[Ip-health] The Internationale

Peter Pitts 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 EU.

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  
fonder.

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  
today.”
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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