Introduction
Influence can take many forms. When it comes to biomedical science policy in the US, the names of some people with clout are obvious, such as Harold Varmus (who serves as a top science advisor for Barack Obama) and Anthony Fauci (who heads the US National Institute of Allergy and Infectious Diseases, and has the ear of the current president). But beyond the Nobel laureates and university presidents there is another set of people who wield power. Some of these influential players, such as patient advocates or experts who churn out reports for think tanks, are well known within their own communities. Others, such as Senate staffers or policy makers at the US National Institutes of Health (NIH), operate under the radar. Here we present a handful of influential people who quietly help keep the wheels of biomedical science turning.
John Edward Porter
Chairman of the Board of Directors, Research!America Partner, Hogan & Hartson
Douglas Grahm
During his time as a Republican US congressman, John Porter served as chair of the subcommittee that holds the purse strings for the NIH budget and championed the doubling of this budget. He continues to advocate for biomedical research with the nonprofit group Research!America, and as a partner at the law firm of Hogan & Hartson he successfully lobbied for more than $100 million for a childhood antiobesity program at the Centers for Disease Control and Prevention (CDC). Porter also has helped revive funding for the National Children's Study, a program that tracks the health of 100,000 children from conception to age 21. He also helped a coalition of professional societies, led by the Biophysical Society, craft legislation that now requires the NIH to conduct research at the interface of the physical and life sciences to develop new experimental tools for biomedical research.
Bettilou Taylor
Minority Staff Director, Subcommittee on Labor, Health and Human Services, Education and Related Agencies, US Senate Committee on Appropriations
Taylor is so effective that her boss, Republican US Senator Arlen Specter, has called her the "101st senator." Backers of the NIH have been lucky in that the congressional staff involved in shaping the agency's budget are generally experienced and well versed in the intricacies of the agency. Taylor might be the queen bee of such endeavors, having worked on NIH issues during the 1990s and into the next decade, when the NIH budget increased with support from Specter, also known for his strong backing of stem cell research.
Tara O'Toole
Director, Center for Biosecurity at the University of Pittsburgh Medical Center
the Center for Biosecurity of UPM
When nobody else had heard of bird flu, Tara O'Toole could not stop talking about it. As the outspoken head of a prominent biosecurity think tank, she has advocated for increased spending to develop bird flu vaccines and pushed for cogent biodefense policies, says Jeffrey Levi, who serves as executive director of Trust for America's Health and has worked closely with O'Toole. "She tells you she is going to scare you, then she scares you, then she tells you what to do about it," says Levi, noting O'Toole's success in gaining support from Wall Street for policies addressing the threat of bird flu.
O'Toole helped launch the Alliance for Biosecurity, a coalition including the Center for Biosecurity and 13 pharmaceutical and biotechnology firms that aims to improve prevention and treatment of infectious diseases threatening global security.
"We are very big on coalition building, which is how you get things done in Washington," says O'Toole.
David Bowen
Majority Staff Director for Health, US Senate Committee on Health, Education, Labor, and Pensions
With a PhD in neurobiology from the University of San Francisco, California, Bowen "knows health policy backwards and forwards," according to Kevin Cain, who works on government affairs at the nonprofit National Health Council. While working under the committee chairman, US Senator Edward Kennedy, Bowen helped resolve last-minute differences between the House and Senate versions of a key NIH reauthorization bill in 2006, says Cain. The bill passed at the eleventh hour. Bowen also serves as a touchstone for stem cell legislation, say policy makers.
Janet Woodcock
Director, Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA)
Newscom
In her more than 20 years at the FDA, Janet Woodcock has served many roles, including leader of the FDA's Critical Path Initiative, which aims to modernize drug development through methods such as the use of biomarkers to evaluate drug effectiveness. This spring, she was appointed to head the CDER, which reviews new medications for safety and effectiveness. She has led the CDER as acting director since October 2007 and had served before as the center's director. As head of the heavily scrutinized CDER, Woodcock faces numerous challenges, including implementing a major law passed by Congress last year that will require new staff and changes such as increased oversight of drugs already on the market.
Keith Yamamoto
Chairman, Board on Life Sciences, National Academies
UCSF School of Medicine
For most scientists, running a high-profile lab at the University of California, San Francisco (UCSF) might be as much as they can handle. But Yamamoto, who also serves as executive vice dean at the UCSF School of Medicine, eagerly steps into the policy sphere. At the venerated National Academy of Sciences, he leads the effort to vet life sciences topics for academy reports—often the substrate for policy changes—and signs off on the final product. Yamamoto co-chaired an advisory committee to the NIH that recommended the first major overhaul of the agency's system of peer review (Nat. Med. 14, 351; 2008). He also finds time to work with the Coalition for Life Sciences, whose aims include educating members of Congress about basic science. "In our community, we say scientists ought to spend more time talking to legislators," says Patrick White, vice president for federal relations at the Association of American Universities. "Yamamoto is someone who does it."
Kathy Hudson
Director, Genetics and Public Policy Center of Johns Hopkins University
Genetics and Public Policy Center at Johns Hopkins University
"Kathy is a force in the ethical and policy issues associated with the era of genomic medicine," says Patrick White at the Association of American Universities. Hudson has worked for years for the passage of legislation outlawing discrimination by health insurers and employers on the basis of genetic information. The Genetic Information Nondiscrimination Act finally passed and became law in the US this past May. Her current work involves looking into the practices of companies offering genetic tests over the internet and developing recommendations for better government oversight of such tests. A molecular biologist by training, Hudson is also the former assistant director of the National Human Genome Research Institute.
David Beier
Senior Vice President, Global Government and Corporate Affairs, Amgen
David Beier leads the Washington, DC lobbying operation for Amgen, which spent more money than any other drug company on lobbying in 2007—$16.3 million, according to the Center for Responsive Politics. Amgen also locked in lucrative drug reimbursement rules at the US Centers for Medicare and Medicaid Services (CMS), which paid nearly $1 billion in reimbursements to the company in 2006 (Nat. Biotechnol. 25, 1193; 2007). In July 2007, CMS changed its policies to sharply curtail reimbursements after the FDA slapped a black box warning on Amgen's anemia drugs, following reports as early as 2003 that they worsened disease in individuals with cancer (Nat. Med. 9, 1439; 2003). However, more than 105 members of the US House of Representatives have signed onto a resolution to overturn the new, stricter CMS policy. Beier served a stint as chief domestic policy advisor to Vice President Al Gore; he also worked previously as a partner at Hogan & Hartson.
Greg Simon
President, FasterCures
FasterCures
Numerous patient groups scramble for recognition and funding in Washington, DC, but, since its founding in 2003, FasterCures has garnered attention for its unusual approach. Unlike most such groups, FasterCures does not focus on a disease—instead, it works on streamlining the entire research and drug development enterprise. "We are trying to fix the system for everyone," according to its president, Greg Simon. Like David Beier of Amgen, Simon served as former chief domestic policy advisor for Vice President Al Gore. He is known for bringing disparate groups together to find new ideas. His group, which does not accept funding from drug companies, has created a service to help philanthropists finance the research that interests them. More recently, Simon has provided input to the US Department of Health and Human Services on its burgeoning medical records program, urging the agency to create policies that keep the doors open for researchers, not just clinicians.
Norka Ruiz Bravo
NIH Deputy Director for Extramural Research
NIH
Bravo's hand helps guide much of the policy that affects the large extramural community at the NIH—and accounts for about 80% of its budget. As part of her work helping to hammer out conflict of interest policies, she has drawn attention to the burden the agency would face if it were to police detailed conflict of interest reports for extramural researchers.
"She has been able to foster a dialogue with the extramural community, fostering a consensus that we need to be able to work together on this issue," says Howard Garrison at the Federation of American Societies for Experimental Biology (FASEB). In collaboration with other people who guide NIH policy, such as Lana Skirboll, director for the Office of Science Policy, Bravo works on other issues, such as reforming the agency's system of grant peer review. She is also known for rapidly mobilizing the effort after Hurricane Katrina to find new workplaces for displaced researchers.
By Charlotte Schubert, Washington, DC
