24 percent of the children of mothers who took valproate (Depakote) during pregnancy showed an IQ in the mental retardation range. That alarming finding was presented at the American Academy of Neurology's 59th Annual Meeting in Boston, April 28 - May 5, 2007.
The class of drugs known as anticonvulsants or, anti-epileptics, are prescribed mostly for unapproved, off-label uses including: bipolar disorder and migraine headaches, according to an analysis by the Epilepsy Foundation. Such reckless prescribing of drugs for unapproved uses are disrupting normal brain function with devastating results.
Doctors' indiscriminate prescribing practices are condemning millions of children to drug-produced mental disabilities. Do we really want to continue to give doctors the unrestricted license to prescribe toxic substances that cause permanent brain damage without any constraints?
"Depakote looks worse than the other drugs in all of these recent studies," said Dr. Kimford J. Meador, a professor of neurology at the University of Florida and the lead author of the new study. "In all, it is compelling evidence that this drug should not be used as a first-line choice for treatment in pregnant women." How long will the FDA drag its feet before issuing label warnings to indicate the use of Valproic acid drugs are contraindicated for pregnant women?
Furthermore, how do we know that prescribing these same drugs for children--as is currently the practice among mental health professionals--that the drugs won't cause the children mental retardation--or worse? Rebecca Riley was a four year old Boston drug casualty: she was prescribed a psychotropic drug cocktail by a psychiatrist. Among the drugs prescribed for her since the tender age of 28 months, was Depakote.
We have documented evidence showing that Rebeca Riley's is not the only child to be heavily medicated: New Jersy's Medicaid roster docments more than 39,000 children who are prescribed psychotropic drugs. Of these, 647 prescriptions were for children age 4 or less. Psychotropic drug prescriptions for children age 2, included 13 antipsychotics, 10 benzodiazepines, and 2 antidepressants
Michigan's Medicaid roster shows that 933 patients under age 5 were prescribed anticonvulsants /Mood Stabilizers; 972 patients under age 5 were prescribed Antidyskinetics--for what condition? One child under Michigan's Medicaid program is currently prescribed 17 psychotropic drugs.
Psychiatrists who defend the practice of medicating children with psychotropic drugs, such as: Dr. Janet Wozniak, director fo the Pediatric Bipolar program at Harvard affiliate, Mass General, and Dr. Nancy Rappaport of the Cambridge Health Alliance, claim without evidence that their prescriptions benefit children: "the overall number of prescriptions is probably small relative to the number of children who need help."
When will sanity and the "First, do no harm" principle in medicine be restored? When will we have a public health policy that bans interaction between pharmaceutical industry and children's care givers? Children's health care and educational providers should not come under drug industry influence.
[Link] American Academy of Neurology (AAN) Wed 11-Apr-2007, Embargo expired: Thu 03-May-2007 Lower IQ Found in Children of Women Who Took Epilepsy Drug
Children of women who took the epilepsy drug valproate during pregnancy appear to be at a greater risk for lower IQ, according to research presented at the American Academy of Neurology's 59th Annual Meeting in Boston, April 28 - May 5, 2007.
Newswise - Children of women who took the epilepsy drug valproate during pregnancy appear to be at a greater risk for lower IQ, according to research presented at the American Academy of Neurology's 59th Annual Meeting in Boston, April 28 - May 5, 2007.
The study looked at IQ results for 187 two-year-old children of mothers who took the epilepsy drugs carbamazepine, lamotrigine, phenytoin, or valproate during pregnancy.
According to the study, 24 percent of the children of mothers who took valproate showed an IQ in the mental retardation range, compared to 12 percent for carbamazepine, nine percent for lamotrigine, and 12 percent for phenytoin. On an IQ test, children whose mothers took carbamazepine scored an average of 93 points, compared to 93 for those who took phenytoin, 96 for lamotrigine, and 84 for valproate. The scores were adjusted to account for the mother's IQ and the drug dosage.
The study also found that children with higher levels of valproate in their blood had lower IQ scores.
"Further studies are needed to confirm these findings, examine IQ at older ages, and to determine the risks for other epilepsy drugs," said study author Kimford Meador, MD, of the University of Florida in Gainesville, FL, and Fellow of the American Academy of Neurology. "However, our findings are consistent with other studies, which have shown valproate poses an increased risk for fetal death and birth defects, and have suggested the drug may harm cognitive development."
The study also found children's IQ was related to their mother's IQ for every epilepsy drug except valproate.
Meador is recommending doctors talk with their patients about the risks associated with valproate.
"Although valproate remains an important treatment option in women who aren't able to use other epilepsy drugs, valproate should not be used as the drug of first choice for women of child bearing potential, and when used, its dosage should be limited if possible," said Meador.
The study was supported by the National Institute of Neurological Disorders and Stroke at the National Institutes of Health.
The American Academy of Neurology, an association of over 20,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimer's disease, epilepsy, multiple sclerosis, Parkinson's disease, and stroke. For more information about the American Academy of Neurology, visit [Link]
C 2007 Newswise. All Rights Reserved. --------------------------------------------------------------------------------
[Link] THE NEW YORK TIMES May 4, 2007 Epilepsy Drug Can Increase Risk for Newborns, Study Says By BENEDICT CAREY
Doctors reported yesterday that expectant mothers with epilepsy who took a commonly prescribed drug to control seizures were at increased risk of having a child with mental deficits.
Toddlers who had been exposed in the womb to the drug Depakote, from Abbott Laboratories, scored seven to eight points lower on I.Q. tests at age 2 than those whose mothers had been taking other epilepsy drugs while pregnant, the study found. They were twice as likely to score in the range associated with mental retardation , according to the authors, who presented the findings at the annual meeting of the American Academy of Neurology in Boston.
Other researchers said the findings should be considered preliminary because I.Q. measures were less reliable in 2-year-olds than in older children; the study will continue, tracking children through age 6.
The report is consistent with several recent studies finding that Depakote is more likely than other so-called anticonvulsant drugs to increase the risk of mental deficits and other birth defects, like neural tube problems. An estimated 24 million American women have taken these drugs - which include Tegretol from Novartis, Lamictal from GlaxoSmithKline and Dilantin from Parke Davis - for an array of problems, including epilepsy, bipolar disorder and migraine headaches, according to an analysis by the Epilepsy Foundation.
"Depakote looks worse than the other drugs in all of these recent studies," said Dr. Kimford J. Meador, a professor of neurology at the University of Florida and the lead author of the new study. "In all, it is compelling evidence that this drug should not be used as a first-line choice for treatment in pregnant women."
Laureen Cassidy, a spokeswoman for Abbott, said that for many women, "Depakote may be the only effective seizure control medication, and that decision should be made thoughtfully between physician and patient to fully evaluate the risk vs. benefit of treatment."
The drug's label now states that Depakote "has been associated with birth defects in children of women who have taken it while pregnant."
Untreated seizures can endanger the life of a fetus and the expectant mother. And some 90 percent of women with epilepsy give birth to healthy, developmentally normal children even though many are taking medication, experts say.
The researchers followed 185 children through age 2, using standard I.Q. measures. The mothers in the study, while pregnant, took either Depakote, Lamictal, Tegretol or Dilantin. After controlling for the mothers' I.Q. scores, the researchers found that 2-year-olds exposed to Depakote scored significantly lower on standard intelligence measures than the others.
"It's fair to say that there has been concern about these drugs, and particularly Depakote, for the past two or three years, but we'll know the complete story about its effect on cognitive development when we look at older children," said Dr. Lewis Holmes, a professor of pediatrics at Harvard Medical School.
Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Liver function tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months. However, physicians should not rely totally on serum biochemistry since these tests may not be abnormal in all instances, but should also consider the results of careful interim medical history and physical examination.
Caution should be observed when administering DEPAKOTE products to patients with a prior history of hepatic disease. Patients on multiple anticonvulsants, children, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease may be at particular risk. Experience has indicated that children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those with the aforementioned conditions. When DEPAKOTE is used in this patient group, it should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. Above this age group, experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups.
The drug should be discontinued immediately in the presence of significant hepatic dysfunction, suspected or apparent. In some cases, hepatic dysfunction has progressed in spite of discontinuation of drug.
Pancreatitis
Cases of life-threatening pancreatitis have been reported in both children and adults receiving valproate. Some of the cases have been described as hemorrhagic with rapid progression from initial symptoms to death. Some cases have occurred shortly after initial use as well as after several years of use. The rate based upon the reported cases exceeds that expected in the general population and there have been cases in which pancreatitis recurred after rechallenge with valproate. In clinical trials, there were 2 cases of pancreatitis without alternative etiology in 2416 patients, representing 1044 patient-years experience. Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation. If pancreatitis is diagnosed, valproate should ordinarily be discontinued. Alternative treatment for the underlying medical condition should be initiated as clinically indicated (See BOXED WARNING).
Urea Cycle Disorders (UCD)
Divalproex sodium is contraindicated in patients with known urea cycle disorders.
Hyperammonemic encephalopathy, sometimes fatal, has been reported following initiation of valproate therapy in patients with urea cycle disorders, a group of uncommon genetic abnormalities, particularly ornithine transcarbamylase deficiency. Prior to the initiation of valproate therapy, evaluation for UCD should be considered in the following patients: 1) those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasmaammonia or glutamine; 2) those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance; 3) those with a family history of UCD or a family history of unexplained infant deaths (particularly males); 4) those with other signs or symptoms of UCD. Patients who develop symptoms of unexplained hyperammonemic encephalopathy while receiving valproate therapy should receive prompt treatment (including discontinuation of valproate therapy) and be evaluated for underlying urea cycle disorders (See CONTRAINDICATIONS and PRECAUTIONS).
Somnolence in the Elderly
In a double-blind, multicenter trial of valproate in elderly patients with dementia (mean age = 83 years), doses were increased by 125 mg/day to a target dose of 20 mg/kg/day. A significantly higher proportion of valproate patients had somnolence compared to placebo, and although not statistically significant, there was a higher proportion of patients with dehydration. Discontinuations for somnolence were also significantly higher than with placebo. In some patients with somnolence (approximately one-half), there was associated reduced nutritional intake and weight loss. There was a trend for the patients who experienced these events to have a lower baseline albumin concentration, lower valproate clearance, and a higher BUN. In elderly patients, dosage should be increased more slowly and with regular monitoring for fluid and nutritional intake, dehydration, somnolence, and other adverse events. Dose reductions or discontinuation of valproate should be considered in patients with decreased food or fluid intake and in patients with excessive somnolence (See DOSAGE AND ADMINISTRATION).
Thrombocytopenia
The frequency of adverse effects (particularly elevated liver enzymes and thrombocytopenia [see PRECAUTIONS]) may be dose-related. In a clinical trial of DEPAKOTE as monotherapy in patients with epilepsy, 34/126 patients (27%) receiving approximately 50 mg/kg/day on average, had at least one value of platelets ≤ 75 x 109/L. Approximately half of these patients had treatment discontinued, with return of platelet counts to normal. In the remaining patients, platelet counts normalized with continued treatment. In this study, the probability of thrombocytopenia appeared to increase significantly at total valproate concentrations of ≥ 110 µg/mL (females) or ≥ 135 µg/mL (males). The therapeutic benefit which may accompany the higher doses should therefore be weighed against the possibility of a greater incidence of adverse effects.
Usage In Pregnancy
VALPROATE CAN PRODUCE TERATOGENIC EFFECTS. DATA SUGGEST THAT THERE IS AN INCREASED INCIDENCE OF CONGENITAL MALFORMATIONS ASSOCIATED WITH THE USE OF VALPROATE BY WOMEN WITH SEIZURE DISORDERS DURING PREGNANCY WHEN COMPARED TO THE INCIDENCE IN WOMEN WITH SEIZURE DISORDERS WHO DO NOT USE ANTIEPILEPTIC DRUGS DURING PREGNANCY, THE INCIDENCE IN WOMEN WITH SEIZURE DISORDERS WHO USE OTHER ANTIEPILEPTIC DRUGS, AND THE BACKGROUND INCIDENCE FOR THE GENERAL POPULATION. THEREFORE, VALPROATE SHOULD BE CONSIDERED FOR WOMEN OF CHILDBEARING POTENTIAL ONLY AFTER THE RISKS HAVE BEEN THOROUGHLY DISCUSSED WITH THE PATIENT AND WEIGHED AGAINST THE POTENTIAL BENEFITS OF TREATMENT.
THERE ARE MULTIPLE REPORTS IN THE CLINICAL LITERATURE THAT INDICATE THE USE OF ANTIEPILEPTIC DRUGS DURING PREGNANCY RESULTS IN AN INCREASED INCIDENCE OF CONGENITAL MALFORMATIONS IN OFFSPRING. ANTIEPILEPTIC DRUGS, INCLUDING VALPROATE, SHOULD BE ADMINISTERED TO WOMEN OF CHILDBEARING POTENTIAL ONLY IF THEY ARE CLEARLY SHOWN TO BE ESSENTIAL IN THE MANAGEMENT OF THEIR MEDICAL CONDITION.
Antiepileptic drugs should not be discontinued abruptly in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.
Human Data
Congenital Malformations
The North American Antiepileptic Drug Pregnancy Registry reported 16 cases of congenital malformations among the offspring of 149 women with epilepsy who were exposed to valproic acid monotherapy during the first trimester of pregnancy at doses of approximately 1,000 mg per day, for a prevalence rate of 10.7% (95% CI 6.3%-16.9%). Three of the 149 offspring (2%) had neural tube defects and 6 of the 149 (4%) had less severe malformations. Among epileptic women who were exposed to other antiepileptic drug monotherapies during pregnancy (1,048 patients) the malformation rate was 2.9% (95% CI 2.0% to 4.1%). There was a 4-fold increase in congenital malformations among infants with valproic acid-exposed mothers compared with those treated with other antiepileptic monotherapies as a group (Odds Ratio 4.0; 95% CI 2.1 to 7.4). This increased risk does not reflect a comparison versus any specific antiepileptic drug, but the risk versus the heterogeneous group of all other antiepileptic drug monotherapies combined. The increased teratogenic risk from valproic acid in women with epilepsy is expected to be reflected in an increased risk in other indications (e.g., migraine or bipolar disorder).
THE STRONGEST ASSOCIATION OF MATERNAL VALPROATE USAGE WITH CONGENITAL MALFORMATIONS IS WITH NEURAL TUBE DEFECTS (AS DISCUSSED UNDER THE NEXT SUBHEADING). HOWEVER, OTHER CONGENITAL ANOMALIES (E.G. CRANIOFACIAL DEFECTS, CARDIOVASCULAR MALFORMATIONS AND ANOMALIES INVOLVING VARIOUS BODY SYSTEMS), COMPATIBLE AND INCOMPATIBLE WITH LIFE, HAVE BEEN REPORTED. SUFFICIENT DATA TO DETERMINE THE INCIDENCE OF THESE CONGENITAL ANOMALIES IS NOT AVAILABLE.
Neural Tube Defects
THE INCIDENCE OF NEURAL TUBE DEFECTS IN THE FETUS IS INCREASED IN MOTHERS RECEIVING VALPROATE DURING THE FIRST TRIMESTER OF PREGNANCY. THE CENTERS FOR DISEASE CONTROL (CDC) HAS ESTIMATED THE RISK OF VALPROIC ACID EXPOSED WOMEN HAVING CHILDREN WITH SPINA BIFIDA TO BE APPROXIMATELY 1 TO 2%. THE AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS (ACOG) ESTIMATES THE GENERAL POPULATION RISK FOR CONGENITAL NEURAL TUBE DEFECTS AS 0.14% TO 0.2%.
Tests to detect neural tube and other defects using current accepted procedures should be considered a part of routine prenatal care in pregnant women receiving valproate.
Evidence suggests that pregnant women who receive folic acid supplementation may be at decreased risk for congenital neural tube defects in their offspring compared to pregnant women not receiving folic acid. Whether the risk of neural tube defects in the offspring of women receiving valproate specifically is reduced by folic acid supplementation is unknown. DIETARY FOLIC ACID SUPPLEMENTATION BOTH PRIOR TO AND DURING PREGNANCY SHOULD BE ROUTINELY RECOMMENDED TO PATIENTS CONTEMPLATING PREGNANCY.
Other Adverse Pregnancy Effects
PATIENTS TAKING VALPROATE MAY DEVELOP CLOTTING ABNORMALITIES (See PRECAUTIONS -GENERAL AND WARNINGS). A PATIENT WHO HAD LOW FIBRINOGEN WHEN TAKING MULTIPLE ANTICONVULSANTS INCLUDING VALPROATE GAVE BIRTH TO AN INFANT WITH AFIBRINOGENEMIA WHO SUBSEQUENTLY DIED OF HEMORRHAGE. IF VALPROATE IS USED IN PREGNANCY, THE CLOTTING PARAMETERS SHOULD BE MONITORED CAREFULLY.
PATIENTS TAKING VALPROATE MAY DEVELOP HEPATIC FAILURE (See WARNINGS - HEPATOTOXICITY AND BOX WARNING). FATAL HEPATIC FAILURES, IN A NEWBORN AND IN AN INFANT, HAVE BEEN REPORTED FOLLOWING THE MATERNAL USE OF VALPROATE DURING PREGNANCY.
Animal Data
Animal studies have demonstrated valproate-induced teratogenicity. Increased frequencies of malformations, as well as intrauterine growth retardation and death, have been observed in mice, rats, rabbits, and monkeys following prenatal exposure to valproate. Malformations of the skeletal system are the most common structural abnormalities produced in experimental animals, but neural tube closure defects have been seen in mice exposed to maternal plasma valproate concentrations exceeding 230 µg/mL (2.3 times the upper limit of the human therapeutic range) during susceptible periods of embryonic development. Administration of an oral dose of 200 mg/kg/day or greater (50% of the maximum human daily dose or greater on a mg/m2 basis) to pregnant rats during organogenesis produced malformations (skeletal, cardiac, and urogenital) and growth retardation in the offspring. These doses resulted in peak maternal plasma valproate levels of approximately 340 µg/mL or greater (3.4 times the upper limit of the human therapeutic range or greater). Behavioral deficits have been reported in the offspring of rats given a dose of 200 mg/kg/day throughout most of pregnancy. An oral dose of 350 mg/kg/day (approximately 2 times the maximum human daily dose on a mg/m2 basis) produced skeletal and visceral malformations in rabbits exposed during organogenesis. Skeletal malformations, growth retardation, and death were observed in rhesus monkeys following administration of an oral dose of 200 mg/kg/day (equal to the maximum human daily dose on a mg/m2 basis) during organogenesis. This dose resulted in peak maternal plasma valproate levels of approximately 280 µg/mL (2.8 times the upper limit of the human therapeutic range).
Hyperammonemia has been reported in association with valproate therapy and may be present despite normal liver function tests. In patients who develop unexplained lethargy and vomiting or changes in mental status, hyperammonemic encephalopathy should be considered and an ammonia level should be measured. If ammonia is increased, valproate therapy should be discontinued. Appropriate interventions for treatment of hyperammonemia should be initiated, and such patients should undergo investigation for underlying urea cycle disorders (See CONTRAINDICATIONS and WARNINGS – Urea Cycle Disorders and PRECAUTIONS - Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use).
Asymptomatic elevations of ammonia are more common and when present, require close monitoring of plasma ammonia levels. If the elevation persists, discontinuation of valproate therapy should be considered. In patients who develop unexplained lethargy, vomiting, or changes in mental status, hyperammonemic encephalopathy should be considered and an ammonia level should be measured. (See CONTRAINDICATIONS and WARNINGS - Urea Cycle Disorders and PRECAUTIONS - Hyperammonemia).
Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use
Concomitant administration of topiramate and valproic acid has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either drug alone. Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy or vomiting. In most cases, symptoms and signs abated with discontinuation of either drug. This adverse event is not due to a pharmacokinetic interaction. It is not known if topiramate monotherapy is associated with hyperammonemia. Patients with inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia with or without encephalopathy. Although not studied, an interaction of topiramate and valproic acid may exacerbate existing defects or unmask deficiencies in susceptible persons. In patients who develop unexplained lethargy, vomiting, or changes in mental status, hyperammonemic encephalopathy should be considered and an ammonia level should be measured. (See CONTRAINDICATIONS and WARNINGS - Urea Cycle Disorders and PRECAUTIONS - Hyperammonemia). General
Because of reports of thrombocytopenia (See WARNINGS), inhibition of the secondary phase of platelet aggregation, and abnormal coagulation parameters, (e.g., low fibrinogen), platelet counts and coagulation tests are recommended before initiating therapy and at periodic intervals. It is recommended that patients receiving DEPAKOTE be monitored for platelet count and coagulation parameters prior to planned surgery. In a clinical trial of DEPAKOTE as monotherapy in patients with epilepsy, 34/126 patients (27%) receiving approximately 50 mg/kg/day on average, had at least one value of platelets ≤ 75 x 109/L. Approximately half of these patients had treatment discontinued, with return of platelet counts to normal. In the remaining patients, platelet counts normalized with continued treatment. In this study, the probability of thrombocytopenia appeared to increase significantly at total valproate concentrations of ≥ 110 µg/mL (females) or ≥ 135 µg/mL (males). Evidence of hemorrhage, bruising, or a disorder of hemostasis/coagulation is an indication for reduction of the dosage or withdrawal of therapy.
Since DEPAKOTE may interact with concurrently administered drugs which are capable of enzyme induction, periodic plasma concentration determinations of valproate and concomitant drugs are recommended during the early course of therapy. (See PRECAUTIONS-DRUG INTERACTIONS.)
Valproate is partially eliminated in the urine as a keto-metabolite which may lead to a false interpretation of the urine ketone test.
There have been reports of altered thyroid function tests associated with valproate. The clinical significance of these is unknown.
Suicidal ideation may be a manifestation of certain psychiatric disorders, and may persist until significant remission of symptoms occurs. Close supervision of high risk patients should accompany initial drug therapy.
There are in vitro studies that suggest valproate stimulates the replication of the HIV and CMVviruses under certain experimental conditions. The clinical consequence, if any, is not known. Additionally, the relevance of these in vitro findings is uncertain for patients receiving maximally suppressive antiretroviral therapy. Nevertheless, these data should be borne in mind when interpreting the results from regular monitoring of the viral load in HIV infected patients receiving valproate or when following CMV infected patients clinically.
Multi-organ Hypersensitivity Reaction
Multi-organ hypersensitivity reactions have been rarely reported in close temporal association to the initiation of valproate therapy in adult and pediatric patients (median time to detection 21 days: range 1 to 40 days). Although there have been a limited number of reports, many of these cases resulted in hospitalization and at least one death has been reported. Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement. Other associated manifestations may include lymphadenopathy, hepatitis, liver function test abnormalities, hematological abnormalities (e.g., eosinophilia, thrombocytopenia, neutropenia), pruritis, nephritis, oliguria, hepato-renal syndrome, arthralgia, and asthenia. Because the disorder is variable in its expression, other organ system symptoms and signs, not noted here, may occur. If this reaction is suspected, valproate should be discontinued and an alternative treatment started. Although the existence of cross sensitivity with other drugs that produce this syndrome is unclear, the experience amongst drugs associated with multi-organ hypersensitivity would indicate this to be a possibility.
Information for Patients
Patients and guardians should be warned that abdominalpain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis and, therefore, require further medical evaluation promptly.
Patients should be informed of the signs and symptoms associated with hyperammonemic encephalopathy (See PRECAUTIONS – Hyperammonemia) and be told to inform the prescriber if any of these symptoms occur.
Since DEPAKOTE products may produce CNSdepression, especially when combined with another CNS depressant (eg, alcohol), patients should be advised not to engage in hazardous activities, such as driving an automobile or operating dangerous machinery, until it is known that they do not become drowsy from the drug.
Since DEPAKOTE has been associated with certain types of birth defects, female patients of child-bearing age considering the use of DEPAKOTE should be advised of the risk and of alternative therapeutic options and to read the Patient Information Leaflet, which appears as the last section of the labeling. This is especially important when the treatment of a spontaneously reversible condition not ordinarily associated with permanent injury or risk of death (e.g., migraine) is considered.
Patients should be instructed that a fever associated with other organ system involvement (rash, lymphadenopathy, etc.) may be drug-related and should be reported to the physician immediately (See PRECAUTIONS - Multi-organ Hypersensitivity Reaction).
Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis
Valproic acid was administered orally to Sprague Dawley rats and ICR (HA/ICR) mice at doses of 80 and 170 mg/kg/day (approximately 10 to 50% of the maximum human daily dose on a mg/m2 basis) for two years. A variety of neoplasms were observed in both species. The chief findings were a statistically significant increase in the incidence of subcutaneous fibrosarcomas in high dose male rats receiving valproic acid and a statistically significant dose-related trend for benignpulmonary adenomas in male mice receiving valproic acid. The significance of these findings for humans is unknown.
Mutagenesis
Valproate was not mutagenic in an in vitrobacterialassay (Ames test), did not produce dominantlethal effects in mice, and did not increase chromosomeaberration frequency in an in vivo cytogenetic study in rats. Increased frequencies of sister chromatid exchange (SCE) have been reported in a study of epileptic children taking valproate, but this association was not observed in another study conducted in adults. There is some evidence that increased SCE frequencies may be associated with epilepsy. The biological significance of an increase in SCE frequency is not known.
Fertility
Chronictoxicity studies in juvenile and adult rats and dogs demonstrated reduced spermatogenesis and testicular atrophy at oral doses of 400 mg/kg/day or greater in rats (approximately equivalent to or greater than the maximum human daily dose on a mg/m2 basis) and 150 mg/kg/day or greater in dogs (approximately 1.4 times the maximum human daily dose or greater on a mg/m2 basis). Segment I fertility studies in rats have shown doses up to 350 mg/kg/day (approximately equal to the maximum human daily dose on a mg/m2 basis) for 60 days to have no effect on fertility. THE EFFECT OF VALPROATE ON TESTICULAR DEVELOPMENT AND ON SPERM PRODUCTION AND FERTILITY IN HUMANS IS UNKNOWN.
Pregnancy
Pregnancy Category D:
See WARNINGS.
Nursing Mothers
Valproate is excreted in breast milk. Concentrations in breast milk have been reported to be 1-10% of serum concentrations. It is not known what effect this would have on a nursing infant. Consideration should be given to discontinuing nursing when divalproex sodium is administered to a nursing woman.
Pediatric Use
Experience has indicated that pediatric patients under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those with the aforementioned conditions (See BOXED WARNING). When DEPAKOTE is used in this patient group, it should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. Above the age of 2 years, experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups.
Younger children, especially those receiving enzyme-inducing drugs, will require larger maintenance doses to attain targeted total and unbound valproic acid concentrations.
The variability in free fraction limits the clinical usefulness of monitoring total serum valproic acid concentrations. Interpretation of valproic acid concentrations in children should include consideration of factors that affect hepatic metabolism and protein binding.
The safety and effectiveness of DEPAKOTE for the treatment of acute mania has not been studied in individuals below the age of 18 years.
The safety and effectiveness of DEPAKOTE for the prophylaxis of migraines has not been studied in individuals below the age of 16 years.
The basic toxicology and pathologic manifestations of valproate sodium in neonatal (4-day old) and juvenile (14-day old) rats are similar to those seen in young adult rats. However, additional findings, including renal alterations in juvenile rats and renal alterations and retinaldysplasia in neonatal rats, have been reported. These findings occurred at 240 mg/kg/day, a dosage approximately equivalent to the human maximum recommended daily dose on a mg/m2 basis. They were not seen at 90 mg/kg, or 40% of the maximum human daily dose on a mg/m2 basis.
Geriatric Use
No patients above the age of 65 years were enrolled in double-blind prospective clinical trials of mania associated with bipolar illness. In a case review study of 583 patients, 72 patients (12%) were greater than 65 years of age. A higher percentage of patients above 65 years of age reported accidental injury, infection, pain, somnolence, and tremor. Discontinuation of valproate was occasionally associated with the latter two events. It is not clear whether these events indicate additional risk or whether they result from preexisting medical illness and concomitant medication use among these patients.
A study of elderly patients with dementia revealed drug related somnolence and discontinuation for somnolence (See WARNINGS-Somnolence in the Elderly). The starting dose should be reduced in these patients, and dosage reductions or discontinuation should be considered in patients with excessive somnolence (See DOSAGE AND ADMINISTRATION).
There is insufficient information available to discern the safety and effectiveness of DEPAKOTE for the prophylaxis of migraines in patients over 65.
FDA Proposes NEW WARNINGS re drug-induced suicideal ideation up to aged 24, then
June 18 2007, 4:04 PM
no need to worry, as at 1 minute after midnight on your 24th birthday you no longer are prone to suffering drug induced suicidal ideation. Must be some sudden bodyclockological thing that kicks in at age 24 and neutralises the harmful parts of the chemical concoction you're taking. I'd just LOVE to see the 'science' that supports this 'hypothesis' of a sudden defence against chemical/physio/neurological interactions at a particular age, but until we get evidenced based medicine and drug regulatory officials that make SCIENCE-based decisions - we have to be grateful for SOME extended warning - as the past option was none at all... then kids... now up to 24.
Media Inquiries: Sandy Walsh, 301-827-6242 Consumer Inquiries: 888-INFO-FDA
FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications
The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).
The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.
"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, M.D., MPH, director of FDA's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."
People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.
The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality.
The proposed labeling update follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants. At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. In addition, FDA directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.
Also in 2005, FDA began a comprehensive review of 295 individual antidepressant trials that included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, to examine the risk of suicidality in adults who are prescribed antidepressants.
In December 2006, FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants. Additionally, the committee noted product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.
FDA has been developing language to revise product labeling and update the Patient Medication Guides for these products. Manufacturers of antidepressants will now have 30 days to submit their revised product labels and revised Medication Guides to FDA for review.
Answers to questions you may have regarding agreements that Eli Lilly and Company entered into to settle the vast majority of the remaining cases in the ZYPREXA® (olanzapine) product liability litigation
Q: What are the implications for health care professionals? Have any healthcare professionals had judgments against them? A: As a part of these agreements, plaintiffs' attorneys have agreed to dismiss all claims that had been made against healthcare professionals in any cases, relating to the prescribing of ZYPREXA, covered by these settlements. Health care professionals will not have to pay a penny toward the settlements and will not have a judgment or settlement to report. To date, no health care professional who was a party in these ZYPREXA product liability claims has had to pay anything or has had a judgment against him or her.
Q: If I was a party in a claim that was included in these settlements, what do I need to do? A: You do not have to do anything. You or your counsel will receive notification that your case has been dismissed.
Q: Do you have resources to help me discuss the benefits and risks of ZYPREXA with my patients? A: Yes, your Lilly sales representatives have simple-to-use materials you can use to discuss ZYPREXA's benefits and potential adverse events with those you treat. They also carry tools that are consistent with established care guidelines to help you monitor your patients as they continue their treatment.
Q: Why did Lilly settle? A: We have been vigorously defending against these claims involving ZYPREXA because we believe they are without merit, and we will continue to do so with any remaining cases going forward. However, we decided that it was in the best interests of patients, healthcare professionals, shareholders, and employees to try to place this product liability litigation behind us.
We have heard from many of you that these lawsuits and lawyer ads stirred concern and interfered with your process of making decisions about which medication best suits an individual patient's needs.
In reaching these agreements with this collection of plaintiffs' attorneys, we have attempted to alleviate this concern. These agreements include the vast majority of current ZYPREXA product liability claims. As a part of these agreements, plaintiffs' attorneys have agreed that all claims against healthcare professionals named in any cases relating to the prescribing of ZYPREXA covered by these settlements will be dismissed. Healthcare professionals will not have to pay a penny toward these settlements and will not have a judgment or settlement to report.
Q: Will I continue to see legal ads from plaintiff attorneys related to ZYPREXA? A: Despite concerns expressed by the Court about the validity of these claims, some lawyers continue to solicit cases. Indeed, similar product liability law suits have been filed against manufacturers of other atypical antipsychotics. Plaintiffs' attorneys have been actively running legal ads mentioning a single agent or several agents within the class. Ads mentioning multiple agents may still include ZYPREXA. If you see such an ad, please call 1-800-LILLYRX to report it.
Q: What is the purported basis for the claims? A: In September 2003, the FDA required label changes for all atypical antipsychotics to alert doctors to the potential risk of diabetes and hyperglycemia. Information that hyperglycemia and diabetes were infrequent adverse events has, in fact, been in the product label since ZYPREXA was introduced in 1996. In most lawsuits, plaintiffs' attorneys claimed that before the label change, the information conveying the risk as an infrequent adverse event was not adequately described.
Q: How can I get a question about the settlement answered? A: Please call 1-800-LillyRX if you have any other questions.
For complete safety profile, see the full Prescribing Information provided below.
ZYPREXA is a registered trademark of Eli Lilly and Company. Zyrtec is a registered trademark of UCB, SA.
Important Safety Information for ZYPREXA®(Olanzapine)
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. ZYPREXA (olanzapine) is not approved for the treatment of elderly patients with dementia-related psychosis.
Cerebrovascular adverse events (CVAE), including stroke, in elderly patients with dementia — Cerebrovascular adverse events (eg, stroke, transient ischemic attack), including fatalities, were reported in trials of olanzapine in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of CVAE in patients treated with olanzapine compared to patients treated with placebo. Olanzapine is not approved for the treatment of patients with dementia-related psychosis.
Hyperglycemia and diabetes mellitus — Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics including olanzapine. All patients taking atypicals should be monitored for symptoms of hyperglycemia. Persons with diabetes who are started on atypicals should be monitored regularly for worsening of glucose control; those with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. Patients who develop symptoms of hyperglycemia during treatment should undergo fasting blood glucose testing.
Neuroleptic malignant syndrome (NMS) — As with all antipsychotic medications, a rare and potentially fatal condition known as NMS has been reported with olanzapine. If signs and symptoms appear, immediate discontinuation is recommended. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Tardive dyskinesia (TD) — As with all antipsychotic medications, prescribing should be consistent with the need to minimize the risk of TD. The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
Medication dispensing and prescribing errors have occurred between ZYPREXA (olanzapine) and Zyrtec (cetirizine HCl). These errors could result in unnecessary adverse events or potential relapse in patients suffering from schizophrenia or bipolar disorder. To reduce the potential for dispensing errors, please write ZYPREXA clearly.
The most common treatment-emergent adverse event associated with intramuscular olanzapine vs placebo IM in 3 short-term (24-hour treatment) trials involving agitated patients with schizophrenia or bipolar mania was somnolence (6% vs 3%). Also observed (intramuscular olanzapine vs placebo IM) were dizziness (4% vs 2%), hypotension (2% vs 0%), asthenia (2% vs 1%), tremor (1% vs 0%), and postural hypotension (1% vs 0%).
The most common treatment-emergent adverse event associated with oral olanzapine (vs placebo) in 6-week acute-phase schizophrenia trials was somnolence (26% vs 15%). Other common events were dizziness (11% vs 4%), weight gain (6% vs 1%), personality disorder (COSTART term for nonaggressive objectionable behavior; 8% vs 4%), constipation (9% vs 3%), akathisia (5% vs 1%), and postural hypotension (5% vs 2%).
The most common treatment-emergent adverse event associated with oral olanzapine (vs placebo) in 3- and 4-week bipolar mania trials was somnolence (35% vs 13%). Other common events were dry mouth (22% vs 7%), dizziness (18% vs 6%), asthenia (15% vs 6%), constipation (11% vs 5%), dyspepsia (11% vs 5%), increased appetite (6% vs 3%), and tremor (6% vs 3%).
To view the entire Important Safety Information, click here.
ZYPREXA is a registered trademark of Eli Lilly and Company. Zyrtec is a registered trademark of UCB, SA. "
Additives blamed for children's tantrums Last updated at 09:50am on 8th May 2007
Join the debate » Parents have been advised by food safety experts to omit several additives from their children's diets, with new research set to confirm a link between the ingredients and behavioural problems.
The study, conducted by Southampton University for the Food Standards Agency, has analysed the effects of a number of preservatives and colourings found in sweets, drinks and processed foods commonly consumed by children. It is thought to have concluded a definite link between the additives and problems such as temper tantrums and hyperactivity.
Although the findings are not due to be released until much later this year, the results have been viewed and considered by the FSA's Committee on Toxicity of Chemicals in Food which officially noted "the public health importance of the findings" which are thought to have been consistent with a similar study in 2000 disputed by the committee.
The first trial, known as the Isle of Wight study, concluded that " significant changes in children's behaviour could be produced by the removal of colourings and additives from their diet and benefit would accrue for all children from such a change."
The committee, however, declared in 2002 that the study was inconclusive.
The FSA then set up the further study to provide conclusive evidence, with a working group of independent experts. The experts have advised consumers to consider removing these additives from children's diets immediately.
The colours, tested on both threeyearolds and eight- to nine-year olds, are tartrazine (E102), ponceau 4R (E124), sunset yellow (E110), carmoisine (E122), quinoline yellow (E104) and allura red AC (E129). The preservative tested was sodium benzoate (E211).
While these additives are widely used in Britain and approved by the EU, some are banned in Scandinavian countries and in the US.
Vyvyan Howard, professor of bioimaging at Ulster University and an expert on the FSA's additives and behaviour working group, said: "It is biologically plausible that there could be an effect from these additives. While you are waiting for the results to come out you can choose not to expose your children to these substances. These compounds have no nutritonal value and I personally do not feed these sorts of foods to my 15-month-old daughter."
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GSK and WYETH admit that Paxil and Effexor lead to Alcohol Abuse
The psychiatrist came to symbolize improper NIH ties to drug firms. He had pleaded guilty to a conflict charge.
By David Willman, Times Staff Writer May 9, 2007
WASHINGTON — A senior researcher at the National Institutes of Health, who became a symbol of the agency's improper entanglements with drug companies and whose lasting presence on the federal payroll enraged members of Congress, has retired from the government.
Dr. P. "Trey" Sunderland III accepted about $612,000 in consulting and speaking fees from Pfizer Inc. and about $200,000 from other companies from 1998 to 2004, all without getting required approvals in advance from the NIH. He pleaded guilty five months ago to a federal conflict-of-interest charge and agreed to pay $300,000 to the government and to perform community service.
Word of Sunderland's retirement surfaced in a probation report filed Thursday with a U.S. District Court in Baltimore. The probation officer, Rasheed J. Tahir, wrote that Sunderland "is now privately practicing psychiatry."
Sunderland has paid the government about one-third of the $300,000 in restitution and performed three-fourths of his required community service, the report said. Sunderland, 55, a psychiatrist who specialized in researching Alzheimer's disease, had remained on the federal payroll through March. His case was among scores that prompted a sweeping ban of drug-company consulting fees and other industry compensation to NIH employees.
The ban, which was ordered in 2005 by the director of the NIH, was fought by many scientists at the agency who wanted the income from the drug companies.
The timing of the ban is of renewed relevance for Sunderland: He told colleagues at a national psychiatric research conference in December 2006 that he was a consultant to Pfizer and another drug-maker, AstraZeneca. Conference materials also show that Sunderland reported that he had received honoraria, typically fees for speaking or making appearances, from Pfizer, Bristol-Myers Squibb and Janssen Pharmaceuticals.
Reached by telephone at the NIH headquarters in Bethesda, Md., Deputy Director Raynard S. Kington declined to say whether the agency had granted Sunderland special permission to accept compensation from any of the four drug companies.
Sunderland's lawyer, Robert F. Muse, declined comment on his client's disclosures at the December conference. He also declined to discuss terms of Sunderland's discharge and retirement.
Three of the four drug companies listed by Sunderland in December had no comment. A spokeswoman for Pfizer, Liz Powers, said: "Sunderland was, at one time, a consultant to Pfizer Inc. He is not currently a consultant."
Sunderland's retirement ended an inquiry by the U.S. Commissioned Corps, the uniformed branch of the Public Health Service of which he had been a member since arriving at the NIH in 1982."
The official who oversees the Commissioned Corps, Adm. John O. Agwunobi, referred inquiries to an aide, who declined to say whether Sunderland had been granted an honorable discharge with full federal retirement benefits.
While accepting the earlier fees from Pfizer, Sunderland had collaborated with the company in his official role. From 1998 to 2003, he and his staff collected samples of spinal fluid from patients at the NIH's Clinical Center, in Bethesda.
Under terms of an agreement between the NIH and Pfizer, Sunderland then provided the samples to the drug company for its analysis and use in seeking clues that might develop a treatment for Alzheimer's disease.
Members of Congress had questioned months ago why the NIH had allowed Sunderland to remain on the federal payroll long after it was first established, in mid-2004, that he had flouted the agency's rules.
At congressional hearings last year, Sunderland's superiors at the NIH's mental-health institute said they were powerless to act against him because he belonged to the Commissioned Corps. Agwunobi told the House Energy and Commerce Committee's investigations subcommittee in September that his staff needed to gather more information.
The then-chairman of the full committee, Rep. Joe L. Barton (R-Texas), called the NIH "an ethical Potemkin village, where a hollow system appears to provide the illusion of integrity, but transgressors never leave."
Regarding Sunderland, Barton told Agwunobi: "You're sitting on your bottom, and you're not doing anything about it. It's a farce."
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US: Convicted Felons Perdue Pharma executives cost firm $634M in fines
June 18 2007, 5:00 PM
Email from N in Ireland:
"OxyContin's Deception Costs Firm $634M
ROANOKE, Va., May 10, 2007(CBS/AP) Two days after agreeing to pay states nearly $20 million for falsely marketing OxyContin, the drug's maker, Perdue Pharma, and three current and former executives plead guilty to federal charges.
The Stamford, Conn.-based maker of the powerful painkiller, and three of its current and former executives, pleaded guilty Thursday to misleading the public about OxyContin's risk of addiction, a federal prosecutor and the company said.
Purdue Pharma L.P., its president, top lawyer and former chief medical officer will pay $634.5 million in fines for claiming the drug was less addictive and less subject to abuse than other pain medications, U.S. Attorney John Brownlee said in a news release.
The plea agreement comes after the company agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe OxyContin.
"With its OxyContin, Purdue unleashed a highly abusable, addictive, and potentially dangerous drug on an unsuspecting and unknowing public," Brownlee said. "For these misrepresentations and crimes, Purdue and its executives have been brought to justice."
Purdue learned from focus groups with physicians in 1995 that they were worried about the abuse potential of OxyContin. The company then gave false information to its sales representatives that the drug had less potential for addiction and abuse than other painkillers, the U.S. attorney said.
Even though the company was warned by health professionals, the media and members of its own sales force, "Perdue continued to push a fraudulent marketing campaign that promoted OxyContin as less addictive, less subject to abuse and less likely to cause withdrawal when they knew in fact that that was not true," Brownlee told CBS News correspondent Barry Bagnato.
"People who are suffering from chronic pain want a drug that can relieve them of that pain and yet the same time is safe not only for themselves but for society," Brownlee said. "And Perdue promised that."
"Doctors are often approached right in their offices by pharmaceutical company sales reps dispensing information about one medication or another," said CBS News medical correspondent Dr. Jon LaPook. "This case is a reminder to doctors not to believe everything they hear — and to drug companies that the FDA will hold them accountable for fraudulent practices."
Purdue Pharma said it accepted responsibility for its employees' actions.
"During the past six years, we have implemented changes to our internal training, compliance and monitoring systems that seek to assure that similar events do not occur again," the company said in a news release.
OxyContin, a trade name for oxycodone, is designed to have a time-released effect on a patient's pain, but people who abuse the medication will crush the pills and then swallow, snort or inject the drug so that its pain-killing properties — meant to be spread out over 12 hours — are absorbed all at once.
From 1996 to 2001, the number of oxycodone-related deaths nationwide increased 400 percent while the annual number of OxyContin prescriptions increased nearly 20-fold, according to a report by the U.S. Drug Enforcement Administration. In 2002, the DEA said the drug caused 146 deaths and contributed to another 318.
The drug became a major problem in Virginia — particularly southwest Virginia and other areas of the Appalachian region, where it got the nickname "hillbilly heroin."
In western Virginia, 228 people died from overdoses of oxycodone from 1996 to 2005, Brownlee said.
Brownlee said the guilty pleas were entered Thursday morning in U.S. District Court in Abingdon, about 135 miles south of Roanoke. In addition to Purdue's plea, company chief executive officer Michael Friedman, general counsel Howard Udell and chief medical officer Paul Goldenheim each pleaded guilty to misdemeanor counts of misbranding the drug. They individually will pay fines totaling $34.5 million.
The fines will be distributed to state and federal law enforcement agencies, the federal government, federal and state Medicaid programs, a Virginia prescription monitoring program and individuals who had sued the company. At least $5 million will go toward a six-year company program to monitor compliance with the agreement.
Prescription Drugs | NYT Analysis Looks at Psychiatrists Who Receive Payments From Drug Companies
[May 10, 2007]
The New York Times on Thursday examined how "the intersection of money and medicine, and its effect on the well-being of patients, has become one of the most contentious issues in health care" -- and "[n]owhere is that more true than in psychiatry, where increasing payments to doctors have coincided with the growing use in children of a relatively new class of drugs known as atypical antipsychotics." Drugs in the best-selling class of antipsychotics -- which includes Risperdal, Seroquel, Zyprexa, Abilify and Geodon -- are being prescribed to more than 500,000 U.S. children "to help parents deal with behavior problems despite profound risks and almost no approved uses for minors," the Times reports.
The Times conducted an analysis of records in Minnesota, the only state that requires public reports of all drug company marketing payments to doctors. The analysis found that from 1997 to 2005, more than one-third of Minnesota's licensed psychiatrists took money from drug manufacturers, including the last eight presidents of the Minnesota Psychiatric Society. The analysis found that from 2000 to 2005, drug maker payments to Minnesota psychiatrists increased more than sixfold to $1.6 million.
During the same period, prescriptions of antipsychotics for children in Minnesota's Medicaid program rose more than ninefold, the Times analysis found. The analysis also found that doctors "who took the most money from makers of atypicals tended to prescribe the drugs to children the most often," the Times reports. Further, Minnesota psychiatrists who received at least $5,000 from manufacturers of atypicals from 2000 to 2005 appear to have written three times as many atypical prescriptions for children as psychiatrists who received less or no money. The analysis found that payments to individual psychiatrists ranged from $51 to more than $689,000, with a median of $1,750.
According to the Times, because the records are "incomplete, these figures probably underestimate doctors' actual incomes." The Times notes that "[n]o one has proved that psychiatrists prescribe atypicals to children because of drug company payments" (Harris et al., New York Times, 5/10). "
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UK: Psychiatrist Bob Johnson (Author of Unsafe at any Dose) Video - 'Curing Mental Pain
Curing mental pain - 1 You cannot change the past, but you can most certainly change its impact. Children are impressionable. They cannot ... all survive on their own, so they learn very deeply what works with the adults around them. This is Attachment Theory. Where insecure attachment prevails, the results can disable that individual for a life time –they need persuading to revisit the trauma, and place it firmly in its childhood context.
This videos shows how the process works. It introduces two books – Emotional Health ISBN 0-9551985-0-X, and Unsafe at any dose ISBN 0-9551985-1-8, see previews at www.amazon.co.uk or at www.TruthTrustConsent.com. Further info is available at www.esc99,org. Many more videos are planned, including – curing panic attacks, curing anorexia, curing depression and bipolar, curing self-harm, curing all varieties of Personality Disorder. For latest info on these videos check out www.TruthTrustConsent.com
Dr Bob Johnson
Consultant Psychiatrist, P O Box 49, Ventnor, Isle of Wight, PO38 9AA UK
e-mail [email protected]www.TruthTrustConsent.com MRCPsych (Member of Royal College of Psychiatrists), MRCGP (Member of Royal College of General Practitioners). Author Emotional Health ISBN 0-9551985-0-X Author Unsafe at any dose ISBN 0-9551985-1-8
A Bastrop County man was sentenced to 10 years probation after pleading guilty to murder.
Robert Crerar, 67, dialed 911 in October 2006 and told dispatchers he had killed his 73-year-old wife in their home near Paige.
Prosecutors say they presented the court with evidence showing the defendant stabbed his wife 47 times. The defense showed Crerar was suffering from severe depression and was taking a dangerous mix of antidepressants.
Some victims' right advocates say the probation sentence sends the wrong message. Bastrop County DA Bryan Goertz says the evidence tells a different story.
"That would be a common reaction. Unless the person was in the courtroom and actually heard the evidence, it would be difficult to say it was an appropriate reaction,"
As a condition of his probation, Crerar will have to undergo psychological counseling."
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UK: Antidepressant Prescriptions in England hit a record high
The number of prescriptions for antidepressants in England has hit a record high despite national guidance advocating alternative treatments.
More than 31 million prescriptions for drugs such as Prozac were issued in 2006 - a 6% rise on the year before.
The figures come as two studies showed "startling" benefits of country walks in people with depression.
Mind, the charity that reported the findings, said GPs should consider "ecotherapy" as a valid alternative.
The National Institute for health and Clinical Excellence issued guidance in 2004 recommending that antidepressants should not be used as first-line therapy for mild to moderate depression.
Instead patients should be offered guided self-help and psychological therapies in the first instance.
But figures from the Information Centre indicate the number of prescriptions for antidepressants are still on the rise.
In particular prescriptions for a group of drugs known as SSRIs, which include Prozac, rose by 10% last year from 14.7m to 16.2m.
There have been fears that the drugs are linked to suicidal thoughts and self-harm in some cases.
In 2003, experts said SSRI antidepressants should not be given to teenagers after experts' concerns they made some patients suicidal.
However, Prozac is still recommended for under-18s, as it is thought that the benefits of taking this particular drug outweigh any potential risk, but only for those with severe depression.
Alternative therapies
Mind, the mental health charity, say the UK is trailing behind other countries in the use of other therapies.
In the Netherlands, Italy, Germany, Austria, Belgium and Slovenia, patients with depression are prescribed agricultural work.
Holland has 600 care farms that are part of the health service compared with 43 in the UK none of which are aimed at mental health.
In a report on ecotherapy, Mind said 93% of GPs have prescribed drugs due to lack of alternatives.
Ecotherapy, described as getting outdoors and getting active in a green environment, should be considered as a treatment option they said.
Researchers at the University of Essex compared a walk in a country park with a walk in a shopping centre in a study of 20 people.
They found 71% reported decreased levels of depression after a country walk compared with 45% after a shopping centre walk.
Participants also felt much less tense and reported greatly increased self esteem after a green walk.
But after a walk in a shopping centre, 50% said their feelings of tension increased and 44% said their self-esteem decreased after the walk in a shopping centre.
A separate survey of 108 people who regularly take part in green activities run by local Mind associations found 90% said it was the combination of nature and exercise that had the greatest effect on them and 94% said green activities had lifted their depression.
Paul Farmer, chief executive of Mind said ecotherapy was a credible, clinically-valid treatment option and needs to be prescribed by GPs especially as access to treatments other than antidepressants was extremely limited.
"We're not saying that ecotherapy can replace drugs but the debate needs to be broadened."
Marjorie Wallace, chief executive of the mental health charity SANE, said: "GPs are now encouraged to diagnose depression yet without the availability of qualified counsellors and therapists they have little choice but to hand out a prescription - or send the patient away empty-handed, leaving them with less hope of treatment and recovery."
The NHS is currently rolling out a programme of providing people with access to computerised CBT and the government has set up 10 pilots to explore ways of speeding up access to talking therapies.
A spokesperson for the Department of Health said: "Central to our efforts is the ability for people who are ill to be able to quickly get the right kind of therapy, instead of being prescribed medication."
They added the demonstration sites were showing early signs that quick access to therapy reduced the time that patients are ill and helps individuals to regain their independence.
Professor Mayur Lakhani, chair of the Royal College of GPs, said: "We reject the suggestion that GPs prescribe antidepressants too readily.
"GPs consider the need for antidepressants only after a careful assessment of the patients? clinical condition.
"The real story is the lack of access to services such as talking therapies and the long waiting lists for these. GPs find themselves in a difficult position because of limited services."
admin
OZ: 17% of docs reported serious complications from combining antidepressants
June 18 2007, 5:40 PM
By Email
"ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, Full Disclosure, and Accountability
An Australian survey of more than 1000 psychiatrists, trainees and medical officers found that 76% had prescribed a combination of antidepressants for their patients--which psychiatrists know is not based on any scientific evidence. Indeed, 17% of those who responded reported they had seen serious complications from the combination of antidepressants.
"Doctors working in psychiatry in Australia, like their colleagues in other countries, are prepared to use treatments in some patients without a firm evidence base."
The damaging effects of psychiatry's irresponsible high risk prescribing practices are documented in children's ruined lives.
Rebecca Riley a Boston toddler was prescribed a lethal combination of drugs since age 28 months--she died at age four. [1]
Anya Bailey, prescribe the antipsychotic, Risperdal at age 12 for "eating disorder." As a result of taking the drug, she exhibits two debilitating, irreversible neurological conditions--dystonia (described in The New York Times, May 10), and tardive dyskinisia--these drug-induced disabling conditions are a sign of brain damage. [2]
A series in the Kansas City Star (December 2006) "America’s Mentally Ill Children: Little Llives in Chaos," describes the out of control behavior of little 6 year old Marcus, a disadvantaged chilid (the oldest of three, fourth on the way). The article mentions that Marcus "heavily medicated." The reporter seems entirely unaware about the adverse effects that psychotropic drugs often have. [3] One thing is certain, the drugs that have been prescribed for Marcus have NOT HELPED. Someone needs to examine whether the drugs have had a toxic effect and thereby exacerbating the child's temper tantrums.
Psychaitry's illegitimate irresponsible prescribing practices have led even leading mainstream child psychiatrists, such as Dr. Gabrielle Carlson, a professor of psychiatry and pediatrics at Stony Brook University School of Medicine on Long Island, to acknowledge : "To me one of the miracle of children’s brains is that we don’t see more harm from these treatments.” [4]
References:
1. Carey Goldberg. Bipolar labels for children stir concern Hull case highlights debate on diagnosis Rebecca Riley's parents are accused of deliberately poisoning her with her prescription medication. BOSTON GLOBE, February 15, 2007 http://ahrp.blogspot.com/2007/02/4-year-old-rebecca-riley-casualty-of.html
DOCTORS are prescribing more than one antidepressant drug at a time to their patients, leading to the risk of serious complications such as epileptic seizures, confusion and mood swings.
A survey of more than 1000 psychiatrists, trainees and medical officers found 76 per cent had prescribed a combination of antidepressants for their patients.
The study by three Melbourne psychiatrists, Dr David Horgan, Dr Seetal Dodd and Professor Michael Berk, was published in Australasian Psychiatry and found 17 per cent of psychiatrists had seen serious complications from the combination of antidepressants.
"Doctors working in psychiatry in Australia, like their colleagues in other countries, are prepared to use treatments in some patients without a firm evidence base," the authors wrote.
The use of combination drug therapy has ignited debate among medical professionals about the risks of experimenting with combinations that have not been properly researched.
The head of psychological medicine at Adelaide Women's and Children's Hospital, Dr Jon Jureidini, said there was little evidence to suggest using antidepressants in combination would be beneficial. "It's like adding a dash of salt or spice to a soup to see if it adds taste or changes the flavour," he said. "It's not actually very scientific."
Dr David Kitching, the chairman of the Psychiatrics Treatment Advisory Committee of the Royal Australian and New Zealand College of Psychiatrists, said he was not surprised at the number of psychiatrists prescribing combination therapy as they tended to see the most acute cases of depression, where it had become a last resort.
Dr Nicholas Keks, professor of psychiatry at Monash University, said he prescribed combination drugs to only 2 per cent of his patients as it was "not something you would be gung-ho about".
Pfizer, the company that acknowledged criminal marketing of Neurontin (2004), the company that paid millions of dollars in settlements for failing to disclose the suicide risks of its antidepressant, Zoloft, now faces criminal charges by the government of Nigeria for criminal testing of a lethal antibiotic that is known to cause liver damage, Trovan (trovafloxan), on children leading to untold deaths.
The Washington Post reports: "The move represents a rare -- perhaps unprecedented -- instance in which the developing world's anger at multinational drug companies has boiled over into criminal charges. It also represents the latest in a string of public-relations blows stemming from the decade-old clinical trial, in which Pfizer says it acted ethically.
The government alleges that Pfizer researchers selected 200 children and infants from crowds at a makeshift epidemic camp in Kano and gave about half of the group an untested antibiotic called Trovan (trovafloxan). Researchers gave the other children what the lawsuit describes as a dangerously low dose of a comparison drug made by Hoffmann-La Roche. Nigerian officials say Pfizer's actions resulted in the deaths of an unspecified number of children and left others deaf, paralyzed, blind or brain-damaged."
The lawsuit further charges researchers with failure to obtain consent from the children's families and with knowledge that Trovan was an experimental drug with life-threatening side effects that was "unfit for human use."
A panel of experts convened by the Nigerian government examined Pfizer's actions, but its final report was suppressed without explanation. The Post obtained a copy last year, which revealed that the panel had concluded Pfizer's actions violated Nigerian law, the international Declaration of Helsinki and the U.N. Convention on the Rights of the Child.
According to the suit, parents were banned from the ward where the drug trial occurred, and the company left no medical records in Nigeria. The criminal charges state: "Pfizer and its doctors agreed to do an illegal act," and behaved "in a manner so rash and negligent as to endanger human life."
"Compared to the reality of the drug industry, my book reads like a vacation post card" John Le Carre, Author, The Constant Gardner.
Indeed, the prescription drug industry's corrupt practices once again pose a danger to the world community. Not since the Nazi Doctors Trial and the trial of 24 board members of the IG Farben the giant chemical-pharmaceutical company (split into BASF, Bayer, Hoechst->Aventis) who were tried and convicted at Nuremberg for crimes against humanity (1946-1947), has a government filed a criminal case against a pharmaceutical company and its contracted doctors. See: [Link]
[Link]Washington Post Pfizer Faces Criminal Charges in Nigeria By Joe Stephens Wednesday, May 30, 2007; Page A10
Officials in Nigeria have brought criminal charges against pharmaceutical giant Pfizer for the company's alleged role in the deaths of children who received an unapproved drug during a meningitis epidemic.
Authorities in Kano, the country's largest state, filed eight charges this month related to the 1996 clinical trial, including counts of criminal conspiracy and voluntarily causing grievous harm. They also filed a civil lawsuit seeking more than $2 billion in damages and restitution from Pfizer, the world's largest drug company.
The move represents a rare -- perhaps unprecedented -- instance in which the developing world's anger at multinational drug companies has boiled over into criminal charges. It also represents the latest in a string of public-relations blows stemming from the decade-old clinical trial, in which Pfizer says it acted ethically.
The government alleges that Pfizer researchers selected 200 children and infants from crowds at a makeshift epidemic camp in Kano and gave about half of the group an untested antibiotic called Trovan. Researchers gave the other children what the lawsuit describes as a dangerously low dose of a comparison drug made by Hoffmann-La Roche. Nigerian officials say Pfizer's actions resulted in the deaths of an unspecified number of children and left others deaf, paralyzed, blind or brain-damaged.
The lawsuit says that the researchers did not obtain consent from the children's families and that the researchers knew Trovan to be an experimental drug with life-threatening side effects that was "unfit for human use." Parents were banned from the ward where the drug trial occurred, the suit says, and the company left no medical records in Nigeria.
Pfizer and its doctors "agreed to do an illegal act," the criminal charges state, and behaved "in a manner so rash and negligent as to endanger human life."
Internal Pfizer records obtained by The Washington Post show that five children died after being treated with the experimental antibiotic, though there is no indication in the documents that the drug was responsible for the deaths. Six children died while taking the comparison drug.
Suspicion stirred by news of the drug trial has been so intense in Kano, the lawsuit says, that parents last year refused to allow their children to be immunized against polio, frustrating a program aimed at wiping out one of the disease's last refuges.
In a statement, Pfizer said it thinks it did nothing wrong and emphasized that children with meningitis have a high fatality rate. "It is indeed regrettable that, more than a decade after the meningitis epidemic in Kano, the Nigerian government has taken legal action against Pfizer and others for an effort that provided significant benefit to some of Nigeria's youngest citizens," the statement said.
"Pfizer continues to emphasize -- in the strongest terms -- that the 1996 Trovan clinical study was conducted with the full knowledge of the Nigerian government and in a responsible and ethical way consistent with the company's abiding commitment to patient safety. Any allegations in these lawsuits to the contrary are simply untrue -- they weren't valid when they were first raised years ago and they're not valid today."
The criminal charges also name Pfizer's Nigerian subsidiary and eight current or former executives and researchers. The charges could result in fines and prison sentences ranging from six months to seven years per count, according to Aliyu Umar, who served as Kano attorney general until earlier this month.
Umar said he filed the charges with the backing of federal and state authorities. He said it took 11 years to bring the action because officials only learned details in recent years, through a series of investigative reports in The Post. Three months ago, Umar's office obtained a six-year-old Nigerian government report that concluded Pfizer's actions violated international law.
"We realize we are the Third World and we need assistance," Umar said. "But we frown on people who think they can take advantage of us, especially if it's for profit. That's why we decided we needed to take action against Pfizer.
"Those people responsible should be punished, whether in Nigeria or in the United States , for what they did to our people."
Pfizer's drug trial came to public attention in December 2000, when The Post published the results of a year-long investigation into pharmaceutical testing in the developing world. Nigerians met the news with street demonstrations and demands for reform.
Nigeria's health minister appointed a panel of experts to look into Pfizer's actions, but its final report was suppressed without explanation. Last year, The Post obtained a copy, which revealed that the panel had concluded Pfizer's actions violated Nigerian law, the international Declaration of Helsinki [Link] mline> and the U.N. Convention on the Rights [Link] =informline> of the Child.
The panel said Pfizer administered an oral form of Trovan that apparently had never been given to children with meningitis. It said there were no records documenting that Pfizer told the children or their parents that they were part of a drug trial. And it said an approval letter from a Nigerian ethics committee, which Pfizer used to justify its actions, was a sham concocted long after the trial ended.
"The families of the children who [Pfizer] used as laboratory guinea pigs were led to believe and in fact understood that the Defendants were providing their children with volunteer relief, clearly focused humanitarian medical intervention and nothing more," the lawsuit says.
Parents were not told that alternative treatments were available, it adds.
The suit charges that parents were barred from Pfizer's ward and that the company's own lab tests had shown Trovan's life-threatening side effects. Researchers allegedly administered the comparison drug, Rocephin, in dangerously low doses to make Trovan look more effective.
The lawsuit contends that Pfizer researchers left the area during the epidemic, took all medical records and "obliterated any evidence" of the trial. "Defendant's illegal conduct was deliberate and solely motivated by financial considerations," it says.
Every surviving child suffered one or more disabilities, the lawsuit says, adding that the state of Kano has incurred major costs caring for the children and otherwise dealing with the drug trial 's repercussions.
In its statement, Pfizer said the drug was in late-stage development and had been tested on 5,000 patients in a number of countries. "Pfizer's doctors had solid scientific evidence that it would provide a safe and effective treatment against the deadly disease," the statement said. The treatment "indisputably helped save the lives of almost 200 children," the company said.
The U.S. Food and Drug Administration never approved Trovan for use in treating American children. After being cleared for adult use in 1997, the drug quickly became one of the most prescribed antibiotics in the United States. But Trovan was later associated with reports of liver damage and deaths, leading the FDA to restrict its use in 1999. It remains available in the United States, but European regulators have banned it.
admin
PFIZER and CRIME
June 18 2007, 5:58 PM
Pfizer have been convicted of crimes in the past, although they so far get fines rather than imprisonment, they are facing criminal charges over causing the deaths of African children by illegally experimenting on them, and could possibly be charged over the following in the future:
A former Pfizer finance executive alleges that Pfizer is a company which hires detectives who pay bribes, use corporate spies, pretexting, and pays off competitor's employees to leak confidential information, and uses other potentially illegal means of obtaining information for the company. And the documents he has provided appear to support his allegations.
The executive is Mr. Ashok S. Idnani, a former Deputy Manager in Pfizer's finance department who spent 28 years working for the company.
Idnani was fired after he informed Pfizer CEO Jeff Kindler of numerous illegal acts and provided documents to Pfizer's Corporate Compliance and Corporate Audit departments in support of his allegations.
In January 2006, a two-member team, Ms. Indrani Franchini, Deputy Compliance Officer, and Ms. Sarah Alper, Compliance Audit Supervisor from Pfizer New York traveled to Mumbai, India, to meet with Idnani.
When they arrived in Mumbai they received written proof that Pfizer India had hired a team of detectives who operated by using bribes, corporate spies, pretexting, and even suggested paying off employees in other companies to leak confidential information which Pfizer desired.
Dinesh Lakhani was one of the persons who had his privacy violated by Pfizer. He was a Parke-Davis shareholder who opposed the Pfizer Warner-Lambert merger.
The Pfizer and Park-Davis merger in India had been approved by a single-judge bench on February 7, 2003. However, four shareholders - Dinesh Lakhani, Janak Mathuradas, Arvind Vyas and Hiren Vyas - appealed against that order and obtained an ad interim stay. The Bombay High Court admitted the appeal by these minority shareholders in May 2003. More here.
This very much angered Pfizer management, and they sent their goons to spy on Dinesh Lakhani and also Janak Mathuradas. Janak Mathurdas is known in India as an activist investor who frequently opposes management, including objecting against fat pay packages. More here.
In this article you'll be able to download and read Pfizer's surveillance reports on these two men and many others.
It is interesting to note that the surveillance reports directly implicate Mr. Kewal Handa, Pfizer India's Managing Director, in this nefarious activity
Hence, these surveillance reports demonstrate that senior Pfizer management was involved in this activity.
It is also clear that Pfizer Corporate Compliance and Corporate Audit appear to have no problem with such clandestine efforts.
After all, if they did, Mr. Handa wouldn't still be the Managing Director of Pfizer India.
According to the June 2003 surveillance strategy, Mr. Handa was requested to approve a plan which included obtaining confidential and personal bank account information for Dinesh Lakhani, the Parke-Davis shareholder who sued Parke-Davis over the terms of Pfizer's acquisition of that company.
The document also lists need for phone records, even bribes are openly discussed.
Additionally, the report makes clear that an office assistant working for Trent Ltd. is available as an in-house spy.
The first set of document have Pfizer's Company Secretary A. Anjeneyan's handwriting and recommendation to Handa (Anjeneyan reported to Handa and has since left the company).
According to the surveillance reports, Pfizer also spied on Shreeharsha Vasant Phene, who at the time was a corporate planning vice president of Trent Ltd, which owns supermarkets and retail stores, and belongs to the TATA group (more here).
Mr. Idnani comments: "Why Pfizer and Handa ordered this surveillance, I cannot fathom. It is possible the Pfizer India people were taking advantage of the situation to settle personal scores or even to harm and blackmail them."
Pramod Lele, one of the targets for Pfizer's investigations, had been the country manager of Warner-Lambert (Parke-Davis) in India, and had started reporting to Pfizer N.Y where the merger had already taken place.
According to Idnani, he had been promised that he would become the Pfizer India managing director of the merged company.
At a meeting in New York he received a shock, when he was suddenly told that Hocine Sidi Said had been designated as the new country manager of the merged Pfizer/Park-Davis organization. More here.
Pramod Lele resigned and took over as the CEO of Hinduja Hospital in 2003 (more here), and later that same year Pfizer's surveillance of him started.
According to the surveillance reports, the investigators working for Pfizer also obtained Mr. Lele's phone records from the Indian cell phone service provider Orange (Orange was later renamed "Hutch").
These phone records have most likely been obtained through "pretexting" a practice in which someone impersonates a person to obtain his private data.
This is a practice which led to the resignation of Hewlett-Packard's chairwoman, Patrica Dunn.
In her case the target was a board member on her own Board of Directors.
Idnani has in his correspondence with Pfizer asked whether any Judge of the Bombay High Court who was hearing the Dinesh Lakhani vs. Parke-Davis. case, was also followed.
He considered this a possibility because he had seen another document, which he no longer has access to, attached to the surveillance reports with a listing of people who were monitored, in which at the top the initials "HCJ 2" was followed vertically by "Lakhani," "Janak," "PL," "Phene."
And even if that were not the case, at a minimum, Pfizer has been exposed as a company going to any length to win the game they're playing, using hired goons to do their shadowy bidding.
admin
US: UTAH joins other states suing ELI LILLY over ZYPREXA
SALT LAKE CITY -- Utah became the latest state to file a lawsuit against drug maker Eli Lilly and Co. over the anti-psychotic drug Zyprexa, alleging that the state was misled about risks to patients who received the drug through Medicaid.
Attorney General Mark Shurtleff filed the lawsuit Thursday in U.S. District Court in Utah, accusing Indianapolis-based Lilly of pushing doctors to prescribe the drug to treat "off-label" conditions like Tourette's syndrome, Alzheimer's and anorexia.
The U.S. Food and Drug Administration approved Zyprexa for treatment of schizophrenia and bipolar disorder.
Doctors are free to prescribe drugs for uses not approved by the FDA, but pharmaceutical companies are prohibited by law from marketing drugs for non FDA-approved uses. And because the prescriptions were subsidized by Medicaid, the state is seeking damages from Eli Lilly.
Eli Lilly spokesman Phil Belt said he was unfamiliar with the lawsuit and could not comment on it specifically. He said the company has training and compliance programs to ensure that all its products are marketed appropriately.
Side effects to Zyprexa can include high blood sugar levels, acute weight gain and pancreatitis, according to the lawsuit.
"Utah has paid millions of dollars for inappropriate and medically unnecessary doses of Zyprexa. As a result, Lilly has been illegally enriched at the expense of the State," the lawsuit said.
The state is seeking civil damages and penalties, including $5,000-$10,000 for each prescription that was "not medically necessary."
Lilly also faces lawsuits filed by attorneys general of Alaska, Louisiana, Mississippi, New Mexico and West Virginia alleging that it marketed Zyprexa for unapproved uses or hid the risks of weight gain and diabetes.
admin
aka 'FDA PROTECTS SSRI MAKERS' with Misleading Suicide Warning
FDA Protects SSRI Makers With Misleading Suicide Warning
By Evelyn Pringle
21 May, 2007 Countercurrents.org
On May 2, 2007, the FDA announced its most misleading warnings to date about selective serotonin reuptake inhibitor antidepressants when it said the drug makers would revise the current black box warning of an increased risk of suicidality in children and adolescents to include adults, but only young adults ages 18 to 24. Apparently at the ripe old age of 25 the increased risk no longer exists.
An FDA advisory committee held a public hearing on December 13, 2006 to review drug company data that show SSRIs to be associated with suicidality in adults. The commonly prescribed SSRIs in the US include Prozac, by Eli Lilly, Paxil by GlaxoSmithKline, Zoloft by Pfizer, and Celexa and Lexapro by Forest Labs, along with various generic versions of the drugs.
Many of the world's leading experts on psychiatric drugs traveled to Washington to appear at the hearing, some of whom have spent years investigating the adverse events associated with SSRIs, to testify about the need to extend the back box warnings about suicidality to all age groups.
Needless to say, advocates and experts alike are outraged over the limited warning, which is widely viewed as another gift to the drug makers by the FDA. "Keeping up with its support of the Psychiatric community and pharmaceutical industry the FDA has again taken the low road," says Kelly Patricia O'Meara, author of "PSYCHED OUT: How Psychiatry Sells Mental Illness and Pushes Pills That Kill."
"Not only is it continuing to minimize the adverse reactions of the antidepressants on the entire population," she notes, "it has now become a cheerleader for the psychiatric community." "When will the well-being of the American People," Ms O'Meara asks, "get the protection it needs and deserves from the nation's leading drug watchdog and when will this nation's lawmakers stand up and be counted on this issue?"
Attorney Karen Barth Menzies is one of the nation's most relentless advocates in the legal field when it comes to pushing the FDA to add warnings about adverse events to the labels of SSRIs. In fact, she has traveled to Washington to speak on behalf of SSRI victims numerous times.
“As I stated in my testimony before the FDA in December 2006,” Ms Menzies notes, “it is not the FDA’s job to promote the virtues of particular drugs nor is it FDA’s job to suggest what treatment people should receive for a particular medical problem.”
“Even the FDA’s Dr. Robert Temple said as much during the December hearing,” she points out.
“Yet that is what the FDA has done with its announcement of the expanded warnings on antidepressants,” she says.
“Aside from the very serious risks of these drugs,” she explains, “there is an overarching issue related to their over-prescription and drug manufacturers preying on vulnerable people by telling them they have a disease that must be treated with their medication.”
A partner in the Baum Hedlund law firm, Ms Menzies considers the FDA's expanded warning a hollow victory. "While it appears that the FDA has finally taken the issue more seriously," she notes, "it is 20 years and thousands of lives too late."
In addition, in the agency’s press release and accompanying Q & A document, Ms. Menzies warns, “The FDA has made some seriously misleading statements that will lead patients and physicians into a false sense of security.”
Ms Menzies says she believes "without question" that drug makers are putting pressure on the FDA. "Despite the controversy over the failures of the FDA in the past several years," she points out, "it appears that the FDA simply cannot muster the guts to act without industry influence."
Critics say the nation's regulatory agencies under the Bush administration have evolved into a protection network for drug makers, in large part, because the industry has created a revolving door where top officials move directly from their government employment into high-paying positions with drug companies.
The latest evidence of this charge appeared in the media on May 4, 2007, with a press release by Prozac-maker Eli Lilly, announcing that Alex Azar II will be joining Lilly as senior vice president, who until February 3, 2007, was the Deputy Secretary of Health and Human Services and served as the "chief operating officer of the largest civilian department in the federal government."
"Azar supervised all operations of the HHS, including the regulation of food and drugs," the press release said, and agencies under his direction included, among others, the FDA.
Azar follows in his former partner, Daniel Troy’s footsteps in defending the drug industry. While Troy left his position as chief counsel at the FDA to work for a law firm representing drug companies, Azar (also a lawyer) went straight to the drug industry itself.
At Lilly, Azar will be responsible for “public relations, governmental affairs, public-policy planning and development, external and internal communications, corporate branding and community relations.”
According to the Indianapolis Star, Azar “takes over the Lilly post as seven states are suing the company, alleging that it promoted off-label uses for Zyprexa, its top-selling drug approved for schizophrenia and bipolar disorder.
“Like other pharmaceutical companies,” the Star points out, “Lilly also faces an array of public- policy challenges, including criticism that it is too cozy with doctors and regulators.”
There is one positive to be noted, at least Troy and Azar are no longer pretending to be protectors of the public health.
Experts say the suicidality risk applies to all SSRI users. "The simple truth is that antidepressants cause suicide in all age groups," according to psychiatrist, Dr Peter Breggin, a court-certified expert on SSRIs, and author of "The Anti-Depressant Fact Book."
"Dragged kicking and screaming into admitting that children and now young adults are at risk for antidepressant-induced suicidality," he says, "the FDA continues to evade reality."
"If the relatively insensitive drug-company rigged short clinical trials pick up suicidality in any age group," Dr Breggin says, "it's almost a certainty that they are causing actual suicides in all ages."
Many other experts agree that safety decisions should not be based on drug maker studies. "The fundamental problem continues to be that the FDA is basing their decisions on studies that are designed and paid for by the very companies that make these drugs," said Dr Timothy Scott, author of, “America Fooled: The Truth about Antidepressants, Antipsychotics and How We've Been Deceived.”
"It is a case," he says, "of the fox guarding the chicken house."
"The research designs used by these studies," he notes, "are incredibly unfair and yet the FDA is allowing this system to continue."
"Dishonest research designs," Dr Scott says, "do not give an honest assessment of the physical or the psychological dangers of long-term antidepressant use."
"Independent research investigations," he states, "repeatedly find adverse events are much, much higher than the rates reported in the studies submitted to the FDA by the drug manufacturers."
For over a decade and a half, Attorney Menzies points out, SSRI makers have enjoyed enormous financial benefits from their manipulations of the clinical trial data and the FDA continues to ignore all evidence aside from data provided by the drug companies. "The FDA is ignoring," she says, "independent analyses conducted by scientists in the field, as well as historical and foreign regulatory actions dating back over 20 years."
Ms Menzies states that clinical trial data from before SSRIs were even approved, signaled the suicidality risk. Documents obtained in litigation show that as early as 1984, Eli Lilly was aware of an increased risk of suicidality with Prozac.
Attorney Menzies calls the FDA's statement that “scientific data does not show an increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality,” “extremely misleading.”
“Rather than accurately informing the public that suicidality can occur in some people at any age,” she notes, “this new warning gives the false perception that certain age groups are entirely safe while others are not. I know for a fact from my review of internal drug company documents that that is not true,” she says.
Critics also find this statement disturbing in light of other independent studies, including a study reported in the May 1, 2006, London Free Press, conducted at the Toronto's Institute for Clinical Evaluative Sciences, that identified suicides among older Ontarians, 66 and up, and found that for patients who were prescribed antidepressants in the 6 months before their deaths, the risk of suicide in the first month for those taking SSRIs was nearly 5 times higher than for seniors taking older antidepressants called tricyclics such as Elavil.
Other experts also object to the piecemeal addition of SSRI warnings. "When the FDA ordered a black box warning for only those 18 and under, it defied common sense that as soon as one turned 19, one was safe," says Dr Bruce Levine, PhD, Clinical Psychologist, author of "STAR*D Wars: The Corruption of the National Institute of Mental Health and the Failure of Antidepressants."
"And now that the warning will extend until 24," Dr Levine adds, "it defies common sense that one becomes safe on one's 25th birthday."
"While some people report antidepressants have benefited them," he notes, "legitimate science shows that these antidepressants are no more helpful for depression than a placebo or no treatment at all."
According to a study analyzing clinical trials submitted to the FDA for drug approval, the efficacy data submitted to the FDA for the six most widely prescribed antidepressants approved between 1987 and 1999, “the pharmacological effects of antidepressants are clinically negligible.” The Emperor’s New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration by Irving Kirsch, Thomas J. Moore, Alan Scorboria and Sarah S. Nicholls.
According to Kirsch, “[a]lthough antidepressant medication is widely regarded as efficacious, a recent meta-analysis of published clinical trials indicates that 75 percent of the response to antidepressants is duplicated by placebo.” Kirsch & Sapirstein, G. (1998). Listening to Prozac but hearing placebo: A meta analysis of antidepressant medication.
Two recent studies conducted in the UK report that exercise in a green environment may be the best remedy for depression. In response to the high cost of drugs, the rise in prescriptions and the fact that 93 percent of GPs reported that “they have prescribed antidepressants against their better judgment owing to a lack of alternatives,” the studies found that “participating in green exercise activities provides substantial benefits for health and wellbeing.”
The “green activities” included gardening, walking, running and bicycling, particularly in a “green” environment.
Another of the world's leading experts on psychiatric drugs, Dr David Healy, author of, "The Creation of Pharmacology (Harvard 2002)," also a frequent visitor traveling from the UK to Washington to testify at FDA hearings, says, "The clinical trial data pointing to a risk was compelling 17 years ago."
"In between 1990 and now," he notes, "the FDA and drug companies have argued that their assessment of risk benefit ratios has not warranted issuing warnings."
"But if we look at the supposed benefits," he explains, "in milder depressions - the vast majority of people who get antidepressants - the FDA analysis in December 2006 showed that only 1 in 10 people who are given antidepressants in clinical trials respond to the drug."
"Four out of 10 respond to being seen and given sensible advice," he notes.
"Putting this 1 in 10 response rate against a 1 in 100 rate of suicidal acts might not seem a bad bet," Dr Healy says, "but suicidal acts are not the only risk of treatment - patients can become severely anxious, homicidal, are at increased risk of broken bones, strokes and bleeds into the gut and other organs, weight gain and its attendant risks."
He also notes that one in two patients on antidepressants experience sexual dysfunction and that it now seems that in a proportion of these people, the problem may be permanent.
"In the case of children," he says, "there are additional risks like failure to grow."
Another serious adverse event with SSRIs is a discontinuation syndrome. Psychiatrist Dr Grace Jackson, author of, "Rethinking Psychiatric Drugs: A Guide for Informed Consent," warns that some patients may not be able to return to living without the drugs, not because they develop a “craving," but because the withdrawal effects they experience during drug cessation are intolerable and are misinterpreted by doctors as “proof” of depressive relapse, for which “lifelong therapy” is mandated.
Over the past several years, many new adverse events related to SSRI use have emerged, including life-threatening birth defects in infants born to mother's taking SSRIs during pregnancy. But because SSRI makers have hidden negative studies for years, experts say patients and doctors were not informed of all the known risks associated with SSRIs.
“Informed consent cannot be obtained for antidepressants---or for any pharmaceutical---unless all of the drugs’ risks are known to the prescribers," according to psychiatrist, Dr Stefan Kruszewski, Faculty, Eastern University, Department of Addictions.
"They cannot be known," he says, "if all of the data is not made available to review or made public - as was the case with Paxil.”
According to Dr Healy, a bigger issue stems from company efforts to make billions of dollars out of these drugs by having them given to people who have little to gain from treatment and a lot to lose."
Dr Healy says most patients with milder depression would get well if seen by a sympathetic physician or therapist and describes three side effects that have resulted from the SSRI controversy:
(1) Physicians have lost confidence in their own ability to help patients without drugs.
(2) A great deal of the problem stems from the fact that close to all of the literature physicians now read is ghostwritten and the articles overemphasize the benefits of treatment and hide the risks.
(3) Antidepressants might be useful drugs, if primarily used for those with severe disorders, but at the moment the drugs probably pose a greater risk than the illness to the lives, careers and relationships of those to whom they are being given.
Clinical pharmacologist, Andrew Herxheimer, also says doctors should be advised not to prescribe drugs, especially SSRIs, to patients with only mild or moderate depression, and if prescribing is deemed necessary, to use the lowest dose that is effective for the individual.
According to Dr Levine, the SSRI makers are not as unhappy as some might think with the warnings and negative publicity. "Patents have run out or are soon to run on all their big sellers," he explains, "and they are preparing their next generation of worthless, dangerous but patented drugs to replace the SSRIs."
Ms Menzies reports that there is a big push to switch people over from taking antidepressants to antipsychotics under the guise that people aren’t depressed after all, they actually have bipolar disorder. “It is a very cleverly orchestrated marketing scheme and it’s a continuation of the manipulation of a vulnerable population,” she says.
Vince Boehm, another persistent advocate for warnings on SSRIs agrees, "This is all about marketing, and not about safety."
"This latest ploy" regarding the expanded antidepressant warnings, Boehm explains, "is a delaying action on the part of the manufacturers with FDA complicity."
"The FDA just commissioned a series of three year studies to evaluate the adult suicide problem," he notes, "and by the time these studies are done and released, the bulk of the medications listed in this announcement will be either off or going off patent."
Medicines and Healthcare products Regulatory Agency (MHRA) Market Towers 1 Nine Elms Lane London SW8 5NQ
Regarding withdrawal of the harmful drug Yentreve
21 May 2007
Yentreve was approved 11 August 2004 for treatment of incontinence [1]. Manufacturer is Eli Lilly. It is exactly the same substance (duloxetine) that is sold as an antidepressant by Lilly, under the name Cymbalta.
As the MHRA knows, Yentreve was never approved in the US. Eli Lilly withdrew its application in January 2005. In BMJ the reason was given: ”The FDA said that studies of women using the drug for incontinence showed that the risk of suicidality among the women was twice that in the general population of middle aged women in the US.”[2]
But in the UK it was approved.
How come the MHRA could approve Yentreve just some months before Lilly withdrew its application to the FDA?
According to newly revealed data Lilly, in its application to British (and other European medical agencies), concealed data about suicides and suicidality – and about the drug’s inefficiency and other harmful effects.
Lilly chose not to include these negative data in its application in Europe. If all data would have been included it is very likely that Yentreve would have been as disapproved in Europe as it was in the US.
The MHRA now knows the facts but has not yet withdrawn Yentreve from the market.
Parts of the known story follow:
The 19-year-old Traci Johnson committed suicide in a clinical trial in February 2004. Data in media said this was in a trial of the antidepressant drug Cymbalta [3]. It was reported in Swedish media in connection with the news that FDA was issuing warnings for suicide risks with antidepressants. A professor in the Swedish Medical Products Agency (MPA) gave the following calming words about the suicidality: that it was “a sign of betterment, that the drug works”, for depressed persons [4].
There was only one problem. Traci Johnson was not depressed and she did not take part in a study of a drug to be marketed for depression (Cymbalta). She was healthy and took part in a study of Yentreve – to be marketed for urinary incontinence.
The results of the study Johnson took part in were approved for publication on Lilly’s web site first 16 November 2006 – the last subject (patient) visit in the study was 18 March 2004. It took Lilly more than 2,5 years to publish the summary of the data [5].
Data from another European agency say this suicide was not known, or part of the Lilly submitted material, at the time of approval of Yentreve, in August 2004.
Neither were full data about suicidality and other harmful effects from another study of Yentreve part of the submitted material. This study, with last subject visit 27 February 2003, was approved for publication first 10 October 2006 – 3,5 years (!) after the last subject visit [6]. The MHRA did not have access to all data at the time of approval of Yentreve, and thus did not know that Lilly had failed to show any positive effect of Yentreve compared to placebo after 36 weeks (“failed to demonstrate a long-term difference in health outcomes”).
What Lilly succeeded to show was that Yentreve caused harmful effects. In the study 224 patients got Yentreve and 227 got placebo. A comparison between reports about mental problems showed that 67 women in the Yentreve group developed some form of such problems, opposed to 30 in the placebo group. Under the heading “Nervous System Disorders” it was reported that 78 women in the Yentreve group experienced such an effect during the study, as opposed to 34 women in the placebo group.
The above study had been ongoing for 36 weeks. The studies forming the basis for the application of Yentreve in Europe were mainly three studies of 12 weeks – where the company had shown some effect above placebo and where the harmful effects had not yet shown up to any greater extent. But the full data from the failed study that had been ongoing for 36 weeks was not part of the application despite the fact that the last subject visit was 27 February 2003 – 1,5 years before the approval of Yentreve.
-------------
This means that women in UK are now subjected to a drug the American authorities could not approve due to harmful effects – and anyone familiar with the normal procedures of the FDA knows that much is required in form of inefficiency and harmful effects before that agency disapproves an application.
It means that the FDA gained access to data about safety risks with Yentreve (as above) after the MHRA approved the drug based on biased data (even if the harmful effects in the SPC is impressive enough).
And it gets even worse – because today the MHRA knows the whole story, but the information why Eli Lilly withdrew the application in the US is classified. Letters from Eli Lilly explaining the reason the drug was disapproved is available to the agency – but not to the public. Lilly could be hurt if the information was officially released.
Isn’t it time for the agency to live up to the principle “we take any necessary action to protect the public promptly if there is a problem”?
Isn’t it time to admit that the approval was a mistake and withdraw Yentreve from the market?
[6] Eli Lilly, clinical trial, Study F1J-MC-SBBA Title of Study: Prospective Outcomes of Duloxetine in Usual Naturalistic Care in Women with Stress Urinary Incontinence, approved summary 10 October 2006,
APA: SSRIs More Likely in Suicides than in Other Young Deaths
By Neil Osterweil, Senior Associate Editor, MedPage Today Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco May 25, 2007
SAN DIEGO, May 25 -- Young suicide victims were significantly more likely to have SSRIs in their bloodstream than were young homicide or accident victims, investigators reported here.
Among the children who committed suicide, SSRIs/venlafaxine were not found more often among those whose deaths were ruled suicide by poison than among those who hung or shot themselves, the researchers noted at the American Psychiatric Association meeting.
But the investigators, from the Virginia Commonwealth University in Richmond and the University of Virginia in Roanoke-Salem, cautioned that their data are descriptive only, and do not establish a causal link between the antidepressants and suicide.
"Finding antidepressants in the 'suicide by poisoning' group may mean any of the following: (1) youths committing suicide received antidepressants for depression; (2) youths committing suicide do so before the antidepressant drugs became effective; (3) antidepressant drugs were 'activating' and this led to suicide; and (4) antidepressant drugs induced suicidal behaviors by other means."
They noted that the hypotheses are not mutually exclusive.
The authors analyzed a total of 2,818 unnatural deaths in children and adolescents, grouped as either from accidents, homicide, or suicide. Of this group, toxicology results were available for 753 cases, of which 732 were either African American or White youths.
They found that:
For all unexpected deaths from any cause, antidepressants were found more commonly among whites than among blacks. Suicide by poisoning occurred more commonly among whites. Recreational drugs were found more commonly among blacks than whites. White female youths were more likely to die by suicide than black females, and black males were more likely to die by homicide than white males. Antidepressants were found in 39 black and white suicides. There were 17 antidepressants, all tricyclics, in suicide by poisoning, and no other antidepressants were found in lethal levels among those who poisoned themselves. SSRIs/venlafaxine appeared more commonly in those who committed suicide (P<0.0001) than in accident or homicide victims. Among the suicides, SSRIs appeared in equal proportion among those who died from poisoning, guns or hanging. (P=0.695).
"As with adults, SSRIs are also used to treat other psychiatric illnesses in children and adolescents," the investigators wrote. "Even though both amitriptyline and doxepin are highly serotonergic tricyclic antidepressants, no tricyclic antidepressants appeared in toxicology findings for our children and adolescents who intentionally shot or hanged themselves. This finding does not support the contention that serotonergic agents provoke suicidal actions."
[So SSRIs have some effect OTHER than serotonergic action that causes suicidality?]
The authors noted that their study was limited by the retrospective design, and by a lack of information describing the mental state before death of the youths who committed suicide.
"Our retrospectively derived data do not reveal whether SSRIs are causally involved in provoking suicidal behavior or suicide. Our report does provide data that may be useful in future meta-analyses addressing this issue," they wrote.
There was no commercial support funding for the study. The authors had no conflicts of interest to declare.
Complete APA Coverage Earn CME/CE credit for reading the news.
Primary source: American Psychiatric Association 2007 Annual Meeting Source reference: Fernandez A et al. "Antidepressants and Suicide in Children and Adolescents in Virginia: Toxicology Findings." Abstract NR730, presented May 23.
politicians & paranoia
UK: BLAIR to use PSYCHIATRY - to lock up SUSPECTS without trial - TO PROTECT VIPs
Fears that doctors could be used to lock up terror suspects without trial
by JASON LEWIS - 26th May 2007
The Government has established a shadowy new national anti-terrorist unit to protect VIPs, with the power to detain suspects indefinitely using mental health laws
The Government has established a shadowy new national anti-terrorist unit to protect VIPs, with the power to detain suspects indefinitely using mental health laws.
The revelation is set to reignite the row over the Government's use of draconian measures to deal with terror suspects amid accusations they are abusing human rights.
The Fixated Threat Assessment Centre (FTAC) was quietly set up last year to identify individuals who pose a direct threat to VIPs including the Prime Minister, the Cabinet and the Royal Family.
It was given sweeping powers to check more than 10,000 suspects' files to identify mentally unstable potential killers and stalkers with a fixation against public figures.
The team's psychiatrists and psychologists then have the power to order treatment - including forcibly detaining suspects in secure psychiatric units.
Using these powers, the unit can legally detain people for an indefinite period without trial, criminal charges or even evidence of a crime being committed and with very limited rights of appeal.
Until now it has been the exclusive decision of doctors and mental health professionals to determine if someone should be forcibly detained.
Scroll down for more...
Killed by a stalker: Anna Lindh (right); Risk Expert: The Fixated Threat Assessment Centre's Robert Halsey
But the new unit uses the police to identify suspects - increasing fears the line is being blurred between criminal investigation and doctors' clinical decisions.
It also raises questions about why thousands of mentally ill individuals have been allowed back into the community - including some who have attacked and killed members of the public - while VIPs are being given special protection.
Scotland Yard, which runs the shadowy unit, refuses to discuss how many suspects have been forcibly hospitalised by the team because of "patient confidentiality".
But at least one terror suspect - allegedly linked to the 7/7 bomb plot and a suicide bombing in Israel - has already been held under the Mental Health Act.
The suspect, who was subject of a control order and cannot be named for legal reasons, later absconded from the hospital and his whereabouts are unknown.
The existence of FTAC, part of the Metropolitan Police's specialist operations department which oversees anti-terrorist investigations and royal and diplomatic protection, slipped out in the fine print of a Home Office report.
The report makes it clear FTAC is a counter-terrorism unit and says: "We aim to make the UK a harder target for terrorists by maintaining effective and efficient protective security for public figures."
NHS documents obtained by The Mail on Sunday reveal the unit's role "concerns the identification and diversion into psychiatric care of mentally ill people fixated on the prominent".
The purpose of the centre is "to evaluate and manage the risk posed to prominent people by...those who engage in inappropriate or threatening communications or behaviours in the context of abnormally intense preoccupations, many of which arise from psychotic illness."
The Mental Health Act requires two doctors or psychiatrists to approve someone's forcible detention for treatment.
So-called 'sectioning' allows a patient to be held for up to six months before a further psychological assessment. Patients are then reviewed every year to determine if they can be released.
FTAC's senior forensic psychiatrist Dr David James, who has made a study of attacks on British and European politicians by people suffering pathological fixations, is qualified to order such a detention, as are other members of his team.
Also on the staff is Robert Halsey, a consultant forensic clinical psychologist who is a specialist in risk assessment.
The centre, which is based at a secret Central London location, has a staff of four police officers, two civilian researchers, a forensic psychiatrist, a forensic psychologist and a forensic community mental health nurse. Job descriptions make it clear they implement "interventions".
Human rights activists fear the team, whose existence has never been publicised, may be being used as a way to detain suspected terrorists without having to put evidence before the courts.[They do seem to have a point there, don't they!]
It also comes amid a continuing row over proposed mental health legislation which will make it easier to 'section' someone deemed a threat to the public.
Last night human rights group Liberty said the secret unit represented a new threat to civil liberties.
Policy director Gareth Crossman said: "There is a grave danger of this being used to deal with people where there is insufficient evidence for a criminal prosecution.
"This blurs the line between medical decisions and police actions. If you are going to allow doctors to take people's liberty away, they have to be independent. That credibility is undermined when the doctors are part of the same team as the police.
"This raises serious concerns. First that you have a unit that allows police investigation to lead directly to people being sectioned without any kind of criminal proceedings.
"Secondly, it is being done under the umbrella of anti-terrorism at a time when the Government is looking at ways to detain terrorists without putting them on trial."
FTAC was set up following an NHS research programme based at Chase Farm Hospital in Enfield, Middlesex, which looked at the threat to prominent figures from "fixated" people.
The team examined thousands of cases and liaised with the FBI, the US Secret Service, the Capitol Hill Police, which protects Congressmen and Senators, and the Swedish and Norwegian secret services.
The Swedish authorities gave the team access to files on the murder of foreign minister Anna Lindh who died from multiple stab wounds after being attacked by a stalker in a Stockholm store in 2003.
The research led to FTAC being set up with a Ł500,000-a-year budget from the Home Office and Department of Health. NHS documents say: "It is a prototype for future joint services."
No one from FTAC was willing to talk to The Mail on Sunday last week and few Whitehall officials seemed aware of the Centre's existence.
Shadow Health Secretary Andrew Lansley said: "The Government is trying to bring in a wider definition of mental disorder and is resisting exclusions which ensure that people cannot be treated as mentally disordered on the grounds of their cultural, political or religious beliefs.
"When you hear they are also setting up something like this police unit, it raises questions about quite what their intentions are.
"The use of mental health powers of detention should be confined to the purposes of treatment. But the Government wants to be able to detain someone who is mentally disordered even when the treatment would have no benefit.
"Combined with the idea that someone could be classed as mentally ill on the grounds of their religious beliefs, it is a very worrying scenario."
Last night a Home Office spokeswoman said there was "nothing sinister" about the unit or its role in counter-terrorism.
She said: "It comes under the remit of royal and diplomatic protection and is administered by that part of the Home Office.
"Psychiatric investigations are undertaken by psychiatric professionals only. Police officers do not assess people with mental health issues. The police provide the intelligence to ensure that psychiatrists have all the information available to make an assessment.
"This is done not only to protect public figures but also to protect the person fixated with the public figure."
Details of FTAC are revealed as the Government faces a new row over its terrorist control orders after three suspects, supposedly under house arrest, absconded last week.
The suspects, who it is feared may have fled the country, include the brothers of Anthony Garcia, who was jailed last month for his role in a plot to bomb London nightclubs and shopping centres. "
admin
PFIZER's ZOLOFT - LUSTRAL - No better than placebo in PTSD
Department of Veterans Affairs, National Center for Posttraumatic Stress Disorder, White River Junction, Vt 05009, USA. [email protected]
OBJECTIVE: To evaluate the efficacy of sertraline in the treatment of posttraumatic stress disorder (PTSD) in a Veterans Affairs (VA) clinic setting involving patients with predominantly combat-related PTSD. METHOD: 169 outpatient subjects with a DSM-III-R diagnosis of PTSD and who scored 50 or higher on Part 2 of the Clinician-Administered PTSD Scale (CAPS-2) at the end of a 1-week placebo run-in period participated. Patients recruited from 10 VA medical centers were randomly assigned to 12 weeks of flexibly dosed sertraline (25-200 mg/day) (N = 86; 70% with combat-related PTSD; 79% male) or placebo (N = 83; 72% combat-related PTSD; 81% male) between May 1994 and September 1996. The primary efficacy measures were the mean change in CAPS-2 total severity score from baseline to endpoint, in the total score from the Impact of Event Scale, and in the Clinical Global Impressions-Severity of Illness and Improvement scales. RESULTS: There were no significant differences between sertraline and placebo on any of the primary or secondary efficacy measures at endpoint. In order to understand the results, gender, duration of illness, severity of illness, type of trauma, and history of alcohol/substance abuse were explored as potential moderators of outcome, but no consistent effects were uncovered. Sertraline was well tolerated, with 13% of patients discontinuing due to adverse events. CONCLUSION: Sertraline was not demonstrated to be efficacious in the treatment of PTSD in the VA clinic settings studied.
US: Violence at Western Hospital, Pfizer et al and increased drug prescriptions
June 18 2007, 7:33 PM
Asked why Pfizer representatives has made almost 200 visits to Western since December 2003, company spokesman Bryant Haskins said, “That’s where our customers are.” Pfizer makes the atypical drug Geodon, one of those linked to agitation.
Drugs might breed violence Attacks on staff rise at Western State Hospital
M. ALEXANDER OTTO; The News Tribune Published: May 28th, 2007 01:00 AM
Violence has been a growing problem at Western State Hospital for years.
If present trends continue, one in four of the Lakewood mental hospital’s more than 1,700 workers can expect to be assaulted by a patient in 2007, according to the state Department of Labor and Industries.
For years, hospital administrators have blamed the violence on familiar causes: not enough staff members, not enough money and increased societal violence that leads to the admission of more-violent patients. But they don’t have the data to back up those assertions.
A News Tribune analysis of drug-prescribing trends at Western since 1999 finds another possible factor: Western is giving more patients psychiatric drugs with side effects that can include extreme agitation and aggression.
The drugs include newer antidepressants and newer anti-psychotics dubbed atypical anti-psychotics.
The newer drugs, which are expensive compared with older, generic alternatives, have been heavily promoted at the hospital by the pharmaceutical companies that make them. Sales representatives for those companies have logged about 1,200 visits to Western since late 2003, when administrators began tracking their activity.
Concerned about their influence on prescribing patterns, the hospital in March banned all drug company representatives from visiting the campus to meet with doctors.
Randy Burkholder, an associate vice president for Pharmaceutical Research and Manufacturers of America, the Washington, D.C.-based drug industry lobby group, acknowledged The News Tribune analysis, saying it’s a “great idea” to discover more about the impact of pharmaceuticals through original investigation.
“There may be something there, there may not be,” he said about the findings. But he cautioned that the analysis doesn’t prove cause and effect. Instead, it just hints at a possible association. Only additional research can make that determination, Burkholder said.
The link between changes in drug use at Western and recent increases in violence “is very plausible,” said Dr. Stefan Kruszewski, a Harvard-trained psychiatrist and an expert on the side effects of anti-psychotic drugs who is on the faculty at Eastern University, outside Philadelphia.
“There is a significant relationship between restlessness and agitation induced by medicine and the propensity for violence,” Kruszewski said.
Western has never studied the idea that changes in drug use could contribute to increased violence, said Dr. Roger Jackson, the hospital’s acting medical director and an employee there since 1993.
Western is not alone in that regard.
“This has not been adequately studied” at any psychiatric hospital, Kruszewski said. “Most studies done on (psychiatric) violence assume violence is secondary to the illness or the surroundings, or because of lack of staff, money or social structures.”
Those assumptions, which have dominated internal and state agency violence studies at Western for more than a decade, do not hold up under analysis.
Since 1999, the staffing ratio of ward workers to patients has improved from 1.18 workers for every patient to 1.34 workers per patient in 2006.
Funding has increased about 50 percent overall – going from $106 million in 1999 to $156 million in 2007 – and has kept pace with medical inflation.
Hospital administrators don’t offer statistical evidence that society has become more violent, leading to a more violent patient population. Meanwhile, violent crime in the areas from which Western draws its patients has dropped significantly, according to U.S. Department of Justice statistics.
What does correspond with the increase in violence is the roughly 35 percent increase since 1999 in the use of drugs that a hospital pharmacy handbook and drug experts say are more likely than similar medications to induce agitation and aggression, The News Tribune analysis indicates.
By the end of 2006, there was roughly one order for these drugs for every patient at Western.
NEW DRUGS, MORE DRUGS
Drug therapy has been the mainstay of psychiatric treatment for decades, and it long has been known that while some medications can make patients drowsy, others can cause extreme agitation and a tendency to lash out.
This restlessness can be physical, mental or both, and is known as akathisia.
“It’s almost like having too many cups of coffee in the morning,” said Dr. Neil Kaye, a psychiatrist and an authority on the condition, as well as a professor at Jefferson Medical College in Philadelphia. “It’s extremely uncomfortable and makes people have a shorter fuse.”
Akathisia “is horrendous,” said Lori Yates, a Western social worker who once was a mental patient in a Texas hospital before her illness was brought under control.
She knows the side effect well, because she had to try several drugs before the right ones were found to help her.
Starting in the mid-1990s, new atypical anti-psychotics came onto the market to treat schizophrenia and related disorders, the most common diagnoses at Western. Currently, there are seven atypical anti-psychotic drugs, three of them new since 2001.
They are expensive, some more than $15 per pill, compared with less than a dollar per pill for the older medications. In 2006, the hospital spent more than $5 million on atypical anti-psychotics, according to Western’s pharmacy.
Promoted by drug companies as safer and more effective, atypicals are widely used at Western and most psychiatric hospitals.
Their growing use, coupled with the continued use of some of the older drugs, has resulted in an increase since 1999 of about 30 percent in the amount of anti-psychotic medication being given to patients at Western, The News Tribune found.
Many patients now receive two or more anti-psychotic drugs at once, a doubling of medication unheard of just eight years ago, when the older drugs were more prevalent.
Jackson, the acting medical director, attributed the increased use of anti-psychotics to several factors. In some cases, he said, disappointing results with one drug led physicians to add a second drug.
And compared with 1999, he said, a greater proportion of patients at Western have schizophrenia and require anti-psychotic drugs.
But there also has “been a very hard sell on the (newer drugs), and a very clever hard sell” to psychiatrists and other doctors worldwide, said Dr. David Healy, a professor of psychiatry at the University of Wales and an internationally recognized authority on psychiatric drug side effects.
Recently, several major medical studies have cast doubt on claims that the newer anti-psychotic drugs are more effective and safer than the typicals.
A British study published last fall by the American Medical Association found that patients did as well or better on the older drugs. Another suggested patients who take the newer drugs could be more likely to develop diabetes and die at an earlier age.
The sales pitches, Healy said, have led the medical community to “assume the evidence is there” to back up the advertising claims.
But the evidence, he said, “just is not there.”
Medical staff at Western said they are aware of the situation, and are rethinking their use of atypicals.
“It is not yet clear to me what will eventually happen with regard to prescribing practices,” said Jackson, “because the newer drugs are still believed to have some benefits, despite the recent findings.
“The jury is still out.”
Burkholder, the drug industry executive, acknowledged the recent findings concerning atypicals, and said the studies should “help doctors tailor treatment to the individual patient.”
ASSUMPTIONS QUESTIONED
Akathisia once was thought to be an uncommon side effect with the newer anti-psychotics, but for three of the atypicals in common use at Western, that’s now in doubt.
Bristol-Myer Squibb’s atypical drug is called Abilify, which hit the market in 2002. Data from the company suggested up to 15 percent of people who took the drug developed akathisia.
Recent studies suggest a higher percentage. Possibly the highest estimate to date came from a small study published in March. Researchers found that five of 12 patients, or 42 percent, developed akathisia after taking Abilify.
At the beginning of December, about one in 10 Western patients received Abilify, according to The News Tribune analysis.
Bristol-Myer Squibb spokesman David Rosen defended his company’s product by pointing out that the small number of patients in the recent Abilify study might have skewed the results.
Despite recent findings, many doctors still assume that atypicals are not likely to cause akathisia, Jackson said, “so their index of suspicion is not as high.”
That could be part of the reason, he said, for a roughly 50 percent drop at Western over the past eight years in the use of drugs – such as tranquilizers and propranolol, a beta blocker drug also used for heart problems – used to control drug-induced anxiety and agitation.
The pharmacy periodically prints out lists of drug orders, giving a snapshot of drug trends at Western.
A printout on Nov. 24, 1998, showed 1,736 orders for drugs often used to calm patients experiencing akathisia, among about 913 patients at the hospital. On Dec. 6, 2006, the most recent day for which data were available, there were 792 orders for those drugs among 860 patients.
FDA ORDERS LABEL WARNINGS
Western State Hospital also has switched to newer types of antidepressants, including Prozac and similar drugs, that are linked to akathisia.
Research by the University of Wales’ Healy and others suggests the drugs sometimes cause such extreme agitation that people commit suicide to escape it or lash out in murderous rage.
The Food and Drug Administration in 2004 required manufacturers to update the drugs’ labels to warn of the possibility of “anxiety, agitation … hostility (aggressiveness), impulsivity, akathisia” and other problems, including suicidal behavior.
Pfizer Pharmaceuticals’ Zoloft was one of the antidepressants whose label was updated. There were 74 orders for the drug at Western State Hospital on a single day, Dec. 6, 2006.
POSSIBILITY, NOT PROOF
Like Burkholder, the psychiatrists interviewed for this story said The News Tribune’s analysis only suggests that changes in drug use might contribute to violence at Western. Proving such a link would require an analysis of patient data not available to the public.
It would be important to analyze incidents of violence to see what drugs patients were on at the time, as well as their histories of violence while not medicated, said Kaye, the Philadelphia psychiatrist and professor.
Hospital administrators and state regulators should pursue such an analysis, said Dr. David Antinucho, a University of Nevada psychiatrist and an authority on psychiatric drugs. That could lead to a new way to combat violence not only at Western, but also at psychiatric hospitals across the nation, he said.
“This should have been done years ago,” said Eastern University’s Kruszewski. “There is little information in the psychiatric and neuropsychiatric literature” analyzing drug use and violence at mental hospitals.
Proof that drug choice influences violence at Western would be “very important for everyone to know,” Kaye agreed, adding that it could lead to better training for doctors on how to recognize, observe and treat akathisia.
After reviewing the findings of The News Tribune analysis, Western State Hospital chief executive officer Andy Phillips said he would be “very interested” in studying the matter further, but said the stumbling block would be finding funding to back such research.
REVOLVING DOOR CLOSES
What stands out in Western’s pharmacy data is that doctors, who can prescribe virtually any anti-psychotic or antidepressant drug they want, rapidly adopt the newest and most expensive drugs from the pharmaceutical industry.
Jackson, the hospital’s acting medical director, said one likely reason is that by the time patients come through Western’s door, some already have failed on the older drugs.
But until they were banned from visiting campus in March, pharmaceutical industry salespeople were a fact of life at Western, as they are in virtually every hospital and doctor’s office in the country.
Western is a huge market for the drug industry, said Phillips.
Since December 2003, sales reps made hundreds of visits a year to Western to brief doctors about their latest products, according to pharmacy logs analyzed by The News Tribune.
About 50 sales representatives from 13 companies, many visiting several times a week, accounted for those visits. Typically, representatives from a given company visited in pairs or small groups, according to pharmacy logs.
For many doctors, there was “no appreciation that what they hear from drug reps (was) a sales pitch,” said Jackson, who refuses to see drug sellers.
From October until the March ban, drug representatives were required to state how much time they spent on campus. Records show visits lasting from 15 minutes to more than three hours.
The vast majority of the visits were by representatives from companies with new antidepressants and atypicals on the market. More than half of the visits were from companies that make atypicals and antidepressants linked to higher rates of akathisia, records show.
Representatives often visited the same doctors repeatedly.
Asked why Pfizer representatives has made almost 200 visits to Western since December 2003, company spokesman Bryant Haskins said, “That’s where our customers are.” Pfizer makes the atypical drug Geodon, one of those linked to agitation.
“At hospitals, we have a number of Pfizer products being used,” he said, “so our sales reps check in regularly to make sure (staff) have new information, samples, and any questions answered.”
Western’s ban on drug representatives’ visits with doctors comes after years of increasing restrictions on pharmaceutical promotions. Several years ago, administrators banned representatives from helping doctors select drugs for specific patients. And physicians may not accept gifts from representatives beyond small items such as pens and note pads.
The ban resulted from doctors feeling pressured by sales pitches, said Dr. Margaret Dean, Western’s medical director until May. At weekly medical review meetings, she said, there sometimes were so many drug sellers that doctors had hard a time finding chairs.
She and others said sales representatives hung out after the meetings to pigeonhole doctors.
“That kind of pushy interaction can’t happen anymore,” Dean said.
Drug companies, however, still buy lunches and dinners and host lectures at local restaurants for Western doctors and nurses, according to one physician, who did not want his name in the paper for fear of losing his job.
Here are some anti-psychotic and antidepressant drugs more likely than others in their class to cause agitating side effects such as restlessness, anxiety and insomnia. Taken as a group, there has been about a 35 percent increase in orders for these drugs at Western State Hospital since 1999. There’s also been a steady increase in assaults on workers over that time. Western averages about 900 patients a day.
Atypical anti-psychotics
Drug Manufacturer Orders on Dec. 6, 2006
Risperdal Janssen 307
Geodon Pfizer 118
Abilify Bristol-Myers Squibb 82
Typical anti-psychotics
Haldol Ortho-McNeil, generic makers 98
Prolixin Bristol-Myers Squibb, generic makers 26
Navane Pfizer, generic makers 6
Antidepressants
Zoloft Pfizer, generic makers 74
EffexorWyeth, generic makers 38
Prozac Eli Lilly, generic makers 37
Wellbutrin GlaxoSmithKline, generic makers 22
Cymbalta Eli Lilly 20 "
admin
China: Head of their FDA sentenced to Death
June 18 2007, 7:45 PM
The handling of Zheng and harsh media warnings reflected government fears that in medicineand other lucrative sectors of China's economy, agencies often modelled on Western examples have failed to staunch abuses and give citizens effective protection, said Mao Shoulong, a public policy expert at the People's University of China.
China said on Thursday the death sentence given to the former head of its drug and food watchdog for corruption was a warning to top officials at a time when the ruling Communist Party is seeking to win popular trust.
Zheng Xiaoyu, former head of the State Food and Drug Administration, faces execution after a Beijing court convicted him on Tuesday of graft and dereliction of duty.
He left the post before a recent wave of medicine safety scandals engulfed China. But state media have acclaimed the harsh sentence as showing the Communist Party's determination to purge corruption.
A commentary in the People's Daily, the party's official paper, said Zheng's fate was a lesson to other officials.
"As a case study of a party member and leading official breaking the law and committing crime, the Zheng Xiaoyu case offers profound lessons that all public servants, especially leading officials at every level, should take to heart," the paper said.
The warning was written by a "specially commissioned commentator" - an uncommon sourcing that suggests the editorial was at the direct behest of top leaders - and appeared in other major papers.
The handling of Zheng and harsh media warnings reflected government fears that in medicine and other lucrative sectors of China's economy, agencies often modelled on Western examples have failed to staunch abuses and give citizens effective protection, said Mao Shoulong, a public policy expert at the People's University of China.
"The key problem is how to monitor the market without giving room to abuse power over the market," he told Reuters.
"I don't think the government has in mind massive changes, but it clearly wants to improve official performance through a series of smaller reforms."
Zheng, 62, head of the agency from 1998 to 2005, took bribes worth some 6.5 million yuan ($A1 million)) from eight companies.
During his tenure, dozens died in China from bad drugs and food products. In 2004 at least 13 babies died of malnutrition in Anhui province after being fed fake milk powder containing no nutrition.
The safety of China's food has also come under the international spotlight after wheat gluten and rice protein containing toxic scrap was exported to the United States and used in pet food, killing some cats and dogs.
Chinese President Hu Jintao and Premier Wen Jiabao have worked to win public trust by promising to defuse discontent about inequality, corruption, poor healthcare and dangerous products.
They are preparing for a congress later this year that is expected to give Hu five more years as party chief.
The stiffly worded warning suggested that leaders wanted to scare off other officials from tainting the party's image.
"Any conduct that hurts the people's interests, any shirking or perfunctoriness, any dereliction of duty will not be tolerated and must be punished," the commentary warned.
"At every moment, give highest prominence to the people's interests."
Officials had to ensure that their families and staff did not abuse their closeness to power, it added.
China has executed, jailed or detained dozens of high-ranking officials for corruption in recent years, including the former party chief of Shanghai who is under investigation for abusing pension funds.
But many ordinary Chinese believe official graft is increasingly entrenched despite these high-profile cases."
WASHINGTON, May 30 (Agence France-Presse) — Bristol-Myers Squibb has agreed to plead guilty and pay a $1 million criminal fine for lying to the government about a patent deal on its blood-thinning drug Plavix, officials said Wednesday.
The Justice Department said in a statement that the company’s actions had threatened to reduce competition for the drug, one of the best-selling prescription medications worldwide.
Government investigators said that a former senior Bristol-Myers executive had made “oral representations” to a Canadian generic drug maker, Apotex, that caused Apotex to conclude that Bristol-Myers would not introduce its own generic version of Plavix.
At the time, the two companies were locked in litigation over the validity of the patent for Plavix. Bristol-Myers, however, was subject to a consent decree that required it to submit any patent settlements for review with the Federal Trade Commission.
The government said that Bristol-Myers had also lied to the government about the arrangement. The government inquiry is still open.
The patent deal’s failure led to the ouster of Bristol-Myers’s chief executive, Peter R. Dolan, in September."
WOW! A * REAL* SCIENCE FICTION CHANNEL
Europe - Coming Soon: Shopping Channel run by Drug Firms
June 18 2007, 8:00 PM
That should be interesting. More pharma misinformation about drugs created without evidence-based science but WITH lashings of scientific misconduct? The Drug Industry are calling it "The European Patient Information Channel" rotfl.
Outside of the drug industry, the industry consultants and the pharma front patient groups they're paying, I think its more likely to be considered a breakthrough in TV history - the first time the world has ever seen a REAL Science Fiction channel in action. I can't wait!
Four of the world's biggest pharmaceutical companies are proposing to launch a television station to tell the public about their drugs, amid strenuous lobbying across Europe by the industry for an end to restrictions aimed at protecting patients. Pharma TV would be a dedicated interactive digital channel funded by the industry with health news and features but, at its heart, would be detailed information from drug companies about their medicines.
A 10-minute pilot DVD, seen by the Guardian, featured a white-coated doctor discussing breast cancer and a woman patient who reassured viewers that "there are many new treatments available". Under the proposals, viewers could use their remote control to click on treatment options and read what manufacturers have to say about the latest branded breast cancer drugs.
Four companies, Johnson & Johnson, Pfizer, Novartis and Procter & Gamble, are behind the pilot, which they are offering to the European commission as a way to give patients more information. The commission is consulting on potential changes to the regulations that ban all direct-to-consumer advertising of medicinal drugs.
The industry has been lobbying in Europe to be allowed direct access to patients. It argues that lifting restrictions would help its competitiveness and has hinted that companies may relocate to the US, where they can advertise to patients who then demand drugs from their doctors. Profits have soared there as a result.
The proposed change in the rules is being led within the commission by its trade arm, DG Enterprise, and not health, DG Sanco. It is backed by a number of influential patient groups that are themselves heavily funded by drug companies. But consumer organisations are opposed, warning that the companies will play down risk, and that their real interest lies in boosting profits.
The International Society of Drug Bulletins (ISDB) - consumer publications which analyse the benefits of drugs and draw comparisons between them - warns that the industry is not a reliable source of trustworthy information.
The US and New Zealand allow drug companies to advertise to the public; the ISDB says in both these countries this has been shown to be detrimental to health.
"Pharmaceutical companies' messages are focused on relatively few top sellers, exaggerating effects and concealing risks, confusing patients and putting pressure on doctors to prescribe drugs they would not use otherwise," it says. "Lack of comparative information in advertising means people cannot choose among several options." Johnson & Johnson presented the companies' proposals to a meeting in Brussels of the Centre for Health, Ethics and Society, a thinktank which describes itself as "developed in partnership with Johnson & Johnson". The audience comprised members of the commission, patient groups and others.
The European Patient Information Channel, as industry is calling it, could be available on the internet as well as TV, and would offer "on demand" information about drugs "to enable patients and citizens to make better decisions", said Scott Ratzan of Johnson & Johnson. It would be self-regulating, with a board of medical, pharmaceutical and patient representatives to hear complaints.
The TV pilot was welcomed by the European Patients' Forum. The forum, an umbrella group, is one of only two patient organisations admitted to the working group set up by the commission to discuss changes in the rules.
Although its executive director, Nicola Bedlington, said the pilot's "slightly sanctimonious and patronising" tone needed improvement, she and other patient representatives present approved it in principle."
admin
From Painkillers to Addiction to Homelessness to Antidepressants - cos he trusted doctor
June 18 2007, 8:06 PM
'Many of those addicted to drugs were first given an addictive pain killer by a licensed doctor out to earn a buck who did not care that his patient would become addicted unknowingly when he trusted that he was being given a good medicine for his injury. Now that the injured patient is addicted, society turns it's back and accuses him of being a low life who does not want to work, is lazy, and has psychological problems... all because he trusted a doctor to take care of his work-related injury so he could go back to work and continue to support his family. Now he's homeless. Now he's addicted. Now he's stigmatized. Now he has perfect reason to develop situational depression and anxiety. Now he's prescribed antidepressants by mental health services that do not solve his problems causing his depression, but exacerbate them by making him suicidal. In essence they create a mental illness when he never really had one.
His depression was situational and what he needed was not damaging drugs but help to resolve his situation. He's dying, all because he trusted a supposedly upstanding citizen.'
I spent the past year and a half learning I knew nothing at all… actually, I was working at a homeless shelter. I’ll never forget my first day. I almost didn’t show up. I figured I’d catch a bad disease, encounter drugs, or be soiled in some way. I was not reassured that I would be a staff member in charge of facilities and intake case management.
Despite my unfounded fears, my work turned out to be fulfilling and rewarding. I loved my job and set out to dedicate my life to it. A year and a half later, I did decide to leave, though not for fear of the homeless. It was a fellow staff member who made attempts at my life. The homeless residents were quite safe and friendly! I got a Restraining Order, but never had it served. It doesn’t matter anymore; I’ve moved on.
My last day was extraordinary! The outpouring from both staff and residents was overwhelming. I did not realize how many people I touched in my day-to-day work. What I considered normal and part of my job had touched other people’s lives for the better.
Clients remembered phone calls of encouragement I made to them when they were waitlisted, nights I’d spent listening when they needed to talk, times I’d ensured everyone had food and refreshments, and multitudes of other things I did in the course of a day that seemed so ‘normal’ to me. But then I realized that the community looks down upon the homeless, steps over them, ignores them, and pushes them aside. I treated them with dignity and respect. They’re human beings, after all.
There is not a single one of us who could not find ourselves homeless. If you scoff at that, consider what would happen if your home and/or business burned down, disabling you in the fire, and your insurance company refused to pay. Anyone!
Interestingly, the homeless are some of the nicest, most honest, ‘real’ people I have ever met. Most of them work at least one job and bend over backwards to help others. I watched many flourish and become productive members of society because they got a reprieve from their plight at the shelter. Many, who have little food, share with those that have none. They look out for other human beings with care and concern and share their stories! I am a better person, both personally and professionally for having worked at the shelter.
The hardest part about leaving was the children. They all fought to sit in my lap… each realizing they were getting wet and looking up to see tears in my eyes. “Auntie? Why are you crying?” “Because they need me at my new job…” They looked away dejected and confused. I was a rock in their lives. Someone they looked up to. And that rock was crumbling. Yeah, I didn’t understand either. Not for the life of me. It was just time to move on.
So, I move forward with lots of work ahead and many more people to meet. I’ll never forget how it is the small, inconsequential, routine things that make the most difference. A moment and a few kind words really can change a life!
Me ka hau’oli a me ke aloha pumehana!
(With warmth, laughter, and love!)
A Current Reflection
had time before beginning my new job to reflect on the well-off segment of society... the society I'd always pretended to be a part of and was a part of, but did not feel like I fit in because I cared about humanity too much. These are the people who lie, cheat, and steal above the law to get ahead via corruption, insults, and stepping on others to "make something of themselves". All they make of themselves is a crook above the law at the expense of people who really care about others. The suits and dresses don't make them something better than the t-shirts and jeans... actually the dress make them worse.
They fight for the almighty dollar at the expense of the health and welfare of us all. Many of these people would do anything to earn a dollar, including supporting vaccines containing mercury knowing full well that mercury is a neurotoxin, promoting the writing prescriptions for antidepressants instead of diagnosing the real causes of fatigue because antidepressants make more money. It does not matter that antidepressants also make people suicidal, are addictive, and difficult to get off of. That's a plus because it means more revenue! This is not stepping on others who trust, this is outright stomping on them in the name of a dollar. Perhaps money and the market should be abolished altogether and all made equal!
I learned those that I should fear are not the homeless, the poor, and the addicted. They are the victims who are struggling to survive because of the those we should fear and their unscrupulous ways! They are the ones who are honest and would not hurt another, but are forced to steal for their basic needs and survival.
Many of those addicted to drugs were first given an addictive pain killer by a licensed doctor out to earn a buck who did not care that his patient would become addicted unknowingly when he trusted that he was being given a good medicine for his injury. Now that the injured patient is addicted, society turns it's back and accuses him of being a low life who does not want to work, is lazy, and has psychological problems... all because he trusted a doctor to take care of his work-related injury so he could go back to work and continue to support his family. Now he's homeless. Now he's addicted. Now he's stigmatized. Now he has perfect reason to develop situational depression and anxiety. Now he's prescribed antidepressants by mental health services that do not solve his problems causing his depression, but exacerbate them by making him suicidal. In essence they create a mental illness when he never really had one.
His depression was situational and what he needed was not damaging drugs but help to resolve his situation. He's dying, all because he trusted a supposedly upstanding citizen.
These upstanding citizens would not offer a crumb for a starving human being and step over homeless men, women, and children sleeping on the sidewalks without offering any assistance. The fear them because they do not understand them. They are different and they fear being like them. If they get near them they might catch the "homeless" disease. They think they are above it all and could never fall victim if they simply ignore the reality of it. They need to think again.
When a young man, a college graduate, went to the doctor to have his injury looked at he was given "medicine" for the pain. The doctor did not tell him oxycontins were addictive. The doctor did not tell him that he would lose his job and be labeled a drug addict and sent for counseling after being routinely urine tested because of a "zero-tolerance" policy that does not take into account the oxycontin was prescribed by a doctor. The doctor did not tell him that he would have difficulty getting a new job for the same reason and be unable to pay his rent as a result.
The doctor did not tell him that his family would have to move into a shelter because he could not find a job and that he would be denied admittance to the shelter and separated from his family because he was on prescription oxycontins and they too had a "zero tolerance" policy. The doctor did not tell him that he would have to sleep on the streets in the dead of winter because his distant family believed he had an addiction and just needed to get his act together. They figured if he "fell" down far enough he'd "wake up" and do something. Instead, he risked freezing to death.
The doctor did not tell him that he would soon learn from others on the streets that hard liquor is the only way to keep warm out there because police would not allow fires in public alleys at night. The doctor did not tell him that this would exacerbate all his other problems and he would now be considered an alcoholic because he did the only thing he could to avoid freezing to death and the cold was bitter and unbearable. He had no money, but alcohol can be found on the streets.
There he was merely trying to survive, to make it another day with hope that he could have his old life back. But now his record is tarnished, his credit bad, and he's been labeled and stigmatized. He will never again have a chance at a good job and will be on the system and require social assistance for the rest of his life. All because he trusted a doctor when he fell playing soccer with his boy on Saturday. Think this could not happen to you? Think again! It is quite a common scenario.
The sad part is that we as a society create these problems. We complain that our tax dollars are being spent to support those we stigmatize, yet those we stigmatize are there because of us. We are all responsible! It is time to wake up and see the truth... before it happens to us!
About the Author
Lourdes Salvador is a writer and social advocate based in Hawaii. She is the president of MCS America and a featured monthly writer for MCS America News at www.mcs-america.org. She is a passionate advocate for the homeless, having worked with her local governor to open new shelters and provide services to the homeless based on a presentation of her ideas. That passion soon turned to advocacy and activism for victims of multiple chemical sensitivity. For more information about Lourdes and her advocacy work, please visit: www.mcs-america.org,
Sen. Richard Burr received over $500,000 in campaign contributions from pharmaceutical executives and political action committees from 2001-2007.
HOW SENATORS VOTED
The Senate voted 49-40 this week to require U.S. officials to certify the safety and effectiveness of prescription medicines imported from foreign countries. The vote effectively killed an effort to allow the importation of cheaper prescription drugs from abroad. A "yes" vote, supported by drugmakers, was a vote to adopt the certification requirement and a "no" vote was a vote to defeat it.
Here are the top recipients of contributions from pharmaceutical executives and political action committees from 2001 through March, and how they voted:
Senator
2001-07 contributions
Vote
Richard Burr, R-N.C.
$520,694
Yes
John Kerry, D-Mass.
$304,888
Yes
Joe Lieberman, I-Conn.
$281,040
Yes
Arlen Specter, R-Pa.
$259,699
Yes
Orrin Hatch, R-Utah
$241,850
Yes
Chuck Grassley, R-Iowa
$216,599
No
Max Baucus, D-Mont.
$199,000
Yes
Chris Dodd, D-Conn.
$192,025
Did not vote
Tom Carper, D-Del.
$183,794
Yes
Mike Enzi, R-Wyo.
$174,338
Yes
Source: USA TODAY analysis of campaign-finance data
By Ken Dilanian, USA TODAY
WASHINGTON — Senators who raised millions of dollars in campaign donations from pharmaceutical interests secured industry-friendly changes to a landmark drug-safety bill, according to public records and interviews.
The bill, which passed 93-1, grants the Food and Drug Administration broad new authority to monitor the safety of drugs after they are approved. It addressed some shortcomings that allowed the painkiller Vioxx to stay on the market for years after initial signs that it could cause heart attacks.
However, the powers granted to the FDA in the bill's original version were pared back during private meetings. And efforts to curb conflicts of interest among FDA advisers and allow consumers to buy cheaper drugs from other countries were defeated in close votes.
• A measure that blocked an effort to allow drug importation passed, 49-40. The 49 senators who voted against drug importation received about $5 million from industry executives and political action committees since 2001 — nearly three quarters of the industry donations to current members of the Senate, according to a USA TODAY analysis of data compiled by two non-partisan groups, Center for Responsive Politics and PoliticalMoneyLine.
• Sen. Pat Roberts, R-Kan., said he demanded removal of language that would have allowed the FDA to ban advertising of high-risk drugs for two years because it would restrict free speech. Roberts has raised $18,000 from drug interests so far this year, records show, and $66,000 since 2001. His spokeswoman, Sarah Little, said he "takes great pains to keep fundraising and official actions separate."
• Sen. Judd Gregg, R-N.H., claimed authorship of a change that reduced the FDA's power to require post-market safety studies. He said he wanted to target drugs only if there was evidence of harm. Gregg has raised $168,500 from drug executives and PACs since 2001 and sided with them in four key votes.
• The bill's chief sponsors — Sens. Edward Kennedy, D-Mass., and Mike Enzi, R-Wyo., — agreed after consultations with industry officials and others to modify a proposal that all clinical drug studies be made public, said Craig Orfield, Enzi's spokesman. Under the change, only those studies submitted to the FDA would be available.
Enzi took in $174,000 from drug interests since 2001; Kennedy, $78,000. Their spokesmen said the money did not influence them.
Senators also voted down an amendment that would have made it harder for scientists who have accepted money from a drug company to advise the FDA on drug approval applications from that firm.
"It's not that money buys votes," said Sen. Bernie Sanders, I-Vt., the lone vote against the bill. "But you have a culture in which big money has significant influence. Big money gains you access, access gives you the time to influence people."
Orfield, Enzi's spokesman, said compromise is necessary in the Senate, where 60 votes are needed to overcome any single senator's objection. "Our objective is to get something that can pass," he said.
The pharmaceutical companies spend more money on lobbying than any other single industry — $855 million from 1998 to 2006, according to the non-partisan Center for Public Integrity.
"I don't think there is any lobbying group in town that has the clout of the drug industry," said Ron Pollack, director of Families USA, a left-leaning consumer advocacy group.
The biggest drug trade group, Pharmaceutical Research and Manufacturers of America, praised the bill after it passed. The group's spokesman, Ken Johnson, said its critics "never point out that a great deal of this money is spent trying to defeat bills … that are designed to cripple this industry."
The bill, which now goes to the House, was based in part on the recommendations of a report by the Institute of Medicine, a division of the National Academy of Sciences. The Institute was asked by the FDA to examine drug safety in the wake of the scandal over Vioxx, which Merck withdrew from the market in 2004 amid evidence that the drug put users at increased risk for heart attack and stroke.
The report offered two dozen recommendations for improvement. Chief among those was that Congress should grant FDA the power to require a system of post-market surveillance, which the Senate bill would do. But two other key recommendations were not followed in the measure: That FDA should have the power to ban consumer advertising for the first two years of a drug's market life; and that FDA scientists who investigate post-market side effects should work in an office separate from those that approve drugs initially.
The bill "does not sufficiently address the underlying problems," said Sen. Chuck Grassley, R-Iowa, who in recent years held hearings featuring FDA whistle-blowers who said their concerns about drug safety were ignored.
Current Topic - MAY 2007: News on SSRIs, other Psych Drugs and Related Issues
Visit RxISK ORG from Data Based Medicine 'the first free website (not sponsored by big pharma or advertising) for patients and their doctors to research, and more importantly, easily report drug side effects'.
24 percent of the children of mothers who took valproate (Depakote) during pregnancy showed an IQ in the mental retardation range. That alarming finding was presented at the American Academy of Neurology's 59th Annual Meeting in Boston, April 28 - May 5, 2007.
Pfizer, the company that acknowledged criminal marketing of Neurontin (2004), the company that paid millions of dollars in settlements for failing to disclose the suicide risks of its antidepressant, Zoloft, now faces criminal charges by the government of Nigeria for criminal testing of a lethal antibiotic that is known to cause liver damage, Trovan (trovafloxan), on children leading to untold deaths.
