Monday, February 21, 2011
What is the term for when a professional organization heavily funded by a pharma company that is trying to get a drug approved for a particular condition issues a statement that the condition is "a real condition and not a fabrication, nor a result of disease mongering"?
This is the situation currently with ISSWSH, the International Society for the Study of Women's Sexual Health.
On Feb 14, 2011, it issued a position statement on female sexual dysfunction http://www.isswsh.org/pdf/ISSWSH%20WISH%20Position%20Statement.pdf
This follows the ISSWSH 2011 Annual Meeting, held 10-Feb-11 to 13-Feb-11 in Scottsdale, Arizona where BioSante presented lots of preliminary unpublished data on its testosterone drug for female sexual dysfunction, LibiGel
BioSante was also the biggest industry funder of the meeting:
Sponsors for ISSWSH 2011
Diamond Contributor – BioSante Pharmaceuticals
What is the right term to describe this situation?
To which I replied that I did not know a specific term for this, besides one of my standard favorites, bribery. I had always assumed that “astroturf” was restricted to the extreme case where a supposed patients’ advocacy group is created more or less out of whole cloth by Pharma. But why bother to create a new group when you can simply go out and buy an existing one, that has a legitimate membership and board, and is willing the kiss the hem of your clothing in exchange for $$$? So I assume that “Astroturf” is the tip of the iceberg in terms of Pharma influence exercised via “patient advocacy” groups or supposedly "professional" medical or scientific associations. (In the case Dr. Tiefer describes, the ISSWSH appears to be a supposedly scholarly/professional rather than a lay or grass roots organization, but the basic idea remains the same-- a drug firm gets to circulate its marketing message as if it came out of the mouths of independent people, not from the company itself.)
If there's an existing term for the more widespread phenomenon, of paying money to supposedly independent patient adocacy groups to create false "grass roots" support for your company's marketing but without actually creating a new organization, please let us know. Alternatively please suggest a new term if you want to invent one. It's been a long time--April 2009 to be precise--since we had the contest to make up a new term, that resulted in "Pharmapologists" to name the people who like to call folks like me "Pharmascolds." (http://brodyhooked.blogspot.com/2009/04/and-winner-is-pharmapologist.html) So maybe it's time for another name-that-tune contest. Winner will receive a free subscription for this blog for one year. (The second prize will be a two-year subscription.)
ADDENDUM 2/21: Dr. Tiefer responded to this post by way of a personal e-mail in which she suggests her own name for this phenomenon, based on my comment above, "a drug firm gets to circulate its marketing message as if it came out of the mouths of independent people, not from the company itself": ventriloquism marketing.
Sunday, February 13, 2011
Rodwin's book looks at conflicts of interest in medicine across the board. Very roughly, one could divide the COI he discusses into three general categories--COI in how physicians are reimbursed for direct patient care; COI in other financial aspects of the health system (e.g., physician ownership of hospitals or labs); and COI created by relationships with third parties such as the pharmaceutical and device industries. Rodwin then looks in some depth at three medical systems: the US, France, and Japan. he compares how the three quite different systems address all the various COIs. He concludes by making some policy recommendations, based on a comparison among what seems to have worked best, or not worked, in each of the three countries.
Compared to most previous material in this blog, Rodwin's approach has a downside and an upside. The downside is that a lot of time and energy are focused on COIs that have nothing to do with the medicine-Pharma interface, and for which the necessary solutions are therefore quite different. The upside is that on occasion, looking at COI with drug and device companies from a more general perspective illuminates the issues in a novel way. I was worried about the downside as I slogged through the acronym soup that was requireed to give a detailed analysis of each health system, but in the end I was persuaded that the upside triumphed.
Rodwin ends up at somewhat the same point I did in HOOKED, arguing that in the end, COI with Pharma will require both addressing physician professionalism, and also instituting a number of legal and regulatory changes. But he has some fresh things to say about how those two different approaches relate to each other.
First, a side trip into the lessons from the three nations. If you were looking for pillars of professional ethics in the French and Japanese systems, you'll be sadly disappointed. At first blush, when you see that those systems come in at about 8-10% of GDP going to health care, while still managing to provide universal coverage for their populations, and the US is about at 17% and has a large swath of the population uninsured--then you might imagine that physicians in France and Japan are professionalism role models, compared to the profligate (and presumably profit-driven) habits of their US counterparts. Rodwin shows that any such view would be terribly overromanticized. France and Japan, to summarize briefly, have professional medical organizations holding a level of power over public policy that the AMA would kill for. Yet neither has taken step one to limit the contacts or the bribe-taking of physicians with Pharma. Moreover, while the French medical society has taken the lead in prohibiting a number of entrepreneurial types of practice, the Japanese society has essentially functioned as a doctors' union pure and simple, doing next to nothing to restrain greed and profit among its members. In short, the international track record, no less than the experience within the US, suggests that professionalism, as a tool to deal effectively with COI and Pharma, is a flop.
So what does Rodwin then propose? He says, "Ironically, professionalism requires a medical economy under mixed rather than professional control, and it functions best when the medical profession, the market, and the state have overlapping authority, each with checks on the others." This is a fairly radical departure from one view of professionalism, which argues that the whole idea behind professionalism is the autonomy of the professional group--that as soon docs end up under the thumb of economic interests or the state, goodbye to all professional ethics. Rodwin claims by contrast that allowing unfettered power in any portion of the system--including the professional group itself--will never lead to optimal ethical behavior around COI at least. Checks and balances is the name of the game.
His prescription is as follows: “How should we deal with physicians’ conflicts of interest in the future? I propose the following. Individual physicians and organized medicine should restrict activities that create conflicts of interest for practitioners and physician organizations. Physicians can change the way they conduct their own medical practice as well as participate in broader change through professional organizations and civic engagement. Physician organizations can develop ethical standards and policies for medical practice, continuing medical education (CME), and other medical activities. Even more important is another step that many physicians will find difficult. Physicians should accept the authority of federal and state government and laymen to reform the medical economy in ways that reduce and regulate physicians’ conflicts of interest.”
As we saw in the last post, that means that Rodwin is in favor of a straight legal ban on Pharma gifts/bribes. He also advises taxing the industry, hospitals, and physicians to fund CME, and turning the funds over to a neutral agency. The agency should assess need and then decide on CME content, rather than allow industry and the speakers to decide what they want to talk about. Rodwin notes that we taxpayers now pay for CME anyway via pass-through of costs, so we might as well have a say in what topics are taught.
If docs need a stick rather than a carrot to accept his recommendations, Rodwin adds, “If physicians want to control their work and influence practice and policy in a robust way, they need to assure the public that their judgment, advice, and advocacy are not compromised. This will require physicians to curb many of their entrepreneurial activities. If they do not, then the state or private entities—spurred by patients, other professionals, and various economic interest groups—probably will.”
Rodwin MA. Conflicts of interest and the future of medicine: the United States, France, and Japan. New York: Oxford U. Press, 2011.
Thursday, February 10, 2011
A quick review--first we decided the way to deal with these gifts was to have professional organizations develop codes of ethics, or for Pharma to self-police. Some victories occurred, such as when Pharma felt really under pressure and feared serious federal laws in 2008-9 and decided to throw all the "reminder items" (coffee mugs, pens, etc with drug logos) under the bus. Pharma showed us what they think really is essential for successful marketing by refusing to consider giving up free meals. Mostly this general strategy has been a flop. Codes of ethics either cannot get past the organization's members (such as the AMA House of Delegates) or else make useless distinctions such as how much is the gift worth, is it directly related to patient care, etc. During the era of mostly relying on codes of ethics and self-policing, physicians in the thrall of the drug industry fell from a high of 94% all the way down to a measly 87%-- a drop many of us would consider not quite equal to the actual need for reform.
Then we decided that sunshine laws were the way to go, just disclose all gifts and the amounts and docs will be ashamed of themselves and stop. So several states passed disclosure laws, generating (as in the case of MN) a lot of paperwork that sat in boxes in a warehouse because there was no budget to process it or put it on the web in searchable form. Not until ProPublica got on this just recently (http://brodyhooked.blogspot.com/2010/10/propublica-launches-database-on-docs.html) was there a really user friendly way to access this info. Too soon to see, therefore, if this approach can work.
So, if these past approaches seem to have little effectiveness, what would be better? Two recent works cut the Gordian knot and propose simply outlawing all these gifts and meals.
First I'll mention Marc A. Rodwin's just-out book, Conflicts of Interest and the Future of Medicine: The United States, France, and Japan. Law prof Rodwin (Suffolk U.) has written an interesting volume that I'll be blogging more about in a little while. The point here is that he views these bribes as against the public interest and therefore suitable for legal action, both in defense of prescribing quality and to control costs.
Next is a paper by a law student who reviews all the arguments for saying that these marketing practices are contrary to public interests, and then proposes a model statute to ban gifts and free meals. Joshua Weiss's main concern in this review is the usual defense used by corporations when restrictions on their marketing are proposed, that this is a violation of free commercial speech. Weiss in lawyerly fashion studies all the legal precedents and shows how he's crafted his model statute to resist the various free speech objections, given that the courts have ruled that you can restrict commercial speech if certain conditions are met. A key condition he addresses is how narrowly the restriction is crafted, so as to eliminate only the specific behaviors that are offensive.
Two comments. I am of course not a lawyer. I note that Rodwin apparently sees no problem in suggesting a legal ban on gifts and free meals. Weiss is worried about free commercial speech objections. What seems possible from a non-lawyer's view is to ban gifts and free meals and still permit as much interaction between drug reps and medical folks as the companies want. That way there is clearly no interference with free speech. The drug industry seems to be betting that if these bribes were totally eliminated, drug reps could hardly get a foot in the door. Let's see.
Next comment--don't expect any of this to be easy. Weiss goes after his fears of legal objections to a model statute by defining at some length exactly what relations between Pharma and docs would be still allowed, vs. what would be prohibited. We can expect that the drug companies would make every effort to find the loophole that would allow them to still shovel something into the docs' pockets that would make them feel indebted to the giver, but it will be speakers' fees or consulting fees or whatever seemed the new line of least resistance. Consider again the example of the device industry--paying docs million-dollar royalties, but insisting that the device on which they get the royalty is a different device from the one they do research on or implant into patients (http://brodyhooked.blogspot.com/2010/12/in-defense-of-paranoia-suspecting.html).
So an interesting question is: legal commentators are quite ready to contemplate laws that simply ban gifts and free meals. Is any legislature ready to undertake this step? It would be at least interesting to see how the Pharma lobbyists would fight against such a bill. Would they go on saying "it's not marketing, it's education," their usual mantra to defend detailing, when the only thing being banned is freebies and not any "education"?
Rodwin MA. Conflicts of interest and the future of medicine: the United States, France, and Japan. New York: Oxford U. Press, 2011.
Weiss J. Note: medical marketing in the United States: a prescription for reform. George Washington University Law Review 79:260-292, November, 2010.
There is a new poster child for academic malfeasance, if an ABC News report is to be believed:
Here's what ABC News's investigvation has shown-- a few years ago, a group at the University of Texas-Southwestern in Dallas headed by Dr. Sharon Nations, a neurologist/neurophysiologist, submitted a manuscript to the journal Neurology reporting on several patients with nerve damage apparently due to high zinc level in the body, and the culprit appeared to be the denture cream, Fixodent, manufactured by Procter & Gamble. Now, to prove cause and effect you need something more than a report of four patients' cases, but it is common that the first way that a serious and yet rare side effect of a medicine comes to light is through just such a case report. So this article seems to have been fully valid and worthy of publication, as the danger of zinc toxicity from that source had not previously been reported. (The four patients, apparently, had been heavy users of Fixodent.)
Neurology sent the paper for review to a dentist, Kenneth Shay, not otherwise identified by ABC, but who Google informs us appears to be an adjunct professor at University of Michigan and a big wheel at the VA Hospital there. (Assuming this is the right Shay; many apologies if it's the wrong person.) Dr.Shay lambasted the study, said it was basically garbage, and managed virtually single handedly to hold up publication for a couple of years and to force the authors considerably to tone down what they said. Unbeknownst to the journal editors (apparently), Shay was a paid consultant to Procter & Gamble, and he also at least once leaked the manuscript to P&G. There was no question of his simply being ignorant of the rules; in an e-mail to P&G, he said, "Please be circumspect because, as a reviewer, I'm not supposed to be passing an unpublished manuscript around."
OK, again assuming the accuracy of charges, there are two very big things wrong with this picture: a conflicted reviewer agreeing to review a manuscript in the first place; and a reviewer violating the confidentiality agreement and sharing the manuscript with anyone, let alone a commercially interested firm. We have to assume the editors at Neurology knew none of this; if somehow they did know then the wrong is greatly multiplied.
Now, let's talk reform. What should happen here? First, U-Mich should investigate and if the charges are substantiated, Shay should be out the door, period. No excuses.
Second, how about this as a statement of adherence to professional ethics? All commercial firms engaged with health-related products should agree to a compact. If any of them is sent a confidential manuscript under review by a misguided paid consultant like Shay or Haffner, the agreement would call for the firm immediately to notify the journal editors.
ADDENDUM 2/11/11: The editors of Neurology have now stated to their subscribers that they had no report of any conflicts of interest in Dr. Shay's case, view his behavior as "egregious misconduct," and have asked the American Academy of Neurology's (the journal's publisher organization) general counsel for options in dealing with the case. However, the editors also differ with the claim that Dr. Shay's review held up publication for two years, stating that the delay arose from the authors' taking that much time to prepare and submit revisions: http://bmartinmd.com/2011/02/peer-reviewer-of-denture-cream.html
Sunday, February 6, 2011
--based in part on her 2005 book, University, Inc.: The Corporate Corruption of Higher Education.
Washburn , a journalist, reviews some of the cases of conflicts of interest at major universities, such as the David Kern and Martin Keller episodes at Brown (on the latter see previous post, http://brodyhooked.blogspot.com/2008/06/alison-basss-side-effects-another-hall.html). The university seems to have taken little of any action against Keller, their chair of psychiatry who brings in huge research grants from industry, despite his serious COI and his role in suppressing unfavorable data about the antidepressant Paxil in kids. Kern, by contrast, blew the whistle on corporate wrongdoing in the defense of public health, and saw his academic career destroyed as a consequence. Seems like Brown University stands ready to beat up any faculty member who upsets a major corporation, but is happy to look the other way at the wrongdoing of another faculty member who brings in a steady stream of corporate cash.
Washburn also cites a worrisome case at Berkeley around a $500M biofuels research alliance. Two resolutions were introduced into the faculty senate. One called for creation of a blue-ribbon faculty panel to oversee the BP alliance and draft protocols to govern similar corporate alliances so as to protect core university values and academic independence from corporate influence. (Note that nothing was said about stopping the alliance or others like it, just that such arrangements need independent oversight.) The second, introduced by a prominent scientist, stated that no faculty should infringe on the "academic freedom" of other faculty to deny them access to whatever research support they choose to pursue. The second resolution won hands down and the first was forgotten.
Washburn diagnoses this incident as a serious misunderstanding of the tradition of "academic freedom." University profs have today fallen into the trap of thinking that this as a purely individual right. Not so, argues Washburn. I think her analysis is worth quoting in detail:
If the academic community wants to address the formidable challenges raised by academic commercialism, it must reject this overly narrow, individualistic interpretation of academic freedom and return to the highly persuasive arguments about collective academic freedom and the public good that the AAUP originally advanced to justify academic freedom in its 1915 Declaration of Principles on Academic Freedom and Academic Tenure and other early statements. This original defense of academic freedom may be roughly summed up as follows: in order for US universities to have the ability to fulfill their research and teaching responsibilities for the benefit of society, professors must be treated not as mere contract employees but rather as professional scholars who are free to think critically and speak openly without fear of arbitrary dismissal or other workplace censorship and retribution. The societal benefits that can emerge from this unique academic sphere include the provision of a broad-based, liberal education; expert advice (for government agencies, industry, and the broader public); pathbreaking scientific research; noncommercial research for the public good; graduate-level training; and other educational and knowledge functions uniquely performed by universities. This founding justification for why the public should grant tenure and intellectual freedom to professors is essentially one of “rational instrumentality”: if society is going to subsidize the university, and its professors are going to be asked to provide scholarship, expertise, and advice, then society must have bona fide assurances that those professors’ research and academic work are rooted in rigorous scholarship, scientific methods, and disinterested inquiry and have not been unduly influenced by outside special interests. This was a profoundly bold concept in 1915: before then, most university boards of trustees treated academic employees as workers for hire who could be dismissed at will.
However, as the AAUP’s founding Declaration makes clear, this extraordinary privilege of academic freedom also comes with responsibilities. In exchange for academic freedom (not to mention financial support), professors are expected to dedicate themselves to the advancement of scholarship, the search for truth, and knowledge generation for the public good. In the words of the 1915 Declaration, “The existence of this association . . . must be construed as a pledge, not only that the profession will earnestly guard those liberties without which it cannot rightly render its distinctive and indispensable service to society, but also that it will with equal earnestness seek to maintain such standards of professional character, and of scientific integrity and competency, as shall make it a fit instrument for that service.”
This is the underlying social compact into which the academic profession entered in order to ensure its intellectual freedom. Our current tendency to view academic freedom as a personal “right”—disaggregated from these collective commitments—has made regulating campus-based commercialism more difficult. Emphasis on individual rights has enabled powerful academic constituencies to use the banner of academic freedom to argue— inappropriately, in my view—for a laissez-faire approach to campus commercialism, which has made collective faculty attempts to rein in commercialism far more challenging.
Washburn goes on to say that the AAUP has been relatively toothless in defending this broader view of academic freedom--for instance, getting involved in the Kern case only after all the damage was done. She offers several suggestions as to how AAUP ought to partner with other non-profit organizations to better protect academic values from commercial corruption.
Friday, February 4, 2011
--warns medical organizations and patient advocacy groups to watch out for financial entanglements with the food industry (and provides a detailed appendix of recent entanglements of note).
One issue I've been following closely (most recently, http://brodyhooked.blogspot.com/2010/12/aafp-and-coca-cola-update.html) is the money paid to the American Academy of Family Physicians by Coca-Cola to develop patient education materials for the AAFP website. The editorial by Yoni Freedhoff and Paul C. Hebert fills in two points that I was previously unaware of. First, they give the actual amount of the "grant," $600,000, which initially AAFP was pretty mealy-mouthed about. Second, they add the detail that the CEO of Coca-Cola attempted to leverage this tie with AAFP when lobbying against a tax on sugary sodas, indicating why corporations think that these financial ties are worth their money. In a pro-con debate over the soda tax in the Atlantic Journal-Constitution, Sandy Douglas, president of Coca-Cola North America, argued against the tax by saying, "At Coca-Cola, we’re playing our part in helping develop and support workable solutions. Let’s stop pointing fingers and start working together productively." As evidence of "working together," Douglas said: "We’re for education, through support for organizations such as the American Academy of Family Physicians, which is providing consumers science-based information about sweeteners" (see full article at http://www.ajc.com/opinion/pro-con-is-a-438123.html).
The most egregious single example Freedhoff and Hebert provide is the Save the Children organization, which started out staunchly in support of the soda tax, and then suddenly changed its mind. It claims that the fact that it recently got big grants from both Coke and Pepsi had nothing to do with its change of heart.
Freedhoff and Hebert start by claiming that the food industry has discovered that its highest and surest profits come from marketing high-calorie, maximally processed foods, that is, foods of the least nutritional value. (Is there another Inverse Benefit Law waiting to be described here?) They also claim that the best research now available targets increased caloric intake rather than lack of exercise as the main driver of today's global obesity "epidemic," yet by buying the loyalties of medical groups and patient organizations, the food industry manages to disseminate the obfuscating message that we'd be able to eat all the junk food we wanted if we'd just get off our duffs. That message coming straight from the food industry would be viewed with the skepticism it deserves; coming from supposedly credible health-related organizations, it works.
Freedhoff and Hebert conclude: "Corporations are not the problem. By definition, corporate spending must serve to increase shareholder value... Health organizations, even when desperate for money or resources, should avoid co-branding with the food industry. At the very least, partnerships should comprise unconditional arm's-length grants with clauses limiting how corporations use health organizations brands.... When they partner, health organizations become inadvertent pitchmen for the food industry."
Thursday, February 3, 2011
Frank Miller, a philosopher-bioethicist at NIH, and Steve Joffe, pediatric oncologist with the Dana-Farber Cancer Institute, write on the question of "equipoise." The standard view today of the ethics of randomized clinical trials takes off from the apparent dilemma of a physician enrolling subjects in a randomized experiment. Traditional medical ethics says that the physician's duty is to advise the patient with regard to therapy, according to the doc's best clinical judgment. This seems inconsistent with allowing a patient of yours to get a treatment, or not, at the toss of a coin. The solution, according to ethical thinkers back in the 1980s, was that a randomized trial is ethical only in a state of clinical equipoise--when the relevant community of physicians considers it a toss-up as to which of the two treatment arms is superior.
First thing to note is that the equipoise rule would prohibit the vast majority of placebo-controlled trials. Yet the FDA routinely requires placebo-controlled trials for most of the meds they approve. So tons of supposedly unethical trials are conducted to win FDA approval. Is the FDA unethical, or does this signal a flaw in the equipopise theory?
A few years back, Frank Miller and I argued that it's the equipoise end of the stick that has the problems. (Not that the FDA doesn't have problems, but that's another post.) We relied at that time heavily on a set of arguments that claim that clinical medicine and clinical research are two quite different enterprises and require different ethical rules. To argue that the clinician trial investigator has the same duty to the research subject as the physician has to the patient mixes up those different sets of rules.
Miller and Joffe here expand that argument considerably by arguing that it's not just a matter of conducting research according to the ethics of the individual physician-patient relationship, erroneous as that may be. There's another issue at stake. The equipoise argument is based on the idea that the only "consumer" of the research findings is the individual doc trying to make treatment decisions for individual patients. If that doc is in a fog about which of two treatments is superior for any given patient, then it's presumably ethical to do a randomized trial. But as soon as that doc becomes unfogged, and has a clear preference for one treatment over the other, then scrap the trial. (Ending trials early, before they allow definitive conclusions, is one deleterious consequence of equipoise that Miller and Joffe list.) Or in the case of clinical equipoise, stop the trial when the relevant community of docs becomes unfogged to a sufficient degree (whatever that is, yet another problem with equipoise).
This view, say Miller and Joffe, is fundamentally incomplete. There are other important consumers of this research, namely policymakers, including those often-derided folks at the FDA. And policymakers don't have the luxury, or the burden, of dealing with patients one at a time. These folks are duty bound to adopt a population perspective, asking what the impact of a drug (for example) is on the entire patient population. To get such data, randomized trials are usually needed (not always), and the trial may have to go on often beyond the stage at which individual physicians have reasonable preferences for one treatment over the other. The policy need for these data is legitimate and ethically sound, and so it's shortsighted to invoke "equipoise" as a reason to rule out those trials, or to stop them too early.
Bottom line--ethics is important in research and the rights of subjects must be adequately protected, but the concept of equipoise is quite a wrong-headed way to go about that task.
Miller FG, Joffe S. Equipoise and the dilemma of randomized clinical trials. New England Journal of Medicine 364:476-80, Feb. 3, 2011.
Miller FG, Brody H. A critique of clinical equipoise: therapeutic misconception in the ethics of clinical trials. Hastings Center Report 33(3):19-28, 2003.