You Know If It You See It! On The Justice's Advice and Conflict of Interest

 

I just published an opinion piece.

 

Kofke  WA:  Disclosure of industry relationships by anesthesiologists:  Is the conflict of interest resolved?  Curr Opinion Anesthesiology 23:177-183, 2010.

 

I was asked to write this and undertook a fairly detailed overview of the literature on the topic.  We use the word “literature” loosely as there is little real data and lots of heart-felt opinion, verities, and dogma; depending on who you read.

 

Medicine is full of examples of people so egregiously conflicted as to astound and produce umbrage.  The top examples:

 

1.       The widespread practice among orthopedic surgeons to “consult” for companies that make the implants they put in patients.  These aren’t little consults.  In quite a few cases the consult fees were in the million(s) dollar range; certainly more than or approximating their clinical income.  Well, these weren’t consults; they were overt bribes in my opinion.  The feds got wind of it and put some controls on the practice through a plea agreement that includes a quantitative listing of company consultants and their fees on their web pages.  This underscored the importance of quantitation in disclosure, a key point of my review.  One defense is that the docs disclosed they were consultants for these companies.  However, I doubt the patients knew their docs were “on the take” for millions.  The amount matters.

 

2.       Docs have been retained by companies to either do research or just consult.  One outcome of such relationships has been the practice of the company writing an article and then asking the doc, for a fee (amount seldom disclosed) to sign off on the content and take authorship credit with the true author not acknowledged.  Disclosure of support is usually acknowledged but not the amount.  This is ghost writing. 

 

The same thing goes on with speakers’ bureaus.  The give the speaker their canned slides and the speaker presents them, acknowledging support, but without quantitative disclosure.  I did this until they made me give the canned talk.  After I refused to do that invites to talk dried up.  I miss the money though, got $1,750 per talk for ESP Pharma.  They try to launder the money by having an education company administer the talks, but the outcome is the same as is the real source of the money.

 

These examples and other such obvious inappropriate practices has led to McCarthy esque backlash with some advocating no interaction of academic centers with industry or that journals not accept industry-supported research for publication.  There are lots of good arguments as to why this is overreacting.

3.      However the extreme to which this can go can lead to scandalous unforeseen consequences as uncritical editors (suckers!) accept without question any article critical of COI practices. 

 

Hirsh published an expose of the August JAMA in Mayo Clinic Proceedings.  The JAMA authors were highly critical of Merck’s ghost writing practices.  This was a very serious and significant article.  Well, it turns out that the authors should get the Pulitzer for unbridled  ribald hypocrisy in medical fiction writing disclosures.

 

 Undisclosed in their article focusing on COI was their own COI, namely that they were themselves consultants for attorneys involved in litigation against Merck!!  Astounding IMHO.  Even more astounding is the almost comically outrageous consulting fees they received:  up to $25 million.  Now, I suggest, the amount matters and this is an undisclosed conflict  with a sum of money that surely impacts on the content of what these authors wrote in JAMA.  Certainly biased work.

 

Between these extremes are a continuum of COI issues which are summarized in the three tables in the article and they are paraphrased here:

 

Table I:  Industry funding of Research

 

              Good Things about it include:

 

·                    Breakthroughs in therapy.

·                    Profit motive drives innovation.

·                    Contract income supports university mission.

·                    Faculty career development is supported.

·                    Create preliminary data for NIH grants.

·                    Attract foreign investment

·                    Development of experts through supporting their involvement in a research area.

 

  However, bad things include: 

 

·                    The emphasis on development of “me-too” drugs means a lot of industry support isn’t driven by innovation but rather market share concerns.

·                    Research is really supported by marketing budgets.

·                    Phase 4 studies are really a marketing means to familiarize docs with new drugs (the company doesn’t care if the research is published).

·                    Research consulting fees can be so excessive as to be kickbacks (bribes) which affect what the consultant (expert) says and writes.

·                    Equity/patent stakes in a company can constitute enormous sums that must induce bias,

·                    Ghost writing, and  ghost speaking

·                    Bounties for per subject research subject recruitment biases entry criteria and can invalidate results.

 

Table II reviews good and bad of industry support of education.

 

            Good Things include:

 

·                    There is a need to get the word out about new things that are available.  Note Steve Shafer’s article on Critical Thinking recounts the issue of a gadget with high grade evidence (but Zilch marketing) for better CPR has not achieved widespread use.

·                    While educating about a product or drug spin off education on related physiology and pharmacology is common.

·                    CME costs less to participants making funds available for other virtuous activities.

·                    Experts can be supported to provide education.

 

Some of the bad things about industry support of education:

·                    Funds come from marketing budgets, reflecting the primary intent of the activity from the sponsor’s perspective.

·                    Speaker pay or financial stake in the sponsor’s success may be enough to guarantee bias.

·                    Junkets to resorts and vacation sites pervert the real intent of the activity while garnering a tax-deductible vacation for speakers and attendees.

·                    Speaker bureaus control what speakers say… “ghost-speaking”.

·                    Involvement of a speaker in a speaker’s bureau gets them out and about enough to become known as an expert who then morphs into a key opinion leader who gives national lectures and writes guidelines. (Grouse)

·                    Ghost writing by industry employees or contractors guarantee bias.

 

Table III overviews industry funding in clinical practice

 

            Good Things include:

 

·                    Timely updates on new products can be provided by industry representatives.

·                    Industry representatives can be a helpful resource for safe introduction of a product into clinical practice.  We see this lot in surgery.

·                    Drug samples can help those who cannot afford them.

·                    Drug samples can allow for low cost evaluation of a drug by a patient and his/her physician

 

Bad things about industry influence in clinical practice include:

 

·                    The primary mission of an industry representative is really to augment company revenue.

·                    Shadowing programs (paid) involving industry representatives can offend patients.

·                    Gifts induce, implicitly, reciprocation.

·                    Kickbacks and bribes happen, but rarely, I think.

·                    Direct to consumer advertising bypasses physician expertise. (My hospital does it too!)

·                    Drug costs seem excessive when viewed in context of lavish drug company profits.

·                    Free samples get patients hooked on expensive drugs.

·                    Free meals are used as a ploy to gain access to docs and develop highly-valued personal relationships with them.

 

So what is a doc to do?  We are just surrounded by these sales pitches and are recurrently subjects of marketing ploys.  There are good spinoffs but also risks of bias of which we all must be wary.  So we should look for disclosures of support by industry and weigh that as we analyze the veracity of what is presented.  Is knowing that enough?

 

No!

 

In my opinion, the amount matters.  I believe disclosures should also include the amount of money, time, and resources made available to a potential instrument of bias.  This instrument could be your doctor, teacher, or reporter of research findings.  Exorbitant support will produce bias.  How do you define exorbitant?  It’s like The Supreme Court Justice Steward said about porno…you know it if you see it.

 

 

 

My Favorite References on COI

 

Angell M. The truth about drug companies. How they deceive us and what to do about it.

New York

: Random House; 2005.

 

Stossel TP. Divergent views on managing clinical conflicts of interest. Mayo Clinic Proc 2007; 82:1013–1014.

 

 Stossel TP. Regulating academic-industrial research relationships: solving problems or stifling progress? N Engl J Med 2005; 353:1060–1065. Stossel TP, Stossel TP. Has the hunt for conflicts of interest gone too far? Yes [see comment]. Br Med J 2008; 336:476.

 

Hirsch LJ. Conflicts of interest, authorship, and disclosures in industry-related scientific publications: the tort bar and editorial oversight of medical journals. Mayo Clinic Proc 2009; 84:811–821.

 

Lanier WL. Bidirectional conflicts of interest involving industry and medical journals: who will champion integrity? Mayo Clinic Proc 2009; 84:771–775.

 

 Lo B, Field MJ  Conflict of interest in medical research, education and practice.

Washington

DC

: Committee on Conflict of Interest in Medical Research, Education, and Practice;

Institute

of

Medicine

.

National

Academy

of Sciences. National Academies Press; 2009.

 

Shafer SL. Critical thinking in anesthesia: eighth Honorary FAER Research Lecture. Anesthesiology 2009; 110:729–737.

 

Toland B. Are doctors getting fees or ’bribes’? Pittsburgh Post-Gazettecom Business [Newspaper] 2007 November 7, 2007 [cited 2009 July 30, 2009; newspaper article]. http://www.postgazette.com/pg/07311/831621-28.stm.

 

27 Grouse L. Physicians for sale: how medical professional organizations exploit their members. Medscape J Med 2008; 10:169.

 

Willyard C. Physicians fight back against disclosure rules. Nature 2009; 460:556–557.