Healthy Skepticism Library item: 15746

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Publication type: news

Jack A.
Drug company ethics on trial
Financial Times 2009 Jun 5
http://www.ft.com/cms/s/0/4a0c524a-51ef-11de-b986-00144feabdc0.html?referrer_id=yahoofinance&ft_ref=yahoo1&segid=03058&nclick_check=1

Full text:

When researchers recently scrutinised some clinical trials for experimental medicines conducted by multinational pharmaceutical companies in India, they were troubled by a number of findings.

The Centre for Studies in Ethics and Rights in Mumbai concluded that local testing of drugs by GlaxoSmithKline, AstraZeneca and Johnson & Johnson violated the guidelines of the Indian Council of Medical Research over the way in which patients were recruited, trials conducted and access to launched products was arranged.

The findings did not suggest the companies did anything illegal. But they did highlight ethical tensions and reputational pitfalls for international groups, which are moving drug testing to the developing world.

Bureaucracy, difficulties in patient recruitment and the resulting delays and costs, have led to a sharp rise in trials conducted at least partly outside western Europe and North America.

The emerging markets of eastern Europe, Latin America and parts of Asia offer large pools of patients who can be swiftly recruited into trials, and of increasingly well trained medical staff to run tests. They also represent increasingly important markets for medicines – if, in line with local regulators’ rules, the drugs are tested on local patients.

The European Medicines Agency (Emea), the EU’s drugs regulator, estimates that between 2005 and 2008 a quarter of patients in pivotal trials for new drugs for use in the EU that it studied were recruited in Latin America, Asia, Africa and the Commonwealth of Independent States.

Such “offshoring” of clinical trials is a concern for policymakers, highlighted this spring in a report commissioned for the European Parliament from two Dutch non-profit groups, Wemos and the Centre for Research on Multinational Corporations .

The study in India found that a trial for Laptinib, a breast cancer drug developed by GSK, recruited seriously ill patients who had not already received treatment. This took advantage of their vulnerable position, and could affect their ability to offer informed consent to take part, it said.

A trial for Risperidone, an acute mania treatment developed by J&J, and AstraZeneca’s Quetiapine for schizophrenia, ran the risk that patients could be harmed if they came off an existing treatment to try an experimental alternative or a placebo.

The companies say they respected regulations, gained approval from local ethical committees and conducted trials in line with their own global guidelines, applying identical procedures in poor and rich countries alike.

The study’s examples show complex and sometimes contradictory ethical rules around the world, often with no legal enforcement or universal acceptance by different bodies. One key issue is access. While patients recruited in India could continue a treatment after the end of the formal trial, free supplies eventually ended.

Aside from some limited company supported “patient assistance programmes”, it is unlikely that more than a very few could benefit from expensive new drugs in the absence of a widely accessible healthcare system.

In other words, while some of the risks of experimental medicines were assumed by patients in poor countries, the benefits largely accrued to those in richer ones.

Wemos points out that only 45 “good clinical practice” inspections by the Emea to verify ethics took place in 2008, and only 16 of these were outside Europe and the US – a tiny proportion of all drug trials.

More European organisations, such as Wemos, are calling for greater transparency in ethical compliance with trials, more authority for the Emea to scrutinise trials while they are under way, and more involvement from local organisations that may be in a good position to identify problems.

The emerging economies are a growing source of both efficiencies and of new markets for pharmaceutical companies. But to capture the full benefits, they must be ever more prepared to respond to the practical issues – such as patient recruitment and access to medicines – thrown up by ethical concerns.