OMNI Postings of 10/6/09
A: A stowaway on a kamikaze plane.
Cocaine Vaccine for the Treatment of Cocaine Dependence in Methadone-Maintained Patients
A Randomized, Double-blind, Placebo-Controlled Efficacy Trial
Bridget A. Martell, MD, MA; Frank M. Orson, MD; James Poling, PhD; Ellen Mitchell, RN; Roger D. Rossen, MD; Tracie Gardner, PhD; Thomas R. Kosten, MD
Arch Gen Psychiatry. 2009;66(10):1116-1123. (http://archpsyc.ama-assn.org/cgi/content/abstract/66/10/1116)
Context Cocaine dependence, which affects 2.5 million Americans annually, has no US Food and Drug Administration–approved pharmacotherapy.
Objectives To evaluate the immunogenicity, safety, and efficacy of a novel cocaine vaccine to treat cocaine dependence.
Design A 24-week, phase 2b, randomized, double-blind, placebo-controlled trial with efficacy assessed during weeks 8 to 20 and follow-up to week 24.
Setting Cocaine- and opioid-dependent persons recruited from October 2003 to April 2005 from greater New Haven, Connecticut.
Participants One hundred fifteen methadone-maintained subjects (67% male, 87% white, aged 18-46 years) were randomized to vaccine or placebo, and 94 subjects (82%) completed the trial. Most smoked crack cocaine along with using marijuana (18%), alcohol (10%), and nonprescription opioids (44%).
Intervention Over 12 weeks, 109 of 115 subjects received 5 vaccinations of placebo or succinylnorcocaine linked to recombinant cholera toxin B-subunit protein.
Main Outcome Measure Semiquantitative urinary cocaine metabolite levels measured thrice weekly with a positive cutoff of 300 ng/mL.
Results The 21 vaccinated subjects (38%) who attained serum IgG anticocaine antibody levels of 43 µg/mL or higher (ie, high IgG level) had significantly more cocaine-free urine samples than those with levels less than 43 µg/mL (ie, low IgG level) and the placebo-receiving subjects during weeks 9 to 16 (45% vs 35% cocaine-free urine samples, respectively). The proportion of subjects having a 50% reduction in cocaine use was significantly greater in the subjects with a high IgG level than in subjects with a low IgG level (53% of subjects vs 23% of subjects, respectively) (P = .048). The most common adverse effects were injection site induration and tenderness. There were no treatment-related serious adverse events, withdrawals, or deaths.
Conclusions Attaining high (>43 µg/mL) IgG anticocaine antibody levels was associated with significantly reduced cocaine use, but only 38% of the vaccinated subjects attained these IgG levels and they had only 2 months of adequate cocaine blockade. Thus, we need improved vaccines and boosters.
Trial Registration clinicaltrials.gov Identifier: NCT00142857
Healthcare IT News (10/5, Monegain) reported, “The number of physicians using electronic prescribing will have more than doubled in 2009, executives of the e-prescribing network Surescripts said.” The company said more than “140,000 — 23 percent of all office-based physicians, nurse practitioners and physician assistants in the United States — are e-prescribing today,” and at the “current pace, Surescripts projects that its active e-prescribers in 2009 will more than double the 74,000 that were e-prescribing at the end of 2008.”
Link: http://healthday.com/Article.asp?AID=631520
MONDAY, Oct. 5 (HealthDay News) — Parents beware: It’s not unusual for children to ingest the “button” batteries that power everything from wristwatches to cameras, a new study warns.
Some kids swallow the batteries, while others stick them up their nose, researchers found after monitoring cases at a pediatric hospital over a 10-year period and checking case reports from elsewhere.
But, the study authors pointed out, parents and health-care providers often aren’t aware of the dangers posed by these miniature disc batteries.
Button batteries, which are about the size of a coin or smaller, power a variety of devices, including hearing aids, calculators, small toys and musical greeting cards, according to information in a news release from the American Academy of Otolaryngology–Head and Neck Surgery Foundation.
An estimated 3,000 people of all ages accidentally ingest the batteries each year in the United States. About two-thirds of the cases involve children under age 5, with 1- and 2-year-olds at highest risk, the researchers noted.
In the most severe cases, serious consequences can develop, such as vocal paralysis, the need for throat and gastrointestinal tubes, and perforation of nasal passages, according to the study authors.
The experts say it’s vital for physicians to promptly identify and treat ingestion of button batteries. They also call for better packaging and markings on button batteries.
According to the U.S. National Institutes of Health, ingested batteries can cause a variety of symptoms, including abdominal pain, chest pain and vomiting.
The study findings were scheduled to be presented by Dr. Dale Amanda Tylor of Vanderbilt University Medical Center, Nashville, Tenn., and Dr. Seth Pransky of San Diego, at the 2009 American Academy of Otolaryngology–Head and Neck Surgery Foundation annual meeting, held Oct. 4 to 7 in San Diego.
MMWR October 2, 2009 / 58(38);1075
Link: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5838a6.htm?s_cid=mm5838a6_e
QuickStats: Prevalence* of Obesity† Among Adults Aged ≥20 Years, by Race/Ethnicity§ and Sex — National Health and Nutrition Examination Survey, United States, 2003–2006

The age-adjusted percentage of adults aged ≥20 years who were obese during 2003–2006 varied by race/ethnicity among women, ranging from 53.3% for non-Hispanic black women to 41.8% for Mexican-American women and 31.6% for non-Hispanic white women. Obesity levels were more similar for Mexican-American men (28.8%), non-Hispanic black men (35.0%), and non-Hispanic white men (32.0%). None of the groups had met the Healthy People 2010 target of 15% (objective 19-02).
SOURCES: National Health and Nutrition Examination Survey, 2003–2006. Available at http://www.cdc.gov/nchs/nhanes.htm.
Healthy People 2010 database. Available at http://wonder.cdc.gov/data2010.
US Department of Health and Human Services. Healthy People 2010. 2nd ed. With understanding and improving health and objectives for improving health. 2 vols. Washington, DC: US Government Printing Office; 2000. Available at http://www.health.gov/healthypeople.
Link: http://www.nytimes.com/2009/10/06/nyregion/06vaccine.html?_r=1&th&emc=th
NY Times
The fear of swine flu is being compounded by new worries, this time among primary care doctors who say that they are swamped by calls from patients seeking the new vaccine, and that they are ill-prepared to cope with the nationwide drive to immunize everyone, particularly children and chronically ill adults.
The federal Centers for Disease Control and Prevention released the first doses of vaccine on Monday. But many doctors, especially pediatricians, say they know little about the program and have been deluged with questions.
At the same time, the pediatricians are struggling to figure out how to administer perhaps thousands of doses quickly in small offices with limited staff, while still dealing with other illnesses.
Some said they were considering hiring nurses just for the vaccinations and setting aside days when children would be vaccinated in alphabetical order.
At Westchester Pediatrics, an office with 6,000 to 8,000 families in Hartsdale, N.Y., exasperated doctors have added a new choice to the office answering machine: “If you have a question about the flu vaccine, please dial 6.” Pressing 6 produces a further message saying that the swine flu vaccine is not yet available, and to keep checking the CDC.gov Web site for updates.
For those who are not satisfied, a sign in the office waiting room counsels patience.
Kathryn Paterno, the office manager, summed up the situation as “a nightmare.”
“People want it,” Ms. Paterno said of the swine flu vaccine. “When they listen to news reports, they pick out bits and pieces — ‘swine flu, get it’ — but they don’t quite comprehend that we don’t have it yet, and we’re dealing with a quite affluent socioeconomic group here.”
When asked whether his office had received vaccine inquiries, Dr. Herbert Lazarus, a pediatrician on the Upper West Side, said only half-jokingly: “Do you think that’s accounting for two-thirds of our phone calls, or three-quarters?”
In Philadelphia, Dr. Shea Cronley of Advocare Society Hill Pediatrics said she was concerned that emergency rooms were starting to see a rise in flu cases, but she did not know when she would be getting her share of vaccine.
“We’re waiting,” she said.
The Centers for Disease Control has embarked on an extensive immunization drive with a goal of producing 195 million to 250 million doses of vaccine.
The vaccine is being distributed free to local jurisdictions, like city and state health departments, which are responsible for taking orders from doctors, hospitals, school systems and the like. Normally, doctors order vaccines directly from manufacturers.
As of Monday, 62 states or localities had put in orders for a total of more than 1.7 million doses.
Actual delivery will lag, however, adding to the confusion about when doctors will get their share. The New York City Department of Health and Mental Hygiene said Friday that it expected to get only 68,800 doses by early this week, and New York State expected 59,000. Increasing amounts of vaccine are expected to be available in the next few weeks.
Even the city’s public hospitals remained uncertain about the logistics. “We are prepared to provide access to the H1N1 vaccine,” said Ana Marengo, a spokeswoman for the New York City Health and Hospitals Corporation, “and the piece of information still missing is knowing when it will be available and how much everyone will get.”
Kathleen Sebelius, secretary of Health and Human Services, acknowledged the concerns, but said it was up to local health departments to run interference between doctors, hospitals and the federal government.
“I’ve heard a lot about how much confusion there is about how to get the vaccine,” Ms. Sebelius said Friday.
“We’ll never, from the mother ship, give one national picture,” she added. “It’s going to be many, many local decisions. What we do need to know is, if that information isn’t getting across, then maybe we can do something about it.”
Many school districts, including New York’s, are making plans to immunize children at school. But in interviews over the last few days, doctors said they were confused about whether they were expected to vaccinate their patients, or whether schools would take the lead.
“That’s a critical issue, and I can’t find out,” said Dr. Max Van Gilder, a New York City pediatrician in an office with about 4,800 patients.
In the Chicago suburb of Evanston, Ill., Dr. Irwin Benuck, a pediatrician in a practice of 8,000 patients, said parents were flooding the office with questions about when the vaccine would be available. He has ordered the vaccine from the local health department, but he does not know when he will get it. He is telling families also to look to other sources, like schools and drugstores.
“We’ve heard nothing in terms of timetables,” he said.
Dr. Jane R. Zucker, assistant commissioner of New York City’s bureau of immunization, said the city considered doctors to be the first line of defense, and the schools a backup for children who did not have private doctors.
She said that New York would be splitting its first shipment of vaccine (in the form of a nasal mist unsuitable for pregnant women and people with chronic health conditions) between health care workers in hospitals and clinics, who are required by state law to be immunized, and doctors treating children.
She said the city expected to get the vaccine into its elementary schools by early November and was considering setting up weekend vaccination clinics for older children.
Some doctors wondered whether the vaccination drive was necessary for a flu that has caused only mild symptoms in most cases. They said some of their patients had expressed doubts about whether the vaccine had been sufficiently tested for safety, and they admitted that they were sympathetic to those fears.
Dr. Lazarus, the Upper West Side pediatrician, recalled that as a child, he had lined up for the polio vaccine on a sugar cube. But it was the early 1960s, he said, and by then the science of that vaccine was well established. “You don’t always want to be the first person on line to get the vaccine — do you think?” he said.
Dr. Jessica Sessions, director of pediatrics at the Ryan Center, which treats many poor patients on the Upper West Side, said that she was reassuring patients that she herself was going to get the vaccination, to protect her twins, who are 4 ½ months old.
Dr. Van Gilder said that when he got his share of vaccine — and he was wondering when that would be — he was planning to conduct a vaccination blitz, immunizing 250 children a day in alphabetical order.
“It’s a logistical nightmare,” he said.