FDA Issues ‘Black Box” Warning for Depo-Provera
New Research Shows Dangers of Condoms in HIV Prevention
UK Sex Ed/ Condom Program Backfires
FDA ISSUES ‘BLACK BOX’ WARNING FOR DEPO-PROVERA, Long-Term Use Linked to Significant Bone Density Loss — this is the strongest warning a drug can carry — to the labeling of Pfizer’s injectable contraceptive Depo-Provera (D-P). It works by releasing a high level of progestin to stop the ovaries from releasing eggs & is administered by a shot from a health care worker about every three months; it has a failure rate of about 1% (Wall Street Journal, 11/18).
Although FDA says the drug remains “safe and effective,” the agency and Pfizer decided to add the warning label to “ensure that physicians and patients have access to this important information,” according to an FDA release (FDA release, 11/17).
The black box warning states that bone density loss increases the longer the drug is used and that such bone density loss is not always completely reversible after use of the drug is discontinued. In addition, the labeling will warn that patients should not use the drug for more than two years unless all other birth control methods have been deemed inadequate (FDA release, 11/17).
FDA issued the warning after reviewing data from two separate studies that showed Depo-Provera’s effect on bone density during prolonged use. One study began in 1994 and enrolled 540 women ages 25 to 38. The other study — which started in 1997 and will continue through 2006 — enrolled about 400 girls ages 12 to 18 who were taking the drug and is examining ways to reverse bone mineral density loss. In addition to the black box warning,
Pfizer also is planning to issue a letter to physicians that will explain the effect of long-term use of the contraceptive on bone density.
[D-P is also considered to have the abortifacient effect of preventing implantation.]
[AP/Yahoo! News, 11/17; N Valko RN http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=26803Kaiser Daily Reproductive Report (not prolife), 11/18/04]
NEW RESEARCH SHOWS DANGERS OF CONDOMS IN HIV PREVENTION – The drumbeat for condoms continues as does the evidence mount that they are not the silver bullet for the HIV/AIDs pandemic. Evidence presented in DC by researchers [Harvard & Univ of California – San Francisco] shows that availability of condoms statistically increase promiscuity and the risk of contracting HIV.
The findings on the “ABC” approach to the HIV/Pandemic, hosted by the Medical Institute for Sexual Health, were critical of the insistence by some NGO’s and policy makers that the “C” (condom) approach will stem the tide of the pandemic.
“20 years into the pandemic there is no evidence that more condoms lead to less AIDS,” stated Dr. Edward C. Green of Harvard’s’ Center for Population and Development Studies. Citing data on condom availability in many African counties, Green went on to say that “we are not seeing what we expected: that higher levels of condom availability result in lower HIV prevalence.”
Dr. Norman Hearst of the University of California — San Francisco supported this analysis with statistics on Kenya, Botswana, and other countries, which show an increasingly alarming pattern of increased condom sale correlation with rising HIV prevalence by year.
Promotion of the “safe-sex” message has reportedly increased numbers of sexual partners. The spread of HIV is a behavioral problem, according to Green, who said that “having multiple sexual partners drives AIDS epidemics. If people did not have multiple sex partners, epidemics would not develop or, once developed, be sustained.” He continued, “over a lifetime, it is the number of sexual partners [that matter]. Condom levels are found to be non-determining of HIV infection levels.”
Unfortunately, Hearst stated, we are “raising a generation of young people in Africa that believe that condoms will prevent HIV.” This is concerning because condoms are not 100% effective, even when used properly. According to Hearst, “the most recent Met-analysis came up with 80%; but even if it is 90%, over time it’s the question of when, not if. You don’t want to give people a false sense of security and A and B are better in the long term.”
In other cases, often reported by proponents of the safe-sex message, countries such as Thailand saw incidence rates for HIV decrease after the government mandated 100% condom use in brothels.
Unfortunately, according to Hearst and Stoneburner, proponents rarely look closer at the data, and in such instances behavior change had much more to do with the decreased rates of transmission. “This is usually attributed to 100% condom use, but visits to sex workers declined by 60%; they did so out of fear and risk avoidance.”
It is the behavior change advocated by the “A” and “B” approach that is additionally supported by data, such as in the famed Uganda case. According to Dr. Rand Stoneburner (formerly of the WHO and an independent advisor to USAID), “declines of HIV in Uganda are linked to behavior change.[and] include primary risk avoidance with a 65% decline in causal sex.”
The Ugandan government, which promoted abstinence and faithfulness, helped bring about a 75% decline in HIV prevalence among 15-19 age group, 60% in the 20-24, and a 54% decline overall by 1998.
Stoneburner and others believe the change was due to different language used. In Uganda, President Museveni reportedly repeated to Ugandans “you are going to die if you don’t stop this!” whereas in other countries, there is little talk of death.
Stoneburner pointed out “25% of South Africans don’t believe HIV causes AIDS” and in many countries “they do not talk about death links to AIDS.” This information proves the unfortunate effectiveness of the “safe sex” message that increasingly places individuals at risk for HIV transmission and STDs worldwide. [Harvard and the Univ of CA – San Francisco; 13 Jan04, Culture of Life Fdn,.www.colfi.org, CULTURE & COSMOS,Volume 1, Number 23]
SEX ED/CONDOM PROGRAM BACKFIRES United Kingdom studies revealed that teen pregnancy rates are highest in areas that are most aggressive in promoting sex education. Teen pregnancy rose from 38,439 in 2001 to 39,286 in 2002, despite the 15 million British pounds spent to counter the problem. In 2001, 17,682 of these babies were aborted. STDs also rose by 62% between 1997 and 2002. Free condoms are distributed and girls are sent a card on their 14th birthday inviting them to receive a confidential medical examination. It should also be noted that EC/MAP has been available OTC since 1/1/01 for those over 16, and by prescription (no parental knowledge) for those under 16. [Sex Education or Indoctrination?, Family Education Trust (FET); The Caleb Report, Mar/Apr 04]