TIME Magazine Retracts False Statement about Amy Philo (yes, that’s me)

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UPDATE:

Today, July 12, TIME made the correction online. It still has the part that implies I had PPD, which is something that other reporters have said before even though I have never said I had PPD. I had anxiety, normal for the situation. Later I had Zoloft-induced psychosis. I call it PPZ.

I don’t think that part is as important as the timing of the dangerous thoughts and hallucinations so I am letting that part go. However I find it strange that psychiatrists have managed to label reasonable fear and protectiveness as part of a mental illness.

The corrected version states, “Her son recovered, but after the incident, Philo became preoccupied with his safety and felt severe anxiety about protecting him — a common symptom of PPD.” The bottom of the article also states,  “The original version of this article stated that after Amy Philo’s newborn suffered an accidental choking incident, Ms. Philo’s preoccupation with his safety included fear of hurting her baby herself. However, Ms. Philo notes that that particular feeling did not intrude until later, after she began taking antidepressant medications.”

Since the incorrect version will be in print I would appreciate it if people could spread the word about the online version and the correction.

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Here’s the ORIGINAL blog entry titled “Time Magazine to Retract False Statement about Amy Philo…” published last night:

First of all, I would just like to preface this post with a statement that I do not feel that the false statement written about me was a malicious statement or reckless mistake by the reporter. I think it was an honest mistake, and perhaps one that anyone could make. I had hoped to just wait for the correction and post the TIME article, “The Melancholy of Motherhood” on this blog as soon as it was fixed. But in order to set the record straight and hopefully minimize potential rumors and misunderstandings, I decided I needed to write about it here as soon as possible. Unfortunately, the magazine has already gone to print, and will be sitting in millions of doctor’s offices, spas, libraries, and living rooms within days. However, according to Catherine Elton, who wrote the article, the online version was supposed to be corrected last night. It’s not fixed yet so I am assuming for now that the editor is just not checking email on the weekend. The issue is the July 20 issue, so you may not have yet seen the article but it is available online.

Overall I was pleased that TIME chose to pay attention to some of the most important problems with The MOTHERS Act and I thought that Catherine Elton did a nice job on this.

However, the false statement written about me was that I had fears that I might hurt Isaac, and then I got put on Zoloft.

“…[I]ncreased screening could lead to an increase in mothers being prescribed psychiatric medication unnecessarily. That concern lies close to the heart of Amy Philo, 31, of Texas, who has become a leader of the anti-Mothers Act movement. In 2004, shortly after her first son was born, he choked on his vomit and needed emergency treatment. Her son recovered, but after the incident, Philo became preoccupied with his safety and even feared hurting him herself — a common symptom of PPD.“

This could not be further from the truth. As I have written about and spoken about for the past four years (on YouTube, radio shows, TV interviews and even to members of the U.S. Senate), I was prescribed Zoloft mainly because I had a panic attack… as my doctor said, for Post Partum Anxiety, to “prevent” PPD because I was considered “at risk.” I was never “diagnosed” with PPD before going to the hospital at 10 days postpartum (the doctor there wasn’t sure what my diagnosis was, but he thought I might have PPD with psychotic features, rather than a reaction to Zoloft. Nor did he think my problems could have been related to reasonable anxiety in the face of witnessing my child almost die – if you read my story you might remember the peachy retort I was fortunate enough to hear from that same doctor,  “Your baby didn’t almost die.” Instead I was labeled paranoid and told to take my meds if I wanted to go home.).

From days 3-6 postpartum, it’s true that I was very worried about Isaac’s safety. During the time between his life-threatening choking incident at Children’s hospital and the time I was placed on Zoloft I was having trouble sleeping and did have extreme anxiety, which seemed to be getting somewhat better over time, but I was simultaneously overjoyed with my baby and motherhood. I couldn’t have been more protective and more in love with my baby, while at the same time very concerned about keeping him safe. I think they call that being a mom.

I told Catherine Elton about how I was worried about Isaac, but I never stated that I was worried I might hurt him before Zoloft, only after Zoloft was started. I realize that some women have thoughts of hurting their children before going on medication. But I never did. I was very much in the mindset of protector and very traumatized by our close call.

Before I was put on Zoloft, I wanted him in the same room as me at all times. I was afraid to let him out of my sight. I was worried that he might choke on formula, turn blue again or stop breathing. At one point my husband took him downstairs when I was lying in bed, and when I realized that Isaac was not in the room I freaked out, went downstairs, and found him in my mother-in-law’s arms, and started crying as I asked if I could please have my baby back.

When Isaac nearly choked to death at the age of three days, it was only minutes after our arrival at the hospital. He was trying to cry and vomit but couldn’t make a sound. The relief I felt when the partially digested formula finally came out and he finally started crying and breathing was tremendous, but at the same time I was in a state of horrible trauma from nearly losing him, and I knew that if I hadn’t insisted on calling 911 and brought him in, he would have died in his bassinet while we slept, or if we were awake, we wouldn’t have been able to save him ourselves.

The only reason we took him in to Children’s was because I happened to notice him in his bassinet before going to bed, and the skin around his mouth was blue. This alarmed me so I picked him up, and found that he was cold and seemed to have shallow breathing, and his hands and feet were also cold and looked blue. I could not wake him up. I told Joel about it but because Joel saw him breathing he didn’t see why I was worried. I asked my mother-in-law what she thought and she said that she thought something didn’t seem right and it would be better to be safe than sorry. I called 911. They arrived at our house within minutes, but couldn’t determine what might be wrong with him but said he needed to be taken to a hospital. They told us to go back to Children’s which was a 30 minute drive, so he could not be taken by ambulance. They would have had to take him to Mercy Hospital in Coon Rapids which they did not recommend, so they had us drive him to Minneapolis. On the way to the hospital in the car I had a flashlight on him (it was very dark) occasionally just to check his breathing. So you can imagine that when he started choking and turning red and purple and could not cry, and this happened literally within 2-3 minutes after we got to Children’s Hospital, I was a total mess.

Sending a social worker in to talk to a mother (whose baby is hooked up to IVs, breathing and heart monitors in a bed at Children’s) because she has been crying all night is not the best way to put her at ease. Telling a mother to let it go, and just let others feed her baby formula while she sleeps is not the best plan for a mother who has just witnessed her baby almost die from choking on formula.

Putting a mother on a drug to “prevent” PPD because her baby almost died is not even a compassionate thing to do. But modern medicine tells women that any time they have fears or anxiety, that they are “at risk” or that this is a symptom of a disease called PPD. Rather than supporting women in their new roles as protectors and supporting their spirits and physical bodies through tremendous changes and physical exhaustion, we are told we are mentally ill. This is the most sexist, disrespectful and dishonorable possible attitude and it does absolutely nothing to help women or their families. Instead, it puts them in danger, because of the fact that these medications are extraordinarily hazardous and toxic.

I agree with Catherine Elton’s article when she concludes, “Ensuring the proper support of mothers, however — whether that means treating depression or caring for women in their new roles — would require an effort much more ambitious than a single law.” Proper support of mothers would require an ambitious effort indeed. Perhaps some laws – definitely not The MOTHERS Act – but perhaps some laws need to be passed to prevent the wholesale drugging of our most vulnerable. Perhaps people need to rethink their attitudes and learn how to support women as new mothers. It’s a big change that can turn your life upside down. It can be wonderful and scary and exhausting all at the same time. It would indeed take far more than a law to teach people how to do this, and how to stop labeling women mentally ill any time they show emotions. It would take more than a law to put a stop to the drugging of women for “clinical depression” while covering up their real problems whether physical, financial, medical, nutritional, hormonal, emotional, relational, or situational.

Why do I care so much that someone thinks I had thoughts of hurting Isaac before the medication? Because it’s not true. Zoloft did not add to an instability (because I was not unstable), it turned me from a sane but loving mother who wanted nothing more than to protect her baby, into my own worst nightmare. The moment that I hallucinated throwing Isaac down the stairs (after being on Zoloft for 3 days) was almost the scariest moment of my life up to that point. The scariest moment prior to that was watching Isaac nearly die in the hospital several days earlier. But as soon as I was afraid I might actually hurt him, I was so intensely afraid for him that I wanted to kill myself. I thought that was the only way to protect him. It wasn’t out of guilt that I wanted to die. There was guilt, and I didn’t know how I could look in the mirror. I hated myself. But mostly I saw no way out, no way for him to be safe with me around.

As many more days and weeks on Zoloft took their toll and Zoloft-induced psychotic feelings set in, and the thoughts of suicide were overpowered with constant thoughts of homicide, I was less and less bothered by the thoughts of killing my son, then later my husband, mother, cats, neighbors, and then committing suicide.

In essence these drugs can take away your feelings about everything, and give you overwhelming, nonsensical, violent urges. There is no motive for them but they are persistent and frightening.

It’s eerie to me that people chalk this up to Post Partum Depression. We have been so programmed as a society to believe this. I read the PPD bloggers’ stories and while reading so many of them I wonder what it would be like to start out your child’s life like that. It seems mild compared to what I went through. I would trade for that.

Fortunately, although I feel that the first several months of my son’s life outside the womb were almost totally stolen from me, by going off of the Zoloft I got my own soul back. And this is all that I want people to know, because if you’re on drugs that are making you a monster, you can get yours back too.

I wish I could go back in time and not go through what I did. I wish I could somehow reach all these women and help them understand it so they don’t have to go through it too. I wish I could go back and pull the pills from the hands of mothers swallowing them during pregnancy or breastfeeding who would someday lose their babies because of it. But I can’t. I wish I could have started out Toby’s life without people wondering if I was really unstable and about to snap like I did after Isaac was born. I wish I could go through life without knowledge of what it’s like to contemplate killing your baby, or wanting to kill yourself. But all I can do at this point is just tell the truth and hope it helps someone else not have to learn the hard way.

So here is the still-incorrect version of TIME’s article, The Melancholy of Motherhood.

Feel free to link here, to this article, before you link to the TIME article, to help me set the record straight and clear up the misunderstanding that is being sent out all around the country in print, so that people will really understand that it was Zoloft that started me down this road. It’s not as important to me what people think about me as it is that they know the truth before they start swallowing these deadly drugs themselves.

Read the full story here: “Docs blame PPD for the horrors of Zoloft” – http://chaada.org/smf/index.php?topic=15.0

Filed under: Coon Rapids, Isaac Philo, Melanie Stokes, PPD, choking, drug "safety", drugging children, mothers act , Amy Philo, Blocker, Catherine Elton, False, Melanie, Retract, Statements, Stokes, The Melancholy of Motherhood, The MOTHERS Act, TIME, TIME Magazine

Marking 10 Years Since Columbine – Moments of Silence

While dozens of drug pushers and drugged mothers are busy blogging, twittering and calling Congress, and possibly hundreds more pharma grant recipeints or employees do the same to promote The Deadly MOTHERS Act, those who survived Columbine mark the 10 year anniversary of that drug-induced shooting. When you see this please take a moment of silence to honor those who died.

To see Michael Moore discuss Dr. Tracy’s book and the true cause of Columbine which he says he got completely wrong in Bowling For Columbine, go to http://www.drugawareness.org/ or see the full movie, The Drugging of Our Children by Gary Null, Ph.D. at http://video.google.com/videoplay?docid=-3609599239524875493&q=DRUGGING%2BOF%2BOUR%2BCHILDREN

Dr. Tracy and others are holding a press conference in Colorado regarding Columbine today. Stay tuned for updates. Given the frequency of school shootings, this is an urgent matter that our country needs to address.

The Colorado State Department of Education adopted the following resolution when learning about the dangers of drugs that Harris and Klebold were taking which drove them to commit the heinous massacre.

Colorado State Board of Education RESOLUTION Promoting The Use Of Academic Solutions To Resolve Problems With Behavior, Attention, And Learning

Whereas, the Colorado State Board of Education is constitutionally charged with the general supervision of K-12 public education; and,Whereas, the Colorado State Board of Education dedicates itself to increasing academic achievement levels for all students; and, Whereas, the responsibility of school personnel is to ensure student achievement; and, Whereas, only medical personnel can recommend the use of prescription medications; and, Whereas, the Colorado State Board of Education recognizes that there is much concern regarding the issue of appropriate and thorough diagnosis and medication and their impact on student achievement; and, Whereas, there are documented incidences of highly negative consequences in which psychiatric prescription drugs have been utilized for what are essentially problems of discipline which may be related to lack of academic success; Therefore Be It Resolved, that the Colorado State Board of Education encourage school personnel to use proven academic and/or classroom management solutions to resolve behavior, attention, and learning difficulties; and, Be It Further Resolved, that the Colorado State Board of Education encourage greater communication and education among parents, educators, and medical professionals about the effects of psychotropic drugs on student achievement and our ability to provide a safe and civil learning environment. November 11, 1999 On this date, the Colorado State Board of Education passed this resolution by a six-to-one vote.

Filed under: Columbine, drugging children, mothers act , #postpartum, advocate, Bowling for Columbine, Columbine 10 year anniversary, Columbine Massacre, Dylan Klebold, Eric Harris, Gary Null, legislation, Melanie Blocker Stokes, Melanie Stokes, mothers act, perinatal, The Drugging of Our Children, twitter

States focus on limiting psychiatric drugging of kids

States focus on limiting psychiatric drugging of kids

Lawyers and Settlements blog by Evelyn Pringle

The Texas legislature is considering a bill that would require doctors to get prior approval before prescribing atypical antipsychotic drugs like Zyprexa, Risperdal, Invega, Abilify, Seroquel and Geodon to children under 11 who are covered by Medicaid in that state, the Dallas Morning News reported on April 1, 2009.The reports on Texas foster children in recent years provide evidence to support such a bill. For instance, in 2007, the top five most commonly prescribed psychotropic drugs to Texas foster children were Ritalin, Risperdal, Clonidine, Seroquel, and Adderall. These five alone accounted for half of the $37.9 million spent on psychiatric drugs for foster children in 2007, according to a report in the August 17, 2008 Dallas Morning News.

The atypicals are the most expensive psychiatric drugs on the market and children all across the US have become the target of the off-label marketing campaigns of their makers. The cost of these drugs as of April 2009 at DrugStore.com was:  Abilify 10mg 90 tablets $1230, Geodon 60mg 100 capsules $787, Invega 6mg 100 tablets $1168, Risperdal 2mg 90 tablets $716, Seroquel 200mg 100 tablets $839,  and Zyprexa 10mg 90 tablets $1195.

The atypicals are being prescribed more often than antidepressants to children in foster care for everything from ADHD to depression to sleep problems. A report on Texas foster children for the year 2005 has a list of the top ten drugs prescribed to children ages 6 to 12, and Seroquel and Risperdal combined beat out the two antidepressants on the list. There were 1,669 prescriptions for Risperdal and 1,103 for Seroquel, compared to 701 for Zoloft and 712 for Trazodone. In fact, the ADHD drug Ritalin was the only medication prescribed more often than Risperdal. Abilify also made the top ten list with 667 prescriptions.

In the three-year-old toddler age group, Seroquel and Risperdal combined were prescribed 115 times. Risperdal also rated second highest in this age group in 2005.

With infants, age 0 to 2, Risperdal and Seroquel prescriptions had a combined total of 28.

In May 2008, a group of New Hampshire legislators wrote to the state’s attorney general asking for a criminal investigation of the atypical makers after learning about the increasingly large amounts of spending by Medicaid for children on the drugs.

Atypical antipsychotic drugging “of children in the Granite state has skyrocketed from under $300,000 in 2000 to nearly $4 million in 2007,” the letter states.

“As you are likely aware, antipsychotics are psychiatry’s most powerful medications with very little FDA approval for children and include side effects ranging such as early death, diabetes, heart failure, psychosis, permanent muscle spasms and more,” the lawmakers pointed out.

They noted the $515 million civil settlement the DOJ entered into with Bristol-Myers Squibb for illegally marketing Abilify for off-label uses and the settlements between private plaintiffs and Eli Lilly for “causing diabetes in 28,500 people with Zyprexa.”

“Any ordinary citizen would minimally be charged with manslaughter or second degree murder for such criminal negligence,” the letter advised.

“It is very important to take such criminal actions as the civil actions merely appear to be write-offs as business expenses to drug manufacturers in cases like Vioxx, OxyContin, Neurontin, Paxil and those mentioned above,” the lawmakers pointed out.

“A criminal deterrent is needed to protect our children and others placed on powerful medications,” they stated.

Last September, attorney Jim Gottstein, the leader of the patient advocacy organization, PsychRights, filed a lawsuit against the state of Alaska seeking to bar the state from paying for off-label prescriptions of all psychiatric drugs to children covered by Medicaid in Alaska.

Evelyn Pringle

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

Filed under: drugging children , Evelyn Pringle, Lawyers and Settlements blog, states focus on limiting psychiatric drugging of kids

Effexor Baby’s Grieving Mother Protests Potential MOTHERS Act, Warns Others

Grieving Mother Christian Delahunty Warns Others About Effexor During Pregnancy and Breastfeeding

(Newswire: http://christiannewswire.com/news/120709939.html)

by Amy Philo

“Please I beg you to learn more. Learn everything you can while there is time… Drugs, whether legal or illegal, should not be used during these most precious months of creation.”

April 2, 2009 — Christian Delahunty of Utah believes Effexor is to blame for the death of her six-week-old daughter Indiana, who passed away last September. Given the overwhelming evidence on the toxicity of Effexor and other psychotropic drugs for adults, children, and babies, it seems to be the obvious cause. But in the minds of those responsible for pushing Effexor on Christian and similar drugs down the throats of pregnant women across America, it may be “impossible” to prove that’s the case.

With Mommy

It is only with that mindset of denial, or simple ignorance, that anyone could possibly justify pushing for the passage of the federal legislation called “The MOTHERS Act,” that will increase the number of pregnant women and new mothers taking psychotropic drugs.

Following the birth of her son Anaid in 2001, Christian first started taking antidepressants around six months postpartum – but primarily for stress, fatigue, and trouble coping with her mother’s death. Eventually Christian settled on Effexor because it gave her the most energy. She says she felt medication was her only option because nearly everyone in her family, from aunts to her mother, had been on some kind of antidepressant and she believed that she probably suffered from some sort of hereditary chemical deficiency.

Although Christian had three children – Gavin, Ayla and Anaid, she knew her mother would have wanted more grandchildren. In 2004, she added another baby, Jake, to her family. During that pregnancy Christian switched from Effexor to Zoloft, a milder antidepressant, at her doctor’s recommendation, but went back on Effexor after she finished nursing.

In 2007 Christian approached a new family doctor about whether she should switch back to Zoloft because she wanted one more baby. She was taking 300 mg of Effexor XR (extended release). But the doctor told her, “Oh no, you and the baby will be fine. There are no studies that prove that the Effexor is even transferred to the baby in utero or in the breast milk.”

During her last pregnancy, Christian had developed gestational diabetes (a known effect of antidepressants), went into premature labor two months early (another effect of Effexor), and had to be put on bed rest. She delivered baby Indiana a few weeks early, one month before the due date (37 weeks is considered full term and 38-42 is a normal length for a pregnancy).

When Christian found out that the doctors planned to break her water rather than try to stop contractions, she says that she told her husband, “Matt you’ve got to grab me my Effexor.”

The attending doctor abruptly reacted with, “What?!”

This doctor, who worked with Christian’s regular OBGYN, explained to Christian and Matt that he had delivered many Effexor babies and had seen a lot of problems.  “It’s not good for the baby and it needed to be stopped in the first trimester,” he said.

Next he called and warned the NICU to get ready because an Effexor baby was coming.

When Indiana was born she had trouble breathing, scored low on her APGARs, and wouldn’t cry. Christian says she was floppy, excessively sleepy and nearly impossible to feed, and states:

“She was just a really sleepy baby and wouldn’t eat. She would eat for maybe ten minutes and fall asleep. To try and nurse her was extremely difficult. In the NICU they would have to shove a bottle into her mouth just to get her to have a little bit. I would have to wake her up to eat because she would go for too long and she was having problems with keeping her food down anyway. I would burp her and she would usually throw up most of what she would eat and I would try the other side.”

Indiana spent a while in the NICU during the hospital stay and had to be on oxygen and have an IV. She was also in and out of the hospital and doctor’s office after they got to go home. Indiana had jaundice and had to be checked for bilirubin levels four different times. She had been losing a lot of weight so she also had to go in for numerous growth checkups.

Christian says she had to work really hard to wake Indiana from a deep sleep for almost every feeding and that she had to wake her up to switch sides. Her excessive sleepiness never improved, even by five weeks of age.

On September 7, 2008 Christian nursed Indiana at 8 am and then put her down for a nap. Christian went back in to wake her up at 10 and found she was not breathing.

Indiana was rushed to Children’s Hospital by paramedics. The staff was finally able to revive her after 45 minutes and she spent the next five days on life support. But it was too late. MRIs showed Indiana’s brain had badly deteriorated and the family had to let her go. She died on September 13 at six weeks of age.

Indiana with Dad

As reported by Vera Sharav, “In April, 2004, the National Toxicology Program – Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR) panel issued a Report after examining all the available published evidence about infants exposed to an antidepressant in utero and / or breast fed by mothers taking an antidepressant.”

Sharav continued, “The NTP-CERHR expert panel found reason for concern:

Late pregnancy exposures were associated with increased incidence of prematurity, reduced birth weight and length at full term, and poorer neonatal condition characterized by admission to special care nursery and adaptation problems (e.g., jitteriness, tachypnea, hypoglycemia, hypothermia, poor tone, respiratory distress, weak or absent cry, or desaturation on feeding).

“The authors concluded that the observed effects are specific to SRI exposure rather than underlying maternal depression.”

This report, titled “The REPRODUCTIVE and DEVELOPMENTAL TOXICITY of FLUOXETINE”, was originally available at http://cerhr.niehs.nih.gov/news/fluoxetine/fluoxetine_final.pdf.

As if the conclusions of the report were not bad enough, various studies demonstrate that antidepressants double spontaneous abortions and stillbirths and quintuple preterm births. Babies exposed to SSRIs have a six-fold increased risk of persistent pulmonary hypertension (PPHN), a potentially fatal lung problem. Nearly a third of women who take SSRIs have a baby who dies, is premature or underweight, or who has seizures.

It seems that certain sectors of the medical industry aren’t paying attention. From 2004-2008 (through the 2nd quarter only) the FDA MedWatch Adverse Events Reporting Database amassed 647 adverse reaction reports (amounting to 432 babies’ cases, since some reactions are reported by lawyers, doctors and consumers for the same child)  for prenatal or neonatal Effexor exposure, including four reports of Sudden Infant Death Syndrome (SIDS). Two Effexor-SIDS cases were specified as a breast milk exposure only, while one was listed as pregnancy exposure. For the other, with a coma followed by SIDS, the timing of exposure was not specified.

There were also 18 intrauterine deaths, 2 neonatal deaths, 2 stillbirths, 51 miscarriages (spontaneous abortions), and numerous other fatal or life-threatening birth defects, for a total of at least 77 deaths from Effexor alone, not counting the prenatal and neonatal deaths caused by the numerous other psychotropic drugs taken by women during pregnancy or breastfeeding over those four years.

Multiply these totals by a factor of between 10 and 100, because the FDA estimates that only 1-10% of adverse reactions are ever reported. (To see the 2004-2008 reports go to http://www.psychdrugdangers.com/MothersAct.html and then select SNRIs, and Venlafaxine from the drug tables.)

The American Academy of Pediatrics publishes and disseminates a long list of drugs that “may be of concern” in breastfed infants. The tables also appear in The Breastfeeding Answer Book (BAB) published by La Leche League (2003), which is given to leaders and subsequently used to counsel nursing mothers when they request information about drugs and breastfeeding.

In these tables, following a list of psychotropic drugs that “may be of concern” but nonetheless are claimed to have “no reported effects,” is a list of “Food and Environmental Agents” that have effects on breastfeeding. On the list are aspartame (NutraSweet) with the warning, “Caution if mother or infant has phenylketonuria” and a “Vegetarian Diet” with the warning, “Signs of B12 deficiency.”

It’s good to warn women about aspartame and diet, but what about drugs that do not have giant warnings plastered on them like NutraSweet does with PKU?

Effexor is not listed anywhere in the AAP drug tables. It seems psychotropic drugs must be incredibly safe in the mind of the Academy because even though numerous patients have nursed babies on the new antidepressants in the last two decades, there are apparently “no reports” of adverse effects on babies for most of them, at least according to the AAP.

“Drugs of Abuse” such as Amphetamine and Cocaine, Heroin and Marijuana are listed in the table with side effects identical to those listed for antidepressants in current warnings. These same side effects are absent from the AAPs tables for prescription psychotropics, with the exception of Prozac and a few antipsychotics.

The effects of street drug on infants include “Irritability, poor sleeping pattern” for Amphetamine, “Cocaine intoxication, irritability, vomiting, diarrhea, tremulousness, and seizures” for Cocaine, “Tremors, restlenssness, vomiting, poor feeding” for heroin, and none reported for Marijuana.

Prozac must be the only unlucky antidepressant that’s bad for breastfed infants, even though according to Thomas Hale, Ph.D. and kellymom.com (a breastfeeding information site), it’s the only antidepressant that’s “recommended” for pregnancy.  Prozac side effects listed in the BAB for nursing infants include colic, irritability, feeding and sleep disorders, and slow weight gain. Although in a 2002 Mothering Magazine article titled “But Is It Safe For My Baby? Medications and Breastfeeding,” Dr. Hale wrote that Prozac had been shown to induce coma in breastfed infants.

According to kellymom.com’s summary of Dr. Hale’s recommendations, “Effexor can also be used in breastfeeding mothers if it is efficacious. It may be effective against hyperactivity.”

However, kellymom.com later implies that Celexa is no safer than Effexor even though it’s an SSRI and therefore supposedly “weaker” because “There have been two cases of excessive somnolence, decreased feeding, and weight loss in breastfed infants,” according to Hale.

Kellymom.com does note that, “Lithium use by the breastfeeding mother is dangerous to the breastfed infant. Valium use by the breastfeeding mother entails a greater risk of infant sedation, and may perhaps increase the risk of SIDS.”

Finally, a “Drug Hierarchy” of Hale’s first to last choice is listed as: Zoloft, Paxil, Celexa, Effexor, and Prozac.

“Dr. Hale concluded his talk by saying that breastfeeding should be supported fully and not interrupted by mom’s needs for medication; and that treatment of postpartum depression can be accomplished relatively safely in breastfeeding mothers. So, in his consideration, moms should continue breastfeeding and should get drug treatment as needed for depression.”

http://www.kellymom.com/health/meds/antidepressants-hale10-02.html#Effexor

However according to Candace S. Brown, PharmD, BCPP, CFNP, writing for femalepatient.com, “Illet et al studied three cases of breast-feeding women using venlafaxine [Effexor], and reported M/P ratios of up to 4.7.28… Given their high M/P ratios and the limited amount of information available on these antidepressants [venlafaxine, bupropion, trazodone, and nefazodone], they are not recommended in lactating women at this time.”

Milk-to-Plasma Ratio: Medication concentration in milk is frequently compared with the concentration in maternal serum to quantify the extent of passage; this is known as the milk-to-plasma ratio (M/P). In general, compounds that are weakly protein-bound, highly lipid-soluble, weakly basic, and small in molecular size have higher M/P ratios. Ratios greater than 1 indicate that the medication is present in higher concentrations in breast milk than in maternal serum. The higher the M/P ratio, the greater the infant exposure to medication.

http://www.femalepatient.com/html/arc/sig/pharma/articles/article_3.asp

The article further explains that:

Infants’ abilities to absorb, metabolize, and eliminate drugs determine how these drugs will affect them. Compared with adults, infants have a higher gastric pH, causing basic compounds, which remain un-ionized, to have higher absorption rates than do acidic compounds.  Infants also have lower levels of albumin, resulting in higher amounts of free/unbound (and therefore active) medication. Liver metabolic enzymes are immature in infants, decreasing the rate of degradation of medication. In addition, neonates’ kidneys have a glomerular filtration rate that is 30% to 40% of that in adults. Finally, the blood-brain barrier in newborns is not fully developed, and central nervous system concentrations of some lipid-soluble compounds may reach levels that are 10 to 30 times those in serum. As a result of all of these factors, medications that reach the serum in neonates, as compared with those that reach the serum of adults or children older than 6 months, are more likely to be active, less likely to be metabolized and excreted, and more likely to cross into the brain.

Given the confusing and contradictory information found with so many varying sources, whether it’s their La Leche League leader or lactation consultant, a magazine article, or even a breastfeeding website, most new mothers will probably ask for a professional opinion from a doctor or pharmacist.  Either one should be readily able to offer the following information straight from the Effexor label, which can be found by merely “Googling” Effexor in breastfeeding or pregnancy:

[Effexor during pregnancy in animal studies resulted in a] “decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. The cause of these deaths is not known. Venlafaxine appears to cross the human placenta near term.

In a prospective study pregnancy outcomes of 150 women exposed to venlafaxine during first trimester were compared with the pregnancy outcomes of a group of pregnant women who received selective serotonin reuptake inhibitor antidepressants and a group of women who received nonteratogenic drugs. The majority of the women in the venlafaxine group took 75 mg/day (range 37.5 to 300 mg/day) of venlafaxine immediate release form. Among the 150 women who were exposed to venlafaxine during pregnancy, 125 had live births, 18 had spontaneous abortions and seven had therapeutic abortions; two of the babies had major malformations.

Yet when Christian Delahunty approached her family doctor about switching from Effexor to a different medication when she wanted to have another baby, she was told that there were “no studies” showing that Effexor even gets to the baby during pregnancy or breastfeeding. According to Christian, the maximum dose of extended release Effexor is 225 mg. She was on 300 mg at the start of her pregnancy and throughout Indi’s life.

Perhaps Christian’s OBGYN and family doctor only recently graduated from medical school, or maybe they both had gone on vacation and missed reading emails when the FDA MedWatch and Wyeth issued a warning letter on June 28, 2004, specifically for doctors on the dangers of Effexor in pregnancy and stated in part, “Neonates exposed to Effexor, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late in the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.”

Today, Christian spends the days coping with the loss of her daughter but says she feels inspired by baby Indi to help others not have to go through the same tragedy. Christian switched to Lexapro after Indiana died because she wanted nothing to do with Effexor, and then started tapering off the drug slowly. Her last dose was four days ago. Already she says, “I am actually starting to feel better because I don’t feel so controlled by a substance… If you don’t take your dose it affects you horribly. This is the first time I’ve been sober in eight years. It makes me want to cry because it did have so much effect on every part of your life. I was just on a rollercoaster ride, that’s what it feels like.”

“I cope by just praying to God, and in my mind having conversations with Indi. I have an incredible support system and I have to believe – and I think one of the biggest things helping me through this – is that I believe this was her purpose. We had to go through what we had to because she needed to make a difference. She needed to help other people realize that this is serious and it is real.”

“I told my OBGYN at my first consultation that I was on Effexor and she didn’t think there was anything wrong with it. Throughout the pregnancy, I had my doubts and my first instinct was that this wasn’t right, but I was being told that it was just fine. The delivering doctor brought up Effexor. After Indi passed away the thought just kept coming back to me and then I started doing my research and found out how dangerous it was. I Googled Effexor baby, Effexor dangers, Effexor and pregnancy… I was so shocked because it was so easy to do that and I should have done that before. Why didn’t the doctors know that? There is so much controversy over it, why don’t the doctors research more into it without taking the rep’s point of view saying it’s just fine?”

When asked what she thinks about The MOTHERS Act, Christian said:

“It puts so many babies at risk for developing so many different problems. And it puts the mother at risk. Postpartum is normal, it’s natural. It’s learning how to cope with your stress and your situation, rather than just taking drugs to forget about it or to mask what’s natural. There are so many people out there who I know are thinking like I thought – you either have family members on antidepressants or you know somebody – it’s just kinda normal, you know we’ll all start taking an antidepressant… Just because it’s prescribed from a doctor it doesn’t make it safe.”

“I trusted my doctor and that mistake – it cost me. It cost my whole entire family. That is why I have to believe that this was Indi’s purpose. Educate yourselves. If the doctors aren’t going to be educated then we need to. We need to take the power back.”

By the way, the March of Dimes, a pharma-funded group that endorses The MOTHERS Act as well as the use of antidepressants during pregnancy, does warn against the use of caffeine in pregnancy due to a risk of miscarriage.

To learn more about the dangers of “The MOTHERS Act,” go to uniteforlife.org.
Please go to this link to watch a video in memory of baby Indiana: http://www.youtube.com/watch?v=LGX_34TmT4w

Note: This article was updated with the latest MedWatch information on July 28,2009. For more reports on drugs commonly given to nursing mothers such as antidepressants and Zyprexa, go to http://momsandmeds.wordpress.com/2009/06/24/breastmilkexposure/

Filed under: Birth Defects, Christian Delahunty, Congress, Effexor, Effexor in pregnancy, FDA Warnings, Indiana, PPD, Pregnancy, The Future of The United States, antidepressants, child endangerment, dead babies, drug "safety", drugging children, eugenics, experimentation, mothers act, pharmacology, toxicity deaths , Breastfeeding, kellymom.com, Thomas Hale

Alaska Says Children Cannot be Protected from Drugging

NEWS RELEASE

FOR IMMEDIATE RELEASE
March 31, 2009

CONTACT:
Jim Gottstein
907-274-7686

jim.gottstein@psychrights.org

Alaska Admits It Is Incapable of Protecting Children and Youth in Its Care from Harmful Psychiatric Drugging

Today, responding to the State of Alaska’s admission in PsychRights v. Alaska that it was incapable of protecting the children and youth in its care from improper and harmful psychiatric drugging, the Law Project for Psychiatric Rights (PsychRights^®) told the court it must step in.

PsychRights v. Alaska was filed last Fall to halt the State of Alaska’s practice of administering and paying for psychiatric drugs being given children and youth without safeguards being in place to make sure proper decision making occurs. In trying to get PsychRights v. Alaska “thrown out of court” the State admitted it was incapable of protecting the children and youth in its care as follows:

A reading of the Complaint makes obvious that the true subject of plaintiff’s grievances is not the Department, but prescribers of psychotropic pharmaceuticals, the pharmaceutical companies which produce and market them, and the overall culture of pediatric psychiatry. The implication that the Department possesses meaningful authority and control over these matters-or is in any realistic position to administer the relief requested even if the court were to order it-is a fiction.

“The point is the State has the responsibility to properly care for the children and youth in its care regardless of the ‘culture of pediatric psychiatry,’” according Mr. Gottstein. Today’s court filing tells the court, “It is shameful the State is abdicating its responsibility when it should be working to correct the problem.”

In the absence of the State being willing to address the problem without court intervention, the lawsuit seeks to solve it by obtaining a court order prohibiting the psychiatric drugging of children and youth by the State unless and until

(i) evidence-based psychosocial interventions have been exhausted,

(ii) rationally anticipated benefits of psychotropic drug treatment outweigh the risks,

(iii) the person or entity authorizing administration of the drug(s) is fully informed of the risks and potential benefits, and

(iv) close monitoring of, and appropriate means of responding to, treatment emergent effects are in place.

Practically every day brings revelations that pediatric psychopharmacology is the result of illegal drug company actions to improperly influence psychiatrists to prescribe extremely harmful drugs to children and youth, in spite of there being no real evidence of their efficacy. “Rather than meeting its mandate to properly care for and protect these children and youth from harm, the actions of the State are reprehensible,” Mr. Gottstein declared, adding “The State is also trying to hide its complicity by stopping the discovery process.”

The defendants in the lawsuit are the State of Alaska, its Department of Health and Social Services (DHSS), and responsible officials, Sarah Palin, Governor, William Hogan, Commissioner of DHSS, Tammy Sandoval, Director of the Office of Children’s Services (OCS), Steve McComb, Director of the Division of Juvenile Justice (DJJ), Melissa Stone, Director of the Division of Behavioral Health (DBH), Ron Adler, CEO of the Alaska Psychiatric Institute (API), and William Streur Deputy Commissioner and Director of Medicaid. All of the substantive filings in the lawsuit are available on the Internet at http://psychrights.org/States/Alaska/PsychRightsvAlaska.htm.

The Law Project for Psychiatric Rights is a public interest law firm devoted to the defense of people facing the horrors of unwarranted forced psychiatric drugging and electroshock. PsychRights is further dedicated to exposing the truth about psychiatric interventions and the courts being misled into ordering people subjected to these brain and body damaging drugs against their will. Extensive information about these dangers, and about the tragic damage caused by electroshock, is available on the PsychRights web site: http://psychrights.org/.

# # #

Filed under: CPS, PsychRights, child endangerment, courts, drugging children , PsychRights v. Alaska, Jim Gottstein

MOTHERS Act and DBSA – pHARMa Front Group – Who cares about money?

FRONT GROUP FINANCIAL INFORMATION: DBSA

This research was conducted by Evelyn Pringle… I hope you can note the inserted comments from her and look below to read my comments, which I’ll leave off the article portion and put in the comment box.

Depression and Bipolar Support Alliance

2005 Annual Report

http://www.dbsalliance.org/pdfs/05annualreport.pdf

Sue Bergeson, President, DBSA

ALLIANCE LEAGUE ($500,000 AND ABOVE)

Wyeth Pharmaceuticals

LEADERSHIP CIRCLE ($150,000-$499,999)

Abbott Laboratories
AstraZeneca Pharmaceuticals
Bristol-Myers Squibb Company
Cyberonics, Inc.
Eli Lilly and Company Foundation
Pfizer Inc

FOUNDERS CLUB ($10,000-149,999)

Forest Laboratories
GlaxoSmithKline
Janssen Pharmaceutica Products
Neuronetics, Inc.
Shire Pharmaceuticals Group

ADVOCATE COUNCIL ($5,000-9,999)

Dr. and Mrs. Edward M. Scolnick

PLATINUM ($1,000-4,999)

Merck & Co. Inc.
Lori L. Altshuler, M.D.
Kay Redfield Jamison, Ph.D.
A. John Rush, M.D.
Mr. Robert C. Schwartz

GOLD ($500-999)

Dr. and Mrs. Mark S. Bauer
Gregory Simon, M.D.

SILVER ($150-499)

Johnson and Johnson
Joseph Biederman, M.D.
Linda L. Carpenter, M.D.
Dr. Ron C. Melzer
National Association of Boards of Pharmacy
Charles O’Brien, M.D.

MATCHING GIFT COMPANIES

GlaxoSmithKline
Merck & Co. Inc
Pfizer Foundation

EMPLOYEE GIVING

Abbott Laboratories

======================

2006

Drug company money to Depression and Bipolar Support Alliance in 2006

(Evelyn’s note:

The 2006 Annual Report for the Depression and Bipolar Support Alliance shows that AstraZeneca gave the group more than $500,000 in 2006. Companies that gave between $150,000 and $499,000 included Abbott Laboratories, Bristol-Myers Squibb and Wyeth Pharmaceuticals. Forest Laboratories, GlaxoSmithKline, Janssen, Pfizer, and Shire Pharmaceuticals each gave between $10,000 and $149,000.)

2006 Annual Report

http://www.dbsalliance.org/pdfs/2006AnnualReport.pdf

=======================

2007

Depression and Bipolar Alliance

Annual Report

http://www.dbsalliance.org/site/DocServer/FINAL_AnnualReport07.pdf?docID=2761

This list reflects donations received through December 31, 2007.

LEADERSHIP CIRCLE ($150,000-$499,999)

AstraZeneca
Pfizer Inc
Wyeth Pharmaceuticals

FOUNDERS CLUB ($10,000-149,999)

Abbott Laboratories
Cyberonics, Inc.
Elli Lilly and Company
Forest Laboratories
GlaxoSmithKline
National Association of State
Mental Health Program Directors
Organon, Inc.
Otsuka American Pharmaceutical, Inc

PLATINUM ($1,000-4,999)

Abbott Laboratories Employee Giving Campaign

GOLD ($500-999)

Lori L Altshuler, MD
David Dunner, MD
Kay Redfield Jamison, PhD
A. J. Rush, MD
Martha Sajatovic, MD
Gregory Simon, MD, MPH
TAP
Dr. James Walker

SILVER ($150-499)

Dr. and Mrs. Paul Berkowitz
Joseph Biederman, MD
Dr. Judith A. A. Cook
Dr. and Mrs. Alan Harris
Dr. Roger W. Helfrich
Nada l. Stotland, MD

CONTRIBUTORS TO THE REBECCA LYNN CUTLER LEGACY OF LIFE FOUNDATION

Abbott Laboratories
AstraZeneca
Eli Lilly and Company
Janssen
Organon, Inc.
Pfizer Inc
Wyeth Pharmaceuticals

EMPLOYEE GIVING COMPANIES

Abbott Laboratories
Eli Lilly and Company
GlaxoSmithKline
Merck Partnership for Giving
Pfizer Foundation

2007 at a Glance: How We Met Our Mission

(Among other things listed are):

Promoted Melanie Blocker-Stokes Postpartum Depression Research & Care Act at invitation of Rep. Bobby Rush (D-Ill.)

Promoted MOTHER’s Act at invitation of Sen. Dick Durbin (D-Ill.)

Launched consumer smoking cessation initiative, funded by Robert Wood Johnson
Foundation’s Smoking Cessation Leadership Center

First-ever DBSA Hope Award for lifetime achievement presented to Frederick K.
Goodwin, MD, & Kay Redfield Jamison, PhD

Active in development & promotion of “Depression Is Real” PSA campaign

=======

DBSA 2007 Fall Newsletter “Outreach”

The issue states: “DBSA gratefully acknowledges its Leadership Circle, Organizations that contributed a minimum of $150,000 during 2007.”

ABBOTT LABORATORIES
ASTRAZENECA PHARMACEUTICALS
PFIZER INC
WYETH PHARMACEUTICALS

http://www.dbsalliance.org/pdfs/outreach/Outreach_Fall2007.pdf

Under “Our 2007 Legislative Milestones” it lists:

DBSA was honored to be asked personally by Senator Dick Durbin (D-Ill.) and Representative Bobby Rush (D-Ill.) to help introduce the postpartum legislation in Illinois.

=========

DBSA Spring 2008 Newsletter “Outreach”

The issue states: “DBSA gratefully acknowledges its Leadership Circle, Organizations that contributed a minimum of $150,000 during 2007.”

ABBOTT LABORATORIES
ASTRAZENECA PHARMACEUTICALS
PFIZER INC
WYETH PHARMACEUTICALS

http://www.dbsalliance.org/pdfs/outreach/Outreach_2008Spring.pdf

It also publishes the following message which explains where some of the drug money went:

Speaking Out for New Moms

Six years ago, after giving birth to her first child, a successful 41-year-old sales manager plunged to her death from a Chicago hotel’s 12th floor as firefighters pleaded with her. Melanie Blocker-Stokes took her own life, despite medical help and the support of family and friends.

Melanie’s tragedy soon prompted legislation in both the U.S. House and Senate. If passed, the Melanie-Blocker Stokes Postpartum Depression and Research Act and the MOTHER’s Act will help the families and women afflicted by postpartum depression (PPD) through lifesaving educational programs and screening services.

In January, DBSA sent an Advocacy Alert asking you to write your legislators in support of these PPD bills. Thousands of you sent letters to Congress through our Legislative Action Center (LAC). As time went on, instead of contacting individual legislators, you began to ask specific congressional committees (like the House Committee on Energy and Commerce), to support a vote rather than just a bill.

Unfortunately, rumors and lies began circulating on the Web, as outspoken opponents began asking people not to support these bills. While they called themselves “experts,” none of them had any expertise in mental health or any PPD-related field. They claimed the legislation was just a conspiracy by big pharmaceutical companies to push new moms to take unnecessary medication.

Tell that to the more than 800,000 women who will develop a diagnosable postpartum mood disorder this year! To debunk these myths, on April 8, DBSA sent you another alert marked “Urgent.” Your response has been nothing less than amazing-unprecedented, Web experts tell us! Just nine hours after our alert, you’d sent 1,200 letters to legislators.

In the next two days, you sent 6,300 more. After one month, you’d sent over 15,000 letters speaking out against the PPD rumors! And, for the first time, other groups are proactively joining us.

Organizations and blog sites like Postpartum Support International (PSI), Postpartum Progress, Moms Speak Up, Becoming Me, Beyond Blue and EmpowerHer are linking their readers to our LAC so that even more letters reach Congress.

Did you know that as few as five letters can make a difference in how your legislator votes? Even if you’ve already sent a letter supporting PPD legislation, please send another.

Help us reach the 20,000 mark for letters supporting PPD legislation! Write Congress today at www.DBSAlliance.org/Advocacy.

================

Some of the drug money funneled through the DBSA is apparently being spent the same way this year by utilizing the postpartum front groups operating on the internet.

==========

Note from Evelyn:

On March 10, 2009, Katherine Stone’s headline on the Postpartum Progress Blog read:

“It’s Petition Signing Time!  Get Out Your Virtual Pen & Support Women with PPD”

Her blog reports “that Susan Stone over at Perinatal Pro is alerting everyone to the new petition created by the Depression and Bipolar Support Alliance to support the Melanie Blocker Stokes MOTHERS Act.  She states that last year’s petition generated more than 24,000 signatures.  The petition has been reintroduced this year to try and get this legislation passed once again.”

The blog carries a live link to an advocacy alert page where “you can scroll down, enter your zip code and generate letters of support in a matter of seconds for the Melanie Blocker Stokes MOTHERS Act that will be sent to your local Congresspeople and Senators.”

Ms Stone further advises: “I just sent my letters.  I know you’re thinking “but I already did that last year.”  Well that was then and this is now.  Do it again.”

Filed under: "prevention", Amy Philo, Birth Defects, Christian Delahunty, Congress, ECT, Effexor in pregnancy, Elizabeth Torlakson, Harry Reid, Indiana, Isaac Philo, Manie, Melanie Stokes, PPD, Paxil in pregnancy, Pregnancy, antidepressants, antipsychotics, big brother, child endangerment, dead babies, drugging children, eugenics, experimentation, mothers act, pharma payments to doctors, pharmacology, profit , Depression and Bipolar Support Alliance Cares About Moolah

Biederman Pushed Risperdal for Pre-School Children

Yes, this is the same guy who earlier stated that he was ranked right below God. Things that make you go, “hmmmmmmm.”

http://blogs.wsj.com/health/2009/03/20/court-papers-biederman-told-jj-study-results-would-be-positive/?mod=crnews

Court Papers: Biederman Told J&J Study Results Would Be Positive

By Sarah Rubenstein

Court documents are coming to light that suggest Harvard psychiatrist Joseph Biederman told Johnson & Johnson, before certain trials of its drugs were started, that he expected positive results.

Biederman is one of a number of prominent doctors targeted by Sen. Chuck Grassley’s investigation into conflicts of interest among doctors. Late last year, he agreed to stop working on clinical trials sponsored by industry until completion of a probe of his alleged lack of disclosure of more than $1.6 million in payments he received from companies including J&J and Eli Lilly, both makers of prominent psychiatric drugs.

According to court documents, Biederman made a presentation to J&J execs in which he displayed a slide that referred to a proposed study of the company’s antipsychotic Risperdal, known generically as risperidone, in preschool children, the New York Times reports. The trial “will support the safety and effectiveness of risperidone in this age group,” as NYT quotes the slide.

Another slide discussed a trial that would compare Risperdal with competitors in managing pediatric bipolar disorder. The trial “will clarify the competitive advantages of risperidone vs. other neuroleptics,” as NYT quotes it the documents.

Biederman’s attorneys are trying to get a judge to seal his testimony and accompanying documents in a multistate suit in which he is a key witness, saying they “could be immensely damaging to him, both personally and professionally,” the Boston Globe reports. The suit involves more than 2,000 patients, including children, who say they have been injured by drugs known as atypical antipsychotics. Growing use of psychiatric drugs in children has been a center of controversy in the past couple of years.

Biederman didn’t comment in the NYT or Globe stories, but he has written before that J&J’s financial support for a research center with which he was involved didn’t interfere with the center’s research findings. J&J has also said funding it provided the center “followed strict guidelines to ensure scientific independence and did not direct the content or conclusions of the research.”

Filed under: Preschool Psychopharmacology Working Group, drugging children , Biederman

Part 3: Psychiatric Drugging of Children Intolerable

http://www.lawyersandsettlements.com/features/Psychiatric-Drugging-three.html

Filed under: drugging children

Psychiatric Drugging of Children Intolerable–Part 1

Psychiatric Drugging of Children Intolerable–Part 1
by Evelyn Pringle

http://www.lawyersandsettlements.com/features/Psychiatric-Drugging-One.htmlFebruary 19, 2009.

Washington, DC: Last September, the Law Project for Psychiatric Rights filed what is sure to become a landmark case against the State of Alaska aimed at stopping the over-prescribing of psychiatric drugs to children covered by public health care programs in that state.

Child Drugs

“The massive over-drugging of America’s youth is an unfolding national horror,” says attorney Jim Gottstein, the leader of the Law Project. The lawsuit seeks an injunction to stop Alaska from authorizing or paying for psychotropic drugs prescribed to children in foster care or children covered by Medicaid “without safeguards being in place to make sure proper decision making occurs.”

Specifically, the complaint is asking for a court order prohibiting the State from giving or paying for these drugs unless and until: (i) evidence-based psychosocial interventions have been exhausted, (ii) rationally anticipated benefits of psychotropic drug treatment outweigh the risks, (iii) the person or entity authorizing administration of the drug(s) is fully informed, and (iv) close monitoring of, and appropriate means of responding to, treatment emergent effects are in place.

“The corrupt influence of the pharmaceutical industry in illegally promoting much of this drugging has been well established,” Mr Gottstein says, “yet the state continues to inflict great harm on the children it has taken away from their families by giving them these drugs.”

“It is absurd to think all these children have a mental illness,” he adds. “They are being drugged because they are upset and bothering people…because decisions to administer medication to children are not made by the children themselves, the administration of psychotropic drugs is involuntary.”

Under the Alaska Constitution, he says, involuntary administration of such drugs infringes upon fundamental rights and the state must have a compelling state interest in doing so. They must be in the best interest of the children and there must be no less intrusive alternatives, the lawsuit notes.

Governor Sarah Palin is named as a defendant in the lawsuit because she is ultimately responsible for the protection of children as Governor of Alaska. “I doubt anyone on the Governor’s staff has even let her know about the problem despite my trying to bring it to her attention ever since she took office,” Mr Gottstein notes.

In fact, as far back as March 14, 2007, he emailed Governor Palin about children in custody in other states dying from the administration of psychotropic drugs, and stated:

“The massive over-drugging of America’s children and youth is a titanic health catastrophe caused by the government’s failure to protect its most precious citizens, who rely on the adults in their lives to shield them from harm, not inflict it upon them. Perhaps the worst of all is the State inflicting this harm on children and youth it has taken from their homes “for their own good.”

Mr Gottstein concluded by asking her to, “Please correct this situation.” On February 4, 2008, he wrote to Governor Palin again, in hopes of avoiding a lawsuit, and sent copies to the Attorney General and others, conveying scientific evidence regarding the harm being done by the over-prescribing of psychotropic drugs to children, and stated in part:

“Children and youth are virtually always forced to take these drugs because, with rare exception, it is not their choice. PsychRights believes the children and youth, themselves, have the legal right to not be subject to such harmful treatment at the hands of the State of Alaska.

“We are therefore evaluating what legal remedies might be available to them. However, instead of going down that route, it would be my great preference to be able to work together to solve this problem. It is for this reason that I am reaching out to you again on this issue.”

“Fewer than ten percent of psychotropic drugs are FDA-approved for any psychiatric use in children and youth,” the lawsuit alleges.

In the February 2009 New York Review, former New England Journal of Medicine editor and Senior Lecturer in Social Medicine at Harvard Medical School, Dr Marcia Angell, wrote:

“Although it is illegal to promote drugs for use in children if the FDA has not approved them for that use, the law is frequently circumvented by disguising marketing as education or research. Eli Lilly recently agreed to pay $1.4 billion to settle civil and criminal charges of marketing the anti-psychotic drug Zyprexa for uses not approved by the FDA (known as “off-label” uses). Zyprexa, which has serious side effects, is one of the drugs frequently used off-label to treat children diagnosed with bipolar disorder.”

She went on to state: “Unlike migraines or shyness, hypertension or high cholesterol can be defined by an objective measurement-a blood pressure or cholesterol level. One can dispute the threshold chosen as abnormal, but the measurement is easily verifiable. The fact that psychiatric conditions are not objectively verifiable underscores the necessity for both diagnosis and treatment to be as impartial as possible. That is why conflicts of interest are more serious in this field than in most others.”

Mr Gottstein’s complaint lays out the evidence of harm to children caused by psychiatric drugs as documented by a program titled, “Critical Risk Rx, A Critical Curriculum on Psychotropic Medications,” designed by a team led by Dr David Cohen, a Professor at Florida International University.

The purpose of the “Critical Think Rx” program is to promote critical thinking skills about psychiatric medication issues related to the authorization of the administration of psychotropic drugs to young patients. The program was developed under a grant from the Attorneys General Consumer and Prescriber Grant Program through the multi-state settlement with Pfizer of consumer fraud claims regarding the off-label promotion of Neurontin, one of the anti-seizure drugs marketed as a mood stabilizer.

Critical Think Rx is funded at the Florida International University, and is the only project targeting non-medically trained professionals in child welfare and mental health. All investigators and consultants involved in the program have agreed to forego pharmaceutical industry funding for the duration of the project in order to maintain complete independence.

The “best practices” recommended in the lawsuit were assembled by the Critical Think team and have been proven effective, Mr Gottstein advises.

Part 2 Next week: The Major Turning Point: the Death of Rebecca Riley

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

This report was written as part of the Pharmaceutical Litigation Roundup series and sponsored by the Baum, Hedlund, Aristei & Goldman law firm.

Filed under: child endangerment, drugging children , Evelyn Pringle

Pharmaceutical Industry Hustlers Part I: SSRI Pushers, by Evelyn Pringle

Pharmaceutical Industry Hustlers – Part I

SSRI Antidepressants Pushers

After twenty long years, it appears that the epidemic in mental disorders in America might be coming to an end. It won’t happen because of any great medical breakthrough but rather because the perpetrators of the greatest healthcare fraud in history are finally being exposed. The demolition of the giant “psycho-pharmaceutical complex” appears to be on the horizon.

For far too long, the focus has been on the drugmakers only. In recent months, the spotlight has shown where it belongs – on the highly-paid opportunists responsible for fueling the epidemic in prescribing of psychiatric drugs by doctors in every field of medicine and the research institutions that enabled the process.

The antidepressants known as selective serotonin reuptake inhibitors, or SSRI’s, such as Prozac, Paxil, Zoloft, Celexa and Lexapro are at the center of the storm. These drugs have been prescribed to more Americans than any other class of medications over the past two decades. Cymbalta, Effexor and Wellbutrin are often referred to as SSRI’s, but they are slightly different chemically. However, the drugs all carry similar side effects and warnings.

The top sales pitch for SSRI’s has been the “chemical-imbalance-in-the-brain” myth. “There is no evidence whatsoever that depression is caused by a biochemical imbalance,” says Dr Peter Breggin, one of the world’s leading experts on psychiatric drugs and author of the new book, “Medication Madness.”

People take for granted pronouncements such as, “You have a biochemical imbalance,” and “mental disorders are like diabetes,” he explains in the book.

“In reality,” Dr Breggin writes, “these are not scientific observations – they are promotional slogans, so adamantly repeated in the media and by individual psychiatrists that people assume them to be true.”

“The psycho-pharmaceutical complex fosters these falsehoods in order to promote the widespread use of their products,” he says. “Reluctant patients by the millions are pushed into taking drugs by doctors who tell them with no uncertainty that they need medication.”

“If you have got a biochemical imbalance in your brain,” Dr Breggin advises in the book, “the odds are overwhelming that your doctor put it there with a psychiatric drug.”

All Eyes on Glaxo

At the moment, all eyes are on Paxil maker, GlaxoSmithKline (formerly SmithKline Beecham), due to reports that the company is under investigation by the US Department of Justice, as well as the Senate Finance Committee, with Iowa’s Senator Charles Grassley, the ranking Republican on the Committee, leading the charge.

The report that led to the investigation by Senator Grassley was generated in litigation and was only recently made public after it was unsealed by the court. It was submitted by Dr Joseph Glenmullen, a Clinical Instructor in Psychiatry at Harvard Medical School and author of “The Antidepressant Solution” and “Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and Other Antidepressants with Safe, Effective Alternatives.” He was retained as an expert by the Los Angeles-based law firm of Baum, Hedlund, Aristei & Goldman. The litigation involves several Paxil-induced suicide cases, including a 13-year-old child.

The report shows that Glaxo knew in 1989, long before Paxil was FDA approved, that people taking the drug were 8 times more likely to engage in suicidal behavior than people given a placebo, or sugar pill. Now, it stands to reason that even the most depressed person would decline to take Paxil if given these facts. Also, parents certainly would decline if they were told about the risks.

Dr Glenmullen explains that, by submitting what he refers to as “bad” Paxil numbers to the FDA, Glaxo was able to avoid adding a warning about suicide to the label when the drug was approved. “GlaxoSmithKline’s ‘bad’ Paxil numbers carried the day: The FDA approved Paxil on December 29, 1992, with no warning to doctors or patients of the significant increased risk of suicidal behavior,” he writes.

Instead, Glaxo listed suicide and suicide attempts that took place during the “run-in” period of the studies as if they happened in the placebo group. The run-in period, also called the “wash-out” phase, occurs when all patients are taken off their existing drugs to let the old drugs wash out of their systems, and all patients are given placebos. The rationale for washing out old drugs is to prevent them from confusing the results of the study, so that patients start out in a similar condition, according to the report.

The official trial only begins after the wash-out phase, once the patients are assigned to receive either the antidepressant or a placebo. The patients who continue to receive the placebo are referred to as the “placebo group.”

“Confusing the pre-study placebo wash-out phase with the placebo group in the actual study is improper,” Dr Glenmullen writes, “especially when the concern is a potentially lethal side effect.”

The “correct data shows that suicide attempts in patients on Paxil occurred at a rate eight times higher than the rate in patients on placebo,” he notes.

Senator Grassley has also asked the FDA to go back and review the clinical trial data submitted on Paxil. In a statement on the Senate floor on June 11, 2008, he said: “Essentially, it looks like GlaxoSmithKline bamboozled the FDA.”

“We cannot live in a nation where drug companies are less than candid, hide information and attempt to mislead the FDA and the public,” he stated. “These companies are selling drugs that we put in our bodies, not sneakers.”

“When they manipulate or withhold data to hide or minimize findings about safety and/or efficacy they put patient safety at risk,” Senator Grassley said. “And with drugs like Paxil, the risks are too great.”

A good start

As the Glaxo scandal unravels, the public will learn that other antidepressant makers such as Eli Lilly, Pfizer, Wyeth and Forest Laboratories are equally guilty. Likewise, there are many more supposedly independent academic doctors who have been receiving substantial financial benefits from drug companies than are currently identified in the media as being under investigation.

Exposing Harvard University’s Joseph Biederman, Thomas Spencer, Timothy Wilens, Stanford’s Alan Schatzberg, Brown University’s Martin Keller, Melissa DelBello at the University of Cincinnati, and Drs Karen Wagner and John Rush, who operated out of the University of Texas, might be a good place to start, but the trail of Big Pharma’s funding “academic research” for marketing purposes certainly does not end with a handful of psychiatrists.

According to Senator Grassley’s June 4, 2008 statement in the Congressional record, although conflict-of-interest disclosure forms make it appear that the Harvard psychiatrists only received a couple hundred thousand from drug companies over the past 7 years, the true figures show Dr Biederman received over “$1.6 million,” Dr Spencer “over $1 million” and Dr Wilens “over $1.6 million” in payments from the drug companies.

“Based on reports from just a handful of drug companies,” he states, “we know that even these millions do not account for all of the money.”

Senator Grassley also notes that Dr Schatzberg owns stock worth more than $6 million in one drug company. Ed Silverman reports on Pharmalot that there are “30 or so physicians at two dozen universities which the Senate Finance Committee is probing concerning disclosure of grants from drugmakers.” The names of those 30 doctors, along with the research mills they operate out of, need to be made public.

The new book, “Side Effects: A Prosecutor, a Whistleblower, and a Best-selling Antidepressant on Trial,” by investigative journalist Alison Bass, provides the inside scoop on the fraudulent SSRI research conducted at Brown University by Dr Keller.

The book also supplies background information on the financial ties between the so-called “opinion leaders” in psychiatry and the other antidepressant makers. For instance, Ms Bass explains that Drs Schatzberg and Keller worked as a team a decade ago to promote Bristol-Myers Squibb’s antidepressant Serzone.

In 1998, Dr Schatzberg was paid to moderate an industry-sponsored symposium that touted the benefits of Serzone, and Dr Keller was one of the paid speakers at the event. The same year, Dr Keller received $77,400 in consulting fees from Bristol-Myers, Ms Bass points out.

Dr Keller later published a study in the New England Journal of Medicine also touting the benefits of Serzone. The drug was removed from the market in 2004 after it was found to cause liver damage but not before a number of patients died.

Ms Bass reports that Keller did not report any income from Glaxo on his 1998 tax return. But during her research for “Side Effects,” she discovered he had earned personal income from Glaxo in 1998, as well as subsequent years. Keller admitted as much during a September 2006 deposition for a lawsuit filed against Glaxo, she says.

It is no longer a case where Americans need only be concerned about the amount of money the academics are pulling in. The pharmaceutical industry also has a stronghold on most major research institutions in this country. Many could not exist if the drug companies withdrew all their research funding, a state of affairs that did not occur by accident.

In fact, according to Dr Aubrey Blumsohn, who publishes the Scientific Misconduct Blog, when all is said and done:

“The chief villains remain our academic institutions and medical leadership. They have colluded with and have acted as apologists for commercial scientific fraud. They have tolerated the telling of lies by senior academics. They have encouraged the prostitution of medicine. They have allowed abuse of the most fundamental safeguards of science. Most importantly, they have set terrible examples for our students.”

Universities keep corrupt academics on board for good reason. “Side Effects” reports that, between 1990 and 1998, “Martin Keller brought in nearly $8.7 million in research funding from pharmaceutical companies.”

The clinical trial industry itself provides a perfect slush fund. Spending in the U.S. was an estimated $25 billion in 2006 and is expected to reach about $32 billion by 2011. Most of the money for trials comes from private industry, and federal funding assumes a second place position, with the National Institute of Health budgeting $3 billion for clinical trials in 2006, according to the paper, “State Medical Board Responses To An Inquiry On Physician Researcher Misconduct,” by Dr Stefan Kruszewski, Dr Richard Paczynski and Marzana Bialy, in the Journal of Medical Licensure and Discipline 2008: Vol 94 No 1.

Paxil Study 329

“Side Effects” also covers the whole sordid affair on Paxil Study 329, the most infamous fraudulent pediatric trial of all time. The study “offers a landmark for the point at which science turned into marketing,” according to Dr David Healy.

Dr Healy is a Professor of psychiatry and Director of the North Wales School of Psychological Medicine at the University of Wales , and an outspoken critic of the psycho-pharmaceutical complex, with 21 books to his name, including “The Creation of Psychopharmacology.”

He explains that, in 1998, Glaxo’s original assessment of Study 329 had concluded that it and another study had shown Paxil did not work for children, but that it would not be “commercially acceptable” to publicize this finding. “Instead the positive findings from the study would be published; they were in an article whose authorship line contains some of the best known names in psychopharmacology (Keller et al., 2001),” Dr Healy writes in the 2007 paper, “The Engineers of Human Souls & Academia.”

Dr Keller gets most of the “credit” for the study, which was completed in the mid-90’s. Keller et al had some difficulty getting it published at first, but finally found a journal willing to take the bate in 2001, the Journal of the American Academy of Child and Adolescent Psychiatry. In all, 20 academics allowed their names to be attached to this ghostwritten infomercial, and not one has stepped forward to acknowledge wrongdoing or to admit that a mistake was made.

Long before the paper was published, the authors of study 329 were fanned out all the way to Canada giving lectures and presentations to prescribing doctors at medical conferences and seminars to promote the off-label use of Paxil for kids. More than any other paper, Study 329 led to an epidemic in pediatric prescribing. “After its publication, the use of antidepressants for children skyrocketed,” Dr Glenmullen notes.

These handsomely paid “key opinion leaders” all deserve to have their names in lights, especially Drs Graham Emslie and Karen Wagner from the University of Texas .

Between 2000 through 2005, Glaxo paid Dr Wagner $160,404, but the only payment she reported to the university was $600 in 2005, according to Senator Grassley. Dr Wagner also failed to disclose earnings of more than $11,000 from Prozac-maker Eli Lilly in 2002.

On August 18, 2008, the Dallas Morning News reported that a “state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list.”

“The Children’s Medication Algorithm Project, or CMAP, was supposed to determine which psychiatric drugs were most effective for children and in what order they should be tried at state-funded mental health centers,” the Morning News explains.

The academics who developed the CMAP include Drs Wagner and Emslie. Records show Dr Emslie may have made up to “$125,000 from drug companies since 2004,” according to the report in the Morning News.

While Dr Keller took the lead on pushing Paxil for children and adolescents, Dr Emslie was the main man on the Prozac trials, and Dr Wagner was the queen bee on Zoloft studies. The co-authors of papers that appear in the medical literature encouraging the use of SSRI’s for kids include Drs Biederman, Schatzberg, Wilens and, of course, Charles Nemeroff.

Dr Nemeroff was recently forced to resign as chairman of Emory’s psychiatry department after Senator Grassley’s investigation revealed that he failed to disclose to his university more than a million dollars in drug industry income. All total, Nemeroff had earnings of $2.8 million from drug companies between 2000 and 2007, but failed to report at least $1.2 million.

A complete list of academics who should to be investigated can be found among the authors of the SSRI papers and studies highlighted in the 2006 Third Edition of, “Essentials of Clinical Psychopharmacology,” described as “a synopsis and update of the most clinically relevant material from ‘The American Psychiatric Publishing Textbook of Psychopharmacology,’” by none other than Drs Schatzberg and Nemeroff.

Keep Following the Money

On July 10, 2008, Senator Grassley extended his investigation to include psychiatry’s top industry-funded front group with a letter to Dr James Scully, Medical Director and Chief Executive Officer of the American Psychiatric Association, asking for “an accounting of industry funding that pharmaceutical companies and/or the foundations established by these companies have provided to the American Psychiatric Association.”

The Senator wants records from January 2003 to the present. According to the July 12, 2008, New York Times, in 2006, the “industry accounted for about 30 percent of the association’s $62.5 million in financing.”

A factor rarely discussed in this debate is the amount of money doctors who prescribe SSRI’s make during brief office calls charged at regular rates. This practice has taken a tremendous toll on public healthcare programs and has resulted in higher insurance premiums and overall healthcare costs for all Americans.

In fact, the bilking of public healthcare programs is what led to the current investigations by the Finance Committee, which has the responsibility of overseeing spending in Federal programs. When doctors prescribe drugs for unnecessary uses, public programs not only have to pay for the drugs, they must also pay the fees of the prescribing doctors and for the medical care for injuries caused by the drugs. Government spending tied to the prescribing of psychiatric drugs has gone through the roof in the past decade.

While testifying before the House Committee on Oversight and Government Reform on February 9, 2007, Lewis Morris, Chief Counsel at the Department of Health and Human Services’ Office of Inspector General, discussed kickbacks to doctors and told the panel:

“Kickbacks potentially increase the costs to Federal programs because they encourage overutilization and may encourage the prescribing of more expensive drugs when clinically appropriate and cheaper options (such as generic drugs) may be equally effective.”

Mr Morris explained that, “kickbacks offered to prescribing physicians by pharmaceutical manufacturers take a variety of forms, ranging from free samples for which the physician bills the programs to all-expense-paid trips and sham consulting agreements.”

Vermont is a rare state in requiring the pharmaceutical industry to disclose the money paid to doctors. On July 8, 2008, Vermont ’s Attorney General William Sorrell released the state’s annual report on “Pharmaceutical Marketing Disclosures,” which lists the payments made by drug companies in 2007. Of the top 100 recipients, once again, psychiatrists received the highest payments. Eleven psychiatrists received a total of $626,379, or about 20% of the total value of payments made, according to the report.

Shrinks on the take are so addicted to industry money that it’s impossible to embarrass them. Last year, the press ran major stories when this report came out, highly critical of how much money they were making. This year, the average amount rose by 25%.

The report also analyzes the payments based upon the drugs being marketed. Of the top 10 drugs for which disclosures were reported, five are used to treat mental illness and include Lilly’s Cymbalta and Forest Lab’s Lexapro. Ironically, Cymbalta sales are also up 25%, according to Lilly’s latest SEC filing.

Overall, estimates indicate that the drug industry spends $19 billion annually on marketing to physicians in the form of gifts, travel, meals and other consulting fees, according to a May 22, 2008, press release by Senator Grassley’s office. In the November 1, 2007, New England Journal of Medicine paper, “Doctors and Drug Companies – Scrutinizing Influential Relationships,” Dr Eric Campell, associate professor at the Institute of Health Policy at Massachusetts General Hospital and Harvard Medical School, writes:

“Individual physicians can take some steps to maximize the benefits for patients and minimize the risks associated with their own industry relationships. They can start by recognizing that such relationships are designed to influence prescribing behavior and by carefully considering the potential effects that their own associations may have on their patients.”

“And they can bear in mind,” he says, “that the costs of industry dinners, trips, and other incentives are passed along to their patients in the form of higher drug prices.”

Antidepressant prescribing is more rampant in this country than any other. The US accounted for 66% of the global market in 2005, compared to 23% in Europe and 11% for the rest of world, according to a December 2006 report by Research and Markets.

A June 2007 survey by the Centers for Disease Control of doctor and hospital visits in 2005 showed that the most commonly prescribed drugs were antidepressants, with 48% of the prescriptions issued by primary care physicians. They have remained in the number one position ever since. Last year, 232 million prescriptions were filled for antidepressants worth nearly $12 billion, according to a March 2008 report by IMS Health.

The top dogs in the pharmaceutical industry are literally laughing all the way to the bank. For example, in 2007, Pfizer CEO Jeff Kindler’s pay package was worth $9.5 million, according to the March 14, 2008, Wall Street Journal. A previous CEO, David Shedlarz, left last year with an “exit package” worth over $34 million. In 2007, the total value of Wyeth’s then-CEO Robert Essner’s pay package was $24.1 million, the Journal reports.

In the meantime, state Medicaid programs are going bankrupt as a result of the mental illness epidemic occurring only in the US . Attorneys General all over the country are using consumer fraud statutes to sue the drug giants to recoup the money lost due to the illegal off-label promotion of psychiatric drugs and the concealment of their side effects.

For instance, Baum Hedlund has been litigating Private Attorney General consumer fraud class-action lawsuits against Glaxo since 2004, on behalf of individuals and entities such as insurance companies in California , Florida , Illinois , Massachusetts , Minnesota , Missouri , New Jersey , North Dakota , Ohio and Washington .

The cases are based on documents showing Glaxo promoted Paxil for kids, fully aware that Paxil failed to out-perform a placebo in the clinical trials and had higher suicidality rates. A national class settlement of individual claims was reached in April 2007 in which Glaxo agreed to reimburse parents for all of the money paid for Paxil prescriptions for their children. A national class settlement on behalf of third party payors (insurance companies) was just approved in September 2008.

If not for the few law firms willing to stay the course, the truth would never have been revealed. Baum Hedlund has been pursuing the SSRI makers for nearly two decades. Most recently, it has taken up the fight for babies born with birth defects caused by SSRI’s.

Because the industry was so successful at keeping the original SSRI trial data hidden, the drugs’ most serious side effects largely became public only as a result of the bravery and integrity of such medical experts as Dr Healy, Dr Glenmullen and Dr Breggin, who could not be bought and could not be bullied.

For fifteen years, the SSRI makers fought against adding a warning about an increased risk of suicidality, knowing all the long that the risk existed. Now, the companies are making the irresponsible argument (in defense of lawsuits claiming they failed to warn doctors and the public of the risk) that the FDA did not require them to add a warning, so they are immune from liability.

Worse yet, the industry-controlled FDA under the Bush Administration is supporting this audacious preemption defense and siding with the SSRI makers against private citizens in courts all over the country, telling judges to rule in favor of the drug companies and throw out the SSRI cases before they even make it to a jury.

Although not an SSRI case, the Supreme Court heard oral argument in a case involving federal preemption, in Wyeth v Levine, on November 3, 2008.

Evelyn Pringle
epringle05@yahoo.com

(Written as part of the Paxil Litigation Round-Up, Sponsored by Baum, Hedlund, Aristei & Goldman’s Pharmaceutical Litigation Department www.baumhedlundlaw.com)

Filed under: Birth Defects, Charles Grassley, FDA, Pregnancy, antidepressants, drugging children, suicide