The Internationale

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  • 11/21/2011

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,

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.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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