I have read about problems with the placenta being associated with Paxil, and I have even known people with this problem whose babies were exposed to Paxil or other antidepressants not from the mother but via the father’s sperm and exposure from semen. I am guessing the exposure from mom taking a drug would probably be more intense but this goes to show how toxic the drugs are. There are reports of drug exposure via semen in the MedWatch database.

I was wondering about umbilical cord abnormalities and antidepressants so I decided to do a google search and couldn’t find much aside from unrelated drug selling websites that used every key word imaginable.

So, I pulled a few reports (not all the reports, just a sampling) from the decrypted MedWatch report database on the topics of intrauterine death and umbilical cord abnormalities (Thank you CCHR!).

Some also have placenta problems although I did not do a search on those specifically. The decrypted MedWatch data seems to be one of the only sources for finding this information on what is really associated with antidepressant use / psych drug use. I think it is really one of the best sites on the internet because you can search for a specific side effect and see how many reports there were. The main psychdrugdangers database even breaks it down for you by age range.  The MOTHERS Act / prenatal / neonatal database section has all the reports you need to see if you are looking for pregnancy and breastfeeding reports since 2004.

I love this site because you are able to see the truth and not have to wonder about any conflicts of interest with the researchers, agendas, or bad motives like you would if you only read the complete b.s. being offered up by websites of moms on drugs, psychs in the pocket of pHARMa, etc.

Because of the seriousness of this issue I feel that every mom should have access to this information so I hope you will share this with your friends, you never know who it may help to save. (See: October 15 Infant and Child Death Awareness and Prevention Day).

On that note, I highly recommend the book Wise Woman Herbal for the Childbearing Year by Susan Weed. It talks about herbs and vitamins that can be used to help prevent miscarriage, to stop miscarriages in progress, promote uterine health, and what herbs and foods to avoid to protect your baby during pregnancy.

I have this book on my shelf, and I looked up some information for a friend once… Using some of the recommended vitamins during a time when she was having bleeding and on bed rest during the second trimester, things improved. Another great product she used is called Carry On which is for bleeding and prevention of miscarriage. Every time I see her baby I think about those products and how they possibly saved that baby’s life. We found out about that product from a friend on a home birth listserv.

If you’re not on any mommy listservs or yahoo groups I recommend trying to find a holistic one to get advice from holistic friends like this. The MADNAP listserv, UNITE listserv, and CHAADA listserv are all hosted on Yahoo and would be a good place to start. We have several home birthing moms on there who have experience with alternative health and can refer you to other resources / groups.

Now for the sample reports I pulled: If you have had a similar incident while taking a psychiatric drug or shortly after withdrawing from one, please consider making a MedWatch report by going here:

https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

http://www.thefetus.net/page.php?id=167 According to this article on velamentous insertion of the umbilical cord, the anomaly is associated with congenital abnormalities and preterm birth. These are problems commonly associated with antidepressants. One study found a nearly five times higher rate of preterm birth for babies exposed to antidepressants. [“Infants exposed to fluoxetine during the third trimester had, compared to those exposed only during the first and second trimester, reduced birth weight and length, an almost 5-fold increased risk of premature delivery, a 2.6-fold increased risk of being admitted to special-care nurseries, and an almost 9-fold increased risk of experiencing respiratory difficulties, cyanosis on feeding, and jitteriness.” Birth outcomes in pregnant women taking fluoxetine. Chambers CD, et al. N Engl J Med, 335(14):1010-5 1996 Oct 3.]

DECRYPTED REPORTS:
http://www.cchrint.org/psychdrugdangers/MothersAct.html

EFFEXOR

M 6026440 4964817 03/01/2006 04/03/2006 Venlafaxine Depression Caesarean Section, Drug Exposure During Pregnancy, Testicular Torsion, Umbilical Cord Abnormality

M 6232679 5232270 07/01/2006 02/07/2007 11/01/2006 Effexor XR CN Anomaly of External Ear Congenital, Intra-Uterine Death, Limb Malformation, Low Set Ears, Skull Malformation, Transmission of Drug Via Semen, Umbilical Cord Abnormality

6040906 4985077 09/07/2005 04/19/2006 Effexor XR Pyramidal Tract Syndrome Brain Malformation, Cerebral Cyst, Drug Exposure During Pregnancy, Exomphalos, Intra-Uterine Death, Talipes

5827164 4692986 06/15/2005 Effexor XR OT Drug Exposure During Pregnancy, Intra-Uterine Death

F 5941024 4845757 11/30/2005 Effexor XR Depression Abortion Spontaneous, Depression, Disease Recurrence, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome, Foetal Growth Retardation, Intra-Uterine Death

PAXIL

F 5892354 4789790 10/06/2005 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Intra-Uterine Death, Placental Disorder, Umbilical Cord Abnormality, Umbilical Cord Vascular Disorder

M 5991062 5464256 11/02/2005 09/21/2007 Paxil CR CN Maternal Condition Affecting Foetus Arrhythmia, Atelectasis, Atrial Septal Defect, Balance Disorder, Blindness, Blood Pressure Increased, Caesarean Section, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Complex Partial Seizures, Convulsion, Coordination Abnormal, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Hemiparesis, Infantile Spasms, Loss of Consciousness, Muscular Weakness, Oedema, Oral Intake Reduced, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pleural Effusion, Post Procedural Complication, Postoperative Thrombosis, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Speech Disorder Developmental, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Umbilical Cord Around Neck, Univentricular Heart, Urinary Tract Infection, Ventricular Hypoplasia, Ventricular Septal Defect, Vesicoureteric Reflux (This one was accidentally copied and pasted, and I just realized doesn’t have umbilcal cord abnormalities, just around the neck, but it was such an awful case I felt I should keep it in.)

F 5654406 4488092 03/23/2004 10/28/2004 Paroxetine MD Depression Cytomegalovirus Infection, Drug Exposure During Pregnancy, Intra-Uterine Death

5819180 4690656 02/24/2005 06/15/2005 02/24/2005 Deroxat CN Drug Exposure During Pregnancy, Intra-Uterine Death

WELLBUTRIN

F 5701388 4536190 09/17/2004 12/23/2004 Bupropion OT Depression Chorioamnionitis, Drug Exposure During Pregnancy, Intra-Uterine Death, Micrognathia, Umbilical Cord Abnormality

26 Years F 6000982 4938300 03/09/2006 Bupropion OT Depression Drug Exposure During Pregnancy, Hypertension, Umbilical Cord Vascular Disorder

M 4011323 4279456 01/27/2004 Wellbutrin MD Depression Abdominal Wall Anomaly, Arteriopathic Disease, Chorioamnionitis, Cleft Palate, Congenital Atrial Septal Defect, Drug Exposure During Pregnancy, Ear Malformation, Intra-Uterine Death, Jaw Fracture, Kyphosis, Liver Disorder, Lymphangiectasia, Macrognathia, Nose Deformity, Pectus Excavatum, Placental Disorder, Spleen Malformation, Thyroid Disorder, Traumatic Delivery

F 6172347 5156305 11/22/2006 Wellbutrin OT Drug Use for Unknown Indication Drug Exposure During Pregnancy, Intra-Uterine Death

Please read Julie Edgington’s blog entry about a reocurring nightmare she has about Manie: http://bigpharmavictim.blogspot.com/2009/09/reoccurring-nightmare.html

There are also several updates on her blog regarding the current Paxil birth defects trial being covered by Bloomberg news.

Reoccurring Nightmare

by Julie Edgington

Last night I had a reoccurring nightmare which I have had since I found out it was Paxil which caused Manie’s birth defect. Usually I wake only remembering bits and pieces of my nightmare, but not this time. This time I woke with tears streaming down my face and a tear soaked pillow.

My Nightmare:

I saw myself standing there in the kitchen of our old house. This was the house I had been living in when I became pregnant with Manie. I knew right away exactly what moment from the past this was. It was so clear this time as if I was really there watching it all happen. Not only was I watching this happen I could physically feel everything that I felt that day. I watch and felt myself push the kitchen chair in that someone had left pulled out. I watch and felt myself get a glass of water. I even felt the coldness of the glass in my hand. I knew what was going to happen next because I had already done this.

At this time I felt someone holding my hand I looked down and it was Manie. He looked up at me and the sadness on his face let me know he knew what was about to happen too. As I looked at him I could hear his heart beating. I knew it was his because of the sound of it. His heart sounds different then any other heart because of the leak. As I continued to look at him I could hear my own heartbeat also. It was as if I could hear his heartbeat in my right ear and mine in the left, both beating at the exact same time. As I stood there looking at him my chest began to ache. With every heartbeat mine was changing to sound just like Manie’s. I felt as if I had ran a marathon and had a heart attack all at the same time. Before I knew it the two heartbeats were now one. I felt scared and worried, but not for me for Manie.

I began to look around for something to help us. I remembered where we were and at what time. I realized I can stop this! As I looked straight ahead of me I saw myself taking the pill from the package. I screamed and I tried to move, but there was nothing I could do! I could not hear myself. My feet were locked to the floor. The more I watch the more I felt our heart pounding and the louder it became. I looked down at Manie and he just stand there crying as if he knew I could do nothing. I continued to scream but nothing worked. Then I could feel it, the feeling of that damn pill in my mouth and the drink of water that carried it down. I felt it as if it was really happening. In a last ditch effort to make it all better I closed my eyes and slowly instead of having just one heartbeat there was two again. The heartbeat in my right ear was normal and healthy. I gave Manie my heartbeat and I took his. As much as my heart ached with pain and as tired as I was I felt good inside. I could feel the scars on my chest. I looked at Manie’s chest his scars were gone. Manie smiled at me and let go of my hand. I could not hear our hearts beating anymore, but I knew he would be alright.

Manie and I were no longer in that old kitchen, we were outside. I watched as Manie ran and ran and ran. I watched as he played football, basketball, baseball and hockey. I watched as he rode the scariest of amusement park rides. There was no more waiting in doctors offices, no more hospitals, no more leg and arm cramps and no more waking in the middle of the night in pain. There was no more medications. Manie did not look tired because he was not tired. He felt good he was finally able to do all the things he ever wanted because the child on the outside finally matched the child on the inside. My nightmare had become a dream. I woke to tears on my face and pillow because Manie was happy. Happy tears turned to sad tears as I slowly realized it was just a dream. The real nightmare is what I live. The nightmare is knowing I can’t make it all better because I really can not change heartbeats with Manie.

So, Glaxo has known since as early as 1980 that Paxil could cause birth defects.

http://www.bloomberg.com/apps/news?pid=20601087&sid=ah9mMl9sDitg

Glaxo Executive’s Memo Suggested Burying Drug Studies (Update4)

By Jef Feeley and Margaret Cronin Fisk

Sept. 15 (Bloomberg) — An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial.

“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.

The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo’s total revenue.

The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Kilker’s mother, Michelle David, blames Paxil for causing life-threatening heart defects in her 3-year-old son.

Glaxo officials urged scientists to withhold information about Paxil’s risks from a paper laying out the company’s “core safety philosophy” for the drug, said Sean Tracey, a lawyer for Kilker and David, in his opening statement in the trial.

“They said if there’s any doubt, take it out,” Tracey told jurors. “They do not want to scare anybody. It’s a very competitive marketplace. It’s a multibillion-dollar industry.”

‘Rare Thing’

Glaxo executives contend that the boy’s heart defect wasn’t caused by Paxil, Chilton Varner, one of the company’s lawyers, told jurors today in her opening statement. In court filings, Glaxo has said it appropriately tested and marketed the antidepressant drug.

“When Lyam Kilker was born in 2005, GSK had not received notice” of his specific type of heart defect in connection with Paxil use, Varner said. “The numbers will tell you the defect is a rare thing.”

The Paxil label at that time reported about animal studies, “including the rate of deaths,” she said.

Glaxo didn’t target pregnant women and its sales force didn’t use strong-arm tactics to push prescriptions, Varner said. “Whatever the marketing was, it played no role in Ms. David’s doctors’ decision to prescribe Paxil or Ms. David’s decision” to take the drug, she said.

Rat Studies

Glaxo officials purchased the compound sold as Paxil from a Danish company that had done animal studies showing young rats died after taking low doses of the drug, Tracey said in his opening statement.

One of the company’s scientists noted in internal documents in 1980 that information in the rat studies suggested Paxil “could be” a cause of birth defects, Tracey said. Still, the drugmaker refused for almost 20 years to do studies on why the young rats died, he added.

Tracey told jurors they would see documents in the trial that the company hadn’t turned over to regulators or congressional investigators. “You are going to see docs that have never seen light of day before,” he said.

For example, Tracey pointed to a 1998 internal review by Glaxo of all reports of side effects tied to Paxil and officials found “an alarmingly high number” of birth-defect reports. Even with those concerns, the report was never turned over to the U.S. Food and Drug Administration and “the alarming language” was deleted from it, the lawyer said.

In 2001, the company received a letter from a woman who used Paxil during her pregnancy and decided to abort her fetus after tests showed it had birth defects, Tracey said.

Internal Report

In analyzing the woman’s case, Glaxo officials concluded in an internal report that it was “almost certain” the fetus’s birth defects were caused by his mother’s Paxil use, the family’s lawyer added. Still, the company didn’t turn over its analysis to the FDA or beef up the drug’s warning label, Tracey said.

It wasn’t until after the FDA ordered Glaxo and other makers of antidepressants in 2003 to do more safety studies on their products that Glaxo officials publicly acknowledged that Paxil increased the risk of birth defects, Tracey said.

The lawyer for David, a college nursing student who was a former cheerleader for the National Basketball Association’s Philadelphia 76ers, told jurors that Glaxo hid Paxil’s problems to protect its profits.

Paxil is “the No. 1 asset to this day this company has ever owned,” the attorney said.

‘Quite Different’

Varner said she will present “quite different” evidence on animal tests tied to Paxil.

“The animal testing did not suggest Paxil caused birth defects,” Varner said. The FDA considered the tests when it approved the drug for use by U.S. consumers in 1992, she said.

When Glaxo officials considered offering Paxil for sale in Japan, internal records show executives worried in 1994 they might have to do more safety testing on the antidepressant, said Dr. David Healy, an Irish psychiatrist testifying as an expert for Kilker’s family in the case.

It may be the “type of study we wish to avoid,” Jenny Greenhorn, an official in Glaxo’s international regulatory affairs unit, said in a memo.

Glaxo also is fighting suits in the U.S., Canada and the U.K. over claims that Paxil, also known by the generic name paroxetine, causes homicidal and suicidal behavior. The company has settled some suicide claims, though terms of the settlements haven’t been released.

New York Settlement

In 2004, the drugmaker agreed to pay the state of New York $2.5 million to resolve claims that officials suppressed research showing Paxil may increase suicide risk in young people. The settlement also required Glaxo to publicly disclose the studies.

The company’s provision for legal and other non-tax disputes as of June 30 was 1.7 billion pounds ($2.8 billion), the company said in a July 22 regulatory filing that didn’t mention the Paxil litigation.

“We do not disclose our legal reserves for any specific litigation matter,” Glaxo spokesman Kevin Colgan said earlier this month.

Glaxo American depositary receipts, each representing two ordinary shares, fell 68 cents, or 1.7 percent, to $38.76 in New York Stock Exchange composite trading today. Glaxo fell 14 pence, or 1.2 percent, to 1,175.5 pence in London.

The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania.

To contact the reporters on this story: Jef Feeley in Philadelphia jfeeley@bloomberg.net; Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net.

Last Updated: September 15, 2009 17:03 EDT

Tomorrow, September 13, 2009 is the one year anniversary of Indiana Delahunty’s death.

Please go to Christian’s & Matt’s blog to offer some moral support to the family.

http://indibaby.wordpress.com/

Please read this article on The Bitter Pill:

http://uniteforlife.wordpress.com/2009/09/05/what-the-media-doesnt-say-about-antidepressants-pregnancy/

Here are a few excerpts:

In reality, you cannot separate the need for the baby to be healthy and to survive from the mother’s mental state. How many mothers honestly do not worry that something could go wrong with their babies or do not feel responsible for protecting their children? How many women who lost children can go on day by day not feeling anything about that loss? Which antidepressant are you supposed to take to help with depression if you’re dealing with loss after your baby dies from an antidepressant?

…

[T]o quote the ACOG release, “[T]he use of antidepressant medications during pregnancy have been associated with negative consequences for the newborn…some studies have linked fetal malformations, cardiac defects, pulmonary hypertension, and reduced birth weight to antidepressant use during pregnancy.”

…

If you had PPD before, then by all means if you are going to take drugs for PPD, do so after the baby is born and don’t do it while nursing. The time it takes you to get your placebo effect should be well worth it considering the peace of mind and increased safety for the baby.

…

Even after considering the fact that antidepressants actually cause depression and suicide, and work about as well as a placebo, this catch phrase makes about as much sense to me as saying that a mom who is addicted to crack, or drinks 5 coffees a day, or smokes, or is an alcoholic, should be told to keep doing those things if it eases her anxiety or fatigue while pregnant. Or about as much sense as telling women to go take Thalidomide because we’re not really sure that Thalidomide causes problems and it was probably actually the morning sickness causing the birth defects and not the Thalidomide. The jury is still out on whether swallowing RAID or drinking bleach while pregnant is bad for your baby. Perhaps working in a nuclear plant or handling plutonium should be considered safe for pregnant women too.

(cross-posted on The Bitter Pill)

Please read this post on Christian Delahunty’s blog indibaby.wordpress.com:

Gestational Diabetes? Our bittersweet results…

http://indibaby.wordpress.com/2009/09/04/gestational-diabetes-our-bitter-sweet-results/

I find it sad that it is so hard to find a midwife who understands the dangers of antidepressants for pregnancy. But even more difficult to grasp is how people can be so cold when dealing with parents who have lost their children to antidepressants. What is this world coming to?

If you lose a child to cancer, you never expect people to say stuff like “Sometimes kids just die” or “Your baby did not die from cancer” or “So would you like a higher dose of drugs” – no, you expect them to have compassion and understanding and sympathy. Why is it hard for people to have sympathy when someone dies from antidepressants? Instead of instantly jumping to defend the drugs, perhaps people should think about how it would feel to have the same thing happen to you.

Unfortunately I have experienced similar responses any time this subject gets brought up. I suppose that it’s beyond comprehension for people to deal with a “medication” killing someone. Or perhaps it’s only something with psychiatric drugs? I can’t imagine if I told you my grandmother died from Vioxx that anyone would start jumping to defend Vioxx.

Wake up people.

http://momsandmeds.com/

Background:

Motherhood has been hijacked by the psychopharmaceutical cartel. Last summer following the first several months of an intense grassroots campaign to stop the federal government from screening pregnant and new mothers via S. 1375 / H.R. 20, it came to our attention that La Leche League of Texas was hosting a celebratory conference in which the key note speaker would be Thomas Hale, Ph.D. and the topic would be how to help lactation counselors, consultants, and other breastfeeding leaders identify depression in breastfeeding women and inform mothers which drugs were recommended as the safest for breastfeeding.

Thus the impetus for a new sector of the UNITE / CHAADA outreach efforts began. A group of activists and experts collaborated and agreed to found and name this group “MADNAP” – Mothers Against Drugging the Nursing and Pregnant. Flyers on MedWatch data and breastfeeding studies, as well as other information obtained over the past few years regarding the risks of drugs for breastfeeding and pregnant mothers were drawn up and copied. UNITE / MADNAP activists drove to the location of the conference and distributed these flyers while Thomas Hale was inside delivering the final key note address to conclude the weekend long breastfeeding conference.

Knowing that mothers want to be able to nurse their children we feel that it is crucial that this desire not be exploited by those who seek to portray the use of potentially lethal psychotropic drugs while nursing as somehow more benign than formula feeding for the baby.

MADNAP, an affiliated group of the UNITE / CHAADA grassroots membership, has spread awareness through our BREATH blog and by other means. We have reached mothers who lost their babies to psychiatric drugs and have been able to publicize this information, leading to others having enough warning to get off of medications before or during pregnancy, potentially saving their unborn babies‘ lives.

We encourage people to share our new home page which is a launch pad to related blogs, information resources, the MedWatch reporting system, and the decrypted MedWatch data – which has been made available to the public for the first time ever, thanks to the tremendous efforts of CCHR International (and very little thanks to the FDA).

See The Bitter Pill for their press release. I have linked at the bottom of the MADNAP  site to their searchable database, including a special page on prenatal and neonatal exposure reactions / deaths.

Please check out the completed home page at http://momsandmeds.com which is also crosslisted as http://medsinmilk.com/ (yes, this is a play on the title of the book called Medications in Mother’s Milk by Thomas Hale, a book shared with lactation consultants around the world, which does not contain complete unbiased information, such as the latest MedWatch data).

Be sure to check out the yahoo group which you can locate from the MADNAP home page.

If you would like to get more involved, join the yahoo group and introduce yourself or send an email to me at amy@uniteforlife.org. Thank you for caring about babies who are currently being involuntarily drugged and whose mothers have been deprived of the right to full informed consent.

And just to fend off any accusations of me being judgmental towards women who nurse their babies on psychotropic medications, I nursed Isaac on Zoloft for four months from the time he was 6 days old. NO, I would NEVER do that again. And no, I do not judge people who do, I believe they have a right to full information before making that choice, and I know that this information has been unavailable to them, until now.

I do not want any babies to have to die the way that so many before them have, because of the misinformed and misleading statements of a few powerful and influential “experts” dictating the (incomplete) information fed to mothers.

Please help me make this viral.

Tidbits from the experiences of one of our MADNAP founders, Rose (to join the MADNAP group and get to know some of our members, go here: http://health.groups.yahoo.com/group/madnap/ ):

I am 55 years old, the mother of four home born, breastfed, cloth diapered, healthy children.  I am the oldest of nine children, born at home and breastfed before there was a La Leche League International. My Father was a Doctor of Chiropractic and always tried to raise us in the most healthy way possible.

I always tried to learn from the mistakes of the past.  My mother was given a drug in 1953 when she was pregnant with me.  She was told it would prevent a miscarriage.  She never filled that prescription.  I was born a little early at home, but I am fine.  When I was in high school in the early 1970’s, the drug my mother was prescribed was pulled from the market because it was found to cause a very rare form of vaginal cancer, cervical abnormalities, adenosis, and testicular cancer. I had classmates in high school and college who underwent hysterectomies. I decided to learn from this mistake and live as healthfully as possible.

http://www.cdc.gov/DES/consumers/about/index.html

I taught at a private, religious school.  I loved the job!  My husband died during my fifth year the week before school began. I took no time off.  My principal suggested that I take antidepressants to help the grieving process. I was tired and depressed, so I took her advice. I went to a doctor who pulled out six weeks of free samples and a prescription for Cymbalta. He barely spoke to me for three minutes. I had never seen him before.  It was like handing out candy. He never followed up on my condition. I developed chronic constipation and joint pain from the drug; this depressed me more. I later learned that the principal is the wife of a prominent medical doctor in the community and she believes in living better through chemistry. This principal has suggested taking antidepressants to other members of the faculty – we were such a happy bunch!  I would love to see her stock portfolio and see how many pharmaceutical companies she is invested in.

I left after two years.

I finished fixing up my home the way my husband and I had discussed for years. I finished raising my young son. I took classes at the local community college.  I rested also.  This did far more to help my mood than taking pills.  I did it myself.  I wish I had taken the time to do all of this when my husband first died.  I could have saved myself a lot of grief.

Today I am happy and productive. I still get pain in my joints, but I exercise to keep limber and elevate my mood.

Mommy cuddling Indi, originally uploaded by MADNAP.

Please help us get the word out before more babies become doomed.

This is a press release from August 4 of last year, concerning an attempt on July 28 to pass The MOTHERS Act without proper procedure and due diligence via a controversial spending bill dubbed by Harry Reid and friends as the “Coburn Omnibus.” See here: http://tinyurl.com/cha9vk (See also http://christiannewswire.com/news/373117355.html )

This year, there is an attempt to include many Orwellian psych screening and treatment and intervention programs in health care reform. Congress is trying once again to pass these programs through before the August recess. We need faxes going in ASAP to your Reps and Senators. That means today! We have to do something to stop these programs from harming more babies like Indiana, and countless other vulnerable people.

Say yes to health and no to death from psychotropic drugs.

For more information on these programs please see: http://tinyurl.com/nhyhet

To take action against The MOTHERS Act specifically, please go to http://www.box.net/shared/810kj0b8g7 and print a PDF that you can fax to the Senate: http://www.box.net/shared/4qx33jhgen

Go to http://mothersact.com/ for more information.

To Indi from your daddy http://tinyurl.com/mgpoyd
and mommy http://tinyurl.com/laf6wh

Family Photos http://tinyurl.com/mg7y6h

To see the letters sent to Dr. Doug Bremner of Emory University ordering him not to use their name on his blog, click here. After much controversy, as you can see, in the final letter, dated today, Emory has recoiled and stated that Dr. Bremner can now once again use his title and university name on his own blog as long as he clarifies that he is speaking for himself and not for the institution.

It seems that Emory was originally concerned that it might be “implicated” in the scandal of the decade, after some anonymous complainer contacted them and threatened to take their concerns to the Georgia Medical Board… all because Dr. Bremner wrote on Emory letterhead that Philip Dawdy should be allowed to smoke in his own apartment.

Apparently now that Congress has decided that tobacco should be regulated by the FDA, doctors cannot make jokes about people smoking in far-off states. Heaven forbid an M.D. make a statement about the effects of nicotine withdrawal…

I wonder, if instead, I mean hypothetically speaking… someone like Zachary Stowe (after taking money from GSK while working on NIH grants) signs a letter written on Emory letterhead, composed by some PR expert at Cohn & Wolf to promote Paxil as safe for breastfeeding, a letter which is then quoted on headlines around the globe with the so-called safety information marketed to lactation specialists and OBGYNs… whether Emory would voluntarily contact Zachary Stowe and order him to stop using his position at Emory to influence medical decisions for babies in far-off states for whom he is not a primary care physician? (Hmmmm… or would it take a Senate investigation to get Emory to reprimand him?)

Wait, I think I already know the answer to that…

When it comes to telling a mature adult that he can make his own choice about smoking, that’s a medical fiasco.

But when it comes to telling a WORLD full of reporters and nursing moms that an SSRI with a BLACK BOX warning is safe to feed to a newborn baby via breast milk, that’s perfectly acceptable. Unless a Senator finds out.

Yet what really has happened to all that “research” that Stowe conducted while on the take? Self-proclaimed “experts” continue using the studies to justify pushing drugs on mothers. It remains to be seen whether and how extensively the truth will trickle down to the moms who need to know it. Most people probably continue on in ignorance, citing the same “information” pushed on breastfeeding moms for the past several years…

Hey, maybe we should give the guy a few more government grants, or cite his “research” papers a few dozen more times and send the new articles (containing the “metaanalyses” of 100 articles all of which cite Stowe’s articles as their source) in for more coverage by the PR firms and PR bloggers to use in their promotion of The MOTHERS Act, or promotions of drugging nursing moms.

Here’s how this all works: If Philip Dawdy smokes in his apartment, a neighbor might have to smell it and that would be inconvenient. And all who condone his smoking, or even poke fun at the apartment complex, should be exposed for their massive lack of “ethics.”

But if millions of childbearing or nursing women take a drug that has been shown to induce SIDS, coma, seizures, etc. according to MedWatch, the doctors responsible are… well, never held responsible. And all those who promote drugging these babies are… given awards and grants and speaking engagements. Just don’t forget to send in the paycheck on time. You don’t want to get someone irritated to the point that they start acting “like a prick.”

I wonder how much negative attention it would take to get some justice for all those dead babies out there who have people like Stowe, Cohn & Wolfe, or GSK to blame for giving their mommies the go-ahead on drugging them.

I’ve been pretty quiet lately, because I am trying to update and synthesize several years worth of observations and research on the effects of psychotropic drugs on breastfed babies. It’s a big task.

Here is a short summary of what I found recently from the FDA MedWatch reports on SSRIs, SNRIs and Zyprexa from 2004-2008. Reports of drug exposure via breast milk which did not have other side effects listed were excluded. If a drug is not listed here it’s because I only made it through the SSRIs and SNRIs and Zyprexa and got tired. Also I wanted to focus on antidepressants since those are more commonly given to moms for PPD. There are many many more psychotropic drugs being given to nursing moms, and Zyprexa is being pushed as “safe” based on a study of 7 babies.

SUMMARY

BREAST MILK ONLY EXPOSURE

First here is the information on Zoloft which is the recommended drug for breastfeeding (Prozac is the recommended drug for pregnancy).

Zoloft breast milk exposure (3 reports):
Convulsions / Epilepsy; Developmental Delay; Hypotonia

Other drugs collectively – breast milk only exposure:

SOMNOLENCE: 4 reports from breast milk alone – Prozac, Cymbalta, Lexapro and Wellbutrin
SIDS from breast milk alone – Effexor (2 reports)
Fatigue – 1 report – Paxil
Hyperreflexia – 1 Paxil
Insomnia – 1 Celexa, 1 Paxil
Gastrointestinal Disorder – 2 Paxil, 1 Celexa
Gastroesophageal Reflux Disease – 1 Celexa
Feeding Problem – 1 Lexapro
Weight Decreased – 1 Celexa
Sleep Disorder – 1 Prozac, 1 Wellbutrin
Irritability – 1 Prozac
Kidney Enlargement – 1 Paxil
Rash – 1 Paxil
Fractures – 1 Effexor
Bloody Stools / Rectal hemmorage – 1 Prozac

Pregnancy Only Exposure – Neonatal Deaths / SIDS
SIDS: 5 cases – 1 each for Celexa, Effexor, Lexapro, Wellbutrin, and Zyprexa
Neonatal Deaths: 11 cases – 3 for Celexa, 2 for Effexor, 1 Wellbutrin, 5 Zyprexa

COMBINED Breast Milk and Pregnancy Exposure
SIDS – 1 Lexapro, 1 Paxil
Autism / Sensory Integrative Dysfunction – 1 Zoloft

METHOD OF EXPOSURE NOT LISTED
SIDS – 1 Effexor (also a coma / loss of consciousness report).

This is a separate analysis looking only at SIDS, neonatal deaths, and breastfeeding exposure. This is not for every drug, just the ones listed here (SSRIs, SNRIs and Zyprexa).

This of course does not include the birth defects and heart disease adverse events, or the many many spontaneous abortions, stillbirths and intrauterine deaths. Focus is on breast milk exposure effects and prolonged pregnancy exposure effects that lead to SIDS / neonatal deaths.

This is contradictory to the claims by conflicted researchers that there are no reports of harm to breastfed infants whose mothers take Zoloft and some other drugs. Perhaps those researchers need to start admitting to the existence of MedWatch or perhaps they should pay attention to the babies being hurt by antidepressant exposure instead of pretending that those cases don’t exist.

Why are there so many more reports for pregnancy exposure-related deaths than breast milk exposure?

Several possibilities:

• People don’t believe breast milk exposure can happen because they are told the exposure is minimal or nonexistent, therefore they do not report it.
• SIDS cases are easily mistaken for suffocation or other unknown causes and thus when babies exposed to antidepressants die from SIDS drugs are not suspected (despite the fact that we know these drugs cause coma, seizures, and sedation).
• People do not know that they can report to, much less know how to report to MedWatch.
• The mothers who take antidepressants for PPD may decide to wean their babies.
• Not many moms breastfeed or do so exclusively.
• Maybe some moms wait until the baby is weaned to start an antidepressant, and only expose the next baby during pregnancy, during which time the baby dies from spontaneous abortion thus preventing any exposure via breast milk.
• Perhaps the number of women taking SSRIs, SNRIs, and Zyprexa while nursing has gone down since 2004 (reports prior to 2004 are not free) along with the black box suicide warning, thus “necessitating” a push for a national law to market drugs to chidlbearing women.

Keep in mind that MedWatch only captures 1-10% of actual adverse events (so multiply by 10 to 100 to estimate what may actually have taken place from 2004 through the 3rd quarter or so of 2008). And on the Thomas Hale breastfeeding information website for Medications in Mother’s Milk, he warns to watch out for sedation in some antidepressants. News flash – by the time you notice your baby is heavily sedated it could be too late. They could have slipped into a coma, started having seizures, or stopped breathing. Most young babies sleep a lot.

And if you do notice sedation and your baby is not in a coma or dead, your choices are: 1) wean the baby suddenly, or 2) go cold turkey off your meds while either weaning suddenly, weaning partially, or continuing to nurse while the meds leave your body, and hoping that the next feeding doesn’t send your baby into a coma, or  3) continue exposing your baby for weeks or months while you taper off. None of those is a great choice.

Go to the website for Dr. James McKenna and read up on SIDS. He theorizes that SIDS may happen when a baby is not awakened from a deep sleep often enough, and says that co-sleeping is one way that babies naturally evolved to protect themselves from SIDS. I also recall reading an article that theorizes that SIDS may be caused by a malfunctioning serotonin system. I need to go find that one again.

Needless to say if you are on antidepressants it’s a good idea to keep an eye on your baby when she sleeps, so co-sleeping would be good in that respect. However it’s also scary to think about those babies getting increased exposure from constant nursing. It’s a real catch 22.

Nestle, you can send me my check now. Ha ha just kidding. For a second I thought I had turned into Zachary Stowe.

This is a great article by Evelyn Pringle about the corruption at the FDA in recommending approval of atypical antipsychotics for children. As you know, Zyprexa is already being pushed as acceptable for breastfeeding. The article covers The MOTHERS Act pushers who could potentially become  ”entities” receiving federal grants to continue pushing drugging of pregnant and nursing mothers, and babies will be the ones to suffer (and die) the most under this plan.

Mothers’ Act Looms as Drug Industry Scam

FDA Throws Lifeline to Antipsychotic Pushers

By EVELYN PRINGLE

http://www.counterpunch.org/pringle06122009.html

On June 11, 2009, FDA News reported that AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly’s Zyprexa atypical antipsychotics “won an FDA advisory panel’s recommendations for approval to treat schizophrenia and bipolar disorder in pediatric and adolescent patients.”

“The FDA’s expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent,” says Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a June 8, 2009 infomail alert.

“Rather than focus on protecting children’s safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children–thereby ensuring that far greater numbers of children will be victimized and die,” according to Sharav.

A recent report by the consulting firm Decision Resources found antipsychotics makers spent $993,000,000 in 2006, to promote these drugs to doctors and patients, she reports. In 2008, at more than $14 billion, antipsychotic revenues topped all other classes of drugs in the US, even cholesterol and diabetes medications.

On November 17, 2008, on the popular Furious Seasons website, Philip Dawdy reported that Zyprexa had killed 3,455 people between 1997 and early 2008, based on a review of an FDA staff document with a summary of adverse events in the agency’s database.

From 1993 through the first three months of 2008, 1,207 children on Risperdal suffered serious adverse events, including 31 who died, according to a report in the November 18, 2008 New York Times.

The deaths included a 9-year-old child, receiving Risperdal for the unapproved use of ADHD, who suffered a stroke twelve days after starting the drug. At least 11 of the deaths were in children whose treatment was for an unapproved use.

In May 2009, CBS News reported that Risperdal was causing boys to grow breasts due to increased prolactin levels caused by the drug. The news segment featured a boy who was prescribed Risperdal for ADHD, and had to undergo a double mastectomy to remove the breasts.

Philadelphia attorney, Steve Sheller, represents six boys who developed breasts after taking Risperdal, in lawsuits against Johnson & Johnson. Two have had mastectomies.

On June 3, 2009, Medscape reported that findings presented at the American Psychiatric Association annual Meeting, on the preliminary results from the “Metabolic Effects of Antipsychotics in Children” study, “show that 12 weeks of initial antipsychotic treatment was associated with significant mean increases in overall adiposity and percentage of body fat, as well as a decrease in whole-body insulin sensitivity.”

“Further,” Medscape said, “the investigators found antipsychotic treatment was also linked to significant increases in body-mass index (BMI) percentile and fasting plasma triglyceride levels, both clinically available indicators of adverse metabolic changes associated with increased adiposity.”

In terms of life-long health issues: “This is a serious problem,” says Dr Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, and past president of the American College of Cardiology.

“The substantial increase in body fat and increased insulin resistance will almost certainly lead to a higher lifelong incidence of diabetes,” he warns.

“Diabetes is a major cause of heart attack, stroke, kidney failure, blindness, and limb amputation,” Dr Nissen points out.

In an April 2008, editorial, in Psychotherapy and Psychosomatics, titled, “Irrational Healers,” Dr David Healy, author of the new book, “Mania: A Short History of Bipolar Disorder,” writes:

“For fifty years, the antipsychotics were viewed as too dangerous to use outside secondary care and were largely restricted to those with chronic psychotic disorders where the trade-off between hazards and benefits justified treatment.”

“Yet now a new generation of possibly even more problematic antipsychotics is being given to preschoolers, in North America, on the basis that they might have a disorder that most of the rest of the world does not believe happens in children.”

“FDA officials are ignoring the real world tragedies–drug-induced deaths of children,” Sharav warns.

On June 6, 2009, the Topeca Capital Journal reported on the death of a Kansas toddler, Destiny Hager, and the confirmation by an autopsy that the child died of fecal impaction, after taking Seroquel and Geodon, with “antipsychotic drugs present in concentrations considered therapeutic in adults.”

Child psychiatrist, Vernon Kliewer, diagnosed Destiny with bipolar disorder and prescribed the drugs. State regulators recently “completed a two-year investigation of Kliewer that found the doctor violated Kansas law while treating Destiny and five other children,” the Journal reported.

A September 14, 2007 petition filed by the Kansas Board of Healing Arts, says Kliewer diagnosed Destiny with Bipolar Disorder in March 2006, at 3-years-old, and she died on April 4, 2006.

The petition contains 6 counts and details the prescribing of multiple drugs by Kliewer to six children including two more 3-year-olds, one 4-year-old and two 2-year-olds. In one case, he began treating a child at 2-years-old and between January 2003 and November 2006, prescribed a total of 9 drugs for the girl, including Risperdal, Abilify, Seroquel, and Geodon.

“The doctor negotiated a settlement in February with the Board of Healing Arts that didn’t require him to admit wrongdoing,” the Journal said. “He voluntarily stopped treating patients under age 6.”

The Board placed Kliewer’s medical license on indefinite probation and ordered him to pay $13,079 to cover the investigation expenses, the Journal reported. Kliewer must also have another physician monitor his treatment of bipolar patients.

“Tragically, most physicians have not been trained or encouraged to think rationally about the hazards of monotherapy, let alone polypharmacy in children,” says Dr Grace Jackson, author of, “Rethinking Psychiatric Drugs: A Guide to Informed Consent, and the new book, “Drug Induced Dementia – a perfect crime.”

“Mental health professionals have an ethical duty to inform parents about the potential lethality of drug combinations,” she advises.

On June 5, 2009, Dawdy posted a link to the FDA’s briefing package on Furious Seasons, available to members of the advisory panel, and posted portions of the introduction by FDA psychiatry products chief, Thomas Laughren, including the following comments on side effects caused by the drugs:

“Adverse reactions that can occur with drugs in the class of atypical antipsychotic drugs include, among others, somnolence, weight gain, increases in blood lipids and glucose, acute extrapyramidal symptoms, and tardive dyskinesia.

“These risks are of particular concern in pediatric patients because of the life-long nature of these disorders and the fact that these patients are considered particularly vulnerable, in part because they may be exposed for many decades, and in part because of possible effects on growth and development,” Laughren noted.

In April 2009, Gabriel Meyers, a 7-year-old Florida boy, committed suicide by hanging in the bathroom of a foster care home. In the last few days of his life: “He was told his mother no longer had visitation rights, that he would probably be going back to Ohio, where he alleged he had been abused; the doctor changed his medication, he changed foster homes and he got a new counselor,” George Sheldon, secretary of the Department of Children and Families, stated in the May 12, 2009 St Petersburg Times.

In the year leading up to his suicide, Gabriel had been on the stimulant drugs Adderall and Vyvanse, the SSRI antidepressant Lexapro, Zyprexa, and Eli Lilly’s Symbyax, a drug containing both Zyprexa and Prozac, recently FDA approved for “treatment resistant” depression.

Gabriel was on Symbyax and Vyvanse when he died and neither prescription had been authorized by either his parents, or a court order signed by a judge, in violation of Florida law. He was listed as being on only Adderall in the Department of Children and Families’ database.

“On six separate occasions, Gabriel’s caseworker, Lawrence Chusid, documented that DCF had “parental consent” for the child’s medications,” according the May 9, 2009, St Petersburg Times “But in the hundreds of records in Gabriel’s file released by DCF late last month, there is only one form signed by his mother, Candace, a blanket authorization for medical treatment for her son,” dated June 29, 2008, the Times reports.

The labeling on Prozac and Symbyax, contains a black box warning of an increased risk of suicide in children. Instead of discouraging the concomitant use of these two powerful medications, Lilly has encouraged such practices by “designing its own “combination” capsule which contains both Prozac and Zyprexa,” says attorney, Andy Vickery, of the Houston law firm, Vickery, Waldner & Mallia, who is involved in Zyprexa suicide litigation.

“The actual number and rate of completed suicides for patients in clinical trials on antipsychotic drugs, as submitted to the FDA, is higher on Zyprexa than on any of the other drugs in this class,” he reports.

“Specifically,” he says, “Lilly reported that, of 2500 patients on Zyprexa, there were 12 completed suicides, as compared to none on placebo.”

For several years, a system called the “Medicaid Drug Therapy Management Program,” was supposed to be monitoring the prescribing habits of doctors for children covered by Florida Medicaid. However, Gabriel’s shrink, Dr Sohail Punjwani, had been red-flagged as having “problematic” prescribing practices in every quarter since the monitoring began in 2006.

According to the Miami Herald: “Punjwani defended the use of psychiatric drugs on children, even if they are not approved for such use, saying the lack of approval stems from the reluctance of drug makers and the medical establishment to launch clinical trials on children.”

“The anti-psychotic drugs, he added, are used routinely to treat mood instability and insomnia among children,” the Herald reported.

The doctor told the Herald that he did not even remember Gabriel. On May 12, 2009, the Herald reported that a “lawmaker who chairs a state Senate committee on children has asked the state to investigate the doctor who treated a foster child who killed himself.”

“In separate letters to the Florida Board of Medicine and the Agency for Health Care Administration, state Sen. Ronda R. Storms, a Brandon Republican who chairs the Children, Families and Elder Affairs Committee, requested investigations leading to a “full report,” according to the Herald.

Following Gabriel’s death, DCF Secretary Sheldon directed a review of the files for every Florida foster child to ensure that any child prescribed psychotropic drugs was accurately recorded in the Department’s system. He also directed a verification of the existence of a parental consent, or a court order signed by a judge, authorizing each child to receive such medication.

The results of the review in a May 28, 2009 report indicate: “No record of consent or judicial order was found for 16.2% of the 2,669 children receiving psychotropic medication.”

On December 13, 2006, four-year-old Rebecca Riley died in a Hull, Massachusetts as a result of a drug overdose. At a mere 28-months-old, Dr Kayoko Kifuji, a psychiatrist at Tufts New England Medical Center in Boston, diagnosed Rebecca with ADHD and bipolar disorder, and subsequently prescribed, Seroquel, Depakote, an antiseizure drug, and clonidine, a blood pressure medication.

The medical examiner noted that “Rebecca’s heart and lungs were damaged and found that this was due to prolonged abuse of these prescription drugs, rather than one incident,” according to police reports.

The legal filings show the two other Riley children, ages 6 and 11 at the time of Rebecca’s death, were also diagnosed with bipolar disorder and ADHD, by the same doctor, and kept on the same 3-drug cocktail for years.

Rebecca’s parents have been charged with murder under the theory that they overdosed the child in attempt to sedate her and she did not bring in government disability payments.

On February 7, 2007, the day after the parents pleaded not guilty to the charges, Dr Kifuji entered into a voluntary agreement with the Massachusetts Board of Registration in Medicine to not practice medicine pending an investigation. “The Agreement entered into by Dr. Kifuji will remain in effect until further order of the Board,” the Board’s February 7, 2007 press release stated.

In April 2008, attorney, Andrew Meyer Jr, filed a malpractice lawsuit against Dr Kifuji on behalf of Rebecca’s estate. “This child was subject to mostly telephone prescriptions and a slipshod diagnosis,” he told the Boston Globe on April 4, 2008.

In an editorial titled, “How many more Rebecca Rileys?, in the January 9, 2009 Patriot Ledger, the author of, “From Difficult to Delightful in Just 30 Days,” Dr Jacob Azerrad, wrote: “To diagnose a 2-year-old as bipolar by adult standards is crazy.”

“A key issue is the misuse of psychiatric diagnostic labels to explain bad behavior in children,” he wrote. “This has resulted in the drugging of young children to a degree unprecedented in our history.”

“Our preschool children are far too young to defend themselves,” he said. “It’s up to parents to “say no to drugs” and teach their children that life is meant to be learned and experienced – it’s not just a pill to be swallowed.”

On March 5, 2009, Weymouth News reported that a “psychiatrist who prescribed drugs for the late Rebecca Riley, who was four at the time of her death, can be charged with malpractice.”

“A Suffolk County tribunal determined on March 5 that there was enough evidence to charge Dr. Kayoko Kifuji,” the News noted.

“Rebecca Riley’s doctor now the target of a grand jury,” was the headline in the May 1, 2009 Patriot Ledger. “Already the target of a civil medical malpractice lawsuit, the psychiatrist who prescribed the drugs that killed 4-year-old Rebecca Riley is now the subject of a grand jury criminal investigation,” reporter Lane Lambert wrote.

“If the grand jury does find the … psychiatrist criminally liable for Rebecca’s death, she could face involuntary-manslaughter charges,” Lambert noted.

Evidence of the grand jury investigation surfaced “amid fresh legal action in both the civil and criminal cases,” Lambert said. “Kifuji’s lawyers asked a Suffolk County judge to postpone her deposition in the civil case indefinitely, and close the entire court record to the public.”

Kifuji’s attorney “said a deposition would force the doctor to claim her Fifth Amendment right not to incriminate herself while the grand jury was looking at the case,” according to the report. The judge denied both motions, it noted.

An attorney for Rebecca estate said Kifuji is scheduled to give a deposition in the civil case on July 6, 2009, after the grand jury is finished. In the March 5, Weymouth News article, Kifuji’s attorney said the murder charges against the Rileys make it difficult to decide if she can be faulted for Rebecca’s death.

“This is not something bizarre that she (Kifuji) did,” he said. “A number of fine doctors feel this was appropriate.”

Back on September 30, 2007, Katie Couric interviewed Dr Joseph Biederman, whose research Dr Kifuji has said influenced her, in a 60 Minutes segment tiled “What Killed Rebecca Riley?”

When questioned about the rise in young children with bipolar disorder, Biederman told Couric: “The average age of onset is about four.”

“It’s solidly in the preschool years,” he stated.

The results of an investigation led by Senator Charles Grassley, on behalf of the Senate Finance Committee, revealed that between 2000 to 2007, Biederman earned at least $1.6 million from drug companies but failed to report at least $1.4 to Harvard University.

On February 26, 2009, Biederman was questioned under oath in a deposition for litigation titled, In re Risperdal/Seroquel/Zyprexa Litigation, Case Code 274, Alma Avila as next fried of Amber Avila versus Johnson & Johnson Company et al, in the Superior Court of New Jersey, Middlesex County.

At one point, when questioned about his participation in medical education events as a paid speaker, he blamed a decline in invitations to speak over the past year on Grassley’s investigation and inferred that the investigation was brought on by media hype over Rebecca’s death.

When asked if he had any idea why he received fewer invitations, Biederman said: “There has been some accusations by Senator Grassley about issues of conflict of interest; and while the investigation is going on, I agreed not to speak.”

“What is the nature of Senator Grassley’s investigation of you?” attorney, Fletch Trammell, asked.

“Senator Grassley read, there was an article in The Boston Globe about a little girl in town that the parents are accused of first-degree murder,” Biederman noted.

“In fact, you may have seen it,” he told the attorney.

“The accusation has been upgraded from second-degree to first-degree murder,” he pointed out.

“But because the child was diagnosed with bipolar illness, it captured the imagination of the media and there was an article in The Boston Globe that talked about the diagnosis and how controversial that is and particularly as it pertains to preschoolers,” Biederman continued.

“And in the article the reporter got — I sent my standard disclosure forms, so he wrote that I have extensive relationships with fifteen or so pharmaceutical companies,” he stated.

“So Senator Grassley wrote a letter to the institution, to Harvard and Mass. General, asking for details,” he said. “And that has been the cascade of events.”

“So Senator Grassley became interested in you because of these people who were accused of killing their kid?” the attorney asked Biederman.

“Senator Grassley claims to be interested in issues of conflict of interest and is interested in making sure that the universities have tight conflict-of-interest rules,” Biederman said. “I have no dispute with that.”

“What interactions have you had with Senator Grassley or his staff?” the attorney asked.

“None,” Biederman stated. “Senator Grassley’s interactions are with Mass. General and with Harvard, not with me directly.”

Biederman said the hospital was paying a law firm to represent him in the matter of Grassley’s investigation and for the deposition.

He acknowledged having a professional relationship with Janssen, Eli Lilly, Bristol-Myers Squibb, AstraZeneca and Pfizer, the makers of atypical antipsychotics. “I have a professional relationship with dozens of manufacturers,” Biederman said.

“In the course of carrying out these relationships with all these drug manufacturers, does the relationship always involve them giving you money?” the attorney asked.

“Most of the time,” Biederman replied.

On March 27, 2009, the New York Times reported that, “Federal prosecutors have issued a subpoena seeking information about the work and statements of three prominent Harvard researchers who have been the focus of a Congressional investigation into conflicts of interest in medicine.”

The researchers, Doctors Joseph Biederman, Thomas Spencer and Timothy Wilens – “are named in the subpoena, which was sent … to Fletch Trammel, a lawyer who represents state attorneys general in lawsuits that claim makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines,” the Times noted.

Up until June 10, the researchers and doctors in the field of psychiatry identified by Grassley’s investigation included Charles Nemeroff from Emory University; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, president of the American Psychiatric Association, from Stanford University; Martin Keller at Brown University; Karen Wagner and Augustus John Rush from the University of Texas; and Fred Goodwin, the former host of the radio show, “Infinite Minds,” broadcast for years by National Pubic Radio.

But on June 10, the name Zachary Stowe was added to the list, with a Wall Street Journal headline: “Emory Psychiatrist Cited in Conflicts of Interest.”

“Emory University has disciplined a prominent psychiatrist who was being paid by an antidepressant maker at the same time he was conducting federal research about the use of such drugs in pregnant women,” the Journal wrote.

Stowe is the director of the “Women’s Mental Health Program” at Emory. Its website says the focus his “clinical research is the use of psychotropic medications during pregnancy and lactation, the psychobiology of mood disorders during pregnancy and the postpartum period, and the impact of maternal mental illness on fetal and neonatal exposures.”

The latest off-label marketing scheme in the works involves federal legislation expected to come up for a vote soon in the US Senate called the Mothers Act. This one involves a plan to screen all pregnant women for a long list of pregnancy related “mood” and “anxiety” disorders.

After covering the Pharma’s off-label marketing schemes using mental illness screening scams since mid-2004, beginning with TeenScreen, the Mothers Act is no different than the others, aside from the fact that a whole new treatment industry was built up around it, and more profiteers are involved. But then, Pharma could hardly expect to keep selling drugs through middle-man pushers forever, while keeping the massive profits to itself.

Amy Philo, the leader of “Unite for Life,” a coalition of 53 groups against the bill, warns that the Mother’s Act is: “Trolling for Mental Patients in a Maternity Ward Near You.”

“If you’ve never been “Teen Screened” in high school, quizzed by a college counselor about your potential perfectionism, mood swings, or alcohol use- or told you might go crazy if you don’t start taking drug x, consider yourself among the fortunate, fading few,” Amy advises.

“Imagine yourself pushing a baby into the world in a hospital somewhere in America,” Amy says, “only to be greeted by a friendly, neighborhood-psychological-screener the very moment baby begins munching down on his first meal.”

“Would either of you like a DSM-IV Mental Disorder diagnosis code with that milk?”

With no psychiatric drugs FDA approved as safe for use by pregnant and nursing mothers and doctors rightfully reluctant to prescribe any drugs harmful to the fetus, a new customer recruitment scheme was needed and the Mothers Act fit the bill.

Opposition to the Act stems from the certainty that it will lead to more forced drugging of infants with no voice of their own to prevent it, with antidepressants, antipsychotics, and antiseizure drugs that cause birth defects, a withdrawal syndrome and many other serious health problems, through pregnant and nursing mothers.

The Act is modeled after a mandatory screening law enacted in New Jersey, the home state of the bill’s main sponsor, Senator Robert Menendez, and also the home state for many drug companies. Attempts to pass the federal version have failed for the past 8 years.

The postpartum websites strung out all over the internet to promote the bill, many run by people benefiting financially from the new treatment industry they created, argue that the Act does not call for mandatory screening, without mentioning that the screening language was removed last year due to strong opposition.

“There is NO MANDATED screening,” Susan Stone wrote in a blog on the website for her treatment center, PerinatalPro, on May 29, 2009.

On May 12, 2009, the Herald News reported that the Act “lacks one vote for approval” in the US Senate, citing a speech made by Menendez, during a press conference. Menendez told the Herald that the national bill would not mandate screening. “Hopefully, states would adopt screening,” he said.

This statement, in May of this year, clearly shows that the goal of passing the federal legislation is to set the stage for states to pass mandatory screening laws, like the one in New Jersey.

A June 16, 2006, press release, by Menendez and Senator Richard Durbin, announcing the bill stated, the “Act was introduced in response to a recently passed, first-of-its-kind New Jersey law requiring doctors and nurses to educate and screen expectant mothers about PPD.”

The Theraurus on my computer lists “require,” as an alternate word for “mandatory.”

On June 8, 2009, New Jersey.com, ran the headline: “E-mail: Drug lobbyist targeted Menendez to help with importation bill,” and reported that the subject line of the email said: “URGENT”

The email called for New Jersey drug companies to ask Menendez to be their champion on an amendment that would effectively kill any attempt to allow cheaper drugs to be imported from other countries, according to the report.

“We need to locate a Democratic lead cosponsor for the second degree amendment,” the e-mail said.

“Can … [Johnson & Johnson], Merck, Novartis, Pfizer and the other New Jersey companies coordinate and contact Senator Menendez’s office and ask him to take the lead?”

The strategy to pursue Menendez became known when the email from the Pharmaceutical Research and Manufacturers of America, the industry trade group, ended up with Senator John McCain, a drug importation advocate. “And McCain read it on the Senate floor – twice,” the article notes.

“Menendez’s office said that while he supports the drug companies’ position, he did not act as their champion,” according to New Jersey.com.

The Mothers Act refers to “entities,” as being eligible for grants and participating in research and the development of screening methods and treatments and delivery.

The bill states: “The Secretary may make grants to eligible entities for projects for the establishment, operation, and coordination of effective and cost-efficient systems for the delivery of essential services to individuals with a postpartum condition and their families.”

Under definitions, it says the term ‘eligible entity’– “means a public or nonprofit private entity;” and “includes a State or local government, public-private partnership, recipient of a grant under section 330H (relating to the Healthy Start Initiative), public or nonprofit private hospital, community-based organization, hospice, ambulatory care facility, community health center, migrant health center, public housing primary care center, or homeless health center.”

“Lawmakers have not specified what constitutes an “entity” so it will be impossible to know if there are conflicts of interest between those who develop the screening tools and conduct research and the pharmaceutical companies who most certainly will benefit financially from the increased diagnosing,” according to Kelly Patricia O’Meara in May 7, 2009 article, “Stress Testing the Mothers Act.”

“Where is the guarantee that the “entities” are not pharmaceutical front-men?”, she writes.

“Given that this research will be used to develop questions or tests for screening new mothers for possible mental disorders, one might find it important to know that the research has integrity and has been validated by the scientific community, free of pharmaceutical largesse,” O’Meara points out.

The Act also calls for a “a coordinated national campaign to increase the awareness and knowledge of postpartum conditions.” Activities under such a campaign may– “include public service announcements through television, radio, and other means;” which will basically provide the new pregnancy-related treatment industry with a tax-payer funded mass advertising campaign.

It would be interesting to know whether “entities” would include the treatment centers owned by Susan Stone and Karen Kleiman, and whether their programs would be eligible for funding. At the “Postpartum Stress Center,” Kleiman teaches seminars for professional training with ads on her website and the heading: “Become an Expert in the Treatment of Postpartum Mood Disorders.”

The first sentence in “Highlights” for this training states: “This is a crash course on diagnosis, screening, assessment, treatment options.” The fee is $750 for a 10-hour course, but they do throw in a book titled, “The Postpartum Stress Center’s Guide to Enhancing your PPD Private Practice: A checklist for successful practice,” for the $750.

For this gig alone, Karen could make $7,500 per seminar by simply recruiting 10 trainees. Nearly all the websites pitch in to promote conferences and seminars, so rounding up 10, or even 20, trainees would likely not be too difficult.

The website shows 4 seminars a year, meaning Karen could earn roughly $30,000 for 40 hours of teaching people how to “Become an Expert.” And if she could round up 20 trainees per class, she could make $60,000 a year, putting her up there with all the other highly paid speakers within the new industry.

In her May 29, 2009 blog, Susan mentions how the Act might help fund “inpatient maternal mental health” programs all across the US. “Just this morning,” she says, “I completed an interview with Parenting Magazine, which plans to feature an article about the nation’s first inpatient maternal mental health unit at UNC, Chapel Hill, NC, as well as focus on the federal legislation and how this bill might help fund other such programs across the country.”

Many sites provide links to “experts” and treatment programs. For instance, Katherine Stone runs “Postpartum Progress,” and in December 2008, she had links to the “Top Women’s PPMD Treatment Programs & Specialists.”

The first program on the list was Dr Stowe’s at Emory, which primarily focuses on “the evaluation and treatment of emotional disorders during pregnancy and the postpartum period,” the website states.

In 2008, Dr Stowe was the primary investigator of an National Institutes of Health grant where the stated purpose was “to stimulate vigorous debate with the emphasis on the reproductive safety of antidepressant medications,” according to Grassley’s June 2, 2009 letter to the president of Emory.

During a 2008 deposition in a Paxil birth defect case, Stowe said that around “80% of his Emory salary ($187,000) comes from his NIH grants,” the letter notes. His total Emory salary was $232,000.

In 2007, Paxil maker, GlaxoSmithKline, paid Stowe $154,400 for 57 promotional talks. He also received $99,300 in the first ten months of 2008 for 38 promotional talks for antidepressant drugs, according to Grassley.

Stowe’s undisclosed income above was from one drug maker. In August 2007, he was listed as an author on a study titled, “Atypical Antipsychotic Administration During Late Pregnancy: Placental Passage and Obstetrical Outcomes,” in the American Journal of Psychiatry.

According to the disclosure section, Stowe has received research support from Glaxo, Pfizer, and Wyeth. He has served on advisory boards for Wyeth, Bristol-Myers Squibb, and Glaxo, and he has served on speaker’s bureaus and/or received honoraria from Lilly, Glaxo, Pfizer, and Wyeth.

Dr Jeffrey Newport is the associate director of Emory’s Women’s Program. Newport was also an author on the “Antipsychotic,” study. He has received research support from Lilly, Glaxo, Janssen, the National Alliance for Research on Schizophrenia and Depression, NIH, and Wyeth, and, he has served on speaker’s bureaus for AstraZeneca, Lilly, Glaxo, Pfizer, and Wyeth, according to the disclosures.

On June 14, 2007, Katherine Stone posted a blog with the headline: “Upcoming Event in Asheville Features My Psychiatrist!”, in an evening for prescribing clinicians called “Postpartum Mood Disorders: A Systemic Approach to Biopsychosocial Treatment.”

“The key speaker will be Dr. Jeffrey Newport, associate director of the Emory Women’s Mental Health Program here in Atlanta and also my psychiatrist!!!!”, she said. “I have firsthand knowledge that Dr. Newport rocks.”

An online announcement shows Dr Stowe gave a seminar titled, “Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough.” The moderator for the seminar was Charles Nemeroff, who earned more than $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million to Emory, according to Grassley.

On July 23, 2008, an article by Nemeroff titled: “Weighing Risk and Benefit for Treatment of Depression in Pregnancy and PostPartum,” was available on Medscape. The Medscape website stated, “This article is temporarily unavailable,” on March 17, 2009.

Nemeroff stepped down as chair of the psychiatry department in 2008 after an Emory found he had failed to report more than $800,000 from Glaxo from 2000 to 2006. “That matter is now being probed by the inspector general for the U.S. Department of Health and Human Services,” according to the Wall Street Journal.

Evelyn Pringle

epringle05@yahoo.com

(Evelyn Pringle is a columnist for Scoop Independent News and an investigative journalist focused on exposing corruption in government and corporate America)

Cohn & Wolfe, the P.R. firm where Katherine Stone of Postpartum Progress got her feet wet, is marketing Zyprexa for Lilly by actually writing articles on Zyprexa, and having doctors sign on to be ghostwriters. Lilly has  also sent out packets instructing employees on how to find doctors who would sign on as the author of ghostwritten articles which would prepare the market for the new intramuscular Zyprexa, which is of course used in psychiatric hospitals and on forced patients.

The new intramuscular version of Zyprexa was approved despite serious safety concerns, and causes extreme sedation. It is a two-week long-acting shot. In fact, I was just talking by phone to a woman who is being injected twice a month with this drug against her will. She says that it does not help with her symptoms and is only making her worse, and she is desperate to get off of it but is being court ordered to accept the shots. What a sad, sad world it is we live in when patients are FORCIBLY treated with drugs that can cause sudden death.

What’s scarier to me is imagining a mom being forcibly injected with this poison during pregnancy or breastfeeding. Considering that Kathleen Kendall-Tackett wrote in Mothering Magazine (in a giant fold out in the middle of an article titled “Overcoming Postpartum Psychosis” which was written by a woman who works with Postpartum Support International) that Zyprexa is acceptable for breastfeeding women, I have no doubt that this could be happening more and more.

Lilly ‘Ghostwrote’ Articles to Market Drug, Files Say

June 11 (Bloomberg) — Eli Lilly & Co. officials wrote medical journal studies about the antipsychotic Zyprexa and then asked doctors to put their names on the articles, a practice called “ghostwriting,” according to unsealed company files.

Lilly employees also compiled a guide to hiring scientists to write favorable articles, complained to journal editors when publication was delayed and submitted rejected articles to other outlets, according to documents filed in drug overpricing suits against the Indianapolis-based company, the largest manufacturer of psychiatric medicines.

Ensuring that medical journal articles presented Zyprexa study results in a positive light was one way for Lilly to reach its sales goal, company officials said in its plan, according to the documents.

To do that, Lilly officials hired ghostwriters to prepare submissions to journals such as Progress in Neurology and Psychiatry, according to the unsealed documents.

“The paper for the Progress in Neurology and Psychiatry supplement has been completed and sent to the journal for peer review,” Kerrie Mitchell, an employee of the public relations agency Cohn & Wolfe, wrote in a Feb. 23, 2001, e-mail to Michael Sale, a Lilly marketing official. The message was among the unsealed files.

“We ‘ghost’ wrote this article and then worked with author Dr. Haddad to work up the final copy,” Mitchell said in the e- mail. Eric Litchfield, a spokesman for Cohn & Wolfe, didn’t immediately return a call requesting comment.

Draft Approved

Peter Haddad, listed as the article’s lead author, didn’t respond to requests for comment.

The global Lilly team approved a draft of Haddad’s ghost- written paper in 2000, according to the unsealed documents. Lilly’s U.K. team had to give final approval to the article because Progress in Neurology and Psychiatry was based there, Mitchell said in the February 2001 e-mail.

To ensure that ghostwritten Zyprexa articles met Lilly’s standards, company officials issued a guide to preparing them, according to the unsealed files.

The guide, “Medical Press: Pre-Launch Feature Outline,” was undated. It’s unclear from the documents which teams in Lilly’s top 10 markets for the drug received it.

The primer provided a how-to for writing such articles, such as instructing the author to use Zyprexa’s generic name, olanzapine, instead of its brand moniker, according to the documents. Scientists in medical research traditionally refer to drugs’ chemical names.

‘Opinion Leader’

The guide also offered tips on how to find authors by identifying a “key opinion leader” and providing them either an outline of the article or a finished copy. Authors could include a study investigator, an advisory board member or “Lilly-friendly” doctor, according to the documents.

A sample article laid out how a Lilly employee may find a doctor to ghostwrite a submission that would “prepare the market” for the launch of an intramuscular injectable version of the drug. It also offered an outline for the contents of the article, beginning with background on another drug, droperidol, which had been withdrawn from several countries.

http://www.bloomberg.com/apps/news?pid=20601202&sid=a6yFu_t9NyTY

Please read about how Cohn & Wolfe helped market anxiety for GSK in order to sell Paxil:

Mother Jones

Disorders Made To Order

Brendan Koerner

http://www.motherjones.com/politics/2002/07/disorders-made-order

Word of the hidden epidemic began spreading in the spring of 2001. Local newscasts around the country reported that as many as 10 million Americans suffered from an unrecognized disease. Viewers were urged to watch for the symptoms: restlessness, fatigue, irritability, muscle tension, nausea, diarrhea, and sweating, among others. Many of the segments featured sound bites from Sonja Burkett, a patient who’d finally received treatment after two years trapped at home by the illness, and from Dr. Jack Gorman, an esteemed psychiatrist at Columbia University. Their testimonials were intercut with peaceful images of a woman playing with a bird, and another woman taking pills.

The disease was generalized anxiety disorder (GAD), a condition that, according to the reports, left sufferers paralyzed with irrational fears. Mental-health advocates called it “the forgotten illness.” Print periodicals were awash in stories of young women plagued by worries over money and men.

The timing of the media frenzy was no accident. On April 16, 2001, the U.S. Food and Drug Administration (FDA) had approved the antidepressant Paxil, made by British pharmaceutical giant GlaxoSmithKline, for the treatment of generalized anxiety disorder. But GAD was a little-known ailment; according to a 1989 study, as few as 1.2 percent of the population merited the diagnosis in any given year. If GlaxoSmithKline hoped to capitalize on Paxil’s new indication, it would have to raise GAD’s profile.

That meant revving up the company’s public-relations machinery. The widely featured quotes from Sonja Burkett, and the images of birds and pills, were part of a “video news release” the drugmaker had distributed to TV stations around the country; the footage also included the comments of Dr. Gorman, who has frequently served as a paid consultant to GlaxoSmithKline. On April 16-the date of Paxil’s approval-a patient group called Freedom From Fear released a telephone survey according to which “people with GAD spend nearly 40 hours per week, or a ‘full-time job,’ worrying.” The survey mentioned neither GlaxoSmithKline nor Paxil, but the press contact listed was an account executive at Cohn & Wolfe, the drugmaker’s P.R. firm.

GlaxoSmithKline’s modus operandi-marketing a disease rather than selling a drug-is typical of the post-Prozac era. “The strategy [companies] use-it’s almost mechanized by now,” says Dr. Loren Mosher, a San Diego psychiatrist and former official at the National Institute of Mental Health. Typically, a corporate-sponsored “disease awareness” campaign focuses on a mild psychiatric condition with a large pool of potential sufferers. Companies fund studies that prove the drug’s efficacy in treating the affliction, a necessary step in obtaining FDA approval for a new use, or “indication.” Prominent doctors are enlisted to publicly affirm the malady’s ubiquity. Public-relations firms launch campaigns to promote the new disease, using dramatic statistics from corporate-sponsored studies. Finally, patient groups are recruited to serve as the “public face” for the condition, supplying quotes and compelling human stories for the media; many of the groups are heavily subsidized by drugmakers, and some operate directly out of the offices of drug companies’ P.R. firms.

The strategy has enabled the pharmaceutical industry to squeeze millions in additional revenue from the blockbuster drugs known as selective serotonin reuptake inhibitors (SSRIs), a family of pharmaceuticals that includes Paxil, Prozac, Zoloft, Celexa, and Luvox. Originally approved solely as antidepressants, the SSRIs are now prescribed for a wide array of heretofore obscure afflictions-GAD, social anxiety disorder, premenstrual dysphoric disorder.

For pharmaceutical companies, marketing existing drugs for new uses makes perfect sense: A new indication can be obtained in less than 18 months, compared to the eight years it takes to bring a drug from the lab to the pharmacy. Managed-care companies also have been encouraging the use of medication, rather than more costly psychotherapy, to treat problems like anxiety and depression.

But while most health experts agree that SSRIs have revolutionized the treatment of mental illness, a growing number of critics are disturbed by the degree to which corporate-sponsored campaigns have come to define what qualifies as a mental disorder and who needs to be medicated. “You often hear: ‘There are 10 million Americans with this, 3 million Americans with that,’” says Barbara Mintzes, an epidemiologist at the University of British Columbia’s Centre for Health Services and Policy Research. “If you start adding up all those millions, eventually you’ll be hard put to find some Americans who don’t have such diagnoses.”

When Paxil hit the market in 1993, the drug’s manufacturer, then known as Smith- Kline Beecham, lagged far behind its competitors. Eli Lilly’s Prozac, the first FDA-approved SSRI, had already been around for five years, and Pfizer had beaten SmithKline to the punch with Zoloft’s debut in 1992. With only a finite number of depression patients to target, Paxil’s sales prospects seemed limited. But SmithKline found a way to set its drug apart from the other SSRIs: It positioned Paxil as an anti-anxiety drug-a latter-day Valium-rather than as a depression treatment.

SmithKline was especially interested in a series of minor entries in the Diagnostic and Statistical Manual of Mental Disorders (DSM), the psychiatric bible. Published by the American Psychiatric Association since the 1950s, the DSM is designed to give doctors and scientists a common set of criteria to describe mental conditions.

Critics note that the DSM process has no formal safeguards to prevent researchers with drug-company ties from participating in decisions of interest to their sponsors. The committee that recommended the GAD entry in 1980, for example, was headed by Robert L. Spitzer of the New York State Psychiatric Institute, which has been a leading recipient of industry grants to research drug treatments for anxiety disorders.

SmithKline’s first forays into the anxiety market involved two fairly well-known illnesses-panic disorder and obsessive-compulsive disorder. Then, in 1998, the company applied for FDA approval to market Paxil for something called social phobia or “social anxiety disorder” (SAD), a debilitating form of shyness the DSM characterized as “extremely rare.” Obtaining such a new indication is a relatively simple affair. The FDA considers a DSM notation sufficient proof that a disease actually exists and, unlike new drugs, existing pharmaceuticals don’t require an exhaustive round of clinical studies. To show that a drug works in treating a new disease, the FDA often accepts in-house corporate studies, even when companies refuse to disclose their data or methodologies to other researchers, as is scientific custom.

With FDA approval for Paxil’s new use virtually guaranteed, SmithKline turned to the task of promoting the disease itself.

To “position social anxiety disorder as a severe condition,” as the trade journal PR News put it, the company retained the New York-based public-relations firm Cohn & Wolfe.

By early 1999 the firm had created a slogan, “Imagine Being Allergic to People,” and wallpapered bus shelters nationwide with pictures of a dejected-looking man vacantly playing with a teacup. “You blush, sweat, shake-even find it hard to breathe,” read the copy. “That’s what social anxiety disorder feels like.”

The posters made no reference to Paxil or SmithKline; instead, they bore the insignia of a group called the Social Anxiety Disorder Coalition and its three nonprofit members, the American Psychiatric Association, the Anxiety Disorders Association of America, and Freedom From Fear.

But the coalition was not a grassroots alliance of patients in search of a cure. It had been cobbled together by SmithKline Beecham, whose P.R. firm, Cohn & Wolfe, handled all media inquiries on behalf of the group. (Today, callers to the coalition’s hot line are greeted by a recording that announces simply, “This program has successfully concluded.”)

Cohn & Wolfe’s strategy did not end with posters. The firm also created a video news release, a radio news release, and a matte release, a bylined article that smaller news-papers often run unedited. Journalists were given a press packet stating that SAD “affects up to 13.3 percent of the population,” or 1 in 8 Americans, and is “the third most common psychiatric disorder in the United States, after depression and alcoholism.”

By contrast, the Diagnostic and Statistical Manual cites studies showing that between 3 and 13 percent of people may suffer the disease at some point in their lives, but that only 2 percent “experience enough impairment or distress to warrant a diagnosis of social phobia.”

Cohn & Wolfe also supplied journalists with eloquent patients, helping to “put a face on the disorder,” as account executive Holly White told PR News. P.R. firms often handpick patients to help publicize a disease, offering them media training and sending them on promotional tours.

In 1994, for example, drugmakers Upjohn and Solvay funded a traveling art show by Mary Hull, a Californian who suffered from obsessive-compulsive disorder and spoke frequently with journalists about the disorder’s toll-as well as her SSRI-aided recovery. Not coincidentally, the companies were awaiting FDA approval to market their SSRI, Luvox, for the treatment of obsessive-compulsive disorder.

Among the patients most frequently quoted in stories about social anxiety disorder was a woman named Grace Dailey, who had also appeared in a promotional video produced by Cohn & Wolfe.

Also featured on that video was Jack Gorman, the Columbia University professor who would later make the rounds on Paxil’s behalf during the GAD media campaign. Gorman appeared on numerous television shows, including ABC’s Good Morning America. “It is our hope that patients will now know that they are not alone, that their disease has a name, and it is treatable,” he said in a Social Anxiety Disorder Coalition press release.

Dr. Gorman was not a disinterested party in Paxil’s promotion. He has served as a paid consultant to at least 13 pharmaceutical firms, including SmithKline Beecham, Eli Lilly, and Pfizer. Another frequent talking head in the SAD campaign, Dr. Murray Stein of the University of California at San Diego, has also served as a SmithKline consultant, and the company funded many of his clinical trials on SAD.

Cohn & Wolfe’s full-court press on SAD paid immediate dividends. In the two years preceding Paxil’s approval, fewer than 50 stories on social anxiety disorder had appeared in the popular press. In May 1999, the month when the FDA handed down its decision, hundreds of stories about the illness appeared in U.S. publications and television news programs, including the New York Times, Vogue, and Good Morning America. A few months later, SmithKline launched a series of ads touting Paxil’s efficacy in helping SAD sufferers brave dinner parties and public speaking.

By the end of last year, Paxil had supplanted Zoloft as the nation’s number-two SSRI, and its sales were virtually on par with those of Eli Lilly’s Prozac. (Neither Prozac nor Zoloft has an indication for SAD.)

The success of the Cohn & Wolfe campaign didn’t escape notice in the industry: Trade journals applauded GlaxoSmithKline for creating “a strong anti-anxiety position” and assuring a bright future for Paxil. Increasing public awareness of SAD and other disorders, the consulting firm Decision Resources predicted last year, would expand the “anxiety market” to at least $3 billion by 2009.

In 2000, the New York chapter of the Public Relations Society of America named the Cohn & Wolfe SAD campaign “Best P.R. Program of 1999.”

The lessons of “Imagine Being Allergic to People” were also not lost on Zoloft’s manufacturer, Pfizer. In 1999, Pfizer gained FDA approval to market Zoloft as a treatment for post-traumatic stress disorder (PTSD). Until then, the condition had been associated almost exclusively with combat veterans and victims of violent crime; now, Pfizer set out to convince Americans that PTSD could, in fact, afflict almost anyone.

The company funded the creation of the PTSD Alliance, a group that is staffed by employees of Pfizer’s New York public-relations firm, the Chandler Chicco Agency, and operates out of the firm’s offices. The Alliance connects journalists with PTSD experts such as Jerilyn Ross, president and ceo of the Anxiety Disorders Association of America, a group that is heavily subsidized by Pfizer as well as GlaxoSmithKline, Eli Lilly, and other drug-industry titans.

In the months following the launch of Pfizer’s campaign, media mentions of PTSD skyrocketed. Just weeks after the Alliance’s founding in 2000, for example, the New York Times ran a story citing Pfizer-supplied statistics on childhood PTSD, according to which 1 in 6 minors who experience the “sudden death of a close friend or relative” will develop the disorder. Other stories highlighted studies promoted by the alliance according to which 1 in 13 Americans will suffer from PTSD at some point in their lives.

Eye-catching figures are integral to disease marketing campaigns, though the quality of the data is sometimes dubious. A report published last February in the Archives of General Psychiatry warned that high estimates on the number of people suffering mental-health conditions often include people whose symptoms are so mild as to not require treatment. “When people look at numbers that say close to 30 percent of the American public has a mental disorder and therefore needs treatment, most would say that is implausibly too high,” the study’s lead author, William E. Narrow, told the Associated Press.

Many of the statistics used to promote new disorders are taken from studies published in second-tier journals, which frequently depend on direct corporate support. One publication that has drawn fire is the Journal of Clinical Psychiatry, whose major funders include GlaxoSmithKline and Eli Lilly. In 1993, the journal published a study claiming that anxiety disorders cost the United States $46.6 billion per year, primarily due to lost productivity. That figure was repeated in countless press releases and made its way into articles in the Washington Post and USA Today.

The study was produced by the Institute for Behavior and Health, a research firm headed by Dr. Robert DuPont, who served as President Ford’s drug czar. The institute’s tax returns indicate that its programs are funded almost exclusively by industry research grants; in 1999, for example, it conducted clinical trials on behalf of Merck, Pfizer, and Solvay. DuPont was paid more than $50,000 that year for 10 hours of work per week, in addition to a $56,000 fee that the institute paid to his for-profit consulting firm. The 1993 anxiety study was paid for in part by Upjohn, maker of the SSRI Luvox.

Studies published in medical journals are also useful in reaching a key audience for disease-awareness campaigns-doctors. Physicians, especially general practitioners, are under growing pressure to make quick diagnoses and to treat mental-health conditions with drugs rather than refer patients to psychotherapy. Primary-care physicians now write upwards of 60 percent of antidepressant prescriptions, according to the Amer-ican Psychiatric Association. “There is a pressure to have treatments that are perceived as faster or more efficient,” says Dr. Robert Michels, chief of psychiatry at Cornell Medical College.

Drug companies are understandably eager to help physicians identify conditions that can be treated with their products. One widely distributed diagnostic checklist, a 15-minute test that promises to screen for 17 different disorders using special software, was developed by GlaxoSmithKline. Pfizer has funded a test designed to help obstetricians and gynecologists identify women with mental-health problems. According to a 2000 study, sponsored by Pfizer and published in the American Journal of Obstetrics, a full 20 percent of all ob-gyn patients may need psychiatric treatment for anything from depression and anxiety to eating disorders.

Most of all, though, pharmaceutical makers seek to build word of mouth about a condition in the general public-the kind of water-cooler buzz that prompts people to ask their doctor about a disease, and the drug that might treat it. To that end, corporations have increasingly embraced patient organizations that work to publicize mental illness. One such group is the National Mental Health Awareness Campaign, created two years ago to eliminate “the fear and shame that is still strongly associated with mental disorders.” The organization is particularly concerned with teenagers, and has run several ads on mtv that encourage unhappy youths to call a toll-free number or visit its Web site. A couple of weeks after the September 11 terrorist attacks, it released the results of a survey, which found that 30 percent of adults questioned felt their mental health had worsened since the tragedy. The group’s press release urged “parents and children traumatized by the recent terrorist attacks to avail themselves of the opportunity to speak to mental health professionals.”

The campaign’s brochures say it has received financial support from the Surgeon General’s office. The organization is less forthright about its ties to FoxKiser, a pharmaceutical lobbying firm whose clients include Bristol-Myers Squibb and AstraZeneca. Michael Waitzkin, a partner at FoxKiser, is on the campaign’s board of directors, and until recently the campaign was headquartered in FoxKiser’s Washington office. (It now operates from the office of the P.R. firm Health Strategies Consultancy.)

The National Mental Health Awareness Campaign wasn’t the only group to step up its profile in the wake of the attacks. On September 26 the PTSD Alliance-the group headquartered in the offices of Pfizer’s P.R. agency, Chandler Chicco-issued a statement warning that post-traumatic stress can affect anyone who has “witnessed a violent act” or experienced “natural disasters or other unexpected, catastrophic, or psychologically distressing events such as the September 11 terrorist attacks.” During the following month, according to the trade jour-nal Psychiatric News, Pfizer spent $5.6 million advertising the benefits of Zoloft in treating PTSD-25 percent more than it had spent, on average, from January to June.

But the biggest presence in TV drug advertising after September 11 was GlaxoSmithKline, which in October 2001 spent $16 million promoting Paxil-more than it had spent in the first six months of the year combined. In December, the company rolled out a series of new commercials, often broadcast during prime-time news programs and built around lines such as “I’m always thinking something terrible is going to happen” and “It’s like a tape in my mind. It just goes over and over and over.”

In their search for new uses, SSRI makers are no longer limiting themselves to disorders with chiefly psychological symptoms. In the March 15 issue of the Journal of Clinical Oncology, Mayo Clinic researchers funded by Eli Lilly reported that Prozac “is a realistic alternative to estrogen replacement for reducing hot flashes” in menopausal women. A recent study at the University of Pennsylvania, funded by the pharmaceutical companies Aventis and Novartis, indicated that SSRIs can decrease the risk of heart attack in smokers.

But by far the most controversial addition to the list of maladies treatable with SSRIs is a condition whose very existence is in dispute: premenstrual dysphoric disorder (PMDD), a female ailment whose symptoms include sharp monthly mood swings and physical pain. PMDD has been listed since 1987 in the Diagnostic and Statistical Manual appendix, which catalogs potential disorders “proposed for further study.”

According to Paula J. Caplan, a psychologist and visiting scholar at Brown University who was a member of a DSM committee that evaluated research on PMDD, proponents of including the condition “claimed they were so careful in defining it that it wasn’t just going to be someone with cramps during their period. But they were talking about 3 to 5 percent of [menstruating] women. If you do the math as conservatively as possible, 3 to 5 percent gives you one and a half million women [in the United States].” Caplan resigned from the committee before it voted to list PMDD in the appendix.

Though the condition remains controversial in the medical profession-one 1992 study found that men and women suffered from PMDD’s symptoms at almost the same rate-its inclusion in the DSM proved a god-send for Eli Lilly, the manufacturer of Prozac. In 2000, the company gained FDA approval to market Prozac as a treatment for the condition; Eli Lilly promptly re-packaged Prozac as a pink-coated pill called Sarafem and launched a P.R. campaign warning that “millions of menstruating women” suffer from PMDD. “Does juggling work, family and personal commitments leave you feeling frazzled and stressed out?” the Sarafem Web site asks. “We have some tools to help.”

The idea of characterizing uncomfortable menstrual symptoms as a mental disorder troubles Caplan, who wonders where the medical community will draw the line. “I could say to you, ‘Well, your propensity to call people and ask them probing questions is a disorder,’” she says. “‘We’ll call it intrusive exploratory disorder.’”

No such malady is yet listed in the DSM. But the quest for new uses for the SSRIs is continuing. At last year’s annual convention of the American Psychiatric Association, researchers presented a major study on a new “hidden epidemic”-compulsive shopping. Jack Gorman, the Columbia psychiatrist who had earlier helped publicize anxiety disorders, made another appearance on Good Morning America to discuss the new condition, which host Charles Gibson told viewers could affect as many as 20 million Americans, 90 percent of them women. In the wake of the new study, Gorman said, scientists would “almost certainly” look into treating the disease with SSRIs.

The study in question was funded by Forest Laboratories, for which Gorman has served as a consultant. A laggard in the SSRI business, the company hopes to carve out the compulsive-shopping niche for its pill, Celexa. Expect the publicity machine for something akin to “persistent purchasing disorder” to rev up soon.

Go to this PDF and scroll to the last page (28) to read this email from Emory psychiatrist Zachary Stowe to GSK (http://www.box.net/shared/cl96iq53eb). Here’s a relevant excerpt:

Hi ____

DAMN IT – just wanted to let you know the amniotic fluid results are now complete for about 20 subjects (4 on paroxetine <2, <2, <2, 3 ng/ml) certainly lower than the others but lost my title of paroxetine undetectable in amniotic fluid. She was taking 60 mg/day+other medications. This is still the least. I will have the manuscript to you for review right after I finish grant stuff.

Zachary “DAMN IT” Stowe loses his title of “paroxetine undetectable in amniotic fluid.” That’s right, he was writing a manuscript called “paroxetine undetectable in amniotic fluid.” He had the title all picked out before even doing the research. And from the looks of this there were potentially other women tested prior to this batch of 20, who had amniotic fluid with higher concentrations of some kind of psychotropic drug.

And, in case you missed it, GSK reviews his scientific papers before he publishes them. Oh, and he’s getting FEDERAL grants to study antidepressants in pregnant women. MOTHERS Act, anyone?

Earlier on in the letter, Grassley refers to a disturbing memo regarding a Paxil and Breast Milk press release. According to this blog, it went something like this:

Meanwhile, Stowe outlined some dealings with Glaxo in a deposition last year taken as part of a lawsuit claiming that Paxil isn’t safe for pregnant women. Stowe was questioned in detail about a 2000 email from an outside public-relations firm to a marketing executive at Glaxo about a planned press release for a new study. The study, conducted by Stowe, found Paxil is safe for breast-feeding mothers. The PR firm’s email to Glaxo reads:

Please review the attached press release and forward me any comments/edits. As you may know, Dr. Stowe is on board for publicity efforts and Sherri and I are coordinating time to meet with him next week to arm him with key messages for this announcement, which is slated for early February. We are sending the release for his review at the same time in efforts to secure distribution on Emory letterhead (as you know, would provide further credibility to data for the media).

In the deposition, Stowe said the quotes in the press release were his own. “They wrote it, we said it,” Stowe said of the involvement of the public-relations agency. As for the assertion by the PR official that Stowe was being provided with “key messages,” the psychiatrist called that “just typical public relations crap” and he said in the deposition he never received help from the PR officials.

I found numerous reports in the MedWatch tables of an Adverse Event that included Drug Exposure Via Breast Milk for Paxil. These included sedation and “hypersomnia.” The SIDS report in the tables for Paxil was “Drug Exposure Via Pregnancy” and “Drug Exposure Via Breast Milk.”

FDA MedWatch Reports show the following infant deaths from SSRIs alone:

From http://www.margaretsoltan.com/?p=13846

Zachary Stowe: I WANT MY MONEY

Professor Zachary Stowe of Emory University wants his money, and he wants it now.

An enthusiastic salesman for Glaxo drugs, Stowe spends a great deal of time giving pitches to various audiences. He doesn’t just say things Glaxo wants to hear; he writes them.

“Dr. Stowe is on board for publicity efforts,” writes a public relations person to Glaxo about a press release. “We [want] to secure distribution [of research results] on Emory letterhead — as you know, [this will] provide further credibility to data for the media.”

Stowe loves the money; Glaxo loves the credibility Emory’s letterhead brings. A perfect relationship, undisclosed to Emory, of course…

Actually, not entirely perfect. Tension occasionally flares between the parties when one or another of Stowe’s promotional talks has to be canceled. Stowe’s policy when this happens is to demand payment in full anyway. He’s an important man. If he’d known the thing would be canceled, he could have made a lot of money at other sales events. He and his Emory letterhead are very much in demand.

Senator Grassley attaches to his latest letter to Emory about its enterprising psychiatry professors a series of emails Stowe wrote demanding payment for canceled events.

Email #1: What provisions do you propose for my compensation for the lost time? …. GSK… should cover the cost of the trip as well.

Email #2: I am willing to discuss… renumeration [sic] for a single talk ($2,500) rather than the two scheduled.

Email #3: [Same idea. Still no response.]

Email #4: Now that I have had to invest the time to find some resolution to this problem, I am no longer in a compromising mood. [Now you owe me] $4,500.

Email #5: I do not want to be a prick, but given the time and frustration, [you] should pay me for both talks.

Second Emory doc reveals conflicts

…documents are soon to be released indicating that AstraZeneca, maker of Seroquel, was instructing its own drug reps to promote the drug as causing “less suicidal ideation than Risperdal or Zyprexa.” “Less suicide ideation” is not exactly a safety-standard that a reputable drug maker should be asking its staff to repeat.

Visit the blog on Psychology Today of Dr. Christopher Lane, author of Shyness: How Normal Behavior Became an Illness, to read this story about the courageous work of Mary Weiss in the wake of her son’s forced participation in a Seroquel study at the University of Minnesota, and his resulting suicide:

http://tinyurl.com/ldvsar

Please go to the story on Psychology Today and participate in the discussion. We have archived the story here.

Is Congress Ignoring Unintended Consequences?

by Jillian Bandes

Julie Edgington was pregnant for six weeks before she realized that she just wasn’t comfortable taking Paxil while she was expecting.

“But by then it was too late,” she said.

Edgington said that her son Manny, now 5, had developed a heart defect – almost fatal – that was the direct result of her taking Paxil, part of a class of drugs called SSRI inhibitors. Since he was born, Manny has undergone 6 surgeries, and will have heart problems for the rest of his life.

Edgington is now part of a campaign against a bill recently passed by the House but stalled in the Senate called the Melanie Blocker Stokes Act, or Mothers Act, which calls for increased visibility and treatment of postpartum mental conditions. She says the bill will encourage mothers like her to start on psychiatric medications without being aware of the potentially deadly consequences.

“There is a lot of connection between Paxil, or SSRIs, and heart defects,” she said. “There’s no wording in the bill that says the pills they may give out might cause birth defects.”

The Mothers Act has fanned the flames of the anti-psychiatry movement, particularly as it applies to the administration of psychiatric medications before, during and after pregnancy. Those against the legislation, like Edgington, consist of a legion of doctors and activist mothers, who are opposed by at least an equal number of doctors and activists who say Mothers Act addresses a critical women’s health issue.

“[The bill] is a very simple thing – it’s about funding more research and services so we can do a better job of caring for these women,” said Catherine Stone, a mother who supports the legislation. “The whole idea that this bill advocates a specific treatment or funds a specific treatment – its just not there.”

Stone suffered from postpartum obsessive compulsive disorder after the birth of her son and was prescribed an anti-depressant that she said provided immeasurable support.

“We need to make sure all women have access to the right care,” said Stone.

The Mothers Act specifically calls for the Secretary of Health and Human Services to “provide education and services with respect to the diagnosis and management of postpartum conditions” and designates 3 million dollars in the federal budget to achieve those goals. Specifically, grants would be handed out to entities that carry out “projects for the establishment, operation, and coordination of effective and cost-efficient systems for the delivery of essential services to individuals with a postpartum condition and their families.”

Critics say these grants represent a free pass for drug companies to launch campaigns that will get mothers hooked on psychiatric medications, leading to a windfall in profits. They also say that the awareness component amounts to nothing more than a free advocacy campaign for the drug lobby.

“The groups that will be getting grants through this programs don’t warn mothers they way they need to. They don’t talk about the risk with the drugs, and downplay every kind of risk that exists,” said Amy Philo, who was hospitalized after giving birth to her first child – which she says was the result of her being prescribed Zoloft. “They try to pretend like they’re not pushing drugs when they really are.”

Sen. Robert Menendez (D-N.J.), a cosponsor of the Mothers Act, says the bill’s origins are benign. When he first introduced the bill, he highlighted its emphasis on education and early treatment in an area that’s currently underfunded.

But Sen. Tom Coburn (R-Okla.), a doctor, opposes the bill and says that he will try and block it if there is a move to pass it out of the Committee on Health, Education, Labor and Pensions, of which he is a member. Coburn objects because it’s disease-specific and because different government agencies are already working on these issues.

“Any time Congress does something there’s unintended consequences, that’s why its important to let scientists drive the research instead of politicians,” said a spokesman for the Senator.

More Republicans than Democrats are lining up against the Act, which Stone thinks is a tragedy.

“I realize it may seem odd for someone who is a Republican to personally endorse a bill that would involve the government in a medical issue,” said Stone. “But we can’t get funders outside of the government to pay attention, so perhaps the Melanie Blocker Stokes Act could jump start that and then the market will follow.”

Read the story and post your comments on the Townhall site by going here.

ALLIANCE FOR HUMAN RESEARCH PROTECTION
A Catalyst for Public Debate: Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org

FYI

The FDA’s expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent. FDA officials are ignoring the real world tragedies–drug-induced deaths of children. Unfortunately for the children, child psychiatrists in particular are noted for irresponsibly prescribing high doses of the most toxic drugs in pharmacopoeia for young children who do not have a valid medical condition, much less a life-threatening illness that would justify the magnitude and scope of risks posed by these drugs, singly and in untested combinations.

The latest child casualty reported by the press, is four-year-old, Destiny Hager, who was prescribed two highly toxic antipsychotic drugs–quetiapine (Seroquel) and ziprasidone (Geodon)–since age three.

The Topeca Capital Journal reports that an X-ray revealed the child’s colon was blocked – a known side effect of Seroquel and Geodon.

An autopsy confirmed that the child died of fecal impaction and had “antipsychotic drugs present in concentrations considered therapeutic in adults.”  Destiny Hager weighed 38 lbs.
http://www.cjonline.com/news/state/2009-06-06/child%E2%80%99s_death_a_tragic
_destiny

This week, on June 9-10, an FDA advisory panel will be considering applications for expanded approval of highly toxic antipsychotics for use in children aged 10 to 17.  The drugs under consideration are:  Seroquel (AstraZeneca), Zyprexa (Eli Lilly) and Geodon (Pfizer).

Rather than focus on protecting children’s safety,  FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children–thereby ensuring that far greater numbers of children will be victimized and die.

FDA has already approved Johnson & Johnson’s antipsychotic Risperdal for use as a chemical restraint to curb aggression in autistic children without a public hearing–and despite the J & J’s withdrawal of its application in the
UK, after the British panel required rigorous medical monitoring of children prescribed risperdone (Risperdal). FDA officials have also approved (aripiprazole) (Abilify), manufactured by  Otsuka Pharmaceutical and Bristol-Myers Squibb (BMS) to treat manic and mixed episodes associated with bipolar I disorder in pediatric patients ages 10-17.

It should be underscored that the diagnoses, schizophrenia and bipolar in children are highly controversial–indeed, pediatric bipolar is not recognized elsewhere in the world and there is evidence uncovered during litigation by the US Attorney strongly suggesting that prominent US academic child psychiatrists promoted both the diagnoses and antipsychotic drugs while receiving considerable cash payments from these drugs’ manufacturers.

[Below, an EXCELLENT Op Ed in NEWS BLAZE cites some of the recently uncovered corrupt practices that should have precluded FDA from even considering expanding market approval for these drugs.]

Most troubling are confirmatory preliminary scientific findings about the rapid onset of severe hazards these drugs pose for children. Alarmed by their findings, researchers reported them at the American Psychiatric Association meeting (below)

Beyond acute weight gain, the researchers reported: “Atypical Antipsychotics Linked to Rapid, Adverse Metabolic Changes in Children.”

In just 12 weeks “the entire group of children exposed to one of the antipsychotic drugs exhibit “striking changes in [metabolic] parameters.”

“These preliminary results suggest that weight gain is associated with a significant decrease in insulin sensitivity.”
http://www.medscape.com/viewarticle/703831

Reuters and The Wall Street Journal quote from a May 8 memo to the advisory committee by Dr. Thomas Laughren, the agency’s director of the FDA’s psychiatric product division:   ”We generally are in agreement that the sponsors have provided adequate support to suggest effectiveness.”

While acknowledging that the risks posed by these drugs are “of particular concern in pediatric patients because of the life-long nature of these disorders.”

Dr. Laughren couched his directive to the advisory committee in “forked tongue” fashion acknowledging concern for safety issues, but hedging on the lack of proof of efficacy. He retreated from evidence for concern by claiming the risks for children appeared “to be qualitatively similar to those observed” with adults.

If approved, these exceedingly toxic drugs will be widely prescribed for children whose misbehavior will condemn them to the drugs’ irreversible hazards.

Question: What are FDA’s medical, scientific, or moral standards for considering approval of demonstrably toxic drugs for use in otherwise physically healthy children who would be irreparably harmed by these drugs?

A concern not acknowledged by the FDA nor ever considered by psychopharmacologic advisory panels is the fact that there is a cumulative incremental danger posed by  these drugs’ multiple severe, adverse, disabling, life-shortening health hazards–including diabetes, metabolic syndrome, and cardiovascular disease and sudden death.

The negative risk / benefit ratio is acknowledged by Dr.Thomas Insel, Director of the National Institute of Mental Health, who recommends precaution:
“With current antipsychotics you risk either metabolic side effects or neurological side effects. Sometimes these
potentially serious risks are worth the benefit, but in children the balance needs to favor minimizing risks.”

Question: What are FDA’s medical, scientific, or moral standards (if any) for considering approval of demonstrably toxic drugs whose hazards are disabling and life-shortening, for use in otherwise physically healthy
children who would be irreparably harmed ?

Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974

http://blogs.wsj.com/health/2009/06/05/fda-sees-benefits-risks-in-antipsychotics-for-children/tab/print/
WALL STREET JOURNAL
June 5, 2009

FDA Sees Benefits, Risks in Antipsychotics for Children

Child taking pillPowerful antipsychotics currently used to treat adults for
schizophrenia and bipolar disorder appear to be effective in treating
children and teens as well, though there are serious risks associated with
the medicines, according to documents put out by the FDA staff today.

AstraZeneca’s Seroquel, Eli Lilly’s Zyprexa and Pfizer’s Geodon are all
being considered by the FDA for use in children. A panel of outside experts
will meet next week to discuss the risks and benefits of these medicines for
use in children and make a recommendation to the FDA.

Though they work at combating serious symptoms such as delusions and
hallucinations in schizophrenia, or severe mood swings associated with
bipolar disorder, the drugs also appear to induce weight gain and
sleepiness, according to Dow Jones.

“These risks are of particular concern in pediatric patients because of the
life-long nature of these disorders,” wrote Thomas Laughren, director of the
FDA’s psychiatric product division, in a memo.

Recent studies of effectiveness have shown that the antipsychotics aren’t as
good as previously believed. “They reduce some symptoms for some people but
they help too few people recover,” Thomas Insel, director of the National
Institute of Mental Health, wrote in an email to the Health Blog. “We really
need a new generation of compounds that will target the full range of
problems in serious mental illness.”

Insel said using antipsychotics in children is a “tough balance” between the
risk vs. the benefits of the medicines. “With current antipsychotics you
risk either metabolic side effects or neurological side effects,” he wrote.
“Sometimes these potentially serious risks are worth the benefit, but in
children the balance needs to favor minimizing risks.”

Currently only two antipsychotics, J&J’s Risperdal and Bristol-Myers’s
Abilify, are approved for use in children.

Copyright 2008 Dow Jones & Company, Inc. All Rights Reserved
~~~~~~~~~~~

NEWS BLAZE
April 16, 2009
Op-Ed Contributor

Is the FDA Bipolar?
By Martha Rosenberg

In February the Justice Department charged Forest Laboratories with
illegally marketing antidepressants Celexa and Lexapro to younger patients
and burying a study that showed suicidal side effects in children. But the
next month the FDA approved Lexapro for depression in adolescents 12 to 17.

In March the Justice Department charged AstraZeneca with knowing and hiding
the diabetes side effects of Seroquel. But this month the FDA considers
expanding the antipsychotic’s approvals to depression and anxiety.

And in January, Eli Lilly pled guilty to promoting its antipsychotic Zyprexa
for unapproved and dangerous uses in a $1.4 billion settlement. But in March
the FDA approved Lilly’s Zyprexa/Prozac combo, Symbyax for treatment
resistant depression (TRD). What do you get when you cross Zyprexa with
Prozac? Someone who gains 100 pounds and feels great about it!

“TRD” is such a new pharma invention it googles as Toyota Racing
Development and Teacher Recruitment Days. But it will soon move ’script like
GAD (general anxiety disorder), MDD (major depressive disorder) ADD
(attention deficit disorder) RLS (restless legs syndrome) GERD
(gastroesophageal reflux disease) and PMDD (Premenstrual dysphoric
disorder)-and for the same reasons.

Of course FDA drug approvals are only as good as the studies. Which is the
problem.

Forest paid Massachusetts General Hospital’s Jeffrey Bostic, MD $750,000 to
chat up Celexa and Lexapro according to US District Court in Boston filings.
AstraZeneca paid University of Minnesota Charles Schulz, MD $112,000 to push
Seroquel according to US District Court in Orlando filings. And a decade of
pain “studies” conducted by Baystate Medical Center’s Scott S. Reuben, MD on
Vioxx, Lyrica, Celebrex and Effexor were completely fabricated-including the
patients say published reports.
And speaking of “made up, Coast IRB, an institutional review board which
oversees some 300 clinical trials and 3,000 researchers agreed last year to
approve a human trial for “Adhesiabloc,” a surgical gel which Congress and
the Government Accountability Office completely made up in a sting
operation. Oops.

And let’s not forget Joseph your-child-is-bipolar Biederman, MD at Harvard
who assured benefactor Johnson & Johnson his studies would have pro
Risperdal results according to the New York Times-in advance of doing them.
(Why leave things up to science?)
And Charles “Paxil” Nemeroff, MD who was forced to step down in December as
psychiatry chairman at Emory University thanks to unreported GlaxoSmithKline
income of up to $800,000.

And the pharma funded studies continue!
Last May a pro Lexapro article, “Escitalopram and Problem-Solving Therapy
for Prevention of Poststroke Depression,” ran in JAMA, the Journal of the
American Medical Association, with no mention of financial ties author
Robert G. Robinson, MD has to Forest.

Why was, “a researcher with a history of being funded by SSRI makers…given
a forum in the national media to tell the general public that anyone who has
had a stroke, whether or not they have been diagnosed with depression,
should start a prophylactic regimen of Lexapro…even though non-medical
approaches perform just as well,” wrote Jonathan Leo, PhD, Associate
Professor of Neuroanatomy at Lincoln Memorial University in the British
Medical Journal in March.
And then there’s AstraZeneca’s “studies.”

Seroquel is linked to high blood sugar, weight gain, diabetes, cholesterol
and triglycerides abnormalities, sudden cardiac death, suicide, Iraq war
veteran deaths and the tardive dyskinesia it is supposed to prevent.

But its “safety” was established by a different kind of chemistry.

Research director for Seroquel, Wayne MacFadden, was having affairs with two
women responsible for Seroquel studies say court documents: a researcher at
the Institute of Psychiatry in London and a ghostwriter at Waltham, MA-based
medical communications firm Parexel.

The studies upon which the FDA approved Seroquel for bipolar disorder-called
“Bolder” I and II-were written by a ghostwriter, possibly accelerated by a
motel room. And seated on the FDA’s Psychopharmacologic Drugs Advisory
Committee at the time was Jorge Armenteros, MD, who has been a paid
AstraZeneca speaker for five years according to the Philadelphia Inquirer.

He now heads the committee as the FDA considers expanding Seroquel approvals
to include depression and anxiety this month-and to children in June.

Hopefully FDA will keep some Seroquel for itself.

Martha Rosenberg is a columnist and cartoonist, who writes about public
health

Copyright C 2009, NewsBlaze, Daily News

THE WALL STREET JOURNAL
JUNE 5, 2009
FDA: Adult Antipsychotic Drugs Effective In Children
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES

WASHINGTON (Dow Jones)–Food and Drug Administration staff said Friday three
drugs currently approved to treat bipolar disorder and schizophrenia in
adults were effective at treating the disorders in children and adolescents,
but carry “significant risks.”

The agency is considering applications for AstraZeneca PLC’s (AZN) Seroquel
and Eli Lilly and Co.’s (LLY) Zyprexa to treat bipolar disorder and
schizophrenia in children and adolescents, and Pfizer Inc.’s (PFE) Geodon to
treat bipolar disorder in children 10 to 17. An FDA panel of outside medical
experts is scheduled to meet to discuss the drugs next Tuesday and
Wednesday. The panel is being asked to vote on whether each product is safe
and effective for children ages 10 to 17.

The FDA as well as the companies said studies showed the products were
effective at treating the symptoms of bipolar and schizophrenia, but the
drugs all had side effects that included sedation and weight gain. Reviews
of the products were posted on FDA’s Web site Friday.

“These risks are of particular concern in pediatric patients because of the
life-long nature of these disorders” said Thomas Laughren, director of the
FDA’s psychiatric product division, in a memo.

The concern with weight gain seen with most antipsychotic drugs whether it
causes additional problems like diabetes and cardiovascular disease.

The FDA said all three products are already being used in children even
though they aren’t approved. Approved products include Risperdal, by a unit
of Johnson & Johnson (JNJ), and Abilify by Bristol-Myers Squibb Co. (BMY)
and Otsuka Pharmaceutical Co., Ltd, the agency said.

The FDA asked each company to look at which side effects were more commonly
seen in children compared to adults who were studied in clinical trials.

Lilly said clinical studies of Zyprexa showed the product was associated
with greater weight gain and changes in blood lipid parameters than seen in
adults using the product.

The company is seeking FDA approval of Zyprexa as a second-treatment for
children and adolescents, meaning that other products should be tried first.
Zyprexa is Lilly’s top-selling drug with $4.7 billion annual sales in 2008.

AstraZeneca said side effects that occurred more frequently in children
compared to adults on Seroquel included increases in blood pressure and
increased appetite. The company also said incidences of certain movement
side effects such as tremors were higher among patient taking Seroquel
compared to patients in placebo groups, or patients not taking the drug.
Seroquel is AstraZeneca’s second-best selling drug with $4.45 billion in
sales in 2008.

Pfizer said children taking Geodon were more likely than adults to report
feeling sleepy, or sedation. The company said the drug didn’t have a big
impact on weight gain with 7% of people taking Geodon experiencing a 7% or
greater gain in weight compared to 4% in the placebo group. The company also
said the drug didn’t increase metabolic markers such as cholesterol.

Schizophrenia afflicts about 1% of Americans. According to the National
Institute of Mental Health, people with schizophrenia may hear voices other
people don’t hear or they may believe that others are reading their minds,
controlling their thoughts or plotting to harm them. The disorder is also a
cause of suicide and is typically diagnosed in a person’s late teens or 20s.
Bipolar disorder also known as manic-depressive illness, is believed to
affect about 1% to 3% of the population, and is characterized by unusual
shifts in mood, energy and activity levels. There’s evidence that bipolar
disorder in children is more severe than typically seen in adults.

- By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
~~~~~~~

http://www.medscape.com/viewarticle/703831
Medscape Medical News
APA 2009: Atypical Antipsychotics Linked to Rapid, Adverse Metabolic Changes
in Children
Caroline Cassels

June 3, 2009 (San Francisco, California) – Early findings from a study
looking initial exposure to atypical antipsychotics in children show that
concurrent with significant improvement in behavioral symptoms, including
severe aggression, irritability, and disruptive behavior across multiple
childhood-onset psychiatric disorders, these medications are associated with
rapid, adverse metabolic changes.

Presented here at the American Psychiatric Association 162nd Annual Meeting,
preliminary results from the Metabolic Effects of Antipsychotics in Children
(MEAC) study show that 12 weeks of initial antipsychotic treatment was
associated with significant mean increases in overall adiposity and
percentage of body fat, as well as a decrease in whole-body insulin
sensitivity.

Further, the investigators found antipsychotic treatment was also linked to
significant increases in body-mass index (BMI) percentile and fasting plasma
triglyceride levels, both clinically available indicators of adverse
metabolic changes associated with increased adiposity.
Dr. Ginger E. Nicol

“The reason we wanted to present these preliminary results is that we saw
such striking changes in these [metabolic] parameters in the entire group of
patients. Weight gain is something that many of us see clinically with these
medications in our pediatric patients, and it is of great concern. However,
these preliminary results suggest that weight gain is associated with a
significant decrease in insulin sensitivity,” study investigator Ginger E.
Nicol, MD, from Washington University School of Medicine, in St. Louis,
Missouri, told Medscape Psychiatry.

A 5-year study funded by the National Institute of Mental Health (NIMH),
under the direction of John Newcomer, MD, from Washington University School
of Medicine, MEAC’s purpose is to quantify antipsychotic treatment-related
changes in adiposity and insulin sensitivity in antipsychotic-naive children
and adolescents with irritability, aggression, and disruptive behaviors,
which are common presenting symptoms for many mental disorders in this
population.

Study subjects included children age 6 to 18 years with Aberrant Behavior
Checklist (ABC) irritability subscale scores of more than 18 who were
randomized to 12 weeks of open-label treatment with olanzapine (Zyprexa,
Lilly), risperidone (Risperdal, Janssen), or aripiprazole (Abilify,
Otsuko/Bristol-Myers Squibb).

“We used 18 as the cutoff score on the ABC irritability subscale because it
is consistent with what has been used in other antipsychotic-treatment
studies of irritability and aggression. Many of these children are very
physically aggressive and as a result have frequently been suspended from
school or are on the verge of hospitalization,” said Dr. Nicol.

The MEAC study seeks to enroll only children in whom other approaches have
failed and who are already under clinical consideration for antipsychotic
treatment.

Children are screened for a variety of potential diagnoses that have
associated symptoms of aggression and irritability, including depression and
attention-deficit/hyperactivity disorder (ADHD), that may have previously
gone undetected or were inadequately treated. In such cases, patients are
referred back to their primary clinician with recommendations to pursue
appropriate first-line treatments.

“The risk/benefit ratio is very carefully considered for each individual
participant in terms of whether they are likely to derive benefit from being
placed on an antipsychotic,” said Dr. Nichol.

Treatment-Naive Population

Following randomization to 1 of the 3 study medications, subjects received
weekly monitoring and scheduled assessments to detect any metabolic change.
The study’s primary end points include measures of body composition with
dual-energy X-ray absorptiometry (DEXA), abdominal magnetic resonance
imaging (MRI), and insulin sensitivity with stable isotopomer tracing during
hyperinsulinemic-euglycemic clamp conditions.

According to Dr. Nicol, MEAC is 1 of the first studies to look at a
treatment-naive pediatric population and is the only study in children
taking antipsychotics to date that is using gold-standard measures of
adiposity and insulin sensitivity.

The preliminary pooled-groups analysis of the first 57 study completers
revealed that 12 weeks of initial antipsychotic treatment was associated
with significant mean increases from baseline in DEXA total fat (2.74 kg)
and DEXA total percent body fat (2.97%),  with an associated mean decrease
in whole-body insulin sensitivity.

Similarly, change in clinically available indicators of adiposity and
insulin sensitivity were also observed, with significant increases in BMI
percentile of 14.8 percentile points and a mean increase in fasting plasma
triglycerides of 18.1 mg/dL.

In a positive light, the study also showed treatment with antipsychotics was
associated with marked reductions in the ABC irritability score, with a mean
drop of 15.37 points.

Study Sheds New Light on Everyday Problem

Asked by Medscape Psychiatry to comment on the study, Lawrence Maayan, MD,
an expert in the metabolic effects of psychotropic medications and treatment
and evaluation of pediatric psychosis, said these early findings shed new
light on the metabolic effects of these medications in children – a problem
that child psychiatrists “see every day.”

“There have been findings from randomized controlled trials showing these
agents cause weight gain, especially with risperidone and olanzapine, but
this study really looks at this group [of agents] broadly and has a number
of different features that haven’t been looked at in children previously,”
said Dr. Maayan, director of outpatient research at the Nathan S. Kline
Institute for Psychiatric Research at New York University.

Dr. Maayan said he looks forward to the final study findings, which will
demonstrate whether there are differences between the 3 agents in terms of
their adverse metabolic effects.

“Certainly there are good data out there showing that olanzapine is most
likely to cause weight gain in susceptible individuals; risperidone seems to
be somewhere in the middle, although it appears it is more likely to cause
weight gain in kids; and the picture for aripiprazole is not clear. But to
have a study like this that is NIMH-funded that really looks at this
question will be very valuable, whatever way it comes out,” said Dr. Maayan.

A number of studies have tested potential interventions to help offset the
metabolic effects of these medications. These include behavioral
interventions that run the gamut of cognitive behavioral therapy to
nutrition counseling, most of which do appear to have at least a modest
effect on weight gain.

Other studies have shown pharmacological interventions, including the use of
the oral antidiabetic agent metformin, can help slow weight gain. Dr. Maayan
said in his own practice he routinely counsels children taking
antipsychotics about the value of exercise and healthy eating choices.

Dr. Nicol reports no disclosures.

American Psychiatric Association 162nd Annual Meeting: Abstract NR5-030.
Presented May 19, 2009.
Authors and Disclosures

Journalist Caroline Cassels is the news editor for Medscape Psychiatry. A
medical and health journalist for 20 years, Caroline has written extensively
for both physician and consumer audiences. She helped launch and was the
editor of Health Digest, an award-winning Canadian consumer health
publication. She was also national editor of the Heart & Stroke Foundation
of Canada’s Web site before joining Medscape Neurology & Neurosurgery in
2005. She is the recipient of the 2008 American Academy of Neurology
Journalism Fellowship Award. She can be contacted at CCassels@webmd.net.

Medscape Medical News C 2009 Medscape, LLC
Send press releases and comments to news@medscape.net.
~~~~~~~~~~~~~~~