PHARMACY

CDC releases annual STD report

BY Michael Johnsen

ATLANTA The Centers for Disease Control and Prevention on Tuesday released its annual report regarding sexually transmitted diseases—finding that STD are most prevalent among women and minorities.

The report, Sexually Transmitted Disease Surveillance, 2007, showed that cases of chlamydia and gonorrhea in the United States exceeded 1.4 million in 2007, making these specific STD’s the most commonly reported infectious diseases.

The report also found continued increases in syphilis, a venereal disease once on the verge of elimination. Syphilis began re-emerging as a threat in 2001 and increased 15.2 percent between 2006 and 2007.

“The widespread occurrence of these diseases should serve as a stark reminder that STDs remain a serious health threat in the United States, especially for women and racial and ethnic minorities,” said John Douglas, Jr., director of CDC’s Division of STD Prevention. “Left untreated, chlamydia and gonorrhea can cause infertility, affecting a woman’s chance to bear children later in life. Such a severe consequence is entirely avoidable, if as a nation we work together to increase the use of proven prevention tools and make them widely available to those who need them.”

Women continue to bear a disproportionate burden of the long-term health consequences of STDs, the agency stated. In 2007, the chlamydia rate among women was three times that of men (543.6 cases per 100,000 women, compared to 190 cases per 100,000 men). The gonorrhea rate was also higher among women (123.5 per 100,000 women, compared to 113.7 per 100,000 among men).

If left untreated, up to 40 percent of chlamydia and gonorrhea infections in women can result in pelvic inflammatory disease — a condition that causes as many as 50,000 women to become infertile each year. Untreated chlamydia or gonorrhea can also cause ectopic pregnancy, chronic pelvic pain, and other serious health problems.

The report found that there were more than 1.1 million chlamydia cases reported in 2007, up from about one million in 2006, making it the largest number of cases ever reported to CDC for any condition. Gonorrhea, the second most commonly reported infectious disease, had more than 350,000 cases reported in 2007. However, it is estimated that more than half of all new infections with chlamydia and gonorrhea continue to go undiagnosed, underscoring the importance of increased screening. CDC recommends annual chlamydia screening for all sexually active women under 26 years old, and supports U.S. Preventive Services Task Force recommendations to screen high-risk, sexually active women for gonorrhea.

CDC’s 2007 STD surveillance report also indicates ongoing racial disparities in the three most common reportable STDs, with African-Americans bearing the greatest burden. While representing 12 percent of the U.S. population, black men and women had about 70 percent of reported gonorrhea cases and almost half of all chlamydia and syphilis cases (48 percent and 46 percent respectively) in 2007, the CDC said.

STDs take an especially heavy toll on black women 15 to 19 years of age, who account for the highest rates of both chlamydia (9,646.7 per 100,000 population) and gonorrhea (2,955.7 per 100,000 population) of any group. STDs in this age group are of particular concern because of the potential threat of these two diseases to a woman’s fertility.

Studies have shown that one of the most important social determinants of sexual health is socioeconomic status. Higher rates of poverty among blacks than whites, and socioeconomic barriers to quality healthcare and STD prevention and treatment services have been associated with higher prevalence and incidence of STDs among racial and ethnic minorities.

“The racial disparities in rates of STDs are among the worst health disparities in the nation for any health condition,” Douglas said. “We must intensify efforts to reach these communities with needed screening and treatment services. Testing and the knowledge of infection is a critical first step toward reducing the continued consequences of these diseases.”

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GSK completes acquisition of Stiefel

BY Allison Cerra

LONDON A drug maker has announced it has completed the acquisition of a company specializing in skin care.

GlaxoSmithKline announced that it has completed its acquisition of Stiefel Labs. GSK has acquired the total share capital of Stiefel for a cash consideration of $2.9 billion. GSK also assumed $0.4 billion of net debt. Under the terms of the agreement, GSK may be obligated to make additional cash payments of up to $0.3 billion depending on the future performance of the business. The new dermatology business unit within GSK will operate under the name Stiefel, a GSK company.

“The Stiefel acquisition demonstrates how we are implementing our strategy to grow and diversify our business through targeted acquisitions,” Deirdre Connelly, president North American Pharmaceuticals at GSK. “We now have established a new world-leading, specialist dermatology business that will immediately generate new revenue flows to GSK.”

Charles Stiefel, Chairman of Stiefel, said, “As part of GSK, we are stronger, more competitive and continue to be a driving force in dermatology around the world. We are excited to combine GSK’s prescription dermatology products, such as Bactroban, Cutivate and Altabax, with Stiefel’s portfolio, including brands such as Duac, Olux E and Soriatane. This combined portfolio, together with our specialty sales force and GSK’s global presence, positions GSK’s dermatology business for significant growth.”

Sales of Stiefel’s products for 2008 were approximately $900 million and sales of GSK’s prescription dermatology products were approximately $550 million. The combined pro forma revenues of approximately $1.5 billion, represent an 8% share of the global prescription dermatology market.

Stiefel is committed to improving and developing new treatments and has a robust development pipeline, with more than 15 projects in late-stage development across a wide variety of such dermatological conditions as acne, dermatoses and fungal infection. The business unit also has access to significant innovative and proprietary formulation technologies.

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Trial for MS drug should continue, company’s DSMB says

BY Alaric DeArment

EDMONTON, Alberta An independent data safety monitoring board has recommended that a phase 3 trial for a multiple sclerosis drug continue.

BioMS Medical Corp. announced Tuesday that the DSMB for its pivotal phase 3 trial of the drug dirucotide in patients with secondary progressive MS has completed its safety analysis and recommended the continuation. This was the fourth of several regularly scheduled reviews by the DSMB, BioMS said.

The study is a randomized, double-blind study that has completed recruitment of more than 500 patients at 67 clinical sites who will receive either dirucotide or placebo intravenously every six months for the next two years.

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