Christine Kilgore

BETHESDA, MD. — A growing body of research suggests dysfunction of the small-fiber axons that mediate pain sensation and autonomic function underlies complex regional pain syndrome, Dr. Anne Louise Oaklander said at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Complex regional pain syndrome (CRPS) is “one of the most mysterious of the pain disorders,” said Dr. Oaklander, a neurologist at Harvard Medical School and director of the nerve injury unit at Massachusetts General Hospital, Boston. With no known cause, few physicians are willing to treat it. Others believe it to be psychosomatic. However, “we are beginning to understand the disease biology,” she said. “It's time to abandon the dichotomy between CRPS I and CRPS II [and to] consider changing the name to 'posttraumatic neuralgia.'

“Small-fiber axonopathy is what causes this,” Dr. Oaklander said.

Current diagnostic criteria for CRPS include the occurrence of a noxious event or other cause of immobilization; continuing or disproportionate pain, allodynia, or hyperalgesia; and edema, changes in skin blood flow, or abnormal sweating in the region of pain.

Most patients are classified as CRPS-I (no known nerve injury); fewer than 10% receive a diagnosis of CRPS-II (a known nerve injury). However, “a physician trained to diagnose nerve injuries can identify minor nerve injuries in most CRPS-1 patients as well,” she said.

CRPS is “what I call a focal 'pain-plus' syndrome. Patients have chronic pain but also vascular dysregulation and sometimes dystonia, contralesional 'mirror' pain … osteopenia, [and focal changes in other innervated tissues],” Dr. Oaklander said. “[The disease] reflects pathological processes, not normal pain mechanisms.”

Most patients with CRPS are young (average age 39) and female (a 4:1 ratio). Most recover spontaneously.

Skin biopsies done in Dr. Oaklander's lab of 18 CRPS-I patients show 30% fewer small-fiber nerve endings in painful CRPS-affected areas.

The identification of posttraumatic small-fiber loss in patients with CRPS was first described in 1996 and has been validated by other researchers, she noted. There is good evidence that trauma disproportionately damages small fibers, probably because they lack protective myelin and saltatory conduction. Pain results when undamaged axons within the same nerve, as well as regenerating axon spouts, malfunction, firing without cause, for instance, triggering neurogenic edema and tissue ischemia. “The problem isn't so much with the nociceptive fibers that are degenerated—it's with their neighbors, and the effects on the central nervous system,” Dr. Oaklander said. “We really can't assume that it takes a severe injury to leave someone with chronic pain—in fact, the opposite may be true.”

A swollen ankle and shallow ulcers are caused by neurogenic edema. Courtesy Dr. Anne Louise Oaklander

BETHESDA, MD. — A growing body of research suggests dysfunction of the small-fiber axons that mediate pain sensation and autonomic function underlies complex regional pain syndrome, Dr. Anne Louise Oaklander said at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Complex regional pain syndrome (CRPS) is “one of the most mysterious of the pain disorders,” said Dr. Oaklander, a neurologist at Harvard Medical School and director of the nerve injury unit at Massachusetts General Hospital, Boston. With no known cause, few physicians are willing to treat it. Others believe it to be psychosomatic. However, “we are beginning to understand the disease biology,” she said. “It's time to abandon the dichotomy between CRPS I and CRPS II [and to] consider changing the name to 'posttraumatic neuralgia.'

“Small-fiber axonopathy is what causes this,” Dr. Oaklander said.

Current diagnostic criteria for CRPS include the occurrence of a noxious event or other cause of immobilization; continuing or disproportionate pain, allodynia, or hyperalgesia; and edema, changes in skin blood flow, or abnormal sweating in the region of pain.

Most patients are classified as CRPS-I (no known nerve injury); fewer than 10% receive a diagnosis of CRPS-II (a known nerve injury). However, “a physician trained to diagnose nerve injuries can identify minor nerve injuries in most CRPS-1 patients as well,” she said.

CRPS is “what I call a focal 'pain-plus' syndrome. Patients have chronic pain but also vascular dysregulation and sometimes dystonia, contralesional 'mirror' pain … osteopenia, [and focal changes in other innervated tissues],” Dr. Oaklander said. “[The disease] reflects pathological processes, not normal pain mechanisms.”

Most patients with CRPS are young (average age 39) and female (a 4:1 ratio). Most recover spontaneously.

Skin biopsies done in Dr. Oaklander's lab of 18 CRPS-I patients show 30% fewer small-fiber nerve endings in painful CRPS-affected areas.

The identification of posttraumatic small-fiber loss in patients with CRPS was first described in 1996 and has been validated by other researchers, she noted. There is good evidence that trauma disproportionately damages small fibers, probably because they lack protective myelin and saltatory conduction. Pain results when undamaged axons within the same nerve, as well as regenerating axon spouts, malfunction, firing without cause, for instance, triggering neurogenic edema and tissue ischemia. “The problem isn't so much with the nociceptive fibers that are degenerated—it's with their neighbors, and the effects on the central nervous system,” Dr. Oaklander said. “We really can't assume that it takes a severe injury to leave someone with chronic pain—in fact, the opposite may be true.”

A swollen ankle and shallow ulcers are caused by neurogenic edema. Courtesy Dr. Anne Louise Oaklander

BETHESDA, MD. — A growing body of research suggests dysfunction of the small-fiber axons that mediate pain sensation and autonomic function underlies complex regional pain syndrome, Dr. Anne Louise Oaklander said at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Complex regional pain syndrome (CRPS) is “one of the most mysterious of the pain disorders,” said Dr. Oaklander, a neurologist at Harvard Medical School and director of the nerve injury unit at Massachusetts General Hospital, Boston. With no known cause, few physicians are willing to treat it. Others believe it to be psychosomatic. However, “we are beginning to understand the disease biology,” she said. “It's time to abandon the dichotomy between CRPS I and CRPS II [and to] consider changing the name to 'posttraumatic neuralgia.'

“Small-fiber axonopathy is what causes this,” Dr. Oaklander said.

Current diagnostic criteria for CRPS include the occurrence of a noxious event or other cause of immobilization; continuing or disproportionate pain, allodynia, or hyperalgesia; and edema, changes in skin blood flow, or abnormal sweating in the region of pain.

Most patients are classified as CRPS-I (no known nerve injury); fewer than 10% receive a diagnosis of CRPS-II (a known nerve injury). However, “a physician trained to diagnose nerve injuries can identify minor nerve injuries in most CRPS-1 patients as well,” she said.

CRPS is “what I call a focal 'pain-plus' syndrome. Patients have chronic pain but also vascular dysregulation and sometimes dystonia, contralesional 'mirror' pain … osteopenia, [and focal changes in other innervated tissues],” Dr. Oaklander said. “[The disease] reflects pathological processes, not normal pain mechanisms.”

Most patients with CRPS are young (average age 39) and female (a 4:1 ratio). Most recover spontaneously.

Skin biopsies done in Dr. Oaklander's lab of 18 CRPS-I patients show 30% fewer small-fiber nerve endings in painful CRPS-affected areas.

The identification of posttraumatic small-fiber loss in patients with CRPS was first described in 1996 and has been validated by other researchers, she noted. There is good evidence that trauma disproportionately damages small fibers, probably because they lack protective myelin and saltatory conduction. Pain results when undamaged axons within the same nerve, as well as regenerating axon spouts, malfunction, firing without cause, for instance, triggering neurogenic edema and tissue ischemia. “The problem isn't so much with the nociceptive fibers that are degenerated—it's with their neighbors, and the effects on the central nervous system,” Dr. Oaklander said. “We really can't assume that it takes a severe injury to leave someone with chronic pain—in fact, the opposite may be true.”

A swollen ankle and shallow ulcers are caused by neurogenic edema. Courtesy Dr. Anne Louise Oaklander

Dr. Della Corcoran's pediatric practice sits over an ice cream shop and across the street from a toy store—a setting that's unfortunate, she said, when it comes to immunization.

“Parents come in [for their children's immunizations] saying 'You're going to get ice cream or a new toy after this.' The kids hear this and think something pretty major is going to happen,” she said. Unwittingly, parents can fuel their child's anxiety and distress with such promises.

The notion that parental demeanor before and during immunization should be calm and matter-of-fact, without excessive reassurance—a notion that Dr. Corcoran tries to convey and model in her practice in Hartford, Conn.—is one of the recommended strategies included in a new review of pain reduction during pediatric immunization.

The review, led by Dr. Neil L. Schechter of the Pain Relief Program at Connecticut Children's Medical Center in Hartford, details how the pain of immunization is a source of anxiety and distress in pediatric practice, and concludes that, ironically, there is “limited research available to address the pain associated with the painful procedure most commonly performed in pediatric office settings.”

Still, according to Dr. Schechter and the small group of experts who reviewed the literature and filled gaps through consensus development, a more systematic application of existing knowledge “should go a long way” toward reducing pain and alleviating the “air of persistent tension that hangs over the clinical encounter” due to anticipation of an injection (Pediatrics 2007:119;e1184–98 [Epub doi:10.1542/peds.2006-1107]).

There is good, consistent scientific evidence, they concluded, to support a number of strategies, from parental demeanor that is supportive and nonapologetic, to the following practices:

▸ Developmentally appropriate preparation for all children over the age of 2 years.

▸ The use of sucrose (administered on a pacifier or directly instilled into the mouth) for children younger than 6 months of age.

▸ The use of distraction techniques during injection.

▸ Selective use of local anesthetics in children who are especially fearful.

Of these measures, the use of sucrose solution is “something that has not been as universally accepted, yet this probably has the strongest database,” Dr. Schechter said in an interview. “There are at least 50 articles that support the routine use of sucrose in infants under 6 months.”

Sucrose loses its efficacy by 4–6 months of age and requires more testing with and without other modalities, but at this point it “clearly has efficacy for young infants,” reliably reducing evidence of distress with injections, he and his associates said in the review.

Past infancy, the data on the influence of parental demeanor on child behavior is just as striking, Dr. Schechter said.

“Although it seems counterintuitive, children often are more distressed when parents are more rather than less involved,” the review said. “A matter-of-fact, supportive, nonapologetic approach is endorsed.”

Dr. Corcoran, who administers vaccines herself, said she tries to guide parents by example and counters excessive reassurance with pinwheels and other distraction stimuli. In response to parents' promises of toys or ice cream, she makes comments like, “Oh, you won't need a new toy after this, you'll be just fine.”

This isn't to say children shouldn't be given “realistic information” about how immunizations will feel, the review said. This information, along with what will happen and how to cope (relaxation, breathing, distraction), should all be part of preparing the child.

Coping isn't necessarily something parents help with, the authors noted: One survey of parents of preschool children showed only 10% offered any strategies to their children at all.

Pediatricians should routinely use—and instruct parents to use—engaging distraction techniques that match the child's age and temperament, because there are “strong data” that distraction reduces distress, the review said. It's unclear, however, whether particular techniques—from blowing or deep breathing to counting backward or listening to a story—are optimal.

The expense and time required for topical anesthetic use means that “universal use of local anesthetics cannot be endorsed at this time,” Dr. Schechter and his associates said. Still, for children who are needle phobic and particularly anxious, these agents “should be considered.”

Evidence is not as strong or consistent in the areas of needle length and injection site, the reviewers said. Up to 18 months of age, the standard injection site is the anterior thigh, with a 7/8- to 1-inch needle for children more than 2 months of age. Over 36 months of age, the deltoid should be used, and at any age, the ventrogluteal site may be an alternative.

Between 18 and 36 months of age, “there is controversy regarding the most appropriate site,” the reviewers said.

Until more research is done, pediatricians “should do what they're comfortable with—there is nothing definitive at this point,” Dr. Schechter said in the interview. “I think if evidence emerges, it will add pluses and minuses and not be powerful one way or the other.”

Pressure at the injection site, applied either manually or with the aid of a mechanical device, has some support in the literature and, because pressure has no adverse effects, it may have value, the reviewers said.

“The adolescents and young women coming in for the Gardasil vaccine are even anxious about these shots,” which says something about the anxiety and distress that routine immunizations cause, Dr. Corcoran said. “The pain [of immunization] is real, and it's magnified significantly by anxiety.”

Since finishing the review, Dr. Schechter has launched the “Injection Protection Project,” an educational effort to bring information and tools—from a poster and video for staff to a brochure for parents—into pediatric practices. Thus far, he has visited about 20 offices, including the three-pediatrician practice of Dr. Corcoran.

Dr. Della Corcoran's pediatric practice sits over an ice cream shop and across the street from a toy store—a setting that's unfortunate, she said, when it comes to immunization.

“Parents come in [for their children's immunizations] saying 'You're going to get ice cream or a new toy after this.' The kids hear this and think something pretty major is going to happen,” she said. Unwittingly, parents can fuel their child's anxiety and distress with such promises.

The notion that parental demeanor before and during immunization should be calm and matter-of-fact, without excessive reassurance—a notion that Dr. Corcoran tries to convey and model in her practice in Hartford, Conn.—is one of the recommended strategies included in a new review of pain reduction during pediatric immunization.

The review, led by Dr. Neil L. Schechter of the Pain Relief Program at Connecticut Children's Medical Center in Hartford, details how the pain of immunization is a source of anxiety and distress in pediatric practice, and concludes that, ironically, there is “limited research available to address the pain associated with the painful procedure most commonly performed in pediatric office settings.”

Still, according to Dr. Schechter and the small group of experts who reviewed the literature and filled gaps through consensus development, a more systematic application of existing knowledge “should go a long way” toward reducing pain and alleviating the “air of persistent tension that hangs over the clinical encounter” due to anticipation of an injection (Pediatrics 2007:119;e1184–98 [Epub doi:10.1542/peds.2006-1107]).

There is good, consistent scientific evidence, they concluded, to support a number of strategies, from parental demeanor that is supportive and nonapologetic, to the following practices:

▸ Developmentally appropriate preparation for all children over the age of 2 years.

▸ The use of sucrose (administered on a pacifier or directly instilled into the mouth) for children younger than 6 months of age.

▸ The use of distraction techniques during injection.

▸ Selective use of local anesthetics in children who are especially fearful.

Of these measures, the use of sucrose solution is “something that has not been as universally accepted, yet this probably has the strongest database,” Dr. Schechter said in an interview. “There are at least 50 articles that support the routine use of sucrose in infants under 6 months.”

Sucrose loses its efficacy by 4–6 months of age and requires more testing with and without other modalities, but at this point it “clearly has efficacy for young infants,” reliably reducing evidence of distress with injections, he and his associates said in the review.

Past infancy, the data on the influence of parental demeanor on child behavior is just as striking, Dr. Schechter said.

“Although it seems counterintuitive, children often are more distressed when parents are more rather than less involved,” the review said. “A matter-of-fact, supportive, nonapologetic approach is endorsed.”

Dr. Corcoran, who administers vaccines herself, said she tries to guide parents by example and counters excessive reassurance with pinwheels and other distraction stimuli. In response to parents' promises of toys or ice cream, she makes comments like, “Oh, you won't need a new toy after this, you'll be just fine.”

This isn't to say children shouldn't be given “realistic information” about how immunizations will feel, the review said. This information, along with what will happen and how to cope (relaxation, breathing, distraction), should all be part of preparing the child.

Coping isn't necessarily something parents help with, the authors noted: One survey of parents of preschool children showed only 10% offered any strategies to their children at all.

Pediatricians should routinely use—and instruct parents to use—engaging distraction techniques that match the child's age and temperament, because there are “strong data” that distraction reduces distress, the review said. It's unclear, however, whether particular techniques—from blowing or deep breathing to counting backward or listening to a story—are optimal.

The expense and time required for topical anesthetic use means that “universal use of local anesthetics cannot be endorsed at this time,” Dr. Schechter and his associates said. Still, for children who are needle phobic and particularly anxious, these agents “should be considered.”

Evidence is not as strong or consistent in the areas of needle length and injection site, the reviewers said. Up to 18 months of age, the standard injection site is the anterior thigh, with a 7/8- to 1-inch needle for children more than 2 months of age. Over 36 months of age, the deltoid should be used, and at any age, the ventrogluteal site may be an alternative.

Between 18 and 36 months of age, “there is controversy regarding the most appropriate site,” the reviewers said.

Until more research is done, pediatricians “should do what they're comfortable with—there is nothing definitive at this point,” Dr. Schechter said in the interview. “I think if evidence emerges, it will add pluses and minuses and not be powerful one way or the other.”

Pressure at the injection site, applied either manually or with the aid of a mechanical device, has some support in the literature and, because pressure has no adverse effects, it may have value, the reviewers said.

“The adolescents and young women coming in for the Gardasil vaccine are even anxious about these shots,” which says something about the anxiety and distress that routine immunizations cause, Dr. Corcoran said. “The pain [of immunization] is real, and it's magnified significantly by anxiety.”

Since finishing the review, Dr. Schechter has launched the “Injection Protection Project,” an educational effort to bring information and tools—from a poster and video for staff to a brochure for parents—into pediatric practices. Thus far, he has visited about 20 offices, including the three-pediatrician practice of Dr. Corcoran.

Dr. Della Corcoran's pediatric practice sits over an ice cream shop and across the street from a toy store—a setting that's unfortunate, she said, when it comes to immunization.

“Parents come in [for their children's immunizations] saying 'You're going to get ice cream or a new toy after this.' The kids hear this and think something pretty major is going to happen,” she said. Unwittingly, parents can fuel their child's anxiety and distress with such promises.

The notion that parental demeanor before and during immunization should be calm and matter-of-fact, without excessive reassurance—a notion that Dr. Corcoran tries to convey and model in her practice in Hartford, Conn.—is one of the recommended strategies included in a new review of pain reduction during pediatric immunization.

The review, led by Dr. Neil L. Schechter of the Pain Relief Program at Connecticut Children's Medical Center in Hartford, details how the pain of immunization is a source of anxiety and distress in pediatric practice, and concludes that, ironically, there is “limited research available to address the pain associated with the painful procedure most commonly performed in pediatric office settings.”

Still, according to Dr. Schechter and the small group of experts who reviewed the literature and filled gaps through consensus development, a more systematic application of existing knowledge “should go a long way” toward reducing pain and alleviating the “air of persistent tension that hangs over the clinical encounter” due to anticipation of an injection (Pediatrics 2007:119;e1184–98 [Epub doi:10.1542/peds.2006-1107]).

There is good, consistent scientific evidence, they concluded, to support a number of strategies, from parental demeanor that is supportive and nonapologetic, to the following practices:

▸ Developmentally appropriate preparation for all children over the age of 2 years.

▸ The use of sucrose (administered on a pacifier or directly instilled into the mouth) for children younger than 6 months of age.

▸ The use of distraction techniques during injection.

▸ Selective use of local anesthetics in children who are especially fearful.

Of these measures, the use of sucrose solution is “something that has not been as universally accepted, yet this probably has the strongest database,” Dr. Schechter said in an interview. “There are at least 50 articles that support the routine use of sucrose in infants under 6 months.”

Sucrose loses its efficacy by 4–6 months of age and requires more testing with and without other modalities, but at this point it “clearly has efficacy for young infants,” reliably reducing evidence of distress with injections, he and his associates said in the review.

Past infancy, the data on the influence of parental demeanor on child behavior is just as striking, Dr. Schechter said.

“Although it seems counterintuitive, children often are more distressed when parents are more rather than less involved,” the review said. “A matter-of-fact, supportive, nonapologetic approach is endorsed.”

Dr. Corcoran, who administers vaccines herself, said she tries to guide parents by example and counters excessive reassurance with pinwheels and other distraction stimuli. In response to parents' promises of toys or ice cream, she makes comments like, “Oh, you won't need a new toy after this, you'll be just fine.”

This isn't to say children shouldn't be given “realistic information” about how immunizations will feel, the review said. This information, along with what will happen and how to cope (relaxation, breathing, distraction), should all be part of preparing the child.

Coping isn't necessarily something parents help with, the authors noted: One survey of parents of preschool children showed only 10% offered any strategies to their children at all.

Pediatricians should routinely use—and instruct parents to use—engaging distraction techniques that match the child's age and temperament, because there are “strong data” that distraction reduces distress, the review said. It's unclear, however, whether particular techniques—from blowing or deep breathing to counting backward or listening to a story—are optimal.

The expense and time required for topical anesthetic use means that “universal use of local anesthetics cannot be endorsed at this time,” Dr. Schechter and his associates said. Still, for children who are needle phobic and particularly anxious, these agents “should be considered.”

Evidence is not as strong or consistent in the areas of needle length and injection site, the reviewers said. Up to 18 months of age, the standard injection site is the anterior thigh, with a 7/8- to 1-inch needle for children more than 2 months of age. Over 36 months of age, the deltoid should be used, and at any age, the ventrogluteal site may be an alternative.

Between 18 and 36 months of age, “there is controversy regarding the most appropriate site,” the reviewers said.

Until more research is done, pediatricians “should do what they're comfortable with—there is nothing definitive at this point,” Dr. Schechter said in the interview. “I think if evidence emerges, it will add pluses and minuses and not be powerful one way or the other.”

Pressure at the injection site, applied either manually or with the aid of a mechanical device, has some support in the literature and, because pressure has no adverse effects, it may have value, the reviewers said.

“The adolescents and young women coming in for the Gardasil vaccine are even anxious about these shots,” which says something about the anxiety and distress that routine immunizations cause, Dr. Corcoran said. “The pain [of immunization] is real, and it's magnified significantly by anxiety.”

Since finishing the review, Dr. Schechter has launched the “Injection Protection Project,” an educational effort to bring information and tools—from a poster and video for staff to a brochure for parents—into pediatric practices. Thus far, he has visited about 20 offices, including the three-pediatrician practice of Dr. Corcoran.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover current medications as well as future needs, said health care consultant Mary Kruczynski at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patients] haven't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is that you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski, who is based in Langhorne, Pa.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, she noted. The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs. “They're asking for data, blood counts, medical records … and checking doses. Some carriers now require you to get every prescription authorized,” Ms. Kruczynski said.

Physicians who care for patients with cancer have meantime “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B.”

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and includes some commentary on Part D drugs, notes the word of physicians who work with patients to determine whether it is better to prescribe the drugs under Part D or Part B.

One option might be preferable to the other, Ms. Kruczynski said, depending on the patient's Part D plan and coverage, and on the patient's spending relative to the doughnut hole and catastrophic coverage The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are permitted to keep the same name while changing costs and benefits each year, the plans sometimes fail to send out required change notices. The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D. MedPAC also is expected to weigh in this year with a report on the program. For now, Ms. Kruczynski said, “it's coming down to us again.” By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.” But that's essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover current medications as well as future needs, said health care consultant Mary Kruczynski at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patients] haven't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is that you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski, who is based in Langhorne, Pa.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, she noted. The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs. “They're asking for data, blood counts, medical records … and checking doses. Some carriers now require you to get every prescription authorized,” Ms. Kruczynski said.

Physicians who care for patients with cancer have meantime “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B.”

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and includes some commentary on Part D drugs, notes the word of physicians who work with patients to determine whether it is better to prescribe the drugs under Part D or Part B.

One option might be preferable to the other, Ms. Kruczynski said, depending on the patient's Part D plan and coverage, and on the patient's spending relative to the doughnut hole and catastrophic coverage The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are permitted to keep the same name while changing costs and benefits each year, the plans sometimes fail to send out required change notices. The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D. MedPAC also is expected to weigh in this year with a report on the program. For now, Ms. Kruczynski said, “it's coming down to us again.” By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.” But that's essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover current medications as well as future needs, said health care consultant Mary Kruczynski at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patients] haven't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is that you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski, who is based in Langhorne, Pa.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, she noted. The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs. “They're asking for data, blood counts, medical records … and checking doses. Some carriers now require you to get every prescription authorized,” Ms. Kruczynski said.

Physicians who care for patients with cancer have meantime “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B.”

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and includes some commentary on Part D drugs, notes the word of physicians who work with patients to determine whether it is better to prescribe the drugs under Part D or Part B.

One option might be preferable to the other, Ms. Kruczynski said, depending on the patient's Part D plan and coverage, and on the patient's spending relative to the doughnut hole and catastrophic coverage The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are permitted to keep the same name while changing costs and benefits each year, the plans sometimes fail to send out required change notices. The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D. MedPAC also is expected to weigh in this year with a report on the program. For now, Ms. Kruczynski said, “it's coming down to us again.” By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.” But that's essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover not only current medications but future needs as well, health care consultant Mary Kruczynski said at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patient] hasn't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is, you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski, who is based in Langhorne, Pa.

“If [your patients] go to the drug store and get told 'it's not on the formulary,' they come back to you,” she said.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more and more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, Ms. Kruczynski noted.

The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs.

“They're asking for data, blood counts, medical records … and checking doses,” Ms. Kruczynski said. “Some carriers now require you to get every prescription authorized.”

Those physicians who care for patients with cancer, in the meantime, have “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B,” Ms. Kruczynski commented.

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and also includes some commentary on Part D drugs, notes the word of those physicians who work with their patients to determine whether it is more beneficial to prescribe the drugs under Medicare Part D or under Part B.

One option might be preferable to the other, Ms. Kruczynski said, depending upon the patient's Part D plan and coverage. The value of one choice over another could also depend on the patient's spending relative to the doughnut hole and any catastrophic coverage that the patient might have.

The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are indeed permitted to retain the same name while substantially changing costs and benefits each year, the plans sometimes fail to send out the required change notices.

The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this in the past.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D, Ms. Kruczynski noted.

MedPAC also is expected to weigh in this year with a report focused on the program.

For now, she said, “it's coming down to us again.”

By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.”

In the meantime, she emphasized, that help is essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover not only current medications but future needs as well, health care consultant Mary Kruczynski said at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patient] hasn't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is, you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski, who is based in Langhorne, Pa.

“If [your patients] go to the drug store and get told 'it's not on the formulary,' they come back to you,” she said.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more and more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, Ms. Kruczynski noted.

The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs.

“They're asking for data, blood counts, medical records … and checking doses,” Ms. Kruczynski said. “Some carriers now require you to get every prescription authorized.”

Those physicians who care for patients with cancer, in the meantime, have “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B,” Ms. Kruczynski commented.

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and also includes some commentary on Part D drugs, notes the word of those physicians who work with their patients to determine whether it is more beneficial to prescribe the drugs under Medicare Part D or under Part B.

One option might be preferable to the other, Ms. Kruczynski said, depending upon the patient's Part D plan and coverage. The value of one choice over another could also depend on the patient's spending relative to the doughnut hole and any catastrophic coverage that the patient might have.

The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are indeed permitted to retain the same name while substantially changing costs and benefits each year, the plans sometimes fail to send out the required change notices.

The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this in the past.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D, Ms. Kruczynski noted.

MedPAC also is expected to weigh in this year with a report focused on the program.

For now, she said, “it's coming down to us again.”

By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.”

In the meantime, she emphasized, that help is essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover not only current medications but future needs as well, health care consultant Mary Kruczynski said at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patient] hasn't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is, you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski, who is based in Langhorne, Pa.

“If [your patients] go to the drug store and get told 'it's not on the formulary,' they come back to you,” she said.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more and more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, Ms. Kruczynski noted.

The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs.

“They're asking for data, blood counts, medical records … and checking doses,” Ms. Kruczynski said. “Some carriers now require you to get every prescription authorized.”

Those physicians who care for patients with cancer, in the meantime, have “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B,” Ms. Kruczynski commented.

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and also includes some commentary on Part D drugs, notes the word of those physicians who work with their patients to determine whether it is more beneficial to prescribe the drugs under Medicare Part D or under Part B.

One option might be preferable to the other, Ms. Kruczynski said, depending upon the patient's Part D plan and coverage. The value of one choice over another could also depend on the patient's spending relative to the doughnut hole and any catastrophic coverage that the patient might have.

The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are indeed permitted to retain the same name while substantially changing costs and benefits each year, the plans sometimes fail to send out the required change notices.

The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this in the past.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D, Ms. Kruczynski noted.

MedPAC also is expected to weigh in this year with a report focused on the program.

For now, she said, “it's coming down to us again.”

By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.”

In the meantime, she emphasized, that help is essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

Updated guidelines on evaluating and treating girls and women with Turner syndrome advise against the practice of delaying puberty to increase height and emphasize the importance of early diagnosis and estrogen treatment.

The guidelines from the international, multidisciplinary Turner Syndrome Consensus Study Group detail how children should be evaluated and cared for, emphasizing, for example, the importance of comprehensive educational evaluation in early childhood.

The guidelines offer age-specific suggestions for ovarian hormone replacement and say that “ideally, natural estradiol and progesterone, rather than analogs, should be delivered by transdermal or transmembranous routes so as to mimic age-appropriate physiological patterns as closely as possible.”

Regimens can vary to meet individuals' tolerance and preference, however, and “the most important consideration is that women actually take ovarian hormone replacement,” the authors say (J. Clin. Endocrinol. Metab. 2007:92:10–25).

Without it, the risk of significant osteoporosis is high. “These women can have severe osteoporosis at 25,” Dr. Carolyn A. Bondy said in an interview.

“I have a 30-year-old patient who has lost 2 inches of height and has a hump.”

Estrogen therapy often is required to induce pubertal development (30% or more will undergo some spontaneous pubertal development), but experts used to recommend delaying estrogen therapy until age 15 to optimize height potential.

Today, Dr. Bondy said, the consensus is that such delay undervalues the psychosocial importance of age-appropriate puberty. Recent evidence also suggests that low-dose estrogen does not inhibit growth hormone-enhanced increases in stature. “There's a new focus on natural, sensitive, and timely puberty induction,” she said.

“The care of adults with TS has received less attention than [has] the treatment of children, and many seem to be falling through the cracks with inadequate cardiovascular evaluation and estrogen treatment,” say the new guidelines, published in the Journal of Clinical Endocrinology & Metabolism.

On the other hand, while medical care must be improved and while many questions about care “remain unanswered,” the experts “realize now that we have a lot more well-functioning people with TS,” according to Dr. Bondy, who is chief of the developmental endocrinology branch at the National Institute of Child Health and Human Development in Bethesda, Md. She chaired the consensus conference and guideline-writing committee for the consensus group, which met last summer to update the recommendations that were issued in 2001. The guidelines mainly represent “consensus judgments” rather than evidence-based conclusions, the committee noted in its document.

The clinical spectrum of TS is “much broader and often less severe than that described in many textbooks”—a finding that seems at odds with a “high elective abortion rate for incidentally diagnosed 45,X and 45,X/mosaic fetuses,” the guidelines say. This means that the content of prenatal counseling “needs updating” with the input of TS patient and parent groups, the document says.

Recent reports of an often-normal quality of life for those receiving comprehensive medical care should encourage—not mitigate—the efforts of physicians to diagnose TS as early as possible and better appreciate its many consequences, she said. Adults with TS should then be regularly screened for hypertension, diabetes, dyslipidemia, aortic enlargement, hearing loss, osteoporosis, and thyroid and celiac diseases. Recent studies have also suggested a broader spectrum of cardiovascular abnormalities than were previously recognized, and the consensus group agreed to bring “the heart to the forefront,” Dr. Bondy said.

Updated guidelines on evaluating and treating girls and women with Turner syndrome advise against the practice of delaying puberty to increase height and emphasize the importance of early diagnosis and estrogen treatment.

The guidelines from the international, multidisciplinary Turner Syndrome Consensus Study Group detail how children should be evaluated and cared for, emphasizing, for example, the importance of comprehensive educational evaluation in early childhood.

The guidelines offer age-specific suggestions for ovarian hormone replacement and say that “ideally, natural estradiol and progesterone, rather than analogs, should be delivered by transdermal or transmembranous routes so as to mimic age-appropriate physiological patterns as closely as possible.”

Regimens can vary to meet individuals' tolerance and preference, however, and “the most important consideration is that women actually take ovarian hormone replacement,” the authors say (J. Clin. Endocrinol. Metab. 2007:92:10–25).

Without it, the risk of significant osteoporosis is high. “These women can have severe osteoporosis at 25,” Dr. Carolyn A. Bondy said in an interview.

“I have a 30-year-old patient who has lost 2 inches of height and has a hump.”

Estrogen therapy often is required to induce pubertal development (30% or more will undergo some spontaneous pubertal development), but experts used to recommend delaying estrogen therapy until age 15 to optimize height potential.

Today, Dr. Bondy said, the consensus is that such delay undervalues the psychosocial importance of age-appropriate puberty. Recent evidence also suggests that low-dose estrogen does not inhibit growth hormone-enhanced increases in stature. “There's a new focus on natural, sensitive, and timely puberty induction,” she said.

“The care of adults with TS has received less attention than [has] the treatment of children, and many seem to be falling through the cracks with inadequate cardiovascular evaluation and estrogen treatment,” say the new guidelines, published in the Journal of Clinical Endocrinology & Metabolism.

On the other hand, while medical care must be improved and while many questions about care “remain unanswered,” the experts “realize now that we have a lot more well-functioning people with TS,” according to Dr. Bondy, who is chief of the developmental endocrinology branch at the National Institute of Child Health and Human Development in Bethesda, Md. She chaired the consensus conference and guideline-writing committee for the consensus group, which met last summer to update the recommendations that were issued in 2001. The guidelines mainly represent “consensus judgments” rather than evidence-based conclusions, the committee noted in its document.

The clinical spectrum of TS is “much broader and often less severe than that described in many textbooks”—a finding that seems at odds with a “high elective abortion rate for incidentally diagnosed 45,X and 45,X/mosaic fetuses,” the guidelines say. This means that the content of prenatal counseling “needs updating” with the input of TS patient and parent groups, the document says.

Recent reports of an often-normal quality of life for those receiving comprehensive medical care should encourage—not mitigate—the efforts of physicians to diagnose TS as early as possible and better appreciate its many consequences, she said. Adults with TS should then be regularly screened for hypertension, diabetes, dyslipidemia, aortic enlargement, hearing loss, osteoporosis, and thyroid and celiac diseases. Recent studies have also suggested a broader spectrum of cardiovascular abnormalities than were previously recognized, and the consensus group agreed to bring “the heart to the forefront,” Dr. Bondy said.

Updated guidelines on evaluating and treating girls and women with Turner syndrome advise against the practice of delaying puberty to increase height and emphasize the importance of early diagnosis and estrogen treatment.

The guidelines from the international, multidisciplinary Turner Syndrome Consensus Study Group detail how children should be evaluated and cared for, emphasizing, for example, the importance of comprehensive educational evaluation in early childhood.

The guidelines offer age-specific suggestions for ovarian hormone replacement and say that “ideally, natural estradiol and progesterone, rather than analogs, should be delivered by transdermal or transmembranous routes so as to mimic age-appropriate physiological patterns as closely as possible.”

Regimens can vary to meet individuals' tolerance and preference, however, and “the most important consideration is that women actually take ovarian hormone replacement,” the authors say (J. Clin. Endocrinol. Metab. 2007:92:10–25).

Without it, the risk of significant osteoporosis is high. “These women can have severe osteoporosis at 25,” Dr. Carolyn A. Bondy said in an interview.

“I have a 30-year-old patient who has lost 2 inches of height and has a hump.”

Estrogen therapy often is required to induce pubertal development (30% or more will undergo some spontaneous pubertal development), but experts used to recommend delaying estrogen therapy until age 15 to optimize height potential.

Today, Dr. Bondy said, the consensus is that such delay undervalues the psychosocial importance of age-appropriate puberty. Recent evidence also suggests that low-dose estrogen does not inhibit growth hormone-enhanced increases in stature. “There's a new focus on natural, sensitive, and timely puberty induction,” she said.

“The care of adults with TS has received less attention than [has] the treatment of children, and many seem to be falling through the cracks with inadequate cardiovascular evaluation and estrogen treatment,” say the new guidelines, published in the Journal of Clinical Endocrinology & Metabolism.

On the other hand, while medical care must be improved and while many questions about care “remain unanswered,” the experts “realize now that we have a lot more well-functioning people with TS,” according to Dr. Bondy, who is chief of the developmental endocrinology branch at the National Institute of Child Health and Human Development in Bethesda, Md. She chaired the consensus conference and guideline-writing committee for the consensus group, which met last summer to update the recommendations that were issued in 2001. The guidelines mainly represent “consensus judgments” rather than evidence-based conclusions, the committee noted in its document.

The clinical spectrum of TS is “much broader and often less severe than that described in many textbooks”—a finding that seems at odds with a “high elective abortion rate for incidentally diagnosed 45,X and 45,X/mosaic fetuses,” the guidelines say. This means that the content of prenatal counseling “needs updating” with the input of TS patient and parent groups, the document says.

Recent reports of an often-normal quality of life for those receiving comprehensive medical care should encourage—not mitigate—the efforts of physicians to diagnose TS as early as possible and better appreciate its many consequences, she said. Adults with TS should then be regularly screened for hypertension, diabetes, dyslipidemia, aortic enlargement, hearing loss, osteoporosis, and thyroid and celiac diseases. Recent studies have also suggested a broader spectrum of cardiovascular abnormalities than were previously recognized, and the consensus group agreed to bring “the heart to the forefront,” Dr. Bondy said.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover not only current medications but future needs as well, health care consultant Mary Kruczynski said at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patient] hasn't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is, you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski. “If [your patients] go to the drug store and get told 'it's not on the formulary,' they come back to you,” she said.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more and more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, she noted. The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs. “They're asking for data, blood counts, medical records … and checking doses,” she said. “Some carriers now require you to get every prescription authorized.”

Physicians who care for patients with cancer, in the meantime, have “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B,” Ms. Kruczynski said.

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and includes some commentary on Part D drugs, notes the word of physicians who work with patients to determine whether it is better to prescribe the drugs under Part D or Part B.

The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are permitted to keep the same name while substantially changing costs and benefits each year, the plans sometimes fail to send out required change notices. The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D, Ms. Kruczynski noted.

For now, she said, “it's coming down to us again.” By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.” But for now, she emphasized, it's essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover not only current medications but future needs as well, health care consultant Mary Kruczynski said at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patient] hasn't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is, you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski. “If [your patients] go to the drug store and get told 'it's not on the formulary,' they come back to you,” she said.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more and more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, she noted. The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs. “They're asking for data, blood counts, medical records … and checking doses,” she said. “Some carriers now require you to get every prescription authorized.”

Physicians who care for patients with cancer, in the meantime, have “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B,” Ms. Kruczynski said.

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and includes some commentary on Part D drugs, notes the word of physicians who work with patients to determine whether it is better to prescribe the drugs under Part D or Part B.

The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are permitted to keep the same name while substantially changing costs and benefits each year, the plans sometimes fail to send out required change notices. The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D, Ms. Kruczynski noted.

For now, she said, “it's coming down to us again.” By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.” But for now, she emphasized, it's essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover not only current medications but future needs as well, health care consultant Mary Kruczynski said at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patient] hasn't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is, you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski. “If [your patients] go to the drug store and get told 'it's not on the formulary,' they come back to you,” she said.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more and more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, she noted. The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs. “They're asking for data, blood counts, medical records … and checking doses,” she said. “Some carriers now require you to get every prescription authorized.”

Physicians who care for patients with cancer, in the meantime, have “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B,” Ms. Kruczynski said.

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and includes some commentary on Part D drugs, notes the word of physicians who work with patients to determine whether it is better to prescribe the drugs under Part D or Part B.

The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are permitted to keep the same name while substantially changing costs and benefits each year, the plans sometimes fail to send out required change notices. The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D, Ms. Kruczynski noted.

For now, she said, “it's coming down to us again.” By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.” But for now, she emphasized, it's essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

Dermatologists and their patients taking isotretinoin are entering the second year of the iPLEDGE mandatory risk management program aimed at preventing isotretinoin-related teratogenicity, and the specialty's leaders on the issue are anticipating further improvement in a system they say remains poorly designed.

“It's safe to say that within the first half of 2007, probably in later spring, there should be additional program improvement. … More improvement is coming,” said Dr. Diane Thiboutot, former chair of the American Academy of Dermatology task force on isotretinoin.

What is not clear, however—and won't be for at least another year—is the impact the program is having on the prevention of pregnancies in women taking the teratogenic drug.

Both Dr. Thiboutot, who will continue serving on the task force, and Dr. Susan Walker, who became the director of the Food and Drug Administration's Division of Dermatology and Dental Products last June, said for the first time in February that there is “preliminary” evidence that the program is reducing the number of women who are pregnant at the time they start isotretinoin therapy.

But they offered no details, and Dr. Thiboutot explained that the manufacturers now plan to use data from the first full year of iPLEDGE “as baseline data” for comparison with pregnancy data collected during the entire second year. Before iPLEDGE was implemented, the pregnancy rate in women taking isotretinoin (Accutane) was about 4 per 1,000 women, she said.

“In the interim, some sort of methodology [for evaluating success of the program] will be determined,” said Dr. Thiboutot, professor of dermatology at Pennsyvania State University, Hershey.

The most significant change to come this year, in the meantime, will likely be an elimination of the 23-day lockout period for women of childbearing potential. With such a rule change, women who do not have their prescriptions filled within 7 days could undergo another pregnancy test and office visit and then get a refill without having to wait 23 days.

The FDA eliminated this lockout period last October for males and females of nonchildbearing potential, while promising that a change in this rule for females of childbearing potential would be “rolled out” in 2007 (INTERNAL MEDICINE NEWS, Dec. 1, 2006, p. 11).

A spokesperson for Covance, the Princeton, N.J.-based company that manages iPLEDGE, confirmed that the firm is “working on eliminating [the lockout].”

Dr. Thiboutot said she and other AAD leaders have been pushing for other changes as well—for instance, the incorporation of specific dates rather than time windows in the iPLEDGE online program—based on input from dermatologists who have communicated with the academy as well as a survey of 400 dermatologists taken this summer. The poll showed that 95% were prescribing isotretinoin and that 90% of them were having difficulty with the iPLEDGE program.

Dr. Stephen Stone, who recently assumed the chairmanship of the academy's task force on isotretinoin, said the academy has a “seat at the table” that it did not have as iPLEDGE was being designed and implemented.

“The FDA is definitely listening to us,” said Dr. Stone, immediate past president of the AAD and professor of clinical medicine at Southern Illinois University, Springfield. “My understanding is that iPLEDGE will be improved, at least in its ease of application.”

Even with the elimination of the 23-day lockout period for men and women of nonchildbearing potential, “participation of these patients in the system is still overly complicated,” he said. “There still [needs to be] some liberalization of rules.”

Dermatologists still are debating the program's effects on prescribing. Dr. Noah Scheinfeld, of the dermatology department of Columbia University, New York, estimated last spring that prescribing in his region had dropped by at least 50%. That estimate still holds true, he said.

Dr. Elaine Siegfried, a dermatologist at St. Louis University who chairs the AAD's Environment and Drugs Committee, said, on the other hand, that the number of isotretinoin prescriptions dropped after implementation of iPLEDGE but now appears to be back up to approximately where it was under the voluntary SMART (System to Manage Accutane-Related Teratogenicity) program.

(The total number of prescriptions dispensed in the United States in the year after SMART was implemented had declined 23% from the previous year.)

According to Covance's data, while the number of prescribers and pharmacies activated has remained about the same in the last 6 months, the number of patients activated in the program has risen significantly, from 140,000 patients last June to more than 244,000 in December.

Calls to the AAD office, meanwhile, have continued to decline—a trend that AAD leaders say likely reflects changes made by Covance in the spring (the company added staff to its call center and made changes to its Web site, for instance, resolving some of the program's operational difficulties), as well as time needed to learn the system and delegate responsibility.

The average wait time for getting help from the iPLEDGE call center in December was 2 minutes, according to Covance spokesperson Laurene Isip.

“The program is definitely running light-years better” than it did at the start, said Dr. James Del Rosso, of the department of dermatology at University of Nevada, Reno, and immediate past chairman of the AAD's Environment and Drugs Committee.

Dr. Sharon Gardepe, who has a solo practice in general dermatology in Huntsville, Ala., called her legislators and the AAD soon after implementation about her concerns and experience with iPLEDGE. She also created a handout listing local legislators to give to her patients who complained about the program. “Giving them the list underlined the fact that it wasn't me,” she said.

One year into the program, Dr. Gardepe said her hour-long phone calls to Covance are a thing of the past, but the requirement that prescriptions be picked up within 7 days and the rule that lab tests be conducted no sooner than 1 day before the office visit still result in “a lot of time spent troubleshooting.

“Some people are optimistic that we might be better able to work with [FDA and Covance], but I'm still skeptical” about the extent of future change, she said.

Dr. Siegfried said such skepticism is understandable. “I really am optimistic. I do think that Dr. Walker [at the FDA] wants to build bridges,” she said. “But in the end it's not her call—it's Congress.”

Dr. Siegfried and other AAD leaders urge physicians to remain vigilant and active. Isotretinoin, they caution, will likely be in the limelight this year, since Rep. Bart Stupak (D-Mich.) has announced that he wants to hold a congressional hearing on the FDA's management of the drug.

Dr. Siegfried said that she believes the decision to collect a full year of baseline data and then another year of comparison data before reporting pregnancy rates—rather than releasing iPLEDGE data quarterly, as was first anticipated—reflects the realization that “if the data were made public [along the way], and there's been one pregnancy, it will haunt us and we won't have the drug [at all].”

Dr. Stone said he too is concerned, saying that iPLEDGE “will minimize the number of pregnancies by forcing people to go through the hoops, but I don't think we'll ever eliminate pregnancies.”

The iPLEDGE program 'is definitely running light-years better' than it did at the start. DR. DEL ROSSO

Dermatologists and their patients taking isotretinoin are entering the second year of the iPLEDGE mandatory risk management program aimed at preventing isotretinoin-related teratogenicity, and the specialty's leaders on the issue are anticipating further improvement in a system they say remains poorly designed.

“It's safe to say that within the first half of 2007, probably in later spring, there should be additional program improvement. … More improvement is coming,” said Dr. Diane Thiboutot, former chair of the American Academy of Dermatology task force on isotretinoin.

What is not clear, however—and won't be for at least another year—is the impact the program is having on the prevention of pregnancies in women taking the teratogenic drug.

Both Dr. Thiboutot, who will continue serving on the task force, and Dr. Susan Walker, who became the director of the Food and Drug Administration's Division of Dermatology and Dental Products last June, said for the first time in February that there is “preliminary” evidence that the program is reducing the number of women who are pregnant at the time they start isotretinoin therapy.

But they offered no details, and Dr. Thiboutot explained that the manufacturers now plan to use data from the first full year of iPLEDGE “as baseline data” for comparison with pregnancy data collected during the entire second year. Before iPLEDGE was implemented, the pregnancy rate in women taking isotretinoin (Accutane) was about 4 per 1,000 women, she said.

“In the interim, some sort of methodology [for evaluating success of the program] will be determined,” said Dr. Thiboutot, professor of dermatology at Pennsyvania State University, Hershey.

The most significant change to come this year, in the meantime, will likely be an elimination of the 23-day lockout period for women of childbearing potential. With such a rule change, women who do not have their prescriptions filled within 7 days could undergo another pregnancy test and office visit and then get a refill without having to wait 23 days.

The FDA eliminated this lockout period last October for males and females of nonchildbearing potential, while promising that a change in this rule for females of childbearing potential would be “rolled out” in 2007 (INTERNAL MEDICINE NEWS, Dec. 1, 2006, p. 11).

A spokesperson for Covance, the Princeton, N.J.-based company that manages iPLEDGE, confirmed that the firm is “working on eliminating [the lockout].”

Dr. Thiboutot said she and other AAD leaders have been pushing for other changes as well—for instance, the incorporation of specific dates rather than time windows in the iPLEDGE online program—based on input from dermatologists who have communicated with the academy as well as a survey of 400 dermatologists taken this summer. The poll showed that 95% were prescribing isotretinoin and that 90% of them were having difficulty with the iPLEDGE program.

Dr. Stephen Stone, who recently assumed the chairmanship of the academy's task force on isotretinoin, said the academy has a “seat at the table” that it did not have as iPLEDGE was being designed and implemented.

“The FDA is definitely listening to us,” said Dr. Stone, immediate past president of the AAD and professor of clinical medicine at Southern Illinois University, Springfield. “My understanding is that iPLEDGE will be improved, at least in its ease of application.”

Even with the elimination of the 23-day lockout period for men and women of nonchildbearing potential, “participation of these patients in the system is still overly complicated,” he said. “There still [needs to be] some liberalization of rules.”

Dermatologists still are debating the program's effects on prescribing. Dr. Noah Scheinfeld, of the dermatology department of Columbia University, New York, estimated last spring that prescribing in his region had dropped by at least 50%. That estimate still holds true, he said.

Dr. Elaine Siegfried, a dermatologist at St. Louis University who chairs the AAD's Environment and Drugs Committee, said, on the other hand, that the number of isotretinoin prescriptions dropped after implementation of iPLEDGE but now appears to be back up to approximately where it was under the voluntary SMART (System to Manage Accutane-Related Teratogenicity) program.

(The total number of prescriptions dispensed in the United States in the year after SMART was implemented had declined 23% from the previous year.)

According to Covance's data, while the number of prescribers and pharmacies activated has remained about the same in the last 6 months, the number of patients activated in the program has risen significantly, from 140,000 patients last June to more than 244,000 in December.

Calls to the AAD office, meanwhile, have continued to decline—a trend that AAD leaders say likely reflects changes made by Covance in the spring (the company added staff to its call center and made changes to its Web site, for instance, resolving some of the program's operational difficulties), as well as time needed to learn the system and delegate responsibility.

The average wait time for getting help from the iPLEDGE call center in December was 2 minutes, according to Covance spokesperson Laurene Isip.

“The program is definitely running light-years better” than it did at the start, said Dr. James Del Rosso, of the department of dermatology at University of Nevada, Reno, and immediate past chairman of the AAD's Environment and Drugs Committee.

Dr. Sharon Gardepe, who has a solo practice in general dermatology in Huntsville, Ala., called her legislators and the AAD soon after implementation about her concerns and experience with iPLEDGE. She also created a handout listing local legislators to give to her patients who complained about the program. “Giving them the list underlined the fact that it wasn't me,” she said.

One year into the program, Dr. Gardepe said her hour-long phone calls to Covance are a thing of the past, but the requirement that prescriptions be picked up within 7 days and the rule that lab tests be conducted no sooner than 1 day before the office visit still result in “a lot of time spent troubleshooting.

“Some people are optimistic that we might be better able to work with [FDA and Covance], but I'm still skeptical” about the extent of future change, she said.

Dr. Siegfried said such skepticism is understandable. “I really am optimistic. I do think that Dr. Walker [at the FDA] wants to build bridges,” she said. “But in the end it's not her call—it's Congress.”

Dr. Siegfried and other AAD leaders urge physicians to remain vigilant and active. Isotretinoin, they caution, will likely be in the limelight this year, since Rep. Bart Stupak (D-Mich.) has announced that he wants to hold a congressional hearing on the FDA's management of the drug.

Dr. Siegfried said that she believes the decision to collect a full year of baseline data and then another year of comparison data before reporting pregnancy rates—rather than releasing iPLEDGE data quarterly, as was first anticipated—reflects the realization that “if the data were made public [along the way], and there's been one pregnancy, it will haunt us and we won't have the drug [at all].”

Dr. Stone said he too is concerned, saying that iPLEDGE “will minimize the number of pregnancies by forcing people to go through the hoops, but I don't think we'll ever eliminate pregnancies.”

The iPLEDGE program 'is definitely running light-years better' than it did at the start. DR. DEL ROSSO

Dermatologists and their patients taking isotretinoin are entering the second year of the iPLEDGE mandatory risk management program aimed at preventing isotretinoin-related teratogenicity, and the specialty's leaders on the issue are anticipating further improvement in a system they say remains poorly designed.

“It's safe to say that within the first half of 2007, probably in later spring, there should be additional program improvement. … More improvement is coming,” said Dr. Diane Thiboutot, former chair of the American Academy of Dermatology task force on isotretinoin.

What is not clear, however—and won't be for at least another year—is the impact the program is having on the prevention of pregnancies in women taking the teratogenic drug.

Both Dr. Thiboutot, who will continue serving on the task force, and Dr. Susan Walker, who became the director of the Food and Drug Administration's Division of Dermatology and Dental Products last June, said for the first time in February that there is “preliminary” evidence that the program is reducing the number of women who are pregnant at the time they start isotretinoin therapy.

But they offered no details, and Dr. Thiboutot explained that the manufacturers now plan to use data from the first full year of iPLEDGE “as baseline data” for comparison with pregnancy data collected during the entire second year. Before iPLEDGE was implemented, the pregnancy rate in women taking isotretinoin (Accutane) was about 4 per 1,000 women, she said.

“In the interim, some sort of methodology [for evaluating success of the program] will be determined,” said Dr. Thiboutot, professor of dermatology at Pennsyvania State University, Hershey.

The most significant change to come this year, in the meantime, will likely be an elimination of the 23-day lockout period for women of childbearing potential. With such a rule change, women who do not have their prescriptions filled within 7 days could undergo another pregnancy test and office visit and then get a refill without having to wait 23 days.

The FDA eliminated this lockout period last October for males and females of nonchildbearing potential, while promising that a change in this rule for females of childbearing potential would be “rolled out” in 2007 (INTERNAL MEDICINE NEWS, Dec. 1, 2006, p. 11).

A spokesperson for Covance, the Princeton, N.J.-based company that manages iPLEDGE, confirmed that the firm is “working on eliminating [the lockout].”

Dr. Thiboutot said she and other AAD leaders have been pushing for other changes as well—for instance, the incorporation of specific dates rather than time windows in the iPLEDGE online program—based on input from dermatologists who have communicated with the academy as well as a survey of 400 dermatologists taken this summer. The poll showed that 95% were prescribing isotretinoin and that 90% of them were having difficulty with the iPLEDGE program.

Dr. Stephen Stone, who recently assumed the chairmanship of the academy's task force on isotretinoin, said the academy has a “seat at the table” that it did not have as iPLEDGE was being designed and implemented.

“The FDA is definitely listening to us,” said Dr. Stone, immediate past president of the AAD and professor of clinical medicine at Southern Illinois University, Springfield. “My understanding is that iPLEDGE will be improved, at least in its ease of application.”

Even with the elimination of the 23-day lockout period for men and women of nonchildbearing potential, “participation of these patients in the system is still overly complicated,” he said. “There still [needs to be] some liberalization of rules.”

Dermatologists still are debating the program's effects on prescribing. Dr. Noah Scheinfeld, of the dermatology department of Columbia University, New York, estimated last spring that prescribing in his region had dropped by at least 50%. That estimate still holds true, he said.

Dr. Elaine Siegfried, a dermatologist at St. Louis University who chairs the AAD's Environment and Drugs Committee, said, on the other hand, that the number of isotretinoin prescriptions dropped after implementation of iPLEDGE but now appears to be back up to approximately where it was under the voluntary SMART (System to Manage Accutane-Related Teratogenicity) program.

(The total number of prescriptions dispensed in the United States in the year after SMART was implemented had declined 23% from the previous year.)

According to Covance's data, while the number of prescribers and pharmacies activated has remained about the same in the last 6 months, the number of patients activated in the program has risen significantly, from 140,000 patients last June to more than 244,000 in December.

Calls to the AAD office, meanwhile, have continued to decline—a trend that AAD leaders say likely reflects changes made by Covance in the spring (the company added staff to its call center and made changes to its Web site, for instance, resolving some of the program's operational difficulties), as well as time needed to learn the system and delegate responsibility.

The average wait time for getting help from the iPLEDGE call center in December was 2 minutes, according to Covance spokesperson Laurene Isip.

“The program is definitely running light-years better” than it did at the start, said Dr. James Del Rosso, of the department of dermatology at University of Nevada, Reno, and immediate past chairman of the AAD's Environment and Drugs Committee.

Dr. Sharon Gardepe, who has a solo practice in general dermatology in Huntsville, Ala., called her legislators and the AAD soon after implementation about her concerns and experience with iPLEDGE. She also created a handout listing local legislators to give to her patients who complained about the program. “Giving them the list underlined the fact that it wasn't me,” she said.

One year into the program, Dr. Gardepe said her hour-long phone calls to Covance are a thing of the past, but the requirement that prescriptions be picked up within 7 days and the rule that lab tests be conducted no sooner than 1 day before the office visit still result in “a lot of time spent troubleshooting.

“Some people are optimistic that we might be better able to work with [FDA and Covance], but I'm still skeptical” about the extent of future change, she said.

Dr. Siegfried said such skepticism is understandable. “I really am optimistic. I do think that Dr. Walker [at the FDA] wants to build bridges,” she said. “But in the end it's not her call—it's Congress.”

Dr. Siegfried and other AAD leaders urge physicians to remain vigilant and active. Isotretinoin, they caution, will likely be in the limelight this year, since Rep. Bart Stupak (D-Mich.) has announced that he wants to hold a congressional hearing on the FDA's management of the drug.

Dr. Siegfried said that she believes the decision to collect a full year of baseline data and then another year of comparison data before reporting pregnancy rates—rather than releasing iPLEDGE data quarterly, as was first anticipated—reflects the realization that “if the data were made public [along the way], and there's been one pregnancy, it will haunt us and we won't have the drug [at all].”

Dr. Stone said he too is concerned, saying that iPLEDGE “will minimize the number of pregnancies by forcing people to go through the hoops, but I don't think we'll ever eliminate pregnancies.”

The iPLEDGE program 'is definitely running light-years better' than it did at the start. DR. DEL ROSSO

One year into a landmark diabetes monitoring program, hemoglobin A_1c test results are streaming from New York City laboratories into the city's health department and, in a sampling of cases, on to medical directors for distribution to clinicians.

City health officials, in the meantime, are working with a national advisory group of diabetes experts to analyze the data in the city's novel A_1c registry—900,000 A_1c test results covering 600,000 individuals, as of last month—and to design subsequent interventions.

The registry, which was launched in January 2006, is being watched by health officials across the country who want to reduce diabetes complications and control what they increasingly view as one of their largest public health crises.

The New York City program mandates that laboratories already reporting communicable diseases must also report results of hemoglobin A_1c tests directly to the city's Department of Health and Mental Hygiene.

As the program develops, the health department plans to routinely provide information to clinicians on their patients with diabetes and offer services and interventions to patients with poor glycemic control.

“The essence [is] to have it be more than just a surveillance system,” said Dr. Diana Berger, who is the medical director of the city's Diabetes Prevention and Control Program.

“We already have a robust system to establish the prevalence of diabetes,” she said. “We wanted a two-pronged initiative: Surveillance plus some sort of intervention.”

For now, in a pilot phase of the program, the city has begun sending quarterly reports to medical directors of seven practices in Manhattan and the South Bronx.

The medical directors are then responsible for distributing the practice reports—which list patients stratified by A_1c levels—to the 274 clinicians in the practices, Dr. Berger said.

The city plans to expand the pilot project to cover all of the South Bronx (approximately 100 practices) this summer, followed by other high-risk neighborhoods later in the year—a roll-out that officials hope will be helpful for fine-tuning reports and eventually designing interventions.

Interpreting the growing body of registry data, in the meantime, has been a significant undertaking.

Test results come in with the patient's full name, date of birth, and address, as well as the date the test was taken and the name and location of the ordering facility and clinician.

This information may be enough for providing profiles to providers, but it's probably not enough to fully understand the epidemic and design optimal interventions, Dr. Berger said.

“The problem is, there's no diagnostic code attached to [the results],” she said. “We don't know whether a patient has diabetes or not [or what type of diabetes it is]. … The database needs a lot of cleaning [and interpretation]—it's a complex process.”

Also complicating the analysis is the fact that the registry, by including all hemoglobin A_1c test results, captures tests used for diabetes screening as well as for monitoring, Dr. Berger said.

“There's a current practice of using A_1c to screen for diabetes,” even though it's not recommended by the American Diabetes Association, she said. “We're estimating that anywhere from 10% to 20% of the A_1c results [coming in] are for screening purposes. … We need to be able to wean these out.”

Another unanswered question is how much hemoglobin A_1c testing is left out of the registry.

As of last month, almost three-fourths of the clinical laboratories required to report all results of blood test hemoglobin A_1c—28 of 38 labs—are now doing so.

Dr. Berger said she anticipates that 100% of laboratories will be reporting test results shortly.

The registry does not, however, include results obtained in office laboratories. Dr. Zachary Bloomgarden of Mount Sinai School of Medicine, New York, said his practice is excluded from the program because he does blood draws and A_1c testing right in his office lab.

Dr. Bloomgarden said he doesn't “have any real sense” of how many other practices perform in-office A_1c testing, and Dr. Berger said she's actively seeking an answer to that question.

“I'm in the process of studying that, trying to get a sense of what we're missing,” Dr. Berger said.

Some practices, she said, utilize finger-stick A_1c testing to be able to present results immediately to patients, “but just anecdotally, I know that some robust endocrinology practices don't actually trust their figures from the A_1c machines and will also get a [blood] draw.”

Dr. Berger said that she hopes to release the first “surveillance report”—a description, in essence, of all the data in the registry—later this spring, after she and others involved in the program have finished analyzing the data with the help of the advisory group.

The seven practices participating in the pilot project are of varying types, ranging from a large practice linked with an academic medical center to a small community health center and a small private practice.

Patients are stratified by success of glycemic control, with hemoglobin A_1c levels less than 7% representing “good control” (the target recommended by the ADA), levels between 7% and 9% reflecting “poorly controlled” diabetes, and levels over 9% representing “very poorly controlled” diabetes.

“It's still very arbitrary,” Dr. Berger said. “We're [providing] a population-based snapshot of the provider's panel. … A provider [can look at the report] and say, 'here are my 15 patients who are doing particularly poorly. Maybe they need to be on insulin, or maybe they need to see a nutritionist.'”

It is too early to know, she and others say, exactly what the practices will do with the reports and what impact the information will have on disease outcomes.

Dr. Donald A. Smith of Mount Sinai School of Medicine said he's hopeful that the program will spur physicians to “get the patients who are lost and out of control back in” for help.

“It will be interesting to see how the sophistication of the report [evolves],” he said. “Publishing the average A_1c by physician would be interesting. … It's incredible how, with stenting and angioplasty, [such physician profiling] has stimulated competitive efforts to improve.”

Dr. Berger said she has received calls from health officials in other municipalities who are seeking advice on starting similar registries.

“My advice is, wait to see what our experience is first. … It has great potential, but we need to implement it and evaluate it first.”

ELSEVIER GLOBAL MEDICAL NEWS

Survey: 13% of Adult New Yorkers Are Diabetic

Those who are awaiting an official description of data being collected in New York City's hemoglobin A_1c registry have some other striking data to digest while they wait: A new citywide survey modeled after a well-known national survey finds that nearly 13% of the city's adults have diabetes and that about one-third of them—almost 4% of city residents—do not know it.

The first New York City Health and Nutrition Examination Survey (HANES)—and the first community-level HANES survey in the country, health department officials say—used a one-time screening test to estimate diabetes prevalence among approximately 2,000 randomly selected New Yorkers from 144 neighborhoods across all boroughs.

The survey findings confirm past estimates from telephone surveys that about 9% of adults in the city have been diagnosed with diabetes, slightly higher than the 7.3% of adults who have diagnosed diabetes nationwide.

But the laboratory results obtained as part of the HANES survey go further, revealing that an additional 3.8% of adults in New York City have undiagnosed diabetes (compared with 3% of adults nationally).

The survey also shows that another 23.5% of adults have prediabetes and that nearly half of all Asian New Yorkers have either diabetes or prediabetes, according to press officials at the New York City Department of Health and Mental Hygiene.

The prevalence of diabetes among Asians, the survey shows, is 16% (nearly 1 in 6). Significantly more Asians—32%–-have prediabetes compared with other ethnic groups. (See chart.)

The higher overall prevalence numbers are “not surprising, [since] we have an extremely ethnically diverse population,” said Dr. Berger.

The high prevalence among Asians specifically, she said, is “somewhat” surprising, though some Asian groups, particularly Southeast Asians, are known to be susceptible to the development of diabetes. “Unfortunately our sample size wasn't large enough to tease out the various Asian groups,” she said.

Among men and women of all ethnicities who have diabetes, the findings show, 52% have well-controlled diabetes (A_1c less than 7), 32% have moderately poorly controlled blood sugar, and about 16% have very poorly controlled blood sugar (A_1c greater than 9%).

Poor diabetes control appears to be common even among people with access to health care. Of New Yorkers with diagnosed diabetes that is uncontrolled, 94% have some sort of health insurance, including Medicaid.

One year into a landmark diabetes monitoring program, hemoglobin A_1c test results are streaming from New York City laboratories into the city's health department and, in a sampling of cases, on to medical directors for distribution to clinicians.

City health officials, in the meantime, are working with a national advisory group of diabetes experts to analyze the data in the city's novel A_1c registry—900,000 A_1c test results covering 600,000 individuals, as of last month—and to design subsequent interventions.

The registry, which was launched in January 2006, is being watched by health officials across the country who want to reduce diabetes complications and control what they increasingly view as one of their largest public health crises.

The New York City program mandates that laboratories already reporting communicable diseases must also report results of hemoglobin A_1c tests directly to the city's Department of Health and Mental Hygiene.

As the program develops, the health department plans to routinely provide information to clinicians on their patients with diabetes and offer services and interventions to patients with poor glycemic control.

“The essence [is] to have it be more than just a surveillance system,” said Dr. Diana Berger, who is the medical director of the city's Diabetes Prevention and Control Program.

“We already have a robust system to establish the prevalence of diabetes,” she said. “We wanted a two-pronged initiative: Surveillance plus some sort of intervention.”

For now, in a pilot phase of the program, the city has begun sending quarterly reports to medical directors of seven practices in Manhattan and the South Bronx.

The medical directors are then responsible for distributing the practice reports—which list patients stratified by A_1c levels—to the 274 clinicians in the practices, Dr. Berger said.

The city plans to expand the pilot project to cover all of the South Bronx (approximately 100 practices) this summer, followed by other high-risk neighborhoods later in the year—a roll-out that officials hope will be helpful for fine-tuning reports and eventually designing interventions.

Interpreting the growing body of registry data, in the meantime, has been a significant undertaking.

Test results come in with the patient's full name, date of birth, and address, as well as the date the test was taken and the name and location of the ordering facility and clinician.

This information may be enough for providing profiles to providers, but it's probably not enough to fully understand the epidemic and design optimal interventions, Dr. Berger said.

“The problem is, there's no diagnostic code attached to [the results],” she said. “We don't know whether a patient has diabetes or not [or what type of diabetes it is]. … The database needs a lot of cleaning [and interpretation]—it's a complex process.”

Also complicating the analysis is the fact that the registry, by including all hemoglobin A_1c test results, captures tests used for diabetes screening as well as for monitoring, Dr. Berger said.

“There's a current practice of using A_1c to screen for diabetes,” even though it's not recommended by the American Diabetes Association, she said. “We're estimating that anywhere from 10% to 20% of the A_1c results [coming in] are for screening purposes. … We need to be able to wean these out.”

Another unanswered question is how much hemoglobin A_1c testing is left out of the registry.

As of last month, almost three-fourths of the clinical laboratories required to report all results of blood test hemoglobin A_1c—28 of 38 labs—are now doing so.

Dr. Berger said she anticipates that 100% of laboratories will be reporting test results shortly.

The registry does not, however, include results obtained in office laboratories. Dr. Zachary Bloomgarden of Mount Sinai School of Medicine, New York, said his practice is excluded from the program because he does blood draws and A_1c testing right in his office lab.

Dr. Bloomgarden said he doesn't “have any real sense” of how many other practices perform in-office A_1c testing, and Dr. Berger said she's actively seeking an answer to that question.

“I'm in the process of studying that, trying to get a sense of what we're missing,” Dr. Berger said.

Some practices, she said, utilize finger-stick A_1c testing to be able to present results immediately to patients, “but just anecdotally, I know that some robust endocrinology practices don't actually trust their figures from the A_1c machines and will also get a [blood] draw.”

Dr. Berger said that she hopes to release the first “surveillance report”—a description, in essence, of all the data in the registry—later this spring, after she and others involved in the program have finished analyzing the data with the help of the advisory group.

The seven practices participating in the pilot project are of varying types, ranging from a large practice linked with an academic medical center to a small community health center and a small private practice.

Patients are stratified by success of glycemic control, with hemoglobin A_1c levels less than 7% representing “good control” (the target recommended by the ADA), levels between 7% and 9% reflecting “poorly controlled” diabetes, and levels over 9% representing “very poorly controlled” diabetes.

“It's still very arbitrary,” Dr. Berger said. “We're [providing] a population-based snapshot of the provider's panel. … A provider [can look at the report] and say, 'here are my 15 patients who are doing particularly poorly. Maybe they need to be on insulin, or maybe they need to see a nutritionist.'”

It is too early to know, she and others say, exactly what the practices will do with the reports and what impact the information will have on disease outcomes.

Dr. Donald A. Smith of Mount Sinai School of Medicine said he's hopeful that the program will spur physicians to “get the patients who are lost and out of control back in” for help.

“It will be interesting to see how the sophistication of the report [evolves],” he said. “Publishing the average A_1c by physician would be interesting. … It's incredible how, with stenting and angioplasty, [such physician profiling] has stimulated competitive efforts to improve.”

Dr. Berger said she has received calls from health officials in other municipalities who are seeking advice on starting similar registries.

“My advice is, wait to see what our experience is first. … It has great potential, but we need to implement it and evaluate it first.”

ELSEVIER GLOBAL MEDICAL NEWS

Survey: 13% of Adult New Yorkers Are Diabetic

Those who are awaiting an official description of data being collected in New York City's hemoglobin A_1c registry have some other striking data to digest while they wait: A new citywide survey modeled after a well-known national survey finds that nearly 13% of the city's adults have diabetes and that about one-third of them—almost 4% of city residents—do not know it.

The first New York City Health and Nutrition Examination Survey (HANES)—and the first community-level HANES survey in the country, health department officials say—used a one-time screening test to estimate diabetes prevalence among approximately 2,000 randomly selected New Yorkers from 144 neighborhoods across all boroughs.

The survey findings confirm past estimates from telephone surveys that about 9% of adults in the city have been diagnosed with diabetes, slightly higher than the 7.3% of adults who have diagnosed diabetes nationwide.

But the laboratory results obtained as part of the HANES survey go further, revealing that an additional 3.8% of adults in New York City have undiagnosed diabetes (compared with 3% of adults nationally).

The survey also shows that another 23.5% of adults have prediabetes and that nearly half of all Asian New Yorkers have either diabetes or prediabetes, according to press officials at the New York City Department of Health and Mental Hygiene.

The prevalence of diabetes among Asians, the survey shows, is 16% (nearly 1 in 6). Significantly more Asians—32%–-have prediabetes compared with other ethnic groups. (See chart.)

The higher overall prevalence numbers are “not surprising, [since] we have an extremely ethnically diverse population,” said Dr. Berger.

The high prevalence among Asians specifically, she said, is “somewhat” surprising, though some Asian groups, particularly Southeast Asians, are known to be susceptible to the development of diabetes. “Unfortunately our sample size wasn't large enough to tease out the various Asian groups,” she said.

Among men and women of all ethnicities who have diabetes, the findings show, 52% have well-controlled diabetes (A_1c less than 7), 32% have moderately poorly controlled blood sugar, and about 16% have very poorly controlled blood sugar (A_1c greater than 9%).

Poor diabetes control appears to be common even among people with access to health care. Of New Yorkers with diagnosed diabetes that is uncontrolled, 94% have some sort of health insurance, including Medicaid.

One year into a landmark diabetes monitoring program, hemoglobin A_1c test results are streaming from New York City laboratories into the city's health department and, in a sampling of cases, on to medical directors for distribution to clinicians.

City health officials, in the meantime, are working with a national advisory group of diabetes experts to analyze the data in the city's novel A_1c registry—900,000 A_1c test results covering 600,000 individuals, as of last month—and to design subsequent interventions.

The registry, which was launched in January 2006, is being watched by health officials across the country who want to reduce diabetes complications and control what they increasingly view as one of their largest public health crises.

The New York City program mandates that laboratories already reporting communicable diseases must also report results of hemoglobin A_1c tests directly to the city's Department of Health and Mental Hygiene.

As the program develops, the health department plans to routinely provide information to clinicians on their patients with diabetes and offer services and interventions to patients with poor glycemic control.

“The essence [is] to have it be more than just a surveillance system,” said Dr. Diana Berger, who is the medical director of the city's Diabetes Prevention and Control Program.

“We already have a robust system to establish the prevalence of diabetes,” she said. “We wanted a two-pronged initiative: Surveillance plus some sort of intervention.”

For now, in a pilot phase of the program, the city has begun sending quarterly reports to medical directors of seven practices in Manhattan and the South Bronx.

The medical directors are then responsible for distributing the practice reports—which list patients stratified by A_1c levels—to the 274 clinicians in the practices, Dr. Berger said.

The city plans to expand the pilot project to cover all of the South Bronx (approximately 100 practices) this summer, followed by other high-risk neighborhoods later in the year—a roll-out that officials hope will be helpful for fine-tuning reports and eventually designing interventions.

Interpreting the growing body of registry data, in the meantime, has been a significant undertaking.

Test results come in with the patient's full name, date of birth, and address, as well as the date the test was taken and the name and location of the ordering facility and clinician.

This information may be enough for providing profiles to providers, but it's probably not enough to fully understand the epidemic and design optimal interventions, Dr. Berger said.

“The problem is, there's no diagnostic code attached to [the results],” she said. “We don't know whether a patient has diabetes or not [or what type of diabetes it is]. … The database needs a lot of cleaning [and interpretation]—it's a complex process.”

Also complicating the analysis is the fact that the registry, by including all hemoglobin A_1c test results, captures tests used for diabetes screening as well as for monitoring, Dr. Berger said.

“There's a current practice of using A_1c to screen for diabetes,” even though it's not recommended by the American Diabetes Association, she said. “We're estimating that anywhere from 10% to 20% of the A_1c results [coming in] are for screening purposes. … We need to be able to wean these out.”

Another unanswered question is how much hemoglobin A_1c testing is left out of the registry.

As of last month, almost three-fourths of the clinical laboratories required to report all results of blood test hemoglobin A_1c—28 of 38 labs—are now doing so.

Dr. Berger said she anticipates that 100% of laboratories will be reporting test results shortly.

The registry does not, however, include results obtained in office laboratories. Dr. Zachary Bloomgarden of Mount Sinai School of Medicine, New York, said his practice is excluded from the program because he does blood draws and A_1c testing right in his office lab.

Dr. Bloomgarden said he doesn't “have any real sense” of how many other practices perform in-office A_1c testing, and Dr. Berger said she's actively seeking an answer to that question.

“I'm in the process of studying that, trying to get a sense of what we're missing,” Dr. Berger said.

Some practices, she said, utilize finger-stick A_1c testing to be able to present results immediately to patients, “but just anecdotally, I know that some robust endocrinology practices don't actually trust their figures from the A_1c machines and will also get a [blood] draw.”

Dr. Berger said that she hopes to release the first “surveillance report”—a description, in essence, of all the data in the registry—later this spring, after she and others involved in the program have finished analyzing the data with the help of the advisory group.

The seven practices participating in the pilot project are of varying types, ranging from a large practice linked with an academic medical center to a small community health center and a small private practice.

Patients are stratified by success of glycemic control, with hemoglobin A_1c levels less than 7% representing “good control” (the target recommended by the ADA), levels between 7% and 9% reflecting “poorly controlled” diabetes, and levels over 9% representing “very poorly controlled” diabetes.

“It's still very arbitrary,” Dr. Berger said. “We're [providing] a population-based snapshot of the provider's panel. … A provider [can look at the report] and say, 'here are my 15 patients who are doing particularly poorly. Maybe they need to be on insulin, or maybe they need to see a nutritionist.'”

It is too early to know, she and others say, exactly what the practices will do with the reports and what impact the information will have on disease outcomes.

Dr. Donald A. Smith of Mount Sinai School of Medicine said he's hopeful that the program will spur physicians to “get the patients who are lost and out of control back in” for help.

“It will be interesting to see how the sophistication of the report [evolves],” he said. “Publishing the average A_1c by physician would be interesting. … It's incredible how, with stenting and angioplasty, [such physician profiling] has stimulated competitive efforts to improve.”

Dr. Berger said she has received calls from health officials in other municipalities who are seeking advice on starting similar registries.

“My advice is, wait to see what our experience is first. … It has great potential, but we need to implement it and evaluate it first.”

ELSEVIER GLOBAL MEDICAL NEWS

Survey: 13% of Adult New Yorkers Are Diabetic

Those who are awaiting an official description of data being collected in New York City's hemoglobin A_1c registry have some other striking data to digest while they wait: A new citywide survey modeled after a well-known national survey finds that nearly 13% of the city's adults have diabetes and that about one-third of them—almost 4% of city residents—do not know it.

The first New York City Health and Nutrition Examination Survey (HANES)—and the first community-level HANES survey in the country, health department officials say—used a one-time screening test to estimate diabetes prevalence among approximately 2,000 randomly selected New Yorkers from 144 neighborhoods across all boroughs.

The survey findings confirm past estimates from telephone surveys that about 9% of adults in the city have been diagnosed with diabetes, slightly higher than the 7.3% of adults who have diagnosed diabetes nationwide.

But the laboratory results obtained as part of the HANES survey go further, revealing that an additional 3.8% of adults in New York City have undiagnosed diabetes (compared with 3% of adults nationally).

The survey also shows that another 23.5% of adults have prediabetes and that nearly half of all Asian New Yorkers have either diabetes or prediabetes, according to press officials at the New York City Department of Health and Mental Hygiene.

The prevalence of diabetes among Asians, the survey shows, is 16% (nearly 1 in 6). Significantly more Asians—32%–-have prediabetes compared with other ethnic groups. (See chart.)

The higher overall prevalence numbers are “not surprising, [since] we have an extremely ethnically diverse population,” said Dr. Berger.

The high prevalence among Asians specifically, she said, is “somewhat” surprising, though some Asian groups, particularly Southeast Asians, are known to be susceptible to the development of diabetes. “Unfortunately our sample size wasn't large enough to tease out the various Asian groups,” she said.

Among men and women of all ethnicities who have diabetes, the findings show, 52% have well-controlled diabetes (A_1c less than 7), 32% have moderately poorly controlled blood sugar, and about 16% have very poorly controlled blood sugar (A_1c greater than 9%).

Poor diabetes control appears to be common even among people with access to health care. Of New Yorkers with diagnosed diabetes that is uncontrolled, 94% have some sort of health insurance, including Medicaid.

One year into a landmark diabetes monitoring program, hemoglobin A_1c test results are streaming from New York City laboratories into the city's health department and, in a sampling of cases, on to medical directors for distribution to clinicians.

City health officials, in the meantime, are working with a national advisory group of diabetes experts to analyze the data in the city's novel hemoglobin A_1c (Hb A_1c) registry—900,000 HbA_1c test results covering 600,000 individuals, as of last month—and to design subsequent interventions.

The registry, which was launched in January 2006, is being watched by health officials across the country who want to reduce diabetes complications and control what they increasingly view as one of their largest public health crises.

The New York City program mandates that laboratories already reporting communicable diseases must also report results of HbA_1c tests directly to the city's Department of Health and Mental Hygiene. As the program develops, the health department plans to routinely provide information to clinicians on their patients with diabetes and offer services and interventions to patients with poor glycemic control.

“The essence [is] to have it be more than just a surveillance system,” said Dr. Diana Berger, medical director of the city's Diabetes Prevention and Control Program.

“We already have a robust system to establish the prevalence of diabetes,” she said. “We wanted a two-pronged initiative: surveillance plus some sort of intervention.”

For now, in a pilot phase of the program, the city has begun sending quarterly reports to medical directors of seven practices in Manhattan and the South Bronx. The medical directors are then responsible for distributing the practice reports—which list patients stratified by HbA_1c levels—to the 274 clinicians in the practices, Dr. Berger said.

The city plans to expand the pilot project to cover all of the South Bronx (approximately 100 practices) this summer, followed by other high-risk neighborhoods later in the year—a roll-out that officials hope will be helpful for fine-tuning reports and eventually designing interventions.

Interpreting the growing body of registry data, in the meantime, has been a significant undertaking.

Test results come in with the patient's full name, date of birth, and address, as well as the date the test was taken and the name and location of the ordering facility and clinician. This information may be enough for providing profiles to providers, but it's probably not enough to fully understand the epidemic and design optimal interventions, Dr. Berger said.

“The problem is, there's no diagnostic code attached to [the results],” she said. “We don't know whether a patient has diabetes or not [or what type of diabetes it is]. … The database needs a lot of cleaning [and interpretation]—it's a complex process.”

Also complicating the analysis is the fact that the registry, by including all HbA_1c test results, captures tests used for diabetes screening as well as for monitoring, Dr. Berger said.

“There's a current practice of using A_1c [levels] to screen for diabetes,” even though it's not recommended by the American Diabetes Association, she said. “We're estimating that anywhere from 10%–20% of the A_1c results [coming in] are for screening purposes … We need to be able to wean these out.”

Another unanswered question is how much HbA_1c testing is left out of the registry.

As of last month, almost three-fourths of the clinical laboratories required to report all results of blood test HbA_1c—28 of 38 labs—are now doing so, and Dr. Berger said she anticipates that 100% will be reporting test results shortly.

The registry does not, however, include results obtained in office laboratories. Dr. Zachary Bloomgarden, clinical professor of medicine at the Mount Sinai School of Medicine, New York, said his practice is excluded from the program because he does blood draws and HbA_1c testing right in his office lab.

Dr. Bloomgarden said he doesn't “have any real sense” of how many other practices perform in-office HbA_1c testing, and Dr. Berger said she's actively seeking an answer to that question. “I'm in the process of studying that, trying to get a sense of what we're missing,” Dr. Berger said.

Some practices, she said, utilize finger-stick HbA_1c testing to be able to present results immediately to patients, “but just anecdotally, I know that some robust endocrinology practices don't actually trust their figures from the A_1c machines and will also get a [blood] draw.”

Dr. Berger said that she hopes to release the first “surveillance report”—a description, in essence, of all the data in the registry—later this spring, after she and others involved in the program have finished analyzing the data with the help of the advisory group.

The seven practices participating in the pilot project are of varying types, ranging from a large practice linked with an academic medical center to a small community health center and a small private practice.

Patients are stratified by success of glycemic control, with HbA_1c levels less than 7% representing “good control” (the target recommended by the ADA), levels between 7% and 9% reflecting “poorly controlled” diabetes, and levels over 9% representing “very poorly controlled” diabetes.

“It's still very arbitrary,” Dr. Berger said. “We're [providing] a population-based snapshot of the provider's panel. … A provider [can look at the report] and say, 'here are my 15 patients who are doing particularly poorly. Maybe they need to be on insulin, or maybe they need to see a nutritionist.'”

It is too early to know, she and others say, exactly what the practices will do with the reports and what impact the information will have on disease outcomes.

Dr. Donald A. Smith, associate professor of medicine at the Mount Sinai School of Medicine said he's hopeful that the program will spur physicians to “get the patients who are lost and out of control back in” for help.

“It will be interesting to see how the sophistication of the report [evolves],” Dr. Smith said. “Publishing the average A_1c by physician would be interesting … it's incredible how, with stenting and angioplasty, [such physician profiling] has stimulated competitive efforts to improve.”

Dr. Berger said she has received calls from health officials in other municipalities who are seeking advice on starting similar registries. “My advice is, wait to see what our experience is first. … It has great potential, but we need to implement it and evaluate it first.”

ELSEVIER GLOBAL MEDICAL NEWS

City Health Survey Shows Diabetes Rate High Among Asians

Those who are awaiting an official description of data being collected in New York City's hemoglobin A_1c registry have some other striking data to digest while they wait: A new citywide survey modeled after a well-known national survey finds that nearly 13% of the city's adults have diabetes and that about one-third of them—almost 4% of city residents—do not know it.

The first New York City Health and Nutrition Examination Survey (HANES)—and the first community-level HANES survey in the country, health department officials say—used a one-time screening test to estimate diabetes prevalence among approximately 2,000 randomly selected New Yorkers from 144 neighborhoods across all boroughs.

The survey findings confirm past estimates from telephone surveys that about 9% of adults in the city have been diagnosed with diabetes, slightly higher than the 7.3% of adults who have diagnosed diabetes nationwide. But the laboratory results obtained as part of the HANES survey go further, revealing that an additional 3.8% of adults in New York City have undiagnosed diabetes (compared with 3% nationally).

The survey also shows that another 23.5% of adults have prediabetes and that nearly half of all Asian New Yorkers have either diabetes or prediabetes, according to press officials at the New York City Department of Health and Mental Hygiene.

The prevalence of diabetes among Asians, the survey shows, is 16% (nearly 1 in 6). Significantly more Asians—32%–-have prediabetes compared with other ethnic groups. (See chart.)

The higher overall prevalence numbers are “not surprising, [since] we have an extremely ethnically diverse population,” said Dr. Berger.

The high prevalence among Asians specifically, she said, is “somewhat” surprising, though some Asian groups, particularly Southeast Asians, are known to be susceptible to the development of diabetes. “Unfortunately our sample size wasn't large enough to tease out the various Asian groups,” she said.

Among men and women of all ethnicities who have diabetes, the findings show, 52% have well-controlled diabetes (hemoglobin A_1c less than 7%), 32% have moderately poorly controlled blood sugar, and about 16% have very poorly controlled blood sugar (hemoglobin A_1c greater than 9%).

Poor diabetes control appears to be common even among people with access to health care. Of New Yorkers with diagnosed diabetes that is uncontrolled, 94% have some sort of health insurance, including Medicaid.

One year into a landmark diabetes monitoring program, hemoglobin A_1c test results are streaming from New York City laboratories into the city's health department and, in a sampling of cases, on to medical directors for distribution to clinicians.

City health officials, in the meantime, are working with a national advisory group of diabetes experts to analyze the data in the city's novel hemoglobin A_1c (Hb A_1c) registry—900,000 HbA_1c test results covering 600,000 individuals, as of last month—and to design subsequent interventions.

The registry, which was launched in January 2006, is being watched by health officials across the country who want to reduce diabetes complications and control what they increasingly view as one of their largest public health crises.

The New York City program mandates that laboratories already reporting communicable diseases must also report results of HbA_1c tests directly to the city's Department of Health and Mental Hygiene. As the program develops, the health department plans to routinely provide information to clinicians on their patients with diabetes and offer services and interventions to patients with poor glycemic control.

“The essence [is] to have it be more than just a surveillance system,” said Dr. Diana Berger, medical director of the city's Diabetes Prevention and Control Program.

“We already have a robust system to establish the prevalence of diabetes,” she said. “We wanted a two-pronged initiative: surveillance plus some sort of intervention.”

For now, in a pilot phase of the program, the city has begun sending quarterly reports to medical directors of seven practices in Manhattan and the South Bronx. The medical directors are then responsible for distributing the practice reports—which list patients stratified by HbA_1c levels—to the 274 clinicians in the practices, Dr. Berger said.

The city plans to expand the pilot project to cover all of the South Bronx (approximately 100 practices) this summer, followed by other high-risk neighborhoods later in the year—a roll-out that officials hope will be helpful for fine-tuning reports and eventually designing interventions.

Interpreting the growing body of registry data, in the meantime, has been a significant undertaking.

Test results come in with the patient's full name, date of birth, and address, as well as the date the test was taken and the name and location of the ordering facility and clinician. This information may be enough for providing profiles to providers, but it's probably not enough to fully understand the epidemic and design optimal interventions, Dr. Berger said.

“The problem is, there's no diagnostic code attached to [the results],” she said. “We don't know whether a patient has diabetes or not [or what type of diabetes it is]. … The database needs a lot of cleaning [and interpretation]—it's a complex process.”

Also complicating the analysis is the fact that the registry, by including all HbA_1c test results, captures tests used for diabetes screening as well as for monitoring, Dr. Berger said.

“There's a current practice of using A_1c [levels] to screen for diabetes,” even though it's not recommended by the American Diabetes Association, she said. “We're estimating that anywhere from 10%–20% of the A_1c results [coming in] are for screening purposes … We need to be able to wean these out.”

Another unanswered question is how much HbA_1c testing is left out of the registry.

As of last month, almost three-fourths of the clinical laboratories required to report all results of blood test HbA_1c—28 of 38 labs—are now doing so, and Dr. Berger said she anticipates that 100% will be reporting test results shortly.

The registry does not, however, include results obtained in office laboratories. Dr. Zachary Bloomgarden, clinical professor of medicine at the Mount Sinai School of Medicine, New York, said his practice is excluded from the program because he does blood draws and HbA_1c testing right in his office lab.

Dr. Bloomgarden said he doesn't “have any real sense” of how many other practices perform in-office HbA_1c testing, and Dr. Berger said she's actively seeking an answer to that question. “I'm in the process of studying that, trying to get a sense of what we're missing,” Dr. Berger said.

Some practices, she said, utilize finger-stick HbA_1c testing to be able to present results immediately to patients, “but just anecdotally, I know that some robust endocrinology practices don't actually trust their figures from the A_1c machines and will also get a [blood] draw.”

Dr. Berger said that she hopes to release the first “surveillance report”—a description, in essence, of all the data in the registry—later this spring, after she and others involved in the program have finished analyzing the data with the help of the advisory group.

The seven practices participating in the pilot project are of varying types, ranging from a large practice linked with an academic medical center to a small community health center and a small private practice.

Patients are stratified by success of glycemic control, with HbA_1c levels less than 7% representing “good control” (the target recommended by the ADA), levels between 7% and 9% reflecting “poorly controlled” diabetes, and levels over 9% representing “very poorly controlled” diabetes.

“It's still very arbitrary,” Dr. Berger said. “We're [providing] a population-based snapshot of the provider's panel. … A provider [can look at the report] and say, 'here are my 15 patients who are doing particularly poorly. Maybe they need to be on insulin, or maybe they need to see a nutritionist.'”

It is too early to know, she and others say, exactly what the practices will do with the reports and what impact the information will have on disease outcomes.

Dr. Donald A. Smith, associate professor of medicine at the Mount Sinai School of Medicine said he's hopeful that the program will spur physicians to “get the patients who are lost and out of control back in” for help.

“It will be interesting to see how the sophistication of the report [evolves],” Dr. Smith said. “Publishing the average A_1c by physician would be interesting … it's incredible how, with stenting and angioplasty, [such physician profiling] has stimulated competitive efforts to improve.”

Dr. Berger said she has received calls from health officials in other municipalities who are seeking advice on starting similar registries. “My advice is, wait to see what our experience is first. … It has great potential, but we need to implement it and evaluate it first.”

ELSEVIER GLOBAL MEDICAL NEWS

City Health Survey Shows Diabetes Rate High Among Asians

Those who are awaiting an official description of data being collected in New York City's hemoglobin A_1c registry have some other striking data to digest while they wait: A new citywide survey modeled after a well-known national survey finds that nearly 13% of the city's adults have diabetes and that about one-third of them—almost 4% of city residents—do not know it.

The first New York City Health and Nutrition Examination Survey (HANES)—and the first community-level HANES survey in the country, health department officials say—used a one-time screening test to estimate diabetes prevalence among approximately 2,000 randomly selected New Yorkers from 144 neighborhoods across all boroughs.

The survey findings confirm past estimates from telephone surveys that about 9% of adults in the city have been diagnosed with diabetes, slightly higher than the 7.3% of adults who have diagnosed diabetes nationwide. But the laboratory results obtained as part of the HANES survey go further, revealing that an additional 3.8% of adults in New York City have undiagnosed diabetes (compared with 3% nationally).

The survey also shows that another 23.5% of adults have prediabetes and that nearly half of all Asian New Yorkers have either diabetes or prediabetes, according to press officials at the New York City Department of Health and Mental Hygiene.

The prevalence of diabetes among Asians, the survey shows, is 16% (nearly 1 in 6). Significantly more Asians—32%–-have prediabetes compared with other ethnic groups. (See chart.)

The higher overall prevalence numbers are “not surprising, [since] we have an extremely ethnically diverse population,” said Dr. Berger.

The high prevalence among Asians specifically, she said, is “somewhat” surprising, though some Asian groups, particularly Southeast Asians, are known to be susceptible to the development of diabetes. “Unfortunately our sample size wasn't large enough to tease out the various Asian groups,” she said.

Among men and women of all ethnicities who have diabetes, the findings show, 52% have well-controlled diabetes (hemoglobin A_1c less than 7%), 32% have moderately poorly controlled blood sugar, and about 16% have very poorly controlled blood sugar (hemoglobin A_1c greater than 9%).

Poor diabetes control appears to be common even among people with access to health care. Of New Yorkers with diagnosed diabetes that is uncontrolled, 94% have some sort of health insurance, including Medicaid.

One year into a landmark diabetes monitoring program, hemoglobin A_1c test results are streaming from New York City laboratories into the city's health department and, in a sampling of cases, on to medical directors for distribution to clinicians.

City health officials, in the meantime, are working with a national advisory group of diabetes experts to analyze the data in the city's novel hemoglobin A_1c (Hb A_1c) registry—900,000 HbA_1c test results covering 600,000 individuals, as of last month—and to design subsequent interventions.

The registry, which was launched in January 2006, is being watched by health officials across the country who want to reduce diabetes complications and control what they increasingly view as one of their largest public health crises.

The New York City program mandates that laboratories already reporting communicable diseases must also report results of HbA_1c tests directly to the city's Department of Health and Mental Hygiene. As the program develops, the health department plans to routinely provide information to clinicians on their patients with diabetes and offer services and interventions to patients with poor glycemic control.

“The essence [is] to have it be more than just a surveillance system,” said Dr. Diana Berger, medical director of the city's Diabetes Prevention and Control Program.

“We already have a robust system to establish the prevalence of diabetes,” she said. “We wanted a two-pronged initiative: surveillance plus some sort of intervention.”

For now, in a pilot phase of the program, the city has begun sending quarterly reports to medical directors of seven practices in Manhattan and the South Bronx. The medical directors are then responsible for distributing the practice reports—which list patients stratified by HbA_1c levels—to the 274 clinicians in the practices, Dr. Berger said.

The city plans to expand the pilot project to cover all of the South Bronx (approximately 100 practices) this summer, followed by other high-risk neighborhoods later in the year—a roll-out that officials hope will be helpful for fine-tuning reports and eventually designing interventions.

Interpreting the growing body of registry data, in the meantime, has been a significant undertaking.

Test results come in with the patient's full name, date of birth, and address, as well as the date the test was taken and the name and location of the ordering facility and clinician. This information may be enough for providing profiles to providers, but it's probably not enough to fully understand the epidemic and design optimal interventions, Dr. Berger said.

“The problem is, there's no diagnostic code attached to [the results],” she said. “We don't know whether a patient has diabetes or not [or what type of diabetes it is]. … The database needs a lot of cleaning [and interpretation]—it's a complex process.”

Also complicating the analysis is the fact that the registry, by including all HbA_1c test results, captures tests used for diabetes screening as well as for monitoring, Dr. Berger said.

“There's a current practice of using A_1c [levels] to screen for diabetes,” even though it's not recommended by the American Diabetes Association, she said. “We're estimating that anywhere from 10%–20% of the A_1c results [coming in] are for screening purposes … We need to be able to wean these out.”

Another unanswered question is how much HbA_1c testing is left out of the registry.

As of last month, almost three-fourths of the clinical laboratories required to report all results of blood test HbA_1c—28 of 38 labs—are now doing so, and Dr. Berger said she anticipates that 100% will be reporting test results shortly.

The registry does not, however, include results obtained in office laboratories. Dr. Zachary Bloomgarden, clinical professor of medicine at the Mount Sinai School of Medicine, New York, said his practice is excluded from the program because he does blood draws and HbA_1c testing right in his office lab.

Dr. Bloomgarden said he doesn't “have any real sense” of how many other practices perform in-office HbA_1c testing, and Dr. Berger said she's actively seeking an answer to that question. “I'm in the process of studying that, trying to get a sense of what we're missing,” Dr. Berger said.

Some practices, she said, utilize finger-stick HbA_1c testing to be able to present results immediately to patients, “but just anecdotally, I know that some robust endocrinology practices don't actually trust their figures from the A_1c machines and will also get a [blood] draw.”

Dr. Berger said that she hopes to release the first “surveillance report”—a description, in essence, of all the data in the registry—later this spring, after she and others involved in the program have finished analyzing the data with the help of the advisory group.

The seven practices participating in the pilot project are of varying types, ranging from a large practice linked with an academic medical center to a small community health center and a small private practice.

Patients are stratified by success of glycemic control, with HbA_1c levels less than 7% representing “good control” (the target recommended by the ADA), levels between 7% and 9% reflecting “poorly controlled” diabetes, and levels over 9% representing “very poorly controlled” diabetes.

“It's still very arbitrary,” Dr. Berger said. “We're [providing] a population-based snapshot of the provider's panel. … A provider [can look at the report] and say, 'here are my 15 patients who are doing particularly poorly. Maybe they need to be on insulin, or maybe they need to see a nutritionist.'”

It is too early to know, she and others say, exactly what the practices will do with the reports and what impact the information will have on disease outcomes.

Dr. Donald A. Smith, associate professor of medicine at the Mount Sinai School of Medicine said he's hopeful that the program will spur physicians to “get the patients who are lost and out of control back in” for help.

“It will be interesting to see how the sophistication of the report [evolves],” Dr. Smith said. “Publishing the average A_1c by physician would be interesting … it's incredible how, with stenting and angioplasty, [such physician profiling] has stimulated competitive efforts to improve.”

Dr. Berger said she has received calls from health officials in other municipalities who are seeking advice on starting similar registries. “My advice is, wait to see what our experience is first. … It has great potential, but we need to implement it and evaluate it first.”

ELSEVIER GLOBAL MEDICAL NEWS

City Health Survey Shows Diabetes Rate High Among Asians

Those who are awaiting an official description of data being collected in New York City's hemoglobin A_1c registry have some other striking data to digest while they wait: A new citywide survey modeled after a well-known national survey finds that nearly 13% of the city's adults have diabetes and that about one-third of them—almost 4% of city residents—do not know it.

The first New York City Health and Nutrition Examination Survey (HANES)—and the first community-level HANES survey in the country, health department officials say—used a one-time screening test to estimate diabetes prevalence among approximately 2,000 randomly selected New Yorkers from 144 neighborhoods across all boroughs.

The survey findings confirm past estimates from telephone surveys that about 9% of adults in the city have been diagnosed with diabetes, slightly higher than the 7.3% of adults who have diagnosed diabetes nationwide. But the laboratory results obtained as part of the HANES survey go further, revealing that an additional 3.8% of adults in New York City have undiagnosed diabetes (compared with 3% nationally).

The survey also shows that another 23.5% of adults have prediabetes and that nearly half of all Asian New Yorkers have either diabetes or prediabetes, according to press officials at the New York City Department of Health and Mental Hygiene.

The prevalence of diabetes among Asians, the survey shows, is 16% (nearly 1 in 6). Significantly more Asians—32%–-have prediabetes compared with other ethnic groups. (See chart.)

The higher overall prevalence numbers are “not surprising, [since] we have an extremely ethnically diverse population,” said Dr. Berger.

The high prevalence among Asians specifically, she said, is “somewhat” surprising, though some Asian groups, particularly Southeast Asians, are known to be susceptible to the development of diabetes. “Unfortunately our sample size wasn't large enough to tease out the various Asian groups,” she said.

Among men and women of all ethnicities who have diabetes, the findings show, 52% have well-controlled diabetes (hemoglobin A_1c less than 7%), 32% have moderately poorly controlled blood sugar, and about 16% have very poorly controlled blood sugar (hemoglobin A_1c greater than 9%).

Poor diabetes control appears to be common even among people with access to health care. Of New Yorkers with diagnosed diabetes that is uncontrolled, 94% have some sort of health insurance, including Medicaid.

An “overwhelming” amount of data now suggest that patients with fibromyalgia and a number of overlapping pain syndromes have augmented pain or sensory processing in the central nervous system, resulting in real differences in pain tolerance, judging from the findings of a recent review.

Genetic findings also are accumulating that suggest specific gene mutations may predispose individuals to developing fibromyalgia (FM), according to the authors.

“It is time for us to move past the rhetoric about whether these conditions are real, and take these patients seriously as we endeavor to learn more about the causes and most effective treatments for these disorders,” reported Dr. Daniel J. Clauw, professor of rheumatology at the University of Michigan, Ann Arbor, and director of the U-M Chronic Pain and Fatigue Research Center, and Richard E. Harris, Ph.D., a researcher at the center and the university.

The hyperactivity of pain processing mechanisms that characterizes FM and related conditions–from irritable bowel syndrome to tension headache and temporomandibular syndrome–can occur in association with psychological factors, “but psychological factors are not in any way required for an individual to develop or maintain this augmented central pain state,” they wrote.

Other investigators said in an interview that they hope to see more reviews like it, particularly since many studies of FM are low budget, small and too easily dismissed unless they are viewed together.

Neuroimaging studies, for instance, “are providing a consistent picture” when viewed together of strong neurobiologic underpinnings for FM, said Dr. Nancy Klimas, professor of medicine at the University of Miami. “But if you pull them apart, you can find faults with any one study in it having limited power, or some other limitation.”

“This is what [the authors] are saying–'look at the whole picture, it's impressive,'” said Dr. Klimas. “There's some real science to go behind the pain observation.”

Dr. Klimas said the review reminded her of a grand-rounds lecture she heard several years ago, in which a “prominent” department chair told students and faculty that fibromyalgia “is all in patients' heads.”

“He essentially said, don't let these patients talk to each other, don't let them read anything, don't let them have any support group meetings,” Dr. Klimas said. “I was livid. These patients [with FM] are often treated badly by their physicians. It's bad enough leaving without any hope that something can be done, but it's worse leaving a doctor's office having been made to feel small or patronized.”

Dr. Laurence Bradley, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama, agreed that the literature is ripe for strong conclusions. “The [review authors] are correct. A lot of new findings have emerged in the last 5–8 years … regarding gene variance that's associated with FM itself or with [related] disorders.

“And a lot of the neuroimaging work that has been done has demonstrated very convincingly that people with FM have enhanced or abnormal transmission of sensory signals through the CNS,” he said. “Behavioral studies–laboratory pain studies–also show consistent displays of abnormal pain responses in individuals with FM.”

In their review, Dr. Clauw and Dr. Harris described functional imaging studies done with single-photon emission computer tomography (SPECT) and functional magnetic resonance imaging (fMRI) that show differences in neural activation between patients with FM and pain-free controls. The studies indicate that FM patients have abnormalities within their central brain structures, they said.

There is evidence in FM that an “increased gain” in pain processing is driven by defects in both descending inhibitory pathways for pain processing and in spinal excitatory activity, the authors added.

Biochemical studies have supported the notion that the pathology might be a result of high levels of pronociceptive compounds (such as “substance P”), low levels of antinociceptive compounds, or both. Conversely “there is considerable evidence that this increased gain could occur because of a deficiency in one of the major endogenous analgesic pathways, the descending antinociceptive serotonergic-noradrenergic pathway” (Curr. Pain Headache Rep. 2006:10;403–7).

The “ultimate proof” that defective central control mechanisms are playing a role in FM and overlapping pain conditions comes from randomized clinical trials showing that neuroactive compounds that either increase inhibitory activity (such as serotonin-norepinephrine reuptake inhibitors) or decrease facilitatory activity (such as antiepileptics) can be efficacious in treating FM as well as neuropathic pain, said Dr. Clauw and Dr. Harris.

Dr. Bradley said that one of the “missing pieces of information” in the growing knowledge of pain transmission in FM is its original source.

“Where's the starting point?” he asked. “[Many experts] think it originates from abnormalities in the deep muscle tissue, but at this point we have a much better understanding of what goes on at the spinal level than we do of what factors contribute to the initiation of sensory signals.”

What's missing from the review itself, he and others noted, is the “consistent” evidence of altered neuroendocrine function in patients with FM.

Dr. Robert Bennett, who has led studies in this area, said that FM also appears to be a manifestation of an abnormal acute stress response involving abnormalities in levels of cortisol and growth hormone, an imbalance in sympathetic and vagal tone, and other phenomena–a notion that puts FM at least partly in the same camp, for underlying mechanisms, as chronic fatigue syndrome.

“The major things we know now [about FM] relate to the pain system,” said Dr. Bennett, professor of medicine at Oregon Health and Science University, Portland. “The neuroendocrine abnormalities–the manifestations of the acute stress response–have still, I think, been underinvestigated.”

Dr. Klimas, director of the University of Miami's chronic fatigue syndrome research center, said that more than 60% of her patients with the syndrome meet the case definition of FM as well, which reflects at least in part the fact that the FM definition is looser and more inclusive while the chronic fatigue syndrome definition has many exclusionary criteria.

Dr. Bradley added that a number of recent studies have also shown a familial aggregation of pain sensitivity. The studies show that first-degree relatives of patients with FM tend to have the “same sorts of unusual sensitivities to pain and abnormal pain responses,” even though this isn't always manifested as FM.

An “overwhelming” amount of data now suggest that patients with fibromyalgia and a number of overlapping pain syndromes have augmented pain or sensory processing in the central nervous system, resulting in real differences in pain tolerance, judging from the findings of a recent review.

Genetic findings also are accumulating that suggest specific gene mutations may predispose individuals to developing fibromyalgia (FM), according to the authors.

“It is time for us to move past the rhetoric about whether these conditions are real, and take these patients seriously as we endeavor to learn more about the causes and most effective treatments for these disorders,” reported Dr. Daniel J. Clauw, professor of rheumatology at the University of Michigan, Ann Arbor, and director of the U-M Chronic Pain and Fatigue Research Center, and Richard E. Harris, Ph.D., a researcher at the center and the university.

The hyperactivity of pain processing mechanisms that characterizes FM and related conditions–from irritable bowel syndrome to tension headache and temporomandibular syndrome–can occur in association with psychological factors, “but psychological factors are not in any way required for an individual to develop or maintain this augmented central pain state,” they wrote.

Other investigators said in an interview that they hope to see more reviews like it, particularly since many studies of FM are low budget, small and too easily dismissed unless they are viewed together.

Neuroimaging studies, for instance, “are providing a consistent picture” when viewed together of strong neurobiologic underpinnings for FM, said Dr. Nancy Klimas, professor of medicine at the University of Miami. “But if you pull them apart, you can find faults with any one study in it having limited power, or some other limitation.”

“This is what [the authors] are saying–'look at the whole picture, it's impressive,'” said Dr. Klimas. “There's some real science to go behind the pain observation.”

Dr. Klimas said the review reminded her of a grand-rounds lecture she heard several years ago, in which a “prominent” department chair told students and faculty that fibromyalgia “is all in patients' heads.”

“He essentially said, don't let these patients talk to each other, don't let them read anything, don't let them have any support group meetings,” Dr. Klimas said. “I was livid. These patients [with FM] are often treated badly by their physicians. It's bad enough leaving without any hope that something can be done, but it's worse leaving a doctor's office having been made to feel small or patronized.”

Dr. Laurence Bradley, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama, agreed that the literature is ripe for strong conclusions. “The [review authors] are correct. A lot of new findings have emerged in the last 5–8 years … regarding gene variance that's associated with FM itself or with [related] disorders.

“And a lot of the neuroimaging work that has been done has demonstrated very convincingly that people with FM have enhanced or abnormal transmission of sensory signals through the CNS,” he said. “Behavioral studies–laboratory pain studies–also show consistent displays of abnormal pain responses in individuals with FM.”

In their review, Dr. Clauw and Dr. Harris described functional imaging studies done with single-photon emission computer tomography (SPECT) and functional magnetic resonance imaging (fMRI) that show differences in neural activation between patients with FM and pain-free controls. The studies indicate that FM patients have abnormalities within their central brain structures, they said.

There is evidence in FM that an “increased gain” in pain processing is driven by defects in both descending inhibitory pathways for pain processing and in spinal excitatory activity, the authors added.

Biochemical studies have supported the notion that the pathology might be a result of high levels of pronociceptive compounds (such as “substance P”), low levels of antinociceptive compounds, or both. Conversely “there is considerable evidence that this increased gain could occur because of a deficiency in one of the major endogenous analgesic pathways, the descending antinociceptive serotonergic-noradrenergic pathway” (Curr. Pain Headache Rep. 2006:10;403–7).

The “ultimate proof” that defective central control mechanisms are playing a role in FM and overlapping pain conditions comes from randomized clinical trials showing that neuroactive compounds that either increase inhibitory activity (such as serotonin-norepinephrine reuptake inhibitors) or decrease facilitatory activity (such as antiepileptics) can be efficacious in treating FM as well as neuropathic pain, said Dr. Clauw and Dr. Harris.

Dr. Bradley said that one of the “missing pieces of information” in the growing knowledge of pain transmission in FM is its original source.

“Where's the starting point?” he asked. “[Many experts] think it originates from abnormalities in the deep muscle tissue, but at this point we have a much better understanding of what goes on at the spinal level than we do of what factors contribute to the initiation of sensory signals.”

What's missing from the review itself, he and others noted, is the “consistent” evidence of altered neuroendocrine function in patients with FM.

Dr. Robert Bennett, who has led studies in this area, said that FM also appears to be a manifestation of an abnormal acute stress response involving abnormalities in levels of cortisol and growth hormone, an imbalance in sympathetic and vagal tone, and other phenomena–a notion that puts FM at least partly in the same camp, for underlying mechanisms, as chronic fatigue syndrome.

“The major things we know now [about FM] relate to the pain system,” said Dr. Bennett, professor of medicine at Oregon Health and Science University, Portland. “The neuroendocrine abnormalities–the manifestations of the acute stress response–have still, I think, been underinvestigated.”

Dr. Klimas, director of the University of Miami's chronic fatigue syndrome research center, said that more than 60% of her patients with the syndrome meet the case definition of FM as well, which reflects at least in part the fact that the FM definition is looser and more inclusive while the chronic fatigue syndrome definition has many exclusionary criteria.

Dr. Bradley added that a number of recent studies have also shown a familial aggregation of pain sensitivity. The studies show that first-degree relatives of patients with FM tend to have the “same sorts of unusual sensitivities to pain and abnormal pain responses,” even though this isn't always manifested as FM.

An “overwhelming” amount of data now suggest that patients with fibromyalgia and a number of overlapping pain syndromes have augmented pain or sensory processing in the central nervous system, resulting in real differences in pain tolerance, judging from the findings of a recent review.

Genetic findings also are accumulating that suggest specific gene mutations may predispose individuals to developing fibromyalgia (FM), according to the authors.

“It is time for us to move past the rhetoric about whether these conditions are real, and take these patients seriously as we endeavor to learn more about the causes and most effective treatments for these disorders,” reported Dr. Daniel J. Clauw, professor of rheumatology at the University of Michigan, Ann Arbor, and director of the U-M Chronic Pain and Fatigue Research Center, and Richard E. Harris, Ph.D., a researcher at the center and the university.

The hyperactivity of pain processing mechanisms that characterizes FM and related conditions–from irritable bowel syndrome to tension headache and temporomandibular syndrome–can occur in association with psychological factors, “but psychological factors are not in any way required for an individual to develop or maintain this augmented central pain state,” they wrote.

Other investigators said in an interview that they hope to see more reviews like it, particularly since many studies of FM are low budget, small and too easily dismissed unless they are viewed together.

Neuroimaging studies, for instance, “are providing a consistent picture” when viewed together of strong neurobiologic underpinnings for FM, said Dr. Nancy Klimas, professor of medicine at the University of Miami. “But if you pull them apart, you can find faults with any one study in it having limited power, or some other limitation.”

“This is what [the authors] are saying–'look at the whole picture, it's impressive,'” said Dr. Klimas. “There's some real science to go behind the pain observation.”

Dr. Klimas said the review reminded her of a grand-rounds lecture she heard several years ago, in which a “prominent” department chair told students and faculty that fibromyalgia “is all in patients' heads.”

“He essentially said, don't let these patients talk to each other, don't let them read anything, don't let them have any support group meetings,” Dr. Klimas said. “I was livid. These patients [with FM] are often treated badly by their physicians. It's bad enough leaving without any hope that something can be done, but it's worse leaving a doctor's office having been made to feel small or patronized.”

Dr. Laurence Bradley, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama, agreed that the literature is ripe for strong conclusions. “The [review authors] are correct. A lot of new findings have emerged in the last 5–8 years … regarding gene variance that's associated with FM itself or with [related] disorders.

“And a lot of the neuroimaging work that has been done has demonstrated very convincingly that people with FM have enhanced or abnormal transmission of sensory signals through the CNS,” he said. “Behavioral studies–laboratory pain studies–also show consistent displays of abnormal pain responses in individuals with FM.”

In their review, Dr. Clauw and Dr. Harris described functional imaging studies done with single-photon emission computer tomography (SPECT) and functional magnetic resonance imaging (fMRI) that show differences in neural activation between patients with FM and pain-free controls. The studies indicate that FM patients have abnormalities within their central brain structures, they said.

There is evidence in FM that an “increased gain” in pain processing is driven by defects in both descending inhibitory pathways for pain processing and in spinal excitatory activity, the authors added.

Biochemical studies have supported the notion that the pathology might be a result of high levels of pronociceptive compounds (such as “substance P”), low levels of antinociceptive compounds, or both. Conversely “there is considerable evidence that this increased gain could occur because of a deficiency in one of the major endogenous analgesic pathways, the descending antinociceptive serotonergic-noradrenergic pathway” (Curr. Pain Headache Rep. 2006:10;403–7).

The “ultimate proof” that defective central control mechanisms are playing a role in FM and overlapping pain conditions comes from randomized clinical trials showing that neuroactive compounds that either increase inhibitory activity (such as serotonin-norepinephrine reuptake inhibitors) or decrease facilitatory activity (such as antiepileptics) can be efficacious in treating FM as well as neuropathic pain, said Dr. Clauw and Dr. Harris.

Dr. Bradley said that one of the “missing pieces of information” in the growing knowledge of pain transmission in FM is its original source.

“Where's the starting point?” he asked. “[Many experts] think it originates from abnormalities in the deep muscle tissue, but at this point we have a much better understanding of what goes on at the spinal level than we do of what factors contribute to the initiation of sensory signals.”

What's missing from the review itself, he and others noted, is the “consistent” evidence of altered neuroendocrine function in patients with FM.

Dr. Robert Bennett, who has led studies in this area, said that FM also appears to be a manifestation of an abnormal acute stress response involving abnormalities in levels of cortisol and growth hormone, an imbalance in sympathetic and vagal tone, and other phenomena–a notion that puts FM at least partly in the same camp, for underlying mechanisms, as chronic fatigue syndrome.

“The major things we know now [about FM] relate to the pain system,” said Dr. Bennett, professor of medicine at Oregon Health and Science University, Portland. “The neuroendocrine abnormalities–the manifestations of the acute stress response–have still, I think, been underinvestigated.”

Dr. Klimas, director of the University of Miami's chronic fatigue syndrome research center, said that more than 60% of her patients with the syndrome meet the case definition of FM as well, which reflects at least in part the fact that the FM definition is looser and more inclusive while the chronic fatigue syndrome definition has many exclusionary criteria.

Dr. Bradley added that a number of recent studies have also shown a familial aggregation of pain sensitivity. The studies show that first-degree relatives of patients with FM tend to have the “same sorts of unusual sensitivities to pain and abnormal pain responses,” even though this isn't always manifested as FM.