Monday, August 27, 2012

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.

Friday, August 24, 2012

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.

Thursday, August 9, 2012

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.