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, 2023 [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.