Alicia Ault

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, due out next year.

“It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

The next meetings of the panel are scheduled for July 20 and October 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, due out next year.

“It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

The next meetings of the panel are scheduled for July 20 and October 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, due out next year.

“It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

The next meetings of the panel are scheduled for July 20 and October 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee, convened at FDA's request, has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies. At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way but could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes in the past decade have made it more difficult to ensure safety, she added.

The United States is now often the first avenue for sales, and drug marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, bringing safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

The FDA is hamstrung by international agreements on how much premarket safety data can be requested, and the agency can't force drug makers to conduct postmarketing safety studies, she said.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers must report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals.

“We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, which is due next year.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

The next meetings of the IOM panel are scheduled for July 20 and Oct. 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee, convened at FDA's request, has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies. At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way but could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes in the past decade have made it more difficult to ensure safety, she added.

The United States is now often the first avenue for sales, and drug marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, bringing safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

The FDA is hamstrung by international agreements on how much premarket safety data can be requested, and the agency can't force drug makers to conduct postmarketing safety studies, she said.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers must report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals.

“We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, which is due next year.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

The next meetings of the IOM panel are scheduled for July 20 and Oct. 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee, convened at FDA's request, has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies. At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way but could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes in the past decade have made it more difficult to ensure safety, she added.

The United States is now often the first avenue for sales, and drug marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, bringing safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

The FDA is hamstrung by international agreements on how much premarket safety data can be requested, and the agency can't force drug makers to conduct postmarketing safety studies, she said.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers must report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals.

“We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, which is due next year.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

The next meetings of the IOM panel are scheduled for July 20 and Oct. 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each group had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, which is due out next year.

“It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

Overall, Dr. Woodcock told the panel, “one of the questions on the table really is how much uncertainty are we willing to tolerate because we will never have total certainty.” When FDA approves a drug for marketing, “that doesn't mean there are no risks, or that there are no risks to the individual patient,” she said, adding that patients and doctors together should weigh benefits and risks.

The next meetings of the panel are scheduled for July 20 and October 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each group had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, which is due out next year.

“It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

Overall, Dr. Woodcock told the panel, “one of the questions on the table really is how much uncertainty are we willing to tolerate because we will never have total certainty.” When FDA approves a drug for marketing, “that doesn't mean there are no risks, or that there are no risks to the individual patient,” she said, adding that patients and doctors together should weigh benefits and risks.

The next meetings of the panel are scheduled for July 20 and October 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each group had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, which is due out next year.

“It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

Overall, Dr. Woodcock told the panel, “one of the questions on the table really is how much uncertainty are we willing to tolerate because we will never have total certainty.” When FDA approves a drug for marketing, “that doesn't mean there are no risks, or that there are no risks to the individual patient,” she said, adding that patients and doctors together should weigh benefits and risks.

The next meetings of the panel are scheduled for July 20 and October 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system, is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, due out next year. “It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

Overall, Dr. Woodcock told the panel, “one of the questions on the table really is how much uncertainty are we willing to tolerate, because we will never have total certainty.” When FDA approves a drug for marketing, “that doesn't mean there are no risks, or that there are no risks to the individual patient,” she said, adding that patients and doctors together should weigh benefits and risks.

The next meetings of the panel are scheduled for July 20 and October 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system, is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, due out next year. “It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

Overall, Dr. Woodcock told the panel, “one of the questions on the table really is how much uncertainty are we willing to tolerate, because we will never have total certainty.” When FDA approves a drug for marketing, “that doesn't mean there are no risks, or that there are no risks to the individual patient,” she said, adding that patients and doctors together should weigh benefits and risks.

The next meetings of the panel are scheduled for July 20 and October 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system, is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, due out next year. “It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

Overall, Dr. Woodcock told the panel, “one of the questions on the table really is how much uncertainty are we willing to tolerate, because we will never have total certainty.” When FDA approves a drug for marketing, “that doesn't mean there are no risks, or that there are no risks to the individual patient,” she said, adding that patients and doctors together should weigh benefits and risks.

The next meetings of the panel are scheduled for July 20 and October 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, due out next year.

“It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

Overall, Dr. Woodcock told the panel, “one of the questions on the table really is how much uncertainty are we willing to tolerate because we will never have total certainty.” When FDA approves a drug for marketing, “that doesn't mean there are no risks, or that there are no risks to the individual patient,” she said, adding that patients and doctors together should weigh benefits and risks.

The next meetings of the panel are scheduled for July 20 and October 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, due out next year.

“It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

Overall, Dr. Woodcock told the panel, “one of the questions on the table really is how much uncertainty are we willing to tolerate because we will never have total certainty.” When FDA approves a drug for marketing, “that doesn't mean there are no risks, or that there are no risks to the individual patient,” she said, adding that patients and doctors together should weigh benefits and risks.

The next meetings of the panel are scheduled for July 20 and October 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, due out next year.

“It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

Overall, Dr. Woodcock told the panel, “one of the questions on the table really is how much uncertainty are we willing to tolerate because we will never have total certainty.” When FDA approves a drug for marketing, “that doesn't mean there are no risks, or that there are no risks to the individual patient,” she said, adding that patients and doctors together should weigh benefits and risks.

The next meetings of the panel are scheduled for July 20 and October 25.

WASHINGTON — Local anesthetic injected into the lumbar spine, either alone or with a steroid, may help patients avoid surgery for as long as 5 years, according to a study presented by K. Daniel Riew, M.D., and colleagues at the annual meeting of the American Academy of Orthopaedic Surgeons.

The study was a follow-up of a trial they published in the Journal of Bone and Joint Surgery in 2000, in which 55 candidates for surgery were randomly assigned instead to a selective nerve root injection of either bupivacaine alone or bupivacaine and betamethasone. Neither the physician nor the patient knew which was being injected.

At that time, 29 of the 55 patients avoided surgery. Dr. Riew, a professor of orthopedic surgery at Washington University in St. Louis, and his colleagues contacted these patients 5 years post injection, and 21 responded.

Of the 21 who responded, 9 patients had been injected with only the local anesthetic; of those patients, 8 had avoided surgery during the intervening years. Twelve of the patients who responded had received the anesthetic plus steroid, and 9 of those 12 had avoided surgery in the intervening years.

There was no significant difference in surgery avoidance between the patients who had the local anesthetic alone and those receiving the bupivacaine with betamethasone. Dr. Riew said the bupivacaine alone may have had a placebo effect. But, he added, the original nerve root irritation could have healed on its own.

Among the 21 responding patients, 14 had spinal stenosis and 7 had a herniated disc as the initial diagnosis. There seemed to be no difference in outcomes between the two groups.

All the patients had significant decreases in symptoms and back pain at 5-year follow-up. Dr. Riew recommended that patients with nerve root pain who are without significant neurologic symptoms be offered nerve root blocks before surgical intervention.

WASHINGTON — Local anesthetic injected into the lumbar spine, either alone or with a steroid, may help patients avoid surgery for as long as 5 years, according to a study presented by K. Daniel Riew, M.D., and colleagues at the annual meeting of the American Academy of Orthopaedic Surgeons.

The study was a follow-up of a trial they published in the Journal of Bone and Joint Surgery in 2000, in which 55 candidates for surgery were randomly assigned instead to a selective nerve root injection of either bupivacaine alone or bupivacaine and betamethasone. Neither the physician nor the patient knew which was being injected.

At that time, 29 of the 55 patients avoided surgery. Dr. Riew, a professor of orthopedic surgery at Washington University in St. Louis, and his colleagues contacted these patients 5 years post injection, and 21 responded.

Of the 21 who responded, 9 patients had been injected with only the local anesthetic; of those patients, 8 had avoided surgery during the intervening years. Twelve of the patients who responded had received the anesthetic plus steroid, and 9 of those 12 had avoided surgery in the intervening years.

There was no significant difference in surgery avoidance between the patients who had the local anesthetic alone and those receiving the bupivacaine with betamethasone. Dr. Riew said the bupivacaine alone may have had a placebo effect. But, he added, the original nerve root irritation could have healed on its own.

Among the 21 responding patients, 14 had spinal stenosis and 7 had a herniated disc as the initial diagnosis. There seemed to be no difference in outcomes between the two groups.

All the patients had significant decreases in symptoms and back pain at 5-year follow-up. Dr. Riew recommended that patients with nerve root pain who are without significant neurologic symptoms be offered nerve root blocks before surgical intervention.

WASHINGTON — Local anesthetic injected into the lumbar spine, either alone or with a steroid, may help patients avoid surgery for as long as 5 years, according to a study presented by K. Daniel Riew, M.D., and colleagues at the annual meeting of the American Academy of Orthopaedic Surgeons.

The study was a follow-up of a trial they published in the Journal of Bone and Joint Surgery in 2000, in which 55 candidates for surgery were randomly assigned instead to a selective nerve root injection of either bupivacaine alone or bupivacaine and betamethasone. Neither the physician nor the patient knew which was being injected.

At that time, 29 of the 55 patients avoided surgery. Dr. Riew, a professor of orthopedic surgery at Washington University in St. Louis, and his colleagues contacted these patients 5 years post injection, and 21 responded.

Of the 21 who responded, 9 patients had been injected with only the local anesthetic; of those patients, 8 had avoided surgery during the intervening years. Twelve of the patients who responded had received the anesthetic plus steroid, and 9 of those 12 had avoided surgery in the intervening years.

There was no significant difference in surgery avoidance between the patients who had the local anesthetic alone and those receiving the bupivacaine with betamethasone. Dr. Riew said the bupivacaine alone may have had a placebo effect. But, he added, the original nerve root irritation could have healed on its own.

Among the 21 responding patients, 14 had spinal stenosis and 7 had a herniated disc as the initial diagnosis. There seemed to be no difference in outcomes between the two groups.

All the patients had significant decreases in symptoms and back pain at 5-year follow-up. Dr. Riew recommended that patients with nerve root pain who are without significant neurologic symptoms be offered nerve root blocks before surgical intervention.

As many as one-fourth of patients in primary care settings could be engaging in hazardous or harmful drinking, and discerning that through careful screening—especially in trauma cases—can lead to better care and more accurate flagging of those who abuse alcohol.

According to a study published online, 17.6 million adults abuse alcohol or are alcohol dependent, and 85,000 deaths may be attributable to alcohol each year.

“With brief interventions, primary care clinicians can help 40% of them (compared with 20% in control groups) reduce their drinking to safe levels,” according to Andrea Canagasaby and Daniel C. Vinson, M.D., professor of family and community medicine at the University of Missouri-Columbia (Alcohol Alcohol. 2005;40:208–13).

In family practice or emergent care settings, physicians generally ask two screening questions: How often do you drink, and on those days, how much do you drink on average? But these have been shown to be somewhat inaccurate for identifying alcohol-use disorder, Dr. Vinson, lead author if the study, told FAMILY PRACTICE NEWS.

It's hard for people to say how much they drink on average when they might consume two drinks each weeknight but a six-pack on the weekend, he said. So physicians might miss some people who abuse alcohol by asking only about frequency and quantity.

Dr. Vinson found that asking, “When was the last time you had more than five drinks in 1 day [or four for a woman]?” flagged people who should be further queried.

The study comprised interviews with 1,537 patients presenting to the ED for an acute injury, 1,151 who came to the ED due to illness, and 1,112 persons randomly phoned in the community as controls.

They were first asked about tobacco use, and then about number of drinks consumed in a day. A yes to four or five drinks in the past 3 months was considered a positive screen. Those patients were then asked to review, day-by-day, their drinking behavior during the previous 28 days, and to answer questions about the quantity and frequency of alcohol use from the Diagnostic Interview Schedule (DIS).

Hazardous drinking was defined as drinking more than four drinks in 1 day or more than 14 in a week for men, and more than three in a day or seven in a week for women, according to National Institute on Alcohol Abuse and Alcoholism criteria.

The investigators calculated results by estimating the area under the receiver operating characteristic (ROC) curve with 95% confidence intervals. The area under the ROC curve is commonly used as a summary measure of diagnostic accuracy. They compared the ability to identify hazardous drinking or alcohol-use disorders for the three approaches: the single question developed by Dr. Vinson, the quantity-frequency responses to the DIS questions, and a question solely about average quantity consumed.

The ROC area for the quantity-frequency questions was slightly higher than for the single question devised by Dr. Vinson, which in turn was higher than the quantity question alone.

But, physicians in busy settings might not always have the time to go through the quantity-frequency questions, and these questions may not be sensitive enough to detect an alcohol-use disorder, Dr. Vinson told this newspaper. A threshold of three or more drinks per occasion has a sensitivity of 77%, but that declines when a threshold of four or more drinks is used. And the scores can be confusing: A quantity-frequency score of 6 could be derived from six drinks less than once a month, three drinks 1–3 days a month, or two drinks once or twice a week.

The single question could be used as a quicker, more efficient screen, although any of the approaches would be better than nothing, he said. One-third of all ED injuries are caused by people who have harmed themselves while drinking, and 10% of people seen in EDs have been harmed by others who were drinking, Dr. Vinson said in the interview.

Identification can lead to treatment and intervention, which inevitably are cost effective, he said. “We can reduce that person's risks for being reinjured just by talking to that person.”

Dr. Vinson's study was funded by the National Institute on Alcohol Abuse and Alcoholism.

As many as one-fourth of patients in primary care settings could be engaging in hazardous or harmful drinking, and discerning that through careful screening—especially in trauma cases—can lead to better care and more accurate flagging of those who abuse alcohol.

According to a study published online, 17.6 million adults abuse alcohol or are alcohol dependent, and 85,000 deaths may be attributable to alcohol each year.

“With brief interventions, primary care clinicians can help 40% of them (compared with 20% in control groups) reduce their drinking to safe levels,” according to Andrea Canagasaby and Daniel C. Vinson, M.D., professor of family and community medicine at the University of Missouri-Columbia (Alcohol Alcohol. 2005;40:208–13).

In family practice or emergent care settings, physicians generally ask two screening questions: How often do you drink, and on those days, how much do you drink on average? But these have been shown to be somewhat inaccurate for identifying alcohol-use disorder, Dr. Vinson, lead author if the study, told FAMILY PRACTICE NEWS.

It's hard for people to say how much they drink on average when they might consume two drinks each weeknight but a six-pack on the weekend, he said. So physicians might miss some people who abuse alcohol by asking only about frequency and quantity.

Dr. Vinson found that asking, “When was the last time you had more than five drinks in 1 day [or four for a woman]?” flagged people who should be further queried.

The study comprised interviews with 1,537 patients presenting to the ED for an acute injury, 1,151 who came to the ED due to illness, and 1,112 persons randomly phoned in the community as controls.

They were first asked about tobacco use, and then about number of drinks consumed in a day. A yes to four or five drinks in the past 3 months was considered a positive screen. Those patients were then asked to review, day-by-day, their drinking behavior during the previous 28 days, and to answer questions about the quantity and frequency of alcohol use from the Diagnostic Interview Schedule (DIS).

Hazardous drinking was defined as drinking more than four drinks in 1 day or more than 14 in a week for men, and more than three in a day or seven in a week for women, according to National Institute on Alcohol Abuse and Alcoholism criteria.

The investigators calculated results by estimating the area under the receiver operating characteristic (ROC) curve with 95% confidence intervals. The area under the ROC curve is commonly used as a summary measure of diagnostic accuracy. They compared the ability to identify hazardous drinking or alcohol-use disorders for the three approaches: the single question developed by Dr. Vinson, the quantity-frequency responses to the DIS questions, and a question solely about average quantity consumed.

The ROC area for the quantity-frequency questions was slightly higher than for the single question devised by Dr. Vinson, which in turn was higher than the quantity question alone.

But, physicians in busy settings might not always have the time to go through the quantity-frequency questions, and these questions may not be sensitive enough to detect an alcohol-use disorder, Dr. Vinson told this newspaper. A threshold of three or more drinks per occasion has a sensitivity of 77%, but that declines when a threshold of four or more drinks is used. And the scores can be confusing: A quantity-frequency score of 6 could be derived from six drinks less than once a month, three drinks 1–3 days a month, or two drinks once or twice a week.

The single question could be used as a quicker, more efficient screen, although any of the approaches would be better than nothing, he said. One-third of all ED injuries are caused by people who have harmed themselves while drinking, and 10% of people seen in EDs have been harmed by others who were drinking, Dr. Vinson said in the interview.

Identification can lead to treatment and intervention, which inevitably are cost effective, he said. “We can reduce that person's risks for being reinjured just by talking to that person.”

Dr. Vinson's study was funded by the National Institute on Alcohol Abuse and Alcoholism.

As many as one-fourth of patients in primary care settings could be engaging in hazardous or harmful drinking, and discerning that through careful screening—especially in trauma cases—can lead to better care and more accurate flagging of those who abuse alcohol.

According to a study published online, 17.6 million adults abuse alcohol or are alcohol dependent, and 85,000 deaths may be attributable to alcohol each year.

“With brief interventions, primary care clinicians can help 40% of them (compared with 20% in control groups) reduce their drinking to safe levels,” according to Andrea Canagasaby and Daniel C. Vinson, M.D., professor of family and community medicine at the University of Missouri-Columbia (Alcohol Alcohol. 2005;40:208–13).

In family practice or emergent care settings, physicians generally ask two screening questions: How often do you drink, and on those days, how much do you drink on average? But these have been shown to be somewhat inaccurate for identifying alcohol-use disorder, Dr. Vinson, lead author if the study, told FAMILY PRACTICE NEWS.

It's hard for people to say how much they drink on average when they might consume two drinks each weeknight but a six-pack on the weekend, he said. So physicians might miss some people who abuse alcohol by asking only about frequency and quantity.

Dr. Vinson found that asking, “When was the last time you had more than five drinks in 1 day [or four for a woman]?” flagged people who should be further queried.

The study comprised interviews with 1,537 patients presenting to the ED for an acute injury, 1,151 who came to the ED due to illness, and 1,112 persons randomly phoned in the community as controls.

They were first asked about tobacco use, and then about number of drinks consumed in a day. A yes to four or five drinks in the past 3 months was considered a positive screen. Those patients were then asked to review, day-by-day, their drinking behavior during the previous 28 days, and to answer questions about the quantity and frequency of alcohol use from the Diagnostic Interview Schedule (DIS).

Hazardous drinking was defined as drinking more than four drinks in 1 day or more than 14 in a week for men, and more than three in a day or seven in a week for women, according to National Institute on Alcohol Abuse and Alcoholism criteria.

The investigators calculated results by estimating the area under the receiver operating characteristic (ROC) curve with 95% confidence intervals. The area under the ROC curve is commonly used as a summary measure of diagnostic accuracy. They compared the ability to identify hazardous drinking or alcohol-use disorders for the three approaches: the single question developed by Dr. Vinson, the quantity-frequency responses to the DIS questions, and a question solely about average quantity consumed.

The ROC area for the quantity-frequency questions was slightly higher than for the single question devised by Dr. Vinson, which in turn was higher than the quantity question alone.

But, physicians in busy settings might not always have the time to go through the quantity-frequency questions, and these questions may not be sensitive enough to detect an alcohol-use disorder, Dr. Vinson told this newspaper. A threshold of three or more drinks per occasion has a sensitivity of 77%, but that declines when a threshold of four or more drinks is used. And the scores can be confusing: A quantity-frequency score of 6 could be derived from six drinks less than once a month, three drinks 1–3 days a month, or two drinks once or twice a week.

The single question could be used as a quicker, more efficient screen, although any of the approaches would be better than nothing, he said. One-third of all ED injuries are caused by people who have harmed themselves while drinking, and 10% of people seen in EDs have been harmed by others who were drinking, Dr. Vinson said in the interview.

Identification can lead to treatment and intervention, which inevitably are cost effective, he said. “We can reduce that person's risks for being reinjured just by talking to that person.”

Dr. Vinson's study was funded by the National Institute on Alcohol Abuse and Alcoholism.

Skin reactions to tumor necrosis factor-α-blocking drugs for rheumatoid arthritis might be more common and more varied than previous studies have indicated, results of a new prospective study show.

The study authors, from Radboud University Nijmegen (the Netherlands) Medical Centre, said theirs is the first large prospective study of skin conditions in rheumatoid arthritis (RA) patients taking TNF-α-blocking medications.

Overall, 25% of the 289 patients taking the biologics got a rash or infection, compared with 13% of the same number of control patients. The odds ratio for a patient taking the biologics to require a skin-care consultation was 2.26 (Arthritis Res. Ther. 2005;7:R666–76). The study was published online at BioMed Central's Web site on April 4.

There seemed to be no characteristic at baseline that predicted which patients might be susceptible to such rashes or infections, the authors said.

In the trial, 289 consecutive patients with RA who were started on TNF-α-blocking therapy—infliximab, etanercept, adalimumab, or the experimental agent lenercept—were compared with 289 patients from a cohort of 500 who have been followed at the medical center since 1985 but who had never taken a TNF-α-blocking agent.

Any patient who visited a dermatologist during the follow-up period was identified, and any new manifestation or exacerbation of a skin disease or any drug-related eruptions were recorded. The researchers also recorded diagnoses, topical and systemic therapeutic actions, outcome of the event, and any information on rechallenge.

Median follow-up time was 2.3 years. Among the patients taking anti-TNF therapy, 70 (24%) had received more than one agent, 8 (3%) had a history of taking more than two. Overall, 167 patients were given infliximab, 108 received adalimumab, 78 received etanercept, and 31 were treated with lenercept.

In total, there were 128 dermatologic events in the TNF group; 56 events occurred with adalimumab, 49 with infliximab, 16 with etanercept, and 13 with lenercept. Skin infections accounted for the largest proportion of these therapy-related events, with 33 fungal, bacterial, and viral infections recorded. TNF-α-blocking therapies are known to increase susceptibility to infections, and the study findings suggest that the immunosuppressive agents might also make patients more vulnerable to skin infections, said the authors.

Eczema was diagnosed 20 times in 19 patients, and 3 patients stopped therapy. One patient was hospitalized. The others were treated with topical corticosteroids.

There were frequent cases of drug-related eruptions in the first 5 months, in particular, said the authors. Most common was a combination of exanthema, urticarial eruptions, lichenoid skin lesions, and purpura. Of 15 patients diagnosed with an eruption, 7 stopped therapy, and 8 continued. One was hospitalized.

In smaller numbers, patients also experienced ulcers, benign and malignant skin tumors, vasculitis, actinic keratosis, edema, chronic venous insufficiency/varices, xerosis cutis, and stasis dermatitis.

The occurrence of psoriasiform eruptions in three patients was “particularly interesting,” given that etanercept is approved for psoriasis, and infliximab may soon get that approval, the researchers said.

The time between the start of therapy and onset of skin conditions varied, but some events looked more likely to be drug related, including the eruptions, cutaneous vasculitis, a case of systemic lupus erythematosus, dermatomyositis, and a lymphomatoid papulosis-like eruption.

Overall, 19 of the 72 patients who had skin problems stopped taking the TNF-α-blocking therapy, they said.

Skin reactions to tumor necrosis factor-α-blocking drugs for rheumatoid arthritis might be more common and more varied than previous studies have indicated, results of a new prospective study show.

The study authors, from Radboud University Nijmegen (the Netherlands) Medical Centre, said theirs is the first large prospective study of skin conditions in rheumatoid arthritis (RA) patients taking TNF-α-blocking medications.

Overall, 25% of the 289 patients taking the biologics got a rash or infection, compared with 13% of the same number of control patients. The odds ratio for a patient taking the biologics to require a skin-care consultation was 2.26 (Arthritis Res. Ther. 2005;7:R666–76). The study was published online at BioMed Central's Web site on April 4.

There seemed to be no characteristic at baseline that predicted which patients might be susceptible to such rashes or infections, the authors said.

In the trial, 289 consecutive patients with RA who were started on TNF-α-blocking therapy—infliximab, etanercept, adalimumab, or the experimental agent lenercept—were compared with 289 patients from a cohort of 500 who have been followed at the medical center since 1985 but who had never taken a TNF-α-blocking agent.

Any patient who visited a dermatologist during the follow-up period was identified, and any new manifestation or exacerbation of a skin disease or any drug-related eruptions were recorded. The researchers also recorded diagnoses, topical and systemic therapeutic actions, outcome of the event, and any information on rechallenge.

Median follow-up time was 2.3 years. Among the patients taking anti-TNF therapy, 70 (24%) had received more than one agent, 8 (3%) had a history of taking more than two. Overall, 167 patients were given infliximab, 108 received adalimumab, 78 received etanercept, and 31 were treated with lenercept.

In total, there were 128 dermatologic events in the TNF group; 56 events occurred with adalimumab, 49 with infliximab, 16 with etanercept, and 13 with lenercept. Skin infections accounted for the largest proportion of these therapy-related events, with 33 fungal, bacterial, and viral infections recorded. TNF-α-blocking therapies are known to increase susceptibility to infections, and the study findings suggest that the immunosuppressive agents might also make patients more vulnerable to skin infections, said the authors.

Eczema was diagnosed 20 times in 19 patients, and 3 patients stopped therapy. One patient was hospitalized. The others were treated with topical corticosteroids.

There were frequent cases of drug-related eruptions in the first 5 months, in particular, said the authors. Most common was a combination of exanthema, urticarial eruptions, lichenoid skin lesions, and purpura. Of 15 patients diagnosed with an eruption, 7 stopped therapy, and 8 continued. One was hospitalized.

In smaller numbers, patients also experienced ulcers, benign and malignant skin tumors, vasculitis, actinic keratosis, edema, chronic venous insufficiency/varices, xerosis cutis, and stasis dermatitis.

The occurrence of psoriasiform eruptions in three patients was “particularly interesting,” given that etanercept is approved for psoriasis, and infliximab may soon get that approval, the researchers said.

The time between the start of therapy and onset of skin conditions varied, but some events looked more likely to be drug related, including the eruptions, cutaneous vasculitis, a case of systemic lupus erythematosus, dermatomyositis, and a lymphomatoid papulosis-like eruption.

Overall, 19 of the 72 patients who had skin problems stopped taking the TNF-α-blocking therapy, they said.

Skin reactions to tumor necrosis factor-α-blocking drugs for rheumatoid arthritis might be more common and more varied than previous studies have indicated, results of a new prospective study show.

The study authors, from Radboud University Nijmegen (the Netherlands) Medical Centre, said theirs is the first large prospective study of skin conditions in rheumatoid arthritis (RA) patients taking TNF-α-blocking medications.

Overall, 25% of the 289 patients taking the biologics got a rash or infection, compared with 13% of the same number of control patients. The odds ratio for a patient taking the biologics to require a skin-care consultation was 2.26 (Arthritis Res. Ther. 2005;7:R666–76). The study was published online at BioMed Central's Web site on April 4.

There seemed to be no characteristic at baseline that predicted which patients might be susceptible to such rashes or infections, the authors said.

In the trial, 289 consecutive patients with RA who were started on TNF-α-blocking therapy—infliximab, etanercept, adalimumab, or the experimental agent lenercept—were compared with 289 patients from a cohort of 500 who have been followed at the medical center since 1985 but who had never taken a TNF-α-blocking agent.

Any patient who visited a dermatologist during the follow-up period was identified, and any new manifestation or exacerbation of a skin disease or any drug-related eruptions were recorded. The researchers also recorded diagnoses, topical and systemic therapeutic actions, outcome of the event, and any information on rechallenge.

Median follow-up time was 2.3 years. Among the patients taking anti-TNF therapy, 70 (24%) had received more than one agent, 8 (3%) had a history of taking more than two. Overall, 167 patients were given infliximab, 108 received adalimumab, 78 received etanercept, and 31 were treated with lenercept.

In total, there were 128 dermatologic events in the TNF group; 56 events occurred with adalimumab, 49 with infliximab, 16 with etanercept, and 13 with lenercept. Skin infections accounted for the largest proportion of these therapy-related events, with 33 fungal, bacterial, and viral infections recorded. TNF-α-blocking therapies are known to increase susceptibility to infections, and the study findings suggest that the immunosuppressive agents might also make patients more vulnerable to skin infections, said the authors.

Eczema was diagnosed 20 times in 19 patients, and 3 patients stopped therapy. One patient was hospitalized. The others were treated with topical corticosteroids.

There were frequent cases of drug-related eruptions in the first 5 months, in particular, said the authors. Most common was a combination of exanthema, urticarial eruptions, lichenoid skin lesions, and purpura. Of 15 patients diagnosed with an eruption, 7 stopped therapy, and 8 continued. One was hospitalized.

In smaller numbers, patients also experienced ulcers, benign and malignant skin tumors, vasculitis, actinic keratosis, edema, chronic venous insufficiency/varices, xerosis cutis, and stasis dermatitis.

The occurrence of psoriasiform eruptions in three patients was “particularly interesting,” given that etanercept is approved for psoriasis, and infliximab may soon get that approval, the researchers said.

The time between the start of therapy and onset of skin conditions varied, but some events looked more likely to be drug related, including the eruptions, cutaneous vasculitis, a case of systemic lupus erythematosus, dermatomyositis, and a lymphomatoid papulosis-like eruption.

Overall, 19 of the 72 patients who had skin problems stopped taking the TNF-α-blocking therapy, they said.

WASHINGTON — Merck's experimental RotaTeq vaccine was effective against moderate and severe rotavirus at the end of its shelf life, which appears to be 18 months, lead investigator Umesh Parashar, M.D., reported at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

A new vaccine is eagerly anticipated, because rotavirus causes 440,000 deaths and leads to 2.1 million inpatient visits in children under age 5 worldwide each year, said Dr. Parashar of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC). Rotavirus causes 5% of deaths in children under age 5 worldwide. In the United States, there are few deaths—only 20–60 per year—but there are 200,000–272,000 emergency department visits and 400,000 outpatient visits because of rotavirus annually.

Stan Block, M.D., a pediatrician in private practice in Bardstown, Ky., presented the RotaTeq data on behalf of trial sites in the United States and Finland.

RotaTeq is a pentavalent oral vaccine, aiming to provide protection against the G1, G2, G3, G4, and P1 strains.

From 2002 to 2004, 1,310 healthy infants aged 6–12 weeks were assigned to receive three doses of RotaTeq (at the end of shelf life) or placebo. The doses were given 4–10 weeks apart. Children with a gastrointestinal disorder, recent surgery, or acute fever or who had taken steroids within 2 weeks of the trial were excluded. RotaTeq could be given simultaneously with other vaccines, said Dr. Block.

Children were monitored for acute gastroenteritis through one rotavirus season.

There were 69 cases of rotavirus, for an overall efficacy of 72.5%. For severe acute gastroenteritis, the vaccine was 100% effective, and for both moderate and severe gastroenteritis, it was 76.3% effective, said Dr. Block.

The vaccine also appeared to be very safe. There were five potential cases of intussusception (all were in the placebo group), but all were negatively adjudicated by an independent safety monitoring board, Dr. Block said.

Children who received RotaTeq did have a statistically significant increase in temperature after the first dose, compared with placebo—13.4% of RotaTeq vaccinees, compared with 8.8% of placebo recipients. However, there was no increase in rates of fever after the second or third dose, he said. Only one child was documented to have a rotavirus vaccine strain a few days after the first dose of vaccine.

Merck is continuing a larger, 70,000-patient safety study. Preliminary results were presented at the CDC's Advisory Committee on Immunization Practices meeting in February, said Penny Heaton, director of clinical research at Merck.

So far, there have been 12 cases of intussusception in the RotaTeq group and 15 in the placebo group, she said.

WASHINGTON — Merck's experimental RotaTeq vaccine was effective against moderate and severe rotavirus at the end of its shelf life, which appears to be 18 months, lead investigator Umesh Parashar, M.D., reported at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

A new vaccine is eagerly anticipated, because rotavirus causes 440,000 deaths and leads to 2.1 million inpatient visits in children under age 5 worldwide each year, said Dr. Parashar of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC). Rotavirus causes 5% of deaths in children under age 5 worldwide. In the United States, there are few deaths—only 20–60 per year—but there are 200,000–272,000 emergency department visits and 400,000 outpatient visits because of rotavirus annually.

Stan Block, M.D., a pediatrician in private practice in Bardstown, Ky., presented the RotaTeq data on behalf of trial sites in the United States and Finland.

RotaTeq is a pentavalent oral vaccine, aiming to provide protection against the G1, G2, G3, G4, and P1 strains.

From 2002 to 2004, 1,310 healthy infants aged 6–12 weeks were assigned to receive three doses of RotaTeq (at the end of shelf life) or placebo. The doses were given 4–10 weeks apart. Children with a gastrointestinal disorder, recent surgery, or acute fever or who had taken steroids within 2 weeks of the trial were excluded. RotaTeq could be given simultaneously with other vaccines, said Dr. Block.

Children were monitored for acute gastroenteritis through one rotavirus season.

There were 69 cases of rotavirus, for an overall efficacy of 72.5%. For severe acute gastroenteritis, the vaccine was 100% effective, and for both moderate and severe gastroenteritis, it was 76.3% effective, said Dr. Block.

The vaccine also appeared to be very safe. There were five potential cases of intussusception (all were in the placebo group), but all were negatively adjudicated by an independent safety monitoring board, Dr. Block said.

Children who received RotaTeq did have a statistically significant increase in temperature after the first dose, compared with placebo—13.4% of RotaTeq vaccinees, compared with 8.8% of placebo recipients. However, there was no increase in rates of fever after the second or third dose, he said. Only one child was documented to have a rotavirus vaccine strain a few days after the first dose of vaccine.

Merck is continuing a larger, 70,000-patient safety study. Preliminary results were presented at the CDC's Advisory Committee on Immunization Practices meeting in February, said Penny Heaton, director of clinical research at Merck.

So far, there have been 12 cases of intussusception in the RotaTeq group and 15 in the placebo group, she said.

WASHINGTON — Merck's experimental RotaTeq vaccine was effective against moderate and severe rotavirus at the end of its shelf life, which appears to be 18 months, lead investigator Umesh Parashar, M.D., reported at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

A new vaccine is eagerly anticipated, because rotavirus causes 440,000 deaths and leads to 2.1 million inpatient visits in children under age 5 worldwide each year, said Dr. Parashar of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC). Rotavirus causes 5% of deaths in children under age 5 worldwide. In the United States, there are few deaths—only 20–60 per year—but there are 200,000–272,000 emergency department visits and 400,000 outpatient visits because of rotavirus annually.

Stan Block, M.D., a pediatrician in private practice in Bardstown, Ky., presented the RotaTeq data on behalf of trial sites in the United States and Finland.

RotaTeq is a pentavalent oral vaccine, aiming to provide protection against the G1, G2, G3, G4, and P1 strains.

From 2002 to 2004, 1,310 healthy infants aged 6–12 weeks were assigned to receive three doses of RotaTeq (at the end of shelf life) or placebo. The doses were given 4–10 weeks apart. Children with a gastrointestinal disorder, recent surgery, or acute fever or who had taken steroids within 2 weeks of the trial were excluded. RotaTeq could be given simultaneously with other vaccines, said Dr. Block.

Children were monitored for acute gastroenteritis through one rotavirus season.

There were 69 cases of rotavirus, for an overall efficacy of 72.5%. For severe acute gastroenteritis, the vaccine was 100% effective, and for both moderate and severe gastroenteritis, it was 76.3% effective, said Dr. Block.

The vaccine also appeared to be very safe. There were five potential cases of intussusception (all were in the placebo group), but all were negatively adjudicated by an independent safety monitoring board, Dr. Block said.

Children who received RotaTeq did have a statistically significant increase in temperature after the first dose, compared with placebo—13.4% of RotaTeq vaccinees, compared with 8.8% of placebo recipients. However, there was no increase in rates of fever after the second or third dose, he said. Only one child was documented to have a rotavirus vaccine strain a few days after the first dose of vaccine.

Merck is continuing a larger, 70,000-patient safety study. Preliminary results were presented at the CDC's Advisory Committee on Immunization Practices meeting in February, said Penny Heaton, director of clinical research at Merck.

So far, there have been 12 cases of intussusception in the RotaTeq group and 15 in the placebo group, she said.

Physicians frustrated with seemingly arbitrarily denied claims will have their day in court later this year with at least six insurers, thanks to a recent Supreme Court decision to deny the plans' appeal of a class action suit.

But settlements related to improper denials by Cigna and Aetna are likely to provide vindication even sooner.

The legal actions affect almost every practicing physician in the United States–about 900,000 doctors.

A series of suits, originally filed by several state and county medical societies, was consolidated in a U.S. District Court in Florida in 2000 and certified as a class action in 2002.

The filing named Aetna, Anthem, Cigna, Coventry, HealthNet, Humana, PacifiCare, Prudential, UnitedHealthcare, and WellPoint as defendants, and alleged that the plans violated the Racketeer Influenced and Corrupt Organizations Act (RICO) by engaging in fraud and extortion in a common scheme to wrongfully deny payment to doctors.

Aetna and Cigna broke off and entered into negotiations, an enormous process involving more than 100 attorneys, 19 state and county medical societies, the American Medical Association, and the plans' CEOs.

The two insurers settled in 2003, but the other parties have vowed to continue to fight, and are scheduled for trial in September in the Florida courtroom of Judge Federico Moreno. Another suit, with 60 Blue Cross and Blue Shield plans as defendants, is also before Judge Moreno.

Still, those other insurers could possibly follow in Aetna and Cigna's footsteps.

The Aetna claims deadline has passed, and physicians had until Feb. 18 to make a claim against Cigna, with two options for recouping losses. One was to make a general claim on Cigna's $30 million settlement pot, which will be divided equally among all who make such a claim. Or, physicians could reconstruct claims and seek repayment according to either a general amount per CPT code or a more specific amount based on a complete medical record.

Physicians who did not meet that deadline will still reap the benefits of the settlement, according to David McKenzie, reimbursement director at the American College of Emergency Physicians, who explained the various options to physicians at a recent ACEP meeting in Orlando, Fla.

Aetna agreed to set aside $300 million for prospective relief, and Cigna agreed to a $400 million figure. These amounts represent what is likely to be paid to physicians now that the two insurers have also agreed to a number of changes in business practices.

For instance, both will pay for vaccines and their administration. And the insurers will no longer automatically downcode evaluation and management codes, and will separately identify and pay modifier −25, which allows physicians to bill for evaluation and management service on the same day as a procedure.

Other coding and editing changes will also lead to future income for physicians.

Both insurers agreed to disclose physician fee schedules and to change the schedules only once a year. Aetna's schedules were posted on a Web site, and Cigna agreed initially to post schedules via e-mail.

Both also said they would make a preadjudication tool available so physicians could determine in advance what they might be paid for a claim.

Clean claims have to be paid within 15 days, whether submitted electronically or on paper. Aetna agreed to pay interest at the lesser rate of prime or 8%, and Cigna agreed to 6%.

A dispute resolution process was established to ensure that Cigna and Aetna are complying with the settlement agreements–in fact, three external independent review boards are monitoring the situation.

Another result of the settlement: Cigna and Aetna agreed to endow two nonprofit foundations devoted to improving medical practice.

The year-old foundations are currently seeking grant proposals.

Aetna put $20 million into the Physicians' Foundation for Health Systems Excellence, and Cigna contributed $15 million to the Physicians' Foundation for Health Systems Innovations.

For more on the foundations, go to www.physiciansfoundation.org

Physicians frustrated with seemingly arbitrarily denied claims will have their day in court later this year with at least six insurers, thanks to a recent Supreme Court decision to deny the plans' appeal of a class action suit.

But settlements related to improper denials by Cigna and Aetna are likely to provide vindication even sooner.

The legal actions affect almost every practicing physician in the United States–about 900,000 doctors.

A series of suits, originally filed by several state and county medical societies, was consolidated in a U.S. District Court in Florida in 2000 and certified as a class action in 2002.

The filing named Aetna, Anthem, Cigna, Coventry, HealthNet, Humana, PacifiCare, Prudential, UnitedHealthcare, and WellPoint as defendants, and alleged that the plans violated the Racketeer Influenced and Corrupt Organizations Act (RICO) by engaging in fraud and extortion in a common scheme to wrongfully deny payment to doctors.

Aetna and Cigna broke off and entered into negotiations, an enormous process involving more than 100 attorneys, 19 state and county medical societies, the American Medical Association, and the plans' CEOs.

The two insurers settled in 2003, but the other parties have vowed to continue to fight, and are scheduled for trial in September in the Florida courtroom of Judge Federico Moreno. Another suit, with 60 Blue Cross and Blue Shield plans as defendants, is also before Judge Moreno.

Still, those other insurers could possibly follow in Aetna and Cigna's footsteps.

The Aetna claims deadline has passed, and physicians had until Feb. 18 to make a claim against Cigna, with two options for recouping losses. One was to make a general claim on Cigna's $30 million settlement pot, which will be divided equally among all who make such a claim. Or, physicians could reconstruct claims and seek repayment according to either a general amount per CPT code or a more specific amount based on a complete medical record.

Physicians who did not meet that deadline will still reap the benefits of the settlement, according to David McKenzie, reimbursement director at the American College of Emergency Physicians, who explained the various options to physicians at a recent ACEP meeting in Orlando, Fla.

Aetna agreed to set aside $300 million for prospective relief, and Cigna agreed to a $400 million figure. These amounts represent what is likely to be paid to physicians now that the two insurers have also agreed to a number of changes in business practices.

For instance, both will pay for vaccines and their administration. And the insurers will no longer automatically downcode evaluation and management codes, and will separately identify and pay modifier −25, which allows physicians to bill for evaluation and management service on the same day as a procedure.

Other coding and editing changes will also lead to future income for physicians.

Both insurers agreed to disclose physician fee schedules and to change the schedules only once a year. Aetna's schedules were posted on a Web site, and Cigna agreed initially to post schedules via e-mail.

Both also said they would make a preadjudication tool available so physicians could determine in advance what they might be paid for a claim.

Clean claims have to be paid within 15 days, whether submitted electronically or on paper. Aetna agreed to pay interest at the lesser rate of prime or 8%, and Cigna agreed to 6%.

A dispute resolution process was established to ensure that Cigna and Aetna are complying with the settlement agreements–in fact, three external independent review boards are monitoring the situation.

Another result of the settlement: Cigna and Aetna agreed to endow two nonprofit foundations devoted to improving medical practice.

The year-old foundations are currently seeking grant proposals.

Aetna put $20 million into the Physicians' Foundation for Health Systems Excellence, and Cigna contributed $15 million to the Physicians' Foundation for Health Systems Innovations.

For more on the foundations, go to www.physiciansfoundation.org

Physicians frustrated with seemingly arbitrarily denied claims will have their day in court later this year with at least six insurers, thanks to a recent Supreme Court decision to deny the plans' appeal of a class action suit.

But settlements related to improper denials by Cigna and Aetna are likely to provide vindication even sooner.

The legal actions affect almost every practicing physician in the United States–about 900,000 doctors.

A series of suits, originally filed by several state and county medical societies, was consolidated in a U.S. District Court in Florida in 2000 and certified as a class action in 2002.

The filing named Aetna, Anthem, Cigna, Coventry, HealthNet, Humana, PacifiCare, Prudential, UnitedHealthcare, and WellPoint as defendants, and alleged that the plans violated the Racketeer Influenced and Corrupt Organizations Act (RICO) by engaging in fraud and extortion in a common scheme to wrongfully deny payment to doctors.

Aetna and Cigna broke off and entered into negotiations, an enormous process involving more than 100 attorneys, 19 state and county medical societies, the American Medical Association, and the plans' CEOs.

The two insurers settled in 2003, but the other parties have vowed to continue to fight, and are scheduled for trial in September in the Florida courtroom of Judge Federico Moreno. Another suit, with 60 Blue Cross and Blue Shield plans as defendants, is also before Judge Moreno.

Still, those other insurers could possibly follow in Aetna and Cigna's footsteps.

The Aetna claims deadline has passed, and physicians had until Feb. 18 to make a claim against Cigna, with two options for recouping losses. One was to make a general claim on Cigna's $30 million settlement pot, which will be divided equally among all who make such a claim. Or, physicians could reconstruct claims and seek repayment according to either a general amount per CPT code or a more specific amount based on a complete medical record.

Physicians who did not meet that deadline will still reap the benefits of the settlement, according to David McKenzie, reimbursement director at the American College of Emergency Physicians, who explained the various options to physicians at a recent ACEP meeting in Orlando, Fla.

Aetna agreed to set aside $300 million for prospective relief, and Cigna agreed to a $400 million figure. These amounts represent what is likely to be paid to physicians now that the two insurers have also agreed to a number of changes in business practices.

For instance, both will pay for vaccines and their administration. And the insurers will no longer automatically downcode evaluation and management codes, and will separately identify and pay modifier −25, which allows physicians to bill for evaluation and management service on the same day as a procedure.

Other coding and editing changes will also lead to future income for physicians.

Both insurers agreed to disclose physician fee schedules and to change the schedules only once a year. Aetna's schedules were posted on a Web site, and Cigna agreed initially to post schedules via e-mail.

Both also said they would make a preadjudication tool available so physicians could determine in advance what they might be paid for a claim.

Clean claims have to be paid within 15 days, whether submitted electronically or on paper. Aetna agreed to pay interest at the lesser rate of prime or 8%, and Cigna agreed to 6%.

A dispute resolution process was established to ensure that Cigna and Aetna are complying with the settlement agreements–in fact, three external independent review boards are monitoring the situation.

Another result of the settlement: Cigna and Aetna agreed to endow two nonprofit foundations devoted to improving medical practice.

The year-old foundations are currently seeking grant proposals.

Aetna put $20 million into the Physicians' Foundation for Health Systems Excellence, and Cigna contributed $15 million to the Physicians' Foundation for Health Systems Innovations.

For more on the foundations, go to www.physiciansfoundation.org