Issue 34 / 9 September 2013

TO get their products approved by regulators so they can access the goldmine that is Australia’s Pharmaceutical Benefits Scheme, pharmaceutical companies need data — and lots of it.

Increasingly, that data comes from clinical trials conducted in developing countries, where costs are lower and — a cynic might suggest — the regulatory framework is less rigorous.

A decade ago, countries such as China and India were routinely excluded from industry-sponsored trials, but no longer.

The number of industry-sponsored trials in China doubled between 2005 and 2010 and there are now more than 3000 trials under way in that country, a large proportion of them sponsored by multinational pharmaceutical companies, according to researchers from Sydney’s George Institute for Global Health.

Writing in JAMA, the researchers say it is time for us to review the terms of engagement when it comes to such trials.

They raise two important questions — one about the quality of data obtained, given the weak regulatory environments in many of these countries, and a second, ethical concern about whether the products are relevant to local health problems and will ultimately be accessible to people in those societies.

Clearly, it is in our interest to find solutions to the first of these problems, as the decisions we make about which drugs are approved and for what indications are increasingly being based on research done in developing countries.

We really don’t know whether such research produces less reliable findings than that done in the developed world, but it seems reasonable to fear that it might.

These authors suggest a centralised, independent system of continuous statistical monitoring might help address the risk of research fraud across all countries, not just those in the developing world.

Strengthening these countries’ regulatory systems would also surely have to be part of any solution.

The second concern is possibly even trickier to address. I have written before about the fraught ethical issues that can arise when trials are conducted in less developed countries where participants may not have any other means of accessing treatment for a condition and may not fully understand the nature and risks of their involvement.

Clinical research should take place in the less prosperous countries of the world. It offers the opportunity to build capacity in those countries and, at least in theory, to ensure their health concerns are addressed.

But if the information obtained is to be reliable — and, perhaps most importantly, useful to the people who took the risks involved in obtaining it — we need to have clear parameters around that.

At the moment, it’s pretty much up to the pharmaceutical industry to regulate itself and the results of that can be mixed.

The New York Times earlier this year reported on an internal audit of GlaxoSmithKline’s China-based research that found a number of alleged irregularities, including a failure to report results of animal studies of a drug that was already being trialled in humans.

In the interest of fairness, though, I should also point out that GSK has in recent years had a better record than its competitors in providing people in developing countries with access to medicines.

The excellent Access to Medicines Index last year gave the company first place in its ranking of the world’s 20 largest research-based pharmaceutical companies.

The index, which was founded in 2008 and is funded by the Gates Foundation and the UK and Dutch governments, looks at a range of factors including pricing, patents and research into relevant health problems in order to come up with its rankings.

One thing you can say with certainty: when it comes to pharmaceutical industry involvement in the developing world, nothing is simple.

Jane McCredie is a Sydney-based science and medicine writer.

One thought on “Jane McCredie: Data disquiet

  1. Dr John B. Myers says:

    Research needs to be locally (A) generated, locally (A) and externally elswhere confirmed, and be locally (A) implemented, monitored and applied.

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