Joyce Frieden

WASHINGTON – Physicians who are too nervous to completely convert their offices to electronic health records can start the process with a few “baby steps” to make it less intimidating, Dr. Daniel Sands said at a health care congress sponsored by the Wall Street Journal and CNBC.

Physicians are often reluctant to leap into an EHR system because of its complexity and expense, said Dr. Sands, of Harvard University, Boston. “If you're a doctor, what do you do? How do you get that [EHR] if you can't take the one big leap?”

One way to start is by using electronic communications with patients and with office staff, he said. “Why don't you get rid of those stupid yellow Post-It notes you use for phone messages? A simple step like that is a good way to get people engaged with technology.”

Electronic prescribing is another way to bridge the gap, said Dr. Sands, who is also chief medical officer of ZixCorp, a Newton, Mass., company that sells eletronic prescribing software. Medications can be prescribed using various devices, including desktop and laptop computers, handhelds, and even mobile phones. Studies have shown that electronic prescribing can reduce medication errors substantially, he said.

Another baby step to take is using online clinical reference materials, Dr. Sands said. “We have lots of data showing that physicians are often faced with questions when taking care of patients, and they can't find the answers because they don't have time, so they just move on. And that's really scary.”

Rather than looking for answers “in a book that's out of date as soon as it's printed, maybe looking online would be a great place to start,” Dr. Sands said.

WASHINGTON – Physicians who are too nervous to completely convert their offices to electronic health records can start the process with a few “baby steps” to make it less intimidating, Dr. Daniel Sands said at a health care congress sponsored by the Wall Street Journal and CNBC.

Physicians are often reluctant to leap into an EHR system because of its complexity and expense, said Dr. Sands, of Harvard University, Boston. “If you're a doctor, what do you do? How do you get that [EHR] if you can't take the one big leap?”

One way to start is by using electronic communications with patients and with office staff, he said. “Why don't you get rid of those stupid yellow Post-It notes you use for phone messages? A simple step like that is a good way to get people engaged with technology.”

Electronic prescribing is another way to bridge the gap, said Dr. Sands, who is also chief medical officer of ZixCorp, a Newton, Mass., company that sells eletronic prescribing software. Medications can be prescribed using various devices, including desktop and laptop computers, handhelds, and even mobile phones. Studies have shown that electronic prescribing can reduce medication errors substantially, he said.

Another baby step to take is using online clinical reference materials, Dr. Sands said. “We have lots of data showing that physicians are often faced with questions when taking care of patients, and they can't find the answers because they don't have time, so they just move on. And that's really scary.”

Rather than looking for answers “in a book that's out of date as soon as it's printed, maybe looking online would be a great place to start,” Dr. Sands said.

WASHINGTON – Physicians who are too nervous to completely convert their offices to electronic health records can start the process with a few “baby steps” to make it less intimidating, Dr. Daniel Sands said at a health care congress sponsored by the Wall Street Journal and CNBC.

Physicians are often reluctant to leap into an EHR system because of its complexity and expense, said Dr. Sands, of Harvard University, Boston. “If you're a doctor, what do you do? How do you get that [EHR] if you can't take the one big leap?”

One way to start is by using electronic communications with patients and with office staff, he said. “Why don't you get rid of those stupid yellow Post-It notes you use for phone messages? A simple step like that is a good way to get people engaged with technology.”

Electronic prescribing is another way to bridge the gap, said Dr. Sands, who is also chief medical officer of ZixCorp, a Newton, Mass., company that sells eletronic prescribing software. Medications can be prescribed using various devices, including desktop and laptop computers, handhelds, and even mobile phones. Studies have shown that electronic prescribing can reduce medication errors substantially, he said.

Another baby step to take is using online clinical reference materials, Dr. Sands said. “We have lots of data showing that physicians are often faced with questions when taking care of patients, and they can't find the answers because they don't have time, so they just move on. And that's really scary.”

Rather than looking for answers “in a book that's out of date as soon as it's printed, maybe looking online would be a great place to start,” Dr. Sands said.

WASHINGTON – Knowing which Medicare managed care plans provide high-quality care is a good idea, but Medicare beneficiaries will need more information to figure out which providers to see within a particular plan, Glenn M. Hackbarth, J.D., said at a meeting of the Medicare Payment Advisory Commission.

In Boston, for instance, “If you're a Medicare beneficiary trying to get good health care, knowing that Harvard Pilgrim Health Care is ranked number one doesn't tell you at all where to go within the Harvard Pilgrim network to get really outstanding care,” said Mr. Hackbarth, a Bend, Ore., health care consultant who is chairman of MedPAC. “That's something that needs to be understood about plan rankings.”

The commission staff ranked about 150 Medicare Advantage plans, which are managed care plans offered to Medicare beneficiaries. Senior analyst Niall Brennan presented their work.

To assess the plans, staff members looked at plan scores on nine different measures within the Health Plan Employer Data and Information Set (HEDIS) database. The researchers looked only at HMO plans; PPO and fee-for-service programs within Medicare Advantage were excluded because they weren't required to report on all HEDIS measures.

Measures included breast cancer screening, ?-blocker treatment after a heart attack, antidepressant medication management, hypertension management, osteoporosis management, cholesterol management, follow-up after mental illness, and colorectal cancer screening. One additional measure, diabetes care, counted double in the scoring, Mr. Brennan said.

Scores were calculated based on how well each plan did compared with other plans–for instance, a plan that scored above the 90th percentile on a particular measure received 1 point, while a plan that scored between the 75th and 90th percentile received a 0.88. Ten points constituted a perfect score.

Mr. Brennan noted that the total scores of the plans the staff evaluated ranged from 1.2 to 9.8. And different measures had very different levels of result. For example, “giving ?-blockers after a heart attack is a well-established quality measure, and plans tend to score very highly on it,” he said. “Other measures [such as osteoporosis management] are a little lower and more widely dispersed.”

In general, bigger plans seemed to perform better, with plans that had more than 50,000 enrollees having an average HEDIS score of 7.5 compared with an average of 5.7 for plans with fewer than 10,000 enrollees. Not-for-profit plans had slightly higher scores than did for-profit plans. And while there was not a lot of geographic variation, Boston area plans did score “significantly higher” in terms of quality, he said.

Scores also appeared to remain stable over time; for example, 74% of the plans in the lowest quartile in 2003 remained in the lowest quartile in 2004. “The results of our analysis are quite interesting, and highlight the need for a pay-for-performance program in Medicare Advantage, and the feasibility of using HEDIS data for differentiating among Medicare Advantage plans,” Mr. Brennan said.

MedPAC commissioners, however, were not sure how useful the scores would be, especially if the quality data were supposed to be used as the basis for a pay-for-performance plan.

“If this looks like a good measure for implementing a pay-for-performance program, I'd like to step back and say that it isn't,” said Commission Vice-Chair Robert D. Reischauer, Ph.D., president of the Urban Institute.

Mr. Hackbarth noted that beneficiaries needed to look at more than just managed care plans. For plan data to be really useful, “beneficiaries ought to be able to compare plan offerings and choices to the ambient level of quality of fee-for-service Medicare in that same community,” he said. “We're moving in the right direction, but there are a host of questions about how you do these things.”

Commission member John M. Bertko, vice president and chief actuary for Humana in Louisville, Ky., said more attention should be given to data collection systems other than HEDIS, which requires use of an electronic health record. “In some markets, we literally need to go and knock on doctors' office [doors] to collect these data,” he said.

WASHINGTON – Knowing which Medicare managed care plans provide high-quality care is a good idea, but Medicare beneficiaries will need more information to figure out which providers to see within a particular plan, Glenn M. Hackbarth, J.D., said at a meeting of the Medicare Payment Advisory Commission.

In Boston, for instance, “If you're a Medicare beneficiary trying to get good health care, knowing that Harvard Pilgrim Health Care is ranked number one doesn't tell you at all where to go within the Harvard Pilgrim network to get really outstanding care,” said Mr. Hackbarth, a Bend, Ore., health care consultant who is chairman of MedPAC. “That's something that needs to be understood about plan rankings.”

The commission staff ranked about 150 Medicare Advantage plans, which are managed care plans offered to Medicare beneficiaries. Senior analyst Niall Brennan presented their work.

To assess the plans, staff members looked at plan scores on nine different measures within the Health Plan Employer Data and Information Set (HEDIS) database. The researchers looked only at HMO plans; PPO and fee-for-service programs within Medicare Advantage were excluded because they weren't required to report on all HEDIS measures.

Measures included breast cancer screening, ?-blocker treatment after a heart attack, antidepressant medication management, hypertension management, osteoporosis management, cholesterol management, follow-up after mental illness, and colorectal cancer screening. One additional measure, diabetes care, counted double in the scoring, Mr. Brennan said.

Scores were calculated based on how well each plan did compared with other plans–for instance, a plan that scored above the 90th percentile on a particular measure received 1 point, while a plan that scored between the 75th and 90th percentile received a 0.88. Ten points constituted a perfect score.

Mr. Brennan noted that the total scores of the plans the staff evaluated ranged from 1.2 to 9.8. And different measures had very different levels of result. For example, “giving ?-blockers after a heart attack is a well-established quality measure, and plans tend to score very highly on it,” he said. “Other measures [such as osteoporosis management] are a little lower and more widely dispersed.”

In general, bigger plans seemed to perform better, with plans that had more than 50,000 enrollees having an average HEDIS score of 7.5 compared with an average of 5.7 for plans with fewer than 10,000 enrollees. Not-for-profit plans had slightly higher scores than did for-profit plans. And while there was not a lot of geographic variation, Boston area plans did score “significantly higher” in terms of quality, he said.

Scores also appeared to remain stable over time; for example, 74% of the plans in the lowest quartile in 2003 remained in the lowest quartile in 2004. “The results of our analysis are quite interesting, and highlight the need for a pay-for-performance program in Medicare Advantage, and the feasibility of using HEDIS data for differentiating among Medicare Advantage plans,” Mr. Brennan said.

MedPAC commissioners, however, were not sure how useful the scores would be, especially if the quality data were supposed to be used as the basis for a pay-for-performance plan.

“If this looks like a good measure for implementing a pay-for-performance program, I'd like to step back and say that it isn't,” said Commission Vice-Chair Robert D. Reischauer, Ph.D., president of the Urban Institute.

Mr. Hackbarth noted that beneficiaries needed to look at more than just managed care plans. For plan data to be really useful, “beneficiaries ought to be able to compare plan offerings and choices to the ambient level of quality of fee-for-service Medicare in that same community,” he said. “We're moving in the right direction, but there are a host of questions about how you do these things.”

Commission member John M. Bertko, vice president and chief actuary for Humana in Louisville, Ky., said more attention should be given to data collection systems other than HEDIS, which requires use of an electronic health record. “In some markets, we literally need to go and knock on doctors' office [doors] to collect these data,” he said.

WASHINGTON – Knowing which Medicare managed care plans provide high-quality care is a good idea, but Medicare beneficiaries will need more information to figure out which providers to see within a particular plan, Glenn M. Hackbarth, J.D., said at a meeting of the Medicare Payment Advisory Commission.

In Boston, for instance, “If you're a Medicare beneficiary trying to get good health care, knowing that Harvard Pilgrim Health Care is ranked number one doesn't tell you at all where to go within the Harvard Pilgrim network to get really outstanding care,” said Mr. Hackbarth, a Bend, Ore., health care consultant who is chairman of MedPAC. “That's something that needs to be understood about plan rankings.”

The commission staff ranked about 150 Medicare Advantage plans, which are managed care plans offered to Medicare beneficiaries. Senior analyst Niall Brennan presented their work.

To assess the plans, staff members looked at plan scores on nine different measures within the Health Plan Employer Data and Information Set (HEDIS) database. The researchers looked only at HMO plans; PPO and fee-for-service programs within Medicare Advantage were excluded because they weren't required to report on all HEDIS measures.

Measures included breast cancer screening, ?-blocker treatment after a heart attack, antidepressant medication management, hypertension management, osteoporosis management, cholesterol management, follow-up after mental illness, and colorectal cancer screening. One additional measure, diabetes care, counted double in the scoring, Mr. Brennan said.

Scores were calculated based on how well each plan did compared with other plans–for instance, a plan that scored above the 90th percentile on a particular measure received 1 point, while a plan that scored between the 75th and 90th percentile received a 0.88. Ten points constituted a perfect score.

Mr. Brennan noted that the total scores of the plans the staff evaluated ranged from 1.2 to 9.8. And different measures had very different levels of result. For example, “giving ?-blockers after a heart attack is a well-established quality measure, and plans tend to score very highly on it,” he said. “Other measures [such as osteoporosis management] are a little lower and more widely dispersed.”

In general, bigger plans seemed to perform better, with plans that had more than 50,000 enrollees having an average HEDIS score of 7.5 compared with an average of 5.7 for plans with fewer than 10,000 enrollees. Not-for-profit plans had slightly higher scores than did for-profit plans. And while there was not a lot of geographic variation, Boston area plans did score “significantly higher” in terms of quality, he said.

Scores also appeared to remain stable over time; for example, 74% of the plans in the lowest quartile in 2003 remained in the lowest quartile in 2004. “The results of our analysis are quite interesting, and highlight the need for a pay-for-performance program in Medicare Advantage, and the feasibility of using HEDIS data for differentiating among Medicare Advantage plans,” Mr. Brennan said.

MedPAC commissioners, however, were not sure how useful the scores would be, especially if the quality data were supposed to be used as the basis for a pay-for-performance plan.

“If this looks like a good measure for implementing a pay-for-performance program, I'd like to step back and say that it isn't,” said Commission Vice-Chair Robert D. Reischauer, Ph.D., president of the Urban Institute.

Mr. Hackbarth noted that beneficiaries needed to look at more than just managed care plans. For plan data to be really useful, “beneficiaries ought to be able to compare plan offerings and choices to the ambient level of quality of fee-for-service Medicare in that same community,” he said. “We're moving in the right direction, but there are a host of questions about how you do these things.”

Commission member John M. Bertko, vice president and chief actuary for Humana in Louisville, Ky., said more attention should be given to data collection systems other than HEDIS, which requires use of an electronic health record. “In some markets, we literally need to go and knock on doctors' office [doors] to collect these data,” he said.

MONTREAL — When members of the Food and Drug Administration's advisory panels make recommendations about placing “black box” labels on selective serotonin reuptake inhibitors, many factors influence their decision making, Philip J. Candilis, M.D., said at the annual meeting of the American Academy of Psychiatry and the Law.

First is the obvious issue of direct pharmaceutical industry influence on the panels, as seen in the cases of Bextra, Vioxx, and Celebrex, Dr. Candilis said. “Early on in the debate on anti-inflammatories, the panels had endorsed their continued use,” he said. “But look at the experts who declared ties to the pharmaceutical industry.” Of the 32 experts on the panel, 10 had declared some ties to the pharmaceutical industry. Each panelist had to vote “yes” or “no” to recommending each of the three medications.

“Those [10] who had consulted to the pharmaceutical industry voted 28 of their total of 30 votes in favor of these medications. Those without such conflicts cast 37 of their 66 votes in favor,” he said. “So there was a substantial and statistically significant difference in how people were supported and how they voted.”

But broader influences are at play as well. For instance, the FDA regulates one-quarter of the gross national product, which comes to “hundreds of billions of dollars,” said Dr. Candilis, of the law and psychiatry program at the University of Massachusetts, Worcester. And to do part of that job, the agency receives millions in fees from the pharmaceutical industry, he said.

“So there's already a dependence there: 40%–50% of the [FDA's] budget comes from fees that industry pays in order for the FDA to govern the medications that they submit.”

The agency also exerts pressure on its own employees, he continued. He noted that one physician testified before Congress that he'd been asked by FDA officials to alter his affidavit concerning the increased risk of suicide in children and youth taking antidepressants.

Slowly, people are becoming more aware of these conflicts and taking action to mitigate them, Dr. Candilis said. For example, Congress is now insisting that pharmaceutical companies register the results of all clinical trials, including negative results. And some professional organizations are precluding experts from peer review entirely if they have conflicts of interest.

The take-home message is this: “If we don't regulate it, Congress will, others will, people with an agenda will,” he said. “We have to start doing full public disclosure of [conflicts of] interest, a transparency model, more explicit policies, less management and more recusal. We must step away from just saying, 'I'm going to tell you what I own.'”

MONTREAL — When members of the Food and Drug Administration's advisory panels make recommendations about placing “black box” labels on selective serotonin reuptake inhibitors, many factors influence their decision making, Philip J. Candilis, M.D., said at the annual meeting of the American Academy of Psychiatry and the Law.

First is the obvious issue of direct pharmaceutical industry influence on the panels, as seen in the cases of Bextra, Vioxx, and Celebrex, Dr. Candilis said. “Early on in the debate on anti-inflammatories, the panels had endorsed their continued use,” he said. “But look at the experts who declared ties to the pharmaceutical industry.” Of the 32 experts on the panel, 10 had declared some ties to the pharmaceutical industry. Each panelist had to vote “yes” or “no” to recommending each of the three medications.

“Those [10] who had consulted to the pharmaceutical industry voted 28 of their total of 30 votes in favor of these medications. Those without such conflicts cast 37 of their 66 votes in favor,” he said. “So there was a substantial and statistically significant difference in how people were supported and how they voted.”

But broader influences are at play as well. For instance, the FDA regulates one-quarter of the gross national product, which comes to “hundreds of billions of dollars,” said Dr. Candilis, of the law and psychiatry program at the University of Massachusetts, Worcester. And to do part of that job, the agency receives millions in fees from the pharmaceutical industry, he said.

“So there's already a dependence there: 40%–50% of the [FDA's] budget comes from fees that industry pays in order for the FDA to govern the medications that they submit.”

The agency also exerts pressure on its own employees, he continued. He noted that one physician testified before Congress that he'd been asked by FDA officials to alter his affidavit concerning the increased risk of suicide in children and youth taking antidepressants.

Slowly, people are becoming more aware of these conflicts and taking action to mitigate them, Dr. Candilis said. For example, Congress is now insisting that pharmaceutical companies register the results of all clinical trials, including negative results. And some professional organizations are precluding experts from peer review entirely if they have conflicts of interest.

The take-home message is this: “If we don't regulate it, Congress will, others will, people with an agenda will,” he said. “We have to start doing full public disclosure of [conflicts of] interest, a transparency model, more explicit policies, less management and more recusal. We must step away from just saying, 'I'm going to tell you what I own.'”

MONTREAL — When members of the Food and Drug Administration's advisory panels make recommendations about placing “black box” labels on selective serotonin reuptake inhibitors, many factors influence their decision making, Philip J. Candilis, M.D., said at the annual meeting of the American Academy of Psychiatry and the Law.

First is the obvious issue of direct pharmaceutical industry influence on the panels, as seen in the cases of Bextra, Vioxx, and Celebrex, Dr. Candilis said. “Early on in the debate on anti-inflammatories, the panels had endorsed their continued use,” he said. “But look at the experts who declared ties to the pharmaceutical industry.” Of the 32 experts on the panel, 10 had declared some ties to the pharmaceutical industry. Each panelist had to vote “yes” or “no” to recommending each of the three medications.

“Those [10] who had consulted to the pharmaceutical industry voted 28 of their total of 30 votes in favor of these medications. Those without such conflicts cast 37 of their 66 votes in favor,” he said. “So there was a substantial and statistically significant difference in how people were supported and how they voted.”

But broader influences are at play as well. For instance, the FDA regulates one-quarter of the gross national product, which comes to “hundreds of billions of dollars,” said Dr. Candilis, of the law and psychiatry program at the University of Massachusetts, Worcester. And to do part of that job, the agency receives millions in fees from the pharmaceutical industry, he said.

“So there's already a dependence there: 40%–50% of the [FDA's] budget comes from fees that industry pays in order for the FDA to govern the medications that they submit.”

The agency also exerts pressure on its own employees, he continued. He noted that one physician testified before Congress that he'd been asked by FDA officials to alter his affidavit concerning the increased risk of suicide in children and youth taking antidepressants.

Slowly, people are becoming more aware of these conflicts and taking action to mitigate them, Dr. Candilis said. For example, Congress is now insisting that pharmaceutical companies register the results of all clinical trials, including negative results. And some professional organizations are precluding experts from peer review entirely if they have conflicts of interest.

The take-home message is this: “If we don't regulate it, Congress will, others will, people with an agenda will,” he said. “We have to start doing full public disclosure of [conflicts of] interest, a transparency model, more explicit policies, less management and more recusal. We must step away from just saying, 'I'm going to tell you what I own.'”

WASHINGTON — The federal government is looking hard at whether to make changes to the “Nutrition Facts” label found on packaged foods, Barbara O. Schneeman, Ph.D., said at a meeting on obesity sponsored by Business Access.

In April, the Food and Drug Administration published two different “advance notices of proposed rulemaking” in the Federal Register outlining the issues it was considering, explained Dr. Schneeman, who is director of the agency's Office of Nutritional Products, Labeling, and Dietary Supplements. “Estimates indicate that more than 70% of consumers will use the panel in their first-time food purchase, and 50% said they have changed a food purchase because of what they saw on the Nutrition Facts panel,” she said. “So it's a very valuable tool.”

One question the FDA is considering is how to make calorie information more prominent on the food label. “Some of the questions we were asking were, 'What are ways to give [calorie information] more prominence? Bold typeface? Larger font size? Should we consider including a daily value of calories?'” Dr. Schneeman said. “Would that create an incentive to change the number of calories in a product?”

Serving size is another issue, she said. Under current law, food packages must provide nutrition information for the “reference amount customarily consumed” (RACC) of a product. The RACC, or serving size, is currently derived from the U.S. Department of Agriculture's Food Consumption Survey, which was taken in the late 1970s and late 1980s. “Do we need to update the RACCs? What database would we use to do that update?” she asked.

In fact, there are several issues concerning serving size, Dr. Schneeman said. “There's a lot of concern about confusion when consumers buy that 20-ounce soda or 4-ounce bag of chips. Do they realize that the labeling is for a single serving and that the container actually has more than one serving?

Dr. Schneeman said she was pleased that some manufacturers have already started including the nutrition information for the entire package of their products, even if the package contains more than one serving.

The comment period for both Federal Register notices has closed, and “I think we received far more comments on serving size than we did on calories,” she noted, adding that the agency was currently analyzing those comments.

WASHINGTON — The federal government is looking hard at whether to make changes to the “Nutrition Facts” label found on packaged foods, Barbara O. Schneeman, Ph.D., said at a meeting on obesity sponsored by Business Access.

In April, the Food and Drug Administration published two different “advance notices of proposed rulemaking” in the Federal Register outlining the issues it was considering, explained Dr. Schneeman, who is director of the agency's Office of Nutritional Products, Labeling, and Dietary Supplements. “Estimates indicate that more than 70% of consumers will use the panel in their first-time food purchase, and 50% said they have changed a food purchase because of what they saw on the Nutrition Facts panel,” she said. “So it's a very valuable tool.”

One question the FDA is considering is how to make calorie information more prominent on the food label. “Some of the questions we were asking were, 'What are ways to give [calorie information] more prominence? Bold typeface? Larger font size? Should we consider including a daily value of calories?'” Dr. Schneeman said. “Would that create an incentive to change the number of calories in a product?”

Serving size is another issue, she said. Under current law, food packages must provide nutrition information for the “reference amount customarily consumed” (RACC) of a product. The RACC, or serving size, is currently derived from the U.S. Department of Agriculture's Food Consumption Survey, which was taken in the late 1970s and late 1980s. “Do we need to update the RACCs? What database would we use to do that update?” she asked.

In fact, there are several issues concerning serving size, Dr. Schneeman said. “There's a lot of concern about confusion when consumers buy that 20-ounce soda or 4-ounce bag of chips. Do they realize that the labeling is for a single serving and that the container actually has more than one serving?

Dr. Schneeman said she was pleased that some manufacturers have already started including the nutrition information for the entire package of their products, even if the package contains more than one serving.

The comment period for both Federal Register notices has closed, and “I think we received far more comments on serving size than we did on calories,” she noted, adding that the agency was currently analyzing those comments.

WASHINGTON — The federal government is looking hard at whether to make changes to the “Nutrition Facts” label found on packaged foods, Barbara O. Schneeman, Ph.D., said at a meeting on obesity sponsored by Business Access.

In April, the Food and Drug Administration published two different “advance notices of proposed rulemaking” in the Federal Register outlining the issues it was considering, explained Dr. Schneeman, who is director of the agency's Office of Nutritional Products, Labeling, and Dietary Supplements. “Estimates indicate that more than 70% of consumers will use the panel in their first-time food purchase, and 50% said they have changed a food purchase because of what they saw on the Nutrition Facts panel,” she said. “So it's a very valuable tool.”

One question the FDA is considering is how to make calorie information more prominent on the food label. “Some of the questions we were asking were, 'What are ways to give [calorie information] more prominence? Bold typeface? Larger font size? Should we consider including a daily value of calories?'” Dr. Schneeman said. “Would that create an incentive to change the number of calories in a product?”

Serving size is another issue, she said. Under current law, food packages must provide nutrition information for the “reference amount customarily consumed” (RACC) of a product. The RACC, or serving size, is currently derived from the U.S. Department of Agriculture's Food Consumption Survey, which was taken in the late 1970s and late 1980s. “Do we need to update the RACCs? What database would we use to do that update?” she asked.

In fact, there are several issues concerning serving size, Dr. Schneeman said. “There's a lot of concern about confusion when consumers buy that 20-ounce soda or 4-ounce bag of chips. Do they realize that the labeling is for a single serving and that the container actually has more than one serving?

Dr. Schneeman said she was pleased that some manufacturers have already started including the nutrition information for the entire package of their products, even if the package contains more than one serving.

The comment period for both Federal Register notices has closed, and “I think we received far more comments on serving size than we did on calories,” she noted, adding that the agency was currently analyzing those comments.

While Guidant Corp., the troubled maker of implantable cardioverter defibrillators, struggles to repair its reputation and salvage its acquisition by Johnson & Johnson, physicians are finding it increasingly difficult to convince patients of the benefits of ICDs.

“It is more common now for a patient to say that they are concerned about whether or not they should have an ICD implanted because of problems they have read about, so I'm having to spend more time explaining the very small risk of the device compared to the huge benefit,” commented Stephen C. Hammill, M.D., director of heart rhythm services at the Mayo Clinic, Rochester, Minn.

“That's a longer discussion now. My concern is that it's deterred people from even pursuing it with the doctor,” Dr. Hammill added.

Lately, Guidant has been at the center of the controversy surrounding the safety of ICDs. In May, the Food and Drug Administration began investigating reports that the company failed to notify physicians for several years that one of its devices had short-circuited in some patients.

In early November, New York State Attorney General Eliot Spitzer filed suit against the company in federal court, alleging: “In April and November 2002, Guidant made manufacturing changes to the Prizm 1861 defibrillator intended to remedy the systemic defect and prevent the short-circuiting and resulting catastrophic failure of the device. Despite making these design changes, Guidant continued to sell Prizm 1861 defibrillators that had been manufactured before April 2002. Guidant did not disclose to physicians and patients that these devices contained a serious design flaw that had been corrected in later devices.”

A few days later, Johnson & Johnson, which had agreed to buy Guidant in a deal valued at more than $25 billion, announced that it was reconsidering the deal. Guidant sued Johnson & Johnson in federal court to force it to complete the buyout. However, Guidant also noted in its 10-Q filing to the Securities and Exchange Commission the same day that the SEC was investigating the company “related to certain of [Guidant's] product disclosures and trading in Guidant stock.”

In the same 10-Q report, Guidant also announced that it had received three requests for information from the attorneys general of Arizona, Illinois, and Oregon relating to whether the company violated any state laws in connection with its ICDs, and that 31 other states and the District of Columbia “are cooperating in these [requests].”

The company also is under scrutiny from the U.S. attorney's office in Boston “concerning marketing practices for pacemakers, ICDs, leads, and related products,” according to the filing.

Eventually, Johnson & Johnson agreed to purchase Guidant Corp. at a reduced price, lowering the value of the deal to $19 billion.

“We are delighted that our companies have reached an according,” Johnson & Johnson CEO William C. Weldon said in a statement. “Our agreement demonstrates that we remain committed to the goal of together building an extraordinary cardiovascular business that can deliver better medical options sooner to millions of patients.”

Meanwhile, as these events transpire at Guidant, device makers and physicians alike are trying to figure out exactly what level of postmarket reporting is needed for problems with ICDs.

“If people want notification about [every] model that has a malfunction, you're going to be hearing about essentially every model of every device,” commented William Maisel, M.D., director of the pacemaker and ICD service at Beth Israel Deaconess Medical Center, Boston, at a meeting sponsored by the Heart Rhythm Society that was held in cooperation with the FDA.

“These things happen, and to draw the line and expect to hear about every single malfunction by notification or letter, you'd be very, very busy,” Dr. Maisel explained.

These disclosure issues will become more prominent as medical device companies' sales volumes increase, said Thomas Gunderson, senior research analyst at Piper Jaffray & Co., a Minneapolis-based investment banking firm. “You can't have a '1-in-10,000' problem until you start selling 10,000 products. In the old days, these companies didn't. Now they do, and they're going to have to provide more data.”

This is especially important in the type of market that device companies now find themselves in, he added. “What you don't want to do in a tight oligopoly with large margins is lose consumer confidence,” Mr. Gunderson said.

And indeed, during mid-November, Guidant issued a 153-page report that listed data on the outcomes for all of its devices.

The company noted that the report was being published “in response to the medical community's call for more detailed description of device performance and access to product performance information. … We understand that lives depend on our products, and that we must seize every opportunity for continuous quality improvement.”

“The detail in this report is meant to provide an open window into this process,” the publication continues.

The Guidant report “looks like a fire hose of information,” Mr. Gunderson commented. “It will be difficult to complain that physicians, patients, Wall Street, and the media are not being provided enough data.”

The Guidant report is available online at www.guidant.com/physician/ppr

While Guidant Corp., the troubled maker of implantable cardioverter defibrillators, struggles to repair its reputation and salvage its acquisition by Johnson & Johnson, physicians are finding it increasingly difficult to convince patients of the benefits of ICDs.

“It is more common now for a patient to say that they are concerned about whether or not they should have an ICD implanted because of problems they have read about, so I'm having to spend more time explaining the very small risk of the device compared to the huge benefit,” commented Stephen C. Hammill, M.D., director of heart rhythm services at the Mayo Clinic, Rochester, Minn.

“That's a longer discussion now. My concern is that it's deterred people from even pursuing it with the doctor,” Dr. Hammill added.

Lately, Guidant has been at the center of the controversy surrounding the safety of ICDs. In May, the Food and Drug Administration began investigating reports that the company failed to notify physicians for several years that one of its devices had short-circuited in some patients.

In early November, New York State Attorney General Eliot Spitzer filed suit against the company in federal court, alleging: “In April and November 2002, Guidant made manufacturing changes to the Prizm 1861 defibrillator intended to remedy the systemic defect and prevent the short-circuiting and resulting catastrophic failure of the device. Despite making these design changes, Guidant continued to sell Prizm 1861 defibrillators that had been manufactured before April 2002. Guidant did not disclose to physicians and patients that these devices contained a serious design flaw that had been corrected in later devices.”

A few days later, Johnson & Johnson, which had agreed to buy Guidant in a deal valued at more than $25 billion, announced that it was reconsidering the deal. Guidant sued Johnson & Johnson in federal court to force it to complete the buyout. However, Guidant also noted in its 10-Q filing to the Securities and Exchange Commission the same day that the SEC was investigating the company “related to certain of [Guidant's] product disclosures and trading in Guidant stock.”

In the same 10-Q report, Guidant also announced that it had received three requests for information from the attorneys general of Arizona, Illinois, and Oregon relating to whether the company violated any state laws in connection with its ICDs, and that 31 other states and the District of Columbia “are cooperating in these [requests].”

The company also is under scrutiny from the U.S. attorney's office in Boston “concerning marketing practices for pacemakers, ICDs, leads, and related products,” according to the filing.

Eventually, Johnson & Johnson agreed to purchase Guidant Corp. at a reduced price, lowering the value of the deal to $19 billion.

“We are delighted that our companies have reached an according,” Johnson & Johnson CEO William C. Weldon said in a statement. “Our agreement demonstrates that we remain committed to the goal of together building an extraordinary cardiovascular business that can deliver better medical options sooner to millions of patients.”

Meanwhile, as these events transpire at Guidant, device makers and physicians alike are trying to figure out exactly what level of postmarket reporting is needed for problems with ICDs.

“If people want notification about [every] model that has a malfunction, you're going to be hearing about essentially every model of every device,” commented William Maisel, M.D., director of the pacemaker and ICD service at Beth Israel Deaconess Medical Center, Boston, at a meeting sponsored by the Heart Rhythm Society that was held in cooperation with the FDA.

“These things happen, and to draw the line and expect to hear about every single malfunction by notification or letter, you'd be very, very busy,” Dr. Maisel explained.

These disclosure issues will become more prominent as medical device companies' sales volumes increase, said Thomas Gunderson, senior research analyst at Piper Jaffray & Co., a Minneapolis-based investment banking firm. “You can't have a '1-in-10,000' problem until you start selling 10,000 products. In the old days, these companies didn't. Now they do, and they're going to have to provide more data.”

This is especially important in the type of market that device companies now find themselves in, he added. “What you don't want to do in a tight oligopoly with large margins is lose consumer confidence,” Mr. Gunderson said.

And indeed, during mid-November, Guidant issued a 153-page report that listed data on the outcomes for all of its devices.

The company noted that the report was being published “in response to the medical community's call for more detailed description of device performance and access to product performance information. … We understand that lives depend on our products, and that we must seize every opportunity for continuous quality improvement.”

“The detail in this report is meant to provide an open window into this process,” the publication continues.

The Guidant report “looks like a fire hose of information,” Mr. Gunderson commented. “It will be difficult to complain that physicians, patients, Wall Street, and the media are not being provided enough data.”

The Guidant report is available online at www.guidant.com/physician/ppr

While Guidant Corp., the troubled maker of implantable cardioverter defibrillators, struggles to repair its reputation and salvage its acquisition by Johnson & Johnson, physicians are finding it increasingly difficult to convince patients of the benefits of ICDs.

“It is more common now for a patient to say that they are concerned about whether or not they should have an ICD implanted because of problems they have read about, so I'm having to spend more time explaining the very small risk of the device compared to the huge benefit,” commented Stephen C. Hammill, M.D., director of heart rhythm services at the Mayo Clinic, Rochester, Minn.

“That's a longer discussion now. My concern is that it's deterred people from even pursuing it with the doctor,” Dr. Hammill added.

Lately, Guidant has been at the center of the controversy surrounding the safety of ICDs. In May, the Food and Drug Administration began investigating reports that the company failed to notify physicians for several years that one of its devices had short-circuited in some patients.

In early November, New York State Attorney General Eliot Spitzer filed suit against the company in federal court, alleging: “In April and November 2002, Guidant made manufacturing changes to the Prizm 1861 defibrillator intended to remedy the systemic defect and prevent the short-circuiting and resulting catastrophic failure of the device. Despite making these design changes, Guidant continued to sell Prizm 1861 defibrillators that had been manufactured before April 2002. Guidant did not disclose to physicians and patients that these devices contained a serious design flaw that had been corrected in later devices.”

A few days later, Johnson & Johnson, which had agreed to buy Guidant in a deal valued at more than $25 billion, announced that it was reconsidering the deal. Guidant sued Johnson & Johnson in federal court to force it to complete the buyout. However, Guidant also noted in its 10-Q filing to the Securities and Exchange Commission the same day that the SEC was investigating the company “related to certain of [Guidant's] product disclosures and trading in Guidant stock.”

In the same 10-Q report, Guidant also announced that it had received three requests for information from the attorneys general of Arizona, Illinois, and Oregon relating to whether the company violated any state laws in connection with its ICDs, and that 31 other states and the District of Columbia “are cooperating in these [requests].”

The company also is under scrutiny from the U.S. attorney's office in Boston “concerning marketing practices for pacemakers, ICDs, leads, and related products,” according to the filing.

Eventually, Johnson & Johnson agreed to purchase Guidant Corp. at a reduced price, lowering the value of the deal to $19 billion.

“We are delighted that our companies have reached an according,” Johnson & Johnson CEO William C. Weldon said in a statement. “Our agreement demonstrates that we remain committed to the goal of together building an extraordinary cardiovascular business that can deliver better medical options sooner to millions of patients.”

Meanwhile, as these events transpire at Guidant, device makers and physicians alike are trying to figure out exactly what level of postmarket reporting is needed for problems with ICDs.

“If people want notification about [every] model that has a malfunction, you're going to be hearing about essentially every model of every device,” commented William Maisel, M.D., director of the pacemaker and ICD service at Beth Israel Deaconess Medical Center, Boston, at a meeting sponsored by the Heart Rhythm Society that was held in cooperation with the FDA.

“These things happen, and to draw the line and expect to hear about every single malfunction by notification or letter, you'd be very, very busy,” Dr. Maisel explained.

These disclosure issues will become more prominent as medical device companies' sales volumes increase, said Thomas Gunderson, senior research analyst at Piper Jaffray & Co., a Minneapolis-based investment banking firm. “You can't have a '1-in-10,000' problem until you start selling 10,000 products. In the old days, these companies didn't. Now they do, and they're going to have to provide more data.”

This is especially important in the type of market that device companies now find themselves in, he added. “What you don't want to do in a tight oligopoly with large margins is lose consumer confidence,” Mr. Gunderson said.

And indeed, during mid-November, Guidant issued a 153-page report that listed data on the outcomes for all of its devices.

The company noted that the report was being published “in response to the medical community's call for more detailed description of device performance and access to product performance information. … We understand that lives depend on our products, and that we must seize every opportunity for continuous quality improvement.”

“The detail in this report is meant to provide an open window into this process,” the publication continues.

The Guidant report “looks like a fire hose of information,” Mr. Gunderson commented. “It will be difficult to complain that physicians, patients, Wall Street, and the media are not being provided enough data.”

The Guidant report is available online at www.guidant.com/physician/ppr

Imaging Accreditation

The Intersocietal Commission for the Accreditation of Magnetic Resonance Laboratories (ICAMRL) has expanded its program to include accreditation for body, cardiovascular, musculoskeletal, and neurologic imaging. The revised accreditation process, which went into effect Nov. 1, was instituted because of widespread interest from neurologists, cardiologists, orthopedic surgeons, radiologists, and others. “It is crucial to the future of this imaging modality that all specialties have access to a fair and equitable accreditation program that enables them to receive peer review of their work and to document to insurers that they are providing quality magnetic resonance studies consistent with established clinical guidelines,” ICAMRL President Edward T. Martin, M.D., said in a statement. Labs can apply in any or all of the specialty areas. In addition, the ICAMRL process enables labs using extremity-only magnets to apply for accreditation.

New Neuroscience Site Coming

The National Institutes of Health is developing a Neuroscience Information Framework to provide information for neuroscientists. The framework, which will be accessible through the Internet, will provide links to neuroscience databases, results of neuroscience-related trials, and tools for exploring information about the brain. It will be designed by a consortium led by Cornell University's Weill Medical College. “Our goal is to make scientific data and findings available in order to help further research and promote a greater understanding of brain function and disease,” said Daniel Gardner, Ph.D., principal investigator for the initiative and head of the neuroinformatics laboratory at the medical college. The framework will be supported through a $550,000 grant for the first 15 months, followed by a $1.1-million grant for the second phase.

Autism and Genetics

Five institutes at the National Institutes of Health and three private organizations have formed a consortium to identify genes that may contribute to the development of autism and autism spectrum disorders. The consortium has funded five grants totaling $10.8 million, to be given out over a 5-year period. “This initiative seeks to expand our knowledge of the genetic factors involved in this disorder that affects so many families,” said Thomas R. Insel, director of the National Institute of Mental Health, one of the consortium members. The other members from NIH are the National Institute on Deafness and Other Communication Disorders, the National Institute of Environmental Health Sciences, the National Institute of Neurological Disorders and Stroke, and the National Institute of Child Health and Human Development. The private organizations are the National Alliance for Autism Research, Cure Autism Now, and the Southwest Autism Research and Resource Center.

Improving End-of-Life Care

The nation's approach to end-of-life care needs to change, according to a new report from the Hastings Center. “In the modern acute care hospital, virtually everything is oriented toward using life-sustaining equipment and techniques, not toward forgoing them,” Thomas H. Murray and Bruce Jennings wrote. “The informal culture of specialty medicine, the reward system, the institutional pressures faced by family members, the range of choices people in extremis are being asked to make—each of these factors and more make up a system that is remarkably resistant to change.” Mr. Murray and Mr. Jennings recommend integrating advance directives more fully into patient care and paying more attention to the appropriate role of patients' family members in surrogate decision making. The report is available online at

www.thehastingscenter.org/default.asp

DTC Ad Guidelines Draw Criticism

Voluntary guidelines for direct-to-consumer (DTC) prescription drug advertising released by the Pharmaceutical Research and Manufacturers of America have drawn criticism from politicians and consumer groups who say they don't go far enough. “While I wish the PhRMA guidelines would have gone farther and proposed a moratorium on DTC advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure,” Senate Majority Leader Bill Frist, M.D. (R-Tenn.), said in a statement. Sidney Wolfe, M.D., director of the Public Citizen Health Research Group, called the PhRMA announcement “a meaningless attempt to fool people into believing the guidelines are stronger than they really are.” The guidelines, which more than 20 companies have signed onto, are available online at

www.phrma.org/publications/policy//2005-08-02.1194.pdf

Imaging Accreditation

The Intersocietal Commission for the Accreditation of Magnetic Resonance Laboratories (ICAMRL) has expanded its program to include accreditation for body, cardiovascular, musculoskeletal, and neurologic imaging. The revised accreditation process, which went into effect Nov. 1, was instituted because of widespread interest from neurologists, cardiologists, orthopedic surgeons, radiologists, and others. “It is crucial to the future of this imaging modality that all specialties have access to a fair and equitable accreditation program that enables them to receive peer review of their work and to document to insurers that they are providing quality magnetic resonance studies consistent with established clinical guidelines,” ICAMRL President Edward T. Martin, M.D., said in a statement. Labs can apply in any or all of the specialty areas. In addition, the ICAMRL process enables labs using extremity-only magnets to apply for accreditation.

New Neuroscience Site Coming

The National Institutes of Health is developing a Neuroscience Information Framework to provide information for neuroscientists. The framework, which will be accessible through the Internet, will provide links to neuroscience databases, results of neuroscience-related trials, and tools for exploring information about the brain. It will be designed by a consortium led by Cornell University's Weill Medical College. “Our goal is to make scientific data and findings available in order to help further research and promote a greater understanding of brain function and disease,” said Daniel Gardner, Ph.D., principal investigator for the initiative and head of the neuroinformatics laboratory at the medical college. The framework will be supported through a $550,000 grant for the first 15 months, followed by a $1.1-million grant for the second phase.

Autism and Genetics

Five institutes at the National Institutes of Health and three private organizations have formed a consortium to identify genes that may contribute to the development of autism and autism spectrum disorders. The consortium has funded five grants totaling $10.8 million, to be given out over a 5-year period. “This initiative seeks to expand our knowledge of the genetic factors involved in this disorder that affects so many families,” said Thomas R. Insel, director of the National Institute of Mental Health, one of the consortium members. The other members from NIH are the National Institute on Deafness and Other Communication Disorders, the National Institute of Environmental Health Sciences, the National Institute of Neurological Disorders and Stroke, and the National Institute of Child Health and Human Development. The private organizations are the National Alliance for Autism Research, Cure Autism Now, and the Southwest Autism Research and Resource Center.

Improving End-of-Life Care

The nation's approach to end-of-life care needs to change, according to a new report from the Hastings Center. “In the modern acute care hospital, virtually everything is oriented toward using life-sustaining equipment and techniques, not toward forgoing them,” Thomas H. Murray and Bruce Jennings wrote. “The informal culture of specialty medicine, the reward system, the institutional pressures faced by family members, the range of choices people in extremis are being asked to make—each of these factors and more make up a system that is remarkably resistant to change.” Mr. Murray and Mr. Jennings recommend integrating advance directives more fully into patient care and paying more attention to the appropriate role of patients' family members in surrogate decision making. The report is available online at

www.thehastingscenter.org/default.asp

DTC Ad Guidelines Draw Criticism

Voluntary guidelines for direct-to-consumer (DTC) prescription drug advertising released by the Pharmaceutical Research and Manufacturers of America have drawn criticism from politicians and consumer groups who say they don't go far enough. “While I wish the PhRMA guidelines would have gone farther and proposed a moratorium on DTC advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure,” Senate Majority Leader Bill Frist, M.D. (R-Tenn.), said in a statement. Sidney Wolfe, M.D., director of the Public Citizen Health Research Group, called the PhRMA announcement “a meaningless attempt to fool people into believing the guidelines are stronger than they really are.” The guidelines, which more than 20 companies have signed onto, are available online at

www.phrma.org/publications/policy//2005-08-02.1194.pdf

Imaging Accreditation

The Intersocietal Commission for the Accreditation of Magnetic Resonance Laboratories (ICAMRL) has expanded its program to include accreditation for body, cardiovascular, musculoskeletal, and neurologic imaging. The revised accreditation process, which went into effect Nov. 1, was instituted because of widespread interest from neurologists, cardiologists, orthopedic surgeons, radiologists, and others. “It is crucial to the future of this imaging modality that all specialties have access to a fair and equitable accreditation program that enables them to receive peer review of their work and to document to insurers that they are providing quality magnetic resonance studies consistent with established clinical guidelines,” ICAMRL President Edward T. Martin, M.D., said in a statement. Labs can apply in any or all of the specialty areas. In addition, the ICAMRL process enables labs using extremity-only magnets to apply for accreditation.

New Neuroscience Site Coming

The National Institutes of Health is developing a Neuroscience Information Framework to provide information for neuroscientists. The framework, which will be accessible through the Internet, will provide links to neuroscience databases, results of neuroscience-related trials, and tools for exploring information about the brain. It will be designed by a consortium led by Cornell University's Weill Medical College. “Our goal is to make scientific data and findings available in order to help further research and promote a greater understanding of brain function and disease,” said Daniel Gardner, Ph.D., principal investigator for the initiative and head of the neuroinformatics laboratory at the medical college. The framework will be supported through a $550,000 grant for the first 15 months, followed by a $1.1-million grant for the second phase.

Autism and Genetics

Five institutes at the National Institutes of Health and three private organizations have formed a consortium to identify genes that may contribute to the development of autism and autism spectrum disorders. The consortium has funded five grants totaling $10.8 million, to be given out over a 5-year period. “This initiative seeks to expand our knowledge of the genetic factors involved in this disorder that affects so many families,” said Thomas R. Insel, director of the National Institute of Mental Health, one of the consortium members. The other members from NIH are the National Institute on Deafness and Other Communication Disorders, the National Institute of Environmental Health Sciences, the National Institute of Neurological Disorders and Stroke, and the National Institute of Child Health and Human Development. The private organizations are the National Alliance for Autism Research, Cure Autism Now, and the Southwest Autism Research and Resource Center.

Improving End-of-Life Care

The nation's approach to end-of-life care needs to change, according to a new report from the Hastings Center. “In the modern acute care hospital, virtually everything is oriented toward using life-sustaining equipment and techniques, not toward forgoing them,” Thomas H. Murray and Bruce Jennings wrote. “The informal culture of specialty medicine, the reward system, the institutional pressures faced by family members, the range of choices people in extremis are being asked to make—each of these factors and more make up a system that is remarkably resistant to change.” Mr. Murray and Mr. Jennings recommend integrating advance directives more fully into patient care and paying more attention to the appropriate role of patients' family members in surrogate decision making. The report is available online at

www.thehastingscenter.org/default.asp

DTC Ad Guidelines Draw Criticism

Voluntary guidelines for direct-to-consumer (DTC) prescription drug advertising released by the Pharmaceutical Research and Manufacturers of America have drawn criticism from politicians and consumer groups who say they don't go far enough. “While I wish the PhRMA guidelines would have gone farther and proposed a moratorium on DTC advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure,” Senate Majority Leader Bill Frist, M.D. (R-Tenn.), said in a statement. Sidney Wolfe, M.D., director of the Public Citizen Health Research Group, called the PhRMA announcement “a meaningless attempt to fool people into believing the guidelines are stronger than they really are.” The guidelines, which more than 20 companies have signed onto, are available online at

www.phrma.org/publications/policy//2005-08-02.1194.pdf

MONTREAL — When members of the Food and Drug Administration's advisory panels make recommendations about placing “black box” labels on selective serotonin reuptake inhibitors, many factors influence their decision-making processes, Philip J. Candilis, M.D., said at the annual meeting of the American Academy of Psychiatry and the Law.

First is the obvious issue of direct pharmaceutical industry influence on the panels, as seen in the cases of Bextra, Vioxx, and Celebrex, Dr. Candilis said. “Early on in the debate on anti-inflammatories, the panels had endorsed their continued use,” he said. “But look at the experts who declared ties to the pharmaceutical industry.” Of the 32 experts on the panel, 10 had declared some ties to the pharmaceutical industry. Each panelist had to vote “yes” or “no” to recommending each of the three medications.

“Those [10] who had consulted to the pharmaceutical industry voted 28 of their total of 30 votes in favor of these medications. Those without such conflicts cast 37 of their 66 votes in favor,” he said. “So there was a substantial and statistically significant difference in how people were supported and how they voted.”

But broader influences are at play as well. For instance, the FDA regulates one-quarter of the gross national product, which comes to “hundreds of billions of dollars,” said Dr. Candilis, of the law and psychiatry program at the University of Massachusetts, Worcester. And to do part of that job, the agency receives millions in fees from the pharmaceutical industry—$825 million from 1993 to 2001, he said.

“So there's already a dependence there: 40%–50% of the [FDA's] budget comes from fees that industry pays in order for the FDA to govern the medications that they submit.”

The agency also exerts pressure on its own employees, he continued. He noted that one physician testified before Congress that he'd been asked by FDA officials to alter his affidavit concerning the increased risk of suicide in children and youth taking antidepressants.

“There was an e-mail from FDA general counsel that read as follows: 'General Counsel did not think it necessary to indicate that this document represents a version of the earlier one by noting that things had been omitted. That simply invites the committee to ask further questions about what was omitted from the affidavit,'” Dr. Candilis said. “And when Congress got ahold of this e-mail and others that suggested to FDA staff that they not speak with congressional staff, they were very, very angry.”

Slowly, people are becoming more aware of these conflicts and taking action to mitigate them, Dr. Candilis said. For example, Congress is now insisting that pharmaceutical companies register the results of all clinical trials, including negative results. And some professional organizations are precluding experts from peer review entirely if they have conflicts of interest.

The take-home message is this: “If we don't regulate it, Congress will, others will, people with an agenda will,” Dr. Candilis said. “We have to start doing full public disclosure of [conflicts of] interest, a transparency model, more explicit policies, less management and more recusal. We must step away from just saying, 'I'm going to tell you what I own.'”

MONTREAL — When members of the Food and Drug Administration's advisory panels make recommendations about placing “black box” labels on selective serotonin reuptake inhibitors, many factors influence their decision-making processes, Philip J. Candilis, M.D., said at the annual meeting of the American Academy of Psychiatry and the Law.

First is the obvious issue of direct pharmaceutical industry influence on the panels, as seen in the cases of Bextra, Vioxx, and Celebrex, Dr. Candilis said. “Early on in the debate on anti-inflammatories, the panels had endorsed their continued use,” he said. “But look at the experts who declared ties to the pharmaceutical industry.” Of the 32 experts on the panel, 10 had declared some ties to the pharmaceutical industry. Each panelist had to vote “yes” or “no” to recommending each of the three medications.

“Those [10] who had consulted to the pharmaceutical industry voted 28 of their total of 30 votes in favor of these medications. Those without such conflicts cast 37 of their 66 votes in favor,” he said. “So there was a substantial and statistically significant difference in how people were supported and how they voted.”

But broader influences are at play as well. For instance, the FDA regulates one-quarter of the gross national product, which comes to “hundreds of billions of dollars,” said Dr. Candilis, of the law and psychiatry program at the University of Massachusetts, Worcester. And to do part of that job, the agency receives millions in fees from the pharmaceutical industry—$825 million from 1993 to 2001, he said.

“So there's already a dependence there: 40%–50% of the [FDA's] budget comes from fees that industry pays in order for the FDA to govern the medications that they submit.”

The agency also exerts pressure on its own employees, he continued. He noted that one physician testified before Congress that he'd been asked by FDA officials to alter his affidavit concerning the increased risk of suicide in children and youth taking antidepressants.

“There was an e-mail from FDA general counsel that read as follows: 'General Counsel did not think it necessary to indicate that this document represents a version of the earlier one by noting that things had been omitted. That simply invites the committee to ask further questions about what was omitted from the affidavit,'” Dr. Candilis said. “And when Congress got ahold of this e-mail and others that suggested to FDA staff that they not speak with congressional staff, they were very, very angry.”

Slowly, people are becoming more aware of these conflicts and taking action to mitigate them, Dr. Candilis said. For example, Congress is now insisting that pharmaceutical companies register the results of all clinical trials, including negative results. And some professional organizations are precluding experts from peer review entirely if they have conflicts of interest.

The take-home message is this: “If we don't regulate it, Congress will, others will, people with an agenda will,” Dr. Candilis said. “We have to start doing full public disclosure of [conflicts of] interest, a transparency model, more explicit policies, less management and more recusal. We must step away from just saying, 'I'm going to tell you what I own.'”

MONTREAL — When members of the Food and Drug Administration's advisory panels make recommendations about placing “black box” labels on selective serotonin reuptake inhibitors, many factors influence their decision-making processes, Philip J. Candilis, M.D., said at the annual meeting of the American Academy of Psychiatry and the Law.

First is the obvious issue of direct pharmaceutical industry influence on the panels, as seen in the cases of Bextra, Vioxx, and Celebrex, Dr. Candilis said. “Early on in the debate on anti-inflammatories, the panels had endorsed their continued use,” he said. “But look at the experts who declared ties to the pharmaceutical industry.” Of the 32 experts on the panel, 10 had declared some ties to the pharmaceutical industry. Each panelist had to vote “yes” or “no” to recommending each of the three medications.

“Those [10] who had consulted to the pharmaceutical industry voted 28 of their total of 30 votes in favor of these medications. Those without such conflicts cast 37 of their 66 votes in favor,” he said. “So there was a substantial and statistically significant difference in how people were supported and how they voted.”

But broader influences are at play as well. For instance, the FDA regulates one-quarter of the gross national product, which comes to “hundreds of billions of dollars,” said Dr. Candilis, of the law and psychiatry program at the University of Massachusetts, Worcester. And to do part of that job, the agency receives millions in fees from the pharmaceutical industry—$825 million from 1993 to 2001, he said.

“So there's already a dependence there: 40%–50% of the [FDA's] budget comes from fees that industry pays in order for the FDA to govern the medications that they submit.”

The agency also exerts pressure on its own employees, he continued. He noted that one physician testified before Congress that he'd been asked by FDA officials to alter his affidavit concerning the increased risk of suicide in children and youth taking antidepressants.

“There was an e-mail from FDA general counsel that read as follows: 'General Counsel did not think it necessary to indicate that this document represents a version of the earlier one by noting that things had been omitted. That simply invites the committee to ask further questions about what was omitted from the affidavit,'” Dr. Candilis said. “And when Congress got ahold of this e-mail and others that suggested to FDA staff that they not speak with congressional staff, they were very, very angry.”

Slowly, people are becoming more aware of these conflicts and taking action to mitigate them, Dr. Candilis said. For example, Congress is now insisting that pharmaceutical companies register the results of all clinical trials, including negative results. And some professional organizations are precluding experts from peer review entirely if they have conflicts of interest.

The take-home message is this: “If we don't regulate it, Congress will, others will, people with an agenda will,” Dr. Candilis said. “We have to start doing full public disclosure of [conflicts of] interest, a transparency model, more explicit policies, less management and more recusal. We must step away from just saying, 'I'm going to tell you what I own.'”

The Centers for Medicare and Medicaid Services has announced that the Medicare program will cover the chemotherapeutic agents oxaliplatin (Eloxatin), irinotecan (Camptosar), cetuximab (Erbitux), and bevacizumab (Avastin) in certain clinical trials for cancer patients.

In a Federal Register notice, CMS noted that all four agents are already approved as first- or second-line treatment for advanced colorectal cancer.

In addition, “the off-label use of irinotecan for the treatment of non-small cell lung cancer is supported in one of the approved drug compendia; therefore, this off-label use is covered by Medicare.” However, no other off-label uses of the drugs are covered.

At the agency's request, the National Cancer Institute identified high priority clinical trials studying off-label uses of these four cancer drugs.

“By covering the use of these agents in selected trials, [CMS] will … ensure continued advancement in knowledge for the appropriate use of these agents … and ensure beneficiaries rapid access to promising new uses of approved technologies under controlled clinical trial conditions,” the agency said. Covering the trials will also “serve as a potential model for additional coverage expansions in clinical trials for other anticancer chemotherapeutic agents,” CMSnoted.

In a standard section of the notice inviting public comments, the agency noted that implementation of the new coverage could be delayed “if we receive comments that persuade us to defer implementation.”

The Centers for Medicare and Medicaid Services has announced that the Medicare program will cover the chemotherapeutic agents oxaliplatin (Eloxatin), irinotecan (Camptosar), cetuximab (Erbitux), and bevacizumab (Avastin) in certain clinical trials for cancer patients.

In a Federal Register notice, CMS noted that all four agents are already approved as first- or second-line treatment for advanced colorectal cancer.

In addition, “the off-label use of irinotecan for the treatment of non-small cell lung cancer is supported in one of the approved drug compendia; therefore, this off-label use is covered by Medicare.” However, no other off-label uses of the drugs are covered.

At the agency's request, the National Cancer Institute identified high priority clinical trials studying off-label uses of these four cancer drugs.

“By covering the use of these agents in selected trials, [CMS] will … ensure continued advancement in knowledge for the appropriate use of these agents … and ensure beneficiaries rapid access to promising new uses of approved technologies under controlled clinical trial conditions,” the agency said. Covering the trials will also “serve as a potential model for additional coverage expansions in clinical trials for other anticancer chemotherapeutic agents,” CMSnoted.

In a standard section of the notice inviting public comments, the agency noted that implementation of the new coverage could be delayed “if we receive comments that persuade us to defer implementation.”

The Centers for Medicare and Medicaid Services has announced that the Medicare program will cover the chemotherapeutic agents oxaliplatin (Eloxatin), irinotecan (Camptosar), cetuximab (Erbitux), and bevacizumab (Avastin) in certain clinical trials for cancer patients.

In a Federal Register notice, CMS noted that all four agents are already approved as first- or second-line treatment for advanced colorectal cancer.

In addition, “the off-label use of irinotecan for the treatment of non-small cell lung cancer is supported in one of the approved drug compendia; therefore, this off-label use is covered by Medicare.” However, no other off-label uses of the drugs are covered.

At the agency's request, the National Cancer Institute identified high priority clinical trials studying off-label uses of these four cancer drugs.

“By covering the use of these agents in selected trials, [CMS] will … ensure continued advancement in knowledge for the appropriate use of these agents … and ensure beneficiaries rapid access to promising new uses of approved technologies under controlled clinical trial conditions,” the agency said. Covering the trials will also “serve as a potential model for additional coverage expansions in clinical trials for other anticancer chemotherapeutic agents,” CMSnoted.

In a standard section of the notice inviting public comments, the agency noted that implementation of the new coverage could be delayed “if we receive comments that persuade us to defer implementation.”

WASHINGTON — Food manufacturers should voluntarily restrict the way they market foods to children, but the government will not seek formal regulations in this area, several speakers said at a meeting on obesity sponsored by Business Access.

“Effective industry self-regulation can play an important role in protecting consumers,” said Lydia Parnes, director of the bureau of consumer protection at the Federal Trade Commission (FTC). “Often, self-regulation can address issues more effectively than government can.”

Michael Lyon, M.D., medical director of the Canadian Center for Functional Medicine, asked why the commission was not planning to take any action on the McDonald's Corporation's recent announcement that the fast-food chain would sponsor a physical education program in elementary schools.

“Does that mean if a tobacco company or a beer company did it, it would be okay with the FTC?” he said. “There's nothing on the McDonald's menu that a child will eat that's healthy and will not promote obesity…. How can the FTC turn a blind eye to that? Is that just because McDonald's is so powerful and loaded with money?”

“Absolutely not,” Ms. Parnes replied. “But you need to focus on what government can do about this in a prohibitory way. Our mandate is to act against deceptive advertising and marketing. Can the government stop McDonald's from sponsoring physical education? There are pretty serious Constitutional problems with that.”

In a separate session, Thomas B. Pahl, assistant director for advertising practices at the FTC, discussed a workshop on childhood obesity that the agency had held earlier in the year.

Mr. Pahl, who said he was speaking only for himself, noted that contrary to critics' claims, researchers for the agency's bureau of economics found that children aged 2–11 were exposed to 34% fewer food advertisements on children's television shows and 50% fewer ads on family shows in 2004 than in 1977.

“Those results are more consistent with what we've heard from the food industry that there hasn't been a great increase in food advertising to children; if anything, it has decreased over the past couple of decades at the same time childhood obesity has been increasing,” he said.

Mr. Pahl said that food manufacturers are trying to offer more healthy choices to children—for example, McDonald's is offering apple slices in its Happy Meals—and are trying to package healthy foods to make them more appealing to children.

Mr. Pahl said that legislating or regulating food marketing practices would be difficult and inefficient.

“The FTC does not believe, based on its past experience, that [regulation] is something practical that could be applied,” he said. “It's difficult sometimes to impose restrictions on food advertising to children, because it tends to raise issues like what's good food, what's bad food, what time of day, and how can you target it.”

As a practical matter, he continued, “even if regulation or legislation were to be imposed, you're talking years and years before any kind of solution like that could be in place. What's more helpful now, given how quickly childhood obesity is increasing and how serious a problem it is, is to see what we can do now. And what we can do now is work with industry and consumer groups to see if we can decrease [inappropriate advertising] without legislative and regulatory alternatives. It would be faster, and may make those alternatives unnecessary.”

WASHINGTON — Food manufacturers should voluntarily restrict the way they market foods to children, but the government will not seek formal regulations in this area, several speakers said at a meeting on obesity sponsored by Business Access.

“Effective industry self-regulation can play an important role in protecting consumers,” said Lydia Parnes, director of the bureau of consumer protection at the Federal Trade Commission (FTC). “Often, self-regulation can address issues more effectively than government can.”

Michael Lyon, M.D., medical director of the Canadian Center for Functional Medicine, asked why the commission was not planning to take any action on the McDonald's Corporation's recent announcement that the fast-food chain would sponsor a physical education program in elementary schools.

“Does that mean if a tobacco company or a beer company did it, it would be okay with the FTC?” he said. “There's nothing on the McDonald's menu that a child will eat that's healthy and will not promote obesity…. How can the FTC turn a blind eye to that? Is that just because McDonald's is so powerful and loaded with money?”

“Absolutely not,” Ms. Parnes replied. “But you need to focus on what government can do about this in a prohibitory way. Our mandate is to act against deceptive advertising and marketing. Can the government stop McDonald's from sponsoring physical education? There are pretty serious Constitutional problems with that.”

In a separate session, Thomas B. Pahl, assistant director for advertising practices at the FTC, discussed a workshop on childhood obesity that the agency had held earlier in the year.

Mr. Pahl, who said he was speaking only for himself, noted that contrary to critics' claims, researchers for the agency's bureau of economics found that children aged 2–11 were exposed to 34% fewer food advertisements on children's television shows and 50% fewer ads on family shows in 2004 than in 1977.

“Those results are more consistent with what we've heard from the food industry that there hasn't been a great increase in food advertising to children; if anything, it has decreased over the past couple of decades at the same time childhood obesity has been increasing,” he said.

Mr. Pahl said that food manufacturers are trying to offer more healthy choices to children—for example, McDonald's is offering apple slices in its Happy Meals—and are trying to package healthy foods to make them more appealing to children.

Mr. Pahl said that legislating or regulating food marketing practices would be difficult and inefficient.

“The FTC does not believe, based on its past experience, that [regulation] is something practical that could be applied,” he said. “It's difficult sometimes to impose restrictions on food advertising to children, because it tends to raise issues like what's good food, what's bad food, what time of day, and how can you target it.”

As a practical matter, he continued, “even if regulation or legislation were to be imposed, you're talking years and years before any kind of solution like that could be in place. What's more helpful now, given how quickly childhood obesity is increasing and how serious a problem it is, is to see what we can do now. And what we can do now is work with industry and consumer groups to see if we can decrease [inappropriate advertising] without legislative and regulatory alternatives. It would be faster, and may make those alternatives unnecessary.”

WASHINGTON — Food manufacturers should voluntarily restrict the way they market foods to children, but the government will not seek formal regulations in this area, several speakers said at a meeting on obesity sponsored by Business Access.

“Effective industry self-regulation can play an important role in protecting consumers,” said Lydia Parnes, director of the bureau of consumer protection at the Federal Trade Commission (FTC). “Often, self-regulation can address issues more effectively than government can.”

Michael Lyon, M.D., medical director of the Canadian Center for Functional Medicine, asked why the commission was not planning to take any action on the McDonald's Corporation's recent announcement that the fast-food chain would sponsor a physical education program in elementary schools.

“Does that mean if a tobacco company or a beer company did it, it would be okay with the FTC?” he said. “There's nothing on the McDonald's menu that a child will eat that's healthy and will not promote obesity…. How can the FTC turn a blind eye to that? Is that just because McDonald's is so powerful and loaded with money?”

“Absolutely not,” Ms. Parnes replied. “But you need to focus on what government can do about this in a prohibitory way. Our mandate is to act against deceptive advertising and marketing. Can the government stop McDonald's from sponsoring physical education? There are pretty serious Constitutional problems with that.”

In a separate session, Thomas B. Pahl, assistant director for advertising practices at the FTC, discussed a workshop on childhood obesity that the agency had held earlier in the year.

Mr. Pahl, who said he was speaking only for himself, noted that contrary to critics' claims, researchers for the agency's bureau of economics found that children aged 2–11 were exposed to 34% fewer food advertisements on children's television shows and 50% fewer ads on family shows in 2004 than in 1977.

“Those results are more consistent with what we've heard from the food industry that there hasn't been a great increase in food advertising to children; if anything, it has decreased over the past couple of decades at the same time childhood obesity has been increasing,” he said.

Mr. Pahl said that food manufacturers are trying to offer more healthy choices to children—for example, McDonald's is offering apple slices in its Happy Meals—and are trying to package healthy foods to make them more appealing to children.

Mr. Pahl said that legislating or regulating food marketing practices would be difficult and inefficient.

“The FTC does not believe, based on its past experience, that [regulation] is something practical that could be applied,” he said. “It's difficult sometimes to impose restrictions on food advertising to children, because it tends to raise issues like what's good food, what's bad food, what time of day, and how can you target it.”

As a practical matter, he continued, “even if regulation or legislation were to be imposed, you're talking years and years before any kind of solution like that could be in place. What's more helpful now, given how quickly childhood obesity is increasing and how serious a problem it is, is to see what we can do now. And what we can do now is work with industry and consumer groups to see if we can decrease [inappropriate advertising] without legislative and regulatory alternatives. It would be faster, and may make those alternatives unnecessary.”

More on Drug-Only Treatment

The number of patients entering treatment for both alcohol and drug abuse problems has declined, but the number of patients getting substance abuse treatment alone has increased, according to data from the Substance Abuse and Mental Health Services Administration. The National Survey of Substance Abuse Treatment Services: 2004 found that of the 1.07 million people enrolled in substance abuse treatment on March 31, 2004, 46% were receiving both drug and alcohol abuse treatment, down from 49% in 1998. Another 34% were in treatment for drug abuse alone, up from 27% in 1998, while 20% were in treatment only for alcohol abuse, down from 24% in 1998. “These data will assist SAMHSA and state and local governments assess the nature and extent of service provided in state-supported and other treatment facilities, and forecast treatment resource requirements,” said SAMHSA Administrator Charles Curie.

Autism and Genetics

Five institutes at the National Institutes of Health and three private organizations have formed a consortium to identify genes that may contribute to the development of autism and autism spectrum disorders. The consortium has funded five grants totaling $10.8 million, to be given out over a 5-year period. “This initiative seeks to expand our knowledge of the genetic factors involved in this disorder that affects so many families,” said Thomas R. Insel, director of the National Institute of Mental Health, one of the consortium members. The other members from NIH are the National Institute on Deafness and Other Communication Disorders, the National Institute of Environmental Health Sciences, the National Institute of Neurological Disorders and Stroke, and the National Institute of Child Health and Human Development. The private organizations are the National Alliance for Autism Research, Cure Autism Now, and the Southwest Autism Research and Resource Center.

Schizophrenia Research Forum

The National Alliance for Research on Schizophrenia and Depression (NARSAD) has introduced the Schizophrenia Research Forum, an Internet site that allows researchers to discuss new findings on schizophrenia and related disorders, as well as check out online resources and share reagents and other specialized lab materials. The site, which can be found online at

www.schizophreniaforum.org

Imaging Accreditation

The Intersocietal Commission for the Accreditation of Magnetic Resonance Laboratories (ICAMRL) has expanded its program to include accreditation for body, cardiovascular, musculoskeletal, and neurologic imaging. The revised accreditation process, which went into effect Nov. 1, was instituted because of widespread interest from neurologists, cardiologists, orthopedic surgeons, radiologists, and others. “It is crucial to the future of this imaging modality that all specialties have access to a fair and equitable accreditation program that enables them to receive peer-review of their work and to document to insurers that they are providing quality magnetic resonance studies consistent with established clinical guidelines,” ICAMRL President Edward T. Martin, M.D., said in a statement. Labs can apply in any or all of the specialty areas. In addition, the ICAMRL process enables labs using extremity-only magnets to apply for accreditation.

HHS Mulls Investigation

The Department of Health and Human Services' Office of Inspector General is looking into the circumstances surrounding the resignation of former Food and Drug Administration Commissioner Lester M. Crawford, D.V.M., Ph.D., to determine whether an investigation should be opened, an OIG spokeswoman said. In a response to a query from Rep. Maurice Hinchey (D-N.Y.), HHS Inspector General Daniel R. Levinson said the OIG is doing an initial review of the facts, not an investigation in any regulatory sense, according to the spokeswoman. “After reviewing the facts, the OIG will determine if an investigation is formally launched,” she said. “Dr. Crawford's departure, a mere 2 months after confirmation to his position, raises significant questions,” Rep. Hinchey and several fellow members of Congress wrote in their request. Dr. Crawford had resigned his position after a 30-year career with the agency, serving as its deputy commissioner and director of the Center for Veterinary Medicine, among other posts.

Alternative Medicine Centers

The National Center for Complementary and Alternative Medicine is funding five new research centers to study complementary and alternative approaches to HIV/AIDS, arthritis, asthma, and pain. Three of the new centers will focus on therapies used in traditional Chinese medicine, such as acupuncture and Chinese herbal mixtures. The other centers will study millimeter wave therapy–a type of energy medicine–and botanical therapies used by traditional healers in Africa.

More on Drug-Only Treatment

The number of patients entering treatment for both alcohol and drug abuse problems has declined, but the number of patients getting substance abuse treatment alone has increased, according to data from the Substance Abuse and Mental Health Services Administration. The National Survey of Substance Abuse Treatment Services: 2004 found that of the 1.07 million people enrolled in substance abuse treatment on March 31, 2004, 46% were receiving both drug and alcohol abuse treatment, down from 49% in 1998. Another 34% were in treatment for drug abuse alone, up from 27% in 1998, while 20% were in treatment only for alcohol abuse, down from 24% in 1998. “These data will assist SAMHSA and state and local governments assess the nature and extent of service provided in state-supported and other treatment facilities, and forecast treatment resource requirements,” said SAMHSA Administrator Charles Curie.

Autism and Genetics

Five institutes at the National Institutes of Health and three private organizations have formed a consortium to identify genes that may contribute to the development of autism and autism spectrum disorders. The consortium has funded five grants totaling $10.8 million, to be given out over a 5-year period. “This initiative seeks to expand our knowledge of the genetic factors involved in this disorder that affects so many families,” said Thomas R. Insel, director of the National Institute of Mental Health, one of the consortium members. The other members from NIH are the National Institute on Deafness and Other Communication Disorders, the National Institute of Environmental Health Sciences, the National Institute of Neurological Disorders and Stroke, and the National Institute of Child Health and Human Development. The private organizations are the National Alliance for Autism Research, Cure Autism Now, and the Southwest Autism Research and Resource Center.

Schizophrenia Research Forum

The National Alliance for Research on Schizophrenia and Depression (NARSAD) has introduced the Schizophrenia Research Forum, an Internet site that allows researchers to discuss new findings on schizophrenia and related disorders, as well as check out online resources and share reagents and other specialized lab materials. The site, which can be found online at

www.schizophreniaforum.org

Imaging Accreditation

The Intersocietal Commission for the Accreditation of Magnetic Resonance Laboratories (ICAMRL) has expanded its program to include accreditation for body, cardiovascular, musculoskeletal, and neurologic imaging. The revised accreditation process, which went into effect Nov. 1, was instituted because of widespread interest from neurologists, cardiologists, orthopedic surgeons, radiologists, and others. “It is crucial to the future of this imaging modality that all specialties have access to a fair and equitable accreditation program that enables them to receive peer-review of their work and to document to insurers that they are providing quality magnetic resonance studies consistent with established clinical guidelines,” ICAMRL President Edward T. Martin, M.D., said in a statement. Labs can apply in any or all of the specialty areas. In addition, the ICAMRL process enables labs using extremity-only magnets to apply for accreditation.

HHS Mulls Investigation

The Department of Health and Human Services' Office of Inspector General is looking into the circumstances surrounding the resignation of former Food and Drug Administration Commissioner Lester M. Crawford, D.V.M., Ph.D., to determine whether an investigation should be opened, an OIG spokeswoman said. In a response to a query from Rep. Maurice Hinchey (D-N.Y.), HHS Inspector General Daniel R. Levinson said the OIG is doing an initial review of the facts, not an investigation in any regulatory sense, according to the spokeswoman. “After reviewing the facts, the OIG will determine if an investigation is formally launched,” she said. “Dr. Crawford's departure, a mere 2 months after confirmation to his position, raises significant questions,” Rep. Hinchey and several fellow members of Congress wrote in their request. Dr. Crawford had resigned his position after a 30-year career with the agency, serving as its deputy commissioner and director of the Center for Veterinary Medicine, among other posts.

Alternative Medicine Centers

The National Center for Complementary and Alternative Medicine is funding five new research centers to study complementary and alternative approaches to HIV/AIDS, arthritis, asthma, and pain. Three of the new centers will focus on therapies used in traditional Chinese medicine, such as acupuncture and Chinese herbal mixtures. The other centers will study millimeter wave therapy–a type of energy medicine–and botanical therapies used by traditional healers in Africa.

More on Drug-Only Treatment

The number of patients entering treatment for both alcohol and drug abuse problems has declined, but the number of patients getting substance abuse treatment alone has increased, according to data from the Substance Abuse and Mental Health Services Administration. The National Survey of Substance Abuse Treatment Services: 2004 found that of the 1.07 million people enrolled in substance abuse treatment on March 31, 2004, 46% were receiving both drug and alcohol abuse treatment, down from 49% in 1998. Another 34% were in treatment for drug abuse alone, up from 27% in 1998, while 20% were in treatment only for alcohol abuse, down from 24% in 1998. “These data will assist SAMHSA and state and local governments assess the nature and extent of service provided in state-supported and other treatment facilities, and forecast treatment resource requirements,” said SAMHSA Administrator Charles Curie.

Autism and Genetics

Five institutes at the National Institutes of Health and three private organizations have formed a consortium to identify genes that may contribute to the development of autism and autism spectrum disorders. The consortium has funded five grants totaling $10.8 million, to be given out over a 5-year period. “This initiative seeks to expand our knowledge of the genetic factors involved in this disorder that affects so many families,” said Thomas R. Insel, director of the National Institute of Mental Health, one of the consortium members. The other members from NIH are the National Institute on Deafness and Other Communication Disorders, the National Institute of Environmental Health Sciences, the National Institute of Neurological Disorders and Stroke, and the National Institute of Child Health and Human Development. The private organizations are the National Alliance for Autism Research, Cure Autism Now, and the Southwest Autism Research and Resource Center.

Schizophrenia Research Forum

The National Alliance for Research on Schizophrenia and Depression (NARSAD) has introduced the Schizophrenia Research Forum, an Internet site that allows researchers to discuss new findings on schizophrenia and related disorders, as well as check out online resources and share reagents and other specialized lab materials. The site, which can be found online at

www.schizophreniaforum.org

Imaging Accreditation

The Intersocietal Commission for the Accreditation of Magnetic Resonance Laboratories (ICAMRL) has expanded its program to include accreditation for body, cardiovascular, musculoskeletal, and neurologic imaging. The revised accreditation process, which went into effect Nov. 1, was instituted because of widespread interest from neurologists, cardiologists, orthopedic surgeons, radiologists, and others. “It is crucial to the future of this imaging modality that all specialties have access to a fair and equitable accreditation program that enables them to receive peer-review of their work and to document to insurers that they are providing quality magnetic resonance studies consistent with established clinical guidelines,” ICAMRL President Edward T. Martin, M.D., said in a statement. Labs can apply in any or all of the specialty areas. In addition, the ICAMRL process enables labs using extremity-only magnets to apply for accreditation.

HHS Mulls Investigation

The Department of Health and Human Services' Office of Inspector General is looking into the circumstances surrounding the resignation of former Food and Drug Administration Commissioner Lester M. Crawford, D.V.M., Ph.D., to determine whether an investigation should be opened, an OIG spokeswoman said. In a response to a query from Rep. Maurice Hinchey (D-N.Y.), HHS Inspector General Daniel R. Levinson said the OIG is doing an initial review of the facts, not an investigation in any regulatory sense, according to the spokeswoman. “After reviewing the facts, the OIG will determine if an investigation is formally launched,” she said. “Dr. Crawford's departure, a mere 2 months after confirmation to his position, raises significant questions,” Rep. Hinchey and several fellow members of Congress wrote in their request. Dr. Crawford had resigned his position after a 30-year career with the agency, serving as its deputy commissioner and director of the Center for Veterinary Medicine, among other posts.

Alternative Medicine Centers

The National Center for Complementary and Alternative Medicine is funding five new research centers to study complementary and alternative approaches to HIV/AIDS, arthritis, asthma, and pain. Three of the new centers will focus on therapies used in traditional Chinese medicine, such as acupuncture and Chinese herbal mixtures. The other centers will study millimeter wave therapy–a type of energy medicine–and botanical therapies used by traditional healers in Africa.