Mary Ellen Schneider

Researchers now have a pathway for conducting early clinical testing of drugs in a small number of human subjects under new guidance from the Food and Drug Administration.

Officials at the FDA finalized guidance on exploratory investigational new drug (IND) studies that allows researchers to move forward with small human studies before beginning traditional phase I safety testing in humans. The guidance, published in January, makes recommendations on safety testing, manufacturing, and clinical approaches in these early studies.

The FDA also published draft guidance and a direct final rule last month that outlines new standards for the manufacture of drugs solely for use in phase I studies. The rule is aimed at making it easier for scientists to produce small quantities of drugs for small-scale, early-phase human testing.

“This is about saving lives and about building medicine's future,” said Dr. Andrew von Eschenbach, acting FDA Commissioner of Food and Drugs.

Currently, fewer than 10% of IND applications for new molecular entities progress beyond the investigational stage, according to the FDA. These changes will remove some of the hurdles from very early drug development, Dr. von Eschenbach said during a media teleconference sponsored by the FDA.

But critics of the approach say it relaxes needed human subjects protections at a time when the safety of clinical trials is already being questioned.

In guidance on the exploratory IND, FDA officials outline their thinking that drug sponsors have not taken full advantage of the flexibility in the existing regulations and often provide more supporting information than is required for an exploratory IND.

Exploratory IND studies involve administering either a subpharmacologic dose of a product or doses that are expected to produce a pharmacologic but not a toxic effect, so the risk to human subjects is considered lower than in a traditional phase I study, FDA said in its guidance documents.

Because exploratory IND studies pose fewer risks, FDA said, they can be initiated in humans with less, or different, preclinical support than what is required for traditional IND studies.

Previously, one of the major obstacles in the development of new drugs was that the requirements for beginning early experimental studies were the same as those for large pharmaceutical companies who are making drugs for thousands of patients, Dr. Steven Rosenberg, chief of surgery at the National Cancer Institute, said during the teleconference.

“We've been at the mercy of large biotech and pharmaceutical companies who have the resources to fulfill the very stringent regulations that exist for taking these new products to very large numbers of patients,” he said.

The changes made by the FDA will make it possible for scientists to take new ideas to small numbers of patients with desperate diseases and test those agents in ways that weren't possible before, he said. Dr. Rosenberg said he expects to see a lot of ideas tested now that might not otherwise have been taken to patients under the old framework.

But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said he remains concerned that the usual protection for human subjects has been “watered down.” Under the new process outlined by the FDA, a safety problem that might have been detected through more extensive animal studies now may be missed, he said.

And he is doubtful of the benefits. Dr. Wolfe said the types of studies described in the exploratory IND are already being done but with the previous protections in place for human subjects.

Sen. Charles Grassley (R-Iowa), chairman of the Senate Committee on Finance, which has been conducting oversight of the FDA's consumer protections, also expressed safety concerns.

“Of course people want to get safer, better drugs faster, but there have to be sufficient checks and balances in the drug approval process,” Sen. Grassley said in a statement. “At a time when new questions are being raised about whether participants in clinical trials are protected and treated ethically, the FDA is loosening the reins on drug companies.”

Researchers now have a pathway for conducting early clinical testing of drugs in a small number of human subjects under new guidance from the Food and Drug Administration.

Officials at the FDA finalized guidance on exploratory investigational new drug (IND) studies that allows researchers to move forward with small human studies before beginning traditional phase I safety testing in humans. The guidance, published in January, makes recommendations on safety testing, manufacturing, and clinical approaches in these early studies.

The FDA also published draft guidance and a direct final rule last month that outlines new standards for the manufacture of drugs solely for use in phase I studies. The rule is aimed at making it easier for scientists to produce small quantities of drugs for small-scale, early-phase human testing.

“This is about saving lives and about building medicine's future,” said Dr. Andrew von Eschenbach, acting FDA Commissioner of Food and Drugs.

Currently, fewer than 10% of IND applications for new molecular entities progress beyond the investigational stage, according to the FDA. These changes will remove some of the hurdles from very early drug development, Dr. von Eschenbach said during a media teleconference sponsored by the FDA.

But critics of the approach say it relaxes needed human subjects protections at a time when the safety of clinical trials is already being questioned.

In guidance on the exploratory IND, FDA officials outline their thinking that drug sponsors have not taken full advantage of the flexibility in the existing regulations and often provide more supporting information than is required for an exploratory IND.

Exploratory IND studies involve administering either a subpharmacologic dose of a product or doses that are expected to produce a pharmacologic but not a toxic effect, so the risk to human subjects is considered lower than in a traditional phase I study, FDA said in its guidance documents.

Because exploratory IND studies pose fewer risks, FDA said, they can be initiated in humans with less, or different, preclinical support than what is required for traditional IND studies.

Previously, one of the major obstacles in the development of new drugs was that the requirements for beginning early experimental studies were the same as those for large pharmaceutical companies who are making drugs for thousands of patients, Dr. Steven Rosenberg, chief of surgery at the National Cancer Institute, said during the teleconference.

“We've been at the mercy of large biotech and pharmaceutical companies who have the resources to fulfill the very stringent regulations that exist for taking these new products to very large numbers of patients,” he said.

The changes made by the FDA will make it possible for scientists to take new ideas to small numbers of patients with desperate diseases and test those agents in ways that weren't possible before, he said. Dr. Rosenberg said he expects to see a lot of ideas tested now that might not otherwise have been taken to patients under the old framework.

But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said he remains concerned that the usual protection for human subjects has been “watered down.” Under the new process outlined by the FDA, a safety problem that might have been detected through more extensive animal studies now may be missed, he said.

And he is doubtful of the benefits. Dr. Wolfe said the types of studies described in the exploratory IND are already being done but with the previous protections in place for human subjects.

Sen. Charles Grassley (R-Iowa), chairman of the Senate Committee on Finance, which has been conducting oversight of the FDA's consumer protections, also expressed safety concerns.

“Of course people want to get safer, better drugs faster, but there have to be sufficient checks and balances in the drug approval process,” Sen. Grassley said in a statement. “At a time when new questions are being raised about whether participants in clinical trials are protected and treated ethically, the FDA is loosening the reins on drug companies.”

Researchers now have a pathway for conducting early clinical testing of drugs in a small number of human subjects under new guidance from the Food and Drug Administration.

Officials at the FDA finalized guidance on exploratory investigational new drug (IND) studies that allows researchers to move forward with small human studies before beginning traditional phase I safety testing in humans. The guidance, published in January, makes recommendations on safety testing, manufacturing, and clinical approaches in these early studies.

The FDA also published draft guidance and a direct final rule last month that outlines new standards for the manufacture of drugs solely for use in phase I studies. The rule is aimed at making it easier for scientists to produce small quantities of drugs for small-scale, early-phase human testing.

“This is about saving lives and about building medicine's future,” said Dr. Andrew von Eschenbach, acting FDA Commissioner of Food and Drugs.

Currently, fewer than 10% of IND applications for new molecular entities progress beyond the investigational stage, according to the FDA. These changes will remove some of the hurdles from very early drug development, Dr. von Eschenbach said during a media teleconference sponsored by the FDA.

But critics of the approach say it relaxes needed human subjects protections at a time when the safety of clinical trials is already being questioned.

In guidance on the exploratory IND, FDA officials outline their thinking that drug sponsors have not taken full advantage of the flexibility in the existing regulations and often provide more supporting information than is required for an exploratory IND.

Exploratory IND studies involve administering either a subpharmacologic dose of a product or doses that are expected to produce a pharmacologic but not a toxic effect, so the risk to human subjects is considered lower than in a traditional phase I study, FDA said in its guidance documents.

Because exploratory IND studies pose fewer risks, FDA said, they can be initiated in humans with less, or different, preclinical support than what is required for traditional IND studies.

Previously, one of the major obstacles in the development of new drugs was that the requirements for beginning early experimental studies were the same as those for large pharmaceutical companies who are making drugs for thousands of patients, Dr. Steven Rosenberg, chief of surgery at the National Cancer Institute, said during the teleconference.

“We've been at the mercy of large biotech and pharmaceutical companies who have the resources to fulfill the very stringent regulations that exist for taking these new products to very large numbers of patients,” he said.

The changes made by the FDA will make it possible for scientists to take new ideas to small numbers of patients with desperate diseases and test those agents in ways that weren't possible before, he said. Dr. Rosenberg said he expects to see a lot of ideas tested now that might not otherwise have been taken to patients under the old framework.

But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said he remains concerned that the usual protection for human subjects has been “watered down.” Under the new process outlined by the FDA, a safety problem that might have been detected through more extensive animal studies now may be missed, he said.

And he is doubtful of the benefits. Dr. Wolfe said the types of studies described in the exploratory IND are already being done but with the previous protections in place for human subjects.

Sen. Charles Grassley (R-Iowa), chairman of the Senate Committee on Finance, which has been conducting oversight of the FDA's consumer protections, also expressed safety concerns.

“Of course people want to get safer, better drugs faster, but there have to be sufficient checks and balances in the drug approval process,” Sen. Grassley said in a statement. “At a time when new questions are being raised about whether participants in clinical trials are protected and treated ethically, the FDA is loosening the reins on drug companies.”

Some Medicare beneficiaries may still qualify for extra help in purchasing drugs through patient assistance programs, despite the new Medicare Part D drug benefit that started last month.

But pharmaceutical manufacturers that offer assistance will have to tread carefully to avoid running afoul of the federal antikickback statute, according to a special advisory bulletin from the Department of Health and Human Services' Office of Inspector General.

In the bulletin, OIG said it would raise serious concerns if a manufacturer of a drug covered under the Part D program were to subsidize cost-sharing for its product.

In the meantime, drug manufacturers that operate patient assistance programs do not need to rush to disenroll all their Part D beneficiaries. During the first year of the drug benefit, OIG officials will take into consideration whether the assistance program is taking “prompt, reasonable, verifiable, and meaningful steps to transition patients who enroll in Part D to alternative assistance models.”

OIG said the practice of pharmaceutical company-sponsored programs offering assistance to Part D beneficiaries could steer patients to particular drugs, increase costs to Medicare, provide a financial advantage over competing drugs, and reduce beneficiaries' incentives to use less expensive alternatives.

The OIG bulletin also raised questions about the practice of bulk replacement in which drug makers donate their products to pharmacies, health centers, clinics, and other facilities. Such programs would need to be evaluated on a case-by-case basis, according to OIG, but these arrangements could potentially violate the antikickback statute if the recipient of the free drugs is in a position to generate federal health care program business for the drug maker.

Alternative program designs could allow beneficiaries to continue to receive assistance. For example, a drug maker could donate its products to an independent, bona fide charity that provides cost-sharing subsidies. This would raise few concerns under the antikickback statute as long as the assistance program was not functioning as a conduit for payments by the drug maker.

Some Medicare beneficiaries may still qualify for extra help in purchasing drugs through patient assistance programs, despite the new Medicare Part D drug benefit that started last month.

But pharmaceutical manufacturers that offer assistance will have to tread carefully to avoid running afoul of the federal antikickback statute, according to a special advisory bulletin from the Department of Health and Human Services' Office of Inspector General.

In the bulletin, OIG said it would raise serious concerns if a manufacturer of a drug covered under the Part D program were to subsidize cost-sharing for its product.

In the meantime, drug manufacturers that operate patient assistance programs do not need to rush to disenroll all their Part D beneficiaries. During the first year of the drug benefit, OIG officials will take into consideration whether the assistance program is taking “prompt, reasonable, verifiable, and meaningful steps to transition patients who enroll in Part D to alternative assistance models.”

OIG said the practice of pharmaceutical company-sponsored programs offering assistance to Part D beneficiaries could steer patients to particular drugs, increase costs to Medicare, provide a financial advantage over competing drugs, and reduce beneficiaries' incentives to use less expensive alternatives.

The OIG bulletin also raised questions about the practice of bulk replacement in which drug makers donate their products to pharmacies, health centers, clinics, and other facilities. Such programs would need to be evaluated on a case-by-case basis, according to OIG, but these arrangements could potentially violate the antikickback statute if the recipient of the free drugs is in a position to generate federal health care program business for the drug maker.

Alternative program designs could allow beneficiaries to continue to receive assistance. For example, a drug maker could donate its products to an independent, bona fide charity that provides cost-sharing subsidies. This would raise few concerns under the antikickback statute as long as the assistance program was not functioning as a conduit for payments by the drug maker.

Some Medicare beneficiaries may still qualify for extra help in purchasing drugs through patient assistance programs, despite the new Medicare Part D drug benefit that started last month.

But pharmaceutical manufacturers that offer assistance will have to tread carefully to avoid running afoul of the federal antikickback statute, according to a special advisory bulletin from the Department of Health and Human Services' Office of Inspector General.

In the bulletin, OIG said it would raise serious concerns if a manufacturer of a drug covered under the Part D program were to subsidize cost-sharing for its product.

In the meantime, drug manufacturers that operate patient assistance programs do not need to rush to disenroll all their Part D beneficiaries. During the first year of the drug benefit, OIG officials will take into consideration whether the assistance program is taking “prompt, reasonable, verifiable, and meaningful steps to transition patients who enroll in Part D to alternative assistance models.”

OIG said the practice of pharmaceutical company-sponsored programs offering assistance to Part D beneficiaries could steer patients to particular drugs, increase costs to Medicare, provide a financial advantage over competing drugs, and reduce beneficiaries' incentives to use less expensive alternatives.

The OIG bulletin also raised questions about the practice of bulk replacement in which drug makers donate their products to pharmacies, health centers, clinics, and other facilities. Such programs would need to be evaluated on a case-by-case basis, according to OIG, but these arrangements could potentially violate the antikickback statute if the recipient of the free drugs is in a position to generate federal health care program business for the drug maker.

Alternative program designs could allow beneficiaries to continue to receive assistance. For example, a drug maker could donate its products to an independent, bona fide charity that provides cost-sharing subsidies. This would raise few concerns under the antikickback statute as long as the assistance program was not functioning as a conduit for payments by the drug maker.

Physicians and individuals with 9 or more years of education are at an increased risk of developing Parkinson's disease, according to a study by Dr. Roberta Frigerio of the Mayo Clinic in Rochester, Minn., and her colleagues.

Individuals such as construction and extractive workers, production workers, metal workers, and engineers who have more physically demanding jobs are at a reduced risk for the disease, the researchers found (Neurology 2005;65:1575–83).

The researchers examined the education levels and occupations of 202 individuals in Olmsted County, Minn., who developed Parkinson's disease from 1976 through 1995. Each case was matched by age and sex to a general population control who was free of Parkinson's disease and living in the same county. Of those individuals, they were able to obtain medical records for 196 cases and 196 controls. In addition, they obtained data from telephone interviews available for 149 cases and 129 controls. But the findings should not be a cause for alarm among physicians or those with higher levels of education, Dr. Demetrius Maraganore, a professor of neurology at the Mayo Clinic and one of the study authors, said in an interview.

The number of physicians in the study was small and therefore the effect size is unstable. “Parkinson's disease is a thousand-piece puzzle,” Dr. Maraganore said.

More research is needed to figure out what these findings mean. For example, the findings could mean that being a physician is an indirect marker for other environmental factors. Or it could be that being a physician or having more education are not risk factors at all, Dr. Maraganore said. Instead, additional years of schooling and becoming a physician could be early manifestations of the disease, which affects personality and behavior.

Parkinson's disease is marked by a deficiency of dopamine, which is important to personality. A deficiency of dopamine could shape personality in a way that makes a person more inclined to sit at a desk and study, he said.

Physicians and individuals with 9 or more years of education are at an increased risk of developing Parkinson's disease, according to a study by Dr. Roberta Frigerio of the Mayo Clinic in Rochester, Minn., and her colleagues.

Individuals such as construction and extractive workers, production workers, metal workers, and engineers who have more physically demanding jobs are at a reduced risk for the disease, the researchers found (Neurology 2005;65:1575–83).

The researchers examined the education levels and occupations of 202 individuals in Olmsted County, Minn., who developed Parkinson's disease from 1976 through 1995. Each case was matched by age and sex to a general population control who was free of Parkinson's disease and living in the same county. Of those individuals, they were able to obtain medical records for 196 cases and 196 controls. In addition, they obtained data from telephone interviews available for 149 cases and 129 controls. But the findings should not be a cause for alarm among physicians or those with higher levels of education, Dr. Demetrius Maraganore, a professor of neurology at the Mayo Clinic and one of the study authors, said in an interview.

The number of physicians in the study was small and therefore the effect size is unstable. “Parkinson's disease is a thousand-piece puzzle,” Dr. Maraganore said.

More research is needed to figure out what these findings mean. For example, the findings could mean that being a physician is an indirect marker for other environmental factors. Or it could be that being a physician or having more education are not risk factors at all, Dr. Maraganore said. Instead, additional years of schooling and becoming a physician could be early manifestations of the disease, which affects personality and behavior.

Parkinson's disease is marked by a deficiency of dopamine, which is important to personality. A deficiency of dopamine could shape personality in a way that makes a person more inclined to sit at a desk and study, he said.

Physicians and individuals with 9 or more years of education are at an increased risk of developing Parkinson's disease, according to a study by Dr. Roberta Frigerio of the Mayo Clinic in Rochester, Minn., and her colleagues.

Individuals such as construction and extractive workers, production workers, metal workers, and engineers who have more physically demanding jobs are at a reduced risk for the disease, the researchers found (Neurology 2005;65:1575–83).

The researchers examined the education levels and occupations of 202 individuals in Olmsted County, Minn., who developed Parkinson's disease from 1976 through 1995. Each case was matched by age and sex to a general population control who was free of Parkinson's disease and living in the same county. Of those individuals, they were able to obtain medical records for 196 cases and 196 controls. In addition, they obtained data from telephone interviews available for 149 cases and 129 controls. But the findings should not be a cause for alarm among physicians or those with higher levels of education, Dr. Demetrius Maraganore, a professor of neurology at the Mayo Clinic and one of the study authors, said in an interview.

The number of physicians in the study was small and therefore the effect size is unstable. “Parkinson's disease is a thousand-piece puzzle,” Dr. Maraganore said.

More research is needed to figure out what these findings mean. For example, the findings could mean that being a physician is an indirect marker for other environmental factors. Or it could be that being a physician or having more education are not risk factors at all, Dr. Maraganore said. Instead, additional years of schooling and becoming a physician could be early manifestations of the disease, which affects personality and behavior.

Parkinson's disease is marked by a deficiency of dopamine, which is important to personality. A deficiency of dopamine could shape personality in a way that makes a person more inclined to sit at a desk and study, he said.

Nearly 25% of trauma surgeons report that they have been denied payment by an insurer in the last 6 months because a patient was under the influence of alcohol or drugs when his or her traumatic injury occurred, according to Dr. Larry M. Gentilello of the University of Texas Southwestern Medical Center at Dallas and his colleagues.

The failure to pay on the part of insurance companies may be affecting alcohol screening and treatment practices in hospitals, the researchers said. They analyzed responses from 98 general trauma surgeons around the country and found that less than half reported routinely measuring blood alcohol concentration among their patients even though 91% of respondents said it was important to do so.

The barrier for many physicians is the Uniform Accident and Sickness Policy Provision Law (UPPL), a national model law that allows insurance carriers to deny coverage for injuries sustained while under the influence of alcohol or drugs. The model law was developed in 1947 by the National Association of Insurance Commissioners, and as of April 2004, it had been adopted by 38 states and the District of Columbia.

But in 2001, the commissioners amended the model law to prohibit insurers from applying the substance abuse exclusion to medical expenses. As of April 2004, six states adopted the new model law.

The survey results indicate that the general fear of insurance denials may be causing some physicians to circumvent the laws by not documenting the use of alcohol or drugs. Dr. Gentilello and his colleagues found that only 37% of surgeons report that half or more of their patients with alcohol problems receive counseling. And 82% of the respondents said that if there were no insurance barriers, they would be willing to help their trauma center establish a brief alcohol intervention program if provided with other clinical tools.

Either physicians are not screening and documenting intoxication or insurers are not applying the law in every case, the researchers wrote, because with 35%–50% of trauma patients estimated to be under the influence of alcohol or drugs, trauma centers could not absorb the resulting cost of uncompensated care.

Studies specifically looking at alcohol screening and intervention among injured patients show that brief interventions can reduce future alcohol use and hospital readmissions, Dr. Gentilello, professor of surgery and chairman of the division of burns, trauma, and critical care at the University of Texas Southwestern Medical School, said in an interview. After being treated for a serious injury resulting from substance abuse, most patients are in an ideal state of mind for this type of counseling.

“They've had a real teachable moment,” Dr. Gentilello said. “Trauma presents a crisis we can capitalize on.”

But the existence of the UPPL means that physicians who practice good medicine by screening and treating alcohol and drug abuse are denied payment, said Eric Goplerud, Ph.D., a George Washington University professor and director of Ensuring Solutions to Alcohol Problems.

Nearly 25% of trauma surgeons report that they have been denied payment by an insurer in the last 6 months because a patient was under the influence of alcohol or drugs when his or her traumatic injury occurred, according to Dr. Larry M. Gentilello of the University of Texas Southwestern Medical Center at Dallas and his colleagues.

The failure to pay on the part of insurance companies may be affecting alcohol screening and treatment practices in hospitals, the researchers said. They analyzed responses from 98 general trauma surgeons around the country and found that less than half reported routinely measuring blood alcohol concentration among their patients even though 91% of respondents said it was important to do so.

The barrier for many physicians is the Uniform Accident and Sickness Policy Provision Law (UPPL), a national model law that allows insurance carriers to deny coverage for injuries sustained while under the influence of alcohol or drugs. The model law was developed in 1947 by the National Association of Insurance Commissioners, and as of April 2004, it had been adopted by 38 states and the District of Columbia.

But in 2001, the commissioners amended the model law to prohibit insurers from applying the substance abuse exclusion to medical expenses. As of April 2004, six states adopted the new model law.

The survey results indicate that the general fear of insurance denials may be causing some physicians to circumvent the laws by not documenting the use of alcohol or drugs. Dr. Gentilello and his colleagues found that only 37% of surgeons report that half or more of their patients with alcohol problems receive counseling. And 82% of the respondents said that if there were no insurance barriers, they would be willing to help their trauma center establish a brief alcohol intervention program if provided with other clinical tools.

Either physicians are not screening and documenting intoxication or insurers are not applying the law in every case, the researchers wrote, because with 35%–50% of trauma patients estimated to be under the influence of alcohol or drugs, trauma centers could not absorb the resulting cost of uncompensated care.

Studies specifically looking at alcohol screening and intervention among injured patients show that brief interventions can reduce future alcohol use and hospital readmissions, Dr. Gentilello, professor of surgery and chairman of the division of burns, trauma, and critical care at the University of Texas Southwestern Medical School, said in an interview. After being treated for a serious injury resulting from substance abuse, most patients are in an ideal state of mind for this type of counseling.

“They've had a real teachable moment,” Dr. Gentilello said. “Trauma presents a crisis we can capitalize on.”

But the existence of the UPPL means that physicians who practice good medicine by screening and treating alcohol and drug abuse are denied payment, said Eric Goplerud, Ph.D., a George Washington University professor and director of Ensuring Solutions to Alcohol Problems.

Nearly 25% of trauma surgeons report that they have been denied payment by an insurer in the last 6 months because a patient was under the influence of alcohol or drugs when his or her traumatic injury occurred, according to Dr. Larry M. Gentilello of the University of Texas Southwestern Medical Center at Dallas and his colleagues.

The failure to pay on the part of insurance companies may be affecting alcohol screening and treatment practices in hospitals, the researchers said. They analyzed responses from 98 general trauma surgeons around the country and found that less than half reported routinely measuring blood alcohol concentration among their patients even though 91% of respondents said it was important to do so.

The barrier for many physicians is the Uniform Accident and Sickness Policy Provision Law (UPPL), a national model law that allows insurance carriers to deny coverage for injuries sustained while under the influence of alcohol or drugs. The model law was developed in 1947 by the National Association of Insurance Commissioners, and as of April 2004, it had been adopted by 38 states and the District of Columbia.

But in 2001, the commissioners amended the model law to prohibit insurers from applying the substance abuse exclusion to medical expenses. As of April 2004, six states adopted the new model law.

The survey results indicate that the general fear of insurance denials may be causing some physicians to circumvent the laws by not documenting the use of alcohol or drugs. Dr. Gentilello and his colleagues found that only 37% of surgeons report that half or more of their patients with alcohol problems receive counseling. And 82% of the respondents said that if there were no insurance barriers, they would be willing to help their trauma center establish a brief alcohol intervention program if provided with other clinical tools.

Either physicians are not screening and documenting intoxication or insurers are not applying the law in every case, the researchers wrote, because with 35%–50% of trauma patients estimated to be under the influence of alcohol or drugs, trauma centers could not absorb the resulting cost of uncompensated care.

Studies specifically looking at alcohol screening and intervention among injured patients show that brief interventions can reduce future alcohol use and hospital readmissions, Dr. Gentilello, professor of surgery and chairman of the division of burns, trauma, and critical care at the University of Texas Southwestern Medical School, said in an interview. After being treated for a serious injury resulting from substance abuse, most patients are in an ideal state of mind for this type of counseling.

“They've had a real teachable moment,” Dr. Gentilello said. “Trauma presents a crisis we can capitalize on.”

But the existence of the UPPL means that physicians who practice good medicine by screening and treating alcohol and drug abuse are denied payment, said Eric Goplerud, Ph.D., a George Washington University professor and director of Ensuring Solutions to Alcohol Problems.

Cancer Screening Record

Officials at the American Academy of Dermatology are hoping for a record-setting year in 2006. AAD officials are recruiting members to participate in an attempt to set a Guinness World Record for the most skin cancer screenings conducted in a single day. The potentially record-setting screening day is set for Saturday, May 6, 2006. The AAD will be organizing large-scale screenings on that day in Washington, Chicago, and New York, but officials are also encouraging members in other areas to conduct their own free screenings. The academy's Melanoma/Skin Cancer Screening Program, which began in 1985, has helped to screen more than 1.5 million people. For more information on the May 6 screening day, e-mail the AAD at

worldrecord@aad.org

Psoriasis Advocates

The patient advocacy group Psoriasis Cure Now has singled out three members of Congress for their work to increase funding for federal research on psoriasis and psoriatic arthritis. The group honored Sen. Arlen Specter (R-Pa.), Rep. Rosa DeLauro (D-Conn.), and Rep. Ralph Regula (R-Ohio) with the group's 2005 Health Care Advocates of the Year award. "People with psoriasis have no Hollywood stars or other glitzy backers to call on for support or to bring attention to this incurable disease," Michael Paranzino, president of Psoriasis Cure Now, said in a statement. "Yet these leaders took up our cause without fanfare and recognized how research on psoriasis will help not just the millions of Americans with the disease, but may also help us better understand other challenging diseases."

Research Grant Program

The Women's Dermatologic Society is developing a new grant program this year to allow residents and young physicians to conduct clinical and basic research on women's health issues. The new grant, which is being sponsored by Ortho-Neutrogena, will provide grants in the amount of $3,000 to $8,000 each. Applicants must have an MD or DO degree and be a resident in an accredited training program or a board-certified or board-eligible dermatologist in the first 3 years after completing postgraduate training. Applications will be reviewed by a newly formed section of the Women's Dermatologic Society called the Academic Dermatologist Interest Group, which will monitor the grants program. A deadline for grant applications has not yet been set. Information on the program is available on the group's Web site at

www.womensderm.org/grant/research.html

Food Allergen Labeling

All food labels now must clearly state if a product contains any ingredients with protein derived from the eight major allergenic foods. Under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), manufacturers are required to identify in plain English the presence of ingredients that contain protein derived from milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, or soybeans in the list of ingredients or to say "contains" followed by the source of the food allergen after or adjacent to the list of ingredients. It is estimated that 2% of adults and 5% of infants and young children in the United States have food allergies. Approximately 30,000 consumers require emergency department treatment and 150 Americans die each year because of allergic reactions to food. The statute, however, does not require manufacturers or retailers to relabel or remove products that don't have the labeling because they were labeled before the effective date.

Rural Access to Part B Drugs

Access problems may prevent rural providers from participating in the new Competitive Acquisition Program (CAP) for Part B drugs and biologicals, Joan Sokolovsky, a senior analyst with the Medicare Payment Advisory Commission (MedPAC), said at a commission meeting last December. Physicians who elect to participate in the program will obtain drugs from a preselected list of vendors, who in turn will take on the responsibility of billing Medicare for the drugs and collecting coinsurance or deductibles from patients. Under CAP rules, drugs must be delivered to the facility where they will be administered. Chemotherapy in rural areas, however, is delivered through satellite facilities, where "sometimes drugs cannot be mixed," Ms. Sokolovsky said. In a recommendation, MedPAC said that the Health and Human Services department should allow an exception to these delivery rules for rural satellite offices of providers.

Pay for Performance Not Local Yet

Despite the national buzz over pay for performance and the interest in Congress, such initiatives have yet to catch on in many local communities, the Center for Studying Health System Change reported in a study. "While there's been plenty of buzz about pay for performance as a way to improve health care quality, the reality is that these initiatives are off to a slow start in many communities," said Paul B. Ginsburg, Ph.D., who is president of HSC. The study was based on site visits to 12 nationally representative communities. Of these communities, only two, Orange County, Calif., and Boston, had significant physician pay-for-performance programs in place. In the other communities, where to date almost no physicians had received quality-related payments, physician attitudes ranged from skeptical to hostile, according to study results.

Cancer Screening Record

Officials at the American Academy of Dermatology are hoping for a record-setting year in 2006. AAD officials are recruiting members to participate in an attempt to set a Guinness World Record for the most skin cancer screenings conducted in a single day. The potentially record-setting screening day is set for Saturday, May 6, 2006. The AAD will be organizing large-scale screenings on that day in Washington, Chicago, and New York, but officials are also encouraging members in other areas to conduct their own free screenings. The academy's Melanoma/Skin Cancer Screening Program, which began in 1985, has helped to screen more than 1.5 million people. For more information on the May 6 screening day, e-mail the AAD at

worldrecord@aad.org

Psoriasis Advocates

The patient advocacy group Psoriasis Cure Now has singled out three members of Congress for their work to increase funding for federal research on psoriasis and psoriatic arthritis. The group honored Sen. Arlen Specter (R-Pa.), Rep. Rosa DeLauro (D-Conn.), and Rep. Ralph Regula (R-Ohio) with the group's 2005 Health Care Advocates of the Year award. "People with psoriasis have no Hollywood stars or other glitzy backers to call on for support or to bring attention to this incurable disease," Michael Paranzino, president of Psoriasis Cure Now, said in a statement. "Yet these leaders took up our cause without fanfare and recognized how research on psoriasis will help not just the millions of Americans with the disease, but may also help us better understand other challenging diseases."

Research Grant Program

The Women's Dermatologic Society is developing a new grant program this year to allow residents and young physicians to conduct clinical and basic research on women's health issues. The new grant, which is being sponsored by Ortho-Neutrogena, will provide grants in the amount of $3,000 to $8,000 each. Applicants must have an MD or DO degree and be a resident in an accredited training program or a board-certified or board-eligible dermatologist in the first 3 years after completing postgraduate training. Applications will be reviewed by a newly formed section of the Women's Dermatologic Society called the Academic Dermatologist Interest Group, which will monitor the grants program. A deadline for grant applications has not yet been set. Information on the program is available on the group's Web site at

www.womensderm.org/grant/research.html

Food Allergen Labeling

All food labels now must clearly state if a product contains any ingredients with protein derived from the eight major allergenic foods. Under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), manufacturers are required to identify in plain English the presence of ingredients that contain protein derived from milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, or soybeans in the list of ingredients or to say "contains" followed by the source of the food allergen after or adjacent to the list of ingredients. It is estimated that 2% of adults and 5% of infants and young children in the United States have food allergies. Approximately 30,000 consumers require emergency department treatment and 150 Americans die each year because of allergic reactions to food. The statute, however, does not require manufacturers or retailers to relabel or remove products that don't have the labeling because they were labeled before the effective date.

Rural Access to Part B Drugs

Access problems may prevent rural providers from participating in the new Competitive Acquisition Program (CAP) for Part B drugs and biologicals, Joan Sokolovsky, a senior analyst with the Medicare Payment Advisory Commission (MedPAC), said at a commission meeting last December. Physicians who elect to participate in the program will obtain drugs from a preselected list of vendors, who in turn will take on the responsibility of billing Medicare for the drugs and collecting coinsurance or deductibles from patients. Under CAP rules, drugs must be delivered to the facility where they will be administered. Chemotherapy in rural areas, however, is delivered through satellite facilities, where "sometimes drugs cannot be mixed," Ms. Sokolovsky said. In a recommendation, MedPAC said that the Health and Human Services department should allow an exception to these delivery rules for rural satellite offices of providers.

Pay for Performance Not Local Yet

Despite the national buzz over pay for performance and the interest in Congress, such initiatives have yet to catch on in many local communities, the Center for Studying Health System Change reported in a study. "While there's been plenty of buzz about pay for performance as a way to improve health care quality, the reality is that these initiatives are off to a slow start in many communities," said Paul B. Ginsburg, Ph.D., who is president of HSC. The study was based on site visits to 12 nationally representative communities. Of these communities, only two, Orange County, Calif., and Boston, had significant physician pay-for-performance programs in place. In the other communities, where to date almost no physicians had received quality-related payments, physician attitudes ranged from skeptical to hostile, according to study results.

Cancer Screening Record

Officials at the American Academy of Dermatology are hoping for a record-setting year in 2006. AAD officials are recruiting members to participate in an attempt to set a Guinness World Record for the most skin cancer screenings conducted in a single day. The potentially record-setting screening day is set for Saturday, May 6, 2006. The AAD will be organizing large-scale screenings on that day in Washington, Chicago, and New York, but officials are also encouraging members in other areas to conduct their own free screenings. The academy's Melanoma/Skin Cancer Screening Program, which began in 1985, has helped to screen more than 1.5 million people. For more information on the May 6 screening day, e-mail the AAD at

worldrecord@aad.org

Psoriasis Advocates

The patient advocacy group Psoriasis Cure Now has singled out three members of Congress for their work to increase funding for federal research on psoriasis and psoriatic arthritis. The group honored Sen. Arlen Specter (R-Pa.), Rep. Rosa DeLauro (D-Conn.), and Rep. Ralph Regula (R-Ohio) with the group's 2005 Health Care Advocates of the Year award. "People with psoriasis have no Hollywood stars or other glitzy backers to call on for support or to bring attention to this incurable disease," Michael Paranzino, president of Psoriasis Cure Now, said in a statement. "Yet these leaders took up our cause without fanfare and recognized how research on psoriasis will help not just the millions of Americans with the disease, but may also help us better understand other challenging diseases."

Research Grant Program

The Women's Dermatologic Society is developing a new grant program this year to allow residents and young physicians to conduct clinical and basic research on women's health issues. The new grant, which is being sponsored by Ortho-Neutrogena, will provide grants in the amount of $3,000 to $8,000 each. Applicants must have an MD or DO degree and be a resident in an accredited training program or a board-certified or board-eligible dermatologist in the first 3 years after completing postgraduate training. Applications will be reviewed by a newly formed section of the Women's Dermatologic Society called the Academic Dermatologist Interest Group, which will monitor the grants program. A deadline for grant applications has not yet been set. Information on the program is available on the group's Web site at

www.womensderm.org/grant/research.html

Food Allergen Labeling

All food labels now must clearly state if a product contains any ingredients with protein derived from the eight major allergenic foods. Under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), manufacturers are required to identify in plain English the presence of ingredients that contain protein derived from milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, or soybeans in the list of ingredients or to say "contains" followed by the source of the food allergen after or adjacent to the list of ingredients. It is estimated that 2% of adults and 5% of infants and young children in the United States have food allergies. Approximately 30,000 consumers require emergency department treatment and 150 Americans die each year because of allergic reactions to food. The statute, however, does not require manufacturers or retailers to relabel or remove products that don't have the labeling because they were labeled before the effective date.

Rural Access to Part B Drugs

Access problems may prevent rural providers from participating in the new Competitive Acquisition Program (CAP) for Part B drugs and biologicals, Joan Sokolovsky, a senior analyst with the Medicare Payment Advisory Commission (MedPAC), said at a commission meeting last December. Physicians who elect to participate in the program will obtain drugs from a preselected list of vendors, who in turn will take on the responsibility of billing Medicare for the drugs and collecting coinsurance or deductibles from patients. Under CAP rules, drugs must be delivered to the facility where they will be administered. Chemotherapy in rural areas, however, is delivered through satellite facilities, where "sometimes drugs cannot be mixed," Ms. Sokolovsky said. In a recommendation, MedPAC said that the Health and Human Services department should allow an exception to these delivery rules for rural satellite offices of providers.

Pay for Performance Not Local Yet

Despite the national buzz over pay for performance and the interest in Congress, such initiatives have yet to catch on in many local communities, the Center for Studying Health System Change reported in a study. "While there's been plenty of buzz about pay for performance as a way to improve health care quality, the reality is that these initiatives are off to a slow start in many communities," said Paul B. Ginsburg, Ph.D., who is president of HSC. The study was based on site visits to 12 nationally representative communities. Of these communities, only two, Orange County, Calif., and Boston, had significant physician pay-for-performance programs in place. In the other communities, where to date almost no physicians had received quality-related payments, physician attitudes ranged from skeptical to hostile, according to study results.

WASHINGTON — Government officials and health information technology leaders plan to spend this year laying the groundwork for a system that would allow for the electronic transfer of ambulatory, emergency department, and laboratory data to public health agencies in less than a day.

Over time, officials would like to implement a real-time nationwide public health monitoring system.

"The system we have is simply not adequate," Mike Leavitt, secretary of the Health and Human Services department, said at a meeting of the American Health Information Community. The United States faces the possibility of a bioterrorist attack and the threat of pandemic, he said.

Mr. Leavitt said he would like to get a "spotty net" of surveillance off the ground quickly by collecting a few key indicators from as many electronic data sources as possible. Getting just 2–4 basic data points from all available sources would be a "quantum leap forward," he said.

Information from small and medium-sized primary care practices will be key to any electronic biosurveillance system, said Dr. David Kibbe, who represented the American Academy of Family Physicians at the meeting. The American Health Information Community is an advisory committee to the HHS department.

"There is widespread agreement that information technology can substantially improve surveillance both for ongoing public health and for health emergencies," said Dr. Thomas R. Frieden, commissioner of the New York City Department of Health and Mental Hygiene, who presented information on current electronic surveillance programs at the meeting.

There is a wide range of biosurveillance activities underway at the federal, state, and local levels, and in the private sector, Dr. Frieden said. For example, the Centers for Disease Control and Prevention operates the Public Health Information Network, which provides an architecture for public health information technology. Most recently, the agency established the BioSense program, which is aimed at supporting the connection of clinical care to public health and supporting "situational awareness" at the national level.

A number of state and local health departments have begun electronic reporting either from clinical laboratories or clinical information systems.

In New York City, the health department uses electronic reporting data on a daily basis. The system, which has been operating for more than 5 years, collects information from ambulance dispatches, emergency department visits, pharmacy purchases, outpatient visits, and other sources. The system also collects free text, which allows officials to evaluate information they might not have thought about otherwise.

Currently, 50 hospitals—representing about 90% of emergency department visits in the city—report daily. The electronic reporting system has proved helpful in the early detection of pockets of influenza. The electronic syndromic system consistently picks up influenza activity 2–3 weeks before any other system.

New York City is not alone. North Carolina has a statewide, hospital-based clinical data monitoring system. It allows for monitoring of real-time inpatient, outpatient, and emergency department data.

But there are major needs that must be addressed to reach the goal of a nationwide system, said Dr. John Loonsk of the federal Office of the National Coordinator for Health Information Technology. For example, data need to be standardized so they can be compared across reporting organizations, privacy and confidentiality must be ensured, and improvements need to be made in the current patchwork of state and local health information technology capability, he said.

In the short term, one area that could be implemented rapidly is the electronic reporting of lab results. This has value both to public health and for the routine use of clinicians, Dr. Loonsk said.

WASHINGTON — Government officials and health information technology leaders plan to spend this year laying the groundwork for a system that would allow for the electronic transfer of ambulatory, emergency department, and laboratory data to public health agencies in less than a day.

Over time, officials would like to implement a real-time nationwide public health monitoring system.

"The system we have is simply not adequate," Mike Leavitt, secretary of the Health and Human Services department, said at a meeting of the American Health Information Community. The United States faces the possibility of a bioterrorist attack and the threat of pandemic, he said.

Mr. Leavitt said he would like to get a "spotty net" of surveillance off the ground quickly by collecting a few key indicators from as many electronic data sources as possible. Getting just 2–4 basic data points from all available sources would be a "quantum leap forward," he said.

Information from small and medium-sized primary care practices will be key to any electronic biosurveillance system, said Dr. David Kibbe, who represented the American Academy of Family Physicians at the meeting. The American Health Information Community is an advisory committee to the HHS department.

"There is widespread agreement that information technology can substantially improve surveillance both for ongoing public health and for health emergencies," said Dr. Thomas R. Frieden, commissioner of the New York City Department of Health and Mental Hygiene, who presented information on current electronic surveillance programs at the meeting.

There is a wide range of biosurveillance activities underway at the federal, state, and local levels, and in the private sector, Dr. Frieden said. For example, the Centers for Disease Control and Prevention operates the Public Health Information Network, which provides an architecture for public health information technology. Most recently, the agency established the BioSense program, which is aimed at supporting the connection of clinical care to public health and supporting "situational awareness" at the national level.

A number of state and local health departments have begun electronic reporting either from clinical laboratories or clinical information systems.

In New York City, the health department uses electronic reporting data on a daily basis. The system, which has been operating for more than 5 years, collects information from ambulance dispatches, emergency department visits, pharmacy purchases, outpatient visits, and other sources. The system also collects free text, which allows officials to evaluate information they might not have thought about otherwise.

Currently, 50 hospitals—representing about 90% of emergency department visits in the city—report daily. The electronic reporting system has proved helpful in the early detection of pockets of influenza. The electronic syndromic system consistently picks up influenza activity 2–3 weeks before any other system.

New York City is not alone. North Carolina has a statewide, hospital-based clinical data monitoring system. It allows for monitoring of real-time inpatient, outpatient, and emergency department data.

But there are major needs that must be addressed to reach the goal of a nationwide system, said Dr. John Loonsk of the federal Office of the National Coordinator for Health Information Technology. For example, data need to be standardized so they can be compared across reporting organizations, privacy and confidentiality must be ensured, and improvements need to be made in the current patchwork of state and local health information technology capability, he said.

In the short term, one area that could be implemented rapidly is the electronic reporting of lab results. This has value both to public health and for the routine use of clinicians, Dr. Loonsk said.

WASHINGTON — Government officials and health information technology leaders plan to spend this year laying the groundwork for a system that would allow for the electronic transfer of ambulatory, emergency department, and laboratory data to public health agencies in less than a day.

Over time, officials would like to implement a real-time nationwide public health monitoring system.

"The system we have is simply not adequate," Mike Leavitt, secretary of the Health and Human Services department, said at a meeting of the American Health Information Community. The United States faces the possibility of a bioterrorist attack and the threat of pandemic, he said.

Mr. Leavitt said he would like to get a "spotty net" of surveillance off the ground quickly by collecting a few key indicators from as many electronic data sources as possible. Getting just 2–4 basic data points from all available sources would be a "quantum leap forward," he said.

Information from small and medium-sized primary care practices will be key to any electronic biosurveillance system, said Dr. David Kibbe, who represented the American Academy of Family Physicians at the meeting. The American Health Information Community is an advisory committee to the HHS department.

"There is widespread agreement that information technology can substantially improve surveillance both for ongoing public health and for health emergencies," said Dr. Thomas R. Frieden, commissioner of the New York City Department of Health and Mental Hygiene, who presented information on current electronic surveillance programs at the meeting.

There is a wide range of biosurveillance activities underway at the federal, state, and local levels, and in the private sector, Dr. Frieden said. For example, the Centers for Disease Control and Prevention operates the Public Health Information Network, which provides an architecture for public health information technology. Most recently, the agency established the BioSense program, which is aimed at supporting the connection of clinical care to public health and supporting "situational awareness" at the national level.

A number of state and local health departments have begun electronic reporting either from clinical laboratories or clinical information systems.

In New York City, the health department uses electronic reporting data on a daily basis. The system, which has been operating for more than 5 years, collects information from ambulance dispatches, emergency department visits, pharmacy purchases, outpatient visits, and other sources. The system also collects free text, which allows officials to evaluate information they might not have thought about otherwise.

Currently, 50 hospitals—representing about 90% of emergency department visits in the city—report daily. The electronic reporting system has proved helpful in the early detection of pockets of influenza. The electronic syndromic system consistently picks up influenza activity 2–3 weeks before any other system.

New York City is not alone. North Carolina has a statewide, hospital-based clinical data monitoring system. It allows for monitoring of real-time inpatient, outpatient, and emergency department data.

But there are major needs that must be addressed to reach the goal of a nationwide system, said Dr. John Loonsk of the federal Office of the National Coordinator for Health Information Technology. For example, data need to be standardized so they can be compared across reporting organizations, privacy and confidentiality must be ensured, and improvements need to be made in the current patchwork of state and local health information technology capability, he said.

In the short term, one area that could be implemented rapidly is the electronic reporting of lab results. This has value both to public health and for the routine use of clinicians, Dr. Loonsk said.

Officials at the Food and Drug Administration are planning to reorganize its Center for Drug Evaluation and Research in an effort to improve the agency's approach to drug safety and to help improve drug development.

The FDA plans to appoint a new associate director at the Center for Drug Evaluation and Research (CDER) to focus on broad drug safety, policy, and communication issues. Agency officials also plan to consolidate some drug safety-related activities and have that staff report to the new associate director. This would include MedWatch reporting staff and Drug Safety Oversight Board staff.

The reorganization plans also call for elevating the status of the current Office of Drug Safety, which is primarily responsible for epidemiology and surveillance activities, and its staff will report to the CDER director. The name of the office will also be changed.

“Over the past year, the Center has been the focus of intense internal and external scrutiny regarding drug safety,” Dr. Steven K. Galson, CDER director, said in a memo to the center staff. “The current organizational structure perpetuates the misperception that ensuring drug safety is solely the responsibility of the current Office of Drug Safety.”

While the Office of Drug Safety is a small unit, about half of CDER's resources are dedicated to drug safety activities, said Deborah Henderson, R.N., director of the Office of Executive Programs at CDER.

But the proposal includes no plans to make the Office of Drug Safety independent from CDER, as some in Congress have proposed. When reviewing drugs, FDA staff members need to balance the effectiveness of the drug against the risks, Ms. Henderson said, so pulling the safety activities out of the center wouldn't be in the best interests of public health.

FDA officials plan to implement the changes over the next 6 months.

The changes will also help to improve regulatory and drug development science through the agency's Critical Path Initiative—a top FDA priority that calls for partnering with industry and academia to improve the drug development process.

Through the Critical Path Initiative, FDA hopes to help industry find better biomarkers and improve clinical trial designs, Ms. Henderson said, which would ultimately lead to better, more targeted drugs.

While a number of CDER staff have been working on the Critical Path Initiative, there has not been a central office within CDER. Under the proposed reorganization, the FDA will create a new office that will report to the CDER director and provide a hub for Critical Path activities.

“A reorganization is not designed to achieve instant solutions to the challenges CDER faces, although I believe it will address many of the criticisms and suggestions which have been offered on how to approach our work, including drug safety,” Dr. Galson said in his memo to CDER staff.

But real improvements in drug safety need to happen outside the FDA, said Curt D. Furberg, M.D., Ph.D., professor in the department of public health sciences at Wake Forest University in Winston-Salem, N.C.

Congress needs to act to give the FDA greater authority to change labels, withdraw drugs, and levy penalties against drug makers who don't live up to their postmarket promises, he said. “FDA can't do that on its own,” Dr. Furberg said. “Congress is failing.”

The streamlining being proposed by the FDA is a good idea, he said, but it won't address the larger problem. “The issue of safety is much bigger,” he said.

Officials at the Food and Drug Administration are planning to reorganize its Center for Drug Evaluation and Research in an effort to improve the agency's approach to drug safety and to help improve drug development.

The FDA plans to appoint a new associate director at the Center for Drug Evaluation and Research (CDER) to focus on broad drug safety, policy, and communication issues. Agency officials also plan to consolidate some drug safety-related activities and have that staff report to the new associate director. This would include MedWatch reporting staff and Drug Safety Oversight Board staff.

The reorganization plans also call for elevating the status of the current Office of Drug Safety, which is primarily responsible for epidemiology and surveillance activities, and its staff will report to the CDER director. The name of the office will also be changed.

“Over the past year, the Center has been the focus of intense internal and external scrutiny regarding drug safety,” Dr. Steven K. Galson, CDER director, said in a memo to the center staff. “The current organizational structure perpetuates the misperception that ensuring drug safety is solely the responsibility of the current Office of Drug Safety.”

While the Office of Drug Safety is a small unit, about half of CDER's resources are dedicated to drug safety activities, said Deborah Henderson, R.N., director of the Office of Executive Programs at CDER.

But the proposal includes no plans to make the Office of Drug Safety independent from CDER, as some in Congress have proposed. When reviewing drugs, FDA staff members need to balance the effectiveness of the drug against the risks, Ms. Henderson said, so pulling the safety activities out of the center wouldn't be in the best interests of public health.

FDA officials plan to implement the changes over the next 6 months.

The changes will also help to improve regulatory and drug development science through the agency's Critical Path Initiative—a top FDA priority that calls for partnering with industry and academia to improve the drug development process.

Through the Critical Path Initiative, FDA hopes to help industry find better biomarkers and improve clinical trial designs, Ms. Henderson said, which would ultimately lead to better, more targeted drugs.

While a number of CDER staff have been working on the Critical Path Initiative, there has not been a central office within CDER. Under the proposed reorganization, the FDA will create a new office that will report to the CDER director and provide a hub for Critical Path activities.

“A reorganization is not designed to achieve instant solutions to the challenges CDER faces, although I believe it will address many of the criticisms and suggestions which have been offered on how to approach our work, including drug safety,” Dr. Galson said in his memo to CDER staff.

But real improvements in drug safety need to happen outside the FDA, said Curt D. Furberg, M.D., Ph.D., professor in the department of public health sciences at Wake Forest University in Winston-Salem, N.C.

Congress needs to act to give the FDA greater authority to change labels, withdraw drugs, and levy penalties against drug makers who don't live up to their postmarket promises, he said. “FDA can't do that on its own,” Dr. Furberg said. “Congress is failing.”

The streamlining being proposed by the FDA is a good idea, he said, but it won't address the larger problem. “The issue of safety is much bigger,” he said.

Officials at the Food and Drug Administration are planning to reorganize its Center for Drug Evaluation and Research in an effort to improve the agency's approach to drug safety and to help improve drug development.

The FDA plans to appoint a new associate director at the Center for Drug Evaluation and Research (CDER) to focus on broad drug safety, policy, and communication issues. Agency officials also plan to consolidate some drug safety-related activities and have that staff report to the new associate director. This would include MedWatch reporting staff and Drug Safety Oversight Board staff.

The reorganization plans also call for elevating the status of the current Office of Drug Safety, which is primarily responsible for epidemiology and surveillance activities, and its staff will report to the CDER director. The name of the office will also be changed.

“Over the past year, the Center has been the focus of intense internal and external scrutiny regarding drug safety,” Dr. Steven K. Galson, CDER director, said in a memo to the center staff. “The current organizational structure perpetuates the misperception that ensuring drug safety is solely the responsibility of the current Office of Drug Safety.”

While the Office of Drug Safety is a small unit, about half of CDER's resources are dedicated to drug safety activities, said Deborah Henderson, R.N., director of the Office of Executive Programs at CDER.

But the proposal includes no plans to make the Office of Drug Safety independent from CDER, as some in Congress have proposed. When reviewing drugs, FDA staff members need to balance the effectiveness of the drug against the risks, Ms. Henderson said, so pulling the safety activities out of the center wouldn't be in the best interests of public health.

FDA officials plan to implement the changes over the next 6 months.

The changes will also help to improve regulatory and drug development science through the agency's Critical Path Initiative—a top FDA priority that calls for partnering with industry and academia to improve the drug development process.

Through the Critical Path Initiative, FDA hopes to help industry find better biomarkers and improve clinical trial designs, Ms. Henderson said, which would ultimately lead to better, more targeted drugs.

While a number of CDER staff have been working on the Critical Path Initiative, there has not been a central office within CDER. Under the proposed reorganization, the FDA will create a new office that will report to the CDER director and provide a hub for Critical Path activities.

“A reorganization is not designed to achieve instant solutions to the challenges CDER faces, although I believe it will address many of the criticisms and suggestions which have been offered on how to approach our work, including drug safety,” Dr. Galson said in his memo to CDER staff.

But real improvements in drug safety need to happen outside the FDA, said Curt D. Furberg, M.D., Ph.D., professor in the department of public health sciences at Wake Forest University in Winston-Salem, N.C.

Congress needs to act to give the FDA greater authority to change labels, withdraw drugs, and levy penalties against drug makers who don't live up to their postmarket promises, he said. “FDA can't do that on its own,” Dr. Furberg said. “Congress is failing.”

The streamlining being proposed by the FDA is a good idea, he said, but it won't address the larger problem. “The issue of safety is much bigger,” he said.

Teen Communication With Parents

Most adolescent girls who have been to publicly funded family planning clinics report having had conversations with their parents about sex. Nearly 42% of the girls said they had talked a “great deal” with their parents about how to say no to sex, according to a survey conducted by researchers at the Guttmacher Institute. But about half of the girls surveyed said they did not talk with their parents at all about how to use condoms. The researchers analyzed questionnaires given to more than 1,500 adolescent girls who obtained services at 79 publicly funded family planning clinics across the United States. The girls were asked about communication with parents about sexual health issues, parent-child connectedness, parental attitudes toward sex and contraception, and parental knowledge of the clinic visit.

Umbilical Cord Stem Cell Bill

President Bush last month signed into law a bill that would provide for the collection and maintenance of human cord blood stem cells for the treatment of patients and use in research. The Stem Cell Therapeutic and Research Act of 2005 (H.R. 2520) directs the secretary of Health and Human Services to enter into one-time contracts with cord blood banks to assist in the collection and maintenance of 150,000 new units of cord blood. This cord blood would be made available for transplantation through the C.W. Bill Young Cell Transplantation Program. This new program is the successor to the National Bone Marrow Donor Registry and would be charged with increasing the number of transplants for suitably matched recipients from biologically unrelated donors of bone marrow and cord blood. Rep. Mike Castle (R-Del.) and Rep. Diana DeGette (D-Colo.) praised the legislation but said it does not serve as a replacement for their proposal to expand government funding of embryonic stem cell research. Rep. Castle and Rep. DeGette are continuing to push for Senate passage of H.R. 810, the Stem Cell Research Enhancement Act of 2005, which passed in the House last May.

Breast Implant Investigation

Sen. Dianne Feinstein (D-Calif.) and Sen. Olympia Snowe (R-Maine) have asked the Food and Drug Administration to investigate claims of safety problems with the Mentor silicone breast implants. A former employee of the company has alleged publicly that there is a design flaw in the implants that has led to a higher rupture rate, which was not accurately reported to the FDA. In addition, the former employee has alleged that Mentor's implants used in surgery leak more than the ones that were used in demonstrations to physicians and patients. But officials at Mentor say the allegations are false and that the former employee has been indicted for stealing breast implants from the company and trying to sell them on eBay. Last summer, Mentor and another company received “approvable” letters from the FDA; however, silicone breast implants will not be available until the FDA sets conditional requirements for the manufacturers.

Teen Health Curriculum

The Physicians for Reproductive Choice and Health have launched a nationwide educational project aimed at teaching physicians more about teens and sexual health. The Adolescent Reproductive Health Education Project is a curriculum that offers modules on adolescent-friendly health services, adolescent reproductive health data, the physician as advocate for adolescent reproductive health, cultural competency, contraception, male adolescent reproductive health, pregnancy counseling, sexuality education, and minors' legal access to confidential health services. The program was developed from a pilot program in Georgia that provided information to physicians, educators, parents, and teens. The curriculum is available free from the Physicians for Reproductive Choice and Health by calling 646-366-1890.

Addressing Underage Drinking

The Century Council, a not-for-profit organization funded by leading distilled spirits manufacturers, has launched a public awareness campaign aimed at improving communication between mothers and daughters about underage drinking. “Girl Talk: Choices and Consequences of Underage Drinking” was designed to help mothers to start conversations about alcohol use. The program comes on the heels of a Century Council survey that showed mothers significantly underestimate their daughters' experience with alcohol. For example, the survey found that 30% of 16− to 18-year-old girls reported drinking with friends but only 9% of their mothers thought their daughters were drinking. The program was developed in partnership with the Society for Women's Health Research and the Montgomery County Maryland Alcohol Beverage Control Board. More information on the program is available at

www.girlsanddrinking.org

Teen Communication With Parents

Most adolescent girls who have been to publicly funded family planning clinics report having had conversations with their parents about sex. Nearly 42% of the girls said they had talked a “great deal” with their parents about how to say no to sex, according to a survey conducted by researchers at the Guttmacher Institute. But about half of the girls surveyed said they did not talk with their parents at all about how to use condoms. The researchers analyzed questionnaires given to more than 1,500 adolescent girls who obtained services at 79 publicly funded family planning clinics across the United States. The girls were asked about communication with parents about sexual health issues, parent-child connectedness, parental attitudes toward sex and contraception, and parental knowledge of the clinic visit.

Umbilical Cord Stem Cell Bill

President Bush last month signed into law a bill that would provide for the collection and maintenance of human cord blood stem cells for the treatment of patients and use in research. The Stem Cell Therapeutic and Research Act of 2005 (H.R. 2520) directs the secretary of Health and Human Services to enter into one-time contracts with cord blood banks to assist in the collection and maintenance of 150,000 new units of cord blood. This cord blood would be made available for transplantation through the C.W. Bill Young Cell Transplantation Program. This new program is the successor to the National Bone Marrow Donor Registry and would be charged with increasing the number of transplants for suitably matched recipients from biologically unrelated donors of bone marrow and cord blood. Rep. Mike Castle (R-Del.) and Rep. Diana DeGette (D-Colo.) praised the legislation but said it does not serve as a replacement for their proposal to expand government funding of embryonic stem cell research. Rep. Castle and Rep. DeGette are continuing to push for Senate passage of H.R. 810, the Stem Cell Research Enhancement Act of 2005, which passed in the House last May.

Breast Implant Investigation

Sen. Dianne Feinstein (D-Calif.) and Sen. Olympia Snowe (R-Maine) have asked the Food and Drug Administration to investigate claims of safety problems with the Mentor silicone breast implants. A former employee of the company has alleged publicly that there is a design flaw in the implants that has led to a higher rupture rate, which was not accurately reported to the FDA. In addition, the former employee has alleged that Mentor's implants used in surgery leak more than the ones that were used in demonstrations to physicians and patients. But officials at Mentor say the allegations are false and that the former employee has been indicted for stealing breast implants from the company and trying to sell them on eBay. Last summer, Mentor and another company received “approvable” letters from the FDA; however, silicone breast implants will not be available until the FDA sets conditional requirements for the manufacturers.

Teen Health Curriculum

The Physicians for Reproductive Choice and Health have launched a nationwide educational project aimed at teaching physicians more about teens and sexual health. The Adolescent Reproductive Health Education Project is a curriculum that offers modules on adolescent-friendly health services, adolescent reproductive health data, the physician as advocate for adolescent reproductive health, cultural competency, contraception, male adolescent reproductive health, pregnancy counseling, sexuality education, and minors' legal access to confidential health services. The program was developed from a pilot program in Georgia that provided information to physicians, educators, parents, and teens. The curriculum is available free from the Physicians for Reproductive Choice and Health by calling 646-366-1890.

Addressing Underage Drinking

The Century Council, a not-for-profit organization funded by leading distilled spirits manufacturers, has launched a public awareness campaign aimed at improving communication between mothers and daughters about underage drinking. “Girl Talk: Choices and Consequences of Underage Drinking” was designed to help mothers to start conversations about alcohol use. The program comes on the heels of a Century Council survey that showed mothers significantly underestimate their daughters' experience with alcohol. For example, the survey found that 30% of 16− to 18-year-old girls reported drinking with friends but only 9% of their mothers thought their daughters were drinking. The program was developed in partnership with the Society for Women's Health Research and the Montgomery County Maryland Alcohol Beverage Control Board. More information on the program is available at

www.girlsanddrinking.org

Teen Communication With Parents

Most adolescent girls who have been to publicly funded family planning clinics report having had conversations with their parents about sex. Nearly 42% of the girls said they had talked a “great deal” with their parents about how to say no to sex, according to a survey conducted by researchers at the Guttmacher Institute. But about half of the girls surveyed said they did not talk with their parents at all about how to use condoms. The researchers analyzed questionnaires given to more than 1,500 adolescent girls who obtained services at 79 publicly funded family planning clinics across the United States. The girls were asked about communication with parents about sexual health issues, parent-child connectedness, parental attitudes toward sex and contraception, and parental knowledge of the clinic visit.

Umbilical Cord Stem Cell Bill

President Bush last month signed into law a bill that would provide for the collection and maintenance of human cord blood stem cells for the treatment of patients and use in research. The Stem Cell Therapeutic and Research Act of 2005 (H.R. 2520) directs the secretary of Health and Human Services to enter into one-time contracts with cord blood banks to assist in the collection and maintenance of 150,000 new units of cord blood. This cord blood would be made available for transplantation through the C.W. Bill Young Cell Transplantation Program. This new program is the successor to the National Bone Marrow Donor Registry and would be charged with increasing the number of transplants for suitably matched recipients from biologically unrelated donors of bone marrow and cord blood. Rep. Mike Castle (R-Del.) and Rep. Diana DeGette (D-Colo.) praised the legislation but said it does not serve as a replacement for their proposal to expand government funding of embryonic stem cell research. Rep. Castle and Rep. DeGette are continuing to push for Senate passage of H.R. 810, the Stem Cell Research Enhancement Act of 2005, which passed in the House last May.

Breast Implant Investigation

Sen. Dianne Feinstein (D-Calif.) and Sen. Olympia Snowe (R-Maine) have asked the Food and Drug Administration to investigate claims of safety problems with the Mentor silicone breast implants. A former employee of the company has alleged publicly that there is a design flaw in the implants that has led to a higher rupture rate, which was not accurately reported to the FDA. In addition, the former employee has alleged that Mentor's implants used in surgery leak more than the ones that were used in demonstrations to physicians and patients. But officials at Mentor say the allegations are false and that the former employee has been indicted for stealing breast implants from the company and trying to sell them on eBay. Last summer, Mentor and another company received “approvable” letters from the FDA; however, silicone breast implants will not be available until the FDA sets conditional requirements for the manufacturers.

Teen Health Curriculum

The Physicians for Reproductive Choice and Health have launched a nationwide educational project aimed at teaching physicians more about teens and sexual health. The Adolescent Reproductive Health Education Project is a curriculum that offers modules on adolescent-friendly health services, adolescent reproductive health data, the physician as advocate for adolescent reproductive health, cultural competency, contraception, male adolescent reproductive health, pregnancy counseling, sexuality education, and minors' legal access to confidential health services. The program was developed from a pilot program in Georgia that provided information to physicians, educators, parents, and teens. The curriculum is available free from the Physicians for Reproductive Choice and Health by calling 646-366-1890.

Addressing Underage Drinking

The Century Council, a not-for-profit organization funded by leading distilled spirits manufacturers, has launched a public awareness campaign aimed at improving communication between mothers and daughters about underage drinking. “Girl Talk: Choices and Consequences of Underage Drinking” was designed to help mothers to start conversations about alcohol use. The program comes on the heels of a Century Council survey that showed mothers significantly underestimate their daughters' experience with alcohol. For example, the survey found that 30% of 16− to 18-year-old girls reported drinking with friends but only 9% of their mothers thought their daughters were drinking. The program was developed in partnership with the Society for Women's Health Research and the Montgomery County Maryland Alcohol Beverage Control Board. More information on the program is available at

www.girlsanddrinking.org

An over-the-counter skin cleanser may have potential in treating head lice, according to a recent disclosure from a California dermatologist.

Dr. Dale L. Pearlman of Menlo Park, Calif., announced in December that the dry-on suffocation pediculicide (DSP) lotion he used in a study published in Pediatrics in 2004 was in fact the over-the-counter cleanser Cetaphil, marketed by Galderma Laboratories (Pediatrics 2004;114:e275–9).

Dr. Pearlman made the announcement in a letter to the editor of Pediatrics that was published in December 2005. In the letter, he said that he was making the disclosure so that physicians could try the treatment on their own (Pediatrics 2005;116:1612).

“I have received [more than] 250 requests from health care practitioners from the United States and abroad for additional information about this treatment; however, no pharmaceutical company, university, or health care entity has stepped forward to perform such studies,” Dr. Pearlman wrote in the letter.

“I now have realized that practitioners who want independent information will need to try out the treatment themselves,” he continued.

In the 2004 article in Pediatrics, Dr. Pearlman detailed the ingredients of the Cetaphil cleanser, which he referred to as “Nuvo lotion.” However, he did not say that it was already available over the counter. A 16-oz. bottle of Cetaphil generally sells for about $10.

The 2004 study showed that the DSP lotion was overall 96% effective and had a 94% overall long-term cure rate. Patients in the study received a once-weekly application of the DSP lotion for up to 3 weeks until cure was achieved.

Dr. Pearlman's protocol called for parents to apply the lotion and wait 2 minutes, then comb out as much lotion as possible.

Next, the protocol called for the child's hair to be thoroughly dried with a handheld hair dryer. The lotion is washed out with the child's regular shampoo in 8 hours or more.

The study was a preliminary proof of concept trial, Dr. Pearlman said in an interview, and he never meant for the public at large to be using the Cetaphil cleanser for the treatment of head lice.

Instead, Dr. Pearlman had hoped that a pharmaceutical company would sign on to study the idea and possibly make improvements to the formulation that would allow for quick drying and include a fluorescent tag to allow for independent confirmation that a child had been treated.

Dr. Pearlman said he's been up front with parents and colleagues from the beginning.“My work exemplifies the highest ethical standards for the medical profession,” he said. “The way has always been open for others to repeat my work.”

For 7 years, he provided his time and the treatment to patients at no cost, but this year he began to charge patients for his professional time and the cost of materials, which includes $40 worth of Cetaphil cleanser, three diagnostic tests for head lice, and an office visit.

So far, feedback from parents whose children were part of the study has been positive, he said. “They've all been very encouraging.” Dr. Pearlman said he suspects that more physicians will want to try his method.

Officials at Galderma said that the company has no plans to seek Food and Drug Administration approval to market the skin cleanser as a treatment for head lice, said Brent Petersen, a spokesman for the company.

While it's an “interesting concept,” Mr. Petersen said that Galderma will continue to promote the product as a gentle skin cleanser.

And Mr. Petersen said that while it was “a bit misleading” for Dr. Pearlman to call the cleanser Nuvo lotion, he was in no legal trouble for using the product in his study.

An over-the-counter skin cleanser may have potential in treating head lice, according to a recent disclosure from a California dermatologist.

Dr. Dale L. Pearlman of Menlo Park, Calif., announced in December that the dry-on suffocation pediculicide (DSP) lotion he used in a study published in Pediatrics in 2004 was in fact the over-the-counter cleanser Cetaphil, marketed by Galderma Laboratories (Pediatrics 2004;114:e275–9).

Dr. Pearlman made the announcement in a letter to the editor of Pediatrics that was published in December 2005. In the letter, he said that he was making the disclosure so that physicians could try the treatment on their own (Pediatrics 2005;116:1612).

“I have received [more than] 250 requests from health care practitioners from the United States and abroad for additional information about this treatment; however, no pharmaceutical company, university, or health care entity has stepped forward to perform such studies,” Dr. Pearlman wrote in the letter.

“I now have realized that practitioners who want independent information will need to try out the treatment themselves,” he continued.

In the 2004 article in Pediatrics, Dr. Pearlman detailed the ingredients of the Cetaphil cleanser, which he referred to as “Nuvo lotion.” However, he did not say that it was already available over the counter. A 16-oz. bottle of Cetaphil generally sells for about $10.

The 2004 study showed that the DSP lotion was overall 96% effective and had a 94% overall long-term cure rate. Patients in the study received a once-weekly application of the DSP lotion for up to 3 weeks until cure was achieved.

Dr. Pearlman's protocol called for parents to apply the lotion and wait 2 minutes, then comb out as much lotion as possible.

Next, the protocol called for the child's hair to be thoroughly dried with a handheld hair dryer. The lotion is washed out with the child's regular shampoo in 8 hours or more.

The study was a preliminary proof of concept trial, Dr. Pearlman said in an interview, and he never meant for the public at large to be using the Cetaphil cleanser for the treatment of head lice.

Instead, Dr. Pearlman had hoped that a pharmaceutical company would sign on to study the idea and possibly make improvements to the formulation that would allow for quick drying and include a fluorescent tag to allow for independent confirmation that a child had been treated.

Dr. Pearlman said he's been up front with parents and colleagues from the beginning.“My work exemplifies the highest ethical standards for the medical profession,” he said. “The way has always been open for others to repeat my work.”

For 7 years, he provided his time and the treatment to patients at no cost, but this year he began to charge patients for his professional time and the cost of materials, which includes $40 worth of Cetaphil cleanser, three diagnostic tests for head lice, and an office visit.

So far, feedback from parents whose children were part of the study has been positive, he said. “They've all been very encouraging.” Dr. Pearlman said he suspects that more physicians will want to try his method.

Officials at Galderma said that the company has no plans to seek Food and Drug Administration approval to market the skin cleanser as a treatment for head lice, said Brent Petersen, a spokesman for the company.

While it's an “interesting concept,” Mr. Petersen said that Galderma will continue to promote the product as a gentle skin cleanser.

And Mr. Petersen said that while it was “a bit misleading” for Dr. Pearlman to call the cleanser Nuvo lotion, he was in no legal trouble for using the product in his study.

An over-the-counter skin cleanser may have potential in treating head lice, according to a recent disclosure from a California dermatologist.

Dr. Dale L. Pearlman of Menlo Park, Calif., announced in December that the dry-on suffocation pediculicide (DSP) lotion he used in a study published in Pediatrics in 2004 was in fact the over-the-counter cleanser Cetaphil, marketed by Galderma Laboratories (Pediatrics 2004;114:e275–9).

Dr. Pearlman made the announcement in a letter to the editor of Pediatrics that was published in December 2005. In the letter, he said that he was making the disclosure so that physicians could try the treatment on their own (Pediatrics 2005;116:1612).

“I have received [more than] 250 requests from health care practitioners from the United States and abroad for additional information about this treatment; however, no pharmaceutical company, university, or health care entity has stepped forward to perform such studies,” Dr. Pearlman wrote in the letter.

“I now have realized that practitioners who want independent information will need to try out the treatment themselves,” he continued.

In the 2004 article in Pediatrics, Dr. Pearlman detailed the ingredients of the Cetaphil cleanser, which he referred to as “Nuvo lotion.” However, he did not say that it was already available over the counter. A 16-oz. bottle of Cetaphil generally sells for about $10.

The 2004 study showed that the DSP lotion was overall 96% effective and had a 94% overall long-term cure rate. Patients in the study received a once-weekly application of the DSP lotion for up to 3 weeks until cure was achieved.

Dr. Pearlman's protocol called for parents to apply the lotion and wait 2 minutes, then comb out as much lotion as possible.

Next, the protocol called for the child's hair to be thoroughly dried with a handheld hair dryer. The lotion is washed out with the child's regular shampoo in 8 hours or more.

The study was a preliminary proof of concept trial, Dr. Pearlman said in an interview, and he never meant for the public at large to be using the Cetaphil cleanser for the treatment of head lice.

Instead, Dr. Pearlman had hoped that a pharmaceutical company would sign on to study the idea and possibly make improvements to the formulation that would allow for quick drying and include a fluorescent tag to allow for independent confirmation that a child had been treated.

Dr. Pearlman said he's been up front with parents and colleagues from the beginning.“My work exemplifies the highest ethical standards for the medical profession,” he said. “The way has always been open for others to repeat my work.”

For 7 years, he provided his time and the treatment to patients at no cost, but this year he began to charge patients for his professional time and the cost of materials, which includes $40 worth of Cetaphil cleanser, three diagnostic tests for head lice, and an office visit.

So far, feedback from parents whose children were part of the study has been positive, he said. “They've all been very encouraging.” Dr. Pearlman said he suspects that more physicians will want to try his method.

Officials at Galderma said that the company has no plans to seek Food and Drug Administration approval to market the skin cleanser as a treatment for head lice, said Brent Petersen, a spokesman for the company.

While it's an “interesting concept,” Mr. Petersen said that Galderma will continue to promote the product as a gentle skin cleanser.

And Mr. Petersen said that while it was “a bit misleading” for Dr. Pearlman to call the cleanser Nuvo lotion, he was in no legal trouble for using the product in his study.

Over the next year or so, leaders in the health information technology community will work on ways to make medication history and some general demographic information available to consumers in a portable health record.

Experts at a Webcast meeting of the American Health Information Community agreed that this is the “low-hanging fruit” that could eventually pave the way for widespread access to portable, consumer-controlled personal health records. The American Health Information Community is an advisory committee to the Department of Health and Human Services.

The development of portable electronic demographic information, or registration information, would be a way to do away with the medical clipboard, HHS Secretary Mike Leavitt said.

“The timeliness of access to medical information is critical to patients,” said Nancy Davenport-Ennis, CEO of the National Patient Advocate Foundation and a member of the American Health Information Community. Today, most patients feel they own their medical record but when they go to get lab results from their physician, it can often take days or weeks, she said.

But one of the major hurdles in creating secure and portable patient health records is authentications, said Dr. Reed Tuckson of UnitedHealth Group, who presented information to the group.

Other obstacles include the inability to locate patient information across multiple settings, segmentation of the consumer market, privacy concerns, low levels of consumer trust, few electronic health records to connect to, and the lack of an established business model.

But there have been some successes, said David Lansky, Ph.D., of the Markle Foundation, who presented information to the group. For example, the Department of Veterans Affairs set up a patient portal, and the Department of Defense has a similar program. And some health plans offer prepopulated personal health records. “We're not starting with a blank slate,” Dr. Lansky said.

Providing medication history electronically to patients is something that could be done quickly, Dr. Lanksy said. The Markle Foundation was one of the groups that helped spearhead efforts to do just that with www.katrinahealth.org

It's helpful that the public already recognizes the value of using this type of information in an emergency situation, Dr. Lansky said.

Providing electronic access to general demographic data or registration information holds the potential for increasing convenience for patients and improving accuracy when sharing information. But privacy issues would need to be addressed and there is the potential for replicating errors, he said.

Over the next year or so, leaders in the health information technology community will work on ways to make medication history and some general demographic information available to consumers in a portable health record.

Experts at a Webcast meeting of the American Health Information Community agreed that this is the “low-hanging fruit” that could eventually pave the way for widespread access to portable, consumer-controlled personal health records. The American Health Information Community is an advisory committee to the Department of Health and Human Services.

The development of portable electronic demographic information, or registration information, would be a way to do away with the medical clipboard, HHS Secretary Mike Leavitt said.

“The timeliness of access to medical information is critical to patients,” said Nancy Davenport-Ennis, CEO of the National Patient Advocate Foundation and a member of the American Health Information Community. Today, most patients feel they own their medical record but when they go to get lab results from their physician, it can often take days or weeks, she said.

But one of the major hurdles in creating secure and portable patient health records is authentications, said Dr. Reed Tuckson of UnitedHealth Group, who presented information to the group.

Other obstacles include the inability to locate patient information across multiple settings, segmentation of the consumer market, privacy concerns, low levels of consumer trust, few electronic health records to connect to, and the lack of an established business model.

But there have been some successes, said David Lansky, Ph.D., of the Markle Foundation, who presented information to the group. For example, the Department of Veterans Affairs set up a patient portal, and the Department of Defense has a similar program. And some health plans offer prepopulated personal health records. “We're not starting with a blank slate,” Dr. Lansky said.

Providing medication history electronically to patients is something that could be done quickly, Dr. Lanksy said. The Markle Foundation was one of the groups that helped spearhead efforts to do just that with www.katrinahealth.org

It's helpful that the public already recognizes the value of using this type of information in an emergency situation, Dr. Lansky said.

Providing electronic access to general demographic data or registration information holds the potential for increasing convenience for patients and improving accuracy when sharing information. But privacy issues would need to be addressed and there is the potential for replicating errors, he said.

Over the next year or so, leaders in the health information technology community will work on ways to make medication history and some general demographic information available to consumers in a portable health record.

Experts at a Webcast meeting of the American Health Information Community agreed that this is the “low-hanging fruit” that could eventually pave the way for widespread access to portable, consumer-controlled personal health records. The American Health Information Community is an advisory committee to the Department of Health and Human Services.

The development of portable electronic demographic information, or registration information, would be a way to do away with the medical clipboard, HHS Secretary Mike Leavitt said.

“The timeliness of access to medical information is critical to patients,” said Nancy Davenport-Ennis, CEO of the National Patient Advocate Foundation and a member of the American Health Information Community. Today, most patients feel they own their medical record but when they go to get lab results from their physician, it can often take days or weeks, she said.

But one of the major hurdles in creating secure and portable patient health records is authentications, said Dr. Reed Tuckson of UnitedHealth Group, who presented information to the group.

Other obstacles include the inability to locate patient information across multiple settings, segmentation of the consumer market, privacy concerns, low levels of consumer trust, few electronic health records to connect to, and the lack of an established business model.

But there have been some successes, said David Lansky, Ph.D., of the Markle Foundation, who presented information to the group. For example, the Department of Veterans Affairs set up a patient portal, and the Department of Defense has a similar program. And some health plans offer prepopulated personal health records. “We're not starting with a blank slate,” Dr. Lansky said.

Providing medication history electronically to patients is something that could be done quickly, Dr. Lanksy said. The Markle Foundation was one of the groups that helped spearhead efforts to do just that with www.katrinahealth.org

It's helpful that the public already recognizes the value of using this type of information in an emergency situation, Dr. Lansky said.

Providing electronic access to general demographic data or registration information holds the potential for increasing convenience for patients and improving accuracy when sharing information. But privacy issues would need to be addressed and there is the potential for replicating errors, he said.