Monday, August 29, 2011

J&J CEO at the White House: The Wider Message

Once again our good friends, in this case Dr. Roy Poses, over at Health Care Renewal provide grist for our mill:

This instructive post first notes how Mr. Bill Weldon, CEO of Johnson & Johnson, was one of eight business leaders invited by President Obama to the White House to give advice in the economy and in particular, to tell the Administration how it could restore their confidence. The remainder of the post is a litany of all the illegal behavior that has earned J&J fines and censure in the past several years, and how Mr. Weldom has been given hefty annual raises despite presiding over this string of disasters. Dr. Poses naturally asks why any Administration would want to gain such a person's confidence.

We could dig into this a little deeper and ask whether this interest on the part of the White House in making nice with big business--potential source of huge piles of campaign cash as the 2012 election looms--has anything at all to do with the Feds doing a one-eighty on some "get tough" conflict of interest provisions, as we discussed recently:

We could also ask about the timing of this sudden desire to regain the "confidence" of big business. It seemed to come right after the Democrats took a whupping in the 2010 elections. From a purely political point of view that timing may have made sense. From a policy point of view it is hard to get away from the fact that we were, in 2010, in the middle of a very deep recession, brought about by the irresponsible behavior of that same big-business community--who continue to tell us that the best way toward future economic prosperity is the same set of policies that got us into that recession--that is, shrink big government, don't regulate business, and above all else don't tax the rich. And, as Charles Ferguson showed dramatically in his brilliant documentary, Inside Job--
--Obama proceeded to appoint to his own economic team almost all of the major architects of the previous disaster.

Saturday, August 27, 2011

More on the Effects of Samples in the Doctor's Office

It's nice to be able to come back to a topic we have not addressed in a while, the good ol' down home matter of the doctor's office sample cupboard. Dr. Richard G. Pinckney and colleagues from the University of Vermont (subscription required to access article) noted that previous attitude surveys about how samples impacted on prescribing practices had usually been restricted to just a few office sites and so set out to do a broader survey, taking advantage of a Vermont statewide primary care database. Now you could immediately object that if you had to survey docs in any state of the US, Vermont might well be the greatest outlier, especially since they are now considering something akin to a single-payer system. Be that as it may, in Vermont they had their database and in Vermont they did their study, which got in the end a 35% response rate, fairly typical for today's world.

Along they way they cited a Kaiser Family Foundation poll that showed that 92% of US physicians reported that at least once in their careers, they'd received samples from a drug rep. I interpret that to mean that 8% of physicians are either liars or have rotten memories.

Pinckney and friends found in this particular instance that about 3/4 of their responding docs had samples in their offices, and they proceeded to compare that group with the remainder who did not. They provided two vignettes involving patients with no insurance and with hypertension and depression, respectively. The majority of docs got the right answer--use a cheap and effective thiazide diuretic for the first-pass treatment of the hypertension, and if the depressed patient needs drug therapy, pick a cheap generic. But there were significant differences between their two groups. Only 70% of the sample-docs picked the thiazide while 91% of the no-sample-docs did, and while 91% of the sample-docs went for the generic antidepressant, every single one of the no-sample-docs did.

They also asked those folks about attitudes toward samples, and again not surprisingly, the sample-docs were significantly more likely to believe that samples expedite treatment, make patients happy, help the indigent, and allow the docs to check out which meds work best. The no-sample-docs were more likely to believe that samples distort treatment plans, increase the costs of care, and lead to overuse. Pinckney et al. noted that actually a majority in both groups agreed that samples increase the costs of care and can affect physicians' prescribing habits.

What's cart and what's horse? It could be of course that docs who have certain attitudes are more likely to elect to dispense with the traditional sample cupboard, or that docs who have samples around all the time end up getting certain attitudes, or a bit of each. From such a study one can only hypothesize associates and not causes. Still this is just a bit more support for the already-fairly-well-documented idea that "free" samples in the office do more harm than good.

(Hat tip to Primary Care Medical Abstracts for the citation.)

Pinckney RG, Helminski AS, Kennedy AG, et al. The effect of medication samples on self-reported prescribing practices: a statewide, cross-sectional survey. Journal of General Internal Medicine 26:40-44, January 2011.

Maybe Starting to Get It: Neurosurgeons on COI in Research

An article and accompanying editorial in the Journal of Neurosurgery back in January are instructive in regard to our present level of understanding of the threats to medical research integrity posed by conflicts of interest.

Dr. Alpesh A. Patel and co-authors, a group of academic orthopedists:
--discuss various recent cases of conflicts of interest in medical research and publication, many of which we've addressed here. They start off with this list of problems raised by these instances:

  • Calling into question the ethics and motives of the involved individuals

  • Creating public distrust of science

  • Calling into question academic medicine's "honor code"

  • Disrupting relationships with patients

  • "They offer salacious opportunities for the lay press to decry the rampant corruption in health care"

  • "Lastly, and most ominously, they draw the attention and scrutiny of the government and politicians"
In the remainder of the article they sort of tack back and forth between the themes they list at the beginning-- that is, sometimes they are worried most about the patient and about the integrity of the science; other times they seem more concerned about what the press will write about us and how the politicians will come in and tell us what to do. When they get around to proposing solutions, they mention several times that eliminating commercial sponsorship of key research would be the ideal. They state that this seems unrealistic in the short run and therefore ways are needed to "manage" COI. The "management" tools they propose are hardly novel but reasonably strict. They advise their colleagues, "...some [clinicians] view any mandatory COI benchmarks as a personal affront. However, rather than contest the imposition of these restrictive regulations, it is imperative that physicians take the lead and accept that they are subject to a higher standard than others..." They focus on the responsibilities of physician-scientists and of the medical journals, respectively.

Dr. Joseph H. Piatt, Jr., a Delaware neurosurgeon, takes up in the accompanying editorial--
--the prevarication in tone in Patel et al's paper. He's stronger about the extent of the problem: "By corrupting the scientific method, commercial bias contaminates our knowledge base and deflects us from the objective best interests of our patients." He then scolds the other authors for placing so much emphasis in professional self-regulation when it has failed thus far to solve the problem: "The challenge of commercial bias in clinical research is not new, and the profession has made sincere but largely toothless attempts to contain it over the years. Patel and coauthors do well to exhort us neurosurgeons to take ownership, but none of their suggestions are game-changing. Look for expanded governmental control of the clinical evaluation and marketing of new medical technologies, particularly as the imperative for the containment of the growth of health care spending by any and all means becomes more acutely felt in the next decade." (The editorial includes a reply from Patel et al. who basically don't disagree with anything that Piatt says.)

What's the take-home message? I propose that we can see the slow evolution of attitudes within academic medicine, in specialties like neurosurgery and orthopedics that have not historically been at the very forefront of ethical advances (if I may express my bias):

  • COI is not a problem.

  • COI is a minor problem and we can easily manage it with a few tweaks.

  • COI is a serious problem and we had better do more to eliminate it, else the dreaded government will take over and tell us what to do.

  • COI is a serious problem, we had our chance to eliminate it and we failed, so we might as well make up our minds that the dreaded government is going to have to come in and fix it, even though there is still much we could do ourselves if we'd grow a bit of backbone.
And backbone, I may add, is what these orthopedists and neurosurgeons claim to be experts in.

(Note: I'm grateful to Rick Bukata and Jerry Hoffman of Primary Care Medical Abstracts for alerting me to this paper, though what I say above is a slightly more sympathetic take on the article than suggested in Jerry's recorded commentary.)

Thursday, August 25, 2011

Controlling the Channels: Pushing the Pharma-Friendly Model of Diabetes

In keeping with my lazy habit of letting others write this blog for me, I will talk about a couple of commentaries included in the July, 2011 edition of Primary Care Medical Abstracts by my friends Rick Bukata and Jerry Hoffman. The first, I will argue, illustrates the concept previously blogged about by the anthropologist, Kalman Applbaum, on the idea of drug "channels" and how drug company marketing works to control these channels effectively. The take-home message in each case is how medical journals have been harnessed to the cause of selling drugs, despite lack of sound evidence, in ways that are usually opaque to the average reader.

Exhibit A for this commentary is a so-called expert consensus panel (McInnes et al., subscription required) on diabetic foot care, published in the British journal Diabetic Medicine. The panel appears to be what evidence-based gurus call BOGSAT, or "bunch of old guys sitting around talking," rather than a systematic evidence-based review with proper methods. The funding for the "old guys" came from a firm called SSL International, which has since been bought out by another firm, which makes a variety of health-related products, mostly for nonprescription home use. I don't see offhand that they make any diabetes drugs. Nothing is said in the article about conflicts of interest, or lack of same, among the authors.

The authors set out to answer the question of what kind of foot care should be provided for diabetics considered to be at relatively low risk. I was puzzled because the article does not say whether they are talking about Type 1 or Type 2 diabetes, so I have to imagine they mean both. It is therefore important to keep in mind that about 90 percent of patients seen by adult practitioners have Type 2 (adult onset) diabetes. As we have discussed in several previous posts, there is at present no compelling evidence that tight control of blood sugar levels (trying to get the hemoglobin A1c blood test within normal limits) effectively prevents the major complications of Type 2 diabetes, in particular diabetic neuropathy which is the cause of most foot problems.

So the "old guys" list four things that they think physicians should advise patients as part of good diabetic foot care. The second is: "maintaining adequate glycaemic control." They proceed to explain: "Numerous clinical studies have demonstrated the positive relationship between reductions in HbA1c and reduced risk of microvascular complications of diabetes, including neuropathy and foot ulcers." Now, this is sort of half right. Numerous studies have shown that if you have two groups of diabetics, one with high levels of A1c (poor control) and others with low A1c (good control), the first group will have many fewer complications. What has never been shown is that giving medicines in Type 2 diabetes to lower A1c reduces the incidence of complications.

So what evidence do these "old guys" cite to prove their point about better control leading to fewer complications, especially in the feet? They mention two references. The first, as Jerry pointed out in his commentary on the paper, was to the DCCT trial published in 1993, which showed that tight control reduced complications in Type 1 diabetics--that is, irrelevant to the vast majority of adult diabetics. The second reference is a paper by Boyko et al. in 2006. This paper has nothing to do with diabetes treatment or the prevention of complications. Rather it is the development of a prediction tool to show which diabetic patients are most likely to develop foot ulcers. Not surprisingly, one of the risk predictors is elevated HbA1c--though interestingly enough, this single factor increases one's risk of foot ulcers by only 10% above baseline, while other predictive facts double or triple the risk. But the Boyko et al. paper says nothing whatever about whether better glycemic control will prevent neuropathy or ulcers.

So what we have here in this journal is a supposed "expert consensus" on preventing foot complications in diabetics, claiming that better blood sugar control is a critical component of this prevention, but unable to cite a single clinical trial showing this to be true for the most common type of diabetes. So long as physicians think that the best way to prevent the complications of Type 2 diabetes is to lower HbA1c, they will write a lot of prescriptions for expensive medications, making the drug companies richer--but doing very little actually to prevent diabetes complications. In this way even an article that seems to be not at all about drug therapy manages to convey a drug-industry-friendly message--and the evidence be damned.

McInnes A, Jeffcote W, Vileikyte L, et al. Foot care education in patients with diabetes at low risk of complications: a consensus statement. Diabetic Medicine 28:162-167, 2011.

Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. New England Journal of Medicine 329:977-986, 1993.

Boyko EJ, Ahroni JH, Cohen V, et al. Prediction of diabetic foot ulcer occurrence using commonly available clinical information: the Seattle Diabetic Foot Study. Diabetes Care 29:1202-1207, 2006.

Tuesday, August 23, 2011

Want to Wreck Things and Rake In Millions? Become a Pfizer CEO

Let me tell you a little story, that has very broad implications about national economic policy, and eventually get around to saying something that relates to the pharmaceutical industry.

Andrew Carnegie, who in his day was sort of Bill Gates and Warren Buffett wrapped into one, wrote an essay called "The Gospel of Wealth." As rich guys go Carnegie was not a bad sort; he believed that the rich should give away most of their wealth to community charities such as libraries and museums. But Carnegie also had pretty strict views about why you should not give direct charity to the poor. He described an instance in which a philanthropist he knew gave a quarter to a beggar. Carnegie was outraged, and insisted that that single stupid act was bad enough to undo all the good work this philanthropist had achieved over a lifetime. First, he was quite sure that the beggar would use that quarter for some immoral purpose--and those were the days when a quarter would actually buy something. But more important, Carnegie was sure that giving assistance to a poor person was a sure way to sap that individual's sense of responsibility, and lead inexorably to what today people would term the "culture of poverty," always waiting around for a handout and doing nothing to pull oneself up by those proverbial bootstraps.

I don't think that Carnegie had a name for this phenomenon, but when conservative economists started creating the theories that led to Reaganism and supply-side policies in the late 1970s, somebody came up with the term "moral hazard." The basic idea is that if people are in unfortunate straits and you give them some sort of aid, all you do is increase the rewards for being in those straits and make that behavior even more attractive in the future, which works directly against the unfortunate bettering themselves. So basically any federal program to help the needy in any way is a bad idea.

Okay, now back to Pharma. Dr. Roy Poses over at Health Care Renewal--
in turn drawing on a report in Fortune magazine/CNN Money--
tells us about the deeds and reimbursement of the most recent crop of CEOs at Pfizer. The basic bottom line is that the investigation viewed their performance as abysmal; their annual pay was in each case in excess of $10M; and during the time they were doing their best to ruin the company, they were actually granted annual raises. One former CEO, "Hank" McKinnell, more or less threw up his hands and declared his job impossible in 2002. He then sort of went missing and left a power vacuum that created severe headaches in the upper reaches of the company until he finally was forced to "retire" in 2006. He was paid $10.7M in 2003, $11.3M in 2004, and $12.8M in 2005.

This says something about bloated CEO pay throughout US corporations. This also says something about ineffective leadership at some large drug firms. But the particular lesson I wish to draw is about moral hazard. Notice that according to the gurus of our economy, if you give a poor man a quarter, you will probably ruin him for life and incidentally cause the collapse of Western civilization. If you pay a CEO extra millions of dollars every year for destroying his company, however, you are apparently following good economic principles; no "moral hazard"

In other words, there are rules for the rich and rules for the poor. And the rich are in charge. And don't you forget it.

NIH Conflict of Interest Rules: Weakened

I recently recapped fears that "get tough" moves at NIH, FDA and DHHS/DOJ regarding conflicts of interest were all being retracted or watered down. I then described some pushback on the FDA front, but according to our friend Dr. Bernard Carroll writing for Health Care Renewal:, the announcement from NIH earlier today on their new COI rules leaves considerable disappointment.

Dr. Carroll notes two major issues. One, that I summarized in my earlier post-- that universities are no longer required to post information about investigators' conflicts of interest in an easily accessible public website. (If you want you can write the university a letter and they are supposed to reply within 5 days.) The second is that the loophole that allows a conflicted investigator who was sanctioned at one institution simply to jump ship to another bottom-feeder university and start applying for NIH grants again right away, remains more or less wide open.

Monday, August 22, 2011

Pressure Builds on FDA to Maintain New COI Rules

In the previous post, I discussed briefly the FDA's apparent desire to retreat from the tough new conflict of interest rules it had earlier announced, particularly, excluding "experts" funded by industry from its advisory committees. Numerous examples have occurred where industry-supported votes made the difference between keeping a dangerous drug on the market and pulling it, for example. But the FDA is now claiming that it simply can't find any real experts who are not in the pay of the industry.

Enter our old friends, journalists Shannon Brownlee and Jeanne Lenzer. Jeanne authored a news item in last week's BMJ (subscription required) highlighting the entry of our other friends, the National Physicians Alliance, into the fray. The main point raised by Brownlee, Lenzer and the NPA is that they had worked hard a little while ago to compile a list of expert physicians who take no industry cash. They were able to come up with a list of over 100 such individuals (full disclosure: I'm on the list, though just what I am an expert in remains to be determined). The NPA and the journalists objected that despite their having been supplied with this list, there's no evidence that anyone at the FDA made any effort to contact any of those physicians. How, then, said the FDA's critics, can anyone claim that these experts are too hard to find?

There is some tentative evidence that the FDA may be backpedalling on their backpedalling, so stay tuned for further exciting adventures.

Lenzer J. Doctors join protest over change to FDA rules on conflicts of interest. BMJ 2011; 343:d5269.

Monday, August 15, 2011

Integrity in Government? Forget About It

Once again I can sit back and let others do all the heavy lifting for this blog, in this case Dr. Roy Poses at Health Care Renewal:

Dr. Poses conveniently combines three breaking news stories, each of which features an unfortunate retreat from integrity by an arm of the Federal government, where previous action that showed a commitment to integrity is in danger of being reversed:

  • The FDA is telling Congress that it cannot find real medical experts who are not in the pay of drug companies, so please excuse them from their goal of excluding these industry shills from FDA advisory committees

  • NIH is now saying that academic medical centers cannot find the resources to maintain websites that list the sources of payment for faculty members with financial conflicts of interest, so it cannot implement a previously announced transparency plan

  • DHHS earlier threatened to exclude Forrest Laboratories CEO Howard Solomon from further dealings with Federal health programs (the so-called fiscal "death penalty") after his firm was found responsible for repeated violations committed on his watch. This was initially hailed as a step to show that finally DHHS was serious about punishing companies that repeatedly broke the rules. Now DHHS says--sorry, we were just kidding; after the U.S. Chamber of Commerce and PhRMA raised a howl. (Forrest hired former Sen. John Breaux as its lobbyist to fight the exclusion.)
See Dr. Poses' long post for details and additional links on each of the three actions, but if there's a summary message, it seems to be a cynical one--the election is approaching and with the US Supreme Court removing all limits on corporate cash flowing into campaign coffers, don't expect either the executive or the legislative branches to stand up to the aggressive corporate lobbying of the drug industry and its cronies. In the case of the NIH my feelings are more mixed due to my own conflict of interest, as a faculty member at an academic medical center. I've seen up close and personal the damage being done to our institutions as both state funds and NIH grants are cut back and every medical school is expected to do more with less. So I have a bit more sympathy there. Still, given the hoopla with which the new NIH COI transparency rules were announced, it is deeply disappointing to see the full-scale retreat with hardly a whimper. Moreover, one has to wonder--is it really the gripe of the academic medical centers that they don't have the resources to staff the websites? Or is it rather that they'd prefer not to interfere with the corporate grant machine that their conflicted faculty help to fuel with the industry's largesse?

Friday, August 12, 2011

More on IOM Report on FDA Scrutiny of Devices

We posted previously on the device industry pushback against the new IOM report urging major reforms of how the FDA regulates medical devices:

Now the New England Journal of Medicine:
--in a "Perspective" authored by their executive editor, Dr. Gregory Curfman, and Dr. Rita Redberg, the editor of Archives of Internal Medicine, adds their word of support to the IOM proposal. Some highlights from the Perspective:

Despite its reasonable (and relatively modest) recommendations, the report has been aggressively attacked by the device industry and by politicians from states where device companies are located. In fact, the attacks began even before the report was released, which is highly unusual for an IOM report.

We believe that the IOM report is insightful, judicious, sensible, and long overdue. ... Unfortunately, the FDA leadership has already suggested that it does not intend to implement this key recommendation of the report, although it may be open to other changes. As the best long-term improvements are contemplated, there are important steps that the agency can take now.

We strongly believe that, in the interest of advancing human health, patients must have easy access to innovative medical devices and that the approval process needs to be sensible and efficient. But no one’s interest is served by putting defective medical devices onto the market where they cause harm to patients, waste health care dollars, and may kill jobs when they are withdrawn. It is essential that the FDA be adequately funded to carry out its mission to ensure the safety and effectiveness of medical devices. The IOM report charts a path that is right for the future, and despite well-financed outside pressures, we urge the FDA to initiate an action plan with congressional support to adopt these important recommendations.

Sunshine Laws Having an Effect? Maybe

A stray e-mail that came across the ol' transom today seems to hint that sunshine laws, requiring the public disclosure of names of physicians who receive payments/gifts from the pharmaceutical industry, might actually be changing the landscape. At least a consulting firm called Alliance Life Sciences thinks so:

Alliance, their website explains, currently works with 8 of the 10 largest pharmaceutical firms around sales and marketing. They have produced this new white paper on what's new with physician Key Opinion Leaders (KOLs) in an era of sunshine. From their e-mail/press release:

“Firms may wish to embrace new marketing paradigms, such as disease-centric product offerings that enhance value propositions for physicians, patients and payers, to compensate for KOL physicians that may no longer be willing or able to collaborate with them,” says Ed Masterson, senior vice president, consulting operations, ALSCG. ... “The new marketing paradigm won’t come from having renowned academics simply present a firm’s PowerPoint deck to auditoriums of doctors,” says Masterson. “It will be based upon research demonstrating improved patient outcomes and avoided costs associated with better compliance that delays or reverses disease progression and acuity.”

What a revolutionary idea--to successfully market new drugs, you might actually have to show that they work. Not simply bribe a famous doctor to show slides over dinner.

The debate over sunshine laws, as we've discussed in numerous previous posts as well as in HOOKED, is how much mileage you get purely out of disclosure. Disclosure of unethical behavior does not turn it into ethical behavior, so if physicians continue to take freebies from industry, and don't care if their names show up on a public website or not, nothing may change. The theory behind the sunshine laws is that if physicians know their names will be made public, they may think twice about their relationships with industry and actual behavior may improve. Alliance Life Sciences seems to be betting that this likely effect is real.

Sunday, August 7, 2011

In Praise of Good Corporate Behavior: Medtronic

I last spoke of Medtronic's shenighans with their spinal surgery devices and products here:

It's critically important that if this blog is to be about ethics at the interface between medicine and for-profit industry (drug or device), that I am equally attentive to good corporate behavior as to scandals. This can be challenging as we've seen numerous examples of egregious corporate behavior spun by creative PR so as to appear virtuous. But if it really seems that a company has seen the error if its ways, we should take note and be appropriately respectful.

So is Medtronic now in this august category?
Two things make me accept this account as indicative of genuine corporate responsibility. First, the person who sent me the link is a hard-headed critic of industry and has often seen through PR fluff in the past when I could have been fooled. Second, the person selected to do the study of Medtronic's products, Dr. Harlan Krumholz, has what I believe to be an unassailable position as an independent industry critic. If you want somebody to paper over your misdeeds, he would be a pretty pooor choice.

If we ever want to have a relationship between the medical profession and the industry that takes full advantage of the benefits of collaboration while avloiding the ethical cesspool of today's conflicts of interest, we need models of effective neutral turf where industry and professional folk can foregather to address the issues and see what sorts of new developments might be proposed, without the setting itself creating new conflicts of interest or dangers of one side controlling the discussion for its own ends. I am not sure that this Yale study will be a model applicable to other such settings, but it's certainly a welcome development if it is what it seems to be.

Friday, August 5, 2011

Econ 101 and Drug Patents

I know that all of you out there keep a copy of HOOKED at your bedside and read a chapter each night before retiring. But in case you've not yet committed the volume to memory, I can take the opportunity of these news items to do a bit of review of a basic concept:

The latter article, from The Guardian, is a commentary by economist Dean Baker (whom I quote in HOOKED) on legislation proposed by Sen. Bernie Sanders (I-VT), which is summarized in the first link.

Here's how Baker starts off his commentary: "Drugs are cheap. There are few drugs that would sell for more than $5-$10 a prescription in a free market. However, many drugs in the United States sell for hundreds of dollars per prescription and, sometimes, several thousand dollars per prescription. There is a simple reason for this fact: government-granted patent monopolies."

Now, this comment may strike you as strange, especially if you were to check out the Pharmaceutical Research and Manufacturers of America website ( There you will find the following statement of the drug industry's core values:

PhRMA's mission is to conduct effective advocacy for public policies that encourage discovery of important new medicines for patients by pharmaceutical and biotechnology research companies. To accomplish this mission, PhRMA is dedicated to achieving these goals in Washington, the states and the world:
• Broad patient access to safe and effective medicines through a free market, without price controls;

• Strong intellectual property incentives;
• And transparent, efficient regulation and a free flow of information to patients.

In case you don't know what "intellectual property" is, read "patents." So how can it be that an economist explains that in a free market, drugs would be really cheap, and the reason they cost so much is because of patents that amount to government monopolies (which are of course a violation of the free market); yet PhRMA insists it is for the free market (and against price controls), yet also for patents?

I mentioned in passing ( that I hope soon to be able to announce the availability of a new book on the subject of economism. Economism, briefly, is the worship of the "free market" as an item of religious faith, though it disguises its religious nature by posing as hard-headed science. Economism, I hope to show, is shot through with internal contradictions and inconsistencies, explaining why its believers have to be faith-based, because neither facts nor logic would support it. PhRMA's two claims of being pro-free-market and pro-patent is just one tiny example of the sorts of contradictions that economism generates--yet at the same time obscures, so that most US politicians and policymakers repeat this nonsense without realizing that it's nonsense.

Baker goes on to explain that a patent is a government-granted monopoly based on a hunch that the extra cost to the public, forced to pay monopoly prices for goods until the patent expires, is a good trade, because the patent forms an incentive to innovate and invent which in turn is a public benefit. This hunch could be well or poorly grounded. Baker argues that right now, we are paying a lot more for drugs through patent monopolies than we are getting benefits from real innovation. If you don't think this is true, you have not been following this blog.

Enter Sen. Sanders. There are wo possible solutions to the mismatch between drug patents and real public benefit. One would be a strictly regulatory approach--change the rules regarding granting patents for new drugs. Demand more evidence of real benefit before granting a patent, or shorten the period of patent protection, or some such. The other approach, which is what Sanders actually has proposed, is a quasi-market approach, using financial incentives rather than regulation. The idea is to impose a tax on both public and private health insurers. The money from the tax would create a prize fund. The prize fund would be used to buy up patents for really useful drugs, as opposed to "me too" drugs. These useful drugs would quickly become generic drugs and would be available cheap.

This, say both Sanders and Baker, would be a win-win. The insurers would more than save in lower drug costs what they paid in the new tax. Drug companies would then have a powerful incentive to discover really useful new drugs, because then they could easily sell the patent for a tidy profit. Baker is perhaps overly sanguine in imagining that in this new system, drug companies would gain no benefit from deceptive marketing of marginally useful or harmful drugs, so they'd simply quit doing that.

Since true believers in economism hate government programs and hate new taxes, and probably hate Bernie Sanders, you can bet there will be little support in those quarters for this proposal. But thanks to Dean Baker for again revealing the hypocrisy of the drug industry's wrapping itself in the "free market" mantle.

ADDENDUM 8/6: A reader much more alert than I was when I wrote this post last night informed me that I had inserted the word "patient" when I obviously meant "patent." This has been corrected above.

Ghostwriting, Again: This Time, Consequences

Some time back--
--I mentioned that we were still awaiting a case where an academic physician suffered clear, negative consequences as a result of being guest author on a ghostwritten paper, though I described a case that provided circumstantial evidence of such consequences. (That particular physician had two strikes against him, of which involvement in ghostwriting was just one, so it was not clear just what offense produced the consequences.)

Thanks to a regular reader of this blog, I now can report what seems a clear case of cause and effect re: ghostwriting and guest authorship, from our neighbors to the North:
This case involves a punishment meted out in 2010 (apparently, as it was not then publicly announced) by McGill University for a paper published in 2000. We need to note that while on the surface, it might seem unduly vengeful and petty to look back so far for a punishable offense, in reality this is often what the academic medical center has to work with. It is often the case that revelations about ghostwriting come to light only following litigation and the release of internal company documents, which most often occurs many years after the actual incident.

A possible defense of this academic was that back in 2000, this sort of behavior seemed routine and noncontroversial, and it was only years later that all the attention began to be paid to the ethical issues related to ghiostwriting. That is, in my view, a fair comment, and if you read the Montreal article closely you'll see that the level of punishment meted out was consistent with that level of seriousness (in my view).

Thursday, August 4, 2011

Even More on Ghostwriting, Or, They Don't Get It in Toronto

Two big questions this time around--first, can academic medicine police itself regarding ghostwriting, or do we need to invoke the law? Second, does the Toronto Globe and Mail get it, or rather, who got to them?

First, on how to police ghostwriting, we start with an article by our old friends Jonathan Leo and Jeffrey Lacasse, this time aided by Andrea Cimino (subscription required). This group tells us that there has been a lot of huffing and puffing among academics and editors as to why ghostwriting really is not that at all, or if it is, well, it's still okay. So the authors try to simplify for us by saying--this is ghostwriting, and if it happens, then it's wrong and you should be throwing the book at somebody. They argue that the essence is: "If a person who should have been listed as an author was left off the byline, then the paper has been ghostwritten."

This would be a nice, concise formula if it were acceptable. I am fearful that it's not. As to why, stay tuned. But anyway, Leo et al. are optimistic that if we academics could just get clear on what ghostwriting really is, we could manage to police it properly. Now along come Simon Stern and Trudo Lemmens from Toronto:
--to say, no way. They review the various conflicts of interest that both journals and academic medical centers have with the drug industry, making it unlikely that either would find the backbone really to put an end to ghostwriting-related practices. They suggest that the only thing left is legal remedies, and they then develop specific legal arguments as to why ghostwriting is fraud, and drug companies conspiring with medical writers and academic "guest authors" is racketeering under the law. (Along the way, they dig up an interesting case from 1944, said to be the only U.S. Supreme Court decision on ghostwriting--it involves a patent on glass manufacturing, of all things.)

Okay, so there you have the debate on the first question. On to the second question. It is pretty unusual for the local newspaper to come out with an editorial that says that a paper just published by two members of the local university faculty, in an academic journal, is all wet. But that's just what the Toronto Globe and Mail did with the Stern-Lemmens paper:

Now, this editorial is such a serious misrepresentation of all the ethical issues in ghostwriting that you have to wonder what prompted it. The point of the editorial is that ghostwriting is good because academic physicians can't write worth beans (mostly true), so if professional writers take over and render one's article readable, then they are doing a great service, and how can you call this fraud and racketeering, etc. They admit grudgingly along the way that "guest authorship" is of course wrong, and if you did not truly contribute to the research or the writing, your name doesn't belong on the paper. But they act as if the ghostwriter is the innocent victim in such a case. They totally fail to address the basic problem, that ghostwriting and guest authorship, together, are part of a larger system by which the drug industry can manufacture "science" to its marketing specifications. They say they are opposed to this, and make this incredibly naive comment: "If, on the other hand, pharmaceutical companies are paying, in whole or in part, for the research, and they supply the ghostwriters, there is a need for particularly vigilant reading of the draft by the researchers, so that no advertising spin creeps in." This of course ignores the reason that the entire process exists, and that the money needed to hire the ghostwriter fell out of the sky to begin with--that "advertising spin" is not an accidental byproduct but the entire intent.

So where did such a wrongheaded and ignorant editorial come from? I can only relate back to our earlier post:
We saw that the medical communications companies that supply the ghostwriters for industry, and that helpfully coordinate the care and feeding of the guest authors, are tired of being sneered at and are launching their own PR blitz (which is, after all, what they are supposed to be good at), trying to take back the ethical high ground. All I can imagine is that some of these dudes captured the ear of a gullible editor at the Globe and Mail and managed to plant their own advertising spin into the editorial. Which tells you a little something about the ethical integrity of that industry.

Back to my comments on Leo et al, in case you're not asleep yet. Why do I doubt that they got it right on their crisp definition of ghostwriting? Here's a case we talk about in an "Ethics of Scientific Research" course we teach here. Prof A goes to do a sabbatical in Prof B's lab. He does an experiment there, using Prof B's lab equipment and support team. Later he goes back home and then works with Prof B to write up the results of his experiment. When he gets the final draft of the paper for his review, he's shocked to see Prof C's name on it, who works at a distant university and had nothing to do with the experiment. Prof B explains that he and Prof C have a deal. They worked together in the past and they simply agreed always to list the other as co-authors of any future papers. When Prof A objects, quite correctly, that this is an unethical violation of the rules of authorship, Prof B retorts that if Prof A will not honor his deal with Prof C, then the B lab will simply take A's name off the paper and publish the results themselves.

Okay, imagine that B carries out his threat. C is a guest author, which is unethical. A, who should ethically have been listed as an author, is not so listed on the paper. Does this make the paper a ghostwritten paper? There is no ghost writer. The people who wrote the paper, B and his colleagues (except for C who's being included unethically), did in fact do the experiment along with A, and legitimately are part of the scientific team responsible for the data. Plus, the case has nothing whatever to do with commercial spin. Yet by the Leo et al. definition, this is an example of ghostwriting. So I think their definition needs more work.

Leo J, Lacasse JR, Cimino AN. Why does academic medicine allow ghostwriting? A prescription for reform. Society (epub July 21, 2011)

Tuesday, August 2, 2011

Medical Device Industry to IOM: Drop Dead

The Institute of Medicine (IOM) of the National Academy of Sciences recently issued a report on FDA regulation of medical devices--unfortunately only a brief summary, which is frankly not all that informative, is available:

As explained in the press coverage:
--the FDA had commissioned this review by the IOM a couple of years ago, and the IOM now argues that the entire system that the FDA uses to regulate and evaluate devices is seriously flawed and should be replaced. As I said, it's hard to get the whole picture from the 4-page summary of the report released thus far. As best as I can tell, the issue is with the so-called 501(k) process, which is based a law passed between 1976 and amended in 1990 and 1997.

By this process, a device can largely escape the need to prove that it's both safe and effective for human use if the company can demonstrate that it's "substantially equivalent" to an already approved device, known as a "predicate device." The IOM committee seems to have two problems with this approach. First, in many cases, the "predicate device" itself was never proven to be safe and effective. Second, the IOM report calls for a continuum of pre-and post-market surveillance for safety issues, and feels that the current 501(k) system fails to address that continuum adequately.

Bottom line, says the IOM: stop tweaking 501(k) and figure out a new regulatory framework to replace it. Problem: the FDA has never gathered enough data about the practical impact of 501(k) to determine what would be a better system; so step one called for by the IOM report is to do that study.

Full disclosure: I am a member of the IOM. IOM is part of the National Academy of Sciences and is supposed to represent an elite cadre of medical thinkers, working independently of government, to address pressing issues in a scientifically informed manner. The IOM's earlier report on medicine and the pharmaceutical industry has generally received the high marks typically granted to the IOM's work, as we summarized:

So, if the IOM says that the regulation and safety monitoring of medical devices is in serious trouble, you'd imagine that the device makers would, if not exactly kissing the hem of IOM's gown, at least feel some need, strategically, to offer an appearance of deference before they start to beat up the findings. But, as Steve Martin might say--naaaah. Matthew Perrone reported for the AP: "The device industry's chief lobbying group also dismissed the proposal, saying its conclusions 'do not deserve serious consideration from the Congress or the administration.'"

Now, just where did that "also" come from? Funny, it seems that the FDA is not itself very pleased with the report that it comissioned. Dutifully, FDA announced they'd convene a public meeting and take comments on the IOM recommendations. But in their press release--
--Dr. Jeffrey Shuren, head of the device agency within FDA, was quoted, “Medical devices in the U.S. have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the U.S. and has helped bring lower-risk devices to market for the patients who need them.”

Are you having difficulty telling who's a flack for the industry and who's speaking on behalf of the government agency that's supposed to be regulating the industry? Hmmm. In defense of the FDA, they have been busily at work proposing refinements to their 501(k) process, and basically object that we should give them a chance and see how these improvements work before we set off the more arduous and politically fraught process of trying to rewrite the legislation.

So that's where we are with the IOM report. I mainly want to note the arrogance of the device makers. As we have previously summarized. In some recent press coverage that I now see I may not have gotten around to reporting on this blog, it seems clear the device makers are feeling their oats. They are throwing around their big donations to key Congresspeople, and threatening to take US jobs offshore if the FDA tightens up on device regulation. And this despite major recent revelations about the rampant corruption of medical science and practice by major device manufacturers, as we have noted:

So when you have government in your back pocket, I guess you can thumb your nose at the IOM with impunity.