Clot Risk for Birth-Control Patch Is Double That of Pill
FDA: Morning After Pill Decision Not Political
HHS: State Health Departments NOT Required to Dispense EC/MAP
UK: Thousands of 13-Year-Olds Given EC Without Parental Knowledge
New Survey from Contraception Promoters Themselves Shows that Condom Pushing Does NOT Work
Class Action Suit: Depo-Provera Causes Osteoporosis
USAID Seeks Reimbursement from Promoters of Morning After Pill (EC) in Peru
Parents Sue after Their 14-year-old Daughter Died While Using the Birth Control Patch…
CLOT RISK FOR PATCH IS DOUBLE THAT OF PILL. A new study shows that women using the Ortho Evra birth-control patch have double the risk of developing blood clots compared with those who take the birth-control pill, the Food and Drug Administration (FDA) said 17Feb06. But the agency called the results preliminary and said they did not require immediate action other than advising women to discuss the risk with their doctors.
The finding comes from one of two studies comparing the patch and the pill, said Ortho Women’s Health and Urology, maker of the once-a-week patch. The company, based in Raritan, N.J., is owned by Johnson & Johnson.
Last year an investigation by The Associated Press, citing federal death and injury reports, found higher rates of blood clots in women using the patch.
The first study found no increased risk of clots. But the interim results from the second study suggested a twofold increase in the risk of venous thromboembolic events, or clots in the legs and lungs, in women using the patch, Ortho said.
At a briefing on Friday, Dr. Daniel Shames, director of the division of reproductive and urological drug products at the F.D.A., said the risk of a nonfatal blood clot was about one per year in 10,000 women not using a contraceptive. For those using a hormonal contraceptive like the patch or pill, the risk rises to 3 to 5 per 10,000, Dr. Shames said.
He noted that in preapproval testing of the patch on about 3,000 women, there were two reports of blood clots, but that one involved a woman who had had surgery.
The continuing studies are also looking at the risk of heart attacks and strokes among users of the two types of contraception. Currently, there is no difference, but the numbers are small, and it will take 18 more months to see if a difference occurs, Dr. Shames said.
The company said the risk of clots remained rare and added that clots were a potential risk of all hormonal contraceptives.
Release of the interim results comes four months after the drug agency warned women that the increased levels of hormones released by the patch put them at higher risk of blood clots and other serious side effects. Ortho said it shared the results of the latest studies with the agency.
Additions to the patch label in November warned women that they would be exposed to about 60 percent more estrogen than those who used birth-control pills.
Since the patch went on sale in 2002, more than four million women have used it.
The investigation by The Associated Press found that patch users died and suffered blood clots at a rate three times as high as that for women taking the pill.
About a dozen women died in 2004 from blood clots believed to be linked to the patch, The Associated Press reported.
Health officials warn that women who smoke should not use the patch, because smoking increases the risk of stroke and heart attack.
[AP, 17Feb06; http://www.nytimes.com/2006/02/18/health/18patch.html?_r=1&pagewanted=all&oref=slogin; n Valko RN, 18Feb06]
FDA Director Tells Congress: Morning After Pill Decision Not Political. Andrew Von Eschenbach, the acting director of the Food and Drug administration, told abortion advocates in Congress on Thursday that the agency’s decision to delay approval of over the counter sales of the morning after pill is not a political decision. Von Eschenbach spoke during a meeting of a House appropriations subcommittee to discuss the agency’s budget. However, pro-abortion Democrats on the panel strongly questioned him on delaying a decision on the Plan B drugs, which can sometimes cause an abortion.
According to an AP report, Von Eschenbach said he wasn’t sure when the agency would hand down its decision on the request to sell the pills without a prescription. “That process will be carried out in the appropriate fashion,” he said. He repeated the reason given by other FDA officials — that the agency is confronting a new set of issues because Barr Labs, the maker of the drug, wants to sell the drug over the counter but only to women above the age of 16. [LifeNews.com, 18Feb06]
LEST WE FORGET EC. Congressional Delegation Letter to ADPH Director Dr. Donald Williamson [15June2004], questioning the dispensation of Emergency Contraception in County Health Departments www.ccbama.org/issues/ALDelegationLetter.pdf
Sec. Tommy Thompson Letter to Congressman Aderholt 23 July 2004, showing that it is NOT required by the federal gov’t that state health departments dispense Emergency Contraception.
HHS Dr. Golden Letter to Dr. Williamson, also showing that it is NOT required by the federal gov’t that state health departments dispense Emergency Contraception. www.ccbama.org/issues/ResponsefromGoldenMAP.pdf
THOUSANDS OF 13-YEAR-OLDS GIVEN ABORTIFACIENT MORNING-AFTER PILLS WITHOUT PARENTS KNOWLEDGE. Statistics obtained from the UKs Department of Health National Health Service revealed that at 302 clinics, about 2,400 girls aged 13 or younger have been given the morning-after pill without their parents knowledge or consent, while another 400 were secretly given long-term (usually by hormonal implant) contraception. The figures do not take into account those girls who obtained the pills independently from pharmacists.
[The Daily Mail obtained the statistics through the Freedom of Information Act.] While growing numbers of young girls are being given contraception and the morning-after pill, we are seeing ever-rising rates of sexually-transmitted infections, warned Norman Wells, director of the charity, Family and Youth Concern.
We should remember that most of the pills and contraceptives handed out are distributed while the parents of the children involved are kept in ignorance, Wells added. (Childrens Minister) Beverley Hughes wants parents to help with teenage behaviour but if you keep parents in the dark, how can they help? Tory spokesman on children, Tim Loughton, meanwhile, criticized the findings: This is further worrying evidence that the Government is losing the battle for responsible sexual behaviour in young people, he said. The potential side effects of giving these contraceptive chemicals to such young girls is also worrying. [16Jan, LifeSiteNews.com, T. Vanderheyden, London; Daily Mail]
NEW SURVEY FROM CONTRACEPTION PROMOTERS SHOWS CONDOM PUSHING DOESNT WORK. A new survey conducted by the Alan Guttmacher Institute [resea
rch arm of Planned Parenthood] offers commanding evidence that neither mixed messages, nor contraception promotion are effective prevention strategies against teen pregnancy and STDs.
The survey questioned more than 1,500 teen girls at 79 U.S. abortion sites. The majority of respondents reported discussions with their parents about both sex and contraception prior to their need for clinic services [i.e. for STD treatment or for abortion].
A significant number of these teen survey respondents were even told by parents where to obtain contraception, yet they ended up in need of [i.e. abortion, STD treatment] services .
The full report may be viewed at: http://www.guttmacher.org/pubs/journals/3719205.html
[Perspectives on Sexual and Reproductive Health, December 2005; Abstinence Clearinghouse E-Mail Update, 01/04/06]
CLASS ACTION SUIT: DEPO-PROVERA CAUSES OSTEOPOROSIS. Women are suing the makers of Depo-Provera birth control, saying it has caused them severe bone loss leading to osteoporosis, as studies are showing.
A $700-million class-action lawsuit has been filed against the drug company Pfizer, that also produces the prescription drugs Viagra, Zoloft and Celebrex.
Pfizer has come under fire in the past for alleged lethal side effects stemming from the use of the anti-depressant Zoloft, and the company currently faces a number of lawsuits in the U.S. over Celebrex, which is alleged to cause heart attacks in users.
The drug Depo-Provera may act as an abortifacient. Given by injections 4 times a year, the artificial hormone prevents a baby in the earliest stages of development [human blastocyst stage] from implanting in the endometrium of the uterus, leading to an early abortion.
The drug is effective in ending pregnancies more than 99% of the time, according to Pfizers website. Advertisers have acclaimed it as a hassle and worry free birth control method, saving women from daily pill popping.
Concerns that the drug also causes massive and partially irreversible bone loss in young women have led to 3 current lawsuits under way in Canada.
The drug has also been linked to increased susceptibility to STDs in users, as much as 3 times higher than normal, according to one study.
Depo-Provera has been at the forefront of foreign-funded birth control programs in the developing world. From 1994-2000, USAID sent over 40 million units of the drug to birth control programs, much of it going to Africa. Proponents of the medication have been accused of contributing to the spread of HIV in Africa by weakening womens immune systems through use of the drug.
[Family Planning Groups Spreading AIDS in Africa with Depo Provera, http://www.lifesite.net/ldn/2004/sep/04090803.html; LifeSiteNews.com http://www.lifesite.net/ldn/2005/dec/05122101.html, 21Dec05, By Gudrun Schultz]
USAID SEEKS REIMBURSEMENT FROM PROMOTERS OF MORNING-AFTER PILL IN PERU – In response to a complaint from the Population Research Institute’s Latin American Director Carlos Polo, the U.S. Agency for International Development (USAID) has imposed sanctions on two groups in Peru that used American tax money to promote the legalization of the morning-after pill (MAP) in that country. Each will have to return part of their grant as a punishment for violating USAID policy.
“We are pleased to see the strong response of USAID headquarters in response to our complaint,” said PRI President Steve Mosher. “This decision sends a strong message to grantees to get out of the business of promoting abortion, including the morning-after pill, or risk losing all or part of your funding.”
The federal government’s Mexico City Policy prohibits the use of federal money for the promotion of any changes in abortion laws overseas. Unfortunately, USAID follows FDA policy, which classifies MAP as “emergency contraception” rather than as an abortifacient, even though MAP’s medical promoters acknowledge that it sometimes causes an abortion rather than prevents conception.
The two grantees from which USAID is seeking a so-far-unspecified amount of money are the Peruvian ombudsman’s office, Defensoria del Pueblo, and a major Peruvian feminist group, Mañuela Ramos, which has received tens of millions of dollars in USAID funding.
“Pro-life groups in other countries should monitor the activities of U.S.-funded feminist and environmentalist groups. If these groups promote the morning-after pill or other forms of abortion, they should document the activity and submit the evidence along with a complaint to USAID,” said Joseph A. D’Agostino, PRI’s Vice President for Communications. “We thank USAID for taking these steps in Peru.” [LifeSiteNews.com, 19Dec05 LIMA]
PARENTS SUE AFTER 14-YEAR-OLD DAUGHTER DIED WITH BIRTH CONTROL PATCH. When the parents of 14 year-old Alycia B. of WI found out their daughter was sexually active, they put her on birth control, choosing the hormonal patch instead of the Pill.
On 7May04, Alycia died suddenly of blood clots in her lower pelvis; her parents decided to sue the drug’s manufacturer in the hopes of having it taken off the market.
The patch, which releases contraceptive hormones into a woman’s blood stream through the skin, has been responsible for at least 17 deaths in women age 17-30 since its release in 2002 [FDA].
In Sept04, a study by the FDA revealed 21 “life-threatening” conditions related to the patch: blood clots, strokes, and heart attacks.
According to the Associated Press (17July2005) investigation, the risk of blood clots with the Patch is 3 Times Higher than that risk with birth control pills.
Earlier this month, Ortho-McNeil agreed to improve the warnings on the labels for the patch to include the information that it had possible fatal side effects. The company admitted that the patch exposes women to about 60 percent more estrogen than those using typical birth-control pills. USFDA, 5600 Fishers Lane, Rockville MD 20857-0001; 1-888-INFO-FDA (1-888-463-6332) [http://www.lifesite.net/ldn/2005/nov/05112102.html 21Nov05 LifeSiteNews.com, H. White; N Valko RN, 27Nov05]
JUDGE WON’T DISMISS LAWSUIT AGAINST FDA ON MORNING AFTER PILL. A federal judge has decided he won’t throw out a lawsuit filed by abortion advocates against the FDA for delaying a decision on whether to allow the morning after pill to be sold over the counter.
Attorneys for the Center for Reproductive Rights, a pro-abortion law firm based in New York, filed the suit in 1/05 on behalf of two pro-abortion groups and nine women who formed a group called Morning After Pill Conspiracy. They claim the agency has delayed a decision as a result of politics, not science and alleges it ignored a statutory deadline for making a decision.
FDA officials say the decision to allow the Plan B drugs, which can sometimes cause an abortion, to be sold to women above the age of 16 without a doctor’s visit, is because of the new and complex enforcement issues involved. Federal District Judge Edward Korman questioned the FDA’s decision-making process on the drug. “This has all the earmarks of an administrative agency filibuster,” he said, according to a Newsday report.
Assistant U.S. Attorney Franklin Amanat argued the lawsuit should be dismissed because the Center does not have legal standing. It is not an individual woman who could have purchased the drugs had they been available at a local pharmacy. [LifeNews.com, 24Dec05]
d. NOTE: For accurate medical information, and studies, on EC/MAP, click Birth Control in the left menu, then EC, or Current Headlines, then Birth Control]