FDA Commissioner Abruptly Resigns: A Brewing Story

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  • #1
McGyver
The commissioner of the Food & Drug Administration for the last three years, Lester Crawford, resigned today amidst sinking morale and criticisms from Congress, MSN reports:

http://www.msnbc.msn.com/id/9455426/

At the center of Crawford's resignation, were unusual steps he took to block the approval and sale of new women's contraceptives - angering the head of that division to resign.

I have not followed the FDA's internal contraceptive issue roughings that closely, but I suspect (Crawford) as a Bush appointee, could have allowed religious beliefs to interfere with the agency's primary responsibility of "public safety," and if so - that is unacceptable. Any of you with more information on this contraceptive issue - please share.

Crawford also took heat for drug safety issues revealed one year ago relating to the arthritis treatment drug, "Vioxx," and the class of "Cox-2 inhibitor" drugs. It remains unclear what role, or accepting of blame, Crawford played with any of these drugs. It was one of the FDA's leading scientist, David Graham, who leveled serious criticisms of the FDA's approval and safety record with a number of leading U.S. drugs. Vioxx related litigation is now underway, with a second trial due to get underway in New Jersey.

As a final thorn, the FDA and Crawford also took heat for not being more proactive and tougher on drug manufacturers for some of their television and print advertisements. It was only in 1996, that prescription drug and device manufacturers were, by passage of special legislation from Congress, permitted to market/advertise directly to consumers. Clearly, this direct to consumer relationship by drug and device manufacturers is still evolving - hopefully for the better.

By: Stephen Dolle
Dolle Communications
www.diaceph.com
 

Answers and Replies

  • #2
SOS2008
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His three-year tenure at FDA was marked by increasing criticism and a particularly rocky final 12 months. The painkiller Vioxx was pulled off the market for safety problems, FDA was embarrassed last fall when its British counterparts shut down a supplier of U.S. flu vaccine for tainted shots, and over the summer recalls of malfunctioning heart devices mounted.

Finally last month, morale at the agency plummeted when Crawford indefinitely postponed nonprescription sales of emergency contraception over the objections of staff scientists who had declared the pill safe. FDA’s women’s health chief resigned in protest.

...he was elevated by President Bush from acting commissioner to the full job.
http://www.msnbc.msn.com/id/9455426/

Contraceptive advocates and doctors groups say easier access could halve the nation’s 3 million annual unintended pregnancies.

“I am disappointed that FDA waited until this late hour to address a legal question that could and should have been resolved months ago,” said Sen. Edward Kennedy, D-Mass. “I urge FDA to act quickly to approve this needed reproductive option for women.”

“It seems improbable to me that ... politics hasn’t trumped science here, which is a tragedy,” said Dr. Alastair Wood of Vanderbilt University, a member of the FDA advisory committee that evaluated Plan B.

'They are acting in bad faith'
“They are acting in bad faith,” said Kirsten Moore of the Reproductive Health Technologies Project, noting that FDA already has logged 17,400 letters from the public and advocacy groups urging it to take one side or the other on Plan B. “How many more comments do they need?”

Crawford broke a personal pledge to Congress to decide Plan B’s fate by Sept. 1, charged two senators who called for congressional hearings into the delay.

“It is a breach of faith,” Sens. Patty Murray, D-Wash., and Hillary Rodham Clinton, D-N.Y., who lifted objections to Crawford assuming leadership of FDA only after his pledge, wrote in a statement. “There is no credible scientific reason to continue to deny increased access to this safe health care option.”

Conservative groups, which have intensely lobbied FDA arguing that over-the-counter emergency contraception would encourage teen sex, welcomed the agency’s decision.
----------------------
If a woman already is pregnant, the pills have no effect. They prevent ovulation or fertilization of an egg. They also may prevent the egg from implanting into the uterus, the medical definition of pregnancy, although recent research suggests that’s not likely.

Laws in seven states — Alaska, California, Hawaii, Maine, New Hampshire, New Mexico and Washington — already allow women to buy Plan B without a prescription, with no age restrictions. Massachusetts is set to become the eighth this fall, as lawmakers are expected to override their governor’s veto of nonprescription sales.
http://www.msnbc.msn.com/id/9087912/

It's the usual fundamentalist fanaticism. This drug would help prevent unwanted pregnancy--thus reducing abortions. They won't be happy until America has been pushed back to the times of the chastity belt.
 
  • #3
russ_watters
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I've heard about this, but I don't see why he resigned. Most of those issues don't seem relevant here. Does anyone have any real facts about why he resigned?
 
  • #4
SOS2008
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russ_watters said:
I've heard about this, but I don't see why he resigned. Most of those issues don't seem relevant here. Does anyone have any real facts about why he resigned?
I was replying primarily to this question in the OP: "Any of you with more information on this contraceptive issue - please share." There have been various news reports on the matter in addition to the links above, but I suppose only Crawford really knows why he resigned.
 
  • #5
McGyver
My gut tells me it is a "bombshell revellation" on Crawford's more intimate involvement along with the Bush White House, in the cited FDA issues that will surface next week - thus the reason for his resignation on Friday - to attract the least amount of publicity. This is classic White House procedure. Could be the emergency contraceptive issue and Bush's post Katrina shift to the left, or perhaps something new. Watch the news!
 
  • #6
McGyver
60 Minutes Aires FDA/Religious Objections to Plan "B" Contraceptive

I felt the need to bring up this earlier FDA thread after 60 Minutes featured a "Plan B Contraceptive" segment this past Sunday, Nov. 27, 2005, and made the clear connection with the FDA Commissioner's earlier abrupt resignation two months ago. Story link is below:

http://www.cbsnews.com/stories/2005/11/22/60minutes/main1068924.shtml

60 Minutes usually only reports on what is current or upcoming headline news. So I'm curious, "Why was this older story aired last night?" What's cooking?

I initially authored this thread a couple months ago when the FDA Commissioner abruptly resigned. I smelled a story, and raised it in my focus on the Commissioner's role in refusing to approve the newer contraceptive pill - and it had nothing to do with safety.

Perhaps the most reprehensible fact that 60 Mintues reported was that pharmacies throughout the state of Kentucky were refusing to sell the Plan B pill - out of personal preference. The state's pharmacy board was clear that pharmacies cannot choose which medicines they sell based on personal preference, rather, such decisions must be based on health and safety. The key national regulatory (religious) objections to Plan B apparently came from a physician in Kentucky, reported by 60 Minutes as handpicked by the Bush White House.

I must admit I was impressed with "60 Minutes" factual and educational (contraceptive) reporting last night on the Plan B pill. Perhaps if the U.S. had more education and contraceptive options like that covered in this story - we'd have far fewer abortions. Interesting reading!

Another irony to this story is that it was Kentucky that was a big producer of illegal moonshine during the years of national alcohol prohibition. In contrast today, Kenturky still has dry counties.
 
  • #7
Curious3141
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SOS2008 said:
http://www.msnbc.msn.com/id/9455426/
http://www.msnbc.msn.com/id/9087912/
It's the usual fundamentalist fanaticism. This drug would help prevent unwanted pregnancy--thus reducing abortions.
FYI, "morning after pills" often work by preventing implantation of a fertilised egg. A lot of people consider this to be tantamount to a termination, albeit a very early one.

Then again, even regularly taken hormonal contraception may end up working the same way at least some of the time. The issue is whether ovulation was prevented by the high levels of sex hormones, and sometimes it isn't. The fact remains that at least some of the time, these hormones will work by preventing implantation after the fertilisation event, so it's illogical to ban emergency contraception whilst allowing regular contraception, at least on pro-life grounds.

IUCDs are quite plainly a means to secure early termination - they work mainly by preventing implantation in-utero. (Although medicated IUCDs may have several secondary effects that work to prevent fertilisation too).

A truly prolife person (who doesn't care about other stuff like chastity, etc.) will only advocate barrier methods of contraception (like condoms). Then again, any method of contraception can and often does fail, so the best course for a prolifer is abstinence, which carries zero risk of course.
 
  • #8
Moonbear
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Based on the MSNBC story cited above, I wouldn't say the delay of contraceptive approval is at the "center" of the story, it just looks like the straw that broke the proverbial camel's back. When you have a division chief resigning over a disagreement with the commissioner, reading between the lines suggests there's been a lot of internal conflict leading up to that. People don't leave such a post on a single disagreement.

The FDA has been taking a lot of heat lately, and whether that's because of decisions Crawford has made that overrode the advice of others there, or if it's just that "the buck stops here," and he's taking the heat regardless of the source, this sounds to me like a move to instill new confidence in the FDA. One thing that we might not be able to determine is whether he has voluntarily stepped down or was pressured to step down. Sometimes there's a behind-the-scenes negotiation when someone in that high of an office is about to be "fired" that if they announce their resignation instead, they'll be saved the public embarrassment and inevitable media circus that being publically asked to step down would result in.
 
  • #9
McGyver
Curious3141 said:
FYI, "morning after pills" often work by preventing implantation of a fertilised egg. A lot of people consider this to be tantamount to a termination, albeit a very early one.
Then again, even regularly taken hormonal contraception may end up working the same way at least some of the time. The issue is whether ovulation was prevented by the high levels of sex hormones, and sometimes it isn't. The fact remains that at least some of the time, these hormones will work by preventing implantation after the fertilisation event, so it's illogical to ban emergency contraception whilst allowing regular contraception, at least on pro-life grounds.
IUCDs are quite plainly a means to secure early termination - they work mainly by preventing implantation in-utero. (Although medicated IUCDs may have several secondary effects that work to prevent fertilisation too).
A truly prolife person (who doesn't care about other stuff like chastity, etc.) will only advocate barrier methods of contraception (like condoms). Then again, any method of contraception can and often does fail, so the best course for a prolifer is abstinence, which carries zero risk of course.
Thank you for your scientific elaboration. You speak like a physician or scientist. Glad you could join us on this internationally important topic from Singapore.
 
  • #10
McGyver
Timing is Everything: Something is Brewing re Pro Life Debate

Not to sound repetitive, but my intuitive senses tell me that something is brewing with the "timing" of the 60 Minutes Nov. 27th story. FDA Commissioner Crawford resigned abruptly back in September - and there was barely a blip on the national news.

Does anyone know of any new political "efforts" to challenge the Bush White House on pro-life constraints concerning contraception?
 
  • #11
Curious3141
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McGyver said:
Thank you for your scientific elaboration. You speak like a physician or scientist. Glad you could join us on this internationally important topic from Singapore.
You're welcome. :) I am a physician, BTW.
 
  • #12
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McGyver said:
Not to sound repetitive, but my intuitive senses tell me that something is brewing with the "timing" of the 60 Minutes Nov. 27th story. FDA Commissioner Crawford resigned abruptly back in September - and there was barely a blip on the national news.
Does anyone know of any new political "efforts" to challenge the Bush White House on pro-life constraints concerning contraception?
No.... But he publically advocated condom use to help prevent HIV spread, today. True, he advocates abstinence and fidelity first, but the fact that condoms made it into his speech in a positive light, was interesting.
 
  • #13
McGyver
Do Birth Control Pills Alter Normal Female Behavior?

Earlier this year, there was a British medical study aired on television which described how female behavior - as to preference of male personality types - changes w/ and w/o women's ovulation period. It was a fascinating study how men could tell by a photo of "when" a woman was ovulating - and conversely, how women chose photos/personality traits of men based upon whether ovulating (selection of male suitor) or not.

In that study, researchers discovered how women repeatedly choose "macho men" when fertile, and "nice guys" when not. Men were also noted to be able to identify, by face photos, when a woman was fertile. It was a fascinating study on what women experience in selecting one type of man when ovulating, and another type when not, and how their personalities must adapt to their altering preferences - and would EXPLAIN why men often view women as crazy, moody, and constantly changing their minds. It has huge significance in male/female relationships - and whether daily Birth Control (BC) pills actually "alter" the female psyche and behavior. I would like to hear from the experts and physicians - esp. Curious3141 - as to the questions I raise herein.

I raise this discussion, in part - because Birth Control may interfere with normal female behavior and male/female relationships (for better or for worse) - and further add issues and impact to the Religious Right's objections to daily BC. The wild personality fluctions during a woman's cycle and more severe Pre-Menstrual Syndrome often leads physicians to place women on BC to better regulate these instabilities - but to what compromise of the female personality. In this regard, is the BC actually serving as a "mood-stabilizer?" I don't recall ever hearing the Religious Right raise a concern over BC's ability to alter female behavior!

I researched the Internet and all I could find is the Faces and Ovulation study linked below, but I know there is a larger study as I described:

http://news.bbc.co.uk/1/hi/health/4396230.stm

The two links below were provided by Curious3141, with the 2nd link offering a page link Q&A on various methods of BC:

http://www.msnbc.msn.com/id/9455426/
http://www.msnbc.msn.com/id/9087912/

Men, women, and religious scholars will find the above BC discussion of great interest.

Stephen Dolle
Dolle Communications
www.diaceph.com
 
  • #14
Moonbear
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Well, gosh darnit, those are the types of studies Congress keeps threatening to revoke funding for. It's hard to conduct studies on what affects women's sexual behavior if nobody can get it funded. Seriously, I get an email at least twice a year about another bill in congress to restrict funding for studies on sexual behavior.

Though, while there are subtle changes in women's sexual behavior over the course of the menstrual cycle, it is indeed subtle. Though, it has been reported as a side effect of birth control pills that they may reduce sexual interest in women. This makes sense since they prevent ovulation, and in most mammals, increased sexual behavior accompanies the time of ovulation. However, it would be debatable whether it's enough of an effect to be concerned about since women who choose to take birth control so that they can engage in intercourse without risk of pregnancy don't generally lose all interest in intercourse once on the pill.
 
  • #15
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I saw this fellow, and he was in church discussing how he was able to do "God's" work, by blocking the over the counter morning after pill. The physician who headed the division was on the segment, and she discussed this and her decision to resign over his mismanagement.
 
  • #16
McGyver
Substantiating the Need for Broader BC Studies

Moonbear said:
Well, gosh darnit, those are the types of studies Congress keeps threatening to revoke funding for. It's hard to conduct studies on what affects women's sexual behavior if nobody can get it funded. Seriously, I get an email at least twice a year about another bill in congress to restrict funding for studies on sexual behavior.
If true, then medical study advocates must "re-phrase" their study names and objectives to be gained!

Though, while there are subtle changes in women's sexual behavior over the course of the menstrual cycle, it is indeed subtle. Though, it has been reported as a side effect of birth control pills that they may reduce sexual interest in women. This makes sense since they prevent ovulation, and in most mammals, increased sexual behavior accompanies the time of ovulation.
Is it suble, or could it be more pronounced than we think. The hormonal forces are a part of the "normal" female psyche and behavior. But I question, that if the effects may be more than subtle, have we (science and progress) traded one set of problems for another!

At times, for fun I will try and see if I can spot women, via their facial energy and expressions, who may be ovulating - just as was undertaken in the medical study cited above. When I raised this discussion last weekend with a 43 yr old female friend - she was real curious. I also raised the common medical fact that women who work or live together tend to have their mentrual cycles become synchronous - and how women on daily BC will not merge into this group. This was brought to my attention by a 28 yr old woman who complained of a long work day in an office with 70 women - most all menstruating and cranky. She was happy NOT to be a part of that group!

However, it would be debatable whether it's enough of an effect to be concerned about since women who choose to take birth control so that they can engage in intercourse without risk of pregnancy don't generally lose all interest in intercourse once on the pill.
I wasn't raising a health concern, but was interested in the level of impact daily BC might have on female interest in sex and perhaps slightly altered behavior towards men while on BC - and whether that aspect is worthy of study when CONSIDERING the various OPTIONS in the overall practice of BC. Certainly, these practices are of major significance in today's modern living - to which the Catholic Church still refuses to address. It's like, "don't ask, don't tell!" And quite obviously, when one examines the U.S. heated polarized exchanges over Abortion - it would appear that their needs to be broader undertaking of studies on BC, and which forms raise certain risks, efficacy, and to include altering of normal female behavior. This latter behavior change also occurs in women who undertake riggorous sports or physical labor.

Are we in agreement here?
 
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  • #17
McGyver
Please Excuse My Accidental Inserting of Discussion in Moonbear

I just realized I inserted a good portion of my last diccussion into your, Moonbear, quote. Darn these Internet options at times!

I think those who read carefully will see my mistaken insertions.

Edit by Moonbear: I've corrected the placement of quote tags in the above post.
 
Last edited by a moderator:
  • #18
McGyver
Catholic Church and BC Broader Agenda: Send Women Back to the Middle Ages

McGyver said:
I wasn't raising a health concern, but was interested in the level of impact daily BC might have on female interest in sex and perhaps slightly altered behavior towards men while on BC...
CONSIDERING the various OPTIONS in the overall practice of BC. Certainly, these practices are of major significance in today's modern living - to which the Catholic Church still refuses to address. It's like, "don't ask, don't tell!" And quite obviously, when one examines the U.S. heated polarized exchanges over Abortion - it would appear that their needs to be broader undertaking of studies on BC, and which forms raise certain risks, efficacy, and to include altering of normal female behavior. This latter behavior change also occurs in women who undertake riggorous sports or physical labor.
Are we in agreement here?
Please allow me to connect a few dots, not considered in my earlier discussions on this BC thread, which I see have arisen - and deserve comment. The Catholic Church's broader agenda seems most consistent with "relagating the role and rights of the modern woman" to that which existed in recorded history until the 1960/70s, when for the 1st time BC care and Abortion became widely available for women. Somewhere along the way - the Christian Right decided to focus their beliefs on one key isse - Abortion, or the Pro-Life position.

In truth, all signs indicate that the Catholic Church's agenda, as well as certain Christian and non-Christian organizations, goes well beyond BC and Abortion. They want women to return to the traditional role of not working or engaging in non-feminen sports and activities, not holding positions of importance (such as in the Clergy), that they dress and act in a manner consistent with the woman's traditional role.

Consistent with that position, they also believe strongly in the traditional role of the man - and this excludes ANY tolerance for homosexuality or alternate sexual preferences. In closing - the availability of BC methods for women, the Pro-Life position, and strict traditional roles for men and women would appear to be the Religious Right's more likely ultimate objective.

The ultimate question in this discussion thread which society and policies must come to answer is, "Which BC methods, BC technologies, and roles for men and women are most ideally suited to sustain humanity?"
 
  • #19
Moonbear
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McGyver said:
If true, then medical study advocates must "re-phrase" their study names and objectives to be gained!
We do. :smile: But there are only so many ways to say it. So far, animal studies haven't been targetted as much as studies of women have, but that leaves our ability to translate what we know from animals, in which sexual behavior is quite different from women, to humans. The concern is that the study objectives are stated well, and NIH study sections (the panels of scientists who peer-review grant proposals) will rank it favorably to get funding, and then Congress comes along and threatens to yank away funding for it because they don't read beyond the phrase "sexual behavior in women." But, this is straying from the issue of FDA (it's your thread, you decide if you want to continue along these lines).

Is it suble, or could it be more pronounced than we think. The hormonal forces are a part of the "normal" female psyche and behavior. But I question, that if the effects may be more than subtle, have we (science and progress) traded one set of problems for another!

At times, for fun I will try and see if I can spot women, via their facial energy and expressions, who may be ovulating - just as was undertaken in the medical study cited above. When I raised this discussion last weekend with a 43 yr old female friend - she was real curious. I also raised the common medical fact that women who work or live together tend to have their mentrual cycles become synchronous - and how women on daily BC will not merge into this group. This was brought to my attention by a 28 yr old woman who complained of a long work day in an office with 70 women - most all menstruating and cranky. She was happy NOT to be a part of that group!
Unless those women have absolutely no social life outside of work, that's pretty unlikely sounding. She may have just been the one having a bad day perceiving everyone else as cranky. The reason it sounds unlikely is that 1) a lot of those women likely ARE on birth control as well, 2) synchronization of menstrual cycles among co-workers would be lessened due to women's exposure to people outside work (at home).

I wasn't raising a health concern, but was interested in the level of impact daily BC might have on female interest in sex and perhaps slightly altered behavior towards men while on BC - and whether that aspect is worthy of study when CONSIDERING the various OPTIONS in the overall practice of BC.
There are health risks too, which every woman knows of (I hope) when she is prescribed birth control...possible side effects like blood clots, shifts in the risk for certain types of cancers, etc.
 
  • #20
McGyver
Moonbear said:
We do. :smile: But there are only so many ways to say it. So far, animal studies haven't been targetted as much as studies of women have, but that leaves our ability to translate what we know from animals, in which sexual behavior is quite different from women, to humans. The concern is that the study objectives are stated well, and NIH study sections (the panels of scientists who peer-review grant proposals) will rank it favorably to get funding, and then Congress comes along and threatens to yank away funding for it because they don't read beyond the phrase "sexual behavior in women." But, this is straying from the issue of FDA (it's your thread, you decide if you want to continue along these lines).
It would appeanr, then, that the hold-up to progress in such studies lies within NIH peer review decisions. I am familiar with the type of influence and pressures that scientists at NIH and FDA are often under, not to mention the full Right political press by the Bush Administration and Republican-controlled Congress.

I felt perhaps that through more CLEAR and forward discussion, such as that which I have raised herein, and could be repeated in other larger public forums, that public pressure might lead to more responsive decisions to the wider needs of the people of the U.S. - not merely the wim of the Christian Right, which I have suggested, have been used and lured into a much wider swath of Neo-Christian beliefs towards women.
 
  • #21
Moonbear
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McGyver said:
It would appeanr, then, that the hold-up to progress in such studies lies within NIH peer review decisions.
Why would you come to that conclusion from what I wrote? The hold-up isn't at NIH. They are willing to fund the research as long as it is of the same quality as any other grant that would receive funding. It's Congress that tries to undermine the peer-review process by second-guessing that funding and trying to revoke it.

I am familiar with the type of influence and pressures that scientists at NIH and FDA are often under, not to mention the full Right political press by the Bush Administration and Republican-controlled Congress.
I felt perhaps that through more CLEAR and forward discussion, such as that which I have raised herein, and could be repeated in other larger public forums, that public pressure might lead to more responsive decisions to the wider needs of the people of the U.S. - not merely the wim of the Christian Right, which I have suggested, have been used and lured into a much wider swath of Neo-Christian beliefs towards women.
I agree that part of the problem is the only voices being heard are those of the very loud extreme groups, which gives the illusion the majority of the citizens are supporting those same beliefs, when the reality is that the more middle-of-the road citizens just don't pay attention until something is taken away that they've gotten used to having. So, until someone tries taking away the current forms of birth control, they don't pay a lot of attention that they aren't given access to newer forms they never knew existed, or that research is being curbed that might provide a safer and more effective version in the future.

It's an interesting perspective about the real effects being curbing of women's rights in general. Perhaps that's the message that people need to get out; it's not just abortion or birth control, it's women's freedoms they are trying to restrict. I'd like to see the AFA go head-to-head with NOW!
 
  • #22
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How about a womens right to say "no glove, no love"? Exercising that right sure would make things easier on everyone, on the left and on the right. One of the key issues not talked about on that issue is taking responsibility for your actions before having to fix your mistakes.

Just a knee-jerk opinion...
 
  • #23
Moonie said:
It's an interesting perspective about the real effects being curbing of women's rights in general. Perhaps that's the message that people need to get out; it's not just abortion or birth control, it's women's freedoms they are trying to restrict. I'd like to see the AFA go head-to-head with NOW!
"They're taking away women's rights!" has been a predominant war cry for quite some time. Indeed they go so far as to say that these people hate women, want to take away their rights to vote, make them subservient to men, ect ect...
Do you really think that women are being targeted?
Do you think that anyone will ever even get close to overturning Roe v. Wade let alone women's right to vote?
It sounds like alot of fear mongering rhetoric to me.
Indeed there are people out there with agendas that may work toward over turning RvW and getting rid of birth control because there still exist ignorant persons who fall for the other side's rhetoric. Does that warrant decending to their level of fear mongering though?
 
  • #24
McGyver
deckart said:
How about a womens right to say "no glove, no love"? Exercising that right sure would make things easier on everyone, on the left and on the right. One of the key issues not talked about on that issue is taking responsibility for your actions before having to fix your mistakes.
Just a knee-jerk opinion...
If we were living in the 1950s, I'd probably agree. But we're in the 21st Century now, and yet using 20th Century BC methods?

When one examines the number of innovative new Rx drugs, by comparison, BC technologies (a large Rx market segment), has only limped along in new innovations - and primarliy as a direct result of reduced federal funding and opposition from religious conservatives. This was "60 minutes" point made of pharmacies in the state of Kentucky. According the pharmacy board law, pharmacies may NOT impose a preferential will or bias on which Rx BC items they will sell. Rather such decision must be based upon potential safety and health risks.
 
  • #25
106
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I guess pharmacies are breaking the law. So much for free enterprise.
 

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