An Update on KOLs

In the previous post I mentioned a collection of essays on institutional corruption in Pharma. One of the essays:
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2272672
--by our old acquaintance Sergio Sismondo at Queen's University in Canada, provides something of an update on the status of KOLs, who were discussed here last with:
http://brodyhooked.blogspot.com/2012/08/you-too-can-be-kol.html

Trying to hit the high points, I note that Sismondo is engaged in an ongoing study of KOLs and their influence that includes having attended a number of industry conferences on KOL identification and management, and interviews with a number of highly paid KOLs and Pharma insiders. He agrees with earlier posts here that the drug firms are increasingly outsourcing KOL management to firms specifically devoted to that enterprise. I have previously tended to stress the KOL who's usually a big fish in a small pond, the physician who's supposedly being paid to talk to other docs, but in reality is being paid bribes for her own high rate of prescribing of the company's drug. Sismondo is concerned more about the other end of the spectrum, the big-pond fish who truly can exert influence across large numbers of docs and are being paid especially to do that. The small-pond types typically command $500 to $1000 per lecture, Sismondo tells us, while the big-pond KOLs can draw down $2500.

One interesting and suggestive observation is that as one moves up the food chain to the truly influential docs, the industry treats them more as partners and with kid gloves, because (as one experienced industry consultant told Sismondo): "the number-one requirement specified by KOLs is: 'protect my reputation.' He goes on to reiterate that KOLs desperately want to avoid the 'appearance of...being an industry 'sell-out.'" This seems extremely important because it suggests that the efforts of us pharmascolds over the past decade has actually had an impact. Since KOLs are, indeed, industry sell-outs, this suggests to me at least that a serious campaign within medicine and biomedical science to thus label them publicly could have a significant impact on the general level of professional behavior. On the other hand, Sismondo is skeptical about transparency alone as a vehicle for positive change, and argues that the new U.S. Sunshine Act will have relatively little impact on KOL activity. If anything, the industry is betting on the continued thriving of KOLs; Sismondo notes that currently 15 to 25 percent of total marketing budgets go to speaking events.

I just now suggested that a possible strategy to reduce the number and the influence of KOLs would be to shame them more. Sismondo seems unsure that this would work: "...the medical profession has been corrupted because a small number of companies with well-defined and narrow interests have inordinate influence over how medical knowledge is produced, circulated, and finally used by physicians to make decisions concerning their patients....Most physicians see the companies as playing legitimate roles when the companies promote products in clinics, when they create and distribute medical research, and when they fund and provide continuing medical education." That is, even if KOLs personally wish to avoid looking like sell-outs to industry, Sismondo claims that the larger profession is quite blasé about whether or not these folks have actually sold out. I'm not sure I totally agree with Sismondo on this pessimistic take on general professional values; see for example:
http://brodyhooked.blogspot.com/2013/07/a-recent-survey-on-physicians-attitudes.html

OK, so what do we do about all this, if Sismondo is unsure that shaming KOLs gets us any traction? The big-enchilada solution, for Sismondo, is to break up the industry, separating the research-and-development portion of pharmaceuticals from the selling-and-marketing part. One set of firms would discover new drugs, and once those drugs had been shown to meet high standards of efficacy and safety, those firms would auction off licenses to make and sell the drugs to other firms. This would, Sismondo thinks, remove many of the perverse financial incentives that arise from marketing getting mixed up with research.

Sismondo agrees that this grand solution won't happen anytime soon, so his temporary backup plan is: ban physicians speaking on behalf of drug companies. He argues that nothing is served by this and while firms have every right to market, they could just as well have sales reps give the talks. Of course this ban is just as likely to happen anytime soon as the other proposal, unfortunately. But the point for medical ethics and professionalism is that it could effective happen tomorrow--if only physicians would grow an ethical spine and simply refuse to attend company-sponsored talks.

Special Journal Issue, “Institutional Corruption and Pharmaceutical Policy”

I’m happy to turn the podium over to Professor Marc Rodwin, who a while back sent me the message below, which I managed to put aside at the time without posting, and am now making amends. The topic his symposium addresses—note the free access to the papers—should be of great interest to readers of this blog:

I thought you and the readers of your blog might be interested in a forthcoming symposium on Institutional Corruption and Pharmaceutical Policy that will be published in the forthcoming issue of the Journal of Law, Medicine & Ethics, 2013: Vol. 14 (3).

Below I list a bit of information about the symposium.  I have also attached a list of the articles with URL links on SSRN which has free access.  Also, these items can also be obtained through the Edmond J. Safra Center Lab on Institutional Corruption Web page,

http://www.ethics.harvard.edu/lab/featured/325-jlme-symposium

The goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution’s objectives or integrity. The pharmaceutical industry’s own purposes are often undermined.  In addition, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, and the Food and Drug Administration’s oversight of pharmaceutical marketing.

I invited a group of scholars to analyze these issues, with each author taking a different look at the sources of corruption, how it occurs and what is corrupted. The articles address five topics: (1) systemic problems, (2) medical research, (3) medical knowledge and practice, (4) marketing, and (5) patient advocacy organizations.

Advanced copies of the 16 symposium articles are now available through SSRN online.  [http://www.ethics.harvard.edu/lab/featured/325-jlme-symposium]

For a summary of each article and the key themes in the symposium see, Marc Rodwin, Institutional Corruption and Pharmaceutical Policy

http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2298140

Marc A. Rodwin, J.D., Ph.D.P

Professor of Law, Suffolk University Law School
Lab Fellow, Edmond J. Safra Center, Harvard University
mrodwin@suffolk.edu

 

Gene Patenting: What Did the Supreme Court Rule in Myriad?

I forget what I was doing back in the late spring when the US Supreme Court issued a couple of major rulings on issues of interest to this blog. I did not have time just then to post about these rulings but made a mental note to get back to them as soon as possible. Right…Anyway, last week’s New England Journal of Medicine has forced my hand (main article for subscribers only).

In Association for Molecular Pathology v. Myriad Genetics, Myriad’s claim to have patented the gene sequence for the BRCA1 and BRCA2 cancer-causing locations, and hence their exclusive right to offer a genetic test for those conditions, was at issue. The article mentions one major downside of one company having this exclusive right to a genetic test—its price. Myriad charges about $4000 and one competitor firm is promising to market a test for $1200. The article omitted to mention an issue that is even more serious regarding medical science and practice. Myriad has been able to sequester data on the effectiveness of its genetic tests as proprietary information. That means any physician counseling a patient on whether or not to be tested, and what a test means, is dependent on the company profiting from the test to say how well its own test works, and that is rather obviously a bad situation.

Lower courts had thrown out first all, then only some of the Myriad patents. The Supreme Court basically split the difference. Some patents involved the actual DNA that makes up the genes. The court said that exists in nature and you cannot patent that. But some patents involve complementary DNA which the company manufactures off messenger RNA that is taken from those genes. That cDNA does not exist in nature, so the court said the company could patent that. (Plaintiffs had alleged that cDNA is really the same as native DNA because what matters is the information in it, not its physical form, and that is the same as the native DNA; the court did not buy that argument.)

Patient advocates such as the ACLU trumpeted the decision as a big win because it does now open the door to competing gene tests. Let’s take a step back, akin to the discussion of patents in HOOKED, and see what basic issues are involved.

First let’s do Patent Law for Dummies. The noise made these days by corporate apologists about “intellectual property rights” obscures the basic fact that a patent is a monopoly. The government is supposed to break up monopolies, not create them. So the whole idea behind patents is that it’s a tradeoff. The government grants temporary monopoly rights. In exchange it’s supposed to get useful innovation that’s in the public good. No patents, no firms willing to invest their cash in bringing new inventions to market, no innovation to benefit the public. Too many or too burdensome patents, prices go way up, public interest is harmed, and in extreme cases (like arguably today’s biotech sector), innovation is actually squelched.

The law says that patents should be granted only if some basic conditions are met. The Supreme Court in Myriad issued a very narrow ruling. It decided one issue only—whether naturally occurring things can be subject to patents—and decided “no,” in keeping with many earlier rulings. The Court refused to review the Myriad patents on other grounds, such as whether they met the conditions of being novel, useful, and non-obvious. Those other grounds are important to most patents relating to Pharma. The argument against the present patent system for drugs is that firms are allowed to patent all different aspects of a drug, even those that are non-useful and obvious. This simply puts barriers in the way of generic competition, and does nothing to spur innovation.

(As I argued in HOOKED, following Marcia Angell, the Patent Office could squelch these nuisance patents without any need for a court ruling, simply by enforcing its own rules. Alternatively, the FDA could refuse to list any such nuisance patents in its reference book that states the conditions for drug approval and generic equivalence. But both Federal bodies are more interested in cozying up to industry, apparently.)

The authors of the NEJM paper provided a bit of good news in that regard—they report that in recent years the Patent Office had issued many fewer patents for naturally occurring gene sequences because they had tightened up their criteria and insisted that biotech companies could not simply patent genes wholesale, they had to make a plausible case that they knew how to do something useful with the discovery. (Presumably the Myriad decision will raise the bar still higher by ruling out all such patents anyway.)

As a bonus, the New England Journal threw in two historical essays:

http://www.nejm.org/doi/full/10.1056/NEJMp1306755

http://www.nejm.org/doi/full/10.1056/NEJMp1306553

These address events leading up to the passage of the Bayh-Dole Act of 1980, that opened the floodgates to universities patenting all manner of scientific discoveries, including those paid for with federal research dollars. They make a case for not regarding Bayh-Dole as carved in stone, but as needing review and updating as conditions have changed so much since its creation.

 

Kesselheim AS, Cook-Degan RM, Winickoff DE, Mello MM. Gene patenting—the Supreme Court finally speaks. New England Journal of Medicine 369:869-874, Aug. 29, 2013.

Why There's No Such Thing as Conflict of Interest

A good deal of this blog is about conflicts of interest at the interface between medicine and the pharmaceutical industry, and we occasionally encounter those who deny that such conflicts of interest represent any serious problem, for instance:
http://brodyhooked.blogspot.com/2011/12/intellectual-conflict-of-interest-rides.html
http://brodyhooked.blogspot.com/2008/01/do-i-hate-capitalism-wild-and-crazy.html

I have also alluded to the ideology that I and some others have termed economism:
http://brodyhooked.blogspot.com/2011/11/shameless-commerce-division-new-book.html
--about which, if anyone is interested in more discussion, they are welcome to peruse my other blog:
http://theeconomismscam.blogspot.com/

All that is a lead-in to a new book, Never Let a Serious Crisis Go to Waste, by a professor of economics at Notre Dame, Philip Mirowski (New York: Verso, 2013). Mirowski explains at a much deeper level why it is that critics of the position taken in this blog, and among the community of pharmascolds, insist that conflict of interest really doesn't exist.

First, on nomenclature--while I offer reasons to prefer the term 'economism' on my blog and in my own book, The Golden Calf, Mirowsky follows the practice of most of our colleagues in history and the social sciences in using the term 'neoliberalism.' So rather than get tangled in who calls it what, I will refer to this ideology henceforth as 'E/N'.

E/N starts off with the claim that the supposedly "free" market is the single most important institution in society, so much so that we ought to regard virtually all of human life as one big market and as following the rules of the marketplace. You might think this is just because a market is such a neat place to buy and sell stuff. But Mirowsky shrewdly notes that one of the great founders of E/N, the Austrian economist Friedrich Hayek, had another reason to glorify the market.

Hayek saw the market as the most perfect information processing system available to human society. If he were writing today, Hayek would probably use the metaphor of the computer. The market is a supercomputer that instantly receives input data from billions of sensors, which are the individual "rational agents" as orthodox neoclassical economics conceives of such a thing.

Now, since all of society ideally ought to be governed by the rules of the market, it follows that the only data worth knowing about anything is its current market price. The market price captures precisely the value of that commodity; the very idea that the market might overvalue or undervalue anything simply does not compute within E/N. The supercomputer of the market takes in all the data from all those who might like to sell a commodity--how much of it they have, and what price they are willing to accept for it. It takes in all the data from everyone who might buy that commodity--how badly they want it, what they might be willing to pay for it, what else they might be willing to forgo, or not, to get some of it. And the computer crunches all those numbers each millisecond to come up with the ever-changing fact, the true market value/price of that commodity.

This is E/N's picture of how society ought to run; and from that picture you can see that there are a number of flies in the ointment, called natural scientists. These folks persist in adhering to a hackneyed, obsolete idea-- that there is another source of valid facts that has nothing to do with how the market functions. These scientists actually think they can consult the body of evidence in their own field, and go into the labs and do experiments, and emerge with data that they view as reliable and true about how the world works.

If these scientists were ever to be taken seriously, all hell would break loose. For the proper role of government, according to E/N, is to stand out of the way and allow the unregulated "free" market to run itself. But so long as these scientists tell politicians that they know some facts--such as, that climate change is a real threat to the human future--then these politicians would be tempted to try to regulate the market to bring about the ends that they desire (like reducing carbon pollution). And that would simply never do. As Hayek famously explained, just let the government think it could regulate even one small thing, and we'd all instantly and permanently lose all of our freedoms.

(As a side issue, whether that was what Hayek really said is quite questionable, and on my other blog I go into some detail about why what today's E/N enthusiasts claim in Hayek's name may actually be a far cry from what Hayek actually wrote:
http://theeconomismscam.blogspot.com/2012/09/republican-worship-of-hayeks-road-to.html
But for now we can ignore that fine point.)

Now, what in heck does all this have to do with conflict of interest? The point is that the entire ethical argument about conflict of interest assumes, well duh, a conflict of interests. Presumably a scientist has an interest (actually a moral duty) to discover and explain the truth according to the best scientific evidence and methods. If the scientist then proceeds to line his pockets with industry money, he acquires a second interest, in making those industry folks happy and telling them what they want to hear--such as their favorite new drug is extremely safe and effective.  The conflict between those two interests is what creates the ethical problem.

How does E/N see this situation? E/N cannot fathom the duality of interests. Since the market is the only reliable source of truth about value, then if the scientists accepts payment on the open market for his opinions, the market value of those opinions, not some silly body of scientific evidence, is what determines their truth. So the scientist creates no conflict of interest by becoming a corporate shill.

Mirowski looks at his fellow academics and notes spectrum of opinion on conflicts of interest. At one extreme end he places the biomedical folks. They have gotten their knickers more in a knot than anyone else over conflicts in their field, and have created this new cottage industry of COI guidelines and rules. Maybe that has something to do with the idea that some of them actually care about whether patients live or die after being given the newest drugs and devices.

At the far other end of the spectrum are the economists. As Mirowski characterizes the field of orthodox neoclassical economics (which has both taken over virtually all university departments of economics, and has also been fully captured by the E/N ideology, to hear his account of it), the typical econ professor takes a ton of money from various corporations, especially banks and financial firms, believes that nonetheless he's a completely neutral arbiter of fact, and discloses none of those financial involvements in his journal articles and other scholarly work. Plaintive calls among a few disgruntled folk after the start of the recent great recession, that the field of economics needed a code of ethics, were ignored.

When we understand what E/N teaches, we can see why the economists have figured out exactly what conflict of interest is all about, and why from their point of view the biomedical scientists are clueless. And that further explains why those within the biomedical community, who have been most sneering and dismissive of conflict of interest as an ethical concern, seem to be among those most committed to the E/N ideology.

Overdiagnosis: A Consequence of Commercial Influence

The phenomenon of overdiagnosis is receiving increasing attention in medicine, and is indeed the subject of an international conference to happen in a couple of weeks at Dartmouth. Last year, Ray Moynihan,. the Australian journalist well known to readers of HOOKED as the author of a great book on “disease mongering,” along with Jenny Doust and David Henry, prepared a nice summary of overdiagnosis for the BMJ in advance of the conference (subscription required).

Overdiagnosis is defined as “when people without symptoms are diagnosed with a disease that ultimately will not cause them to experience symptoms or early death.” I think it important to distinguish overdiagnosis (which most people have never heard of) from false positive test results (which most people have at least some idea about). Let’s take breast cancer as an example. If you have a false positive mammogram, it shows a shadow suggestive of cancer, but when you do a biopsy or more definitive test, they see no cancer cells. But if you have overdiagnosis, the shadow on the mammogram actually has cancer cells when looked at under the microscope. The problem is that some cancer cells never grow very fast or spread, and if you have that form of indolent cancer (these authors call it “pseudocancer”), finding out about it early produces no benefit for you. You’ll have treatments to attack the cancer, and those treatments will cause serious side effects, and you’ll be forever labeled a “cancer patient,” but if the “disease” had simply been left alone, you’d never have known the difference. (Most lay people, I would wager, have no idea that there exists a form of “cancer” that can act like this.)

The authors list a number of causes of overdiagnosis: while one big one is screening tests, others are increasingly sensitive tests that find smaller and smaller abnormalities, and redefinitions of “disease” that include more people with milder cases. The authors mention a study of asthma which found that nearly 30% of people diagnosed as such did not really have asthma after all, and 66% of those diagnosed did not need any medicines for it. (The irony here is that we also know that there are people with true asthma who remain underdiagnosed and untreated, too often fatally so.)

The authors list these conditions as currently subject to overdiagnosis (again, not to deny that at least some people with these conditions are currently underdiagnosed and/or lack access to proper care):

·         Asthma

·         Attention deficit-hyperactivity disorder

·         Breast cancer

·         Chronic kidney disease

·         Pregnancy-related diabetes

·         High blood pressure

·         High cholesterol

·         Lung cancer

·         Osteoporosis

·         Prostate cancer

·         Pulmonary embolism (blood clots in lung)

·         Thyroid cancer

So why does all this happen? Improved technology is one big reason, along with our love affair with screening and “prevention” and our near-religious faith that early diagnosis is always good. But coming right up next on the list is commercial influence, with the companies that make money off the screening tests and the companies that make money off the drugs and devices that are then prescribed when more people are labeled as sick doing everything they can to move the curve in the direction of overdiagnosis. (Indeed, if you look back at Don Light’s and my article on the Inverse Benefit Law:

http://brodyhooked.blogspot.com/2011/01/inverse-benefit-law-making-sense-of-how.html
--and review the forces that produce what we called the “left shift” that categorizes more and more previously healthy people as candidates for drug therapy, you’ll see a lot of overlap with the factors described in this paper.)

Moynihan R, Doust J, Henry D. Preventing overdiagnosis: how to stop harming the healthy. BMJ 2012; 344:e3502.

The Fate of a Scientist Who Reveals Drug-Related Harms? The Bennett Case

Initially, our friend Dr. Roy Poses blogged about this on Health Care Renewal:

http://hcrenewal.blogspot.com/2013/08/the-mystery-of-northwestern-settlement.html

I was tempted also to blog about this but held off at the time because I was concerned that the facts were not all available, and it was just possible that I would be defending someone who was, in fact, guilty of fraudulent behavior—a concern Dr. Poses shared because he called for more investigation.

Dr. Poses has meanwhile posted again:

http://hcrenewal.blogspot.com/2013/08/the-mystery-of-northwestern-settlement_20.html

--and in turn referenced an article by Paul Goldberg in The Cancer Letter of Aug. 9:

http://www.cancerletter.com/articles/20130809

--which now seem to provide enough factual background to at least raise some serious concerns. Let’s see if I can tell this tale the right way around for our purposes, even though it’s a convoluted story.

Let’s go back to the debate over drugs like epoetin that are used in kidney dialysis and cancer care to treat anemia by stimulating the production of red blood cells:

http://brodyhooked.blogspot.com/2012/05/hiding-truth-about-drugs-how-long-are.html

Companies like Amgen, that manufactured these lucrative drugs, were quite upset when studies began to show that higher doses of the drugs increased blood counts by too much and led to life-threatening clotting complications. The problem was that both cancer docs and dialysis centers were being paid on commission, meaning if they used higher doses, they got more money, and so had a strong financial incentive (which of course also benefited the drug’s manufacturer) to use the higher doses. Dr. Charles Bennett of Northwestern University med school played a role in reporting both on the scientific evidence of harm from too-high doses, and later on the role of the drug firms in trying to hide this information—for example:

http://jama.jamanetwork.com/article.aspx?articleid=181533

Dr. Bennett eventually created a unit at Northwestern, the Research on Adverse Drug Events and Reports project, specifically to study serious adverse drug reactions; and it is not too much of a stretch to suggest that his work helped to create the climate in which Amgen pleaded guilty to charges that it misbranded its epoetin drug Aranesp and paid a settlement of $762M in 2012. When Dr. Bennett left Northwestern in 2009, it was to take the offer of $6M in startup funds to study the safety of drugs in South Carolina.

Now let’s look at issues at Northwestern regarding the administration of research grants.

As Goldberg recounts, Northwestern has previously had problem in this area, and a decade ago had to repay the NIH $5.75M that it obtained through inflated reimbursement for faculty effort. Just recently, Northwestern agreed to pay the Feds a settlement of about $3M due to questionable payments on another grant, in this case one whose principal investigator was Dr. Bennett.

Just before this recent Federal settlement was announced, a former Northwestern employee, Feyifunmi Sangoleye, pleaded guilty in U.S. District Court to embezzling $86,000. She worked in the Northwestern cancer division’s grants administration office and set up a phony account, into which she proceeded to divert grant monies that she eventually used to pay for a wedding in Europe.

The statements issued by the Feds and by Northwestern regarding their recent settlement focus on the allegations that Dr. Bennett used NIH grant funds illegally to pay for consulting jobs for family members and for personal travel unrelated to the grant. The whistleblower credited with exposing this wrongdoing, and who as a result takes home a nearly half-million-dollar share of the award, is Melissa Theis, who was a temp employee at Northwestern in 2007-8. What Goldberg finds intriguing about her role is that she apparently never worked directly in the cancer center, so it’s unclear how she obtained information about Dr. Bennett’s grant.

In the normal course of events (as Dr. Poses stressed) Dr. Bennett could not simply pay himself money out of his grant and do whatever with it. He had to submit the expenses to the administration, and they had to approve that the costs were justified before any payment could be issued. The people who would have had to sign off would have been first, the administrator, the recently convicted felon Sangoleye, and the director of the cancer center, Dr. Steven Rosen. Dr. Rosen was initially listed as a co-defendant but his name was dropped as the Federal settlement proceeded.

Dr. Bennett told Goldberg that he did not do any of the things alleged regarding inappropriate payments, that he noted irregularities in the way Northwestern was handling grant funds, and that he duly reported these concerns to his superiors before leaving Northwestern.

The publicity surrounding the Federal settlement was what first attracted Dr. Poses’ attention. The Chicago newspapers jumped on the charges against Dr. Bennett, but completely ignored the Sangoleye guilty plea. Both Northwestern and the Feds seemed primarily interested in alleging that it was all Dr. Bennett’s fault and specifically in clearing Dr. Rosen of any wrongdoing, even though officially he was the person where the buck stopped in approving payouts from the grants.

Goldberg talked with several colleagues of Dr. Bennett who testified that he was not the sort of person one would expect to commit fraud with grant money, and was in fact a scientist dedicated to sniffing out the truth about adverse drug reactions.

Goldberg hints broadly in the article that Dr. Bennett collected his share of foes due to his work on epoetin drugs and their dangers, and that it would not be that strange if at least some of all this recent scandal reflected an effort to smear his reputation. And given that the administrator who oversaw his grant is now a convicted felon, if anyone played fast and loose with money from his grant, it might well not have been Dr. Bennett. And, finally, if there was lax supervision of grants at Northwestern, it would seem that Dr. Rosen and not Dr. Bennett should be answering for it.

 

I hope Dr. Bennett will have his day in court and have a chance to defend himself against these charges and that we’ll eventually find out the truth. Meanwhile, as we tally up what happens to scientists’ reputations later in life, it seems much safer to put your name on a ghostwritten article for a drug company, than to earn their ire by exposing the toxic effects of drugs that could be harming patients.

Oregon DOJ Demands More Transparency of Device Payments to Docs

Nick Budnick of The Oregonian reports:
http://www.oregonlive.com/health/index.ssf/2013/08/oregon_case_suggests_patients.html
--that the state Department of Justice has gone out ahead of national trends in demanding that physicians reveal to patients the payments they receive from device manufacturers, that could provide a financial incentive for them to implant more devices.
Two Salem cardiologists were fined $25,000 each in settlements in which they admitted no wrongdoing, for failing to inform their patients of fees they received from Biotronik regarding that company's defibrillators and pacemakers. The physicians were being paid fees of $400 to $1250 per implant when a company trainee was present at the procedure.
Let's look at this practice in more detail. First thing to note is that these extra "training" fees effectively doubled the payments the docs received from insurers for performing these procedures. The two physicians made a total of $97,000 and $131,000 over a several-year period, respectively, from these payments. So it's reasonable to conclude that these amounts were large enough to sway the doc's judgments about when and how many devices to implant. (Court documents revealed that one of the docs once complained to the company that he had to do an implant and there was no trainee available on that day.)
Second point--the official reason for these payments was that the company wanted its employees to know all there was to know about the device and its adjustment and placement, so that they could in turn properly instruct new physicians on their proper use. These experienced physicians were merely serving the company in this legitimate function and thereby earning all the dollars paid to them on the up and up. The problem with this is the long history of device companies pulling every trick in the book to disguise paybacks and bribes to docs, in exchange for greater volume of use of the company's product, as if it was payment for some fully legitimate service. Just how many procedures did employees need to see in order to be "trained"? Just what sort of "training" actually occurred at these sessions ("Okay, I am going to implant this device, you can come and watch")?
There is a third point that is a bit more speculative, but relates to an earlier post on this topic:
http://brodyhooked.blogspot.com/2011/10/more-on-device-industry-from-aslme-coi.html
I noted previously how, according to an insider who knows the device-implant scene much better than I do, it is not the case that these company employees are being "trained" so that they can help physicians do their jobs better. At least in some instances the company employees are being provided to the docs as free labor. They do the technical adjustments of the device which the physicians are too "busy" to learn how to do, and unwilling to pay their own technician to do for them. Having this free labor provided is of course a huge financial incentive to use that particular company's device.
Reasons to suspect that all is not on the up and up include the report, by Budnick, that Biotronik started off as a relatively small German firm and has rapidly gained U.S. market share in recent years. Reportedly its marketing practices are also under Federal investigation.
It's important to note that Biotronik was not directly a party to the Oregon DOJ action, which focused solely on the physicians' behavior. However, Biotronik did come to the defense of its docs, saying it was unfair to single them out when other drug and device companies have paid so much to so many other Oregon doctors. Somehow that does not strike this "ethicist" as a solid defense.
Another ethicist, however, was more pliant. Budnick quotes an affidavit that Biotronik also helpfully submitted to the Oregon DOJ, from my esteemed colleague Jonathan Moreno of Penn. He argued that there was no legal or ethical basis for a claim that the physicians should have informed patients of the company payments. An obvious question--unanswered in Budnick's coverage--is how much payment Prof. Moreno received for this service to Biotronik. (Another esteemed bioethics colleague, Carl Elliott of Minnesota, who's been quoted here many times before, was cited by Budnick as disagreeing with Prof. Moreno--as I would.)