Condoms Fail the Safety Test, FDA Halts Imports (9/05)
Ugandan Condom Promotion Fails to Reduce Risk, Study Shows (9/05)
Planned Parenthood Turns A Deal on Morning After Pill Sales
Condom Errors Increase Gonorrhea Risk Among Men (AJHB,7-8/05)
Study Suggests Importance of Documenting the Impact – or Failure -of Condom Promotion
Birth Control Patch Manufacturer Faces Class Action Lawsuit
Right of Conscience for Pharmacists…
CONDOMS FAIL SAFETY TEST, FDA HALTS IMPORTS – The Sydney Morning Herald reports that a shipment of condoms from Thailand
to the United States from Ansell, makers of Lifestyles, Mates and Kama Sutra brands, has failed the FDA safety standard tests.
This is the second consecutive failure for the condom companys Thailand plant. Ansell officials refused to identify which brand had failed inspection.
The LifeStyle condom is the third largest seller in the world, with 11 percent of world condom sales. According to the Herald, Ansell reported August total sales for all products of $824 million, up from $791 million in August of 2004.
According to the Sydney Morning Herald, the Thailand plant has been placed on Level 2 and can not ship products to the United States until ten consecutive shipments pass the safety tests. If another shipment fails, the plant will be placed on Level 3 detention and must be recertified. The company is making contingency plans to cover situation.
The Herald reports that this is not the first time Ansell has failed FDA standards tests. Rubber gloves from Malaysia failed in October 2002. Ansell also points out that two of its competitors have had recent shipments placed under Level 1 detention as well.
[Sydney Morning Herald, Ansell fails quality test; US bars its condoms, 17Sept05; Abstinence Clearinghouse, 9/17/05]
UGANDAN CONDOM PROMOTION FAILS TO REDUCE RISK, STUDY SHOWS – The Journal of Acquired Immune Deficiency Syndrome has published a study which questions the wisdom of condom promotion. According to an AIDS Map article, the study was designed to study barriers to condom usage.
The study, which followed the scientific method, found that while men who had received HIV and condom education and access to free condoms were more likely to take the free condoms from the clinics, than men who only received HIV education and access to the condoms. Any benefits that may have been predicted from the hypothesized increased condom usage were not seen in the results.
According to AIDS Map, even though the men in the intervention group were more likely to be married, they reported significantly more casual sex partners during the six-months of the study, with no change in the actual use of condoms.
The net result is less monogamy, more sex and more sex without condoms. These results mirror a similar study from England published in the Lancet, January of 2001.
AIDS Map demonstrated other evidence that condoms were not responsible for the decrease in the HIV/AIDS prevalence in Uganda. In 2004, the journal Science published a Cambridge University study, which concluded that increased youth abstinence (a delay in sexual debut) and increased monogamy (a reduction in sexual partners) were responsible for the positive news from Uganda.
Kajubi, P., et al. Increasing condom use without reducing HIV risk: results of a controlled community trial in Uganda. J Acq Immune Defic Syndr 40 (1): 77-82, 2005.
Richens J. Imrie J, Conas A, et al., Condoms and Seatbelts: The Parallels and the Lessons, The Lancet, Vol. 355, Issue 9201, 29 January 2000, Pages 400-403
Stoneburner, RL, and Low-Beer, D. Population-Level HIV Declines and Behavioral Risk Avoidance in Uganda. Science, Vol 304, Issue 5671, 714-718 , 30 April 2004
[AIDS Map News, Condom promotion in Uganda not reducing HIV risk, study shows, 13Sept05,
Abstinence Clearinghouse, 9/13/05]
PLANNED PARENTHOOD TURNS A DEAL ON MORNING AFTER PILL (EC) SALES — Within the next week, the Food and Drug Administration is expected to announce its decision on whether a drug known as Plan B will be available over the counter without a doctor’s prescription.
Plan B is a morning-after pill — an “emergency contraceptive,” or so
its manufacturers say. FDA approval would not only represent an ideological victory for Planned Parenthood Federation of America, but it would also generate a financial windfall.
Because of a series of shrewd business agreements, the organization could be in position to make a minimum of $100 million profit over a five-year period from Plan B sales if the FDA gives the go-ahead for over-the-counter distribution.
The details came tumbling out when internal Planned Parenthood e-mails were made public during a California court case. These documents detail how Planned Parenthood worked out a deal with Barr
Pharmaceuticals, Plan B’s owner. Under a five-year agreement, Planned Parenthood would be able to buy Plan B from Barr at bargain-basement prices, undercut local pharmacies, and clear an average $20 profit on each Plan B kit.
But even if the FDA turns down over-the-counter (OTC) status, Planned Parenthood has already turned a tidy profit on Plan B. To Read
the complete story, go to: [by Jim Sedlak, http://www.lifenews.com/nat1563.html]
NOTE: Please be aware that major studies continue to show that Plan B – Emergency Contraception — does NOT work!!
We were told it would cut abortion rates by 50%!!
Well, tell that to Sweden (teen abortions went up by 31%) and to the UK (abortion rates have risen each year since EC went over the counter in Jan 2001). Studies in Scotland and San Francisco have shown the same or increased numbers…
And this is without even mentioning MAJOR medical problems with EC/MAP: no physician oversight, tripled ectopic pregnancy rates, girls forced to use by sex predators, promiscuity, increased STD rates (with increased cervical cancer and HIV rates), no long-term studies to research the effect of high-dose hormones on young female bodies over extended periods of time, proposals to use EC/MAP for rape victims, instead of emergency care at a hospital, and of course, increased abortion rates result in increased emotional and physical problems, clinical depression, suicide, breast cancer, pre-term births in subsequent pregnancies which can lead to cerebral palsy and other health problems for the baby — the list goes on and on…
CONDOM ERRORS INCREASE GONORRHEA RISK AMONG MEN – Many visitors to a sexual health clinic report incorrect usage of condoms, which appears to lead to a statistically significant increase risk of gonorrhea among men, according to the results of a new study.
[The researchers] interviewed 1124 people visiting an STD clinic about their use of condoms and if they made any mistakes while using a condom in the past 30 days.
More than half of the people interviewed during the study said they had not used a condom the last time they had sex.
Within the past month, more than 40 percent of both men and women said they had not [used a condom correctly]. More than 40 percent of men and more than 30 percent of women reported that a condom broke during intercourse in the last month.
More than 15 percent of study participants had either gonorrhea or chlamydia, some both. Men who said a condom had broken during the last 30 days were more than 90 percent more likely to have gonorrhea.
“The tendency to assume that consistent condom users are using condoms correctly seriously underestimates their risk of transmitting or contracting STDs or becoming pregnant unintentionally,” Grimley and her team conclude.
[American Journal of Health Behavior, July/August 2005; Reuters Health, 08/16/05; Abstinence Clearinghouse, 16Aug05]
STUDY SUGGESTS IMPORTANCE OF DOCUMENTING IMPACT OR FAILURE OF CONDOM PROMOTION The latest study on contraception education published in the journal Sexually Transmitted Diseases shows that despite claims of success, condom promotion programs fail to protect the health of individuals.
The study performed by Family Health International and Cameroons Care and Health Program evaluated patterns of short and long term male condom use among partners of nearly one thousand women. Even though the women received 8 monthly counseling sessions promoting condom use, consistent condom use declined both while women received the counseling and more than a year after the study finished.
To read more details about the study results, see: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15849531&query_hl=1.
Source: Wong EL, Roddy RE, Tucker H, Tamoufé U, Ryan K, Ngampoua F. Use of male condoms during and after randomized, controlled trial participation in Cameroon. Sex Transm Dis 2005;32(5):300-307. [Abstinence Clearinghouse E-Mail Update, 07/13/05]
ABORTION-CAUSING BIRTH CONTROL PATCH MANUFACTURER FACES CLASS-ACTION LAWSUIT Ortho Evra manufacturer, Ortho McNeil, is facing a lawsuit filed by 10 women 25July05 for damages related to use of its abortifacient so-called birth-control patch. The women, who all suffered from strokes or serious blood clots, described the drug as unreasonably dangerous, and defectively designed, according to a CNN report.
The women, ranging in age from 18 – 47, are from across the US and all suffer from long-term debilitating effects from the patch. Nineteen year-old Amanda B described suffering two strokes and recurring migraines after developing a 10-inch blood clot in her brain after use of the patch in 2004. It’s not fun to have to get up and not be able to go to school and live the life that you were living, you know? she said.
When used as labeled, Ortho Evra is a safe and effective birth control choice for many women, a company statement claimed.
Federal drug safety reports obtained by AP under a Freedom of Information Act request, indicate that in 2004 — when 800,000 women were on the patch — the risk of dying or suffering a survivable blood clot while using the device was about three times higher than while using birth control pills.
The AP report also noted that 23 deaths were attributed to use of the patch since its US [FDA] approval in 2001. Doctors who reviewed the 23 death cases found about 17 that appeared to be clot-related, including 12 from last year.
AP points out that the majority of the women were young and in otherwise good health and at low risk for blood clots [15July2005 LifeSiteNews.com] An FDA spokesman assured women that evidence indicates the product is safe and effective, [CNN].
[Related coverage: Birth Control Patch Claims 23 Lives and Counting; http://www.lifesite.net/ldn/2005/jul/05071506.html; AP, http://wusatv9.com/health/health_article.aspx?storyid=41226; New York, 27July2005, LifeSiteNews.com; N Valko RN, 29July05]
For an archival [4/04; 11/04] article in this site, on Ortho Evra, click here.
Addendum to above article [this is excerpted from “Fatalities Blamed On Birth Control Patch”, AP, 7/13/2005 http://wusatv9.com/health/health_article.aspx?storyid=41226]:
Ortho McNeil, a subsidiary of Johnson & Johnson, says none of the deaths can be directly attributed to the patch.
Blood clots are an accepted risk from hormonal birth control because estrogen promotes blood coagulation.
But how many clots are too many?
The AP found that before the patch was approved, the FDA had already noticed nonfatal blood clots from the patch were three times that of the pill. The AP then examined what has actually happened since the patch came on the market and found that deaths also appear to be at least three times as high.
If you are a woman taking the pill who doesn’t smoke and is under 35, the chance that you are going to have a blood clot that doesn’t kill you is between 1 and 3 in 10,000. Your risk of dying from a blood clot while using the pill is about 1 in 200,000.
By contrast, with the patch, the rate of nonfatal blood clots was about 12 out of 10,000 users during the clinical trials, while the rate of deaths appears to be 3 out of 200,000.
Clots usually form in the legs, and become serious problems if they travel to a woman’s heart, lungs or brain.
In 2000, doctors at the FDA reviewing clinical trials of the wafer-thin, plastic patch warned that blood clots could be a problem if it was approved.
In those trials, two of the 3,300 women using the patch were treated for blood clots that traveled to their lungs. Ortho McNeil says one of those women shouldn’t be counted because she had undergone surgery. But an FDA reviewer, using capital letters and underscoring his comments, took issue with Ortho McNeil.
“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases …,” said the report. “The incidence rates quoted by the sponsor may be misleading.”
The reviewer said “the label should clearly reflect this reviewer’s safety concern about a potential increased risk.” It would be important to study users after the patch came on the market for clot problems, he wrote.
But when the patch was approved in the U.S. in 2001, there were no requirements for follow-up studies beyond routine FDA reviews of reports called in by consumers, doctors and manufacturers.
The label’s safety warning says two different and seemingly contradictory things: First, it says the patch is expected to be associated with similar risks as the pill. Then, it says it is unknown if the risk of blood clots from the patch is different from the pill.
The AP reviewed what has happened since the patch came on the market in 2002.
The FDA responded to a FOIA request by providing the AP with a database that contained about 16,000 different reports of adverse reactions associated with the patch.
These ranged from mild rashes to deaths, and there were many duplicate reports. Within this collection of reports, the AP found 23 different deaths associated with the patch. The primary cause of death in those reports isn’t always clear — some mention suicide, others abortion. Doctors who reviewed the 23 cases found about 17 that appeared to be clot-related, including 12 from last year.
“That number of deaths certainly sounds suspicious,” said Dr. Pamela Berens, associate professor of obstetrics and gynecology at the University of Texas Medical School at Houston. “There may be something about the way the drug is metabolized that could increase the risk for clots.”
Although the estrogen levels are similar in the patch and the pill, the hormones in a pill must be processed through the intestinal tract before they enter the blood stream. Hormones in the patch, on the other hand, go directly into the bloodstream.
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, a consumer advocacy organization founded by Ralph Nader, said that the deaths and high rate of clots are “worrisome” and should be investigated. “These days, more often than not the problems with a drug show up after they’re approved,” he said.
Other doctors who prescribe the patch warned that women should not overreact to news of deaths. It is more risky to remove the patch and become pregnant, several pointed out. [apparently, pregnancy is more dangerous to a woman than death…]
[“Fatalities Blamed On Birth Control Patch”, AP, 7/13/2005 http://wusatv9.com/health/health_article.aspx?storyid=41226]
EC / MAP & RIGHT OF CONSCIENCE — A House committee on Monday held a hearing on the problems associated with legislation that is forcing pharmacists to dispense abortion-causing drugs like the morning after pill.
The hearing featured a debate on patient access to drugs versus respecting the moral beliefs of health care professionals.
Illinois Congressman Don Manzullo, a Republican, opened the House Small Business Committee hearing with comments about problems in his own home state.
There, Gov. Rod Blagojevich issued an executive order forcing all pharmacists to fill all prescriptions for legal drugs, including the morning after pill which can sometimes cause an abortion. Blagojevich faces three lawsuits from several pharmacists in the state seeking to overturn the order.
“No one, least of all a health care provider, should be required to violate his or her conscience by participating in procedures that he or she deems harmful,” Manzullo said. “The government should never force anyone to choose between his business or his beliefs.”
Rep. Nadia Velazquez, a New York Democrat, disagreed and said she found it “ironic” that Republicans support individual rights when it comes to pharmacists but don’t when it comes to abortion.
But, Illinois pharmacist Luke Vander Bleek said the debate was a human rights issue.
“I will not invest, and I will not practice in an environment in which we are legally obligated to be involved in the destruction of human life,” he told lawmakers. He said Blagojevich’s order “creates an environment in Illinois whereby a person holding deep moral convictions concerning the unborn cannot own and operate a licensed pharmacy.”
Manzullo questioned Blagojevich senior policy advisor Sheila Nix. She admitted that the governor’s order would not force doctor’s to prescribe the morning after pills, but would mandate that pharmacists fill such orders.
During the hearing, one witness claimed she was “humiliated and discriminated against” by a pharmacist who told her he couldn’t fill her prescription. She later admitted she was able to get it filled at another nearby pharmacy just 20 minutes later.
Rep. Marilyn Musgrave, a Colorado Republican, told the witness that she shouldn’t expect convenience to trump moral convictions.
Manzullo’s committee is studying whether a federal law is needed to prevent pharmacists from facing employment discrimination in cases when they refuse to dispense drugs they believe cause abortions.
Wendy Wright, a policy director for Concerned Women of America, applauded Manzullo for the hearing.
She said the hearing provided a “thoughtful examination of Gov. Blagojevich’s insensitive order demanding that all pharmacies in Illinois provide the controversial drug known as the morning-after pill.”
“At risk is each person’s ability to follow one’s conscience not to perform an activity that one believes could end another human’s life, and the survival of small businesses serving rural economies,” she explained.
[DC, Ertelt, LifeNews.com 26July 2005, http://www.lifenews.com/nat1478.html, N Valko RN, 29July05]