How well do physicians understand pharmacogenomics? And what is the likelihood that physicians will use these technologies in their clinical practice?
A small team of researchers in the United Kingdom will soon set out to learn the answers to these questions. The current state of pharmacogenomics education at medical schools in the United States and Europe, and thus the use of pharmacogenomics technologies among physicians, means the team will have its work cut out for it.
“My concern is that there is a significant lack of knowledge in the physician community in [pharmacogenomics],” Gary Peltz, head of genetics and genomics at Roche Bioscience, said recently, echoing drug makers’ and tool vendors’ concerns that their innovations may rot on the vine. “My impression is that it’s not a large part of the medical curriculum.” [see 5/9/03 SNPtech Reporter]
Graham Lewis, a researcher from the sciences and technology unit at the University of York, hopes to find out why big pharma types like Peltz feel this way — and what can be done to turn the tide. “What we’re interested in is the pathways between the laboratories and the clinic. This pathway is not straightforward … [but] it does seem to be at a turning point right now.”
Beginning in January, the researchers will embark on a 30-month, £150,000 (approximately $177,000) study to look at how these technologies are used in oncology, cardiovascular disease, psychiatric disease, and asthma. “These areas are exemplars, where the development of pharmacogenomics is active and also will bring particular benefits.”
Though the researchers must still flesh out the details of their project, they plan to examine not only what kinds of technologies physicians may use — from genotyping platforms to analyte-specific reagents and existing in vitro diagnostics — to the regulatory and reimbursement issues that await them. “Obviously, there’s a whole range of issues here,” said Lewis.
One issue in particular that is causing some anxiety among drug and diagnostic makers is the notion that very few physicians know enough to prescribe even the handful of pharmacogenomics-based procedures, such as ASRs and IVDs, available to them today. “There’s a number of pharmacogenomics tests already available; these are not used that much,” said Lewis. “There’s a number of issues around physician acceptance” of these tests, he said. “’Why don’t clinicians use the pharmacogenomic tests that are available at present? What factors and influences allow you to use them in the future as more become available?’” One aim of Lewis’ study is to answer these questions.
The project follows research the group conducted that studied the clinical and commercial development of pharmacogenomics. “One of the findings that became clear to us [during this trial] is this whole area about what it would take to … incorporate these technologies into health-delivery systems, which means into the clinic.”
The study also comes on the heels of two regulatory watersheds in the United States and in Europe: The US Food and Drug Administration earlier this month issued its much-awaited draft guidance on the use and submission of pharmacogenomics data in pre-clinical and clinical trials [see 11/6/03 SNPtech Reporter]; and Britain’s Department of Health in June issued a white paper outlining the role of genetics in health-services delivery, which many in industry viewed as an important step in helping define the government’s take on pharmacogenomics [view the white paper here: http://www.doh.gov.uk/genetics/whitepaper.htm].
Lewis said he has also noticed a “general expansion of knowledge about [pharmacogenomics],” and the number of industry-based clinical trials underway. But regulatory green lights and private-sector investment may not be enough by themselves: Consumers — in this case, physicians — must also be up to speed for the discipline to take off.
Not all the news is bad on the ignorant-physician front, however. In fact, not all medical schools, and thus not all medical doctors, are in the dark about pharmacogenomics. The University of California system, for example, has been aggressively incorporating pharmacogenomics into its medical school and pharmacy school curricula.
At UC San Diego, for instance, school administrators are betting nearly $8 million in state and matching federal funds that students from their medical school and nascent pharmacy school will not only need to learn about SNPs, haplotypes, and gene expression, and how they relate to phenotypes, but that they will ultimately need to use this knowledge together as caregivers [see 10/30/03 SNPtech Reporter].
An hour to the north, at UCLA, officials have created a pharmacogenomics research group to study genetic components linked to disorders affecting Mexican-Americans. There, the program recently received a modest NIH grant to study the pharmacogenetics of depression in this population.
More recently, UC San Francisco established a program to build knowledge of pharmacogenomics among in its pharmacy school students. Though the program itself remains modest — it currently supports 45 students — it has caught the attention of at least two big pharmaceutical companies eager for more pharmacogenomics-literate graduates to enter the workforce.
The medical school of the University of Vermont, not known for genomics, has also retooled its curriculum from the ground up recently and now offers a genetics track that runs through all four years of its MD program. (It doesn’t hurt that Alan Guttmacher, deputy director of the National Human Genome Research Institute, was the school’s director for genetics for a time.)
For his part, Lewis said he intends to speak with tool vendors, such as Illumina and Affymetrix, and pharmacogenomics-technology consumers like Roche Diagnostics and GlaxoSmithKline. “We already have some contact with industry, but obviously we’ll be building those contacts,” he said. Lewis said that topics for discussion with private-sector players are still evolving.
At a later date, he said, his group may develop solutions — “policy prescriptions” — once the original study is over. The Economic and Social Research Council, a UK-based non-governmental organization that is the main funding body in Britain for economic and social research, will pay for Lewis’ research. Most of the ESRC’s £78-million annual budget is funded through the British government’s Office of Science and Technology, according to the group’s web site. Lewis’ study, which is one of three genomics-related research projects, is funded by the ESRC’s Science in Society program [view the ESRC web site here: http://sbs-xnet.sbs.ox.ac. uk/scisoc/].
“This is a great interest to us, and it is something that needs to receive greater publicity,” said Jay Flatley, CEO of Illumina. “I think what [Lewis will] find is, in general, physicians know little today — if anything — about pharmacogenetics or pharmacogenomics and how to apply it.”
“The reason for this is that genomics tests have not been available very long, and anybody who has been a practicing physician would have graduated from school long before any of those tests were available, or before any of the [existing] pharmacogenomics capabilities existed,” he said.
Flatley said Illumina and Lewis have no formal relationship, but he is willing to participate in the study.