Re: Dr. Rost: The FDA is Finished READ MORE: 2006, Investigations ... Ilena posted on Google

[Guest guest]

I have mixed feelings about this article. Though I don't want the FDA to make decisions solely on what pressures are put on them by any political group, however, I agree with not allowing Plan B to be so easily assessable. We live in a society that feels drugs fix everything. All we need to do is take a pill and still live irresponsibly. I have seen this with friends many years ago, they would take a pill to prevent hang-overs and then drink like crazy. I don't feel we are doing our young women justice by giving them such an easy way out of irresponsible sex. This allows them to think that there are no consequences for possible destructive behaviors. Rogene S <saxony01@...> wrote: > The FDA is Finished READ MORE: 2006, Investigations > The

FDA is here to protect us and to ensure, among> other things, safe drugs.> > > ><http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_21827.htm> l>>http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_218...> > > This is a tough task, a task which will often result> in criticism. > > And when the FDA is caught red handed making> decisions that have > nothing to do with science, and everything to do> with politics and > religion, the trust in the FDA effectively ends. > > The FDA, as we know it, is finished, and here's why:> > > It was just revealed that two key Food and Drug> Administration

> officials recently testified that former FDA> Commissioner Lester > Crawford took them out of the agency's normal drug> approval process, > in order for him to personally block> over-the-counter sales of an > important early pregnancy contraceptive or> "morning-after pill." > > We're talking about Crawford's decision in August> 2005 to block > nonprescription sales of Plan B even though the key> agency officials > wanted to approve them. > > And who's behind this decision? The usual suspects.> Conservative > groups and religious fundamentalists have lobbied> the FDA and the > White House against nonprescription Plan B sales. > > Religious fanatics argue that Plan B causes> abortions, although the > scientific truth is that the drug, when it's taken> within 72 hours of > unprotected sex,

simply prevents pregnancy. > > According to transcripts of the depositions, Dr.> Galson, > director of the FDA's drug evaluation center, and> Dr. Janet Woodcock, > deputy operations commissioner, Crawford removed> them from involvement > in the agency's decision on Plan B. > > Galson, who testified he was unhappy with the FDA's> Plan B process, > said: "What happened around that time frame is that> Dr. Crawford, who > was the acting commissioner then, told me that he> was concerned about > where we were heading because he knew that I was> heading towards this > recommendation [approval], and he told me that he> was going to make > the decision on what to do with the application." > > He, he. Sounds different than when Galson motivated> FDA's rejection of > Barr's application for Plan B

non-prescription sales> earlier, in May > 2004. > > On May 6, 2004, Galson wrote in a memo: "Some staff> have expressed the > concern that this decision is based on non-medical> implications of > teen sexual behavior, or judgments about the> propriety of this > activity. These issues are beyond the scope of our> drug approval > process, and I have not considered them in this> decision." > > Right. The truth doesn't always get out, but> sometimes it does. > > So, in August 2005, Crawford blocked Plan B and said> the FDA needed > more time to consider a revised application from> Barr to allow Plan B > sales without a prescription to women 16 and older> but with a > prescription to girls 15 and under. > > Dr. F. Wood, the FDA's top women's health> officer, then resigned > in

protest over Crawford's handling of this matter. > > The end of the saga is that the drug is still not> approved without a > prescription and Dr. Crawford the former, eminent> FDA czar, is now > under investigation himself. > > The criminal investigation of Dr. Crawford by a> federal grand jury > over accusations of financial improprieties and> false statements to > Congress, was revealed only a month ago. Dr.> Crawford resigned in > September 2005, less than three months after the> Senate confirmed him > as the permanent FDA commissioner, a position which> he had held on an > "acting" basis for a couple of years. He said then> that it was time > for someone else to lead the agency. > > Yep, criminal charges can do that to you. Time to> move on. > > Question is when the clowns who are messing with

our> healthcare system > and approval of vital drugs will be charged with> their crimes.> > > >

[Guest guest]

,

Our young women are not having sex because something is

available. They are doing it anyway. And the morning after pill is

not a picnic in the park.

I would rather have this than have someone go through an abortion.

I think it is far more responsible and so much less traumatic for

all, and it does not give them license to do anything they are not

already doing. It has nothing to do with religion, just

reality. And we, of all women, are certainly having to live in

reality. We know about the irresponsibility of the medical profession.

Just a social worker point of view.

Lynda

At 07:31 AM 6/2/2006, you wrote:

>I have mixed feelings about this article. Though I don't want the

>FDA to make decisions solely on what pressures are put on them by

>any political group, however, I agree with not allowing Plan B to be

>so easily assessable. We live in a society that feels drugs fix

>everything. All we need to do is take a pill and still live

>irresponsibly. I have seen this with friends many years ago, they

>would take a pill to prevent hang-overs and then drink like

>crazy. I don't feel we are doing our young women justice by giving

>them such an easy way out of irresponsible sex. This allows them to

>think that there are no consequences for possible destructive behaviors.

>

>

>

>Rogene S <saxony01@...> wrote:

>

> > The FDA is Finished READ MORE: 2006, Investigations

> > The FDA is here to protect us and to ensure, among

> > other things, safe drugs.

> >

> >

> >

> >

><<http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_21827.htm>h\

ttp://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_21827.htm

> > l>

> >

><http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_218...>http:\

//www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_218...

> >

> >

> > This is a tough task, a task which will often result

> > in criticism.

> >

> > And when the FDA is caught red handed making

> > decisions that have

> > nothing to do with science, and everything to do

> > with politics and

> > religion, the trust in the FDA effectively ends.

> >

> > The FDA, as we know it, is finished, and here's why:

> >

> >

> > It was just revealed that two key Food and Drug

> > Administration

> > officials recently testified that former FDA

> > Commissioner Lester

> > Crawford took them out of the agency's normal drug

> > approval process,

> > in order for him to personally block

> > over-the-counter sales of an

> > important early pregnancy contraceptive or

> > " morning-after pill. "

> >

> > We're talking about Crawford's decision in August

> > 2005 to block

> > nonprescription sales of Plan B even though the key

> > agency officials

> > wanted to approve them.

> >

> > And who's behind this decision? The usual suspects.

> > Conservative

> > groups and religious fundamentalists have lobbied

> > the FDA and the

> > White House against nonprescription Plan B sales.

> >

> > Religious fanatics argue that Plan B causes

> > abortions, although the

> > scientific truth is that the drug, when it's taken

> > within 72 hours of

> > unprotected sex, simply prevents pregnancy.

> >

> > According to transcripts of the depositions, Dr.

> > Galson,

> > director of the FDA's drug evaluation center, and

> > Dr. Janet Woodcock,

> > deputy operations commissioner, Crawford removed

> > them from involvement

> > in the agency's decision on Plan B.

> >

> > Galson, who testified he was unhappy with the FDA's

> > Plan B process,

> > said: " What happened around that time frame is that

> > Dr. Crawford, who

> > was the acting commissioner then, told me that he

> > was concerned about

> > where we were heading because he knew that I was

> > heading towards this

> > recommendation [approval], and he told me that he

> > was going to make

> > the decision on what to do with the application. "

> >

> > He, he. Sounds different than when Galson motivated

> > FDA's rejection of

> > Barr's application for Plan B non-prescription sales

> > earlier, in May

> > 2004.

> >

> > On May 6, 2004, Galson wrote in a memo: " Some staff

> > have expressed the

> > concern that this decision is based on non-medical

> > implications of

> > teen sexual behavior, or judgments about the

> > propriety of this

> > activity. These issues are beyond the scope of our

> > drug approval

> > process, and I have not considered them in this

> > decision. "

> >

> > Right. The truth doesn't always get out, but

> > sometimes it does.

> >

> > So, in August 2005, Crawford blocked Plan B and said

> > the FDA needed

> > more time to consider a revised application from

> > Barr to allow Plan B

> > sales without a prescription to women 16 and older

> > but with a

> > prescription to girls 15 and under.

> >

> > Dr. F. Wood, the FDA's top women's health

> > officer, then resigned

> > in protest over Crawford's handling of this matter.

> >

> > The end of the saga is that the drug is still not

> > approved without a

> > prescription and Dr. Crawford the former, eminent

> > FDA czar, is now

> > under investigation himself.

> >

> > The criminal investigation of Dr. Crawford by a

> > federal grand jury

> > over accusations of financial improprieties and

> > false statements to

> > Congress, was revealed only a month ago. Dr.

> > Crawford resigned in

> > September 2005, less than three months after the

> > Senate confirmed him

> > as the permanent FDA commissioner, a position which

> > he had held on an

> > " acting " basis for a couple of years. He said then

> > that it was time

> > for someone else to lead the agency.

> >

> > Yep, criminal charges can do that to you. Time to

> > move on.

> >

> > Question is when the clowns who are messing with our

> > healthcare system

> > and approval of vital drugs will be charged with

> > their crimes.

> >

> >

> >

> >

>

>

>

>

[Guest guest]

Lynda, I agree that some are going to have sex anyway. However, I do think there are some who are too scared of pregnancy to risk it. My oldest step son claims that he has goals and that they do not include having a child at a young age, so he is still a virgin at 18 1/2. Im not sure if he would still ban sex if he knew his girlfriend could just "pop a pill." My other concern is if teens can get them over the counter without parents knowing. I would be devestated if my daughter took one without my knowledge and then had an severe adverse side effect. How would I know to help her? What can this pill do to her body? I don't trust drug manufactures to actually care about her body. They just want to make a pill that plays on our fears and makes money. It saddens me to think that is the world we live in. A young girl is damned if she doesn't and maybe damned if she

does. I have three girls and I pray they wont be faced with such a difficult position. Lynda <coss@...> wrote: ,Our young women are not having sex because something is available. They are doing it anyway. And the morning after pill is not a picnic in the park.I would rather have this than have someone go through an abortion.I think it is far more responsible and so much less traumatic for all, and it does not give them license to do anything they are not already doing. It has nothing to do with religion, just reality. And we, of all women, are certainly having to live in reality. We know about the irresponsibility of the medical profession.Just a social worker point of view.LyndaAt

07:31 AM 6/2/2006, you wrote:>I have mixed feelings about this article. Though I don't want the >FDA to make decisions solely on what pressures are put on them by >any political group, however, I agree with not allowing Plan B to be >so easily assessable. We live in a society that feels drugs fix >everything. All we need to do is take a pill and still live >irresponsibly. I have seen this with friends many years ago, they >would take a pill to prevent hang-overs and then drink like >crazy. I don't feel we are doing our young women justice by giving >them such an easy way out of irresponsible sex. This allows them to >think that there are no consequences for possible destructive behaviors.>>>>Rogene S <saxony01@...> wrote:>> > The FDA is Finished READ MORE: 2006, Investigations> > The FDA is here

to protect us and to ensure, among> > other things, safe drugs.> >> >> >> >><<http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_21827.htm>http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_21827.htm> > l>> >><http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_218...>http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_218...> >> >> > This is a tough task, a task which will often result> > in criticism.> >> >

And when the FDA is caught red handed making> > decisions that have> > nothing to do with science, and everything to do> > with politics and> > religion, the trust in the FDA effectively ends.> >> > The FDA, as we know it, is finished, and here's why:> >> >> > It was just revealed that two key Food and Drug> > Administration> > officials recently testified that former FDA> > Commissioner Lester> > Crawford took them out of the agency's normal drug> > approval process,> > in order for him to personally block> > over-the-counter sales of an> > important early pregnancy contraceptive or> > "morning-after pill."> >> > We're talking about Crawford's decision in August> > 2005 to block> > nonprescription sales of Plan B even though the key> > agency

officials> > wanted to approve them.> >> > And who's behind this decision? The usual suspects.> > Conservative> > groups and religious fundamentalists have lobbied> > the FDA and the> > White House against nonprescription Plan B sales.> >> > Religious fanatics argue that Plan B causes> > abortions, although the> > scientific truth is that the drug, when it's taken> > within 72 hours of> > unprotected sex, simply prevents pregnancy.> >> > According to transcripts of the depositions, Dr.> > Galson,> > director of the FDA's drug evaluation center, and> > Dr. Janet Woodcock,> > deputy operations commissioner, Crawford removed> > them from involvement> > in the agency's decision on Plan B.> >> > Galson, who testified he was unhappy with the

FDA's> > Plan B process,> > said: "What happened around that time frame is that> > Dr. Crawford, who> > was the acting commissioner then, told me that he> > was concerned about> > where we were heading because he knew that I was> > heading towards this> > recommendation [approval], and he told me that he> > was going to make> > the decision on what to do with the application."> >> > He, he. Sounds different than when Galson motivated> > FDA's rejection of> > Barr's application for Plan B non-prescription sales> > earlier, in May> > 2004.> >> > On May 6, 2004, Galson wrote in a memo: "Some staff> > have expressed the> > concern that this decision is based on non-medical> > implications of> > teen sexual behavior, or judgments about the> > propriety

of this> > activity. These issues are beyond the scope of our> > drug approval> > process, and I have not considered them in this> > decision."> >> > Right. The truth doesn't always get out, but> > sometimes it does.> >> > So, in August 2005, Crawford blocked Plan B and said> > the FDA needed> > more time to consider a revised application from> > Barr to allow Plan B> > sales without a prescription to women 16 and older> > but with a> > prescription to girls 15 and under.> >> > Dr. F. Wood, the FDA's top women's health> > officer, then resigned> > in protest over Crawford's handling of this matter.> >> > The end of the saga is that the drug is still not> > approved without a> > prescription and Dr. Crawford the former, eminent> >

FDA czar, is now> > under investigation himself.> >> > The criminal investigation of Dr. Crawford by a> > federal grand jury> > over accusations of financial improprieties and> > false statements to> > Congress, was revealed only a month ago. Dr.> > Crawford resigned in> > September 2005, less than three months after the> > Senate confirmed him> > as the permanent FDA commissioner, a position which> > he had held on an> > "acting" basis for a couple of years. He said then> > that it was time> > for someone else to lead the agency.> >> > Yep, criminal charges can do that to you. Time to> > move on.> >> > Question is when the clowns who are messing with our> > healthcare system> > and approval of vital drugs will be charged with> > their

crimes.> >> >> >> >>>>>

[Guest guest]

Yes, but teaching morals is the property of the parents and the

church, not the government. That is why we have a separation of

church and state. Science alone should determine what is medically

available, not someone's religious beliefs. Our government was

founded on this principle, and to decide otherwise is undermining the

very principles that made this country great.

I totally agree with abstinence, but never will agree that religious

doctrine should decide scientific decisions and that one person's

beliefs (or a number of person's beliefs) should decide doctrine for

our government. That would make our government too much like a

dictatorship or a government like Iran, where religion rules

everybody, even if they have different beliefs.

You must teach your children your values and trust them to uphold

them. I must do the same. It is not the government's job.

Lynda

At 08:47 AM 6/2/2006, you wrote:

>Lynda,

>

>I agree that some are going to have sex anyway. However, I do think

>there are some who are too scared of pregnancy to risk it. My

>oldest step son claims that he has goals and that they do not

>include having a child at a young age, so he is still a virgin at 18

>1/2. Im not sure if he would still ban sex if he knew his

>girlfriend could just " pop a pill. " My other concern is if teens

>can get them over the counter without parents knowing. I would be

>devestated if my daughter took one without my knowledge and then had

>an severe adverse side effect. How would I know to help her? What

>can this pill do to her body? I don't trust drug manufactures to

>actually care about her body. They just want to make a pill that

>plays on our fears and makes money. It saddens me to think that is

>the world we live in. A young girl is damned if she doesn't and

>maybe damned if she does. I have three girls and I pray they wont

>be faced with such a difficult position.

>

>

>

>Lynda <coss@...> wrote:

>,

>

>Our young women are not having sex because something is

>available. They are doing it anyway. And the morning after pill is

>not a picnic in the park.

>

>I would rather have this than have someone go through an abortion.

>

>I think it is far more responsible and so much less traumatic for

>all, and it does not give them license to do anything they are not

>already doing. It has nothing to do with religion, just

>reality. And we, of all women, are certainly having to live in

>reality. We know about the irresponsibility of the medical profession.

>

>Just a social worker point of view.

>

>Lynda

>At 07:31 AM 6/2/2006, you wrote:

> >I have mixed feelings about this article. Though I don't want the

> >FDA to make decisions solely on what pressures are put on them by

> >any political group, however, I agree with not allowing Plan B to be

> >so easily assessable. We live in a society that feels drugs fix

> >everything. All we need to do is take a pill and still live

> >irresponsibly. I have seen this with friends many years ago, they

> >would take a pill to prevent hang-overs and then drink like

> >crazy. I don't feel we are doing our young women justice by giving

> >them such an easy way out of irresponsible sex. This allows them to

> >think that there are no consequences for possible destructive behaviors.

> >

> >

> >

> >Rogene S <saxony01@...> wrote:

> >

> > > The FDA is Finished READ MORE: 2006, Investigations

> > > The FDA is here to protect us and to ensure, among

> > > other things, safe drugs.

> > >

> > >

> > >

> > >

> ><<<http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_

>

b_21827.htm>http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_21\

827.htm>http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_21827.\

htm

> > > l>

> > >

> ><<http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b

>

_218...>http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_218...\

>http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_218...

> > >

> > >

> > > This is a tough task, a task which will often result

> > > in criticism.

> > >

> > > And when the FDA is caught red handed making

> > > decisions that have

> > > nothing to do with science, and everything to do

> > > with politics and

> > > religion, the trust in the FDA effectively ends.

> > >

> > > The FDA, as we know it, is finished, and here's why:

> > >

> > >

> > > It was just revealed that two key Food and Drug

> > > Administration

> > > officials recently testified that former FDA

> > > Commissioner Lester

> > > Crawford took them out of the agency's normal drug

> > > approval process,

> > > in order for him to personally block

> > > over-the-counter sales of an

> > > important early pregnancy contraceptive or

> > > " morning-after pill. "

> > >

> > > We're talking about Crawford's decision in August

> > > 2005 to block

> > > nonprescription sales of Plan B even though the key

> > > agency officials

> > > wanted to approve them.

> > >

> > > And who's behind this decision? The usual suspects.

> > > Conservative

> > > groups and religious fundamentalists have lobbied

> > > the FDA and the

> > > White House against nonprescription Plan B sales.

> > >

> > > Religious fanatics argue that Plan B causes

> > > abortions, although the

> > > scientific truth is that the drug, when it's taken

> > > within 72 hours of

> > > unprotected sex, simply prevents pregnancy.

> > >

> > > According to transcripts of the depositions, Dr.

> > > Galson,

> > > director of the FDA's drug evaluation center, and

> > > Dr. Janet Woodcock,

> > > deputy operations commissioner, Crawford removed

> > > them from involvement

> > > in the agency's decision on Plan B.

> > >

> > > Galson, who testified he was unhappy with the FDA's

> > > Plan B process,

> > > said: " What happened around that time frame is that

> > > Dr. Crawford, who

> > > was the acting commissioner then, told me that he

> > > was concerned about

> > > where we were heading because he knew that I was

> > > heading towards this

> > > recommendation [approval], and he told me that he

> > > was going to make

> > > the decision on what to do with the application. "

> > >

> > > He, he. Sounds different than when Galson motivated

> > > FDA's rejection of

> > > Barr's application for Plan B non-prescription sales

> > > earlier, in May

> > > 2004.

> > >

> > > On May 6, 2004, Galson wrote in a memo: " Some staff

> > > have expressed the

> > > concern that this decision is based on non-medical

> > > implications of

> > > teen sexual behavior, or judgments about the

> > > propriety of this

> > > activity. These issues are beyond the scope of our

> > > drug approval

> > > process, and I have not considered them in this

> > > decision. "

> > >

> > > Right. The truth doesn't always get out, but

> > > sometimes it does.

> > >

> > > So, in August 2005, Crawford blocked Plan B and said

> > > the FDA needed

> > > more time to consider a revised application from

> > > Barr to allow Plan B

> > > sales without a prescription to women 16 and older

> > > but with a

> > > prescription to girls 15 and under.

> > >

> > > Dr. F. Wood, the FDA's top women's health

> > > officer, then resigned

> > > in protest over Crawford's handling of this matter.

> > >

> > > The end of the saga is that the drug is still not

> > > approved without a

> > > prescription and Dr. Crawford the former, eminent

> > > FDA czar, is now

> > > under investigation himself.

> > >

> > > The criminal investigation of Dr. Crawford by a

> > > federal grand jury

> > > over accusations of financial improprieties and

> > > false statements to

> > > Congress, was revealed only a month ago. Dr.

> > > Crawford resigned in

> > > September 2005, less than three months after the

> > > Senate confirmed him

> > > as the permanent FDA commissioner, a position which

> > > he had held on an

> > > " acting " basis for a couple of years. He said then

> > > that it was time

> > > for someone else to lead the agency.

> > >

> > > Yep, criminal charges can do that to you. Time to

> > > move on.

> > >

> > > Question is when the clowns who are messing with our

> > > healthcare system

> > > and approval of vital drugs will be charged with

> > > their crimes.

> > >

> > >

> > >

> > >

> >

> >

> >

> >