A Public Health Time Bomb

December 28, 2009

Emma Back and Alix Beith, consultants to the CGD Drug Resistance Working Group, contributed to this post.

There’s a lot of attention being paid to the counterfeit drug trade at the moment. Former President of France, Jacques Chirac, recently chaired a meeting with West African leaders to discuss how to crack down on counterfeiting. Meanwhile, the Wellcome Trust and the American Pharmaceutical Group held an Opinion Formers’ conference on counterfeit medicines (presentations here); the International Federation of Pharmaceutical Manufacturers and Associations produced a brief on the issue; and Roger Bate has continued to draw attention to counterfeits and other drug quality issues in developing countries, including through his book Making a Killing. And this is all on top of the WHO-hosted IMPACT initiative on counterfeits, which started in 2006.

This attention is fully justified. Counterfeit drugs kill – and they do it while shaking people’s confidence in governments’ ability to protect the health of their citizens. The Pharmaceutical Security Institute, an industry supported non-profit, identified 1,834 incidents of known counterfeiting in 2008. While some counterfeits are close copies of the original drug, most are not, and many contain no active ingredients at all. The result for the patient is prolonged illness and even death, with the risks particularly high for children suffering an acute febrile illness, such as malaria.

But the public health risks go beyond such immediate suffering. Drugs that contain a little – but not enough – active ingredient, or that include only one active ingredient where a combination is needed for effective therapy, present ideal conditions for microbes to mutate in response to the drug. The drug resistance that results creates a huge additional cost, threatening the usefulness of quality-assured products for all prospective patients.

Drug manufacturers share responsibility with regulatory authorities for providing safe, quality-assured drugs and for tracking their continued effectiveness. Pharmaceutical companies should be more actively engaged in efforts to ensure that the drugs that reach patients are what they say they are. While there are examples of industry investing in this area – as GSK did through the Alexander Project when they had investments in antibiotics to protect – more is needed.

The CGD Drug Resistance Working Group’s draft report recommends development of industry-wide standards for pharmaceutical companies and distributors to encourage them to pay attention to quality issues that affect drug resistance beyond the manufacturing stage, as they package, store, and distribute their products. Such standards might also cover post-marketing surveillance activities, and the information provided to healthcare providers and patients, for example through promotional materials or package inserts.

Another part of the answer is to strengthen national drug regulatory agencies so they are better equipped to stem the circulation of substandard and counterfeit products on their markets. The CGD draft report recommends using regional regulatory networks to facilitate the sharing of data on substandard and counterfeit products as well as other information relevant to drug resistance.

For now, the attention of politicians, national drug regulators, global health agencies, and pharmaceutical companies is focused on tackling counterfeiting. But as they meet, they must keep drug resistance and other public health impacts uppermost in their minds. Counterfeiting is a crime. But its victims go beyond the companies whose intellectual property has been stolen and the procurement agencies whose resources are being wasted. The victims are sick patients everywhere, now and in the future – and substandard products of every type, not just counterfeits, present a risk. Sadly, every day we wait to address this problem, the number of victims grows.

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2 Responses to “A Public Health Time Bomb”

Steven Earl Salmony Says:
January 2nd, 2010 at 10:56 am

Dear Rachel Nugent and Friends,

It appears the human family has more than one ticking time bomb to defuse.

I hope you and your families as well as everyone else in the Center for Global Development community enjoy the happiest of new years in 2010. Perhaps it will be all right if I make a personal appeal here to you now.

Very few experts have commented on the research of Hopfenberg and Pimentel concerning human population ecology http://www.panearth.org/ What does matter is that peer-reviewed research regarding a colossal, human-driven global challenge is openly discussed. Getting this “right” and acting accordingly by responding ably to this “mother” of global challenges does count for something, I believe, because the implications of the evidence appear absolutely vital to the maintenance of future human wellbeing and environmental health.

Please note that many experts from a great variety of disciplines have commented directly as members of the Center community in these blogs. At this late date, perhaps there is still some point in asking the question, “Is there anyone who fundamentally agrees with and will publicly support the evidence from Hopfenberg and Pimentel?” That is to say, is one expert wiling to speak out loudly and clearly before the new decade we have just entered closes and it could indeed be too late for human action to save the planet as a fit place for the children to inhabit? It seems to me that one decade when silence was triumphant over the science of human population ecology is enough because time is running out. No substitute exists for the best available scientific evidence.

Joe Bish of the Population Media Center is the leader in 2010 of Global Population Speak Out. http://gpso.wordpress.com/ A colleague of mine in psychology, John C. Feeney, began this remarkably successful campaign last year. Look at a partial list of pre-eminent endorsers of the GPSO efforts:

Jack Alpert, Ph.D.,
Albert A. Bartlett, Ph.D.,
Joe Bish, GPSO 2010 Coordinator;
William R. Catton, Jr., Ph.D.,
Gretchen Daily Ph.D.,
Anne Ehrlich,
Paul Ehrlich, Ph.D.,
John Feeney, Ph.D., GPSO Founder,
Dennis Meadows, Ph.D.,
Frederick Meyerson, Ph.D., J.D.,
Jeffrey K. McKee, Ph.D.,
Eric Rimmer,
William Ryerson,
Carl Safina, Ph.D.,
Peter Salonius, Ph.D.,
Lorna Salzman,
Rick Shea,
J. Kenneth Smail, Ph.D.,
Emily Spence,
Marian Starkey,
Robert J. Walker.

If someone associated with GPSO or the Population Media Center or the Society of Conservation Biology or the community of ecologists worldwide or any other expert with appropriate expertise or any of you at CGD would respond to the following request, I would be most appreciative,

If you agree with the research of Hopfenberg and Pimentel, please, please, someone report your findings regarding this evidence that appears to indicate rather simply that the population dynamics of the human species is essentially common to, not different from, the population dynamics of other living things. If that hypothesis is somehow correct, then no global challenge looming before the family of humanity can be more vital to acknowledge, address and overcome than the challenge posed to the human community by the unbridled, skyrocketing growth of absolute global human population numbers in our time, I suppose.

Sincerely,

Steve
Types of Chemotherapy Drugs Says:
February 1st, 2010 at 4:04 pm

The public health risks go beyond such immediate suffering.Drugs that contain a little but not enough active ingredient.The drugs resistance that results creates a huge additional cost, threatening the usefulness of quality assured products for all prospective patients.