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Science  26 Jun 2009:
Vol. 324, Issue 5935, pp. 1658-1659
DOI: 10.1126/science.324_1658

26 June 2009

Edited by Edward W. Lempinen

Science and Health

Personalized Medicine: Successes Tempered By Significant Challenges

Future diagnosis. Rapid screening of the genome has helped researchers identify clinically important biomarkers for a range of medical conditions.

Since the decoding of the human genome in 2000, researchers and clinicians have sought to translate the new wealth of genetic information into custom-tailored treatments for patients. But the practice of personalized medicine still faces significant scientific and policy challenges, experts said at a recent colloquium co-organized by the Food and Drug Law Institute and AAAS.

Even the most successful forays into individualized diagnoses have had mixed results, the speakers agreed. And issues of regulation, physician training, and insurance have clouded at least the immediate future of the field.

While promising molecular discoveries and new diagnostic tests proliferate, said Dietrich Stephan, president of the Ignite Institute for Individualized Health, there has been "very little oversight on what's real and what's not real" in the realm of personalized medicine.

Speakers paid particular attention to the quest for biomarkers—molecular signposts for disease or a patient's response to a drug that are gleaned from roughly 20,000-25,000 human genes. The approach offers a way to circumvent some of the false starts and lengthy searches common with the trial-and-error method of drug discovery.

The challenge, said Rick Hockett, chief medical officer for the biotechnology company Affymetrix, is to sift through "this vast ocean of stuff"—millions of small segments of DNA and huge numbers of proteins—for biomarkers connected to an actual medical condition.

It's a task, agreed Klaus Lindpaintner of Roche Molecular Medicine Laboratories, "about as difficult, or perhaps even more difficult, than finding a new drug."

There have been some promising early developments. A woman with breast cancer can now discover whether her tumor is overproducing a gene product called HER-2. If she tests positive for the biomarker, she is a good candidate for a drug called Herceptin that targets the excess HER-2 and cuts the risk of disease recurrence nearly in half.

Another biomarker test can tell whether a patient has a particular genetic combination of liver enzymes, known as cytochrome P450, that help metabolize more than half of all drugs. The test can be used to fine-tune drug dosage based on a person's metabolism rather than on cruder factors such as body weight.

Even when good diagnostic tests are available, many health care professionals can have difficulty interpreting the tests and explaining genetic risks to patients, said Joseph McInerney, executive director of the National Coalition for Health Professional Education in Genetics. He cited a 2007 U.S. and Canadian study which found that three-quarters of the 112 medical schools responding taught medical genetics in the first year of course work, usually with an emphasis on general concepts rather than practical clinical applications.

The regulatory picture for these tests is also complicated. Tests distributed by commercial manufacturers must be reviewed by the U.S. Food and Drug Administration before marketing, said Courtney C. Harper, head of the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety. But tests developed for use in a single lab—even those intended for personalized medicine—do not need to undergo FDA pre-market review.

As personalized medicine enters the mainstream, insurers will face decisions on whether to cover novel tests and procedures. Pamela Sankar, a medical ethicist at the University of Pennsylvania, noted that CIGNA decided late last year not to cover the cytochrome P450 test because the insurer considered it to be "experimental, investigational or unproven."

Louis B. Jacques, director of the division of items and devices at the U.S. Centers for Medicare & Medicaid Services, said the agency will be looking for clear evidence of clinical benefit as it decides on Medicare coverage for genetic tests. And if a test "is not ordered by a physician," he said, "we won't pay for it."

Despite these obstacles, many consumers have an interest in participating in personalized medicine, the experts agreed, and some are turning to commercial gene-testing companies to learn more about their propensity for particular diseases. States such as California have acted to halt unlicensed Internet sales of genetic tests to their residents.

Sankar cautioned against overly optimistic projections for personalized medicine. Some of the resources now devoted to personalized medicine research, she suggested, might be better spent on pressing national health issues such as infant mortality, AIDS, and obesity.

The colloquium "brought together diverse views on an important topic that merges science, ethics, and policy," said Mark S. Frankel, director of AAAS's Scientific Freedom, Responsibility and Law Program. "We wanted to provide the public with a balanced assessment of an emerging issue that will affect their lives."

International

Mapping the Frontiers of Science and Diplomacy

LONDON—With a growing corps of nations embracing science and technology as essential to future prosperity, influential research and policy leaders from around the world met here to explore the promise and potential obstacles of science diplomacy as a means for addressing challenges and easing tensions on a global scale.

A question of capacity. Mohamed Hassan, executive director of the Academy of Sciences for the Developing World, urged more opportunities for researchers from developed and developing nations to work together.

Hosted by the Royal Society and co-sponsored by AAAS, the two-day meeting offered S&T leaders a chance to explore the facets of science and diplomacy—ranging from science education and national security to research in the Islamic world and the environmental future of the Arctic. Speakers suggested the meetings would help create a foundation for future efforts in science diplomacy and research collaboration.

Even during the Napoleonic Wars of the 19th century, French and British scientists maintained working contacts, said Lorna Casselton, foreign secretary of the Royal Society. Today, she said, science remains a means of "rising above political and diplomatic affairs."

"The discussions in London made clear that science diplomacy is a tremendously timely concept," added Alan I. Leshner, chief executive officer of AAAS and executive publisher of Science. "So many of our great challenges have science and technology at their cores, and they cannot be solved by any one country working alone. And scientific collaboration allows non-governmental organizations to help build constructive relationships among peoples of the world, even when governmental ties are strained."

The London meeting, held 1-2 June, was evidence of a growing interest in employing science diplomacy more systematically. The meeting attracted nearly 200 speakers and participants from two dozen countries in Asia, the Middle East, Africa, South and North America, and Europe. Among the speakers were prominent researchers, NGO leaders, and top government science advisers.

The emerging sense of possibility for science diplomacy was underscored when U.S. President Barack Obama used his 4 June address in Cairo to announce science research and education initiatives with the Muslim world that will focus on health, technology, job creation, and additional scientific collaboration. Others say science diplomacy could be critical in the run-up to the December climate change conference in Copenhagen.

Journalists are interested, too: While in London, Leshner and Ehsan Masood, who has written extensively on science and Islam, were interviewed at length on BBC Radio 3's "Night Waves" program. Leshner also took part in a news briefing on the prospects for science diplomacy in the Arctic.

To be sure, many academic institutions, NGOs, and governmental bodies are already engaged in ongoing joint international projects. But speakers described the efforts as "fragmented" and "patchwork." And, some said, the needs are so great in fields suchas climate, food production, infectious disease, and science education that efforts must be undertaken now to build S&T relationships that link the developed world and the developing world.

Mohamed Hassan, executive director of the Academy of Sciences for the Developing World, said north-south partnerships shaped at centers of excellence such as Nairobi-based ICIPE—the International Center of Insect Physiology and Ecology—could produce both excellent research and increased research capacity in the developing world.

During the conference, several speakers expressed concern that the term "science diplomacy" could provide cover for manipulative political activity that undermines the integrity of research efforts. John Beddington, chief scientific adviser to the U.K. government, and Nina Fedoroff, science and technology adviser to U.S. Secretary of State Hillary Clinton, both warned against efforts to use science as a political tool in foreign relations.

But they and other speakers suggested that protocols and safeguards built into the scientific enterprise could help manage such risks.

Norman P. Neureiter, senior adviser to the AAAS Center for Science Diplomacy, acknowledged the need for semantic nuance. Diplomacy can imply government use of science for political purposes, he said. Soft power suggests that science could be used as a competitive tool, and science engagement, to some, connotes military action.

Neureiter's solution: "For now, I'm going to stick with science diplomacy: the employment of science for building better relationships throughout the world."

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