- Having to pay a total of $121.4M to the Feds in all the actions combined
- Paying docs sham consulting fees and kickbacks for using Orthofix products
- Paying bribes to Mexican government officials to obtain sales contracts with Mexican government-owned hospitals
What do we mean by "egregious"? Well, even if you are now jaded by all the repeated accounts of company wrongdoing, this stuff may get your attention. Here's the partial rundown:
- Docs were paid as much as $8000/month under fictitious consulting agreements, and some were awarded phony research grants for up to $18,000
- Blackstone sales tactics routinely included wining and dining docs, taking them to strip clubs, and paying for prostitutes
- One Blackstone female sales manager was urged by two surgeons whom she took to a strip club to disrobe and join the strippers on stage--after she complied, she was demoted but not fired
- The bribes paid to Mexican government officials were referred to in Orthofix documents as "chocolates," but consisted of cash, laptop computers, TVs, and appliances given directly to the officials or via front companies
That brings us back to the non-quote with which I began. We would like to talk about corporate integrity, on the industry side, and professionalism on the physicians' side. What does corporate integrity mean when companies act in the way that Orthofix has--apparently as a standard business arrangement? What does professionalism mean when a company offers strippers and prostitutes as well as funny money to surgeons, and expects that this will gain them points with their customers, instead of enraging and offending the surgeons? ("We've already established what you are; we're just haggling over the price"?) And what does professionalism mean when a company assumes that surgeons will find these offers attractive and acceptable--and the surgeons, in fact, do accept them, eagerly?
Well, it turns out that one problem we may be facing here is that both the corporate leaders and their surgeon-customers are wealthy. And going back to Health Care Renewal again:
http://hcrenewal.blogspot.com/2012/07/quantitating-corruption-of-finance.html
--we're reminded that there is starting to be a body of experimental and survey literature that documents a general trend of rich folks to be less honest and more likely to feel entitled to bend the rules in their favor than average people.
This is the opposite of what the popular political discourse proclaims. When we hear mention of "entitlement programs," we are not likely to think of corporate welfare for the rich, but rather of programs that aid the poor and middle class, and make those nasty people into bad folks who feel "entitled" to things they did not properly earn. But the available research suggests that it's rather those who grew up under privilege that somehow are conditioned to believe that they earned every bit of that advantage and that they can expect it to keep rolling in. (Which is what F. Scott Fitzgerald, in the legitimate quote, actually did say about the rich.)
So I conclude that for some corporations to develop integrity, and for some physicians to develop professionalism, would require a dose of anti-entitlement pills. The drug company that seeks to market that particular product might get my blessing.
Wednesday, November 7, 2012
A Non-Psychiatrist Dares to Comment on Psychiatry
I have occasionally posted about the controversy aroused by the American Psychiatric Association's (APA)forthcoming DSM-V classification of mental illnesses, for example:
http://brodyhooked.blogspot.com/2009/07/more-on-psychiatrys-dsm-v-mess.html
http://brodyhooked.blogspot.com/2009/06/will-psychiatrys-dsm-v-be-huge-growth.html
http://brodyhooked.blogspot.com/2012/01/from-health-care-renewal-egregious.html
I will now offer a further comment based on two posts, first, Dr. Bernard Carroll over on Health Care Renewal:
http://hcrenewal.blogspot.com/2012/11/does-american-psychiatry-matter.html
--who in turn cites the 1 Boring Old Man blog run by a retired psychiatrist:
http://1boringoldman.com/index.php/2012/11/02/cest-la-vie/
The short form of these two posts is that the APA has antagonized so many folks with the way they have mishandled the DSM-V business that they risk making both DSM-V and themselves irrelevant to mental health, and that smart people will ignore DSM-V and turn elsewhere for classifications of mental illness.
What follows is my attempt to synthesize some important ideas from these two recent posts, and I'll use the excuse that even though I am not a psychiatrist, the other two bloggers are, and so I am simply trying to pass along what they have said.
1 Boring Old Man recalls what it was like to practice psychiatry in the 1970s and 1980s. He recalls that a thousand flowers bloomed. There were many disparate, incompatible theories and schools of psychiatry--and that was good. Psychiatrists read Freud and benefited from the reading, but very few were the cardboard-caricarture Freudians that now are derided and are trotted out as the excuse as to why psychiatry had to reform itself. When the DSM-III (the first modern version) came out, most psychiatrists realized why it had been created, and basically supported the idea that some sort of standard diagnostic approach was necessary; but hardly anyone found it clinically useful. The eclectic mix of disparate schools and theories was confusing to the statisticians and epidemiologists, but a rich mine ideas for the psychiatrist who had to confront a wide variety of symptoms in a wide variety of people. The eclectic mix gave them the freedom to do what worked best under any given circumstance.
This state of affairs, these psychiatrists say, has evolved from toolbox to straitjacket as the new DSM-V seems a further attempt to impose a rigid orthodoxy on the field that stresses brain biology and drug treatment--so much so that many are now saying they'll have none of it and the APA can go take a hike.
Okay, now I'll add my own ideas. When eclecticism is working for a field, and people decide to throw out the eclecticism and replace it with something clinically much less helpful, that's bad. What this blog is mostly concerned about is the impact of industry-driven commercialization on medicine. So the next question is, how much of this bad stuff can be traced to drug industry influence.
In a previous post:
http://brodyhooked.blogspot.com/2010/05/whitakers-anatomy-of-epidemic.html
--I recounted journalist Robert Whitaker's history of the APA (in his Anatomy of an Epidemic) giving the specific dates (between 1974 and 1980) when the APA decided they had major problems on their hands, that those problems could be solved by a big influx of Pharma dollars, and that their policies therefore should shift to make APA an extremely Pharma-friendly venue. The above-listed posts further document how the new DSM-V appears to be an even bolder move toward allowing the Pharma fox to guard the psychiatric-diagnosis henhouse, in ways that maximize industry profits and the drugging of patients with even mild symptoms.
So does this shift in the DSM, that results in a further flight from clinical utility, have something to do with Pharma influence? Yes.
http://brodyhooked.blogspot.com/2009/07/more-on-psychiatrys-dsm-v-mess.html
http://brodyhooked.blogspot.com/2009/06/will-psychiatrys-dsm-v-be-huge-growth.html
http://brodyhooked.blogspot.com/2012/01/from-health-care-renewal-egregious.html
I will now offer a further comment based on two posts, first, Dr. Bernard Carroll over on Health Care Renewal:
http://hcrenewal.blogspot.com/2012/11/does-american-psychiatry-matter.html
--who in turn cites the 1 Boring Old Man blog run by a retired psychiatrist:
http://1boringoldman.com/index.php/2012/11/02/cest-la-vie/
The short form of these two posts is that the APA has antagonized so many folks with the way they have mishandled the DSM-V business that they risk making both DSM-V and themselves irrelevant to mental health, and that smart people will ignore DSM-V and turn elsewhere for classifications of mental illness.
What follows is my attempt to synthesize some important ideas from these two recent posts, and I'll use the excuse that even though I am not a psychiatrist, the other two bloggers are, and so I am simply trying to pass along what they have said.
1 Boring Old Man recalls what it was like to practice psychiatry in the 1970s and 1980s. He recalls that a thousand flowers bloomed. There were many disparate, incompatible theories and schools of psychiatry--and that was good. Psychiatrists read Freud and benefited from the reading, but very few were the cardboard-caricarture Freudians that now are derided and are trotted out as the excuse as to why psychiatry had to reform itself. When the DSM-III (the first modern version) came out, most psychiatrists realized why it had been created, and basically supported the idea that some sort of standard diagnostic approach was necessary; but hardly anyone found it clinically useful. The eclectic mix of disparate schools and theories was confusing to the statisticians and epidemiologists, but a rich mine ideas for the psychiatrist who had to confront a wide variety of symptoms in a wide variety of people. The eclectic mix gave them the freedom to do what worked best under any given circumstance.
This state of affairs, these psychiatrists say, has evolved from toolbox to straitjacket as the new DSM-V seems a further attempt to impose a rigid orthodoxy on the field that stresses brain biology and drug treatment--so much so that many are now saying they'll have none of it and the APA can go take a hike.
Okay, now I'll add my own ideas. When eclecticism is working for a field, and people decide to throw out the eclecticism and replace it with something clinically much less helpful, that's bad. What this blog is mostly concerned about is the impact of industry-driven commercialization on medicine. So the next question is, how much of this bad stuff can be traced to drug industry influence.
In a previous post:
http://brodyhooked.blogspot.com/2010/05/whitakers-anatomy-of-epidemic.html
--I recounted journalist Robert Whitaker's history of the APA (in his Anatomy of an Epidemic) giving the specific dates (between 1974 and 1980) when the APA decided they had major problems on their hands, that those problems could be solved by a big influx of Pharma dollars, and that their policies therefore should shift to make APA an extremely Pharma-friendly venue. The above-listed posts further document how the new DSM-V appears to be an even bolder move toward allowing the Pharma fox to guard the psychiatric-diagnosis henhouse, in ways that maximize industry profits and the drugging of patients with even mild symptoms.
So does this shift in the DSM, that results in a further flight from clinical utility, have something to do with Pharma influence? Yes.
Monday, November 5, 2012
Let's Do It Again: Latest Federal Settlement (Boehringer Ingelheim)
We are back to our standard form, to report the latest incident of a drug firm settling with the Feds over alleged lawbreaking:
Drug company: Boehringer Ingelheim
Drugs involved: Combivent (ipratropium/albuterol), Micardis (telmisartan), Aggrenox (aspirin/dipyridamole)
Amount of settlement: $95M
Settlement equals what percentage of one year's sales of the drug?: I could quickly locate annual US sales figures only for two of the drugs in 2010, Micardis and Combivent; the settlement amount is 4% of that combined figure.
Did the company admit wrongdoing? Yes/No: Of course not
Link to detailed news coverage:
http://www.washingtonpost.com/business/pharmaceutical-company-to-pay-95m-to-settle-allegations-of-improper-promotion/2012/10/25/ef595032-1ee1-11e2-8817-41b9a7aaabc7_story.html
http://articles.courant.com/2012-10-26/business/hc-boehringer-ingelheim-fraud-20121026_1_hypertension-drug-civil-settlement-risk-of-heart-attacks
This is such small potatoes in the balance sheet of a big drug firm, less than $100M, that it's hardly worth even mentioning, except that the Feds claimed that besides evidence for off-label promotion which amounted to lying about the drug's effectiveness, the company also engaged in paying kickbacks to docs for prescribing the drugs. Not surprising to any regular readers of this blog, the kickbacks consisted of payment for serving on advisory boards, speaker panels, speakers' training programs, and consultancies.
The company, in denying any wrongdoing, commented that industry standards had recently changed, that the company was cooperating fully, and that they had entered into a supposed integrity agreement. Given the frequency with which other drug companies in the past have entered into such agreements and then repeatedly re-violated, one can be forgiven for skepticism that this amounts to any significant deterrent.
Hat tip to our Health Care Renewal friends for tipping us off:
http://hcrenewal.blogspot.com/2012/10/just-another-day-at-office-boehringer.html
Drug company: Boehringer Ingelheim
Drugs involved: Combivent (ipratropium/albuterol), Micardis (telmisartan), Aggrenox (aspirin/dipyridamole)
Amount of settlement: $95M
Settlement equals what percentage of one year's sales of the drug?: I could quickly locate annual US sales figures only for two of the drugs in 2010, Micardis and Combivent; the settlement amount is 4% of that combined figure.
Did the company admit wrongdoing? Yes/No: Of course not
Link to detailed news coverage:
http://www.washingtonpost.com/business/pharmaceutical-company-to-pay-95m-to-settle-allegations-of-improper-promotion/2012/10/25/ef595032-1ee1-11e2-8817-41b9a7aaabc7_story.html
http://articles.courant.com/2012-10-26/business/hc-boehringer-ingelheim-fraud-20121026_1_hypertension-drug-civil-settlement-risk-of-heart-attacks
This is such small potatoes in the balance sheet of a big drug firm, less than $100M, that it's hardly worth even mentioning, except that the Feds claimed that besides evidence for off-label promotion which amounted to lying about the drug's effectiveness, the company also engaged in paying kickbacks to docs for prescribing the drugs. Not surprising to any regular readers of this blog, the kickbacks consisted of payment for serving on advisory boards, speaker panels, speakers' training programs, and consultancies.
The company, in denying any wrongdoing, commented that industry standards had recently changed, that the company was cooperating fully, and that they had entered into a supposed integrity agreement. Given the frequency with which other drug companies in the past have entered into such agreements and then repeatedly re-violated, one can be forgiven for skepticism that this amounts to any significant deterrent.
Hat tip to our Health Care Renewal friends for tipping us off:
http://hcrenewal.blogspot.com/2012/10/just-another-day-at-office-boehringer.html
Saturday, November 3, 2012
Roses (and Thorns) by Any Other Name: ACRE's New "Guidelines"
I have blogged at length about the Association of Clinical Researchers and Educators (ACRE), the primary outlet for pharmapologist sentiments, for example:
http://brodyhooked.blogspot.com/2012/01/another-planet-heard-from-sunshine-law.html
http://brodyhooked.blogspot.com/2010/04/encounters-with-dr-tom-stossel.html
http://brodyhooked.blogspot.com/2010/02/another-county-heard-from-acre.html
ACRE has now come out with what seems alternatively to be called either a "statement" or "guidelines" on "relationships between physicians and industry":
http://www.policymed.com/2012/11/association-of-clinical-researchers-and-educators-releases-statement-on-relationships-between-physicians-and-industry.html
(Side note: I looked for this statement first on ACRE's own website and found that their latest posted news release was dated mid-2011, so I'm not sure what's up with them, but for all I can tell this statement is legit.)
If you want to cut to the chase and read the statement directly, not the summary of it in the press release, you can go to:
http://aace.metapress.com/content/k12021244705x03w/fulltext.pdf
The summary says that this is to be published in the journal Endocrine Practice, which is not exactly a high-impact journal, but leave that aside. Corresponding author is Dr. Michael A. Weber of SUNY-Downstate, with our old friends Drs. Tom Stossel, Avi Markowitz, and philosopher Lance Stell among the writing committee.
OK, so why should a pharmascold blog like this one devote (virtual) ink to anything coming out of ACRE? I decided it might be instructive to see what happens when this organization attempts to be positive and actually issue a set of practical guidelines. Think of an analogy with the Romney campaign. Romney had it easy early on when all he had to do was attack "Obamacare." Then things got tougher when unkind folks asked him what his own health plan consisted of. When forced to come up with concrete policy proposals, Romney suddenly discovered that he actually agreed with some parts of the Affordable Care Act. So one might ask whether any similar "aha" moments might emerge from ACRE's recent efforts.
Let's quickly review ACRE's track record. Perhaps guided by in-house philosopher Stell, ACRE has never been content to quibble about the details of the ethics of the Pharma-medicine relationship. They have always gone for the jugular, attacking the core assumptions of the pharmascold position (if I may caricature it that way for brevity).
What are those assumptions? Folks like me always start with a collection of ideas:
So, having trashed all the more usual ethical assumptions on which one could base guidelines for physician-industry interactions, and which in fact were relied on by folks like the IOM, NIH, and AAMC in their proposed guidelines, what can ACRE come up with?
Their summary statement seems to be: "While there may be strengths and weaknesses to [current] approaches [to regulate these relationships], the best course is a middle road: one that values transparency of such relationships, but does not harm patients or slow innovation in the process."
They then begin their statement with a substatement: "The vast majority of collaborations between physicians and industry has added considerably to improved patient care. Moreover, these collaborations have been conducted with integrity and commitment. Critics of these collaborations have raised concerns, largely speculative and theoretical, that have created complicated and counterproductive regulations and rules regarding these relationships."
This sounds like the old ACRE, trashing the pharmascold position as based solely on theoretical concerns when everyone knows that in the real world, nothing but benefits flow from the exchange of cash between docs and industry. And in fact, a good deal of the verbiage in the actual statement consists of a long list of all the advantages to science and patient care provided by industry and strong relationships between medicine and industry. But wait...
Here are some comments culled from the summary review, which reflect the language in the statement itself:
On medical societies: "Accordingly, ACRE recommended that leaders of medical societies have a strong obligation to create internal operational procedures ... to ensure corporate support does not create inappropriate endorsements of industry products. ... societies should be proactive in protecting themselves and their corporate supporters against the appearance of inappropriate endorsements."
On CME: "Faculty should create their own talks"
On publishing: "Cannot prevent or delay publication of unfavorable results... Begin before outlines of article or any drafts are written ... 'ghostwriting' should be avoided and the use of external writing agencies or 'editorial assistance' should be undertaken with great care..."
On travel expenses for meeting attendance: "Travel support to attend a meeting as a member of the audience, not the faculty, should be declined...Acceptance of travel support must not be linked in any way to prescribing performance or other support of the sponsor’s products"
On consulting/advising: "Avoid giving the impression of primarily defending industry interests"
Comments:
http://brodyhooked.blogspot.com/2012/01/another-planet-heard-from-sunshine-law.html
http://brodyhooked.blogspot.com/2010/04/encounters-with-dr-tom-stossel.html
http://brodyhooked.blogspot.com/2010/02/another-county-heard-from-acre.html
ACRE has now come out with what seems alternatively to be called either a "statement" or "guidelines" on "relationships between physicians and industry":
http://www.policymed.com/2012/11/association-of-clinical-researchers-and-educators-releases-statement-on-relationships-between-physicians-and-industry.html
(Side note: I looked for this statement first on ACRE's own website and found that their latest posted news release was dated mid-2011, so I'm not sure what's up with them, but for all I can tell this statement is legit.)
If you want to cut to the chase and read the statement directly, not the summary of it in the press release, you can go to:
http://aace.metapress.com/content/k12021244705x03w/fulltext.pdf
The summary says that this is to be published in the journal Endocrine Practice, which is not exactly a high-impact journal, but leave that aside. Corresponding author is Dr. Michael A. Weber of SUNY-Downstate, with our old friends Drs. Tom Stossel, Avi Markowitz, and philosopher Lance Stell among the writing committee.
OK, so why should a pharmascold blog like this one devote (virtual) ink to anything coming out of ACRE? I decided it might be instructive to see what happens when this organization attempts to be positive and actually issue a set of practical guidelines. Think of an analogy with the Romney campaign. Romney had it easy early on when all he had to do was attack "Obamacare." Then things got tougher when unkind folks asked him what his own health plan consisted of. When forced to come up with concrete policy proposals, Romney suddenly discovered that he actually agreed with some parts of the Affordable Care Act. So one might ask whether any similar "aha" moments might emerge from ACRE's recent efforts.
Let's quickly review ACRE's track record. Perhaps guided by in-house philosopher Stell, ACRE has never been content to quibble about the details of the ethics of the Pharma-medicine relationship. They have always gone for the jugular, attacking the core assumptions of the pharmascold position (if I may caricature it that way for brevity).
What are those assumptions? Folks like me always start with a collection of ideas:
- Conflict of interest
- Professionalism
- Trust (alleging that conflicts threaten patient and public trust in medicine)
So, having trashed all the more usual ethical assumptions on which one could base guidelines for physician-industry interactions, and which in fact were relied on by folks like the IOM, NIH, and AAMC in their proposed guidelines, what can ACRE come up with?
Their summary statement seems to be: "While there may be strengths and weaknesses to [current] approaches [to regulate these relationships], the best course is a middle road: one that values transparency of such relationships, but does not harm patients or slow innovation in the process."
They then begin their statement with a substatement: "The vast majority of collaborations between physicians and industry has added considerably to improved patient care. Moreover, these collaborations have been conducted with integrity and commitment. Critics of these collaborations have raised concerns, largely speculative and theoretical, that have created complicated and counterproductive regulations and rules regarding these relationships."
This sounds like the old ACRE, trashing the pharmascold position as based solely on theoretical concerns when everyone knows that in the real world, nothing but benefits flow from the exchange of cash between docs and industry. And in fact, a good deal of the verbiage in the actual statement consists of a long list of all the advantages to science and patient care provided by industry and strong relationships between medicine and industry. But wait...
Here are some comments culled from the summary review, which reflect the language in the statement itself:
On medical societies: "Accordingly, ACRE recommended that leaders of medical societies have a strong obligation to create internal operational procedures ... to ensure corporate support does not create inappropriate endorsements of industry products. ... societies should be proactive in protecting themselves and their corporate supporters against the appearance of inappropriate endorsements."
On CME: "Faculty should create their own talks"
On publishing: "Cannot prevent or delay publication of unfavorable results... Begin before outlines of article or any drafts are written ... 'ghostwriting' should be avoided and the use of external writing agencies or 'editorial assistance' should be undertaken with great care..."
On consulting/advising: "Avoid giving the impression of primarily defending industry interests"
Comments:
- As I noted, ACRE's past publications have ruthlessly trashed the ideas of COI, professionalism, and concern about public trust. But their new statement/guidelines offers no alternative set of principles on which ethical conclusions might be based. And many observers would note that the above-quoted recommendations make no sense at all unless one implicitly assumes concerns about COI, professionalism, and breaches of trust.
- Put another way, whenever the principal actors in ACRE have allowed us to peek behind the curtain to see what basic philosophy motivates them, we see some version of economism, or a faith that the unregulated free market will solve all human problems (see http://brodyhooked.blogspot.com/2011/11/shameless-commerce-division-new-book.html). This proposed set of guidelines is inconsistent with that philosophy. If the market did not want ghostwriting to exist, it would not be so profitable and hence so commonplace. So the guidelines represent a tacit admission that the marketplace cannot solve all these problems on its own, and that the unregulated marketplace indeed creates problems for medicine.
- ACRE's champions have always insisted that pharmascolds have blown a very few anecdotes way out of proportion, to claim that problems at the Pharma-medicine interface are serious and widespread. But if you look at what this blog has repeatedly documented, and then look at what ACRE's guidelines call for, you see that behavior that their own guidelines criticize occurs commonly. So these guidelines represent a tacit admission by ACRE that their past dismissal of these problems is ill-founded.
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