Tuesday, November 30, 2010
Basically the article recounts how at the start of the 20th century, the granddaddies of the big drug firms of today had to make a choice--"patent" medicines, which were characterized by secret ingredients and exaggerated advertising claims of cure, or "ethical" medicines (so-called from the AMA Code of Ethics), which were openly labeled drugs listed in the official U.S. Pharmacopoeia and advertised to physicians rather than to the general public. Obviously there was a lot of short-term profit in the patent medicine trade, but the companies looking at the big picture realized how they could carve a market niche on the "ethical" side, using the "ethical" label itself as a signal of corporate integrity. While "ethical" in the AMA's view meant advertising only to docs, the companies started pushing the envelope right off. They began with ads that named no specific medicines, but that were aimed at getting consumers to associate their name with quality and reliability. They effectively derailed any protests from the AMA by including in the ads a lot of reminders that consumers should seek medical advice from their physician before taking any drugs, so that the ads were as much ads for "go see your doctor" as for "buy our medicines." As the century wore on, the companies pushed the envelope a bit more. For instance, Parke, Davis initially had the patent on Benadryl, as one of the first truly effective antihistamines. A 1960 full-color magazine ad pictures Ward Cleaver and his family (OK, maybe not them exactly, but an equally idealized middle American family) enjoying a picnic and barbecue in their back yard, despite (as the text explains) a serious allergy problem they all share. The title runs: "This is what we work for at Parke, Davis." The text is ostensibly not about recommending any drug (Benadryl is never named) but simply using the development of a new antihistamine as just one example of the general benefits the drug industry provides for society. Yet it would not take much thinking to infer from the ad that if you have allergies and want to enjoy your back yard in the summer, you should go ask your doctor pronto for this new drug made by Parke, Davis.
A perhaps even cleverer use of an apparently innocuous "general information" ad to implicitly peddle a specific drug occured when Roerig, a division of Pfizer, introduced Atarax, its minor tranquilizer (which happens to be a pharmacological relative of Benadryl). In a 1957 newsreel, a know-it-all wife is informing her idiot (but anxious) husband about the physiology of stress. The film segues to a narrator who takes the viewer inside a drug laboratory to describe the latest developments in the fight against this dread affliction. He mentions in passing that a state of peaceful bliss could also be termed "ataraxia" and that therefore a new drug to achieve this state might be called "ataraxic." Of course, any relation to the brand name Atarax is strictly coincidental.
After updating the story to the modern era of direct-to-consumer ads, Greene and Herzberg make several points. One of their main points is one that I emphasized in HOOKED--that if you look at only one level or one channel of pharmaceutical industry influence over physicians or the public (or both), you seldom see what is really going on, as the industry is a master at using multiple levels and channels in synchrony to get their marketing message out. The present article shows that this expertise is not something that the industry arrived at yesterday, but rather is a skill honed over many decades. Federal regulation of drug ads, by contrast, almost always focuses on a single channel of communication, and thus is fated always to be two steps behind the pharmaceutical companies. The authors call for understanding that marketing of the sort they describe will probably always be with us, making it essential that we develop better ways of preventing truly harmful advertising--while at the same time they admit how hard that is. The whole point of their previous discussion, after all, has been that whatever is going on in drug company advertising is seldom what meets the eye.
Another important point is contained in: "The popular promotion of pharmaceuticals, in short, needs to be understood as a longstanding--if often covert--dimension of prescription drug marketing... This should come as no surprise given the industry's location within a resolutely commercial--and consumerist--medical system." It has been easy, when we try our best to focus on ethics, to portray medicine as fundamentally a profession which is supposed to be dedicated to the patient's well-being ahead of profit. This appropriate goal risks, however, ignoring the actual history of American medicine, especially when we are reminded that the AMA was for so much of the 20th century the public face of that enterprise. And the AMA, from its founding (but especially in the middle of the 20th century), has been ambivalent over its ethical identity. When it suited, the organization trumpeted its deep commitmnt to ethics and professionalism. But the AMA also resolutely insisted that the only appropriate model for medical practice in the US was the entrepreneurial physician, the doc as small businessman. My teachers in medical school could recall the days when you could be kicked out of the county medical society for joining an early form of HMO, or even, for that matter, a group practice, instead of the solo practice valorized by the AMA. When the organization that spoke for American medicine could not get it straight between a patient-centered ethic and a profit-centered business model, how could we expect any other part of the health care system to do better?
Greene JA, Herzberg D. Hidden in plain sight: marketing prescription drugs to consumers in the Twentieth Century. American Journal of Public Health 100:793-803, May 2010.
I started to respond by appending a comment of my own, but decided that the matter was too important to risk burying in a pile of comments.
Both Wilson and Matheson, in the main post, address this issue. Basically both of them work for the drug industry. Both wish they were not forced to do so. Both, in the present economy, are happy to have a paying job. Both have found of late a lot more paying jobs in the drug industry than in the field of academics that they'd prefer to work in.
So-- do blogs like this one unfairly and unproductively villify people who are stuck in those circumstances? And what about all the other people who work for Pharma in one capacity or another, are decent and ethical people, and in their small corner of the world work as hard as they can to do good and not to do evil, sometimes managing to mitigate what would otherwise be a serious problem (like when the marketers threaten to completely dominate a writing project, and the science writer manages to veer the result back towards real science)?
I think it is always helpful to be reminded of this question and I have three answers.
- I know that at times I get too much into the flow of blame and recrimination, because of feeling self-righteous or whatever other character flaw I am indulging in that day. When all is said and done, we need to find allies within the industry who want it to live up to its real potential for human betterment. Without such allies we will never have an ethical relationship between medicine and the pharmaceutical industry, which is what this blog is all about.
- Having admitted as much, I wish the drug industry would send up fewer clay pigeons for me to shoot at. I tell people regularly that just when I think I have probed this whole issue to the very bottom, and nothing that any drug company is found to be doing would surprise me any more, the next week I learn of some new revelation that surprises me. If we pharmascold bloggers seem to be going overboard, it is at least partly because we have such a rich supply of material. I for one would love it if I had a lot less material. (I make no money off this blog, as should be obvious, and I certainly am not paid by the word. Having to do a post once a month instead of several times a week would be no sacrifice for my to-do list.)
- At risk of boring long-time readers, I must again repeat just who this blog is primarily aimed at (just as was the case with its parent, the book HOOKED). I assume (at least for purposes of argument) that it's part of our great capitalist system for drug companies to turn a handsome profit, and that people who work for the drug industry are supposed to do its bidding and help it to make a profit. (If they happen to have ethical values as well, and try their best to make the world a better place, great.) But I make a sharp distinction between medicine's role and industry's. Medicine is supposed to be a profession--a concept that has not yet, I fervently hope, been relegated to the ashheap of history. A profession is supposed to be about the patients and not about the profits. So if there are any villains in this blog (there ought to be none, I agree), they are the physicians, especially the highly placed academic leaders, who have allowed money and privilege to divert and distort their professional obligations. Getting down to the issue that Bruce Wilson is writing about, the science writer working for the MECC that works for the company is not my main target; it's the academic KOL who allows his name to be put on the ghostwritten article and who pockets the speakers' and consulting fees. That character already has a paying job and could make plenty of bucks--much more than the average joe--just doing his job. If in order to make even more money he abandons his duty of advocating for the patients' health, and becomes a shill for the industry, then I hold him morally accountable.
I hope I've been able to offer some clarification of my intent.
--deftly tells the story of a 269-page textbook aimed at family physicians, written by two leading lights in psychiatry, and published by the American Psychiatric Association's press in 1999: Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. The listed authors were the dynamic duo well known to readers of this blog for accusations of unprofessional ties to Pharma--Dr. Charles Nemeroff, formerly chair of psychiatry at Emory and then taken in by University of Miami when Emory finally got fed up with him; and Dr. Alan Schatzberg, chair at Stanford (see for instance http://brodyhooked.blogspot.com/2010/06/dr-thomas-insel-and-rehabilitation-of.html and http://brodyhooked.blogspot.com/2009/06/will-psychiatrys-dsm-v-be-huge-growth.html).
According to Drs. Nemeroff and Schatzberg, they had an unrestricted educational grant from SmithKline Beecham (as it was then called; now GlaxoSmithKline unless they did another merger last week that I have not yet heard of). They wrote the whole book themselves and never gave the drug company any sign-off on the contents.
The documents unearthed by Wilson, as a result of ongoing legal action against the company forcing the release of internal memos, tell quite a different story. They show the drug company's money going to Scientific Therapeutics Information, a medical communications firm, to develop a detailed outline of the content and then to prepare drafts. The drafts were to be submitted back to the drug company for approval prior to publication. In short, it appears that the bulk of the book was ghostwritten, if not all of it.
While we've devoted a lot of space here to the ghostwriting of medical journal articles, Wilson quotes former FDA commissioner Dr. David Kessler: “To ghostwrite an entire textbook is a new level of chutzpah. ...I’ve never heard of that before. It takes your breath away.” A bioethicist with California State University-Northridge, Leemon B. McHenry, who consults for the law firm suing GlaxoSmithKline, told Wilson that while these documents have been released, many other equally damning documents remain sealed by the court: “This is only the tip of the iceberg.”
If there's a difference of opinion between what the (purported) authors of the textbook say and what the court documents show, who should we believe? Here I would return to some comments by the Welsh psychiatrist, Dr. David Healy, that I quoted in HOOKED. Dr. Healy was disturbed by ghostwriting, but he was equally disturbed by the emergence of an elite overclass of academic scientists who when confronted, expressed surprise that there were still peons who actually wrote their own papers to submit to journals. These dudes, according to Healy, flitted about the world from conference to conference, from one company consulting gig to another, flying first class, and simply never had time to write a paper on their own even if they wished to (and any longer had anything original to say). Now, I challenge anyone to look today at what it takes, timewise, to be a chair of a major university clinical department. (Most academics would say that when you accept the post of department chair, you can pretty much kiss your life as a serious research investigator goodbye, though you can still be active in getting grants and so on as a member of the team.) Next, look at the CV of a fellow like Dr. Nemeroff and count all the papers he is supposed to have published during the years when he was presumably that busy--as well as traveling about the world as described above. Then you be the judge of whether it was humanly possible for him to have written all that stuff on his lonesome.
Sunday, November 28, 2010
I’m delighted you saw fit to read and comment on my BioSocieties article. It’s a thought-provoking commentary and raises several points for me to respond to.
First, I should acknowledge that I am dependent on pharma for about half my income. I wish things were different – I would love to work in a university, or even simply to have university affiliation to put on publications – but this is the reality I am currently stuck with. My financial dependency did not make me hold back when I wrote the article, but my working relationships did mean I had to take confidentiality clauses and sundry other legal issues into account.
As for why I had some good things to say about pharma, the reason was simple: I wanted to be objective. Pharma does do some good, and in my experience employs largely decent people. Basic biological research conducted by pharma has helped elucidate numerous cellular and physiological mechanisms. Pharma may have produced a truck-load of mediocre, over-hyped drugs, but it has produced a truck-load of good ones too. I expect every last firebrand critic will gulp, inject or infuse pharma’s wares into their bodies at some stage in order to keep well or keep living. Any fair-minded analysis of pharma should acknowledge these truths – but most of all, an analysis like mine should do so, given its concern with standards of truth and truthfulness. If I am going to criticise pharma for bias, I must be unbiased myself. Ergo, if the application of the term "tarts" to some doctors was light-hearted (and it was), then I should say so.
But if we grant that pharma employs decent people and does useful work, how then can it be that it also does bad? Here we get to the nub of things, but I will confine my remarks to a couple of points.
First up: when we say that pharma does this or does that, what do we actually mean? Who exactly are we pointing the finger at? Although I wouldn’t place Howard in this category, I do get the feeling that some of pharma’s more boisterous critics watched too many Hollywood movies when they were growing up. Because if we really want to understand what is unwholesome about pharma, the first thing we have to do is ditch the idea that it is controlled by Darth Vader.
There is no Dark Lord or secret cult pulling the levers. What we have instead goes beyond the control of any individual - a mass of research, development and marketing programs, meetings, strategies, agendas, organizational relationships, personal motives and compromises, operating on numerous levels, both inside the pharma corporations and its satellite industries, and with respect to pharma’s external engagements. The ultimate driving force is of course profit and money is the lubricant, but the system as a whole is hugely diverse, dynamic and robust, and is shaped not only by strategic planning but by the continual selection and replication, in a Darwinian sense, of commercially successful strategies.
That is the type of entity we are dealing with. Now, with regard to the question of why pharma has an unwholesome side, you’ll have to read my article, although the root of the problem is of course money. To return to Howard’s commentary, however, the point I wish to make here is that one of the most insidious and troubling things about pharma is the way it infiltrates cultures, practices and discourses. It weaves itself seamlessly into them, then subtly transforms and regulates them in such a way that it becomes reasonable within the terms of the parasitized discourse to use pharma products. My own work has examined the way pharma penetrates and transforms the discourses and practices of medicine and science to make the use of drugs seem reasonable, undermining in the process the very values of truth and truthfulness that should set science apart.
Therefore, my contention that pharma does a lot of good science, and has lots of decent people working within it, has more about it than meets the eye. It is precisely because pharma does some decent science, and employs or co-opts many decent scientists and medics, that it is able to permeate science and medicine as effectively as it does. Like some subtle pathogen, it is exactly because it adopts the characteristics of the host that it is able to get into the marrow.
Indeed, one of the phrases I used and which Howard cites - "It is through convincing science, not conspicuous marketing, that pharma prefers to engineer commercially productive knowledge "- is not, in fact, a ringing endorsement of pharma, but an observation with a degree of ambiguity and irony about it.
Finally on this subject, I would like to comment on Howard’s suggestion that pharma’s “just-take-the-pill” ethos undermines personal responsibility for health. Maybe that’s true, but if so it’s only part of the picture. When one sees the efforts pharma puts into television advertising and direct-to-consumer disease mongering, what we are witnessing is not the destruction of personal responsibility, but rather its invasion and transformation, such that it is reconfigured and amplified in a way that drives increased sales of drugs. Pharma penetrates, manipulates and feeds upon the personal health anxieties of consumer culture in a fashion analogous to the way it penetrates, manipulates and feeds upon the professional cultures of science and medicine.
I don’t think my critique of pharma is trying to find some kind of middle ground or meet pharma halfway. On the contrary, I think it’s one of the most telling critiques around, because it tries to get right inside how pharma actually works.
Howard, thanks again for your excellent commentary on my paper, and for giving me the opportunity to contribute a reply!
Thursday, November 25, 2010
Matheson (who's based somewhere in the UK) begins his essay, "Corporate Science and the Husbandry of Scientific and Medical Knowledge by the Pharmaceutical Industry," by stating that his research method is that of the informed insider writing about his own experiences, working for a decade in various roles within the pharmaceutical industry. He compares himself briefly with Michael Oldani, the former-drug-rep-turned-medical-anthropologist. But in one way the comparison is misleading. Oldani writes primarily as a convert; from the vantage point of his former Pharma colleagues, he's a turncoat. He now rejects the value system that guided his work when he was a rep. Matheson, by contrast, seems not to want to burn bridges with his former bosses. He writes as a moderate, someone trying to find the middle position between Pharma and its most severe critics. He regularly reminds us that in his opinion, Pharma does a lot of good with its research and adds considerably to the store of medical knowledge. A typical sentence is: "It is through convincing science, not conspicuous marketing, that pharma prefers to engineer commercially productive knowledge."
A cynical reaction to Matheson is that he's really a turncoat but for whatever reason wishes to cover his proverbial hind end, and so all this pro-industry language is really just a smoke screen. A more sympathetic reading is thatMatheson believes the good things that he says about the industry and its research. That is important because he also says a lot of highly critical things, and in the end offers a severe critique of the industry as it now functions. These criticisms might be ho-hum coming from pharmascolds like me, but cause us to sit up and take notice when emanating from someone both knowledgeable about the industry and also sympathetic to many of its aims.
Matheson's case on the industry is rather deep and theoretical. He's concerned about how medical knowledge is ultimately constructed, and argues that presently, the knowledge-construction business is influenced much more by industry marketing and profit-seeking behavior than anyone who takes the scientific truth-searching agenda seriously could be comfortable with:
"Pharma's influence within the overall dispositif of biomedical knowledge production is pervasive, reaching beyond research per se into the networks, institutions, cultures and mind-sets of academic medicine and scienc--though many within these communities may be but dimly aware of such influence. Pharma's contribution to medical-scientific knowledge is manifest on many levels, including the dominance of the biomechanistic model of human health, the choice of what problems are investigated, the drugs themselves and associated clinical and mechanistic research, and the way specific aspects of human biology, pathology and medicine are constructed.... From pharma's perspective, the trajectory of scientific knowledge may be partially contingent with respect to the possibilities human biology affords, but it is non-contingent with respect to market potential. [Some] have suggested that disease classification is driven increasingly by the reported effects of drugs, but a fuller statement would be that our conceptualization of drugs and diseases are adjusted each to the other, with human biology and market potential jointly arbitrating the negotiation..."
To spend just a minute unpacking a bit of this, let's take the claim that pharma's influence over medical knoweldge helps to drive and perpetuate "the biomechanistic model of human health." It's an article of faith among primary care physicians like me that this model, for all the great discoveries that it has generated through the 20th century, also has substantial weaknesses and may indeed be reaching the limits of its usefulness, especially in the US where it has fed out-of-control health costs. Within the confines of this model, it is very difficult to talk about personal responsibility for health, the importance of lifestyle change on health, or the importance of social and psychological variables in determining health and illness. Yet pharma's role in the construction of medical knowledge helps to assure, first, that this model continues to dominate thinking within the major medical institutions; and second, that pharma's role in promoting this model remains well concealed. If people (both physicians and the general public) came to believe widely in what the critics of this model say, then fewer people would be persuaded of what Pharma wants them to believe deep in their bones--that the shortest road to good health lies in swallowing a bunch of pills, the more expensive the better.
A couple of other choice quotes: "Systems by which KOLs [key opinion leaders, prominent physicians selected by drug companies to transmit their messages] are selected, positioned and used to exert influence are well established--indeed software for managing KOLs is commecially available." And: "Within the KOL caste there is structure and hierarchy, beginning with new blood and 'rising stars' and culminating with the grandees. KOLs considered sympathetic to a product are sometimes describes as 'friends'; those thought overly anxious to offer endorsement for rewards may be light-heartedly referred to as 'tarts'." (The addition of the phrase "light-heartedly" here, which challenges credulity, may tend to push one toward a more cynical reading of Matheson's pro-Pharma stance.)
Matheson ends by calling for creation of some sort of International Standard of Integrity in Science. He's a realist and knows that science will always be carried out in a social context, and that social context will help to determine what is seen as "truth" within science. Yet he also argues that as of now, the commercial pressures on that "truth" are simply too great for anyone who cares about science to accept.
Matheson A. Corporate science and the husbandry of scientific and medical knowledge by the pharmaceutical industry. BioSocieties 3:355-382, 2008.
Egilman D, Ardolino E. The pharmaceutical industry, disease industry: a prescription for illness and death. In: The Bottom Line or Public Health: Tactics Corporations Use to Influence Health and Health Policy, and What We Can Do to Counter Them, ed. Wiist WH. New York: Oxford University Press, 2010.
Tuesday, November 23, 2010
--and next on the "Health Care for All" blog:
The new site is said to be great for investigators because it is more easily searchable than other states' sites, and has a number of built-in reports that provide valuable data. However, only 12% of Massachusetts physicians are listed. With recent surveys showing more than 80% of docs having some sort of relationship with the pharmaceutical industry (http://brodyhooked.blogspot.com/2010/11/are-physicians-taking-fewer-bribesgifts.html), one would imagine that 12% undercounts the true figures by a good bit. On the other hand, it may be that with the strict new state law limiting gifts that physicians may receive, the percentage of docs in the state who get more than $50 worth may have declined significantly, which if true would be a major finding.
Monday, November 22, 2010
An issue this blog and theirs have both been concerned about is the fact that when wrongdoing, even criminal wrongdoing occurs within the drug industry (as well as in high places in academia), no individual ever appears to suffer any negative consequences to his/her career, and whatever monetary fine is imposed seems to be blown off by the company as simply a business expense.
So it was in fact a real breakthrough when the Feds banned Marc Hermelin of KV Pharmaceuticals from doing any business with them for 20 years, over a criminal act of negligence involving safety reporting. He had been fired as CEO in 2008 and now resigned from the Board.
That's part of the story. It turns out that KV is not exactly free of Hermelin's influence after all. His son and grandson remain as board members and his family still owns 52% of the company stock.
So we seem to have two lessons here--first, that maybe at long last the government is getting serious about enforcing the law with drug execs; and second, that when you have enough money and power you can find a way to hang onto both much easier than we commoners can.
Friday, November 19, 2010
Having now done so, I could not pass up this gem of a quote. The article focuses on physicians who have been disciplined by the Texas Medical Board and yet are paid large sums as speakers by drug companies. The article then proceeds to report interviews with several of the physicians. One is a Dallas psychiatrist, Dr. Dhiren Patel, who was accused by a patient of inappropriate sexual contact, a charge that was upheld by the licensing board:
"Patel denied the patient's allegations and defended the pharmaceutical fees. 'It's not my position to judge other physicians,' he said. 'I know many around this area who have done far worse and are paid by pharmaceuticals to speak.' "
How's that for a cogent ethical justification of one's actions?
Thursday, November 18, 2010
Earlier, ProPublica had announced their "Dollars for Docs" database of physicians receiving drug company payments (http://projects.propublica.org/docdollars/), and had done some initial reporting about what these figures showed in collaboration with several major newspapers:
This latest dip into the seamy world of physician bribes from Pharma has focused on a simple recipe: first get the database of docs getting money from the drug industry, then access the public databases showing physicians who have been disciplined by their state licensing boards, and stir. The result was that after they had eliminated the minor infractions that seemed not to implicate the physicians' quality of patient care, some 290 names showed up on both lists--and 70 names indicated multiple disciplinary actions.
Two physicians were interviewed in the ProPublica article linked to above, and each denied any wrongdoing that actually affected patient care. And I think fairness requires the acknowledgement that there are times when an innocent physician is being unfairly accused before the licensing board, and the sheer time and expense of fighting to clear one's name leads to the prudent decision to accept a plea-bargain agreement (I am familiar with several physicians railroaded into such a situation when their only "offense" was prescribing adequate opiates for patients with severe chronic pain. I was also told that if one wishes to fight an unfair ruling of the Texas Medical Board in court, plan to spend at least a quarter of a million dollars.)
It would have been nice if ProPublica had told us what percentage of the docs in their database this 290 makes up-- is it 20% or 2%?
All that said, there are a couple of important implications of this finding. First, I hope that once again these data will put a nail in the coffin of the idea of "Key opinion leaders." The industry has always claimed that the reason it paid big bucks to Doc X is that Doc X is the most talented and knowledgeable guy on this particular disease on the planet. This in turn has led others like the FDA (before the new leadership took over) to claim that if they tried to exclude docs with financial conflicts of interest from review panels, guideline committees, etc. they would lose the input of the best and the brightest. If it turns out that the folks selected for these payments/bribes actually include a fair number of medicine's bottom feeders, then we can see even more clearly that these bribes are nothing but rewards for high prescribing and have nothing whatever to do with the talents and knowledge of the recipients.
Another great point was made in the ProPublica piece by my bioethicist colleage Josephine Johnston at the Hastings Center. She points out that when you are sitting on the fat bankrolls of the major drug firms, you can afford to do most anything you want--including prescreening docs for licensing violations before you sign them up. The fact that the industry never bothered to do this is therefore somewhat telling.
ProPublica obviously struck a nerve. As the article notes, at least four major drug firms, on being interviewed for the piece, said that they would immediately review their procedures to see why these physicians had been signed up and consider better screening in the future.
And, no matter what the content, it is sort of nice to see that investigative reporting by newspapers has not completely died out.
Wednesday, November 17, 2010
--I looked over at the field of health information technology to see if there were parallels with some of the issues we face in connection with pharmaceuticals. The initial reports were worrisome. After notable success with the first generation of "home grown" electrionic health records (EHRs), software firms saw a market for off-the-shelf records systems that they could peddle to hospitals and doctors' offices. In the process they often failed to debug the system or to address the criticial software-user interface issues, so that we began to hear increased reports of patient harm or risk resulting from the implementation of flawed EHR products. Yet the politicians continued to extol the EHR as if it could do no wrong and would solve all the cost and quality problems in health care. The Obama Administration seems poised to pour billions into EHRs with minimal attention to quality control.
Hence I was delighted to see an e-mail from my esteemed Michigan colleague and EHR expert, Dr. Scott Monteith:
"I’m in DC at the American Medical Informatics Association (AMIA) meeting... [S]uffice [it] to say that the medical informaticists/HIT experts are tempering their enthusiasm for HIT, with many questioning ... HIT safety/efficacy, etc ... For example, there was a standing-room-only debate addressing this question: are EHRs safe and effective? After the debate the audience of largely medical informaticists voted NO, they are not. "
Dr. Monteith here describes an important shift in opinion. Most of the physicians who became "early adopters" of EHRs were passionate about the potential advantages and initially were very reluctant to voice any concerns. The few who became the pioneer nay-sayers were often treated as outcasts. Yet now the concerns are fast becoming mainstream.
My personal story is that during the last 5 years I was actively seeing patients, 2001-2006, my academic family practice group used an electronic record that we researched carefully before purchasing. Our experience was overall highly positive, and I came away quite enamored of the advantages of EHRs and was a bit slow on the uptake to recognize the downside. So I am far from being an opponent of the EHR myself. But, to repeat my previously posted comment, a software company that starts to sell EHRs must acknowledge that it just became a medical device manufacturer, and whatever the ethics are of selling software to take the redeye out of your home snapshots, medical devices are a different matter entirely and the responsibility for safety and quality just went up by a factor of 10 or 100. Fortunately at least the docs heavily involved with HIT/EHRs are starting to get this message.
Tuesday, November 16, 2010
The main article was a meta-analysis of the antidepressant, reboxetine, manufactured by Pfizer. This drug, a newer generation antidepressant that selectively inhibits norepinephrine reuptake rather than serotonin, has been approved for sale in several European countries, but was rejected by the US FDA. Published meta-analyses showed that the drug was modestly effective, and perhaps about the same in both efficacy and safety as other popular antidepressants.
Somehow the IGWIG folks were able to figure out that the published trials did not embrace the total number of subjects actually enrolled in research studies. Their initial assessment of the drug was that due to missing data, they could not issue a recommendation. Initially Pfizer complained about this, but then changed tack and for some reason, actually disclosed all their in-house data to the IGWIG people. Based on that new body of data, the IGWIG team performed a new meta-analysis, which BMJ published. (The second article describes the process by which IGWIG secured the data.)
The new meta-analysis reveals that although nearly 4600 subjects were enrolled in trials of reboxetine (comparing it to either placebo or SSRI antidepressants), the published data on which previous meta-analyses relied included only about 1/4 of those. If the totality of the data are reviewed, the IGWIG team concluded: "Reboxetine is, overall, an ineffective and potentially harmful antidepressant."
If you bother to look at the BMJ paper's figures, you'll see the graphic presentations of the various trials of the drug, either for drug efficacy or for side effects and safety. Each plot shows what would appear to be clear publication bias. If Pfizer had reviewed all the studies, and had elected to publish out of about 13 studies the 1 or 2 studies that were most favorable to reboxetine, then the resulting plots would have been exactly what you see in the IGWIG meta-analysis.
BMJ accompanied the two IGWIG papers with an editorial:
--in which they said, "Lost in the sometimes rancorous debate over research transparency, and the reasons for publication and non-publication, is the most important thing: efforts are needed to restore trust in existing evidence. To that end, the BMJ is more interested in constructive use of data than finger pointing or blame. " They promised to publish a special theme issue late in 2011 on the problem of research publication transparency and offered to print any useful suggestions for reforming the present system, which as seems obvious is simply broken beyond repair.
For a while, it seemed our salvation was going to lie with trial registries. Just force the companies to register trials when they start, and it will become very har for them to pretend the trial did not exist if they later don't like the outcome. That was a hope that seemed alive when I wrote HOOKED. It now seems, sadly, that registries are not the sole answer, at a minimum. One problem is that registries don't seem to talk to each other very well so that the lack of a single, unified registry is becoming problematic. The second problem is that there are a lot of things the industry can do to the raw data that never show up in any registry--such as happened with the VIGOR trial, for instance, in which reportedly, just enough deaths that were probably due to heart attacks were reclassified as due to something else so as to make Vioxx seem safer than it was.
But as a small bright spot, something apparently worked--since in the US, the FDA never approved reboxetine.
Friday, November 12, 2010
Dr. Eric G. Campbell and colleagues were responsible for the survey published in 2007, that used 2004 data to show that 94% of American docs had some sorts of financial ties with the drug industry. Repeating the survey in 2009 (subscription needed to access), they found this had dropped to 84%.
There were similar drops in just about every category of "gift": drug samples fell from 78% to 63.8%; food and beverages from 83% to 70.6%; speakers bureau payments, 16% to 8.6%; consulting payments, 18% to 6.7%. In one area, the new PhRMA code of conduct may actually have nearly omitted one egregious sort of payola--tickets to cultural or sporting events fell from 7% to 1.3%.
The investigators noted specialty-specific differences in which of these categories fell the most. Overall, cardiologists remained most "on the take" of any specialty. The data also showed that physicians reporting financial ties to Pharma were less likely than physicians with no tie to report that they prescribed generic drugs instead of equivalent brand-name drugs.
The biggest weakness in this study, as the authors gamely noted, is that it's strictly self-report. Therefore the falling figures may reflect not actual behavior, but rather the fact that it's now less socially acceptable to admit taking bribes.
In sum, we have seen (and have reported in HOOKED and on this blog) a number of events occurring between 2004 and 2009 that tended in the direction of urging physicians to take a harder look at financial ties to the drug indutry and to take actions to limit those entanglements. The data would provide some suggestion that maybe a few docs are listening--and also that we have a long way yet to go.
Campbell EG, Gruen RL, Mountford J, et al. A national survey of physician-industry relationships. New England Journal of Medicine 356:1742-50, 2007.
Campbell EG, Rao SR, DesRoches, CM, et al. Physician professionalism and changes in physician-industry relationships from 2004 to 2009. Archives of Internal Medicine 170:1820-26, Nov. 8, 2010.
Monday, November 8, 2010
An opportunity to do a rationalization review is provided by this newspaper article by Bill Lascher for the Clark County (Washington) Columbian:
Now, how would I know what's being printed in the Clark County Columbian? Mr. Lascher phoned me and asked for an interview, after he followed up on the new ProPublica database (http://brodyhooked.blogspot.com/2010/10/propublica-launches-database-on-docs.html). Let me first comment on the part of the article that contains that interview. I am sure I was not misquoted and that I said the words that were reported. Yet I still have a sense that my context was distorted, as I come across in this article sounding much more accepting and blase about docs taking money from Pharma than any reader of this blog would be aware of. Anyway if I had the interview to do over again I would certainly approach it differently.That's merely by the way, however, as my main agenda here is to look at what Mr. Lascher found in his home county, and what the various players had to say about it. I'll report that in the form of "Quote" from the article and "Translation" into plain English, stripped of the usual rationalizations.
A good deal of the article discusses a certain Dr. Jeffrey J. Hansen, who topped out the local doc's money list at $107,302, about 5 times more than his nearest competitor. Here's what Dr. Hansen had to say about his take:
Quote: “I don’t believe it influences my prescribing practices because I work with a number of companies,” Hansen said. “I want to make sure that no matter who’s sponsoring my speaking the message is the same.”
Translation: Lots to discuss here. Does it influence his prescribing? The companies surely hope so. We've seen recently--http://brodyhooked.blogspot.com/2010/10/from-propublica-seamy-side-of-pharma.html--yet more evidence that being picked to be on a company's speakers' bureau is more about the volume of their stuff you prescribe and a lot less about your speaking abilities. Does it make a difference if he works for many companies? I wonder how often he recommends exercise instead of drugs for mild to moderate depression, or how often he talks about the body of research that suggests that the newer SSRI antidepressants are little better than placebo in large meta-analyses. Is the message the same? Very unlikely; most companies supply their speakers with the company PowerPoint and demand they stick with the script, since deviating from it could land the company in hot water with the Feds.
Quote: “When I partner with a pharmaceutical company they actually cover the cost of my overhead in presenting this data,” he said. “I enjoy the process of speaking and talking about psychiatry and I do think it improves quality of care for patients.”
Translation: Well, if $107K just barely covers his office overhead, then either he's gone a heckuva lot or else he really makes a ton of money in his office. In HOOKED I described a family doc in California who was said to not schedule any patients between 10:30 and 2:30 each day, so that he could get away to give lunch-time drug talks at any location within an hour's drive of his office--and by doing so cleared an extra $160,000 a year. I'm sure that just barely covered his overhead, too.
Quote: Most of the money Hansen received came from Eli Lilly. Hansen said he spoke ... about a disease state associated with major depressive episodes. He talked about new research on neuroimagery and genetics and didn’t discuss Eli Lilly’s product for the disease....“It’s truly an educational series just based on education related to illness,” Hansen said.
Translation: Since it's education and not marketing, it must be just a coincidence that Eli Lilly pays for this, and pays for it out of its marketing budget. Drug companies know exactly how to teach docs about "the mechanisms and genetics of disease" in such a way that the take home message is that one and only one drug is best for the condition. Or else they just stress drug treatment for the disease in general, knowing that their drug has a certain percentage of market share, and that if docs prescribe any drug, they'll pick up that percentage.
Now we'll give the good Dr. Hansen a respite and go to the section of the article about local hospital systems and their regulations about conflicts of interest.
Quote: Southwest Washington Medical Center prohibits pharmaceutical representatives from holding raffles, drawings or “other activities that lead to personal gifts for providers or employees.” The policy also says doctors — most of whom are not employees of the hospital but partner with its Southwest Medical Group — “should not directly solicit or receive personal gifts from pharmaceutical companies.” Southwest does not prohibit doctors from receiving payment for work that they do with pharmaceutical companies, however.
Translation: Southwest has no effective rules.
Quote: Legacy Health System’s policies say payments, reimbursements or subsidies should not be accepted to cover travel or to compensate for time spent away from practice. Limited exceptions apply for doctors who incur out-of-pocket expenses, and only then under certain conditions. Legacy directly employs about 900 people in Clark County, 30 to 40 of whom are doctors, spokesman Brian Willoughby said. Legacy’s administrative policy — which is updated every three years, most recently in January — prevents doctors with whom it contracts from accepting cash or cash equivalents. It also prohibits doctors from accepting gifts totaling more than $75 per year from any given vendor. Willoughby said the policy covers foundation board members and members of Legacy’s management team, not just its doctors. “We hire people with integrity,” Willoughby said.
Translation: Legacy seems to be starting off from a serious stance about physician COI. The next question is that now the data on physicians' take from Pharma is starting to become available, whether anyone at Legacy has consulted the figures for their physician employees, to see if they are actually complying with the policies.
Dr. Roy Poses discusses a recent blog posting by Prof. Richard Epstein of the University of Chicago and New York University law schools (funny thing; as an academic I have always found it as much as I could manage to work for one institution at a time; I never tried working for two). (Link to Epstein posting is in URL above) Prof. Epstein is a strong defender of the so-called free market and believes that undue restrictions on financial conflicts of interest are stifling important innovation in Pharma. (What else would you expect? The blog on which he posted his comments is called "The Libertarian.") One of Dr. Poses' special hobbies, which warms my philosophical heart, is to analyze people's arguments in search of logical fallacies. He finds a whole raft of them in Epstein's recent post and lists them all for your edification.
For earlier mention of Prof. Epstein in this blog, see http://brodyhooked.blogspot.com/2007/08/epstein-vs-relman-debate-to-overlook.html
Friday, November 5, 2010
This seems to be the latest chapter in the Lucentis-Avastin saga:
Genentech's problem: It manufactures both Avastin, a cancer drug, and Lucentis, a drug made from the active portion of the same molecule as Avastin (a classic "me too drug" strategy). Avastin injected into the eye is very good for treating wet macular degeneration. A dose of Lucentis for this indication costs $2000 while a dose of Avastin (used off label) costs $20-50. Looked at another way, in 2008, Medicare paid for 480,000 injections of Avastin, because so many retinal specialists (to their credit) want to use the cheaper but equally effective drug. Only 337,000 injections of Lucentis were paid for that year. Yet the smaller number of Lucentis injections cost the US taxpayer $537M compared to $20M for the Avastin.
Genentech would love to get more docs to use Lucentis, which this year has reached blockbuster drug status in the US with $1.1B in sales, especially before the results of a large scale trial are reported next spring, which many predict will show Avastin to be either the same or even better than Lucentis for this disease.
The answer: a rebate program that rewards docs who use high volumes of Lucentis and who increase their use of Lucentis from quarter to quarter. This is legal, but it seems interesting from an ethical standpoint that Genetech has operated this program in secret. Docs who sign up have to promise not to reveal even the existence of the program, let alone its terms.
Dr. Greg Rosenthal, one of the leaders among retinal specialists for the cost-saving use of Avastin, is quoted in the article, "There's no way to look at [the rebate program] without calling it bribery." The American Academy of Ophthalmology has said it will investigate. The bribery seems to be working--Lucentis sales are up 29% in the first 9 months of 2010.