FDA and Plan B

[ultracet]

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Ok so people should really discuss this article without flaming....


http://content.nejm.org/cgi/content/abstract/NEJMp058222


Click on "PDF" to get the full text.



Its basically a Doctor(s) trying to get people stirred up about what the FDA is and how they are ignoring science.



Do you all think there are other instances where the FDA has "ignored" science?



Oh and remember.... Nothing but 😍

 

[WVUPharm2007]

Claratin, Clarinex
Nexium, Prilosec
Albuterol, Xopenex
....nah, they ALWAYS are aware of science..... 🙄

 

[dgroulx]

It seems to me that the FDA succumbed to political pressure. Science in this country is returning to the dark ages. This is due to the current political climate, which I hope will change someday. We need a new age of enlightenment, but you can't teach people what they don't want to hear.

 

[ultracet]

I would definitely agree with the fact that science is being subject to political pressure.

As far as individual drugs go... it seems to me that the "more" patients know about their medication the worse off we are. I know there are people out there that think the government has a cure for the common cold but favors the drug companies and does not allow it released for monetary gain.

another example: a patient going into the MD and saying i have X, Y, and Z, I think i need Drug A.
I do realize it is the physician's responsibility to take charge but we all know that some patients will change MDs if they don't get what they want.

I think the public opinion then, in turn, pressures the gov't into doing things they shouldnt.


but then again isn't everything subcoming to political pressure these days?

 

[Caverject]

Claratin, Clarinex
Nexium, Prilosec
Albuterol, Xopenex
....nah, they ALWAYS are aware of science..... 🙄

I remember when Schering-Plough went to the FDA and cried about how unsafe Claritin was without proper supervision and then just like magic two days prior to it going generic, Schering-Plough came back and found a "new" study that contraindicated every piece of evidence they ever presented to the FDA!

RE: bb's example of a patient dx'ing themselves, if they do have a cold and do not get the antibiotic they demand, chances are that patient will never come back because the dr "refused" treatment to the patient.

I really have no doubt that there is political pressure on the FDA right now about the morning after pill. If you think otherwise, you must be blind no matter your political affiliation. It really is sad, but the only thing we can do is vote.

 

[twester]

I find this controversy to be so 1950s. I thought all but the extremely orthodox had long ago adopted birth control as being in the best interests of a woman's health and welfare. I guess I must live in a liberal cocoon or something.

I think it's unfortunate that the FDA is bowing to social/political pressure from a fringe group of the religiously orthodox and patently patriarchal. But more than that, I wish the women of this country would stand up and make their outrage known (if it exists). Whatever happened to feminism? As a male, I can only make sure that I keep track of my sperm. Women have so much more at stake. That's why women call the shots (or should be able to) in the case of pregnancy.

I think EC should be available to anyone who asks for it, but I'm more than a little uncomfortable with the idea of finding levonorgestrel next to the Tums in my grocery store. Reproductive services centers should be funded to the level that they can remain open 7 days a week. That would allow women to seek EC at anytime it's needed. If an immature woman asks for EC, a red flag should go up (provided adequate funding) that brings social services into play.

When I say social services, I don't mean the ones that exist now. I mean the ones that WOULD exist if state and federal governments recognized that their primary duty is to their citizens. Governments should exist for no other reason.

Anyway...this male says "EC for everyone". What do the females think?

Troy

 

[PharmDeb]

I wish the women of this country would stand up and make their outrage known (if it exists). Whatever happened to feminism?

I was preparing a speech to present to a class on Pharm's refusing to fill EC and had to do a pre-survey of opinions. Can you believe ALL females who responded answered with "no opinion". All of the male respondents had an opinion...most against the pharmacist's actions. I thought that was pretty strange so asked about it after my speech. The women had no idea there was any controversy going on, or that the FDA was considering going OTC.
So I guess this is the general reason for no outrage, they're not aware.

Reproductive services centers should be funded to the level that they can remain open 7 days a week. That would allow women to seek EC at anytime it's needed.

But this leaves out too many places like the rural town I live in where there are no centers. The only option on weekends is the ER. Nearest city with a clinic is 60 miles. I think EC should be available in pharmacies OTC. If it must be restricted to over 18, fine. But, even if the under-aged get their hands on it, isn't prevention much better than the decisions they will be forced to make if pregnancy occurs? Oops, sorry, don't want to start that debate.

For those who believe it will be overused/abused/create promiscuity, the same things were said in the UK before it went OTC in Jan '01. A follow up study printed in the British Medical Journal showed that just isn't true. It did not influence women's sexual attitudes or behavior, and there was no change in the rate of EC use. The only change they saw was that most women bought it thru the pharmacy instead of a doctor/hospital/family planning clinic.

The FDA is running scared. They've been in the public spotlight too many times lately. That's being compounded by the current administration pushing it's morality where it doesn't belong. We'll probably just have to wait it out.

 

[bananaface]

Resistance tends to be higher in rural areas.

 

[Caverject]

This is the exact reason why I am not in favor of releasing ALL clinical trials to the public domain. Look what happens when joe blow average american gets ahold of too much information

http://morningsentinel.mainetoday.com/view/letters/1899767.shtml

 

[ultracet]

This is the exact reason why I am not in favor of releasing ALL clinical trials to the public domain. Look what happens when joe blow average american gets ahold of too much information

http://morningsentinel.mainetoday.com/view/letters/1899767.shtml

my kind of guy 😉

j/k

ok just to clarify.... i mean the guy who wrote the article....NOT c-ject

yeah i have to agree... i don't think the public needs access to clinical trials. i mean they do not have the education to interpret the information.

i really do feel sorry for people that might encounter this man in a line at the drug store....

i mean that's something that's not really talked about... the embarassment of carrying it around and taking it to the counter and having to have everyone in line know what you are buying.

 

[dgroulx]

This is the exact reason why I am not in favor of releasing ALL clinical trials to the public domain. Look what happens when joe blow average american gets ahold of too much information

http://morningsentinel.mainetoday.com/view/letters/1899767.shtml

He's not an average American he's one of the religious right. I'm so glad I'm not a Christian. I'd hate to be lumped in with the looney-tunes like him.

 

[Doctor Bagel]

I'm not a pharmacist, but this issue just makes me see red. As stated above, there's no scientific reason not to have plan b available otc, none whatsoever. Keeping it on a prescription basis is just politics and super-scary politics for any women. We all take for granted easy access to birth control pills -- is that going to be the next thing limited?

Yeah, the supreme court ruled that states couldn't ban birth control in the 50s, and birth control is well-accepted by almost all aspects of the community except for a few hard-line catholics and members of other fringe groups. So, it is sort of amazing that there's such hostility to emergency contraception. Honestly, I think a lot of it stems from ignorance because people assume it's an "abortion pill" when it's really the same as birth control pills.