Posted on 01/26/2005 6:24:48 AM PST by Embraer2004
FDA Caved to Political Pressure
A Republican governor-elect is really the least of Senator Barbara Boxer’s worries.
Granted, California’s political landscape is changing. But the Senator is now in damage control and may be forced to walk a razor thin line between her passionate pro-choice views and women’s safety in the wake of a constituent’s death.
Senator Boxer’s troubles began on Sept. 17 when Holly Patterson died after a chemical abortion she sought from a Planned Parenthood clinic. The 18-year-old was 7-weeks pregnant when she entered the Hayward, Calif. clinic for mifepristone, or RU-486. Four days later, she was taken to the Valley Care Medical Center with severe cramping and bleeding and sent home with painkillers. Holly’s condition only worsened, so she returned early on September 17 and subsequently died of septic shock caused by a massive systemic infection. An attending physician told Holly’s father that parts of the fetus were still in her uterus.
Everyone is conducting an investigation – Planned Parenthood, the FDA and the Valley Care Medical Center. But VCMC is taking things a step further and asking Senator Diane Feinstein and Senator Boxer for an investigation on the national level.
Why?
Three groups representing more than a half-million members filed a citizen petition over a year ago claiming the FDA loosened its own guidelines and relaxed distribution requirements to approve RU-486. Filed by the Christian Medical Association, the American Association of Pro-Life Obstetricians and Gynecologists and Concerned Women for America in August 2002, the petition has yet to be answered.
“There were a lot of things in there that raised our eyebrows,” said Kathy Campbell, a spokesperson for VCMC. “I can’t tell you that we absolutely agree with the petition (but) this is a legal document. It has a case number and it’s been sitting there for over a year and we’re supporting that there should be a response.”
Among the groups’ complaints is that the FDA approved RU-486 under its Subpart H, which is designed only for drugs that are meant to treat life-threatening illnesses, like cancer – not abortions. Neither the French nor the U.S. clinical trials to test the drug’s safety and efficacy met the FDA’s standards. Furthermore, the FDA never tested the drug on minors, a violation of its own “pediatric rule,” giving no explanation.
“This was not tested on adolescents,” said Campbell. “That’s who’s taking the pill. That’s of concern to us.”
What should be of concern to Senator Boxer is a letter she sent the FDA commissioner in June 2000 after the agency wrote its own guidelines for RU-486. At that time the FDA wanted only licensed physicians who were familiar with the drug regimen to prescribe mifepristone to patients. The physician had to be certified to perform an ultrasound on the woman first, which would allow detection of an ectopic pregnancy, be able to perform a surgical abortion in case of complications, and have access to a hospital equipped to give blood transfusions and terminate pregnancies.
But Senator Boxer wrote that such life-saving safety measures were “draconian restrictions.”
“Barriers to RU-486 could discourage women from receiving a safe and effective alternative to surgical abortion, prevent effective treatment of other diseases,… compromise the physical safety of women and physicians at reproductive health facilities, and threaten privacy,” she wrote.
The letter worked. The FDA caved under political pressure, choosing to relax the guidelines and thus, compromise the safety of women seeking chemical abortions – women like Holly Patterson.
It is unclear whether Holly would have died if the FDA had withstood Senator Boxer’s pressure to relax regulations and stuck with their original guidelines for RU-486. But if such “draconian regulations” and “barriers” were in place, as the FDA initially mandated, Holly may have survived.
But now Senator Boxer has been asked to initiate a “complete investigation” on the national level.
“She should help get the FDA to respond to it,” Campbell said of the citizen petition. “I think with our calling on her, they need to respond.”
Planned Parenthood could also be liable for Holly’s death since it advertises chemical abortions up to the first 63 days of pregnancy on its website – a violation of the FDA’s 49-day limit. Holly was 7-weeks pregnant when she sought Planned Parenthood’s services, but it is unclear whether she fell above or below the 49-day threshold.
The FDA also requires a physician – not a clinic – to administer misopristol, the second prescription in a chemical abortion. It appears that Planned Parenthood violated that regulation as well, and gave Holly the drug to administer to herself.
Holly “was a very strong, courageous and a very healthy girl,” her father told CBS’s The Early Show, “and I had actually no idea that she would succumb to dying from an abortion.”
But the petitioners did know something like this could happen, as did members of Congress who lobbied against the FDA’s approval.
“RU-486 is not just poison for babies, it is potential poison for the mothers who take it,” said Rep. Chris Smith (R-NJ) at a press conference after RU-486 was approved.
Rep. Dave Weldon (R-FL), a licensed physician, said, “American women need to know…that their health can be in grave danger with these drugs. It's not the panacea the abortion industry had hoped for. Approval of this drug is a grave mistake by the FDA because RU-486 will kill unborn children and harm the health and well-being of women who take it.”
More than likely, Senator Boxer will wheel her PR team into place while the FDA, Planned Parenthood and the hospital search for answers into Holly’s death.
“We want the FDA to come out and say the pill is safe and here are the protocols or we want them to pull it off the market,” said Campbell.
Maybe now the FDA will comply.
There is no such thing as a SAFE ABORTION........
That's especially and always true for the baby/human being being killed/murdered.
Barbara Boxer was reelected. Californians are too stupid
to deserve any better.
and I am from california.
Why would those who support ABORTION and the murder of the most innocent be concerned about constituents?
..Oh!, It we could only go back in time and tell your own mother that, she was suffering from a disease. Sen. Boxer?
Is there such a thing as a "safe" miscarriage?
You are exactly right because in EVERY abortion at least one person dies.
*****************
This indicates that this father knew his daughter was going to have an abortion.
He is now without his daughter and grandchild.
No. Red badger (reply #10) is correct.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.