Stopping smoking — even in the first weeks of a pregnancy — appears to avert many of the adverse effects of tobacco on the fetus, researchers reported.
In a prospective cohort analysis, women who stopped smoking when they found they were pregnant had babies that were similar in size to those of women who had never smoked, according to Nick Macklon, MD, and colleagues at the University of Southampton in Southampton, England.
A similar effect was observed for head size and gestational age at birth, Macklon reported at the annual meeting of the European Society of Human Reproduction and Embryology in Stockholm.

“We can now give couples hard evidence that making the effort to stop smoking in the periconceptional period will be beneficial for their baby,” Macklon said in a statement.

The finding comes from an analysis of more than 50,000 pregnancies and births at the University of Southampton medical center between 2002 and 2010, Macklon reported.

Low birthweight is the most common negative outcome of smoking during pregnancy, Macklon and colleagues noted, although other adverse effects are also possible, including prematurity.

For this analysis, the researchers analyzed clinical, lifestyle and socioeconomic data and, in particular, information on smoking habits, he reported, and looked for associations with birthweight, head circumference, and gestational age at birth.

Women in the study were divided into seven groups, according to their smoking status, and analysis showed that: 52% of the women said they had never smoked. 14.2% had stopped more than a year before the pregnancy. 6.8% had stopped during the year before conceiving. 8.3% stopped when they had the pregnancy confirmed.

The remaining women smoked during the pregnancy, including 10.9% of the total who reported smoking up to 10 cigarettes a day, 7.2% who smoked from 10 through 20 a day, and 0.8% who smoked more than 20 a day.

In a univariate analysis, the average birthweight of babies born to never-smokers was 3.43 kilograms, or about 7.56 pounds, Macklon reported.

In comparison, women who stopped smoking after they learned they were pregnant had babies that weighed 3.45 kilograms on average.

As well, those who stopped a more than or less than a year before pregnancy had babies whose average birthweight was 3.50 and 3.45 kilograms, respectively.

On the other hand, among the smokers, the average birthweight was 3.24 kilograms in those smoking up to 10 cigarettes day, 3.17 kilograms in those smoke 10 through a day, and 3.11 in women who smoked more than 20 a day, Macklon reported.

After adjusting for such things as gestational age, mother’s age, body mass index, and socioeconomic class, the dose-dependent effect remained significant ( P <0.05), he reported.

A similar pattern was seen for head circumference and the risk of prematurity, he added.

“We hope that our research will provide additional encouragement to mothers-to-be to give up cigarettes,” Macklon said.

The researchers did not report any external support for the study or any financial conflicts.

Among older men and women, a hip fracture increases the risk of death from any cause for at least 10 years after the injury, researchers said.

A meta-analysis showed that the risk of all-cause mortality is increased between five- and eight-fold in the first three months after the fracture, according to Patrick Haentjens, MD, PhD, of the Vrije Universiteit Brussel, in Brussels, and colleagues.

That risk drops substantially during the first two years after the broken hip, but for up to 10 years it remains significantly higher than among uninjured people, Haentjens and colleagues reported in the March 16 issue of Annals of Internal Medicine.

At any time, they also found, the risk of death was greater for men than for women.

The excess risk of death in the few months after a broken hip is well established, Haentjens and colleagues noted, but what happens after that is less clear.

To shed some light on the matter, the researchers looked for prospective cohort studies published from 1957 to May 2009 that contained both a life-table analysis, and survival curves of the hip fracture group and age- and sex-matched controls.

All told, they found 24 articles that looked at 22 unique cohorts of women and 17 unique cohorts of men, 50 or older, as well as age- and sex-matched controls. The cohorts included a total of 578,436 women and 154,276 men with hip fracture.

Analysis showed: In the first three months after injury, women with a hip fracture had a relative hazard for death of 5.75, with a 95% confidence interval from 4.94 to 6.67, which was significant at P<0.001. In the same time period, men had a relative hazard for death of 7.95, with a 95% confidence interval from 6.13 to 10.30, which was also significant at P<0.001. For women, nine to 10 years after the injury, the relative hazard dropped to 1.96, compared with controls, but remained significant at P=0.001. For men by that time, the relative hazard was 1.79, significant at P=0.012.

Compared with age-matched women who did not have a fracture, life-table methods showed that women who have a hip fracture at age 80 have excess annual mortality, of 8%, 11%, 18%, and 22% at one, two, five, and 10 years after injury, respectively.

The comparable figures for men were 18%, 22%, 26%, and 20%, the researchers said.

The study has several limitations, the researchers acknowledged, including the possibility of publication bias. Also, studies varied in size, duration of observation, selection of control populations, ascertainment of death, and adjustment for comorbid conditions.

The analysis did not quantify how much of the observed excess mortality is directly attributable to hip fracture, and mortality rates in both populations may vary over time and could bias the estimates.

The generalizability of the findings is limited, the researchers wrote, because the models only included a white U.S. population. Finally, the study was not prospective.

The study was supported by the Fund for Scientific Research and Willy Gepts Foundation, Universitair Ziekenhuis Brussel.

The researchers reported no conflicts.

FORT WORTH, Tex., Jan. 6 — For mild-to-moderate acne in patients 12 and older, the FDA has approved a once-a-day gel that combines adapalene and benzoyl peroxide gel (Epiduo Gel 0.1%, 2.5%), the drug maker announced.

According to Galderma, the combination gel “treats both inflammatory and non-inflammatory lesions with no
evidence of promoting antibiotic resistance, simplifying the management of mild-to-moderate acne.”

The approval followed a 517-patient phase II trial published last year in the Journal of the American Academy of Dermatology that found the gel reduced the median number of total acne lesions by more than 50% by the end of the 12-week study.

That was significantly better than monotherapy with either adapalene or benzoyl peroxide (median reduction in total lesion count 35.4% and 35.6%, respectively), said the company.

A long-term safety and efficacy study published last year in the Journal of Drugs in Dermatology found that discontinuation of the medication because of adverse events was low, occurring in 2% of all patients.

Common adverse effects included redness, scaling, dryness, stinging, and burning. Skin irritation and contact dermatitis may also occur.

Excessive exposure to sunlight and topical products containing resorcinol, salicyclic acid, and sulfur should be avoided while using the drug, said the company.

Women who develop high blood pressure during pregnancy may have fewer associated complications if obstetricians routinely induce labor once the pregnancy has exceeded 37 weeks gestation, according to Dutch researchers.

HYPITAT, a multicenter study of 756 pregnant women who developed gestational hypertension or mild preeclampsia, found that 31% of the women who were induced had a poor outcome versus 44% of the women who had expectant monitoring.

The difference of 49 women was significant (P<0.0001), wrote Corine M. Koopmans, MD, of University Medical Centre in Groningen, and colleagues. The findings were published online in The Lancet.

“We believe that induction of labor should be advised for women with gestational hypertension and a diastolic blood pressure of 95 mmHg or higher or mild preeclampsia at a gestational age beyond 37 weeks,” Koopmans wrote.

The authors said the finding underscored the importance of “frequent blood pressure monitoring during the concluding weeks of pregnancy.”

They noted that the finding had implications for the U.S. and other developed nations where induction of labor in women with these conditions is common practice. But “until now, this recommendation has not been based on the results of randomized clinical trials,” they said.

The women with singleton pregnancies were recruited at six academic medical centers and 32 nonacademic hospitals from October 2005 through March 2008. All women were at 36 to 41 weeks’ gestation and all had gestational hypertension or mild preeclampsia.

The women were randomized 1:1 to induction of labor or expectant monitoring. The primary endpoint was a composite measure of poor maternal outcome.

That measure included maternal mortality and maternal morbidity — specifically, HELLP syndrome (hemolytic anemia, elevated liver enzymes, and low platelet count), pulmonary edema, thomboembolic disease, and placental abruption — as well as progression to severe hypertension or proteinuria, and/or loss of more than 1,000 mL blood due to postpartum hemorrhage.

In the induction group, 117 of the 377 women reached the composite primary outcome versus 166 of the 379 controls.

There was, however, no cases of maternal or neonatal death in either group, and the difference in outcomes was primarily driven by a difference in blood pressure.

Only 55 women who were induced developed severe systolic hypertension, while 62 had diastolic pressures above normal. In the control group, 88 women developed systolic hypertension and 103 had severe elevations in diastolic pressure, for an absolute risk reduction of 8.63% for systolic and 10.73% for diastolic hypertension.

There were fewer cesarean sections in the induced group, 54 versus 72, but this difference was not statistically significant.

In a commentary published with the HYPITAT results, Donna D. Johnson, MD, of the Medical University of South Carolina, said one concern about the study design was the inclusion of women at 36 weeks’ gestation.

“Although serious neonatal complications are uncommon, late preterm birth can adversely affect the neonate,” she wrote. “In a subgroup analysis, composite maternal morbidity was not improved by induction of labor at this gestational age (36-37 weeks).”

She pointed out that while the study was not powered to detect differences at each gestational age “we should be hesitant to induce labor in women before 37 weeks of gestation for mild preeclampsia or gestational hypertension.”

The trial was funded by ZonMw, the Netherlands organization for health research and development, program Doelmatigheidsonderzoek.

Koopman and co-investigators declared no conflicts of interest.

Johnson declared that she had no conflicts of interest.

Primary source: The Lancet

Source reference:

Koopmans CM “Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks’ gestation (HYPITAT): a multicentre, open-label randomised contolled trial” Lancet 2009; DOI: 10.1016/S0140-6736(09)60736-4.

The human papillomavirus (HPV) vaccine offered excellent protection against the precursors (CIN2 and CIN3) of invasive cervical cancer, plus partial protection against four other nonvaccine oncogenic HPV types, according to two studies.

An important finding of the first study was the high efficacy of the bivalent HPV vaccine (Cervarix) particularly among adolescent girls not yet sexually active. These results, published in The Lancet Oncology, suggest the importance of modifying screening programs to target early adolescents, said Matti Lehtinen, PhD, of the University of Tampere in Finland.

The four-year end-of-study analysis of PATRICIA (PApilloma TRIal against Cancer In young Adults) showed excellent efficacy against CIN3+ and adenocarcinoma in situ irrespective of HPV DNA in the lesion. The trial included almost 19,000 healthy women ages 15 to 25, who were HPV-naive at baseline, with no more than six lifetime sexual partners.

The women — who were from 14 countries in the Asia-Pacific region, Europe, Latin America, and North America — were randomly assigned to receive the HPV-16/18 vaccine, which targets about 70% of cervical cancers, or a control (hepatitis A vaccine).

Vaccine efficacy against CIN3+ associated with HPV-16/18 was 100% (95% CI 85.5 to 100) in the total vaccinated cohort of women with no evidence of infection (TVC-naive) and 45.7% (CI 22.9 to 62.2) in the total vaccinated cohort group (TVC).

Vaccine efficacy against all CIN3+ (irrespective of HPV type and including lesions with no HPV DNA detected) was 93.2% (CI 78.9 to 98.7) in young women not infected with HPV (TVC-naive) versus 45.6% (CI 28.8 to 58.7) in the total vaccinated cohort (TVC group). In the TVC-naive women, vaccine efficacy against all CIN3+ was higher than 90% in all age groups.

In the previously unexposed women (TVC), vaccine efficacy against all CIN3+ and CIN3+ associated with HPV-16/18 was highest in the 15 to 17 age group, and decreased progressively in the 18 to 20 and 21 to 25 age groups. Vaccine efficacy against all adenocarcinoma in situ was 100% in the never-infected group and 76.9% in the total vaccinated cohort (TVC).

Serious adverse events occurred in 835 (9%) and 829 (8.9%) of women in the vaccine and control groups, respectively. Only ten events (0.1%) and five events (0.1%), respectively, were considered to be related to vaccination.

Study limitations included the fact that the distribution of women from various countries across the different cohorts may weaken the study’s generalizability. Also, the exclusion of women with more than six lifetime sexual partners lessened generalizability, especially in the 21 to 25 year age group in the TVC, where some of the excluded women most likely had multiple infections.

Population-based vaccination that incorporates the HPV-16/18 vaccine and high coverage of young adolescents before their sexual debut will probably achieve maximum benefits, Dr. Lehtinen wrote. The researchers also noted substantial vaccine efficacy in a population approximating the general population of sexually active women, suggesting that catch-up vaccination would provide some benefit.

In a second Lancet Oncology study analyzing results from the PATRICIA trial, Cosette Wheeler, PhD, of the University of New Mexico in Albuquerque, and colleagues reported that the bivalent HPV vaccine showed cross-protection efficacy against four oncogenic nonvaccine HPV types in different trial cohorts representing diverse groups of women: HPV-33 HPV-31 HPV-45 HPV-51

These four types, plus HP-16/18, cause about 85% of cervical cancer they said. Furthermore, there is a particularly high risk of HPV-33 infection progressing to cervical lesions, while HPV-45 is over-represented in adenocarcinoma.

Consistent vaccine efficacy against persistent infection and CIN2+ (with or without HPV-16/18 coinfection) was seen across cohorts for HPV-33, HPV-31, HPV-45, and HPV-51, the researchers reported

In the most conservative analysis of vaccine efficacy against CIN2+, where all cases coinfected with HPV-16/18 were removed, vaccine efficacy was noted for HPV-33 in all cohorts, and for HPV-31 in two other groups: ATP-E (no evidence of infection at the outset with the HPV type under analysis) and TVC-naive (uninfected at the outset).

Vaccine efficacy against CIN2+ was associated with the composite of 12 nonvaccine HPV types, with or without HPV-16/18 coinfection, at 46.8% in the ATP-E group, 56.2% in the TVC-naive group, and 34.2% in the TVC group. Corresponding values for CIN3+ were 73.8% in ATP-E group, 91.4% in the TVC-naive group, and 47.5% in the TVC group.

Overall, Wheeler said, these findings suggest that the the cross-protective efficacy of the vaccine when given to HPV-naive women might provide additional protection against cervical cancer but long-term follow-up is needed.

In an accompanying commentary, Mark Schiffman, PhD, and Sholom Wacholder, PhD, of the National Cancer Institute in Bethesda, Md., wrote that increasing coverage, particularly of sexually-naive adolescent females, is the most important public health issue in HPV vaccine efforts. Nonetheless, they said, despite vaccine efficacy near 100% in HPV-naive women, the efficacy in the total vaccinated group decreased steeply with increasing age.

They also expressed concern about low vaccination rates in areas where cervical cancer and mortality rates are high; where alternative prevention is inadequate; and where current vaccines are too expensive and often difficult to deliver.

The long-term proof of the safety of HPV vaccine is a public-health priority. Use will increase as public trust in safety increases, they concluded.

The Lehtinen study was funded by GlaxoSmithKline, the makers of Cervarix.

All investigators at clinical sites, including Lehtinen, were funded through their institutions.

Many of the researchers are employees of GlaxoSmithKline Biologicals; G. Dubin holds a relevant patent. Other firms contributing to the study include Merck Sharpe & Dohme, and Roche Molecular Systems.

WASHINGTON — Codifying recommendations made at a meeting last month, the Medicare Payment Advisory Commission (MedPAC) has officially recommended that physician reimbursement under the Medicare program be increased by 1% in 2012.

MedPAC — an independent agency of 17 trustees that provides Congress with advice on Medicare — sends a report to Congress each March on Medicare’s fee-for-service payment system and recommends payment updates for the following year.

In its report to Congress last year, MedPAC also recommended a 1% pay increase, justifying the size by explaining that most Medicare patients have access to physicians and there doesn’t appear to be any doctor shortage.

This year, they said it’s just as easy for a Medicare beneficiary to access a doctor as it is for someone with private insurance, adding a caveat that a “small share” of people with Medicare do report difficulty in finding a primary care doctor.

In addition, they noted, contrary to threats that doctors will stop accepting new Medicare patients, the vast majority of physicians are not shutting their doors.

“In light of these positive indicators and the modest expected growth in physicians’ and other health professionals’ costs, the Commission recommends an update of 1% for physician fee-schedule services in 2012,” the trustees wrote.

MedPAC’s recommendations are in sharp contrast to the numbers produced by the sustainable growth rate (SGR) formula that is supposed to govern Medicare payments. The SGR math results in large cuts in Medicare reimbursement year after year.

In December, similar to previous years, Congress passed a $15 billion, one-year “doc fix” bill to prevent a looming 25% cut in physician reimbursement under the SGR formula that was scheduled to take effect Jan. 1. Unless the SGR formula is changed, physicians will be facing that 25% cut — or perhaps an even larger one — again in 2012.

The commission has previously recommended moving away from fee-for-service and to a different pay system that would give incentives to physicians to provide higher quality care, and reiterated that message in its most recent report.

In 2009, Medicare spent $64 billion on physician and other health professional services.

Small Increase for Hospitals

The MedPAC trustees also recommended a 1% payment update to hospitals that treat Medicare patients.

In 2009, Medicare paid $148 billion for 10 million inpatient admissions and 147 million outpatient services delivered at 3,500 hospitals. Medicare payments per fee-for-service beneficiary grew by 6% from 2008 to 2009, the report said.

The 1% payment update recommendation is better news for hospitals than last year’s report, in which MedPAC recommended a 2% reduction each year for the next three years to make up for overpayments made in 2008 and 2009. The overpayments were the result of changes in the use of new diagnosis-related groups in 2008.

Congress should pass legislation that allows the government to recoup those overpayments, the trustees wrote.

The report found that the supply of hospitals, the range of services offered, and the volume of outpatient services provided at hospitals have grown over the past several years.

The quality of hospital care appears to be improving as well: Hospitals reduced mortality rates across five common medical conditions; however, readmission rates haven’t improved significantly, the trustees said.

The cost per patient discharged grew by 3% in 2009, compared with 2008, which saw the lowest growth since 2000, the report found. That “reflects the hospital industry’s response to the financial crisis that occurred in fall 2008, which increased pressure on hospitals to constrain their cost growth in 2009,” the trustees wrote.

Home Health Targeted for Cuts

In this year’s report, MedPAC criticized many aspects of the home healthcare system, pointing to the large amounts of fraud and the “flawed” way that Medicare pays for home health services.

MedPAC recommended that HHS totally revamp how it pays for home healthcare, including tacking on a copayment in order to make beneficiaries “more apt to consider the value of the benefit and share in decision making about when to use home health services.”

The trustees recommended no payment update for home healthcare services, because the number of home health agencies has increased to “an all-time high” and Medicare’s payments have exceeded their costs by nearly 18% for the 10th consecutive year, according to a press release from MedPAC.

The commission also said that fraud in home healthcare has become “a significant concern” and recommended that the Secretary of Health and Human Services and the Office of the Inspector General review counties with “aberrant home health utilization” and suspend provider enrollment and payment in counties where widespread fraud is discovered.

While AARP lauded MedPAC’s recommendation to give physicians a pay increase for 2012, the senior’s group expressed concern over the suggestions for home healthcare.

“While some of MedPAC’s other proposals for home healthcare address the root cause of rising costs, adding a copayment would simply shift costs to vulnerable seniors who often don’t have the resources to compare alternative treatments,” said AARP Legislative Policy Director David Certner in a prepared statement.

The MedPAC report also recommended: An increase of 0.5% for ambulatory surgical centers in 2012 A 1% increase for outpatient dialysis services A 1% increase for hospice facilities No payment increase for skilled nursing facilities, inpatient rehabilitation facilities, long-term care hospitals

MedPAC said managing payment updates “will not solve the fundamental problem with current Medicare [fee-for-service] payment systems — that providers are paid more when they deliver more services without regard to the quality or value of those additional services.”

DRESDEN, Germany, June 16 — Like Pinocchio’s nose, the olfactory bulb volume has a plasticity that can reveal some truths.

Changes in olfactory bulb volume correlate significantly with changes in smell function, suggesting prognostic and perhaps therapeutic implications for olfactory loss, a small clinical study suggested.

The investigators used serial MRI imaging to examine the relationship between olfactory bulb volume and olfactory function in 20 patients with olfactory deficits. The duration of the deficits ranged from three months to six years.

In initially hyposmic individuals, changes in olfactory bulb volume closely tracked changes in odor threshold, Thomas Hummel, M.D., of the University of Dresden, and colleagues reported in the June issue of Archives of Otolaryngology Head and Neck Surgery.

The findings provide the first longitudinal clinical evidence that the human olfactory bulb is a plastic structure that responds to changes in olfactory status.

“The correlation between [olfactory bulb] volume and olfactory function may potentially be used in combination with other factors influencing olfaction such as remaining olfactory function, age, and duration of olfactory loss as a means to provide patients with individual information on the prognosis of their disease,” the authors said.

“Especially since therapeutic options in patients with olfactory loss are limited, at present, this type of information is of high clinical significance,” they added.

Previous studies have examined olfactory bulb size in patients with posttraumatic and postinfectious olfactory deficits, congenital anosmia, and neurodegenerative diseases, as well as those with a normal sense of smell. The studies have indicated that olfactory bulb volume changes with olfactory function, decreases with duration of olfactory loss, and is reduced in patients with parosmia, the authors said.

Studies of animals have demonstrated a high level of plasticity in the olfactory bulb throughout life.

The clinical and preclinical observations have led to speculation that changes in olfactory bulb volume might reflect changes in olfactory function.

“This would support the idea of olfactory bulb volumetry as a prognostic tool in assessing the course of postinfectious and posttraumatic olfactory loss,” the authors said.

The study population consisted of 14 patients with postinfectious olfactory deficits, and the remaining six patients had posttraumatic olfactory loss. Seven patients had anosmia at the first evaluation and 13 had hyposmia.

Each patient’s olfactory function was assessed by means of a validated test kit comprising three evaluations: phenyl ethyl alcohol odor threshold, odor discrimination, and odor identification. Overall olfactory function was derived from the sum of the scores on the three individual tests.

The patients were evaluated twice, including MRI studies, at intervals 13 to 19 months apart. Separate correlation analyses between the change in olfactory sensitivity and olfactory bulb volume were performed for the hyposmic and anosmic patients.

In the 13 initially hyposmic patients, changes in olfactory bulb volume correlated significantly with odor threshold changes (r=0.82, P=0.001), indicating improvement in olfactory function and increased olfactory bulb volume. No correlations were seen for odor discrimination or odor identification.

“The present study emphasizes that olfactory bulb volume correlates with olfactory function, and our data support the evidence that the human olfactory bulb is a highly plastic structure,” the authors concluded.

The authors had no disclosures.

Primary source: Archives of Otolaryngology Head and Neck Surgery

Source reference:
Haehner A, et al “Correlation of olfactory function with changes in the volume of the human olfactory bulb” Arch Otolaryngol Head Neck Surg 2008; 134: 621-624.

ATLANTA, Dec. 13 – A strategy for treating low-grade B-cell lymphomas with Rituxan (rituximab) and tumor-specific vaccination appears to increase response rates and time to progression over Rituxan alone, reported investigators here.

In a phase II trial in patients with follicular B-cell non-Hodgkin’s lymphomas (NHL), Rituxan followed by vaccination with an antibody directed against a lymphoma-specific tumor idiotype resulted in a 64% overall response rate compared with Rituxan alone, Omer Koc, M.D., of the Cleveland Clinic and colleagues reported today at the American Society of Hematology meeting.

“This strategy of rituximab followed by the vaccination, if it can change the natural course of the disease, is very attractive for patients, because it does not contain chemotherapy,” Dr. Koc said in an interview.

He and his colleagues evaluated the combination of Rituxan for cytoreduction followed by the anti-tumor idiotype vaccination, called FavId.

The trial included 103 patients, all of whom had received Rituxan at 375 mg/m2 intravenously weekly for four weeks. Those patients who had either stable disease or a response to Rituxan then went on to receive the FavId vaccinations in a dose of 1 mg delivered subcutaneously monthly for six months, starting on week 12, with GM-CSF at 250 mcg subcutaneously on days one through four.

The patients could also receive booster vaccinations with FavId on a reduced schedule until disease progression.

At three months, 44 of the 89 patients had a treatment response following Rituxan, for an overall response rate of 49%, as measured by centralized reading of CT scans. Following the vaccinations, 57 of the 89 patients (64%) were determined to have a response.

The median time for improved response following the first vaccination was 6.6 months (5.8 – 23.4 months), “which was consistent with the time required to demonstrate an immune response in those patients tested,” Dr. Koc and colleagues noted.

Time to tumor progression was significantly shorter for patients with liver involvement (hazard ratio (HR) 9.3, P=0.0017) and those who had undergone three or more prior therapeutic regimens (HR, 4.7, P=0.0035).

At the time of presentation, the median time to progression had not been reached in either the 34 treatment-naive patients or in 26 patients who had relapsed after prior chemotherapy. The actuarial 18-month progression-free survival rate was about 70% for these patients, the authors reported.

The longest time-to progression was among the 23 treatment-naive patients who responded to the initial course of Rituxan; four of these patients (17%) have had disease progression.

At a median 22 months of observation, 19% of the total treatment-naive patients and 13% percent of the Rituxan responders have had disease progressed. The median time to progression among the 23 patients who relapsed following chemotherapy is projected to be 24.2 months, compared with 10.2 for historical controls.

In addition to the improvement in overall response rates, 29% of patients with stable disease improved to partial responses after the initiation of FavId, 5% improved from stable disease to a complete response, and 21% improved from a partial to a complete response.

Primary source: American Society of Hematology 47th Annual Meeting

Source reference:
Koc O et al. Extended Follow-Up and Analysis with Central Radiological Review of Patients Receiving FavId (Id/KLH) Vaccine Following Rituximab. Abstract #772, presented Dec. 13, 2005.

The cumulative prevalence of arrest for non-traffic violations for adolescents and young people (ages 8 to 23) increased substantially between 1997 and 2008, according an analysis of the National Longitudinal Survey of Youth (NLSY).
By the age of 18, the in-sample cumulative arrest rate was between 15.9% and 26.8%. At age 23, it ran between 25.3% and 41.4%, reported Robert Brame, PhD, from the University of North Carolina at Charlotte, and colleagues, in the January 2012 issue of Pediatrics.
When the researchers assumed that missing cases were at least as likely to have been arrested as the observed cases, the in-sample age-23 prevalence was between 30.2% and 41.4%. The greatest growth in the cumulative prevalence occurred between late adolescence and early adulthood.

The NLSY is a prospective household study including those who were between 12 and 16 years when the study was undertaken in 1997. Since then, 11 more surveys had been conducted through 2008 and released to the public.

Of the 7,355 youths who had self-reported arrests in, 6,748 (92%) participated in the NLSY 1997. To account for missing reports, they assumed that the missing cases were at least as likely as the known cases to have been arrested, or missing at random (MAR).

The authors noted that criminal behavior is a risk factor for adverse health, social, academic, occupational, economic outcomes. Their findings raise questions about pediatricians’ intervention opportunities and their consequences.

They found a growth in the cumulative arrest prevalence. beginning at around age 12 when the MAR estimate was near zero. By age of 18, the MAR rate was 17.8 and then appears to flatten out over the remaining years.

The researchers compared their findings to a 1965 survey for the Institute of Defense analysis (Task Force Report: Science and Technology 1967: 216-228). The 1965 MAR estimates were higher than those in the current analysis through the age of 15. From 16 to 18, the estimates between the two studies were comparable.

In people ages 19 to 23, the 1965 estimates increased at a much slower pace then those derived from the NLSY. By age 23, the 1997 figure of 30.2% was much higher than the 22% foreseen in 1965. The earlier estimate lies outside the 95% confidence interval for the NLSY-based estimate.

The researchers noted a limitation to their study was that they did not know the confidence intervals for the 1965 estimates, and the underlying assumption of the MAR estimate cannot be tested. Also, the arrest data was self-reported which may have limited accuracy and truthfulness.

“Using a contemporary U.S. sample of adolescents and young adults, we estimated the cumulative arrest prevalence through the age of 23,” the authors wrote. “The results suggest a substantial increase in the cumulative prevalence of arrest since the 1960s.”

The authors pointed out there is plenty of research published in Pediatrics regarding delinquency and problem social behaviors, such as drinking, drug use, and abuse.

But “until now there simply was no contemporary national prevalence estimate of the risk of a criminal arrest for American youth,” they said.”This is in spite of the fact that having an arrest record is known to be an important risk marker for violence involvement, violent victimizations, and an unhealthy and unsafe lifestyle.”

Pediatricians should be able to identify early risk factors for delinquency and play a pivotal role in early intervention, they added.

The authors noted no relevant financial relationships to disclose.

SAN DIEGO — The number of donor lungs that would be viable for transplantation could rise dramatically if novel handling techniques were used, researchers suggested.

In clinical testing to date, an investigational system for ex vivo warm perfusion and ventilation of donor organs improved lung function sufficiently to allow transplantation of 31 of 36 initially rejected lungs, Shaf Keshavjee, MD, director of the Toronto Lung Transplant Program, reported at the technology-focused Tech-Con portion of the Society of Thoracic Surgery conference here.

That novel technology alone could boost the number of donated lungs that are actually used to 60% from the current national average of 15%, Keshavjee projected.

According to the U.S. Human Resources and Services Administration, there are more than 1,800 Americans currently on the waiting list for lung transplants and, as with other donor organs, there is a shortage of available and viable lungs.

Another ex vivo lung perfusion technology described at the same session aims to improve the quality of all donated lungs to prevent organ deterioration.

This system uses a portable device that allows donor lungs to be put directly into warm perfusion with continuous monitoring of function for transport to the transplant hospital, eliminating cold ischemia, Kenneth R. McCurry, MD, of the Cleveland Clinic, explained to attendees.

The system is just entering testing in human lungs following positive animal studies that showed stable lung characteristics over six to eight hours of storage in the device.

However, Keshavjee criticized the decision to start testing the new technology in an international randomized trial using viable organs and then moving into testing it for lungs that don’t meet transplantation criteria — since there is a risk of ruining usable organs if the novel technology doesn’t pan out.

McCurry argued that the organ care system could offer a big advantage by improving the quality of even viable lungs, given the 20% to 57% rate of primary graft dysfunction after transplantation.

As well, the two techniques are not necessarily complementary, according to Keshavjee.

He argued that the focus should be regeneration and repair of donor organs, not on slowing down death of the organ after explantation.

“We can reach for the stars in terms of what we can do for that organ,” Keshavjee said after his presentation.

Keshavjee’s group designed a perfusion system to repair lungs received after hours on cold storage that used about $5,000 of disposables plus standard equipment available in all transplant centers: an ICU ventilator, reservoir, membrane oxygenator, leukocyte filter, pump, a chamber for the lungs, and tubing to hook it all together.

He presented preliminary results with the system in the HELP II trial. Of 306 consecutive multi-organ deceased donor offers, 23 of the 169 lungs rejected for transplantation met study criteria for ex vivo lung perfusion and the 111 accepted for transplantation acted as controls.

After four hours on ex vivo lung perfusion with lung protective ventilation, 20 of the ex vivo perfusion group lungs met transplant criteria and went on to be implanted.

Ex vivo lung perfusion significantly improved lung function as measured by the ratio of arterial oxygen concentration to the fraction of inspired oxygen and kept lung volume, pulmonary vascular resistance, and dynamic lung compliance stable.

Survival of transplant recipients was equal for both groups out to about 1.5 years post-transplantation (P=0.68).

These results were using the “best of the worst” donor lungs, Keshavjee noted.

“We should have a higher proportion of ones that don’t make it because then we really know we’ve got every potential organ we could have fixed,” he told MedPage Today. “We’re really trying to push further and see where the limit is.”

Keshavjee and McCurry agreed that ex vivo organ management technology could be spun off for use with other donated organ types to improve the number of usable organs — as well as the quality, safety, and outcomes of the transplants performed.

McCurry reported being the former chair of the data safety and monitoring board for Transmedics for a heart transplant trial.

Keshavjee reported having received research support from Vitrolife, Astellas Canada, Axela, and Xceed Molecular and holding a chair in transplantation research supported by the Canadian Institutes of Health Research and Wyeth (Pfizer).