kent nickell
Well-known member
http://www.nytimes.com/2008/12/17/health/17FDA.html?_r=1&ref=us
F.D.A. Commissioner and Other Top Health Officials Plan to Step Down
By GARDINER HARRIS
December 16, 2008
WASHINGTON ? The Food and Drug Administration commissioner, Dr. Andrew C. von Eschenbach, said Tuesday that he would resign on Inauguration Day, Jan. 20, part of a parade of expected departures at the nation's crucial public health agencies.
Leaders of these agencies have sometimes straddled administrations, but the Obama administration is expected to make a clean sweep in part because of repeated assertions that the Bush administration allowed politics to play an unusually forceful role in science policy, and because each of the current leaders has fierce critics on Capitol Hill and in the public health community.
The Obama administration's choice for each slot will signal how it plans to deal with issues like stem cell policy and the safety of imported drugs and foods; how it might take advantage of advances in genomic research; its approach to pandemic flu planning; and whether huge investments in bioterrorism prevention will continue.
The incoming administration's vetting process at each agency has been unusually thorough, with transition officials speaking to current officials as well as a broad range of outside interest groups, according to people who have been through previous transitions.
Dr. Elias Zerhouni has already left his post as director of the National Institutes of Health. Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention, wrote in a November e-mail message to her staff that she expects to leave "after the administration changes." And Dr. John E. Niederhuber, director of the National Cancer Institute, is expected to surrender his leadership job, although he may remain at the institute.
Tommy Vietor, an Obama transition spokesman, declined to comment on any of these positions.
The most difficult of the transitions will be at the F.D.A.
Dr. Joshua Sharfstein, a pediatrician and health commissioner of Baltimore, is leading the Obama transition team for the agency and is widely considered a top contender for the commissioner's job. Dr. Sharfstein, 39, made national headlines last year when he petitioned the agency to ban some pediatric over-the-counter cough and cold medicines.
He was a staff member for Representative Henry A. Waxman, Democrat of California, the incoming chairman of the powerful House Energy and Commerce Committee. Dr. Sharfstein declined to comment Tuesday.
Also on the short list for F.D.A. commissioner, according to people with knowledge of the situation, is Dr. Steven E. Nissen, 60, chairman of cardiology at the Cleveland Clinic who has gained fame in recent years as a fierce critic of the safety of several big-selling medications.
"This is a failed agency," Dr. Nissen said in a recent interview, "and it has lost the public's confidence." He advocated greater transparency for the results of industry drug trials and said the process for approving medical devices needs an overhaul.
Dr. Robert M. Califf, a Duke University cardiologist and vice chancellor, and Dr. Alan Garber, director of the Center for Health Policy at Stanford University, are also being considered, according to people with knowledge of the situation. Neither could be reached.
If Dr. Sharfstein or Dr. Nissen is chosen, the selection is likely to signal the end of an era at the agency in which the speed of the drug approval process often took priority over the certainty of a drug's safety.
Drug makers and drug-safety advocates ? normally fierce opponents ? agree, along with powerful members of Congress, that the agency needs an overhaul.
"You really need some revolutionary changes at the F.D.A.," said Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America. Diana Zuckerman, president of the National Research Center for Women and Families, said, "The F.D.A. has increasingly lost its emphasis on public health, and all of us have been harmed as a result."
In a farewell note to his staff, Dr. von Eschenbach wrote that he would return to his family in Texas. "I have said it is hard to fall in love with the F.D.A. from outside the agency because so few can fully appreciate who you are and what you mean to this country, but it is impossible not to fall in love with the agency and its mission once you are inside," he wrote.
The Obama transition team for the National Institutes of Health includes Dr. Harold Varmus, a former director, and Dr. Francis Collins, former director of the genome institute at the agency. Dr. Varmus declined to comment, and Dr. Collins did not return phone messages.
Several people with knowledge of the situation said top candidates for the director of the health institutes include Dr. Collins as well as directors of other institutes, including Dr. Elizabeth G. Nabel of the National Heart, Lung and Blood Institute; Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases; and Dr. Griffin P. Rogers of the National Institute of Diabetes and Digestive and Kidney Diseases.
Dr. Fauci has twice declined the job of director of the health institutes and is said by those close to him to be unlikely to change his mind.
At the disease centers, Dr. Gerberding is said to be interested in keeping her job. But Dr. Jeffrey P. Koplan, who preceded Dr. Gerberding as director of the disease centers, is leading the Obama administration's C.D.C. transition team. Dr. Koplan has publicly criticized Dr. Gerberding's leadership.
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some excerpts from Are We Ready? Public Health Since 9/11 by David Rosner and Gerald Markowitz (2006)
Gene Matthews basically supported the view that smallpox had to be taken off the table, 'my view was that CDC could not afford to assume that this is not a real threat'. It is these kinds of low-risk, high-consequence issues that drive people in government crazy.
.... Maintaining confidence in health agencies becomes all the more important because Matthews and other federal officals consider an attack a question not of if but of when.
Jeffrey Koplan is a bit more specific in assessing the problems for public health infrastructure resulting from an increasing focus on bioterrorism: "We are a public health agency, not a part of the military. We had a culture where it was easy to have interchanges among scientists and we realized the need to reach out to the coummunity. The bioterrorism concerns were real but were at odds with the ways of public health's doing things. By its very nature bioterrorism has close ties to law enforcement and the military. Public health does not have close ties to these intstitutions but rather seeks ties to community groups."
F.D.A. Commissioner and Other Top Health Officials Plan to Step Down
By GARDINER HARRIS
December 16, 2008
WASHINGTON ? The Food and Drug Administration commissioner, Dr. Andrew C. von Eschenbach, said Tuesday that he would resign on Inauguration Day, Jan. 20, part of a parade of expected departures at the nation's crucial public health agencies.
Leaders of these agencies have sometimes straddled administrations, but the Obama administration is expected to make a clean sweep in part because of repeated assertions that the Bush administration allowed politics to play an unusually forceful role in science policy, and because each of the current leaders has fierce critics on Capitol Hill and in the public health community.
The Obama administration's choice for each slot will signal how it plans to deal with issues like stem cell policy and the safety of imported drugs and foods; how it might take advantage of advances in genomic research; its approach to pandemic flu planning; and whether huge investments in bioterrorism prevention will continue.
The incoming administration's vetting process at each agency has been unusually thorough, with transition officials speaking to current officials as well as a broad range of outside interest groups, according to people who have been through previous transitions.
Dr. Elias Zerhouni has already left his post as director of the National Institutes of Health. Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention, wrote in a November e-mail message to her staff that she expects to leave "after the administration changes." And Dr. John E. Niederhuber, director of the National Cancer Institute, is expected to surrender his leadership job, although he may remain at the institute.
Tommy Vietor, an Obama transition spokesman, declined to comment on any of these positions.
The most difficult of the transitions will be at the F.D.A.
Dr. Joshua Sharfstein, a pediatrician and health commissioner of Baltimore, is leading the Obama transition team for the agency and is widely considered a top contender for the commissioner's job. Dr. Sharfstein, 39, made national headlines last year when he petitioned the agency to ban some pediatric over-the-counter cough and cold medicines.
He was a staff member for Representative Henry A. Waxman, Democrat of California, the incoming chairman of the powerful House Energy and Commerce Committee. Dr. Sharfstein declined to comment Tuesday.
Also on the short list for F.D.A. commissioner, according to people with knowledge of the situation, is Dr. Steven E. Nissen, 60, chairman of cardiology at the Cleveland Clinic who has gained fame in recent years as a fierce critic of the safety of several big-selling medications.
"This is a failed agency," Dr. Nissen said in a recent interview, "and it has lost the public's confidence." He advocated greater transparency for the results of industry drug trials and said the process for approving medical devices needs an overhaul.
Dr. Robert M. Califf, a Duke University cardiologist and vice chancellor, and Dr. Alan Garber, director of the Center for Health Policy at Stanford University, are also being considered, according to people with knowledge of the situation. Neither could be reached.
If Dr. Sharfstein or Dr. Nissen is chosen, the selection is likely to signal the end of an era at the agency in which the speed of the drug approval process often took priority over the certainty of a drug's safety.
Drug makers and drug-safety advocates ? normally fierce opponents ? agree, along with powerful members of Congress, that the agency needs an overhaul.
"You really need some revolutionary changes at the F.D.A.," said Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America. Diana Zuckerman, president of the National Research Center for Women and Families, said, "The F.D.A. has increasingly lost its emphasis on public health, and all of us have been harmed as a result."
In a farewell note to his staff, Dr. von Eschenbach wrote that he would return to his family in Texas. "I have said it is hard to fall in love with the F.D.A. from outside the agency because so few can fully appreciate who you are and what you mean to this country, but it is impossible not to fall in love with the agency and its mission once you are inside," he wrote.
The Obama transition team for the National Institutes of Health includes Dr. Harold Varmus, a former director, and Dr. Francis Collins, former director of the genome institute at the agency. Dr. Varmus declined to comment, and Dr. Collins did not return phone messages.
Several people with knowledge of the situation said top candidates for the director of the health institutes include Dr. Collins as well as directors of other institutes, including Dr. Elizabeth G. Nabel of the National Heart, Lung and Blood Institute; Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases; and Dr. Griffin P. Rogers of the National Institute of Diabetes and Digestive and Kidney Diseases.
Dr. Fauci has twice declined the job of director of the health institutes and is said by those close to him to be unlikely to change his mind.
At the disease centers, Dr. Gerberding is said to be interested in keeping her job. But Dr. Jeffrey P. Koplan, who preceded Dr. Gerberding as director of the disease centers, is leading the Obama administration's C.D.C. transition team. Dr. Koplan has publicly criticized Dr. Gerberding's leadership.
----------------
some excerpts from Are We Ready? Public Health Since 9/11 by David Rosner and Gerald Markowitz (2006)
Gene Matthews basically supported the view that smallpox had to be taken off the table, 'my view was that CDC could not afford to assume that this is not a real threat'. It is these kinds of low-risk, high-consequence issues that drive people in government crazy.
.... Maintaining confidence in health agencies becomes all the more important because Matthews and other federal officals consider an attack a question not of if but of when.
Jeffrey Koplan is a bit more specific in assessing the problems for public health infrastructure resulting from an increasing focus on bioterrorism: "We are a public health agency, not a part of the military. We had a culture where it was easy to have interchanges among scientists and we realized the need to reach out to the coummunity. The bioterrorism concerns were real but were at odds with the ways of public health's doing things. By its very nature bioterrorism has close ties to law enforcement and the military. Public health does not have close ties to these intstitutions but rather seeks ties to community groups."