Experimental antiretroviral treated vaginal ring

I've been reading JAMA for about 30 years, and reports of using African women and children as lab animals never cease to surprise me, because the benefits are usually accrued to western women. All the early contraceptive testing of 50+ years ago by the major drug companies, some really harmful; many nutrition tests on babies some getting supplements, some not, which could never be done in Europe or the USA; bed nets for malaria prevention when the disease was all but conquered by DDT before Rachel Carson.

" Antiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection. Abstract

The latest I saw is an experimental antiretroviral treated vaginal ring, randomized, double-blind, placebo-controlled study in Malawi, South Africa, Uganda and Zimbabwe.  168 acquired HIV, 71 from the treated ring group and 97 from the placebo group. And when data from 2 sites were excluded, there was higher rates of protection. I wonder how the researchers obtained consent? I wonder if the women were told that the only way to avoid HIV is no sex at all, since being sexually active was one of the requirements to participate. And I looked through the instructions.  Compliance must have been rough. And for 18-21 year olds there was low adherence--no surprise there. In most cases, an investigational drug must be proven effective and must show continued safety in a Phase III clinical trial to be considered for approval by FDA for sale in the United States.

http://www.nejm.org/doi/full/10.1056/NEJMoa1506110#t=article

http://www.niaid.nih.gov/news/QA/Pages/ASPIRE-ring-study-qa.aspx

http://www.ipmglobal.org/the-ring-study

http://www.ipmglobal.org/our-work/our-products

What you should know about ethinyl estradiol and estonogestrel --NuvaRing

From the product warnings:

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Avoid using a diaphragm with the ethinyl estradiol and etonogestrel vaginal ring. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

The ethinyl estradiol and etonogestrel vaginal ring will not prevent pregnancy if you wear it only during intercourse. You must wear the ring for 3 full weeks, followed by 1 full week without a ring. The timing of ring insertion and removal is very important for this medicine to be effective as a form of birth control.

Some drugs can make ethinyl estradiol and etonogestrel less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.