Mary Ellen Schneider

SAN FRANCISCO — Preventing and treating overweight in children begin with good advice to parents—no force feeding, don't use food as a reward, and get active as a family.

That's how Michelle L. May, M.D., a family physician in Phoenix, Ariz., advises families in her practice.

It only takes a minute or two during a well-child visit, and it gives parents permission not to make their child eat everything on his or her plate, Dr. May said at the annual meeting of the American Academy of Family Physicians.

“We know that we have an obesity epidemic in our population, and we are seeing this more and more in children,” Dr. May said.

While body mass index (BMI) is not calculated in children younger than 2 years, physicians should calculate BMI, in addition to height and weight, in all children aged 2–18 years. And Dr. May advocates that BMI should be added to the vital signs at the top of every chart.

The Americans in Motion toolkit, available from AAFP online at www.aafp.org/x22874.xmlwww.cdc.gov/growth

Physicians need to decide on a treatment approach for children who are at risk for or are already overweight, she said.

The advantage in treating overweight children is the chance to work with the entire family, she said. In many cases, there are multiple family members with the same problem and addressing the child's overweight could motivate other family members to take action.

Treating childhood overweight also requires physicians to be nonjudgmental and open, said Dr. May. These children have likely been teased about their weight at school or by friends and don't need to be criticized by their physician too.

Dr. May said she tries not to focus on weight as the problem, especially since children can grow into their weight. Instead, she focuses on interventions. For example, instead of counseling a child to lose weight, she will talk about increasing activity as a way to improve cholesterol.

Physicians also need to let parents know that children are born with the instinctive ability to know when and how much to eat. Counseling parents in this area should start right away, she said. Force feeding an infant a bottle can lead the child to associate food with comfort, Dr. May said.

And letting parents know that infants will take in the proper amount of food on their own takes the pressure off the parents, she said.

The same is true as a child gets older and is self-feeding. Parents should be careful not to heap praise on their child for finishing all of his or her dinner or coerce their child to eat all the food on the plate.

Dr. May is the author of “Am I Hungry? What to Do When Diets Don't Work.”

SAN FRANCISCO — Preventing and treating overweight in children begin with good advice to parents—no force feeding, don't use food as a reward, and get active as a family.

That's how Michelle L. May, M.D., a family physician in Phoenix, Ariz., advises families in her practice.

It only takes a minute or two during a well-child visit, and it gives parents permission not to make their child eat everything on his or her plate, Dr. May said at the annual meeting of the American Academy of Family Physicians.

“We know that we have an obesity epidemic in our population, and we are seeing this more and more in children,” Dr. May said.

While body mass index (BMI) is not calculated in children younger than 2 years, physicians should calculate BMI, in addition to height and weight, in all children aged 2–18 years. And Dr. May advocates that BMI should be added to the vital signs at the top of every chart.

The Americans in Motion toolkit, available from AAFP online at www.aafp.org/x22874.xmlwww.cdc.gov/growth

Physicians need to decide on a treatment approach for children who are at risk for or are already overweight, she said.

The advantage in treating overweight children is the chance to work with the entire family, she said. In many cases, there are multiple family members with the same problem and addressing the child's overweight could motivate other family members to take action.

Treating childhood overweight also requires physicians to be nonjudgmental and open, said Dr. May. These children have likely been teased about their weight at school or by friends and don't need to be criticized by their physician too.

Dr. May said she tries not to focus on weight as the problem, especially since children can grow into their weight. Instead, she focuses on interventions. For example, instead of counseling a child to lose weight, she will talk about increasing activity as a way to improve cholesterol.

Physicians also need to let parents know that children are born with the instinctive ability to know when and how much to eat. Counseling parents in this area should start right away, she said. Force feeding an infant a bottle can lead the child to associate food with comfort, Dr. May said.

And letting parents know that infants will take in the proper amount of food on their own takes the pressure off the parents, she said.

The same is true as a child gets older and is self-feeding. Parents should be careful not to heap praise on their child for finishing all of his or her dinner or coerce their child to eat all the food on the plate.

Dr. May is the author of “Am I Hungry? What to Do When Diets Don't Work.”

SAN FRANCISCO — Preventing and treating overweight in children begin with good advice to parents—no force feeding, don't use food as a reward, and get active as a family.

That's how Michelle L. May, M.D., a family physician in Phoenix, Ariz., advises families in her practice.

It only takes a minute or two during a well-child visit, and it gives parents permission not to make their child eat everything on his or her plate, Dr. May said at the annual meeting of the American Academy of Family Physicians.

“We know that we have an obesity epidemic in our population, and we are seeing this more and more in children,” Dr. May said.

While body mass index (BMI) is not calculated in children younger than 2 years, physicians should calculate BMI, in addition to height and weight, in all children aged 2–18 years. And Dr. May advocates that BMI should be added to the vital signs at the top of every chart.

The Americans in Motion toolkit, available from AAFP online at www.aafp.org/x22874.xmlwww.cdc.gov/growth

Physicians need to decide on a treatment approach for children who are at risk for or are already overweight, she said.

The advantage in treating overweight children is the chance to work with the entire family, she said. In many cases, there are multiple family members with the same problem and addressing the child's overweight could motivate other family members to take action.

Treating childhood overweight also requires physicians to be nonjudgmental and open, said Dr. May. These children have likely been teased about their weight at school or by friends and don't need to be criticized by their physician too.

Dr. May said she tries not to focus on weight as the problem, especially since children can grow into their weight. Instead, she focuses on interventions. For example, instead of counseling a child to lose weight, she will talk about increasing activity as a way to improve cholesterol.

Physicians also need to let parents know that children are born with the instinctive ability to know when and how much to eat. Counseling parents in this area should start right away, she said. Force feeding an infant a bottle can lead the child to associate food with comfort, Dr. May said.

And letting parents know that infants will take in the proper amount of food on their own takes the pressure off the parents, she said.

The same is true as a child gets older and is self-feeding. Parents should be careful not to heap praise on their child for finishing all of his or her dinner or coerce their child to eat all the food on the plate.

Dr. May is the author of “Am I Hungry? What to Do When Diets Don't Work.”

While the prospect of maintaining certification is met with resistance by many physicians, some internists say the process is useful and relevant.

In a recent issue of the New England Journal of Medicine, two internists who were certified before 1990 and therefore have grandfathered lifetime certifications detailed their experiences of going through the maintenance of certification process.

Troyen A. Brennan, M.D., president of Brigham and Women's Hospital Physician's Organization and past chair of the American Board of Internal Medicine (ABIM), was motivated to voluntarily recertify by a feeling of hypocrisy in advocating the process for his younger colleagues but not going through it himself.

And he was growing uncomfortable with some relevant clinical issues such as new antiretroviral drugs for HIV infection. “I was not just letting myself down: I had patients to consider,” Dr. Brennan wrote (N. Engl. J. Med. 2005;353:1989–92).

He allotted 2 years to complete the maintenance of certification process. The biggest hurdle, Dr. Brennan wrote, was the exam. Even after reviewing the literature and online textbooks, he found the ABIM's self-evaluation program modules difficult. But despite his struggle to prepare for the exam, Dr. Brennan wrote that the material was both relevant and useful.

“My review improved my hunches about common medical problems and made me comfortable in areas that used to be somewhat murky,” he wrote.

Another grandfathered internist, Richard J. Baron, M.D., has also been through the process of voluntary maintenance of certification and described his experience completing an ABIM practice improvement module for diabetes (N. Engl. J. Med. 2005;353:1992–3).

Dr. Baron, an internist in Philadelphia and a director at ABIM, found mixed results in his practice. To complete the module, he mailed a structured patient survey to a random sample of 21 patients with diabetes and audited their charts.

All of the patients surveyed reported that it wasn't a problem to reach the office with a question or get a referral. However, only 60% of patients said they “definitely” knew what to do to alleviate symptoms of low blood sugar, and only half of the patients rated their overall diabetes care as “excellent” or “very good.”

Dr. Baron also found out that while all 21 patients had current glycosylated hemoglobin measurements, only 15 of the 21 patients had urinary microalbumin results available.

The results will help him to improve patient education and implement systems designed to increase the number of diabetes patients who undergo annual urinary microalbumin testing, he wrote.

One of the big challenges facing officials at the ABIM is convincing grandfathered physicians to recertify, ABIM's President and CEO Christine K. Cassel, M.D., said in an interview.

About 80,000 internists—out of approximately 180,000 ABIM diplomates—hold only lifetime certificates. Of those, about 3% have voluntarily participated in maintenance of certification, according to ABIM.

Part of the problem is that physicians don't realize the process is very low risk. Physicians with time-limited certificates may stress over the test because they could lose their certification, but grandfathered physicians will always have their lifetime certificate, she noted.

Dr. Cassel said she is hopeful that more grandfathered physicians will volunteer for recertification, especially if it can help them in other areas such as gaining recognition or higher payments from a health plan.

Starting in January, internists will face new requirements for maintenance of certification. The practice assessment component, which is currently voluntary, will become a requirement next month.

Physicians will have a number of options for fulfilling this requirement, including using any of the ABIM's practice-improvement modules, its peer-and- patient feedback module, or existing patient data from an insurer. Another option is participating in an approved quality-improvement program.

Also in January, ABIM will introduce a point system to eliminate the need to count modules. Instead of a requirement to complete five self-evaluation modules with one medical knowledge module in the physician's area, the new process will call for completing self-evaluation models to earn 100 points.

Physicians must earn 20 points in medical knowledge, 20 points in practice performance, and 60 points in electives. The points are valid for 10 years from the date the modules are completed.

The point system will make it easier for physicians to renew certificates in more than one area, according to ABIM. The same 100 points will satisfy all self-evaluation requirements regardless of how many certificates the physicians renews. So to renew a second certificate, physicians will only need to be licensed and in good standing, to pass the secure exam in the two areas, and to earn 100 points.

Details on changes to ABIM's maintenance of certification process are available online at www.abim.org/moc/moc_new.shtm

While the prospect of maintaining certification is met with resistance by many physicians, some internists say the process is useful and relevant.

In a recent issue of the New England Journal of Medicine, two internists who were certified before 1990 and therefore have grandfathered lifetime certifications detailed their experiences of going through the maintenance of certification process.

Troyen A. Brennan, M.D., president of Brigham and Women's Hospital Physician's Organization and past chair of the American Board of Internal Medicine (ABIM), was motivated to voluntarily recertify by a feeling of hypocrisy in advocating the process for his younger colleagues but not going through it himself.

And he was growing uncomfortable with some relevant clinical issues such as new antiretroviral drugs for HIV infection. “I was not just letting myself down: I had patients to consider,” Dr. Brennan wrote (N. Engl. J. Med. 2005;353:1989–92).

He allotted 2 years to complete the maintenance of certification process. The biggest hurdle, Dr. Brennan wrote, was the exam. Even after reviewing the literature and online textbooks, he found the ABIM's self-evaluation program modules difficult. But despite his struggle to prepare for the exam, Dr. Brennan wrote that the material was both relevant and useful.

“My review improved my hunches about common medical problems and made me comfortable in areas that used to be somewhat murky,” he wrote.

Another grandfathered internist, Richard J. Baron, M.D., has also been through the process of voluntary maintenance of certification and described his experience completing an ABIM practice improvement module for diabetes (N. Engl. J. Med. 2005;353:1992–3).

Dr. Baron, an internist in Philadelphia and a director at ABIM, found mixed results in his practice. To complete the module, he mailed a structured patient survey to a random sample of 21 patients with diabetes and audited their charts.

All of the patients surveyed reported that it wasn't a problem to reach the office with a question or get a referral. However, only 60% of patients said they “definitely” knew what to do to alleviate symptoms of low blood sugar, and only half of the patients rated their overall diabetes care as “excellent” or “very good.”

Dr. Baron also found out that while all 21 patients had current glycosylated hemoglobin measurements, only 15 of the 21 patients had urinary microalbumin results available.

The results will help him to improve patient education and implement systems designed to increase the number of diabetes patients who undergo annual urinary microalbumin testing, he wrote.

One of the big challenges facing officials at the ABIM is convincing grandfathered physicians to recertify, ABIM's President and CEO Christine K. Cassel, M.D., said in an interview.

About 80,000 internists—out of approximately 180,000 ABIM diplomates—hold only lifetime certificates. Of those, about 3% have voluntarily participated in maintenance of certification, according to ABIM.

Part of the problem is that physicians don't realize the process is very low risk. Physicians with time-limited certificates may stress over the test because they could lose their certification, but grandfathered physicians will always have their lifetime certificate, she noted.

Dr. Cassel said she is hopeful that more grandfathered physicians will volunteer for recertification, especially if it can help them in other areas such as gaining recognition or higher payments from a health plan.

Starting in January, internists will face new requirements for maintenance of certification. The practice assessment component, which is currently voluntary, will become a requirement next month.

Physicians will have a number of options for fulfilling this requirement, including using any of the ABIM's practice-improvement modules, its peer-and- patient feedback module, or existing patient data from an insurer. Another option is participating in an approved quality-improvement program.

Also in January, ABIM will introduce a point system to eliminate the need to count modules. Instead of a requirement to complete five self-evaluation modules with one medical knowledge module in the physician's area, the new process will call for completing self-evaluation models to earn 100 points.

Physicians must earn 20 points in medical knowledge, 20 points in practice performance, and 60 points in electives. The points are valid for 10 years from the date the modules are completed.

The point system will make it easier for physicians to renew certificates in more than one area, according to ABIM. The same 100 points will satisfy all self-evaluation requirements regardless of how many certificates the physicians renews. So to renew a second certificate, physicians will only need to be licensed and in good standing, to pass the secure exam in the two areas, and to earn 100 points.

Details on changes to ABIM's maintenance of certification process are available online at www.abim.org/moc/moc_new.shtm

While the prospect of maintaining certification is met with resistance by many physicians, some internists say the process is useful and relevant.

In a recent issue of the New England Journal of Medicine, two internists who were certified before 1990 and therefore have grandfathered lifetime certifications detailed their experiences of going through the maintenance of certification process.

Troyen A. Brennan, M.D., president of Brigham and Women's Hospital Physician's Organization and past chair of the American Board of Internal Medicine (ABIM), was motivated to voluntarily recertify by a feeling of hypocrisy in advocating the process for his younger colleagues but not going through it himself.

And he was growing uncomfortable with some relevant clinical issues such as new antiretroviral drugs for HIV infection. “I was not just letting myself down: I had patients to consider,” Dr. Brennan wrote (N. Engl. J. Med. 2005;353:1989–92).

He allotted 2 years to complete the maintenance of certification process. The biggest hurdle, Dr. Brennan wrote, was the exam. Even after reviewing the literature and online textbooks, he found the ABIM's self-evaluation program modules difficult. But despite his struggle to prepare for the exam, Dr. Brennan wrote that the material was both relevant and useful.

“My review improved my hunches about common medical problems and made me comfortable in areas that used to be somewhat murky,” he wrote.

Another grandfathered internist, Richard J. Baron, M.D., has also been through the process of voluntary maintenance of certification and described his experience completing an ABIM practice improvement module for diabetes (N. Engl. J. Med. 2005;353:1992–3).

Dr. Baron, an internist in Philadelphia and a director at ABIM, found mixed results in his practice. To complete the module, he mailed a structured patient survey to a random sample of 21 patients with diabetes and audited their charts.

All of the patients surveyed reported that it wasn't a problem to reach the office with a question or get a referral. However, only 60% of patients said they “definitely” knew what to do to alleviate symptoms of low blood sugar, and only half of the patients rated their overall diabetes care as “excellent” or “very good.”

Dr. Baron also found out that while all 21 patients had current glycosylated hemoglobin measurements, only 15 of the 21 patients had urinary microalbumin results available.

The results will help him to improve patient education and implement systems designed to increase the number of diabetes patients who undergo annual urinary microalbumin testing, he wrote.

One of the big challenges facing officials at the ABIM is convincing grandfathered physicians to recertify, ABIM's President and CEO Christine K. Cassel, M.D., said in an interview.

About 80,000 internists—out of approximately 180,000 ABIM diplomates—hold only lifetime certificates. Of those, about 3% have voluntarily participated in maintenance of certification, according to ABIM.

Part of the problem is that physicians don't realize the process is very low risk. Physicians with time-limited certificates may stress over the test because they could lose their certification, but grandfathered physicians will always have their lifetime certificate, she noted.

Dr. Cassel said she is hopeful that more grandfathered physicians will volunteer for recertification, especially if it can help them in other areas such as gaining recognition or higher payments from a health plan.

Starting in January, internists will face new requirements for maintenance of certification. The practice assessment component, which is currently voluntary, will become a requirement next month.

Physicians will have a number of options for fulfilling this requirement, including using any of the ABIM's practice-improvement modules, its peer-and- patient feedback module, or existing patient data from an insurer. Another option is participating in an approved quality-improvement program.

Also in January, ABIM will introduce a point system to eliminate the need to count modules. Instead of a requirement to complete five self-evaluation modules with one medical knowledge module in the physician's area, the new process will call for completing self-evaluation models to earn 100 points.

Physicians must earn 20 points in medical knowledge, 20 points in practice performance, and 60 points in electives. The points are valid for 10 years from the date the modules are completed.

The point system will make it easier for physicians to renew certificates in more than one area, according to ABIM. The same 100 points will satisfy all self-evaluation requirements regardless of how many certificates the physicians renews. So to renew a second certificate, physicians will only need to be licensed and in good standing, to pass the secure exam in the two areas, and to earn 100 points.

Details on changes to ABIM's maintenance of certification process are available online at www.abim.org/moc/moc_new.shtm

New guidance from the Food and Drug Administration proposes that latex condom labels inform users that condoms greatly reduce, but do not eliminate, the risk of pregnancy and the risk of contracting or spreading HIV or other sexually transmitted diseases.

The draft guidance from FDA, which is nonbinding, also recommends that the package insert for latex condoms say that condoms cannot protect against STDs such as human papilloma virus (HPV) and genital herpes when they are spread through contact with infected skin outside the area covered by the condom.

The draft guidance also includes statements that nonoxynol-9 could irritate the vagina and rectum and therefore may increase the risk of acquiring HIV/AIDS from an infected partner.

The proposed guidance is the result of a 5-year-old law that directs the FDA to ensure that condom labels are medically accurate, specifically in regard to their overall effectiveness in preventing STDs.

But the original congressional supporters of the provision—Sen. Tom Coburn (R-Okla.) and Rep. Mark Souder (R-Ind.)—are not completely satisfied with the FDA's conclusions.

“This is a step in the right direction,” Rep. Souder said in a statement. “Inasmuch as the new label recommendations finally acknowledge that condoms will not protect against some STDs.”

But he added that he is discouraged that FDA's recommendation says that condom use may lower the risk of developing HPV-related diseases, such as genital warts and cancer.

“This dangerous assurance overlooks the fact that condoms will not protect a user from contracting or spreading the sexual disease to others,” he said.

Reproductive health advocates, on the other hand, say that FDA officials did their best to produce evidence-based guidance in the context of political pressure from social conservatives who want to undermine public confidence in condoms.

But the FDA should continue to make improvements to the guidance, Vanessa Cullins, M.D., vice president for medical affairs at the Planned Parenthood Federation of America said in an interview.

It's important for the labeling to include a statement saying that condoms are the best protection against STDs for sexually active individuals, she said. This information is crucial to provide the necessary context to all the information that FDA is trying to convey, she said.

The FDA draft guidance is available online at www.fda.gov/cdrh/comp/guidance/1548.html

New guidance from the Food and Drug Administration proposes that latex condom labels inform users that condoms greatly reduce, but do not eliminate, the risk of pregnancy and the risk of contracting or spreading HIV or other sexually transmitted diseases.

The draft guidance from FDA, which is nonbinding, also recommends that the package insert for latex condoms say that condoms cannot protect against STDs such as human papilloma virus (HPV) and genital herpes when they are spread through contact with infected skin outside the area covered by the condom.

The draft guidance also includes statements that nonoxynol-9 could irritate the vagina and rectum and therefore may increase the risk of acquiring HIV/AIDS from an infected partner.

The proposed guidance is the result of a 5-year-old law that directs the FDA to ensure that condom labels are medically accurate, specifically in regard to their overall effectiveness in preventing STDs.

But the original congressional supporters of the provision—Sen. Tom Coburn (R-Okla.) and Rep. Mark Souder (R-Ind.)—are not completely satisfied with the FDA's conclusions.

“This is a step in the right direction,” Rep. Souder said in a statement. “Inasmuch as the new label recommendations finally acknowledge that condoms will not protect against some STDs.”

But he added that he is discouraged that FDA's recommendation says that condom use may lower the risk of developing HPV-related diseases, such as genital warts and cancer.

“This dangerous assurance overlooks the fact that condoms will not protect a user from contracting or spreading the sexual disease to others,” he said.

Reproductive health advocates, on the other hand, say that FDA officials did their best to produce evidence-based guidance in the context of political pressure from social conservatives who want to undermine public confidence in condoms.

But the FDA should continue to make improvements to the guidance, Vanessa Cullins, M.D., vice president for medical affairs at the Planned Parenthood Federation of America said in an interview.

It's important for the labeling to include a statement saying that condoms are the best protection against STDs for sexually active individuals, she said. This information is crucial to provide the necessary context to all the information that FDA is trying to convey, she said.

The FDA draft guidance is available online at www.fda.gov/cdrh/comp/guidance/1548.html

New guidance from the Food and Drug Administration proposes that latex condom labels inform users that condoms greatly reduce, but do not eliminate, the risk of pregnancy and the risk of contracting or spreading HIV or other sexually transmitted diseases.

The draft guidance from FDA, which is nonbinding, also recommends that the package insert for latex condoms say that condoms cannot protect against STDs such as human papilloma virus (HPV) and genital herpes when they are spread through contact with infected skin outside the area covered by the condom.

The draft guidance also includes statements that nonoxynol-9 could irritate the vagina and rectum and therefore may increase the risk of acquiring HIV/AIDS from an infected partner.

The proposed guidance is the result of a 5-year-old law that directs the FDA to ensure that condom labels are medically accurate, specifically in regard to their overall effectiveness in preventing STDs.

But the original congressional supporters of the provision—Sen. Tom Coburn (R-Okla.) and Rep. Mark Souder (R-Ind.)—are not completely satisfied with the FDA's conclusions.

“This is a step in the right direction,” Rep. Souder said in a statement. “Inasmuch as the new label recommendations finally acknowledge that condoms will not protect against some STDs.”

But he added that he is discouraged that FDA's recommendation says that condom use may lower the risk of developing HPV-related diseases, such as genital warts and cancer.

“This dangerous assurance overlooks the fact that condoms will not protect a user from contracting or spreading the sexual disease to others,” he said.

Reproductive health advocates, on the other hand, say that FDA officials did their best to produce evidence-based guidance in the context of political pressure from social conservatives who want to undermine public confidence in condoms.

But the FDA should continue to make improvements to the guidance, Vanessa Cullins, M.D., vice president for medical affairs at the Planned Parenthood Federation of America said in an interview.

It's important for the labeling to include a statement saying that condoms are the best protection against STDs for sexually active individuals, she said. This information is crucial to provide the necessary context to all the information that FDA is trying to convey, she said.

The FDA draft guidance is available online at www.fda.gov/cdrh/comp/guidance/1548.html

Parental Notification Fails

An attempt to require parental notification for minors seeking an abortion in California failed last month in a special election. The vote on Proposition 73 was 52.6% against and 47.4% for the measure, according to the California Board of Elections. Voters were asked to amend the California constitution to prohibit abortion for an unemancipated minor until 48 hours after a physician notifies the minor's parent or legal guardian. The proposal would have allowed for an exception in the case of a medical emergency or with a court order waiving notice. If enacted, Proposition 73 would have authorized monetary damages against physicians for violating the notice requirement. The proposal was opposed by a number of groups including the American Academy of Pediatrics California chapter and the American College of Obstetricians and Gynecologists, District IX chapter.

Yates Conviction Overturned

The Texas Court of Appeals last month upheld a lower court ruling that overturned the murder conviction of Andrea Yates in the drowning deaths of three of her children. The case is likely to go to trial again unless the district attorney's office and the defense can reach a plea deal. “We're extremely disappointed and surprised by the decision,” Alan Curry, assistant district attorney for the appellate division of the Harris County district attorney's office told this newspaper. The ruling by the lower court—the Court of Appeals for the First District of Texas—found that false testimony given by a psychiatrist testifying for the prosecution could have substantially affected the judgment of the jury and violated the defendant's right to due process. The psychiatrist testified falsely that an episode of “Law & Order” on postpartum depression in which a woman drowned her children in the bathtub had aired shortly before Ms. Yates committed the murders.

Groups Demand Action on Plan B

The Food and Drug Administration should abandon the current proposed rulemaking process for Plan B emergency contraception and approve over-the-counter status for the product for women of all ages, according to a letter from the American College of Obstetricians and Gynecologists and a number of other women's health advocates. The coalition sent the letter during the comment period the agency opened in August to gather more information on the application from Barr Laboratories to make Plan B (levonorgestrel) available over the counter for women aged 16 years and older. “Plan B needs to be on the counter with condoms and other over-the-counter contraceptives to encourage use of the product,” the groups wrote in the letter. “A dual status product will force Plan B behind the counter in most pharmacies, needlessly increasing the cost and burden to pharmacists and to women, and likely, discourage use.”

Costs of Intimate Partner Violence

The average cost for a woman who is the victim of intimate partner violence is about $948 per incident, according to researchers from the Centers for Disease Control and Prevention (CDC). The cost includes the cost of medical care, mental health services, and productivity losses. The average cost for men who are victims of domestic violence is about $387. Intimate partner violence includes physical, sexual, or psychological harm to another by a current or former partner or spouse and affects more than 32 million Americans each year, according to the CDC. Researchers found that intimate partner violence against women leads to more emergency department visits and hospitalizations, compared with violence against men. The findings were published in the journal Violence and Victims (2005;20:379–91). “This study clearly shows the true impact of domestic violence,” said Ileana Arias, Ph.D., director of CDC's National Center for Injury Prevention and Control and coauthor of the study, in a press release. “Domestic violence, especially against women, causes a range of emotional, physical, and financial harm for victims and their families. We need to continue our efforts to prevent this type of violence, including broadening our focus to also address the needs of men who are victims.”

Teenage Birth Rate Drops

The birth rate among teenage girls continued to decline in 2004, according to the CDC's National Center for Health Statistics. The birth rate for girls aged 15–19 years dropped to the historic low of 41 births per 1,000 last year. Births rose among older women, increasing 4% for women aged 35–39 years and 3% for women aged 40–44 years The NCHS reported 4.1 million births in 2004, up nearly 1% from 2003. The general fertility rate rose slightly last year to 66.3 live births per 1,000 women, compared with 66.1 live births per 1,000 women in 2003.

Parental Notification Fails

An attempt to require parental notification for minors seeking an abortion in California failed last month in a special election. The vote on Proposition 73 was 52.6% against and 47.4% for the measure, according to the California Board of Elections. Voters were asked to amend the California constitution to prohibit abortion for an unemancipated minor until 48 hours after a physician notifies the minor's parent or legal guardian. The proposal would have allowed for an exception in the case of a medical emergency or with a court order waiving notice. If enacted, Proposition 73 would have authorized monetary damages against physicians for violating the notice requirement. The proposal was opposed by a number of groups including the American Academy of Pediatrics California chapter and the American College of Obstetricians and Gynecologists, District IX chapter.

Yates Conviction Overturned

The Texas Court of Appeals last month upheld a lower court ruling that overturned the murder conviction of Andrea Yates in the drowning deaths of three of her children. The case is likely to go to trial again unless the district attorney's office and the defense can reach a plea deal. “We're extremely disappointed and surprised by the decision,” Alan Curry, assistant district attorney for the appellate division of the Harris County district attorney's office told this newspaper. The ruling by the lower court—the Court of Appeals for the First District of Texas—found that false testimony given by a psychiatrist testifying for the prosecution could have substantially affected the judgment of the jury and violated the defendant's right to due process. The psychiatrist testified falsely that an episode of “Law & Order” on postpartum depression in which a woman drowned her children in the bathtub had aired shortly before Ms. Yates committed the murders.

Groups Demand Action on Plan B

The Food and Drug Administration should abandon the current proposed rulemaking process for Plan B emergency contraception and approve over-the-counter status for the product for women of all ages, according to a letter from the American College of Obstetricians and Gynecologists and a number of other women's health advocates. The coalition sent the letter during the comment period the agency opened in August to gather more information on the application from Barr Laboratories to make Plan B (levonorgestrel) available over the counter for women aged 16 years and older. “Plan B needs to be on the counter with condoms and other over-the-counter contraceptives to encourage use of the product,” the groups wrote in the letter. “A dual status product will force Plan B behind the counter in most pharmacies, needlessly increasing the cost and burden to pharmacists and to women, and likely, discourage use.”

Costs of Intimate Partner Violence

The average cost for a woman who is the victim of intimate partner violence is about $948 per incident, according to researchers from the Centers for Disease Control and Prevention (CDC). The cost includes the cost of medical care, mental health services, and productivity losses. The average cost for men who are victims of domestic violence is about $387. Intimate partner violence includes physical, sexual, or psychological harm to another by a current or former partner or spouse and affects more than 32 million Americans each year, according to the CDC. Researchers found that intimate partner violence against women leads to more emergency department visits and hospitalizations, compared with violence against men. The findings were published in the journal Violence and Victims (2005;20:379–91). “This study clearly shows the true impact of domestic violence,” said Ileana Arias, Ph.D., director of CDC's National Center for Injury Prevention and Control and coauthor of the study, in a press release. “Domestic violence, especially against women, causes a range of emotional, physical, and financial harm for victims and their families. We need to continue our efforts to prevent this type of violence, including broadening our focus to also address the needs of men who are victims.”

Teenage Birth Rate Drops

The birth rate among teenage girls continued to decline in 2004, according to the CDC's National Center for Health Statistics. The birth rate for girls aged 15–19 years dropped to the historic low of 41 births per 1,000 last year. Births rose among older women, increasing 4% for women aged 35–39 years and 3% for women aged 40–44 years The NCHS reported 4.1 million births in 2004, up nearly 1% from 2003. The general fertility rate rose slightly last year to 66.3 live births per 1,000 women, compared with 66.1 live births per 1,000 women in 2003.

Parental Notification Fails

An attempt to require parental notification for minors seeking an abortion in California failed last month in a special election. The vote on Proposition 73 was 52.6% against and 47.4% for the measure, according to the California Board of Elections. Voters were asked to amend the California constitution to prohibit abortion for an unemancipated minor until 48 hours after a physician notifies the minor's parent or legal guardian. The proposal would have allowed for an exception in the case of a medical emergency or with a court order waiving notice. If enacted, Proposition 73 would have authorized monetary damages against physicians for violating the notice requirement. The proposal was opposed by a number of groups including the American Academy of Pediatrics California chapter and the American College of Obstetricians and Gynecologists, District IX chapter.

Yates Conviction Overturned

The Texas Court of Appeals last month upheld a lower court ruling that overturned the murder conviction of Andrea Yates in the drowning deaths of three of her children. The case is likely to go to trial again unless the district attorney's office and the defense can reach a plea deal. “We're extremely disappointed and surprised by the decision,” Alan Curry, assistant district attorney for the appellate division of the Harris County district attorney's office told this newspaper. The ruling by the lower court—the Court of Appeals for the First District of Texas—found that false testimony given by a psychiatrist testifying for the prosecution could have substantially affected the judgment of the jury and violated the defendant's right to due process. The psychiatrist testified falsely that an episode of “Law & Order” on postpartum depression in which a woman drowned her children in the bathtub had aired shortly before Ms. Yates committed the murders.

Groups Demand Action on Plan B

The Food and Drug Administration should abandon the current proposed rulemaking process for Plan B emergency contraception and approve over-the-counter status for the product for women of all ages, according to a letter from the American College of Obstetricians and Gynecologists and a number of other women's health advocates. The coalition sent the letter during the comment period the agency opened in August to gather more information on the application from Barr Laboratories to make Plan B (levonorgestrel) available over the counter for women aged 16 years and older. “Plan B needs to be on the counter with condoms and other over-the-counter contraceptives to encourage use of the product,” the groups wrote in the letter. “A dual status product will force Plan B behind the counter in most pharmacies, needlessly increasing the cost and burden to pharmacists and to women, and likely, discourage use.”

Costs of Intimate Partner Violence

The average cost for a woman who is the victim of intimate partner violence is about $948 per incident, according to researchers from the Centers for Disease Control and Prevention (CDC). The cost includes the cost of medical care, mental health services, and productivity losses. The average cost for men who are victims of domestic violence is about $387. Intimate partner violence includes physical, sexual, or psychological harm to another by a current or former partner or spouse and affects more than 32 million Americans each year, according to the CDC. Researchers found that intimate partner violence against women leads to more emergency department visits and hospitalizations, compared with violence against men. The findings were published in the journal Violence and Victims (2005;20:379–91). “This study clearly shows the true impact of domestic violence,” said Ileana Arias, Ph.D., director of CDC's National Center for Injury Prevention and Control and coauthor of the study, in a press release. “Domestic violence, especially against women, causes a range of emotional, physical, and financial harm for victims and their families. We need to continue our efforts to prevent this type of violence, including broadening our focus to also address the needs of men who are victims.”

Teenage Birth Rate Drops

The birth rate among teenage girls continued to decline in 2004, according to the CDC's National Center for Health Statistics. The birth rate for girls aged 15–19 years dropped to the historic low of 41 births per 1,000 last year. Births rose among older women, increasing 4% for women aged 35–39 years and 3% for women aged 40–44 years The NCHS reported 4.1 million births in 2004, up nearly 1% from 2003. The general fertility rate rose slightly last year to 66.3 live births per 1,000 women, compared with 66.1 live births per 1,000 women in 2003.

Competitive Drug Acquisition

Starting April 3, 2006, physicians can begin the initial vendor election process as part of Medicare's Competitive Acquisition Program (CAP) for physician-administered drugs covered under Medicare Part B. The voluntary program allows physicians to obtain Part B drugs from vendors who are selected in a competitive bidding process. Vendors would then bill Medicare and collect any applicable deductible and coinsurance from beneficiaries for the drugs. Physicians would continue to be paid for the cost of drug administration. Physicians can obtain drugs through the program starting on July 1, 2006. Officials at the Centers for Medicare and Medicaid Services announced refinements to the CAP process last month, including establishing a process for approved vendors to furnish additional drugs under the program and establishing a framework for vendors to enter into arrangements with CAP physicians for the collection of coinsurance.

Alternative Medicine Centers

The National Center for Complementary and Alternative Medicine (NCCAM) is funding five new research centers to study complementary and alternative approaches to HIV/AIDS, arthritis, asthma, and pain. Three of the new centers will focus on therapies used in traditional Chinese medicine, such as acupuncture and Chinese herbal mixtures. The other centers will study millimeter wave therapy—a type of energy medicine—and botanical therapies used by traditional healers in Africa. For example, NCCAM has awarded $1.2 million in first-year funding to the Center for Arthritis and Traditional Chinese Medicine at the University of Maryland in Baltimore. Researchers there will conduct a clinical trial of an 11-herb Chinese formula known as HLXL for osteoarthritis of the knee; assess acupuncture's effect on inflammatory pain in an animal model; and study the efficacy of HLXL in an animal model of autoimmune arthritis. NCCAM is a component of the National Institutes of Health.

The Research Pipeline

Drug researchers are currently developing 446 medicines aimed at diseases that disproportionately affect women in the United States, according to a report from the Pharmaceutical Research and Manufacturers of America (PhRMA). Seventy-two of the drugs are being developed for arthritis or musculoskeletal disorders. The 41 million women with arthritis in the United States account for 70% of rheumatoid arthritis sufferers and 60% of osteoarthritis sufferers, according to PhRMA. In addition, researchers are working on 47 drugs for autoimmune diseases including lupus, fibromyalgia, psoriasis, and multiple sclerosis. These medicines are either in clinical trials or awaiting approval by the Food and Drug Administration.

Unproven Health Claims

The Food and Drug Administration issued warning letters to 29 companies for making unproven claims that their products treat or prevent disease. The letters were issued to companies that manufacture, market, or distribute products made from cherries and other fruits. The companies made a range of claims about diseases including arthritis, cancer, and heart disease. Under the Federal Food, Drug, and Cosmetic Act, products intended for use in the “diagnosis, cure, mitigation, treatment, or prevention of disease” are considered drugs and must be approved for safety and effectiveness by the FDA.

Cream Skimming Continues

Specialty hospitals are under scrutiny once again. A study found that Arizona heart physicians who partly owned cardiac specialty hospitals were more likely than were physicians with no ownership stake to treat low-acuity, high-profit cases in their own facilities and refer the more complex, lower-profit cases to community hospitals. Jean Mitchell, Ph.D., a professor of public policy at Georgetown University, Washington, analyzed 6 years of inpatient discharge data to compare the practice patterns of physicians who were owners of cardiac specialty hospitals in Phoenix and Tucson with those of physicians who only treated patients in full-service community hospitals with an accredited cardiac care program. She found that physician-owners treated higher percentages of patients with Medicare fee-for-service or commercial PPOs, and lower percentages of patients enrolled in Medicaid and HMOs. The American Medical Association endorses the existence of such hospitals, although the Center for Medicare and Medicaid Services has reinstituted a freeze on the approval of new specialty hospitals until it completes a review next year. The study appeared as a Health Affairs Web-exclusive article.

HHS Considers Investigation

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

Competitive Drug Acquisition

Starting April 3, 2006, physicians can begin the initial vendor election process as part of Medicare's Competitive Acquisition Program (CAP) for physician-administered drugs covered under Medicare Part B. The voluntary program allows physicians to obtain Part B drugs from vendors who are selected in a competitive bidding process. Vendors would then bill Medicare and collect any applicable deductible and coinsurance from beneficiaries for the drugs. Physicians would continue to be paid for the cost of drug administration. Physicians can obtain drugs through the program starting on July 1, 2006. Officials at the Centers for Medicare and Medicaid Services announced refinements to the CAP process last month, including establishing a process for approved vendors to furnish additional drugs under the program and establishing a framework for vendors to enter into arrangements with CAP physicians for the collection of coinsurance.

Alternative Medicine Centers

The National Center for Complementary and Alternative Medicine (NCCAM) is funding five new research centers to study complementary and alternative approaches to HIV/AIDS, arthritis, asthma, and pain. Three of the new centers will focus on therapies used in traditional Chinese medicine, such as acupuncture and Chinese herbal mixtures. The other centers will study millimeter wave therapy—a type of energy medicine—and botanical therapies used by traditional healers in Africa. For example, NCCAM has awarded $1.2 million in first-year funding to the Center for Arthritis and Traditional Chinese Medicine at the University of Maryland in Baltimore. Researchers there will conduct a clinical trial of an 11-herb Chinese formula known as HLXL for osteoarthritis of the knee; assess acupuncture's effect on inflammatory pain in an animal model; and study the efficacy of HLXL in an animal model of autoimmune arthritis. NCCAM is a component of the National Institutes of Health.

The Research Pipeline

Drug researchers are currently developing 446 medicines aimed at diseases that disproportionately affect women in the United States, according to a report from the Pharmaceutical Research and Manufacturers of America (PhRMA). Seventy-two of the drugs are being developed for arthritis or musculoskeletal disorders. The 41 million women with arthritis in the United States account for 70% of rheumatoid arthritis sufferers and 60% of osteoarthritis sufferers, according to PhRMA. In addition, researchers are working on 47 drugs for autoimmune diseases including lupus, fibromyalgia, psoriasis, and multiple sclerosis. These medicines are either in clinical trials or awaiting approval by the Food and Drug Administration.

Unproven Health Claims

The Food and Drug Administration issued warning letters to 29 companies for making unproven claims that their products treat or prevent disease. The letters were issued to companies that manufacture, market, or distribute products made from cherries and other fruits. The companies made a range of claims about diseases including arthritis, cancer, and heart disease. Under the Federal Food, Drug, and Cosmetic Act, products intended for use in the “diagnosis, cure, mitigation, treatment, or prevention of disease” are considered drugs and must be approved for safety and effectiveness by the FDA.

Cream Skimming Continues

Specialty hospitals are under scrutiny once again. A study found that Arizona heart physicians who partly owned cardiac specialty hospitals were more likely than were physicians with no ownership stake to treat low-acuity, high-profit cases in their own facilities and refer the more complex, lower-profit cases to community hospitals. Jean Mitchell, Ph.D., a professor of public policy at Georgetown University, Washington, analyzed 6 years of inpatient discharge data to compare the practice patterns of physicians who were owners of cardiac specialty hospitals in Phoenix and Tucson with those of physicians who only treated patients in full-service community hospitals with an accredited cardiac care program. She found that physician-owners treated higher percentages of patients with Medicare fee-for-service or commercial PPOs, and lower percentages of patients enrolled in Medicaid and HMOs. The American Medical Association endorses the existence of such hospitals, although the Center for Medicare and Medicaid Services has reinstituted a freeze on the approval of new specialty hospitals until it completes a review next year. The study appeared as a Health Affairs Web-exclusive article.

HHS Considers Investigation

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

Competitive Drug Acquisition

Starting April 3, 2006, physicians can begin the initial vendor election process as part of Medicare's Competitive Acquisition Program (CAP) for physician-administered drugs covered under Medicare Part B. The voluntary program allows physicians to obtain Part B drugs from vendors who are selected in a competitive bidding process. Vendors would then bill Medicare and collect any applicable deductible and coinsurance from beneficiaries for the drugs. Physicians would continue to be paid for the cost of drug administration. Physicians can obtain drugs through the program starting on July 1, 2006. Officials at the Centers for Medicare and Medicaid Services announced refinements to the CAP process last month, including establishing a process for approved vendors to furnish additional drugs under the program and establishing a framework for vendors to enter into arrangements with CAP physicians for the collection of coinsurance.

Alternative Medicine Centers

The National Center for Complementary and Alternative Medicine (NCCAM) is funding five new research centers to study complementary and alternative approaches to HIV/AIDS, arthritis, asthma, and pain. Three of the new centers will focus on therapies used in traditional Chinese medicine, such as acupuncture and Chinese herbal mixtures. The other centers will study millimeter wave therapy—a type of energy medicine—and botanical therapies used by traditional healers in Africa. For example, NCCAM has awarded $1.2 million in first-year funding to the Center for Arthritis and Traditional Chinese Medicine at the University of Maryland in Baltimore. Researchers there will conduct a clinical trial of an 11-herb Chinese formula known as HLXL for osteoarthritis of the knee; assess acupuncture's effect on inflammatory pain in an animal model; and study the efficacy of HLXL in an animal model of autoimmune arthritis. NCCAM is a component of the National Institutes of Health.

The Research Pipeline

Drug researchers are currently developing 446 medicines aimed at diseases that disproportionately affect women in the United States, according to a report from the Pharmaceutical Research and Manufacturers of America (PhRMA). Seventy-two of the drugs are being developed for arthritis or musculoskeletal disorders. The 41 million women with arthritis in the United States account for 70% of rheumatoid arthritis sufferers and 60% of osteoarthritis sufferers, according to PhRMA. In addition, researchers are working on 47 drugs for autoimmune diseases including lupus, fibromyalgia, psoriasis, and multiple sclerosis. These medicines are either in clinical trials or awaiting approval by the Food and Drug Administration.

Unproven Health Claims

The Food and Drug Administration issued warning letters to 29 companies for making unproven claims that their products treat or prevent disease. The letters were issued to companies that manufacture, market, or distribute products made from cherries and other fruits. The companies made a range of claims about diseases including arthritis, cancer, and heart disease. Under the Federal Food, Drug, and Cosmetic Act, products intended for use in the “diagnosis, cure, mitigation, treatment, or prevention of disease” are considered drugs and must be approved for safety and effectiveness by the FDA.

Cream Skimming Continues

Specialty hospitals are under scrutiny once again. A study found that Arizona heart physicians who partly owned cardiac specialty hospitals were more likely than were physicians with no ownership stake to treat low-acuity, high-profit cases in their own facilities and refer the more complex, lower-profit cases to community hospitals. Jean Mitchell, Ph.D., a professor of public policy at Georgetown University, Washington, analyzed 6 years of inpatient discharge data to compare the practice patterns of physicians who were owners of cardiac specialty hospitals in Phoenix and Tucson with those of physicians who only treated patients in full-service community hospitals with an accredited cardiac care program. She found that physician-owners treated higher percentages of patients with Medicare fee-for-service or commercial PPOs, and lower percentages of patients enrolled in Medicaid and HMOs. The American Medical Association endorses the existence of such hospitals, although the Center for Medicare and Medicaid Services has reinstituted a freeze on the approval of new specialty hospitals until it completes a review next year. The study appeared as a Health Affairs Web-exclusive article.

HHS Considers Investigation

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

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,” CDER Director Steven K. Galson, M.D., 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, the 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.

The FDA also plans to make other changes, including establishing an Office of Counterterrorism and Emergency Operations, which will report to the Office of the Center Director; and realigning the Division of Scientific Investigations from the Office of Medical Policy into the Office of Compliance.

“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, 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,” CDER Director Steven K. Galson, M.D., 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, the 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.

The FDA also plans to make other changes, including establishing an Office of Counterterrorism and Emergency Operations, which will report to the Office of the Center Director; and realigning the Division of Scientific Investigations from the Office of Medical Policy into the Office of Compliance.

“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, 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,” CDER Director Steven K. Galson, M.D., 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, the 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.

The FDA also plans to make other changes, including establishing an Office of Counterterrorism and Emergency Operations, which will report to the Office of the Center Director; and realigning the Division of Scientific Investigations from the Office of Medical Policy into the Office of Compliance.

“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, 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.

The pharmaceutical industry may be breathing a collective sigh of relief over the latest court verdict involving Merck & Co.'s Vioxx, but it may not be time to pop the cork on the champagne.

Experts say the two different jury decisions handed down so far could still have some negative implications for the pharmaceutical industry—and for physicians.

In August, a Texas jury awarded $253 million to the widow of a man who died after taking Vioxx (rofecoxib), but in November a New Jersey jury found no fault with the company's actions in the case of a man who claimed that Vioxx contributed to his heart attack.

This latest verdict is “definitely a huge victory for Merck,” with its implication that at least some of the 6,000 pending cases against the company will be dropped, said Daphne Monie, Ph.D., an analyst in the immune and inflammatory disorders group at Decision Resources Inc., a market research firm that conducts analysis of trends in the drug industry.

However, it could spell trouble for the pharmaceutical industry.

The first case shows that a jury is willing to hold the company responsible for the adverse effects of the drug, even as a different jury concluded that the company provided adequate warning to physicians and the public about risks. When taken together, it sends the message that drug companies could be held liable for adverse effects even when the risks are properly disclosed, she said.

And it's possible that physicians could also become the target of lawsuits. If the precedent is set that Merck can be held liable for adverse events even when providing adequate warning about the risks, physicians may be held responsible for prescribing the drugs. At press time, Dr. Monie knew of no such cases against physicians involving Vioxx.

But Eric Matteson, M.D., a rheumatologist and professor of medicine at the Mayo Clinic in Rochester, Minn., said that cases against physicians are unlikely because Vioxx was an FDA-approved drug and there were limited warnings about its use. “I think physicians prescribed in good faith,” he said.

The two verdicts in these cases reflect the complexity of trying to attribute cardiovascular events to exposure to a particular drug especially when other drugs and comorbidities are involved, he added.

The risk information about cyclooxygenase-2 (COX-2) inhibitors in general has made everyone a lot more cautious. It definitely seems to be slowing down the release of new COX-2s onto the market, he said, and it may affect the willingness of physicians to prescribe COX-2s when they do become available.

Regardless of the verdicts, the courtroom is not the best place to be debating the safety of Vioxx, said W. Hayes Wilson, M.D., a national medical adviser for the Arthritis Foundation and chief of rheumatology at Piedmont Hospital in Atlanta.

“There is no correlation between jury verdicts and scientific literature,” Dr. Wilson said. “Scientific literature is not best evaluated in a court of law.”

The pharmaceutical industry may be breathing a collective sigh of relief over the latest court verdict involving Merck & Co.'s Vioxx, but it may not be time to pop the cork on the champagne.

Experts say the two different jury decisions handed down so far could still have some negative implications for the pharmaceutical industry—and for physicians.

In August, a Texas jury awarded $253 million to the widow of a man who died after taking Vioxx (rofecoxib), but in November a New Jersey jury found no fault with the company's actions in the case of a man who claimed that Vioxx contributed to his heart attack.

This latest verdict is “definitely a huge victory for Merck,” with its implication that at least some of the 6,000 pending cases against the company will be dropped, said Daphne Monie, Ph.D., an analyst in the immune and inflammatory disorders group at Decision Resources Inc., a market research firm that conducts analysis of trends in the drug industry.

However, it could spell trouble for the pharmaceutical industry.

The first case shows that a jury is willing to hold the company responsible for the adverse effects of the drug, even as a different jury concluded that the company provided adequate warning to physicians and the public about risks. When taken together, it sends the message that drug companies could be held liable for adverse effects even when the risks are properly disclosed, she said.

And it's possible that physicians could also become the target of lawsuits. If the precedent is set that Merck can be held liable for adverse events even when providing adequate warning about the risks, physicians may be held responsible for prescribing the drugs. At press time, Dr. Monie knew of no such cases against physicians involving Vioxx.

But Eric Matteson, M.D., a rheumatologist and professor of medicine at the Mayo Clinic in Rochester, Minn., said that cases against physicians are unlikely because Vioxx was an FDA-approved drug and there were limited warnings about its use. “I think physicians prescribed in good faith,” he said.

The two verdicts in these cases reflect the complexity of trying to attribute cardiovascular events to exposure to a particular drug especially when other drugs and comorbidities are involved, he added.

The risk information about cyclooxygenase-2 (COX-2) inhibitors in general has made everyone a lot more cautious. It definitely seems to be slowing down the release of new COX-2s onto the market, he said, and it may affect the willingness of physicians to prescribe COX-2s when they do become available.

Regardless of the verdicts, the courtroom is not the best place to be debating the safety of Vioxx, said W. Hayes Wilson, M.D., a national medical adviser for the Arthritis Foundation and chief of rheumatology at Piedmont Hospital in Atlanta.

“There is no correlation between jury verdicts and scientific literature,” Dr. Wilson said. “Scientific literature is not best evaluated in a court of law.”

The pharmaceutical industry may be breathing a collective sigh of relief over the latest court verdict involving Merck & Co.'s Vioxx, but it may not be time to pop the cork on the champagne.

Experts say the two different jury decisions handed down so far could still have some negative implications for the pharmaceutical industry—and for physicians.

In August, a Texas jury awarded $253 million to the widow of a man who died after taking Vioxx (rofecoxib), but in November a New Jersey jury found no fault with the company's actions in the case of a man who claimed that Vioxx contributed to his heart attack.

This latest verdict is “definitely a huge victory for Merck,” with its implication that at least some of the 6,000 pending cases against the company will be dropped, said Daphne Monie, Ph.D., an analyst in the immune and inflammatory disorders group at Decision Resources Inc., a market research firm that conducts analysis of trends in the drug industry.

However, it could spell trouble for the pharmaceutical industry.

The first case shows that a jury is willing to hold the company responsible for the adverse effects of the drug, even as a different jury concluded that the company provided adequate warning to physicians and the public about risks. When taken together, it sends the message that drug companies could be held liable for adverse effects even when the risks are properly disclosed, she said.

And it's possible that physicians could also become the target of lawsuits. If the precedent is set that Merck can be held liable for adverse events even when providing adequate warning about the risks, physicians may be held responsible for prescribing the drugs. At press time, Dr. Monie knew of no such cases against physicians involving Vioxx.

But Eric Matteson, M.D., a rheumatologist and professor of medicine at the Mayo Clinic in Rochester, Minn., said that cases against physicians are unlikely because Vioxx was an FDA-approved drug and there were limited warnings about its use. “I think physicians prescribed in good faith,” he said.

The two verdicts in these cases reflect the complexity of trying to attribute cardiovascular events to exposure to a particular drug especially when other drugs and comorbidities are involved, he added.

The risk information about cyclooxygenase-2 (COX-2) inhibitors in general has made everyone a lot more cautious. It definitely seems to be slowing down the release of new COX-2s onto the market, he said, and it may affect the willingness of physicians to prescribe COX-2s when they do become available.

Regardless of the verdicts, the courtroom is not the best place to be debating the safety of Vioxx, said W. Hayes Wilson, M.D., a national medical adviser for the Arthritis Foundation and chief of rheumatology at Piedmont Hospital in Atlanta.

“There is no correlation between jury verdicts and scientific literature,” Dr. Wilson said. “Scientific literature is not best evaluated in a court of law.”

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,” CDER Director Steven K. Galson, M.D., 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.

The FDA also plans to make other changes, including establishing an Office of Counterterrorism and Emergency Operations, which will report to the Office of the Center Director; and realigning the Division of Scientific Investigations from the Office of Medical Policy into the Office of Compliance.

“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 a memo to CDER staff.

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,” CDER Director Steven K. Galson, M.D., 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.

The FDA also plans to make other changes, including establishing an Office of Counterterrorism and Emergency Operations, which will report to the Office of the Center Director; and realigning the Division of Scientific Investigations from the Office of Medical Policy into the Office of Compliance.

“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 a memo to CDER staff.

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,” CDER Director Steven K. Galson, M.D., 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.

The FDA also plans to make other changes, including establishing an Office of Counterterrorism and Emergency Operations, which will report to the Office of the Center Director; and realigning the Division of Scientific Investigations from the Office of Medical Policy into the Office of Compliance.

“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 a memo to CDER staff.

The long-awaited national pandemic influenza plan unveiled last month could also help solve chronic problems in production of seasonal flu vaccine.

“We don't need to have a disaster to get a benefit from this influenza planning,” said Andrew T. Pavia, M.D., professor and chief of the division of pediatric infectious diseases at the University of Utah, Salt Lake City.

The government's plan puts a strong emphasis on developing the capacity to produce influenza vaccine, rather than just focusing on stockpiling, said Dr. Pavia, who is also a member of the pandemic influenza task force for the Infectious Diseases Society of America.

The plan also begins to address the issue of why manufacturers have left the vaccine market, he said in an interview.

In a speech at the National Institutes of Health on Nov. 1, President George W. Bush outlined the administration's strategy for dealing with a possible influenza pandemic and requested $7.1 billion in emergency funding from Congress to implement the plan. But the proposal has hit some snags in Congress. At press time, funding for the initiative was still up in the air. In mid-November, members of a House-Senate conference committee agreed to appropriate less than $1 billion for annual and pandemic influenza preparedness but that spending bill, which also included unpopular cuts to social programs, was voted down in the House.

Under the President's proposal, the bulk of the funding—$2.9 billion—would go toward accelerating development of cell-culture technology for vaccine production. Use of such technology should allow manufacturers to produce enough vaccine for every American within 6 months of the start of a pandemic, President Bush said.

The President also requested $800 million for development of new treatments and vaccines for pandemic influenza.

Another $1.5 billion would be used for the Department of Health and Human Services and the Department of Defense to purchase influenza vaccines. Researchers at NIH have developed a vaccine, now in clinical trials, that is based on the current strain of the avian flu virus, President Bush said. The government plans to purchase enough doses of this vaccine from manufacturers to vaccinate about 20 million people.

Although this vaccine would not provide full coverage against a pandemic influenza strain, it would offer some protection during the early months of an outbreak, President Bush said, adding that he is also seeking about $1 billion to stockpile antiviral medications.

The administration is also requesting $251 million to detect and contain outbreaks before they spread. That money would be used to help other countries train personnel, expand surveillance and testing, and improve preparedness plans, as well as take action to contain outbreaks. At home, the president has launched the National Bio-Surveillance Initiative, aimed at rapid detection of and response to disease outbreaks. In addition, the administration is seeking $644 million to help all levels of government prepare to respond to a potential pandemic outbreak.

Surge capacity in hospitals is a major challenge in preparing for a flu pandemic or another major event such as a bioterrorist attack, said Gregory J. Moran, M.D., a clinical professor in the department of emergency medicine and infectious disease at the University of California, L.A.

Hospitals need to develop plans to create extra bed capacity in nonpatient care areas of the hospital. But hospital administrators can't do this alone and need community interest and investment, Dr. Moran said in an interview.

Information on the government's pandemic flu plan is available online at www.pandemicflu.gov

The long-awaited national pandemic influenza plan unveiled last month could also help solve chronic problems in production of seasonal flu vaccine.

“We don't need to have a disaster to get a benefit from this influenza planning,” said Andrew T. Pavia, M.D., professor and chief of the division of pediatric infectious diseases at the University of Utah, Salt Lake City.

The government's plan puts a strong emphasis on developing the capacity to produce influenza vaccine, rather than just focusing on stockpiling, said Dr. Pavia, who is also a member of the pandemic influenza task force for the Infectious Diseases Society of America.

The plan also begins to address the issue of why manufacturers have left the vaccine market, he said in an interview.

In a speech at the National Institutes of Health on Nov. 1, President George W. Bush outlined the administration's strategy for dealing with a possible influenza pandemic and requested $7.1 billion in emergency funding from Congress to implement the plan. But the proposal has hit some snags in Congress. At press time, funding for the initiative was still up in the air. In mid-November, members of a House-Senate conference committee agreed to appropriate less than $1 billion for annual and pandemic influenza preparedness but that spending bill, which also included unpopular cuts to social programs, was voted down in the House.

Under the President's proposal, the bulk of the funding—$2.9 billion—would go toward accelerating development of cell-culture technology for vaccine production. Use of such technology should allow manufacturers to produce enough vaccine for every American within 6 months of the start of a pandemic, President Bush said.

The President also requested $800 million for development of new treatments and vaccines for pandemic influenza.

Another $1.5 billion would be used for the Department of Health and Human Services and the Department of Defense to purchase influenza vaccines. Researchers at NIH have developed a vaccine, now in clinical trials, that is based on the current strain of the avian flu virus, President Bush said. The government plans to purchase enough doses of this vaccine from manufacturers to vaccinate about 20 million people.

Although this vaccine would not provide full coverage against a pandemic influenza strain, it would offer some protection during the early months of an outbreak, President Bush said, adding that he is also seeking about $1 billion to stockpile antiviral medications.

The administration is also requesting $251 million to detect and contain outbreaks before they spread. That money would be used to help other countries train personnel, expand surveillance and testing, and improve preparedness plans, as well as take action to contain outbreaks. At home, the president has launched the National Bio-Surveillance Initiative, aimed at rapid detection of and response to disease outbreaks. In addition, the administration is seeking $644 million to help all levels of government prepare to respond to a potential pandemic outbreak.

Surge capacity in hospitals is a major challenge in preparing for a flu pandemic or another major event such as a bioterrorist attack, said Gregory J. Moran, M.D., a clinical professor in the department of emergency medicine and infectious disease at the University of California, L.A.

Hospitals need to develop plans to create extra bed capacity in nonpatient care areas of the hospital. But hospital administrators can't do this alone and need community interest and investment, Dr. Moran said in an interview.

Information on the government's pandemic flu plan is available online at www.pandemicflu.gov

The long-awaited national pandemic influenza plan unveiled last month could also help solve chronic problems in production of seasonal flu vaccine.

“We don't need to have a disaster to get a benefit from this influenza planning,” said Andrew T. Pavia, M.D., professor and chief of the division of pediatric infectious diseases at the University of Utah, Salt Lake City.

The government's plan puts a strong emphasis on developing the capacity to produce influenza vaccine, rather than just focusing on stockpiling, said Dr. Pavia, who is also a member of the pandemic influenza task force for the Infectious Diseases Society of America.

The plan also begins to address the issue of why manufacturers have left the vaccine market, he said in an interview.

In a speech at the National Institutes of Health on Nov. 1, President George W. Bush outlined the administration's strategy for dealing with a possible influenza pandemic and requested $7.1 billion in emergency funding from Congress to implement the plan. But the proposal has hit some snags in Congress. At press time, funding for the initiative was still up in the air. In mid-November, members of a House-Senate conference committee agreed to appropriate less than $1 billion for annual and pandemic influenza preparedness but that spending bill, which also included unpopular cuts to social programs, was voted down in the House.

Under the President's proposal, the bulk of the funding—$2.9 billion—would go toward accelerating development of cell-culture technology for vaccine production. Use of such technology should allow manufacturers to produce enough vaccine for every American within 6 months of the start of a pandemic, President Bush said.

The President also requested $800 million for development of new treatments and vaccines for pandemic influenza.

Another $1.5 billion would be used for the Department of Health and Human Services and the Department of Defense to purchase influenza vaccines. Researchers at NIH have developed a vaccine, now in clinical trials, that is based on the current strain of the avian flu virus, President Bush said. The government plans to purchase enough doses of this vaccine from manufacturers to vaccinate about 20 million people.

Although this vaccine would not provide full coverage against a pandemic influenza strain, it would offer some protection during the early months of an outbreak, President Bush said, adding that he is also seeking about $1 billion to stockpile antiviral medications.

The administration is also requesting $251 million to detect and contain outbreaks before they spread. That money would be used to help other countries train personnel, expand surveillance and testing, and improve preparedness plans, as well as take action to contain outbreaks. At home, the president has launched the National Bio-Surveillance Initiative, aimed at rapid detection of and response to disease outbreaks. In addition, the administration is seeking $644 million to help all levels of government prepare to respond to a potential pandemic outbreak.

Surge capacity in hospitals is a major challenge in preparing for a flu pandemic or another major event such as a bioterrorist attack, said Gregory J. Moran, M.D., a clinical professor in the department of emergency medicine and infectious disease at the University of California, L.A.

Hospitals need to develop plans to create extra bed capacity in nonpatient care areas of the hospital. But hospital administrators can't do this alone and need community interest and investment, Dr. Moran said in an interview.

Information on the government's pandemic flu plan is available online at www.pandemicflu.gov

Imaging Accreditation

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

Cream Skimming Continues

Specialty hospitals are under scrutiny once again. A study found that Arizona heart physicians who partly owned cardiac specialty hospitals were more likely than were physicians with no ownership stake to treat low-acuity, high-profit cases in their own facilities and to refer the more complex, lower-profit cases to community hospitals. Jean Mitchell, Ph.D., a professor of public policy at Georgetown University, Washington, analyzed 6 years of inpatient discharge data to compare the practice patterns of physicians who were owners of cardiac specialty hospitals in Phoenix and Tucson with those of physicians who only treated patients in full-service community hospitals with an accredited cardiac care program. She found that physician-owners treated higher percentages of patients with Medicare fee-for-service or commercial PPOs, and lower percentages of patients enrolled in Medicaid and HMOs. The American Medical Association endorses the existence of such hospitals, although the Center for Medicare and Medicaid Services has reinstituted a freeze on the approval of new specialty hospitals until it completes a review next year. The study appeared as a Health Affairs Web-exclusive article.

HHS Mulls Investigation

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

Unproven Health Claims

The Food and Drug Administration issued warning letters to 29 companies for making unproven claims that their products treat or prevent disease. The letters when out to companies that manufacture, market, or distribute products made from cherries and other fruits. The companies made a range of claims about diseases including heart disease, arthritis, and cancer. Under the federal Food, Drug, and Cosmetic Act, products intended for use in the “diagnosis, cure, mitigation, treatment, or prevention of disease” are considered drugs and must be approved for safety and effectiveness by the FDA.

Imaging Accreditation

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

Cream Skimming Continues

Specialty hospitals are under scrutiny once again. A study found that Arizona heart physicians who partly owned cardiac specialty hospitals were more likely than were physicians with no ownership stake to treat low-acuity, high-profit cases in their own facilities and to refer the more complex, lower-profit cases to community hospitals. Jean Mitchell, Ph.D., a professor of public policy at Georgetown University, Washington, analyzed 6 years of inpatient discharge data to compare the practice patterns of physicians who were owners of cardiac specialty hospitals in Phoenix and Tucson with those of physicians who only treated patients in full-service community hospitals with an accredited cardiac care program. She found that physician-owners treated higher percentages of patients with Medicare fee-for-service or commercial PPOs, and lower percentages of patients enrolled in Medicaid and HMOs. The American Medical Association endorses the existence of such hospitals, although the Center for Medicare and Medicaid Services has reinstituted a freeze on the approval of new specialty hospitals until it completes a review next year. The study appeared as a Health Affairs Web-exclusive article.

HHS Mulls Investigation

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

Unproven Health Claims

The Food and Drug Administration issued warning letters to 29 companies for making unproven claims that their products treat or prevent disease. The letters when out to companies that manufacture, market, or distribute products made from cherries and other fruits. The companies made a range of claims about diseases including heart disease, arthritis, and cancer. Under the federal Food, Drug, and Cosmetic Act, products intended for use in the “diagnosis, cure, mitigation, treatment, or prevention of disease” are considered drugs and must be approved for safety and effectiveness by the FDA.

Imaging Accreditation

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

Cream Skimming Continues

Specialty hospitals are under scrutiny once again. A study found that Arizona heart physicians who partly owned cardiac specialty hospitals were more likely than were physicians with no ownership stake to treat low-acuity, high-profit cases in their own facilities and to refer the more complex, lower-profit cases to community hospitals. Jean Mitchell, Ph.D., a professor of public policy at Georgetown University, Washington, analyzed 6 years of inpatient discharge data to compare the practice patterns of physicians who were owners of cardiac specialty hospitals in Phoenix and Tucson with those of physicians who only treated patients in full-service community hospitals with an accredited cardiac care program. She found that physician-owners treated higher percentages of patients with Medicare fee-for-service or commercial PPOs, and lower percentages of patients enrolled in Medicaid and HMOs. The American Medical Association endorses the existence of such hospitals, although the Center for Medicare and Medicaid Services has reinstituted a freeze on the approval of new specialty hospitals until it completes a review next year. The study appeared as a Health Affairs Web-exclusive article.

HHS Mulls Investigation

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

Unproven Health Claims

The Food and Drug Administration issued warning letters to 29 companies for making unproven claims that their products treat or prevent disease. The letters when out to companies that manufacture, market, or distribute products made from cherries and other fruits. The companies made a range of claims about diseases including heart disease, arthritis, and cancer. Under the federal Food, Drug, and Cosmetic Act, products intended for use in the “diagnosis, cure, mitigation, treatment, or prevention of disease” are considered drugs and must be approved for safety and effectiveness by the FDA.