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Adolescent Obesity Study
Drs. Timothy Halliday and Sally Kwak, economics professors at the University of Hawaii at Manoa, recently published a paper in Economics and Human Biology titled, "Weight Gain in Adolescents and Their Peers." The article examines trends in adolescent body mass index (BMI) in a nationally representative dataset.
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NYC Law Makes It Easier To Press Charges Against Antiabortion Protesters Outside Clinics
A New York City law that will go into effect in July could make it easier for antiabortion-rights protesters to be arrested for restricting access to abortion clinics or harassing people trying to enter the facilities, the New York Times reports. Current law allows authorities to make arrests only if the person directly affected, such as a woman entering a clinic, is willing to press charges. However, the new law would allow third parties, such as clinic workers, to press charges if they witnessed the activity, the Times reports. New York City"s Dr. Emily"s Women"s Health Center and NARAL Pro-Choice New York spearheaded efforts to pass the legislation in response to antiabortion-rights demonstrators who target women on their way to clinics and attempt to persuade them to carry their pregnancies to term. Clinic workers report that the protesters also have harassed women as they left the subway or surrounded them as they walked to the clinic. New York City Mayor Michael Bloomberg signed the law in April. Joan Malin, president and CEO of Planned Parenthood of New York City, said the group is "not against people demonstrating. But there is a line between freedom of speech and harassment and bullying" (Bosman, New York Times, 6/6).
News of the day
Major Medical Groups Back Comp Effectiveness Legislation
"Major medical organizations are urging health committees in the House and Senate to make comparative-effectiveness research a key component of healthcare reform," Modern HealthCare reports. The Senate Health, Education, Labor and Pension Committee"s bill "plans for a new federal center on health outcomes research was seen by some GOP members as a possible means to ration healthcare." But "a letter, co-signed by the American Medical Association and more than 60 other groups, countered that comparative-effectiveness research would not lead to "cookbook" medicine or rationing of expensive forms of care" (Lubell, 6/26).
Medical Devices

Antares Pharma And Population Council Announce Preliminary Positive Phase 2 Trial Results

Antares Pharma, Inc. (NYSE Amex: AIS) and the Population Council announced preliminary positive results from the Phase 2 trial for a novel contraceptive gel containing the progestin Nestorone and the bio-identical estrogen estradiol (NES/E2) utilizing the Antares ATD (advanced transdermal delivery) gel system. The trial is a dose finding, open-label, cross-over study to evaluate the effect of NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women. Eighteen women have participated in the trial, which is taking place in three sites: Los Angeles, California; Santo Domingo, Dominican Republic; and Santiago, Chile, and is scheduled to conclude active treatment in October 2009. The preliminary data shows that all doses suppress ovulation. In addition, no serious adverse events have been recorded, and there have been no instances of skin irritation to date in the study. Each woman in the study receives three separate doses of the gel for 21 days, separated by a washout month in which no products are administered. The primary objective of the study is to find the lowest acceptable dose of the NES/E2 gel to achieve appropriate therapeutic levels for effective contraception (ovulation suppression), as measured by progesterone levels and ultrasound evaluation of follicular development. Secondary objectives include determining the plasma profile of estradiol needed to reach estrogen replacement levels and to maintain regular bleeding patterns. General safety and tolerability of the NES/E2 gel, including any local skin irritation, is also being assessed. This study follows on the successful completion of a Phase 1 study, which found an effective combined dose that consistently delivered Nestorone. In the Phase 1 study, serum levels, following multiple administrations, matched the target range expected to provide effective contraception. Blood levels for estradiol were also, on average, within the range for maintenance of a normal estrogenic environment and likely resulting in regular bleeding patterns. Commenting on the progress of the current study, Regine Sitruk-Ware, executive director for research and development in the Reproductive Health Program of the Population Council, said, "We are encouraged by the preliminary results for this study. This is the first time these formulations have been used with ovulating women, and thus far they are meeting our expectations for both safety and efficacy." Antares senior vice president and managing director of the pharmaceutical group Dario Carrara Ph.D., said, "We are very pleased with the progress of the study and that the interim results validate the product concept. A transdermal gel offers an excellent opportunity to provide safe and effective contraception through an innovative drug delivery system in a large and growing global market segment." The National Survey of Family Growth has revealed that 31 percent of women discontinue use of reversible contraceptives for method-related reasons within six months of starting use, and 44 percent do so within 12 months. The novel NES/E2 transdermal gel offers a potentially attractive contraceptive option, in that both the formulation and the active compounds are designed to reduce the adverse events profile observed with current contraceptive methods and therefore could result in higher continuation rates by users. Worldwide contraception product sales in 2005 were $3.6 billion, with projections of approximately $4.5 billion by 2010, as reported by Thomson Pharma®. Under the terms of a joint development agreement, Antares is responsible for research and development activities as they relate to ATD formulation and manufacturing, using the Population Council"s patented and other proprietary information covering the compound. The Population Council is responsible for research on Nestorone and clinical trial design development and management. Together the parties expect to partner Nesterone with a worldwide or regional organization in order to commercialize it. About Nestorone® Nestorone is a fourth-generation synthetic progestin contraceptive derived from progesterone that has no androgenic hormonal effects and a good safety profile. It is not active when administered orally and is therefore especially appropriate for topical application as well as for use when breastfeeding. About ATD™ Gel Technology ATD™ Gel Technology is a hydroalcoholic transdermal gel containing less than 50 percent ethanol and a patented mixture of penetration enhancers. The matrix including Nestorone and bio-identical estradiol is designed to simultaneously deliver both drugs across the skin in a controlled and sustained fashion over a 24-hour period, and result in therapeutic plasma levels. The gel is crystal clear and cosmetically appealing, and dries readily after application to the abdomen, thighs, arms, or shoulders without leaving residues. Due to the low ethanol content, the gel is minimally irritating, as demonstrated by a similar FDA-approved formulation using ATD™ Gel Technology, ELESTRIN™ (low-dose estradiol for treating menopausal hot flashes). Antares Pharma


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