Okay, now we can go back to the standard form:
Company: Amgen
Drug: Aranesp (darepoetin alfa)
Offense: Marketing drug for off-label uses (anemia in all cancer patients when approval only for patients receiving chemotherapy)
Amount of settlement: $762M (including both criminal and civil penalties)
Settlement is what percentage of annual revenues from drug sales: 38%
Did company admit wrongdoing: Yes, pleaded guilty to one misdemeanor account
The facts are summarized in the usual insightful post by Dr. Roy Poses at Health Care Renewal:
http://hcrenewal.blogspot.com/2012/12/amgen-settles-pleads-guilty-to.html
--which in turn cites the New York Times:
http://www.nytimes.com/2012/12/19/business/amgen-agrees-to-pay-762-million-in-drug-case.html?_r=0&adxnnl=1&adxnnlx=1356376699-qWKLtjN7sro23upHGgd5Yg
All this is same song, third verse for readers of this blog who might remember these previous two posts:
http://brodyhooked.blogspot.com/2012/05/hiding-truth-about-drugs-how-long-are.html
http://brodyhooked.blogspot.com/2008/01/lobbying-congress-on-anemia-drugs-how.html
--on which more in a minute. Basically, drugs to treat anemia in both cancer patients and kidney dialysis patients have been pushed heavily by drug companies, despite evidence (that was successfully hidden for some years) that higher doses of these meds, leading to higher blood counts, actually caused more patient deaths by leading to blood clotting. Aranesp is one of this family of drugs (generally referred to as epoetins). While as a technicality Amgen was nailed on off label marketing for claiming that all cancer patients, and not just those on chemotherapy, needed their red blood cells boosted up with this medication, the real offense was aggressively pushing the drug despite risks of harm.
Now, as the older of the two previous posts made clear, the blame for this sad state of affairs only partially lies with the drug firm, though they clearly did everything they could to milk extra profits even over the bodies of dead patients. The other part of the puzzle is the crazy way the Feds have reimbursed kidney dialysis and cancer docs. They are virtually the only physicians paid on commission for prescribing either more expensive drugs, or higher doses of drugs. So when Amgen came to these docs and said, your patients have this terrible anemia, use our expensive drug to boost their red cell count, and don't worry about those nasty rumors about lack of safety when you use the highest possible doses, they were preaching to the choir, as these docs pocketed extra money both for using the drug in the first place and also for using more of it. As I said in the original post, how anyone could be so insane as to imagine that such a system would result in high-quality patient care truly amazes me, and I'm pretty much beyond being amazed.
As is his constant refrain, Dr. Poses notes that no one at Amgen is doing any jail time, or even is worried about it, after the company pleaded guilty to criminal charges. When the drug, even now that docs have finally been warned and are using less of it, sells $2B worth every year, the company can easily afford a $700M settlement. In the face of these business realities--just pay your fine and go your merry way, and no company executive will ever suffer personally--then the fact that Amgen signed a "corporate integrity agreement" as part of the settlement remains nothing but a really bad joke. It was only as short time ago that we (thanks again to Dr. Poses) noted the repeat offenses of another company that has now signed enough corporate integrity agreements to paper the CEO's suite:
http://brodyhooked.blogspot.com/2012/12/doing-it-again-after-pomising-not-to.html
Monday, December 24, 2012
Tuesday, December 18, 2012
A Major Figure in Pain Medicine Recants--Partially
Thanks to a post at Health Care Renewal by Dr. Roy Poses:
http://hcrenewal.blogspot.com/2012/12/the-king-of-pain-recants-pharmaceutical.html
--I was guided to a recent Wall Street Journal piece by Catan and Perez (subscription required) that addresses an issue I have previously blogged about at some length:
http://brodyhooked.blogspot.com/2012/02/baby-bathwater-and-prescribing-for.html
http://brodyhooked.blogspot.com/2011/12/painful-to-report-propublica-skewers.html
My own take on this issue differs a bit from Dr. Poses' so I refer the reader to the earlier posts in which I state my basic sympathy with the goal of treating chronic pain aggressively, with narcotics if other modalities don't work and if the patient seems a suitable candidate and is carefully monitored.
In taking that position over many years of (former) practice, however, I must admit that I was heavily influenced by the writing of one person, Dr. Russell Portenoy, who became head of pain medicine at Beth Israel Medical Center in New York. Dr. Portenoy was an early advocate of much liberalized use of narcotic medications for chronic pain, basically saying that one could take the same lessons learned in treating terminal cancer patients and apply them to the much larger population of adults with chronic non-cancer pain. Traditional physicians cried wolf when hospice first came on the scene, warning that liberal use of opiate drugs would kill cancer patients from depression of their breathing and turn all of them into addicts. When the drugs did neither, some of us concluded that a general "opiophobia" among physicians and nurses might be standing in the way of rational practice more generally. Dr. Portenoy was a leader in applying that logic to chronic pain.
It is therefore painful (no pun intended) for folks like me to read in this article that in a recent interview, Dr. Portenoy freely admitted that the advice he handed out back then was probably wrong-- particularly, that narcotics are much more dangerous and addiction-prone than he made out to be. This generally more cautious attitude is mirrored in what studies have recently become available on the topic--for example, this study by Dillie and colleagues:
http://www.jabfm.org/content/21/2/108.long
--looking at the association between dosage and reported quality of life in chronic pain, opiate-treated patients and showing that the better quality of life was related to lower and not higher dosages of the medication.
Dr. Poses correctly notes that there was not, when Dr. Portenoy began his campaign, nor is their today, any solid high-quality evidence that narcotics work effectively and safely in treating chronic non-malignant pain. I would simply ask one to consider what it would take to launch a definitive randomized, controlled, double-blind trial to answer this question, and I don't think it's a great surprise that there have been no such studies. This is especially the case since there is very limited NIH support for studies of pain generally.
OK, so all this is very disppointing when it comes to treating chronic pain. The aspect that especially concerns us in this blog is the role of conflicts of interest and industry funding. The WSJ article makes clear that Portenoy accepted huge sums of cash from the drug companies that make opiates, especially the problem-prone OxyContin manufactured by Purdue Pharma, the now-infamous "hillbilly heroin." The old excuse we heard from the pain docs and pain associations is that they had no choice but to accept industry money if they wanted to get any research done at all, given the dearth of federal funds. This article (and others in the previous posts) show that it was not just a matter of research funds; many of these docs became high-rolling "key opinion leaders" feathering their own nests with dollars not intended for research at all. And as was usually the case back then, articles they wrote for medical journals, or guidelines they authored for various national organizations, seldom if ever disclosed those conflicts.
Here is where Dr. Portnenoy's mea culpa hardly extends far enough. He seems to have learned that the safety profile of opiates is not as rosy as he made it out to be 10 and 20 years ago. But he does not seem to have gained any perspective on the dangers of being bribed by industry. He told the interviewer, "My viewpoint is that I can have those [financial] relationships, they would benefit my educational mission, they benefit my research mission, and to some extent, they can benefit my own pocketbook, without producing in me any tendency to engage in undue influence or misinformation."
Well, since Dr. Portenoy began his career, new evidence has emerged about the efficacy and safety of narcotics in chronic pain. New evidence has also emerged about the degree to which docs are influenced by Pharma money, even if they deny it. Dr. Portenoy seriously needs a refresher course in the latter body of evidence, just as he seems to have had some helpful re-education regarding the first.
Catan T, Perez E. "A Pain-Drug Champion Has Second Thoughts." Wall Street Journal, Dec. 15, 2012, P. A1.
http://hcrenewal.blogspot.com/2012/12/the-king-of-pain-recants-pharmaceutical.html
--I was guided to a recent Wall Street Journal piece by Catan and Perez (subscription required) that addresses an issue I have previously blogged about at some length:
http://brodyhooked.blogspot.com/2012/02/baby-bathwater-and-prescribing-for.html
http://brodyhooked.blogspot.com/2011/12/painful-to-report-propublica-skewers.html
My own take on this issue differs a bit from Dr. Poses' so I refer the reader to the earlier posts in which I state my basic sympathy with the goal of treating chronic pain aggressively, with narcotics if other modalities don't work and if the patient seems a suitable candidate and is carefully monitored.
In taking that position over many years of (former) practice, however, I must admit that I was heavily influenced by the writing of one person, Dr. Russell Portenoy, who became head of pain medicine at Beth Israel Medical Center in New York. Dr. Portenoy was an early advocate of much liberalized use of narcotic medications for chronic pain, basically saying that one could take the same lessons learned in treating terminal cancer patients and apply them to the much larger population of adults with chronic non-cancer pain. Traditional physicians cried wolf when hospice first came on the scene, warning that liberal use of opiate drugs would kill cancer patients from depression of their breathing and turn all of them into addicts. When the drugs did neither, some of us concluded that a general "opiophobia" among physicians and nurses might be standing in the way of rational practice more generally. Dr. Portenoy was a leader in applying that logic to chronic pain.
It is therefore painful (no pun intended) for folks like me to read in this article that in a recent interview, Dr. Portenoy freely admitted that the advice he handed out back then was probably wrong-- particularly, that narcotics are much more dangerous and addiction-prone than he made out to be. This generally more cautious attitude is mirrored in what studies have recently become available on the topic--for example, this study by Dillie and colleagues:
http://www.jabfm.org/content/21/2/108.long
--looking at the association between dosage and reported quality of life in chronic pain, opiate-treated patients and showing that the better quality of life was related to lower and not higher dosages of the medication.
Dr. Poses correctly notes that there was not, when Dr. Portenoy began his campaign, nor is their today, any solid high-quality evidence that narcotics work effectively and safely in treating chronic non-malignant pain. I would simply ask one to consider what it would take to launch a definitive randomized, controlled, double-blind trial to answer this question, and I don't think it's a great surprise that there have been no such studies. This is especially the case since there is very limited NIH support for studies of pain generally.
OK, so all this is very disppointing when it comes to treating chronic pain. The aspect that especially concerns us in this blog is the role of conflicts of interest and industry funding. The WSJ article makes clear that Portenoy accepted huge sums of cash from the drug companies that make opiates, especially the problem-prone OxyContin manufactured by Purdue Pharma, the now-infamous "hillbilly heroin." The old excuse we heard from the pain docs and pain associations is that they had no choice but to accept industry money if they wanted to get any research done at all, given the dearth of federal funds. This article (and others in the previous posts) show that it was not just a matter of research funds; many of these docs became high-rolling "key opinion leaders" feathering their own nests with dollars not intended for research at all. And as was usually the case back then, articles they wrote for medical journals, or guidelines they authored for various national organizations, seldom if ever disclosed those conflicts.
Here is where Dr. Portnenoy's mea culpa hardly extends far enough. He seems to have learned that the safety profile of opiates is not as rosy as he made it out to be 10 and 20 years ago. But he does not seem to have gained any perspective on the dangers of being bribed by industry. He told the interviewer, "My viewpoint is that I can have those [financial] relationships, they would benefit my educational mission, they benefit my research mission, and to some extent, they can benefit my own pocketbook, without producing in me any tendency to engage in undue influence or misinformation."
Well, since Dr. Portenoy began his career, new evidence has emerged about the efficacy and safety of narcotics in chronic pain. New evidence has also emerged about the degree to which docs are influenced by Pharma money, even if they deny it. Dr. Portenoy seriously needs a refresher course in the latter body of evidence, just as he seems to have had some helpful re-education regarding the first.
Catan T, Perez E. "A Pain-Drug Champion Has Second Thoughts." Wall Street Journal, Dec. 15, 2012, P. A1.
Monday, December 17, 2012
Doing It Again, After Promising Not To--Pfizer's Amazing Record
Once again I can kick back and let the nice folks over at Health Care Renewal do all the heavy lifting:
http://hcrenewal.blogspot.com/2012/12/pfizers-13th-legal-settlement-will-it.html
I want to highlight several things reported in that post that pick up on themes previously discussed here.
Dr. Roy Poses tracked down a couple of recent Federal settlements involving Pfizer. These settlements did not get much media attention--in one case Dr. Poses could not even find any details about what the company supposedly did wrong--and the amounts of the settlements are chickenfeed compared to earlier numbers, less than $100M each. So I won't even go to the trouble to do my usual scorecard of latest Pharma fraud judgments.
What does matter, and as Dr. Poses noted, was not mentioned at all in the very limited media coverage, was Pfizer's overall track record of paying settlements due to alleged or admitted illegal behavior. As he has reconstructed it, and he admits he might have missed a few things, it looks like this since the turn of the century:
As Dr. Poses (and previous posts here) have noted, several of these settlements involed promises by Pfizer that it had learned its lesson and would not do those sorts of things again. They obviously did learn their lesson, which is that you can do these sorts of things again, pay your fine, and keep merrily toting up all the profits.
Dr. Poses then appropriately juxtaposes these recent small-potatoes judgments against Pfizer with two larger events. The one you may have heard of is the scandal involving the monster British bank HSBC, found to have laundered money for Mexican drug cartels, and to have helped numerous bad guys around the world dodge international sanctions. As the New York Times opined in an editorial:
http://www.nytimes.com/2012/12/12/opinion/hsbc-too-big-to-indict.html?_r=0
--the Feds's failuire to indict any top executives of this bank shows that "the government has bought into the notion that too big to fail is too big to jail."
The other event that you probably never heard about was the 15th International Anti-Corruption Conference, sponsored by Transparency International, in Brasilia, which led to the Brasilia Declaration decrying the failure of governments to properly punish corrupt officials. Without such punishment, said the group, don't expect any reduction in corrupt practices:
http://15iacc.org/about/declarations/the-brasilia-declaration/
As I have previously blogged:
http://brodyhooked.blogspot.com/2011/05/where-in-world-do-you-find-corruption.html
--it's naive to imagine that corruption is something that happens in poor nations on the other side of the globe, when we have splendid examples of corporate corruption cropping up all over the US and Europe. So the rules for what needs to be done to thwart corruption should be applied here first and foremost.
http://hcrenewal.blogspot.com/2012/12/pfizers-13th-legal-settlement-will-it.html
I want to highlight several things reported in that post that pick up on themes previously discussed here.
Dr. Roy Poses tracked down a couple of recent Federal settlements involving Pfizer. These settlements did not get much media attention--in one case Dr. Poses could not even find any details about what the company supposedly did wrong--and the amounts of the settlements are chickenfeed compared to earlier numbers, less than $100M each. So I won't even go to the trouble to do my usual scorecard of latest Pharma fraud judgments.
What does matter, and as Dr. Poses noted, was not mentioned at all in the very limited media coverage, was Pfizer's overall track record of paying settlements due to alleged or admitted illegal behavior. As he has reconstructed it, and he admits he might have missed a few things, it looks like this since the turn of the century:
- 2002: Pfizer and affiliates Warner-Lambert and Parke-Davis, $49M, failure to pay proper federal and state rebates for Lipitor
- 2004: Pfizer and affiliate Warner-Lambert, $430M, off-label promotion of Neurontin
- 2007: Pfizer and affiliate Pharmacia & Upjohn, $35M, illegal kickbacks to promote Genotropin
- 2009: Pfizer, $2.3B, illegal marketing of Bextra
- 2010: Jury finds Pfizer guilty of violation of anti-racketeering statute for marketing of Neurontin, assesses $142M damages
- 2010: Another case, no details provided
- 2011: Pfizer affiliate Pharmacia, settlement with New York for overcharging
- 2011: Pfizer and affiiliate Quigley settle class action suit for $265M over asbestos exposure
- 2011: Pfizer, $14.5M, illegal marketing of Detrol
- 2012: Pfizer, $60M, allegations of subsidiaries bribing foreign government officials
- 2012: Pfizer and subsidiary Wyeth, $55M, illegal marketing of Protonix
- 2012: Pfizer, $43M paid to 33 states, illegal marketing of Zyvox and Lyrica
As Dr. Poses (and previous posts here) have noted, several of these settlements involed promises by Pfizer that it had learned its lesson and would not do those sorts of things again. They obviously did learn their lesson, which is that you can do these sorts of things again, pay your fine, and keep merrily toting up all the profits.
Dr. Poses then appropriately juxtaposes these recent small-potatoes judgments against Pfizer with two larger events. The one you may have heard of is the scandal involving the monster British bank HSBC, found to have laundered money for Mexican drug cartels, and to have helped numerous bad guys around the world dodge international sanctions. As the New York Times opined in an editorial:
http://www.nytimes.com/2012/12/12/opinion/hsbc-too-big-to-indict.html?_r=0
--the Feds's failuire to indict any top executives of this bank shows that "the government has bought into the notion that too big to fail is too big to jail."
The other event that you probably never heard about was the 15th International Anti-Corruption Conference, sponsored by Transparency International, in Brasilia, which led to the Brasilia Declaration decrying the failure of governments to properly punish corrupt officials. Without such punishment, said the group, don't expect any reduction in corrupt practices:
http://15iacc.org/about/declarations/the-brasilia-declaration/
As I have previously blogged:
http://brodyhooked.blogspot.com/2011/05/where-in-world-do-you-find-corruption.html
--it's naive to imagine that corruption is something that happens in poor nations on the other side of the globe, when we have splendid examples of corporate corruption cropping up all over the US and Europe. So the rules for what needs to be done to thwart corruption should be applied here first and foremost.
Tuesday, December 11, 2012
Obama's FDA-- Same Ol', Same Ol'
No one was surprised when under the Bush Administration, FDA's leadership took a decidedly pro-industry tilt. There was briefly some hope when Obama's people took over that a new breeze might be blowing there and that positive changes were underway--such as:
http://brodyhooked.blogspot.com/2010/05/are-we-seeing-new-fda-emerge.html
Therefore an article published back in March in BMJ:
http://www.bmj.com/content/344/bmj.e1086?view=long&pmid=22442352
--by Drs. Lisa Schwartz and Steve Woloshin of Dartmouth represents very depressing evidence that nothing really has changed and that the FDA remains the lapdog and not the watchdog of Pharma.
The background you need to know is that donepezil (brand name, Aricept, manufactured by Eisai and marketed by Pfizer) is one of several drugs intended to slow the progress of Alzheimer's disease, but that have never been shown to work very well. In research studies, the drugs will improve thinking, memory, or function by a few points on some measuring scale, but typically the patient or family cannot detect any real improvement. People feel obliged to use these drugs anyway since Alzheimer's is such a bad disease and we have nothing better to offer.
OK, so it's 2010, and Aricept, previously made in 5 and 20 milligram doses, is about to go off patent, and sales will be lost to the generic makers. How to evergreen this drug? Eisai apparently took a page from Abbott Labs' experience with fenofibrate:
http://brodyhooked.blogspot.com/2012/04/yet-another-evergreening-ploy-more-on_10.html
As we've discussed here and in HOOKED, the more usual evergreening process (extending the patent life of a drug to keep profits rolling in) has involved going into the chemistry lab to tweak the drug molecule in some minor way, then claiming that one has discovered a new miracle breakthrough drug. But why bother even to go into the lab if you can con the regulators to allow you simply to make a new dosage form of the drug, then claim that it's a brand new drug and deserves patent protection?
So Eisai went to the FDA with a new, 23-milligram form of Aricept with studies purporting to show that it was safe and effective. The FDA's own staff, as Schwartz and Woloshin tell the tale, said this was garbage--the study failed to show that the new dose was any more effective than the old 10 mg dose in global disease improvement. (There was a statistically significant, but clinically tiny improvement in cognitive function.) The staff also noted that when you upped the dose, guess what, patients suffered a lot more side effects--and side effects in the frail elderly can be nothing to sniff at. The chiefs of that section of the FDA overruled the staff and approved the "new" drug.
Eisai-Pfizer then launch a huge ad campaign aimed at both the general public and at docs. The campaign for the public transmitted the message that if you don't beg your doctor to prescribe this new wonder drug for Grandma, then obviously you don't love her. The ad for docs blatantly misrepresented the study data and claimed that the new dose form had been shown to be superior on global measures to the old one--and soft-pedaled the evidence for worse side effects.
When various do-gooders pointed out this lie, the FDA looked into it and discovered that they could not legally fault the company for the ads, because the ads contained the same information as was in the official FDA-approved product label. Apparently when the company sent in the proposed text for the new label, the FDA goofed and approved the incorrect language, despite their own in-house evidence that the labelling was false. Eventually the FDA fixed both the label and the ad campaign--only 18 months and 68,000 prescriptions after the ad campaign started.
In short, if this one instance is any clue, it's business as usual at the FDA, and it doesn't seem to matter who's in the White House.
(Hat tip to Drs. Rick Bukata and Jerry Hoffman of Primary Care Medical Abstracts for alerting me to the Schwartz-Woloshin paper.)
http://brodyhooked.blogspot.com/2010/05/are-we-seeing-new-fda-emerge.html
Therefore an article published back in March in BMJ:
http://www.bmj.com/content/344/bmj.e1086?view=long&pmid=22442352
--by Drs. Lisa Schwartz and Steve Woloshin of Dartmouth represents very depressing evidence that nothing really has changed and that the FDA remains the lapdog and not the watchdog of Pharma.
The background you need to know is that donepezil (brand name, Aricept, manufactured by Eisai and marketed by Pfizer) is one of several drugs intended to slow the progress of Alzheimer's disease, but that have never been shown to work very well. In research studies, the drugs will improve thinking, memory, or function by a few points on some measuring scale, but typically the patient or family cannot detect any real improvement. People feel obliged to use these drugs anyway since Alzheimer's is such a bad disease and we have nothing better to offer.
OK, so it's 2010, and Aricept, previously made in 5 and 20 milligram doses, is about to go off patent, and sales will be lost to the generic makers. How to evergreen this drug? Eisai apparently took a page from Abbott Labs' experience with fenofibrate:
http://brodyhooked.blogspot.com/2012/04/yet-another-evergreening-ploy-more-on_10.html
As we've discussed here and in HOOKED, the more usual evergreening process (extending the patent life of a drug to keep profits rolling in) has involved going into the chemistry lab to tweak the drug molecule in some minor way, then claiming that one has discovered a new miracle breakthrough drug. But why bother even to go into the lab if you can con the regulators to allow you simply to make a new dosage form of the drug, then claim that it's a brand new drug and deserves patent protection?
So Eisai went to the FDA with a new, 23-milligram form of Aricept with studies purporting to show that it was safe and effective. The FDA's own staff, as Schwartz and Woloshin tell the tale, said this was garbage--the study failed to show that the new dose was any more effective than the old 10 mg dose in global disease improvement. (There was a statistically significant, but clinically tiny improvement in cognitive function.) The staff also noted that when you upped the dose, guess what, patients suffered a lot more side effects--and side effects in the frail elderly can be nothing to sniff at. The chiefs of that section of the FDA overruled the staff and approved the "new" drug.
Eisai-Pfizer then launch a huge ad campaign aimed at both the general public and at docs. The campaign for the public transmitted the message that if you don't beg your doctor to prescribe this new wonder drug for Grandma, then obviously you don't love her. The ad for docs blatantly misrepresented the study data and claimed that the new dose form had been shown to be superior on global measures to the old one--and soft-pedaled the evidence for worse side effects.
When various do-gooders pointed out this lie, the FDA looked into it and discovered that they could not legally fault the company for the ads, because the ads contained the same information as was in the official FDA-approved product label. Apparently when the company sent in the proposed text for the new label, the FDA goofed and approved the incorrect language, despite their own in-house evidence that the labelling was false. Eventually the FDA fixed both the label and the ad campaign--only 18 months and 68,000 prescriptions after the ad campaign started.
In short, if this one instance is any clue, it's business as usual at the FDA, and it doesn't seem to matter who's in the White House.
(Hat tip to Drs. Rick Bukata and Jerry Hoffman of Primary Care Medical Abstracts for alerting me to the Schwartz-Woloshin paper.)
Saturday, December 8, 2012
What To Do about Worthless Guidelines
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.
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.
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.
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