VIA Bob Fiddaman:
"Last Friday, March 26, 2010, a United States District Court Judge in Los Angeles rejected Eli Lilly and Company (“Lilly”) and Sandoz Inc.’s attempt to dismiss a case arising from the suicide of Noe Carrasco, a 26-year-old Southern Californian man who was taking the generic version of the antidepressant Prozac at the time of his suicide. The lawsuit was brought by the young man’s mother, Rosemary Dorsett, who claims the manufacturers failed to warn of the suicide risks associated with fluoxetine (Prozac)."
"Despite her own personal tragedy, Rosemary Dorsett has taken proactive steps to try to prevent others from having to endure the emotional pain she has been forced to suffer. She traveled to Maryland for the December 13, 2006 Psychopharmacologic Drugs Advisory Committee meeting to testify about her son’s death and to urge the FDA to issue stronger warnings about the increased risk of suicidality associated with antidepressants, including fluoxetine. Her testimony is available online at:
www.baumhedlundlaw.com/fda_testimony/rosemary_dorsett.php
"Ms. Dorsett is represented by the national law firm, Baum, Hedlund, Aristei & Goldman. Baum Hedlund has the longest track-record of handling SSRI (selective serotonin reuptake inhibitor) antidepressant cases such as Prozac, Paxil and Zoloft, and is currently representing hundreds of antidepressant birth defect clients in addition to suicide cases."
Read the article in entirety HERE.
Wednesday, March 31, 2010
Tuesday, March 30, 2010
life formation
the lake was alive with life this morning. tiny buds forming on the trees, that will soon unfold to become summer leaves. there was a blue heron perched on a tree stump along the water's edge. the lake was covered in new lily pads. the sun peaked out from the clouds and the air was cold and crisp. the nearby hills displayed a dusting of snow, a result of the early spring weather. transforming oneself into a place of being, taking energy and truly just being, in the woods, by the lake, gives peace at all times. then the beauty admired in nature goes along with us all day.
"Beyond the beauty of external forms, there is more here: something that cannot be named, something ineffable, some deep, inner, holy essence. Whenever and wherever there is beauty, this inner essence shines through somehow. It only reveals itself to you when you are present".
--Eckhart Tolle
*photograph is standing next to the lake on the trail near the beaver dam
"Beyond the beauty of external forms, there is more here: something that cannot be named, something ineffable, some deep, inner, holy essence. Whenever and wherever there is beauty, this inner essence shines through somehow. It only reveals itself to you when you are present".
--Eckhart Tolle
*photograph is standing next to the lake on the trail near the beaver dam
Monday, March 29, 2010
The top 20 largest pharmaceutical companies, billions of dollars
VIA Reuters:
The chart is listing in billions of US dollars, I've listed a few products familiar to readers:
1.PFIZER $41.7--(Chantix, Geodon, Neurontin, Viagra, Xanax, Zoloft)
2.NOVARTIS $36.7--(Clozaril,Tegretol,Ritalin,Trileptal)
3.SANOFI-AVENTIS $35.1--(Ambien)
4.GLAXO SMITH KLINE(GSK)$34.3--(Paxil, Lamictal,Avandia)
5.ASTRAZENECA $33.2--(Seroquel)
6.ROCHE $31.3--(Valium)
7.JOHNSON&JOHNSON $26.9--(Invega, Topomax,Concerta,Risperdal,Risperdal Consta)
8.MERCK&CO $25.0--(Saphris)
Take a look at the rest in the article HERE.
The chart is listing in billions of US dollars, I've listed a few products familiar to readers:
1.PFIZER $41.7--(Chantix, Geodon, Neurontin, Viagra, Xanax, Zoloft)
2.NOVARTIS $36.7--(Clozaril,Tegretol,Ritalin,Trileptal)
3.SANOFI-AVENTIS $35.1--(Ambien)
4.GLAXO SMITH KLINE(GSK)$34.3--(Paxil, Lamictal,Avandia)
5.ASTRAZENECA $33.2--(Seroquel)
6.ROCHE $31.3--(Valium)
7.JOHNSON&JOHNSON $26.9--(Invega, Topomax,Concerta,Risperdal,Risperdal Consta)
8.MERCK&CO $25.0--(Saphris)
Take a look at the rest in the article HERE.
between the rain showers and quotes for the day
"When you are sorrowful look again in your heart, and you shall see that in truth you are weeping for that which has been your delight."-Kahlil Gibran
so this is what i was feeling when i got choked up and cried on my walk. i was not feeling sadness i was feeling the delight in my heart for the person i love and miss. this quote actually gives solace, to me, that leaves me to say to myself, then don't cry, when feeling the longing or wanting to be together in person, let the delight and joy be the focus.
so this is what i was feeling when i got choked up and cried on my walk. i was not feeling sadness i was feeling the delight in my heart for the person i love and miss. this quote actually gives solace, to me, that leaves me to say to myself, then don't cry, when feeling the longing or wanting to be together in person, let the delight and joy be the focus.
life is a journey, we all know that. ours is taking an adjustment, but i am finding solace and joy in the beauty around me.
the gift from the walks that i never knew would be such a profound gift someone could give another person---walking shoes and walking trails. which is my gratitude list today, the gift of friendship, companionship and love. And appreciation for life, by example. thank you honey.
--
--
what i did with my tears which were not at all too horrendous, (lol) was to walk until they stopped, using the energy and pushing it into a positive by being physically active as an outlet and with determination, walked it out.
--
a mindful learning quote for the day
"Your living is determined not so much by what life brings to you as by the attitude you bring to life; not so much by what happens to you as by the way your mind looks at what happens."-Kahlil Gibran
earlier in the morning, i watched the torrential downpour of rain and waited for (hoped for, and received) a break in the storm for my morning walk with the dog. i saw the opportunity open up, grabbed the umbrella and off i went. not a single other person was outside walking. the paths were definitely muddy and flooded, and i saw this little fern unfurling along the way. i made another loop back and saw the trillium is still there, alas no one has picked it! haven't found another one yet, just that one, and it is there with magnificent splendor for all to see and enjoy.
--
i just looked out the window and it is raining with big, giant, enormous drops, assuring that March leaves like a lion i guess!
Sunday, March 28, 2010
the trillium is back!
last year we had a lot of fun watching the trilliums (and finding them)change from pure white to pink to purple. I headed out on the path for my walk this morning and wondered if i would find one, they are elusive---and i spotted the tree where we found it last year and here it is! the first one i've found. i was so excited!
Saturday, March 27, 2010
Tufts Medical Center: psychiatrist testifies with immunity: Rebecca Riley's father: GUILTY OF MURDER BY PSYCH MEDS
VIA The Boston Globe:
"Michael Riley, 37, faces a mandatory sentence of life in prison without parole for the murder of his daughter Rebecca. In a separate trial in the same case, his wife, Carolyn, 35, was convicted Feb. 9 of second-degree murder."
AND
"After the verdict, Plymouth District Attorney Timothy J. Cruz said he believes the psychiatrist, Dr. Kayoko Kifuji, who prescribed the drugs to Rebecca, should not be allowed to practice medicine in Massachusetts, and he will ask the Board of Registration to reopen an investigation into her medical care.
"Dr. Kifuji is unfit to have a medical license," he said after the verdict was announced. "If what Dr. Kifuji did in this case is the acceptable standard of care for children in Massachusetts, then there is something very wrong in this state."
AND
"In closing arguments in Michael Riley’s trial, both sides lambasted Kifuji for her careless attention to Rebecca. The father's attorney, John Darrell, said that Kifuji “authorized every piece of that poison” that killed Rebecca; and prosecutor Frank J. Middleton referred to her as a “quack” and a “disgrace” to the medical profession."
"Michael Riley, 37, faces a mandatory sentence of life in prison without parole for the murder of his daughter Rebecca. In a separate trial in the same case, his wife, Carolyn, 35, was convicted Feb. 9 of second-degree murder."
AND
"After the verdict, Plymouth District Attorney Timothy J. Cruz said he believes the psychiatrist, Dr. Kayoko Kifuji, who prescribed the drugs to Rebecca, should not be allowed to practice medicine in Massachusetts, and he will ask the Board of Registration to reopen an investigation into her medical care.
"Dr. Kifuji is unfit to have a medical license," he said after the verdict was announced. "If what Dr. Kifuji did in this case is the acceptable standard of care for children in Massachusetts, then there is something very wrong in this state."
AND
"In closing arguments in Michael Riley’s trial, both sides lambasted Kifuji for her careless attention to Rebecca. The father's attorney, John Darrell, said that Kifuji “authorized every piece of that poison” that killed Rebecca; and prosecutor Frank J. Middleton referred to her as a “quack” and a “disgrace” to the medical profession."
sitting on benches
when i arrived to take her out on the saturday outing i got a bit choked up, and had to buck up and shove a few tears off of my face with a mighty swipe of the sleeve. got out of the car and stood up and tall, took a deep breath and moved it forward. when the "no man's land" elevator door opened to her hallway, there she was waiting on the other side of the locked double doors. i wave happily and ring the buzzer to alert someone with a key to come open the door. i greet her, and we are off and out of there.
--
not a single word was spoken from her
but i talk to her as if she is talking to me. she is doing great with pointing the last few times, for the radio, for a choice of soda to drink, etc. at this park, i prompted her to "let's go walk and look at the view or you can just go to that bench". when i said that, i think it gave her a choice of personal space what she could handle. plus i had candy. lol she walked past the bench and looked out to the water. down below this bluff is an active train track, and one went speeding by...she was smiling and i asked her to let me take a photo. before i could take the photo, she walked away. "i missed the photo op, ah come on and go back for a picture" i said. huh, she did. she walked over to the fence and this was the photograph.
--
not a single word was spoken from her
but i talk to her as if she is talking to me. she is doing great with pointing the last few times, for the radio, for a choice of soda to drink, etc. at this park, i prompted her to "let's go walk and look at the view or you can just go to that bench". when i said that, i think it gave her a choice of personal space what she could handle. plus i had candy. lol she walked past the bench and looked out to the water. down below this bluff is an active train track, and one went speeding by...she was smiling and i asked her to let me take a photo. before i could take the photo, she walked away. "i missed the photo op, ah come on and go back for a picture" i said. huh, she did. she walked over to the fence and this was the photograph.
--
we strolled through the dollar store and she didn't nod yes to any playdoh, activity book etc, but walked directly to a freezer and chose an ice cream bar. we purchased that and she ate it as we strolled the plaza, where i pointed out a used book store and asked her if she wanted to look inside. nope.
--
she never did sit on that bench i showed her. she went past the bench to look out to the gorgeous islands and water. i sat on the bench and admired the entire view, with her in it.
Reality is disability is here, and that needs to be appropriately addressed
This is an excellent post written by a mother who has a severely disabled daughter. Her daughter has survived a recent intense crisis, and Claire writes straight up truth about the life, and the quality of it, with her daughter. She goes to places most people do not, while writing about the harsh reality of life and death, and being in a spiritual battle of sorts at times, wanting her daughter to live and wonder how her body has held on this long. I find her blog to be inspiring, and grounding at the same time.
"The fact of the matter is, my daughter is severely disabled...both physically and cognitively...she is indeed in need of "special" services and "special" treatment. She is not "just like any other child". This is not a demeaning concept. It is an accurate one, one that allows the world to define and address her needs more appropriately."
---
The post above has helped me think, to put together the words I have been trying to write about here, about my daughter the last 2 weeks.
She had a non-verbal IQ test last week. I attended to bring along junior mints and encouragement and also to be able to explain to the psychologist how to communicate with my daughter. It's not hard to communicate with a non verbal person, at least that's what I either have some sort of bizarre talent to do, or I am just observant of subtle communications my daughter does express, if one is watching or paying attention. She has body language and facial expressions. It's obvious when she has internal stuff distracting her in her mind. I humor her at one point, and say, "leave all of that on the back burner and tune in, eyes on the paper", or "hey earth to L!" it's not degrading, it's bringing her in a bit to get the task done. This test, is part of a plan to assess her IQ and ability, and another one will assess what she knows, as in hot/cold, safety topics.
All of these tests are supposedly a base for appropriate housing and long term care.
But they want her to talk.
The doctor and the psychologist the last 2 weeks have commented that she needs to talk to do one of the tests for assessment.
She is who she is, right now and has been for several years. She has only recently, last August began to talk in brief spurts with us, and that comes and goes. I haven't heard her speak now for weeks again. That hasn't stopped me from taking her on outings or being able to know what she needs or wants. She stays with me on walks, before we cross a street I verbalize to stop, look and listen. In essence, yes I am aware of keeping her safe....being there with her, a vulnerable person, who has had something happen to her brain.
Is it the drugs? was it the trauma? I've spent the last 4 years asking those questions, taking her to MRI appointments and trying my damn best to care for her. All the while receiving no services or support, other than one defunct case manager based out of the mental health system, who was also annoyed that my daughter wasn't talking to do her out patient assessment. I answered the questions for my daughter. The case manager was stumped on how to allow my daughter come to "groups" for support, because she was disabled this way. I ended up being brought in to act as an "interpreter".
My daughter listens and responds to various things, verbal, written notes, sometimes both. Often repeating the phrase with different words works, and you become quite able to come up with 3 word sentences. Sometimes, just knowing her is all you need to do. Know what she likes to do, what she likes to eat. Ofter that, and watch her face. She speaks volumes with her facial expressions. Write a note of list of choices, tell her verbally "circle what you want to do/eat" and write that instruction on the note. My friend, and her advocate did that one outing, when we were not getting a reaction from her of what she wanted to do or eat for lunch.
He got out a notepad and wrote a list. She took the pencil, and checked the box for going on a walk and for playing basketball, and eating mcDonald's for lunch.
It's taking the time to accept her where she is at and stop expecting her to perform like anyone else, because yes, she is a person, she is disabled. I don't like it either, but it is how it is right now. She cannot be expected to do what she cannot, and for an assessment of level of care it is ridiculous to expect her to talk or do things she isn't.....otherwise the expectations are skewed for where she might reside. Make her look too functional and she won't get the appropriate services due to her. Make her look less functional, the same thing could happen.
It is a fine line of finding a placement where she will be encouraged to explore, have activities and peers and not just be parked in a place with a TV. She does respond to positives and she does smile and laugh at times.
Of course it goes without saying that I miss her old self. But that is not fair to her, to who she is now, or to myself. Mourning a child you once knew, while still living is what I did the last several years. Always never giving up on her and always knowing she is in there. She is still here. It's just different now. That's the emotional side.
The reality side, is that she needs to be acknowledged today and a person who is just 22 years old and has a disability, needs help getting organized to get dressed in the morning, reminded to do things most people don't need reminding of, so yes, the assessment for housing requiring her to talk, is like asking her deaf ear to suddenly not be profoundly deaf. Like my left ear.
You learn to be quite observant, to lip read and things when you have a profound hearing loss. You tune into people a little better, maybe understand the world differently through your eyes.
That's it. Understanding my daughter's world through her eyes. That is the key.
"The fact of the matter is, my daughter is severely disabled...both physically and cognitively...she is indeed in need of "special" services and "special" treatment. She is not "just like any other child". This is not a demeaning concept. It is an accurate one, one that allows the world to define and address her needs more appropriately."
---
The post above has helped me think, to put together the words I have been trying to write about here, about my daughter the last 2 weeks.
She had a non-verbal IQ test last week. I attended to bring along junior mints and encouragement and also to be able to explain to the psychologist how to communicate with my daughter. It's not hard to communicate with a non verbal person, at least that's what I either have some sort of bizarre talent to do, or I am just observant of subtle communications my daughter does express, if one is watching or paying attention. She has body language and facial expressions. It's obvious when she has internal stuff distracting her in her mind. I humor her at one point, and say, "leave all of that on the back burner and tune in, eyes on the paper", or "hey earth to L!" it's not degrading, it's bringing her in a bit to get the task done. This test, is part of a plan to assess her IQ and ability, and another one will assess what she knows, as in hot/cold, safety topics.
All of these tests are supposedly a base for appropriate housing and long term care.
But they want her to talk.
The doctor and the psychologist the last 2 weeks have commented that she needs to talk to do one of the tests for assessment.
She is who she is, right now and has been for several years. She has only recently, last August began to talk in brief spurts with us, and that comes and goes. I haven't heard her speak now for weeks again. That hasn't stopped me from taking her on outings or being able to know what she needs or wants. She stays with me on walks, before we cross a street I verbalize to stop, look and listen. In essence, yes I am aware of keeping her safe....being there with her, a vulnerable person, who has had something happen to her brain.
Is it the drugs? was it the trauma? I've spent the last 4 years asking those questions, taking her to MRI appointments and trying my damn best to care for her. All the while receiving no services or support, other than one defunct case manager based out of the mental health system, who was also annoyed that my daughter wasn't talking to do her out patient assessment. I answered the questions for my daughter. The case manager was stumped on how to allow my daughter come to "groups" for support, because she was disabled this way. I ended up being brought in to act as an "interpreter".
My daughter listens and responds to various things, verbal, written notes, sometimes both. Often repeating the phrase with different words works, and you become quite able to come up with 3 word sentences. Sometimes, just knowing her is all you need to do. Know what she likes to do, what she likes to eat. Ofter that, and watch her face. She speaks volumes with her facial expressions. Write a note of list of choices, tell her verbally "circle what you want to do/eat" and write that instruction on the note. My friend, and her advocate did that one outing, when we were not getting a reaction from her of what she wanted to do or eat for lunch.
He got out a notepad and wrote a list. She took the pencil, and checked the box for going on a walk and for playing basketball, and eating mcDonald's for lunch.
It's taking the time to accept her where she is at and stop expecting her to perform like anyone else, because yes, she is a person, she is disabled. I don't like it either, but it is how it is right now. She cannot be expected to do what she cannot, and for an assessment of level of care it is ridiculous to expect her to talk or do things she isn't.....otherwise the expectations are skewed for where she might reside. Make her look too functional and she won't get the appropriate services due to her. Make her look less functional, the same thing could happen.
It is a fine line of finding a placement where she will be encouraged to explore, have activities and peers and not just be parked in a place with a TV. She does respond to positives and she does smile and laugh at times.
Of course it goes without saying that I miss her old self. But that is not fair to her, to who she is now, or to myself. Mourning a child you once knew, while still living is what I did the last several years. Always never giving up on her and always knowing she is in there. She is still here. It's just different now. That's the emotional side.
The reality side, is that she needs to be acknowledged today and a person who is just 22 years old and has a disability, needs help getting organized to get dressed in the morning, reminded to do things most people don't need reminding of, so yes, the assessment for housing requiring her to talk, is like asking her deaf ear to suddenly not be profoundly deaf. Like my left ear.
You learn to be quite observant, to lip read and things when you have a profound hearing loss. You tune into people a little better, maybe understand the world differently through your eyes.
That's it. Understanding my daughter's world through her eyes. That is the key.
Friday, March 26, 2010
Golden Whistleblower Award
This award was created by and awarded to me with many thanks! from the blog author Stan who writes about mental health topics and more, with passion and never sugarcoating the topics.
Golden Whistle Blower Award
"Created for blogs that go way beyond set norms, by writing and reporting what others are too corrupted to report or are just afraid to."
This one goes out to:
Bob Fiddaman- GSK Paxil/Seroxat U.K. accountability, and author of new book
PharmaGossip-AstraZeneca and so much more
Dr. Aubrey Blumsohn -Stood up for truth and ethics, a true hero
Borepatch-Questions authority,global warming and Internet security
Shearlings Got Plowed-Shining the flood light, on Saphris for example
Dr.Peter Rost-Former Pfizer marketing VP, author
Clinical Psychology and Psychiatry: A Closer Look -Questions the roles of KOL's and great data interpretation
Alison Bass-Health care reform and author
Seroxat/Paxil truthman-Exposing Paxil/GSK truth
Mark's blog-Writing in real time with an SZ diagnosis
Now, GO READ.
friday motivational music
what's on the other side of the bridge are golden moments
yeah i'm walking and i'm running and i'm kicking ass, 'cause damn if life is gonna take me down any more! i'm taking the energy and moving anytime anxiety attempts to find a path to my soul i get up and i go on a walk, i walk long and far and then accomplish a task. one piece at a time, anyone who is fighting hard to change life for the better must not give up. be determined.
love can move mountains--yes it can
A cynical mind
Won't help you through the night
And it can't hold you up
When you're too tired to fight
Where you didn't have the strength
To look after yourself
You find all that you need
For somebody else
But love can move mountains
Love can move mountains
Love can move mountains yes it ca-a-an
Love can move mountains
That impossible task
You're thinking of
Is one you can complete
When you're driven by love
And the strength that you find
Won't go slipping away
Once it enters your soul
It's re-born every day
Love can move mountains
Love can move mountains
Love can move mountains yes it ca-a-n
So if you're lucky enough to live
To see love come your way
Be thankful every day
That it stays
Love that it stays
A cynical mind
Won't help you through the night
And it can't hold you up
When you're too tired to fight
But love can move mountains
Love can move mountains
Love can move mountains yes it c-a-an
Love can move mountains.
*the proclaimers
Thursday, March 25, 2010
old notes can make you smile
my daughter's eyes bothered her by being rolled upward as a side effect of Zyprexa. this was a short trip into Canada: (in her own words)
--
april 2002, age 14
"We went to the hotel gift shop and went to a store across the street then we were going to swim but decided not to because my eyes were bugging me. The second day we were there I woke up and took a shower and we went to a diner and ate eggs, potatoes, sausage, milk, and banana bread and toast. Then we went to the Aquatic Center where you go swimming --by accident--we thought it was the [sea]Aquarium."
--
"Then we finally found the aquarium.Before we entered the aquarium we saw a little black squirrel running around-it came right up to us. There were lots of them.Then we went inside.In the first tank that was by the entrance there were fish and possibly sharks in the same one. We saw barking sea lions because they were hungry and seals. The seal followed my finger up and down and all around. It was really cute."
--
"The only thing i bought on the trip with my own money was gum and humbugs candies."
---
We didn't get on the road until about 3:45. Then mom stopped for gas when we were about an hour away from home and we were in the middle of a bunch of fast food so mom got us all a medium PB cup blizzard."
--
april 2002, age 14
"We went to the hotel gift shop and went to a store across the street then we were going to swim but decided not to because my eyes were bugging me. The second day we were there I woke up and took a shower and we went to a diner and ate eggs, potatoes, sausage, milk, and banana bread and toast. Then we went to the Aquatic Center where you go swimming --by accident--we thought it was the [sea]Aquarium."
--
"Then we finally found the aquarium.Before we entered the aquarium we saw a little black squirrel running around-it came right up to us. There were lots of them.Then we went inside.In the first tank that was by the entrance there were fish and possibly sharks in the same one. We saw barking sea lions because they were hungry and seals. The seal followed my finger up and down and all around. It was really cute."
--
"The only thing i bought on the trip with my own money was gum and humbugs candies."
---
We didn't get on the road until about 3:45. Then mom stopped for gas when we were about an hour away from home and we were in the middle of a bunch of fast food so mom got us all a medium PB cup blizzard."
twenty steps running
finishing my thought from my previous post, after that stop and chat session on the walk yesterday, is when i went full steam ahead and accomplished a goal of quickly, with faster pace and effort--getting to the top of a hilly switch back part of the walk.as i reached the top, i turned to look at where i had walked, and i was flooded with joy and immense happiness, that my life, though in immediate difficult moments while sorting things out...is so rich. indeed, God did hear my cry in 2008 "could you give me a friend? just one?" it's probably buried in the archives on the blog somewhere. well, God, the Universe et al gave me a true blessing. oh, i digress in getting overly sappy.
so today, i made it a goal to increase the running. and i counted the steps and it was 20 at a time. full on running. i was the only one out there today, i made it to the same place and back home in half the time, because i was running with a stride that someone does when they are running with determination. toward a future, toward happiness and bliss and toward a goal. i was running and realized i was enjoying it. imagine that.me, running in the rain.
rain, sweat and tears
something foreign on the forehead while winding the walk/run down. hot water on the forehead, a tear of joy on the cheek and rain all over my soaking wet head and jacket. (that foreign water was actually sweat on the head lol).
gratitude list for the day
i'm grateful for my life. i'm grateful i was blessed with someone who showed me how to enjoy the small pleasures and joys in nature, even more than i ever did. im grateful for the ability to be able to walk and run. i'm thankful for the endurance last year on the walks that built my knees up to be able to do this now. these little daisys are everywhere now. this photo is from last april. the daisies are in the grass at the institution, at the nearby park i walk past, they are happy little flowers that grow in grass. the yard was filled with big fat red robins today, and on the walk there was a song bird singing away. it reminded me of that verse, (not exact, but from memory) "hope is the thing with feathers that perches in the soul and sings the tune without any words at all.....
Wednesday, March 24, 2010
the tiny daisies in the grass
daisies the size of your thumb in the grass. one of my favorite things about this area. "oh what kind of dog is he?" siberian husky. we all chatted. i felt like this goose. as they left i turned around and observed what they were wearing. i looked down and saw my flapping sweatpants, mismatched fleece, jacket and shoes and felt, so ugly. so odd.
JAMA: Ensuring Integrity in Industry-Sponsored Research: AVANDIA
VIA the JAMA:
Ensuring Integrity in Industry-Sponsored Research:
"The most fundamental principle of medicine, primum non nocere, holds for every physician, whether functioning as a clinician providing direct patient care; as a researcher, reviewer, or editor involved in medical publishing; or as an administrator overseeing an academic institution, health care organization, or pharmaceutical company research program. In all situations affecting patients, physicians must do no harm.
The Commentary in this issue of JAMA by Nissen1 describes a disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial of rosiglitazone and reveals a situation in which concerns about preserving market share apparently trumped concerns about the potential for causing patient harm.2 Analyzing this situation and others involving misleading reporting and possible misrepresentation of industry-sponsored research3-7 has become only too common, and it appears that physicians functioning at several levels failed to put the well-being of patients first. "
---
Avandia diabetes drug inspires JAMA-FiercePharma
"The latest brouhaha over Avandia isn't just a tempest in a teapot. It has actually touched off calls for journal-publication reform. In the wake of a U.S. Senate committee report criticizing Avandia-maker GlaxoSmithKline's handling of data on the drug, JAMA editors are arguing that all industry-sponsored trials should come under the scrutiny of independent scientists, not just researchers with financial ties to the drugmaker in question."
--
Rosiglitazone/Avandia:
"References
1.^ Details for patent 5,002,953
2.^ a b Ajjan RA, Grant PJ (2008). "The cardiovascular safety of rosiglitazone". Expert Opin Drug Saf 7 (4): 367–76. doi:10.1517/14740338.7.4.367. PMID 18613801.
3.^ Controversial Diabetes Drug Harms Heart, U.S. Concludes By GARDINER HARRIS, New York Times, February 19, 2010
4.^ Thiazolidinediones, Hannele Yki-Järvinen, New Engl J Med 351:1106-1118 (September 9, 2004)
5.^ Mohanty P, Aljada A, Ghanim H, Hofmeyer D, Tripathy D, Syed T, Al-Haddad W, Dhindsa S, Dandona P (2004). "Evidence for a potent antiinflammatory effect of rosiglitazone". J Clin Endocrinol Metab 89 (6): 2728–35. doi:10.1210/jc.2003-032103. PMID 15181049.
6.^ Risner ME et al. (2006). "Efficacy of rosiglitazone in a genetically defined population with mild-to-moderate Alzheimer's disease". The Pharmacogenomics Journal 6: 246–254.
7.^ http://www.alzforum.org/drg/drc/detail.asp?id=116
8.^ Lewis JD, Lichtenstein GR, Deren JJ, et al. (2008). "Rosiglitazone for Active Ulcerative Colitis: A Randomized Placebo Controlled Trials". Gastroenterology 134: 688–695. doi:10.1053/j.gastro.2008.03.030.
9.^ Boggild AK, Krudsood S, Patel SN, Serghides L, Tangpukdee N, Katz K, Wilairatana P, Liles WC, Looareesuwan S, Kain KC (2009). "Use of Peroxisome proliferator-activated receptor gamma agonists as adjunctive treatment for Plasmodium falciparum malaria: A randomized, double-blind, placebo-controlled trial.". Clin. Infect. Dis..
10.^ Nissen SE, Wolski K (2007). "Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes". N Engl J Med 356 (24): 2457–71. doi:10.1056/NEJMoa072761. PMID 17517853. http://content.nejm.org/cgi/content/full/356/24/2457. Lay summary – Associated Press (2007-05-21).
11.^ U.S. Food and Drug Administration (May 21, 2007). "FDA Issues Safety Alert on Avandia". http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html.
12.^ Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. The Lancet. In Press, Corrected Proof. Available at: http://www.sciencedirect.com/science/article/B6T1B-4WGD87Y-1/2/0efabb7eba7ca1f4f7c556bd636e19ab.
13.^ "Diabetes Drug Avandia Targeted By Reviewers on Safety". ABC News. 2010-02-23. http://abcnews.go.com/GMA/OnCall/diabetes-drug-avandia-targeted-fda-reviewers-safety/story?id=9914308.
14.^ a b Ranii, David (2010-02-23). "Avandia fallout could hit Triangle". News & Observer. http://www.newsobserver.com/2010/02/23/353164/avandia-fallout-could-hit-triangle.html?storylink=misearch. Retrieved 2010-03-05.
15.^ Cobitz, Alexander R (February 2007). Clinical Trial Observation of an Increased Incidence of Fractures in Female Patients Who Received Long-Term Treatment with Avandia (rosiglitazone maleate) Tablets for Type 2 Diabetes MellitusPDF (49.9 KiB). GlaxoSmithKline. Retrieved on 10 April 2007.
16.^ Kahn S, Haffner S, Heise M, Herman W, Holman R, Jones N, Kravitz B, Lachin J, O'Neill M, Zinman B, Viberti G (2006). "Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy". N Engl J Med 355 (23): 2427–43. doi:10.1056/NEJMoa066224. PMID 17145742.
17.^ CMAJ
18.^ R. Baselt, Disposition of Toxic Drugs and Chemicals in Man, 8th edition, Biomedical Publications, Foster City, CA, 2008, pp. 1399-1400.
19.^ http://www.mmm-online.com/FDA-toughens-Avandia-warnings/article/96354/
20.^ http://www.usatoday.com/news/health/2007-07-25-avandia-fda_N.htm
21.^ http://www.bloomberg.com/apps/news?pid=20601087&sid=aHobgoX8jyfg&refer=home
22.^ Ranii, David (2010-03-05). "Avandia could cost GSK billions". News & Observer. http://www.newsobserver.com/2010/03/05/371760/avandia-could-cost-gsk-billions.html?storylink=misearch. Retrieved 2010-03-05.
23.^ Ranii, David (2010-03-01). "California county sues Glaxo over diabetes drug". News & Observer. http://www.newsobserver.com/2010/03/01/365150/california-county-sues-glaxo-over.html?storylink=misearch. Retrieved 2010-03-05.
[edit] External links
Official website
MedlinePlus article
Medscape
ClinicalTrials.gov NCT00265148 Brain Imaging Study of Rosiglitazone Efficacy and Safety in Alzheimer's Disease
[show]v • d • eGlaxoSmithKline plc
Corporate Directors: Lawrence Culp · Crispin Davis · Jean-Pierre Garnier · Chris Gent · Julian Heslop · Deryck Maughan · Ian Prosser · Ronaldo Schmitz · Lucy Shapiro · Robert Wilson · Tadataka Yamada
Products: Bupropion (Zyban) · Co-amoxiclav (Augmentin) · Paroxetine (Paxil, Seroxat, Aropax) · Rosiglitazone (Avandia) · Sumatriptan(Imitrex)
--
Annual Revenue: $39.0 billion USD (▲2% FY 2004) · Employees: 100,019 · Stock Symbol: LSE: GSK NYSE: GSK · Website: www.gsk.com
[show]v • d • eOral anti-diabetic drugs and Insulin analogs (A10)
Insulin Sensitizers Biguanides Metformin# · Buformin‡ · Phenformin‡
TZDs (PPAR) Pioglitazone · Rivoglitazone† · Rosiglitazone · Troglitazone‡
Dual PPAR agonists Aleglitazar† · Muraglitazar§ · Tesaglitazar§
Secretagogues K+ ATP Sulfonylureas 1st generation: Acetohexamide · Carbutamide · Chlorpropamide · Gliclazide · Tolbutamide · Tolazamide
2nd generation: Glibenclamide (Glyburide)# · Glipizide · Gliquidone · Glyclopyramide
3rd generation: Glimepiride
Meglitinides/"glinides" Nateglinide · Repaglinide · Mitiglinide
GLP-1 analogs Exenatide · Liraglutide · Taspoglutide† · Albiglutide†
DPP-4 inhibitors Alogliptin† · Linagliptin† · Saxagliptin · Sitagliptin · Vildagliptin
Analogs/other insulins fast acting (Insulin lispro · Insulin aspart · Insulin glulisine) · Short acting (Regular insulin) · long acting (Insulin glargine · Insulin detemir) · Inhalable insulin (Exubera)‡ · NPH insulin
Other Alpha-glucosidase inhibitors Acarbose · Miglitol · Voglibose
Amylin analog Pramlintide
SGLT2 inhibitor Dapagliflozin† · Remogliflozin† · Sergliflozin†
Ensuring Integrity in Industry-Sponsored Research:
"The most fundamental principle of medicine, primum non nocere, holds for every physician, whether functioning as a clinician providing direct patient care; as a researcher, reviewer, or editor involved in medical publishing; or as an administrator overseeing an academic institution, health care organization, or pharmaceutical company research program. In all situations affecting patients, physicians must do no harm.
The Commentary in this issue of JAMA by Nissen1 describes a disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial of rosiglitazone and reveals a situation in which concerns about preserving market share apparently trumped concerns about the potential for causing patient harm.2 Analyzing this situation and others involving misleading reporting and possible misrepresentation of industry-sponsored research3-7 has become only too common, and it appears that physicians functioning at several levels failed to put the well-being of patients first. "
---
Avandia diabetes drug inspires JAMA-FiercePharma
"The latest brouhaha over Avandia isn't just a tempest in a teapot. It has actually touched off calls for journal-publication reform. In the wake of a U.S. Senate committee report criticizing Avandia-maker GlaxoSmithKline's handling of data on the drug, JAMA editors are arguing that all industry-sponsored trials should come under the scrutiny of independent scientists, not just researchers with financial ties to the drugmaker in question."
--
Rosiglitazone/Avandia:
"References
1.^ Details for patent 5,002,953
2.^ a b Ajjan RA, Grant PJ (2008). "The cardiovascular safety of rosiglitazone". Expert Opin Drug Saf 7 (4): 367–76. doi:10.1517/14740338.7.4.367. PMID 18613801.
3.^ Controversial Diabetes Drug Harms Heart, U.S. Concludes By GARDINER HARRIS, New York Times, February 19, 2010
4.^ Thiazolidinediones, Hannele Yki-Järvinen, New Engl J Med 351:1106-1118 (September 9, 2004)
5.^ Mohanty P, Aljada A, Ghanim H, Hofmeyer D, Tripathy D, Syed T, Al-Haddad W, Dhindsa S, Dandona P (2004). "Evidence for a potent antiinflammatory effect of rosiglitazone". J Clin Endocrinol Metab 89 (6): 2728–35. doi:10.1210/jc.2003-032103. PMID 15181049.
6.^ Risner ME et al. (2006). "Efficacy of rosiglitazone in a genetically defined population with mild-to-moderate Alzheimer's disease". The Pharmacogenomics Journal 6: 246–254.
7.^ http://www.alzforum.org/drg/drc/detail.asp?id=116
8.^ Lewis JD, Lichtenstein GR, Deren JJ, et al. (2008). "Rosiglitazone for Active Ulcerative Colitis: A Randomized Placebo Controlled Trials". Gastroenterology 134: 688–695. doi:10.1053/j.gastro.2008.03.030.
9.^ Boggild AK, Krudsood S, Patel SN, Serghides L, Tangpukdee N, Katz K, Wilairatana P, Liles WC, Looareesuwan S, Kain KC (2009). "Use of Peroxisome proliferator-activated receptor gamma agonists as adjunctive treatment for Plasmodium falciparum malaria: A randomized, double-blind, placebo-controlled trial.". Clin. Infect. Dis..
10.^ Nissen SE, Wolski K (2007). "Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes". N Engl J Med 356 (24): 2457–71. doi:10.1056/NEJMoa072761. PMID 17517853. http://content.nejm.org/cgi/content/full/356/24/2457. Lay summary – Associated Press (2007-05-21).
11.^ U.S. Food and Drug Administration (May 21, 2007). "FDA Issues Safety Alert on Avandia". http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html.
12.^ Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. The Lancet. In Press, Corrected Proof. Available at: http://www.sciencedirect.com/science/article/B6T1B-4WGD87Y-1/2/0efabb7eba7ca1f4f7c556bd636e19ab.
13.^ "Diabetes Drug Avandia Targeted By Reviewers on Safety". ABC News. 2010-02-23. http://abcnews.go.com/GMA/OnCall/diabetes-drug-avandia-targeted-fda-reviewers-safety/story?id=9914308.
14.^ a b Ranii, David (2010-02-23). "Avandia fallout could hit Triangle". News & Observer. http://www.newsobserver.com/2010/02/23/353164/avandia-fallout-could-hit-triangle.html?storylink=misearch. Retrieved 2010-03-05.
15.^ Cobitz, Alexander R (February 2007). Clinical Trial Observation of an Increased Incidence of Fractures in Female Patients Who Received Long-Term Treatment with Avandia (rosiglitazone maleate) Tablets for Type 2 Diabetes MellitusPDF (49.9 KiB). GlaxoSmithKline. Retrieved on 10 April 2007.
16.^ Kahn S, Haffner S, Heise M, Herman W, Holman R, Jones N, Kravitz B, Lachin J, O'Neill M, Zinman B, Viberti G (2006). "Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy". N Engl J Med 355 (23): 2427–43. doi:10.1056/NEJMoa066224. PMID 17145742.
17.^ CMAJ
18.^ R. Baselt, Disposition of Toxic Drugs and Chemicals in Man, 8th edition, Biomedical Publications, Foster City, CA, 2008, pp. 1399-1400.
19.^ http://www.mmm-online.com/FDA-toughens-Avandia-warnings/article/96354/
20.^ http://www.usatoday.com/news/health/2007-07-25-avandia-fda_N.htm
21.^ http://www.bloomberg.com/apps/news?pid=20601087&sid=aHobgoX8jyfg&refer=home
22.^ Ranii, David (2010-03-05). "Avandia could cost GSK billions". News & Observer. http://www.newsobserver.com/2010/03/05/371760/avandia-could-cost-gsk-billions.html?storylink=misearch. Retrieved 2010-03-05.
23.^ Ranii, David (2010-03-01). "California county sues Glaxo over diabetes drug". News & Observer. http://www.newsobserver.com/2010/03/01/365150/california-county-sues-glaxo-over.html?storylink=misearch. Retrieved 2010-03-05.
[edit] External links
Official website
MedlinePlus article
Medscape
ClinicalTrials.gov NCT00265148 Brain Imaging Study of Rosiglitazone Efficacy and Safety in Alzheimer's Disease
[show]v • d • eGlaxoSmithKline plc
Corporate Directors: Lawrence Culp · Crispin Davis · Jean-Pierre Garnier · Chris Gent · Julian Heslop · Deryck Maughan · Ian Prosser · Ronaldo Schmitz · Lucy Shapiro · Robert Wilson · Tadataka Yamada
Products: Bupropion (Zyban) · Co-amoxiclav (Augmentin) · Paroxetine (Paxil, Seroxat, Aropax) · Rosiglitazone (Avandia) · Sumatriptan(Imitrex)
--
Annual Revenue: $39.0 billion USD (▲2% FY 2004) · Employees: 100,019 · Stock Symbol: LSE: GSK NYSE: GSK · Website: www.gsk.com
[show]v • d • eOral anti-diabetic drugs and Insulin analogs (A10)
Insulin Sensitizers Biguanides Metformin# · Buformin‡ · Phenformin‡
TZDs (PPAR) Pioglitazone · Rivoglitazone† · Rosiglitazone · Troglitazone‡
Dual PPAR agonists Aleglitazar† · Muraglitazar§ · Tesaglitazar§
Secretagogues K+ ATP Sulfonylureas 1st generation: Acetohexamide · Carbutamide · Chlorpropamide · Gliclazide · Tolbutamide · Tolazamide
2nd generation: Glibenclamide (Glyburide)# · Glipizide · Gliquidone · Glyclopyramide
3rd generation: Glimepiride
Meglitinides/"glinides" Nateglinide · Repaglinide · Mitiglinide
GLP-1 analogs Exenatide · Liraglutide · Taspoglutide† · Albiglutide†
DPP-4 inhibitors Alogliptin† · Linagliptin† · Saxagliptin · Sitagliptin · Vildagliptin
Analogs/other insulins fast acting (Insulin lispro · Insulin aspart · Insulin glulisine) · Short acting (Regular insulin) · long acting (Insulin glargine · Insulin detemir) · Inhalable insulin (Exubera)‡ · NPH insulin
Other Alpha-glucosidase inhibitors Acarbose · Miglitol · Voglibose
Amylin analog Pramlintide
SGLT2 inhibitor Dapagliflozin† · Remogliflozin† · Sergliflozin†
tree topper
7:46pm
the spring sky beholds the brightest star at the top of the trees in the woods. as if nature placed the star 'upon the highest bough'.
quote of the day, goes out with the junk ramble
Follow your bliss and the universe will create doors for you where there were only walls.
--Joseph Campbell
you know the day the toaster oven lit up on fire? indeed karma spoke to the other mechanical devices and made sure the heater knew to fry itself as well! on this sunny and 60 degree day it's all good so far faring fine with the down comforters, to hell with electric heaters, better weather is on the horizon.that's my little side trivia. so, today i walked up and down hills with the dog and got a nice work out in, met lots of good dogs and smiling people, my dog loved greeting other dogs and the toddler preschool kids, because i think he believes he is one. mowed the grass yesterday and rolled the hose up and mowed that area today, as well as loading up several big hefty bags of junk to go to the refuse disposal, er otherwise known as the dump! i thought this quote was a good one, because it's truly what is inspiring me to forge ahead and chip away one piece at a time, all of those annoying loose ends in my life (like clearing out junk, paperwork, et al). because my bliss, is my time with my best buddy and i am totally blessed to have been given such a gift in my lifetime. here's to continued pushing forward to achieve the goal. i hope the Universe is listening!
--Joseph Campbell
you know the day the toaster oven lit up on fire? indeed karma spoke to the other mechanical devices and made sure the heater knew to fry itself as well! on this sunny and 60 degree day it's all good so far faring fine with the down comforters, to hell with electric heaters, better weather is on the horizon.that's my little side trivia. so, today i walked up and down hills with the dog and got a nice work out in, met lots of good dogs and smiling people, my dog loved greeting other dogs and the toddler preschool kids, because i think he believes he is one. mowed the grass yesterday and rolled the hose up and mowed that area today, as well as loading up several big hefty bags of junk to go to the refuse disposal, er otherwise known as the dump! i thought this quote was a good one, because it's truly what is inspiring me to forge ahead and chip away one piece at a time, all of those annoying loose ends in my life (like clearing out junk, paperwork, et al). because my bliss, is my time with my best buddy and i am totally blessed to have been given such a gift in my lifetime. here's to continued pushing forward to achieve the goal. i hope the Universe is listening!
Tuesday, March 23, 2010
half moon, spring evening sky
this is the old institution dairy farm tree i photographed on the second of january. in the dead of winter, spring and summer were in hibernation along with the leaf and floral display of this tree. it was the first day we encountered the 22 acre dog park, without my daughter and several weeks before the setting in place of the standing order to go outside and with us on outings.--
this is the tree today. what a joy to have her there to see this. you can see the edge of the dog park in the background.
the floral and leaf buds in the process of blooming are about one inch in size, very fat buds and very intriguing to me, as i walked underneath the tree the age of the tree is very apparent. it surely is part of the old orchard that once gave outside time to patients on the farm.
as i photographed (cell phone photography) the buds my daughter stood watching and listening to me ramble saying that because i am a nerd i must photograph these flowers! i surmise to her and wonder, "is it an apple tree? or a cherry tree? will the flowers be white or are these leaves?".
--
we walked to the nearby lake. i sat on a bench admiring the sunlight reflecting on the water. she stood nearby and at one point gave me an annoyed look, "like come on--- who wants to sit there on a bench?"
--
tonight
i walked out into the backyard this evening, while it is still daylight the half moon is in the spring sky.
the progress report
a test/assessment day this week to document the acknowledgment of her developmental disability for appropriate housing outside of the mental health world. this has been a diligent process of advocacy from my daughter's advocate. it's finally on the calendar, and i will be there with support for her and goodies (candy) for encouragement to get the job done.
---
AS we entered the elevator doorway after the outing, she was in charge today and pushed all of the appropriate buttons. as we rode the elevator (the place i call no man's land) she leaned over to me, and i placed my arm around her shoulders. i reminded her this is all moving toward something good and better. she had enjoyed eating junior mints in the car while listening to the radio, and i took her with me to put some gas in the car and i washed the car windows.
--
oh yes, she did smile at me when i asked her, "dare me to kick my heels up while i walk?" and i jaunted forward and my two left feet leaped up an entire two inches off of the ground. swear. LOL
--
december 2009. from, 'in the psych ward' series
Monday, March 22, 2010
200,000 hits
and the car has its own record for karma this last month or so. i started these rambles as an outlet over three years ago. in the beginning it was to tell a story that had transpired, and then it unfolded from there. i guess this is when i say cheers, and thank you for reading. keep on truckin'.the face of hope
there is something to be said about the word hope. at times, over the last decade i've lived on that word alone, grew to embrace it, hate it and embrace it more. the word hope also refines itself with faith.
with each step, on the walks with my daughter i remember that.
i tell her every single time i take her out that i am thankful for the time we have to do the outings and how much i love her and am proud of her. i told her yesterday, to keep her chin up. i didn't feel silly saying it either. it's imperative for her not to give up, and i remind her that this is all going toward good and better days, and that she has all of us.
in the meantime, there's something to be appreciated about the joyous face of the silent young woman sitting across from me thinking, as she thoroughly enjoyed a oreo cookie milkshake. she deserves her dignity, hope and a good life.
Sunday, March 21, 2010
tears reflecting from the road
the drive isn't always sunshine and forest. most of it these days as i travel the 120 round trip are spent watching the gauges to make sure nothing is overheating or out of oil. the entire time i was with my daughter today was spent with scattered clouds and dark clouds surrounding us. we always take a nice long walk on the old farm property of the hospital and the last two days she chose the path.there are many paths to choose from, created from farming roads and old buildings. the patients used to be able to have therapeutic work such as outdoors on a dairy farm, until the '70s when the grassroots people (hi, that might be me about now, i believe in civil liberty and rights) decided the state couldn't make money off of mental health patients via the farm. so the "groups" started.
i am positive that bead bracelets made in groups or discussing the where and to and how of what got you there now works better. (not)
--
the road in the photograph depicts a reflection of water in the sky called a rainbow. these things (rainbows) are written about , sang about and landed in the Bible. as promises of hope, wonder and beauty they became an icon of sort.
--
AS i drove, through the sideway blowing rain and hail all the 90 minutes home it was in front of me. with each freeway interchange the storm lingered. i was literally driving in the storm as it moved.
--
the rainbow often reflected so brightly i could not see. strange, i think to myself--- to be blinded by such a magnificent illusion. and this one was a double.
week 13
she's entering week 14 in the institution after being transferred there on 12.21.09
Saturday, March 20, 2010
bring on the good stuff
karma meter needs to be cranked up and i'm working on that. If anyone remembers how the toaster burned up you might appreciate how the all-electric-house-and-that-includes-the-heater-furnace that melted down friday night. send it all this way, you know those good thoughts, karma and all.
Friday, March 19, 2010
GSK Avandia diabetes drug: 90% supporters had ties to GSK: COI, Conflict of Interest
BMJ:AVANDIA supporters had ties to GSK-FiercePharma- March 2010
"After GlaxoSmithKline's diabetes drug Avandia was linked to heart disease in May 2007, a fierce debate ensued, with much of it played out in scholarly journals. Just who wrote all those articles? That's what the Mayo Clinic wanted to find out.
Now, researchers have analyzed more than 200 articles that appeared after that infamous 2007 analysis published in the New England Journal of Medicine that found a 43 percent increased risk of heart attack associated with the medicine. Of the scientists who authored articles, reviews or commentaries that supported Avandia's safety, 90 percent had financial ties to GSK, the researchers found."
2007
This from 2007
Senator Grassley emails and the silencing of the AVANDIA critic in 2007-Bob Fiddaman
"FDA Week - Sep. 14, 2007
Sen. Charles Grassley (IA) said in a Senate floor speech Wednesday (Sept. 12) he has two internal e-mails from GlaxoSmithKline showing the company tried to silence a medical researcher who suggested Avandia may have health risks beyond those stated on the label.
John Buse, a medical researcher at the University of North Carolina, is the subject of the e-mails.
"Based on this e-mail exchange, it seems to me that at least two drug company officials did attempt to silence a critic," said Grassley, ranking Republican on the Finance Committee. "In fact, Dr. Buse stopped making any critical statements about Avandia shortly after this e-mail exchange," which is dated June 25, 1999.
One e-mail, titled "Avandia Renegade," says Buse has "repeatedly and intentionally misrepresented Avandia data."
---
Further reading:
February 2010, "Pull Avandia from the market!"-soulful sepulcher
"the trumped up AVANDIA scandal, this guy did prison and lost medical license-March 4, 2010- soulful sepulcher
"Dr. Gilbert Ross, the author of the Op-Ed defending GSK and calling the call for removal of AVANDIA from the market a "trumped-up scandal":
"Ross actually had to abandon medicine on July 24, 1995, when his license to practice as a physician in New York was revoked by the unanimous vote of a state administrative review board for professional misconduct.
Instead of tending to patients, Ross spent all of 1996 at a federal prison camp in Schuylkill, Pennsylvania, having being sentenced to 46 months in prison for his participation in a scheme that ultimately defrauded New York's Medicaid program of approximately $8 million."
--
March 19, 2010
Diabetes Drug Supporters Had Financial Tie to Glaxo, Study Says- Bloomberg, March 19, 2010:
The Mayo researchers examined more than 200 articles that appeared after an analysis in the New England Journal of Medicine linked Avandia to a 43 percent increased risk of heart attacks, and a subsequent clinical trial found no greater danger of heart disease. Almost 90 percent of scientists who wrote positive articles, reviews or commentaries about Avandia had financial ties to London-based Glaxo, the study published in the British Medical Journal found.
"After GlaxoSmithKline's diabetes drug Avandia was linked to heart disease in May 2007, a fierce debate ensued, with much of it played out in scholarly journals. Just who wrote all those articles? That's what the Mayo Clinic wanted to find out.
Now, researchers have analyzed more than 200 articles that appeared after that infamous 2007 analysis published in the New England Journal of Medicine that found a 43 percent increased risk of heart attack associated with the medicine. Of the scientists who authored articles, reviews or commentaries that supported Avandia's safety, 90 percent had financial ties to GSK, the researchers found."
2007
This from 2007
Senator Grassley emails and the silencing of the AVANDIA critic in 2007-Bob Fiddaman
"FDA Week - Sep. 14, 2007
Sen. Charles Grassley (IA) said in a Senate floor speech Wednesday (Sept. 12) he has two internal e-mails from GlaxoSmithKline showing the company tried to silence a medical researcher who suggested Avandia may have health risks beyond those stated on the label.
John Buse, a medical researcher at the University of North Carolina, is the subject of the e-mails.
"Based on this e-mail exchange, it seems to me that at least two drug company officials did attempt to silence a critic," said Grassley, ranking Republican on the Finance Committee. "In fact, Dr. Buse stopped making any critical statements about Avandia shortly after this e-mail exchange," which is dated June 25, 1999.
One e-mail, titled "Avandia Renegade," says Buse has "repeatedly and intentionally misrepresented Avandia data."
---
Further reading:
February 2010, "Pull Avandia from the market!"-soulful sepulcher
"the trumped up AVANDIA scandal, this guy did prison and lost medical license-March 4, 2010- soulful sepulcher
"Dr. Gilbert Ross, the author of the Op-Ed defending GSK and calling the call for removal of AVANDIA from the market a "trumped-up scandal":
"Ross actually had to abandon medicine on July 24, 1995, when his license to practice as a physician in New York was revoked by the unanimous vote of a state administrative review board for professional misconduct.
Instead of tending to patients, Ross spent all of 1996 at a federal prison camp in Schuylkill, Pennsylvania, having being sentenced to 46 months in prison for his participation in a scheme that ultimately defrauded New York's Medicaid program of approximately $8 million."
--
March 19, 2010
Diabetes Drug Supporters Had Financial Tie to Glaxo, Study Says- Bloomberg, March 19, 2010:
The Mayo researchers examined more than 200 articles that appeared after an analysis in the New England Journal of Medicine linked Avandia to a 43 percent increased risk of heart attacks, and a subsequent clinical trial found no greater danger of heart disease. Almost 90 percent of scientists who wrote positive articles, reviews or commentaries about Avandia had financial ties to London-based Glaxo, the study published in the British Medical Journal found.
friday ramble 2
Addendum :The above Golden Paw Award (Dog Power!) goes to Stan, author of the blog that sugarcoats nothing, (and everyone else) and yeah this award is way more appropriate than the girl power one there lol
up and at 'em idiom
"Get going, get busy, as in Up and at 'em—there's a lot of work to be done. This colloquial idiom, often uttered as a command, uses at 'em (for “at them”) in the general sense of tackling a project, and not in reference to specific persons."
---
that's right! 2 cups of coffee down so far, i have embraced the sunny morning and now it's time to "get up and at 'em"!
any one who wants to add this pic to their blog, go for it!
friday ramble
this is the view from the outing yesterday with my daughter. the institution sw assured me, that she is diligently working on appropriate setting for my daughter's developmental delay/disability so she will not be discharging into a mental health place. the improvement of quality of care, activities offered and hopefully peers her own age and with similar ways of thinking, and well...just being who they are. i'm finding myself awake in those wee small hours of the morning this week. the time from dusk to dawn for me is the hardest w/o my s/o . life is a challenge, and embracing change has always been difficult for me and i despise that about myself, but i am holding onto the faith, because that's what strong people do. the social worker told me not to worry about my daughter and the outcome. she said to take that off of my plate and let them help. OK. there's a fortune cookie fortune sitting on my desk in front of me, it says your courage will guide your future. well, God, i am tired of having to have faith, really could you help me? i think to myself. as i walked with my daughter yesterday, it was a beautiful, sunny spring afternoon and i looked up at the sky and at the trees, and thought, something good has to come of all of this, that i must trust and hold on to hope. but, in these wee small hours of the morning this week, my heart wakes me up. i long for my wonderful, full of life partner. i have notes all over the place reminding me, "this is temporary". life itself is temporary isn't it. the miles may be separating us but my heart holds you right here, wherever i go. 'whatever doesn't kill us makes us stronger'. i am learning about myself and the biggest learning lesson is how a person reacts to life makes the difference. falling apart just isn't an option, because that is not being kind to self or others and removes ability to focus. when your big picture is not certain, it's easy to panic, that's when you have to stop and say, "have faith", it's going to be OK.Thursday, March 18, 2010
AstraZeneca wins 1 of 26,000 lawsuits :diabetes, antipsychotic SEROQUEL
VIA Bloomberg:
"-- AstraZeneca Plc officials properly warned a Vietnam veteran’s doctors about the diabetes risk posed by its Seroquel antipsychotic drug, a jury ruled in the first case over the medicine to go to trial.
The state court panel in New Brunswick, New Jersey, deliberated a total of six hours over two days before finding the company’s warnings to Ted Baker’s doctors absolved AstraZeneca of responsibility for his injuries. Baker, 61, took Seroquel for lingering effects of post-traumatic stress syndrome caused by his military service in Vietnam. His was the first of about 26,000 claims over the drug to be considered by jurors."
---
My opinion
Though the evidence is clear that AstraZeneca knew of the diabetes and weight gain possibility (buried Study 15) the company won this particular case, blaming the patient and doctor for the diabetes, not the drug.
There are 25,999 more cases to go to trial.
The outrageous part of this trial, is that the man was prescribed SEROQUEL FOR PTSD, OFF-LABEL USE. SEROQUEL IS NOT FDA APPROVED FOR TREATMENT OF PTSD, and has a black box warning for diabetes.
This is a crime against humanity and a public health risk that this drug is remaining on the market. Seroquel was part of the deadly cocktail of drugs that killed 4 year old Rebecca Riley.
When will justice prevail, and when will the FDA ever become a true watch dog for public health and safety?
--
More on the Seroquel Scandal read this article at PharmaGossip, "What's the latest? Sales and Marketing Practices", HERE.
Read more background on Seroquel by clicking the labels below this post.
"-- AstraZeneca Plc officials properly warned a Vietnam veteran’s doctors about the diabetes risk posed by its Seroquel antipsychotic drug, a jury ruled in the first case over the medicine to go to trial.
The state court panel in New Brunswick, New Jersey, deliberated a total of six hours over two days before finding the company’s warnings to Ted Baker’s doctors absolved AstraZeneca of responsibility for his injuries. Baker, 61, took Seroquel for lingering effects of post-traumatic stress syndrome caused by his military service in Vietnam. His was the first of about 26,000 claims over the drug to be considered by jurors."
---
My opinion
Though the evidence is clear that AstraZeneca knew of the diabetes and weight gain possibility (buried Study 15) the company won this particular case, blaming the patient and doctor for the diabetes, not the drug.
There are 25,999 more cases to go to trial.
The outrageous part of this trial, is that the man was prescribed SEROQUEL FOR PTSD, OFF-LABEL USE. SEROQUEL IS NOT FDA APPROVED FOR TREATMENT OF PTSD, and has a black box warning for diabetes.
This is a crime against humanity and a public health risk that this drug is remaining on the market. Seroquel was part of the deadly cocktail of drugs that killed 4 year old Rebecca Riley.
When will justice prevail, and when will the FDA ever become a true watch dog for public health and safety?
--
More on the Seroquel Scandal read this article at PharmaGossip, "What's the latest? Sales and Marketing Practices", HERE.
Read more background on Seroquel by clicking the labels below this post.
Wednesday, March 17, 2010
Eli Lilly target of $75 million stolen Zyprexa, Cymbalta, Prozac, Strattera & more: Lilly's statement
VIA Eli Lilly website, news release:
List of stolen/impacted products/ pharmaceuticals:
Alimta(R) (pemetrexed disodium)
Cymbalta(R) (duloxetine hydrochloride)
Effient(TM) (prasugrel)
Gemzar(R) (gemcitabine hydrochloride)
Prozac(R) (fluoxetine hydrochloride)
Strattera(R) (atomoxetine hydrochloride)
Symbyax (olanzapine / fluoxetine hydrochloride) *(Zyprexa/Prozac combo pill)
Zyprexa(R) (olanzapine)
"Lilly is advising practitioners, retailers and consumers to check all pharmaceutical products for signs of tampering or damage prior to purchase and/or use. Pharmacists and other health care professionals should not use the product if it has been removed from the sealed bottle or container, if the induction seal has been compromised, or in the case of glass vials, if the flip cap appears to have been disturbed in any way.
To assist the FDA and the law enforcement agencies in their investigation, Lilly stopped distributing product with the affected lot numbers on Monday, March 15, 2010.
Lilly is asking for the public's help in reporting any information regarding the stolen products to FDA's Office of Criminal Investigations (OCI) by calling (800) 551-3989 or by visiting the OCI website www.fda.gov/OCI."
--
Related reading:
$75 million dollar drug heist, Lilly's warehouse hit-article
List of stolen/impacted products/ pharmaceuticals:
Alimta(R) (pemetrexed disodium)
Cymbalta(R) (duloxetine hydrochloride)
Effient(TM) (prasugrel)
Gemzar(R) (gemcitabine hydrochloride)
Prozac(R) (fluoxetine hydrochloride)
Strattera(R) (atomoxetine hydrochloride)
Symbyax (olanzapine / fluoxetine hydrochloride) *(Zyprexa/Prozac combo pill)
Zyprexa(R) (olanzapine)
"Lilly is advising practitioners, retailers and consumers to check all pharmaceutical products for signs of tampering or damage prior to purchase and/or use. Pharmacists and other health care professionals should not use the product if it has been removed from the sealed bottle or container, if the induction seal has been compromised, or in the case of glass vials, if the flip cap appears to have been disturbed in any way.
To assist the FDA and the law enforcement agencies in their investigation, Lilly stopped distributing product with the affected lot numbers on Monday, March 15, 2010.
Lilly is asking for the public's help in reporting any information regarding the stolen products to FDA's Office of Criminal Investigations (OCI) by calling (800) 551-3989 or by visiting the OCI website www.fda.gov/OCI."
--
Related reading:
$75 million dollar drug heist, Lilly's warehouse hit-article
Eli Lilly target of drug heist $75 million Zyprexa, Cymbalta and Prozac stolen from warehouse
VIA Hartford Courant:
It appears the Mission Impossible style heist netted approximately $75 million dollars worth of the antipsychotic Zyprexa, the antidepressant Cymbalta, and the antidepressant Prozac.
From the article:
"Sometime in the early morning Sunday, thieves scaled the walls of the Eli Lilly warehouse on Freshwater Boulevard.
As a light rain fell, they cut a hole in the roof of the 70,000-square-foot building and slid down ropes to get inside.
They disabled the building's alarm system, and police believe they loaded several dozen pallets of prescription drugs — worth $75 million — into at least one truck parked at the rear of the building, and drove away.
The heist wasn't discovered until the afternoon, when an employee went to work.
The theft at the Eli Lilly & Co. warehouse, one of three distribution centers in the nation for the international pharmaceutical firm, was well-planned and "extremely substantial," Police Chief Carl Sferrazza said.
Edward Sagebiel, a spokesman for Eli Lilly, said Tuesday that the theft "certainly has the appearance of a sophisticated, well-planned criminal action."
AND
"Experts said that the heist shared many traits with warehouse thefts of pharmaceuticals last year near Richmond, Va.; Memphis, Tenn.; and Olive Branch, Miss. Those thieves also cut through ceilings and sometimes used trapeze-style rigging to get inside and disable the main and backup alarms. In some cases, they sprayed dark paint on the lenses of security cameras; in others, they stole disks in the security recording devices."
--
What does Tom Cruise think?
Nice job? "I know psych meds"?
Let's spread the diabetes, withdrawals and placebo effects world-wide via Internet sales and back alley deals of stolen Lilly drugs.
AstraZeneca should watch over their shoulders, because Seroquel already has street value. Antipsychotics and antidepressants in the drug heist news category. Prescription and FDA approved meds are not just your average junkie fix any more! Who knew?
It appears the Mission Impossible style heist netted approximately $75 million dollars worth of the antipsychotic Zyprexa, the antidepressant Cymbalta, and the antidepressant Prozac.
From the article:
"Sometime in the early morning Sunday, thieves scaled the walls of the Eli Lilly warehouse on Freshwater Boulevard.
As a light rain fell, they cut a hole in the roof of the 70,000-square-foot building and slid down ropes to get inside.
They disabled the building's alarm system, and police believe they loaded several dozen pallets of prescription drugs — worth $75 million — into at least one truck parked at the rear of the building, and drove away.
The heist wasn't discovered until the afternoon, when an employee went to work.
The theft at the Eli Lilly & Co. warehouse, one of three distribution centers in the nation for the international pharmaceutical firm, was well-planned and "extremely substantial," Police Chief Carl Sferrazza said.
Edward Sagebiel, a spokesman for Eli Lilly, said Tuesday that the theft "certainly has the appearance of a sophisticated, well-planned criminal action."
AND
"Experts said that the heist shared many traits with warehouse thefts of pharmaceuticals last year near Richmond, Va.; Memphis, Tenn.; and Olive Branch, Miss. Those thieves also cut through ceilings and sometimes used trapeze-style rigging to get inside and disable the main and backup alarms. In some cases, they sprayed dark paint on the lenses of security cameras; in others, they stole disks in the security recording devices."
--
What does Tom Cruise think?
Nice job? "I know psych meds"?
Let's spread the diabetes, withdrawals and placebo effects world-wide via Internet sales and back alley deals of stolen Lilly drugs.
AstraZeneca should watch over their shoulders, because Seroquel already has street value. Antipsychotics and antidepressants in the drug heist news category. Prescription and FDA approved meds are not just your average junkie fix any more! Who knew?
PETA gets involved in prevention of marketing Fukitol ER
i read the fine print PI sheet on Fukitol ER meds extended release version. it comes with free boot straps! not sure of the straps though, it says 'one size fits all'. attach to shoes or boots or barefeet, pull upward, and hold on, using hands as attachment. Instructions for use of free straps: go about daily business, buck up, stop whining and get your shit together.
not sure how to drive a car holding straps up but, the CNS section of medication PI sheet says the way Fukitol works is actually a placebo effect, though more studies need to be conducted.
100% use of placebo patients in trial said the pill worked immediately, though this is not in a benzo class of drugs, therefore it is a placebo effect.
75% had visions of pots of gold at the end of the rainbow
50% of patients trialed Fukitol said it's mind over matter
25% randomly sang "the sun will come out tomorrow"
15% got neck cramps from keeping chins up higher than usual
2% said the pill strangly appeared to look like a 'tic tac'
1% said it made them feel like kicking ass, and confident
the study was funded by kimberly clark brand tissue, and the dairy association of KCS (Keep cows safe) prevention of leather straps used for boots. PETA stepped in and ordered pleather straps to be issued to all people who purchased Fukitol ER tabs with free boot straps attached to the package. the FDA (fukitol dept administration) has recalled ER version, Wayne McFiddin put a call in for collection of all straps for a "project".
NEWS ALERT
Washington woman last seen hiking through wooded trails with a dog wearing pleather straps under his arm pits, woman was lecturing dog to buck up, telling dog he looked like a cissy in those pleather straps. Dog was heard woofing back not to tell his friend Sammy about the incident. All pleather boot straps were found tossed in the woods near an old burned out car.
The two walked out of the woods, on their own, smiling saying arf! and randomly howling 'somewhere over the rainbow'.
--
*disclaimer note this is humor, satire and does not depict peta or pharma or cows seriously. all rights to the cow photo are mine, since i took it standing along a country drive road myself.
wednesday ramble, matters of the heart
in attempt to find statistics on tears, their content and the effect on the brain i came across this article, it's interesting. it also had these "facts". actually this is an attempt to write a news article about mental health, and this is the closest i could come, after writing and removing to draft one post several times, i'll try and get through this one.
that's what i'm doing, managing my crying. the tears flood my face, washing down like an ocean, and my heart was not prepared, i was not prepared for how this time apart was going to hit me, i'm completely distraught and devastated like a freight train dropped a ton of bricks on me. i miss my best friend and soul mate terribly, i miss you isn't even a good enough description. oh damn here they go, the blurred vision through tears as i type. (it's time for courage. i can do this. it's OK. it will be an adjustment but you can do it. )
six in the morning without you.
the worst feeling in the world.
----
20% of bouts of crying last longer than 30 minutes
8% go on for longer than one hour
70% of criers make no attempt to hide their crying
77% of crying takes place at home
15% at work or in the car
40% of people weep alone
39% of crying occurs in the evening, the most popular time compared with morning, afternoon, and night (16, 29 and 17 per cent respectively)
6-8pm is the most common time for crying
88.8% feel better after a cry
47: average number of times a woman cries each year
7: annual number of crying episodes for a man
VIA the Article, 'How Crying can make you healthier'.
that's what i'm doing, managing my crying. the tears flood my face, washing down like an ocean, and my heart was not prepared, i was not prepared for how this time apart was going to hit me, i'm completely distraught and devastated like a freight train dropped a ton of bricks on me. i miss my best friend and soul mate terribly, i miss you isn't even a good enough description. oh damn here they go, the blurred vision through tears as i type. (it's time for courage. i can do this. it's OK. it will be an adjustment but you can do it. )
six in the morning without you.
the worst feeling in the world.
----
20% of bouts of crying last longer than 30 minutes
8% go on for longer than one hour
70% of criers make no attempt to hide their crying
77% of crying takes place at home
15% at work or in the car
40% of people weep alone
39% of crying occurs in the evening, the most popular time compared with morning, afternoon, and night (16, 29 and 17 per cent respectively)
6-8pm is the most common time for crying
88.8% feel better after a cry
47: average number of times a woman cries each year
7: annual number of crying episodes for a man
VIA the Article, 'How Crying can make you healthier'.
Sunday, March 14, 2010
running toward tomorrow
Oh, give us pleasure in the flowers to-day;
And give us not to think so far away
As the uncertain harvest; keep us here
All simply in the springing of the year.
Oh, give us pleasure in the orchard white,
Like nothing else by day, like ghosts by night;
And make us happy in the happy bees,
The swarm dilating round the perfect trees.
And make us happy in the darting bird
That suddenly above the bees is heard,
The meteor that thrusts in with needle bill,
And off a blossom in mid air stands still.
For this is love and nothing else is love,
The which it is reserved for God above
To sanctify to what far ends He will,
But which it only needs that we fulfil. --Robert Frost
when you feel the cold wind and the sting of the hail hitting your skin, you know you're alive!
chipping away at the goal a piece at a time
looking at it from segments of time during the day
break it into pieces
one day at a time
have faith
--
while adjusting to and taking care of some life business that needs much of my focus right now, these small catch-phrases here and in the post below, that we often hear are what i'm applying now daily. the segments of time is helping me focus to chip away at several facets.
--
be well
keep your chin up
smile , seriously smile
it will be OK
we can do this
Saturday, March 13, 2010
i can see for miles and miles
laughter is the best medicine
absence makes the heart grow fonder
keep your chin up
what doesn't kill us makes us stronger
the road to enlightenment leads us through adversity
keep strong
have faith
things will get better
--
the road to a friend's house is never long.
Wednesday, March 10, 2010
tell me more, with six words
This post over at Borepatch has continued to capture my imagination with the PostSecret idea of writing something profound on a small space, with few words. Because of this article.
The article's inspiration is from Ernest Hemingway, that a story can be told in six words. I started thinking about writing a postcard with six words on it. "Which part of my life would I write about?", I thought. Motherhood? dreams achieved, lost or remembered? an ode to a loved one? love?
"Dad bought tires for my car".
"Go buy tires for your car." love, Dad
I found that note from him recently, in a drawer. It's from 2006, when the tires on my car were bald from driving to hospitals by the hundreds of miles. He sent me money to replace the tires. This week, the car dashboard reads 150,000 miles. That happened on the way home from the hospital. The same tires my Dad bought for me are on the car.
"My Dad built his own airplane."
"The plane crashed into a mountainside."
"Life, in six words is profound."
"I'm glad I saved the note."
The article's inspiration is from Ernest Hemingway, that a story can be told in six words. I started thinking about writing a postcard with six words on it. "Which part of my life would I write about?", I thought. Motherhood? dreams achieved, lost or remembered? an ode to a loved one? love?
"Dad bought tires for my car".
"Go buy tires for your car." love, Dad
I found that note from him recently, in a drawer. It's from 2006, when the tires on my car were bald from driving to hospitals by the hundreds of miles. He sent me money to replace the tires. This week, the car dashboard reads 150,000 miles. That happened on the way home from the hospital. The same tires my Dad bought for me are on the car.
"My Dad built his own airplane."
"The plane crashed into a mountainside."
"Life, in six words is profound."
"I'm glad I saved the note."
awareness
"The mind is more comfortable in a landscaped park because it has been planned through thought; it has not grown organically. There is an order here that the mind can understand. In the forest, there is an incomprehensible order that to the mind looks like chaos. It is beyond the mental categories of good and bad. You cannot understand it through thought, but you can sense it when you let go of the thought, become still and alert, and don't try to understand or explain. Only then can you be aware of the sacredness of the forest. As soon as you sense that hidden harmony, that sacredness, you realize that you are not separate from it, and when you realize that, you become a conscious participant in it. In this way, nature can help you become realigned with the wholeness of life."
Ekhart Tolle, A New Earth, p.195
---
This was found at this blog, life with a severely disabled child. The author is enduring life changes via a move to a new home and town, and leaves this for thought in her post about surviving the move, as a storm:
"I had believed myself to be quite grounded. Tearing me from all things familiar has shown me to what extent I had become dependent upon those things as benchmarks for my sanity. I am currently adrift without an anchor. "
--
Ekhart Tolle, A New Earth, p.195
---
This was found at this blog, life with a severely disabled child. The author is enduring life changes via a move to a new home and town, and leaves this for thought in her post about surviving the move, as a storm:
"I had believed myself to be quite grounded. Tearing me from all things familiar has shown me to what extent I had become dependent upon those things as benchmarks for my sanity. I am currently adrift without an anchor. "
--
PhRMA:Pharmaceutical Research and Manufacturers of America, transcript FDA regulation of social media: Universal symbol
Read the 8 page pdf transcript HERE.
A meeting with and for reporters and bloggers regarding concerns over social media for pharmaceutical companies and the FDA asking the FDA to approve a universal symbol (seal of approval).
Would you trust it, just because the FDA approved it? they approved Seroquel, Avandia, Saphris, Fanapt, Zyprexa, Vioxx......
---
Snippets from the transcript: March 2010
"Because of the high interest in the FDA’s regulation of social media, we’d like to limit our questions to just that topic. And then finally, when the call is opened to the question-and answer period, please begin with your name and your media outlet or blog. Thank you very much. Now I’ll turn the call over to Jeffrey Francer. He is PhRMA’s assistant general counsel." --page 2
"The FDA’s leadership on this topic is essential. Today, more than half of adults first turn to the Internet to find health information. And regrettably, sometimes the information they find is unregulated and erroneous. PhRMA is proposing that the FDA issue new guidance detailing how biopharmaceutical research companies may responsibly use the Internet and social media.
I’ll briefly highlight our top three proposals before taking your questions. First, a universal symbol: The FDA should develop a single universal symbol that would in a single click take users directly to pages displaying FDA-regulated risk-and-benefit information about medicine.
The use of the FDA’s own logo or another FDA-approved symbol would shine a brighter spotlight on official Web sites of FDA-approved medical products containing regulated, comprehensive information about the benefits and risks of medicine. This symbol would also serve as a reminder that all medicines carry risk."- page 2
"MR. FRANCER: Sure. Well, right now, as you know, the FDA and the White House
and the Department of Health and Human Services all use the microblog Twitter as a way of providing newsworthy information using new media.
The FDA in particular, I think, has set a good example of the use of Twitter to broadcast I think what they believe to be newsworthy events, such as new drug approvals. And we provided an example of the FDA’s use of Twitter in our comments on page seven.
We believe that the agency should allow manufacturers to microblog about significant
scientific or regulatory events. Right now, there are no standards – no Internet-specific standards– on how manufacturers can use these media, and therefore, there’s some confusion.
There is some scientific exchange and some news exchange that is not promotion. And
the FDA should provide standards to help manufacturers differentiate between what information would be considered promotion and what information would be considered scientific exchange.
That’s the sort of standard that we’re asking for."--page 6
AND
"With respect to the FDA’s resources, PhRMA has continued to support a strong and well financed FDA. In the last PDUFA round, as you know, PhRMA supported the user fee that would have helped FDA to review direct-to-consumer television ads in a timely way. We’d have to look at any proposal for continued funding or user-fee funding for DDMAC, but we have supported – we have supported user-fee fundings to help DDMAC do its job in the past."--Francer, from Pharmaceutical Research and Manufacturers of America (PhRMA)--page 8
--
Oh yes, a strong and well-financed FDA. That's what we need as a public watchdog for drug safety.
BTW, I found this pdf on TWITTER! Go HERE to vote on a universal symbol
A meeting with and for reporters and bloggers regarding concerns over social media for pharmaceutical companies and the FDA asking the FDA to approve a universal symbol (seal of approval).
Would you trust it, just because the FDA approved it? they approved Seroquel, Avandia, Saphris, Fanapt, Zyprexa, Vioxx......
---
Snippets from the transcript: March 2010
"Because of the high interest in the FDA’s regulation of social media, we’d like to limit our questions to just that topic. And then finally, when the call is opened to the question-and answer period, please begin with your name and your media outlet or blog. Thank you very much. Now I’ll turn the call over to Jeffrey Francer. He is PhRMA’s assistant general counsel." --page 2
"The FDA’s leadership on this topic is essential. Today, more than half of adults first turn to the Internet to find health information. And regrettably, sometimes the information they find is unregulated and erroneous. PhRMA is proposing that the FDA issue new guidance detailing how biopharmaceutical research companies may responsibly use the Internet and social media.
I’ll briefly highlight our top three proposals before taking your questions. First, a universal symbol: The FDA should develop a single universal symbol that would in a single click take users directly to pages displaying FDA-regulated risk-and-benefit information about medicine.
The use of the FDA’s own logo or another FDA-approved symbol would shine a brighter spotlight on official Web sites of FDA-approved medical products containing regulated, comprehensive information about the benefits and risks of medicine. This symbol would also serve as a reminder that all medicines carry risk."- page 2
"MR. FRANCER: Sure. Well, right now, as you know, the FDA and the White House
and the Department of Health and Human Services all use the microblog Twitter as a way of providing newsworthy information using new media.
The FDA in particular, I think, has set a good example of the use of Twitter to broadcast I think what they believe to be newsworthy events, such as new drug approvals. And we provided an example of the FDA’s use of Twitter in our comments on page seven.
We believe that the agency should allow manufacturers to microblog about significant
scientific or regulatory events. Right now, there are no standards – no Internet-specific standards– on how manufacturers can use these media, and therefore, there’s some confusion.
There is some scientific exchange and some news exchange that is not promotion. And
the FDA should provide standards to help manufacturers differentiate between what information would be considered promotion and what information would be considered scientific exchange.
That’s the sort of standard that we’re asking for."--page 6
AND
"With respect to the FDA’s resources, PhRMA has continued to support a strong and well financed FDA. In the last PDUFA round, as you know, PhRMA supported the user fee that would have helped FDA to review direct-to-consumer television ads in a timely way. We’d have to look at any proposal for continued funding or user-fee funding for DDMAC, but we have supported – we have supported user-fee fundings to help DDMAC do its job in the past."--Francer, from Pharmaceutical Research and Manufacturers of America (PhRMA)--page 8
--
Oh yes, a strong and well-financed FDA. That's what we need as a public watchdog for drug safety.
BTW, I found this pdf on TWITTER! Go HERE to vote on a universal symbol
Tuesday, March 09, 2010
glance toward the summit
Live your life each day as you would climb a mountain. An occasional glance towards the summit keeps the goal in mind, but many beautiful scenes are to be observed from each new vantage point.
-- Harold B. Melchart
-- Harold B. Melchart
tell me more
Read more secrets like this one at PostSecret blog: "PostSecret is an ongoing community art project where people mail in their secrets anonymously on one side of a postcard."
surf on your government paycheck at work?
199.156.178.184.4k.usda.gov
IP Address
199.156.178.184 ISP
USDA OFFICE OF OPERATIONS
Domain
USDA.GOV --State : Utah City : Paradise
---La Sal Utah--Microsoft WinXP Browser Internet Explorer 6.0
--
if you are going to continue to click on and read the entire archives, email me, or leave a comment for crying out loud. find something better to do on your government job computer.
IP Address
199.156.178.184 ISP
USDA OFFICE OF OPERATIONS
Domain
USDA.GOV --State : Utah City : Paradise
---La Sal Utah--Microsoft WinXP Browser Internet Explorer 6.0
--
if you are going to continue to click on and read the entire archives, email me, or leave a comment for crying out loud. find something better to do on your government job computer.
AstraZeneca, antipsychotic turned antidepressant Seroquel Scandal :Ethics breach in marketing
VIA PharmaGossip blog:
---
(You got fat for a reason, you were a marketing target by a pharmaceutical company that used you to create a million dollar blockbuster drug, then re-marketed it as an antidepressant before the patent expires, now it turns out they withheld information that they knew would give you diabetes and cause weight gain)
---
VIA FT,(Financial Times):
"AstraZeneca failed to accurately reflect the side effects of its top-selling antipsychotic drug Seroquel in an advertisement to doctors, a UK regulatory panel has ruled.
The Anglo-Swedish group breached three points of the British pharmaceutical industry’s code of practice with a marketing claim that Seroquel had “a favourable weight profile across the full dose range” compared with rival drugs, according to a preliminary ruling by the Prescription Medicines Code of Practice Authority.
The decision by the authority, the self-regulatory arm of the Association of the British Pharmaceutical Industry, will be a blow to AstraZeneca as it defends itself against a series of claims brought by patients and regulators on Seroquel in the US courts totalling $1.2bn (£800m). " --Read more of that article VIA Financial Times
--
Study 15, the buried study
Seroquel Study 15--you got fat for a reason
Read more background of the Seroquel Scandal on this blog, HERE.
Bloomberg,AstraZeneca’s Seroquel Ad May Have Breached U.K. Industry Rules. -March 9, 2010
----
Promotion of Seroquel Complaints
PMCPA-Prescription Medicines Code of Practice Authority U.K.
AUTH/2297/1/10 - Ex-employee v AstraZeneca
... Complainant: Ex-employee Respondent: AstraZeneca Subject: Promotion of Seroquel Case Status: Both the complainant and respondent can appeal ...
PMCPA Case - peterclift - 03/09/2010 - 09:21 - 0 attachments
AUTH/2296/1/10 - Member of the public v AstraZeneca
... Complainant: Member of the public Respondent: AstraZeneca Subject: Promotion of Seroquel Case Status: Both the complainant and respondent can appeal ...
PMCPA Case - peterclift - 03/09/2010 - 09:17 - 0 attachments
AUTH/2294/1/10 - Journalist v AstraZeneca
... Complainant: Journalist Respondent: AstraZeneca Subject: Promotion of Seroquel Case Status: The respondent can appeal (Case Reports, Ongoing ...
--
When there is truth and transparency regarding the marketing of a psych drug, let me know. Otherwise, use at your own risk, because these medications are marketing blitzes for million dollar corporations that take advantage of a medical modality based on no evidence that it exists, the DSM is full of labels (target audience), and in 2013 the DSM-5 will have such broad label expansions these companies will be throwing these medications at you, full on....suckers!
---
(You got fat for a reason, you were a marketing target by a pharmaceutical company that used you to create a million dollar blockbuster drug, then re-marketed it as an antidepressant before the patent expires, now it turns out they withheld information that they knew would give you diabetes and cause weight gain)
---
VIA FT,(Financial Times):
"AstraZeneca failed to accurately reflect the side effects of its top-selling antipsychotic drug Seroquel in an advertisement to doctors, a UK regulatory panel has ruled.
The Anglo-Swedish group breached three points of the British pharmaceutical industry’s code of practice with a marketing claim that Seroquel had “a favourable weight profile across the full dose range” compared with rival drugs, according to a preliminary ruling by the Prescription Medicines Code of Practice Authority.
The decision by the authority, the self-regulatory arm of the Association of the British Pharmaceutical Industry, will be a blow to AstraZeneca as it defends itself against a series of claims brought by patients and regulators on Seroquel in the US courts totalling $1.2bn (£800m). " --Read more of that article VIA Financial Times
--
Study 15, the buried study
Seroquel Study 15--you got fat for a reason
Read more background of the Seroquel Scandal on this blog, HERE.
Bloomberg,AstraZeneca’s Seroquel Ad May Have Breached U.K. Industry Rules. -March 9, 2010
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Promotion of Seroquel Complaints
PMCPA-Prescription Medicines Code of Practice Authority U.K.
AUTH/2297/1/10 - Ex-employee v AstraZeneca
... Complainant: Ex-employee Respondent: AstraZeneca Subject: Promotion of Seroquel Case Status: Both the complainant and respondent can appeal ...
PMCPA Case - peterclift - 03/09/2010 - 09:21 - 0 attachments
AUTH/2296/1/10 - Member of the public v AstraZeneca
... Complainant: Member of the public Respondent: AstraZeneca Subject: Promotion of Seroquel Case Status: Both the complainant and respondent can appeal ...
PMCPA Case - peterclift - 03/09/2010 - 09:17 - 0 attachments
AUTH/2294/1/10 - Journalist v AstraZeneca
... Complainant: Journalist Respondent: AstraZeneca Subject: Promotion of Seroquel Case Status: The respondent can appeal (Case Reports, Ongoing ...
--
When there is truth and transparency regarding the marketing of a psych drug, let me know. Otherwise, use at your own risk, because these medications are marketing blitzes for million dollar corporations that take advantage of a medical modality based on no evidence that it exists, the DSM is full of labels (target audience), and in 2013 the DSM-5 will have such broad label expansions these companies will be throwing these medications at you, full on....suckers!
Sunday, March 07, 2010
Pharma targets Veterans with antipsychotic cocktails for PTSD: antipsychotic turned antidepressant, SEROQUEL
Is Something Not Quite Right With Stan - A Mental Health Blog: Pharma targets Veterans with antipsychotic cocktails for PTSD :
From the article:
"A few months after starting a drug regimen combining the antidepressant Paxil, the mood stabilizer Klonopin and a controversial anti-psychotic drug manufactured by pharmaceutical giant AstraZeneca, Seroquel, the Iraq war veteran was "suffering from incontinence, severe depression [and] continuous headaches," according to his widow, Janette Layne." (my note*Klonopin is a benzo)
AND
"Andrew was taking Seroquel, Klonopin, Paxil and prescription painkillers for PTSD after returning home from his Iraq tour. Like Layne, he deteriorated physically and mentally on the prescribed cocktail until experiencing a sudden, inexplicable death.
"When six people die from peanut butter we shut the factories down, but at least 87 military men have died in the past six years on Seroquel and similar drugs and no alarm sounds," Stan White told AlterNet."-- Martha Rosenberg
--
*Seroquel is not approved by the FDA for treatment of PTSD, which means this is off-label use.
From the article:
"A few months after starting a drug regimen combining the antidepressant Paxil, the mood stabilizer Klonopin and a controversial anti-psychotic drug manufactured by pharmaceutical giant AstraZeneca, Seroquel, the Iraq war veteran was "suffering from incontinence, severe depression [and] continuous headaches," according to his widow, Janette Layne." (my note*Klonopin is a benzo)
AND
"Andrew was taking Seroquel, Klonopin, Paxil and prescription painkillers for PTSD after returning home from his Iraq tour. Like Layne, he deteriorated physically and mentally on the prescribed cocktail until experiencing a sudden, inexplicable death.
"When six people die from peanut butter we shut the factories down, but at least 87 military men have died in the past six years on Seroquel and similar drugs and no alarm sounds," Stan White told AlterNet."-- Martha Rosenberg
--
*Seroquel is not approved by the FDA for treatment of PTSD, which means this is off-label use.
quote of the week
In the depth of winter I finally learned that there was in me an invincible summer.
--Albert Camus
--Albert Camus
inadvertent disclosure of personal health information through peer-to-peer file sharing programs :Doctor's music and patient info study
Journal of the American Medical Informatics Association
Research paper --The inadvertent disclosure of personal health information through peer-to-peer file sharing programs:
Abstract
Objective
There has been a consistent concern about the inadvertent disclosure of personal information through peer-to-peer file sharing applications, such as Limewire and Morpheus. Examples of personal health and financial information being exposed have been published. We wanted to estimate the extent to which personal health information (PHI) is being disclosed in this way, and compare that to the extent of disclosure of personal financial information (PFI).
Design
After careful review and approval of our protocol by our institutional research ethics board, files were downloaded from peer-to-peer file sharing networks and manually analyzed for the presence of PHI and PFI. The geographic region of the IP addresses was determined, and classified as either USA or Canada.
Measurement
We estimated the proportion of files that contain personal health and financial information for each region. We also estimated the proportion of search terms that return files with personal health and financial information. We ascertained and discuss the ethical issues related to this study.
Results
Approximately 0.4% of Canadian IP addresses had PHI, as did 0.5% of US IP addresses. There was more disclosure of financial information, at 1.7% of Canadian IP addresses and 4.7% of US IP addresses. An analysis of search terms used in these file sharing networks showed that a small percentage of the terms would return PHI and PFI files (ie, there are people successfully searching for PFI and PHI on the peer-to-peer file sharing networks).
Conclusion
There is a real risk of inadvertent disclosure of PHI through peer-to-peer file sharing networks, although the risk is not as large as for PFI. Anyone keeping PHI on their computers should avoid installing file sharing applications on their computers, or if they have to use such tools, actively manage the risks of inadvertent disclosure of their, their family's, their clients', or patients' PHI.
VIA FierceBioTech
--
ARTICLE VIA The Gazette:
"Doctors who trade music on file-sharing programs might also be accidentally swapping something else: their patients' health records."
Research paper --The inadvertent disclosure of personal health information through peer-to-peer file sharing programs:
Abstract
Objective
There has been a consistent concern about the inadvertent disclosure of personal information through peer-to-peer file sharing applications, such as Limewire and Morpheus. Examples of personal health and financial information being exposed have been published. We wanted to estimate the extent to which personal health information (PHI) is being disclosed in this way, and compare that to the extent of disclosure of personal financial information (PFI).
Design
After careful review and approval of our protocol by our institutional research ethics board, files were downloaded from peer-to-peer file sharing networks and manually analyzed for the presence of PHI and PFI. The geographic region of the IP addresses was determined, and classified as either USA or Canada.
Measurement
We estimated the proportion of files that contain personal health and financial information for each region. We also estimated the proportion of search terms that return files with personal health and financial information. We ascertained and discuss the ethical issues related to this study.
Results
Approximately 0.4% of Canadian IP addresses had PHI, as did 0.5% of US IP addresses. There was more disclosure of financial information, at 1.7% of Canadian IP addresses and 4.7% of US IP addresses. An analysis of search terms used in these file sharing networks showed that a small percentage of the terms would return PHI and PFI files (ie, there are people successfully searching for PFI and PHI on the peer-to-peer file sharing networks).
Conclusion
There is a real risk of inadvertent disclosure of PHI through peer-to-peer file sharing networks, although the risk is not as large as for PFI. Anyone keeping PHI on their computers should avoid installing file sharing applications on their computers, or if they have to use such tools, actively manage the risks of inadvertent disclosure of their, their family's, their clients', or patients' PHI.
VIA FierceBioTech
--
ARTICLE VIA The Gazette:
"Doctors who trade music on file-sharing programs might also be accidentally swapping something else: their patients' health records."
fleeting
i always appreciate all of the moments and today was an example of the way things go with my daughter, it was a wordless world today for her on the outing. there's a storm blowing in that could give a few late winter early spring snow showers here. it started to rain a little while ago. just shows how fast things change. enjoy the golden moments for they are fleeting, enjoy the moments that aren't so golden too, because life is short.
Saturday, March 06, 2010
sitting on benches in the sun
spectacular day today, sunny and 60 degrees, the weather has officially sent all things in motion for full bloom. what a great day it was, my friend and i took my daughter out on her saturday outing. first independent thing she did was to sign her own paperwork for the day pass, was ready to go when we arrived. she has now re-mastered being able to work the soda machines at self-serve soda counters at mcdonalds and costco! she spoke more today, after many weeks of virtual non verbal again, today she said what she wanted at costco, which is one of the "big trips" we had conquered during the summer before this hospitalization began in august. the big box store is full of input and noise, and today when i asked her if she could handle that, she spoke and said, "yeah" with enthusiasm. she chose and filled her own soda cup and ordered pizza (not the hot dog) and a different ice cream flavor. wow! to describe this is, to imagine someone being taken around for a couple of years with me, going to the post office, grocery store, shopping, daily task things and she was there but only watching. then last spring (april 09)we conquered the zoo, and it just went from there. small and slow steady increases of independence and regaining some words and abilities. she still has internal stimuli in her head, but she was happy today. we walked a long walk around the 22 acre dog park, and through the dog park and sat on a bench, all 3 of us in the sun. another accomplishment, because she has spacial and crowding intolerance. "hey let's do the wave", i laugh and joke and stand up with my arms in the air as if i was in the stands at a baseball game and she did it! LOL we all did. we admired the daffodils i so poignantly wrote about here before, the " the daffodils holding guard as soldiers that stand at the entrance to the hospital", we admired the gorgeous pink blooming trees and she inspected the gopher mounds in the grass. people let her pet their dogs with smiles and grace today. these are days, that i cherish and will forever.
--
when she got into the car she cussed
she said the F-bomb. yes, she sure did. my friend turned to look at her (remember how mute she was?) and he said, "did you just cuss?" "yes, i am cussing" "no you are not, that's not appropriate", he said back. i have to laugh, after all of the mute years this was one of the most "normal" and "real life" conversations we've had. it's like the 17 year old arrived back in F-bomb style, and had to be reminded of appropriate words to say. now that is living. a regular saturday, on a sunny spring day, doing the wave on a bench in the dog park. i'm gonna say it:
life is good.
--
when she got into the car she cussed
she said the F-bomb. yes, she sure did. my friend turned to look at her (remember how mute she was?) and he said, "did you just cuss?" "yes, i am cussing" "no you are not, that's not appropriate", he said back. i have to laugh, after all of the mute years this was one of the most "normal" and "real life" conversations we've had. it's like the 17 year old arrived back in F-bomb style, and had to be reminded of appropriate words to say. now that is living. a regular saturday, on a sunny spring day, doing the wave on a bench in the dog park. i'm gonna say it:
life is good.
Antipsychotic re-marketed as antidepressant : $3, 416 million dollars of Seroquel
US sales in 2009 of AstraZeneca's blockbuster antipsychotic Seroquel increased with the promotion of the extended release version of the drug now approved for MDD, originally created for treatment of schizophrenia. AstraZeneca appears to be getting it's bang for the buck before the patent in the US expires.
FROM Fierce Pharma:
"In the US, Seroquel sales were up 5 percent to $872 million in the fourth quarter. Total prescriptions for the Seroquel franchise increased by 1 percent in the fourth quarter, whilst total prescriptions for Seroquel XR more than tripled compared to the fourth quarter 2008. Market share for the Seroquel franchise was a market-leading 31.3 percent in December 2009 (unchanged in the quarter) of which 3.5 percentage points were for Seroquel XR, which was up 51 basis points. Seroquel XR accounted for 11 percent of total prescriptions for the franchise in December 2009.
US sales of Seroquel for the full year were $3,416 million, 13 percent ahead of last year.
Seroquel sales in the Rest of World were $389 million in the fourth quarter, an 8 percent increase despite the 52 percent decline in Canada due to generic competition. Sales growth was driven by the performance of Seroquel XR, which accounted for 24 percent of franchise sales in the Rest of World markets in 2009. Seroquel sales in Western Europe were up 11 percent. Sales in Emerging Markets were up 13 percent.
For the full year (2009), Seroquel sales in the Rest of World increased by 8 percent to $1,450 million. "
--
Though in litigation for diabetes caused by Seroquel lawsuits: (Bloomberg)
AstraZeneca Opposed Seroquel Weight-Gain Word (March 5, 2010)
"March 5 (Bloomberg) -- AstraZeneca Plc officials opposed changing the wording of the antipsychotic drug Seroquel’s internal safety documents about the amount of weight gained by some of the medicine’s users, an executive testified.
Dr. Wayne Geller, who once served as Seroquel’s global safety officer, told a New Jersey jury today some colleagues fought his June 2000 push to strengthen the company’s internal description of Seroquel’s side effects about weight gain.
Geller and other researchers wanted the word “limited” removed from the explanation of the drug’s potential for causing some users to gain weight. He testified in the trial of a lawsuit accusing the drug of causing a former user to gain weight and develop diabetes. "
---
Further reading:
US FDA approves Seroquel for kids 10 and older. (this blog)
Seroquel Study 15 you got FAT for a reason: (this blog)
"Jeffrey Lieberman, a Columbia University psychiatrist who led the federal study, said doctors missed clues in evaluating antipsychotics such as Seroquel. If a doctor had known about Study 15, he added, "it would raise your eyebrows."
--
October 2009 Jim Edwards, BNET blog, "AstraZeneca's Fuzzy Seroquel Math: When 45% Gain Weight, It's "Weight-Neutral":"Even though AstraZeneca executives wrote emails in 1997 saying they believed Seroquel caused weight gain, AZ instructed product managers to promote the drug as having only a “a neutral effect on weight,” according to documents unveiled in litigation in a Florida federal court."
--
It appears that gaining 50 lbs. on Seroquel might just be in your imagination, not because of the antipsychotic or your good cooking."
--
So much bang for the buck!
FROM Fierce Pharma:
"In the US, Seroquel sales were up 5 percent to $872 million in the fourth quarter. Total prescriptions for the Seroquel franchise increased by 1 percent in the fourth quarter, whilst total prescriptions for Seroquel XR more than tripled compared to the fourth quarter 2008. Market share for the Seroquel franchise was a market-leading 31.3 percent in December 2009 (unchanged in the quarter) of which 3.5 percentage points were for Seroquel XR, which was up 51 basis points. Seroquel XR accounted for 11 percent of total prescriptions for the franchise in December 2009.
US sales of Seroquel for the full year were $3,416 million, 13 percent ahead of last year.
Seroquel sales in the Rest of World were $389 million in the fourth quarter, an 8 percent increase despite the 52 percent decline in Canada due to generic competition. Sales growth was driven by the performance of Seroquel XR, which accounted for 24 percent of franchise sales in the Rest of World markets in 2009. Seroquel sales in Western Europe were up 11 percent. Sales in Emerging Markets were up 13 percent.
For the full year (2009), Seroquel sales in the Rest of World increased by 8 percent to $1,450 million. "
--
Though in litigation for diabetes caused by Seroquel lawsuits: (Bloomberg)
AstraZeneca Opposed Seroquel Weight-Gain Word (March 5, 2010)
"March 5 (Bloomberg) -- AstraZeneca Plc officials opposed changing the wording of the antipsychotic drug Seroquel’s internal safety documents about the amount of weight gained by some of the medicine’s users, an executive testified.
Dr. Wayne Geller, who once served as Seroquel’s global safety officer, told a New Jersey jury today some colleagues fought his June 2000 push to strengthen the company’s internal description of Seroquel’s side effects about weight gain.
Geller and other researchers wanted the word “limited” removed from the explanation of the drug’s potential for causing some users to gain weight. He testified in the trial of a lawsuit accusing the drug of causing a former user to gain weight and develop diabetes. "
---
Further reading:
US FDA approves Seroquel for kids 10 and older. (this blog)
Seroquel Study 15 you got FAT for a reason: (this blog)
"Jeffrey Lieberman, a Columbia University psychiatrist who led the federal study, said doctors missed clues in evaluating antipsychotics such as Seroquel. If a doctor had known about Study 15, he added, "it would raise your eyebrows."
--
October 2009 Jim Edwards, BNET blog, "AstraZeneca's Fuzzy Seroquel Math: When 45% Gain Weight, It's "Weight-Neutral":"Even though AstraZeneca executives wrote emails in 1997 saying they believed Seroquel caused weight gain, AZ instructed product managers to promote the drug as having only a “a neutral effect on weight,” according to documents unveiled in litigation in a Florida federal court."
--
It appears that gaining 50 lbs. on Seroquel might just be in your imagination, not because of the antipsychotic or your good cooking."
--
So much bang for the buck!
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