You Too Can Be a KOL

As in the previous post, I'm grateful to our friends at Health Care Renewal blog for this pair of items.

I have, more times than I wish to count, mentioned the infamous KOL--the Key Opinion Leader, a.k.a.Shill, the doc who engages in marketing for the drug firm and reaps rewards in the form of speakers fees, consulting contracts, involvement in seeding trials, and the like.

So--how do you get to be a KOL?

The first post in order of appearance is by Franz Wiesbauer on a blog called MedCrunch, which describes itself as, "A new kind of online magazine covering health, medicine, entrepreneurship and technology all centered around new trends and the challenge of being a physician."

In a post dated January 14, 2011, Wiesbauer discussed "Pharma Marketing 101":
http://www.medcrunch.net/pharma-marketing-101-two-things-pharma-needs-from-you/

Wiesbauer first reassures the readre that everything he says is strictly on the up-and-up: "While certain physicians have taken advantage of these unethical matters, many of our peers have skillfully used their liaisons to the pharmaceutical industry for the advancement of their careers in an entirely ethical way, and you can do the same." Nobody here except us highly ethical physicians, boss.

The post then goes on to explain what makes a KOL--first, writing a lot of prescriptions so the company wants you on their side; and second, having influence over your peers. Wiesbauer helpfully concludes, "So, to sum up, pharma can provide you with a platform to increase your network, enhance your visibility and strengthen your personal brand. As a physician, you are THE critical component to pharma’s marketing and sales outlets. Know your value and use your influence wisely. It entirely depends on you if you are the ball or the player in the pharma marketing game."

Funny thing--when I took the physician's oath upon graduating from medical school, I have no recollection of any mention of my "personal brand" as a key aspect of my career in medicine.

Now fast forward to August 21, 2012, and to Dr. Lukas Zinnagl writing on a different blog, KevinMD.com. Dr. Zinnagl, we learn, is co-founder of MedCrunch, and he references the earlier post by Wiesbauer in this entry, which adds a new wrinkle--social media:
http://www.kevinmd.com/blog/2012/08/doctors-key-opinion-leader-social-media.html

The earlier post said that if you want to sell yourself to Pharma as a KOL, you need influence. This new post explains how you can get influence virtually overnight if you're a savvy blogger or Facebooker or Tweeter, or whatever today's new thing is. But don't expect that to last long because whatever niche you now fill in the social media world, expect to be jostled by a horde of other docs tomorrow as they move into your turf. So I guess the lesson is, get it while you can. Or as Dr. Zinnagl summarizes: "If you’re one of the physicians who understand and master Twitter & Co, you’re well on your way to establishing your personal brand. But be aware that this advantage will become smaller and smaller as more and more physicians catch the social media train."

Funny--there's that "personal brand" thing again. I really must have a talk with the curriculum committee here at the med school and ask why we don't have a course or clinical clerkship in personal branding. Sounds much more important than anatomy or neurology. Or ethics or professionalism.

Pfizer: Make That Criminal Settlement #10

A not atypical scenario-- while I've been napping over here, the people at Health Care Renewal have been posting a number of important items. You might for example want to read about the hospital CEO who's collected $1.5M in severance pay after wrecking his institution and after one of his VPs was sentenced to jail for (among other things) stealing artwork from the hospital. But in this message I will merely call attention to: http://hcrenewal.blogspot.com/2012/08/pfizers-pforeign-pfiasco.html

Pfizer, it seems, recently agreed with DOJ and SEC to pay $60M to settle cases involving accusations of foreign bribery, mostly in Eastern Europe:
http://www.bloomberg.com/news/2012-08-07/pfizer-agrees-to-settle-foreign-bribery-case-with-u-s-.html

More on foreign bribery in a moment. Our esteemed colleague Dr. Roy Poses at HCRenewal walks us through the previous instances in the last decade where Pfizer has paid whopping fines (the top one being $2.3B) to settle cases involving fraud and other criminal matters--making this latest #10 on the list.

Dr. Poses goes on:

Yet the company has not failed or been restructured, and none of its leaders has ever faced any negative consequences. In fact, last year its CEO made over $18 million, up from over $6 million the year before...


So obviously it is not just that one company's culture has become seriously corrupt. We seem to live in such a corrupt nation, and maybe such a corrupt global society that such corrupt cultures thrive in our major corporations and organizations. Despite stories like this in health care, just like in finance despite the global financial collapse, as Charles Ferguson said at the Oscar awards last year, " not a single ... executive has gone to jail, and that's wrong."

Back to foreign bribery-- when I was writing HOOKED, one of the first books I came across in my research was a 1984 volume by an Australian sociologist of business, John Braithwaite, with the telling title, Corporate Crime in the Pharmaceutial Industry. Much of the corporate crime Braithwaite documented was overseas and involved countries where official corruption was rampant and where US corporations figured it was just a cost of doing business to pay bribes to officials. Silly me--I had imagined that since Braithwaite first wrote, laws had tightened up, reforms had occurred, and companies maybe now had a cleaner track record overseas. Silly me.

What's Rotten in Denmark: SLAPP Having Its Day in Europe?

For this news item from  Denmark see:
http://sciencenordic.com/pharma-giant-threatens-danish-scientist
http://www.nejm.org/doi/full/10.1056/NEJMoa1204242

The second link takes you to a scientific study in the New England Journal by Anders Perner and colleagues, funded by the Danish Research Council, comparing the use of an intravenous fluid containing hydroxyethyl starch with a different fluid for support of patients in intensive care with severe infections (sepsis). The study found that the chances of death or kidney failure were somewhat greater in the group getting the starch.

The first link takes you to a news article indicating that one of the manufacturers of the starch fluid, the German company Fresenius Kabi, is now threatening to sue Dr. Perner for monetary damages for lost sales unless he retracts the paper and issues a new report correcting what the company calls erroneous and incorrect information.

In earlier posts, most recently:
http://brodyhooked.blogspot.com/2012/01/from-health-care-renewal-egregious.html
--I have called attention to SLAPP (strategic lawsuits against public participation) as a device periodically resorted to by the pharmaceutical industry. SLAPPs typically are employed when one party has deep pockets and can easily afford to pay high legal fees to bring a suit, even when in reality the suit has almost no chance of success in court. The aggressor party reasons that the other side of the suit (or threatened suit) will cave in and cease to say bad things about the deep-pockets party, or whatever their bothersome behavior has been, out of fear of going bankrupt paying legal fees to defend against the suit. The overall goal is less to get back at the actual respondent to the suit or threatened suit, and more to have a chilling effect on anyone thinking about taking future actions unfriendly to the deep-pockets corporation.

In this case the SLAPP is apparently threatened rather than actual--for some reason the news article says that the American lawyers of the drug firm sent the threatening letter to the scientist, raising the question of whether the firm's Danish or German lawyers were not intimidating enough. The Danish scientific and medical communities have fortunately responded forcefully, backing Dr. Perner and promising to support his legal case, and denouncing the company's tactics. Only with such a response can the playing field be somewhat leveled when a SLAPP is threatened.

Ghostwriting: Still No Consequences for Academic Physicians

As Paul Basken writes in the Chronicle of Higher Education:
http://chronicle.com/article/Academic-Researchers-Escape/133325/?key=SW53Il9vZXNHYnpgOGtBNW1VYSBrOEt3YCEQbS9zbltcFQ==

--some academic medical centers might be uncomfortable with the new spotlight thrown by the recent GlaxoSmithKline record $3B fraud settlement (see: http://brodyhooked.blogspot.com/2012/07/breaking-news-record-fine-for-gsk.html). Or then again, they might not.

A centerpiece of the GSK fraud case was Paxil Study 329: http://brodyhooked.blogspot.com/2012/07/inside-paxil-study-329-courtesy-justice.html
A number of the schools where faculty are appointed, who were listed as authors of this study, had previously launched some sort of investigation of charges that these faculty allowed their names to be attached to a ghostwritten article that falsely pumped up the benefits and downplayed the risks of this antidepressant in children.  In none of those cases was any action taken against the faculty member.

Now that the Federal settlement is public, and the full record of fraud is out there, are any of these universities revisiting the matter and considering further action? Not according to anything Basken was able to learn. (Full discloure: One of these faculty now works at my own institution, and rules regarding personnel matters do not allow me to comment on that case.)

One of the features of the case that has no doubt undercut any decisive action is that the lead author, Martin Keller of Brown University, recently retired. I suspect Brown thinks it has now washed its hands of the case and need not take any further action.

Basken has toted up all the Federal research grants awarded to listed authors of this study since it appeared, and they run into the tens of millions. So you can see both the downside of failure to take action against these academics, as well as the main reason why no action is taken. These folks are the geese that lay golden eggs, insofar as the department chair and dean are concerned, so why mess with financial success. In an era where it is nearly impossible to discern any difference between how one runs an academic medical center vs. a for-profit business, you can see what values reign.

A while ago I mentioned a good article that recommended just what should happen to faculty who are found to have allowed their names to be appended to a ghostwritten paper--see: Leo J, Lacasse JR, Cimino AN. Why does academic medicine allow ghostwriting? A prescription for reform. Society (epub July 21, 2011). More later on their recommendations.

Appeals Court Looks Askance at Pay-for-Delay

Edward Wyatt in the New York Times--
http://www.nytimes.com/2012/07/27/health/policy/drug-makers-deals-with-generic-rivals-may-face-justices-review.html
--reports on a ruling of the U.S. Third Circuit Court of Appeals that brand-name drug companies paying generic companies to delay the entry of generic drugs into the market is anti-competitive. This ruling runs contrary to rulings by other courts that support these payments and makes it more likely that the U.S. Supreme Court will have to take up the issue.

Wyatt adds that a bill now stuck in the Senate to end these pay-for-delay arrangements has been estimated by the Congressional Budget Office to promise $4.8B in savings over a decade for the Federal government, and overall drug savings of $11B.

The industry point of view--which, for a change, both the brand-name and generic drug companies agree on-- is that pay-for-delay is good business and good for the consumer because it actually speeds the entries of generic drugs into the market. How so? The usual stimulus for such an agreement is a patent dispute between the two companies. The companies have two options--make a deal; or fight a lengthy court battle to resolve the patent dispute. It's more efficient and ultimately cheaper for all parties, they say, so go the out-of-court-settlement route.

As I explained in HOOKED, there might be some merit in this argument if the patent dispute were truly a serious matter. The problem is, that it usually is far from that. The U.S. Patent Office, and the FDA oversight of drug patents, have gotten so loosy-goosey over the whole business that a brand-name firm can patent all sorts of trivial features of the pill, including famously its color, and then drag out a court battle with the generic company for years. The ultimate solution to this problem is to do away not only with pay-for-delay, but also with senseless, trivial patents, and for judges to simply throw out all such lawsuits.

AAUP Chimes In: The Trend toward Tougher COI Regulations

The American Association of University Professors has announced the publication of a draft version of "AAUP Recommended Principles & Practices to Guide Academy-Industry Relationships," and asked for open comments: http://www.aaup.org/AAUP/comm/rep/industry.htm

At a total of some 300 pages, the AAUP managed to exceed the length of Freeh report on the scandal at Penn State. Disclaimer: what follows here is based on my review of the first 40 pages that give a quick summary of the recommendations and an overview of the general approach. Full disclosure: I am an AAUP member.

For those of you who aren't academics, AAUP is an organization that represents faculty interests in higher education and is, in some places, the teacher's union. The present document is an amalgam of guidelines issued by other national groups such as IOM and AAMC, along with new principles generated by AAUP. AAUP justifies a new report because many previous recommendations have been made only for portions of the university such as a medical center, and AAUP argues that the impact on the entire university community needs to be considered.

Some of the 56 recommendations are standard AAUP boilerplate about how faculty should have a say in uinversity covernance regarding industry relationships. But a lot of the report seems well worth our attention because it suggests that the trend these days is toward tougher approaches to conflicts of interest in academia.

For example, the AAUP is a staunch defender of academic freedom and therefore admits that some faculty have used this as an argument against any regulation of financial relationships with industry--that individual faculty members should be allowed to make their own choices about their relationships with drug companies, research and consulting, etc. The report replies, "Their arguments obscure the fact that academic freedom evolved as a concept not only to protect individual rights but to insulate the academy and safeguard the discovery process from powerful social forces, initially the church and later big business. Some rules are necessary to preserve freedom of research, teaching, and inquiry. At stake are the standards that govern universities, their reputations, and public trust.



"Academic freedom does not entitle faculty members to accept outside responsibilities that make it impossible to do their primary jobs. Academic freedom does not entitle faculty members to sign away their freedom to disseminate research results. Academic freedom does not entitle faculty members to ignore financial conflicts of interest that could dangerously compromise the informed-consent process and the impartiality of research."
 
In sum-- stringent regulations against COI in industry relationships protect the core values of academic freedom.
 
On one issue that I have been harping on for many years, the report is similarly uncompromising. It accepts as a guiding principle that the mere disclosure and "management" of COI is seldom the right way to proceed, and that as a rule, eliminating and avoiding COI is much better--while formal plans for managing COI should be adopted for the minority of cases where it is indeed unavoidable without serious harm to vital public interests.
 
The AAUP also implicitly rejects the argument that since all faculty are biased in one way or another, "intellectual COI" is ubiquitous and therefore special regs to limit financial COI are unneeded:
In short, this draft report considers some key arguments against tougher COI regulations, rejects them, and proceeds to recommend a fairly uncompromising set of guidelines. The way AAUP operates, this report can never become a standard uniform set of regulations for all universities; rather the hope is that individual universities will turn to this report for general guidance as to their policies and then craft policies that take local needs and issues into account--in some cases, the report admits, perhaps adopting more lenient standards.
"Of course, faculty investigators also have biases—whether they arise from scholarly debates, personal affinities, or political and religious commitments. Faculty status does not confer independence from the activities and interests of the communities in which faculty members live and work. The heart of the matter, however, is that faculty not be contractually obligated to represent positions at odds with their professional judgment and public commitments, or placed in compromised situations, financial and otherwise, that are more likely to produce bias."

The AAUP is very clear that public trust in the academy and its research is at stake, for example:
"When corporations, or nominally nonprofit funding agencies, effectively bribe faculty members to, for example, publish articles with doubtful product claims, dubious economic assessments, or attacks on well-established science, the faculty betray their professional and public responsibilities."

"Dualities of Interest"-- the Latest Fig Leaf?

Medical anthropologist Joan E. Paluzzi has written a study (subscription required) on the incestuous relationships between drug companies and disease-specific patient advocacy organizations, often mediated by physician experts ("key opinion  leaders") with major financial interests in the drug firms. She looks particularly at three disease areas-- osteoporosis, diabetes, and restless leg syndrome.

There's not a whole lot new for readers of HOOKED but she uses as her title one interesting phrase which I had not heard before. The American Diabetes Association published in 2010 (in the journal Diabetes Care) an update to their "Diabetes Standard of Care." The committee that wrote these guidelines had 15 members, and a separate document lists 77 separate relationships these docs had with pharmaceutical firms and other industry folks. Now, simple-minded people like me would have imagined these relationships to be conflicts of interest, but the ADA hastened to assure readers that no such thing could possibly be the case. Instead, they headed the list "Dualities of Interest."

As Paluzzi comments, "That these relationships were explicitly characterized as 'dualities' (implying a state of complementarity) rather than the long-accepted representation of 'conflicts' of interest (which highlights the potential for vested self-interest) is understood here as an attempt to normalize or, at least, to minimize perceptions of potentially unethical conduct."

As I say, this particular manner of applying lipstick to a pig is one I had not previous been aware of--no doubt just showing how far out of the loop I am.

Paluzzi JE. "Dualities of interest": the inter-organizational relationships between disease-specific nonprofits and the pharmaceutical industry. International Journal of Health Services 42:323-339, 2012.