FDA advisory committee to review OTC availability of HIV test in May
BETHLEHEM, Pa. — OraSure Technologies on Wednesday announced that the Food and Drug Administration’s Blood Products Advisory Committee will consider making its OraQuick Rapid HIV-1/2 test available over the counter on May 15.
At the meeting, OraSure will present its consumer-usage studies — approximately 5,800 subjects were enrolled and tested in this phase across 20 states, the company said, which helped identify more than 100 previously undiagnosed individuals.
"There is an urgent need for additional testing options to identify individuals who are HIV- positive, link them to care and reduce transmission of the virus," OraSure president and CEO Douglas Michels said. "Our belief is that the availability of an easy-to-use, accurate in-home HIV test will enable more people to learn their presumptive HIV status so that they can receive necessary care and support."
According to the Centers for Disease Control and Prevention, there are approximately 1.2 million people in the United States who have HIV and despite current HIV testing options, approximately 240,000 of them are unaware of their status. It is estimated that those undiagnosed are responsible for up to 70% of the approximately 50,000 new HIV infections occurring each year in the United States. The CDC recommends all people ages 13 to 64 years be offered an HIV test in healthcare settings, with more frequent testing for people at higher risk.
Citing clinical studies conducted by OraSure, the CDC noted the OraQuick oral fluid test correctly identified 99.3% of people who were infected with HIV (sensitivity) and 99.8% of people who were not infected with HIV (specificity). The Food and Drug Administration expects clinical laboratories will obtain similar results.
The OraQuick rapid HIV test for use with blood was waived under the Clinical Laboratory Improvements Amendments of 1988 in January 2003, and waived for use with oral fluid in June 2004. A waived test can be used in any facility with a CLIA certificate, rather than only in traditional laboratories. As such, a waived test can be used in many non-clinical settings.
Such was the case last summer when Walgreens teamed with Greater Than AIDS on a national awareness campaign around HIV/AIDS in the United States, to distribute informational resources and specialized HIV-related services at more than 300 Walgreens pharmacies in affected communities.
At these specialized pharmacy locations, Walgreens had pharmacists on hand to offer one-on-one medication counseling and other support services that provide customers living with HIV/AIDS and their families with compassionate, confidential care. Free rapid oral HIV testing was available at select Walgreens with technical support and guidance from the Centers for Disease Control and Prevention and test kits from OraSure Technologies.
State and local health departments and community-based organizations in the local markets conducted the tests and providing pre- and post-test counseling.
That means this could be the first switch application that could significantly benefit from a pharmacist or nurse practitioner intervention in the wake of last month’s FDA public meeting on expanding the switch paradigm. One of the concerns associated with an OTC HIV test is the availability of counseling following a positive/false positive result. The OraQuick Rapid HIV point-of-care test produces results in 20 minutes — and if that 20 minutes transpires in a pharmacist or nurse clinician consultation room a person finding out that they are HIV positive would have immediate access to a healthcare professional.
To review the OraQuick Advance package insert, a product presently available to clinicians, click here.
Americans buying supplements even as they tighten their belts
WASHINGTON — More than two-thirds of Americans (71%) reported the economy has not affected their household’s purchasing habits of dietary supplements, according to a survey released Wednesday by the Council for Responsible Nutrition.
The CRN study is in line with a special report in AdAge magazine titled “The New Necessities: What Products and Services Can Consumers Not Live Without?,” citing a study by advertising agency Leo Burnett which studies the impact of consumer "wants" versus "needs" in a down economy. In a diagram of wants versus needs, vitamins were listed as something that consumers couldn’t bear to cut back on, which was on par with car insurance, routine car maintenance, mobile phone service and household repairs.
“What’s interesting about our survey findings and those of Leo Burnett is that, even in the midst of trying economic times, dietary supplements are not something consumers are willing to sacrifice," CRN SVP communications Judy Blatman said. "While they certainly are looking for ways to save money, they clearly know the value of using dietary supplements to promote overall health and wellness,” she said. “Given the ongoing debate about health care in America, it’s encouraging to see consumers taking proactive steps, such as incorporating dietary supplements into their health regimen.”
The remaining respondents (29%), however, reported that the economy has impacted their household’s purchasing habits of supplements. The study asked specifically how it affected their purchasing habits, and only 7% of Americans report they have stopped purchasing supplements altogether because of the economy.
Still, overall use of dietary supplements is on the rise with 69% of all Americans reporting that they use supplements, up from 66% in 2010. For the 3-in-10 of consumers whose supplement purchasing habits have been affected by the economy, many are engaging in a variety of money saving tactics, including buying fewer supplements as a means to save money; buying supplements only when they are on sale; and purchasing less expensive supplement brands.
The CRN survey also found that the supplement purchasing habits of those ages 55 years and older were least affected by the trying economy, with 78% of that group indicating as such, followed by consumers ages 18 years to 34 years (70%) and those ages 35 years to 54 years (65%). Gender didn’t appear to be a factor.
The 2011 CRN Consumer Survey on Dietary Supplements was conducted Aug. 25 to 29, 2011 by Ipsos Public Affairs and funded by CRN. The survey was conducted online and included a national sample of 2,015 adults ages 18 years and older from Ipsos’ U.S. online panel. The survey has been conducted annually since 2000.
Wellness works: More than half of employers include wellness program in health package
NEW YORK — More employers continue to start wellness programs, and the majority of organizations with programs currently in place are looking to invest and expand, according to the "2011 Willis Health and Productivity Survey" by Willis North America’s Human Capital Practice released Tuesday.
According to the survey, 60% of respondents indicated they have some type of wellness program, an increase of 13% from 2010. Additionally, employers are not scaling back — 58% indicated they plan to expand their wellness initiatives with added programs or resources. “Wellness programs continue to evolve, and it is encouraging to see more organizations initiate programs despite economic pressures and continuing challenges in accurately measuring outcomes and results,” stated Jennifer Price, senior health outcomes consultant at Willis Human Capital Practice.
Additional key findings from the survey include:
60% of employers indicated they had some type of wellness program. Of those with a wellness program, 40% reported they have an “intermediate” program in place;
The most common types of wellness programs being offered by respondents included physical activity programs (53%), tobacco cessation programs (49%) and weight management programs (45%); and
43% of employers said the leading barrier to measuring success was difficulty in determining the influence of wellness compared with other factors impacting healthcare costs. Insufficient data and not enough staffing/time remain common barriers to measuring success.
The survey represents the findings received from 1,598 employers representing a cross-section of industries, locations and organizational sizes. Forty-four percent of respondents had 1,000 or more employees.
To download the survey click here.