BTW, Speaking about justice…

Access is not enough

Posted on: June 6, 2010

Securing access means nothing when access is to ineffective drugs.

That’s the lesson I got from  Prof John Abraham‘s talk at Nottingham University’s Critical Perspective Series.

Standard drug regulatory review process requires drugs to be tested in at least 3 phases, but  in “exceptional circumstances”, there are regulations that allow approval for market application without going through some of the phases. This is the focus of Prof Abraham’s talk: Accelerated Access to pharmaceuticals.

Disease politics theorizes that accelerated access is a result of patient activism. Institutions such as FDA are simply responding to public demands in granting faster approvals for drugs. In short, there is an evolution of patients’ role from “needing state protection” to “consumer who deserves access” (Daemmrich, 2004).

Prof Abraham disagrees. Putting on his critical perspective hat, he argues that the drive for accelerated approval is due to increased public-private partnerships (especially in USA, UK, and Europe), not patient activism, where government and industry partnership works in the commercial interest of pharmaceutical industry.

The patient pressure theory fails to explain this phenomenon because manufacturers often fund patients and patient groups. Testimonies and drug promotion not through cash handouts, but through Access Expansion Programs where drugs are made available for people who are not eligible for clinical trials.

Putting on my social justice and politics hat, few thoughts spring to mind:

Why does it sound as if governments are like stamp machines, approving this and that depending on who puts more pressure. Why bother with developing democracy and strong capable governments if we assume government institutions simply respond to EITHER patient demands for more access OR industry pressure. After all, patients ARE the market target for healthcare (both service and product). If everything is back to market, market and market; state’s role is not any different than a parking validation man sitting in a booth.

The way I see it, democracy has a role in deciding government’s purpose. Clear government purpose has to be up front: as safety net provider or springboard for welfare? (of course there are grey areas where roles interchange and seep through, but a clear purpose for not just one administration period but for perhaps a generation should be in place). One cannot be Jekyll and Hyde at the same time, but one can be both depending on the context.

As far as accelerated approval go, I agree with Prof Abraham that it is not the best decision for anybody.

For states with universal provision systems, putting money into ineffective drugs is a waste of resource. It also shaves public trust in the government as being an extension of market interests than the protector of public welfare. Drugs are made to work, not to be out in the market fast.

For companies, as far as innovation can be a competitive advantage, accelerated approval of ineffective drive is not sustainable innovation, nor does it generate more innovation. As a matter of fact, accelerated approval does the opposite, innovation rates fall significantly. It makes no sense for scientists to build on failures expecting for future success, much like blindly building a tower on pile of soft sponge thinking that the sponge is a strong/stable foundation because it has “APPROVED” stuck to it.

Thinking in social justice terms for health, one of the biggest debate is on access. When people are denied access to opportunity, it becomes unjust. However, with the case of accelerated approval to pharmaceuticals, perhaps we should keep in mind that securing access does not mean we are securing justice. Third world countries often demand access to new drugs developed by western pharma, which ironically, these drugs are sometimes not even approved or withdrawn from markets in USA, UK or Europe!

Tough to be “the government”, eh?

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Lishia Erza

Searching for answers about life, these are the ones I have found.

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