Tuesday, February 21, 2012

Is There Such a Thing as “Created” COI?

Our friend Dr. Roy Poses, over at Health Care Renewal blog, has coined a new term, “created” conflict of interest:

Here’s the basic idea: “We have repeatedly discussed the adverse effects of conflicts of interest on health care. Recently, I argued that the most pernicious are conflicts of interest created as an incentive for trusted health care leaders, usually respected health care professionals or academics, to promote the vested interests of those who pay them, in the guise of the leaders' professional roles. In this capacity, the leaders are often dubbed "key opinion leaders" by those who employ them, but may be regarded as mere "salesmen" by the corporate personnel who recruit them. (See posts here and here) These relationships may be hidden, often behind confidentiality agreements, unless revealed by litigation. Documents revealed by discovery in legal actions showed how companies planned other organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post here about marketing of Lexapro, and here about Neurontin).”

So let me see if I can dissect this a bit. Some COIs simply appear or emerge. An example: A case comes before a judge. At first glance there is nothing suggestive of a COI, the judge does not know of any special relationship he might have with any of the parties to the case. But as the facts unfold, the judge comes to realize that one of the parties to the case has a close relationship with Company X, and a close relative of the judge is an executive with company X. The judge now decides to recuse himself because of possible bias. If we call this COI and not simply “bias” then it would seems a good example of non-created COI. No one set out to create a situation in which this judge would be biased; it simply seemed to happen.
I take it that the contrast then is with a drug company bribing a KOL. The company deliberately set out to create the COI. Now, is that quite an accurate description? In one sense the company did not set out to create a conflict of interest; they merely wished to create a strong interest in the KOL shilling for them loyally and enthusiastically. But in another sense they did create the conflict quite deliberately. The KOL has to have interest #2 (supposedly being a neutral and unbiased scientific authority) in order for the company to regard him as a KOL and so worth tempting with interest #1.

One could further quibble: just who “created” the conflict? One could of course say the drug company did; they set out to corrupt this person to be used as a marketing tool. But one could also say that the would-be KOL could have said no to the company and so by agreeing it was the individual and not the company that “created” the COI.

So I end up with the skeptical stance that once we explain (ethically) just what is worrisome about COI, I am not sure that we say a heck of a lot more by adding the modifier “created.” Some COIs are in fact innocent and others are problematic but relatively easily managed. So COI lies along a spectrum of severity.

Of all COIs, I agree with Dr. Poses that instances where the industry deliberately corrupts KOLs so as to use their supposed scientific objectivity for marketing purposes are among the most severe. The reason for this (as I discussed in HOOKED, citing the work of my colleague Len Weber) is the way in which medical professionalism is deliberately dragged into the gutter for profit. This is a form of COI even more to be ethically deplored for that reason.

I cannot in the end dispute the use of the modifier “created” for come COIs. So why am I resisting? I guess my only reason is that I see COI, as noted, lying along a spectrum of severity. I think a spectrum metaphor is a more useful way to approach the COI question that a dichotomy, “created” vs. “not created.” But let’s let Dr. Poses run with his idea and I’ll see if he’ll convince me of its utility.

Monday, February 20, 2012

60 Minutes Weighs In on Antidepressants

I was just checking out on line yesterday's "60 Minutes" segment--
--that features a friend, Dr. Irving Kirsch of Harvard, a psychologist whose work on placebo effect and expectancy I have long admired. But the segment is only peripherally about placebo effect; it's rather about Kirsch's now oft-repeated finding that except for severe depression, the difference between antidepressants and placebos in clinical trials is negligible.

As seems typical, the news program featured as "gosh golly gee whiz" news stuff that we've been over in this blog many times before:

  • The serotonin theory of depression, on which most antidepressant therapy is based, is either only a part of the story or else dead wrong

  • The drug companies selectively publish the drug trials that show benefit and selectively hide the trials that don't

  • Several independent investigations have agreed with Kirsch's original work that in mild to moderate depression, there is hardly any difference between drug and placebo effects
What I personally found new was an interview with a British psychaitrist reporting that the UK National Health Service had independently replicated Kirsch's studies and found the same results. So they are now actively discouraging the use of antidepressant drugs for mild-to-moderate depression (the categories for which prescriptions in the US have exploded in the past 20 years) and are now busy working hard to implement--guess what--psychotherapy counseling and exercise programs which work just as well for those patients.

If I had any major quibble with the program, it was that the magic words "side effects" were first mentioned at around 11:30 of the 13:40 segment (by the British psychiatrist). Those words tell the whole story. Placebos might be equivalent to drug in regards to benefits--but certainly not with regard to adverse reactions. We have been incredibly slow (aided by aggressive drug company marketing) to realize in medicine that most of these "nonaddictive" drugs actually have serious withdrawal syndromes, such that the worsening symptoms when patients go off their antidepressants--interpreted by the drug companies as sure proof that they work--might just as well be drug withdrawal symptoms as recurrence-of-depression symptoms.

The other fun part of the program was watching the US psychiatrist (and of course, consultant for several drug firms) who was put on to defend the track record of these drugs. He naturally made no mention of side effects whatever, but he did insist that in his own independent studies, 14% of moderately depressed patients do better on drug than on placebo. (He admitted that it was a wash in mild depression.) In his mind this justified current practice. Can you believe it--14%??? For a condition where the drugs have serious side effects and where talk therapy or exercise work as well? And that's apparently the best rebuttal the drug industry can come up with?

I must here repeat the usual disclaimer--don't try this at home--if you're depressed see your doctor and do what the doctor says, and above all don't discontinue any drug without the doctor's advice.

Sunday, February 19, 2012

Baby, Bathwater, and Prescribing for Chronic Pain

John Fauber, the indefatigable investigative reporter from Milwaukee, has a new article out on how the current overuse of opiate narcotics for treating chronic pain was spurred by heavy industry funding of major pain organizations, including one at University of Wisconsin:

I have blogged on this topic before: http://brodyhooked.blogspot.com/2011/12/painful-to-report-propublica-skewers.html--and also got out a little bit ahead of it back in HOOKED when I sympathized with the pain organizations but also criticized them for taking industry money and leaving themselves open to these charges.

I agree therefore with Fauber that these organizations issued tainted statements and guidelines due to their willingness to take funding from industry--which at the time might have seemed understandable because no one else was willing to put funding into pain issues, despite the estimated 75-100 million Americans who live with undertreated chronic pain. It is important that we don't lose sight of this critical public health need for better pain management while getting on the latest bandwagon deploring the overprescription of narcotics.

Where I would take Fauber's article somewhat to task is for 20-20 hindsight. Today we have some reasonable evidence to urge caution in prescribing opiates for chronic pain, especially in higher dose ranges. This evidence was not generally available 10-15 years ago when many of the ideas about improved treatment of chronic pain were first formulated. While it is true that these pain guidelines were unfortunately influenced by money from Pharma, it is also true that there were reasons to believe in the older style of pain therapy that was willing to go to higher doses of narcotics, and the evidence then available did not clearly indicate its hazards or limits.

As a family physician I never was a pain "specialist" but cared for a number of patients with severe chronic pain before I ceased patient care in 2006. If I knew then what I now believe to be the case, I would have managed some of them differently. But at the time I could point to apparently authoritative guidelines to support what I did, and I had all too few real options available--another point ignored by Fauber's article. What do you do with chronic pain that's not responsive to lower-dose opiates? The ideal answer, so far as I now know, is to refer the patient to a multidisciplinary pain clinic with a team approach that includes pain psychology, physical and occupational therapy, and so on along side pain medicine--and that's also willing to prescribe narcotics if that's justified in any individual case. Such clinics are few and far between--and if your patient is Medicaid, which is very commonly the case, then it's even harder to find such help for treating them adequately.

I would also disagree with one rather sweeping conclusion Fauber offers, that "pseudoaddiction" is a concept promoted by industry marketing, now known to be invalid. Pseudoaddiction refers to the fact that patients with untreated severe pain will in fact be "drug seekers"--they will display behavior which health providers often interpret as that of an addict just trying to get a fix, when the underlying problem is pain and not addiction, and if you gave enough drug to eliminate the pain, all the "drug seeking" behavior would disappear. As a clinician I would argue that this concept remains valid. Fauber seems to dismiss it because it's obviously invalid if one assumes that any patient showing such behavior is not an addict but has undertreated pain. I don't know any pain expert who has ever recommended this perspective; the suggestion as I have always understood it is that pseudoaddiction should be considered as a possibility alongside other explanations for the patient's behavior.

The sad news from a public health perspective is that if high-dose opiates are not the way to properly treat chronic pain, simply saying so, and ceasing to prescibe opiates that way, does nothing to diminish the serious problem of undertreated pain in our society. One of the wisest things I ever hard about this problem came from a colleague who had training in both palliative care and addiction medicine. She said that there are three kinds of patients who suffer from serious diseases and that deserve our sympathy as well as the best treatment we can come up with. The first group has severe pain. The second group has addiction. The third group has both of the above. While all three deserve our sympathy and care, what's the right type of care depends critically on locating each patient withyin the correct category out of the three. Sadly many practitioners in the US today don't have the sort of help they ideally need to make that determination, let alone administer the correct therapy.

Saturday, February 18, 2012

More on Bioethicists and COI

I've had considerable feedback both in the form of blog comments and off-line e-mail regarding the previous post on bioethicists and conflicts of interest. One e-mail raised a factual issue which I have tried to correct in an addendum to the original post.

However a couple of writers have raised a response which I need to identify and challenge. The claim is that Dr. Glenn McGee may have done something ethically questionable, if not actually shameful, by becoming an executive and spokesperson for a for-profit company that markets unapproved stem cell therapy. But this is of no interest to the field of bioethics. If there is shame, it falls solely on his own head.

Sorry, in my view, this won't wash. When I do our course on "professionalism" for our medical students, if one of them says, "Look, if I want to have sex with my patients, I will go ahead and do it; if somebody objects, the responsibility is solely my own and has nothing to do with the professional of medicine as a whole," then I would gently try to set him or her straight on what professionalism means. (OK, maybe not quite so gently.) The idea that becoming a part of a profession constitutes a sort of collective promise of ethical behavior to society at large is a concept that many of our students, imbued with good ol' American individualism, resist mightily. I would argue that nonetheless it is the only way to think coherently about the concept of professionalism as an ethical or normative (not as a sociological or descriptive) notion.

Now, just what bioethics is has been debated for decades, and many assert for good reasons that it is not a profession as such. (There is, for instance, no standard licensing exam.) That said, and not boring you with that debate, I would assert that bioethicists should regard themselves as professionals, and most are in fact professionals of one stripe or another--physicians, nurses, attorneys, university professors. So I think bioethics cannot evade the implication that bad behavior by one of us reflects badly on the entire "profession" or field or whatever; and without that assumption I would have had no grounds for calling attention to Dr. McGee's behavior or offering my opinion of it.

One writer suggested in an e-mail that Dr. McGee has now left the field of bioethics, so presumably if he wants to make a bundle of money doing something questionable (to put it as kindly as I can), so be it. If that were true, I wish he would have said so, instead of accepting a position that has "ethics" in its official title.

NOTE ADDED 2/29/12: Nature has chimed in with news coverage to confirm that Celltex is not only banking and growing stem cells, for a hefty price tag, but also is involved in injecting the cells into patients, which is not FDA approved and is considered unproven therapy:
The Nature coverage also quotes Dr. McGee as claiming that he's at work designing new, ethically sound rules for Celltex's research, which again does not suggest that he thinks he has "left the field" of bioethics. It may be worth noting that no one at Celltex, Dr. McGee included, was willing to answer Nature's questions on the record regarding what treatments thay are now offering to patients.

Tuesday, February 14, 2012

Bioethicists and Conflicts of Interest

I write this post with some trepidation because the issue is still evolving. However, I have been committed to the idea that those of us in bioethics should be willing to subject ourselves to the same scrutiny that we apply to others, and so feel a need to walk the walk even at risk of being premature. Plus I invite comments from my fellow bioethicists to this post and maybe the comments will prove more illuminating than the post.

The latest flap in our bioethics neck of the woods has to do with the editorship of the American Journal of Bioethics and the doings of the recent editor-in-chief, Glenn McGee, PhD. According to various of my colleagues, Dr. McGee is either a) an unethical bioethicist and should be roundly condemned or b) the victim of scurrilous character assassination.

Here is some of the anti-McGee background:


Briefly, Dr. McGee was originally on the faculty at Art Caplan's prestigious bioethics program at Penn, but left when he failed to get tenure there--not necessarily a black mark as I doubt Aristotle would be granted tenure at Penn. He then became director of the bioethics institute at Albany Medical College, but left there under a cloud--lest I be accused of more character assassination I'll let the Scientific American do it instead:

The above-cited article quotes Dr. McGee as saying, "I am going to be entering a new phase of my career in which I am a dartboard." Dartboard or no, he next landed at the Center for Practical Bioethics in Kansas City where he held the John B. Francis Chair--not a terribly severe demotion, it would seem. All this time he continued to act as editor of AJOB, which he founded, and spun off two new AJOB journals, including one called AJOB Primary Research.

The controversy gets going sometime late in 2011 when Dr. McGee apparently left the Center in Kansas City to take up a position with a firm called Celltex in Sugar Land, outside Houston. Celltex is a very controversial outfit down in these parts, storing and injecting adult stem cells taken from a person's fat cells, a process which has not been FDA approved but endorsed by legislation that Gov. Rick Perry pushed through the Texas Legislature after he reportedly had a dramatic response to these injections for his back pain. Celltex is run by Gov. Perry's physician and a former Perry political ally. Dr. McGee was first listed as President of Strategic Initiatives at Celltex while a more recent news release (http://www.scribd.com/doc/81588050/February-10-2012-Celltex-Press-Release) has him as President of Ethics and Strategic Initiatives.

Now, I have to add a prequel here--a Korean firm, RNL Bio, involved in the stem cell tourism industry, had two patients die after receiving their stem cell infusions. A US group called the International Cellular Medicine Society investigated in November 2010. Dr. McGee was then on the ICMS board of directors and conducted a bioethics inquiry, which, according to Carl Elliott in one of the above posts, "found little fault with RNL Bio; he recommended better informed consent procedures and more ethics training." Now, Celltex has a close relationship with RNL Bio, having paid them a reported $30M to license their stem cell procedure. If I were to issue an "ethics" report that said Firm X was on the up and up, and then shortly after took a job with Firm Y which relies on a relationship with Firm X to be able to market its main product, then you would have reasons to be suspicious of biasin my "ethics" report, it would appear to me.

After complaints surfaced that it was inappropriate for Dr. McGee to remain as editor while working for a for-profit stem cell firm, he stepped down as editor while apparently remaining as head of the "AJOB family of journals" for the publisher, Taylor and Francis. The new co-editors of AJOB are Dr. David Magnus of Stanford, an old colleague of Dr. McGee's from Penn days, and Dr. Summer Johnson McGee, formerly managing editor of the journal, and incidentally, Mrs. Glenn McGee.

The fact that Dr. McGee retains his position as head of all the AJOB journals is significant because the Primary Research journal is now edited by Robert Nelson, a bioethicist and pediatrician. Dr. Nelson works at the FDA and is in the division that would review any application for approval of the adult stem cell treatments that Celltex promotes. So you could say that Dr. McGee is the boss of the guy at the FDA who might end up approving or disapproving his company's product.

That'a the anti-McGee case and critics are calling for the remainder of the editorial board of AJOB to at least meet and demand an acocunting of these measures if not resign en masse in protest.

On the other side, it's been pointed out (mostly on listservs where I don't have permission to copy the entries) that the editorial board is supposed to advise the editor on editorial policy, not advise the publisher on hiring and firing of editors, so it's not the job of the editorial board to decide who should or should not be editor of AJOB. Dr. McGee, it has been said, noted a potential conflict of interest and managed it appropriately by resigning as editor. His wife, as a long-time central figure in the day-to-day running of the journal, is very well qualified to assume a role as co-editor, and it's sexist and patronizing to view her as a mere appendage of her husband for this purpose.

Dr. Leigh Turner of U-Minnesota, in the post cited at the beginning, accuses Dr. McGee of scrubbing the Internet to alter the records of when he was in what position, to obfuscate the fact that he was involved in these conflicts of interest. As I review the instances he cites, the majority of these look more like updating rather than "scrubbing." But the one instance where this charge seems to hold water is with the most recent Celltex news release. That makes it seem that Dr. McGee had left his previous posts before assuming his role with Celltex, whereas it appears that there was at least a few months' overlap. As Dr. Turner alleges, the intent of the news release seems to be to appear to backdate his resignation as editor of the journal.

If anyone is still reading after all this, I will hesitantly offer some opinions.

I am not sure that the charge of conflict of interest can stick at this point with regard to the editorship of AJOB. The argument that there was a conflict, and Dr. McGee resolved same by resigning, seems reasonable. Normally when one transfers ownership of something to one's spouse, it's a transparent mechanism of trying to remain within a conflict while pretending to resolve the conflict; but the argument that Dr. Summer McGee has valid reasons to assume editorship in her own right seems plausible. The charge of COI seems to stick however with regard to Dr. McGee's role in naming Dr. Nelson to be editor of the other journal, and remaining in a position to oversee him as editor, when Dr. Nelson has a role at the FDA that could involve Celltex's interests.

I wonder if my bioethics colleagues, who are ordinarily very good at making fine ethical distinctions, are actually conflating two separate issues:

  • Is it a COI for Dr. McGee to edit AJOB?

  • Is it seemly for a bioethicist to work for Celltex?
I have just given my reasons to be skeptical of the first; what about the second? I spent some time looking for information on how Celltex markets its services--perhaps significantly, I was unable to locate a company website. If you read the news release, Dr. McGee says that the company is completely legit, they tell everyone that adult stem cell treatments are experimental, and all procedures have IRB approval. But various press reports (for example, http://houston.culturemap.com/newsdetail/12-26-11-nations-largest-stem-cell-lab-opens-in-sugar-land/) show Celtex marketing its wares and making a hefty bundle upfront; and a blog from a Celltex patient indicates that at least one recipient is sure she's getting real therapy and is immensely grateful to the fine people who are treating her disease: http://debbiebertrand.blogspot.com/2012/02/best-offering.html

My personal opinion is that it is highly unseemly and embarrassing for the field of bioethics to have one of our own working for this sort of firm, and giving ethical "cover" to their activities. It appears that contrary to the claim that their activities are highly ethical and are fully disclosed as experimental only, Celltex is seeking to make profits by presenting what it does to the public as effective therapy. There seems ton be a conflict of interest within the firm if the news release is to be taken seriously and Dr. McGee is actually charged with creating a true ethics program within the company. If he were to succeed in fully informing all patients that this is an unproven, experimental "treatment," it would seem to seriously cut into any chance of the company recouping the $30M they paid RNL Bio for the stem cell license. So one has reason to doubt that the firm is serious about their "ethicist" and his activities.

I explained in HOOKED that I agree with Ed Erde that the core ethical issue at the heart of conflict of interest is trust in a social role. "Bioethicist" is a social role and all of us have a stake in making the role as trustworthy as possible in the public eye. It seems to me that what Dr. McGee is doing with Celltex is predictably going to diminish trust in our field. (For evidence that this is already happening see http://leiterreports.typepad.com/blog/2012/02/american-journal-of-bioethics-redux-is-this-for-real.html).

So my current advice to my bioethics colleagues, based on what I have learned so far, is: if you think that Dr. McGee is a discredit to bioethics, talk about his role with Celltex. If on the other hand you think he's a fine fellow unfairly besmirched, then defend his role with Celltex. But forget about the side issue of the AJOB editorship which is just a distraction in my view. Now, bioethicists, have at me and send your comments.

NOTE ADDED 2/18/12: Off line, I have been taken to task for my attempted witticism regarding getting tenure at Penn. It was pointed out to me that a number of distinguished people in bioethics were in fact granted tenure there, and I apologize if my ill-timed humor seemed to cast an aspersion on that university.

NOTE ADDED 2/21/12: Nature has now chimed in with news coverage:

NOTE ADDED 2/27/12: Dr. David Magnus, one of the co-editors of AJOB, has asked me to correct misinformation in the main post above: "You suggest that even though Glenn stepped down as EIC of AJOB, he retains his position as "head" of all three journals. This is not the case. Glenn has no role regarding the content of any of the three journals (and in fact never had any such role for AJOB Primary Research). Robert "Skip" Nelson has his own contract with Taylor and Francis and has no reporting line to Summer and me or to Glenn or to anyone other than Taylor and Francis. The relationship between the three journals relates to how they are marketed, sold (they are bundled in institutional subscriptions), and some shared management regarding Manuscript Central and Scholar One. And to be very clear, Glenn's resignation included discontinuing any role at all in the running and management of the AJOB family of journals." My apologies for any erroneous information I may have conveyed.

NOTE ADDED 3/6/12: I had the pleasure of speaking with Dr. Robert “Skip” Nelson, editor of AJOB Primary Research. Dr. Nelson clarified his role at the FDA. He functions as a pediatric ethicist and advises various centers within the FDA about ethical issues in pediatric research. He has no authority to issue any rulings with regard to the approval of any therapy. Again, I apologize for anything I may have said in the original post that gave an incorrect impression. Dr. Nelson also informed me that his role at the journal has been clarified by naming him “editor-in-chief,” to show that the three AJOB journals actually all function independently of each other editorially.

Friday, February 3, 2012

A New Paradigm for Drug Reps, or, "M-I-C...K-E-Y..."

Jonathan D. Rockoff wrote a little while ago in the Wall Street Journal online:
--that while people like me were paying attention to other issues at the medicine-Pharma interface, and ignoring our old friends the drug reps, a paradigm shift may have begun to occur in that field.

First off, Rockoff updates us on a trend that was just beginning at the time HOOKED came out, that from a peak in 2007 of 105,000 drug reps in the US, industry has been trimming steadily down to a present force of about 72,000. The firms had decided that too many reps were tripping over each other and duplicating effort.

But the real paradigm shift is what these reps are now supposed to do, at least according to the picture Rockoff paints (focusing on a particular Eli Lilly rep who peddles neurological and psychiatric drugs in North Carolina). Instead of the old hard sell where reps were trained to "close the sale" and push their docs to promise that they'd write the next 5-10 prescriptions in that class for the company's drug, reps are being urged to use a softer and friendlier technique, do more listening, and try harder to find out what the physicians think and want and better meet their needs.

Hence my subtitle--as Rockoff reported, "Lilly's most recent national sales meeting, held at Disney's business training institute in Florida in February, was devoted to customer service, not product training. Sales representatives watched how Animal Kingdom workers greeted families at the gate and answered questions around the attractions."

Now, here's the most serious aspect of the paradigm shift: "In the wake of costly settlements by other drug makers over illegal marketing practices, British drug giant GalxoSmithKline PLC stopped evaluating salespeople based on the number of prescriptions written. Instead, companies are considering how well physicians rate their representatives." Whoa-- bonuses for reps no longer based on sales volume pure and simple? That's huge.

Not, you understand, that companies have changed how they see the rep's job--just that you can catch more of the proverbial flies with proverbial honey: "'Increasing physician satisfaction, it turns out, is a much better way to promote a pharmaceutical agent than simply telling them to write more prescriptions or what the benefits' are, said David Ricks, president of Lilly's global business unit."

The new generation rep, says Rockoff, is more ready to admit the downside of the company's drug and give docs useful information about side effects. For example, the "new" rep Rockoff profiles, Michaelene Greenly, helped one of her physicians troubled by a patient's weight gain on the Lilly antipsychotic Zyprexa, recommending a special Lilly-sponsored nutrition program. (What drugs the patient might have been switched to besides an antipsychotic appears not to have been part of the conversation.)

As an example of how this goes over with the physicians, Rockoff tells us about Dr. Carey Cottle, Jr., a psychiatrist on Ms. Greenly's circuit:

Before the change in tactics, psychiatrist Carey Cottle Jr. says he was more likely to write prescriptions for a competing antidepressant like Pfizer Inc.'s Effexor over Cymbalta, because Lilly representatives had a "high-pressure, car sales-type approach, and it was just not appropriate." Fed up several years ago, Dr. Cottle called their Lilly manager and complained that the reps' visits were "wasting our time."

Now, Ms. Greenly's service has lifted the bias he had against prescribing Lilly medicines, Dr. Cottle says. When he had a patient who was breast-feeding, she supported his conclusion that it would be safer if the woman took the antipsychotic Risperdal instead of Lilly's Zyprexa because Risperdal had more safety data on that point.

Let's talk about this for a minute. First, it's a great step forward that the rep would actually suggest a rival company's drug due to a safety issue--even though, once again, one has to ask whether the patient truly needed an antipsychotic, given how much evidence we have of massive overprescribing of psychoactive drugs.

On the other hand, personally, as a patient, I would not want to be treated by a physician who used not to prescribe a certain company's drugs because he did not like their rep, and now prescribes that company's drugs because the rep is nicer. Whatever happened to the quaint idea of prescribing the drug that you think, based on the available scientific evidence, is really best for this particular patient? Or are you really saying that the choice of a drug is like Tweedledum and Tweedledee, and that you might as well toss a coin anyway based on the scientific data, so why not go with the company that sent their reps to Disney? Somehow I don't think that's what even the "new" reps tell the physicians, even though in many drug categories it's probably true.

So in some ways the paradigm seems really to be shifting, but in the most basic way, it hasn't. The challenge to docs is still: do you want to get your information about drugs from a person who was sent to your office specifically with one mission, which is to represent a company and try to maximize their sales?

Thursday, February 2, 2012

More on Journal Reviews Paid For by Pharma

A little while back I posted this commentary/summary of an item from Marilyn Mann's Blog:

At the time, I drew some unflattering conclusions about the journal (Reviews in Cardiovascular Medicine) and its editor and authors, based only on the review of a single article. Making up for my sloppiness and laziness now comes Kevin Lomangino in a guest post on the Health News Review blog:

Mr. Lomangino took the time to dig into a number of articles this journal printed, and to compare the conflicts of interest disclosed in the journal to information now available on the ProPublica "Dollars for Docs" database. Not surprisingly, he found a lot of people writing enthusiastically about drugs for companies with whom they had significant financial ties, and often not reporting same in the journal article.

The conclusion Mr. Lomangino leaves us with is the impression that I had on reviewing the single article on fibrates, only now backed up by more searching--which is that Reviews in Cardiovascular Medicine is basically what's known in medical jargon as a "throwaway" journal. A throwaway journal is a journal that's not peer reviewed and generally not indexed in the National Library of Medicine's Medline/PubMed system. It's advertising pure and simple. The articles are generally written by spokespersons for the companies; they are lavishly illustrated with nice color graphics; and the journal is sent free to physicians. Such journals are totally funded by industry.

The problem with Reviews in Cardiovascular Medicine is that while it seems to walk, talk, and quack like a throwaway journal, it is disguised as a real journal. They have somehow concocted some sort of peer review process, and the journal as I noted before carries the imprimatur of the American College of Cardiology. And the journal is listed in PubMed.

Physicians have traditionally known exactly what to expect from "throwaway" journals, but that doesn't mean that they don't read them. The articles are generally much more snappily written than the stodgy pages of real medical journals (who can't afford to hire professional writers), and the pictures look pretty, and the information is often fed to docs in highly useful nuggets for the busy practitioner. Again, a very smart and profitable industry doesn't waste money on marketing that doesn't work. So I suspect that Reviews in Cardiovascular Medicine is widely read in the field despite having all the distinguishing marks of advertising pure and simple. (If anyone attached to this journal is trolling the web for mentions of their product, and wants to comment on or rebut these statements, be my guest.)