Saturday, May 23, 2009

A Stealth Campaign to Shanghai CE Research?

I have previously posted on the campaign, apparently launched by the drug industry, to impede and derail comparative effectiveness (CE) research while mouthing approval of it. This is especially the case for any CE research that takes cost into account--as the industry knows full well that in many cases, the expensive brand-name drug would be found no better than cheaper alternatives.

To see how far this campaign has progressed, we can start with Merrill Goozner's blog: Merrill refers us to the Wall Street Journal Health blog: Finally we are redirected from that blog to the WSJ Washington Wire:

What we learn from these sources is that there's an organization called the Partnership to Improve Patient Care. It is headed by Tony Coelho, a former Democratic congressman noted for his role in passing the Americans with Disabilities Act (impeccable liberal credentials, you'd think). Now, here's the test. Go to the PIPC website at You'll immediately see a mission statement:

We all need good information to make good decisions about our health, and our health care. Comparative effectiveness research can help us make good health care choices. But it is important to make sure this research isn't misused to make these decisions for us.

The Partnership to Improve Patient Care exists to advance proposals for comparative effectiveness research that are focused on supporting providers and patients with the information they need, improving health care quality and supporting continued medical progress.

Sounds pretty benign, and supportive of CE research, right? Now keep clicking around the website. You'll see that PhRMA is one of a slew of impressive organizations that are all part of the coalition that makes up PIPC, along with a number of medical and patient-advocacy organizations. I challenge you, however, to find on their website what Goozner and WSJ report as the primary characteristic of PIPC--that it is primarily if not solely funded by PhRMA.

Now, let's follow the trail farther. PIPC supports a new CE research bill introduced by Rep. Kurt Schrader, D-OR. which you can read about at,24&itemid=141. The news release tells us that the bill is the product of the New Democrat Coalition, and stresses how important CE research is for giving doctors and patients the information necessary to make the best medical decisions. You would never guess from this news release that the supporters of this bill are anything other than big fans of CE research.

At the very bottom the press release describes the features of the bill. Here's the kicker--the bill would:

--Establish a non-government institute responsible for managing and guiding health research programs. The institute will be governed by a board that would include representatives from HHS, NIH, CMS, VA, DOD, physicians, patients, state health agencies, insurance, industry, researchers and other experts.

There is no explanation here of what's wrong with the current conduct of CE research by the NIH or AHRQ. Why should the new institute be "non-governmental"? Just who is the "industry" that will be represented on the governing board? Just who are the "physicians" and "patients"? (Representatives of front organizations claiming to be grass roots, but behind the scenes actually all funded by PhRMA?) Will the governing board simply set an overall research agenda, or will it have a say in which specific projects get funded? How much say?

In short, we currently have a "governmental" approach to CE research, with these projects being conducted by NIH or AHRQ, in accord with the standard system of competitive grant submission followed by scientific peer review. Now, any candid scientist with a couple of beers in him/her would wax eloquent about the flaws and shortcomings of the current peer review system, but the fact remains that it's the best system anyone has yet come up with to assure scientific validity and integrity in the research process. Before somebody sells us a new, "non-governmental" method of doing CE research, we have a right to inquire how this new method would stack up on the science side. What are the safeguards to assure that the scientific quality of the results will be equal to that of the existing system? Especially with a new raft of special interest groups all crowding the table?

Here's more from the PIPC website: The entire research process of a new CE [research] entity – from deciding priorities to finalizing and communicating research results – should be open and transparent to the public.

I'll leave it to you to decide just how "open and transparent to the public" all this activity has been so far.

ADDENDUM: If you want to read a great column from a wise psychiatrist, about the pressing need for CE research as well as the dangers of letting the Pharma fox guard that particular henhouse, check out (thanks again to Merrill Goozner for the tip).

Tuesday, May 19, 2009

Studies--but not Editorials--Confirm Generic Equivalence

Playing catch-up on a study published last December (subscription required to access on line): Kesselheim and colleagues performed a systematic review of studies comparing generic to brand-name cardiovascular drugs in terms of clinical outcomes, published between 1984 and 2008. They also did a content analysis of editorials in medical journals on this topic, published during the same interval.

The overwhelming results of the 47 studies they reviewed were that generic and brand-name drugs performed the same. This was true both in drugs overall and also for drugs that are thought to be especially sensitive to small dosage and absorption differences ("narrow therapeutic index").

So, if you were to believe the studies, all is well, at least in cardiovascular drug land. You can save your money and buy the cheap generic drugs. Also, indirectly, we have some reassurance that the FDA's system of requiring bioequivalence data for generic drug approval ain't broke.

But the editorials told a very different story. Fully 53% of the 43 they reviewed expressed negative views about generic substitution, and only 28% actually encouraged use of generics.

As to why the editorial writers were so far out of step with the published trial results, Kesselheim et al. hazarded the hunch, "Another possible explanation is that the conclusions may be skewed by financial relationships of editorialists with brand-name pharmaceutical companies, which are not always disclosed." And we could here add--and what about the financial relationship between the medical journal and the brand-name drug company that fills it up with ads? If editorialists write biased and non-evidence-based screeds slamming generic drugs, somebody had to pick those guys in the first place, and somebody had to print the editorial after they wrote it.

Kesselheim AS, Misono AS, Lee JL, et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA 300:2514-26, 2008.

Monday, May 18, 2009

Vermont Tightens Sunshine Law into Gift Ban

Thanks to our friends at the Prescription Project for this tip.

The Vermont legislature has followed up in spades on the previous state law that first required disclosure of drug company payments to physicians. The law, for all its pioneering status, became something of a joke because it contained a huge loophole that companies could conveal gifts they claimed to be trade secrets--and suddenly more than half the gifts to docs in Vermont became trade secrets.

As reported in the Burlington Free Press (, the new bill not only closed the "secret" loophole, but went even farther in banning gifts--for example, banning meals for physicians and their staffs as well as restricting other gifts. The big debate was over requiring the disclosure of the names of physicians who received samples. There was considerable pushback on that from docs and the bill's sponsors backed off lest the good features in the rest of the bill be jeopardized. The compromise was that the state would continue to study the sample issue.

Sunday, May 17, 2009

A Marketing Expose, and Reflections on Anecdotal Evidence

This post began as what I assumed would be an expose of more sleazy behavior on the part of the big drug firms, and somehow morphed into a commentary on anecdotal evidence in today's culture.

Several of my esteemed fellow bloggers picked up on an article in the Wall Street Journal (subscription required to access), revealing Bristol-Myers Squibb's problems with a "celebrity" spokesperson, one Andy Behrman. Briefly the story goes like this. Behrman had described his problems with bipolar disorder in his 2002 book, Electroboy:A Memoir of Mania. Bristol-Myers got him on their new antipsychotic, Abilify, and in 2004-2005 paid him $400,000 to give speeches telling the world how Abilify had revolutionized his therapy, especially by eliminating the terrible side effects he had suffered from previous drugs for bipolar. In fact, he made his first video extolling life on Abilify after only 4 days of treatment, far too early for most of the side effects to show up. He ended up having sufficiently severe side effects to discontinue the drug in less than a year. (Accounts differ on how much of that information he shared with his company handlers.) Company PR people kept telling him the script he was expected to follow in these talks: Abilify had no side effects, it gave him his life back, and he was not being paid any money by Bristol-Myers to say this.

Apparently believing that he had a career doing this sort of thing, Behrman and his lawyer approached Bristol-Myers with a long-term contract deal, which fell through. The company says he demanded $7.5M; Behrman and his lawyer insist it was not that much, but don't say what they did ask. Behrman then tried to shake down the company for other support, such as agreeing to back a new book venture (could there have been a hint here that the new book would say nice things about Abilify only if he was paid?). By this time apparently even Bristol-Myers had had enough of this dude, so no support was forthcoming. Behrman then waited until the 3 years were up on the nondisclosure agreement that he had signed with the company when he first started speaking for them, and began to go public with his new claims. He is now, he says, writing a book to warn about the dangers of overly aggressive drug company marketing, which he claims misled him.

Bottom line: If you want to accuse Bristol-Myers of sleaze for hiring on such a guy to extol their drug on such flimsy grounds, you also have to measure Mr. Behrman's own behavior on the sleaze-o-meter, and it seems by his own admission that he was quite happy to lie about the drug's side-effect profile so long as B-M was paying him generously to do so. The marriage between Andy Behrman and B-M was one made in heaven, it would seem. So I cannot use as reliable a source as Mr. Behrman as any sort of barometer as to the extent of skullduggery in drug company marketing.

What I can do, however, is note that (as we have exhaustively covered in previous postings) the companies that make so-called "second-generation" antipsychotics like Abilify have invested muchos bucks in slanting the scientific database, making it seem that their drugs are more effective and safer than they really are, both for conditions for which they seem truly to be indicated (psychosis) as well as for conditions where the indications are far more tenuous (bipolar). It is only in the last year or so that careful reviews and meta-analyses have begun to make it clear that these drugs are simply not what they were cracked up to be. But what's of import here is that Bristol-Myers was not content merely to cloud the scientific evidence. They obviously felt the need to pile on anecdotal testimony and were willing apparently to pay top dollar for it. (Behrman at one point collected $10,000 per day in speaking for the company, while "key opinion leaders" on physician speakers' bureaus might see only a third or half of that amount.)

What are we to make of this in an era in which, we are told, the randomized controlled trial is king, and evidence-based medicine is the emperor, and anecdotal evidence is so far down the food chain that it can no longer even be detected?

This in turn makes me wonder about the way the popular media now covers "medical breakthroughs." I believe there is a consistent pattern. Docs on the faculty at Stanvard Medical School do a major study providing evidence that statin drugs make warts go away. So this study gets trumpeted on the evening TV news and in the daily paper (assuming there are any more daily papers). They summarize the trial data and interview the study's author, and maybe one outside physician to show that it's all kosher. But there is an obligatory further piece to the story. There has to be an interview with John Jones of Oshkosh, WI, who was a subject in the study, who reports that yes indeed he took the statins and yes indeed his warts went away.

I have given some interviews to reporters in the last couple of years in which I discussed randomized trial data with them, and then they asked me if I could provide them with a "real" patient they could interview. In my case the answer was nearly always "no." You could hear their eyes glaze over on the phone line, and they lost no time in finding an excuse to hang up on me.

The PR folks at Stanvard Med School know this, so that when the news release goes out about the statin-warts trial, you can be sure that they tell the media that not only is the study author available for an interview, but Mr. Jones is standing by in Oshkosh.

My question: If med schools are supposed to be about educating the public about real medical science, is it really appropriate for Stanvard's flacks to push Mr. Jones onto the media, thereby reinforcing and giving more legs to the idea that only if you have personal testimony is something really real in medical science? Or should Stanvard grow a spine and tell the media, if they ask for an interview, "sorry, we keep our patient and subject records confidential; and besides we don't think that personal stories prove anything one way or the other in medical science"? If they followed this last tack, is it possible that we might see a slow re-education of the general public about the weaknesses of anecdotal evidence? I know-- dream on.

Wang SS. A celebrity patient's backing turns sour for drug company. Wall Street Journal, May 14, 2009:A1.

Tuesday, May 12, 2009

Health Reform: What Are the Big Guys Most Scared Of?

This post is about health reform. My only excuse for posting it on this blog is that one of the major players in the current debate is our ol' pal, the pharmaceutical industry. There is thus some overlap between issues that could make or break efforts to reform health care in the US, and the issues we regularly address here.

Some background: On Monday, a group of major health care interest groups, most of whom have in the past been staunch opponents of health reform, sent a letter to President Obama ( They promised to support his cause of making health care more affordable in the US by working to lower the annual inflation rate of health care costs by 1.5%, which would save 2 trillion dollars over 10 years. They would do so through such measures as better coordination of care, standardized insurance forms, more information technology, and eliminating unnecessary tests and procedures.

Reactions varied. The President himself expressed himself as very pleased with the letter ( Columnist and economist Paul Krugman was both very pleased and somewhat wary, noting that a gift from these guys was likely to be a Trojan horse, but that on balance, having them at the table rather that flinging Harry and Louise ads at you from a distance was a positive move ( Psychiatrist and blogger Doug Bremner was much less polite, referring to the four biggest guys in the group as the Gang of Four, and suggesting you could trust that gang about as far as you could throw them (

My own somewhat long-winded reaction follows.

This year so far I have found myself feeling oddly detached from the health reform debate. You'd think by contrast that I'd be passionately engaged. For many years I have been a member of Physicians for a National Health Program and I strongly favor a single-payer-type plan. This year, the chances that something might really happen seem greater than any time since 1993, and so far, Obama's approach has been demonstrably smarter than the Clintons' ill-fated effort in that earlier year (largely because Obama has plotted out each of the Clintons' earlier mistakes and avoided them).

You'd think that I'd be passionate for single-payer, and I'd be passionately enraged at the recent treatment of single-payer advocates by the Democratic leadership, with the most extreme manifestation being the arrest of several PNHP folks at Sen. Max Baucus's committee room because they had the nerve to demand that their plan at least be considered rather than ruled off the table. Single-payer advocates were dragged out of the room in handcuffs while the Senator fawned over representatives of the special interest groups that signed onto the letter.

On the one hand I am deeply distressed by the way Baucus and Company are treating my friends and allies. On the other hand I fully sympathize.

When no action seems possible, a politician can make friends with a wide range of folks. When it seems that something actually has become possible, your margins narrow. You have to make a shrewd calculation. You figure that you can wring so many concessions out of your foes, and then you have to settle for the best compromise you can get, or the time to make a deal will have passed you by. In such times your worst enemies, if you are a Democrat, are your former allies who stand just to the left of where you think you are going to have to draw the line in order to get a deal. The people who imagine that you are their ally, and who are going to try to push you just a bit farther than you think you can safely go, and who will consider you a vile traitor if you don't go along with them, have now become your greatest headache.

Last October I had to give a lecture on ethics and health reform. I said that one of the major reasons that we have not yet gotten to health reform is that everyone has a Plan A but no one has a Plan B. Each group of advocates has a preferred way of doing reform, whether single-payer, Massachusetts style, medical savings acounts, or whatever. There are so many such proposals out there that none can command a clear majority in its favor. Where we get into real trouble is that advocates for these various plans, once they see that they are not going to get everything they want, have no reformist fall-back position. They conclude that the next best plan is the status quo, and take their football and go home. So the majority vote, ironically, ends up being for the broken non-system of health non-care that virtually everyone in the US agrees is a huge mess and embarrassment.

So I have been of late less and less happy to be seen in the company of my PHNP friends because they refuse to offer any Plan B. It is single payer or nothing. On the one hand I think it is important that single payer at least be discussed and debated, and it is a shame that our political types imagine that it is a complete nonstarter. And to offer your Plan B too early in the game is of course a self-defeating negotiating strategy. But at some point, if we could get meaningful reform in 2009 but cannot hope to achieve a full single-payer system right away, a single-payer-or-nothing stance will become self-defeating too.

Let me put it in ethical terms. Suppose the Plan B could extend health insurance coverage to an additional 10 million Americans; and let us also suppose that there is nothing about Plan B that would make further extension of universal coverage harder to achieve in the future. Suppose you oppose Plan B because it is not single payer, and the end result is no reform at all this year. I think you have some ethical explaining to do to the 10 million folks whom you deprived of coverage.

Now, having said all that, I have some sympathy with Obama and Baucus and others who wish my single-payer allies would disappear. But now let me turn it around and ask what the behavior of the Gang of Four, or whatever you call them, tells us.

We have developed a general strategy or assessing the drug industry's probable motives, based on the apparent fact that the industry could not honestly say what it really thinks if its life depended on it. It has wrapped itself up in so many layers of PR and marketing flimflam that its leaders no longer know truth from falsehood. So you cannot depend on any statement from the industry as evidence of its real concerns and plans. What do you do? You watch its behavior to see what it seems most scared of. In that way we discover, for instance, that sunshine laws are pretty likely to put a serious spoke in the industry's wheels. How do we know? Because legislators in Massachusetts reported that they saw unprecedented swarms of drug industry lobbyists descend upon their statehouse when they considered (and passed) a sunshine bill.

So what is the Gang of Four, one of which is PhRMA, really, really scared of in health reform? As we have seen in previous posts, the industry is really scared of comparative effectiveness research. It seems as if they are really scared of single-payer. They are even more scared of having the government offer a publicly-financed insurance option alongside of commercial insurance, beause that might pass while they think single payer won't pass--and they see any sort of government-sponsored insurance for the whole population the camel's nose under the tent for single-payer in the future.

None of this is rocket science. What do we have to do to reform health care so as to make it affordable and efficient in the future, so that we can cover all Americans? We have to rein in out-of-control administrative costs, which eat up roughly a quarter of each private insurance dollar, while the administrative costs of government-run health care runs about 3-5%. And we have to find ways to eliminate the roughly one-third of US health "care" that provides no benefit to patients but huge profits to industry and to providers.

So if either single-payer, or a government-sponsored public insurance option alongside commercial insurance, really were to work, the people who would suffer are the providers and the industries who today collect the bills for that one-third of "care" that is unnecessary and non-beneficial; and the commercial insurers who charge those high administrative costs (part of which they rake off as profits). So guess which groups don't want those things to happen. And guess which groups don't even want CE research, that will start to prove what works and what does not. Guess where PhRMA is among that gang.

Let's get hypothetical again. I am reminded of a story about Britain's National Health Service. It became law in 1948. Initially the British Medical Association fought tooth and nail against it, just as the AMA in the US has fought health reform ever since 1920. But in the end, the BMA more or less acquiesced. Aneurin Bevan, the Labor minister who took the lead role in the negotiations that led to the NHS, was asked how he brought the BMA around. He replied, "I stuffed their mouths with gold." In the end he built so many fee increases for docs into the NHS that he simply bought off their opposition.

So let's say that in the end the Gang of Four were willing to bargain just like the BMA did. (They should, after all; they are in it for the money.) If only we were to sweeten the pot enough for each of them--something nice to guarantee the drug companies so many more years of excessive profits; something to allow the private insurers to stay in business and make a small bundle; assurances to the cardiologists that they could keep on putting in a lot of their caths and stents unmolested despite dubious outcome data--they'd back off and let us have a system of universal coverage. At what point would we be duty bound to protest this extortion and fight for a "pure" plan in the public interest? At what point would we say, oh what the hell, give them the extra that they want and let's cut a deal, next year or the year after we'll just have to go after them again and hope for better results?

Maybe that's the way to make sausage and health reform. I fear my single-payer friends don't want to hear that.

Study Shows Small "Reminder" Items Influence Med Students

A study in the current Archives of Internal Medicine provides some evidence that medical students are influenced by "reminder items" with drug company logos prominently displayed, and also by medical school policies approving or disapproving of contacts between students and drug industry marketers.

Penn's David Grande and colleagues studied 3rd and 4th year students at Penn and Miami using both explicit questions and the Implicit Association Test. The IAT has been thoroughly studied and validated as a psychological instrument to reveal subconscious prejudices such as racial bias, and has also been used to study marketing influence. Penn has a strict policy banning drug company reps, meals, and samples; Miami has a permissive policy. Half the students at each site where signed into the study using clipboards and notepads that prominently displayed a "Lipitor" logo. The explicit and implicit attitudes measured were the comparisons between Lipitor and Zocor as statin drugs (the latter being a drug considered generally equivalent and now available as a cheaper generic).

No differences of any sort were shown among the various groups of 3rd year students. The 4th year students displayed a more complex picture. At Miami, being exposed to the Lipitor logo yielded a significant change in the IAT favoring use of Lipitor. At Penn, the opposite result occurred. The authors interpreted the results as consistent with a boomerang effect of drug marketing in an environment where such marketing had explicitly been labeled as problematic--so that when students saw an obvious marketing ploy, it turned them off rather than making them favorably disposed toward the drug. This suggestion was reinforced by the explicit questionnaire data that showed that the Penn students had conscious views of drug marketing that were significantly more skeptical than those of the Miami students.

The fact that no differences were observed among the 3rd year students might be seen as calling into question the robustness of the findings with the 4th year students. The authors further suggest, however, that their results are consistent with the 4th year students being farther along in clinical training and hence more ready to display a preference for one drug over another.

The Archives accompanied the study by Grande et al. with a pointed editorial by Dr. Philip Greenland of Northwestern. Greenland notes that as of January 1 of this year, these "reminder items" like notepads and pens have supposedly been banned by the new PhRMA code of conduct. But the ban does not extend to meals, samples, and CME programs; hence Greenland suggests that the findings of the study are every bit as pertinent as they would have been prior to the new code. Greenland goes on:

We believe (1) that the evidence is solid that [drug company sponsored interactions with physicians] are designed for the purposes of influencing and biasing the physician-patient interaction and (2) that these adverse effects are achieved as a consequence of the interactions. ... Why are most of us still waiting? The evidence is clear, and the path is defined. It is time to act.

One of the most prevalent and long-lived rationalizations that we hear in response to attempts at reform at the medicine-Pharma interface is that physicians are highly trained scientists and that we can never be influenced by something as simple or as blatant as a pen or notepad. Grande et al. have just made that rationalization a bit harder to swallow.

One minor point is that in a typical interaction between a physician and a drug rep (at least before the Code of Conduct), the physician would be given the "reminder item" as a gift and then would be re-exposed to the drug logo each time the item was subsequently used. There would therefore be two routes of influence-- first, the sense of debt and reciprocity owed to a person who has given you a gift; and second, the effect of being reminded of the drug's name regularly. The Grande et al. study might therefore actually underestimate considerably the power of "reminder items" to influence physicians.

While subscriptions are required to link to the article and editorial, a press account of the study can be found at

Grande D, Frosch DL, Perkins AW, Kahn BE. Effect of exposure to small pharmaceutical promotional items on treatment preferences. Arch Intern Med 169:887-893, May 11, 2009.

Greenland P. Time for the profession to act: new policies needed now on interactions between pharmaceutical companies and physicians [editorial]. Arch Intern Med 169:829-831, May 11, 2009.

Tuesday, May 5, 2009

Briefly, Back to the EMR--Another Market Failure?

No, I promise, this is not going to stop being a blog about medicine and the pharmaceutical industry, and turn into a blog on electronic medical records. But just one more brief comment on the latter topic that I really think ties indirectly to many of the issues we discuss here.

Thanks again to Roy Poses' blog for linking this neat article:

The gist: Many years ago the VA system built its own electronic medical record. At the same time as this was happening, the VA was shedding its old image as the armpit of US health care and zooming to the top of the charts as the new quality leader. Many credit the medical record system with being at least a part of this revolution. Being a government agency, the VA made its record with open source software. Anyone and her duck can download it and set up her own system using that software, called VistA. (You still have to buy the computers and the time of the technical staff to run the thing of course.)

Since most VA patients are part of the VA system, the VA seldom bills insurers or other government programs for care, so billing is really not part of VistA. But experts say that it is pretty simple to tack on the billing function.

The Globe article shows that the state of West Virginia has recently had great success in converting all of its state-run hospitals and nursing homes to electronic records using VistA, and saved a ton compared to the cost of commercial EMR.

According to my theory of how the EMR has turned sour in many cases after its initial success and promise, VistA should be an excellent system to adopt, much better than many of the new EMRs sold off the shelf to gullible hospitals and offices. It was built from the ground up and extensively debugged by zealots who really believed in the EMR concept and who knew that all VA docs would eventually have to buy into the program. Thye knew that making it user-friendly would have to be a big part of the job. To the extent that its EMR helped the VA achieve its current high quality standing, it is also a proven product.

So given that it is out there for free, you'd expect it would be widely used, right? And you'd expect that commercial folks would see the potential in tech support companies that would take VistA and adapt it to your special needs, right? (Flexibility and adaptability are features, experts say, that were built into VistA.)

Well, no. The Globe article shows that there has been minimal take-up of VistA and that there is still only one relatively small firm doing consulting and tech support for it (the one WV used).

What's with this? One comment in the article is that no one has any financial interest in marketing VistA. Apparently it's easier for a major player in the software industry to design its own crappy EMR, rush it into production before it is properly debugged, and market the heck out of it, and hospitals will eagerly lap it up.

So what does any of this have to do with pharmaceuticals and ethics? Many of the defenses of how today's pharmaceutical industry operates, and why docs should jump into bed with the industry, are examples of extolling the imagined virtues of the "free market." We know that in many ways, health care represents a huge area of market failure--as evidenced by the lack of any conceivable system by which the unrestrained market on its own will provide universal coverage. The EMR seems to represent yet one more example of market failure--what makes the most sense, and best serves the public health, is not what's most marketable, and vice versa. Bottom line: stop worshipping the free market and look at the facts. As one wag put it, the market is a great thing, but it needs adult supervision.

Merck's Fake Journal: Down and Dirty Down Under

Because the Healthy Skepticism group is based in Australia, the doings of the drug industry down under tend to be oversampled among those of us interested in such matters. Just lately the big news among this crowd is an article in The Scientist (registration required to access free article):

Litigation around Vioxx sprung loose this news about a publication called the Australasian Journal of Bone and Joint Medicine (see a sample copy at The magazine was published by the major journal company Elsevier back around 2003, and would look to the average reader like a peer reviewed journal--at any rate it has none of the glitzy ads and photo layouts that generally mark the drug company "throw-away" journal that docs routinely recognize as pure marketing. Its articles disproportionately feature the Merck drugs Fosamax and Vioxx and coincidentally, the studies published all show that the drugs work splendidly.

Elsevier has admitted that Merck bought and paid for the "journal" in toto, and indirectly admits that it would not pass muster in today's stricter disclosure climate. Elsevier, in keeping with the tightlipped practices journal publishers presently maintain, refused to say how much money Merck paid for this publication. Experienced journal editors were quoted by The Scientist as saying that the "journal" included many features usually seen in peer-reviewed scientific publications and care and attention would be needed to reveal that it was not a real journal of that type. The "journal" has no website and never had any, so it is difficult to trace its origins and its demise, or to track its circulation.

Anyway, just when we thought we had heard everything...

Another "Key Opinion Leader" Sees the Light

The Milwaukee Journal-Sentinel continues its excellent series on academic medical centers' conflicts of interest with Pharma:

Here we read about cardiologist James Stein of the University of Wisconsin. He describes for the newspaper's John Fauber how he became "hooked" as a young faculty member on the speakers' fees provided by the drug companies for talking about statins, starting at $500 a pop and going eventually to $2000-3000--and how long it took him to realize that he was being used by the industry and that the independence that he fondly imagined he had retained was in his own head only. He first started donating all his speakers' and consulting earnings to charity, and then curtailed all income from Pharma except for actual research grants.

Roy Poses in his Health Care Renewal blog ( adds some shrewd comments about the extent to which the industry actually creates many of its so-called "key opinion leaders." Perhaps the KOLs are not people who become independently famous and then are picked up by the companies at a price. Maybe at least some of the KOLs are young, impressionable and malleable folks that the industry decides it can bend to its will. The industry can then make its stable of starlets into KOLs through arranging exposure at all the major national and international meetings, and generally by throwing around its weight and its money. I am reminded of a chilling statistic that David Healy came up with some years ago, that articles in psychiatry ghostwritten by industry hacks end up being cited in the literature three times more often than honestly authored papers. This speaks to the ability of the industry to get its message, and its messengers, out there in the public eye in most whatever way they desire.

PhRMA on IOM; When Will They Come Clean on Costs?

By way of reminding me that the Pharmaceutical Research and Manufacturers of America keep an eye on this blog, soon after I did my last post on the new IOM report on conflicts of interest, a very polite person there e-mailed me to be sure that I had seen their news release and comment on IOM:

The statement is what we have come to expect from PhRMA: they are wonderful people who discover lifesaving new drugs; conflict of interest is a serious matter but let's not go overboard and jettison information-sharing that can enhance patient care; the new PhRMA Code of Conduct is really what is needed to eliminate worrisome practices, anyway.

In passing, however, the following paragraph appears in the comment (specifically quoting PhRMA senior VP Ken Johnson):

"Additionally, it is important to clarify that America’s pharmaceutical research companies spend far more on research and development (R&D) than on marketing. In 2007, pharmaceutical companies invested $63.2 billion on R&D of new medicines, while spending around $11.5 billion on promotional activity directed to physicians, journal advertising and consumer advertising, according to IMS Health. Last year, pharmaceutical companies spent a record $65.2 billion on R&D. "

Now, as I go to lengths to explain in HOOKED, these figures are (as best as one can tell) bogus. PhRMA continues to trot out these figures, but economists and investigators not tied to the industry continue to refute them. Even IMS Health pegs the total promotional expenditures at nearly $30B annually, not $11.5B. And the best independent study I know of has put the actual numbers at around $57B (see: Anyone who has analyzed the data the drug firms file with the SEC has concluded that on average a big company spends about 3 times as much on marketing as it does on R&D. We also know the companies pad the R&D figures like crazy and shift as many costs as they can out of the marketing column and into the R&D column.

In my years of doing research on the industry, I have read the various published studies that call the PhRMA figures into question, but I have yet to see a straight-out reply or rebuttal from PhRMA of its minions. Instead they baldly repeat their own figures over and over. They never explain how it is that independent analysis have come up with completely different numbers.

One has to wonder--when they won't come clean on something as basic as this, just what is it that they say that we can credit as trustworthy?

Sunday, May 3, 2009

IOM Report on COI: Yes, We Really Mean It

You can tell that I'm not a truly dedicated blogger because I allowed the small matter of being out of town for a few days to delay my posting on the big news of this past week, which of course is the new conflict of interest report just out from the Institute of Medicine. While there are a number of examples of media coverage, the best way into the Report is probably the full text available on line--

--where you have the option of going into the report itself to find the 20-page executive summary, or else sneaking a peek at a couple of 4-page briefs. Also, the New England Journal posted a "Perspective" on the report on its website, that has a 1-page summary of the major recommendations:

Full disclosure: First, I have read the NEJM perspective, the briefings, and the executive summary, but not yet the full report. (Told you I wasn't dedicated.) As a member of IOM I have a high opinion of that organization's heft and prestige. But I was not a member of the committee that wrote the report, and was turned down when I volunteered to be a reviewer of the draft. A couple of folks whom I respect very highly as bioethicists were members of the committee.

So what can I say based on the above? First, the report is quite comprehensive in the different sorts of COI that it addresses--medical practice; research; all levels of medical education; clinical guidelines; and academic institutions. The IOM panel recommends passage of the federal Physician Payment Sunshine Act but with expanded reporting requirements compared to the present bill now before Congress. In general, the report will disappoint some true believers, but comes down pretty strongly on the side of reformers who argue that the more arm's-length the financial relationship between the industry and medicine, the better. In short, from the perspective of this blog, it is a reasonably hard-hitting and positive report. Inevitably, given the multiplicity of previous reports on these matters (Robert Steinbrook in NEJM counted 16 that were cited), it breaks little new ground in its specific recommendations. So mostly the importance of the IOM report is to add further weight to these previous calls for reform.

There is one specific area where an interesting fight might be looming. IOM calls for a major overhaul of continuing medical education--without being able to say what the new system ought to look like, it is quite sure that we need to replace the current system where the industry pays for roughly half of all CME costs, to an industry-money-free system within 2 years. The ACCME, by contrast, that actually runs CME, reportedly (again according to Steinbrook) has said just recently that it is quite pleased with its present rules for managing COI with industry and sees no need for any major overhaul. (Ironically, the position I took in HOOKED would tend to support the ACCME position, at least until more evidence is gathered that the relatively new, stricter ACCME guidelines are not working as intended.)

The IOM is also forthright on an issue that many previous reports (but not HOOKED) have sidestepped. They note that universities are eager to enact policies that beat up their individual faculty over COI, but much less willing to face the prospect of institutional COI. They call upon boards of trustees to develop institutional COI oversight mechanisms and also for NIH to develop nation-wide rules on institutional COI. This at least begins to suggest that institutional COI will be addressed on a level where some sort of meaningful action can take place.