U.S. Issues Federal Government develops new abortion pill

Taco John · 08-14-2010, 07:39 PM

Just the sort of thing our Framers intended our government to do...

Federal drug regulators on Friday approved a new form of emergency contraceptive pill that prevents pregnancies if taken as many as five days after unprotected intercourse.

Related
F.D.A. Easing Access to ‘Morning After’ Pill (April 23, 2009) The pill, called ella, will be available by prescription only. Developed in government laboratories, it is more effective than Plan B, the morning-after pill now available over the counter to women 17 and older.

That pill gradually loses efficacy and can be taken at most three days after sex. Ella, by contrast, works just as well on the fifth day as the first after sex.

Women who have unprotected intercourse have about 1 chance in 20 of becoming pregnant. Those who take Plan B within three days cut that risk to about 1 in 40, while those who take ella would cut that risk to about 1 in 50, regulators say. Studies show that ella is less effective in obese women.

The decision was greeted with enthusiasm by abortion rights groups and denounced by anti-abortion activists. But in recent years both sides have treated the emergency contraceptive pills as a side issue in the wider debate over abortion.

Studies have found that many women fail to realize they are at risk for an unplanned pregnancy after unprotected sex. So they tend not to use the emergency contraceptives even when they receive them free.

“Emergency contraception has no effect on pregnancy rates or abortion rates,” said Dr. James Trussell, director of the Office of Population Research at Princeton, who has consulted without charge for ella’s maker. “Women just don’t use them enough to make an impact.”

Still, the decision by the Food and Drug Administration to approve ella, less than two months after a federal advisory committee voted unanimously to recommend approval, marks a decided shift for the agency.

Under President George W. Bush, White House political advisers overruled united F.D.A. scientists, delaying the decision to make Plan B available over the counter and barring such distribution to women under 18.

Some advocates said Friday that the agency’s relatively rapid adoption of its scientists’ advice meant that its traditional separation from political considerations had returned.

“It’s really important the F.D.A. made a decision that’s based on the scientific evidence and not on the political controversy,” said Diana Zuckerman, president of the National Research Center for Women and Families.

But Wendy Wright, president of Concerned Women for America, which opposes abortion, said that political considerations were still at work inside the agency.

“The fact that the F.D.A. waited until late on a Friday night in August to release this when they hoped nobody was paying attention underscores that this is a political decision,” she said.

Ms. Wright warned that men might slip ella to unsuspecting women, and she said testing so far was not adequate to establish whether it was safe.

In studies, the most common side effects associated with ella’s use were mild to moderate headache, nausea, abdominal pain, painful menstrual cramps, fatigue and dizziness.

Ella’s approval may also intensify a long-simmering controversy about whether pharmacists and doctors can refuse to prescribe or fill prescriptions for birth control measures they find personally objectionable.

Much of the debate over the drug springs from an argument over how it works, which despite considerable research remains something of a mystery. It blocks the effects of progesterone, a female hormone that spurs ovulation. It is, however, a chemical relative to RU-486, the abortion pill, and there is some evidence that ella makes the womb less hospitable to a fertilized egg by reducing the lining of the uterus.

To the scientists on the advisory committee, whether the pill works by preventing ovulation or implantation was mostly immaterial to the decision about whether it is safe and effective. But to religious groups, the distinction is crucial, since they consider that preventing implantation of a fertilized egg is akin to abortion.

Animal studies showed that ella had little effect on established pregnancies, suggesting it acts differently from RU-486.

Ella, which was approved in Europe last fall, is manufactured by HRA Pharma, a small French drug maker. In the United States it will be distributed by Watson Pharmaceuticals, a company based in California and New Jersey, which plans to introduce it by the end of the year.

The pill was originally developed by the National Institute of Child Health and Human Development, part of the National Institutes of Health and now named after Eunice Kennedy Shriver. It decided in 2002 to finance a crucial study to assess the drug’s efficacy as an emergency contraceptive.

Studies have shown that more than one million women who do not want to get pregnant are estimated to have unprotected sex every night in the United States, and that more than 25,000 become pregnant every year after being sexually assaulted. Half of all pregnancies in the United States are unintended.

http://www.nytimes.com/2010/08/14/he...pill.html?_r=1

stevieray · 08-14-2010, 08:22 PM

Quote:

Originally Posted by Taco John

. Half of all pregnancies in the United States are unintended.

in other words, the path to hell is paved with good unintentions.

**AustinChief** · 08-14-2010, 08:26 PM

HUH? It is a pill developed by HRA Pharma..the FDA didn't "develop" anything, they just approved it.. as well they should. FDA approval of drugs should NOT be contingent on politics... period.

I find it hard to believe that YOU would have any problem with this?

Dave Lane · 08-14-2010, 08:29 PM

It's mostly a literacy issue

irishjayhawk · 08-14-2010, 08:38 PM

He's going to point out this.

Quote:

F.D.A. Easing Access to ‘Morning After’ Pill (April 23, 2009) The pill, called ella, will be available by prescription only. Developed in government laboratories, it is more effective than Plan B, the morning-after pill now available over the counter to women 17 and older.

**AustinChief** · 08-14-2010, 08:53 PM

Quote:

Originally Posted by irishjayhawk

He's going to point out this.

WTF? How is a pill developed by a Paris based company "developed" in govt labs? Unless they were French govt labs....

healthpellets · 08-14-2010, 08:58 PM

yes! clearly found in the general welfare clause.

AndChiefs · 08-14-2010, 09:00 PM

Quote:

Originally Posted by Taco John

Studies have found that many women fail to realize they are at risk for an unplanned pregnancy after unprotected sex. So they tend not to use the emergency contraceptives even when they receive them free.

http://www.nytimes.com/2010/08/14/he...pill.html?_r=1

Really?!?!

Taco John · 08-15-2010, 08:22 PM

Quote:

Originally Posted by irishjayhawk

He's going to point out this.

this.

**AustinChief** · 08-16-2010, 12:06 AM

Quote:

Originally Posted by Taco John

this.

Yes I saw that.. but it's either just complete BS or they are speaking of french govt labs OR they are saying "developed" includes the FDA testing process which is a crap argument.

Even if it were developed in these mythical "govt labs" it would have most likely (as most drugs are) been developed for another use and then made its way to its current form ...

It's just silly.

joesomebody · 08-16-2010, 02:39 AM

"Ms. Wright warned that men might slip ella to unsuspecting women, "

That is just about the stupidest argument I've ever heard. Like an unsuspecting woman can't poke a hole in a condom or lie about being on birth control? A woman also has the choice of having an abortion, giving up a child for adoption, and one of these magic morning after beans.

A man has no choice but to pay child support for 18-22 years. I truly laugh at the idea of "Ms. Wright warned that men might slip ella to unsuspecting women, " being a reason to keep the pill from being legal...

orange · 08-16-2010, 04:25 AM

Quote:

Originally Posted by AustinChief

Yes I saw that.. but it's either just complete BS or they are speaking of french govt labs OR they are saying "developed" includes the FDA testing process which is a crap argument.

Even if it were developed in these mythical "govt labs" it would have most likely (as most drugs are) been developed for another use and then made its way to its current form ...

It's just silly.

Also known as CDB-2914, HRP-2000 and RTI-3021-012, ulipristal acetate was originally synthesized by Research Triangle Institute (RTI) under contract with the National Institute of Child Health and Human Development (NICHD) (Cook et al, 1992 and 1994). Considering its ability to modulate the progesterone receptor with reduced anti-glucocorticoid activity relative to other SPRMs, NICHD sought to develop the compound for therapeutic and contraceptive uses, in particular as an emergency contraceptive drug for postcoital use (Wagner et al, 1996). In support of the development of ulipristal acetate as an emergency contraceptive agent, the Contraceptive Development Branch (CDB) of NICHD carried out pharmacology and toxicology studies on the compound, synthesized bulk quantities of the drug, applied for and obtained an IND in 1995, and proceeded to conduct Phase 1 and Phase 2/3 clinical studies (Rao et al, 1999 and 2000).

HRA Pharma, a European pharmaceutical company that has been involved in the field of EC for more than a decade, licensed-in ulipristal acetate in 2000 in view of registration and marketing as a nextgeneration emergency contraceptive. HRA Pharma entered into a Collaborative Research and Development Agreement with NICHD in 2002, and development of the compound was thereafter undertaken in a collaborative fashion, with HRA Pharma taking over sponsorship of all subsequent manufacturing, nonclinical and clinical trials for EC (Figure 9). In addition, HRA Pharma has initiated development programs in other reproductive health indications, either alone or in partnership with other organizations, which are currently ongoing.

http://www.fda.gov/downloads/Advisor.../UCM215510.pdf

**AustinChief** · 08-16-2010, 04:44 AM

Quote:

Originally Posted by orange

Also known as CDB-2914, HRP-2000 and RTI-3021-012, ulipristal acetate was originally synthesized by Research Triangle Institute (RTI) under contract with the National Institute of Child Health and Human Development (NICHD) (Cook et al, 1992 and 1994). Considering its ability to modulate the progesterone receptor with reduced anti-glucocorticoid activity relative to other SPRMs, NICHD sought to develop the compound for therapeutic and contraceptive uses, in particular as an emergency contraceptive drug for postcoital use (Wagner et al, 1996). In support of the development of ulipristal acetate as an emergency contraceptive agent, the Contraceptive Development Branch (CDB) of NICHD carried out pharmacology and toxicology studies on the compound, synthesized bulk quantities of the drug, applied for and obtained an IND in 1995, and proceeded to conduct Phase 1 and Phase 2/3 clinical studies (Rao et al, 1999 and 2000).

HRA Pharma, a European pharmaceutical company that has been involved in the field of EC for more than a decade, licensed-in ulipristal acetate in 2000 in view of registration and marketing as a nextgeneration emergency contraceptive. HRA Pharma entered into a Collaborative Research and Development Agreement with NICHD in 2002, and development of the compound was thereafter undertaken in a collaborative fashion, with HRA Pharma taking over sponsorship of all subsequent manufacturing, nonclinical and clinical trials for EC (Figure 9). In addition, HRA Pharma has initiated development programs in other reproductive health indications, either alone or in partnership with other organizations, which are currently ongoing.

http://www.fda.gov/downloads/Advisor.../UCM215510.pdf

Well, I'll be damned... I had no idea it was originally devloped by RTI (which is NOT a govt lab). BUT if they were funded by NICHD, I can see why the statement in question was made. I still have no problem with "ellla" but I do agree with Taco that a govt funded (mostly) Contraceptive Development Branch of the NICHD is not exactly kosher. I have known about "ella" for quite awhile but apparently just assumed since it had been under HRA for so long that they had developed it...

Thanks for the CORRECT info! Apologies to TJ, I have no issue with the drug, but I do take some issue with what I see as an "elective" drug research lab (CDB portion of NICHD) being govt funded. Not a moral thing, more a WTF.. why is this govts place??? thing...

**AustinChief** · 08-16-2010, 04:47 AM

Not to pick nits... but I still think the reporter did a shoddy job... a better statement would have been "Developed with government funding..." (RTI isn't a govt lab)

Garcia Bronco · 08-16-2010, 07:58 AM

Government: Killing your baby before breakfest.

08-14-2010, 07:39 PM
Taco John 12on Paul Join Date: Jun 2001 Casino cash: $10085242	Federal Government develops new abortion pill Just the sort of thing our Framers intended our government to do... Federal drug regulators on Friday approved a new form of emergency contraceptive pill that prevents pregnancies if taken as many as five days after unprotected intercourse. Related F.D.A. Easing Access to ‘Morning After’ Pill (April 23, 2009) The pill, called ella, will be available by prescription only. Developed in government laboratories, it is more effective than Plan B, the morning-after pill now available over the counter to women 17 and older. That pill gradually loses efficacy and can be taken at most three days after sex. Ella, by contrast, works just as well on the fifth day as the first after sex. Women who have unprotected intercourse have about 1 chance in 20 of becoming pregnant. Those who take Plan B within three days cut that risk to about 1 in 40, while those who take ella would cut that risk to about 1 in 50, regulators say. Studies show that ella is less effective in obese women. The decision was greeted with enthusiasm by abortion rights groups and denounced by anti-abortion activists. But in recent years both sides have treated the emergency contraceptive pills as a side issue in the wider debate over abortion. Studies have found that many women fail to realize they are at risk for an unplanned pregnancy after unprotected sex. So they tend not to use the emergency contraceptives even when they receive them free. “Emergency contraception has no effect on pregnancy rates or abortion rates,” said Dr. James Trussell, director of the Office of Population Research at Princeton, who has consulted without charge for ella’s maker. “Women just don’t use them enough to make an impact.” Still, the decision by the Food and Drug Administration to approve ella, less than two months after a federal advisory committee voted unanimously to recommend approval, marks a decided shift for the agency. Under President George W. Bush, White House political advisers overruled united F.D.A. scientists, delaying the decision to make Plan B available over the counter and barring such distribution to women under 18. Some advocates said Friday that the agency’s relatively rapid adoption of its scientists’ advice meant that its traditional separation from political considerations had returned. “It’s really important the F.D.A. made a decision that’s based on the scientific evidence and not on the political controversy,” said Diana Zuckerman, president of the National Research Center for Women and Families. But Wendy Wright, president of Concerned Women for America, which opposes abortion, said that political considerations were still at work inside the agency. “The fact that the F.D.A. waited until late on a Friday night in August to release this when they hoped nobody was paying attention underscores that this is a political decision,” she said. Ms. Wright warned that men might slip ella to unsuspecting women, and she said testing so far was not adequate to establish whether it was safe. In studies, the most common side effects associated with ella’s use were mild to moderate headache, nausea, abdominal pain, painful menstrual cramps, fatigue and dizziness. Ella’s approval may also intensify a long-simmering controversy about whether pharmacists and doctors can refuse to prescribe or fill prescriptions for birth control measures they find personally objectionable. Much of the debate over the drug springs from an argument over how it works, which despite considerable research remains something of a mystery. It blocks the effects of progesterone, a female hormone that spurs ovulation. It is, however, a chemical relative to RU-486, the abortion pill, and there is some evidence that ella makes the womb less hospitable to a fertilized egg by reducing the lining of the uterus. To the scientists on the advisory committee, whether the pill works by preventing ovulation or implantation was mostly immaterial to the decision about whether it is safe and effective. But to religious groups, the distinction is crucial, since they consider that preventing implantation of a fertilized egg is akin to abortion. Animal studies showed that ella had little effect on established pregnancies, suggesting it acts differently from RU-486. Ella, which was approved in Europe last fall, is manufactured by HRA Pharma, a small French drug maker. In the United States it will be distributed by Watson Pharmaceuticals, a company based in California and New Jersey, which plans to introduce it by the end of the year. The pill was originally developed by the National Institute of Child Health and Human Development, part of the National Institutes of Health and now named after Eunice Kennedy Shriver. It decided in 2002 to finance a crucial study to assess the drug’s efficacy as an emergency contraceptive. Studies have shown that more than one million women who do not want to get pregnant are estimated to have unprotected sex every night in the United States, and that more than 25,000 become pregnant every year after being sexually assaulted. Half of all pregnancies in the United States are unintended. http://www.nytimes.com/2010/08/14/he...pill.html?_r=1
Posts: 49,409

08-14-2010, 08:26 PM	#3
AustinChief Administrator Join Date: Aug 2000 Location: Austin Casino cash: $1675468	HUH? It is a pill developed by HRA Pharma..the FDA didn't "develop" anything, they just approved it.. as well they should. FDA approval of drugs should NOT be contingent on politics... period. I find it hard to believe that YOU would have any problem with this?
Posts: 11,292

08-14-2010, 08:29 PM	#4
Dave Lane Space Cadet Join Date: Aug 2000 Location: Kansas City, Mo, USA Casino cash: $2198974	It's mostly a literacy issue __________________ Ignorance more frequently begets confidence than does knowledge: it is those who know little, and not those who know much, who so positively assert that this or that problem will never be solved by science. Charles Darwin
Posts: 19,482

08-16-2010, 02:39 AM	#11
joesomebody Waiting to be voted off Join Date: Feb 2004 Location: Columbia, MO Casino cash: $729	"Ms. Wright warned that men might slip ella to unsuspecting women, " That is just about the stupidest argument I've ever heard. Like an unsuspecting woman can't poke a hole in a condom or lie about being on birth control? A woman also has the choice of having an abortion, giving up a child for adoption, and one of these magic morning after beans. A man has no choice but to pay child support for 18-22 years. I truly laugh at the idea of "Ms. Wright warned that men might slip ella to unsuspecting women, " being a reason to keep the pill from being legal... __________________ Having more credibility than a Chargers fan is like winning the special olympics.
Posts: 2,538

08-16-2010, 04:47 AM	#14
AustinChief Administrator Join Date: Aug 2000 Location: Austin Casino cash: $1675468	Not to pick nits... but I still think the reporter did a shoddy job... a better statement would have been "Developed with government funding..." (RTI isn't a govt lab)
Posts: 11,292

08-16-2010, 07:58 AM	#15
Garcia Bronco No Keys, No Problem Join Date: Sep 2000 Location: Denver Casino cash: $60308	Government: Killing your baby before breakfest.
Posts: 20,411

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