Sunday, March 25, 2007

Access to Essential Drugs

By way of promoting a book I co-edited, here's a review of said product in this week's medical journal THE LANCET.

The Lancet 2007 24 March

Book Review

Access to essential drugs and the pendulum of power

The Power of Pills: Social, Ethical and Legal Issues in Drug Development, Marketing and Pricing
Jillian Clare Cohen, Patricia Illingworth and Udo Schuklenk, eds.
Pluto Press, 2006, ISBN 0-745-32402-9.

Pp 320. £19·99, US$35·00

Many factors have influenced my commitment to campaign for access to essential medicines, but two immediately leap out. When I was working in Bangladesh I witnessed a certain drug company promote the virtues of a sugar-coated vitamin pill as the most important factor in helping children grow and stay healthy. Families spent a day's wages on these useless tablets when they could have been buying bananas, spinach, and dahl instead. As I watched parents make sacrifices to pay for these pills, I realised that I was obliged to do something about this profoundly unjust situation:

I knew what was going on, doing nothing would make me complicit in the drug company's actions.

Years later, in my role as a medical editor, I accepted an invitation to lunch with the Association of the British Pharmaceutical Industry. It was just after the South African Government had won their landmark court case against the pharmaceutical industry, in April, 2001, and I wanted
to hear the association's view of the outcome. It was in London's Grosvenor Hotel and everyone apart from me was tucking into a three-course meal under the chandeliers. I felt alone in my disapproval of drug companies' evangelical zeal to uphold patents, and uncomfortable about the way those present were talking about African people. After I said my piece, I left the dining room and a Brazilian waiter came running after me to thank me for what I had said.

And here lies the problem. The activities of drug companies that put patents before public health—encouraged by the World Trade Organisation's rule on Trade-Related Intellectual Property Rights (TRIPS)—places the pharmaceutical industry and campaigners on different sides of an impasse that is so wide there seems to be no possibility of meeting in the middle. In the real world, the outcome of this polarised debate depends on who has the most power, which unfortunately for now is the drug companies. But if there is any hope of making progress, there has to be some mutual recognition and acknowledgement of each other's point of view. Will I find any thought-provoking reasoning in The Power of Pills to help me appreciate the
position of drug companies?

The Power of Pills explains the social, ethical, and legal issues involved in drug development, marketing, and pricing and has contributions from an eclectic mix of academics, activists, economists, ethicists, health-care professionals, lawyers, and philosophers. There is one contributor from the pharmaceutical industry. Most of the essays are beautiful examples
of moral, philosophical, and economic reasoning at its best. For example, Michael Selgelid and Eline Sepers argue that drug companies should be "incentivised" to research diseases in developing countries. The need for governments in the south to implement a comprehensive public-private policy that sets the agenda is the focus of Joao Carapinha's essay. Steve Miles suggests that the socioeconomic gap between rich and poor countries is likely to grow unless
developing countries establish their own research capacity that prioritises the health needs of their populations. The case for abolishing the patent system is made convincingly by Adam Mannan and Alan Story. And Brook Baker argues that access to essential medicines is a human right and proposes that the international community should put it firmly on the human rights agenda.
The drug industry is represented by Robert Freeman, a pharma veteran. He offers a predictable defence arguing for "strong intellectual property rights, a stable regulatory, pricing and reimbursement environment, and the recognition that pharmaceutical innovation is a major contribution to the health of nations." We are back at the impasse. I am not convinced.

Another prime example of pharma dogma is in the 2005 report from the Millennium Project Working Group on Access to Essential Medicines, one of the Millennium Development Goal targets, which discusses the way forward.
The report's authors come up with similar solutions to those outlined in The Power of Pills, such as fair pricing of essential medicines and innovative methods of research and development that are not led by the pharmaceutical industry. However, at the back of the report is a statement of dissent by representatives of the research-based pharmaceutical industry and signed by
Eli Lilly, Merck, and Pfizer. Although representatives for the industry were part of the working group they refused to sign the report, "because of the enormous visionary gap between ourselves and the working group in identifying root causes of the access challenge". Their reasons are so important in understanding why there is a stand-off position when it comes
to access to essential medicines that I think their response is worth quoting. They state, "We do not believe that the main problem in barring medicines to the poor is patent protection, nor do we accept that individual pricing practises are fundamental to explaining why one-third of
the world's poor lack access to basic, low cost essential medicines." They conclude, "In short, the report fails to provide the balanced and accurate perspective necessary to stimulate fresh policy approaches that could make a real difference to the lives of the poor. To allow these inaccuracies and misinterpretations to become accepted truth and as the basis of moving policies forward does no one any service, least of all patients who rely most on the commitments we have made. It would significantly diminish our ability to fulfil commitments to current and future partnerships—most importantly—our capacity to produce new drugs, diagnostics, and vaccines."

I am left wondering how much more evidence and reasoning it will take for the drug industry to meet somewhere along the impasse. Is there any way forward? A WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property may offer some hope. The group's aim is to help devise a global strategy to boost research and development for neglected diseases, including looking at new ideas such as patent pooling, to address the barriers posed by patents for individual drugs. But experience to date shows that drug companies will do everything they can to cling on the status quo where they hold all of the power. The pendulum of power will need to swing to the other side before there is any reasonable progress.

So imagine this: after deciding to diversify and invest in its own research and development, a former Indian generic drug company has come up with a new compound that could be of major benefit to people with lung cancer—the leading cause of death from cancer in rich countries. The company has tested its drug in clinical trials, it has been approved for use, and as is within the company's rights, according to TRIPS, the company patents it and charges a premium so that the cost for treating one patient for 1 year with the new drug is £50?000. Can you imagine the response to this situation, including the tabloid headlines? Now why should the response to access to life-saving treatment, such as antiretroviral therapy, for people in developing
countries be any different? Is it because they are poor? Is it because they are powerless? Or is it because, on the whole, the international community just does not care? The power is not with the pills. It is with the pill makers.

nathan ford < >

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