Joel B. Finkelstein

WASHINGTON — The failure to address low physician pay and looming reimbursement cuts in the Medicare program is starting to affect beneficiaries, members of Medicare's Practicing Physicians Advisory Council said at their recent meeting.

PPAC member Dr. Vincent J. Bufalino, a cardiologist from Naperville, Ill., offered an example to the council. “We have in our community the beginnings of physicians walking away from Medicare. Four of the busiest internists in town have said 'No' and ripped up their [Medicare] agreement,” Dr. Bufalino said.

Although the Centers for Medicare and Medicaid Services tracks physician participation, such trends might not reveal the whole picture, he added. Half of the physicians in Dr. Bufalino's community are no longer accepting new Medicare patients, he said. Although the CMS still counts them as participating in the program, the trend is having a profound effect on beneficiaries' access to physician services.

“We don't think that participation rates, assignment rates, really reflect what is going on,” Dr. Bufalino told CMS Deputy Administrator Leslie Norwalk.

The CMS has to rely on the numbers gathered by physician groups, she responded. “I suspect that the best way to go about this is probably at the state level where you would ask your state medical society to survey members and let us know what it is that you see. … It may help inform the debate,” Ms. Norwalk said, noting that federal officials are legally barred from telling people to lobby Congress.

Lawmakers will have to be the ones to make changes to the current mechanism for updating physician payments. Based on the sustained growth rate (SGR) formula, mandated by the Balanced Budget Act of 1997, physicians are currently slated for a 5.1% cut in reimbursement starting Jan. 1. In past years, Congress has averted cuts or given doctors a small raise.

PPAC members urged CMS officials to use what influence they have to encourage lawmakers to do so again based on the recommendation from the Medicare Payment Advisory Commisssion that physician pay be increased by 2.8% in 2007.

“If you look at the data from 2001 to 2007, physicians' costs are up 18%, yet Medicare payments are down 5%. … Only physicians are subject to arbitrary spending cuts. Hospitals have had a 3.7% update; nursing homes, a 3.1%; [and] Medicare Advantage now gets 111% of the fee-for-service rate and is slated for another 4.8% increase,” said PPAC member Dr. M. LeRoy Sprang, an ob.gyn. from Evanston, Ill.

But government estimates show that giving physicians a Medicare pay raise of 2%–3% over the next 5 years would carry a $58 billion price tag. Dr. Mark McClellan, the CMS administrator, has testified to Congress that any action taken to improve physician pay should be accompanied by provisions that allow the agency to better control how it spends the money through strategies such as pay for performance.

“The more we can identify steps that lead to reductions in overall costs of care as a result of quality improvements, the easier it is to support a more stable system of payment rates,” said Dr. McClellan, who has since resigned his post, at the meeting.

Physicians don't object to the agency's push for pay for performance, but you can't expect to purchase quality on the cheap, said PPAC member Dr. Geraldine O'Shea, an internist from Jackson, Calif.

“We understand the cost is the bottom line, but as we're moving toward this, we want to make sure it stays in the forefront [and] that health outcomes of our patients are still our No. 1 concern,” she said.

PPAC members asked CMS officials to keep in mind that physicians who improve quality and lower costs should also be credited for savings that may show up as reduced hospital spending due to preventive screening or disease management services provided in doctors' offices.

WASHINGTON — The failure to address low physician pay and looming reimbursement cuts in the Medicare program is starting to affect beneficiaries, members of Medicare's Practicing Physicians Advisory Council said at their recent meeting.

PPAC member Dr. Vincent J. Bufalino, a cardiologist from Naperville, Ill., offered an example to the council. “We have in our community the beginnings of physicians walking away from Medicare. Four of the busiest internists in town have said 'No' and ripped up their [Medicare] agreement,” Dr. Bufalino said.

Although the Centers for Medicare and Medicaid Services tracks physician participation, such trends might not reveal the whole picture, he added. Half of the physicians in Dr. Bufalino's community are no longer accepting new Medicare patients, he said. Although the CMS still counts them as participating in the program, the trend is having a profound effect on beneficiaries' access to physician services.

“We don't think that participation rates, assignment rates, really reflect what is going on,” Dr. Bufalino told CMS Deputy Administrator Leslie Norwalk.

The CMS has to rely on the numbers gathered by physician groups, she responded. “I suspect that the best way to go about this is probably at the state level where you would ask your state medical society to survey members and let us know what it is that you see. … It may help inform the debate,” Ms. Norwalk said, noting that federal officials are legally barred from telling people to lobby Congress.

Lawmakers will have to be the ones to make changes to the current mechanism for updating physician payments. Based on the sustained growth rate (SGR) formula, mandated by the Balanced Budget Act of 1997, physicians are currently slated for a 5.1% cut in reimbursement starting Jan. 1. In past years, Congress has averted cuts or given doctors a small raise.

PPAC members urged CMS officials to use what influence they have to encourage lawmakers to do so again based on the recommendation from the Medicare Payment Advisory Commisssion that physician pay be increased by 2.8% in 2007.

“If you look at the data from 2001 to 2007, physicians' costs are up 18%, yet Medicare payments are down 5%. … Only physicians are subject to arbitrary spending cuts. Hospitals have had a 3.7% update; nursing homes, a 3.1%; [and] Medicare Advantage now gets 111% of the fee-for-service rate and is slated for another 4.8% increase,” said PPAC member Dr. M. LeRoy Sprang, an ob.gyn. from Evanston, Ill.

But government estimates show that giving physicians a Medicare pay raise of 2%–3% over the next 5 years would carry a $58 billion price tag. Dr. Mark McClellan, the CMS administrator, has testified to Congress that any action taken to improve physician pay should be accompanied by provisions that allow the agency to better control how it spends the money through strategies such as pay for performance.

“The more we can identify steps that lead to reductions in overall costs of care as a result of quality improvements, the easier it is to support a more stable system of payment rates,” said Dr. McClellan, who has since resigned his post, at the meeting.

Physicians don't object to the agency's push for pay for performance, but you can't expect to purchase quality on the cheap, said PPAC member Dr. Geraldine O'Shea, an internist from Jackson, Calif.

“We understand the cost is the bottom line, but as we're moving toward this, we want to make sure it stays in the forefront [and] that health outcomes of our patients are still our No. 1 concern,” she said.

PPAC members asked CMS officials to keep in mind that physicians who improve quality and lower costs should also be credited for savings that may show up as reduced hospital spending due to preventive screening or disease management services provided in doctors' offices.

WASHINGTON — The failure to address low physician pay and looming reimbursement cuts in the Medicare program is starting to affect beneficiaries, members of Medicare's Practicing Physicians Advisory Council said at their recent meeting.

PPAC member Dr. Vincent J. Bufalino, a cardiologist from Naperville, Ill., offered an example to the council. “We have in our community the beginnings of physicians walking away from Medicare. Four of the busiest internists in town have said 'No' and ripped up their [Medicare] agreement,” Dr. Bufalino said.

Although the Centers for Medicare and Medicaid Services tracks physician participation, such trends might not reveal the whole picture, he added. Half of the physicians in Dr. Bufalino's community are no longer accepting new Medicare patients, he said. Although the CMS still counts them as participating in the program, the trend is having a profound effect on beneficiaries' access to physician services.

“We don't think that participation rates, assignment rates, really reflect what is going on,” Dr. Bufalino told CMS Deputy Administrator Leslie Norwalk.

The CMS has to rely on the numbers gathered by physician groups, she responded. “I suspect that the best way to go about this is probably at the state level where you would ask your state medical society to survey members and let us know what it is that you see. … It may help inform the debate,” Ms. Norwalk said, noting that federal officials are legally barred from telling people to lobby Congress.

Lawmakers will have to be the ones to make changes to the current mechanism for updating physician payments. Based on the sustained growth rate (SGR) formula, mandated by the Balanced Budget Act of 1997, physicians are currently slated for a 5.1% cut in reimbursement starting Jan. 1. In past years, Congress has averted cuts or given doctors a small raise.

PPAC members urged CMS officials to use what influence they have to encourage lawmakers to do so again based on the recommendation from the Medicare Payment Advisory Commisssion that physician pay be increased by 2.8% in 2007.

“If you look at the data from 2001 to 2007, physicians' costs are up 18%, yet Medicare payments are down 5%. … Only physicians are subject to arbitrary spending cuts. Hospitals have had a 3.7% update; nursing homes, a 3.1%; [and] Medicare Advantage now gets 111% of the fee-for-service rate and is slated for another 4.8% increase,” said PPAC member Dr. M. LeRoy Sprang, an ob.gyn. from Evanston, Ill.

But government estimates show that giving physicians a Medicare pay raise of 2%–3% over the next 5 years would carry a $58 billion price tag. Dr. Mark McClellan, the CMS administrator, has testified to Congress that any action taken to improve physician pay should be accompanied by provisions that allow the agency to better control how it spends the money through strategies such as pay for performance.

“The more we can identify steps that lead to reductions in overall costs of care as a result of quality improvements, the easier it is to support a more stable system of payment rates,” said Dr. McClellan, who has since resigned his post, at the meeting.

Physicians don't object to the agency's push for pay for performance, but you can't expect to purchase quality on the cheap, said PPAC member Dr. Geraldine O'Shea, an internist from Jackson, Calif.

“We understand the cost is the bottom line, but as we're moving toward this, we want to make sure it stays in the forefront [and] that health outcomes of our patients are still our No. 1 concern,” she said.

PPAC members asked CMS officials to keep in mind that physicians who improve quality and lower costs should also be credited for savings that may show up as reduced hospital spending due to preventive screening or disease management services provided in doctors' offices.

WASHINGTON — Members of the scientific community have raised a red flag over increasing influence of money and politics on what are supposed to be the independent and unbiased internal workings of the Food and Drug Administration and other federal agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug despite their reservations and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: “The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future.”

Such influences have led to a “crisis in public confidence,” according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee.

“We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value,” he said at a panel discussion on conflict of interest on government science panels sponsored by the Center for Science in the Public Interest. CSPI is a nonprofit consumer organization focused on food, nutrition, and health issues.

Dr. Nissen criticized the agency's top leaders for “whining incessantly” to Congress about the burden of regulation rather than asking for more authority. “While the American people worry about the safety of drugs, the top FDA leadership tells us we need fast drug approval,” he said.

Dr. Nissen said the appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, he said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

“In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter,” Dr. Nissen said.

Also speaking as part of the panel discussion, Dr. Gottlieb refused to address those observations, but defended FDA policy that allows the agency leeway in impaneling advisory committee members who have financial ties to industry.

The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. “That's the kind of advice that you can only get from people who are heavily engaged in clinical trials.”

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

“I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized,” recounted one respondent to the survey by the Union of Concerned Scientists. The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

“We get the data that is presented to us and … you can tell where the agency wants you to go,” said Dr. Nissen.

Changes to the Advisory Process

The FDA recently announced several steps it will take to codify the processes for bringing in expert voices and managing the agency's advisory committees.

“There are places where we can bring more consistency potentially to our processes. There are places where we can bring more transparency to the work we do. We know that and we feel that doing so is important to inspiring confidence in the process,” said Dr. Gottlieb.

Those changes are to include:

▸ Revamped guidance identifying more clearly the conditions under which conflict-of-interest waivers are granted.

▸ New guidance specifying when those waivers will be disclosed to the public and what information will be made available.

▸ New guidance specifying when briefing materials used by advisory committees will be made available to the public.

▸ Broader dissemination of advisory committee schedules through mailings to public groups and electronic notifications through FDA listservs and the Web site.

▸ A streamlined approach to the appointment of members to drug-related advisory committees.

WASHINGTON — Members of the scientific community have raised a red flag over increasing influence of money and politics on what are supposed to be the independent and unbiased internal workings of the Food and Drug Administration and other federal agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug despite their reservations and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: “The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future.”

Such influences have led to a “crisis in public confidence,” according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee.

“We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value,” he said at a panel discussion on conflict of interest on government science panels sponsored by the Center for Science in the Public Interest. CSPI is a nonprofit consumer organization focused on food, nutrition, and health issues.

Dr. Nissen criticized the agency's top leaders for “whining incessantly” to Congress about the burden of regulation rather than asking for more authority. “While the American people worry about the safety of drugs, the top FDA leadership tells us we need fast drug approval,” he said.

Dr. Nissen said the appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, he said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

“In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter,” Dr. Nissen said.

Also speaking as part of the panel discussion, Dr. Gottlieb refused to address those observations, but defended FDA policy that allows the agency leeway in impaneling advisory committee members who have financial ties to industry.

The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. “That's the kind of advice that you can only get from people who are heavily engaged in clinical trials.”

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

“I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized,” recounted one respondent to the survey by the Union of Concerned Scientists. The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

“We get the data that is presented to us and … you can tell where the agency wants you to go,” said Dr. Nissen.

Changes to the Advisory Process

The FDA recently announced several steps it will take to codify the processes for bringing in expert voices and managing the agency's advisory committees.

“There are places where we can bring more consistency potentially to our processes. There are places where we can bring more transparency to the work we do. We know that and we feel that doing so is important to inspiring confidence in the process,” said Dr. Gottlieb.

Those changes are to include:

▸ Revamped guidance identifying more clearly the conditions under which conflict-of-interest waivers are granted.

▸ New guidance specifying when those waivers will be disclosed to the public and what information will be made available.

▸ New guidance specifying when briefing materials used by advisory committees will be made available to the public.

▸ Broader dissemination of advisory committee schedules through mailings to public groups and electronic notifications through FDA listservs and the Web site.

▸ A streamlined approach to the appointment of members to drug-related advisory committees.

WASHINGTON — Members of the scientific community have raised a red flag over increasing influence of money and politics on what are supposed to be the independent and unbiased internal workings of the Food and Drug Administration and other federal agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug despite their reservations and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: “The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future.”

Such influences have led to a “crisis in public confidence,” according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee.

“We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value,” he said at a panel discussion on conflict of interest on government science panels sponsored by the Center for Science in the Public Interest. CSPI is a nonprofit consumer organization focused on food, nutrition, and health issues.

Dr. Nissen criticized the agency's top leaders for “whining incessantly” to Congress about the burden of regulation rather than asking for more authority. “While the American people worry about the safety of drugs, the top FDA leadership tells us we need fast drug approval,” he said.

Dr. Nissen said the appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, he said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

“In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter,” Dr. Nissen said.

Also speaking as part of the panel discussion, Dr. Gottlieb refused to address those observations, but defended FDA policy that allows the agency leeway in impaneling advisory committee members who have financial ties to industry.

The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. “That's the kind of advice that you can only get from people who are heavily engaged in clinical trials.”

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

“I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized,” recounted one respondent to the survey by the Union of Concerned Scientists. The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

“We get the data that is presented to us and … you can tell where the agency wants you to go,” said Dr. Nissen.

Changes to the Advisory Process

The FDA recently announced several steps it will take to codify the processes for bringing in expert voices and managing the agency's advisory committees.

“There are places where we can bring more consistency potentially to our processes. There are places where we can bring more transparency to the work we do. We know that and we feel that doing so is important to inspiring confidence in the process,” said Dr. Gottlieb.

Those changes are to include:

▸ Revamped guidance identifying more clearly the conditions under which conflict-of-interest waivers are granted.

▸ New guidance specifying when those waivers will be disclosed to the public and what information will be made available.

▸ New guidance specifying when briefing materials used by advisory committees will be made available to the public.

▸ Broader dissemination of advisory committee schedules through mailings to public groups and electronic notifications through FDA listservs and the Web site.

▸ A streamlined approach to the appointment of members to drug-related advisory committees.

WASHINGTON – The failure to address low physician pay and looming reimbursement cuts in the Medicare program is starting to affect beneficiaries, said members of Medicare's Practicing Physicians Advisory Council at their recent meeting.

PPAC member Dr. Vincent J. Bufalino, a cardiologist from Naperville, Ill., offered an example to the council. “We have in our community the beginnings of physicians walking away from Medicare. Four of the busiest internists in town have said 'No' and ripped up their [Medicare] agreement,” Dr. Bufalino said.

Half of the physicians in Dr. Bufalino's community are no longer accepting new Medicare patients, he said. Although the CMS still counts them as participating in the program, the trend is having a profound effect on beneficiaries' access to physician services.

“We don't think that participation rates, assignment rates, really reflect what is going on,” Dr. Bufalino told CMS Deputy Administrator Leslie Norwalk.

The CMS has to rely on the numbers gathered by physician groups, she responded. “I suspect that the best way to go about this is probably at the state level where you would ask your state medical society to survey members and let us know what it is that you see,” Ms. Norwalk suggested, noting that administration officials are legally barred from telling people to lobby Congress.

Lawmakers will have to be the ones to make changes to the current mechanism for updating physician payments. Based on the sustained growth rate (SGR) formula, mandated by the Balanced Budget Act of 1997, physicians are currently slated for a 5.1% cut in reimbursement starting Jan. 1. In past years, Congress has averted cuts or given doctors a small raise.

PPAC members urged CMS officials to use what influence they have to encourage lawmakers to do so again based on the recommendation from the Medicare Payment Advisory Commission that physician pay be increased by 2.8% in 2007.

“If you look at the data from 2001 to 2007, physicians' costs are up 18%, yet Medicare payments are down 5%. … Only physicians are subject to arbitrary spending cuts. Hospitals have had a 3.7% update; nursing homes, a 3.1%; [and] Medicare Advantage now gets 111% of the fee-for-service rate and is slated for another 4.8% increase,” said PPAC member M. LeRoy Sprang, an ob.gyn. from Evanston, Ill.

However, government estimates show that giving physicians a Medicare pay raise of 2%–3% over the next 5 years would carry a $58 billion price tag. Dr. Mark McClellan, the outgoing CMS administrator, has testified to Congress that any action taken to improve physician pay should be accompanied by provisions that allow the agency to better control how it spends the money through strategies such as pay for performance.

Physicians don't object to the agency's push for pay for performance, but you can't expect to purchase quality on the cheap, said PPAC member Dr. Geraldine O'Shea, an internist from Jackson, Calif.

“We understand the cost is the bottom line, but as we're moving toward this, we want to make sure it stays in the forefront [and] that health outcomes of our patients are still our No. 1 concern,” she said.

WASHINGTON – The failure to address low physician pay and looming reimbursement cuts in the Medicare program is starting to affect beneficiaries, said members of Medicare's Practicing Physicians Advisory Council at their recent meeting.

PPAC member Dr. Vincent J. Bufalino, a cardiologist from Naperville, Ill., offered an example to the council. “We have in our community the beginnings of physicians walking away from Medicare. Four of the busiest internists in town have said 'No' and ripped up their [Medicare] agreement,” Dr. Bufalino said.

Half of the physicians in Dr. Bufalino's community are no longer accepting new Medicare patients, he said. Although the CMS still counts them as participating in the program, the trend is having a profound effect on beneficiaries' access to physician services.

“We don't think that participation rates, assignment rates, really reflect what is going on,” Dr. Bufalino told CMS Deputy Administrator Leslie Norwalk.

The CMS has to rely on the numbers gathered by physician groups, she responded. “I suspect that the best way to go about this is probably at the state level where you would ask your state medical society to survey members and let us know what it is that you see,” Ms. Norwalk suggested, noting that administration officials are legally barred from telling people to lobby Congress.

Lawmakers will have to be the ones to make changes to the current mechanism for updating physician payments. Based on the sustained growth rate (SGR) formula, mandated by the Balanced Budget Act of 1997, physicians are currently slated for a 5.1% cut in reimbursement starting Jan. 1. In past years, Congress has averted cuts or given doctors a small raise.

PPAC members urged CMS officials to use what influence they have to encourage lawmakers to do so again based on the recommendation from the Medicare Payment Advisory Commission that physician pay be increased by 2.8% in 2007.

“If you look at the data from 2001 to 2007, physicians' costs are up 18%, yet Medicare payments are down 5%. … Only physicians are subject to arbitrary spending cuts. Hospitals have had a 3.7% update; nursing homes, a 3.1%; [and] Medicare Advantage now gets 111% of the fee-for-service rate and is slated for another 4.8% increase,” said PPAC member M. LeRoy Sprang, an ob.gyn. from Evanston, Ill.

However, government estimates show that giving physicians a Medicare pay raise of 2%–3% over the next 5 years would carry a $58 billion price tag. Dr. Mark McClellan, the outgoing CMS administrator, has testified to Congress that any action taken to improve physician pay should be accompanied by provisions that allow the agency to better control how it spends the money through strategies such as pay for performance.

Physicians don't object to the agency's push for pay for performance, but you can't expect to purchase quality on the cheap, said PPAC member Dr. Geraldine O'Shea, an internist from Jackson, Calif.

“We understand the cost is the bottom line, but as we're moving toward this, we want to make sure it stays in the forefront [and] that health outcomes of our patients are still our No. 1 concern,” she said.

WASHINGTON – The failure to address low physician pay and looming reimbursement cuts in the Medicare program is starting to affect beneficiaries, said members of Medicare's Practicing Physicians Advisory Council at their recent meeting.

PPAC member Dr. Vincent J. Bufalino, a cardiologist from Naperville, Ill., offered an example to the council. “We have in our community the beginnings of physicians walking away from Medicare. Four of the busiest internists in town have said 'No' and ripped up their [Medicare] agreement,” Dr. Bufalino said.

Half of the physicians in Dr. Bufalino's community are no longer accepting new Medicare patients, he said. Although the CMS still counts them as participating in the program, the trend is having a profound effect on beneficiaries' access to physician services.

“We don't think that participation rates, assignment rates, really reflect what is going on,” Dr. Bufalino told CMS Deputy Administrator Leslie Norwalk.

The CMS has to rely on the numbers gathered by physician groups, she responded. “I suspect that the best way to go about this is probably at the state level where you would ask your state medical society to survey members and let us know what it is that you see,” Ms. Norwalk suggested, noting that administration officials are legally barred from telling people to lobby Congress.

Lawmakers will have to be the ones to make changes to the current mechanism for updating physician payments. Based on the sustained growth rate (SGR) formula, mandated by the Balanced Budget Act of 1997, physicians are currently slated for a 5.1% cut in reimbursement starting Jan. 1. In past years, Congress has averted cuts or given doctors a small raise.

PPAC members urged CMS officials to use what influence they have to encourage lawmakers to do so again based on the recommendation from the Medicare Payment Advisory Commission that physician pay be increased by 2.8% in 2007.

“If you look at the data from 2001 to 2007, physicians' costs are up 18%, yet Medicare payments are down 5%. … Only physicians are subject to arbitrary spending cuts. Hospitals have had a 3.7% update; nursing homes, a 3.1%; [and] Medicare Advantage now gets 111% of the fee-for-service rate and is slated for another 4.8% increase,” said PPAC member M. LeRoy Sprang, an ob.gyn. from Evanston, Ill.

However, government estimates show that giving physicians a Medicare pay raise of 2%–3% over the next 5 years would carry a $58 billion price tag. Dr. Mark McClellan, the outgoing CMS administrator, has testified to Congress that any action taken to improve physician pay should be accompanied by provisions that allow the agency to better control how it spends the money through strategies such as pay for performance.

Physicians don't object to the agency's push for pay for performance, but you can't expect to purchase quality on the cheap, said PPAC member Dr. Geraldine O'Shea, an internist from Jackson, Calif.

“We understand the cost is the bottom line, but as we're moving toward this, we want to make sure it stays in the forefront [and] that health outcomes of our patients are still our No. 1 concern,” she said.

WASHINGTON — Members of the scientific community have raised a red flag over the apparent increasing influence of money and politics on what are supposed to be the independent, unbiased internal workings of the Food and Drug Administration and other federal watchdog agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug about which they had reservations and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: “The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future.”

Such influences have led to a “crisis in public confidence,” according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee.

“We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value,” he said at a panel discussion about conflict of interest on government science panels sponsored by the Center for Science in the Public Interest. CSPI is a nonprofit consumer organization focused on food, nutrition, and health issues; it is perhaps best known for its efforts to disclose the nutritional content of fast-food products.

Dr. Nissen criticized the agency's top leaders for “whining incessantly” to Congress about the burden of regulation rather than asking for more authority.

“While the American people worry about the safety of drugs, the top FDA leadership tells us we need fast drug approval,” he said.

The appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, Dr. Nissen said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

“In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter,” Dr. Nissen said.

Also speaking as part of the panel, Dr. Gottlieb refused to address those charges, but defended FDA policy that allows the agency leeway in impaneling advisory committee members who have financial ties to industry.

The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. “That's the kind of advice that you can only get from people who are heavily engaged in clinical trials.”

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

“I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized,” recounted one respondent to the survey by the Union of Concerned Scientists. The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

“As advisers, we get the data that is presented to us and … you can tell where the agency wants you to go,” said Dr. Nissen. “The material you get has to be unbiased, and I'm worried that it might not be.”

It is easy to overlook the more subtle value that advisory committees can provide, said Dr. Gottlieb.

“The advice we are getting is not necessarily in many cases whether or not a drug can make it to market, but the contours of the approval, what the language should look like, what indications this drug should be approved for, should it be restricted, what is an appropriate postmarket monitoring plan,” he said.

Changes to the FDA Advisory Process

The FDA recently announced several steps it will take to codify the processes for bringing in expert voices and managing the agency's advisory committees.

“There are places where we can bring more consistency potentially to our processes. There are places where we can bring more transparency to the work we do. We know that and we feel that doing so is important to inspiring confidence in the process,” said Dr. Gottlieb.

Those changes are to include:

▸ Revamped advisory committee guidelines identifying more clearly the conditions under which conflict-of-interest waivers are to be granted.

▸ New guidance specifying when those waivers will be disclosed to the public and what information will be made available.

▸ New guidance specifying when briefing materials used by advisory committees will be made available to the public.

▸ Broader dissemination of advisory committee schedules through mailings to public groups and electronic notifications through FDA listservs and the Web site.

▸ A streamlined approach to the appointment of members to drug-related advisory committees.

WASHINGTON — Members of the scientific community have raised a red flag over the apparent increasing influence of money and politics on what are supposed to be the independent, unbiased internal workings of the Food and Drug Administration and other federal watchdog agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug about which they had reservations and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: “The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future.”

Such influences have led to a “crisis in public confidence,” according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee.

“We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value,” he said at a panel discussion about conflict of interest on government science panels sponsored by the Center for Science in the Public Interest. CSPI is a nonprofit consumer organization focused on food, nutrition, and health issues; it is perhaps best known for its efforts to disclose the nutritional content of fast-food products.

Dr. Nissen criticized the agency's top leaders for “whining incessantly” to Congress about the burden of regulation rather than asking for more authority.

“While the American people worry about the safety of drugs, the top FDA leadership tells us we need fast drug approval,” he said.

The appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, Dr. Nissen said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

“In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter,” Dr. Nissen said.

Also speaking as part of the panel, Dr. Gottlieb refused to address those charges, but defended FDA policy that allows the agency leeway in impaneling advisory committee members who have financial ties to industry.

The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. “That's the kind of advice that you can only get from people who are heavily engaged in clinical trials.”

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

“I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized,” recounted one respondent to the survey by the Union of Concerned Scientists. The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

“As advisers, we get the data that is presented to us and … you can tell where the agency wants you to go,” said Dr. Nissen. “The material you get has to be unbiased, and I'm worried that it might not be.”

It is easy to overlook the more subtle value that advisory committees can provide, said Dr. Gottlieb.

“The advice we are getting is not necessarily in many cases whether or not a drug can make it to market, but the contours of the approval, what the language should look like, what indications this drug should be approved for, should it be restricted, what is an appropriate postmarket monitoring plan,” he said.

Changes to the FDA Advisory Process

The FDA recently announced several steps it will take to codify the processes for bringing in expert voices and managing the agency's advisory committees.

“There are places where we can bring more consistency potentially to our processes. There are places where we can bring more transparency to the work we do. We know that and we feel that doing so is important to inspiring confidence in the process,” said Dr. Gottlieb.

Those changes are to include:

▸ Revamped advisory committee guidelines identifying more clearly the conditions under which conflict-of-interest waivers are to be granted.

▸ New guidance specifying when those waivers will be disclosed to the public and what information will be made available.

▸ New guidance specifying when briefing materials used by advisory committees will be made available to the public.

▸ Broader dissemination of advisory committee schedules through mailings to public groups and electronic notifications through FDA listservs and the Web site.

▸ A streamlined approach to the appointment of members to drug-related advisory committees.

WASHINGTON — Members of the scientific community have raised a red flag over the apparent increasing influence of money and politics on what are supposed to be the independent, unbiased internal workings of the Food and Drug Administration and other federal watchdog agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug about which they had reservations and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: “The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future.”

Such influences have led to a “crisis in public confidence,” according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee.

“We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value,” he said at a panel discussion about conflict of interest on government science panels sponsored by the Center for Science in the Public Interest. CSPI is a nonprofit consumer organization focused on food, nutrition, and health issues; it is perhaps best known for its efforts to disclose the nutritional content of fast-food products.

Dr. Nissen criticized the agency's top leaders for “whining incessantly” to Congress about the burden of regulation rather than asking for more authority.

“While the American people worry about the safety of drugs, the top FDA leadership tells us we need fast drug approval,” he said.

The appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, Dr. Nissen said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

“In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter,” Dr. Nissen said.

Also speaking as part of the panel, Dr. Gottlieb refused to address those charges, but defended FDA policy that allows the agency leeway in impaneling advisory committee members who have financial ties to industry.

The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. “That's the kind of advice that you can only get from people who are heavily engaged in clinical trials.”

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

“I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized,” recounted one respondent to the survey by the Union of Concerned Scientists. The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

“As advisers, we get the data that is presented to us and … you can tell where the agency wants you to go,” said Dr. Nissen. “The material you get has to be unbiased, and I'm worried that it might not be.”

It is easy to overlook the more subtle value that advisory committees can provide, said Dr. Gottlieb.

“The advice we are getting is not necessarily in many cases whether or not a drug can make it to market, but the contours of the approval, what the language should look like, what indications this drug should be approved for, should it be restricted, what is an appropriate postmarket monitoring plan,” he said.

Changes to the FDA Advisory Process

The FDA recently announced several steps it will take to codify the processes for bringing in expert voices and managing the agency's advisory committees.

“There are places where we can bring more consistency potentially to our processes. There are places where we can bring more transparency to the work we do. We know that and we feel that doing so is important to inspiring confidence in the process,” said Dr. Gottlieb.

Those changes are to include:

▸ Revamped advisory committee guidelines identifying more clearly the conditions under which conflict-of-interest waivers are to be granted.

▸ New guidance specifying when those waivers will be disclosed to the public and what information will be made available.

▸ New guidance specifying when briefing materials used by advisory committees will be made available to the public.

▸ Broader dissemination of advisory committee schedules through mailings to public groups and electronic notifications through FDA listservs and the Web site.

▸ A streamlined approach to the appointment of members to drug-related advisory committees.

WASHINGTON — Members of the scientific community have raised a red flag over the apparent increasing influence of money and politics on what are supposed to be the independent and unbiased internal workings of the Food and Drug Administration and other federal watchdog agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug about which they had reservations and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: “The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future.”

Such influences have led to a “crisis in public confidence,” according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee.

“We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value,” he said at a panel discussion on conflict of interest on government science panels, sponsored by the Center for Science in the Public Interest. CSPI is a nonprofit consumer organization focused on food, nutrition, and health issues; it is perhaps best known for its efforts to disclose the nutritional content of fast-food products.

Dr. Nissen criticized the agency's top leaders for “whining incessantly” to Congress about the burden of regulation rather than asking for more authority.

“While the American people worry about the safety of drugs, the top FDA leadership tells us we need fast drug approval,” he said.

Dr. Nissen said the appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, he said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

“In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter,” Dr. Nissen said.

Also speaking as part of the panel, Dr. Gottlieb refused to address those charges, but defended FDA policy that allows the agency leeway in impaneling advisory committee members who have financial ties to industry.

The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. “That's the kind of advice that you can only get from people who are heavily engaged in clinical trials.”

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

“I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized,” recounted one respondent to the survey by the Union of Concerned Scientists.

The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

“As advisers, we get the data that is presented to us and … you can tell where the agency wants you to go,” said Dr. Nissen. “The material you get has to be unbiased, and I'm worried that it might not be.”

It is easy to overlook the more subtle value that advisory committees can provide, said Dr. Gottlieb. “The advice we are getting is not necessarily in many cases whether or not a drug can make it to market, but the contours of the approval, what the language should look like, what indications this drug should be approved for, should it be restricted, what is an appropriate postmarket monitoring plan,” he said.

WASHINGTON — Members of the scientific community have raised a red flag over the apparent increasing influence of money and politics on what are supposed to be the independent and unbiased internal workings of the Food and Drug Administration and other federal watchdog agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug about which they had reservations and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: “The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future.”

Such influences have led to a “crisis in public confidence,” according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee.

“We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value,” he said at a panel discussion on conflict of interest on government science panels, sponsored by the Center for Science in the Public Interest. CSPI is a nonprofit consumer organization focused on food, nutrition, and health issues; it is perhaps best known for its efforts to disclose the nutritional content of fast-food products.

Dr. Nissen criticized the agency's top leaders for “whining incessantly” to Congress about the burden of regulation rather than asking for more authority.

“While the American people worry about the safety of drugs, the top FDA leadership tells us we need fast drug approval,” he said.

Dr. Nissen said the appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, he said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

“In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter,” Dr. Nissen said.

Also speaking as part of the panel, Dr. Gottlieb refused to address those charges, but defended FDA policy that allows the agency leeway in impaneling advisory committee members who have financial ties to industry.

The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. “That's the kind of advice that you can only get from people who are heavily engaged in clinical trials.”

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

“I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized,” recounted one respondent to the survey by the Union of Concerned Scientists.

The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

“As advisers, we get the data that is presented to us and … you can tell where the agency wants you to go,” said Dr. Nissen. “The material you get has to be unbiased, and I'm worried that it might not be.”

It is easy to overlook the more subtle value that advisory committees can provide, said Dr. Gottlieb. “The advice we are getting is not necessarily in many cases whether or not a drug can make it to market, but the contours of the approval, what the language should look like, what indications this drug should be approved for, should it be restricted, what is an appropriate postmarket monitoring plan,” he said.

WASHINGTON — Members of the scientific community have raised a red flag over the apparent increasing influence of money and politics on what are supposed to be the independent and unbiased internal workings of the Food and Drug Administration and other federal watchdog agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug about which they had reservations and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: “The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future.”

Such influences have led to a “crisis in public confidence,” according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee.

“We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value,” he said at a panel discussion on conflict of interest on government science panels, sponsored by the Center for Science in the Public Interest. CSPI is a nonprofit consumer organization focused on food, nutrition, and health issues; it is perhaps best known for its efforts to disclose the nutritional content of fast-food products.

Dr. Nissen criticized the agency's top leaders for “whining incessantly” to Congress about the burden of regulation rather than asking for more authority.

“While the American people worry about the safety of drugs, the top FDA leadership tells us we need fast drug approval,” he said.

Dr. Nissen said the appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, he said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

“In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter,” Dr. Nissen said.

Also speaking as part of the panel, Dr. Gottlieb refused to address those charges, but defended FDA policy that allows the agency leeway in impaneling advisory committee members who have financial ties to industry.

The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. “That's the kind of advice that you can only get from people who are heavily engaged in clinical trials.”

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

“I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized,” recounted one respondent to the survey by the Union of Concerned Scientists.

The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

“As advisers, we get the data that is presented to us and … you can tell where the agency wants you to go,” said Dr. Nissen. “The material you get has to be unbiased, and I'm worried that it might not be.”

It is easy to overlook the more subtle value that advisory committees can provide, said Dr. Gottlieb. “The advice we are getting is not necessarily in many cases whether or not a drug can make it to market, but the contours of the approval, what the language should look like, what indications this drug should be approved for, should it be restricted, what is an appropriate postmarket monitoring plan,” he said.

WASHINGTON — Members of the scientific community have raised a red flag over the apparent increasing influence of money and politics on what are supposed to be the independent and unbiased internal workings of the Food and Drug Administration and other federal watchdog agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug about which they had reservations, and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: “The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future.”

Such influences have led to a “crisis in public confidence,” according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee. “We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value,” he said at a panel discussion on conflict of interest on government science panels sponsored by the Center for Science in the Public Interest. CSPI is a nonprofit consumer organization focused on food, nutrition, and health issues; it is perhaps best known for its efforts to disclose the nutritional content of fast-food products.

Dr. Nissen criticized the agency's top leaders for “whining incessantly” to Congress about the burden of regulation rather than asking for more authority.

“While the American people worry about the safety of drugs, the top FDA leadership tells us we need fast drug approval,” he said.

Dr. Nissen said the appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, he said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

“In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter,” Dr. Nissen said.

Also speaking as part of the panel, Dr. Gottlieb refused to address those charges, but defended FDA policy that allows the agency leeway in impaneling advisory committee members who have financial ties to industry. The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. “That's the kind of advice that you can only get from people who are heavily engaged in clinical trials.”

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. (See box.) However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

“I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized,” recounted one respondent to the survey by the Union of Concerned Scientists. The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

“As advisers, we get the data that [are] presented to us and … you can tell where the agency wants you to go,” Dr. Nissen said. “The material you get has to be unbiased, and I'm worried that it might not be.”

It is easy to overlook the more subtle value that advisory committees can provide, Dr. Gottlieb said.

“The advice we are getting is not necessarily in many cases whether or not a drug can make it to market, but the contours of the approval, what the language should look like, what indications this drug should be approved for, should it be restricted, what is an appropriate postmarket monitoring plan,” he said.

Advisory Process Undergoes Facelift

The FDA recently announced several steps it will take to codify the processes for bringing in expert voices and managing the agency's advisory committees.

“There are places where we can bring more consistency potentially to our processes. There are places where we can bring more transparency to the work we do. We know that and we feel that doing so is important to inspiring confidence in the process,” Dr. Gottlieb said.

Those changes are to include:

▸ Revamped guidance identifying more clearly the conditions under which conflict-of-interest waivers are granted.

▸ New guidance specifying when those waivers will be disclosed to the public and what information will be made available.

▸ New guidance specifying when briefing materials used by advisory committees will be made available to the public.

▸ Broader dissemination of advisory committee schedules through mailings to public groups and electronic notifications through FDA listservs and the Web site.

▸ A streamlined approach to the appointment of members to drug-related advisory committees.

WASHINGTON — Members of the scientific community have raised a red flag over the apparent increasing influence of money and politics on what are supposed to be the independent and unbiased internal workings of the Food and Drug Administration and other federal watchdog agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug about which they had reservations, and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: “The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future.”

Such influences have led to a “crisis in public confidence,” according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee. “We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value,” he said at a panel discussion on conflict of interest on government science panels sponsored by the Center for Science in the Public Interest. CSPI is a nonprofit consumer organization focused on food, nutrition, and health issues; it is perhaps best known for its efforts to disclose the nutritional content of fast-food products.

Dr. Nissen criticized the agency's top leaders for “whining incessantly” to Congress about the burden of regulation rather than asking for more authority.

“While the American people worry about the safety of drugs, the top FDA leadership tells us we need fast drug approval,” he said.

Dr. Nissen said the appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, he said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

“In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter,” Dr. Nissen said.

Also speaking as part of the panel, Dr. Gottlieb refused to address those charges, but defended FDA policy that allows the agency leeway in impaneling advisory committee members who have financial ties to industry. The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. “That's the kind of advice that you can only get from people who are heavily engaged in clinical trials.”

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. (See box.) However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

“I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized,” recounted one respondent to the survey by the Union of Concerned Scientists. The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

“As advisers, we get the data that [are] presented to us and … you can tell where the agency wants you to go,” Dr. Nissen said. “The material you get has to be unbiased, and I'm worried that it might not be.”

It is easy to overlook the more subtle value that advisory committees can provide, Dr. Gottlieb said.

“The advice we are getting is not necessarily in many cases whether or not a drug can make it to market, but the contours of the approval, what the language should look like, what indications this drug should be approved for, should it be restricted, what is an appropriate postmarket monitoring plan,” he said.

Advisory Process Undergoes Facelift

The FDA recently announced several steps it will take to codify the processes for bringing in expert voices and managing the agency's advisory committees.

“There are places where we can bring more consistency potentially to our processes. There are places where we can bring more transparency to the work we do. We know that and we feel that doing so is important to inspiring confidence in the process,” Dr. Gottlieb said.

Those changes are to include:

▸ Revamped guidance identifying more clearly the conditions under which conflict-of-interest waivers are granted.

▸ New guidance specifying when those waivers will be disclosed to the public and what information will be made available.

▸ New guidance specifying when briefing materials used by advisory committees will be made available to the public.

▸ Broader dissemination of advisory committee schedules through mailings to public groups and electronic notifications through FDA listservs and the Web site.

▸ A streamlined approach to the appointment of members to drug-related advisory committees.

WASHINGTON — Members of the scientific community have raised a red flag over the apparent increasing influence of money and politics on what are supposed to be the independent and unbiased internal workings of the Food and Drug Administration and other federal watchdog agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug about which they had reservations, and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: “The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future.”

Such influences have led to a “crisis in public confidence,” according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee. “We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value,” he said at a panel discussion on conflict of interest on government science panels sponsored by the Center for Science in the Public Interest. CSPI is a nonprofit consumer organization focused on food, nutrition, and health issues; it is perhaps best known for its efforts to disclose the nutritional content of fast-food products.

Dr. Nissen criticized the agency's top leaders for “whining incessantly” to Congress about the burden of regulation rather than asking for more authority.

“While the American people worry about the safety of drugs, the top FDA leadership tells us we need fast drug approval,” he said.

Dr. Nissen said the appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, he said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

“In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter,” Dr. Nissen said.

Also speaking as part of the panel, Dr. Gottlieb refused to address those charges, but defended FDA policy that allows the agency leeway in impaneling advisory committee members who have financial ties to industry. The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. “That's the kind of advice that you can only get from people who are heavily engaged in clinical trials.”

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. (See box.) However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

“I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized,” recounted one respondent to the survey by the Union of Concerned Scientists. The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

“As advisers, we get the data that [are] presented to us and … you can tell where the agency wants you to go,” Dr. Nissen said. “The material you get has to be unbiased, and I'm worried that it might not be.”

It is easy to overlook the more subtle value that advisory committees can provide, Dr. Gottlieb said.

“The advice we are getting is not necessarily in many cases whether or not a drug can make it to market, but the contours of the approval, what the language should look like, what indications this drug should be approved for, should it be restricted, what is an appropriate postmarket monitoring plan,” he said.

Advisory Process Undergoes Facelift

The FDA recently announced several steps it will take to codify the processes for bringing in expert voices and managing the agency's advisory committees.

“There are places where we can bring more consistency potentially to our processes. There are places where we can bring more transparency to the work we do. We know that and we feel that doing so is important to inspiring confidence in the process,” Dr. Gottlieb said.

Those changes are to include:

▸ Revamped guidance identifying more clearly the conditions under which conflict-of-interest waivers are granted.

▸ New guidance specifying when those waivers will be disclosed to the public and what information will be made available.

▸ New guidance specifying when briefing materials used by advisory committees will be made available to the public.

▸ Broader dissemination of advisory committee schedules through mailings to public groups and electronic notifications through FDA listservs and the Web site.

▸ A streamlined approach to the appointment of members to drug-related advisory committees.

WASHINGTON — Members of the scientific community have raised a red flag over the apparent increasing influence of money and politics on what are supposed to be the independent and unbiased workings of the Food and Drug Administration and other federal watchdog agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug about which they had reservations, and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: "The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future."

Such influences have led to a "crisis in public confidence," according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee.

"We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value," he said at a panel discussion on conflict of interest on government science panels sponsored by the Center for Science in the Public Interest.

Dr. Nissen said the appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, he said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

"In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter," Dr. Nissen said.

Also speaking as part of the panel, Dr. Gottlieb refused to address the charges, but defended FDA policy allowing the agency leeway in impaneling advisory committee members with financial ties to industry.

The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. "That's the kind of advice that you can only get from people who are heavily engaged in clinical trials."

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

"I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized," recounted one respondent to the survey by the Union of Concerned Scientists.

The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

"As advisers, we get the data that is presented to us and … you can tell where the agency wants you to go," said Dr. Nissen. "The material you get has to be unbiased, and I'm worried that it might not be."

WASHINGTON — Members of the scientific community have raised a red flag over the apparent increasing influence of money and politics on what are supposed to be the independent and unbiased workings of the Food and Drug Administration and other federal watchdog agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug about which they had reservations, and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: "The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future."

Such influences have led to a "crisis in public confidence," according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee.

"We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value," he said at a panel discussion on conflict of interest on government science panels sponsored by the Center for Science in the Public Interest.

Dr. Nissen said the appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, he said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

"In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter," Dr. Nissen said.

Also speaking as part of the panel, Dr. Gottlieb refused to address the charges, but defended FDA policy allowing the agency leeway in impaneling advisory committee members with financial ties to industry.

The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. "That's the kind of advice that you can only get from people who are heavily engaged in clinical trials."

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

"I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized," recounted one respondent to the survey by the Union of Concerned Scientists.

The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

"As advisers, we get the data that is presented to us and … you can tell where the agency wants you to go," said Dr. Nissen. "The material you get has to be unbiased, and I'm worried that it might not be."

WASHINGTON — Members of the scientific community have raised a red flag over the apparent increasing influence of money and politics on what are supposed to be the independent and unbiased workings of the Food and Drug Administration and other federal watchdog agencies.

In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug about which they had reservations, and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.

Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.

In the words of one staff scientist: "The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future."

Such influences have led to a "crisis in public confidence," according to Dr. Steven Nissen, who until last year chaired the FDA's Cardiovascular and Renal Drugs Advisory Committee.

"We have to work a lot harder now … to keep the politicians out of the science as much as possible and to keep the commercialization of science from coloring everything we see and hear of scientific value," he said at a panel discussion on conflict of interest on government science panels sponsored by the Center for Science in the Public Interest.

Dr. Nissen said the appointments of Lester Crawford, D.V.M., Ph.D., and Dr. Andrew von Eschenbach as acting FDA commissioner and Dr. Scott Gottlieb as FDA deputy commissioner for policy also have raised some troubling questions about conflict of interest with the agency, he said. (Dr. Crawford eventually gained Senate confirmation to his position, but resigned shortly thereafter.)

"In his role as director of the National Cancer Institute, [acting commissioner von Eschenbach] must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict of interest. Even worse, the administration has appointed Scott Gottlieb as deputy commissioner, who came to this job with no regulatory experience, directly from Wall Street where he served as a biotech analyst and stock promoter," Dr. Nissen said.

Also speaking as part of the panel, Dr. Gottlieb refused to address the charges, but defended FDA policy allowing the agency leeway in impaneling advisory committee members with financial ties to industry.

The advice the FDA receives from advisory committees must span the breadth of both clinical research and clinical practice, he said. "That's the kind of advice that you can only get from people who are heavily engaged in clinical trials."

Dr. Gottlieb also announced FDA plans to revamp the advisory committee guidelines, including updated rules that determine whether members need to be recused due to a potential conflict of interest. However, it is unclear how those changes will relieve the concern, both inside and outside the agency, that these panels are being manipulated.

"I've observed that [FDA] management and [drug and device manufacturing] companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized," recounted one respondent to the survey by the Union of Concerned Scientists.

The anonymous respondent went on to describe these techniques.

Within the FDA, scheduling conflicts can be used to exclude a committee member who is expected to oppose a drug's approval, and managers have been known to massage the presentations to the committee to soften damaging findings. Drug companies have also learned that by hiring experts as consultants, they can deny FDA access to them, and that by hiring committee members themselves, they can force them to be excluded from voting on a company's drug.

"As advisers, we get the data that is presented to us and … you can tell where the agency wants you to go," said Dr. Nissen. "The material you get has to be unbiased, and I'm worried that it might not be."

WASHINGTON — Strained by rising demand and insufficient resources, the nation's emergency care is in a precarious state, an Institute of Medicine expert panel has concluded, and Congress must act to shore up the system.

Emergency departments are closing, the pool of available on-call specialists is drying up, and access to timely care in an appropriate setting is on the decline, warned Dr. A. Brent Eastman, chief medical officer of Scripps Health in San Diego, at the public release of the report compiled by the IOM's Committee on the Future of Emergency Care in the U.S. Health System.

The emergency care system's troubles are an especially frightening reality considering that it has traditionally provided the care of last resort, catching those unfortunate patients who have slipped through the gaps of the health care safety net, Dr. Eastman added. There is no longer any guarantee that it will be there when those patients need it, he cautioned at the meeting on emergency care sponsored by the Institute of Medicine.

The IOM panel recommended that Congress establish a single lead agency to oversee and manage emergency care, pulling together resources that are now currently overseen by an array of departments within various agencies, including the Department of Health and Human Services, the Department of Homeland Security, and the Department of Transportation.

As the committee envisioned it, that new lead agency would have planning and budgetary authority over the majority of emergency care activities at the federal level. Such an agency could raise the visibility of emergency medicine and emphasize the need to fund it. The agency would also coordinate how those federal dollars are spent.

Among other recommendations, the panel urged Congress to fund a demonstration program, to the tune of $88 million a year for 5 years, to assess strategies to coordinate and streamline the emergency care system. Federal agencies also need to support the development of national standards for measuring performance, the IOM said.

The report documents a host of issues besetting the emergency care system, including crowding, boarding, and diversions.

“The signs of distress are unmistakable,” said Dr. Arthur Kellermann, an IOM committee member and professor of emergency medicine at Emory University in Atlanta.

Over the past decade, visits to the emergency department—now up to about 114 million a year—have risen twice as fast as population growth. During the same period, the number of EDs shrank by 425, and the number of inpatient hospital beds fell by nearly 200,000.

“Do the math—with more people needing care and few resources available to provide that care, crowding in the ED was inevitable,” Dr. Kellermann said.

And with fewer hospital beds available, more severely ill and injured patients are boarded in the emergency department's exam rooms or even hallways until an inpatient bed can be made available.

“Some of them wait for hours, others wait for days. Meanwhile, other emergency patients are arriving every hour,” he said.

Often, EDs have no alternative but to divert inbound ambulances to other facilities. “When I started in my career, this was considered a rare and disturbing event,” Dr. Kellermann said. “It now happens more than half a million times a year in the United States.”

Demand Outpaces Resources

Emergency department responsibilities have grown over the years, with many now being expected to provide primary care to the uninsured, diagnostic services at night or on the weekend, and behavioral health care to the community.

Meanwhile, revenue has not kept pace. Medicare and Medicaid pay below cost for many emergency services, and uncompensated care has risen.

The emergency department is considered such an important public good that it is the only medical service that all Americans have a legal right to access. But hospitals are expected to finance that care through the free market system, Carmela Coyle, senior vice president for policy at the American Hospital Association, said during a briefing the day before release of the IOM report.

And because of low, and sometimes no, reimbursement, hospitals are finding it increasingly difficult to convince specialists to agree to be on call to the emergency department.

Liability, especially in a setting where many uninsured patients are in poor health, is also a major concern for specialists, according to an AHA survey.

“It's tough to get called at two or three o'clock in the morning to come in for a case where you know you might not get paid and you might get sued,” Ms. Coyle said.

Some hospitals have begun to pay specialists a retainer to be on-call, but that is just another financial burden making emergency departments a money-losing proposition, she said.

Stress on the System

Such financial difficulties have led to the closing of scores of emergency departments, which places more pressure on the remaining facilities.

Hospitals aren't inclined to give up inpatient beds to admit patients from the emergency department, who may pay at Medicaid rates or not at all, Dr. Kellermann said.

“Right now, all the incentives are to leave the patient in the ED so that they can keep admitting electives. You are financially penalized for making the right decision for patient care, because it is the wrong decision for your business,” he said.

The IOM committee also concluded that the emergency care system is not equipped to cope with a large-scale emergency.

“You've got to ask yourself, 'If our emergency departments are struggling to handle their daily and nightly load of 911 calls, how in the world are they going to handle a mass casualty event following a terrorist strike, an outbreak of infectious disease, or a natural disaster?” Dr. Kellermann said.

Federal funding for emergency preparedness has been and remains inadequate, the committee found. In 2002 and 2003, emergency care providers received 4% of $3.38 billion in first-responder funding distributed by the Department of Homeland Security—although emergency medical services personnel make up one-third of first responders. That has left EMS providers with scant training or planning to deal with a disaster situation.

Time to Act

The committee's findings show that emergency departments cannot continue to operate without more financial support, said Dr. Rick Blum, president of the American College of Emergency Physicians.

“Hospitals must be reimbursed for the significant amounts of uncompensated emergency and trauma care they provide,” he said in a statement.

Dr. Blum called for Congress to hold hearings on the state of emergency medicine and to pass the Access to Emergency Medical Services Act, introduced in the House last September and in the Senate in May 2006.

The legislation targets several problems addressed in the report, including boarding, the lack of on-call specialists, and poor reimbursement for emergency care services.

Although emergency care on the whole is deeply troubled, the IOM committee found that there are islands of excellence—a select few facilities that have developed innovative approaches to dealing with the problems that all emergency departments face. Those islands provide a starting point on which to build a better system, committee members said.

“Our goal should be for these islands to coalesce and eventually blanket the United States with an emergency care system that has no holes,” Dr. Eastman said.

The panel envisioned a new regionalized system to coordinate care, so that patients are only taken to facilities that are appropriate and prepared to care for them, he said.

“Where there is no vision, the people perish,” Dr. Kellermann said. “Our committee has described a vision for a coordinated, regionalized, and accountable emergency care system. It's time to act.”

Secondary Report Cites Gaps in EMS

Problems with the state of hospital-based emergency care received the most focus in the release of the Institute of Medicine reports, but an accompanying report shows that systemic issues with emergency medical services also have an impact on Americans' access to appropriate emergency care.

Ambulance and other emergency medical services suffer from a level of fragmentation that has led to critical problems in efficiency, efficacy, and coordination, according to the committee's report on emergency medical services.

The system is severely lacking in data to drive, or even gauge, performance. What few data do exist point to wide variations between communities, said committee member Shirley Gamble, chief operating officer for United Way Capital Area of Austin, Tex.

“There is as much as a 10-fold difference by community in survival rates for sudden cardiac arrest,” she said. “In one community, your chance for survival could be 5%, and in another community, your chances could be 50%.”

The committee also found that the patchwork nature of emergency medical services creates barriers to communication among emergency medical service providers and between those providers and emergency departments.

The panel recommended that the federal government support efforts to gather an evidence base to help improve the performance of emergency medical services. They also advised that all paramedic training programs be accredited to ensure consistent quality across services.

Further, the IOM committee recommended that emergency preparedness efforts should focus on updating the infrastructure of the emergency medical system.

“Money needs to be advanced to provide training for EMS providers at every hospital and to provide equipment and communications systems,” said Gamble. “Many of the communications systems in our communities were put in place in the 1970s, over 35 years ago.”

WASHINGTON — Strained by rising demand and insufficient resources, the nation's emergency care is in a precarious state, an Institute of Medicine expert panel has concluded, and Congress must act to shore up the system.

Emergency departments are closing, the pool of available on-call specialists is drying up, and access to timely care in an appropriate setting is on the decline, warned Dr. A. Brent Eastman, chief medical officer of Scripps Health in San Diego, at the public release of the report compiled by the IOM's Committee on the Future of Emergency Care in the U.S. Health System.

The emergency care system's troubles are an especially frightening reality considering that it has traditionally provided the care of last resort, catching those unfortunate patients who have slipped through the gaps of the health care safety net, Dr. Eastman added. There is no longer any guarantee that it will be there when those patients need it, he cautioned at the meeting on emergency care sponsored by the Institute of Medicine.

The IOM panel recommended that Congress establish a single lead agency to oversee and manage emergency care, pulling together resources that are now currently overseen by an array of departments within various agencies, including the Department of Health and Human Services, the Department of Homeland Security, and the Department of Transportation.

As the committee envisioned it, that new lead agency would have planning and budgetary authority over the majority of emergency care activities at the federal level. Such an agency could raise the visibility of emergency medicine and emphasize the need to fund it. The agency would also coordinate how those federal dollars are spent.

Among other recommendations, the panel urged Congress to fund a demonstration program, to the tune of $88 million a year for 5 years, to assess strategies to coordinate and streamline the emergency care system. Federal agencies also need to support the development of national standards for measuring performance, the IOM said.

The report documents a host of issues besetting the emergency care system, including crowding, boarding, and diversions.

“The signs of distress are unmistakable,” said Dr. Arthur Kellermann, an IOM committee member and professor of emergency medicine at Emory University in Atlanta.

Over the past decade, visits to the emergency department—now up to about 114 million a year—have risen twice as fast as population growth. During the same period, the number of EDs shrank by 425, and the number of inpatient hospital beds fell by nearly 200,000.

“Do the math—with more people needing care and few resources available to provide that care, crowding in the ED was inevitable,” Dr. Kellermann said.

And with fewer hospital beds available, more severely ill and injured patients are boarded in the emergency department's exam rooms or even hallways until an inpatient bed can be made available.

“Some of them wait for hours, others wait for days. Meanwhile, other emergency patients are arriving every hour,” he said.

Often, EDs have no alternative but to divert inbound ambulances to other facilities. “When I started in my career, this was considered a rare and disturbing event,” Dr. Kellermann said. “It now happens more than half a million times a year in the United States.”

Demand Outpaces Resources

Emergency department responsibilities have grown over the years, with many now being expected to provide primary care to the uninsured, diagnostic services at night or on the weekend, and behavioral health care to the community.

Meanwhile, revenue has not kept pace. Medicare and Medicaid pay below cost for many emergency services, and uncompensated care has risen.

The emergency department is considered such an important public good that it is the only medical service that all Americans have a legal right to access. But hospitals are expected to finance that care through the free market system, Carmela Coyle, senior vice president for policy at the American Hospital Association, said during a briefing the day before release of the IOM report.

And because of low, and sometimes no, reimbursement, hospitals are finding it increasingly difficult to convince specialists to agree to be on call to the emergency department.

Liability, especially in a setting where many uninsured patients are in poor health, is also a major concern for specialists, according to an AHA survey.

“It's tough to get called at two or three o'clock in the morning to come in for a case where you know you might not get paid and you might get sued,” Ms. Coyle said.

Some hospitals have begun to pay specialists a retainer to be on-call, but that is just another financial burden making emergency departments a money-losing proposition, she said.

Stress on the System

Such financial difficulties have led to the closing of scores of emergency departments, which places more pressure on the remaining facilities.

Hospitals aren't inclined to give up inpatient beds to admit patients from the emergency department, who may pay at Medicaid rates or not at all, Dr. Kellermann said.

“Right now, all the incentives are to leave the patient in the ED so that they can keep admitting electives. You are financially penalized for making the right decision for patient care, because it is the wrong decision for your business,” he said.

The IOM committee also concluded that the emergency care system is not equipped to cope with a large-scale emergency.

“You've got to ask yourself, 'If our emergency departments are struggling to handle their daily and nightly load of 911 calls, how in the world are they going to handle a mass casualty event following a terrorist strike, an outbreak of infectious disease, or a natural disaster?” Dr. Kellermann said.

Federal funding for emergency preparedness has been and remains inadequate, the committee found. In 2002 and 2003, emergency care providers received 4% of $3.38 billion in first-responder funding distributed by the Department of Homeland Security—although emergency medical services personnel make up one-third of first responders. That has left EMS providers with scant training or planning to deal with a disaster situation.

Time to Act

The committee's findings show that emergency departments cannot continue to operate without more financial support, said Dr. Rick Blum, president of the American College of Emergency Physicians.

“Hospitals must be reimbursed for the significant amounts of uncompensated emergency and trauma care they provide,” he said in a statement.

Dr. Blum called for Congress to hold hearings on the state of emergency medicine and to pass the Access to Emergency Medical Services Act, introduced in the House last September and in the Senate in May 2006.

The legislation targets several problems addressed in the report, including boarding, the lack of on-call specialists, and poor reimbursement for emergency care services.

Although emergency care on the whole is deeply troubled, the IOM committee found that there are islands of excellence—a select few facilities that have developed innovative approaches to dealing with the problems that all emergency departments face. Those islands provide a starting point on which to build a better system, committee members said.

“Our goal should be for these islands to coalesce and eventually blanket the United States with an emergency care system that has no holes,” Dr. Eastman said.

The panel envisioned a new regionalized system to coordinate care, so that patients are only taken to facilities that are appropriate and prepared to care for them, he said.

“Where there is no vision, the people perish,” Dr. Kellermann said. “Our committee has described a vision for a coordinated, regionalized, and accountable emergency care system. It's time to act.”

Secondary Report Cites Gaps in EMS

Problems with the state of hospital-based emergency care received the most focus in the release of the Institute of Medicine reports, but an accompanying report shows that systemic issues with emergency medical services also have an impact on Americans' access to appropriate emergency care.

Ambulance and other emergency medical services suffer from a level of fragmentation that has led to critical problems in efficiency, efficacy, and coordination, according to the committee's report on emergency medical services.

The system is severely lacking in data to drive, or even gauge, performance. What few data do exist point to wide variations between communities, said committee member Shirley Gamble, chief operating officer for United Way Capital Area of Austin, Tex.

“There is as much as a 10-fold difference by community in survival rates for sudden cardiac arrest,” she said. “In one community, your chance for survival could be 5%, and in another community, your chances could be 50%.”

The committee also found that the patchwork nature of emergency medical services creates barriers to communication among emergency medical service providers and between those providers and emergency departments.

The panel recommended that the federal government support efforts to gather an evidence base to help improve the performance of emergency medical services. They also advised that all paramedic training programs be accredited to ensure consistent quality across services.

Further, the IOM committee recommended that emergency preparedness efforts should focus on updating the infrastructure of the emergency medical system.

“Money needs to be advanced to provide training for EMS providers at every hospital and to provide equipment and communications systems,” said Gamble. “Many of the communications systems in our communities were put in place in the 1970s, over 35 years ago.”

WASHINGTON — Strained by rising demand and insufficient resources, the nation's emergency care is in a precarious state, an Institute of Medicine expert panel has concluded, and Congress must act to shore up the system.

Emergency departments are closing, the pool of available on-call specialists is drying up, and access to timely care in an appropriate setting is on the decline, warned Dr. A. Brent Eastman, chief medical officer of Scripps Health in San Diego, at the public release of the report compiled by the IOM's Committee on the Future of Emergency Care in the U.S. Health System.

The emergency care system's troubles are an especially frightening reality considering that it has traditionally provided the care of last resort, catching those unfortunate patients who have slipped through the gaps of the health care safety net, Dr. Eastman added. There is no longer any guarantee that it will be there when those patients need it, he cautioned at the meeting on emergency care sponsored by the Institute of Medicine.

The IOM panel recommended that Congress establish a single lead agency to oversee and manage emergency care, pulling together resources that are now currently overseen by an array of departments within various agencies, including the Department of Health and Human Services, the Department of Homeland Security, and the Department of Transportation.

As the committee envisioned it, that new lead agency would have planning and budgetary authority over the majority of emergency care activities at the federal level. Such an agency could raise the visibility of emergency medicine and emphasize the need to fund it. The agency would also coordinate how those federal dollars are spent.

Among other recommendations, the panel urged Congress to fund a demonstration program, to the tune of $88 million a year for 5 years, to assess strategies to coordinate and streamline the emergency care system. Federal agencies also need to support the development of national standards for measuring performance, the IOM said.

The report documents a host of issues besetting the emergency care system, including crowding, boarding, and diversions.

“The signs of distress are unmistakable,” said Dr. Arthur Kellermann, an IOM committee member and professor of emergency medicine at Emory University in Atlanta.

Over the past decade, visits to the emergency department—now up to about 114 million a year—have risen twice as fast as population growth. During the same period, the number of EDs shrank by 425, and the number of inpatient hospital beds fell by nearly 200,000.

“Do the math—with more people needing care and few resources available to provide that care, crowding in the ED was inevitable,” Dr. Kellermann said.

And with fewer hospital beds available, more severely ill and injured patients are boarded in the emergency department's exam rooms or even hallways until an inpatient bed can be made available.

“Some of them wait for hours, others wait for days. Meanwhile, other emergency patients are arriving every hour,” he said.

Often, EDs have no alternative but to divert inbound ambulances to other facilities. “When I started in my career, this was considered a rare and disturbing event,” Dr. Kellermann said. “It now happens more than half a million times a year in the United States.”

Demand Outpaces Resources

Emergency department responsibilities have grown over the years, with many now being expected to provide primary care to the uninsured, diagnostic services at night or on the weekend, and behavioral health care to the community.

Meanwhile, revenue has not kept pace. Medicare and Medicaid pay below cost for many emergency services, and uncompensated care has risen.

The emergency department is considered such an important public good that it is the only medical service that all Americans have a legal right to access. But hospitals are expected to finance that care through the free market system, Carmela Coyle, senior vice president for policy at the American Hospital Association, said during a briefing the day before release of the IOM report.

And because of low, and sometimes no, reimbursement, hospitals are finding it increasingly difficult to convince specialists to agree to be on call to the emergency department.

Liability, especially in a setting where many uninsured patients are in poor health, is also a major concern for specialists, according to an AHA survey.

“It's tough to get called at two or three o'clock in the morning to come in for a case where you know you might not get paid and you might get sued,” Ms. Coyle said.

Some hospitals have begun to pay specialists a retainer to be on-call, but that is just another financial burden making emergency departments a money-losing proposition, she said.

Stress on the System

Such financial difficulties have led to the closing of scores of emergency departments, which places more pressure on the remaining facilities.

Hospitals aren't inclined to give up inpatient beds to admit patients from the emergency department, who may pay at Medicaid rates or not at all, Dr. Kellermann said.

“Right now, all the incentives are to leave the patient in the ED so that they can keep admitting electives. You are financially penalized for making the right decision for patient care, because it is the wrong decision for your business,” he said.

The IOM committee also concluded that the emergency care system is not equipped to cope with a large-scale emergency.

“You've got to ask yourself, 'If our emergency departments are struggling to handle their daily and nightly load of 911 calls, how in the world are they going to handle a mass casualty event following a terrorist strike, an outbreak of infectious disease, or a natural disaster?” Dr. Kellermann said.

Federal funding for emergency preparedness has been and remains inadequate, the committee found. In 2002 and 2003, emergency care providers received 4% of $3.38 billion in first-responder funding distributed by the Department of Homeland Security—although emergency medical services personnel make up one-third of first responders. That has left EMS providers with scant training or planning to deal with a disaster situation.

Time to Act

The committee's findings show that emergency departments cannot continue to operate without more financial support, said Dr. Rick Blum, president of the American College of Emergency Physicians.

“Hospitals must be reimbursed for the significant amounts of uncompensated emergency and trauma care they provide,” he said in a statement.

Dr. Blum called for Congress to hold hearings on the state of emergency medicine and to pass the Access to Emergency Medical Services Act, introduced in the House last September and in the Senate in May 2006.

The legislation targets several problems addressed in the report, including boarding, the lack of on-call specialists, and poor reimbursement for emergency care services.

Although emergency care on the whole is deeply troubled, the IOM committee found that there are islands of excellence—a select few facilities that have developed innovative approaches to dealing with the problems that all emergency departments face. Those islands provide a starting point on which to build a better system, committee members said.

“Our goal should be for these islands to coalesce and eventually blanket the United States with an emergency care system that has no holes,” Dr. Eastman said.

The panel envisioned a new regionalized system to coordinate care, so that patients are only taken to facilities that are appropriate and prepared to care for them, he said.

“Where there is no vision, the people perish,” Dr. Kellermann said. “Our committee has described a vision for a coordinated, regionalized, and accountable emergency care system. It's time to act.”

Secondary Report Cites Gaps in EMS

Problems with the state of hospital-based emergency care received the most focus in the release of the Institute of Medicine reports, but an accompanying report shows that systemic issues with emergency medical services also have an impact on Americans' access to appropriate emergency care.

Ambulance and other emergency medical services suffer from a level of fragmentation that has led to critical problems in efficiency, efficacy, and coordination, according to the committee's report on emergency medical services.

The system is severely lacking in data to drive, or even gauge, performance. What few data do exist point to wide variations between communities, said committee member Shirley Gamble, chief operating officer for United Way Capital Area of Austin, Tex.

“There is as much as a 10-fold difference by community in survival rates for sudden cardiac arrest,” she said. “In one community, your chance for survival could be 5%, and in another community, your chances could be 50%.”

The committee also found that the patchwork nature of emergency medical services creates barriers to communication among emergency medical service providers and between those providers and emergency departments.

The panel recommended that the federal government support efforts to gather an evidence base to help improve the performance of emergency medical services. They also advised that all paramedic training programs be accredited to ensure consistent quality across services.

Further, the IOM committee recommended that emergency preparedness efforts should focus on updating the infrastructure of the emergency medical system.

“Money needs to be advanced to provide training for EMS providers at every hospital and to provide equipment and communications systems,” said Gamble. “Many of the communications systems in our communities were put in place in the 1970s, over 35 years ago.”

BALTIMORE — Personal health records may be the next step in the evolution of health information technology, but these electronic documents raise several legal and security issues for long-term care facilities.

“PHRs might in fact have the opportunity to leapfrog over things that are happening in electronic health records,” Dr. Steven Labkoff, director of business technology for Pfizer Inc., said at a meeting on long-term care health information technology.

The main difference between personal health records (PHRs) and electronic health records is who owns them. Ideally, patients should own their PHRs. But it is still unclear who should control what information is entered in the document and, perhaps more important, who should be able to delete information from the record, experts said at the meeting, sponsored by the American Health Information Management Association (AHIMA).

An online public survey conducted in 2003 found that 71% of respondents believed that personal health records would improve the quality of health care, said Jill Burrington-Brown, practice manager for health information management products and services at AHIMA.

“The time is now to accelerate the development of personal health records,” she said, citing a report from Connecting for Health, a project of the Markle Foundation to promote the adoption and use of personal health records.

“A second finding was that PHRs are a means to necessary ends, such as increased consumer health awareness, activation, safety, and self-efficacy,” she said.

During roundtable discussions, meeting attendees said that they thought personal health records are a potentially important component of health information technology efforts, but many also had misgivings about the security risk represented by giving seniors, some with cognitive deficits, electronic access to their health records.

“Every day is a day that we work on security to make sure it is tight and concise,” said Daniel Wilt, director of information technology for Erickson Retirement Communities.

Erickson has launched a pilot program that allows residents to remotely access laboratory results, physician notes, and medical histories. The system also allows residents to schedule appointments and keep health journals.

“They want their labs. That's the one thing they really want. They go to the medical center, they run back upstairs, they go to their computers, and they ask, 'It's been twenty minutes; where are my labs?' We have to explain to them that it takes 24 hours to obtain lab results,” he said.

Although most users really like the system in the Erickson pilot program, administrators have had to struggle with how much access they believe the public should have.

For example, Mr. Wilt said, should administrators allow adult children to look at personal health records or let residents change information that they deem incorrect?

By definition, personal health records need to be individually owned, Ms. Burrington-Brown said.

“The individuals own the PHR in a similar way as we own money in the bank. There is some conversation in the industry about who really owns that, because of who produces it. That is a conversation that is going to be going on” for quite some time, she said.

A number of industry groups are working on a standard format for personal health records.

In addition, groups such as the American Health Information Community and the National Committee on Vital and Health Statistics are developing standards to ensure interoperability and security of those documents.

“We have a lot of PHR activities occurring at many levels,” she said.

BALTIMORE — Personal health records may be the next step in the evolution of health information technology, but these electronic documents raise several legal and security issues for long-term care facilities.

“PHRs might in fact have the opportunity to leapfrog over things that are happening in electronic health records,” Dr. Steven Labkoff, director of business technology for Pfizer Inc., said at a meeting on long-term care health information technology.

The main difference between personal health records (PHRs) and electronic health records is who owns them. Ideally, patients should own their PHRs. But it is still unclear who should control what information is entered in the document and, perhaps more important, who should be able to delete information from the record, experts said at the meeting, sponsored by the American Health Information Management Association (AHIMA).

An online public survey conducted in 2003 found that 71% of respondents believed that personal health records would improve the quality of health care, said Jill Burrington-Brown, practice manager for health information management products and services at AHIMA.

“The time is now to accelerate the development of personal health records,” she said, citing a report from Connecting for Health, a project of the Markle Foundation to promote the adoption and use of personal health records.

“A second finding was that PHRs are a means to necessary ends, such as increased consumer health awareness, activation, safety, and self-efficacy,” she said.

During roundtable discussions, meeting attendees said that they thought personal health records are a potentially important component of health information technology efforts, but many also had misgivings about the security risk represented by giving seniors, some with cognitive deficits, electronic access to their health records.

“Every day is a day that we work on security to make sure it is tight and concise,” said Daniel Wilt, director of information technology for Erickson Retirement Communities.

Erickson has launched a pilot program that allows residents to remotely access laboratory results, physician notes, and medical histories. The system also allows residents to schedule appointments and keep health journals.

“They want their labs. That's the one thing they really want. They go to the medical center, they run back upstairs, they go to their computers, and they ask, 'It's been twenty minutes; where are my labs?' We have to explain to them that it takes 24 hours to obtain lab results,” he said.

Although most users really like the system in the Erickson pilot program, administrators have had to struggle with how much access they believe the public should have.

For example, Mr. Wilt said, should administrators allow adult children to look at personal health records or let residents change information that they deem incorrect?

By definition, personal health records need to be individually owned, Ms. Burrington-Brown said.

“The individuals own the PHR in a similar way as we own money in the bank. There is some conversation in the industry about who really owns that, because of who produces it. That is a conversation that is going to be going on” for quite some time, she said.

A number of industry groups are working on a standard format for personal health records.

In addition, groups such as the American Health Information Community and the National Committee on Vital and Health Statistics are developing standards to ensure interoperability and security of those documents.

“We have a lot of PHR activities occurring at many levels,” she said.

BALTIMORE — Personal health records may be the next step in the evolution of health information technology, but these electronic documents raise several legal and security issues for long-term care facilities.

“PHRs might in fact have the opportunity to leapfrog over things that are happening in electronic health records,” Dr. Steven Labkoff, director of business technology for Pfizer Inc., said at a meeting on long-term care health information technology.

The main difference between personal health records (PHRs) and electronic health records is who owns them. Ideally, patients should own their PHRs. But it is still unclear who should control what information is entered in the document and, perhaps more important, who should be able to delete information from the record, experts said at the meeting, sponsored by the American Health Information Management Association (AHIMA).

An online public survey conducted in 2003 found that 71% of respondents believed that personal health records would improve the quality of health care, said Jill Burrington-Brown, practice manager for health information management products and services at AHIMA.

“The time is now to accelerate the development of personal health records,” she said, citing a report from Connecting for Health, a project of the Markle Foundation to promote the adoption and use of personal health records.

“A second finding was that PHRs are a means to necessary ends, such as increased consumer health awareness, activation, safety, and self-efficacy,” she said.

During roundtable discussions, meeting attendees said that they thought personal health records are a potentially important component of health information technology efforts, but many also had misgivings about the security risk represented by giving seniors, some with cognitive deficits, electronic access to their health records.

“Every day is a day that we work on security to make sure it is tight and concise,” said Daniel Wilt, director of information technology for Erickson Retirement Communities.

Erickson has launched a pilot program that allows residents to remotely access laboratory results, physician notes, and medical histories. The system also allows residents to schedule appointments and keep health journals.

“They want their labs. That's the one thing they really want. They go to the medical center, they run back upstairs, they go to their computers, and they ask, 'It's been twenty minutes; where are my labs?' We have to explain to them that it takes 24 hours to obtain lab results,” he said.

Although most users really like the system in the Erickson pilot program, administrators have had to struggle with how much access they believe the public should have.

For example, Mr. Wilt said, should administrators allow adult children to look at personal health records or let residents change information that they deem incorrect?

By definition, personal health records need to be individually owned, Ms. Burrington-Brown said.

“The individuals own the PHR in a similar way as we own money in the bank. There is some conversation in the industry about who really owns that, because of who produces it. That is a conversation that is going to be going on” for quite some time, she said.

A number of industry groups are working on a standard format for personal health records.

In addition, groups such as the American Health Information Community and the National Committee on Vital and Health Statistics are developing standards to ensure interoperability and security of those documents.

“We have a lot of PHR activities occurring at many levels,” she said.

WASHINGTON – Strained by rising demand and insufficient resources, the nation's emergency care is in a precarious state, an Institute of Medicine expert panel has concluded, and Congress must act to shore up the system.

Emergency departments are closing, the pool of available on-call specialists is drying up, and access to timely care in an appropriate setting is on the decline, warned Dr. A. Brent Eastman, chief medical officer of Scripps Health in San Diego, at the public release of the report compiled by the IOM's Committee on the Future of Emergency Care in the U.S. Health System.

The emergency care system's troubles are an especially frightening reality considering that it has traditionally provided the care of last resort, catching those unfortunate patients who have slipped through the gaps of the health care safety net, Dr. Eastman added. There is no longer any guarantee that it will be there when those patients need it, he cautioned at the meeting on emergency care sponsored by the Institute of Medicine.

The IOM panel recommended that Congress establish a single lead agency to oversee and manage emergency care, pulling together resources that are now currently overseen by an array of departments within various agencies, including the Department of Health and Human Services, the Department of Homeland Security, and the Department of Transportation.

As the committee envisioned it, that new lead agency would have planning and budgetary authority over the majority of emergency care activities at the federal level. Such an agency could raise the visibility of emergency medicine and emphasize the need to fund it.

Among other recommendations, the panel urged Congress to fund a demonstration program, to the tune of $88 million a year for 5 years, to assess strategies to coordinate and streamline the emergency care system. Federal agencies also need to support the development of national standards for measuring performance, the IOM said.

The report documents a host of issues besetting the emergency care system, including crowding, boarding, and diversions.

“The signs of distress are unmistakable,” said Dr. Arthur Kellermann, an IOM committee member and professor of emergency medicine at Emory University in Atlanta.

Over the past decade, visits to the emergency department–now up to about 114 million a year–have risen twice as fast as population growth. During the same period, the number of EDs shrank by 425, and the number of inpatient hospital beds fell by nearly 200,000.

“Do the math–with more people needing care and few resources available to provide that care, crowding in the ED was inevitable,” Dr. Kellermann said.

And with fewer hospital beds available, more severely ill and injured patients are boarded in the emergency department's exam rooms or even hallways until an inpatient bed can be made available.

Often, EDs have no alternative but to divert inbound ambulances to other facilities. “When I started in my career, this was considered a rare and disturbing event,” Dr. Kellermann said. “It now happens more than half a million times a year in the United States.”

Demand Outpaces Resources

Emergency department responsibilities have grown over the years, with many now being expected to provide primary care to the uninsured, diagnostic services at night or on the weekend, and behavioral health care to the community.

Meanwhile, revenue has not kept pace. Medicare and Medicaid pay below cost for many emergency services, and uncompensated care has risen.

The emergency department is considered such an important public good that it is the only medical service that all Americans have a legal right to access. But hospitals are expected to finance that care through the free market system, Carmela Coyle, senior vice president for policy at the American Hospital Association, said during a briefing the day before release of the IOM report.

And because of low, and sometimes no, reimbursement, hospitals are finding it increasingly difficult to convince specialists to agree to be on call to the emergency department. Liability, especially in a setting where many uninsured patients are in poor health, is also a major concern for specialists, according to an AHA survey.

Some hospitals have begun to pay specialists a retainer to be on-call, but that is just another financial burden making emergency departments a money-losing proposition, she said.

Stress on the System

Such financial difficulties have led to the closing of scores of emergency departments, which places more pressure on the remaining facilities. Hospitals aren't inclined to give up inpatient beds to admit patients from the emergency department, who may pay at Medicaid rates or not at all, Dr. Kellermann said.

“Right now, all the incentives are to leave the patient in the ED so that they can keep admitting electives,” he said.

The IOM committee also concluded that the emergency care system is not equipped to cope with a large-scale emergency.

“You've got to ask yourself, 'If our emergency departments are struggling to handle their daily and nightly load of 911 calls, how in the world are they going to handle a mass casualty event following a terrorist strike, an outbreak of infectious disease, or a natural disaster?” Dr. Kellermann said.

Federal funding for emergency preparedness has been and remains inadequate, the committee found. In 2002 and 2003, emergency care providers received 4% of $3.38 billion in first-responder funding distributed by the Department of Homeland Security–although emergency medical services personnel make up one-third of first responders.

Time to Act

The committee's findings show that emergency departments cannot continue to operate without more financial support, said Dr. Rick Blum, president of the American College of Emergency Physicians.

“Hospitals must be reimbursed for the significant amounts of uncompensated emergency and trauma care they provide,” he said in a statement.

Dr. Blum called for Congress to hold hearings on the state of emergency medicine and to pass the Access to Emergency Medical Services Act, introduced in the House last September and in the Senate in May 2006. The legislation targets several problems addressed in the report, including boarding, the lack of on-call specialists, and poor reimbursement for emergency care services.

While emergency care on the whole is deeply troubled, the IOM committee found that there are islands of excellence–a select few facilities that have developed innovative approaches to dealing with the problems that all emergency departments face.

“Our goal should be for these islands to coalesce and eventually blanket the United States with an emergency care system that has no holes,” Dr. Eastman said.

The panel envisioned a new regionalized system to coordinate care, so that patients are only taken to facilities that are appropriate and prepared to care for them, he said.

“Where there is no vision, the people perish,” Dr. Kellermann said. “Our committee has described a vision for a coordinated, regionalized, and accountable emergency care system. It's time to act.”

WASHINGTON – Strained by rising demand and insufficient resources, the nation's emergency care is in a precarious state, an Institute of Medicine expert panel has concluded, and Congress must act to shore up the system.

Emergency departments are closing, the pool of available on-call specialists is drying up, and access to timely care in an appropriate setting is on the decline, warned Dr. A. Brent Eastman, chief medical officer of Scripps Health in San Diego, at the public release of the report compiled by the IOM's Committee on the Future of Emergency Care in the U.S. Health System.

The emergency care system's troubles are an especially frightening reality considering that it has traditionally provided the care of last resort, catching those unfortunate patients who have slipped through the gaps of the health care safety net, Dr. Eastman added. There is no longer any guarantee that it will be there when those patients need it, he cautioned at the meeting on emergency care sponsored by the Institute of Medicine.

The IOM panel recommended that Congress establish a single lead agency to oversee and manage emergency care, pulling together resources that are now currently overseen by an array of departments within various agencies, including the Department of Health and Human Services, the Department of Homeland Security, and the Department of Transportation.

As the committee envisioned it, that new lead agency would have planning and budgetary authority over the majority of emergency care activities at the federal level. Such an agency could raise the visibility of emergency medicine and emphasize the need to fund it.

Among other recommendations, the panel urged Congress to fund a demonstration program, to the tune of $88 million a year for 5 years, to assess strategies to coordinate and streamline the emergency care system. Federal agencies also need to support the development of national standards for measuring performance, the IOM said.

The report documents a host of issues besetting the emergency care system, including crowding, boarding, and diversions.

“The signs of distress are unmistakable,” said Dr. Arthur Kellermann, an IOM committee member and professor of emergency medicine at Emory University in Atlanta.

Over the past decade, visits to the emergency department–now up to about 114 million a year–have risen twice as fast as population growth. During the same period, the number of EDs shrank by 425, and the number of inpatient hospital beds fell by nearly 200,000.

“Do the math–with more people needing care and few resources available to provide that care, crowding in the ED was inevitable,” Dr. Kellermann said.

And with fewer hospital beds available, more severely ill and injured patients are boarded in the emergency department's exam rooms or even hallways until an inpatient bed can be made available.

Often, EDs have no alternative but to divert inbound ambulances to other facilities. “When I started in my career, this was considered a rare and disturbing event,” Dr. Kellermann said. “It now happens more than half a million times a year in the United States.”

Demand Outpaces Resources

Emergency department responsibilities have grown over the years, with many now being expected to provide primary care to the uninsured, diagnostic services at night or on the weekend, and behavioral health care to the community.

Meanwhile, revenue has not kept pace. Medicare and Medicaid pay below cost for many emergency services, and uncompensated care has risen.

The emergency department is considered such an important public good that it is the only medical service that all Americans have a legal right to access. But hospitals are expected to finance that care through the free market system, Carmela Coyle, senior vice president for policy at the American Hospital Association, said during a briefing the day before release of the IOM report.

And because of low, and sometimes no, reimbursement, hospitals are finding it increasingly difficult to convince specialists to agree to be on call to the emergency department. Liability, especially in a setting where many uninsured patients are in poor health, is also a major concern for specialists, according to an AHA survey.

Some hospitals have begun to pay specialists a retainer to be on-call, but that is just another financial burden making emergency departments a money-losing proposition, she said.

Stress on the System

Such financial difficulties have led to the closing of scores of emergency departments, which places more pressure on the remaining facilities. Hospitals aren't inclined to give up inpatient beds to admit patients from the emergency department, who may pay at Medicaid rates or not at all, Dr. Kellermann said.

“Right now, all the incentives are to leave the patient in the ED so that they can keep admitting electives,” he said.

The IOM committee also concluded that the emergency care system is not equipped to cope with a large-scale emergency.

“You've got to ask yourself, 'If our emergency departments are struggling to handle their daily and nightly load of 911 calls, how in the world are they going to handle a mass casualty event following a terrorist strike, an outbreak of infectious disease, or a natural disaster?” Dr. Kellermann said.

Federal funding for emergency preparedness has been and remains inadequate, the committee found. In 2002 and 2003, emergency care providers received 4% of $3.38 billion in first-responder funding distributed by the Department of Homeland Security–although emergency medical services personnel make up one-third of first responders.

Time to Act

The committee's findings show that emergency departments cannot continue to operate without more financial support, said Dr. Rick Blum, president of the American College of Emergency Physicians.

“Hospitals must be reimbursed for the significant amounts of uncompensated emergency and trauma care they provide,” he said in a statement.

Dr. Blum called for Congress to hold hearings on the state of emergency medicine and to pass the Access to Emergency Medical Services Act, introduced in the House last September and in the Senate in May 2006. The legislation targets several problems addressed in the report, including boarding, the lack of on-call specialists, and poor reimbursement for emergency care services.

While emergency care on the whole is deeply troubled, the IOM committee found that there are islands of excellence–a select few facilities that have developed innovative approaches to dealing with the problems that all emergency departments face.

“Our goal should be for these islands to coalesce and eventually blanket the United States with an emergency care system that has no holes,” Dr. Eastman said.

The panel envisioned a new regionalized system to coordinate care, so that patients are only taken to facilities that are appropriate and prepared to care for them, he said.

“Where there is no vision, the people perish,” Dr. Kellermann said. “Our committee has described a vision for a coordinated, regionalized, and accountable emergency care system. It's time to act.”

WASHINGTON – Strained by rising demand and insufficient resources, the nation's emergency care is in a precarious state, an Institute of Medicine expert panel has concluded, and Congress must act to shore up the system.

Emergency departments are closing, the pool of available on-call specialists is drying up, and access to timely care in an appropriate setting is on the decline, warned Dr. A. Brent Eastman, chief medical officer of Scripps Health in San Diego, at the public release of the report compiled by the IOM's Committee on the Future of Emergency Care in the U.S. Health System.

The emergency care system's troubles are an especially frightening reality considering that it has traditionally provided the care of last resort, catching those unfortunate patients who have slipped through the gaps of the health care safety net, Dr. Eastman added. There is no longer any guarantee that it will be there when those patients need it, he cautioned at the meeting on emergency care sponsored by the Institute of Medicine.

The IOM panel recommended that Congress establish a single lead agency to oversee and manage emergency care, pulling together resources that are now currently overseen by an array of departments within various agencies, including the Department of Health and Human Services, the Department of Homeland Security, and the Department of Transportation.

As the committee envisioned it, that new lead agency would have planning and budgetary authority over the majority of emergency care activities at the federal level. Such an agency could raise the visibility of emergency medicine and emphasize the need to fund it.

Among other recommendations, the panel urged Congress to fund a demonstration program, to the tune of $88 million a year for 5 years, to assess strategies to coordinate and streamline the emergency care system. Federal agencies also need to support the development of national standards for measuring performance, the IOM said.

The report documents a host of issues besetting the emergency care system, including crowding, boarding, and diversions.

“The signs of distress are unmistakable,” said Dr. Arthur Kellermann, an IOM committee member and professor of emergency medicine at Emory University in Atlanta.

Over the past decade, visits to the emergency department–now up to about 114 million a year–have risen twice as fast as population growth. During the same period, the number of EDs shrank by 425, and the number of inpatient hospital beds fell by nearly 200,000.

“Do the math–with more people needing care and few resources available to provide that care, crowding in the ED was inevitable,” Dr. Kellermann said.

And with fewer hospital beds available, more severely ill and injured patients are boarded in the emergency department's exam rooms or even hallways until an inpatient bed can be made available.

Often, EDs have no alternative but to divert inbound ambulances to other facilities. “When I started in my career, this was considered a rare and disturbing event,” Dr. Kellermann said. “It now happens more than half a million times a year in the United States.”

Demand Outpaces Resources

Emergency department responsibilities have grown over the years, with many now being expected to provide primary care to the uninsured, diagnostic services at night or on the weekend, and behavioral health care to the community.

Meanwhile, revenue has not kept pace. Medicare and Medicaid pay below cost for many emergency services, and uncompensated care has risen.

The emergency department is considered such an important public good that it is the only medical service that all Americans have a legal right to access. But hospitals are expected to finance that care through the free market system, Carmela Coyle, senior vice president for policy at the American Hospital Association, said during a briefing the day before release of the IOM report.

And because of low, and sometimes no, reimbursement, hospitals are finding it increasingly difficult to convince specialists to agree to be on call to the emergency department. Liability, especially in a setting where many uninsured patients are in poor health, is also a major concern for specialists, according to an AHA survey.

Some hospitals have begun to pay specialists a retainer to be on-call, but that is just another financial burden making emergency departments a money-losing proposition, she said.

Stress on the System

Such financial difficulties have led to the closing of scores of emergency departments, which places more pressure on the remaining facilities. Hospitals aren't inclined to give up inpatient beds to admit patients from the emergency department, who may pay at Medicaid rates or not at all, Dr. Kellermann said.

“Right now, all the incentives are to leave the patient in the ED so that they can keep admitting electives,” he said.

The IOM committee also concluded that the emergency care system is not equipped to cope with a large-scale emergency.

“You've got to ask yourself, 'If our emergency departments are struggling to handle their daily and nightly load of 911 calls, how in the world are they going to handle a mass casualty event following a terrorist strike, an outbreak of infectious disease, or a natural disaster?” Dr. Kellermann said.

Federal funding for emergency preparedness has been and remains inadequate, the committee found. In 2002 and 2003, emergency care providers received 4% of $3.38 billion in first-responder funding distributed by the Department of Homeland Security–although emergency medical services personnel make up one-third of first responders.

Time to Act

The committee's findings show that emergency departments cannot continue to operate without more financial support, said Dr. Rick Blum, president of the American College of Emergency Physicians.

“Hospitals must be reimbursed for the significant amounts of uncompensated emergency and trauma care they provide,” he said in a statement.

Dr. Blum called for Congress to hold hearings on the state of emergency medicine and to pass the Access to Emergency Medical Services Act, introduced in the House last September and in the Senate in May 2006. The legislation targets several problems addressed in the report, including boarding, the lack of on-call specialists, and poor reimbursement for emergency care services.

While emergency care on the whole is deeply troubled, the IOM committee found that there are islands of excellence–a select few facilities that have developed innovative approaches to dealing with the problems that all emergency departments face.

“Our goal should be for these islands to coalesce and eventually blanket the United States with an emergency care system that has no holes,” Dr. Eastman said.

The panel envisioned a new regionalized system to coordinate care, so that patients are only taken to facilities that are appropriate and prepared to care for them, he said.

“Where there is no vision, the people perish,” Dr. Kellermann said. “Our committee has described a vision for a coordinated, regionalized, and accountable emergency care system. It's time to act.”