Ca Cuts Fractures In Healthy Seniors

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SEATTLE — Calcium supplementation appears to reduce by 34% the 5-year risk of fracture in elderly women, according to a population-based study presented at the annual meeting of the American Society for Bone and Mineral Research.

The benefit was seen as early as 13 months, even though women were deemed at baseline to be getting adequate calcium—a mean of 960 mg/day, said Richard Prince, M.D., of Sir Charles Gairdner Hospital, Perth, Australia.

The 1,460 healthy ambulatory women, aged 70 or older, were randomly assigned to receive 600 mg calcium carbonate twice daily or placebo. Calcium intake was assessed and dual x-ray absorptiometry (DXA) scans were taken at baseline and again at least 1 year later. During the 5-year study, the rates of death, withdrawal, and treatment cessation were similar between the two groups. In all, 235 individuals sustained 296 fractures; 118 in those taking calcium and 178 in those taking placebo, for an overall 34% reduction in fractures in patients in the calcium group who stuck to the protocol for the entire study period.

Calcium appeared to improve bone mineral density at cortical bone sites, according to DXA findings. At 13 months, there were early indications of a reduction in fracture rates among patients in the calcium group.

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SEATTLE — Calcium supplementation appears to reduce by 34% the 5-year risk of fracture in elderly women, according to a population-based study presented at the annual meeting of the American Society for Bone and Mineral Research.

The benefit was seen as early as 13 months, even though women were deemed at baseline to be getting adequate calcium—a mean of 960 mg/day, said Richard Prince, M.D., of Sir Charles Gairdner Hospital, Perth, Australia.

The 1,460 healthy ambulatory women, aged 70 or older, were randomly assigned to receive 600 mg calcium carbonate twice daily or placebo. Calcium intake was assessed and dual x-ray absorptiometry (DXA) scans were taken at baseline and again at least 1 year later. During the 5-year study, the rates of death, withdrawal, and treatment cessation were similar between the two groups. In all, 235 individuals sustained 296 fractures; 118 in those taking calcium and 178 in those taking placebo, for an overall 34% reduction in fractures in patients in the calcium group who stuck to the protocol for the entire study period.

Calcium appeared to improve bone mineral density at cortical bone sites, according to DXA findings. At 13 months, there were early indications of a reduction in fracture rates among patients in the calcium group.

SEATTLE — Calcium supplementation appears to reduce by 34% the 5-year risk of fracture in elderly women, according to a population-based study presented at the annual meeting of the American Society for Bone and Mineral Research.

The benefit was seen as early as 13 months, even though women were deemed at baseline to be getting adequate calcium—a mean of 960 mg/day, said Richard Prince, M.D., of Sir Charles Gairdner Hospital, Perth, Australia.

The 1,460 healthy ambulatory women, aged 70 or older, were randomly assigned to receive 600 mg calcium carbonate twice daily or placebo. Calcium intake was assessed and dual x-ray absorptiometry (DXA) scans were taken at baseline and again at least 1 year later. During the 5-year study, the rates of death, withdrawal, and treatment cessation were similar between the two groups. In all, 235 individuals sustained 296 fractures; 118 in those taking calcium and 178 in those taking placebo, for an overall 34% reduction in fractures in patients in the calcium group who stuck to the protocol for the entire study period.

Calcium appeared to improve bone mineral density at cortical bone sites, according to DXA findings. At 13 months, there were early indications of a reduction in fracture rates among patients in the calcium group.

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Sciatica Helped Little by IV Methylprednisolone

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Sciatica Helped Little by IV Methylprednisolone

SAN ANTONIO — A single, intravenous injection of methylprednisolone performed just slightly better than placebo in alleviating pain from acute discogenic sciatica, Axel Finckh, M.D., said at the annual meeting of the American College of Rheumatology.

Dr. Finckh presented a study in which 59 patients with radiographically confirmed discogenic sciatica were randomized to either a single, 500-mg, intravenous bolus of methylprednisolone or to placebo, and then followed for 10 days.

Both groups had significant improvement in pain on the first day, as shown with a 100-point, visual analog scale, with a greater mean improvement for the methylprednisolone group.

However, mean scores in both groups were about the same by the third day and remained comparable through day 10.

Both groups had gradual diminishment of pain from day 3 onward, said Dr. Finckh, of Brigham and Women's Hospital, Boston.

Nor were response rates significantly different on a straight leg test for radicular irritation, a McGill Pain Score for global pain, a flexibility score, and a functional disability questionnaire, Dr. Finckh explained.

The patients in the study had all had sciatica for at least 1 week, and not more than 6 weeks, prior to being treated.

Use of nonsteroidal anti-inflammatory drugs was permitted.

The use of corticosteroids in sciatica is controversial, Dr. Finckh said.

Most studies of oral administration have not demonstrated any benefit.

Some studies of epidural administration, however, have shown positive findings.

His group conducted the study because they hypothesized that giving the corticosteroid intravenously might be a way to achieve high drug levels quickly, without the risks and pain typically associated with epidural administration.

Despite the negative results, Dr. Finckh seemed unwilling to give up completely on intravenous injection for sciatica.

He noted that 48% of the steroid-treated patients had pain improvement, versus 28% of the placebo patients.

Long-term treatment using the technique might have more of an effect, he said.

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SAN ANTONIO — A single, intravenous injection of methylprednisolone performed just slightly better than placebo in alleviating pain from acute discogenic sciatica, Axel Finckh, M.D., said at the annual meeting of the American College of Rheumatology.

Dr. Finckh presented a study in which 59 patients with radiographically confirmed discogenic sciatica were randomized to either a single, 500-mg, intravenous bolus of methylprednisolone or to placebo, and then followed for 10 days.

Both groups had significant improvement in pain on the first day, as shown with a 100-point, visual analog scale, with a greater mean improvement for the methylprednisolone group.

However, mean scores in both groups were about the same by the third day and remained comparable through day 10.

Both groups had gradual diminishment of pain from day 3 onward, said Dr. Finckh, of Brigham and Women's Hospital, Boston.

Nor were response rates significantly different on a straight leg test for radicular irritation, a McGill Pain Score for global pain, a flexibility score, and a functional disability questionnaire, Dr. Finckh explained.

The patients in the study had all had sciatica for at least 1 week, and not more than 6 weeks, prior to being treated.

Use of nonsteroidal anti-inflammatory drugs was permitted.

The use of corticosteroids in sciatica is controversial, Dr. Finckh said.

Most studies of oral administration have not demonstrated any benefit.

Some studies of epidural administration, however, have shown positive findings.

His group conducted the study because they hypothesized that giving the corticosteroid intravenously might be a way to achieve high drug levels quickly, without the risks and pain typically associated with epidural administration.

Despite the negative results, Dr. Finckh seemed unwilling to give up completely on intravenous injection for sciatica.

He noted that 48% of the steroid-treated patients had pain improvement, versus 28% of the placebo patients.

Long-term treatment using the technique might have more of an effect, he said.

SAN ANTONIO — A single, intravenous injection of methylprednisolone performed just slightly better than placebo in alleviating pain from acute discogenic sciatica, Axel Finckh, M.D., said at the annual meeting of the American College of Rheumatology.

Dr. Finckh presented a study in which 59 patients with radiographically confirmed discogenic sciatica were randomized to either a single, 500-mg, intravenous bolus of methylprednisolone or to placebo, and then followed for 10 days.

Both groups had significant improvement in pain on the first day, as shown with a 100-point, visual analog scale, with a greater mean improvement for the methylprednisolone group.

However, mean scores in both groups were about the same by the third day and remained comparable through day 10.

Both groups had gradual diminishment of pain from day 3 onward, said Dr. Finckh, of Brigham and Women's Hospital, Boston.

Nor were response rates significantly different on a straight leg test for radicular irritation, a McGill Pain Score for global pain, a flexibility score, and a functional disability questionnaire, Dr. Finckh explained.

The patients in the study had all had sciatica for at least 1 week, and not more than 6 weeks, prior to being treated.

Use of nonsteroidal anti-inflammatory drugs was permitted.

The use of corticosteroids in sciatica is controversial, Dr. Finckh said.

Most studies of oral administration have not demonstrated any benefit.

Some studies of epidural administration, however, have shown positive findings.

His group conducted the study because they hypothesized that giving the corticosteroid intravenously might be a way to achieve high drug levels quickly, without the risks and pain typically associated with epidural administration.

Despite the negative results, Dr. Finckh seemed unwilling to give up completely on intravenous injection for sciatica.

He noted that 48% of the steroid-treated patients had pain improvement, versus 28% of the placebo patients.

Long-term treatment using the technique might have more of an effect, he said.

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Standard-Dose Infliximab Tied to Few Infections

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Standard-Dose Infliximab Tied to Few Infections

SAN ANTONIO — Postmarketing trial data indicate that at the standard dosage, infliximab is not associated with an excess risk of infection during the first year of therapy, but higher doses may be, David Yocum, M.D., reported at the annual meeting of the American College of Rheumatology.

Dr. Yocum's investigation included patients with a history of active or latent TB and found no evidence that the biologic therapy reactivated infection.

“I think this reaffirms the positive risk-benefit ratio of the approved dose of infliximab,” said Dr. Yocum, who presented the results of the safety trial, which was initiated by the manufacturer, Centocor, to satisfy Food and Drug Administration requirements.

From the outset, the trial was designed to include patients with comorbidities in an effort to discern the risks from therapy in a “real-life” clinical setting, as opposed to the typical study population, he added.

In the trial, 1,082 patients were divided nearly equally into three treatment arms. The first group of study participants received placebo and then crossed over to receive standard-dose infliximab, 3 mg/kg, at weeks 22, 26, 30, 38, and 46.

The second group received standard-dose infliximab until week 22, at which point the dosage increased by 1.5-mg/kg increments every 8 weeks, as deemed necessary. The third group received infliximab 10 mg/kg through week 46.

All patients continued to receive concomitant methotrexate at a dose of 25 mg/wk or greater.

During the first 22-week phase of the trial, the group treated with standard-dose infliximab had the same rate of serious infections as the methotrexate-only group (1.7%).

By comparison, the infection rate among patients treated at the 10-mg/kg dose was nearly three times higher (5.3%), said Dr. Yocum who conducted the study at the University of Arizona, Tucson.

During the entire 54-week trial, infection rates were equal among the group on placebo that started infliximab therapy at 22 weeks and the group taking standard-dose therapy with the option to increase the dosage (3.6% each).

By comparison, 8.9% of those patients on the 10-mg/kg dosage developed serious infections.

The data suggest that if and when infections do occur in patients on infliximab, they tend to occur early. In addition, dose escalation is not a factor as long as the dose remains below 10 mg/kg, Dr. Yocum said.

Of the 54 patients who took escalating doses, 93% needed only two increases (1.5 mg/kg each time), and only 7 patients required 9 mg/kg.

The most common serious infection, pneumonia, occurred in 1.5% of the group that started infliximab later and in 1.4% of the group with the option of increasing the dosage.

Pneumonia developed in 1.9% of the high-dose group.

The multicenter trial included patients who had a history of active or latent tuberculosis.

There was one case of tuberculosis in the group who started late, two cases in the group who escalated, and four cases in the high-dose group.

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SAN ANTONIO — Postmarketing trial data indicate that at the standard dosage, infliximab is not associated with an excess risk of infection during the first year of therapy, but higher doses may be, David Yocum, M.D., reported at the annual meeting of the American College of Rheumatology.

Dr. Yocum's investigation included patients with a history of active or latent TB and found no evidence that the biologic therapy reactivated infection.

“I think this reaffirms the positive risk-benefit ratio of the approved dose of infliximab,” said Dr. Yocum, who presented the results of the safety trial, which was initiated by the manufacturer, Centocor, to satisfy Food and Drug Administration requirements.

From the outset, the trial was designed to include patients with comorbidities in an effort to discern the risks from therapy in a “real-life” clinical setting, as opposed to the typical study population, he added.

In the trial, 1,082 patients were divided nearly equally into three treatment arms. The first group of study participants received placebo and then crossed over to receive standard-dose infliximab, 3 mg/kg, at weeks 22, 26, 30, 38, and 46.

The second group received standard-dose infliximab until week 22, at which point the dosage increased by 1.5-mg/kg increments every 8 weeks, as deemed necessary. The third group received infliximab 10 mg/kg through week 46.

All patients continued to receive concomitant methotrexate at a dose of 25 mg/wk or greater.

During the first 22-week phase of the trial, the group treated with standard-dose infliximab had the same rate of serious infections as the methotrexate-only group (1.7%).

By comparison, the infection rate among patients treated at the 10-mg/kg dose was nearly three times higher (5.3%), said Dr. Yocum who conducted the study at the University of Arizona, Tucson.

During the entire 54-week trial, infection rates were equal among the group on placebo that started infliximab therapy at 22 weeks and the group taking standard-dose therapy with the option to increase the dosage (3.6% each).

By comparison, 8.9% of those patients on the 10-mg/kg dosage developed serious infections.

The data suggest that if and when infections do occur in patients on infliximab, they tend to occur early. In addition, dose escalation is not a factor as long as the dose remains below 10 mg/kg, Dr. Yocum said.

Of the 54 patients who took escalating doses, 93% needed only two increases (1.5 mg/kg each time), and only 7 patients required 9 mg/kg.

The most common serious infection, pneumonia, occurred in 1.5% of the group that started infliximab later and in 1.4% of the group with the option of increasing the dosage.

Pneumonia developed in 1.9% of the high-dose group.

The multicenter trial included patients who had a history of active or latent tuberculosis.

There was one case of tuberculosis in the group who started late, two cases in the group who escalated, and four cases in the high-dose group.

SAN ANTONIO — Postmarketing trial data indicate that at the standard dosage, infliximab is not associated with an excess risk of infection during the first year of therapy, but higher doses may be, David Yocum, M.D., reported at the annual meeting of the American College of Rheumatology.

Dr. Yocum's investigation included patients with a history of active or latent TB and found no evidence that the biologic therapy reactivated infection.

“I think this reaffirms the positive risk-benefit ratio of the approved dose of infliximab,” said Dr. Yocum, who presented the results of the safety trial, which was initiated by the manufacturer, Centocor, to satisfy Food and Drug Administration requirements.

From the outset, the trial was designed to include patients with comorbidities in an effort to discern the risks from therapy in a “real-life” clinical setting, as opposed to the typical study population, he added.

In the trial, 1,082 patients were divided nearly equally into three treatment arms. The first group of study participants received placebo and then crossed over to receive standard-dose infliximab, 3 mg/kg, at weeks 22, 26, 30, 38, and 46.

The second group received standard-dose infliximab until week 22, at which point the dosage increased by 1.5-mg/kg increments every 8 weeks, as deemed necessary. The third group received infliximab 10 mg/kg through week 46.

All patients continued to receive concomitant methotrexate at a dose of 25 mg/wk or greater.

During the first 22-week phase of the trial, the group treated with standard-dose infliximab had the same rate of serious infections as the methotrexate-only group (1.7%).

By comparison, the infection rate among patients treated at the 10-mg/kg dose was nearly three times higher (5.3%), said Dr. Yocum who conducted the study at the University of Arizona, Tucson.

During the entire 54-week trial, infection rates were equal among the group on placebo that started infliximab therapy at 22 weeks and the group taking standard-dose therapy with the option to increase the dosage (3.6% each).

By comparison, 8.9% of those patients on the 10-mg/kg dosage developed serious infections.

The data suggest that if and when infections do occur in patients on infliximab, they tend to occur early. In addition, dose escalation is not a factor as long as the dose remains below 10 mg/kg, Dr. Yocum said.

Of the 54 patients who took escalating doses, 93% needed only two increases (1.5 mg/kg each time), and only 7 patients required 9 mg/kg.

The most common serious infection, pneumonia, occurred in 1.5% of the group that started infliximab later and in 1.4% of the group with the option of increasing the dosage.

Pneumonia developed in 1.9% of the high-dose group.

The multicenter trial included patients who had a history of active or latent tuberculosis.

There was one case of tuberculosis in the group who started late, two cases in the group who escalated, and four cases in the high-dose group.

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Heart Failure More Common in Rheumatoid Arthritis Patients

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Heart Failure More Common in Rheumatoid Arthritis Patients

SAN ANTONIO — Rheumatoid arthritis patients develop heart failure more frequently than the general population, and this increase does not appear to be explained by traditional risk factors, Cynthia Crowson said at the annual meeting of the American College of Rheumatology.

There have been many studies of heart disease in rheumatoid arthritis, but no one has previously looked at heart failure in particular, said Ms. Crowson, a statistician at the Mayo Clinic, Rochester, Minn.

The study followed 575 rheumatoid arthritis patients and 583 control subjects from the time they were 50–60 years of age (mean age 57 years) for 11–15 years, to see how many developed heart failure and what role was played by known cardiovascular risk factors.

Over the course of the study, 165 of the rheumatoid arthritis (RA) patients developed heart failure, as did 115 of the control subjects.

A statistical analysis of the subjects with heart failure—one that took into account each individual's risk factors—indicated that risk factors such as sedentary lifestyle and smoking played less of role in the heart failure of the RA patients than did that of the controls. Instead, the pathogenesis of RA itself may be to blame for the rates of heart failure, Ms. Crowson suggested.

Overall, the analysis indicated that 83% of the heart failure in the control subjects could be attributed to known cardiovascular risk factors and ischemic heart disease. By comparison, 45% of the heart failure in the rheumatoid arthritis patients could be attributed to such factors.

In the control subjects, 64% of the risk of heart failure was attributable to hypertension, but only 18% of the risk was associated with hypertension in the rheumatoid arthritis patients.

A history of ischemic heart disease (myocardial infarction, silent myocardial infarction, angina, or a revascularization procedure) was present in 26% of the control subjects, but only 17% of the risk in the RA patients.

Smoking accounted for 14% of the attributable risk in the control subjects, but only 3% in RA patients.

Body mass index tended to be fairly similar in the two groups; 23% of the RA patients had a BMI greater than 30, compared with 24% of the controls.

Smoking or a history of smoking was more common in the RA patients, but not dramatically so (55% versus 45%).

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SAN ANTONIO — Rheumatoid arthritis patients develop heart failure more frequently than the general population, and this increase does not appear to be explained by traditional risk factors, Cynthia Crowson said at the annual meeting of the American College of Rheumatology.

There have been many studies of heart disease in rheumatoid arthritis, but no one has previously looked at heart failure in particular, said Ms. Crowson, a statistician at the Mayo Clinic, Rochester, Minn.

The study followed 575 rheumatoid arthritis patients and 583 control subjects from the time they were 50–60 years of age (mean age 57 years) for 11–15 years, to see how many developed heart failure and what role was played by known cardiovascular risk factors.

Over the course of the study, 165 of the rheumatoid arthritis (RA) patients developed heart failure, as did 115 of the control subjects.

A statistical analysis of the subjects with heart failure—one that took into account each individual's risk factors—indicated that risk factors such as sedentary lifestyle and smoking played less of role in the heart failure of the RA patients than did that of the controls. Instead, the pathogenesis of RA itself may be to blame for the rates of heart failure, Ms. Crowson suggested.

Overall, the analysis indicated that 83% of the heart failure in the control subjects could be attributed to known cardiovascular risk factors and ischemic heart disease. By comparison, 45% of the heart failure in the rheumatoid arthritis patients could be attributed to such factors.

In the control subjects, 64% of the risk of heart failure was attributable to hypertension, but only 18% of the risk was associated with hypertension in the rheumatoid arthritis patients.

A history of ischemic heart disease (myocardial infarction, silent myocardial infarction, angina, or a revascularization procedure) was present in 26% of the control subjects, but only 17% of the risk in the RA patients.

Smoking accounted for 14% of the attributable risk in the control subjects, but only 3% in RA patients.

Body mass index tended to be fairly similar in the two groups; 23% of the RA patients had a BMI greater than 30, compared with 24% of the controls.

Smoking or a history of smoking was more common in the RA patients, but not dramatically so (55% versus 45%).

SAN ANTONIO — Rheumatoid arthritis patients develop heart failure more frequently than the general population, and this increase does not appear to be explained by traditional risk factors, Cynthia Crowson said at the annual meeting of the American College of Rheumatology.

There have been many studies of heart disease in rheumatoid arthritis, but no one has previously looked at heart failure in particular, said Ms. Crowson, a statistician at the Mayo Clinic, Rochester, Minn.

The study followed 575 rheumatoid arthritis patients and 583 control subjects from the time they were 50–60 years of age (mean age 57 years) for 11–15 years, to see how many developed heart failure and what role was played by known cardiovascular risk factors.

Over the course of the study, 165 of the rheumatoid arthritis (RA) patients developed heart failure, as did 115 of the control subjects.

A statistical analysis of the subjects with heart failure—one that took into account each individual's risk factors—indicated that risk factors such as sedentary lifestyle and smoking played less of role in the heart failure of the RA patients than did that of the controls. Instead, the pathogenesis of RA itself may be to blame for the rates of heart failure, Ms. Crowson suggested.

Overall, the analysis indicated that 83% of the heart failure in the control subjects could be attributed to known cardiovascular risk factors and ischemic heart disease. By comparison, 45% of the heart failure in the rheumatoid arthritis patients could be attributed to such factors.

In the control subjects, 64% of the risk of heart failure was attributable to hypertension, but only 18% of the risk was associated with hypertension in the rheumatoid arthritis patients.

A history of ischemic heart disease (myocardial infarction, silent myocardial infarction, angina, or a revascularization procedure) was present in 26% of the control subjects, but only 17% of the risk in the RA patients.

Smoking accounted for 14% of the attributable risk in the control subjects, but only 3% in RA patients.

Body mass index tended to be fairly similar in the two groups; 23% of the RA patients had a BMI greater than 30, compared with 24% of the controls.

Smoking or a history of smoking was more common in the RA patients, but not dramatically so (55% versus 45%).

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Downplay Cancer Risk With HPV Infection-Associated Venereal Warts

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Downplay Cancer Risk With HPV Infection-Associated Venereal Warts

YOSEMITE, CALIF. — Patients with venereal warts should be reassured that the condition does not substantially increase their risk of developing cervical cancer, said Laura J. Grimshaw, assistant medical director of the STD Center for Excellence at Rivington House, New York.

That's because the human papilloma virus (HPV) types that cause most condylomata acuminatum are not usually associated with cancer. Even though HPV infection is so common that exposure is virtually universal, the incidence of cervical cancer is only 8/100,000 women per year.

Patients often come in having surfed the Internet and learned that HPV is associated with cancer, Ms. Grimshaw said at a meeting on obstetrics and gynecology sponsored by Symposia Medicus. These patients need to be counseled and to be told that although HPV is common, cervical cancer is rare.

Studies have shown that at any one time, 1%-2% of sexually active men and women between the ages of 15 and 49 years have genital warts, 14% have a subclinical infection detected only by looking for DNA, and 60% have antibodies indicating previous infection.

That translates into a 75% lifetime risk of being infected, Ms. Grimshaw said.

“The message here is: If you have ever had sex with anyone else who has ever had sex with anyone else, you have probably been exposed to HPV,” she said.

The types of HPV that cause condyloma acuminatum most commonly are types 6 and 11. Even though HPV is associated in 93% of cases of cervical cancer, types 6 and 11 are not. The types most commonly associated with cervical cancer are 16, 18, 31, and 45, and they are found involved in 80% of cervical cancers.

One thing you cannot tell a patient with such certainty is why the partner suddenly developed genital warts when he or she was supposed to be monogamous, Ms. Grimshaw said.

It is not known how long HPV can persist before it is eradicated by the immune system, even though in the majority of cases it has been cleared by 2 years. It is always possible the partner had a subclinical infection for a long time before the warts appeared, or that the patient had no warts but was the source of the partner's infection. “There can be a latency for years,” she said.

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YOSEMITE, CALIF. — Patients with venereal warts should be reassured that the condition does not substantially increase their risk of developing cervical cancer, said Laura J. Grimshaw, assistant medical director of the STD Center for Excellence at Rivington House, New York.

That's because the human papilloma virus (HPV) types that cause most condylomata acuminatum are not usually associated with cancer. Even though HPV infection is so common that exposure is virtually universal, the incidence of cervical cancer is only 8/100,000 women per year.

Patients often come in having surfed the Internet and learned that HPV is associated with cancer, Ms. Grimshaw said at a meeting on obstetrics and gynecology sponsored by Symposia Medicus. These patients need to be counseled and to be told that although HPV is common, cervical cancer is rare.

Studies have shown that at any one time, 1%-2% of sexually active men and women between the ages of 15 and 49 years have genital warts, 14% have a subclinical infection detected only by looking for DNA, and 60% have antibodies indicating previous infection.

That translates into a 75% lifetime risk of being infected, Ms. Grimshaw said.

“The message here is: If you have ever had sex with anyone else who has ever had sex with anyone else, you have probably been exposed to HPV,” she said.

The types of HPV that cause condyloma acuminatum most commonly are types 6 and 11. Even though HPV is associated in 93% of cases of cervical cancer, types 6 and 11 are not. The types most commonly associated with cervical cancer are 16, 18, 31, and 45, and they are found involved in 80% of cervical cancers.

One thing you cannot tell a patient with such certainty is why the partner suddenly developed genital warts when he or she was supposed to be monogamous, Ms. Grimshaw said.

It is not known how long HPV can persist before it is eradicated by the immune system, even though in the majority of cases it has been cleared by 2 years. It is always possible the partner had a subclinical infection for a long time before the warts appeared, or that the patient had no warts but was the source of the partner's infection. “There can be a latency for years,” she said.

YOSEMITE, CALIF. — Patients with venereal warts should be reassured that the condition does not substantially increase their risk of developing cervical cancer, said Laura J. Grimshaw, assistant medical director of the STD Center for Excellence at Rivington House, New York.

That's because the human papilloma virus (HPV) types that cause most condylomata acuminatum are not usually associated with cancer. Even though HPV infection is so common that exposure is virtually universal, the incidence of cervical cancer is only 8/100,000 women per year.

Patients often come in having surfed the Internet and learned that HPV is associated with cancer, Ms. Grimshaw said at a meeting on obstetrics and gynecology sponsored by Symposia Medicus. These patients need to be counseled and to be told that although HPV is common, cervical cancer is rare.

Studies have shown that at any one time, 1%-2% of sexually active men and women between the ages of 15 and 49 years have genital warts, 14% have a subclinical infection detected only by looking for DNA, and 60% have antibodies indicating previous infection.

That translates into a 75% lifetime risk of being infected, Ms. Grimshaw said.

“The message here is: If you have ever had sex with anyone else who has ever had sex with anyone else, you have probably been exposed to HPV,” she said.

The types of HPV that cause condyloma acuminatum most commonly are types 6 and 11. Even though HPV is associated in 93% of cases of cervical cancer, types 6 and 11 are not. The types most commonly associated with cervical cancer are 16, 18, 31, and 45, and they are found involved in 80% of cervical cancers.

One thing you cannot tell a patient with such certainty is why the partner suddenly developed genital warts when he or she was supposed to be monogamous, Ms. Grimshaw said.

It is not known how long HPV can persist before it is eradicated by the immune system, even though in the majority of cases it has been cleared by 2 years. It is always possible the partner had a subclinical infection for a long time before the warts appeared, or that the patient had no warts but was the source of the partner's infection. “There can be a latency for years,” she said.

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Congenital Syphilis Declined in 2000-2002

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Congenital Syphilis Declined in 2000-2002

The incidence of congenital syphilis declined 21% between 2000 and 2002, with the largest decreases occurring in the groups where the incidence had been highest—racial and ethnic minorities and women living in the South—the Centers for Disease Control and Prevention reported.

There were 578 reported cases in this country in 2000 and 451 cases in 2002, according to the federal agency's surveillance.

The decreases continue a pattern of decline in syphilis seen throughout the 1990s and follow the 1999 implementation of the National Plan to Eliminate Syphilis (MMWR 2004;53:716-9).

Between 1997 and 2002, the incidence rate of congenital syphilis declined 63%.

Other observations noted in the report include the following:

▸ Many of the cases occurred in women who had no documented treatment or received inadequate treatment, even though it appeared that many had received prenatal care. Of the 288 cases reported for 2002, 63% of the mothers received prenatal care.

In 238 cases, the trimester in which the first prenatal visit occurred was known. In 86 cases, prenatal care began in the first trimester. In 93 cases, it began in the second trimester. In 59 cases it began in the third trimester. Eighteen mothers had a first visit less than 30 days before delivery.

This may indicate that providers are not adhering to syphilis screening recommendations, the report said. A 1999-2000 survey found that 14% of ob.gyns. did not report routinely screening pregnant women, and many who do screen do so only once during pregnancy.

▸ Seventy-four percent of the cases occurred in mothers who were untreated, had inadequate treatment, or did not have documented treatment. Fourteen percent occurred in mothers who were adequately treated but did not have an adequate serologic response to therapy, and the infant was inadequately evaluated for congenital syphilis. Nine percent occurred in mothers who did not have an adequate serologic response to treatment and the infant's evaluation revealed signs of congenital syphilis.

The remaining cases occurred in other situations.

▸ The rates of congenital syphilis declined in the South by 29%, and decreases occurred in all regions of the country except the Northeast.

The rate of congenital syphilis declined 51% among American Indian/Alaska Native infants, 22% among Hispanic infants, 21% among Asian/Pacific Islander infants, and 20% among non-Hispanic black infants.

There was no decline among non-Hispanic white infants.

▸ In 2002, 18 of the infants with congenital syphilis were stillborn and 8 died within 30 days of delivery.

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The incidence of congenital syphilis declined 21% between 2000 and 2002, with the largest decreases occurring in the groups where the incidence had been highest—racial and ethnic minorities and women living in the South—the Centers for Disease Control and Prevention reported.

There were 578 reported cases in this country in 2000 and 451 cases in 2002, according to the federal agency's surveillance.

The decreases continue a pattern of decline in syphilis seen throughout the 1990s and follow the 1999 implementation of the National Plan to Eliminate Syphilis (MMWR 2004;53:716-9).

Between 1997 and 2002, the incidence rate of congenital syphilis declined 63%.

Other observations noted in the report include the following:

▸ Many of the cases occurred in women who had no documented treatment or received inadequate treatment, even though it appeared that many had received prenatal care. Of the 288 cases reported for 2002, 63% of the mothers received prenatal care.

In 238 cases, the trimester in which the first prenatal visit occurred was known. In 86 cases, prenatal care began in the first trimester. In 93 cases, it began in the second trimester. In 59 cases it began in the third trimester. Eighteen mothers had a first visit less than 30 days before delivery.

This may indicate that providers are not adhering to syphilis screening recommendations, the report said. A 1999-2000 survey found that 14% of ob.gyns. did not report routinely screening pregnant women, and many who do screen do so only once during pregnancy.

▸ Seventy-four percent of the cases occurred in mothers who were untreated, had inadequate treatment, or did not have documented treatment. Fourteen percent occurred in mothers who were adequately treated but did not have an adequate serologic response to therapy, and the infant was inadequately evaluated for congenital syphilis. Nine percent occurred in mothers who did not have an adequate serologic response to treatment and the infant's evaluation revealed signs of congenital syphilis.

The remaining cases occurred in other situations.

▸ The rates of congenital syphilis declined in the South by 29%, and decreases occurred in all regions of the country except the Northeast.

The rate of congenital syphilis declined 51% among American Indian/Alaska Native infants, 22% among Hispanic infants, 21% among Asian/Pacific Islander infants, and 20% among non-Hispanic black infants.

There was no decline among non-Hispanic white infants.

▸ In 2002, 18 of the infants with congenital syphilis were stillborn and 8 died within 30 days of delivery.

The incidence of congenital syphilis declined 21% between 2000 and 2002, with the largest decreases occurring in the groups where the incidence had been highest—racial and ethnic minorities and women living in the South—the Centers for Disease Control and Prevention reported.

There were 578 reported cases in this country in 2000 and 451 cases in 2002, according to the federal agency's surveillance.

The decreases continue a pattern of decline in syphilis seen throughout the 1990s and follow the 1999 implementation of the National Plan to Eliminate Syphilis (MMWR 2004;53:716-9).

Between 1997 and 2002, the incidence rate of congenital syphilis declined 63%.

Other observations noted in the report include the following:

▸ Many of the cases occurred in women who had no documented treatment or received inadequate treatment, even though it appeared that many had received prenatal care. Of the 288 cases reported for 2002, 63% of the mothers received prenatal care.

In 238 cases, the trimester in which the first prenatal visit occurred was known. In 86 cases, prenatal care began in the first trimester. In 93 cases, it began in the second trimester. In 59 cases it began in the third trimester. Eighteen mothers had a first visit less than 30 days before delivery.

This may indicate that providers are not adhering to syphilis screening recommendations, the report said. A 1999-2000 survey found that 14% of ob.gyns. did not report routinely screening pregnant women, and many who do screen do so only once during pregnancy.

▸ Seventy-four percent of the cases occurred in mothers who were untreated, had inadequate treatment, or did not have documented treatment. Fourteen percent occurred in mothers who were adequately treated but did not have an adequate serologic response to therapy, and the infant was inadequately evaluated for congenital syphilis. Nine percent occurred in mothers who did not have an adequate serologic response to treatment and the infant's evaluation revealed signs of congenital syphilis.

The remaining cases occurred in other situations.

▸ The rates of congenital syphilis declined in the South by 29%, and decreases occurred in all regions of the country except the Northeast.

The rate of congenital syphilis declined 51% among American Indian/Alaska Native infants, 22% among Hispanic infants, 21% among Asian/Pacific Islander infants, and 20% among non-Hispanic black infants.

There was no decline among non-Hispanic white infants.

▸ In 2002, 18 of the infants with congenital syphilis were stillborn and 8 died within 30 days of delivery.

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Monthly Bisphosphonate as Effective as Daily

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SEATTLE — Monthly dosing of the bisphosphonate ibandronate appears to be just as effective as daily dosing, according to the findings of a controlled study presented at the annual meeting of the American Society for Bone and Mineral Research.

Such findings are welcome, given that compliance with bisphosphonate regimens tends to be challenging. In addition to causing esophagitis, the drugs require long fasts before and after they are taken. Prescribing a bisphosphonate that requires monthly, rather than daily, dosing could potentially greatly improve compliance, noted Paul D. Miller, M.D., director of the Colorado Center for Bone Research in Lakewood, Colo.

Dr. Miller presented a randomized, blinded study comparing three different doses of oral ibandronate given monthly with the standard dose given daily. The monthly regimens consisted of two 50-mg doses (328 patients), a single 100-mg dose (311 patients), or a single 150-mg dose (320 patients).

All three of the monthly regimens were at least equivalent to the standard 2·5-mg daily dose regimen at improving bone mineral density over 1 year of treatment, he said in a poster presentation.

In the 318 osteoporotic women treated with daily ibandronate, lumbar spine density increased by a mean of 4%. All three of the monthly regimens produced similar increases, with the 150-mg dose increasing lumbar spine density by a mean of 4·5%.

Density measurements at the total hip and hip trochanter showed greater mean increases with the monthly dosing compared with daily dosing. Total hip density increased by a mean of 2% in the daily group, compared with 3% in the group taking 150 mg/month.

The overall rate of adverse events was similar in all the groups. Upper gastrointestinal adverse events were slightly higher with 150 mg/month than with the other regimens (20% vs. 18%), but the only patients who withdrew from the trial because of adverse events were in the daily and 100-mg divided-dose groups.

Moreover, the first-phase reactions that some patients have when they initially use a bisphosphonate—fever, arthralgia, and nausea—were no more common with the monthly regimen (10%-15%) than the daily regimen and no more severe, Dr. Miller said in an interview.

Standard-dose ibandronate (Boniva) was approved in May 2003. If the monthly formulation is approved it may help improve compliance, but there are no guarantees.

In a study tracking the compliance of 2,741 postmenopausal women receiving their first prescription of alendronate or risedronate, Joyce A. Cramer, of Yale University, New Haven, found that weekly dosing improved compliance over daily dosing, but that even with weekly dosing compliance is not very good.

Ms. Cramer analyzed prescription-fill rates and found that 44% of women prescribed weekly therapy and 31% of those taking it daily were still on medication after a year, according to her poster presentation.

Moreover, 31% of the women who had received a prescription for weekly medication filled them no more than twice compared with 21% of those on daily medication.

A trial looking at a large number of patients representative of those being treated in private practice showed that 45% of patients prescribed a weekly regimen were compliant at least 80% of the time.

Similarly, 33% of those prescribed a daily bisphosphonate were compliant at least 80% of the time, Robert R. Recker, M.D., said in a poster presentation.

Records from 211,319 patients who were followed for 1 year suggest that even with a once-weekly regimen, too few patients are compliant enough to be getting proper benefit from their treatment, said Dr. Recker, director of the Osteoporosis Research Center at Creighton University, Omaha, Neb.

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SEATTLE — Monthly dosing of the bisphosphonate ibandronate appears to be just as effective as daily dosing, according to the findings of a controlled study presented at the annual meeting of the American Society for Bone and Mineral Research.

Such findings are welcome, given that compliance with bisphosphonate regimens tends to be challenging. In addition to causing esophagitis, the drugs require long fasts before and after they are taken. Prescribing a bisphosphonate that requires monthly, rather than daily, dosing could potentially greatly improve compliance, noted Paul D. Miller, M.D., director of the Colorado Center for Bone Research in Lakewood, Colo.

Dr. Miller presented a randomized, blinded study comparing three different doses of oral ibandronate given monthly with the standard dose given daily. The monthly regimens consisted of two 50-mg doses (328 patients), a single 100-mg dose (311 patients), or a single 150-mg dose (320 patients).

All three of the monthly regimens were at least equivalent to the standard 2·5-mg daily dose regimen at improving bone mineral density over 1 year of treatment, he said in a poster presentation.

In the 318 osteoporotic women treated with daily ibandronate, lumbar spine density increased by a mean of 4%. All three of the monthly regimens produced similar increases, with the 150-mg dose increasing lumbar spine density by a mean of 4·5%.

Density measurements at the total hip and hip trochanter showed greater mean increases with the monthly dosing compared with daily dosing. Total hip density increased by a mean of 2% in the daily group, compared with 3% in the group taking 150 mg/month.

The overall rate of adverse events was similar in all the groups. Upper gastrointestinal adverse events were slightly higher with 150 mg/month than with the other regimens (20% vs. 18%), but the only patients who withdrew from the trial because of adverse events were in the daily and 100-mg divided-dose groups.

Moreover, the first-phase reactions that some patients have when they initially use a bisphosphonate—fever, arthralgia, and nausea—were no more common with the monthly regimen (10%-15%) than the daily regimen and no more severe, Dr. Miller said in an interview.

Standard-dose ibandronate (Boniva) was approved in May 2003. If the monthly formulation is approved it may help improve compliance, but there are no guarantees.

In a study tracking the compliance of 2,741 postmenopausal women receiving their first prescription of alendronate or risedronate, Joyce A. Cramer, of Yale University, New Haven, found that weekly dosing improved compliance over daily dosing, but that even with weekly dosing compliance is not very good.

Ms. Cramer analyzed prescription-fill rates and found that 44% of women prescribed weekly therapy and 31% of those taking it daily were still on medication after a year, according to her poster presentation.

Moreover, 31% of the women who had received a prescription for weekly medication filled them no more than twice compared with 21% of those on daily medication.

A trial looking at a large number of patients representative of those being treated in private practice showed that 45% of patients prescribed a weekly regimen were compliant at least 80% of the time.

Similarly, 33% of those prescribed a daily bisphosphonate were compliant at least 80% of the time, Robert R. Recker, M.D., said in a poster presentation.

Records from 211,319 patients who were followed for 1 year suggest that even with a once-weekly regimen, too few patients are compliant enough to be getting proper benefit from their treatment, said Dr. Recker, director of the Osteoporosis Research Center at Creighton University, Omaha, Neb.

SEATTLE — Monthly dosing of the bisphosphonate ibandronate appears to be just as effective as daily dosing, according to the findings of a controlled study presented at the annual meeting of the American Society for Bone and Mineral Research.

Such findings are welcome, given that compliance with bisphosphonate regimens tends to be challenging. In addition to causing esophagitis, the drugs require long fasts before and after they are taken. Prescribing a bisphosphonate that requires monthly, rather than daily, dosing could potentially greatly improve compliance, noted Paul D. Miller, M.D., director of the Colorado Center for Bone Research in Lakewood, Colo.

Dr. Miller presented a randomized, blinded study comparing three different doses of oral ibandronate given monthly with the standard dose given daily. The monthly regimens consisted of two 50-mg doses (328 patients), a single 100-mg dose (311 patients), or a single 150-mg dose (320 patients).

All three of the monthly regimens were at least equivalent to the standard 2·5-mg daily dose regimen at improving bone mineral density over 1 year of treatment, he said in a poster presentation.

In the 318 osteoporotic women treated with daily ibandronate, lumbar spine density increased by a mean of 4%. All three of the monthly regimens produced similar increases, with the 150-mg dose increasing lumbar spine density by a mean of 4·5%.

Density measurements at the total hip and hip trochanter showed greater mean increases with the monthly dosing compared with daily dosing. Total hip density increased by a mean of 2% in the daily group, compared with 3% in the group taking 150 mg/month.

The overall rate of adverse events was similar in all the groups. Upper gastrointestinal adverse events were slightly higher with 150 mg/month than with the other regimens (20% vs. 18%), but the only patients who withdrew from the trial because of adverse events were in the daily and 100-mg divided-dose groups.

Moreover, the first-phase reactions that some patients have when they initially use a bisphosphonate—fever, arthralgia, and nausea—were no more common with the monthly regimen (10%-15%) than the daily regimen and no more severe, Dr. Miller said in an interview.

Standard-dose ibandronate (Boniva) was approved in May 2003. If the monthly formulation is approved it may help improve compliance, but there are no guarantees.

In a study tracking the compliance of 2,741 postmenopausal women receiving their first prescription of alendronate or risedronate, Joyce A. Cramer, of Yale University, New Haven, found that weekly dosing improved compliance over daily dosing, but that even with weekly dosing compliance is not very good.

Ms. Cramer analyzed prescription-fill rates and found that 44% of women prescribed weekly therapy and 31% of those taking it daily were still on medication after a year, according to her poster presentation.

Moreover, 31% of the women who had received a prescription for weekly medication filled them no more than twice compared with 21% of those on daily medication.

A trial looking at a large number of patients representative of those being treated in private practice showed that 45% of patients prescribed a weekly regimen were compliant at least 80% of the time.

Similarly, 33% of those prescribed a daily bisphosphonate were compliant at least 80% of the time, Robert R. Recker, M.D., said in a poster presentation.

Records from 211,319 patients who were followed for 1 year suggest that even with a once-weekly regimen, too few patients are compliant enough to be getting proper benefit from their treatment, said Dr. Recker, director of the Osteoporosis Research Center at Creighton University, Omaha, Neb.

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Registry Mandated for Isotretinoin Use

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The Food and Drug Administration will scrap isotretinoin's handful of voluntary risk management programs in favor of one mandatory, more restrictive system like that used for thalidomide.

Although many physicians are relieved that isotretinoin won't be removed from the market, some expressed concern that the FDA's decision may prompt more doctors to stop prescribing the teratogenic acne drug—and could push patients to seek the drug from sources on the Internet.

“In the long run, this [policy] is short sighted,” said Hilary Baldwin, M.D., vice chair of dermatology at the State University of New York, Brooklyn. “I'm just very sad.”

The new program is expected to go into effect this year. Prescribing physicians, dispensing pharmacies, and patients will be required to register in a program known as RiskMAP (risk minimization action plan). This program will be run by the drug-development services company Convance Inc., which has contracted with Roche, the manufacturer of Accutane, as well as with the manufacturers of generic isotretinoin.

The new program was announced shortly after a senior FDA official testified to the Senate that in his opinion isotretinoin was one of five drugs that ought to be either withdrawn from the market or more severely restricted.

The close timing of the two events may have been coincidence, however. In a statement, the FDA said it was able to make the announcement now because an agreement was reached with Celgene Corp., which owns a patent on the STEPS (System for Thalidomide Education and Prescribing Safety) program, on which the isotretinoin program will be based.

A more restrictive risk management program had been expected since March 2004, when two FDA advisory committees concluded that Roche's System to Manage Accutane Related Teratogenicity (SMART) and similar programs for generic isotretinoin had failed to prevent pregnancy exposures (FAMILY PRACTICE NEWS, April 2004, p.95).

At the meeting of those committees, data were presented that showed 127 pregnancy exposures occurred in the year before SMART was implemented, compared with 120 pregnancy exposures the year after, despite the fact that isotretinoin prescriptions declined by 23%.

Moreover, when SMART and the other programs were approved by FDA, the agency had threatened that further restrictions would be imposed unless 60% of women who were written a prescription enrolled in a voluntary, ongoing survey run by the manufacturers. That goal was not met.

The Shape of Restrictions to Come

Under RiskMAP, the following conditions must be met before isotretinoin can be dispensed:

▸ documentation of patient education by the provider;

▸ a signed informed-consent form; and

▸ a negative pregnancy test, which will have to be repeated in order for the patient to obtain refills.

More specific details of the program have yet to be determined.

A major advantage of the new program is that physicians will no longer have to adhere to the requirements of four similar but distinct programs, each run by different manufacturers. Some physicians found that confusing, the FDA said. Instead, there will be a single, unified program covering all brands of isotretinoin.

In contrast to what has occurred under the isotretinoin risk management programs, pregnancy exposures to thalidomide have been well controlled under the STEPS program. About 4,000 women of childbearing age have taken thalidomide since it was reintroduced into the market for the treatment of cancer and leprosy. Only one pregnancy exposure has occurred, which resulted in a spontaneous abortion.

Most patients treated with thalidomide are older, and they are being treated for multiple myeloma. Therefore, they are very sick and probably not inclined to have sexual intercourse.

The FDA's action prompted a statement from Rep. Bart Stupak (D-Mich.), a well-known critic of isotretinoin, whose son committed suicide while taking the drug.

Rep. Stupak's statement suggested that the wrangling over isotretinoin may continue. The congressman vowed to respond if the FDA's final risk management program was not strict enough, and he called for hearings specifically on isotretinoin.

“This latest scheme is a great marketing tool by the manufacturers, but it does not go far enough to ensure the safety of the American people or reduce the number of birth defects caused by Accutane,” Stupak said in the statement.

Kevin Foley, Research/Forhad S. Hossain, Design

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The Food and Drug Administration will scrap isotretinoin's handful of voluntary risk management programs in favor of one mandatory, more restrictive system like that used for thalidomide.

Although many physicians are relieved that isotretinoin won't be removed from the market, some expressed concern that the FDA's decision may prompt more doctors to stop prescribing the teratogenic acne drug—and could push patients to seek the drug from sources on the Internet.

“In the long run, this [policy] is short sighted,” said Hilary Baldwin, M.D., vice chair of dermatology at the State University of New York, Brooklyn. “I'm just very sad.”

The new program is expected to go into effect this year. Prescribing physicians, dispensing pharmacies, and patients will be required to register in a program known as RiskMAP (risk minimization action plan). This program will be run by the drug-development services company Convance Inc., which has contracted with Roche, the manufacturer of Accutane, as well as with the manufacturers of generic isotretinoin.

The new program was announced shortly after a senior FDA official testified to the Senate that in his opinion isotretinoin was one of five drugs that ought to be either withdrawn from the market or more severely restricted.

The close timing of the two events may have been coincidence, however. In a statement, the FDA said it was able to make the announcement now because an agreement was reached with Celgene Corp., which owns a patent on the STEPS (System for Thalidomide Education and Prescribing Safety) program, on which the isotretinoin program will be based.

A more restrictive risk management program had been expected since March 2004, when two FDA advisory committees concluded that Roche's System to Manage Accutane Related Teratogenicity (SMART) and similar programs for generic isotretinoin had failed to prevent pregnancy exposures (FAMILY PRACTICE NEWS, April 2004, p.95).

At the meeting of those committees, data were presented that showed 127 pregnancy exposures occurred in the year before SMART was implemented, compared with 120 pregnancy exposures the year after, despite the fact that isotretinoin prescriptions declined by 23%.

Moreover, when SMART and the other programs were approved by FDA, the agency had threatened that further restrictions would be imposed unless 60% of women who were written a prescription enrolled in a voluntary, ongoing survey run by the manufacturers. That goal was not met.

The Shape of Restrictions to Come

Under RiskMAP, the following conditions must be met before isotretinoin can be dispensed:

▸ documentation of patient education by the provider;

▸ a signed informed-consent form; and

▸ a negative pregnancy test, which will have to be repeated in order for the patient to obtain refills.

More specific details of the program have yet to be determined.

A major advantage of the new program is that physicians will no longer have to adhere to the requirements of four similar but distinct programs, each run by different manufacturers. Some physicians found that confusing, the FDA said. Instead, there will be a single, unified program covering all brands of isotretinoin.

In contrast to what has occurred under the isotretinoin risk management programs, pregnancy exposures to thalidomide have been well controlled under the STEPS program. About 4,000 women of childbearing age have taken thalidomide since it was reintroduced into the market for the treatment of cancer and leprosy. Only one pregnancy exposure has occurred, which resulted in a spontaneous abortion.

Most patients treated with thalidomide are older, and they are being treated for multiple myeloma. Therefore, they are very sick and probably not inclined to have sexual intercourse.

The FDA's action prompted a statement from Rep. Bart Stupak (D-Mich.), a well-known critic of isotretinoin, whose son committed suicide while taking the drug.

Rep. Stupak's statement suggested that the wrangling over isotretinoin may continue. The congressman vowed to respond if the FDA's final risk management program was not strict enough, and he called for hearings specifically on isotretinoin.

“This latest scheme is a great marketing tool by the manufacturers, but it does not go far enough to ensure the safety of the American people or reduce the number of birth defects caused by Accutane,” Stupak said in the statement.

Kevin Foley, Research/Forhad S. Hossain, Design

The Food and Drug Administration will scrap isotretinoin's handful of voluntary risk management programs in favor of one mandatory, more restrictive system like that used for thalidomide.

Although many physicians are relieved that isotretinoin won't be removed from the market, some expressed concern that the FDA's decision may prompt more doctors to stop prescribing the teratogenic acne drug—and could push patients to seek the drug from sources on the Internet.

“In the long run, this [policy] is short sighted,” said Hilary Baldwin, M.D., vice chair of dermatology at the State University of New York, Brooklyn. “I'm just very sad.”

The new program is expected to go into effect this year. Prescribing physicians, dispensing pharmacies, and patients will be required to register in a program known as RiskMAP (risk minimization action plan). This program will be run by the drug-development services company Convance Inc., which has contracted with Roche, the manufacturer of Accutane, as well as with the manufacturers of generic isotretinoin.

The new program was announced shortly after a senior FDA official testified to the Senate that in his opinion isotretinoin was one of five drugs that ought to be either withdrawn from the market or more severely restricted.

The close timing of the two events may have been coincidence, however. In a statement, the FDA said it was able to make the announcement now because an agreement was reached with Celgene Corp., which owns a patent on the STEPS (System for Thalidomide Education and Prescribing Safety) program, on which the isotretinoin program will be based.

A more restrictive risk management program had been expected since March 2004, when two FDA advisory committees concluded that Roche's System to Manage Accutane Related Teratogenicity (SMART) and similar programs for generic isotretinoin had failed to prevent pregnancy exposures (FAMILY PRACTICE NEWS, April 2004, p.95).

At the meeting of those committees, data were presented that showed 127 pregnancy exposures occurred in the year before SMART was implemented, compared with 120 pregnancy exposures the year after, despite the fact that isotretinoin prescriptions declined by 23%.

Moreover, when SMART and the other programs were approved by FDA, the agency had threatened that further restrictions would be imposed unless 60% of women who were written a prescription enrolled in a voluntary, ongoing survey run by the manufacturers. That goal was not met.

The Shape of Restrictions to Come

Under RiskMAP, the following conditions must be met before isotretinoin can be dispensed:

▸ documentation of patient education by the provider;

▸ a signed informed-consent form; and

▸ a negative pregnancy test, which will have to be repeated in order for the patient to obtain refills.

More specific details of the program have yet to be determined.

A major advantage of the new program is that physicians will no longer have to adhere to the requirements of four similar but distinct programs, each run by different manufacturers. Some physicians found that confusing, the FDA said. Instead, there will be a single, unified program covering all brands of isotretinoin.

In contrast to what has occurred under the isotretinoin risk management programs, pregnancy exposures to thalidomide have been well controlled under the STEPS program. About 4,000 women of childbearing age have taken thalidomide since it was reintroduced into the market for the treatment of cancer and leprosy. Only one pregnancy exposure has occurred, which resulted in a spontaneous abortion.

Most patients treated with thalidomide are older, and they are being treated for multiple myeloma. Therefore, they are very sick and probably not inclined to have sexual intercourse.

The FDA's action prompted a statement from Rep. Bart Stupak (D-Mich.), a well-known critic of isotretinoin, whose son committed suicide while taking the drug.

Rep. Stupak's statement suggested that the wrangling over isotretinoin may continue. The congressman vowed to respond if the FDA's final risk management program was not strict enough, and he called for hearings specifically on isotretinoin.

“This latest scheme is a great marketing tool by the manufacturers, but it does not go far enough to ensure the safety of the American people or reduce the number of birth defects caused by Accutane,” Stupak said in the statement.

Kevin Foley, Research/Forhad S. Hossain, Design

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Four-Visit Intervention Helps Back Pain Patients

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Four-Visit Intervention Helps Back Pain Patients

HONOLULU – A psychological intervention designed to help chronic back pain patients overcome fear of movement significantly reduced their activity limitations a year later, James E. Moore, Ph.D., said at the annual meeting of the American Psychological Association.

Interventions designed to get back-pain patients moving to combat deconditioning are becoming increasingly popular in pain clinics because a number of recent studies suggest that it is not only possible and safe, but very beneficial, Dr. Moore, director of the pain management program at the Virginia Mason Medical Center, Seattle, said in an interview with this newspaper.

Dr. Moore's study of the four-visit intervention (two to a psychologist and two to a physical therapist) enrolled 119 chronic back pain patients who received the intervention and 121 patients who received usual care and served as controls.

During the first visit, participants met with the psychologist, discussed their fears about back pain and resuming normal activities, and set an exercise goal.

Ten days later, the patients met with a physical therapist, who performed an examination, gave them specific exercises, and counseled them about overcoming barriers to meeting their exercise goal. The third visit was also with the physical therapist and was a follow-up to the prior visit. The final visit was again with the psychologist, to review progress.

The patients who received the intervention had significantly greater improvement in their Roland Disability Questionnaire scores, a worry rating, a fear-avoidance rating, and an average pain intensity score, Dr. Moore said in a poster presentation. Their improvement was greater at each of the follow-up times in the study: 2 months, 6 months, and 12 months.

“The main thing we addressed was fear,” Dr. Moore said in the interview. “The goal was to make people understand that most back pain is benign.”

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HONOLULU – A psychological intervention designed to help chronic back pain patients overcome fear of movement significantly reduced their activity limitations a year later, James E. Moore, Ph.D., said at the annual meeting of the American Psychological Association.

Interventions designed to get back-pain patients moving to combat deconditioning are becoming increasingly popular in pain clinics because a number of recent studies suggest that it is not only possible and safe, but very beneficial, Dr. Moore, director of the pain management program at the Virginia Mason Medical Center, Seattle, said in an interview with this newspaper.

Dr. Moore's study of the four-visit intervention (two to a psychologist and two to a physical therapist) enrolled 119 chronic back pain patients who received the intervention and 121 patients who received usual care and served as controls.

During the first visit, participants met with the psychologist, discussed their fears about back pain and resuming normal activities, and set an exercise goal.

Ten days later, the patients met with a physical therapist, who performed an examination, gave them specific exercises, and counseled them about overcoming barriers to meeting their exercise goal. The third visit was also with the physical therapist and was a follow-up to the prior visit. The final visit was again with the psychologist, to review progress.

The patients who received the intervention had significantly greater improvement in their Roland Disability Questionnaire scores, a worry rating, a fear-avoidance rating, and an average pain intensity score, Dr. Moore said in a poster presentation. Their improvement was greater at each of the follow-up times in the study: 2 months, 6 months, and 12 months.

“The main thing we addressed was fear,” Dr. Moore said in the interview. “The goal was to make people understand that most back pain is benign.”

HONOLULU – A psychological intervention designed to help chronic back pain patients overcome fear of movement significantly reduced their activity limitations a year later, James E. Moore, Ph.D., said at the annual meeting of the American Psychological Association.

Interventions designed to get back-pain patients moving to combat deconditioning are becoming increasingly popular in pain clinics because a number of recent studies suggest that it is not only possible and safe, but very beneficial, Dr. Moore, director of the pain management program at the Virginia Mason Medical Center, Seattle, said in an interview with this newspaper.

Dr. Moore's study of the four-visit intervention (two to a psychologist and two to a physical therapist) enrolled 119 chronic back pain patients who received the intervention and 121 patients who received usual care and served as controls.

During the first visit, participants met with the psychologist, discussed their fears about back pain and resuming normal activities, and set an exercise goal.

Ten days later, the patients met with a physical therapist, who performed an examination, gave them specific exercises, and counseled them about overcoming barriers to meeting their exercise goal. The third visit was also with the physical therapist and was a follow-up to the prior visit. The final visit was again with the psychologist, to review progress.

The patients who received the intervention had significantly greater improvement in their Roland Disability Questionnaire scores, a worry rating, a fear-avoidance rating, and an average pain intensity score, Dr. Moore said in a poster presentation. Their improvement was greater at each of the follow-up times in the study: 2 months, 6 months, and 12 months.

“The main thing we addressed was fear,” Dr. Moore said in the interview. “The goal was to make people understand that most back pain is benign.”

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Four Factors Useful in Identifying Eating Disorders in Girls

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HONOLULU – There are four factors that can help distinguish a girl who has an eating disorder from one who simply diets, Catherine M. Shisslak, Ph.D., said at the annual meeting of the American Psychological Association.

More than 50% of adolescent girls report dieting, either chronically, or intermittently, or occasionally, according to the results of a longitudinal study that followed 1,170 girls for 4 years through high school.

Any girl who reports dieting in the past year and has these four other risk factors–high body mass index, onset of menstruation before the sixth grade, overly concerned with weight or shape, and teasing by peers–should be carefully screened for an eating disorder, Dr. Shisslak said in a poster presentation.

Those factors correctly identified 88% of the girls in the study who reported that they were chronic dieters. Eighty percent of the girls who were chronic dieters had an eating disorder at the start of the study or developed one during high school.

The unexpected finding of the study was that peer teasing appeared to play such a prominent role in the eating disorders, Dr. Shisslak said in an interview. Past studies have noted that critical comments about weight from parents can be implicated in the development of an eating disorder. But this study suggests that comments from peers can be much more influential and devastating. It also suggests that the girl who does not report regular dieting but suddenly starts a diet may be more likely to develop an eating disorder than the girl who occasionally but regularly diets. Eight percent of those girls classified as intermittent dieters were found to have an eating disorder, compared with 2% of those who were occasional dieters.

Intermittent dieters were defined as those who reported dieting only 1 or 2 years during the 4 years of the study.

Dr. Shisslak and her coinvestigators followed the girls using a 103-question survey, completed each year. They also measured height and weight annually to determine body mass index, and they personally conducted a semistructured interview designed to identify eating disorders.

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HONOLULU – There are four factors that can help distinguish a girl who has an eating disorder from one who simply diets, Catherine M. Shisslak, Ph.D., said at the annual meeting of the American Psychological Association.

More than 50% of adolescent girls report dieting, either chronically, or intermittently, or occasionally, according to the results of a longitudinal study that followed 1,170 girls for 4 years through high school.

Any girl who reports dieting in the past year and has these four other risk factors–high body mass index, onset of menstruation before the sixth grade, overly concerned with weight or shape, and teasing by peers–should be carefully screened for an eating disorder, Dr. Shisslak said in a poster presentation.

Those factors correctly identified 88% of the girls in the study who reported that they were chronic dieters. Eighty percent of the girls who were chronic dieters had an eating disorder at the start of the study or developed one during high school.

The unexpected finding of the study was that peer teasing appeared to play such a prominent role in the eating disorders, Dr. Shisslak said in an interview. Past studies have noted that critical comments about weight from parents can be implicated in the development of an eating disorder. But this study suggests that comments from peers can be much more influential and devastating. It also suggests that the girl who does not report regular dieting but suddenly starts a diet may be more likely to develop an eating disorder than the girl who occasionally but regularly diets. Eight percent of those girls classified as intermittent dieters were found to have an eating disorder, compared with 2% of those who were occasional dieters.

Intermittent dieters were defined as those who reported dieting only 1 or 2 years during the 4 years of the study.

Dr. Shisslak and her coinvestigators followed the girls using a 103-question survey, completed each year. They also measured height and weight annually to determine body mass index, and they personally conducted a semistructured interview designed to identify eating disorders.

HONOLULU – There are four factors that can help distinguish a girl who has an eating disorder from one who simply diets, Catherine M. Shisslak, Ph.D., said at the annual meeting of the American Psychological Association.

More than 50% of adolescent girls report dieting, either chronically, or intermittently, or occasionally, according to the results of a longitudinal study that followed 1,170 girls for 4 years through high school.

Any girl who reports dieting in the past year and has these four other risk factors–high body mass index, onset of menstruation before the sixth grade, overly concerned with weight or shape, and teasing by peers–should be carefully screened for an eating disorder, Dr. Shisslak said in a poster presentation.

Those factors correctly identified 88% of the girls in the study who reported that they were chronic dieters. Eighty percent of the girls who were chronic dieters had an eating disorder at the start of the study or developed one during high school.

The unexpected finding of the study was that peer teasing appeared to play such a prominent role in the eating disorders, Dr. Shisslak said in an interview. Past studies have noted that critical comments about weight from parents can be implicated in the development of an eating disorder. But this study suggests that comments from peers can be much more influential and devastating. It also suggests that the girl who does not report regular dieting but suddenly starts a diet may be more likely to develop an eating disorder than the girl who occasionally but regularly diets. Eight percent of those girls classified as intermittent dieters were found to have an eating disorder, compared with 2% of those who were occasional dieters.

Intermittent dieters were defined as those who reported dieting only 1 or 2 years during the 4 years of the study.

Dr. Shisslak and her coinvestigators followed the girls using a 103-question survey, completed each year. They also measured height and weight annually to determine body mass index, and they personally conducted a semistructured interview designed to identify eating disorders.

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