Don’t do the crime, if you can’t do the time
Punishing Health Care Fraud — Is the GSK Settlement Sufficient?
New England Journal of Medicine
by Kevin Outterson, J.D., LL.M.
September 12, 2012
[Full Text On-Line]
On July 2, 2012, the Department of Justice announced the largest settlement ever in a case of health care fraud in the United States. GlaxoSmithKline [GSK] agreed to plead guilty to three criminal counts and settle civil charges brought under various federal statutes; the company will pay a total of $3 billion to the federal government and participating states. Since 2009, the federal government has collected more than $11 billion in such settlements under the False Claims Act. In the Federal District Court in Boston a few days later, GSK pleaded guilty to two criminal counts for sales of misbranded Paxil [paroxetine] and Wellbutrin [bupropion]. These drugs are considered misbranded when they are promoted for indications for which they have not been approved by the Food and Drug Administration — the practice commonly known as off-label promotion. Providers cannot be reimbursed for misbranded drugs under federal and state rules. GSK also pleaded guilty to a third crime, failing to report safety data related to Avandia [rosiglitazone]. Failing to report safety data violates the Food, Drug, and Cosmetic Act and leads to serious questions about whether clinicians are basing their decisions on the best evidence. GSK also settled related civil liabilities for these and other drugs.Despite the size of the fine and civil settlements, it would be a mistake to assume that GSK was an outlier in the global pharmaceutical and medical-device industries. Indeed, many of the major companies have settled with the Department of Justice in recent years. When the GSK settlement was announced, 25 major companies and 8 of the top 10 global pharmaceutical companies were under “corporate integrity agreements”. Corporate integrity agreements, now a routine part of settlements for health care fraud, typically require enhanced compliance activities within the company for 5 years, including reports to the government from an independent monitor.
But questions remain about the efficacy of fines and corporate integrity agreements in deterring corporate misbehavior. The 2012 fines against Abbott Laboratories and GSK represent a modest percentage of those companies’ revenue. Companies might well view such fines as merely a cost of doing business — a quite small percentage of their global revenue and often a manageable percentage of the revenue received from the particular product under scrutiny. If so, little has been done to change the system; the government merely recoups a portion of the financial fruit of firms’ past misdeeds. One partial solution would be to impose penalties on corporate executives rather than just the company as a whole…
Twilight of the Anechoic Effect? – New England Journal of Medicine Article Discusses Previously Taboo Topic of Bad Corporate Health Care Leadership
Heathcare Renewal
by Roy Poses
September 14, 2012
We have often complained of the anechoic effect, that the issues we discuss on Health Care Renewal often do not seem to be considered topics of polite conversation. Any discussion that might question the brilliance, integrity, dedication, or selflessness of the leaders of health care organizations seems particularly taboo. So a major aim of this blog has been to discuss the numerous publicly available examples of leadership that is ill-informed, uncaring about or hostile to the values of health care professionals, incompetent, self-interested, conflicted, or outright corrupt, and of governance that lacks accountability, transparency, integrity, honesty, or ethics. We have postulated that such problems with leadership and governance are not only causes, but the major causes of the increasing dysfunction of our health care system. That discussing these issues is simply not done in many contexts, including academic health care, medical and health care journals, and health policy fora has only accelerated health care dysfunction.The New England Journal on Punishing Health Care Fraud
Therefore, I note with some surprise that the New England Journal of Medicine just published an article that implicitly challenged the leadership of some large health care organizations.
So now that it is no longer taboo to question the pretensions of some leaders of health care organizations to near divine purity, let me state as I did in 2008,
As long as health care leaders can shrug off the consequences of unethical behavior merely as acceptable costs of doing business, absent any serious attempts to get health care organizations to enforce internal codes of ethical behavior or to avoid hiring ethically challenged leaders, the procession will likely continue. The effects will be continually rising costs, declining quality, shrinking access, and rising numbers of demoralized health professionals.As I wrote in 2009,
Until bad leadership of health care organizations leads to negative consequences for those practicing it, health care leadership can be expected to continuously degrade.
As I commented on Pharmalot not long ago, a feature of professions is that they regulate themselves. We should not need third parties (Universities, Office of Research Integrity at NIH) to step in here. We know who the academic authors of Study 329 are. We know what professional societies they belong to. We know that these professional societies have codes of ethics that sing of integrity.
So, now that GSK has admitted criminal fraud in relation to Study 329, where are the leaders of these professional societies in requiring integrity and ethical behavior from their members who (ahem) co-authored the study? A no-brainer would be for the professional societies to require these academic authors to retract the fraudulent report. They could slap on these authors a ban from society activities and a ban on publication in society journals until the retraction occurs. And instead of hiding their heads in the sand, the leaders of these professional societies could issue PR statements to educate the public about our professional values.
Will any of this happen? Let’s see. They have been put on notice.
1BOM and Dr. Carroll,
In 2007/8, the outcry in the blogosphere, the courtroom, and the professional literature was just as intense. The reaction of the professional society to which Drs. Keller, Ryan, and Wagner belong? Their reaction at that time to being put on notice? The “Transparency Portal” to which I referred in my earlier comments. The recruitment of Drs. Ryan and DelBello to help counsel their fellow child psychiatrists on the fine points of ethics.
I am not sanguine about the reaction of professional society leadership in 2012/13.
Perhaps they will form anoter panel and recruit Wagner as well this time around. She has, after all been one of the names psychiatrists in both the complaint against Forrest and the complaint against GSK. Per the standars they apparently applied in 2007/2008 this would be a logical choice.
Those choices certainly did not lead to any consequences that would give them pause to react the same way this time around.
This is not to be defeatist.
It is to say that there needs to be a broader constituency this time around or 2012/13 will be a repeat of 2007/8.
What will cause a broader number of people to care and act tomorrow, who do not already care and act today?
Hiding their heads in the sand WORKS. At least to a large extent.
If you are a member of a professional society who are you going to be more concerned about offending? Leaders who can potentially impact your grants, your presentations/publications, your referrals, your advancement. Or a group of bloggers and an anonymous commenter?
I argue against targeting the paper and the authors because I believe that will be weathered until the targeting fades, just like the last time around.
Companies take action around shoddy products because they are afraid that if they don’t it will tarnish their brand. Shareholders take action when they become concerned that the actions of officers in a company will damage the long term standing of the organization. It may be realistic to expect more from individual physicians in their 1:1 dealings, but I think it’s unrealistic to expect more on an organizational level. Professional societies, particularly small ones, live or die on the perceived quality of their brand.
I am suggesting that if AACAP/JAACAP’s brand could be at risk with legislators, primary care providers, and families, and there is the perception amongst rank and file that their voice will be marginalized due to umbrage at the actions of a relative few among them, then, and only then, will meaningful action be taken.
Until then it is a no-brainer for an organization to do nothing.
When your sites are able to successfully sustain a message with enough legislators and/or primary care physicians then I think you’ll see more change from within. A message that may simply be that an organization that can tacitly (sometimes explicitly) endorse such studies, and those responsible for them, and who seem to think that knowing that someone received more than $10,000 (when they may have received a quarter of a million dollars total from that company) is a laudable level of transparency, may not be trustworthy.
To be frank, what is more of a surprise to me than most else is that Paul D. Thacker, with the attention he paid both Study 329 and Dr. DelBello, never turned his attention to AACAP. Recently seeing that AACAP had picked both Dr. Ryan and Dr. DelBello for that ethics panel, at the height of both controversies, seems like an F-U to him, if you’ll pardon my language. I would not have thought he would take kindly to that, but perhaps he has moved on to other things. Also, given that he worked then with POGO (Project on Goverment Oversight) perhaps it was too far afield.
I think the guilds will act when they actually believe they have more to lose by not doing so. It would be nice if now, 5 years later, someone comes up with a successful formula for doing so. It would be in their long term best interest it would seem.
Though I doubt you will be thanked for doing them the favor.
At the bottom of your More on echo echo echo post you said “No don’t comment, “why don’t you do it?” because I don’t know what to do either. But if anybody has some ideas, I’d be glad to hear them…”
I wish I knew. You are doing a great service by taking the time and energy to keep putting information out there. The over a decade since the JAACAP paper suggests someone (maybe who reads your blog?) needs to pick up on those echoes and find a way to better motivate others to act (and provide them ways to do it).
This quote: “Thinking back, I think of SSRIs in adolescents that way – at times useful in Anxiety Disorders and OCD. Depression, not so much.”
There are few places on the web where one could be reading a rant (I mean that in a good way, ranting is justified) and then read a reflection that seems as thoughtful and balanced as that one.
For what it’s worth from an anonymous commentator (so perhaps not even worth the photons it takes to create the image):
1BOM, I may not always agree with you.
And, I continue to hope someone picks up on what you’re saying and moves this agenda forward.
But, you are always a great read.
Transparency Portal may be a laughable misnomer. But it pales in comparison to 1boringoldman.
Annonymous, when I wrote my comment I wasn’t thinking about AACAP. They are clearly part of the problem, so they are unlikely to be part of the solution – though I am willing to be pleasantly surprised and I have communicated directly with them in recent weeks. No, I had in mind the top tier professional societies like American College of Neuropsychopharmacology. ACNP holds itself out as the premier professional society in our field. They have a record of issuing public position statements on controversial topics – their Task Force report endorsing use of antidepressant drugs in youth comes to mind.
It would be inspiring for ACNP to call on its members who co-authored the Glaxo Study 329 report for a retraction. After all, that’s what the ACNP Core Value of Integrity calls for.
Like I said, the leaders of ACNP have been put on notice. Will they meet their own self declared standard of integrity?
Dr. Carroll,
As you had at one time been on ACNP’s council you are clearly more familiar with them than me. However, it is unclear to me why your expectations for ACNP are qualitatively different than those for AACAP. Particularly after looking at the task force ACNP had chosen to examine the topic of SSRIs and Suicide in Youth (the one I believe you were referencing):
http://www.acnp.org/programs/taskDetail.aspx?cid=f84f1162-7e38-43cd-af57-b84174d72df8
Looking at the 2006 paper, I would be willing to venture a guess at your question of whether they will meet their own self-declared standard of integrity. I see it no more likely that ACNP will do this out of sense of honor and disavow their own 2006 paper than AACAP will do so out of a similar sense of honor and disavow the 2001 JAACAP paper.
I too would be willing to be pleasantly surprised.
1BOM,
Here is one concrete, but pie in the sky, and very intensive, approach that may not have been tried. AACAP’s website keeps emphasizing advocacy, both at the state and federal legislative level. What if a small distilled portfolio of this information were compiled and then delivered to staffers in federal and state legislative offices of likely AACAP allies. With the goal of them asking anyone from AACAP who approaches them: what are you guys doing to address these issues? Because the Transparency Portal and the 2008 Consensus panel is just not going to cut it. I.e., we want to be receptive to AACAP’s advocacy for children by these questions of integrity are of concern.
That would be cared about. That feedback would also be going to members of AACAP involved in advocacy and so most likely to actually try to do something about it. Because it would potentially impact their abort to advocate for things they care about.
It would seem, at least theoretically, that Paul D. Thacker, having been a congressional staffer as well as having a clear interest in this area, might be able to comment of whether such an idea was feasible.
That might provide an impetus for change. An impetus for the organization to hew closer to a core value of integrity. To better maintain its ability to advocate for the well being of kids. Not so horrible a thing, really.
Assuming that one could craft an approach that would get the attention and interest of legislative staff. Which is a big assumption.
Anyway, just a thought.
Speak of the Devil!
Pharmagossip just posted this:
Paul Thacker is now at Harvard
http://pharmagossip.blogspot.com/2012/09/paul-thacker-is-now-at-harvard.html?m=1
Paul D. Thacker
Lab Fellow
Harvard University
Edmond J. Safra Center for Ethics
Cell: 202.460.7410
thackerpd@gmail.com
1BOM, My attempt to comment link to the new Paul Thacker Pharmagossip post about his new position at the Edmond J. Safra Center for Ethics at Harvard failed. When you have the opportunity could you allow it to post?
I can’t find Thacker at the Safra website so I am unsure the Pharmagossip post is accurate. Just an FYI.