Pharmacogenetics overhyped?

UK body says full benefits are 15-20 years away, suggests incentives to spur drug development

By | September 26, 2005

The field of pharmacogenetics has been overhyped and is still more than a decade away from living up to its promise in clinical practice, largely due to shortages in researchers and lack of international coordination, according to a report from the Royal Society, the UK's national academy of science.

"When the human genome was sequenced, I think that--not unreasonably--the press and some of the scientists themselves gave the impression it was going to change medicine practically overnight," David Weatherall, chair of the working group that wrote the report, told The Scientist.

The Royal Society report notes that, in the UK, the development of personalized medicines is being hindered by a shortage of researchers in relevant disciplines. "It goes back to the teaching of pharmacology in medical schools," Weatherall said. "Clinical pharmacology has died off in recent years."

He and his colleagues also argue that there needs to be a better system for sharing genetic information across borders. "Variation in the laws for conducting genetic research between countries makes it difficult to combine data from across the globe into large-scale clinical trials," he said. This is an issue that could be dealt with by international organizations and the World Health Organization, Weatherall suggested.

Overall, the report, published last Wednesday (September 21), suggests that it will be another 15 to 20 years before the use of medicines tailored to individual genotypes is widespread. "Personalized medicines show promise but they have undoubtedly been overhyped," Weatherall said.

Ian Hall, from the University of Nottingham, disagreed, suggesting the impact of pharmacogenetics on clinical medicine would be felt more quickly. "I think that 10-15 years is too negative, to be honest with you," he told The Scientist. "We already do pharmacological tests…and I think there will be new tests in oncology at least over the next 5 years."

Hall, who gave evidence to the Royal Society working group, noted that there still are several steps that need to be taken to make pharmacogenetics a reality, including establishing the size of the evidence base needed to show efficacy, evaluating the cost-effectiveness, and educating the physicians who will be administering the treatment. Still, he predicted that pharmacogenetics will become more popular gradually. "The other driver here is the regulator—the EMEA and FDA," Hall said, referring to the European Agency for the Evaluation of Medicinal Products and the Food and Drug Administration. He noted the FDA had already taken baby steps towards pharmacogenetics, by indicating certain drugs should be used in select populations, such as specific ethnic groups.

The Royal Society's report points out that pharmacogenetics will result in the development of drugs with relatively small market sizes. "The age of the blockbuster drug…may be over if the application of pharmacogenetics reduces its target population," the report says. According to industry sources cited in the report, within 5 years some 10% of drugs in phase III development will come with an associated diagnostic test to determine who will benefit most from the drugs. This could rise to 20% within 10 years, the report says.

Considering this, the Royal Society authors recommend that governments and drug regulators offer financial incentives at the national and European level to encourage pharmaceutical companies to develop pharmacogenetic drugs with potentially small markets.

Richard Ley, spokesman for the Association of the British Pharmaceutical Industry, agreed that such incentives might be useful but added, "it's very early days, so it will depend on how it evolves. In fact, there could actually be cost savings for companies as well [from pharmacogenetics]," he told The Scientist. "It could mean a shortening of the research process, for example."

Finally, the report's authors call on the UK government to develop an ethical framework for industry and academic researchers who will be generating or using large databases of patient information. "The gathering and analysis of patient data introduces issues of how you store the information securely, who has access to it and how far it is anonymized," Weatherall said.

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