CLOZARIL: Patient (34) Dies of Clozapine/Caffeine/Nicotine Poisoning

pills in hands

CLOZARIL DEATH, DRUG BUILDUP

More Than 7 Times The Toxic Level

What a horrible way for this young man’s loved ones to learn that something as seemingly harmless in our society as caffeinated drinks or nicotine withdrawal could add to the toxic buildup of this drug to the point of producing death! Of course I would hope you know there is NOTHING harmless about caffeine or nicotine. Caution must always be taken with stimulants in both the use and withdrawal of any stimulant drug. For those with loved ones on this drug or any other drug in this family of atypical antipsychotic drugs please take heed of this warning! From the original article below we read:

“Mr Gittins told the family of Christopher Davies, 34, he also had other cases yet to be heard which involved the use of clozapine, which Mr Davies had been prescribed for schizophrenia…..

“He had been a heavy smoker but reduced the habit even though he didn’t like electronic cigarettes.

“He also drank a large quantity of carbonated drinks.

“A post-mortem examination by pathologist Dr Pauline Dowling found death was due to clozapine poisoning as Mr Davies had more than seven times the toxic level of the drug.

“But the coroner said he had been made aware not only that the level might have been distorted following death, but it could have been affected by a reduction in smoking and by consumption of carbonated drinks.

“William Davies said: “We were warned very clearly about the dangers of not taking the tablets but not about the effects of reducing smoking and the caffeine.”

“He told the coroner the monthly monitoring merely checked his son’s blood and not the clozapine levels.

“Asked by the coroner whether he felt those two matters played a significant part in his son’s death, Mr Davies replied: “Yes.”

“Mr Gittins said in the light of the family’s concerns and the fact he was due to conduct other inquests involving the use of clozapine he would issue a Regulation 28 report under his duty to prevent future deaths.”

ORIGINAL ARTICLE: http://www.newsnorthwales.co.uk/news/138755/hawarden-man-with-schizophrenia-died-from-clozapine-poisoning.aspx#.VClDkPRIWGk.twitter

CLOZARIL WARNINGS FROM PACKAGE INSERT

After reading this Black Box Warning on Clozaril my question would be why anyone would ever take this drug other than by force or why any health professional would consider giving anything this dangerous to a patient in light of the Hippocratic oath they have taken?!!!

And since they do not spell out here how very deadly agranulocytosis is in this Black Box Warning allow me to relate that it is a very deadly blood disorder where you cannot produce red blood cells and become transfusion dependent. A dear friend of mine, Susan Johnson, from Atlanta, GA contracted agranulocytosis from her use of Prozac and went with us to testify to the FDA in 1991 on the first FDA hearing on antidepressants and suicide. She boldly told the FDA that they had better take action because her blood was already on their hands and the blood of many others would be on their hands if they did not take action then. Of course we know they did not take action then and still have not taken enough action to warn. Susan passed away less than two years after that from the agranulocytosis.

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IMPORTANT SAFETY INFORMATION
WARNING: AGRANULOCYTOSIS; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Agranulocytosis: CLOZARIL treatment has caused agranulocytosis, defined as an absolute neutrophil count (ANC) less than 500/mm3. Agranulocytosis can lead to serious infection and death. Prior to initiating treatment with CLOZARIL, obtain a baseline white blood cell count (WBC) and ANC. The ANC must be greater than or equal to 2000/mm3 and the WBC must be greater than or equal to 3500/mm3 for a patient to begin treatment with CLOZARIL. During treatment, patients must have regular monitoring of ANC and WBC. Discontinue CLOZARIL and do not rechallenge if the ANC is less than 1000/mm3 or the WBC is less than 2000/mm3. Advise patients to immediately report symptoms consistent with agranulocytosis or infection (e.g., fever, weakness, lethargy, or sore throat) [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].
Because of the risk of agranulocytosis, CLOZARIL is available only through a restricted program called the Clozaril National Registry. Under the Clozaril National Registry, prescribers, patients, and pharmacies must enroll in the program [see Warnings and Precautions (5.2)].

Orthostatic Hypotension, Bradycardia, Syncope: Orthostatic hypotension, bradycardia, syncope, and cardiac arrest have occurred with CLOZARIL treatment. The risk is highest during the initial titration period, particularly with rapid dose escalation. These reactions can occur with the first dose, with doses as low as 12.5 mg per day. Initiate treatment at 12.5 mg once or twice daily; titrate slowly; and use divided dosages. Use CLOZARIL cautiously in patients with cardiovascular or cerebrovascular disease or conditions predisposing to hypotension (e.g., dehydration, use of antihypertensive medications) [see Dosage and Administration (2.2, and 2.5) and Warnings and Precautions (5.3)].

Seizures: Seizures have occurred with CLOZARIL treatment. The risk is dose-related. Initiate treatment at 12.5 mg, titrate gradually, and use divided dosing. Use caution when administering CLOZARIL to patients with a history of seizures or other predisposing risk factors for seizure (CNS pathology, medications that lower the seizure threshold, alcohol abuse). Caution patients about engaging in any activity where sudden loss of consciousness could cause serious risk to themselves or others [see Dosage and Administration (2.2), Warnings and Precautions (5.4)].

Myocarditis and Cardiomyopathy: Fatal myocarditis and cardiomyopathy have occurred with CLOZARIL treatment. Discontinue CLOZARIL and obtain a cardiac evaluation upon suspicion of these reactions. Generally, patients with clozaril-related myocarditis or cardiomyopathy should not be rechallenged with CLOZARIL. Consider the possibility of myocarditis or cardiomyopathy if chest pain, tachycardia, palpitations, dyspnea, fever, flu-like symptoms, hypotension, or ECG changes occur [see Warnings and Precautions (5.5)].

Increased Mortality in Elderly Patients with Dementia-Related Psychosis:
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CLOZARIL is not approved for use in patients with dementia-related psychosis [see Warnings and Precautions (5.6)].

 

Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & http://ssristories.drugawareness.org
Author: ”Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

WITHDRAWAL HELP: You can find the hour and a half long CD on safe and effective withdrawal helps here: http://store.drugawareness.org/ And if you need additional consultations with Ann Blake-Tracy, you can book one at www.drugawareness.org or sign up for one of the memberships for the International Coalition for Drug Awareness which includes free consultations as one of the benefits of that particular membership plan.

WITHDRAWAL WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

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Amy – Zoloft Survivor

In 2004, I gave birth to my son, Isaac, on Thursday, July 8. I had significant stresses in my life for several years and especially in the months prior to the birth, but throughout it all I remained happy and healthy and calm and patient. One major stress was moving from Georgia to Minnesota when I was about 8 months pregnant. I loved Georgia but dreaded Minnesota, and was being forced to move for my husband Joel’s new job.

Though I had wanted to deliver naturally, I ended up having Pitocin, an epidural, an episiotomy, epinephrine (synthetic adrenaline), and a vacuum extraction. I also had oxygen therapy for most of the end of labor and delivery. (I recently learned that epinephrine leads to mental disturbances. Pitocin and epidurals can cause an abnormal fetal heart rate, and epidurals can cause respiratory issues.) The final contraction for the baby’s delivery had to be induced with an increase in Pitocin. I was so numb in my lower body I couldn’t even feel when I was supposed to be pushing. I had pushed for an hour and 15 minutes before the doctor grew impatient with me and decided to intervene. Nevertheless I was enamored with my new baby and motherhood and nursing.

The nurses were concerned about Isaac’s weight loss early on (I recently learned that the infant’s weight loss is excessive when you have an epidural, which involves a drug derived from cocaine, and babies exposed to IV fluids are more likely to lose a large amount of weight after birth and get jaundice & hypoglycemia). They had taken him to the nursery overnight twice and told me he could go several hours without eating, but then wondered why he was losing weight. They blamed it on my milk not coming in yet. They shoved us out of the hospital at 48 hours postpartum with some formula samples.

The next morning, when he was three days old, Isaac had to go to the ER. A nurse called me at 10 a.m. to ask me how many diapers Isaac had since we brought him home. When I told her he hadn’t had one in almost eight hours, she told me to take him to Children’s to check for dehydration and jaundice. The ER doctor at Children’s said he seemed fine but sent us home with a bottle of formula just in case we needed it. Back at home again, Joel fed it to him (it was way too much for a newborn), and Isaac threw it up projectile style. Then Isaac fell asleep. Later I noticed he looked a little blue on the skin around his mouth and on his hands and feet. I couldn’t wake him.

We called 911. The paramedics couldn’t find any reason for the overly lethargic baby, blue hands, feet and mouth, but recommended we take him back to Children’s.

A few minutes after we walked into the ER, Isaac nearly choked to death. The staff saved him and he was admitted over night. I was scared he might choke again during or following a feeding, or from getting a small object in his mouth. The doctors explained that Isaac would be just fine with eating, and that the 8 ounce bottle (which they had given us earlier) had just been too much for a newborn. Coincidentally, had it not been for the vacuum extraction, Isaac wouldn’t have had high hemoglobin that made him look like he was turning blue, the first signal to me that something was not right. When we returned home my anxiety worsened from somewhat normal to severe. I had a panic attack. I called my OB and he said I might be having a heart attack and need to go to the ER, or it could be a panic attack. I didn’t want to go to the hospital any more so I just tried to rest.

I felt somewhat better the next day but the home health nurse who came out to check on us advised me to start taking drugs for anxiety. She set up an appointment with my OB/GYN.

For days I refused to let others feed him a bottle unless I was there to watch or listen to make sure he didn’t choke. For the most part I was nursing, but occasionally I let someone feed him a bottle because of medical advice that I “get my rest, and let others take care of Isaac” while I took care of myself. But I could not sleep with others feeding him a bottle, and even when he wasn’t eating, I couldn’t sleep out of fear I was going to wake up to a dead baby. I slept a lot of the time with my hand draped into the bassinet on his tummy to feel it move up and down with each breath.

I walked into my OB’s office with my baby, on Wednesday one week after the birth. The nurse at the desk asked if I was here for my 6-week appointment. I said, no, the baby was only six days old. Then, with a look of horror, she said, “Oh, you must be having problems, then.” I nodded. The nurse let me in within a few minutes and took my blood pressure. It was like 149 over 120 or something, way higher than usual.

When I saw the doctor, I began to talk about the stress of the ER visits, the panic attack, my blood pressure, my inability to sleep, etc. He interrupted me after about one minute and said, “What did the nurse you saw at home yesterday tell you?” I replied that she said I had anxiety and needed drugs. He quickly recommended I start taking 50 mg of Zoloft and possibly up my dose. He said that Zoloft is the standard of care for post-partum depression. Then he said, “Or post-partum anxiety in your case, although people don’t recognize that as much as they do PPD.”

The sample package of Zoloft he gave me was labeled for use in PMDD. He said it would take six weeks to work and I might need to stay on it for six months to a year or longer. He said he felt we needed to be aggressive in treating this, and not to stop taking it once I felt better because it was probably going to get worse and maybe even dangerous if I didn’t take the drugs. There was no information label attached to the sample pack.

I asked about having my thyroid checked because my mother-in-law was worried that could be causing my problems. I had been on thyroid medication for years and never needed a dose adjustment, and my doctor knew this. He said that there are no valid post-partum thyroid levels and he didn’t want to test it.

I asked about Zoloft’s safety for nursing and the doctor said it would make my baby happy too. He also prescribed Clonipin in case of more panic attacks, but told me I needed to check with my son’s pediatrician before taking it (I never took the Clonipin because I didn’t have any more panic attacks). He started to leave and told me to call if I had any side effects that bothered me. I asked if I could take the Zoloft right away and if it would help my blood pressure, and he said to go ahead.

Within minutes on Zoloft I began to feel a little less anxious. We walked to Joel’s office (a few blocks) to show off the new baby. I even let some woman at the office hold him. I had a sense that my anxiety had been too strong and that Zoloft was going to make it better.

Within several hours I felt a bit detached from my new baby, my family, and even my own emotions. While earlier that day I was fearful and protective, with a strong need to have my baby in my arms at all times, yet extremely overjoyed with my baby and life all at the same time, within hours I felt like a different person.

Things gradually got worse and I struggled to feel the joy that was mine a few hours before. Sometimes I felt a bit giddy, but I didn’t feel really happy. I could laugh and make jokes and play with the baby, but it was temporary. I couldn’t feel the overwhelming love I had before I took Zoloft. I continued this way until the most unimaginable thing happened.

That Friday, sleep deprived, I sat next to my mom on the couch, trying to nurse a very sleepy baby in the middle of the night. I remember thinking I had lost my love and adoration for my baby because I was too tired to feel anything. I knew that I loved him but I couldn’t feel it the way I had a few days before. I couldn’t understand why I had to be the only one to stay up all the time and never sleep, and my baby, who needed to eat, couldn’t stay awake long enough to get much food.

As I gave up on the feeding and walked past the stairs to our bedroom to lay the baby in his bassinet, I hallucinated – I saw myself standing about half-way down the stairs, throwing the baby down.

I had no history of mental illness. Never could I have imagined I would think such a thought, let alone hallucinate killing my baby. I went to the kitchen with my mom after I put the baby down and started to cry and told her I was afraid I was going to lose my mind and hurt myself or hurt the baby. She said that wouldn’t happen. She hugged me and told me to get some sleep. Upstairs in bed, I still cried for a long time and then told Joel I was afraid I was going to lose it and that I couldn’t sleep. He told me to get some sleep. I can’t remember if I got any sleep that night.

The next morning Joel and I were holding the baby and watching movies in the living room. But I couldn’t stop being afraid. I was convinced that I was on the edge of losing my mind. I felt like I couldn’t hold the baby, and I asked Joel to hold him. He didn’t understand why. I said I couldn’t hold him, or carry him past the stairs in the state of mind I was in. Joel got really freaked out as I told him about what had happened; he said what I was telling him was disturbing. I just wanted help. I told him I didn’t know why it all happened but I was really scared and I was afraid to hold the baby. I just wanted him to take over and maybe calm me down. He suggested I go take a bath and relax. But I couldn’t do that because I was having thoughts of suicide. I was afraid if I went in the bathroom by myself I would certainly find a way to kill myself with a razor or pills. I was so scared I was going to hurt the baby that I wanted to protect him from me by killing myself. But at the same time I knew this was all crazy and I didn’t want to die. I didn’t want to hurt the baby.

We called the help line for our insurance and the nurse recommended I go to an ER right away. Joel asked what they could do for me at the ER and she said they would give me drugs to stop the thoughts and make me feel better.
This seemed to me like a reasonable thing.

At this point my son was nine days old. We went to the ER, where the doctors pretty much ignored me for a while, gave me some disgusting hospital food, and then came in to talk to me. The doctor nonchalantly told me I wasn’t evil and that I just wanted to kill myself because I was feeling guilty about having thoughts of hurting my baby. I asked how long the thoughts would continue and he said, maybe three weeks or even three months. This was unbearable to me. I already felt bad enough, and to imagine having thoughts of harming my baby for even three days, let alone weeks, was too much. I burst into tears for about the 5th time in the ER room. As I waited and waited for another visit from the next in the series of hospital employees, and I tried to sleep, I was so tired I almost instantly passed out, but only to a vision of myself drowning my baby in our bathtub. Every time I closed my eyes to rest I got frightened and opened my eyes again. I could not let myself fall asleep. I was afraid I was going to fall asleep, and my spirit and mind would die, and when I woke up, I would be someone else.

Then a woman came in with a computer and asked me a bunch of questions and entered in my responses. She tried to make Joel leave for the questioning but I wouldn’t allow it. Judging from a report I obtained months later, she distorted the information I was telling her, making things seem even worse than they already were.

Following her computerized “diagnostic” process, she recommended I be admitted to the psychiatric ward so I could “get someone to talk to and get some help.”

I asked if I could be admitted to a room in a non-psychiatric ward where I could have Joel and Isaac stay with me like they did in the maternity ward. She said no. I said that I didn’t want to be admitted if it meant I had to leave my family. She told me that I could go home after 12 hours if I wanted to, that the admission was voluntary unless a doctor decided to keep me there longer.
She had me sign some admission form and then the nurse walked me and Joel up to the psychiatric ward.

I had only to take one look at the inside before I knew I wanted to go home. I started crying to Joel to take me home, but he said he didn’t want to do that because I needed help, and he was afraid for me and the baby. The nurse told me that I should give it a try. But leaving wasn’t an option anyway since I had signed the admission form. Joel left to get me some things I would need and the nurse took me to a room where he asked me a few questions and had me sign some more forms.
He made me agree that I was willing to do anything to help my treatment. Then he took me to my room and left me there. I didn’t like my room, and there was a girl in there trying to sleep so I left and tried to find some place to sit. There weren’t many places to sit except the room, and there was a phone with a line of patients waiting for it, a few nasty, mismatched chairs, some broken shelves with old games, and a small dining area. I went to the nurses’ station and knocked on the glass and asked to talk to my nurse. I told him I wasn’t happy here and wanted to just go home and that I had changed my mind about the voluntary admission. He told me that the doctors would never let me leave this soon anyway and I should just wait for the doctor to see me and start getting my help. I asked when I could see the doctor and he said not until the next day, or maybe Monday.

I said I needed someone to talk to and he wasn’t being helpful and neither were the doctors. I asked how I could get released and he told me I had to sign an intent-to-leave form and wait 12 hours from that time and I could be released unless the doctor decided to place a hold on me for up to 72 hours. I filled out the form and awaited Joel’s arrival with my bag.

What had started out as a voluntary admission quickly became involuntary. Joel arrived and we waited for an answer from the nurse who was already in the process of checking on my release. Soon we were told that the doctor had placed a 72-hour hold on me but that it wouldn’t start until Monday morning (this was Saturday) when he could see me. We couldn’t understand why the doctor wouldn’t release me when he hadn’t met me or talked to me.

Joel stayed with me as long as he could but then left to go to our house and take care of Isaac (my mom had been taking care of him all day). Later that night the nurses came in to give me meds. They brought me my Synthroid, and several additional drugs- I think they were an anti-psychotic, a tranquilizer, and Ambien. But with these new meds came some information sheets. I quickly read the indications and the warnings, and refused to take them. Not only were they unsafe for nursing, they were indicated to treat “schizophrenia and other mental illnesses” and had many dangerous sounding side effects, such as nightmares, suicidal thoughts, etc. This was the first time I had seen a fact sheet like this, since my Zoloft samples from the OB/GYN three days earlier came with no fact sheet or warnings whatsoever. I also got a fact sheet for Zoloft for the first time.

All alone and with no one to talk to, there was nothing I could do but cry or sleep. I did a lot of crying and pumping of my milk for the baby, even one session in the middle of the night, but I also did a lot of sleeping.

The next morning, Sunday, I felt pretty good in comparison to the day before. I felt more rested than I had been since before my baby was born. And I didn’t feel as unstable or frightened as I had the day before. Since I had been taking Zoloft in the mornings, I hadn’t had a dose for over 24 hours. It occurred to me that perhaps Zoloft could be causing my problems.

I phoned Joel and said that I felt a lot better and wanted to talk to the doctor before taking any more Zoloft.

The nurses reported to the doctor that I was refusing to take my meds and the doctor did see me that day. He talked to me for no more than 10 minutes and told me to keep taking my Zoloft. I expressed concern about its side effects but he said to keep taking it anyway, that all my problems were not caused by Zoloft. It was clear the only reason he came to see me was so he could gather the required information for his background report. The only questions he asked me relating to a mental illness were whether I check the locks a lot and whether I have a family history of mental or emotional problems. I told him that I do check locks occasionally, but not repeatedly, but I have to check them because Joel forgets to lock the door (which he still does to this day). I told him that some members of my family had some emotional issues but not severe ones. I answered every biographical question honestly. I couldn’t really understand why it was important for him to know what clubs I was in during high school or whether I had a serious boyfriend as a teen. And why wasn’t he asking me about the events leading up to my prescription for Zoloft?

I tried to get something more from him and asked him if he thought I could have PTSD from witnessing my son nearly die in the ER from choking. But he said “I have no idea.” And he also said “Your son didn’t almost die.” (Later I learned from reading my file that the lady with the computer had written that I was obsessed about my baby and had imagined him turning blue and taken him to the ER twice where nothing was found to be wrong with him). Then when I expressed my desire to leave because I wasn’t getting counseling and I felt the environment was depressing and the nurses were rude and borderline verbally abusive to me and other patients, he said that was just my paranoia.

My mom, Joel, and Isaac came later that day for a visit. I explained what was going on, how I had been ridiculed for requesting sanitary pads after mine had been taken from my bathroom while I slept, and was treated rudely when I asked for access to my Tucks pads, a place to clean my episiotomy, and the chance to talk to the doctor before taking any more meds, and how I had been not allowed to sanitize my breast pump or get anyone to talk with me about my emotional problems. I explained that the doctor spent about seven minutes with me, left, and wanted to leave me there for an indefinite proportion of the maximum 72 hours from Monday.

Joel and mom could not believe the mistreatment and lack of treatment and threatened to call a lawyer or the press, because the doctor (who was on-call) refused to come up to the hospital or even talk to Joel on the phone that day. One of the nurses was in the room along with an OB/GYN consulting doctor as my mom explained several incidences of ridiculous behavior on the part of the staff. The psychiatric nurse and the OB were really shocked at all the staff had done to me.

That night as my family left, I felt my heart being ripped out again because of my desperate need to be with the people who loved me, and to be with my newborn son.

Monday the doctor requested a family meeting. He agreed to release me with several conditions- that I get psychiatric outpatient care, take parenting classes, stay on Zoloft, and get counseling. He said I had post-partum depression with psychotic features and left it up to my mom and husband to protect me and my son.

As I left the hospital, my mom called her friend who was a Ph.D. Clinical Psychologist. She put me on the phone. I told her my new “diagnosis” and she said I might need to try to get up to a more therapeutic dose of 150 mg, and that 50 mg is just a starting dose.

Over the course of a few weeks I sought counseling, psychiatric help, and adjusted my dose of Zoloft up. My mom tried to convince me that Zoloft was possibly the reason for my problems, but I didn’t listen to her. I listened to the doctors who said I was psychotic. But each time I adjusted my dose, the violent thoughts got worse. I was no longer having hallucinations but I was plagued by persistent “bad thoughts” and the feeling that I had little control over myself. I practiced “I’m in control” messages constantly and used a calming down technique that I learned in therapy. My therapist explained to me that I wasn’t like the moms who kill their babies because I wasn’t angry at the baby, I was just afraid I was going to hurt him, and that I always sought help when I felt overwhelmed, so I would be able to do it again if necessary. For months I worked on my goal of being able to take care of my son without supervision from my mom and Joel.

Most people believe co-sleeping is dangerous. I fully believed this at the time, and I feared rolling over on my son, even though my mother encouraged me to co-sleep and nurse exclusively (and even though I remembered sleeping with my own parents and siblings in our family bed). Psychiatrists told me I needed to let others care for Isaac at night and get at least 8 hours of sleep to stay healthy. Joel and my mom would feed Isaac at night while I slept. Joel started to get sleep deprived and my mom had to take over after he had a car accident. My mom would stay up much of the night with Isaac and then all day with me to keep me feeling safe, and when Joel got home from work she would go to bed to rest for her night duty. I had to set up safeguards for myself so I felt I would not leave the room and kill my baby in the night or kill myself while others were asleep. Eventually Isaac moved from our room to the guest room with my mom. She would bring him to me for feedings in the morning, and sit in the recliner and watch me feed him in bed. Throughout the day she was constantly watching me. If she left me alone with the baby for five minutes, I would freak out. Once she was taking a bath, and I yelled to her to hurry up because I was going to put Isaac in his crib and lock myself out of the house. Eventually, she would take her bath as soon as Joel got home, and then go to bed, to rest for her night duty.

My therapist suggested I add another bottle of formula to the regimen each day so I could get more time to myself. She thought I was having a hard time with motherhood because of the demands of breastfeeding. My psychiatrist increased my dose of Zoloft twice and I still didn’t get better – just worse each time the dose went up. She wanted to switch me to anti-psychotics and stop nursing to do this. I considered going along with it but decided against it because I didn’t want to lose time and progress by going through withdrawal and adjusting to new medications. I also did not want to completely stop nursing.

I began to reconsider everything. I started to nurse more. Finally one night when Isaac was about six weeks old I decided to take him to bed because I was more afraid of falling asleep and dropping him from the chair than I was of rolling on him in the bed. I discovered I could co-sleep and breastfeed simultaneously. Since then I get enough sleep, and so does my family.

Around the same time I had my 6-week checkup with my OB. By this time he was willing to test my thyroid. Two days after the appointment, I got a call from him reporting that I had hyperthyroidism and I needed to back off of my Synthroid and see an endocrinologist.
mood disorders Melanie Blocker Sto
I began to understand what was wrong with me. I knew that I could have breast-fed my baby just fine without nurses taking him and making him starve in the newborn nursery, without bottles of formula, and still get all my sleep as I was now getting through co-sleeping. And I also began to see the pattern that had emerged. Repeated interference from medical staff had resulted in a less-than-desirable labor & delivery, emergencies for my son, subsequent panic for me, Zoloft, and subsequent hospitalization. All the while this was aggravated by Synthroid on top of underlying, undetected hyperthyroidism.

My endocrinologist dismissed the notion that Zoloft could be a culprit in my psychosis. But she did attribute the symptoms to my post-partum thyroiditis and also probably thought I was a little bit nuts. She said had she seen me earlier, she could have helped me more by giving me beta blockers. I learned much later that beta blockers can also cause depression, so I’m actually thankful that my OB didn’t refer me earlier, as I may have had to deal with Zoloft and beta blockers at the same time!

Empowered by my new diagnosis and treatment, I began to feel healthier. But the thoughts never went away. I just felt better physically. It really bothered me that I couldn’t get these thoughts out of my head. Despite my growing ability to spend increasing amounts of time alone with my son, I didn’t feel right. I started believing that it was possible that Zoloft had planted some foreign thoughts in my mind.

I began to consider stopping Zoloft. Every doctor I was in contact with didn’t like that idea. Isaac’s pediatrician said that Zoloft just gives people enough energy to kill themselves. She didn’t touch the violence issue. The psychiatrist all but refused to give me withdrawal information until I called her and told her I had already started to cut back and wanted information on how to do so safely.

My mom was planning to go back to Texas, so I had to get better. I withdrew from Zoloft over a few weeks and started to feel more like myself again.

Since I stopped taking Zoloft, I feel normal. I take care of Isaac by myself and stay socially active. I never feel out of control like I did on Zoloft, but the memories of losing my grip on sanity will never go away. Never again will I subject myself to drugs to “heal” my mind.

I am looking forward to a long life. It is something that Zoloft tried to take away from me. But I beat it. I beat the thoughts, the urges, and I regained my hope. As a result of this ordeal I am more confident in my true self and my ability to get through the worst life can offer you.

Amy Philo
Zoloft Survivor

I can’t remember if I stated this before, however when certain comments were added to my most recent youtube video it made me wonder if I was very clear in telling this story of what happened to me. Yes, a lot of people have thyroid problems which lead to prescriptions for drugs. However I do not believe in the slightest that my thyroid had anything to do with the suicidal urges and homicidal urges.

I have since had a second baby. This time I had a home birth with a midwife attending. I did notice that I felt crummy and irritable if I did not eat enough or rest enough (I have since learned why this happens, you lose a ton of blood continuously and it gets worse if you don’t rest because your uterus is literally bleeding until it completely contracts and you stop having post-baby bleeding). Some of the worst advice I ever got in my life all compounded into one giant insurmountable confusion-fest which was only made worse by Zoloft, most of the bad advice started with my OBGYN’s statement to me that I was too fat and breastfeeding is a great time to lose weight / diet, but a lot of it coming from other sources as well. These included the advice to formula feed rather than telling me I could breastfeed while sleeping (if I hadn’t fed Isaac the bottle when he was 3 days old, he never would have nearly choked to death), the anti-cosleeping dogma that is prevalent in our society, and the blatant lies and omissions from psychiatrists and nurses who should have known or told me that there was a possibility that my really bad psychotic symptoms were drug-related.
The panic attack was absolutely legitimate, perhaps I would not have had it if my baby never almost died, or if I wasn’t rapidly coming down from the effects of labor drugs and pain meds. However a panic attack is not in any way similar to what Zoloft does.

Those who doubt that Zoloft can do this, I want you to go pick up a copy of David Healy’s Let Them Eat Prozac. In this book he outlines all the evidence that SSRIs induce violence and suicide. He states that a good example of proof is the dose-dependent relationship between suicidality and SSRIs. Also, a challenge, dechallenge, and rechallenge protocol has been used to demonstrate the effect.

David Healy is critical of SSRIs but he still prescribes them to some patients. If someone who is in one sense an advocate for the drugs can admit in a several hundred page book all the negative things about SSRIs then I do not understand why people insist on disbelieving that.

When I was on Zoloft there was clearly a dose dependent relationship between homicidal urges and Zoloft. Every time the dose went up, the thoughts got worse. I also had terrible withdrawal (not physical pain necessarily but definitely jitters) including worsening homicidal thoughts. At times I would think things like “If I just kill myself and the baby now, this hell will be over and I will never have to deal with this again.”

This is the type of hell that people somehow think is an acceptable side effect. The number of people suffering from this is not insignificant, and in fact at least 60% of patients discontinue SSRIs within a few weeks because they find it unacceptable. How many others are trapped into staying on them by bad advice and delusions given toa them by their doctors, or by insurmountable withdrawal syndrome?

Nothing of the sort of psychological torture I endured on Zoloft has visited me after my second baby. Doctors warned me to not have any more kids because there is supposedly a 90% chance that PPD will return. I am thankful that I did not listen to them, and it saddens me to think of all the babies like Toby who never got to be born because of poisonous lies from the pharma dogma. It’s almost like a form of population control / eugenics!!!!!!

By the way, Isaac is now 3.5 and Toby is 15 months…

Here is mine

http://chaada.org/smf/index.php?topic=15.0

Join the Coalition! Sign the Petition! StopThe MOTHERS Act!

uniteforlife.org

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Experts: Women are drinking more, DUIs are up 28.8% from 1998-2007

Note from Ann Blake-Tracy: After researching and warning for two decades that this crisis with alcohol consumption would come, I can tell you the reason so many women are now drinking is because they are the main ones taking antidepressants which in turn cause overwhelming cravings for alcohol. And it has long been known that women suffer more adverse reactions to antidepressants than men do.

But why cravings for alcohol? These drugs drop the blood sugar causing cravings for sugar and/or alcohol and NutraSweet. Sugar and alcohol initially bring the blood sugar up quickly causing one to instinctively reach for them in a “self medicating” way because they quickly address the low blood sugar level. The problem with doing this is that both substances then drop the sugar levels even lower than before thus producing a vicious cycle of craving more and more sugar and/or alcohol. (To read the science behind this go to www.drugawareness.org)
Another aspect to this increased use in alcohol being tied to antidepressant use is the fact that antidepressants produce mania or Bipolar Disorder so frequently. (See the research article we posted earlier this week showing that 81% of those diagnosed with Bipolar Disorder have been found to have previously taken antidepressants or Ritalin.)
Initially doctors refused to prescribe the first SSRI, Prozac, because of its strong potential to chemically induce mania. There are several types of mania that are recognized. Many have never even heard of these types of mania. And most do not think of these various types of mania when they hear the term Bipolar. Let’s list just a few to shed some additional light on this drinking problem women, who have always taken more antidepressants than men, have developed since these drugs have become so widespread in use.

Pyromania: A compulsion to start fires
Kleptomania: A compulsion to embezzle, shoplift, commit robberies
Dipsomania: An uncontrollable urge to drink alcohol
Nymphomania and erotomania: Sexual compulsions – a pathologic preoccupation with sexual fantasies or activities

So there it is in black and white plain as day – one of the forms of mania, dipsomania, is described as an “uncontrollable urge to drink alcohol.” Could it be any clearer?

Learn More

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And look at one of the comments from the article below:
“Younger women feel more empowered, more equal to men, and have been beginning to exhibit the same uninhibited behaviors as men,” said Chris Cochran of the California Office of Traffic Safety.
Does that not describe manic behavior – “empowered” or all powerful with grandiose thoughts of one’s self and “uninhibited”? Those have always been earmarks warning of mania.
Hopefully this news about women and drinking will FINALLY wake America up to what first caught my attention with the use of antidepressants – the OVERWHELMING out-of-character cravings for alcohol that is produced by these drugs. (Find much more additional information on this subject at www.drugawareness.org)
Ann Blake Tracy, Ph.D., Executive Director,
International Coalition For Drug Awareness
Website:
www.drugawareness.org & www.ssristories.drugawareness.org
Author: Prozac: Panacea or Pandora? – Our Serotonin Nightmare
& CD or audio tape on safe withdrawal: “Help! I Can’t Get
Off My Antidepressant!”
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Experts: Women are drinking more, DUIs are up

http://us.rd.yahoo.com/dailynews/ap/brand/SIG=br2v03/*http://www.ap.org

AP – Graphic shows driving under the influence arrests for men and women for 1998 and 2007; includes alcohol-impaired …
By LISA A. FLAM, Associated Press Writer Lisa A. Flam, Associated Press Writer 10 mins ago

NEW YORK – It seemed too horrendous even to imagine. But the case of the mother who caused a deadly wrong-way crash while drunk and stoned is part of a disturbing trend: Women in the U.S. are drinking more, and drunken-driving arrests among women are rising rapidly while falling among men.

And some of those women, as in the New York case, are getting behind the wheel with kids in the back.

Men still drink more than women and are responsible for more drunken-driving cases. But the gap is narrowing, and among the reasons cited are that women are feeling greater pressures at work and home, they are driving more, and they are behaving more recklessly.

“Younger women feel more empowered, more equal to men, and have been beginning to exhibit the same uninhibited behaviors as men,” said Chris Cochran of the California Office of Traffic Safety.

Another possible reason cited for the rising arrests: Police are less likely to let women off the hook these days.

Nationwide, the number of women arrested for driving under the influence of alcohol or drugs was 28.8 percent higher in 2007 than it was in 1998, while the number of men arrested was 7.5 percent lower, according to FBI figures that cover about 56 percent of the country. (Despite the incomplete sample, Alfred Blumstein, a Carnegie Mellon University criminologist, said the trend probably holds true for the country as a whole.)

“Women are picking up some of the dangerously bad habits of men,” said Chuck Hurley, CEO of Mothers Against Drunk Driving.

In New York’s Westchester County, where Diane Schuler’s crash killed her and seven other people last month, the number of women arrested for drunken driving is up 2 percent this year, and officers said they are noticing more women with children in the back seat.

“We realized for the last two to three years, the pattern of more female drivers, particularly mothers with kids in their cars, getting arrested for drunk driving,” said Tom Meier, director of Drug Prevention and Stop DWI for the county.

In one case there, a woman out clubbing with her teenage daughter was sent to prison for causing a wrong-way crash that killed her daughter’s friend.

Another woman was charged with driving drunk after witnesses said she had been drinking all day before going to pick up her children at school. Authorities said the children were scared during the ride, and once they got home, they jumped out of the car, ran to a neighbor’s house and told an adult, who called police. The mother lay passed out in the car, and police said her blood alcohol level was 0.27 percent — more than three times the legal limit.

In California, based on the same FBI figures, women accounted for 18.8 percent of all DUI arrests in 2007, up from 13.5 percent in 1998, according to the California Office of Traffic Safety.

Nearly 250 youngsters were killed in alcohol-related crashes in the U.S. in 2007, and most of them were passengers in the car with the impaired driver, according to the National Highway Safety Administration.

“Drunk drivers often carry their kids with them,” said MADD’s Hurley. “It’s the ultimate form of child abuse.”

Arrests of drunken mothers with children in the car remain rare, but police officers can generally list a few.

In the Chicago suburb of Wheaton, Supreme Court Justice Antonin Scalia‘s daughter was stopped by police after she pulled away from a McDonald’s with three of her kids in the car. She pleaded guilty to drunken driving and was sentenced to 18 months of court supervision.

Sgt. Glen Williams of the Creve Coeur, Mo., police department recalls stopping a suspected drunken driver on her way to pick up two preschoolers.

Sometime later, “she told me it actually changed her life, getting arrested,” he said. “She was forced to get help and realized she’d had a problem.”

The increase in arrests comes as women are drinking excessively more than in the past.

One federal study found that the number of women who reported abusing alcohol (having at least four drinks in a day) rose from 1.5 percent to 2.6 percent over the 10-year period that ended in 2002. For women ages 30 to 44, Schuler’s age group, the number more than doubled, from 1.5 percent to 3.3 percent.

The problem has caught the attention of the federal government. The Transportation Department’s annual crackdown on drunken driving, which begins later this month, will focus on women.

“There’s the impression out there that drunk driving is strictly a male issue, and it is certainly not the case,” said Rae Tyson, spokesman for the National Highway Traffic Safety Administration. “There are a number of parts of the country where, in fact, the majority of impaired drivers involved in fatal crashes are female.”

Schuler’s relatives have denied she was an alcoholic and said they were shocked to learn of her drug and alcohol use before the July 26 crash. The wreck, about 35 miles north of New York City, killed Schuler, her 2-year-old daughter, her three nieces and three men in an oncoming SUV she hit with her minivan. Schuler’s 5-year-old son survived his injuries.

Schuler, a cable company executive, could have had a drinking problem that her family didn’t know about, said Elaine Ducharme, a psychologist in Connecticut who has seen more excessive drinking, overeating, smoking and drug abuse during the recession.

Unlike men, women tend to drink at home and alone, which allows them to conceal a problem more easily.

Because of this, they seek treatment less often than men, and when they do, it is at a later stage, often when something catastrophic has already happened, said Dr. Petros Levounis, director of the Addiction Institute of New York at St. Luke’s-Roosevelt Hospital Center.

“Our society has taught us that women have an extra burden to be the perfect mothers and perfect wives and perfect daughters and perfect everything,” Levounis said. “They tend to go to great lengths to keep everything intact from an external viewpoint while internally, they are in ruins.”

In the current recession, women’s incomes have become more important because so many men have lost their jobs, experts say. Men are helping out more at home, but working mothers still have the bulk of the child rearing responsibilities.

“Because of that, they have a bigger burden then most men do,” said clinical psychologist Carol Goldman. “We have to look at the pressures on women these days. They have to be the supermom.”

And just becoming a parent doesn’t mean people will stop using drugs or alcohol, Ducharme said: “If you have a real addictive personality, just having a child isn’t going to make the difference.”

___

Associated Press writers Solvej Schou in Los Angeles, Mark Tarm in Chicago and Betsy Taylor in St. Louis contributed to this report.


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CELEXA: Youth in India Dies During Clinical Trial

Paragraph 10 reads: “Concerns about the ethics of clinical trials do not exist merely in the realm of speculation. The GVK exposés are not unusual. An increasing number of reports are coming to light of unethical and illegal practices that exploit people’s social and economic vulnerability, subject them to serious risks without their knowledge and consent, and do not even assure them of access to the drugs developed from the trials. Certain types of trials depend on paid volunteers who desperately need money. In Gujarat, unemployed diamond workers and migrants from Uttar Pradesh and Bihar get paid between INR 5000 and INR 20,000 to take part in bioequivalence trials – sums large enough for them to put money over personal safety. Indeed, trial participants may be both financially and socially vulnerable. It is reported that Surender, who died in the Hyderabad felodipine trial, was one of a number of Dalit students being recruited for clinical trials in that city. Likewise, some years ago, a 22-year-old Adivasi youth died in a bioequivalence trial of the antidepressant citalopram [Celexa] by the Sun Pharma Advanced Research Centre in Vadodara. ”

http://www.himalmag.com/Bodies-for-hire;-The-outsourcing-of-clinical-trials_nw3213.html

Bodies for hire; The outsourcing of clinical trials August 2009
By: Sandhya Srinivasan

Medical testing by Western countries is having a staggering impact on India, if only we were to care to pay attention. And the government’s own policies are encouraging this.

Karen Haydock
In November 2008, the Hindustan Times’ LiveMint broke the story of an infant in Bangalore having died after being administered a vaccine in a drugs trial. The Drugs Controller-General of India (DCGI), Dr Surinder Singh, halted the testing, reportedly the first time that the office of the DCGI had taken such action. The trial, for a new pneumonia vaccine, was being conducted by a Hyderabad-based contracted research organisation, GVK Biotech, for the US-based multinational Wyeth Pharmaceuticals. The infant had been recruited from St. John’s Medical College, a reputed private medical institution in Bangalore.

GVK’s spokesperson claimed that the vaccine had nothing to do with the death, as the child had received an approved and widely used vaccine – not the experimental product. However, the DCGI’s investigation revealed that the infant had a heart condition, and that the trial had been meant to be conducted only on healthy babies. According to C M Gulhati, editor of the Monthly Index of Medical Specialities, India and a Delhi-based expert on clinical-trial regulations, the investigation revealed a number of other irregularities as well: the informed-consent document had not been signed before the child was recruited; and the St John’s ethics committee had not been properly constituted, as it was not chaired by an external member to ensure independent functioning.

Yet the infant’s death was not an aberration. In December 2008, 25-year-old K Surender, of Hyderabad, died in a ‘bioequivalence’ trial of a blood-pressure drug, felodipine. Bioequivalence trials test generic versions of drugs to ensure that they are as effective as the original, and involve administering the drug and then monitoring the individual through blood tests and other investigations. These tests are conducted on healthy people who are paid for their participation. The Hyderabad trial also happened to be run by GVK Biotech, which subsequently issued a statement that Surender had simultaneously been part of many bioequivalence studies, with GVK as well as other contracted research organisations. This multiple trial participation could have accounted for his death, argued the company.

Such an explanation is unconvincing. If Surender had taken part in many trials, it would only have been for the money, which would amount to an inducement according to national and international ethical guidelines for research – an inducement that might have made him overlook the risks of the trials. And, in any case, why did the company let him take part in the felodipine trial when it was aware that he had taken part in many others? The answer to this question lies in the compulsions of the global pharmaceutical industry. The GVK trials are among the increasing number of international clinical trials that are taking place in India – and the concerns that they raise will come up increasingly frequently in the future. The reports of various government and private bodies put the potential of the clinical-trial industry into billions of dollars, though the method of calculating these numbers is not available. One market-research company, Frost and Sullivan, reportedly estimates a USD two billion turnover by 2010.

Marcin Bondarowicz
The growth of the outsourced clinical-trial industry in India followed changes in the law in January 2005 that encourage clinical research in India. The most important of these was an amendment to the Drugs and Cosmetics Rules, permitting clinical trials in India to be carried out at the same time that they are done in other countries, rather than waiting until the results of drug trials in other countries were made public. Previously, this ‘phase lag’ had ensured that India was of no interest to big pharmaceutical companies to test their drugs. At that time, Phase II trials were permitted in India only after the results of a Phase III trial abroad were declared. And Phase I trials of foreign drugs were simply not permitted. (Phase I or safety trials are done on healthy ‘volunteers’, Phase II trials look at the drug’s safety and effectiveness on patients, and Phase III trials also look at safety and effectiveness, but in large numbers of patients.) It should be noted, though, that an exception was made for drugs deemed of importance to India. While the Drugs and Cosmetics Rules do not specify, such drugs would probably include the HIV vaccine.

This changed in January 2005, and India is now prominently on the radar screen of the international pharmaceutical industry in terms of clinical trials, given its vast population of potential trial subjects. As of today, the bulk of clinical trials are still located in rich countries. To illustrate, as of 19 July 2009, the US government clinical-trial database lists a total of 76,018 trials, of which 44,758 have sites in North America and 17,878 have sites in Europe – accounting for the bulk of trials. In contrast, only 1021 clinical trials have sites in India, in addition to 122 in Pakistan, 61 in Bangladesh and 12 each in Nepal and Sri Lanka.

However, the number of trials in India is growing fast. Figures given by the DCGI’s office show that the number of newly approved trials every year went from 100 in 2005, when the new rules kicked in, to about 500 in 2008. What is of concern here is that many of the trials that come to countries such as India are likely to be those rejected as unethical in Western countries. As trials shift to countries such as India, there has been an international debate on ethical concerns of the outsourcing boom. This debate has been partly responsible for amendments in the World Medical Association’s Declaration of Helsinki, “Ethical Principles for Medical Research Involving Human Subjects” in 1996, 2000 and in October 2008. Drug regulators in Europe and the US require that clinical trials submitted to them adhere to the Declaration.

Some of these changes have dealt with placebos or ‘sugar pills’. The October 2008 revision took a strong stance against the use of a placebo in a trial when a treatment exists. Clinical trials compare the effect of an experimental drug to an existing drug. If there is no drug for the condition, the experimental drug may be compared to a placebo. Using a placebo when a treatment exists deprives the trial participant of effective treatment. The ethical guidelines of the Indian Council of Medical Research and the World Medical Association’s Declaration of Helsinki both forbid the use of a placebo when an effective treatment exists, with certain specific exceptions. While both of these documents have been a bit ambiguous in the past, the 2008 revision of the Helsinki Declaration is clear: placebos can be used only when absolutely methodologically necessary, and when the risk to the participant is low. This revision was reportedly preceded by behind-the-scenes lobbying by the drug industry to permit greater use of placebo controls.

In the same month that the revised Declaration was announced, the US Food and Drug Administration (FDA) amended its own requirements for clinical trials. While placebos are rarely necessary, regulatory bodies such as the FDA require placebo-controlled trials to give marketing approval to new drugs. Yet as of October 2008, trials conducted for FDA approval no longer had to adhere to the Declaration of Helsinki – an internationally accepted document, but not binding unless incorporated into national regulations. The FDA would continue to require placebo controls, and no one was going to tell them otherwise.

Concerns about the ethics of clinical trials do not exist merely in the realm of speculation. The GVK exposés are not unusual. An increasing number of reports are coming to light of unethical and illegal practices that exploit people’s social and economic vulnerability, subject them to serious risks without their knowledge and consent, and do not even assure them of access to the drugs developed from the trials. Certain types of trials depend on paid volunteers who desperately need money. In Gujarat, unemployed diamond workers and migrants from Uttar Pradesh and Bihar get paid between INR 5000 and INR 20,000 to take part in bioequivalence trials – sums large enough for them to put money over personal safety. Indeed, trial participants may be both financially and socially vulnerable. It is reported that Surender, who died in the Hyderabad felodipine trial, was one of a number of Dalit students being recruited for clinical trials in that city. Likewise, some years ago, a 22-year-old Adivasi youth died in a bioequivalence trial of the antidepressant citalopram by the Sun Pharma Advanced Research Centre in Vadodara.

Certain types of trials are more likely to be conducted in India and other countries where regulatory and monitoring mechanisms are weak, or regulators are too willing to please drug companies. The use of placebos is a good example, as it is not difficult to conduct placebo trials in India. In 2005-06, Indian patients with schizophrenia were taken off their regular medication and given either a new, ‘extended-release’ formulation of an approved drug (quetiapine, marketed by AstraZeneca) or a placebo, to compare the time it took for people in each group to have a relapse attack of schizophrenia. The trial was conducted by a Contract Research Organisation (CRO) called Quintiles, in India as well as a number of countries in Eastern Europe. One patient (not in India) who was on the placebo committed suicide. Experts are unanimous in their view that a placebo was methodologically unnecessary in that trial, as the new formulation could have been compared to the existing ‘immediate-release’ drug. But the European regulators required a placebo-controlled trial, noted Irene Schipper and Francis Weyzig of the Dutch research organisation Centre for Research on Multinational Corporations, in a 2008 report. They also argued that placebo-controlled trials for severe conditions, which put the participants at greater risk, are more likely to be conducted in developing countries.

Trials in government hospitals in India can also be of special concern. In one trial, 290 people who had been hospitalised because they were having a severe attack of acute mania were given either a drug (risperidone, marketed by Johnson & Johnson) or a placebo. The idea, of course, was to examine how many people recovered with the drug, and how many with the placebo. This subjected seriously ill people to harm. The majority of patients in this India-only trial, also conducted by Quintiles, were recruited from government hospitals where, according to the principal investigator of the trial, the most seriously ill patients could be found. It is also where patients can be recruited easily, because trial participation ensures a hospital bed and free, quality treatment.

Another concern about trials in government hospitals is that they are conducted on poor people who may have no access to the drugs tested on them after the trial is over. In August 2008, the media reported that 49 children died in 42 clinical trials that were conducted over two and a half years in the Department of Paediatrics at the All India Institute of Medical Sciences (AIIMS) in Delhi. An investigation ordered by the National Human Rights Commission concluded that the trials were conducted properly: the children in the trials were seriously ill, and all the deaths occurred because of the serious illnesses, not the treatments. However, the committee’s report left many questions unanswered. What, for instance, was the purpose of these trials? Would they help other poor children in India?

One of these trials tested the blood-pressure drug valsartan, supplied by its manufacturer Novartis. Paediatric hypertension is indeed a serious condition, but companies conduct paediatric trials for various reasons, including to get information for the benefit of doctors who prescribe the drug to children. Another reason is because the US FDA extends a drug’s exclusive marketing rights when it is tested on children; this provision is meant to encourage research on children who are otherwise prescribed drugs based on the results of research on adults. However, companies also use this clause to maximise their profits. Another trial was linked to gene-activated human glucocerebrosidase, a treatment for Gaucher’s disease, a serious genetic condition in which a fatty substance (lipid) gets deposited in cells and specific organs. The drug for this trial was provided by the US-based Shire Human Genetic Therapies. Will the drug be made available in India once it is proved effective? Both the Helsinki Declaration and the ICMR’s guidelines emphasise that a community on which a drug is tested should have access to the drugs, if proven effective, once the trial is over. Unfortunately, this is rarely the case. Although all of the new drugs being tested in India will indeed be available in India, this will be at prices unaffordable to the very people who agree to have them tested on their bodies.

More generally, but of no less concern, AIIMS has stated that the trials did not “target” children from poor backgrounds. But there is no need to target poor people at AIIMS – they constitute the majority of patients at this government referral hospital. The simple fact is that the vast majority of people seeking care at the AIIMS centre would be there because they cannot afford treatment elsewhere.

Body market
The pharmaceutical industry depends on constantly getting new drugs into the market. New drugs include new uses for old drugs (a cancer drug that can also be used for infertility?) or ‘improved’ or ‘me-too’ versions of older drugs (all those antacids, blood-pressure and cholesterol-lowering drugs, anti-depressants or antibiotics). These drugs must be tested on human beings before they can go into the market. Permission has to be obtained, patients have to be recruited, trials carried out and the results filed – all at top speed, because time is money.

This is where the Contract Research Organisation – the CRO, such as GVK Biotech referred to earlier – steps in. The CRO undertakes all aspects of the process involved in getting regulatory clearance: getting the necessary permissions, tying up with doctors and hospitals to recruit patients on whom the drugs are to be tested, analysing the data that emerges from the trials, monitoring the trial to make sure that the information collected meets standards, putting together reports and even ghostwriting articles for publication in medical journals. Of course, the most important aspects of all this is the recruitment of patients. The best place to recruit patients for, say, a diabetes-drug trial, is a country with a large diabetic population. And diabetics who have not received treatment make better trial subjects, as the results of drugs tested on them will not be ‘contaminated’ with the results of drugs that they have already used.

Clinical trials in developing countries depend not only on physical infrastructure – hospitals and laboratories – and trained human power. They also depend on drug companies getting access to bodies on which they can test their drugs. So, CROs in India market Indian bodies. In a 2006 advertisement on their website (which has since been removed), a CRO named Igate advertised the ‘India advantage’ as “40 million asthmatics, about 34 million diabetics, 8-10 million people HIV positive, 8 million epileptic patients, 3 million cancer patients.”

CROs in India all claim to have ‘access’ to patients with various health problems for which drugs can be tested. For instance, a research group called Veeda claims to have “access to vast patient populations and has specific expertise in recruiting patients with cardiovascular disease, oncology, diabetes, renal disease”. The CRO Quintiles India once boasted that, for a paediatric-flu-vaccine trial, it recruited 201 one- to three-year-olds from three sites in India in just six days. What kind of network does Quintiles have, and what kind of influence does it have with the medical profession, that it can round up 200 children and convince their parents to let them get an experimental flu shot – all in just six days flat?

It seems that at least some of this is able to take place through wilful misinformation. Spectrum Clinical Research specialises in recruiting patients, collecting patients through networks of private clinics, hospitals, specialists and family physicians. It also runs ‘awareness campaigns’ – for instance, a “white ribbon initiative” on osteoporosis, co-organised with the women’s magazine Femina of the Times of India stable, collected data on 2000 patients with osteoporosis. Another campaign, this time to “defeat diabetes”, collected data on 1000 patients with diabetes. In these ways, people who think they are joining patient-support groups are actually being tracked so they can potentially be put on a trial.

Behind a veil
Other than the boasts of CROs, there is little information available on the hundreds of clinical trials being conducted in India. This is despite the evidence that many of these trials are conducted for the benefit of international drug companies, at unacceptable cost to the local population; that trial subjects could be put at risk; that subjects often have not given their informed consent to participate; that they might be provided care that is of lower quality than if they had been recruited for a trial in the West; that injuries during a trial might not be investigated thoroughly, and that those injured may not receive treatment of the highest standard, or even compensation; and that drugs that are tested are often too expensive for people who need them in India.

The only institution to have direct power over the conduct of a trial is the ethics committee (EC). Research institutions appoint their own institutional ethics committee to conduct an ethics review of all research proposals from within the institution. Independent or freelance ethics committees undertake ethics review for a fee, from anyone who applies – usually the CRO or drug company who coordinates the trial at a number of small nursing homes or private clinics, which don’t have their own ethics committee. The EC is a collection of specialists from various fields who review trial documents, including the trial design, the manner in which subjects are recruited, the patient information sheet and the informed-consent form, and approve or reject the application. These committees also have the authority to investigate a trial, and even to stop it if they feel that something is not right.

Ethicist Amar Jesani points out that ethics committees have a lot of power, as the DCGI requires that all trials be passed by such an appointed group. In fact, the DCGI only requires approval by an ethics committee, since it does not monitor the actual conduct of the trial – it does not check that informed consent is taken, that the investigators do their job correctly, that subjects are not harmed, and so on. Thus, says Jesani, it is the ethics committee, not the DCGI, that is the real regulator of clinical trials.

Yet the effectiveness of an ethics committee depends entirely on the setting in which it functions. Important factors, for instance, include the institution that funds the committee’s work or that determines its level of independence, the training of its members, and their competence in terms of doing a proper ethics review. Likewise ‘independent’ or freelance ethics committees are more accountable to the companies that pay for their services. Even the patient information sheet and informed-consent document are treated as confidential documents by the ethics committee – and, of course, the trial’s sponsor. These contain the information on the purpose of the trial, its risks and benefits, and an assurance that a patient’s treatment will not be jeopardised by refusal to participate, or withdrawal from a trial. There is nothing here of proprietary value – on the contrary, everything in these documents is of public interest, and they should be available to the public. Ethics committees are also often poorly educated in their responsibilities.

The reports of people dying in trials are likely to be merely the tip of the proverbial iceberg. And many more are likely to suffer an injury related to the trial drug, injuries that require treatment and that could result in temporary or permanent disability. Indian guidelines require that trial participants be compensated for injuries suffered during research. However, a study by Urmila Thatte and others in a 2009 issue of the UK-based Journal of Medical Ethics found that many trial investigators as well as ethics committee members are not even aware of this requirement. The guidelines of trial sponsors – such as drug companies – provide for medical treatment of any participant who suffers a trial-related injury, or reimbursement of their medical costs. However, Thatte and her colleagues found that none of the companies sponsoring trials, or ethics committees reviewing their trials, had a policy of compensation for trial-related disability or death. Yet for ethics committees to be a law unto themselves is hardly surprising, given the overall environment of lax regulation and monitoring.

Now, the FDA’s decision to do away with the Declaration of Helsinki will create a dilemma for the DCGI. If CROs in India are to follow the FDA requirements – such as using a placebo even when it is not absolutely necessary, and when it might put subjects at risk – they will be violating Indian regulations, which require that the Declaration of Helsinki be followed. The latest revision of the Declaration is quite clear that the placebo may be used in very few circumstances. At the moment, however, the DCGI’s record – permitting a number of unethical trials – suggests that his office places greater value on the potential financial returns of clinical trial outsourcing than on protecting the people who take part in drug trials in India.

Sandhya Srinivasan is a Bombay-based journalist specialising in public health and development issues. She is executive editor of the Indian Journal of Medical Ethics.

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PROZAC: Man Hallucinates for Two Weeks: U.S.A.

Paragraphs 2 and 3 read: “I had a bout of hallucinations about 10 years ago. I was suffering quite badly with depression and had been on anti-depressants for years. Then came along Prozac®. The doc thought they would be good so off I went!

The three stages of my hallucinations always happened at night and in bed. I had always been asleep for a while and was awakened by the goings on. They happened in quite quick succession, perhaps over the space of two weeks, then stopped.

http://www.clusterflock.org/2009/08/dear-clusterflock-have-you-ever-hallucinated.html

August 1, 2009

Dear Clusterflock: Have you ever hallucinated?

I had a bout of hallucinations about 10 years ago. I was suffering quite badly with depression and had been on anti-depressants for years. Then came along Prozac®. The doc thought they would be good so off I went!

The three stages of my hallucinations always happened at night and in bed. I had always been asleep for a while and was awakened by the goings on. They happened in quite quick succession, perhaps over the space of two weeks, then stopped.

1. I woke violently as a tiger jumped from sitting above the bedroom door, onto my pillow and then jumped up onto a shelf (which didn’t exist in reality) above the bed. I woke my wife, quite calmly pointed out said tiger, but was told to return to sleep as there wasn’t one. He only appeared once.

2. I woke to see a man standing in the doorway of the bedroom — that would have been about 4 feet from me. He didn’t scare me. I came around slowly to see him standing there. I don’t remember colour — I do remember him being an Abe Lincoln type ­ stovepipe hat, and a beard. He wasn’t moving. I woke my wife and asked her quite calmly if she could see the man stood in the corner ­ she could not. I lay there for a while looking at him, closing my eyes and opening them. He stayed for a while and then left.

He returned for quite a few nights. He was always in the same place, always in monochrome and he never spoke. Unfortunately, I never spoke to him.

3. I woke one night. I was lying on my back, and as I looked up at the ceiling it was alive with a sea of frogs ­ all moving as one. I again woke my wife ­ just for the reality check. They stayed until I closed my eyes, say 20 minutes, then disappeared.

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Culberson vs. Pfizer

Culberson vs. Pfizer

Jury: Pfizer Drug Did Not Cause Woman’s Death

Reuters

A jury on Monday found that the prescription drug Rezulin did not contribute to the death of a diabetic woman who died in January 2000, Pfizer Inc., whose subsidiary Warner-Lambert made the drug, said.
Culberson vs. Pfizer

12/17/2001

Jury: Pfizer Drug Did Not Cause Woman’s Death

http://www.reuters.com/news_article.jhtml?type=sciencenews&StoryID=461150

Reuters

The last thing that diabetics need is a drug that causes liver failure, yet that is precisely the kind of drug the FDA approved for diabetes patients.

“According to the FDA, an estimated 1.9 million patients with diabetes were prescribed Rezulin, with fewer than 100 reported acute liver failures leading to death or transplant as of the drug’s withdrawal in March 2000 following the introduction of two newer medicines of the same class.”

This case against this drug demonstrates that the public is unprotected from deadly, FDA-approved drugs. The FDA is no longer rigorous in its new speedy drug evaluation an approval process. As was revealed in the Pulitzer Prize winning series by David Willman in The Los Angeles Times, [1998-2001], the FDA has been approving harmful, even deadly drugs in rapid succession.

The case demonstrates how difficult it is for individuals to successfully sue the Goliath pharmaceutical industry. Is this the best service our government can provide to the citizens of this country?

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Contact: Vera Hassner Sharav Tel: 212-595-8974 veracare@rcn.com

A jury on Monday found that the prescription drug Rezulin did not contribute to the death of a diabetic woman who died in January 2000, Pfizer Inc., whose subsidiary Warner-Lambert made the drug, said.

The verdict, in District Court in Harris County, was the first jury decision in litigation involving thousands of claims against the diabetes drug Rezulin, including current trials in Liberty, Missouri, and Corpus Christi, Texas.

The drug, now withdrawn, has been blamed in 63 liver failure deaths worldwide for the period from 1997 to 2000 during which it was sold.

Norma Culberson, 58, had diabetes and took Rezulin, approved by the Food and Drug Administration in 1997 for the treatment of Type II diabetes, which affects about 15 million Americans, starting in late 1997 for a period of about two years, according to trial testimony.

Lawyers for Culberson’s daughters, who were seeking $25 million in damages, argued that the drug damaged her liver, leading to a coma and her eventual death in January 2000.

But Pfizer, the world’s largest drugmaker, argued that the risks from a drug like Rezulin had to be weighed against the threat posed by a disease like diabetes.

“Insulin has 395 deaths in every 100,000 patients,” attorney Jack Urquhart he told jurors. “Why do we tolerate 395 deaths in every 100,000 with insulin? There is no replacement right now,” he said.

Culberson’s death certificate listed kidney or renal failure due to diabetes as cause of death, with liver damage as a secondary factor.

Paul Miller, executive vice president and general counsel for Pfizer said in a statement “We are pleased … that the jury in Houston differentiated between the kidney failure which was the immediate cause of Norma Culberson’s death and the positive role Rezulin played in treating her diabetes.”

Pfizer, which affirmed on Monday it expects earnings to grow at least 20 percent next year, closed up $0.89 or 2.26 percent to $40.33.

“From June 2000, when Pfizer acquired Warner-Lambert,” Miller added, “we have clearly stated that Pfizer is committed to the fair and reasonable resolution, without litigation, of claims arising from those very rare injuries experienced by Rezulin patients.

“We have also said that, in cases where the alleged harm has not been demonstrably caused by Rezulin or where the plaintiff makes excessive demands, Pfizer will go to trial.” Other cases have been settled out of court with undisclosed terms.

The trial began on Nov. 27.

According to the FDA, an estimated 1.9 million patients with diabetes were prescribed Rezulin, with fewer than 100 reported acute liver failures leading to death or transplant as of the drug’s withdrawal in March 2000 following the introduction of two newer medicines of the same class.

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6/3/2000 – Prozac-induced death of child via impaired liver function

Finally reports are being made of deaths of children due to the toxicity
associated with Prozac. Below is an abstract on the death of a child due to
Prozac (fluoxetine). If you have not read my article entitled “The Next
Generation of Medical Guinea Pigs – Our Prozac, Zoloft and Paxil Babies” be
sure to do so. It is on our website and was published in the summer of 1998
and warns of the deadly effects of this liver enzyme system and children on
the SSRIs.

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org
__________________________________

“Fluoxetine-related death in a child with cytochrome P- 450 2D6 genetic
deficiency” Sallee FR, DeVane CL, Ferrell RE J Child
Adolesc Psychopharmacol 10(1):27-34 (2000)

ABSTRACT:

The clinical course of a 9-year-old diagnosed with attention-deficit
hyperactivity disorder, obsessive-compulsive disorder, and Tourette’s
disorder and treated with a combination of methylphenidate, clonidine, and
fluoxetine is described. The patient experienced over a 10-month period,
signs and symptoms suggestive of metabolic toxicity marked by bouts of
gastrointestinal distress, low-grade fever, incoordination, and
disorientation. Generalized seizures were observed, and the patient lapsed
into status epilepticus followed by cardiac arrest and subsequently
expired. At autopsy, blood, brain, and other tissue concentrations of
fluoxetine and norfluoxetine were several-fold higher than expected based on
literature reports for overdose situations. The medical examiner’s report
indicated death caused by fluoxetine toxicity. As the child’s adoptive
parents controlled medication access, they were investigated by social
welfare agencies. Further genetic testing of autopsy tissue revealed the
presence of a gene defect at the cytochrome P450 CYP2D locus, which results
in poor metabolism of fluoxetine. As a result of this and other evidence, the
investigation of the adoptive parents was terminated. This is the first
report of a fluoxetine-related death in a child with a confirmed genetic
polymorphism of the CYP2D6 gene that results in impaired drug metabolism.
Issues relevant to child and adolescent psychopharmacology arising from this
case are discussed.

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5/7/2000 – Drugmaker: Breast Cancer Drug Linked to Death

Adverse Reaction
Drugmaker: Breast Cancer Drug Linked to Death

By Jessie Seyfer
The Associated Press

S A N F R A N C I S C O, May 5 — Pharmaceutical maker
Genentech Inc. has warned doctors that the breast cancer drug
Herceptin is linked to 15 deaths and 47 other adverse reactions
in patients.

In a letter to doctors sent Thursday, the company said the
adverse effects included allergic shock and extreme respiratory
distress.

“We sent the letter to oncologists to heighten their awareness
and educate them about infrequent adverse events that can
occur in certain patients,” Genentech spokesman Neil Cohen
said.

An estimated 23,000 patients have been treated with Herceptin.

Severe Reactions
Severe reactions to Herceptin had not occurred in clinical trials
before the drug gained Food and Drug Administration approval
in 1998, Cohen said.

But sometimes reactions can’t be foreseen in trials, he said.

“A lot of times you might see some safety issues once the drug
gets put into a larger patient population,” Cohen said.

Cohen said he didn’t know when the company first heard of the
deaths and reactions, but analysis had confirmed the link to
Herceptin.

Symptoms Seen Within 24 Hours
In nine of the 15 deaths, symptoms arose within 24 hours of the
time Herceptin was administered, according to the letter.

Genentech is working with the FDA to have the drug’s label
amended to reflect the new risks, Cohen said.

Herceptin is used to treat breast cancer patients that have too
many copies of the HER2 gene. A healthy version of this gene
produces a protein that signals cells to grow and multiply
normally. But in women with too much HER2, the breast cells
reproduce out of control and spread throughout the body.
Herceptin, an antibody, blocks excess HER2, shrinking and
eliminating tumors.

Copyright 2000 The Associated Press. All rights reserved. This
material may not be published, broadcast, rewritten or
redistributed.

http://www.abcnews.go.com/sections/living/DailyNews/breastca
ncer_drug0505.html

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The Aftermath of Antidepressants

The Aftermath Of Prozac, Zoloft, Luvox, Fen-Phen, & Many Other Serotonergic Drugs

By Ann Blake-Tracy – Executive Director,
International Coalition For Drug Awareness

Ann Blake-Tracy has specialized for 10 years in adverse reactions to serotonergic medications. She is the executive director of the International Coalition for Drug Awareness (www.drugawareness.org) and author of the book PROZAC:PANACEA OR PANDORA?

WARNING: IT SHOULD BE NOTED THAT A GRADUAL TAPERING OFF OF MEDICATIONS IS SAFEST WITHDRAWAL METHOD TO AVOID SERIOUS WITHDRAWAL EFFECTS

Often there is the terrible withdrawal associated with the SSRIs. Unless patients are warned to come very slowly off these drugs by shaving minuscule amounts off their pills each day, as opposed to cutting them in half or taking a pill every other day, they can go into terrible withdrawal which is generally delayed several months. This withdrawal includes bouts of overwhelming depression, terrible insomnia and fatigue, and can include life-threatening physical effects, psychosis, or violent outbursts.

Note: Keep in mind that these drugs are all serotonergic agents and clones or “copy cat” drugs of Prozac – the first SSRI antidepressant introduced to the market in America. Basically what applies to one, applies to the others. For instance we have more data out on Prozac because it has been around longer, but as the mode of action is the same for all of these meds the effects will be the same for the other drugs on this list as it is for Prozac. If we are discussing one drug, similar effects would be expected from any other company’s version of the drug. In fact it would be more honest to give them the titles of Prozac #1, Prozac #2,Prozac #3, etc. rather than the brand names they have been given, from the second clone, Zoloft, to the latest Prozac clone, Celexa.

My concern is that each new SSRI introduced seems to be a little stronger on serotonin reuptake and therefore potentially more dangerous. And the all too common practice of going from one SSRI to another blocks additional receptors and magnifies the harmful effects of these medications. It is crucial to learn that according to medical research the theory behind this group of drugs is invalid. Known as serotonin reuptake inhibitors. They are designed to block serotonin in the brain, thereby increasing brain levels of this neurotransmitter. Yet for three decades researchers have been intensely interested in serotonin because LSD and PCP produce their psychedelic effects by mimicking serotonin. Elevated serotonin is found in: psychosis or schizophrenia, mood disorders, organic brain disease, mental retardation, autism and Alzheimer’s. While low levels of the metabolism of serotonin (which also produces high serotonin), are found in those with: depression, anxiety, suicide, violence, arson, substance abuse, insomnia, violent nightmares, impulsive behavior, reckless driving, exhibitionism, hostility, argumentative behavior, etc. The drugs increase serotonin and decrease the metabolism of serotonin leading to any and all of the above results. This information is extremely crucial for patients and physicians to learn as soon as possible. We have a high rate of use of these drugs nationwide. Raising serotonin and lowering the metabolism of serotonin in such a large number of people can produce very serious, widespread and long term problems for all of society.

So why are we now in the 90’s being told that increased serotonin is good for us? Is it because it is good for the pocketbooks of the manufacturers? One manufacturer is running full page newspaper and magazine ads and half hour TV infomercials to bring in over $7 million daily, while on the other hand they are settling Prozac suicide cases for huge amounts of money in exchange for silence from victim’s families on the details of those settlements. The silence in the court cases insures that the drug will be allowed to finish out its patent time, thus bringing in the highest possible profits for the company. They know that with $7 million coming in daily, they can afford to settle a large number of lawsuits and still come out “smelling like a rose” financially.

Eli Lilly has been sued for Prozac related deaths in numerous state and federal courts with most of these cases being settled or dismissed – many were dismissed due to the unethical manipulation of the Wesbecker verdict
(see time line for details).

We have witnessed no decrease in suicide, but increases in murder/suicide, suicide, unwed pregnancies, domestic violence, manic-depression, MS, hypoglycemia, diabetes, bankruptcies, divorce, mothers (parents) killing children, road rage, school shootings, cancer, Chronic Fatigue Syndrome, and Fibromyalgia since these serotonergic drugs have become so popular and I relate it directly to the effects of these drugs.

The death toll has continued to climb drastically since I wrote PROZAC: PANACEA OR PANDORA? Some of the cases you may be familiar with are:

1. Mr. and Mrs. Phil Hartman (Zoloft), Prozac was found in the van of Mark Barton, the Atlanta day trader, who recently killed his family and others in a shooting spree before taking his own life;
2. Neal Furrow, in LA Jewish school shooting was reported to have been court ordered to be on Prozac along with several other medications;
3. The Salt Lake Family History Library shooting;
4. School shootings in Littleton, Colorado (Luvox), Atlanta, Georgia, Springfield, Oregon (Prozac), and Caldwell, Idaho;
5. Another boy in Pocatello, ID in 1998 who in seizure activity from Zoloft had a stand off at the school;
6. 15 year old Chris Shanahan (Paxil) in Rigby, ID who out of the blue killed a woman;
7. The shooting at the lottery in Connecticut last spring by Matthew Beck (Luvox) that left five dead in a murder/suicide;
8. The New York City Subway bombing by Edward Leary (Prozac);
9. Nick Mansies (Paxil) in New Jersey who was convicted of killing a little boy who was selling cookies door to door;
10. In Orange County, CA Dana Sue Gray (Paxil) who co-workers described as a very caring nurse killed several elderly people;
11. Officer Stephen Christian (Prozac) one of the finest officers on the Dallas Police force, who ran into a police substation shooting at fellow officers and was killed;
12. 13 year old Chris Fetters (Prozac) in Iowa who killed her favorite aunt;
13. David Rothman (Prozac) killed two co-workers and himself at the Dept. of Agriculture in Ingelwood, CA;
14. Williams Evans (Zoloft) shot one co-worker at the Ohio Bureau of Employment Services before shooting himself in Columbus, OH;
15. Winatchee, WA where 43 people were wrongfully imprisoned in a false accusation of sexual abuse “witch hunt” fury started by a child under the influence of Prozac and Paxil;
16. Christopher Vasquez (Zoloft) killed Michael Morrow in Central Park;
17. Megan Hogg (Prozac) duct taped the mouths and noses of her three little girls and took a handful of pills; Vera Espinoza (Prozac) in Randolph, VT shot her small son and daughter before shooting herself;
18. An elderly man (Prozac) in Layton, UT axed his wife and daughter to death;
19. Margaret Kastanis (Prozac) used a knife and hammer to kill her three children before stabbing herself to death;
20. An elderly man (Paxil) in Dallas, TX strangled his wife before shooting himself twice in the chest;
21. Larramie Huntzinger (Zoloft) blacked out and ran his car into three young girls killing two in Salt Lake City, UT;
22. Mary Hinkelman (Prozac), a nurse in Baroda, MI shot her two small daughters and her sister before shooting herself;
23. Lisa Fox (Prozac) shot her small son and her dog before shooting herself in Brighton, MI;
24. Debi Louselle (Zoloft) shot daughter and then herself in Salt Lake City, UT;
25. A father in Wyoming shot his wife, daughter and baby grand-daughter then himself after only days on Paxil;
26. A mother (Prozac) in Pleasant Grove, UT killed her 17 year old son with a sledge hammer while he slept before she attempted suicide by drinking Drano;
27. Larry Butz, a superintendent of schools in Ames, IA shot his wife, son and daughter before shooting himself – many cases pending in court are not mentioned.

This is only a handful of MANY, MANY more cases – there would not be room for anything else if I continued listing the cases.

A few additional famous victims: Princess Di (Prozac) and Dodi Fayed -via their driver Henri Paul (Prozac), Monica Lewinsky (Prozac, Zoloft, Effexor, Serzone and Phen-Fen), Chris Farley (Prozac), Pres. Clinton’s ex-partner Jim Mc Dougal (Prozac), Abby Hoffman (Prozac), Del Shannon (Prozac), Danielle Steele’s son (Prozac), INXS singer Michael Hutchence (Prozac), Sarah – Dutchess of York (Phen-Fen)

The latest figures show Prozac has about 44,000 adverse reports filed with the FDA. Out of those reports there are about 2,500 deaths with the large majority of them linked to suicide or violence.

The suicide statistics relating to women are shocking. According to the CDC there are about 30,000 suicides yearly in the United States. Out of those about 6,000 are women – a ratio of about 4.3 to 1, male to female. About twice as many women as men are treated for depression demonstrating that generally men are more than 8 times as lethal in their suicidal gestures as women. Women were known to use less lethal means until the SSRI antidepressants hit the market. But on Prozac and Paxil, women committed 40% of the suicides – many were strikingly violent and clearly leaving no
means for rescue. (Remember that because Prozac was the first of this group of drugs its track record gives us a vision of what is to come with other serotonergic antidepressants, especially when they are so powerful in the reuptake of serotonin.)

TIME LINE OF CRITICAL INFORMATION DISCOVERED SINCE THE BOOK:

*NOTE: Any documents beginning with PZ are Lilly documents on Prozac which have been ferreted out by attorneys and are now being used in lawsuits against the drug company. (Christian vs. Eli Lilly, by Vickery & Waldner, Houston, TX)

* Mid 1950’s: Dr. Felix Sulman began his research on those who suffer from high serotonin levels because of an inability to metabolize serotonin. He found that serotonin is a stress neuro-hormone leading even rabbits, the most docile of creatures, to be aggressive. He coined the term “serotonin irritation syndrome.” He found that those who were unable to break down serotonin would have the levels increase. They were in effect being poisoned by the serotonin produced by their own bodies, the irritation victims suffered from migraines, hot flashes, irritability, sleeplessness, pains around the heart, difficulty in breathing, a worsening of bronchial complaints, irrational tension and anxiety. . . horrifying nightmares. It also caused his volunteers to sleep badly – that is, always on the edge of consciousness so that they were not properly rested – and to wake after only a few hours of sleep.” (sleep apnea) He also found it caused pregnant women to abort.
* October, 1977: Slater, et.al., Inhibition of REM Sleep by Fluoxetine, a Specific Inhibitor of Serotonin Uptake, October 1977, at p. 385 – Prozac was found to affect sleep habits, specifically to suppress deep sleep, which the scientists call REM (rapid eye movement) sleep in cats. By the fourth day of drug treatment the cats receiving the larger doses, which had been friendly for years, began to growl and hiss. After cessation of the drug treatment, the cats returned to their usual friendly behavior in a week or two; those on the higher doses recovering more slowly. – – 1977: [PZ 1298 1999] “A total of six dogs from the high dose group were removed from treatment … due to severe occurrences of either aggressive behavior, ataxia, or anorexia.”]
* July 31, 1978: [PZ1061 1025-28, July 31, 1978] Human subjects began to be used by Lilly in controlled clinical trials. The first group of patients showed no improvement in their depression, but there were a “large number of reports of adverse reactions.” The first human to receive Prozac experienced “dystonia resembling an extrapyramidal reaction” – an uncontrollable, Parkinson-like shaking or trembling.
* July 23, 1979 [PZ 1297 969] The clinical studies in depression showed that “some patients have converted from severe depression to agitation within a few days; in one case the agitation was marked and the patient had to be taken off drug. In future studies the use of benzodiazepines to control the agitation will be permitted.”
* August 3, 1979: The clinical trials excluded patients who had serious suicidal risk. [E.g. control #001519, IND Protocol No. 14, August 3, 1979; PZ1135 695, July 2, 1986 memorandum of Dr. Wernicke].
* December 17, 1984: [PZ 65 449, report of Lilly to FDA] Lilly reported to the FDA that benzodiazepines and other sedatives were given with Prozac throughout the clinical trials. This was to help offset the stimulant effect of the drug. In a memorandum of Lilly scientist Charles Beasley [PZ 541 2007-08] issues of “agitation vs. sedation” and concomitant sedative medications like benzodiazepines (to control the agitation) are discussed. Concerns are that agitation in a suicidal patient can induce suicide.
* March 3, 1986 Lilly controlled the flow of information to the FDA and decided that suicide data on Prozac should not be evaluated, “in the safety-update for the FDA the number of suicides and suicide attempts will not be especially evaluated.” [PZ 879 1966, March 3, 1986 telex]
* September 12, 1986: German BGA very concerned with the risk of suicide and ultimately approved Prozac on the condition that physicians be warned of the risk of suicide and told to consider using sedatives and closely monitor patients. [PZ 878 1383, report of Lilly consultant Pohlmeier; PZ 2467 299, September 12, 1986] Lilly actually warned physicians in Germany and other countries that this measure “can be necessary” to minimize the risk of suicide, [PZ 1341 402, December 6, 1989 German warning; PZ 2469 490]
* February 7, 1990: In response to the Harvard study, Teicher, et al., Lilly’s top scientist, Leigh Thompson, told his fellow executives that “Lilly can go down the tubes if we lose Prozac”. [PZ 1941 827, February 7, 1990]. In the ensuing months Dr. Thompson spoke frequently with his principal FDA regulator about the issue, once at 6:15 in the morning. [PZ 391 1959, July 18, 1990]. Lilly later described the man as “our defender”. [PZ1941 2256, September 12, 1990]
* May 29, 1990, Lilly added “suicidal ideation” in the section dealing with post-marketing reports. [PZ883 562, July 26, 1990 memorandum]
* September 14, 1990: Contrary to the advice of his staff, Dr. Thompson told the Eli Lilly Board of Directors that suicide and hostile acts were probably, caused by the patients’ underlying disorders rather than Prozac. [PZ542 2101, September 14, 1990; PZ4002 889, Board Minutes]. The staff was concerned because they knew that this issue was never studied during the clinical trials.
* September 11, 1990: Note from Dr. Bruce Stadel, Chief of the Epidemiology Branch, attaching an analysis done by Dr. David Graham, Section Chief within the Epidemiology Branch, of Lilly’s July 17, 1990 submission to the FDA on the Prozac/suicidality/violence issue. The following factors were (a) brought to the attention of those in the higher echelons of the FDA, but (b) ignored, discounted or “trashed” by them: #1 Lilly’s analysis improperly excluded 76 out of 97 suicides; as Dr. Stadel expressed it, “[i]t is inappropriate in a safety analysis to exclude such a large proportion of case”; #2 Lilly admitted that its clinical trials “were not designed for the prospective evaluation of suicidality” and that “[i]n these trials, patients with current suicidal ideation were excluded”; #3 Lilly admitted that the HAMD-3 rating scale it used to assess suicidality in clinical trials was inadequate; and that Lilly’s statements about violence only demonstrated “how great under-reporting is” and that “[t]he actual data showed a higher percentage of treatment-emergent suicidality among fluoxetine (2.9% than tricyclic (0.8%) patients . . . [which percentage] was similar to that reported by Teicher.”
* July 1, 1992: A study lead by Dr. Lorne Brandes of the Manatoba Institute of Cell Biology in Winnipeg, Canada was published in CANCER RESEARCH linking the two most popular anti-depressants, Elavil and Prozac to cancer.
* 1994: A study headed by Howard Markell published in The Journal of Pediatrics showed LSD flashbacks and LSD reactions induced by Prozac.
* June 9, 1994: The New York Review of Books article by Dr. Sherwin Nuland slams Peter Kramer for pushing Prozac in his book Listening to Prozac. He pointed out that all docs are taught in med school this little poem about serotonin: “This man was addicted to moanin’, confusion, edema, and groanin’, intestinal rushes, great tricolored blushes, and died from too much serotonin.” He listed constriction of lungs and intestines, diarrhea, wheezing, flushing, mental confusion, tightening of bronchioles, and lessening conscious control over behavior from increases in serotonin. “Moreover, . . . it is still too early to arrive at a reliable estimate of possible dangers that may appear in the long term,” and 15% dropped out of the clinical trials on Prozac because of adverse reactions. He also discussed the similarity of serotonin to the psychedelics like LSD and PCP.
* November, 1994: Krystal JH, Webb E, Cooney N, et al., “Specificity of Ethanol-like Effects Elicited in Serotonergic and Noradrenergic Mechanisms,” ARCHIVES OF GENERAL PSYCHIATRY, Vol. 51, Issue 11, pgs 898-911, 1994 demonstrated that an increase in brain levels of either of two neurotransmitters, serotonin or noradrenalin, produces:
#1 a craving for alcohol,
#2 anger,
#3 anxiety.
They found this to be especially true for those who have a history of alcoholism. An increase serotonin in turn increases noradrenalin. Numerous reports have been made by reformed alcoholics who are being “driven” to alcohol again after being prescribed a serotonergic drug. And many other patients who had no previous history of alcoholism have continued to report an “overwhelming compulsion” to drink while using these drugs.

A few personal accounts:

#1 A young woman, a recovering alcoholic, reported that during the eight month period she had been using Prozac she found it necessary to attend AA meetings every day in order to fight off the strong compulsions to begin drinking again.
#2 In the Southeastern United States a middle aged psychologist, also a recovering alcoholic, after being prescribed Prozac, found herself needing to attend AA meetings morning, noon, and night to keep from destroying the sobriety she had achieved.
#3 A young father, who was Mormon and had never before in his life used alcohol, found himself drinking Ever Clear and exhibiting bizarre as well as violent behavior, after being prescribed Prozac and Ritalin.
#4 A young mother who had never used alcohol before began drinking large amounts within weeks of being prescribed Prozac and quickly found herself committed to a mental institution due to the psychotic behavior that resulted. Added to her Prozac prescription were anti-psychotic meds and electric shock treatments. She then began to experience seizures and was started on anti-seizure meds.
#5 A concerned neighbor reported her friend was drinking straight Vodka on a regular basis after being prescribed Zoloft. #6 A daughter reported her father, sober for 15 years, began drinking again on Prozac.

* December, 1994: Not guilty verdict on Wesbecker wrongful death suit against Lilly’s Prozac.
* Treatment emergent suicidality with Prozac has been demonstrated to be two to three times higher than any other anti-depressant. (Jick, et al., Antidepressants and Suicide)
* May, 1995: Judge John Potter who presided over the Wesbecker case filed documents to demand that Lilly be forced to disclose the secret deal they made with the plaintiffs to withhold very damaging evidence in exchange for settlement. In his pleading to the court Potter stated, “Lilly sought to buy not just the verdict, but the court’s judgment as well.” Potter accused Lilly of “giving the verdict the widest possible publicity” accompanied by the claim that Lilly had “proven in a court of law that Prozac was safe.” Furious with Lilly’s attempt to turn his courtroom into an advertising agency for Prozac, he claims his motion reflects “the court’s duty to protect the integrity of the judicial system.” He believes, as do prominent legal ethicists, that a full and open disclosure of the terms of the settlement is a necessary public safety issue.
* July, 1997: Mayo Clinic found that the increased serotonin, which produces blood clotting, was causing a gummy glossy substance to build up on heart valves. Dr. Heidi Connolly with the Divisions of Cardiovascular Diseases and Internal Medicine, who headed the study stated, “We do know that fenfluramine and phentermine [Fen-Phen] alter the way the brain chemical serotonin is metabolized, and serotonin that circulates in the blood can cause valve injury.” Fenfluramine produces a rapid release of serotonin, inhibits serotonin reuptake, and may also have receptor agonist activity. The study’s revelations should send a loud and very clear warning throughout the medical community concerning all serotonergic medications.
* August 25, 1997: Letter to Ann Blake-Tracy, “I caught the last part of your presentation on Radio Station KEX, Portland, while flipping through the dial last night. I was flabbergasted to hear you speak of the horrible potential side effects from Prozac, which I have been taking for approximately four years, particularly since I have been diagnosed recently with cardiomyalgia, severe artery disease, congestive heart failure and also Fibromyalgia. (I was a very “well” person prior to taking the Prozac and am now exhausted all the time, with horrible aching joints and considerable pain and a massive heart problem.) The adverse cardiovascular effects from Prozac, the one drug in this class of drugs out long enough to have somewhat of track record, are listed in the drug information sheet put out by the manufacturer. The “frequent” effects listed are hemorrhage and hypertension. The “infrequent” effects include very serious adverse effects: congestive heart failure, myocardial infarct, tachycardia, angina pectoris, arrhythmia, hypotension, migraine syncope and vascular headache.
* September, 1997: Redux and Phen-Fen were pulled from the market.
* October 20, 1997: Dr. Candace Pert, Research Professor at Georgetown University Medical Center, past head of the brain chemistry department at the National Institute of Health, and author of the new book, MOLECULES OF EMOTION, sounded an alarm in TIME, October 20. She stated, “I am alarmed at the monster that Johns Hopkins neuroscientist Solomon Snyder and I created when we discovered the simple binding assay for drug receptors 25 years ago. Prozac and other antidepressant serotonin-receptor-active compounds may also cause cardiovascular problems in some susceptible people after long-term use, which has become common practice despite the lack of safety studies.”
As we are being led to believe these drugs produce effects only in the brain, Dr. Pert accuses the medical profession of oversimplifying the action of these drugs and adds that “the public is being misinformed about the precision of these selective serotonin-uptake inhibitors.” It is critical that both physicians and patients be made aware of these adverse physical reactions. She points out that the medical profession not only oversimplifies the action of these drugs in the brain, but “ignores the body as if it exists merely to carry the head around!” And that, “these molecules of emotion regulate every aspect of our physiology.” The body plays a very significant role in how we feel and act the way we do. This fact can no longer be ignored. Serotonin and serotonin receptors exist throughout the body, as well as the brain, and every aspect of the body’s physiology is affected by these serotonergic medications. In fact approximately 90% of the body’s serotonin is produced in the intestinal tract. According to Dr. Michael Gershon of New York’s Columbia Presbyterian, this is the reason why Prozac produces so many gastrointestinal side effects.
* March, 1998: Two new studies published. One that shows Prozac so strongly inhibits one particular serotonin receptor that this produces both obesity and seizures and the other discusses the blockage of muscle and neuronal nicotinic acetylcholine receptors indicating interactions between the serotonergic and cholinergic systems in the central nervous system.
* April, 1998: Our next generation of guinea pigs – one month before a 15 year old on Prozac, Kip Kinkel, in Springfield OR killed his parents and two classmates the American Psychiatric Association and the American Academy of Pediatric Psychiatrists asked the FDA to consider the serotonergic antidepressants for use in children as young as two and drugs for anxiety, aggression and manic depression in babies only one month old! The use of Prozac among young children ages 6 – 12 has increased an alarming 400% from 1995 (51.000 new prescriptions) to 1996 (203,000 new prescriptions).
* June, 1999: CLINICAL PSYCHIATRY NEWS reported that Dr. Malcolm Bowers a psychiatrist at Yale has found that physicians are not paying enough attention to patient factors that could make initiation of SSRIs dangerous. He found that “SSRI-induced psychosis has accounted for 8% of all general hospital psychiatric admissions over a recent 14-month period.” And “What is surprising is that this particular group of side effects is really underplayed.” (The 8% figure represents over 150,000 SSRI induced psychotic breaks per year!!!!!!!)

WARNING: Children so often get coughs and colds, yet using a cough or cold medication with dextromethorphan could cause the serotonin syndrome, a very serious and potentially fatal adverse reaction and/or produce PCP reactions.

Serotonin syndrome remains an often misdiagnosed or unrecognized fatal reaction due to the medical profession being so uninformed about this drug-induced disorder.

Developing brains are far more vulnerable than adult brains and brain damage generally becomes more apparent after the brain is fully developed, rather than immediately. Increases in cortisol produce brain damage while medical research shows that one single 30mg dose of Prozac DOUBLES the level of cortisol. This drastic increase in cortisol causes a multitude of serious physical reactions including impairment of linear growth, as well as impairing the development and regeneration of the liver, kidneys, muscles, etc. In light of so many unspeakable tragedies, I have grown weary of all the silly philosophical discussions we have heard since Kramer’s LISTENING TO PROZAC came out. Patients are dying or having their health destroyed mentally as well as physically (when do we begin to discuss the very serious physical side effects associated with high levels of serotonin?). These patients and their families are frantically searching for answers while this research sits right under our noses and could easily be made available to them. The widespread use of Prozac and its clones is not a statement of either their safety or their effectiveness. It is a statement about the effectiveness of an infinite marketing budget and incredible advertising campaign! These drugs have very serious physical side effects, as well as dangerous psychiatric side effects.

To prevent further tragedy this medical research must be acknowledged and addressed in headline news without delay rather than remain buried in seldom read medical research documents as has been the case in the past with other mind- altering medications, once thought to be safe, which were subsequently prohibited by law, i.e. LSD, PCP, cocaine, etc.

PRAISE FOR PROZAC: PANACEA OR PANDORA?

“I started having bad reactions . . . Oct ’96 I found Prozac to be causing joint and muscle pain itself . . . signs of Cushing’s Syndrome. . . I was very pro-Prozac until last October and wouldn’t have listened to anything said against it until I got problems (thought it was saving my life, while all the time it was insidiously and interested but quite skeptical. However, since reading it and having suffered so many problems with Prozac, I have come to the conclusion that the book is brilliant, and a life-line as far as I am concerned. I tried to fault the research and reasoning, but could not and still can’t. I would like to extend my thanks to you for your heroic stance on this enormously important issue. I have tremendous respect and admiration for your hard work, determination and courage in pursuing this subject so vigorously, against so much powerful opposition for the benefit of people like me. Your integrity puts many, if not most doctors and psychiatrists to shame. It is reassuring to find that there are a few people who are prepared to fight for the truth for the benefit of mankind.” Oct. 1998 note from a British nurse

“PROZAC: PANACEA OR PANDORA? is an incredible compilation of medical data that will lay the groundwork to educate other professionals and the general public about the new SSRI antidepressants – Prozac, Zoloft, Paxil, Luvox, Effexor and Serzone.” (Jeff Wise, psychologist, Salt Lake County Drug and Alcohol Abuse )

“In 15 years of reading books on drugs I have never read a book with more information or so well documented as PROZAC: PANACEA OR PANDORA?” (Dr. Kevin Millet, Bountiful, UT)

“As I lecture to physicians nationwide on the medical use of psychoactive drugs PROZAC: PANACEA OR PANDORA? always accompanies me in my brief case.” (Dr. Bruce Woolley, neuropsychopharmacologist, Brigham Young University)

“I found PROZAC: PANACEA OR PANDORA? fascinating reading and the most complete analysis of the various factors pertaining to the Prozac controversy.” (Attorney Donald Sokol, Susanville, CA)

“PROZAC: PANACEA OR PANDORA? literally saved my life, and if I’d known about it a year earlier, could have saved me untold grief and agony as well. It is the only collated, comprehensive source I know of for this information , . . .. this book described everything that had happened to me in great detail, gave scientific reasons why it happened, backed it all up with solid research, included testimonials from hundreds of others in the same situation, it immaculately details, explains, and refers one to the latest research on a whole hornet’s nest of ‘atypical’ side-and/or after-effects from the use of these antidepressants. It also contains information on how to reduce the severity of problems encountered while starting on or going off these meds.” (Nick Jameson, Prozac patient)

“Magnificent! This text is a monument to Ann Tracy’s tenacity and love for her fellow human beings.” (Dr. Paul Kennedy, N.J.)

“PROZAC: PANACEA OR PANDORA? has not left one question about these drugs unanswered! Ann Tracy has covered them all.” (Margaret McCaffery, N.Y. who lost her daughter, a neurosurgeon, in a Prozac suicide)

“The work Ann Blake-Tracy is doing is very important and she is truly a heroine.” (Dr. Candace Pert, Washington, DC, one of the two developers of the serotonin binding process which made possible the development of the serotonergic drugs. Dr. Pert has boldly stated, speaking of these serotonergic medications, “I am alarmed at the monsters I created!”)

WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

The FDA also now warns that any abrupt change in dose of an antidepressant can produce suicide, hostility or psychosis. And these reactions can either come on very rapidly or even be delayed for months depending upon the adverse effects upon sleep patterns when the withdrawal is rapid! You can find the CD on safe and effective withdrawal helps here: http://store.drugawareness.org/

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4/17/2000 – Ritalin May Have Led to Boy’s Death

Medical Examiner: Ritalin May Have Led to Boy’s Death
Monday, April 17, 2000

THE ASSOCIATED PRESS

PONTIAC, Mich. — A medical examiner says long-term use of
Ritalin, a drug used to treat hyperactive children, may have led to
a 14-year-old boy’s death.

Matthew Smith collapsed at his home on March 21 while playing
with a skateboard and was pronounced dead at a hospital a
short time later. Oakland County Medical Examiner Ljubisa
Dragovic concluded that the boy died of a heart attack the likely
cause of which was 10 years of taking Ritalin for attention deficit
hyperactivity disorder.

“This was a gradual development,” Dragovic said Sunday in The
Oakland Press. “There were changes that occurred in the small
blood vessels that supply the heart muscle.

Smith’s family told Dragovic the teen-ager occasionally
complained of chest discomfort and racing heart, signs that
something was wrong, the medical examiner said. “This is not a
heart condition, which could have been diagnosed just like that,”
Dragovic said. “You just don’t see this in the younger population.”

But Dragovic’s naming of Ritalin as a suspect in the boy’s death
is being questioned by some experts who say the drug has been
shown to be extremely safe. Ritalin is a popular brand name for
the stimulant methylphenidate, believed to increase a child’s
alertness by stimulating the central nervous system.

Joseph Biederman, professor of psychology at Harvard
University and a longtime researcher of stimulants, said
Dragovic’s conclusion was unfounded.

“It is a free country and people can have whatever opinion they
want,” Biederman said. “But Ritalin has a long history of safety
unparalleled by any other drug.”

Cardiac side effects to Ritalin are rare and don’t include death,
said David Rosenberg, a child psychiatrist with Children’s
Hospital of Michigan in Detroit.

“There have been reported increases in blood pressure and
pulse that aren’t clinically significant,” Rosenberg said. “But I
would want to avoid it in someone with an underlying heart
condition.”

Biederman, who also is chief of pediatric pharmacology at
Massachusetts General Hospital in Boston said it is not unusual
for people to take Ritalin their entire lives.

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