I have previously addressed the debate over the safety of the diabetes drug Avandia (rosiglitazone) between Steve Nissen, head of cardiology at the Cleveland Clinic, and GlaxoSmithKline, the drug's manufacturer:
http://brodyhooked.blogspot.com/2010/04/more-on-avandia-saga.html
http://brodyhooked.blogspot.com/2010/02/secret-avandia-tapes-comedy-or-smoking.html
http://brodyhooked.blogspot.com/2010/02/avandia-story-failures-of-regulation.html
So a further round of fisticuffs between these worthy opponents in the European Heart Journal (subscription required) might seem like old news--were it not for the bit of interest GSK added by calling on the journal to censor Dr. Nissen's previous editorial.
Dr. Nissen had written his editorial, "The Rise and Fall of Rosiglitazone," giving his take on the whole matter. The journal had published the editorial on line but it had not yet appeared in the print edition. GSK, in the person of Moncef Slaoui, Chair of Research & Development, wrote a long letter to the editor of the journal disputing Nissen's account point by point, and including the statement: "We strongly disagree with several key points...most importantly those which imply misconduct on the part of GSK... On this basis GSK believes that it is necessary for the journal to withdraw this editorial from the website and refrain from publishing it in hard copy, until the journal has investigated these inaccuracies and unsubstantiated allegations."
Nissen responded with his own point by point refutation of GSK's point by point refutation. He introduced his letter: "Pharmaceutical companies have abundant resources for delivering their messages to physicians and the public. Physician-scientists essentially have only medical journals through which we communicate... If we allow a pharmaceutical company to control what we are allowed to publish, scientific discussion and debate would suffer irreparable harm. This demand from GSK constitutes an unacceptable attempt to interfere with the editorial decisions of a major medical journal."
The EHJ editors chimed in, "Scientists know what a good argument is and will consider its merits and evidence...However, we cannot suppress concerns, data or divergent opinions--we must consider them and argue with data, numbers and plausibility. Only through such a discourse can progress evolve."
As a side matter, one of the Nissen accusations at which GSK took the greatest umbrage was that they "stole" a copy of the manuscript of Nissen's meta-analysis while it was still under review with the New England Journal. To defend their counterclaim that they were essentially innocent bystanders who received a faxed copy of the manuscript that they had never requested, they cited an earlier publication that I did not realize existed, in which the leak of the manuscript was reported as a news item in Nature by Brian Vastag about 7 months after the event occurred. Vastag offered an interview with the leaker, Dr. Steven Haffner of the University of Texas-San Antonio. At that time, and apparently later as well, the New England Journal declined to say anything about what had been done with Haffner, though they added that routinely such an offense would lead to a future ban from reviewing and from contributing editorials and review articles. Vastag quoted Haffner about his decision to fax the copy of the manuscript to a former resarch collaborator who worked for GSK, "Why I sent it is a mystery...I really don't understand it. I wasn't feeling well. It was a bad judgment." He went on to say--this is apparently the part that GSK liked and why they cited Vastag's article in their reply to Nissen--that his collaborator at GSK had not requested the manuscript (how could he if the manuscript was presumably under confidential editorial review at the time) and was "probably a bystander." No further comment.
Nissen SE. The rise and fall of rosiglitazone [editorial]. European Heart Journal 31:773-776, 2010.
Slaoui M. The rise and fall of rosiglitazone: reply [letter to editor]. European Heart Journal (advance access e-published April 23, 2010).
Nissen SE. The painful truth [letter to editor]. European Heart Journal (advance access e-published April 23, 2010).
Luscher TF, Landmesser U, Ruschitzka F. Standing firm: the European Heart Journal, scientific controversies and the industry [editorial]. European Heart Journal doi:10.1093/eurheartj/ehq127 (advance access e-published April 23, 2010).
Vastag B. Reviewer leaked Avandia study to drug firm. Nature 451:509, 2008.
Friday, April 30, 2010
What Do Patients Think of Docs' Financial Ties?
Adam Licurse, leading a team primarily from Yale, has contributed to our understanding of patient attitudes toward physicians having financial ties to industry (subscription required). Licurse et al. attempted a systematic review of the available literature on this subject. They identified 20 studies, most of decent or better quality, that addressed their questions. Let me quote their key conclusion: "When asked about the importance of disclosing certain [financial ties], patients and research participants largely want to know about physician and researcher [financial ties]. In clinical care, many patients believed that industry gifts of a personal nature to physicians are unacceptable, whereas fewer found professional gifts to be unacceptable. Patients are concerned that these gifts affect the cost and quality of care and that these gifts influence clinical judgment." The situation seemed less clear in research; most studies wanted to know whether people would be less likely to participate as subjects in research if they knew that the investigator had financial ties, but several studies seemed to indicate that this would not be a very big factor.
People coming at the subject from my own bias would tend to wish that the research would show massive distrust of physicians if patients found out about financial ties. The research that is available hardly shows that univocal or extreme an answer. However, neither does it support a claim one now hears from our friends the pharmapologists-- that there are simply no compelling data that the issue of financial ties and disclosure has anything to do with public trust in medicine at all. For example, here is Dr. Thomas Huddle, replying to his critics in a January article that I blogged about previously (http://brodyhooked.blogspot.com/2010/02/what-would-it-take-to-prove-harm-from.html): "Surveys have repeatedly shown that large majorities of patients do not regard the promotional items and food involved in typical detailing to be ethically problematic."
Dr. Huddle is strictly correct, but his assessment tells only a piece of the story. Plus he cites only three sources for his claim, all published before 2000. The Licurse review includes several surveys conducted within the last decade. One of them, by Jastifer and Roberts, notes in passing that more recent reviews appear to show patients as more critical of financial ties than surveys done in the 1990s (as would be very reasonable given recent publicity, and findings in some early studies that few patients were even aware of the nature of these ties).
Here is how I would summarize the Licurse et al. review: There is sufficient evidence to believe that a significant number of patients are concerned about financial ties between physicians and industry, in ways that implicate public trust in medicine.
Licurse A, Barber E, Joffe S, Gross C. The impact of disclosing financial ties in research and clinical care. Archives of Internal Medicine 170:675-82, April 26, 2010.
Jastifer J, Roberts S. Patients' awareness of and attitudes toward gifts from pharmaceutical companies to physicians. International Journal of Health Services 39:405-14, 2009.
People coming at the subject from my own bias would tend to wish that the research would show massive distrust of physicians if patients found out about financial ties. The research that is available hardly shows that univocal or extreme an answer. However, neither does it support a claim one now hears from our friends the pharmapologists-- that there are simply no compelling data that the issue of financial ties and disclosure has anything to do with public trust in medicine at all. For example, here is Dr. Thomas Huddle, replying to his critics in a January article that I blogged about previously (http://brodyhooked.blogspot.com/2010/02/what-would-it-take-to-prove-harm-from.html): "Surveys have repeatedly shown that large majorities of patients do not regard the promotional items and food involved in typical detailing to be ethically problematic."
Dr. Huddle is strictly correct, but his assessment tells only a piece of the story. Plus he cites only three sources for his claim, all published before 2000. The Licurse review includes several surveys conducted within the last decade. One of them, by Jastifer and Roberts, notes in passing that more recent reviews appear to show patients as more critical of financial ties than surveys done in the 1990s (as would be very reasonable given recent publicity, and findings in some early studies that few patients were even aware of the nature of these ties).
Here is how I would summarize the Licurse et al. review: There is sufficient evidence to believe that a significant number of patients are concerned about financial ties between physicians and industry, in ways that implicate public trust in medicine.
Licurse A, Barber E, Joffe S, Gross C. The impact of disclosing financial ties in research and clinical care. Archives of Internal Medicine 170:675-82, April 26, 2010.
Jastifer J, Roberts S. Patients' awareness of and attitudes toward gifts from pharmaceutical companies to physicians. International Journal of Health Services 39:405-14, 2009.
Wednesday, April 28, 2010
Federal Settlements: The ACRE Perspective
A brief footnote to the previous post on AstraZeneca and Seroquel:
As I reported a little while back, I had the pleasure recently of listening to a major presentation (at Davidson College, NC) by our colleague at Harvard and ACRE, Dr. Thomas P. Stossel: http://brodyhooked.blogspot.com/2010/04/encounters-with-dr-tom-stossel.html
Dr. Stossel did such a nice job of summarizing the world view of the ACRE folks that I will take this opportunity to comment on one point that's relevant to the recent AstraZeneca case.
Dr. S. was fully aware that when he tries to present his rosy view of the great advances in human well-being produced by recent Pharma and biotech breakthroughs, his critics will trot out "anecdotal" evidence of industry wrongdoing. One such anecdote is the settlement agreed to by a major drug firm when charged by the Feds with criminal conduct. As I recall, Dr. S. even provided his own list on a slide of some two dozen of these recent settlements.
He then gave the Pharma spin on that list. First of all, he said, if you think about all the wonderful new drugs and all the lives that they have saved, etc. this list looks pretty puny.
Second, we have to realize that in these cases, the drug companies are basically powerless and the Feds hold all the cards. The penalty the Feds can exact is capital punishment--a drug company found guilty of a crime automatically loses all ability to do business with Federal programs such as Medicare, Medicaid, VA, etc. for a certain number of years. That would be the death knell for any drug firm. So companies accused of crimes by the Feds cannot take the risk of defending themselves in court; they have no choice but to settle. Therefore (implies Dr. S.) most of these charges are completely false and baseless, and the companies settle solely because they are forced into it. (And of course, in most cases, the company denies wrongdoing as part of the settlement.)
OK, so that is the ACRE take on the matter. My replies:
As I reported a little while back, I had the pleasure recently of listening to a major presentation (at Davidson College, NC) by our colleague at Harvard and ACRE, Dr. Thomas P. Stossel: http://brodyhooked.blogspot.com/2010/04/encounters-with-dr-tom-stossel.html
Dr. Stossel did such a nice job of summarizing the world view of the ACRE folks that I will take this opportunity to comment on one point that's relevant to the recent AstraZeneca case.
Dr. S. was fully aware that when he tries to present his rosy view of the great advances in human well-being produced by recent Pharma and biotech breakthroughs, his critics will trot out "anecdotal" evidence of industry wrongdoing. One such anecdote is the settlement agreed to by a major drug firm when charged by the Feds with criminal conduct. As I recall, Dr. S. even provided his own list on a slide of some two dozen of these recent settlements.
He then gave the Pharma spin on that list. First of all, he said, if you think about all the wonderful new drugs and all the lives that they have saved, etc. this list looks pretty puny.
Second, we have to realize that in these cases, the drug companies are basically powerless and the Feds hold all the cards. The penalty the Feds can exact is capital punishment--a drug company found guilty of a crime automatically loses all ability to do business with Federal programs such as Medicare, Medicaid, VA, etc. for a certain number of years. That would be the death knell for any drug firm. So companies accused of crimes by the Feds cannot take the risk of defending themselves in court; they have no choice but to settle. Therefore (implies Dr. S.) most of these charges are completely false and baseless, and the companies settle solely because they are forced into it. (And of course, in most cases, the company denies wrongdoing as part of the settlement.)
OK, so that is the ACRE take on the matter. My replies:
- It is reassuring to know that the Feds do not find evidence of criminal wrongdoing in the marketing of every single drug that has recently come on the market. What I think the list proves, however long or short it is, is exactly the point that I have stressed ad nauseum in this blog--that we see here a recurring business strategy across the entire industry and not the actions of an occasional rogue firm.
- If you look at what it takes to put together one of these legal actions against a drug company--usually an inside whistle blower plus some 5-6 years of legal investigation--it is not surprising that a relatively small number have been brought. We can argue over whether these are all unjust accusations against firms of stellar virtue, or merely the tip of the criminal iceberg.
- The "capital punishment" works both ways. The Feds (specifically, the White House and DHHS, given that the executive branch and DOJ are the ones bringing the suit) know what would be the consequence of actually putting AstraZeneca, Pfizer, Merck et al out of business. First, all their thousands of employees are thrown out of work in the middle of a major recession. Second, millions of patients who rely on brand-name drugs that have no generic equivalent suddenly are deprived of those drugs without warning. If you imagine the political pressure generated by both of those aggrieved lobbies, you can see why the Feds simply would never lower the boom completely on a drug company guilty of even the most egregious behavior. (We have to add that the actual criminal behavior was no doubt engaged in by a tiny handful of company employees, with the vast majority of the workforce being blameless.)
- The end result is that the Feds go well out of their way to never shut down a big drug firm--and resort to subterfuges such as in the Pfizer case, where they "shut down" two drug firms that had actually shut down years previously and no longer existed except as paper targets (http://brodyhooked.blogspot.com/2010/04/cnn-pfizer-too-big-to-prosecute-shadow.html).
- So the real power remains in the hand of the drug firm that's "too big to shut down," analogous to the Wall St. bank that's "too big to fail."
The Cost of Doing Business: Same Song, 83rd Verse
And today, the drug company settling with the Federal government on criminal charges against off label marketing is:
AstraZeneca
The drug involved is: Seroquel (quetiapine)
The amount of the settlement is: $520M
The settlement equals what percentage of one year's sales of the drug?: 10.6%
Did the company admit wrongdoing? Yes/No: Of course not
Link to detailed news coverage: http://www.nytimes.com/2010/04/28/business/28drug.html?emc=tnt&tntemail0=y
As you can see, it saves time if I just make it a fill-in-the-blank form.
First, general background: Seroquel is one of the supposedly new-generation antipsychotics that was initially touted as both more effective and safer than the older antipsychotics of the thorazine-haloperidol era. More recent research has disputed the claims of both greater efficacy and greater safety, and calls into question the entire concept of "generations" of these drugs--see for instance http://brodyhooked.blogspot.com/2009/01/are-second-generation-antipsychotic.html. We are sadly not surprised to learn that at every step of the way, the drug companies sponsoring the research, and their physician lackeys, have worked their tails off to distort the research record and to make these sows' ears look like silk purses. In the process they have especially pushed the drugs (due to their supposed safety profile) for use in the elderly, despite the fact that the drugs can cause serious weight gain and tip susceptible patients over into frank diabetes. Because psychiatrists see too few patients to create a really blockbuster market, and expert psychiatrists might actually know something about the downside of these drugs, much of the marketing focus has been on my colleagues in primary care--again relying on the supposed safety profile of the drugs to encourage non-psychiatrists to feel comnfortable prescribing them.
The Feds charge that AZ paid kickbacks to docs as part of a scheme to market the drug for unapproved uses, especially in kids and the elderly. The specific Fed claims include:
Based on some of the buzz on the Healthy Skepticism listserv, it appears that this story will not go away quickly. The Feds appear ready to out the academic and other physicians who took those kickbacks.
Being held to public ridicule for taking drug company money to shill for them, illegally, may produce a small incentive among academic physicians at least to watch out for these sorts of entanglements with Pharma in the future. As we have seen many times before, the amount of the settlement, by itself, is hardly a factor, since the company gets about 9 times that much in revenues for every year the drug remains on the market. You can add to that the $656M that AZ has reportedly spent so far to defend itself against about 25,000 civil lawsuits over Seroquel. (If the Vioxx/Merck example is any indication, AZ stands ready to win the vast majority of those suits, given the near-impossibility of proving in a court of law that any individual patient developed diabetes or any other complication solely due to Seroquel and not due to any other co-existing conditions.)
As we have said before, so long as the "cost of doing business" is so reasonable, we can expect drug companies to push the legal envelope regularly, and like Pfizer, swear never to do such dastardly deeds again at the same time as they are planning the next set of dastardly deeds with a newer drug (see http://brodyhooked.blogspot.com/2010/04/cnn-pfizer-too-big-to-prosecute-shadow.html).
AstraZeneca
The drug involved is: Seroquel (quetiapine)
The amount of the settlement is: $520M
The settlement equals what percentage of one year's sales of the drug?: 10.6%
Did the company admit wrongdoing? Yes/No: Of course not
Link to detailed news coverage: http://www.nytimes.com/2010/04/28/business/28drug.html?emc=tnt&tntemail0=y
As you can see, it saves time if I just make it a fill-in-the-blank form.
First, general background: Seroquel is one of the supposedly new-generation antipsychotics that was initially touted as both more effective and safer than the older antipsychotics of the thorazine-haloperidol era. More recent research has disputed the claims of both greater efficacy and greater safety, and calls into question the entire concept of "generations" of these drugs--see for instance http://brodyhooked.blogspot.com/2009/01/are-second-generation-antipsychotic.html. We are sadly not surprised to learn that at every step of the way, the drug companies sponsoring the research, and their physician lackeys, have worked their tails off to distort the research record and to make these sows' ears look like silk purses. In the process they have especially pushed the drugs (due to their supposed safety profile) for use in the elderly, despite the fact that the drugs can cause serious weight gain and tip susceptible patients over into frank diabetes. Because psychiatrists see too few patients to create a really blockbuster market, and expert psychiatrists might actually know something about the downside of these drugs, much of the marketing focus has been on my colleagues in primary care--again relying on the supposed safety profile of the drugs to encourage non-psychiatrists to feel comnfortable prescribing them.
The Feds charge that AZ paid kickbacks to docs as part of a scheme to market the drug for unapproved uses, especially in kids and the elderly. The specific Fed claims include:
- AZ inapproprately influenced the content of CME courses they funded
- AZ hired docs to give talks and do research on unapproved uses
- AZ recruited medical "opinion leaders" to be the fake authors of ghostwritten articles touting Seroquel for unapproved uses, and AZ then used those articles for marketing
- AZ paid docs to come to fancy resorts to "advise" AZ on how best to market Seroquel for unapproved uses
Based on some of the buzz on the Healthy Skepticism listserv, it appears that this story will not go away quickly. The Feds appear ready to out the academic and other physicians who took those kickbacks.
Being held to public ridicule for taking drug company money to shill for them, illegally, may produce a small incentive among academic physicians at least to watch out for these sorts of entanglements with Pharma in the future. As we have seen many times before, the amount of the settlement, by itself, is hardly a factor, since the company gets about 9 times that much in revenues for every year the drug remains on the market. You can add to that the $656M that AZ has reportedly spent so far to defend itself against about 25,000 civil lawsuits over Seroquel. (If the Vioxx/Merck example is any indication, AZ stands ready to win the vast majority of those suits, given the near-impossibility of proving in a court of law that any individual patient developed diabetes or any other complication solely due to Seroquel and not due to any other co-existing conditions.)
As we have said before, so long as the "cost of doing business" is so reasonable, we can expect drug companies to push the legal envelope regularly, and like Pfizer, swear never to do such dastardly deeds again at the same time as they are planning the next set of dastardly deeds with a newer drug (see http://brodyhooked.blogspot.com/2010/04/cnn-pfizer-too-big-to-prosecute-shadow.html).
Tuesday, April 27, 2010
How Good Are Generic Drugs?
Thanks to Merrill Goozner for his report and insights:
http://www.thefiscaltimes.com/Issues/Health-Care/2010/04/22/Generic-Drugs-on-the-Hot-Seat.aspx
First, some of my own background: There are several issues that concern us on this blog that all in some way implicate the safety and efficacy of generic drugs as equivalent to brand-name drugs. Specifically, if it were to turn out that we could not rely on generics as reasonably equivalent to the brand-name in a therapeutic sense, then a number of the pieces of advice that we'd like to give to the physician, on how to save money for patients, how to keep well informed about drugs, etc. would no longer be valid and we'd have to start over from scratch. That is why it was a truly big deal when, back in 1989, a Congressional inquiry revealed a payola scandal within the FDA's generics division that allowed non-equivalent drugs to slip through the net (as I briefly described in HOOKED). What I have written since then all assumes that the problem at the FDA was fixed. The issue is especially timely today as many widely-prescribed brand-name drugs either have just gone generic in the past couple of years or are poised soon to do so.
Now, over to Gooz--his article briefly reviews recent charges, taken up by some popular magazines and by psychiatrists in particular, about patients who switched to a generic drug and had an immediate worsening of their symptoms. This led the FDA to convene an advisory committee to review the standards it uses for determining bioequivalence. The short answer is that the FDA internal investigation showed that even if they had adopted a stricter standard, the specific drugs that have recently been questioned all fell within those tighter limits--so there was no scientific reason to change the standards.
Gooz's analysis is extremely helpful because he distinguishes two FDA functions--generic drug approval and on-site inspection of drug manufacturing facilities. Megabrand Generic Drugs Inc. might submit their formulation for a generic version of (say) Zoloft to the FDA. There is, at present, no evidence at all that there's anything wrong with the process the FDA uses to approve that chemical formulation. But then somebody actually has to run a big machine in a big factory and make millions of those generic pills or capsules. And that is where the available evidence would suggest that things could get dicey--especially if the factory is in China or some other country prone to either official corruption or sloppy standards or both. The FDA, it is now widely admitted, has way too few inspectors to keep an eye on all the outsourced drug factories that supply their wares to the US market, as we found out with tainted Chinese heparin recently. So we should fix that and not worry about the official generic approval standards.
Now, my own advice as a no-longer-practicing family doc. What should the physician do when the patient says that after switching over to a generic brand, he has a new side effect, or the drug stopped working? As I understand the matter, two different brands of the drug may be chemically different, having, for instance, a different type of chemical filler. So I have no trouble believing that no matter what FDA standard the generic drug passed, this individual patient just might have a chemical idiosyncrasy so that his body absorbs some substances differently, etc. (Or he might not--the difference truly might be imaginary, or a negative placebo effect--but the research needed to find out for sure is way beyond the time and abilities of most practitioners.) In such cases I always wrote the prescription so as to return to the brand name drug. I never told the patient I did not believe him, or that what he said could not be true because generic drugs are equivalent. And if the insurer did not want to pay the higher price, I always went to bat for the patient (and made sure the reported difference was documented in my chart note to back up the patient's story). But at the same time, I felt obliged to tell the patient not to assume that this meant that other generic drugs were no good. I explained that the same thing could have happened, had he initially been on a generic drug and had been switched to the brand name version. The problem in his case, I proposed, was switching to a different chemical formulation, not to a (generally) worse chemical formulation. The number of patients who ended up needing this special treatment was a miniscule percentage of my practice, so I never thought of it as breaking the bank, but rather as personalized medical care.
http://www.thefiscaltimes.com/Issues/Health-Care/2010/04/22/Generic-Drugs-on-the-Hot-Seat.aspx
First, some of my own background: There are several issues that concern us on this blog that all in some way implicate the safety and efficacy of generic drugs as equivalent to brand-name drugs. Specifically, if it were to turn out that we could not rely on generics as reasonably equivalent to the brand-name in a therapeutic sense, then a number of the pieces of advice that we'd like to give to the physician, on how to save money for patients, how to keep well informed about drugs, etc. would no longer be valid and we'd have to start over from scratch. That is why it was a truly big deal when, back in 1989, a Congressional inquiry revealed a payola scandal within the FDA's generics division that allowed non-equivalent drugs to slip through the net (as I briefly described in HOOKED). What I have written since then all assumes that the problem at the FDA was fixed. The issue is especially timely today as many widely-prescribed brand-name drugs either have just gone generic in the past couple of years or are poised soon to do so.
Now, over to Gooz--his article briefly reviews recent charges, taken up by some popular magazines and by psychiatrists in particular, about patients who switched to a generic drug and had an immediate worsening of their symptoms. This led the FDA to convene an advisory committee to review the standards it uses for determining bioequivalence. The short answer is that the FDA internal investigation showed that even if they had adopted a stricter standard, the specific drugs that have recently been questioned all fell within those tighter limits--so there was no scientific reason to change the standards.
Gooz's analysis is extremely helpful because he distinguishes two FDA functions--generic drug approval and on-site inspection of drug manufacturing facilities. Megabrand Generic Drugs Inc. might submit their formulation for a generic version of (say) Zoloft to the FDA. There is, at present, no evidence at all that there's anything wrong with the process the FDA uses to approve that chemical formulation. But then somebody actually has to run a big machine in a big factory and make millions of those generic pills or capsules. And that is where the available evidence would suggest that things could get dicey--especially if the factory is in China or some other country prone to either official corruption or sloppy standards or both. The FDA, it is now widely admitted, has way too few inspectors to keep an eye on all the outsourced drug factories that supply their wares to the US market, as we found out with tainted Chinese heparin recently. So we should fix that and not worry about the official generic approval standards.
Now, my own advice as a no-longer-practicing family doc. What should the physician do when the patient says that after switching over to a generic brand, he has a new side effect, or the drug stopped working? As I understand the matter, two different brands of the drug may be chemically different, having, for instance, a different type of chemical filler. So I have no trouble believing that no matter what FDA standard the generic drug passed, this individual patient just might have a chemical idiosyncrasy so that his body absorbs some substances differently, etc. (Or he might not--the difference truly might be imaginary, or a negative placebo effect--but the research needed to find out for sure is way beyond the time and abilities of most practitioners.) In such cases I always wrote the prescription so as to return to the brand name drug. I never told the patient I did not believe him, or that what he said could not be true because generic drugs are equivalent. And if the insurer did not want to pay the higher price, I always went to bat for the patient (and made sure the reported difference was documented in my chart note to back up the patient's story). But at the same time, I felt obliged to tell the patient not to assume that this meant that other generic drugs were no good. I explained that the same thing could have happened, had he initially been on a generic drug and had been switched to the brand name version. The problem in his case, I proposed, was switching to a different chemical formulation, not to a (generally) worse chemical formulation. The number of patients who ended up needing this special treatment was a miniscule percentage of my practice, so I never thought of it as breaking the bank, but rather as personalized medical care.
Friday, April 23, 2010
Council of Medical Specialty Societies Code: Strong Enough?
The Council of Medical Specialty Societies, of which 32 medical specialty professional organizations are members, has announced a new "Code for Interactions with Companies." Their press release is at http://www.cmss.org/DefaultTwoColumn.aspx?id=110, and the full Code is accessible at http://www.cmss.org/uploadedFiles/Site/CMSS_Policies/CMSS%20Code%20for%20Interactions%20with%20Companies%204-19-10.pdf.
The news release suggests that this is a well-intentioned attempt to address conflicts of interest in medical specialty societies, with a special focus on their role in writing clinical practice guidelines. The Preamble states: "Members and patients count on Societies to be authoritative, independent voices in the world of science and medicine. Public confidence in our objectivity is critical... We know the public relies on is to minimize actual and perceived conflicts of interest. ... [E]very society must be sure its interactions with Companies meet high ethical standards."
I read through the complete Code to try to form an opinion as to how much teeth the Code actually possesses. Based on the most recent flap regarding my own medical specialty society to come to my attention--the AAFP-Coca-Cola deal-- I paid special attention to whether that deal would have been prohibited by this Code. (AAFP is one of the members of CMSS). (For the most recent post here on AAFP, see http://brodyhooked.blogspot.com/2009/12/aafp-coca-cola-deal-letter-to-member.html.) As everyone with whom I have consulted, except for the AAFP leadership, seems to believe that the Coke deal was a clear no-no and a serious conflict of interest, I figured it was a reasonable test case.
As best as I can read the Code, AAFP would have a green light on Coca-Cola. There seems no doubt that the general spirit of this Code runs contrary to the AAFP-Coke deal. But at each critical juncture, the Code seems to leave enough wiggle room for the deal to be justified. For example, so long as AAFP claims to have done all the following:
A good deal of space is devoted (appropriately) to CME programs. Here I would criticize the Code for being too quick to rely on having funding from multiple firms to make sure everything is above-board. As we have discussed numerous times, getting funding from many drug companies does not eliminate bias in CME; rather, it tends to assure that all the presentations at the CME program will be about drug therapy, with nothing said about exercise, diet, etc. The Code does call for presenters at CME "to give a balanced view of therapeutic options."
We next come to the critical section on practice guidelines-- critical because it has been generally held by guideline critics that of all practice guidelines, those published by medical specialty societies are most likely to be riddled with commercial biases and conflicts. Here I was hoping for a strong statement that guideline panels would be made up of individuals without conflicts of interest, period. The Code instead insists on disclosing conflicts and requires then only that a majority of panelists are free from conflicts of interest relevant to the subject matter of the guidelines. There also seems to be a major loophole in that commercial firms cannot fund guideline development; but they can give funds to a society for later distribution and "repurposing" (whatever that is). To me this suggests a likely route for a sweetheart deal. A firm might let it be known that if a society comes up with a practice guideline that strongly endorses a treatment strategy using a drug that the firm sells, it will later on be willing to pay millions of bucks for "further distribution" of those guidelines. The society might well decide it's worth it to front its own funds to write the guideline, knowing that the firm's later largesse will effectively reimburse it for all expenses and then some. Finally the Code states, "Societies will recommend that Guideline development panel members decline offers from affected Companies to speak about the Guidelines on behalf of the Company for a reasonable period after publication" (emphasis added). Why be mealy mouthed about it? Why not just say flat out that if you agree to serve on a guideline panel, you also agree not to also serve on a company speaker's bureau for X number of years--period?
CMSS proposes to post a list on its website of Societies that sign onto this Code (including societies that are not CMSS members). Societies will be encouraged to certify annually to CMSS that they continue to adhere to the Code." Again-- why not demand annual cerification as a condition of being listed?
Great first draft, guys. When you next revise it, stiffen it up a bit. The Code emphasizes that individual Societies are welcome to adopt stricter provisions than what is in this Code--and I hope they do so.
Note added 4/24: Our esteemed colleage Dr. Danny Carlat had a very amusing and rather more cynical take on this Code-- see his post: http://carlatpsychiatry.blogspot.com/2010/04/medical-societies-new-ethics-code.html
In short he depicts the Code as pure PR fluff with no substance at all.
The news release suggests that this is a well-intentioned attempt to address conflicts of interest in medical specialty societies, with a special focus on their role in writing clinical practice guidelines. The Preamble states: "Members and patients count on Societies to be authoritative, independent voices in the world of science and medicine. Public confidence in our objectivity is critical... We know the public relies on is to minimize actual and perceived conflicts of interest. ... [E]very society must be sure its interactions with Companies meet high ethical standards."
I read through the complete Code to try to form an opinion as to how much teeth the Code actually possesses. Based on the most recent flap regarding my own medical specialty society to come to my attention--the AAFP-Coca-Cola deal-- I paid special attention to whether that deal would have been prohibited by this Code. (AAFP is one of the members of CMSS). (For the most recent post here on AAFP, see http://brodyhooked.blogspot.com/2009/12/aafp-coca-cola-deal-letter-to-member.html.) As everyone with whom I have consulted, except for the AAFP leadership, seems to believe that the Coke deal was a clear no-no and a serious conflict of interest, I figured it was a reasonable test case.
As best as I can read the Code, AAFP would have a green light on Coca-Cola. There seems no doubt that the general spirit of this Code runs contrary to the AAFP-Coke deal. But at each critical juncture, the Code seems to leave enough wiggle room for the deal to be justified. For example, so long as AAFP claims to have done all the following:
- decide that writing educational materials for consumers on healthy eating is part of its mission
- decide to include guidance on beverages and soft drinks, independent of the Coke deal
- reveal funding from Coca-Cola
- assure everyone that the content of the materials will not be determined or dictated by Coca-Cola
- Have an internal set of conflict-of-interest policies which it follows in dealing with Coca-Cola
A good deal of space is devoted (appropriately) to CME programs. Here I would criticize the Code for being too quick to rely on having funding from multiple firms to make sure everything is above-board. As we have discussed numerous times, getting funding from many drug companies does not eliminate bias in CME; rather, it tends to assure that all the presentations at the CME program will be about drug therapy, with nothing said about exercise, diet, etc. The Code does call for presenters at CME "to give a balanced view of therapeutic options."
We next come to the critical section on practice guidelines-- critical because it has been generally held by guideline critics that of all practice guidelines, those published by medical specialty societies are most likely to be riddled with commercial biases and conflicts. Here I was hoping for a strong statement that guideline panels would be made up of individuals without conflicts of interest, period. The Code instead insists on disclosing conflicts and requires then only that a majority of panelists are free from conflicts of interest relevant to the subject matter of the guidelines. There also seems to be a major loophole in that commercial firms cannot fund guideline development; but they can give funds to a society for later distribution and "repurposing" (whatever that is). To me this suggests a likely route for a sweetheart deal. A firm might let it be known that if a society comes up with a practice guideline that strongly endorses a treatment strategy using a drug that the firm sells, it will later on be willing to pay millions of bucks for "further distribution" of those guidelines. The society might well decide it's worth it to front its own funds to write the guideline, knowing that the firm's later largesse will effectively reimburse it for all expenses and then some. Finally the Code states, "Societies will recommend that Guideline development panel members decline offers from affected Companies to speak about the Guidelines on behalf of the Company for a reasonable period after publication" (emphasis added). Why be mealy mouthed about it? Why not just say flat out that if you agree to serve on a guideline panel, you also agree not to also serve on a company speaker's bureau for X number of years--period?
CMSS proposes to post a list on its website of Societies that sign onto this Code (including societies that are not CMSS members). Societies will be encouraged to certify annually to CMSS that they continue to adhere to the Code." Again-- why not demand annual cerification as a condition of being listed?
Great first draft, guys. When you next revise it, stiffen it up a bit. The Code emphasizes that individual Societies are welcome to adopt stricter provisions than what is in this Code--and I hope they do so.
Note added 4/24: Our esteemed colleage Dr. Danny Carlat had a very amusing and rather more cynical take on this Code-- see his post: http://carlatpsychiatry.blogspot.com/2010/04/medical-societies-new-ethics-code.html
In short he depicts the Code as pure PR fluff with no substance at all.
Tuesday, April 20, 2010
Encounters with Dr. Tom Stossel
I spent some of last week at Davidson College in North Carolina, in the company of Dr. Thomas P. Stossel, driving force behind ACRE (Association of Clinical Researchers and Educators). Both Dr. Stossel and ACRE have come in for considerable criticism on this blog, so I thought a brief report was appropriate. I am first happy to be able to say that Danny Carlat, over at his psychiatry blog, was correct--I found Dr. Stossel to be personally very congenial and affable regardless what one thinks of his opinions on medicine-Pharma issues. I discovered that he and I have equally compelling reasons for psychopathology, having each of us been raised in our tender years as Chicago Cubs fans.
He and I each spoke at the Speas Colloquium, an annual medical ethics program at Davidson (where our host was Lance Stell, philosopher and another ACRE stalwart). I spoke in defense of the meaningfulness and relevance of the notion of conflict of interest. Dr. Stossel gave an overview of the ACRE position that defends financial ties between medicine and Pharma as the engine that drives innovation, and that sees all recent attempts to limit those ties as both unnecessary and harmful. My limited attempt to hold out an olive branch was to note that ACRE contains a lot of expertise on how medicine can collaborate with Pharma around biotech and pharmaceutical research, so that they could be leading the way to develop an ethically sounder relationship between medicine and the pharmaceutical industry--if only they would admit, for starters, that we currently have a problem. Dr. Stossel obviously was having none of that. He continues the trend in his previously published work of minimizing all bad stuff that happens at the med/Pharma interface--the stuff I have to find time weekly or even more often to post here--as disconnected, rare anecdotes, not as any sort of recurring or worrisome pattern.
In most respects I thought that the talk he gave at Davidson was more or less what we would expect, based on his previous publications. The exception was one slide that he presented on professionalism. The primary source he cited was the recent book by David Wootton, Bad Medicine. The point seemed to be that when folks like me who are concerned about undue influence of commercial interests on medical practice cite "professionalism" as our concern, this ought to be questioned if not dismissed--that much more harm than good has been done over the centuries by invoking "professionalism" in medicine, that "professionalism" has often stood in the way of accepting new scientific evidence, and that it is simply wrong to characterize medicine as something over and above a business. (In short, the sorts of arguments that result when one ignores the more recent, ethical sense of 'professionalism' and invokes only the descriptive, sociological sense of the term.)
My comment here would be that it is perhaps indicative of the strength of the arguments raised by the ACRE folks, to see how wide a swath of ethical countryside they have to lay waste to, in order to defend their chosen position. They want to defend docs taking bundles of cash from Pharma; we invoke conflict of interest as an ethical concern with that approach; so they decide they have to throw out conflict of interest. (Not limit or refine the scope of conflict of interest, mind you, but completely dispense with it.) So now we continue to worry about their heels with some quaint ideas of medical professionalism; and they now find it necessary to dispense completely and totally with medical professionalism. It is not merely a matter of throwing out the baby with the bathwater. It appears to be the baby, the rest of the family, the dog, and the hearth, and still they are not done.
He and I each spoke at the Speas Colloquium, an annual medical ethics program at Davidson (where our host was Lance Stell, philosopher and another ACRE stalwart). I spoke in defense of the meaningfulness and relevance of the notion of conflict of interest. Dr. Stossel gave an overview of the ACRE position that defends financial ties between medicine and Pharma as the engine that drives innovation, and that sees all recent attempts to limit those ties as both unnecessary and harmful. My limited attempt to hold out an olive branch was to note that ACRE contains a lot of expertise on how medicine can collaborate with Pharma around biotech and pharmaceutical research, so that they could be leading the way to develop an ethically sounder relationship between medicine and the pharmaceutical industry--if only they would admit, for starters, that we currently have a problem. Dr. Stossel obviously was having none of that. He continues the trend in his previously published work of minimizing all bad stuff that happens at the med/Pharma interface--the stuff I have to find time weekly or even more often to post here--as disconnected, rare anecdotes, not as any sort of recurring or worrisome pattern.
In most respects I thought that the talk he gave at Davidson was more or less what we would expect, based on his previous publications. The exception was one slide that he presented on professionalism. The primary source he cited was the recent book by David Wootton, Bad Medicine. The point seemed to be that when folks like me who are concerned about undue influence of commercial interests on medical practice cite "professionalism" as our concern, this ought to be questioned if not dismissed--that much more harm than good has been done over the centuries by invoking "professionalism" in medicine, that "professionalism" has often stood in the way of accepting new scientific evidence, and that it is simply wrong to characterize medicine as something over and above a business. (In short, the sorts of arguments that result when one ignores the more recent, ethical sense of 'professionalism' and invokes only the descriptive, sociological sense of the term.)
My comment here would be that it is perhaps indicative of the strength of the arguments raised by the ACRE folks, to see how wide a swath of ethical countryside they have to lay waste to, in order to defend their chosen position. They want to defend docs taking bundles of cash from Pharma; we invoke conflict of interest as an ethical concern with that approach; so they decide they have to throw out conflict of interest. (Not limit or refine the scope of conflict of interest, mind you, but completely dispense with it.) So now we continue to worry about their heels with some quaint ideas of medical professionalism; and they now find it necessary to dispense completely and totally with medical professionalism. It is not merely a matter of throwing out the baby with the bathwater. It appears to be the baby, the rest of the family, the dog, and the hearth, and still they are not done.
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