Sunday, May 25, 2008
Thursday, March 20, 2008
Senate Bill Proposes to Screen and Medicate Mothers
Senate Bill Proposes to Screen and Medicate MothersBy Ann Shibler Published: 2008-03-13 18:24 Email this page printer friendly version
ARTICLE SYNOPSIS:Called the MOTHERS Act, S. 1375 seeks to encourage and implement education, screening, health services, and anti-depressant medications for mothers-to-be or new mothers for post-partum depression, all according to the dictates of the federal government.
Follow this link to the original source: "MOTHERS Act Seeks to Drug Expectant Mothers with Anti-depressants to “Treat” Postpartum Depression"
COMMENTARY:Here’s another fabulously clever way for the government to have more people drawn into its clutches through a nationwide screening program, this time focusing on post-partum depression. And it is brought to you by the very busy and liberal Senator Robert Menendez, (NJ), and co-sponsored by Senators Hillary Clinton and Barack Obama.
Introduced in May 2007, and presently lodged in the Committee on Health, Education, Labor, and Pensions, S. 1375 would provide the impetus and funds necessary to institute a program that would promote referral of mothers-to-be and new moms by nurses, doctors and mid-wives to "mental health care specialists" if they exhibit any signs of "mood disorders," even if it’s during the pregnancy.
The bill is a bitter pill, but its language is unsurprisingly sugar coated:A bill to ensure that new mothers and their families are educated about postpartum depression, screened for symptoms, and provided with essential services, and to increase research at the National Institutes of Health on postpartum depression.
The use of selective serotonin reuptake inhibitors (SSRIs), a class of antidepressants — i.e., psychotropic drugs — would be recommended and administered as part of the "essential services" program. The effectiveness of SSRIs that include Prozac, Zoloft, Lexapro, etc., have been questioned. There have also been concerns about side effects from the drugs leading to violent behavior.
Most SSRIs carry black box warnings for "suicide" as a side effect, or even "homicidal ideation." Obviously real physical and mental damage could occur in unborn developing babies if their mothers are coerced into taking these dangerous, addictive, and unpredictable drugs, not to mention to the mothers themselves. A popular opinion among medical caregivers these days is that "post-partum mood disorders" are a sign of an underlying biochemical imbalance, so the answer must be drugs. But many women report getting through their real post-partum depression with the love, help, and support of family and friends, and alternative methods. Some have discovered alternatives (scroll down toward the end) to treating post-partum depression that can be as simple as diet changes, supplements, or exercise.
The relative effectiveness of drug treatments for post-partum depression or for any other medical condition is not really the point, however. The real issue is federal involvement. A course of treatment should be an individualized arrangement formed through doctor-patient consultation. The federal government should not be involved, given the potential that Big Pharma lobbyists might well desire a program, such as the one proposed, because it would lead to lucrative sales. Not content with "mental health" screenings for school children and military veterans that have real and permanent consequences, now big government plans to intrude into the womb as well.Ann ShiblerAnn is the Editorial Assistant for the John Birch Society.
read more digg story
ARTICLE SYNOPSIS:Called the MOTHERS Act, S. 1375 seeks to encourage and implement education, screening, health services, and anti-depressant medications for mothers-to-be or new mothers for post-partum depression, all according to the dictates of the federal government.
Follow this link to the original source: "MOTHERS Act Seeks to Drug Expectant Mothers with Anti-depressants to “Treat” Postpartum Depression"
COMMENTARY:Here’s another fabulously clever way for the government to have more people drawn into its clutches through a nationwide screening program, this time focusing on post-partum depression. And it is brought to you by the very busy and liberal Senator Robert Menendez, (NJ), and co-sponsored by Senators Hillary Clinton and Barack Obama.
Introduced in May 2007, and presently lodged in the Committee on Health, Education, Labor, and Pensions, S. 1375 would provide the impetus and funds necessary to institute a program that would promote referral of mothers-to-be and new moms by nurses, doctors and mid-wives to "mental health care specialists" if they exhibit any signs of "mood disorders," even if it’s during the pregnancy.
The bill is a bitter pill, but its language is unsurprisingly sugar coated:A bill to ensure that new mothers and their families are educated about postpartum depression, screened for symptoms, and provided with essential services, and to increase research at the National Institutes of Health on postpartum depression.
The use of selective serotonin reuptake inhibitors (SSRIs), a class of antidepressants — i.e., psychotropic drugs — would be recommended and administered as part of the "essential services" program. The effectiveness of SSRIs that include Prozac, Zoloft, Lexapro, etc., have been questioned. There have also been concerns about side effects from the drugs leading to violent behavior.
Most SSRIs carry black box warnings for "suicide" as a side effect, or even "homicidal ideation." Obviously real physical and mental damage could occur in unborn developing babies if their mothers are coerced into taking these dangerous, addictive, and unpredictable drugs, not to mention to the mothers themselves. A popular opinion among medical caregivers these days is that "post-partum mood disorders" are a sign of an underlying biochemical imbalance, so the answer must be drugs. But many women report getting through their real post-partum depression with the love, help, and support of family and friends, and alternative methods. Some have discovered alternatives (scroll down toward the end) to treating post-partum depression that can be as simple as diet changes, supplements, or exercise.
The relative effectiveness of drug treatments for post-partum depression or for any other medical condition is not really the point, however. The real issue is federal involvement. A course of treatment should be an individualized arrangement formed through doctor-patient consultation. The federal government should not be involved, given the potential that Big Pharma lobbyists might well desire a program, such as the one proposed, because it would lead to lucrative sales. Not content with "mental health" screenings for school children and military veterans that have real and permanent consequences, now big government plans to intrude into the womb as well.Ann ShiblerAnn is the Editorial Assistant for the John Birch Society.
read more digg story
Wednesday, February 20, 2008
No recourse, of course
For decades, we've been kept in the dark about the risks of drugs because of FDA bias. Now that we finally know more about a few drugs, the government is pushing us to ignore the risks, take the drugs, and not complain when more people die.
The Supreme Court says we can't sue medical device makers if a wrongful death occurs, and apparently the Bush administration made it legal for states to prohibit lawsuits against drug companies for FDA-approved drugs. We already have the pandemic vaccine immunity law. What next?
I have this friend, we'll call her Kate. Kate has been taking antidepressants for years. When she heard about a petition to ban the deadly drugs, she got her panties in a wad. You see, Kate thinks her quality of life depends on the drugs, and she doesn't think we should take them away from her. It's more important that she feels like she will earn an A in her psychiatry 101 class in grad school than it is that my neighbor's daughter is not stillborn. Yep. I see the logic there. Kate says that if she stops taking her drugs, she can't function - at all! So I ask, if you need the drugs then why do you try to stop taking them... no reply.
I have this other story for you... it's about the petition against the MOTHERS Act. (See: http://www.thepetitionsite.com/1/stop-the-dangerous-and-invasive-mothers-act) Unfortunately, the hero to so many people - presidential candidate Barack Obama, is a cosponsor of this bill. You see, Barack got all his advice from NAMI. That's pretty much all you have to hear to want to take a pit stop at the airsickness bag aisle of your brain's mental grocery store.
Listening to anything that the wonderful people over at NAMI have said is like agreeing with George Bush if he tells you to waste gas when it costs $3 per gallon, or buying a shirt with giant holes in the breast area. It's a bit counterproductive and stupid. And bad for everyone (ok except the breasty shirt holes idea, that might come in handy for nursing or something!).
When the NIU shooting story first came on the air, I was in the middle of dinner at our local pizzeria with my family. It was Valentine's day. I have to say I really wasn't shocked. I was sad, and just waiting for the news of which drugs the shooter had taken. It turns out, he stopped Prozac 3 weeks before killing all those people. Yet, he was still taking 2 other psych drugs!
People say, stay on your meds - but that's exactly what leads to deaths like Heath Ledger, Anna Nicole Smith, etc. And Britney's manager is crushing drugs and putting them in her food to keep her quiet.
The "big-brother is quite alright", majorly stupid mentality of this country has got to stop.
Looking for any evidence of Barak's potential innocent ignorance on the MOTHERS Act, I decided to stop off at his website. It says on there that he supports mental health parity as one of his MAIN goals for the country. His estimated impact on the US economy for untreated mental illness is like $100 billion or something like that...
But he doesn't mention the cost of actual treatment of mental illnesses, which I think is a number like $2 trillion per year (is that worldwide or in the US? Not sure, but I think it's just us...). And more important is the cost in lives.
When you add it all up, everyone loses. Drugs that kill. Doctors that force. And treatments that harm and are incredibly expensive. Where does all this money go? Into further efforts to oppress us, take away our rights even more, and kill more people.
The impact in terms of lives is a cost that we can't begin to measure.
How much is my life, or my son's life, or my second baby's life worth to you, or to Barack Obama? I am guessing he would much rather trade my life any day just so he could be president.
Until Barack Obama is enlightened, I can't support his campaign. If you look into other candidates, you might find a few who are actually in favor of securing your rights, not just talking pretty to the masses, and with the corporate stamp of approval.
The Supreme Court says we can't sue medical device makers if a wrongful death occurs, and apparently the Bush administration made it legal for states to prohibit lawsuits against drug companies for FDA-approved drugs. We already have the pandemic vaccine immunity law. What next?
I have this friend, we'll call her Kate. Kate has been taking antidepressants for years. When she heard about a petition to ban the deadly drugs, she got her panties in a wad. You see, Kate thinks her quality of life depends on the drugs, and she doesn't think we should take them away from her. It's more important that she feels like she will earn an A in her psychiatry 101 class in grad school than it is that my neighbor's daughter is not stillborn. Yep. I see the logic there. Kate says that if she stops taking her drugs, she can't function - at all! So I ask, if you need the drugs then why do you try to stop taking them... no reply.
I have this other story for you... it's about the petition against the MOTHERS Act. (See: http://www.thepetitionsite.com/1/stop-the-dangerous-and-invasive-mothers-act) Unfortunately, the hero to so many people - presidential candidate Barack Obama, is a cosponsor of this bill. You see, Barack got all his advice from NAMI. That's pretty much all you have to hear to want to take a pit stop at the airsickness bag aisle of your brain's mental grocery store.
Listening to anything that the wonderful people over at NAMI have said is like agreeing with George Bush if he tells you to waste gas when it costs $3 per gallon, or buying a shirt with giant holes in the breast area. It's a bit counterproductive and stupid. And bad for everyone (ok except the breasty shirt holes idea, that might come in handy for nursing or something!).
When the NIU shooting story first came on the air, I was in the middle of dinner at our local pizzeria with my family. It was Valentine's day. I have to say I really wasn't shocked. I was sad, and just waiting for the news of which drugs the shooter had taken. It turns out, he stopped Prozac 3 weeks before killing all those people. Yet, he was still taking 2 other psych drugs!
People say, stay on your meds - but that's exactly what leads to deaths like Heath Ledger, Anna Nicole Smith, etc. And Britney's manager is crushing drugs and putting them in her food to keep her quiet.
The "big-brother is quite alright", majorly stupid mentality of this country has got to stop.
Looking for any evidence of Barak's potential innocent ignorance on the MOTHERS Act, I decided to stop off at his website. It says on there that he supports mental health parity as one of his MAIN goals for the country. His estimated impact on the US economy for untreated mental illness is like $100 billion or something like that...
But he doesn't mention the cost of actual treatment of mental illnesses, which I think is a number like $2 trillion per year (is that worldwide or in the US? Not sure, but I think it's just us...). And more important is the cost in lives.
When you add it all up, everyone loses. Drugs that kill. Doctors that force. And treatments that harm and are incredibly expensive. Where does all this money go? Into further efforts to oppress us, take away our rights even more, and kill more people.
The impact in terms of lives is a cost that we can't begin to measure.
How much is my life, or my son's life, or my second baby's life worth to you, or to Barack Obama? I am guessing he would much rather trade my life any day just so he could be president.
Until Barack Obama is enlightened, I can't support his campaign. If you look into other candidates, you might find a few who are actually in favor of securing your rights, not just talking pretty to the masses, and with the corporate stamp of approval.
Tuesday, January 15, 2008
"Recovering without medication thread removed for moderator review"
http://www.mothering.com/discussions/showthread.php?t=828645
Fortunately I archived everything I had at:
http://babywhys.org/mdc.htm
How long until the next one gets deleted
See the suicidal on antidepressants thread (if drugs work so well at preventing suicide please explain this!!!!)
http://www.mothering.com/discussions/showthread.php?p=10288110&posted=1#post10288110
archived at:
http://babywhys.org/MDCsuicidalantidepressantusers.htm
Fortunately I archived everything I had at:
http://babywhys.org/mdc.htm
How long until the next one gets deleted
See the suicidal on antidepressants thread (if drugs work so well at preventing suicide please explain this!!!!)
http://www.mothering.com/discussions/showthread.php?p=10288110&posted=1#post10288110
archived at:
http://babywhys.org/MDCsuicidalantidepressantusers.htm
Monday, January 14, 2008
Here we go again
Let's see how long it takes for this one to go south. http://www.mothering.com/discussions/showthread.php?p=10281450&posted=1#post10281450
I wonder how many of these people are drug reps lurking to pounce on anti-drug messages.
I wonder how many of these people are drug reps lurking to pounce on anti-drug messages.
Leading Families to the Slaughter: An Open Letter to all so-called Breastfeeding "Advocates"
The hypocrisy of conclusions in "But is it safe for my baby" and "Overcoming Postpartum Psychosis" featured in Mothering Magazine, and other actions of breastfeeding advocates is quite disturbing.
I feel that it is relevant to include some background about the way that families have been led astray, particularly by institutions and people who claim to be promoting natural health.
First, here is some background on how I became aware of the issues that tie breastfeeding and psychiatric drugs.
In 2004, my 3-day-old son suffered a life-threatening choking incident (from formula he could not digest) only a few minutes after we arrived at Children's Hospital, having brought him in on the recommendation of paramedics due to the fact that he was overly lethargic and looked like he was blue around his mouth, on his hands, and on his feet. The staff at Children's hospital saved his life and admitted him for observation overnight, but I was so upset about having witnessed him choking nearly to death that I became extremely anxious about his safety. To make a long story short, I was given Zoloft samples by my OBGYN at 6 days postpartum, for anxiety, and as a "preventive" treatment to ward of the possibility of severe PPD. By postpartum day 9 (day 3 on Zoloft), I was suicidal and homicidal. I checked into an ER and they forcibly held me in a psych unit for 2 days. They tried to give me several new drugs in addition to Zoloft and told me that I had to keep taking Zoloft. If I had not been breastfeeding my son, I may have agreed to take them, but all of the new drugs they tried to give me (one of which was Zyprexa) were listed as being clearly contraindicated for nursing mothers. I declined the new drugs.
I observed other patients in the hospital who were sleeping nonstop for the first couple of days they were there, and one man who was so disabled by his medications that his speech was slurred, he could barely keep his balance, and he was extremely confused. I also observed a patient locked in a padded room who jumped violently at the window and stared out with wide bloodshot eyes- he reminded me of an angered caged animal. I was thankful that I had not become as disabled as they were and it was obvious to me that the drugs I was taking were not quite as physically toxic as the ones they wanted me to add.
I returned home with strict orders from the psychiatrist to stay on Zoloft and see a psychiatrist, a therapist and take parenting classes. Over the next few months I experienced a dose-dependent worsening of homicidal thoughts from increases in Zoloft dosage. Finally I got off the drugs and went back to being a normal person not obsessed with homicide or suicide. Since then I have been following the actions of the FDA, drug companies, and breastfeeding advocates closely.
Thanks to the FDA black box warnings I am confident that my life, my son's life, and many others that I have come in contact with have been spared. This is not good news for Eli Lilly, Pfizer, or any other multi-billion dollar drug company.
Prior to my decision to discontinue Zoloft, the homicidal urges were so bad that my psychiatrist recommended that I wean my son and go on Zyprexa. She clearly stated I would not be allowed to breastfeed if I took it, and this was one factor in my decision not to try Zyprexa. The continuation of Zoloft also eventually led to my realization that Zoloft was not working for me no matter how many months' time I let it "start to work."
I eventually wrote a letter to a breastfeeding advocate and psychologist named Kathleen Kendall-Tackett expressing my concern that new mothers were being encouraged to breastfeed while taking SSRIs because this could lead to psychosis and the perceived need to wean to take drugs like Zyprexa. see: http://chaada.org/smf/index.php?topic=189.0 http://chaada.org/smf/index.php?topic=236.0 and
http://uniteforlife.org/breastfeeding.html
I also wrote to Peggy O'Mara at Mothering Magazine to ask her to do an article about the dangers of pharmaceutical drugs like SSRIs for new moms.
To my surprise, this past spring Mothering Magazine ("Natural Family Living" is its subtitle) published an article titled "Overcoming Postpartum Psychosis" in which they cited Kathleen Kendall-Tackett's opinions and Thomas Hale's research (he is the author of Medications in Mother's Milk) as justification to condone breastfeeding continuing, despite the use of drugs like Zyprexa.
This article was the story of one mother who went psychotic, and was hospitalized. In the hospital she recommended that her psychiatrist check out Hale's book, and the psychiatrist actually allowed her husband and child to come to the hospital to stay with her 24-7 and cosleep and allow the baby to nurse on demand for the 9 day stay while she was also taking antipsychotic drugs. Breastfeeding was touted as the only connection the mother had left to reality and sanity and the only healing force in her life. (So why take the antipsychotic drugs?)
The author described her first experience in the hospital as one where they injected her with a drug because she was rambling off a paranoid delusional speech about her fears that someone was plotting to murder her grandmother, and after the injection she quickly passed out and slept for the first time in a long time. The article claimed that mothers should be allowed to take antipsychotic drugs while breastfeeding as long as they avoided nursing during peak concentration times.
I was truly shocked at the position of the magazine and the so-called health experts, both because of their failure to address the dangers of drugs, and their endorsement of a practice that puts mothers and babies at serious risk.
To make a very long story much shorter, over the past year I have seen antipsychotic drugs promoted for breastfeeding moms in New Beginnings (LLL magazine), Mothering Magazine, and on the Thomas Hale website. Knowing that Mothering Magazine's online forums have a lot of natural-health minded people, I also attempted several times to post information about the dangers of psychiatric drugs. Almost invariably, my threads were deleted. At two different points I complained but I was told that my posts were deleted due to violation of the User Agreement. This seemed to be untrue because my posts were only deleted after I began posting proof of what I was saying by posting articles and abstracts that demonstrated the dangers clearly.
Prior to my providing additional proof when what I was saying had been "discredited" by drug users on the forum, I had violated the user agreement from the very first post. Yet the threads I was posting in were going on as debates for weeks before the threads eventually were removed altogether. (To read the paradoxical and restrictive user agreement, click here: http://www.mothering.com/mdc/mdc_useragreement.html It prohibits posting links to other forums, even if you wrote the thread, for instance my personal story on the CHAADA message board was not allowed because it disrupted the continuity of their message board by taking you to another, you are not allowed to post any links or text that go to a website that is critical of Mothering Magazine or their discussion boards or website, you are not allowed to debate sensitive topics, you are not allowed to debate with a moderator or raise any public questions about what the moderator has done, and you are not allowed to post text of any copyrighted material that exceeds 100 words despite fair use guidelines which allow this for educational and non-profit distribution).
After my threads were deleted (without warning, so I do not have a copy of the first thread which was removed) I got into a dispute over this issue with the administrators and Peggy O'Mara, and eventually I was quite rudely written off. I stayed away from the boards for a while but then went back to post on different topics and also noticed that some of my threads were removed without explanation or comment.
So if you go to the PPD board or any other board on Mothering.com's discussion board, you can see that the only information that is invariably allowed and not subject to removal is that which promotes a pharmaceutical agenda. Although you may find information about alternatives, if you say anything negative (especially if the information is compelling) about psychiatric drugs, your posts are likely to be removed.
According to a friend I met on the forum who came to my defense, Mothering Magazine has been engaging in discrimination against certain sectors of society (including Scientologists) since the 1980s. This realization was a disappointment considering their appearance as being a magazine about acceptance and tolerance and natural family living. Why would a PPD forum which promotes drugs to new breastfeeding mothers fit in with that mission?
In addition, I was not the only one who was censored. A long-time member of the board who wrote a book on the dangers of vaccines was censored and angered to the point that she left the board altogether and all of her posts from several years were removed by moderators.
My friend's posts have also been subject to censorship and removal and she has received warnings of being banned. The moderators even removed threads she had written about her husband's death while she was newly grieving.
I have noticed other turnarounds in the Mothering magazine opinions, notably on breastfeeding in public. They went from writing about the power of women (they even published a report I wrote claiming our constitutional rights to stand up for each other and defend nursing in public as a human right, to a position which claims that our rights are non-existent due to a lack of enforcement or a lack of adequate state and local laws. See: http://www.babywhys.org/nurse%20in.htm and http://www.mothering.com/articles/new_baby/breastfeeding/lactation-law.html
and also http://www.babywhys.org/philosophyoflactivism.htm and http://www.mothering.com/resources/bfpocketguide.pdf and http://www.mothering.com/articles/new_baby/breastfeeding/breastfeeding-law.html )
Although, it seems, based on the dates, that the magazine has just been confused. One year you need to be afraid, the next year breastfeeding is fine, the next year you better bring your lawyer and 2,000 supporters if you want to feed your baby.
Now it seems they have also begun to turn around on the stance against vaccines, publishing an article in the most recent edition by a doctor who is in favor of vaccinating every patient no matter the consequences. Mothering Magazine has long been known as the most radical of anti-vaccine advocates in all of the major parenting publications. They have even come out against HIV and AIDS drugs for women who want to breastfeed, saying that it's perfectly ok to risk giving your baby HIV by breastfeeding, and not to use them to help your own case of HIV or AIDS (because they are contraindicated for nursing). Yet now it seems that to these breastfeeding advocates, an unnecessary and dangerous drug for a nonexistent chemical imbalance is fine to use while nursing an infant, and can rightly be promoted as a good preventive for severe cases of Possible Andrea Yates Copycat Disorder. (PAYCD)
It would not surprise me very much if they soon start to come out against cosleeping or in favor of circumcision or hospital birth with epidurals. Although the root of this recent position on drugs and breastfeeding seems to be the notion that you must breastfeed at all costs. However as I stated in the original UNITE article "Leading Families to the Slaughter" - formula has never put a baby into a coma, as far as I am aware.
Recent studies undertaken on antipsychotic drugs have revealed that patients on placebo actually improved more than those taking atypical antipsychotics, like Zyprexa. Any magazine or advocate who ignores the facts and censors those who try to get the word out about dangers poses a very serious danger to families and society and shows a total disregard for ethics. We have been slowly deluded and our society is being eaten away, our rights are eroded and ignored, and our health and safety threatened.
I have been reluctant to speak out against Mothering, Thomas Hale, Kathleen Kendall Tackett, and New Beginnings because I know people make mistakes. But this type of mistake seems to be more a generally intended goal than an accident.
I examined the research which has been claimed as evidence of safety of both SSRIs and of Zyprexa for nursing moms and what I found was disturbing. A full written analysis is forthcoming - but in short, the studies were done on extremely small samples, side effects were disregarded, and most of the women in the studies were not exclusively breastfeeding. When a significant portion of a baby's diet is formula, it's obvious that any exposure will be reduced.
Given the absolute refusal of the FDA and certain mental health advocates to accept the negative outcomes from our current slew of psychiatric drugs and interventions, it is not too surprising that others such as those in the media or in positions of influence in the natural health community can get away with ignoring the facts.
I guess it all comes back to the original lies of chemical imbalances and the backwards serotonin theory (see http://uniteforlife.org/links.html#books)
For anyone who has not seen it, the DVD Psychiatry: An Industry of Death is extremely informative on the history of psychiatry and psychology. I highly recommend you watch it. You can find it at http://www.cchr.org/index/5285/15242/
Needless to say, my subscription to Mothering Magazine is not being renewed. I encourage others to speak out if they too have been censored or if they disagree with the ideas in the magazine. The readers won't continue buying the magazine if it becomes too full of false and dangerous ideas. In fact one of the only reasons to continue reading would be to monitor the manner in which decline of reason and the rise of dangerous dogma are promoted and innocent young families are unknowingly deluded.
To Mothering Magazine, should you read this blog, I urge you to prove me wrong by changing your ways and apologizing to those who have been censored. I also encourage you to overhaul your user agreement and revamp or remove the PPD and mental health forums so they will not be players in supporting one of the most evil of all enterprises we face in our world.
I feel that it is relevant to include some background about the way that families have been led astray, particularly by institutions and people who claim to be promoting natural health.
First, here is some background on how I became aware of the issues that tie breastfeeding and psychiatric drugs.
In 2004, my 3-day-old son suffered a life-threatening choking incident (from formula he could not digest) only a few minutes after we arrived at Children's Hospital, having brought him in on the recommendation of paramedics due to the fact that he was overly lethargic and looked like he was blue around his mouth, on his hands, and on his feet. The staff at Children's hospital saved his life and admitted him for observation overnight, but I was so upset about having witnessed him choking nearly to death that I became extremely anxious about his safety. To make a long story short, I was given Zoloft samples by my OBGYN at 6 days postpartum, for anxiety, and as a "preventive" treatment to ward of the possibility of severe PPD. By postpartum day 9 (day 3 on Zoloft), I was suicidal and homicidal. I checked into an ER and they forcibly held me in a psych unit for 2 days. They tried to give me several new drugs in addition to Zoloft and told me that I had to keep taking Zoloft. If I had not been breastfeeding my son, I may have agreed to take them, but all of the new drugs they tried to give me (one of which was Zyprexa) were listed as being clearly contraindicated for nursing mothers. I declined the new drugs.
I observed other patients in the hospital who were sleeping nonstop for the first couple of days they were there, and one man who was so disabled by his medications that his speech was slurred, he could barely keep his balance, and he was extremely confused. I also observed a patient locked in a padded room who jumped violently at the window and stared out with wide bloodshot eyes- he reminded me of an angered caged animal. I was thankful that I had not become as disabled as they were and it was obvious to me that the drugs I was taking were not quite as physically toxic as the ones they wanted me to add.
I returned home with strict orders from the psychiatrist to stay on Zoloft and see a psychiatrist, a therapist and take parenting classes. Over the next few months I experienced a dose-dependent worsening of homicidal thoughts from increases in Zoloft dosage. Finally I got off the drugs and went back to being a normal person not obsessed with homicide or suicide. Since then I have been following the actions of the FDA, drug companies, and breastfeeding advocates closely.
Thanks to the FDA black box warnings I am confident that my life, my son's life, and many others that I have come in contact with have been spared. This is not good news for Eli Lilly, Pfizer, or any other multi-billion dollar drug company.
Prior to my decision to discontinue Zoloft, the homicidal urges were so bad that my psychiatrist recommended that I wean my son and go on Zyprexa. She clearly stated I would not be allowed to breastfeed if I took it, and this was one factor in my decision not to try Zyprexa. The continuation of Zoloft also eventually led to my realization that Zoloft was not working for me no matter how many months' time I let it "start to work."
I eventually wrote a letter to a breastfeeding advocate and psychologist named Kathleen Kendall-Tackett expressing my concern that new mothers were being encouraged to breastfeed while taking SSRIs because this could lead to psychosis and the perceived need to wean to take drugs like Zyprexa. see: http://chaada.org/smf/index.php?topic=189.0 http://chaada.org/smf/index.php?topic=236.0 and
http://uniteforlife.org/breastfeeding.html
I also wrote to Peggy O'Mara at Mothering Magazine to ask her to do an article about the dangers of pharmaceutical drugs like SSRIs for new moms.
To my surprise, this past spring Mothering Magazine ("Natural Family Living" is its subtitle) published an article titled "Overcoming Postpartum Psychosis" in which they cited Kathleen Kendall-Tackett's opinions and Thomas Hale's research (he is the author of Medications in Mother's Milk) as justification to condone breastfeeding continuing, despite the use of drugs like Zyprexa.
This article was the story of one mother who went psychotic, and was hospitalized. In the hospital she recommended that her psychiatrist check out Hale's book, and the psychiatrist actually allowed her husband and child to come to the hospital to stay with her 24-7 and cosleep and allow the baby to nurse on demand for the 9 day stay while she was also taking antipsychotic drugs. Breastfeeding was touted as the only connection the mother had left to reality and sanity and the only healing force in her life. (So why take the antipsychotic drugs?)
The author described her first experience in the hospital as one where they injected her with a drug because she was rambling off a paranoid delusional speech about her fears that someone was plotting to murder her grandmother, and after the injection she quickly passed out and slept for the first time in a long time. The article claimed that mothers should be allowed to take antipsychotic drugs while breastfeeding as long as they avoided nursing during peak concentration times.
I was truly shocked at the position of the magazine and the so-called health experts, both because of their failure to address the dangers of drugs, and their endorsement of a practice that puts mothers and babies at serious risk.
To make a very long story much shorter, over the past year I have seen antipsychotic drugs promoted for breastfeeding moms in New Beginnings (LLL magazine), Mothering Magazine, and on the Thomas Hale website. Knowing that Mothering Magazine's online forums have a lot of natural-health minded people, I also attempted several times to post information about the dangers of psychiatric drugs. Almost invariably, my threads were deleted. At two different points I complained but I was told that my posts were deleted due to violation of the User Agreement. This seemed to be untrue because my posts were only deleted after I began posting proof of what I was saying by posting articles and abstracts that demonstrated the dangers clearly.
Prior to my providing additional proof when what I was saying had been "discredited" by drug users on the forum, I had violated the user agreement from the very first post. Yet the threads I was posting in were going on as debates for weeks before the threads eventually were removed altogether. (To read the paradoxical and restrictive user agreement, click here: http://www.mothering.com/mdc/mdc_useragreement.html It prohibits posting links to other forums, even if you wrote the thread, for instance my personal story on the CHAADA message board was not allowed because it disrupted the continuity of their message board by taking you to another, you are not allowed to post any links or text that go to a website that is critical of Mothering Magazine or their discussion boards or website, you are not allowed to debate sensitive topics, you are not allowed to debate with a moderator or raise any public questions about what the moderator has done, and you are not allowed to post text of any copyrighted material that exceeds 100 words despite fair use guidelines which allow this for educational and non-profit distribution).
After my threads were deleted (without warning, so I do not have a copy of the first thread which was removed) I got into a dispute over this issue with the administrators and Peggy O'Mara, and eventually I was quite rudely written off. I stayed away from the boards for a while but then went back to post on different topics and also noticed that some of my threads were removed without explanation or comment.
So if you go to the PPD board or any other board on Mothering.com's discussion board, you can see that the only information that is invariably allowed and not subject to removal is that which promotes a pharmaceutical agenda. Although you may find information about alternatives, if you say anything negative (especially if the information is compelling) about psychiatric drugs, your posts are likely to be removed.
According to a friend I met on the forum who came to my defense, Mothering Magazine has been engaging in discrimination against certain sectors of society (including Scientologists) since the 1980s. This realization was a disappointment considering their appearance as being a magazine about acceptance and tolerance and natural family living. Why would a PPD forum which promotes drugs to new breastfeeding mothers fit in with that mission?
In addition, I was not the only one who was censored. A long-time member of the board who wrote a book on the dangers of vaccines was censored and angered to the point that she left the board altogether and all of her posts from several years were removed by moderators.
My friend's posts have also been subject to censorship and removal and she has received warnings of being banned. The moderators even removed threads she had written about her husband's death while she was newly grieving.
I have noticed other turnarounds in the Mothering magazine opinions, notably on breastfeeding in public. They went from writing about the power of women (they even published a report I wrote claiming our constitutional rights to stand up for each other and defend nursing in public as a human right, to a position which claims that our rights are non-existent due to a lack of enforcement or a lack of adequate state and local laws. See: http://www.babywhys.org/nurse%20in.htm and http://www.mothering.com/articles/new_baby/breastfeeding/lactation-law.html
and also http://www.babywhys.org/philosophyoflactivism.htm and http://www.mothering.com/resources/bfpocketguide.pdf and http://www.mothering.com/articles/new_baby/breastfeeding/breastfeeding-law.html )
Although, it seems, based on the dates, that the magazine has just been confused. One year you need to be afraid, the next year breastfeeding is fine, the next year you better bring your lawyer and 2,000 supporters if you want to feed your baby.
Now it seems they have also begun to turn around on the stance against vaccines, publishing an article in the most recent edition by a doctor who is in favor of vaccinating every patient no matter the consequences. Mothering Magazine has long been known as the most radical of anti-vaccine advocates in all of the major parenting publications. They have even come out against HIV and AIDS drugs for women who want to breastfeed, saying that it's perfectly ok to risk giving your baby HIV by breastfeeding, and not to use them to help your own case of HIV or AIDS (because they are contraindicated for nursing). Yet now it seems that to these breastfeeding advocates, an unnecessary and dangerous drug for a nonexistent chemical imbalance is fine to use while nursing an infant, and can rightly be promoted as a good preventive for severe cases of Possible Andrea Yates Copycat Disorder. (PAYCD)
It would not surprise me very much if they soon start to come out against cosleeping or in favor of circumcision or hospital birth with epidurals. Although the root of this recent position on drugs and breastfeeding seems to be the notion that you must breastfeed at all costs. However as I stated in the original UNITE article "Leading Families to the Slaughter" - formula has never put a baby into a coma, as far as I am aware.
Recent studies undertaken on antipsychotic drugs have revealed that patients on placebo actually improved more than those taking atypical antipsychotics, like Zyprexa. Any magazine or advocate who ignores the facts and censors those who try to get the word out about dangers poses a very serious danger to families and society and shows a total disregard for ethics. We have been slowly deluded and our society is being eaten away, our rights are eroded and ignored, and our health and safety threatened.
I have been reluctant to speak out against Mothering, Thomas Hale, Kathleen Kendall Tackett, and New Beginnings because I know people make mistakes. But this type of mistake seems to be more a generally intended goal than an accident.
I examined the research which has been claimed as evidence of safety of both SSRIs and of Zyprexa for nursing moms and what I found was disturbing. A full written analysis is forthcoming - but in short, the studies were done on extremely small samples, side effects were disregarded, and most of the women in the studies were not exclusively breastfeeding. When a significant portion of a baby's diet is formula, it's obvious that any exposure will be reduced.
Given the absolute refusal of the FDA and certain mental health advocates to accept the negative outcomes from our current slew of psychiatric drugs and interventions, it is not too surprising that others such as those in the media or in positions of influence in the natural health community can get away with ignoring the facts.
I guess it all comes back to the original lies of chemical imbalances and the backwards serotonin theory (see http://uniteforlife.org/links.html#books)
For anyone who has not seen it, the DVD Psychiatry: An Industry of Death is extremely informative on the history of psychiatry and psychology. I highly recommend you watch it. You can find it at http://www.cchr.org/index/5285/15242/
Needless to say, my subscription to Mothering Magazine is not being renewed. I encourage others to speak out if they too have been censored or if they disagree with the ideas in the magazine. The readers won't continue buying the magazine if it becomes too full of false and dangerous ideas. In fact one of the only reasons to continue reading would be to monitor the manner in which decline of reason and the rise of dangerous dogma are promoted and innocent young families are unknowingly deluded.
To Mothering Magazine, should you read this blog, I urge you to prove me wrong by changing your ways and apologizing to those who have been censored. I also encourage you to overhaul your user agreement and revamp or remove the PPD and mental health forums so they will not be players in supporting one of the most evil of all enterprises we face in our world.
My Objection to a New 2-Week Injectable Version of Zyprexa (an NDA with the FDA)
If you see the open letter to Mothering Magazine below, I stated that I did not believe that Thomas Hale would recommend antipsychotic drugs during breastfeeding. I was wrong. Based on a 2003 study of 7 women, 6 of whom were "evaluable," the entire world now is subject to the irresponsible recommendation to use Zyprexa while breastfeeding. Lilly wants more patent protection for Zyprexa so they are proposing a new injectable formulation that is a 2-week long-lasting shot. Please read my letter to the FDA below and send your objection letter to the email address or fax number provided here.
This written testimony is being submitted to the FDA for the Feb. 6 Zyprexa hearing on concerns about increased somnolence with the new formulation.You have until January 18 to submit your written testimony to:
Diem-Kieu H. Ngo, Pharm.D., BCPS LCDR, U.S. Public Health Service Program Management Officer Food and Drug Administration Office of Executive Programs Advisors and Consultants Staff (HFD-21) 5630 Fishers Lane Room 1093, Rockville MD, 20857 Telephone: 301-827-6765 Fax: 301-827-6778 diem.ngo@fda.hhs.gov
======================================================================
I submit this testimony as an extreme objection to possible approval of any NDAs for new formulations of the highly dangerous drug Zyprexa, and particularly to the proposed intramuscular, extended-release, long-acting (2 week) version. A 2-week-long extended-release formulation which could potentially threaten children who are incapable of efficiently metabolizing it (such as breastfeeding infants), and which carries increased somnolence effects compared to older formulations, will inevitably lead to "SIDS" in some infants if the drug is allowed to be given to breastfeeding women. Should this occur, increased cases of depression in mothers who lose their infants because of drugs will increase subsequent profits for Eli Lilly through additional sales and continued drugging of grieving mothers and families.
For the sake of expediency I'll assume you understand that psychosis is commonly caused in postpartum women by administration of SSRIs. (I know that it is, because I survived the dose-dependent worsening of homicidal and suicidal urges and even one hallucination which started after only 3 days on Zoloft. My family and I suffered through for about 5 months - starting with Zoloft samples at 6 days postpartum following the birth and near death of my son in July 2004, and continuing through months of frightening urges, expensive hospital bills and visits to psychiatrists and therapists, my condition worsening to the point of near loss of control over my own thoughts or actions until I discontinued the drug. I also know this from the research that I have read over the past 3 years.) I believe that the push to medicate mothers with antipsychotic drugs serves more than the purpose of attempting to control psychosis, bipolar disorder, or extreme depression (which Zyprexa does not do - recent studies undertaken on "antipsychotic" drugs have revealed that patients on placebo actually improved more than those taking atypical antipsychotics, like Zyprexa).
Even if Zyprexa were discontinued by someone who tried it, in favor of a lesser poison, an SSRI would only lead people back to a place where they feel they cannot function without antipsychotic drugs. And so the cycle of sacrifice on the altar of profit and power will continue... Among the effects produced by Zyprexa (and there are almost 3,000 known side effects), somnolence seems to be the most advantageous to the psychiatric staff who will be dealing with patients. With or without breastfeeding mothers' use, a long-lasting extended-release version which increases somnolence beyond what these major tranquilizers already do will make the task of filling beds and subduing psychiatric patients much easier and more profitable. And it will pose a serious threat to young children whose parents and doctors are quick to medicate them for the "symptoms" which are nothing more than the effects of other toxic drugs and foods - things that your organization should never have allowed to be legally fed to and injected into children.
The current cost of atypical antipsychotics is $300-$600 more per month than older antipsychotic agents and sales are steadily increasing. This is Eli Lilly's best-selling drug, and with all the new users of SSRIs and other psychosis-inducing, FDA-approved drugs, it is likely to remain a profitable drug as long as it enjoys FDA approval, patent protection and inadequate warnings, and even potentially bring in huge sales as a generic drug.Even though Zyprexa has not been studied in under 18s, I can tell you that every day parents feed their children antipsychotic drugs like Zyprexa because of court orders. Why in a country supposedly regulated by your agency is this allowed to happen? This is criminal! If you do approve the new intramuscular version of Zyprexa extended-release I hope you will do the right thing and create requirements for this drug to be severely controlled. It should be illegal for a psychiatrist to force-drug a child with this medication or any medication which causes permanent neurological damage and tics. It should be illegal for a pregnant or breastfeeding mother to take it.
According to the package label for current formulations, intramuscular administration of Zyprexa results in a plasma level 5 times that of oral dosage tablets and reaches that concentration within 15-45 minutes, compared to 6 hours for the oral version. What will be the speed and exposure level of a longer-acting version? In addition, the somnolence effect is more pronounced in current intramuscular versions compared to oral tablets, and it is reported to be worse in the newer version for which Lilly seeks the patent.
And what are intramuscular injections used for? Most commonly they are used in cases of forced treatment for hospitalized patients. Given the fact that almost every patient who enters a psych ward will be given an antipsychotic agent, the potential for worsened adverse events is profound. The situation which we are faced with is one where the order of a doctor - even one who has never met the patient - but is told of her situation over the phone - can legally require a patient to be locked up, deprived of informed consent, and force-drugged with poisons approved by your organization. So I ask, are you the FDA, charged with regulating drugs and foods that the public faithfully trusts are safe or "safe enough," or are you merely a tool drug companies use to persuade the public to trust in their so-called science, proprietary and twisted as it may be?
The label for Zyprexa includes a warning against nursing an infant while taking the medication. However, recently Dr. Thomas Hale and Kathleen Kendall-Tackett (among others) have encouraged breastfeeding mothers who experience psychotic episodes to make their way immediately to a hospital and get treatment with Zyprexa without interrupting breastfeeding. According to Mothering Magazine, psychotic breastfeeding mothers can safely continue nursing while taking Zyprexa if they avoid feeding during peak plasma concentration.
What is the likelihood that a doctor will know when the peak concentration in a nursing mother will be, when only one study has been cited by advocates of this position as an excuse for evidence of safety, and this was conducted on a sample with 7 women? Most breastfeeding studies have samples this small, even for drugs like Zoloft, with samples as small as 4 women, and totaling around 30 women in all. In addition, many studies purporting to study breastfeeding women have actually involved mostly women who were not exclusively breastfeeding, with the infant who was exclusively breastfed being the one who experienced seizures and coma and other serious effects.
Not to mention that psychiatric patients are often given multiple drugs which cause concentrations of Zyprexa to become elevated and increase the somnolence effect. The Zyprexa package label also cites reports of pregnant women using Zyprexa which led to 1 neonatal death, 3 therapeutic abortions, and 1 spontaneous abortion (or miscarriage). Though the package label states that infant exposure through breast milk is as high as 1.8% of the maternal dose, the article cited by Thomas Hale in his recommendations that Olanzapine is an acceptable drug for breastfeeding mothers claims that out of the six "evaluable" samples... the exposure was only 1% of the maternal dose. They only studied 7 people, 6 of whom were "evaluable", yet on this weak basis the drug is recommended to breastfeeding mothers for psychosis, bipolar disorder and extreme depression.
How can we in good conscience expose infants to risks like excessive somnolence, hypotension, seizures, tardive dyskinesia and multiple other effects? This drug has not been studied or approved for children under 18, yet it is now being prescribed to breastfeeding mothers and apparently some pregnant mothers as well.
This is completely irresponsible, and even though the advice of breastfeeding advocates differs from what the package inserts say (as to the the level of exposure to the baby, the claims of no side effects in babies, and in the attitude about the reasoning behind the claims being based on liability versus risk), people are currently going along in droves with the most dangerous advice, rather than heeding the most cautious approach.
How is a mother who is under the influence of a drug which causes extreme somnolence supposed to prevent the baby from nursing at peak concentration times? Anyone who has ever seen a patient under the influence of antipsychotic agents knows that the other profound effects of Zyprexa can incapacitate you to the point that you would not even be able to care for yourself, much less an infant. A drooling, barely able to walk or talk woman, whose bodily functions have been disrupted cannot be expected to do anything to take care of a baby safely, and the expectation that she would is dangerous. If any woman taking the drug actually were able to continue caring for her baby she would at minimum be severely impaired. Perhaps she could lie around nursing her child 24 hours a day and increase the exposure, but it is doubtful she could do much more.
A mother who is told to take Zyprexa while nursing cannot be expected to manage breastfeeding in a way that would minimize exposure at a peak concentration time, particularly if she is also taking another agent like Prozac which enhances plasma levels of olanzapine. If concomitant medications or intramuscular injection are used, the concentration multiplies 5 times or more, and could reach peak concentration in a shorter amount of time (according to the package label, 15-45 minutes from intramuscular injection alone and potentially faster if mixed with other drugs). How is a mother supposed to guess how all the factors play a role? Furthermore, Zyprexa increases prolactin levels and will thus increase milk supply and overall exposure for the baby (especially by increasing the likelihood of engorgement and mastitis, thereby encouraging the mother to nurse more frequently, especially during potentially peak concentration times).
Most women who would be so insistent on nursing as to continue doing so while taking this medication would be those who are also co-sleeping and night nursing. Increased somnolence above and beyond current levels caused by existing formulations, in this type of co-sleeping situation, would be even more dangerous than somnolence in other patients due to the lack of the awareness of the baby's whereabouts and the potential for a mother to fail to notice whether her baby is nursing when a potentially peak concentration time is taking place. Is increased bonding worth the risk that these drugs pose to infants? Somnolence, seizures, coma, inability to regulate temperature, all effects of Zyprexa... these pose so much risk to babies for SIDS that it sounds like population control or eugenics to recommend them. Even if all psychotic mothers and their babies were accidentally killed by drugs we will still have more come along because of SSRIs and other FDA-approved drugs.
Infants cannot metabolize drugs at the same rate as adults - drugs are more readily absorbed, more free-floating drug courses through their veins, their kidneys work at 30-40% the capacity of adults, and brain concentrations are always higher than the dose would suggest (10 to 30 times higher) due to the immature blood-brain barrier. It takes infants much longer to rid themselves of a single dose. How long will it take an infant exposed to Zyprexa to eliminate it - especially if the child is a newborn? If the toxic effects are noted in an infant who is exposed to an even longer-lasting formulation (such as a 2-week formulation), it will already be too late to do anything to save the child. Prozac has caused coma in infants exposed through mother's milk... why would we put them at risk with a drug much more toxic?
Involuntary injection with a formulation of a highly dangerous drug which will not wear off for 2 weeks will pose a particularly serious threat in any case of a breastfeeding mother who comes to the hospital for psychosis. It is not unreasonable to assume that psychiatric staff may at some point inject a woman with this prior to learning that a mother is breastfeeding, nor is it unlikely that the mother may insist on the basis of Hale's endorsement that she can continue nursing her baby on this drug. If this is allowed, there is no doubt that mothers who start the treatment will probably continue an oral version if they are sent home. If the drug were to be banned to breastfeeding women (a burdensome choice you could easily enact by declaration due to safety concerns), then any mother mistakenly forcibly injected with this drug will also be forced to discontinue breastfeeding, most likely permanently.
If the FDA approves the New Drug Application and hands Eli Lilly another several years of patent protection in a market that has grown to over 4 billion dollars per year and is ever-expanding, we will have a dire situation on our hands.
Doctors do not abide by your recommendations, or even necessarily those of drug companies, and currently even though the package insert says that pregnant and breastfeeding women should not use Zyprexa - or women who use it should not breastfeed, this advice is not being heeded. Three years ago I was told that I should wean my baby and take Zyprexa - that the "symptoms" I was having stood a better chance of relief with a toxic drug that my baby could not have. I chose not to go on Zyprexa or wean my son. Instead I eventually realized that no matter how long I gave Zoloft to work, it was only going to make me more homicidal. I was even told it was not Zoloft, but that I was just crazy, and ought never to have more children. But I got off Zoloft and as a result I got better. I had a second child (an un-interfered-with home birth attended by a CNM), and experienced no PPD whatsoever in the past 16 months since my second son was born.
Psychiatrists have demonstrated no concern for safety whatsoever, even prescribing cocktails of drugs to very young children for completely ridiculous reasons despite the evidence that children can die from being given these medications (not to mention that adults can too).
You go after chiropractors or doctors who administer unapproved hormone treatments, sandwich carts that serve tainted food, and vaccine manufacturers who put contaminated drugs into vials intended for injection into newborns, and you should equally go after judges who court-order parents to drug their children, psychiatrists who prescribe these drugs and others in a cocktail, and any hospital that force-treats someone with harmful medications. There should be some sort of improved warning or prescription process that applies to Zyprexa and the entire class of drugs so that mothers will not be led astray and into dangerous territory by people who haphazardly attempt to be their advocates.
We have entered a brave new world where drug companies seek FDA approval for new versions of old drugs for financial reasons alone. Much of the public has seen how dangerous Zyprexa is, yet it remains a growing market for those who are unaware, or for those who are forced, or for those who mistakenly believe they have chemical imbalances which can only be corrected by the "right" medication. To consider approving a more dangerous version of Zyprexa simply for the financial gain of Eli Lilly, knowing that it puts patients at even greater risk is unthinkable. This drug currently costs several hundred dollars more per month than older antipsychotic agents. The very clear incentive to prescribe such an expensive drug or forcibly inject it into a patient should make you all pause and ask yourselves if you are in this organization for the ultimate mission of ensuring the safety of Americans or for keeping the drug companies profitable and powerful.
On behalf of the 257 members of CHAADA (Children and Adults Against Drugging America) and on behalf of members and friends who are unable to attend this meeting or submit written testimony due to the fact that they are currently in the midst of having their children forcibly poisoned and ruined by these drugs, I urge you to do the right thing and consider what possible implications your actions will have. The Eli Lilly corporation does not need more patent protections for a drug that is already causing so much disease in our country, especially in an even more dangerous form than the current formulation. Hopefully by the time their existing patent expires in 2011, this drug and others will already have suffered a ban, or the government will rein in their out of control actions and regulate them like a company that claims to promote health should be regulated instead of a company out for profit and more disease markets.
Your SSRI black box warning for suicide played a role in saving my life in 2004, secured my son's safety with me as his sole caregiver for the first time in his life, and made it possible for me to go on to have another child. The public has been deluded for too long and it is your responsibility to issue the types of warnings, bans, and denials of drug approval applications that will ensure public safety. We do not need more Zyprexa, more expensive Zyprexa, or more long-lasting Zyprexa. There are enough generic, less toxic drugs and placebos for doctors to experiment on us with to last us until the sun implodes or explodes, our planet is destroyed, and the solar system gets its claws on Eli Lilly and pulls it straight to Hell (unless I am mistaken and we are already living in it).
Sincerely,
Amy PhiloBreastfeeding mother of two boys
Founder, http://www.uniteforlife.org/Co-Founder, http://www.chaada.org/FOunder, http://www.babywhys.org/
This written testimony is being submitted to the FDA for the Feb. 6 Zyprexa hearing on concerns about increased somnolence with the new formulation.You have until January 18 to submit your written testimony to:
Diem-Kieu H. Ngo, Pharm.D., BCPS LCDR, U.S. Public Health Service Program Management Officer Food and Drug Administration Office of Executive Programs Advisors and Consultants Staff (HFD-21) 5630 Fishers Lane Room 1093, Rockville MD, 20857 Telephone: 301-827-6765 Fax: 301-827-6778 diem.ngo@fda.hhs.gov
======================================================================
I submit this testimony as an extreme objection to possible approval of any NDAs for new formulations of the highly dangerous drug Zyprexa, and particularly to the proposed intramuscular, extended-release, long-acting (2 week) version. A 2-week-long extended-release formulation which could potentially threaten children who are incapable of efficiently metabolizing it (such as breastfeeding infants), and which carries increased somnolence effects compared to older formulations, will inevitably lead to "SIDS" in some infants if the drug is allowed to be given to breastfeeding women. Should this occur, increased cases of depression in mothers who lose their infants because of drugs will increase subsequent profits for Eli Lilly through additional sales and continued drugging of grieving mothers and families.
For the sake of expediency I'll assume you understand that psychosis is commonly caused in postpartum women by administration of SSRIs. (I know that it is, because I survived the dose-dependent worsening of homicidal and suicidal urges and even one hallucination which started after only 3 days on Zoloft. My family and I suffered through for about 5 months - starting with Zoloft samples at 6 days postpartum following the birth and near death of my son in July 2004, and continuing through months of frightening urges, expensive hospital bills and visits to psychiatrists and therapists, my condition worsening to the point of near loss of control over my own thoughts or actions until I discontinued the drug. I also know this from the research that I have read over the past 3 years.) I believe that the push to medicate mothers with antipsychotic drugs serves more than the purpose of attempting to control psychosis, bipolar disorder, or extreme depression (which Zyprexa does not do - recent studies undertaken on "antipsychotic" drugs have revealed that patients on placebo actually improved more than those taking atypical antipsychotics, like Zyprexa).
Even if Zyprexa were discontinued by someone who tried it, in favor of a lesser poison, an SSRI would only lead people back to a place where they feel they cannot function without antipsychotic drugs. And so the cycle of sacrifice on the altar of profit and power will continue... Among the effects produced by Zyprexa (and there are almost 3,000 known side effects), somnolence seems to be the most advantageous to the psychiatric staff who will be dealing with patients. With or without breastfeeding mothers' use, a long-lasting extended-release version which increases somnolence beyond what these major tranquilizers already do will make the task of filling beds and subduing psychiatric patients much easier and more profitable. And it will pose a serious threat to young children whose parents and doctors are quick to medicate them for the "symptoms" which are nothing more than the effects of other toxic drugs and foods - things that your organization should never have allowed to be legally fed to and injected into children.
The current cost of atypical antipsychotics is $300-$600 more per month than older antipsychotic agents and sales are steadily increasing. This is Eli Lilly's best-selling drug, and with all the new users of SSRIs and other psychosis-inducing, FDA-approved drugs, it is likely to remain a profitable drug as long as it enjoys FDA approval, patent protection and inadequate warnings, and even potentially bring in huge sales as a generic drug.Even though Zyprexa has not been studied in under 18s, I can tell you that every day parents feed their children antipsychotic drugs like Zyprexa because of court orders. Why in a country supposedly regulated by your agency is this allowed to happen? This is criminal! If you do approve the new intramuscular version of Zyprexa extended-release I hope you will do the right thing and create requirements for this drug to be severely controlled. It should be illegal for a psychiatrist to force-drug a child with this medication or any medication which causes permanent neurological damage and tics. It should be illegal for a pregnant or breastfeeding mother to take it.
According to the package label for current formulations, intramuscular administration of Zyprexa results in a plasma level 5 times that of oral dosage tablets and reaches that concentration within 15-45 minutes, compared to 6 hours for the oral version. What will be the speed and exposure level of a longer-acting version? In addition, the somnolence effect is more pronounced in current intramuscular versions compared to oral tablets, and it is reported to be worse in the newer version for which Lilly seeks the patent.
And what are intramuscular injections used for? Most commonly they are used in cases of forced treatment for hospitalized patients. Given the fact that almost every patient who enters a psych ward will be given an antipsychotic agent, the potential for worsened adverse events is profound. The situation which we are faced with is one where the order of a doctor - even one who has never met the patient - but is told of her situation over the phone - can legally require a patient to be locked up, deprived of informed consent, and force-drugged with poisons approved by your organization. So I ask, are you the FDA, charged with regulating drugs and foods that the public faithfully trusts are safe or "safe enough," or are you merely a tool drug companies use to persuade the public to trust in their so-called science, proprietary and twisted as it may be?
The label for Zyprexa includes a warning against nursing an infant while taking the medication. However, recently Dr. Thomas Hale and Kathleen Kendall-Tackett (among others) have encouraged breastfeeding mothers who experience psychotic episodes to make their way immediately to a hospital and get treatment with Zyprexa without interrupting breastfeeding. According to Mothering Magazine, psychotic breastfeeding mothers can safely continue nursing while taking Zyprexa if they avoid feeding during peak plasma concentration.
What is the likelihood that a doctor will know when the peak concentration in a nursing mother will be, when only one study has been cited by advocates of this position as an excuse for evidence of safety, and this was conducted on a sample with 7 women? Most breastfeeding studies have samples this small, even for drugs like Zoloft, with samples as small as 4 women, and totaling around 30 women in all. In addition, many studies purporting to study breastfeeding women have actually involved mostly women who were not exclusively breastfeeding, with the infant who was exclusively breastfed being the one who experienced seizures and coma and other serious effects.
Not to mention that psychiatric patients are often given multiple drugs which cause concentrations of Zyprexa to become elevated and increase the somnolence effect. The Zyprexa package label also cites reports of pregnant women using Zyprexa which led to 1 neonatal death, 3 therapeutic abortions, and 1 spontaneous abortion (or miscarriage). Though the package label states that infant exposure through breast milk is as high as 1.8% of the maternal dose, the article cited by Thomas Hale in his recommendations that Olanzapine is an acceptable drug for breastfeeding mothers claims that out of the six "evaluable" samples... the exposure was only 1% of the maternal dose. They only studied 7 people, 6 of whom were "evaluable", yet on this weak basis the drug is recommended to breastfeeding mothers for psychosis, bipolar disorder and extreme depression.
How can we in good conscience expose infants to risks like excessive somnolence, hypotension, seizures, tardive dyskinesia and multiple other effects? This drug has not been studied or approved for children under 18, yet it is now being prescribed to breastfeeding mothers and apparently some pregnant mothers as well.
This is completely irresponsible, and even though the advice of breastfeeding advocates differs from what the package inserts say (as to the the level of exposure to the baby, the claims of no side effects in babies, and in the attitude about the reasoning behind the claims being based on liability versus risk), people are currently going along in droves with the most dangerous advice, rather than heeding the most cautious approach.
How is a mother who is under the influence of a drug which causes extreme somnolence supposed to prevent the baby from nursing at peak concentration times? Anyone who has ever seen a patient under the influence of antipsychotic agents knows that the other profound effects of Zyprexa can incapacitate you to the point that you would not even be able to care for yourself, much less an infant. A drooling, barely able to walk or talk woman, whose bodily functions have been disrupted cannot be expected to do anything to take care of a baby safely, and the expectation that she would is dangerous. If any woman taking the drug actually were able to continue caring for her baby she would at minimum be severely impaired. Perhaps she could lie around nursing her child 24 hours a day and increase the exposure, but it is doubtful she could do much more.
A mother who is told to take Zyprexa while nursing cannot be expected to manage breastfeeding in a way that would minimize exposure at a peak concentration time, particularly if she is also taking another agent like Prozac which enhances plasma levels of olanzapine. If concomitant medications or intramuscular injection are used, the concentration multiplies 5 times or more, and could reach peak concentration in a shorter amount of time (according to the package label, 15-45 minutes from intramuscular injection alone and potentially faster if mixed with other drugs). How is a mother supposed to guess how all the factors play a role? Furthermore, Zyprexa increases prolactin levels and will thus increase milk supply and overall exposure for the baby (especially by increasing the likelihood of engorgement and mastitis, thereby encouraging the mother to nurse more frequently, especially during potentially peak concentration times).
Most women who would be so insistent on nursing as to continue doing so while taking this medication would be those who are also co-sleeping and night nursing. Increased somnolence above and beyond current levels caused by existing formulations, in this type of co-sleeping situation, would be even more dangerous than somnolence in other patients due to the lack of the awareness of the baby's whereabouts and the potential for a mother to fail to notice whether her baby is nursing when a potentially peak concentration time is taking place. Is increased bonding worth the risk that these drugs pose to infants? Somnolence, seizures, coma, inability to regulate temperature, all effects of Zyprexa... these pose so much risk to babies for SIDS that it sounds like population control or eugenics to recommend them. Even if all psychotic mothers and their babies were accidentally killed by drugs we will still have more come along because of SSRIs and other FDA-approved drugs.
Infants cannot metabolize drugs at the same rate as adults - drugs are more readily absorbed, more free-floating drug courses through their veins, their kidneys work at 30-40% the capacity of adults, and brain concentrations are always higher than the dose would suggest (10 to 30 times higher) due to the immature blood-brain barrier. It takes infants much longer to rid themselves of a single dose. How long will it take an infant exposed to Zyprexa to eliminate it - especially if the child is a newborn? If the toxic effects are noted in an infant who is exposed to an even longer-lasting formulation (such as a 2-week formulation), it will already be too late to do anything to save the child. Prozac has caused coma in infants exposed through mother's milk... why would we put them at risk with a drug much more toxic?
Involuntary injection with a formulation of a highly dangerous drug which will not wear off for 2 weeks will pose a particularly serious threat in any case of a breastfeeding mother who comes to the hospital for psychosis. It is not unreasonable to assume that psychiatric staff may at some point inject a woman with this prior to learning that a mother is breastfeeding, nor is it unlikely that the mother may insist on the basis of Hale's endorsement that she can continue nursing her baby on this drug. If this is allowed, there is no doubt that mothers who start the treatment will probably continue an oral version if they are sent home. If the drug were to be banned to breastfeeding women (a burdensome choice you could easily enact by declaration due to safety concerns), then any mother mistakenly forcibly injected with this drug will also be forced to discontinue breastfeeding, most likely permanently.
If the FDA approves the New Drug Application and hands Eli Lilly another several years of patent protection in a market that has grown to over 4 billion dollars per year and is ever-expanding, we will have a dire situation on our hands.
Doctors do not abide by your recommendations, or even necessarily those of drug companies, and currently even though the package insert says that pregnant and breastfeeding women should not use Zyprexa - or women who use it should not breastfeed, this advice is not being heeded. Three years ago I was told that I should wean my baby and take Zyprexa - that the "symptoms" I was having stood a better chance of relief with a toxic drug that my baby could not have. I chose not to go on Zyprexa or wean my son. Instead I eventually realized that no matter how long I gave Zoloft to work, it was only going to make me more homicidal. I was even told it was not Zoloft, but that I was just crazy, and ought never to have more children. But I got off Zoloft and as a result I got better. I had a second child (an un-interfered-with home birth attended by a CNM), and experienced no PPD whatsoever in the past 16 months since my second son was born.
Psychiatrists have demonstrated no concern for safety whatsoever, even prescribing cocktails of drugs to very young children for completely ridiculous reasons despite the evidence that children can die from being given these medications (not to mention that adults can too).
You go after chiropractors or doctors who administer unapproved hormone treatments, sandwich carts that serve tainted food, and vaccine manufacturers who put contaminated drugs into vials intended for injection into newborns, and you should equally go after judges who court-order parents to drug their children, psychiatrists who prescribe these drugs and others in a cocktail, and any hospital that force-treats someone with harmful medications. There should be some sort of improved warning or prescription process that applies to Zyprexa and the entire class of drugs so that mothers will not be led astray and into dangerous territory by people who haphazardly attempt to be their advocates.
We have entered a brave new world where drug companies seek FDA approval for new versions of old drugs for financial reasons alone. Much of the public has seen how dangerous Zyprexa is, yet it remains a growing market for those who are unaware, or for those who are forced, or for those who mistakenly believe they have chemical imbalances which can only be corrected by the "right" medication. To consider approving a more dangerous version of Zyprexa simply for the financial gain of Eli Lilly, knowing that it puts patients at even greater risk is unthinkable. This drug currently costs several hundred dollars more per month than older antipsychotic agents. The very clear incentive to prescribe such an expensive drug or forcibly inject it into a patient should make you all pause and ask yourselves if you are in this organization for the ultimate mission of ensuring the safety of Americans or for keeping the drug companies profitable and powerful.
On behalf of the 257 members of CHAADA (Children and Adults Against Drugging America) and on behalf of members and friends who are unable to attend this meeting or submit written testimony due to the fact that they are currently in the midst of having their children forcibly poisoned and ruined by these drugs, I urge you to do the right thing and consider what possible implications your actions will have. The Eli Lilly corporation does not need more patent protections for a drug that is already causing so much disease in our country, especially in an even more dangerous form than the current formulation. Hopefully by the time their existing patent expires in 2011, this drug and others will already have suffered a ban, or the government will rein in their out of control actions and regulate them like a company that claims to promote health should be regulated instead of a company out for profit and more disease markets.
Your SSRI black box warning for suicide played a role in saving my life in 2004, secured my son's safety with me as his sole caregiver for the first time in his life, and made it possible for me to go on to have another child. The public has been deluded for too long and it is your responsibility to issue the types of warnings, bans, and denials of drug approval applications that will ensure public safety. We do not need more Zyprexa, more expensive Zyprexa, or more long-lasting Zyprexa. There are enough generic, less toxic drugs and placebos for doctors to experiment on us with to last us until the sun implodes or explodes, our planet is destroyed, and the solar system gets its claws on Eli Lilly and pulls it straight to Hell (unless I am mistaken and we are already living in it).
Sincerely,
Amy PhiloBreastfeeding mother of two boys
Founder, http://www.uniteforlife.org/Co-Founder, http://www.chaada.org/FOunder, http://www.babywhys.org/
Wednesday, October 03, 2007
History of Neuroleptics and Dangers of SSRIs
http://4thoutlawpsychiatry.blogspot.com/
Click on the title above to read the blog...
Click on the title above to read the blog...
Tuesday, September 25, 2007
Breastfeeding and Medications: "Experts" Lead Families to the Slaughter
I have analyzed some common advice given to moms with PPD about medications and breastfeeding. It's important to note that Hale only claims to have studied about 30 babies when he recommended Zoloft. Also, Prozac can cause COMA in the baby. SSRIs work the same way.
Also it's important to note that Omega 3s have been so successful for treating depression, that a recent study on bipolar disorder was halted because they considered it unethical to continue the placebo group and immediately put them all on 14 tabs of fish oil a day.
Please also see the home page of uniteforlife.org for some very important articles and announcements.
Also it's important to note that Omega 3s have been so successful for treating depression, that a recent study on bipolar disorder was halted because they considered it unethical to continue the placebo group and immediately put them all on 14 tabs of fish oil a day.
Please also see the home page of uniteforlife.org for some very important articles and announcements.
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