Thanks once again to Dr. Roy Poses over at the Health Care Renewal Blog for this account--
http://hcrenewal.blogspot.com/2012/03/conflicts-of-interest-or-bribes-biomet.html--
--of recent judgments against two medical device firms for international corruption in violation of US laws. (The post includes links to supporting documents and media accounts.)
What most impressed Dr. Poses was an issue I've addressed here before:
http://brodyhooked.blogspot.com/2010/12/in-defense-of-paranoia-suspecting.html
To summarize quickly, those who defend current industry practices that people like me attack as inappropriate conflicts of interest (whatever the device industry equivalent is of "pharmapologists") note that physicians who get things like royalties and consulting fees make important intellectual contributions to improved patient care. But, as the legal documents reveal in the two companies' cases, when the industry elects to pay flat-out bribes to docs for using their devices, they don't exactly take out an ad in the local paper. Instead they deliberately conceal the bribe, and the most usual way to conceal it is to call it a consulting fee or a royalty or something that sounds legit. So you could imagine you have a straightforward COI, which raises red flags but does not (as I explained in HOOKED) necessarily convict the doc of actual wrongdoing--and only later discover (if you ever do) that what was going on was actually out-and-out corruption.
A basic ethical pearl that was circulated way back at the beginning of the debate over medicine and industry was that if you don't want people to know about what you're doing, then there's a high likelihood that what you're doing is ethically questionable. As simplistic as that sounds, it remains pretty good advice. A spinoff of that is that when you've been caught several times before (both companies are repeat offenders as Dr. Poses lists) hiding your corrupt behavior, then protestations that we need to trust you because you've reformed tend to ring hollow.
Thursday, March 29, 2012
Friday, March 23, 2012
Industry Support of CME Declining--Is There a Downside?
An important piece in this week's New England Journal:
http://www.nejm.org/doi/full/10.1056/NEJMp1114776
--by Drs. Michael Steinman, Seth Landefeld, and Robert Baron updates us on current trends in drug industry support for continuing medical education programs.
Major news flash is that industry funding of CME rose to a peak in 2007 but has since been declining. At the height, if you add in all sources of industry support, the drug and related industries paid for more than half the costs of CME in the US. Direct support of CME is now down to 31%.
The authors note, "These changes did not arise from one or two events. Rather, they resulted from shifting norms in the culture of medicine. It is doubtful that all industry involvement with CME will cease in the near future, and the recent decline in industry support may also reflect difficult economic times. However, we appear to be entering a new era in which earlier norms of acceptability no longer apply."
Will the result be a deterioration in the quality of CME? The authors suggest that the reverse is more likely: "Although reducing reliance on industry funds will not be painless, it remains highly feasible to do so in a manner that preserves (and in some ways enhances) access and quality. Costs can be substantially reduced by avoiding high-priced venues such as the hotel conference spaces where CME events are often held. ... Moreover, CME providers are de-emphasizing traditional lecture-hall–based teaching in favor of more interactive, interprofessional, and competency-based learning strategies. Such strategies include online teaching tools, point-of-care CME, and performance-improvement CME, which not only offer pedagogical value but in many cases can also be provided at relatively low cost. This trend is likely to continue as CME is increasingly linked to practice-improvement and maintenance-of-certification processes that require explicit practice-based learning."
Having decided that this trend is here to stay--they reject the hypothesis that shrinking CME support by industry is merely a reaction to the economic downturn--and having opined that on the whole this is a good development, the authors ask if there's any downside. Their biggest concern is the shift in marketing funds away from accredited CME and into activities such as dinner lectures, where the company can totally control the presentation because it need not meet any accreditation standards. The authors suggest that the impact on medicine would be deleterious if docs stopped going to CME sessions and instead went out with the drug reps for steak and wine.
I am less worried about this because there was a reason why the industry, which always had the option of the dinner lecture, nevertheless felt it advisable to shove so much cash in the direction of CME. Pharma knows that docs think differently about a program that grants CME credit and attribute a higher level of authority to such a presentation. Plus the pressures on docs to get a certain number of CME credits per year come from outside industry and have not changed--most physicians need CME to retain licensure and specialty certification. In short, I think that Dr. Steinman and colleagues have correctly assessed the positive about shrinking industry support for CME and have perhaps slightly inflated the negative.
http://www.nejm.org/doi/full/10.1056/NEJMp1114776
--by Drs. Michael Steinman, Seth Landefeld, and Robert Baron updates us on current trends in drug industry support for continuing medical education programs.
Major news flash is that industry funding of CME rose to a peak in 2007 but has since been declining. At the height, if you add in all sources of industry support, the drug and related industries paid for more than half the costs of CME in the US. Direct support of CME is now down to 31%.
The authors note, "These changes did not arise from one or two events. Rather, they resulted from shifting norms in the culture of medicine. It is doubtful that all industry involvement with CME will cease in the near future, and the recent decline in industry support may also reflect difficult economic times. However, we appear to be entering a new era in which earlier norms of acceptability no longer apply."
Will the result be a deterioration in the quality of CME? The authors suggest that the reverse is more likely: "Although reducing reliance on industry funds will not be painless, it remains highly feasible to do so in a manner that preserves (and in some ways enhances) access and quality. Costs can be substantially reduced by avoiding high-priced venues such as the hotel conference spaces where CME events are often held. ... Moreover, CME providers are de-emphasizing traditional lecture-hall–based teaching in favor of more interactive, interprofessional, and competency-based learning strategies. Such strategies include online teaching tools, point-of-care CME, and performance-improvement CME, which not only offer pedagogical value but in many cases can also be provided at relatively low cost. This trend is likely to continue as CME is increasingly linked to practice-improvement and maintenance-of-certification processes that require explicit practice-based learning."
Having decided that this trend is here to stay--they reject the hypothesis that shrinking CME support by industry is merely a reaction to the economic downturn--and having opined that on the whole this is a good development, the authors ask if there's any downside. Their biggest concern is the shift in marketing funds away from accredited CME and into activities such as dinner lectures, where the company can totally control the presentation because it need not meet any accreditation standards. The authors suggest that the impact on medicine would be deleterious if docs stopped going to CME sessions and instead went out with the drug reps for steak and wine.
I am less worried about this because there was a reason why the industry, which always had the option of the dinner lecture, nevertheless felt it advisable to shove so much cash in the direction of CME. Pharma knows that docs think differently about a program that grants CME credit and attribute a higher level of authority to such a presentation. Plus the pressures on docs to get a certain number of CME credits per year come from outside industry and have not changed--most physicians need CME to retain licensure and specialty certification. In short, I think that Dr. Steinman and colleagues have correctly assessed the positive about shrinking industry support for CME and have perhaps slightly inflated the negative.
Consumers Digest Discovers Pharma Influence over Medicine
Consumers Digest (subscription required; article will be free on line in 2 months I understand) features in their March/April issue an article by Catherine Elton, "Under the Influence: How Doctors Are Courted by Drugmakers." An accompanying editorial proclaims, "It's Enough to Make You Sick."
The article might initially produce the reaction from all four regular readers of this blog, "Where have you been all this time?" Most of what is said about Pharma's ways of influencing physicians through free dinners, samples, drug rep visits, speakers' bureaus etc. is totally old news.
The value of this article seems merely to be a reminder of how surprised and aghast regular folks are when they did not know about all this and discover it for the first time. The reaction is certainly not what the pharmapologists confidently predict, "So what? I trust my doctor."
The one new feature perhaps of this discussion is a strong recommendation to patients to refuse free samples from the physician. The article and editorial note how likely it is that a sample drug 1) won't be the one your doctor would ideally have chosen for you and 2) will likely end up costing you more money down the road even if it saves you a buck now. This is a novel approach I don't recall hearing previously, and it would certainly do a lot to dampen the eagerness of docs to keep a stock of samples. I wish the article had mentioned the excellent Unbranded Doctor Campaign of the National Physicians Alliance:
http://npalliance.org/action/the-unbranded-doctor/
--which offers docs resources for their offices such as pamphlets and posters explaining to patients why they don't stock samples. (The editorial does quote liberally from Dr. Jean Silver-Isenstadt, NPA executive director.)
The article might initially produce the reaction from all four regular readers of this blog, "Where have you been all this time?" Most of what is said about Pharma's ways of influencing physicians through free dinners, samples, drug rep visits, speakers' bureaus etc. is totally old news.
The value of this article seems merely to be a reminder of how surprised and aghast regular folks are when they did not know about all this and discover it for the first time. The reaction is certainly not what the pharmapologists confidently predict, "So what? I trust my doctor."
The one new feature perhaps of this discussion is a strong recommendation to patients to refuse free samples from the physician. The article and editorial note how likely it is that a sample drug 1) won't be the one your doctor would ideally have chosen for you and 2) will likely end up costing you more money down the road even if it saves you a buck now. This is a novel approach I don't recall hearing previously, and it would certainly do a lot to dampen the eagerness of docs to keep a stock of samples. I wish the article had mentioned the excellent Unbranded Doctor Campaign of the National Physicians Alliance:
http://npalliance.org/action/the-unbranded-doctor/
--which offers docs resources for their offices such as pamphlets and posters explaining to patients why they don't stock samples. (The editorial does quote liberally from Dr. Jean Silver-Isenstadt, NPA executive director.)
Thursday, March 15, 2012
More from Celltex--Legal Threats Against Academic Whistleblowing
Since I first posted on the operation just up the road in the Houston suburbs called Celltex--
http://brodyhooked.blogspot.com/2012/02/bioethicists-and-conflicts-of-interest.html
--a good deal has happened and I thought it a good idea briefly to update.
The first big event was that Dr. Glenn McGee, the bioethicist who stared the controversy within that field by taking a job as "President of Ethics" for Celltex, abruptly resigned:
http://www.pharmalot.com/2012/03/mcgee-resigns-from-celltex-i-have-had-enough/
Dr. McGee reportedly promised in a tweet, "I am preparing timely, lengthy, pointed comments on the whole matter." The world is awaiting that interesting document.
The next development of note is that Dr. Leigh Turner, one of two University of Minnesota bioethicists most involved in launching criticisms of the McGee-Celltex affair, wrote to the FDA to request a formal investigation of Celltex's practices. As you can see from his letter:
http://www.scribd.com/doc/83524239/February-21-2012-Request-FDA-Investigation-of-CellTex-and-RNL-Bio
--he offers a well-documented and dispassionate statement that avoids making any claims but simply asks that matters be looked into. He does not, for example, say that Celltex is not only banking clients' stem cells (as they claim) but is also injecting the stem cells (as they deny). He merely points to publicity that would suggest the latter and asks the FDA to look into it.
Chapter 3 in the recent saga is the letter that Celltex's attorneys wrote to the University of Minnesota:
http://freepdfhosting.com/3bb531bc2c.pdf
The firm notes that Dr. Turner wrote his letter to the FDA on University stationery, identifying himself as a faculty member in the Center for Bioethics. The attorneys ask if this means that Dr. Turner was qualified to speak on behalf of the University. If not they demand that the U. "disclaim any sponsorship of the Turner letter, retract the letter, remove the letter from the internet, prevent further distribution of the letter, and prevent recurrence of this type of action."
Whew. Most everyone knows that if I write you a letter on my University stationery, it simply means that I'm identifying myself so that you know where I work and what I do. (Also that I'm too cheap to buy my own stationery if the University will supply it to me.) So there's no suggestion, to anyone vaguely familiar with academic practices, that the University of Minnesota officially endorsed Turner's letter. The attorneys' demands would seem to suggest two things--first of all, that as a U.S. citizen Turner has no right to ask a U.S. government agency to investigate a matter where there have been public suggestions of problems; and second, that the U. is entitled to take a number of steps that would severely infringe on Prof. Turner's academic freedom, a very basic principle that universities are sworn to respect (to say nothing of freedom of speech under the Constitution).
These demands are all predicated on the attorneys' claim that "Turner's letter contains numerous material false and defamatory allegations." I invite you to explore the language of the Turner letter to the FDA and decide whether the letter makes any defamatory allegations or simply raises significant questions for possible investigation.
I have posted previously (and wrote in HOOKED) about the type of lawsuit termed SLAPP (strategic lawsuit against public participation), for example:
http://brodyhooked.blogspot.com/2011/07/slapp-and-stem-cell-clinics.html
The letter from the Celltex attorneys is of course not a lawsuit but could be a precursor to one, and seems clearly to fall into the SLAPP category. Legally they probably have no leg to stand on, would be my nonlawyerly guess. The purpose of the letter is first, apparently, to scare Turner and any like-minded academics away from messing with their business; and second, to scare the University of Minnesota into isolating Turner and denying him any legal protection under the institution and its legal counsel. All of which, as various commentators have since noted--
http://www.pharmalot.com/2012/03/celltex-muscles-ethics-professor-for-contacting-fda/--
is perhaps an indication as to what Celltex thinks the FDA would find if it actually checked things out.
If I get a similar letter after this post I'll be sure to let you know.
http://brodyhooked.blogspot.com/2012/02/bioethicists-and-conflicts-of-interest.html
--a good deal has happened and I thought it a good idea briefly to update.
The first big event was that Dr. Glenn McGee, the bioethicist who stared the controversy within that field by taking a job as "President of Ethics" for Celltex, abruptly resigned:
http://www.pharmalot.com/2012/03/mcgee-resigns-from-celltex-i-have-had-enough/
Dr. McGee reportedly promised in a tweet, "I am preparing timely, lengthy, pointed comments on the whole matter." The world is awaiting that interesting document.
The next development of note is that Dr. Leigh Turner, one of two University of Minnesota bioethicists most involved in launching criticisms of the McGee-Celltex affair, wrote to the FDA to request a formal investigation of Celltex's practices. As you can see from his letter:
http://www.scribd.com/doc/83524239/February-21-2012-Request-FDA-Investigation-of-CellTex-and-RNL-Bio
--he offers a well-documented and dispassionate statement that avoids making any claims but simply asks that matters be looked into. He does not, for example, say that Celltex is not only banking clients' stem cells (as they claim) but is also injecting the stem cells (as they deny). He merely points to publicity that would suggest the latter and asks the FDA to look into it.
Chapter 3 in the recent saga is the letter that Celltex's attorneys wrote to the University of Minnesota:
http://freepdfhosting.com/3bb531bc2c.pdf
The firm notes that Dr. Turner wrote his letter to the FDA on University stationery, identifying himself as a faculty member in the Center for Bioethics. The attorneys ask if this means that Dr. Turner was qualified to speak on behalf of the University. If not they demand that the U. "disclaim any sponsorship of the Turner letter, retract the letter, remove the letter from the internet, prevent further distribution of the letter, and prevent recurrence of this type of action."
Whew. Most everyone knows that if I write you a letter on my University stationery, it simply means that I'm identifying myself so that you know where I work and what I do. (Also that I'm too cheap to buy my own stationery if the University will supply it to me.) So there's no suggestion, to anyone vaguely familiar with academic practices, that the University of Minnesota officially endorsed Turner's letter. The attorneys' demands would seem to suggest two things--first of all, that as a U.S. citizen Turner has no right to ask a U.S. government agency to investigate a matter where there have been public suggestions of problems; and second, that the U. is entitled to take a number of steps that would severely infringe on Prof. Turner's academic freedom, a very basic principle that universities are sworn to respect (to say nothing of freedom of speech under the Constitution).
These demands are all predicated on the attorneys' claim that "Turner's letter contains numerous material false and defamatory allegations." I invite you to explore the language of the Turner letter to the FDA and decide whether the letter makes any defamatory allegations or simply raises significant questions for possible investigation.
I have posted previously (and wrote in HOOKED) about the type of lawsuit termed SLAPP (strategic lawsuit against public participation), for example:
http://brodyhooked.blogspot.com/2011/07/slapp-and-stem-cell-clinics.html
The letter from the Celltex attorneys is of course not a lawsuit but could be a precursor to one, and seems clearly to fall into the SLAPP category. Legally they probably have no leg to stand on, would be my nonlawyerly guess. The purpose of the letter is first, apparently, to scare Turner and any like-minded academics away from messing with their business; and second, to scare the University of Minnesota into isolating Turner and denying him any legal protection under the institution and its legal counsel. All of which, as various commentators have since noted--
http://www.pharmalot.com/2012/03/celltex-muscles-ethics-professor-for-contacting-fda/--
is perhaps an indication as to what Celltex thinks the FDA would find if it actually checked things out.
If I get a similar letter after this post I'll be sure to let you know.
Tuesday, March 13, 2012
Does Pharma Have a New Business Model--Besides Outsourcing?
An article by Martha Rosenberg in Counterpunch--
http://www.counterpunch.org/2012/03/12/outsourcing-the-drug-industry/
raises some interesting questions about the future of the drug industry. Having not had the opportunity to cross-check the background facts, rather than endorse her conclusions outright I will simply state them as questions worth inquiring into, and invite anyone from the industry who might chance to read this blog to enlighten us as to the answers.
I take Ms. Rosenberg to be making two main points:
Cutting drug rep positions, as we saw in an earlier post here:
http://brodyhooked.blogspot.com/2012/02/new-paradigm-for-drug-reps-or-m-i-ck-e.html
--does not necessarily threaten the health of Americans. However, outsourcing research and manufacturing to countries where the FDA has less ability to inspect for safety and to enforce quality standards can hurt Americans, as shown most visibly in the case of the tainted heparin imported from China in 2007:
http://brodyhooked.blogspot.com/2011/09/none-dare-call-it-corruption.html
A business model that would restore the pharmaceutical industry to its once-widely-respected place among American institutions would be to commit itself to the discovery of new drugs that are safe and offer real advantages over existing drugs, and not to market products that fail to meet those high standards. It is worrisome if Ms. Rosenberg is right and the industry is currently unable to come up with such a model, so that sending jobs overseas is the only arrow in its quiver.
http://www.counterpunch.org/2012/03/12/outsourcing-the-drug-industry/
raises some interesting questions about the future of the drug industry. Having not had the opportunity to cross-check the background facts, rather than endorse her conclusions outright I will simply state them as questions worth inquiring into, and invite anyone from the industry who might chance to read this blog to enlighten us as to the answers.
I take Ms. Rosenberg to be making two main points:
- The world has shifted, making the previous blockbuster model of drug development and marketing increasingly insecure. Ms. Rosenberg cites Germany as one country that has gone the farthest toward demanding that drug companies produce firm evidence that expensive newer drugs do better than old generic drugs, before their health system will pay for them. The industry currently lives in fear that other countries will follow Germany's lead in this (which would of course be an amazingly intelligent thing to do, so don't expect the US to behave that way anytime soon).
- That being the case, how has Pharma revised its business plan to take these new realities on board? According to Ms. Rosenberg, the industry has only one plan thus far--outsourcing and cost cutting. She states, "Almost 20,000 jobs have vanished at AstraZeneca, Novartis and Pfizer in the last 12 months alone. (AstraZeneca scrapped 21,600 more since 2007). "
Cutting drug rep positions, as we saw in an earlier post here:
http://brodyhooked.blogspot.com/2012/02/new-paradigm-for-drug-reps-or-m-i-ck-e.html
--does not necessarily threaten the health of Americans. However, outsourcing research and manufacturing to countries where the FDA has less ability to inspect for safety and to enforce quality standards can hurt Americans, as shown most visibly in the case of the tainted heparin imported from China in 2007:
http://brodyhooked.blogspot.com/2011/09/none-dare-call-it-corruption.html
A business model that would restore the pharmaceutical industry to its once-widely-respected place among American institutions would be to commit itself to the discovery of new drugs that are safe and offer real advantages over existing drugs, and not to market products that fail to meet those high standards. It is worrisome if Ms. Rosenberg is right and the industry is currently unable to come up with such a model, so that sending jobs overseas is the only arrow in its quiver.
Monday, March 12, 2012
Med Schools Improving Their Grades, Students Say
PostScript at Community Catalyst:
http://postscript.communitycatalyst.org/?p=3202
--informs us that medical schools continue to improve on the scores they receive from the American Medical Student Association on efforts to reduce pharmaceutical industry influence over education. According to the AMSA scorecard issued last week, two-thirds of the schools now earn an A or B, and several schools have jumped from an F on previous report cards up to a B. The overall ranking shows steady progress each of the last several years.
The "Pharm-Free Score Card" idea that AMSA developed several years ago has proven to be one of the most effective publicity tools to push academic medical centers toward stricter policies on conflict of interest. (The students who dreamed that one up have a career ahead of them in politics as well as in medicine.) When medical school deans saw that their own students gave them an "F" on school policies related to pharmaceutical influence, things happened. It's an interesting and inspiring illustration of how supposedly powerless groups (medical students regard themselves as the very bottom of the food chain in medical centers) can have substantial influence when they approach an issue thoughtfully and persistently.
Lately I have seen indications of COI policies in academic medical centers that even to me, as a strong advocate of eliminating COI, seem overly onerous and burdensome. I have to admit that this would be a great problem to have in the future.
http://postscript.communitycatalyst.org/?p=3202
--informs us that medical schools continue to improve on the scores they receive from the American Medical Student Association on efforts to reduce pharmaceutical industry influence over education. According to the AMSA scorecard issued last week, two-thirds of the schools now earn an A or B, and several schools have jumped from an F on previous report cards up to a B. The overall ranking shows steady progress each of the last several years.
The "Pharm-Free Score Card" idea that AMSA developed several years ago has proven to be one of the most effective publicity tools to push academic medical centers toward stricter policies on conflict of interest. (The students who dreamed that one up have a career ahead of them in politics as well as in medicine.) When medical school deans saw that their own students gave them an "F" on school policies related to pharmaceutical influence, things happened. It's an interesting and inspiring illustration of how supposedly powerless groups (medical students regard themselves as the very bottom of the food chain in medical centers) can have substantial influence when they approach an issue thoughtfully and persistently.
Lately I have seen indications of COI policies in academic medical centers that even to me, as a strong advocate of eliminating COI, seem overly onerous and burdensome. I have to admit that this would be a great problem to have in the future.
Monday, March 5, 2012
From GoozNews: Inside Scoop on Medical Device Industry Lobbying
Thanks to Merrill Goozner, we have a handy summary:
http://gooznews.com/?p=3680
--of the current efforts of the medical device industry to lobby Congress to further loosen already-loose standards for FDA approval of potentially dangerous medical devices.
As I have posted about several times, most recently:
http://brodyhooked.blogspot.com/2011/10/more-on-device-industry-from-aslme-coi.html
--the device industry boldly launched a frontal pre-emptive strike against a recent report from the Institute of Medicine that revealed how inadequate patient protection currently is under existing rules, and is trying to get even those rules watered down. This from an industry that has increased its profits between 2009 and 2010 by 57 percent.
As I reported also some time back, when the device industry lobbies Congress, their trump card seems to be--either let us rush potentially dangerous devices to market with minimal FDA oversight, or we'll decide that the business climate in the US is unfriendly to our industry and take well-paying jobs overseas. Fascinating that our elected representatives, when their palms are sufficiently greased, cave to that sort of blackmail.
http://gooznews.com/?p=3680
--of the current efforts of the medical device industry to lobby Congress to further loosen already-loose standards for FDA approval of potentially dangerous medical devices.
As I have posted about several times, most recently:
http://brodyhooked.blogspot.com/2011/10/more-on-device-industry-from-aslme-coi.html
--the device industry boldly launched a frontal pre-emptive strike against a recent report from the Institute of Medicine that revealed how inadequate patient protection currently is under existing rules, and is trying to get even those rules watered down. This from an industry that has increased its profits between 2009 and 2010 by 57 percent.
As I reported also some time back, when the device industry lobbies Congress, their trump card seems to be--either let us rush potentially dangerous devices to market with minimal FDA oversight, or we'll decide that the business climate in the US is unfriendly to our industry and take well-paying jobs overseas. Fascinating that our elected representatives, when their palms are sufficiently greased, cave to that sort of blackmail.
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