Wednesday, July 29, 2009
Thomas Stossel is a senior physician (Hematology) at the Brigham and Women's Hospital and a professor at Harvard Medical School. As I wrote last week, Stossel was the prime mover & shaker in arranging a conference for a group dedicated to the proposition that industry collaboration with physicians has been much more beneficial than harmful to patients over the past several decades. The goal of the group (Association of Clinical Researchers and Educators, or ACRE) is to organize a pushback against what they see as a movement comprised of anti-industry "zealots" who are out to "infect...medical school ethics instruction with guilt." (NB: this is more a paraphrase than an exact quote, although every word in quotations comes directly from his testimony.)
I noted after perusing their website that they were long on hot rhetoric but short on facts, and after reading Dr. Stossel's statement to the Senate Special Committee I remain not terribly impressed. His thinking seems to rely on a characterization of industry-funded CME critics as Luddites, who have a reflexive hatred of the profit motive: the "oft-repeated mantra that 'companies have a fiduciary responsibility to shareholders whereas physicians' fiduciary responsibility is to patients'...[is an] opaque platitude imply[ing] that business has no social responsibility and that physicians only behave in a venal manner when contaminated by business." In other words, Stossel believes his opponents think that industry (or profit, or both) is always equivalent to evil, and that physicians must remain pure from the evil profit motive.
Of course, that notion itself is so facile it can only induce a sigh. The issue, at least from my perspective, has always been one of bias. Physicians are a bit like little siblings of scientists in that scientists try to discover "truth" and in doing so are constantly vigilant against anything that could bias their view, while physicians have more practical concerns (their ultimate goal is generally to heal patients) but still are, and should be, deeply preoccupied with bias. Well, if lucrative financial deals don't constitute a profound source of bias, then pray tell what does?! It's not about the good or evil that comes of the profit motive, and indeed, the absolutely abominable behavior of some of the drug companies has given a bad name to the many good corporate citizens who do churn out useful products and deserve to profit from them. But to pretend that such bad behavior doesn't exist is to stick one's head in the sand. Moreover, regardless of the extent of bad behavior that has gone on in the past several years (of which there are an ample number of examples), ignoring the potential bias that can result in a physician's mind from financial perks doesn't merely ignore common sense, it ignores a great deal of psychology research that would suggest otherwise.
One can get a yuk or two in (should one be inclined to get yuks out of reading congressional testimony) by glancing at the beginning of Dr. Stossel's statement, in which he alleges that even the use of the phrase "conflict of interest" is a ploy (his exact word! see shortly) designed by that coterie of critics who wish to create an uneven playing field in the public relations war designed to win the hearts and minds of the public, and that nobody has any business even bringing the phrase to the discussion. I'm not kidding. Here is the paragraph (which, as a former English teacher, induces a cringe in me for being the polar opposite of lucid, with all of its subordinate clauses piled on top of one another, but you be the judge):
"'Conflict of interest' is only a meaningful term in terms of regulatory implications in the context of self-dealing by persons in positions of political or judicial power--and physicians and researchers do not even come close to having such influence. Therefore, the intent of the phrase in the context of medicine is a ploy, used since the beginning of recorded history, of adversaries to invoke allegedly evil motives of an opponent--such as greed--as a weapon in an argument they cannot win on substance."
Got that? Only someone in a position of political or judicial power can have a conflict of interest. Alas, this very, very narrow reading of the term is not what most people think when they utter the phrase "conflict of interest." Take this very simple, workman-like definition from Webster's New World College Dictionary: "a conflict between one's obligation to the public good and one's self-interest." That's how lots of people would define it, although even "public good" seems a touch narrow, since teachers or lawyers or the clergy have obligations to students, clients, and parishioners respectively rather than the public good. You can see how this contention that "conflict of interest" is a manufactured phrase doesn't hold up under even cursory scrutiny.
More damning to Stossel's contention, however, is the definition provided by the National Institutes of Health. That is, this is the principal body in the US that defines the ethical behavior of medical research: "a conflict of interest occurs when individuals involved with the conduct, reporting, oversight, or review of research also have financial or other interests, from which they can benefit, depending on the results of the research." Their definition doesn't even trouble itself with the characters that Stossel wants to reserve for exclusive use--judges and politicians.
Ignoring such obvious interpretations of the term might be viewed as, you know, maybe, um, a weapon in an argument one cannot win on substance.
(If the former English teacher can also get in a teaching point here, it is this: please read out loud your statement to a Senate committee before you go to Washington! The phrase the intent of the phrase in the context of medicine is a ploy really should have been written the phrase is a ploy--an "intent" can't be a ploy. Eliminate useless words, class! If there is evidence in this blog entry to the contrary, keep in mind that this blog is pretty much a first-version essay each time out with no time for revisions, and I'm not testifying before Congress.)
It's quite tedious to have to respond to the more fanciful accusations riddling Dr. Stossel's remarks: that nobody wants industry to fail, that physicians can have collegial relations (or even productive collaborations) with medical industry corporate employees, that...oh, you get the picture. The point that has to be made, again and again apparently, is that physicians can be biased by pharmaceutical companies, and that pharmaceutical companies have a responsibility to make money while physicians have a responsibility to treat patients. It's good that there's a profit incentive for corporations. It's bad when physicians are given financial incentives to try to influence the prescription patterns of their colleagues--precisely because those financial incentives allow bias not merely to creep in, but rather knock down the door, barge in, put up its feet on the coffee table, pop open a beer (or, since were talking about physicians, uncork a nice bottle of cabernet) and watch TV. That's bad for patients.
Dr. Stossel also implies that critics of my ilk are clamoring for governmental oversight into every nook and cranny of the industry-physician relationship. For my part I would prefer that government not have to legislate on such matters. Honestly. But here's the rub: I would likewise prefer that my professional brethren and sistren regard the baubles offered by the pharmaceutical industry with contempt, for after all, if the drugs the company makes are good, they will surely flourish under a peer-reviewed system in which no conflict of interest exists, right? I would hope that this would be the prevailing attitude among medical students, for instance. But--good God!--it's not even the majority position among the faculty! And if we can't get the house in order, and further and further evidence of abuses mounts, leading any sane person to conclude that there's a systemic problem out there, well...that's when you get Congress to take note. And as we have found in so many recent episodes in our country, it's not necessarily a good thing when Congress gets involved. But if it does, the fault will lie at the doorstep of the physicians who have abused the goodwill of their patients, as well as their apologists like Dr. Thomas Stossel.
Dr. Stossel's statement can be found here. It takes some time to get through but for those interested in the CME issue it's worth the time investment. In the coming days I hope to have more to offer on some of the other witnesses (or even some of the Senators!).
Hat-tip to the Carlat Blog for the link as well as his attendance. I wanted to make it to the conference as it's down the road from my house, but pressing research issues (including a meeting with the boss) took precedence.
Tuesday, July 28, 2009
The economists are rather philosophical adversaries: Stuart Butler serves as the vice president for domestic and economic policy studies for the conservative think tank The Heritage Foundation, and Paul Krugman (a favorite of Billy's) recently won the Nobel Prize in Economics, writes a column for the NY Times and is a champion of political liberalism. As always, such terms as "conservative" and "liberal" get a little slippery and often aren't helpful, although in this case I use the labels since they indicate their general attitude toward their faith in "free markets" and whether they believe government involvement can improve or worsen a more laissez-faire system. Both men are highly articulate and offer a much more in-depth discussion than that found on cable network news. Moreover, given their divergent perspectives, it is astonishing listening to how much they agree about in terms of how ridiculous, wasteful, expensive and ultimately ruinous the current system is.
Tuesday, July 21, 2009
So what's the conference and why such a big deal?
First, some background and a little explanation of the "war." Over the past decade or so, an increasingly vocal but small minority of physicians have begun to publicly question the relationship that physicians have with for-profit companies involved in medicine, primarily pharmaceutical companies. They have noted that many physicians have become wealthy, for instance, by serving as "professional experts" earning honoraria speaking to audiences of physicians who are fed free dinners (compliments of the company sponsoring the event) and who receive credit for "continuing medical education." They have questioned the structure of postgraduate medical education, which can be heavily influenced by the pharmaceutical industry in the form of Medical Education and Communication Companies, or "MECCs," allowing pharm companies to sidestep sticky conflict-of-interest issues by paying physicians directly for teaching, instead using the MECC as a third-party payer. Indeed, they have highlighted the problems of medical school education as well, since many of these doctors who serve as paid speakers for drug companies also teach medical students without ever revealing that they do so.
Many docs have become involved in this critique of the current relationship between physicians and industry--and I count myself among these people--but probably none is more important than Marcia Angell, whose book The Truth About Drug Companies: How They Deceive Us and What to Do About It lays out in just over 300 pages, and in fairly lurid detail, the tactics used by the pharmaceutical industry to deceive physicians and patients alike in order to boost sales and profits. It is an excellent and highly readable book, and remains the best overview of the critical problems in this often overlooked area of medicine.
There is a lot of pushback by the industry and those physicians already co-opted by them. One small, precious example can be found here, where one Jonathan Leo, professor of Neuroanatomy at Lincoln Memorial University in Tennessee, tried to point out to the Journal of the American Medical Association, one of the premier medical journals in the US, that one of the lead authors of a paper had not properly disclosed a serious conflict-of-interest to the journal. The study involved giving antidepressants to stroke victims prior to developing depression in an attempt to prevent it (depression being a common condition following stroke); the lead author had been a paid consultant by the very company whose drug was being studied. When Dr. Leo questioned the conflict, he never received a reply from the JAMA editors, so nearly six months later he had his letter published in the British Medical Journal, which was met with howling outrage by the JAMA editors who not only verbally threatened Dr. Leo, but also told reporters at the Wall Street Journal that Leo was a "nobody and a nothing," and that "he is trying to make a name for himself." (Question: isn't that what you're supposed to do in academics? And he sure did! And for the right reasons!) Best part: while the study showed that treatment with the study drug (Lexapro, generic name escitalopram) was significantly better than placebo, it failed to show that it was significantly better than psychotherapy. The mainstream media who picked up the piece, however, quoted the study authors as saying that they believed all stroke patients should be given antidepressants--no quotes could be found about the fact that the drug was no better than therapy.
Anyway, Thursday's get-together at Harvard is the inaugural meeting of a group called the Association of Clinical Researchers and Educators. They state that "ACRE seeks to define and promote balanced policies at academic medical centers and within government that will enhance rather than interfere with our highly valued collaboration." Seems entirely innocuous, no? After all, who isn't for "balanced policies," whatever that is?
More specifics can be found elsewhere in the website, where they state that "ACRE is to be a forum for what we believe is a hitherto silent majority of individuals engaged in clinical service, medical education and medical innovation ready to oppose (but not debate) a small but well organized and well-funded coterie responsible for an anti-industry movement. This movement has inverted reality by extrapolating from an astonishingly small number of adverse events related to industry compared to the incontrovertible evidence of social good that has eventuated from thousands of industry actions over my lifetime in medicine. The movement particularly demonizes industry marketing, despite the lack of any evidence that, on balance, such marketing impacts anything but positively on patient care."
What the writer--who appears to be Dr. Thomas Stossel of Harvard, but not fully clear--means by "oppose but not debate" is unclear to me although it sounds vaguely undemocratic, but the idea that there is a "well organized and well-funded coterie responsible for an anti-industry movement" is so remarkably laughable that it must rank as one of the great overestimations in recent American history. (I particularly like the use of the word "coterie," as if somehow I've been sitting around in a parlor sipping tea with Doc Angell snarling about the bad guys of big pharma.) If critics like Dr. Angell, or the bloggers Dr. Dan Carlat, Dr. Doug Bremner or Allison Bass are so well-funded yet so anti-industry, who has the money to fund them? The local chapter of the American Communist Party?
More disturbing is a complete lack of data on the website; as far as I can tell ACRE does not marshal one fact to support their hypothesis. There are no references on the website, although there is a "link" page which includes several articles complaining about the critics, nearly half of those articles written by Dr. Stossel. Given that this is a website whose leadership consists of academic medical researchers, one would figure there would be at least a modicum of references and facts marshaled in order to make a convincing argument. But from what I can see, there's a lot of hemming and hawwing but no argument based in evidence. Ironically, the statement above notes that "the movement demonizes industry marketing despite the lack of any evidence that...such marketing impacts anything but positively on patient care" [my emphasis], which makes one wonder whether or not the authors have taken the time to even glance at the first page of The Truth About Drug Companies. Or Jerome Kassirer's book On The Take: How Medicine's Complicity With Big Business Can Endanger Your Health. Or Jerry Avorn's book Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs. Might ACRE disagree with their conclusions? Perhaps. But to me it seems fairly ludicrous to suggest that this whole critique has been generated of whole cloth. Meanwhile, ACRE has not generated one shred of evidence to support their claim on the website.
My suspicion is that they can't rely on evidence because it's not on their side, and they require strawmen to knock down so that they can look reasonable. I myself cannot speak for the other critics, but my main objection is that some doctors are allowed to generate large sums of money in the service of pharmaceutical companies in a variety of ways, and do not consider this inappropriate. Well, I consider this inappropriate, and I believe the overwhelming majority of patients consider it equally so. And I consider it inappropriate because drug companies exist primarily to make money while doctors exist primarily to serve their patients. Anyone who refuses to see that a physician cannot serve both ends hasn't been reading about what's been happening in medicine for the past two decades.
One last link: don't say docs don't have a sense of humor! Here is a link to a satirical twin of the ACRE website: "Academics Craving Reimbursement for Everything." One juicy quote: "ACRE is to be a forum for a hitherto silent majority of doctors which believes that a small but well organized coterie of do-gooders are conspiring to prevent them from buying that third home on the lake." They even get that coterie word in. Love that.
As a quick post-script, I note that one of the featured speakers at the event will be Dr. Jeffrey Flier, who is the current Dean of Harvard Medical School. A few months ago I had written about the Harvard medical students who launched a protest about the conflict-of-interest issues in the pharmacology course, and noted that Dr. Flier had made noises that he wanted to change the policies at HMS. While those changes have partially taken place (following the lead of Johns Hopkins, although this new policy is through the hospitals affiliated with HMS, not the medical school itself), I can't say I am especially encouraged by Dr. Flier's acceptance to speak at this gathering, though we will have to see what he will say.
Monday, July 13, 2009
The vaccine rate for MMR was quite high in England until 1998, when a gastroenterologist named Andrew Wakefield held a press conference where he presented research that indicated the MMR vaccine was linked with autism. The "findings" were trumpeted by the British press, and the vaccination rate fell over the next several years from 92 percent to below 80 percent. Alas, Dr. Wakefield's research was later found to have massive financial conflicts of interest; by March 2004 a dozen of Wakefield's co-authors, including some of the preeminent names in medical research in the UK, withdrew their names from the paper. But by that time the horses were out of that particular barn, and the effects are still being felt there today. And the problem has spread to our shores as well, with any number of otherwise educated people spouting about the vaccines-autism connection as if it were fact. Newsweek magazine provides the whole story in all its sordid details here. They did a commendable job of providing crucial context and essential details; would that mainstream journalism produce this kind of work more often.
Since most Americans--or for that matter most anyone who lives in a relatively developed country--hardly give it a thought, a couple of facts about the measles might be worth sharing. It is one of the most highly contagious viruses known to humans; consequences of infection can range from mild (a few days of generalized illness and the famous facial rash) to serious (among other things, a slowly progressive brain disorder called subacute sclerosing panencephalitis, which is as ugly as it sounds), to death. In fact, in countries where the MMR vaccine is not available due to adequate funds, refrigeration, or trained personnel to administer the vaccine, it is an all-out killer: in 1999 it had killed 873,000 children (and a smaller number of adults) in just one year. As part of a massive vaccination campaign in the areas where the children are not immunized or given boosters (mostly India, Indonesia, Pakistan, Somalia, Sudan and the distant rural provinces of China), the World Health Organization has been trying to get the number under control, with the annual mortality down to under 250,000 children in recent years. To give you some sense of perspective, in any given year just a bit over 10,000 children younger than age 14 die in the US each year. So this is by no means a trivial problem.
For further reading, you can peruse the information here (a guide to the studies about vaccines and autism) and here (stuff about vaccine ingredients), among other places. Also, Dr. Paul Offit, one of vaccine's greatest and most lucid proponents has written a book about the whole controversy entitled Autism's False Prophets, which I have not read but it is on my reading list. I am, however, working my way through journalist Arthur Allen's tome Vaccine: The Controversial Story of Medicine's Greatest Lifesaver, and it's been a very good read thus far.
Wednesday, July 8, 2009
On Fox & Friends a little chat was taking place over what under any sane conditions would be a study that would receive approximately zero attention by any serious science or health journalist, though nobody would confuse any of the three hosts of this show with such a beast. The study under discussion involved Scandanavian seniors, among whom those who had remained married appeared to be less likely to have Alzheimer's dementia.
Much could be said about the generally minimal worth of such a study, but that is merely a sideshow to the main attraction, which came when co-host Brian Kilmeade explained why he thought the results of such a study did not apply in the US. His reasoning? "We are...we keep marrying other species and other ethnics and other..." was his first foray into the thickets of reason.
Immediately--and to her great credit--his fair-haired co-host Gretchen Carlson tried to cut him off with a not-so-subtle rebuke: "You're sure you're not suffering from some of the causes of dementia right now?" Say what you will about the formulaic arrangement of a pretty blonde chatting with two guys on the morning news; she understood the potential for ugly consequences within milliseconds of hearing the sounds that issued from Kilmeade's mouth.
Undaunted, Kilmeade pressed on, saying, "See, the problem is the Swedes have pure genes. Because they marry other Swedes .... Finns marry other Finns, so they have a pure society." Again, Carlson responded with a look of puzzlement worthy of an Emmy, and third co-host Dave Briggs appeared to try to find middle ground with a half-question half-exclamation of "Huh?!" in response. You really have to see this thing to believe it.
The nakedly racist bent of Kilmeade's "analysis" is really only half the point (and requires no further commentary). At least as important though is the idea that this man--who reveals himself through this short little piece to be a woefully uninformed and deeply unsophisticated anchor--has been chosen by a major television news network to hold forth on the latest in medical research. Moreover, said anchor is spouting off on this inconsequential study, chosen by some superior, instead of any number of other medical or scientific topics that might be of some actual use to its viewers. Lastly, the size & reach of Fox News relative to, say, the "Health & Medicine" section of the New York Times is of course considerably larger, so the impact of such vapidity is amplified.
Video is here:
Monday, July 6, 2009
Among the unremarkable features of the article includes a little medical soliloquy, and it's unremarkable because we've seen this happen before in national political discussions. Purdum wrote:
More than once in my travels in Alaska, people brought up, without prompting, the question of Palin’s extravagant self-regard. Several told me, independently of one another, that they had consulted the definition of “narcissistic personality disorder” in the Diagnostic and Statistical Manual of Mental Disorders—“a pervasive pattern of grandiosity (in fantasy or behavior), need for admiration, and lack of empathy”—and thought it fit her perfectly. When Trig was born, Palin wrote an e-mail letter to friends and relatives, describing the belated news of her pregnancy and detailing Trig’s condition; she wrote the e-mail not in her own name but in God’s, and signed it “Trig’s Creator, Your Heavenly Father.”
There it is--Purdum, who is in theory a journalist, includes accusations that Sarah Palin has Narcissistic Personality Disorder because "several people told" him, and apparently they read the Diagnostic and Statistical Manual for Mental Disorders (in the biz called simply the "DSM") and it looked to them like it fit. Within days of the article's release, TV and radio personalities as well as various websites began trumpeting the Governor's "diagnosis" basically assuming it was factually true; for instance, a Yahoo! news bit can be found here, while Salon's War Room (Billy is normally a fan) discussed it here.
This is prattling nonsense of the worst sort, with armchair diagnosis passing for professional opinion, and then repeated again and again as if it were fact. As if to substantiate his own claim, Purdum includes a lil' note from Palin on the birth of her child Trig, noting that it was signed "Your Heavenly Father." Is it a touch odd for Palin to sign the note thus? From my perspective, yes, but I'm an agnostic east-coast Jew so I'm not so sure whether or not this is just a cultural thing and perhaps passes for normal and heartwarming among Christians in Alaska. Does it indicate that Palin thinks--as the placement of this story in this particular paragraph suggests--that she is the Heavenly Father, or speaks directly for him? That seems like such a stretch to me that Purdum appears guilty of the worst kind of guilt-by-innuendo journalism that marks so much of political reportage these days.
For what it's worth, here is the current DSM definition of Narcississtic Personality Disorder:
The symptoms of narcissistic personality disorder revolve around a pattern of grandiosity, need for admiration, and sense of entitlement. Often individuals feel overly important and will exaggerate achievements and will accept, and often demand, praise and admiration despite worthy achievements. They may be overwhelmed with fantasies involving unlimited success, power, love, or beauty and feel that they can only be understood by others who are, like them, superior in some aspect of life.
There is a sense of entitlement, of being more deserving than others based solely on their superiority. These symptoms, however, are a result of an underlying sense of inferiority and are often seen as overcompensation. Because of this, they are often envious and even angry of others who have more, receive more respect or attention, or otherwise steal away the spotlight.
This, though, doesn't describe the features which distinguish personality disorders as a whole from the unflattering qualities that they represent. DSM elaborates on this, noting that to be diagnosed with a personality disorder, the following criteria must be met:
-Symptoms have been present for an extended period of time, are inflexible and pervasive, and are not a result of alcohol or drugs or another psychiatric disorder.
-The history of symptoms can be traced back to adolescence or at least early adulthood.
-The symptoms have caused and continue to cause significant distress or negative consequences in different aspects of the person's life.
-Symptoms are seen in at least two of the following areas:
Thoughts (ways of looking at the world, thinking about self or others, and interacting)
Emotions (appropriateness, intensity, and range of emotional functioning)
Interpersonal Functioning (relationships and interpersonal skills)
Could Governor Palin be vain, vindictive, grandiose, have a sense of entitlement, and demand praise and admiration? Certainly--and I think there's plenty of evidence to indicate that at least some of these adjectives apply to her. But that doesn't give her the diagnosis of Narcissistic Personality Disorder. And Vanity Fair's Purdum (to say nothing of his editors), in blithely repeating these assertions from unnamed sources who almost definitely are not mental health professionals, attaches a clinical tag to her troubles. (Indeed, when considering this list of personal attributes and applying them to other politicians, President Obama's Chief of Staff Rahm Emmanuel has a reputation for being profoundly vindictive; one can find more than a whiff of vindictiveness in this story about how the White House is offended by one lefty Democratic congressman's willingness to call out the administration on what he believed was a lousy energy bill. Do they all have personality disorders as well?)
Liberal readers may recall that the shoe was on the other foot not too long ago, when then Senate Majority Leader and potential Presidential candidate (and, lest we not forget, actual physician) Bill Frist took to the Senate floor to pronounce his diagnosis that Terri Schiavo was not in a persistent vegetative state. At the time, the howls of indignation came from many corners, and rightly so: Frist was so far out of bounds as to deserve censure from his state medical ethics board in my opinion.
In Palin's case this is no less true. Nobody but appropriately qualified professionals should be bandying about diagnoses. Sarah Palin does not have a personality disorder; she does, however, have a personality disorder problem--the problem of snarky and shallow journalists shoving this kind of bilge on what appears to be an uncritical public.
I find Sarah Palin the politician contemptible in any number of ways. My principal objections to her is that she appears to be not merely uninformed but incurious, and she also appears to revel in anti-intellectualism. But I don't claim to know anything about Sarah Palin the person. From a distance I see a woman who made it to the position of Governor by her early forties--no mean feat, that--and has a family who appear to love her, whatever issues they may have (as all families do). I am perfectly willing to condemn any number of stands that she has taken since she has risen to political prominence. I am fearful of the prospect of a President Palin, although this happily seems to be increasingly unlikely. But I am not willing to go along with the idea that its okay for journalists to lazily repeat assertions of her supposed personality disorder.