[Ip-health] The Internationale
ppitts at cmpi.org
Mon Nov 21 05:54:44 PST 2011
I’ve just returned from the Third International Conference for
Improving Use of Medicines (ICIUM). The meeting was held in Antalya,
Turkey – not that there was any Thanksgiving-related iconography.
The first thing to remember is that in the world of NGO healthcare
policy, “international” means “non-Western.”
There were quite a lot of government officials from Africa, Asia, the
Middle East, and a dusting of officials from the US (mostly USAID) and
The third ICIUM, for the first time, included members of the innovator
pharmaceutical industry. They were not asked to wear yellow stars.
Noticeable by their absence were any generics manufacturers.
Not surprisingly, most of the ICIUM participants fall into the
category of old familiar faces, although there were some noticeable by
their absence – like Jamie Love. Well, absence makes the heart grow
It was an acronym-heavy event, with the most commonly used
abbreviation being “RUM” for “Rational Use of Medicine.” (And
remember, you can’t spell “rational” without R-A-T-I-O-N.) The other
acronym of note was LMIC (“Lower/Middle Income Countries) also
referred to as “indexed countries” (IC).
Every day brought a slew of interesting commentary. For those of you
unable to make the voyage, some selected tidbits:
Kathleen Anne Holloway (WHO) raised the issue of the deleterious
impact of competition among NGOs (as well as the WHO) for project
funding. She was blunt about the negative consequences of
“competition for prestige, attention, and priorities.” Those negative
consequences, it turns out, result in less funding for some WHO
projects. Not that the majority of the audience gives marketplace
competition any credence – although it’s surprising such incredulity
also seems to extend to the marketplace of ideas.
Klaus Leisinger (Novartis Foundation for Sustainable Development)
spoke about the need for everyone engaged in the international debate
over the improved use of medicines to stop stereotyping each other.
(Amen. It’s about time we fought to put the “civil” back in “civil
society.”) He then called for the creation of a “grand coalition”
think tank to address the opportunities that working together might
offer. Klaus – sign me up.
Richard Laing (WHO), after praising GSK CEO Andrew Witty for his
company’s devotion to corporate social responsibility, offered that
“There is often an unfortunate disconnect between pharma HQs and their
marketing departments when it comes to the issue of access to
medicines.” Is a word to the wise sufficient?
(Remember -- A Word to the Wise was a 1770 play by the Irish writer
Hugh Kelly. His first work was the 1767 hit False Delicacy.)
Dr. Laing also acknowledged the absence of both national and global
generics companies from the ICIUM event -- a rather gaping hole that
needs to be filled next time around. This issue came up again and
again as panelists pointed out (again and again) that in many markets
the prices of both branded and non-branded generics are actually
higher than (off-patent) innovator medicines.
The role of generics cannot be overlooked considering that something
on the order of 98-99% of all medicines on the WHO’s Essential Drug
List were either never patented of their patents have long since
expired in the IC countries. That being the case, there must be other
reasons (beyond the traditional whipping boy of intellectual property
rights) to explain why millions of people do not enjoy regular and
reliable access to life-saving medicines.
Eva Ombaka (identified only as “formerly of the Tanzanian Ecumenical
Pharmaceutical Network”) suggested that pharmaceutical companies
should redirect their spending on “inappropriate marketing” to the
public health dissemination of “access to medicine information.”
Note to Big Pharma – please refocus all “inappropriate marketing” line
items to this effort.
Batool Jaffer Suleiman (Oman Ministry of Health) said that, when it
comes to promoting RUM programs, government should “be seen as a
support rather than the police.” Indeed. But support for whom and for
what? Price or patients? She also shared that her office publishes a
regular RUM newsletter called “Pharmaco-Logical.” Who said Omanis
don’t have a sense of humor?
Jing Sun (China National Health Development Research Center, Ministry
of Health, China) offered an excellent presentation on her nation’s
nascent healthcare reform efforts. Her complete presentation will
shortly be available on the ICIUM website, http://www.inrud.org/ICIUM/ICIUM-2011.cfm
She noted that China currently spends 5.14% of GDP on healthcare and
(of that 5.14%) 44.5% is spent on pharmaceuticals (about 2.5% of total
GDP). When you compare this to the roughly 17% of GDP spent on
healthcare by most western nations (with roughly 12% directed towards
medicines), there should be some questions asked. And the first one
should be; is the higher Chinese percent spend on pharmaceuticals a
good thing or a bad thing?
Time and again, speakers from the LMICs noted that their spending on
pharmaceuticals was regularly in the 30-40 percent range of their
annual healthcare expenditures (i.e., Jordan with 10% of GDP spent on
healthcare and 34% of that amount on medicines). Considering that
product costs for index nations are significantly lower than western
prices, perhaps the higher LMIC spend on pharmaceuticals is because
medicines are something these nations can offer their populations –
making up for a dearth of spending on the medical professionals and
hospitals they do not have – but which represent the lion’s share of
western healthcare spending.
In this respect, the high percentage of spending on modern medicines
is akin to the LMIC telecom leap-frogging that has created a much
higher penetration of mobile phones per capita than in the West.
Something to think about.
Another question to ponder is to what extent government interventions
may account for higher medicine prices in LMICs. Many governments
implement aggressive protectionist policies that allow local generics
companies to charge higher prices for products that are off patent –
paying too much for older medicines that should be available to
patients at commodity prices.
Saul Walker (Department for International Development, United Kingdom)
bemoaned the unfortunate and counterproductive tension between
“sustainability and innovation.” He also pointed out, with great
honesty, that “government is not a unified entity” when it comes to
developing and implementing healthcare policy. (He was directing his
comments at the LMICs – but it’s equally true across the board and
around the globe.) He also mentioned “Big P and Small P” battles being
fought both within governments and NGOs. And the P (in case you
haven’t guessed) stands for “politics.” Perhaps a panel at the next
ICIUM can focus on a new definition of “P value for public health.”
(And, while we’re on the subject of ICIUM IV, there should be a
subject track on safety. There was almost no discussion of
bioequivalence, GMPs, narrow therapeutic indexing, therapeutic
switching, or biosimilars.)
Jonathan Quick (Management Sciences for Health, USA) asked if
universal health care was “the golden ring or a Trojan horse?” His
answer seemed to be “yes,” concluding that “failure to fully maximize
needed expertise” is a major reason that universal healthcare systems
are failing. One might also add “failure to understand the realities
of market-based economies.” Socialism, as they say, works great until
you run out of other people’s money.
Maryam Bigdeli (WHO) made the excellent point that, “Many of today’s
problems are because of yesterday’s solutions.” Or as Abraham Lincoln
said, “You cannot escape the responsibility of tomorrow by evading it
Danya Qato (Brown University), offering one of the few US-centric
presentations, made the excellent point that when it comes to
medicines (specifically) and healthcare (more broadly) the barrier
isn’t just cost. (Shocking, right?) Her US-based research among a
largely Medicare-eligible population demonstrates that racial, social,
and geographic disparities play a major role and that “access does not
equate to use.” Reality. What a concept.
The other US-based presentation was by Elissa Ladd (MGH Institute of
Health Professions). Her talk was on the detailing practices of Big
Pharma towards the growing population of nurse-prescribers. (According
to Ms. Ladd, there are 150,000 nurse-prescribers in the US, compared
with only 100,000 physicians in general practice.) You’ve heard the
argument before – pharmaceutical detailing is “bad” because it helps
to “sell” products for profit!
She provided no evidence (anecdotal or otherwise) that the information
pharmaceutical detailers provide to nurse-prescribers is in any way
slanted or anything other than factual and 100% FDA-compliant. Her
organization undertook some “educational” efforts that resulted in
nurse-prescribers questioning the reliability of pharma-provided
information. She positioned this as “success.” But – is having nurse-
prescribers (or, for that matter, any prescriber) discount important
medical information really a move in the right direction?
And then there’s the Access to Medicine Index (ATMi). The ATMi is an
attempt to measure and compare the corporate social responsibility of
both innovator (20) and generics (7) companies based on a number of
different (and often quixotic) indicators. According the Access to
Medicine Foundation, the index “aims to help poor people in developing
countries gain access to medicine by encouraging the pharmaceutical
industry to improve its commitments and practices related to this
issue.” Since it’s a comparison, the theory is that competition
amongst companies will drive desirous “socially responsible” behaviors.
A noble goal – but the devil is in the details. Consider
subjectivity. For example (and most notably) the index’s four
strategic pillars are “commitments, transparency, performance, and
innovation.” And its “technical” benchmarks include such vague
categories as General Access to Medicines Management, Public Policy
and Market Influence, and Capability Advancement in Product
Development and Distribution.
As Goran Tomson (Karolinska Institute) pointed out, the index’s
methodology cannot be reproduced, hence it cannot be considered
statistically valid -- unless you choose to abide the Marxist (Karl
not Groucho) maxim that “a special environment creates a special class.”
There are also troubling issues relative to the ATMi’s metrics for
success. As the index’s methodological designer, Afshin Mehrpouya
(HEC, Paris), opined, the only current measurements are “web hits and
media coverage.” Not very exciting, plausible, or helpful from a
health policy analysis perspective.
Another ATMi metric is the opinion of patient groups. When asked why
certain patient groups were chosen (they are not named in the ATMi),
the answer was that groups were chosen based on their “credibility.”
In NGO-land that’s code for groups who do not accept funding from the
pharmaceutical industry or may not share the anti-private sector bias
of the party line. At minimum, that’s a dubious selection bias.
Most damning was Dr, Mehrpouya’s admission that the index, “doesn’t
take the patient viewpoint into perspective.
Dr. Tomson also pointed out that the ATMi’s “review committee”
consisted almost entirely of “familiar faces,” thus creating an issue
of normative bias.
These are all polite ways of saying that the design criterion stacks
the deck. But, hey – doesn’t the end justify the means?
What the ATMi has succeeded in doing is getting the attention of
innovator companies who want to strut their corporate social
responsibility stuff index-wise. The result is that many LMICs are
considering the index when making national formulary decisions, thus
giving additional points to innovators over generics companies. Some
observers at the ICIUM conference viewed this as an unintended
negative consequence. But the truth hurts.
To paraphrase Adlai Stevenson, “If NGOs and generics companies will
stop telling lies about pharmaceutical innovators, perhaps Big Pharma
will stop telling the truth about them.”
One suggestion that came up during the panel debate on the ATMi is to
create a parallel index that measures LMICs by whether or not their
policies and political environment facilitate or hinder their
citizens’ access to healthcare. One such measure, as bravely noted by
Jeffrey Kemprecos (Merck), is to measure and address the 800-pound
gorilla in the room – the lack of transparency in the public sector
and – yes, he dared utter the word -- corruption.
Goran Tomson put the discussion about the ATMi -- as well as the
entire ICIUM enterprise -- into perspective when he said the index
lacked for “higher ambitions.”
Any maybe that’s the best go-forward message from and for ICIUM – let
us strive for “higher ambitions” as colleagues who can (in the words
of Klaus Leisinger) “agree to disagree.” Easier said than done. But
it’s worth a try.
In other words – let’s talk turkey.
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