From the Editor: We Need Real Data on Counterfeits and Real Debate on Imports

Until data gathering is taken seriously, the extent of the counterfeiting problem will never be known.

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By Agnes Shanley, Editor in Chief

For an industry that relies on quantitative data — where the position of a decimal point can mean the difference between life and death, a blockbuster or a recall — the drug industry has a long way to go where counterfeiting is concerned. We know that counterfeiting is on the rise, but can furnish only scattered, outdated, and mainly anecdotal evidence to prove it.

Time after time, the same old reports are trotted out — the World Health Organization’s estimates, inexact figures on China and India that are several years old. Why does the industry continue to shy away from developing the infrastructure needed to assess the size of the global problem?

The answer is simple: fears of bad publicity and impacts on stock prices.

Ideally, manufacturers should be tied into government agencies in every country where they operate, and a two-way data stream should send information on counterfeits, when they are found, in real time. Such an infrastructure would take years to develop, and would require the cooperation of international authorities such as Interpol, the U.N., WHO, customs and police. But exactly such an infrastructure is needed to prevent the death that continues, unreported and unassessed, in every corner of the world today.

Dora Akunyili, director general of Nigeria’s FDA equivalent, has seen counterfeiters at very close range. Their hired thugs have raided her house and tried, on numerous occasions, to kill her for standing up to them. In an article published in April’s issue of Public Library of Science Medicine, Akunyili and her colleagues at Oxford University argue convincingly for the need for closer government-industry ties and more reporting.

In the U.S, we also need real data to determine what impact legitimate imports would have on our pharmaceutical supply chain. And I’m not talking about material sourced from fly-by-night Web drugstores, but a limited volume of drugs made in Canada or Europe from sources that have been thoroughly vetted and approved.

That data can only come if there is serious, and public, debate on both sides of the importation issue. Not debate in Senate committees, but a public, televised debate.

To date, each side of the importation argument has been more interested in discrediting the other than in shedding real light on the issues, the costs and the risks.

Like many people vitally interested in the industry, I had looked forward to reading Giuliani Partners’ long-awaited final report on the safety of imported pharmaceuticals. Unfortunately, most of the study was a rehash of the same tired stories we’ve heard for well over two years — the oft-cited FDA/Custom’s port pilot studies, the Global Options study citing past connections between terror groups and counterfeits — IRA and Hezbollah in particular. The study also featured anecdotes and innuendos, few of them new, connecting Al Qaeda and the “Axis of Evil.” Oh, and I almost forgot the four-year-old data on China, India and the outdated WHO report.

This is not to dismiss the very real links that the report makes between organized crime, terror networks and counterfeiters. The connections are valid, frightening, and important, But we cannot continue to rehash old information. We need new data, and we need it now.

And it insults the public’s intelligence to make knee-jerk connections between terror networks and legitimate, controlled imports.

Interestingly, Giuliani’s report came out just about the same time that AARP released its study of drug prices, which rose by 7% last year, far outstripping inflation. The study has consumers up in arms.

Open, public debate on imports is as essential as new, hard facts on counterfeiting. The industry’s reputation depends on it. But is the industry ready?

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