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Subject:
From:
Elizabeth Brooks <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Mon, 13 Sep 2010 21:49:19 -0400
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Jan, look at the very bottom of the IBLCE page at
http://americas.iblce.org/what-are-cerps; that has a little summary note
about  CERPs not going to commercial entities that sell Lactation-related
Stuff.  See p. 3 and p. 9, in particular, of the IBLCE CERPs Provider
Packet, http://americas.iblce.org/upload/CERPsProviderPacket-2010.pdf.  If
you visit the international portion of the IBLCE site, you will see their
BOD Exectuive Summaries of March and Sept 2009  discuss a Task Force created
to review awarding of CERPS.  I thought IBLCE issued a statement, too, but I
can't seem to dig that up on the their website now; perhaps it has been
removed.

I am similarly stumped: what the heck *is* a "commercial entity?"  I suspect
-- merely suspect -- they are trying to describe the medical-device and
pharmaceutical manufacturers who have been the object of recent scrutiny by
the ethics arms of various medical and health care societies ... but you'll
have to ask IBLCE what they mean by that one to know for sure.  Now ya'll
know why Lawyer Liz is constantly yapping about the importance of
definitions in documents or policies which we are honor- or duty-bound to
follow.  It makes a big honking difference.

OK. Quick lesson on conflicts-of-interest (COI)... real, and imagined.

(1)  Simply put:  a COI occurs if you have a **personal stake** in the
outcome of some sort of official decision-making you must make.  Imagine I
have a job opening to fill.  I can hire a stranger, or hire my child.  It is
a COI for me to hire my kid, because -- regardless of my kid's
qualififcations -- the impression is that my kid got the job just cuz she's
my kid.

Identifying a COI is only step one, though.  It can be "cured" so that it
does not matter anymore.  One way is to recuse yourself from the
decision-making process.  When my kid says, "Gee, Mom, I'm thinking of
sending my resume in for that job you posted," I would immediately remove
myself from any part of the job-applications and hiring process.

Another way is **full and prior disclosure** to all parties involved, to get
their **prior** consent.   Lawyers do this all the time.  Let's say I
represented the grocery store ten years ago on a contract dispute.  Now, a
potential new client wants me to sue the grocery store in a slip-and-fall
tort action.  Before I can take the injured victim as a client, I first have
to get the OK of everyone -- the grocery store, their new lawyer, and my
client.  The notion is that if I represented the grocery store 10 years ago,
I may have knowleddge about the way they do business that gives me an
unfair, insider's advantage now that I want to sue them.

(2)  Then there is the much broader, murkier (and confusing) area of
**appearance** of a COI.

Let's say my kid got hired at my company, after I had fully recused myself
from the process, and she was hired on her own stellar merits.  She will be
supervised by someone else, work in a division that is in another city, and
I will only hear about her job when she is home for the holidays.  Everyone
knew about the situation up front, I was totally out of the process to hire
her; human resources is cool with this -- all of the COI genies are back in
the bottle.  Hip hip hooray, we are good to go.

Now my kid's blind date finds out she has a new job at the same company
where her mom works.  His first thought to himself is "Nepotism.  She got
the job cuz her mom works there."

He is making an assumption based on the **appearance** of a COI.  And he is
free to draw this conclusion because he was not a part of the process by
which it was all accomplished in a squeaky clean fashion.

(3)  Some professions (think judges) will not tolerate even the
**appearance** of a COI.  So judges will go to extraordinary lengths to
avoid scenarios where others can draw the wrong conclusions about whether
they have a cozy relationship with a person or company or group.

(4)  OK -- so now let's get back to IBCLCs.  Our Code of Ethics wisely tells
us to "remain free of COI" (Tenet 5), provide proper information about
appropriate products (Tenet 12) and "disclose any financial of other COIs in
relevant organizations providing goods or services" (Tenet 17).  This goes
to the "which hat are you wearing?" conundrum that many of us face in our
work.

Let's say I am an IBCLC who sees a mom, and I am about to recommend to her
-- for very valid clinical reasons -- that she use a nipple shield.  I also
sell nipple shields.  It can certainly give rise to an **appearance** of a
COI that I am telling her to use the shield because I want to sell it to
her.  I can **cure** the COI by various means.  I can choose not to sell
stuff when I am in a clinical setting.  I can show her a list of places she
can get a nipple shield, including my retail establishment (or not).  I can
explain (up front) that while I do sell various items, if I finid I need
to recommend something to Mom, it will be based on clinical reasons unique
to her situation.  You get the idea.

(5)  One basic premise of any COI examination is that receiving gifts and
freebies creates a sense of reciprocity.  Because you got something nice
FROM someone, you now have a BIAS in their favor.

Having your attendance at a conference paid by the host -- especially when
the host is the manufacturer of a product that you may have to later
recommend as part of your clinical work -- creates not only the
**appearance** of a COI, but in fact a very real tension whereby you'll be
inclined to recommend that product simply because you were the beneficiary
of their largesse.  There is a reason why Big Pharma spends billions (that's
with a "b") in giving free samples and gifts to medical
professionals.   Volumes have been written about this notion; one of my
favorites is from the [USA] National Academy of Sciences at
http://www.ncbi.nlm.nih.gov/bookshelf/br.fcgi?book=nap12598&part=a2001902bddd00134.
See the recommendations against physicians accepting any items of value,
absent a payment at fair market value.

(6)  Note that this sort of tension -- where receivers of freebies start to
feel beholden to the gift-giver -- is not a true "conflict of interest" as I
defined it above.  But people often loosely describe this very real ethics
issue as a "conflict of interest."  The reason the health care professions
are (rightly) so itchy-scratchy about this is that we are supposed to be
thinking -- first and foremost -- about the care of the patient/client.  The
health care provider is said to have "conflict of **professional**
interest if s/he is (wittingly or not) starting to makes decisions that
favor the company over the client/patient.  Yeah, I know,  Confusing.  But
there you have it.

(7)  And let's state the obvious:  any session, offered by any manufacturer
of anything, has one overriding goal:  to sell their stuff.  Call it
whatever you want -- I guarantee you that when you go to this session, you
will see lots of logos and brands of the company that paid for it to
happen.  Because -- doh -- the company paid for it to happen.

(8)  So let's take it up a notch.  Some IBCLCs feel more passionately about
avoiding an **appearance** of a COI than others.  Some of us will say "I
will pay fair market value to attend the pump company conference, and go,
knowing that it is ethical to do so.  I do not have a COI, and I am not
going to worry about misinformed people who form the wrong impression about
my attendance."  Others of us will say "I won't even go near that
conference.  What if the nurses see me there, after I just spent World BF
Week teaching about the Ten Steps and avoiding collusion with formula and
bottle manufacturers?  They won't know I paid  fair market value, and I will
have egg on my face that I don't even deserve."

(8)  And lastly, let's bring in the WHO Code.  IBCLCs are asked not to
accept inducements (freebies) from the marketers of the four product-types
covered by the WHO Code.  For all of the reasons alluded to above.  We
(rightly) get itchy-scratchy) whenever the products covered by teh WHO Code
are part of the picture.  Tenet 24 of the IBLCE Code of Ethics.

(9)  I will close by saying that I visited the website, posted subsequent to
my first rant on this topic ... and had to shake my head at loophole
ingenuity.  I thought the original inquiry was about IBLCLCs going to a
conference **for free** because the host (a medical device manufacturer) was
going to pay the way.  Well, wrong.  Their website clearly states: no CERPs
can be awarded for these talks, AND it costs a fairly reasonable fee to
attend.  Hmm.  So the WHO Code loophole hhas been found.

But that still begs the questions ... does it pass your own personal smell
test to spend money to go to a conference hosted by an entity whose
overriding goal, in all they do, is to sell their stuff?  Will the
information you receive  be skewed to flatter that manufacturer? Maybe yes;
maybe no. Will you "merely" walk away with a warm and fuzzy feeling about
that company ... one they will be able to capitalize on next time they see
you at your facility?  I'm thinking yes.  ("Hey!  It was great to see you at
our conference last week!  Yeah, too bad you couldn't earn CERPs, even
though it was a pretty good deal, doncha think?  Let's go have a cup of
coffee in your hopsital cafeteria now, and we can talk about what we
learned.  By the way, I have some brochures here about the new product we
are unveling next month.  Would you like to hear about that too?")

(10)  Bottom line -- an IBCLC can find ways to ethically interact with
producers of any piece of equipment, and any product falling under the WHO
Code.  IBCLCs do it every day.  But it takes a lot of work, and it hard to
figure out.

Liz Brooks JD IBCLC FILCA
Wyndmoor, PA, USA

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