COMMENTARY

Talking Turkey About Access to Medicines

Index of social responsibility is deeply flawed.

PETER J. PITTS

The Burrill Report

“The result is that many low- and middle-income countries are considering the index when making national formulary decisions, thus giving additional points to innovators over generics companies.”

I’ve just returned from the Third International Conference on Improving Use of Medicines known as ICIUM. The meeting was held in Antalya, Turkey – not that there was any Thanksgiving-related iconography. There were quite a lot of government officials from Africa, Asia, the Middle East, and a dusting of officials from the United States and the European Union. But, for the first time, the conference also included members of the innovator pharmaceutical industry.

The industry has taken a keen interest in the Access to Medicine Index or ATMi. The index 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. It was an issue of some contention at the conference.

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. That’s a noble goal, but the devil is in the details.

Consider subjectivity. For example, 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, professor of international health systems research at Karolinska Institute pointed out, the index’s methodology cannot be reproduced, hence it cannot be considered statistically valid.

There are also troubling issues relative to the index’s metrics for success. As the index’s methodological designer, Afshin Mehrpouya, an assistant professor of accounting and management control at the international business school HEC Paris, said that the only current measurements are “web hits and media coverage.” That’s not very exciting, plausible, or helpful from a health policy analysis perspective.

Another metric is the opinion of patient groups. When asked why certain patient groups were chosen (they are not named in the index), the answer was that groups were chosen based on their “credibility.” That’s code for groups who do not accept funding from the pharmaceutical industry or may share the anti-private sector bias of the party line. At minimum, that’s a dubious selection bias.

Most damning was Mehrpouya’s admission that the index, “doesn’t take the patient viewpoint into perspective.

Karolinska’s Tomson also pointed out that the index’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 index 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 low- and middle-income countries are considering the index when making national formulary decisions, thus giving additional points to innovators over generics companies. Some observers at the 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 index is to create a parallel index that measures low- and middle income countries 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, director of external affairs for Merck, is to measure and address the 800-pound gorilla in the room—the lack of transparency in the public sector and corruption.

Karolinska’s Tomson put the discussion about the index—as well as the entire ICIUM enterprise—into perspective when he said the index lacked for “higher ambitions.”

Maybe that’s the best go-forward message from and for the conference: Let us strive for “higher ambitions” as colleagues who can agree to disagree. That’s easier said than done, but it’s worth a try.

In other words—let’s talk turkey.





Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest.











November 22, 2011
http://www.burrillreport.com/article-talking_turkey_about_access_to_medicines.html