The new diabetes generation and more

Adult psychiatric drug for the treatment of schizophrenia and bipolar disorder in children and adolescents.

Here's what most people on this drug don't get told...

www.rxlist.com/cgi/generic/risperid.htm
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. RISPERDAL®(risperidone) is not approved for the treatment of dementia-related psychosis (see BOXED WARNING).
Neuroleptic Malignant Syndrome (NMS)

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. 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.

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases in which the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology.

The management of NMS should include: (1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; (2) intensive symptomatic treatment and medical monitoring; and (3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.
Tardive Dyskinesia

A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.

The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.

There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Given these considerations, RISPERDAL® (risperidone) should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that: (1) is known to respond to antipsychotic drugs, and (2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a patient treated with RISPERDAL®, drug discontinuation should be considered. However, some patients may require treatment with RISPERDAL® despite the presence of the syndrome.
Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients With Dementia-Related Psychosis

Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients (mean age 85 years; range 73-97) in trials of risperidone in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with risperidone compared to patients treated with placebo. RISPERDAL® is not approved for the treatment of patients with dementia-related psychosis (See also BOXED WARNING, WARNINGS: Increased Mortality in Elderly Patients with Dementia-Related Psychosis.)
Hyperglycemia and Diabetes Mellitus

Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including RISPERDAL®. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available.

Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
PRECAUTIONS
General
Orthostatic Hypotension

RISPERDAL® (risperidone) may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period, probably reflecting its alpha-adrenergic antagonistic properties. Syncope was reported in 0.2% (6/2607) of RISPERDAL®-treated patients in Phase 2 and 3 studies. The risk of orthostatic hypotension and syncope may be minimized by limiting the initial dose to 2 mg total (either QD or 1 mg BID) in normal adults and 0.5 mg BID in the elderly and patients with renal or hepatic impairment (see DOSAGE AND ADMINISTRATION). Monitoring of orthostatic vital signs should be considered in patients for whom this is of concern. A dose reduction should be considered if hypotension occurs. RISPERDAL® should be used with particular caution in patients with known cardiovascular disease (history of myocardial infarction or ischemia, heart failure, or conduction abnormalities), cerebrovascular disease, and conditions which would predispose patients to hypotension, e.g., dehydration and hypovolemia. Clinically significant hypotension has been observed with concomitant use of RISPERDAL® and antihypertensive medication.
Seizures

During premarketing testing, seizures occurred in 0.3% (9/2607) of RISPERDAL®-treated patients, two in association with hyponatremia. RISPERDAL® should be used cautiously in patients with a history of seizures.
Dysphagia

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer’s dementia. RISPERDAL® and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia. (See also BOXED WARNING, WARNINGS: Increased Mortality in Elderly Patients with Dementia-Related Psychosis.)
Hyperprolactinemia

As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.

Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds. Longstanding hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male subjects.

Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with previously detected breast cancer. An increase in pituitary gland, mammary gland, and pancreatic islet cell neoplasia (mammary adenocarcinomas, pituitary and pancreatic adenomas) was observed in the risperidone carcinogenicity studies conducted in mice and rats (see PRECAUTIONS – Carcinogenesis, Mutagenesis, Impairment of Fertility). Neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans; the available evidence is considered too limited to be conclusive at this time.
Potential for Cognitive and Motor Impairment

Somnolence was a commonly reported adverse event associated with RISPERDAL® treatment, especially when ascertained by direct questioning of patients. This adverse event is dose-related, and in a study utilizing a checklist to detect adverse events, 41% of the high-dose patients (RISPERDAL® 16 mg/day) reported somnolence compared to 16% of placebo patients. Direct questioning is more sensitive for detecting adverse events than spontaneous reporting, by which 8% of RISPERDAL® 16 mg/day patients and 1% of placebo patients reported somnolence as an adverse event. Since RISPERDAL® has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that RISPERDAL® therapy does not affect them adversely.
Priapism

Rare cases of priapism have been reported. While the relationship of the events to RISPERDAL® use has not been established, other drugs with alpha-adrenergic blocking effects have been reported to induce priapism, and it is possible that RISPERDAL® may share this capacity. Severe priapism may require surgical intervention.
Thrombotic Thrombocytopenic Purpura (TTP)

A single case of TTP was reported in a 28 year-old female patient receiving RISPERDAL® in a large, open premarketing experience (approximately 1300 patients). She experienced jaundice, fever, and bruising, but eventually recovered after receiving plasmapheresis. The relationship to RISPERDAL® therapy is unknown.
Antiemetic Effect

Risperidone has an antiemetic effect in animals; this effect may also occur in humans, and may mask signs and symptoms of overdosage with certain drugs or of conditions such as intestinal obstruction, Reye’s syndrome, and brain tumor.
Body Temperature Regulation

Disruption of body temperature regulation has been attributed to antipsychotic agents. Both hyperthermia and hypothermia have been reported in association with oral RISPERDAL® use. Caution is advised when prescribing for patients who will be exposed to temperature extremes.
Suicide

The possibility of a suicide attempt is inherent in patients with schizophrenia and bipolar mania, including children and adolescent patients, and close supervision of high-risk patients should accompany drug therapy. Prescriptions for RISPERDAL® should be written for the smallest quantity of tablets, consistent with good patient management, in order to reduce the risk of overdose.
Use in Patients With Concomitant Illness

Clinical experience with RISPERDAL® in patients with certain concomitant systemic illnesses is limited. Patients with Parkinson’s Disease or Dementia with Lewy Bodies who receive antipsychotics, including RISPERDAL®, are reported to have an increased sensitivity to antipsychotic medications. Manifestations of this increased sensitivity have been reported to include confusion, obtundation, postural instability with frequent falls, extrapyramidal symptoms, and clinical features consistent with the neuroleptic malignant syndrome.

Caution is advisable in using RISPERDAL® in patients with diseases or conditions that could affect metabolism or hemodynamic responses. RISPERDAL® has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were excluded from clinical studies during the product's premarket testing.

Increased plasma concentrations of risperidone and 9-hydroxyrisperidone occur in patients with severe renal impairment (creatinine clearance <30 mL/min/1.73 m²), and an increase in the free fraction of risperidone is seen in patients with severe hepatic impairment. A lower starting dose should be used in such patients (see DOSAGE AND ADMINISTRATION).
Laboratory Tests

No specific laboratory tests are recommended.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis

Carcinogenicity studies were conducted in Swiss albino mice and Wistar rats. Risperidone was administered in the diet at doses of 0.63, 2.5, and 10 mg/kg for 18 months to mice and for 25 months to rats. These doses are equivalent to 2.4, 9.4, and 37.5 times the maximum recommended human dose (MRHD) for schizophrenia (16 mg/day) on a mg/kg basis or 0.2, 0.75, and 3 times the MRHD (mice) or 0.4, 1.5, and 6 times the MRHD (rats) on a mg/m² basis. A maximum tolerated dose was not achieved in male mice. There were statistically significant increases in pituitary gland adenomas, endocrine pancreas adenomas, and mammary gland adenocarcinomas. The following table summarizes the multiples of the human dose on a mg/m² (mg/kg) basis at which these tumors occurred.

Multiples of Maximum
Human Dose in mg/m²
(mg/kg)
Tumor Type Species Sex Lowest
Effect Level Highest No-
Effect Level
Pituitary adenomas mouse female 0.75 (9.4) 0.2 (2.4)
Endocrine pancreas adenomas rat male 1.5 (9.4) 0.4 (2.4)
Mammary gland adenocarcinomas mouse female 0.2 (2.4) none
rat female 0.4 (2.4) none
rat male 6.0 (37.5) 1.5 (9.4)
Mammary gland neoplasm, Total rat male 1.5 (9.4) 0.4 (2.4)

Antipsychotic drugs have been shown to chronically elevate prolactin levels in rodents. Serum prolactin levels were not measured during the risperidone carcinogenicity studies; however, measurements during subchronic toxicity studies showed that risperidone elevated serum prolactin levels 5-6 fold in mice and rats at the same doses used in the carcinogenicity studies. An increase in mammary, pituitary, and endocrine pancreas neoplasms has been found in rodents after chronic administration of other antipsychotic drugs and is considered to be prolactin-mediated. The relevance for human risk of the findings of prolactin-mediated endocrine tumors in rodents is unknown (see PRECAUTIONS, General -Hyperprolactinemia).
Mutagenesis

No evidence of mutagenic potential for risperidone was found in the Ames reverse mutation test, mouse lymphoma assay, in vitro rat hepatocyte DNA-repair assay, in vivo micronucleus test in mice, the sex-linked recessive lethal test in Drosophila, or the chromosomal aberration test in human lymphocytes or Chinese hamster cells.
Impairment of Fertility

Risperidone (0.16 to 5 mg/kg) was shown to impair mating, but not fertility, in Wistar rats in three reproductive studies (two Segment I and a multigenerational study) at doses 0.1 to 3 times the maximum recommended human dose (MRHD) on a mg/m² basis. The effect appeared to be in females, since impaired mating behavior was not noted in the Segment I study in which males only were treated. In a subchronic study in Beagle dogs in which risperidone was administered at doses of 0.31 to 5 mg/kg, sperm motility and concentration were decreased at doses 0.6 to 10 times the MRHD on a mg/m² basis. Dose-related decreases were also noted in serum testosterone at the same doses. Serum testosterone and sperm parameters partially recovered, but remained decreased after treatment was discontinued. No no-effect doses were noted in either rat or dog.
Pregnancy
Pregnancy Category C

The teratogenic potential of risperidone was studied in three Segment II studies in Sprague-Dawley and Wistar rats (0.63-10 mg/kg or 0.4 to 6 times the maximum recommended human dose [MRHD] on a mg/m² basis) and in one Segment II study in New Zealand rabbits (0.31-5 mg/kg or 0.4 to 6 times the MRHD on a mg/m² basis). The incidence of malformations was not increased compared to control in offspring of rats or rabbits given 0.4 to 6 times the MRHD on a mg/m² basis. In three reproductive studies in rats (two Segment III and a multigenerational study), there was an increase in pup deaths during the first 4 days of lactation at doses of 0.16-5 mg/kg or 0.1 to 3 times the MRHD on a mg/m² basis. It is not known whether these deaths were due to a direct effect on the fetuses or pups or to effects on the dams.

There was no no-effect dose for increased rat pup mortality. In one Segment III study, there was an increase in stillborn rat pups at a dose of 2.5 mg/kg or 1.5 times the MRHD on a mg/m²basis. In a cross-fostering study in Wistar rats, toxic effects on the fetus or pups, as evidenced by a decrease in the number of live pups and an increase in the number of dead pups at birth (Day 0), and a decrease in birth weight in pups of drug-treated dams were observed. In addition, there was an increase in deaths by Day 1 among pups of drug-treated dams, regardless of whether or not the pups were cross-fostered. Risperidone also appeared to impair maternal behavior in that pup body weight gain and survival (from Day 1 to 4 of lactation) were reduced in pups born to control but reared by drug-treated dams. These effects were all noted at the one dose of risperidone tested, i.e., 5 mg/kg or 3 times the MRHD on a mg/m² basis.

Placental transfer of risperidone occurs in rat pups. There are no adequate and well-controlled studies in pregnant women. However, there was one report of a case of agenesis of the corpus callosum in an infant exposed to risperidone in utero. The causal relationship to RISPERDAL® therapy is unknown. Reversible extrapyramidal symptoms in the neonate were observed following postmarketing use of risperidone during the last trimester of pregnancy.

RISPERDAL® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery

The effect of RISPERDAL® on labor and delivery in humans is unknown.
Nursing Mothers

In animal studies, risperidone and 9-hydroxyrisperidone are excreted in milk. Risperidone and 9-hydroxyrisperidone are also excreted in human breast milk. Therefore, women receiving risperidone should not breast-feed.
Pediatric Use

The safety and effectiveness of RISPERDAL® in pediatric patients with schizophrenia or bipolar mania have not been established.

The efficacy and safety of RISPERDAL® in the treatment of irritability associated with autistic disorder were established in two 8-week, placebo-controlled trials in 156 children and adolescent patients, aged 5 to 16 years (see CLINICAL PHARMACOLOGY - Clinical Trials, INDICATIONS AND USAGE, and ADVERSE REACTIONS). Additional safety information was also assessed in a long-term study in patients with autistic disorder, or in short- and long-term studies in more than 1200 pediatric patients with other psychiatric disorders who were of similar age and weight, and who received similar dosages of RISPERDAL® as patients who were treated for irritability associated with autistic disorder.

The safety and effectiveness of RISPERDAL® in pediatric patients with autistic disorder less than 5 years of age have not been established.
Tardive Dyskinesia

In clinical trials in 1885 children and adolescents with autistic disorder or other psychiatric disorders treated with risperidone, 2 (0.1%) patients were reported to have tardive dyskinesia, which resolved on discontinuation of risperidone treatment (see WARNINGS – Tardive Dyskinesia).
Weight Gain

In long-term, open-label trials (studies in patients with autistic disorder or other psychiatric disorders), a mean increase of 7.5 kg after 12 months of RISPERDAL® treatment was observed, which was higher than the expected normal weight gain (approximately 3 to 3.5 kg per year adjusted for age, based on Centers for Disease Control and Prevention normative data). The majority of that increase occurred within the first 6 months of exposure to RISPERDAL®. The average percentiles at baseline and 12 months, respectively, were 49 and 60 for weight, 48 and 53 for height, and 50 and 62 for body mass index. When treating patients with RISPERDAL®, weight gain should be assessed against that expected with normal growth. (See also ADVERSE REACTIONS.)
Somnolence

Somnolence was frequently observed in placebo-controlled clinical trials of pediatric patients with autistic disorder. Most cases were mild or moderate in severity. These events were most often of early onset with peak incidence occurring during the first two weeks of treatment, and transient with a median duration of 16 days. (See also ADVERSE REACTIONS.) Patients experiencing persistent somnolence may benefit from a change in dosing regimen (see DOSAGE AND ADMINISTRATION – Irritability Associated with Autistic Disorder).

Hyperprolactinemia, Growth, and Sexual Maturation

Risperidone has been shown to elevate prolactin levels in children and adolescents as well as in adults (see PRECAUTIONS - Hyperprolactinemia). In double-blind, placebo-controlled studies of up to 8 weeks duration in children and adolescents (aged 5 to 17 years) 49% of patients who received risperidone had elevated prolactin levels compared to 2% of patients who received placebo.

In clinical trials in 1885 children and adolescents with autistic disorder or other psychiatric disorders treated with risperidone, galactorrhea was reported in 0.8% of risperidone-treated patients and gynecomastia was reported in 2.3% of risperidone-treated patients.

The long-term effects of risperidone on growth and sexual maturation have not been fully evaluated.
Geriatric Use

Clinical studies of RISPERDAL® in the treatment of schizophrenia did not include sufficient numbers of patients aged 65 and over to determine whether or not they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, a lower starting dose is recommended for an elderly patient, reflecting a decreased pharmacokinetic clearance in the elderly, as well as a greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). While elderly patients exhibit a greater tendency to orthostatic hypotension, its risk in the elderly may be minimized by limiting the initial dose to 0.5 mg BID followed by careful titration (see PRECAUTIONS). Monitoring of orthostatic vital signs should be considered in patients for whom this is of concern.

This drug is substantially excreted by the kidneys, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION).
Concomitant use with Furosemide in Elderly Patients with Dementia-Related Psychosis

In two of four placebo-controlled trials in elderly patients with dementia-related psychosis, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone when compared to patients treated with risperidone alone or with placebo plus furosemide. No pathological mechanism has been identified to explain this finding, and no consistent pattern for cause of death was observed. An increase of mortality in elderly patients with dementia-related psychosis was seen with the use of RISPERDAL® regardless of concomitant use with furosemide. RISPERDAL® is not approved for the treatment of patients with dementia-related psychosis. (See BOXED WARNING, WARNINGS: Increased Mortality in Elderly Patients with Dementia-Related Psychosis.)
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FDA Approves Adult Psychiatric Drug for Use on Adolescent Patients
(AP) 02:23:21 PM (ET), Wednesday, August 22, 2007 (WASHINGTON)

The Food and Drug Administration on Wednesday approved a widely used adult psychiatric drug for the treatment of schizophrenia and bipolar disorder in children and adolescents.

The action permits use of Risperdal for schizophrenia in youths aged 13 to 17 and for bipolar disorder in those aged 10 to 17, FDA said.

It was approved last fall for treatment of irritability in autism.

Risperdal, manufactured by Janssen, L.P. of Titusville, N.J., is the No. 3 anti-psychotic drug, with $2.3 billion in sales in 2005, according to the pharmaceutical data company IMS Health. Janssen is a unit of Johnson & Johnson.

Risperdal was approved for use in adults in 1993.

Until now, FDA said, there has been no approved drug for the treatment of schizophrenia in youths and only lithium is approved for the treatment of bipolar disorder in adolescents.

The dose approved for youths is slightly lower than the adult dose, FDA said.

Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported, the agency said.

Almonds Amended

In the post below on cyanide compounds in berries and fruit I mention this move to destroy almonds as a healing food because of blind government intervention.

Here is an update on the issue. Please take action.

New FDA Law Requires Organic Almond Pasteurization
From Rich Johansen, 8-21-7

Today, Monday, August 20, 2007 many Almond Farmers attended a meeting in Modesto, California that sealed the future of Almond crops everywhere. What food will be next?

Description/History -

Starting in August or September of 2007, raw almonds available in the USA, Canada and Mexico, will no longer be "truly raw" due to a mandate passed by the USDA, FDA and the California Almond Board, announcing that all almonds including organic must be pasteurized. This means that the Almond farmer will have to truck thousands of pounds of almonds to one of the five facilities that are already set up for the pasteurization process and then truck them back again to the processing plant. Besides having a vital part of our food supply pasteurized--against our will, it will now have a huge cost attached to it. Information is available at the following link:

http://www.almondboard.com/Programs/content.cfm
?ItemNumber=890&snItemNumber=450

Action Plan and Pasteurization - Frequently Asked Questions

The problem is the law has been passed with little public input (if any) or notification whatsoever.

In addition, all pasteurized almonds available in the marketplace will still be labeled as raw almonds. Can this be considered fraudulence or an outright lie? Are you willing to give up your food freedom choices?

The primary reasons for passing this law are two isolated outbreaks of salmonella, in conjunction with conventional almond farms a few years ago. To the best of our knowledge no salmonella outbreaks have EVER been associated with organic almonds.

Within the past 10 years tomatoes, spinach, green onions, peanuts, grapes, melons, lettuce, and sprouts have all been linked to salmonella outbreaks. Does that mean we should eliminate all fresh produce? Absolutely not!!! But they are going to try.

Almonds, the heartbeat of all nuts, literally, have been associated with reduced risk of heart disease, a rich source of calcium, magnesium, vitamin E, protein, fiber and antioxidants to name a few . These amazing and life enhancing health benefits, will be devastatingly reduced if not completely eliminated in the pasteurization process.

Three of the potential suggested methods of pasteurization are:

- Propylene Oxide (PPO) Fumigation (propylene oxide was also used as an insecticidal fumigant till 1988 when its registration was terminated. California Prop.65 rates PPO as a CARCINOGEN. (Cited from www.mbow.org)

- High Heat (which degrades the integrity of the nuts and enzyme structure).

- Steam Pasteurization (will also further devalue the nutrients, enzyme activity and antioxidants.)

This is a call to all those who care about their health, we need to join forces by bringing this to the attention of everyone from the mass media to the common consumer before it goes any further than almonds! It is our basic right to choose unprocessed foods! We have created a petition that we will present to the California Almond Board, the FDA and the USDA. Go to www.livingnutz.com and click on the almond pasteurization petition link on the front of our page and sign your name as well as your state, town, and zipcode. E-mail us at info@livingnutz.com This e-mail address is being protected from spam bots, you need JavaScript enabled to view it with any other questions, media relations, ideas or information you may have relevant to this cause.

Just say NO. Shout it, write it, Do not put up with this crime against humanity!

The Pain in Spain is Mainly in the Main

As a former critical care nursing practitioner the issue of pain is one of familiarity. Reading this article I can say that most of what the writer says is very accurate. My question is: "Why nothing but pills?"

I now work only with natural health approaches, and have used many natural approaches to pain for my clients with good benefit. I educate many people about pain treatment options too.

I've been injured and have had to manage pain, but have the benefit of knowing what to do to work with it. My approach is not to deaden the nerves to stop pain perception, but to nourish them so they heal. Then pain is resolved, not managed.

I knew someone in law enforcement was severely injured in the apprehension of a criminal. He was a tall,large man. His degree of pain required something very different than a woman of 80 weighing 100 pounds. His career was destroyed by an over-aggressive Washington state investigation, eventually proven to be nothing more than a political attack. He was making an effort to clean up the sheriff's department and the powers that be wanted the door kept closed. The prosecutor that lost this case was the same one who allowed a perpetrator to get free of a charge of arson on my home.

People are harmed by suffering with pain. Prescribers need to know their patients well enough to take a stand for them having the kind and amount of pain medication appropriate for good care. Physicians need to be in charge of medicine, not insurers.

Those believing that every one on pain medication is an addict need to research why the war on drugs never worked.

First, do no harm.

AP IMPACT: Analysis Finds Pain Medicine Use Has Risen by 90 Percent
By FRANK BASS Associated Press Writer
(AP) 09:00:13 AM (ET), Monday, August 20, 2007 (MYRTLE BEACH, S.C.)

People in the United States are living in a world of pain and they are popping pills at an alarming rate to cope with it.

The amount of five major painkillers sold at retail establishments rose 90 percent between 1997 and 2005, according to an Associated Press analysis of statistics from the Drug Enforcement Administration.

More than 200,000 pounds of codeine, morphine, oxycodone, hydrocodone and meperidine were purchased at retail stores during the most recent year represented in the data. That total is enough to give more than 300 milligrams of painkillers to every person in the country.

Oxycodone, the chemical used in OxyContin, is responsible for most of the increase. Oxycodone use jumped nearly six-fold between 1997 and 2005. The drug gained notoriety as "hillbilly heroin," often bought and sold illegally in Appalachia. But its highest rates of sale now occur in places such as suburban St. Louis, Columbus, Ohio, and Fort Lauderdale, Fla.

The world of pain extends beyond big cities and involves more than oxycodone.

In Appalachia, retail sales of hydrocodone _ sold mostly as Vicodin _ are the highest in the nation. Nine of the 10 areas with the highest per-capita sales are in mostly rural parts of West Virginia, Kentucky or Tennessee.

Suburbs are not immune to the explosion.

While retail sales of codeine have fallen by one-quarter since 1997, some of the highest rates of sales are in communities around Kansas City, Mo., and Nashville, Tenn., and on New York's Long Island.

The DEA figures analyzed by the AP include nationwide sales and distribution of drugs by hospitals, retail pharmacies, doctors and teaching institutions. Federal investigators study the same data trying to identify illegal prescription patterns.

An AP investigation found these reasons for the increase:

_The population is getting older. As age increases, so does the need for pain medications. In 2000, there were 35 million people older than 65. By 2020, the Census Bureau estimates the number of elderly in the U.S. will reach 54 million.

_Drugmakers have embarked on unprecedented marketing campaigns. Spending on drug marketing has gone from $11 billion in 1997 to nearly $30 billion in 2005, congressional investigators found. Profit margins among the leading companies routinely have been three and four times higher than in other Fortune 500 industries.

_A major change in pain management philosophy is now in its third decade. Doctors who once advised patients that pain is part of the healing process began reversing course in the early 1980s; most now see pain management as an important ingredient in overcoming illness.

Retired Staff Sgt. James Fernandez, 54, of Fredericksburg, Va., survived two helicopter crashes and Gulf War Syndrome over 20 years in the Marine Corps. He remains disabled from his service-related injuries and takes the equivalent of nine painkillers containing oxycodone every day.

"It's made a difference," he said. "I still have bad days, but it's under control."

Such stories should hearten longtime advocates of wider painkiller use, such as Russell Portenoy, head of New York's Beth Israel pain management department. But they have not.

"I'm concerned and many people are concerned," he said, "that the pendulum is swinging too far back."

Consider:

_More people are abusing prescription painkillers because the medications are more available. The vast majority of people with prescriptions use the drugs safely. But the number of emergency room visits from painkiller abuse has increased more than 160 percent since 1995, according to the government.

_Spooked by high-profile arrests and prosecutions by state and federal authorities, many pain-management specialists now say they offer guidance and support to patients but will not write prescriptions, even for the sickest people. The increase in painkiller retail sales continues to rise, but only barely. There was a 150 percent increase in volume in 2001. Four years later, the year-to-year increase was barely 2 percent.

_People who desperately need strong painkillers are forced to drive a long way _ often to a different state _ to find doctors willing to prescribe high doses of medicine. Siobhan Reynolds, the widow of a New Mexico patient who needed large amounts of painkillers for a connective tissue disorder, said she routinely drove her late husband to see an accommodating doctor in Oklahoma.

Perhaps no place illustrates the trends and consequences for the world of pain better than Myrtle Beach, a sprawling community of strip malls, hotels and bars perched along a 60-mile strip of sand on the Atlantic Ocean. The metro area, which includes three counties, is home to 350,000 people but sees more than 14 million tourists annually, drawn to its warm water, golf courses and shopping.

During the eight-year period reflected in government figures, oxycodone distribution increased 800 percent in the area of Myrtle Beach, partly due to a campaign by Purdue Pharmaceuticals of Stamford, Conn. The privately held company has pleaded guilty to lying to patients, physicians and federal regulators about the addictive nature of the drug.

Use of other drugs soared in the area, too: Hydrocodone use increased 217 percent; morphine distribution went up 180 percent; even meperidine, most commonly sold as Demerol, jumped 20 percent.

It is no small wonder that federal authorities suspected the area was home to a notorious "pill mill," or a clinic that dispenses prescription medication without verifying that it's needed.

The U.S. attorney for South Carolina secured a 58-count indictment in June 2002 against seven physicians and one employee of the Comprehensive Care and Pain Management Center, a nondescript storefront on Myrtle Beach's main drag.

Tipped off by local pharmacists concerned about an increase in the volume of painkiller prescriptions, the federal investigation created a furor in the medical profession. The owner, D. Michael Woodward, was sentenced to 15 years in the case and has relinquished his license.

A second physician, Deborah Bordeaux, had worked at the clinic less than two months before quitting in disgust. Bordeaux, now serving a two-year prison term, was threatened with a 100-year sentence if she did not help the prosecution.

Officials with the Justice Department and the DEA would not discuss what some activists say is a "war on doctors."

Reynolds, the widow who drove her late husband hundreds of miles for his pills, became an activist after the Myrtle Beach indictments. She contributed money to appeal some of the criminal convictions in South Carolina and started the Pain Relief Network, an advocacy organization for people living in pain. She believes the doctors sent to prison were railroaded.

"It was a witch hunt," she said.

Bordeaux's husband, Edworth Swaim, agrees. A retired U.S. Postal Service employee, Swaim believes his wife was sentenced to two years because she would not turn on her former colleagues. Even though Bordeaux had worked at the clinic less than two months and eventually sued over what she alleged was rampant Medicare fraud, he said she did not stand a chance of avoiding prison.

"She wasn't guilty of anything, so she wasn't going to plead to anything," Swaim said. "She was absolutely railroaded, made an example of. I can't tell you how angry I am."

Myrtle Beach physicians are not convinced that the "Myrtle Beach Eight," as they became known, were innocent.

A Myrtle Beach internist who also works in addiction medicine, Brian Adler, said physicians were flooded with patients seeking pain medicine after the clinic was shut down.

The community has a slightly higher-than-average number of older people and relatively high numbers of people between 21 and 64 who describe themselves as disabled.

"There's a significant problem with narcotics in this area," Adler said. After the pain management clinic closed, "all those folks were like rats, scurrying from a burning building, trying to get their fix."

Other physicians were concerned about patients with legitimate needs for painkillers. The federal bust raised the stakes.

When radio commentator Rush Limbaugh settled a federal case charging him with illegally obtaining painkillers, he did not get prison time. Neither did NFL star Brett Favre, who publicly acknowledged an addiction to Vicodin that he obtained legally.

To pain management specialists, they were being blamed for everyone's addiction.

The DEA cites 108 prosecutions of physicians during the past four years; 83 pleaded guilty or no contest, while 16 others were convicted by juries. Eight cases are pending, and one physician is being sought as a fugitive.

In congressional testimony, the agency's deputy assistant administrator, Joseph T. Rannazzisi, estimated that fewer than 1 percent of the nation's physicians _ under 9,000 _ illegally provide prescription drugs to patients. He told lawmakers it is far more common for people to illegally obtain prescription drugs from friends and family members.

"It is not merely illegal but could feed or lead to an addiction and place that loved one in a life-threatening situation," Rannazzisi said.

It is impossible to reliably measure painkiller abuse.

A 2004 government study estimated between 2 million and 3 million doses of codeine, hydrocodone and oxycodone are stolen annually from pharmacies, distributors and drug manufacturers. The AP's analysis only included retail sales and did not include estimates of diverted pharmaceuticals.

John Charles, director of medical affairs at the Grand Strand Regional Medical Center in Myrtle Beach, practices pain management. A few years ago, Charles said, he took a drastic step to reduce his potential legal risks: He stopped prescribing painkillers.

The decision gave him peace of mind, but he does not expect there to be less of a need for painkillers or physicians who prescribe them.

"People with cancer are surviving longer, elderly people are living longer," Charles said. "So, physicians are walking a fairly fine line. We're walking a narrow path. And I think we'll continue to see it for a while."

Copyright 2007 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

More to trans fat than you know now

In an effort to stop the ingestion of trans fat, which may be a good idea in the long run, diet dictocrats often seem to overlook the problem with canola.

A plant oil canola is. A healthy food it is not.

There is a toxic-to-the-liver substance known as Eurycic acid. This compound is the result of processing canola seed, a member of the mustard family.

When canola is processed, the processing causes the oil to become a trans-fat. The Eurycic acid is found at 4%, when at a 2% level it becomes toxic to the liver.

Additionally, oils packaged in plastic, because of heat and light exposure such as on the supermarket shelf, tend to cause transfer of xenoestrogens from the plastic to the oil. Xenoestrogens are carcinogenic.

Read your labels and watch out for canola, it is pervasive in the food supply.

I use this oil in mt truck as a fuel additive, giving me and extra 6 miles per gallon so far.

'Zero Grams Trans Fat' Doesn't Always Mean Zero When It Comes to Food Labels By STEPHANIE NANO
Associated Press Writer
(AP) 04:57:47 PM (ET), Sunday, August 19, 2007 (NEW YORK)

Stroll the aisles of any grocery store and you're sure to spot labels declaring "zero grams trans fat" on the front of snack foods, cookies and crackers. But does zero really mean there's NO artery-clogging fat inside?

Maybe, maybe not.

Federal regulations allow food labels to say there's zero grams of trans fat as long as there's less than half a gram per serving. And many packages contain more than what's considered one serving.

"The problem is that often people eat a lot more than one serving," said Dr. Dariush Mozaffarian of Harvard School of Public Health. "In fact, many people eat two to three servings at a time."

Those small amounts of trans fat can add up, said Michael Jacobson of the consumer advocacy Center for Science in the Public Interest. To find out if there might be some trans fat, he said shoppers can check the list of ingredients to see if partially hydrogenated oil _ the primary source of trans fat _ is included.

"When it says zero grams, that means something different from no trans fat," said Jacobson. His group has urged the government to bar food producers from using any partially hydrogenated oils at all.

The Food and Drug Administration began forcing food companies to list the amount of trans fat on nutrition labels of packaged foods in January 2006. That led many companies to switch to alternative fats.

Trans fat occurs naturally in some dairy and meat products, but the main source is partially hydrogenated oils, formed when hydrogen is added to liquid vegetable oils to harden them.

Consumer groups and health officials have campaigned to get rid of trans fat because it contributes to heart disease by raising levels of LDL or bad cholesterol while lowering HDL or good cholesterol. Fast-food restaurants are switching to trans fat-free oils and New York City and Philadelphia are forcing restaurants to phase out their use of trans fat.

The American Heart Association recommends that people limit trans fats to less than 2 grams per day.

Julie Moss of the FDA's Office of Nutrition, Labeling and Dietary Supplements, said the half-gram threshold for labeling was adopted because it is difficult to measure trans fat at low levels and the same half-gram limit is used for listing saturated fat. She said the FDA would soon be doing consumer research on trans fat labeling, including whether a footnote such as "Keep your intake of trans fat as low as possible" should be added to food labels.

Robert Earl of the Grocery Manufacturers Association said any trans fat in products labeled zero trans fat is likely to be far less than the half-gram threshold. For example, he said, a little partially hydrogenated oil might be used to help seasoning stick.

"I think the industry has been extremely responsive. Most of them were ahead of the curve to either remove or reduce trans fat in most food products," he said.

Earl said shoppers should be looking at the entire food label.

Jacobson is also concerned that people are focusing too much on the trans fat content alone, and not considering other ingredients such as saturated fat, which also raises the risk of heart disease.

"The bigger problem is foods that have no labels at all," Mozaffarian said, citing food served not only at restaurants, but at bakeries, cafeterias and schools.

New York resident Diana Fiorini said she's just recently started paying attention to labels. Holding a box of microwave popcorn at a Manhattan store, she scanned the label and was happy to see that it listed zero grams trans fat.

"I look at the labels. It's still hard to stop yourself when you know you should," she said.

It's the cyandide compounds in seeded fruit that helps health

Some three to four decades ago the US FDA banned Laetrile. Laetrile is an anti-cancer compound found in the seed of pits from seeded fruit like plums, apricots, peaches, nectarines, etc., and almonds.

The offending compound, after the anti-cancer benefit, was the pit inside the seed of apricots used for this health benefit.

Almonds have a similar benefit to a lesser extent. The anthocyanidin compounds are also found in blueberries, blackberries, raspberries, strawberries, gooseberries and other similar type multi-seeded fruit.

Over the last five or more years the government has attempted to ban any natural supplement with these cyanide compounds. And, in its definition of wisdom, has a current plan to fumigate and / or irradiate almonds, making them a health risk from toxic sprays and radiation exposure.

This is not the first article to support the anti-cancer benefit of foods with proanthocyanidins.

You can decide why the FDA wants a ban on products containing these compounds.

Natural pigments that give certain fruit and vegetables a rich red, purple or blue colour act as powerful anti-cancer agents, according to a study by American scientists.

The compounds, found in foods such as aubergines, red cabbage, elderberries and bilberries, restricted the growth of cancer cells and in some cases killed them off entirely, leaving healthy cells unharmed.

The study combined laboratory tests on human cancer cells with experiments on animals that were designed to see whether a diet rich in the foods made a difference to their risk of developing cancer.

Foods with the highest levels of the compounds were most effective at slowing cancer growth, with exotic purple corn and chokeberries stopping the growth of colon cancer cells and killing 20% in lab tests. Foods less enriched with the pigments, such as radishes and black carrots, slowed the growth of colon cancer cells by 50% to 80%.

The findings bring scientists closer to unravelling the key ingredients responsible for giving fruit and vegetables their cancer-fighting properties.

Because the pigments, which belong to a class of antioxidant compounds known as anthocyanins, are not easily absorbed by the bloodstream, they travel through the stomach to the gastrointestinal tract, where they are taken up by surrounding tissues.

Their survival through to the lower part of the intestine may be the key to their role in preventing cancers in the tract, the scientists believe.

Researchers led by Monica Giusti, an expert in plant nutrients at Ohio State University, extracted anthocyanins from a variety of exotic and more common fruits and vegetables that all had a deep red, blue or purple hue and added them to flasks containing a suspension of human colon cancer cells.

When the team calculated how much of each extract was needed to reduce cancer cell growth by 50%, they found anthocyanin from purple corn to be the most potent. Chokeberries and bilberries were nearly as effective, while radish anthocyanin required nine times as much - or 131 micrograms per millilitre of cancer cell solution to cut cell growth by half.

In a second study, the researchers fed rats with colon cancer a diet of anthocyanin extracts from bilberries and chokeberries, which are most often used as flavourings in jams and fruit drinks. Colon tumours in the rats fell by 60% to 70% compared with a control group that were not given anthocyanin.

"These foods contain many compounds and we're just starting to figure out what they are and which ones provide the best health effects," said Dr Giusti.

"All fruits and vegetables that are rich in anthocyanins have compounds that can slow down the growth of colon cancer cells, whether in experiments in laboratory dishes or inside the body."

The research was presented yesterday at the annual meeting of the American Chemical Society in Boston.

The team are now investigating whether it is possible to modify the structure of the pigment compounds to make them even more potent. Tentative results so far suggest that grafting an extra sugar or acid molecule to the anthocyanins improved their effectiveness.

The work is part of a long-term investigation aimed at a greater understanding of the 600 anthocyanins found in nature. "We're just beginning to scratch the surface of understanding how the body absorbs and uses these different structures," Dr Giusti said.

In June, market researchers reported that sales of anthocyanin-rich blueberries had doubled in the past two years. The berries joined a growing list of what associations marketing the products call "superfoods", alongside oily fish, brazil nuts and tomatoes. Anthocyanins have previously been linked to helping towards a healthy heart and with treating skin conditions.

Stealth Watching People sort of...

Distributed Internet Measurements and Simulations
The DIMES headquarters are situated in Tel-Aviv University 's EE-Systems department.

Questionable Activities Perhaps

Ever wonder why DIMES HQ is located in Israel when it is an FDA cohort run by a tech named Brenda Cosby in Maryland. When it logs your blog, website, or other activity you wonder why and what they wish to know?

Number of Entries:3
Entry Page Time:16th August 2007 09:56:13
Visit Length:Multiple visits spread over more than one day
Browser:MSIE 6.0
OS: Windows 2000
Resolution: unknown
Returning Visits:
Location: Maryland, Gaithersburg, United States
Hostname:wallwhale-pub.fda.gov (150.148.0.27) [Label IP Address]
Entry Page:
Exit Page:
Referring URL: No referring link

Spying must be one of those bureaucratic activities engaged in to fill up the time available, under management-by-other-means protocols.

This is AKA "The Peter Principle".

Depression is 'over-diagnosed'

At least this physician is open enough to express the exact status of this issue today, as driven by the Big Pharma quest for profits.

"Over the last 30 years the formal definitions for defining clinical depression have expanded into the territory of normal depression, and the real risk is that the milder, more common experiences risk being pathologised."

An example of this is the development of new so-called conditions that are designed by drug companies in their drive to sell more drugs. Shyness has been turned into a mental condition. "Dysmorphic" dis-order applies to women for natural monthly cycle imbalances. Give an SSRI but don't address - or even attempt to discover - the root cause. In most cases the root cause is nutritionally based, an area where medicine has no basis of practice. The doctors don't want to learn about nutrition or more natural and safer approaches.

Another area that has anti-depressants thrown at it, instead of consoling care and counseling, is grief following the death of a loved one. Natural sadness from the loss is not depression, and a pill fails to meed the needs of the person experiencing this process. Elisabeth Kubler-Ross helped some of us learn this in the 60s.

To me it boils down to a scientific method I never learned in all the biology, chemistry, physics and physiology classes I excelled in in high school and college.

One never knows, just be aware.

Too many people are being diagnosed with depression when all they are is unhappy, a leading psychiatrist says.

Professor Gordon Parker claims the threshold for clinical depression is too low and risks treating normal emotional states as illness.

Writing in the British Medical Journal, he calls depression a "catch-all" diagnosis driven by clever marketing.

But another psychiatrist writing in the journal contradicts his views, praising the increased diagnosis of depression.

The milder, more common experiences risk being pathologised.

Professor Ian Hickie writes that an increased diagnosis and treatment of depression has led to a reduction in suicides and removal of the old stigma surrounding mental illness.

Under the current diagnosis guidelines, around one in five adults is thought to suffer depression during their lifetime. This costs the UK economy billions in lost productivity and treatment.

Professor Parker, from the University of New South Wales, in Australia, said the "over-diagnosis" began around 25 years ago.

Study of teachers

The professor, who carried out a 15-year study of 242 teachers, found that more than three-quarters of them met the current criteria for depression.

He writes in the BMJ that almost everyone had symptoms such as "feeling sad, blue or down in the dumps" at some point in their lives - but this was not the same as clinical depression which required treatment.

HAVE YOUR SAY

People get a bit fed up with life and think they have depression, but if they had actually suffered with depression they would know about it Mrs Jackman, Wirral, UK
He said prescribing medication may raise false hopes and might not be effective as there was nothing biologically wrong with the patient.

He said: "Over the last 30 years the formal definitions for defining clinical depression have expanded into the territory of normal depression, and the real risk is that the milder, more common experiences risk being pathologised."

But Professor Hickie said if only the most severe cases were treated, people would die unnecessarily.

Marjorie Wallace, chief executive of the mental health charity Sane, said: "Depression can be a complex and challenging condition ranging from feeling low to being so disabled that the person may be unable to get out of bed in the morning, sustain relationships or work.

"It is not surprising that with such a wide range of symptoms, identification varies from one doctor to another.

"Sane believes that it is better to risk over diagnosis than to leave depression untreated. One in ten people with severe depression may take their own life."

The number of prescriptions for antidepressants in England hit a record high of more than 31 million prescriptions earlier this year - a 6% rise in two years.

Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/6950733.stm
Published: 2007/08/17 04:13:39 GMT
© BBC MMVII

Can You Really Believe This?

My regular readers know what I have to say about lying with statistics. I guess you can fool people with hilarious headlines too. And remember the the courts have said it is ok to lie in the media...

This study is off, by well more than a mile, and here's why.

First of all the report gives no information about who provided the funding or the supplements. Remember that Pfizer's junque vitamin Centrum gets to tout all the marvelous benefits of viatmins. Because its Pfizer, a big campaign donor to the current administration, whose lobbyists get to participate in writing new drug legislation a when no one else can, also gets its vitamins paid for in the Senior drug payola to the drug companies program. If it was anyone else or some small company any claim is off limits without raising the ire of the FDA, strongly protecting the drug companies from the other side of the door.

Another important issue not reported in this study is that the amounts provided participants is extremely low in comparison to therapeutic dosing, or in what we refer to as orthomolecular medicine.

What the study failed to do was to provide the basic requirement of vitamin c for an adult. This happens to be 3000 mg a day because humans do not make their own vitamin C as do primates and other animals. This basic amount was determined through primate studies.

Therapeutic doses are substantially higher in many cases. Right now I am taking 12500 mg daily in five divided doses because it is harvest where I live and the dust is causing me to have unhappy lungs. With the vitamin C at this level I have no respiratory issues and this reduces stress on my heart. I too am in the age range of this study's participants. In addition I take non-soy vitamin E, 800 IU daily and a combination vitamin A / Beta Carotene tablet of 25,000 IU a day. Many people, including researchers, may not know that beta-carotene cannot convert to vitamin A alone.

"The women consumed either 500 milligrams of ascorbic acid (vitamin C) every day, 600 international units of vitamin E every other day, or 50 milligrams of beta carotene every other day."

In itself, the above reference to the study informs me that the outcome was to show vitamins do no good for health.

Don't be fooled, see more here from the experts.

And as far as getting enough vitamins in the diet is groundless because of corporate agricultural methods and food processing, all permitted by your government.

CHICAGO (Reuters) 13 August 07
Common vitamins no help for women's hearts: study -
Middle-aged women at risk for heart disease received little benefit from taking vitamins C, E or beta carotene, researchers said on Monday.

Though vitamin supplements provided no heart benefit, eating a diet rich in those vitamins does make for healthier heart, their study noted.

Experts believe a nutritious diet rich in these vitamins protect the body's cardiovascular system by counteracting compounds known as "free radicals." These harmful compounds build up in the body and can damage artery linings, encourage blood clots and alter the function of blood vessels.

"Single antioxidants (vitamins) may not reflect the complex vitamins and nutrients found in foods, which may explain the discrepancies between most intervention trials and studies of fruits and vegetables," wrote study author Nancy Cook of Brigham and Women's Hospital and Harvard Medical School in Boston.

"While additional research into combinations of agents, particularly for stroke, may be of interest, widespread use of these individual agents for cardiovascular protection does not appear to be warranted," she concluded.

Among the more than 8,000 women, average age 61, involved in the study only a combination of vitamins C and E conferred a slightly lower risk of stroke compared to placebos.

The participants were tracked for roughly nine years for fatal heart disease, heart attacks, strokes and heart-related surgery, the study published in the Archives of Internal Medicine said. Heart disease is the leading cause of death in the industrialized world.

"Do we expect these supplements to reverse 30 years of heart disease? Of course they won't," said Andrew Shao of the Council for Responsible Nutrition, a trade group for the industry that produces $20 billion in U.S. states annually.

"But studies show that supplementation with modest amounts of antioxidants over a long period of time, 10 years or more, (produces) modest benefits," he said. "They're subtle, as should be expected when you're talking about nutrients and not pharmaceuticals," or prescription drugs.

Importantly, the study showed taking the supplements did not harm the women, Shao said, as some recent research has suggested based on deaths from all causes.

The women consumed either 500 milligrams of ascorbic acid (vitamin C) every day, 600 international units of vitamin E every other day, or 50 milligrams of beta carotene every other day. Some consumed more than one.

Another FDA Funny

UPDATE:
I received a reply of sorts from the FDA along with a visit from the spyputer at FDAs DIMES HQ (ref: Elk Watching People). The reply was not from Dr. Galson to whom I wrote, but was an unsigned so-called response from an unnamed party at the FDA aka 'CDER'. The reply did not answer my query but danced around the issues in typical bureaucratic style.

I understand this because at one time in my career I worked with HHS and the USPHS, as well as the Washington state DSHS. Several years was enough to make clearly understand why integrity is so much a critical philosophy in my life.

If you would like to read a 2004 in depth article regarding statins from two key researchers, please see Dangers of Statin Drugs: What You Haven’t Been Told About Popular Cholesterol-Lowering Medicines

***

The FDA once again targets natural treatments while avoiding the ever increasing number of problems with their "approved" drugs.

What you don't read here is that RRY is the very statin that is the basis for the pharmaceutical industry's drug.

Statins are associated with rhabdomyolysis which can lead to very serious side effects, kidney failure and death. The statins have been associated with death yet remain on the market.

The statins also lead to cancer and Alzheimer's disease.

There is a prohibition of selling a substance that causes cancer, yet the FDA kow-tows to Big Pharma in deference to patients who can do as well or better with natural approaches to health problems.

And yes, there is a "cholesterol myth" but the FDA doesn't tell you about this either. The agency just waits for another BIG PAYOFF from Big Pharma to push yet another dangerous drug with little or no benefit, except taking your money...

Wonder why only Swanson and Sunburst Biorganics brands are being attacked when there are a number of companies selling RRY? I am waiting for this answer too, just as I wait for a prescribing physician to explain the risks of the statin drugs to their patients.

FDA Warns Against Use of Red Yeast Rice Supplements

ROCKVILLE, Md., Aug. 10 -- The FDA has warned consumers against using three brands of red yeast rice, a product marketed as a natural remedy for high cholesterol, because they may contain lovastatin, the active ingredient in Mevacor.

The products, marketed in stores or on the Web, are Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, and manufactured by Nature's Value, and Kabco, respectively; and Cholestrix, sold by Sunburst Biorganics.

FDA investigators conducting routine testing of the supplement detected lovastatin, which was the first statin approved by the FDA. It has been available as a generic drug since 2002.

Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research, said consumers may be unaware of side effects associated with lovastatin. These include rhabdomyolysis, especially when lovastatin is combined with the antidepressant nefazodone, certain antibiotics, drugs for fungal infections and HIV infections, and other cholesterol-lowering medications.

The FDA recommended that consumers who use any red yeast rice product obtain medical advice if they have muscle pain or other problems that may be associated with the red yeast.

The agency issued warning letters advising Swanson and Sunburst Biorganics to stop promoting and selling the products.

The FDA's warning letters said that the products Red Yeast Rice, Red Yeast Rice/Policosonal Complex, and Cholestrix represent unapproved new drugs that are marketed in violation of the Federal Food, Drug, and Cosmetic Act.

More Folly

With flu season gearing up for another frivolus PR campaign, watch that trap that goes for the jab!

Bush Set To Veto To Remove Mercury From Infant Vaccines
Posted by: SAFE MINDS
on 07-20-2007.

"HHS-Labor-Education Appropriations Bill has objectionable provisions such as a measure to ban the use of childhood flu vaccines that contain thimerosal."

President Bush would veto the HHS-Labor-Education Appropriations Bill because of the cost and "objectionable provisions" such as a measure to ban the use of childhood flu vaccines that contain thimerosal, a mercury-based preservative.

Autism advocacy groups are outraged because President Bush stated in a questionnaire during his 2004 campaign: "I support the removal of Thimerosal from vaccines on the childhood national vaccine schedule. During a second term as President, I will continue to support increased funding to support a wide variety of research initiatives aimed at seeking definitive causes and/or triggers of autism. It is important to note that while there are many possible theories about causes or triggers of autism, no one material has been definitely included or excluded."

But since 2005, President Bush has steadfastly refused to issue an Executive Order banning high amounts of mercury in vaccines that would protect children and pregnant women despite repeated requests from the autism community that he uphold his campaign promise. Under his current administration, mercury has been and will continue to be knowingly injected into the youngest of American citizens. The controversial mercury-containing preservative thimerosal has been linked by thousands of parents as being the cause of their children's mercury poisoning and autism.

The flu vaccine which continues to be manufactured with mercury is recommended for all pregnant women, infants and children despite the fact that the Institute of Medicine in 2001 recommended against the policy of exposing these same sensitive groups to thimerosal containing vaccines. According to the EPA, one in every six women of childbearing age already has blood levels of mercury high enough to cause neurological damage to their unborn children due to environmental exposures alone.

"Injecting even more mercury into the bodies of pregnant women, infants and children when it is not a necessary component of vaccines is just bad medicine," said Lyn Redwood, president of SafeMinds and parent of a mercury-injured child. "It defies logic that a flu vaccine must be disposed of as a hazardous waste if it is not used, but somehow injecting the same mercury-containing vaccine into a baby is safe."

another thought might be the expense of hazardous waste disposal or maybe a connection with behavioral change and cellular (EMF/WI-FI) transmissions...
only the Shadow knows!

Dialing for Dinosaurs

Polls are interesting, usually because a predetermined result is expected based upon the way one writes the questions to be posed. I learned this in grad school when reading a required text titled "How to Lie With Statistics".

While I've always been skeptical of polls, based on my knowledge, this one isn't too bad.

Of course you would have to admit, if you read this blog regularly, I am a bit biased in favor of natural health care. My bias is because I know it works and I want all people to be able to have the option as their right of choice. Some will choose it, some will not.

Part of the problem lies with doctors who refuse to admit that non-medical treatment options offer hope and benefit.

Consider the Everett WA cardiologist in the Western Washington Medical Group who was exceptionally rude and disrespectful to a client of mine who was there for an evaluation of her condition.

I gave her a medicalarticle addressing the effective use of three supplements for heart conditions.

This doctor refused it and instead of looking at it and taking it for further reading, threw it back to her saying "I don't know anything about this, and it's not proven."

The same attitude prevails withe the cancer industry and the providers who adamantly adhere to false knowledge that supplements, nutritional, herbal and other treatments
do not work for cancer or interfere with the slash and burn techniques of chemo and radiation.

The best one I've hear came from a client taking chemo in a Lewiston, ID medical center. She was told not to eat broccoli because it would interfere with the chemo.

Now my take on that is that, yes, it interferes for the better because the brassica family of foods, of which broccoli is a member, is anti-cancerand so you would ultimately be able to get a better effect and possibly take fewer treatments.

For the 9.6% that stick with what they believe is 'proven', it might help them to know that it really isn't. The current methods are just what is used, and the real effective rate of cure is about 2%. It's the old rule, "we've always done it this way so we will keep doing it this way" mentality. After all, it is a cash cow first, and maybe a few might survive the damage. Survive the treatment's damage? Maybe that's good is you move on to a life on a lot of drugs to keep living in a compromised state.

What concerns me is the misunderstanding shown in the last section of questions. The majority of supplements are already proven to be safe and effective. The science is there. It's just that the consumer never hears about this body of knowledge.

And media outlets like MSNBC fail in their mission to give you the facts. Maybe Dan Abrams or Keith Olbermann will read this and call me to explain.

So, if 52% of those questioned would try something different, or 41% keep taking supplements it is a good thing. Then, I think the dinosaurs of the AMA and mainstream medicine should get going and read up on some of the proven studies, get a second opinion from me or take some of my classes.

Media pollsters can do the same.

52% Would Try Alternatives Over Chemo
MSNBC, 9 August, 07

Would you be willing to try alternative medicine for a serious health condition?
*3637 responses

Yes, I'd try an alternative therapy before undergoing something proven but unhealthy, such as chemo.
52%

I might supplement my doctor's suggested treatment with natural medicine.
33%

No. I'm sticking to what the medical community has found to be tried and true.
9.6%

I'm not sure.
5.3%

Do you take dietary supplements, including herbs and vitamins?
*8457 responses

Regularly
84%

Occasionally
8.8%

No
7.7%

Will the FDA's new manufacturing standards for supplements change your mind on the products?
* 8420 responses

Yes. At least now I'll know they contain what they promise and aren't contaminated with something scary.
45%

No. I already trust the supplements I take, so this won't make a difference to me.
41%

No. Makers of these products still don't have to prove they do any good. I'll keep steering clear.
6.3%

I'm not sure.
7.8%
http://www.msnbc.msn.com/id/19371372/

More Junque Science

The first question I have to pose is, "Who paid for this study?"

The second issue is the one that perhaps is much more important, stomach cancer.

It may be considered 'safe' to use these very mas marketed drugs if you have a concern for the health of your heart. And it may not, over longterm use. Of course no one is telling.

And what else they are not telling you, is something very important, and something we've addressed in other posts on this BLOG.

Nexium and Prilosec block what is called the P450 Cytochrome Pathway.

The P450 Cytochrome Pathway is critical to detoxification physiology that occurs in your liver.

When you use these drugs consistently your body incurs a risk of severe toxicity and the degelopment of stomach cancer, or cancers in corresponding organs such as the liver, pancreas, et al.

Now, when you have 'heartburn' one of the reasons is that you have TOO LITTLE hydrochloric acid in your stomach and you don't digest protein very well. Another is that you do not chew your food thoroughly, because, in case you did not know, digestion starts in the mouth.

It's that gulp and go process that dogs do all the time, but they are geared up for it by their physiology.

Another concern, especially if you are very, very young or over 35, is that you do not have adequate digestive enzymes to help you with proper digestion and assimilation of nutrients.

Then you could try a teaspoon of raw organic apple cider vinegar in a glass of water about 15 minutes before you eat, or a lick of celtic or Nine Times Taoist salt.

20 mg Prilosec Rx costs $360.97, active ingredients cost $0.52, profit is 69,417%.

And for your additional consideration -

Long term side effect of stomach acid blockers such as Pepcid, Tagamet, Zantac, Prilosec.
Potentially harmful acidity develops in the tissues of the body when the system's ability to eliminate the acids that are produced (metabolic waste, acid forming foods, and the system's various stress mechanisms) is reduced. The stomach is one of the primary venting mechanisms for this build up of hydrogen ions (acids are typified by an abundance of such ions) and when our stomach's acid producing mechanisms are pharmaceutically inhibited, the hydrogen ion concentrations become too abundant to be efficiently eliminated by other pathways of elimination. Consequently, the acids build up in the tissues and fluid compartments of the body, where they greatly interfere with the normal cellular functions. The overly acidic condition of the intercellular fluid compartment makes it an ideal breeding ground for harmful micro-organisms, creating an enormous burden on the immune system. This build-up can lead to fatigue, poor mental and emotional health and eventual chronic degenerative illness.

Stomach Acid Suppression and Increased Risk of Pneumonia -
The normal acidity of the stomach via hydrochloric acid production acts as a natural protective barrier against bacteria and viruses. Apparently, chronic use of acid suppressing medications increases risk for pneumonia. Normally the gastric pH is below 4, an environment that kills most pathogens. However, the dispensing of antacids can interfere with this natural barrier and lead to increased colonization of ingested pathogens.
Risk of Community-Acquired Pneumonia and Use of Gastric Acid-Suppressive Drugs. Laheij, RJF, et al. JAMA 292,16, 2004

Nutrient Depletion caused by acid blocking drugs -
Lansoprazole: 1) Omeprazole, a drug closely related to lansoprazole, taken for seven days led to a near-total loss of stomach acid in healthy people and interfered with the absorption of a single administration of 120 mg of beta-carotene.1 It is unknown whether repeated administration of beta-carotene would overcome this problem or if absorption of carotenoids from food would be impaired. Persons taking omeprazole and related acid-blocking drugs for long periods may want to have carotenoid blood levels checked, eat plenty of fruits and vegetables, and consider supplementing with carotenoids. 2) Folic acid is needed by the body to utilize vitamin B12. Antacids, including lansoprazole, inhibit folic acid absorption.2 People taking antacids are advised to supplement with folic acid. 3) Omeprazole, a drug closely related to lansoprazole, has interfered with the absorption of vitamin B12 from food (though not supplements) in some,3 4 but not all, studies.5 6 This interaction has not yet been reported with lansoprazole. However, a fall in vitamin B12 status may result from decreased stomach acid caused by acid blocking drugs, including lansoprazole.

Omeprazole: 1) Folic acid is needed by the body to utilize vitamin B12. Antacids, including omeprazole, inhibit folic acid absorption.1 People taking antacids are advised to supplement with folic acid. 2) Omeprazole interferes with the absorption of vitamin B12 from food (though not from supplements) in some2 3 4 5 but not all6 7 studies. A true deficiency state, resulting in vitamin B12-deficiency anemia, has only been reported in one case.8 The fall in vitamin B12 status may result from the decrease in stomach acid required for vitamin B12 absorption from food caused by the drug. This problem may possibly be averted by drinking acidic juices when eating foods containing vitamin B12. However, all people taking omeprazole need to either supplement with vitamin B12 or have their vitamin B12 status checked on a yearly basis. Even relatively small amounts of vitamin B12 such as 10–50 mcg per day, are likely to protect against drug induced vitamin depletion.

Our advice - ask what the risks are versus benefit before you accept a drug.

Ask what options are available, starting with sound nutrition and lifestyle changes.

FDA: Heartburn drugs seem OK for heart

9 August 2007

The popular heartburn drugs Prilosec and Nexium don't appear to spur heart problems, say preliminary U.S. and Canadian probes announced Thursday.

The Food and Drug Administration and its Canadian counterpart began reviewing the drugs, used by tens of millions of people, back in May, when manufacturer AstraZeneca provided them an early analysis of two small studies that suggested the possibility of a risk.

Those studies compared treating the chronic heartburn known as gastroesophageal reflux disease, or GERD, with either of the two drugs or with surgery, and tracked patients for five to 14 years. The company's initial analysis counted more patients treated with drugs who had had heart attacks, heart failure or heart-related sudden death.

The FDA followed up on those studies, and found that they seemed skewed: Patients who underwent surgery were younger and healthier than those treated by drugs, suggesting the heart link was a coincidence.

While the studies' designs make safety assessments difficult, many of the participants who developed heart problems had risk factors before starting the drugs, Health Canada said Thursday.

The FDA then looked at 14 additional studies of the drugs, and found no evidence of heart risks. In fact, in a few studies where patients received either medication or a dummy pill, those who took the heartburn drugs actually had a lower incidence of heart problems.

The FDA plans to complete its probe within three months, but issued a public notice Thursday that it "does not believe that health care providers or patients should change either their prescribing practices or their use of these products at this time."

Health Canada reached the same initial conclusion. It also urged doctors and patients to make no changes until its own probe is finished by year's end, noting that untreated GERD can lead to serious complications.

The drugs are among a family of acid-reducers known as proton pump inhibitors. FDA's Dr. Paul Seligman said Thursday that while the agency's focus is on Nexium and Prilosec, it is "interested in the data from all similar products" as it looks for all available evidence to settle the heart question.

Nexium is the world's No. 2 selling drug, with 2006 sales of $6.7 billion, according to health care research firm IMS Health.

More on Natural Cancer Therapies

Dr Tullio Simoncini believes that cancer doesn’t depend on mysterious causes (genetic, immunological or auto immunological) as the official oncology proposes, but it comes down from a simple fungal infection, whose destroying power in the deep tissues is actually under estimated.

His Premise -

The present work is based on the conviction, supported by many years of observations, comparisons and experiences, that the necessary and sufficient cause of the tumour is to be sought in the vast world of the fungi, the most adaptable, aggressive and evolved micro-organisms known in nature.

I have tried many times to explain this theory to leading institutions involved in cancer issues (the Ministry of Health, the Italian Medical Oncological Association, etc.) elaborating on my thinking, but I have been brushed aside because of the impossibility of setting my idea in a conventional context.

A different, international audience represents the possibility of sharing a view about health, which differs, from what is widely accepted by today's medical community, either officially or from the sidelines.

There is an opposition between the allopathic and the Hippocratic medical ideal. The former has the disadvantage of its inability to consider the individual as a whole. Therefore it brings with it all the distortions and aberrations which such a point of view entails (excessive specialisation, therapeutic aggressiveness, superficiality, harmfulness etc.). The latter approach instead tends in the direction of being too generic, non-scientific, and devoid of therapeutic incisiveness.

The position that I promote represents instead a meeting point of these two conceptions of health, since, from the conceptual point of view, it sublimates and adds value to both, while highlighting how they both are victims of a common conformist language.

The hypothesis of a fungal aetiology in chronic-degenerative illness, able to connect the ethical qualities of the individual with the development of specific pathologies, reconciles the two orientations (allopathic and holistic) of medicine. The hypothesis is a strong candidate for being that missing element of psychosomatics that has been sought but never found by one of the fathers of psychosomatics, Wiktor Von Weiszäcker.

In considering the biological dimensions of the fungi, for instance, it is possible to compare the different degrees of pathogenicity in relation to the condition of organs, tissues and cells of a guest organism, which in turn also and especially depend on the behaviour of the individual.

Each time the recuperative abilities of a known psycho-physic structure are exceeded, there is an inevitable exposure, even considering possible accidental cofounders, to the aggression -- even at the smallest dimensions -- of those external agents that otherwise would be harmless.

In the presence of an indubitable connection between patient morale and disease it is no longer legitimate to separate the two domains (allopathic and naturopathic) which are both indispensable for improving the health of individuals.

The Platonic separation of the human mind from the human body, responsible for the present mechanistic and materialistic character of today's medicine, is outdated. So is the pessimistic Kantian position concerning integration of the rational and emotional sides of man ("the starred sky above me, the moral law within me"), which generates the present myopia of today's medical epistemology. With such outdated cognitive frameworks inevitably come all the mindsets that carry similar restrictive and limiting presuppositions.

There's More to IVC for Cancer Than Doctors Admit

Biochemical individuality based nutritional therapy is the core of health. I work from this model every day and see great results. I too wish more people had this knowledge and therapy available to them. I also with that more medical people would open their minds to this process.

Dr. Gayle

INTRAVENOUS VITAMIN C and CANCER, from the orthomolecular perspective

"...it takes much more than logic and clear-cut demonstrations to overcome the inertia and dogma of established thought." — Irving Stone

Irving Stone was an early thinker and writer about vitamin C (its scientific name is ascorbic acid). He knew it would be an uphill battle to change the way the medical profession viewed vitamin C. While most doctors accept that scurvy is a vitamin C deficiency illness, few have made the rather humongous jump to seeing high dose intravenous vitamin C as a major player in the management of cancer.

There is actually a wide spectrum of medical uses for vitamin C. Evidence exists documenting it as the best antiviral agent now available ... IF used at the proper dose. Vitamin C can neutralize and eliminate a wide range of toxins. Vitamin C will enhance host resistance, greatly augmenting the immune system's ability to neutralize bacterial and fungal infections. Now the National Institutes of Health has published evidence demonstrating vitamin C's anti-cancer properties. With so many medical benefits, why do so few doctors know of them?

One explanation stems from ascorbic acid's designation as a "vitamin." Consider Dorland's Illustrated Medical Dictionary's definition of vitamin: A general term for a number of unrelated organic substances that occur in many foods in small amounts that are necessary in trace amounts for the normal metabolic functioning of the body. As a vitamin, only a minuscule 60 mg of ascorbic acid is needed to prevent the emergence of scurvy symptoms. As a medical treatment for cancer and life-threatening infections and toxic exposures, tens of thousands of milligrams of ascorbic acid must be administered, often by the intravenous (IV) as well as the oral route.

The Center's founder, Dr. Hugh Riordan, was a true scientist who believed in the power of scientific measurement over dogma. With the establishment of The Center in 1975, he routinely checked plasma vitamin C levels in chronically ill patients. He found these sick patients to be consistently low in their plasma C levels. Interestingly enough, the cancer patients he was seeing had VERY LOW vitamin C reserves. This matched scientific literature documenting low vitamin C levels in cancer patients. Cancer cells were actively taking up vitamin C in a way that depleted tissue reserves of C.

PET scans are commonly ordered by oncologists to evaluate their cancer patients for metastases (cancer spread to other organs). What is actually injected into the patient at the start of the scan is radioactive glucose. Cancer cells are anaerobic obligates, which means they depend upon glucose as their primary source of metabolic fuel. Cancer cells employ transport mechanisms called glucose transporters to actively pull in glucose.

In the vast majority of animals, vitamin C is synthesized from glucose in only four metabolic steps. Hence, the molecular shape of vitamin C is remarkably similar to glucose. (Figure 1) Cancer cells will actively transport vitamin C into themselves, possibly because they mistake it for glucose. Another plausible explanation is that they are using the vitamin C as an antioxidant. Regardless, the vitamin C accumulates in cancer cells.

If large amounts of vitamin C are presented to cancer cells, large amounts will be absorbed. In these unusually large concentrations, the antioxidant vitamin C will start behaving as a pro-oxidant as it interacts with intracellular copper and iron. This chemical interaction produces small amounts of hydrogen peroxide.

Because cancer cells are relatively low in an intracellular anti-oxidant enzyme called catalase, the high dose vitamin C induction of peroxide will continue to build up until it eventually lyses the cancer cell from the inside out! This effectively makes high dose IVC a non-toxic chemotherapeutic agent that can be given in conjunction with conventional cancer treatments. Based on the work of several vitamin C pioneers before him, Dr. Riordan was able to prove that vitamin C was selectively toxic to cancer cells if given intravenously. This research was recently reproduced and published by Dr. Mark Levine at the National Institutes of Health.

As feared by many oncologists, small doses may actually help the cancer cells because small amounts of vitamin C may help the cancer cells arm themselves against the free-radical induced damage caused by chemotherapy and radiation. Only markedly higher doses of vitamin C will selectively build up as peroxide in the cancer cells to the point of acting in a manner similar to chemotherapy. These tumor-toxic dosages can only be obtained by intravenous administration.

Over a span of 15 years of vitamin C research, Dr. Riordan's RECNAC (cancer spelled backwards) research team generated 20 published papers on vitamin C and cancer. RECNAC even inspired its second cancer research institute, known as RECNAC II, at the University of Puerto Rico. This group recently published an excellent paper in Integrative Cancer Therapies, titled "Orthomolecular Oncology Review: Ascorbic Acid and Cancer 25 Years Later." RECNAC data has shown that vitamin C is toxic to tumor cells without sacrificing the performance of chemotherapy.

Intravenous vitamin C also does more than just kill cancer cells. It boosts immunity. It can stimulate collagen formation to help the body wall off the tumor. It inhibits hyaluronidase, an enzyme that tumors use to metastasize and invade other organs throughout the body. It induces apoptosis to help program cancer cells into dying early. It corrects the almost universal scurvy in cancer patients. Cancer patients are tired, listless, bruise easily, and have a poor appetite. They don't sleep well and have a low threshold for pain. This adds up to a very classic picture of scurvy that generally goes unrecognized by their conventional physicians.

When Center cancer patients receive IVC, they report that their pain level goes down, and that they are better able to tolerate their chemotherapy. They bounce back quicker since the IVC reduces the toxicity of the chemotherapy and radiation without compromising their cancer cell killing effects. IVC is complementary to oncologic care. IVC is not "either/or" - it's a good "both/and" proposition. IVC can help cancer patients withstand the effects of their traditional therapies, heal faster, be more resilient to infection, develop a better appetite, and remain more active overall. These things promote a better response to their cancer therapy.

IVC has been used for three decades here at The Center. There have been no serious complications, but there are a couple of potential complications that need to be screened for. Because vitamin C enhances iron absorption, iron overload must be ruled out. The high sodium load of IVC can create a fluid overload in a patient with congestive heart failure, renal insufficiency or failure. We also check our patients for G6PD deficiency (an enzyme used to maintain stability of the red blood cell membranes). Although many physicians worry that large doses of vitamin C may cause kidney stones, we have rarely seen the phenomenon, and several huge clinical trials in the medical literature refute this misconception.

To summarize, most organisms make their own vitamin C. When they are under stress, either by illness or injury, Mother Nature has provided them with a means to facilitate healing: they synthesize more ascorbic acid. As a result, they are in less pain, they remain active, they can sleep, and they have a better appetite: all functions which promote healing.

Dr. Riordan once said that here at The Center, we don't treat cancer... we treat people who happen to have cancer. IVC is a tool that allows our Center physicians to harness a healing mechanism that our human ancestors lost long ago: the ability to dramatically increase tissue levels of vitamin C. Research shows that the astonishingly high levels achievable only by IVC not only help fight the risk of infection and the pain of metastases, they actually aid in the defeat of the cancer cells themselves, through a very elegant mechanism that does no harm to healthy cells. It's a discovery that the medical world is only beginning to discover.

Ron Hunninghake, M.D.,
Chief Medical Officer, Olive W. Garvey Center for Healing Arts

About Loss

Our deepest sympathy goes out to the families of those lost in the Minnesota bridge tragedy.

These same sentiments go daily to those lost in the terrible conflict in the mid-east, loved ones and families...

May peace be with you all.

Here's What's Up

The people's hero, David Graham, MD, a drug safety officer at the F.D.A., called for Avandia’s withdrawal. Dr. Graham estimated that its toxic effects on the heart had caused as many as 205,000 heart attacks, strokes and death from 1999 to 2006. For every month that Avandia is sold, he said, another 1,600 to 2,200 patients are likely to suffer from heart attacks and strokes, some of them fatal.

Meanwhile, back at 'the ranch'- depending on whether you define this as the Oval Office which benefits from millions in Pharma Cartel money, the new 'faster track' fast-track drug approval for money scheme, thousands paid in lobbying efforts to senators and representatives to pass the recent drug bill originally brought to you by Teddy Kennedy, or the failure to pass a Medicare drug bill allowing price negotiation (a Bush giveaway) - the people have been had. Especially any one with diabetes.

We reported over four years ago to all the people with diabetes on our news service alert plan the cardiac risks of Avandia. Readers of our most recent newsletter learned more.

This is not unlike how more than fifteen years ago we began warning women NOT to submit to mammography because it DOES cause cancer. Today you read this same news again because someone did a new study. yet when do you see that there has been a change to thermography or ultrasound for diagnosis in all these years. You don't. And you don't because of the $$$.

We agree with Dr. Graham. In the mean time, so should you.

We also agree that everyone should force this issue with their elected officials, especially if they are ones who voted for this FDA bill (see a recent post about being screwed by Congress). And we strongly agree that there should be NO drug on the market with any serious health risk as a side effect. For the FDA, to do less is unconscionable.

Read here about drugs: http://Rxlist.com (skip the patient information, because that's just fluff).

And if you want to know healthful and safe approaches to prevent and care for diabetes, let us know. The VA has proven it is reversible, so the facts are in.

There is help for Type I too.

Advisers: Avandia should stay on market

By ANDREW BRIDGES, Associated Press Writer Mon Jul 30, 6:41 PM ET

The widely used diabetes drug Avandia should remain on the market, government health advisers overwhelmingly recommended Monday, saying evidence of an increased risk of heart attack doesn't merit removal.

The nonbinding recommendation to the Food and Drug Administration came on a 22-1 vote by the panel.

"We're being asked today to take a very draconian action based on studies that have very significant weaknesses and are inadequate for us to make that kind of decision," said Rebecca Killion, a diabetic from Bowie, Md., and the panel's patient representative.

However, in an earlier 20-3 vote, the panelists said that available data show the drug does increase heart risks.

Panelists said the drug's label should include a so-called "black-box" warning, the most severe the FDA can require, to flag that risk. Some suggested the label caution against using the drug together with insulin because doing so may elevate heart risks. That joint use is currently FDA-approved. The experts also asked that the drug be studied further.

The FDA isn't required to follow the advice of its advisory committees but usually does.

The manufacturer, GlaxoSmithKline PLC, earlier recommended continuing long-term studies of the drug and updating the label to inform doctors and patients of what's known so far about any heart risks. FDA scientist Dr. David Graham said waiting for more results could subject as many as 2,200 people a month to serious side effects from the drug.

Graham also told the joint panel of experts that the drug's heart risks, combined with its lack of unique short-term benefits in helping diabetics control blood sugar, meant continued sales were not justified.

But Glaxo contended there is no increased risk, citing its own analyses of studies of Avandia, also called rosiglitazone.

"The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence rosiglitazone is different from any other oral antidiabetes agents," said Dr. Ronald Krall, the company's senior vice president and chief medical officer.

Previously, the FDA had said information from dozens of studies pointed to an increased risk of heart attack.

That conclusion swayed the panel but apparently did not rise to the level of requiring any regulatory action more dire than beefed-up warnings and continued scrutiny.

"It's suggestive but by no means conclusive," said Dr. Thomas Pickering, an assistant professor of medicine at Columbia University Medical Center.

The lone dissenting panel member on the main vote, Arthur Levin, said there was a strong suggestion of a safety signal. That, along with widely shared doubts that further study would settle the issue and the enormity of the potential risk to the public health, moved him to vote "no."

"I logically can't find any way to leave this drug on the market," said Levin, director of the Center for Medical Consumers in New York.

About 1 million Americans with Type 2 diabetes use Avandia to control blood sugar by increasing the body's sensitivity to insulin. That sort of treatment has long been presumed to lessen the heart risks already associated with the disease, which is linked to obesity. News that Avandia might actually increase those risks would represent a "serious limitation" of the drug's benefit, according to the FDA.

Graham's boss, Dr. Gerald Dal Pan, also said the balance between the risks and benefits of Avandia didn't favor the drug. But the FDA isn't of one mind on the drug: the issue exposed a rift between agency officials charged with approving new medicines and those who monitor their safety once on the market.

"It is important that the committee understand there is a fundamental disagreement within (the FDA's drugs office) on the scientific conclusions that should be drawn," said Dr. Robert Meyer, head of the FDA office that reviews new diabetes drugs.

The FDA moved up the date of Monday's meeting after the May publication of a study in The New England Journal of Medicine that generated new concerns about Avandia's safety. The analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.

Separately, the FDA is working to add so-called "black box" warnings to the labels of both Avandia and a second oral diabetes drug, Actos, to caution patients about the increased risk of heart failure associated with the drugs. That risk is separate from those discussed Monday.

The diabetes epidemic affects more than 18 million Americans. Most have Type 2, where the body makes too little insulin or cannot use what it does produce.

Each day, there are 4,100 new cases of diabetes in the United States, and 810 deaths, said Dr. Robert Ratner, vice president of medical affairs at the MedStar Research Institute. Of those deaths, 60 percent are due to heart disease, Ratner told the panel.

Congress has pointed to Avandia as evidence of FDA's fumbling of safety problems that emerge long after drugs win agency approval. The House and Senate are at work on legislation to overhaul the FDA.
___

On the Net:
http://www.nytimes.com/2007/07/30/health/30cnd-avandia.html?ei=5090&en=99cebe0695132539&ex=1343448000&adxnnl=1&partner=rssuserland&emc=rss&adxnnlx=1185915836-9+YCcKa2QolwI3fgltYfOA&pagewanted=print
Avandia: http://www.avandia.com/
Food and Drug Administration: http://www.fda.gov/

July 30, 2007
F.D.A. Panel Votes to Keep Diabetes Drug on Market
By GARDINER HARRIS

GAITHERSBURG, Md., July 30 — A federal drug advisory committee voted 20 to 3 late this afternoon that Avandia, a controversial diabetes drug made by GlaxoSmithKline, raises the risks of heart attacks, but it then voted 22 to 1 that the drug should nonetheless remain on the market.

The divided vote came after committee members said that studies concerning Avandia were too murky to merit drastic regulatory action and that other diabetes medicines might have similar risks.

“My feeling here is that we’re being asked to take a very draconian action based on studies that are very inadequate for us to make that kind of decision,” said Rebecca Killion, a patient representative and committee member from Bowie, Md.

Dr. Clifford J. Rosen, chairman of the committee who is from St. Joseph Hospital in Bangor, Me., said after the meeting that “there was enough concern on the advisory committee that virtually everybody felt there was risk” of heart attacks from taking Avandia.

Patients who have congestive heart failure or a history of cardiovascular disease, or those taking insulin or nitrates should not be given Avandia, Dr. Rosen said.

“There are going to be changes in the way this is promoted and certainly in how physicians use this drug,” Dr. Rosen predicted.

GlaxoSmithKline told the committee that it did not believe that Avandia increases the risks of heart attacks “and we still don’t,” said Christopher A. Viehbacher, president of the company’s American drug business, after the meeting ended.

He said that if the F.D.A. ordered a strong warning placed on Avandia’s label, some patients would take other medicines that might be more dangerous. “I don’t think it’s a slam dunk yet as to what the F.D.A. is going to do with this,” he said.

The votes came after an extraordinary meeting in which officials from the Food and Drug Administration, which brought the committee together, openly disagreed with one another about the right course to take.

Dr. David Graham, a drug safety officer at the F.D.A., called for the drug’s withdrawal and estimated that its toxic effects on the heart had caused as many as 205,000 heart attacks, strokes and death from 1999 to 2006. For every month that Avandia is sold, he said, another 1,600 to 2,200 patients are likely to suffer from heart attacks and strokes, some of them fatal.

Dr. Robert Meyer, director of the office within the F.D.A. that approved Avandia’s initial application, immediately disagreed with Dr. Graham.

“I think it’s important that the committee understand there’s a fundamental disagreement” within the agency, he said. Other diabetes drugs also have risks, Dr. Meyer said, and doctors and patients need a variety of treatment options.

Dr. Douglas C. Throckmorton, a deputy director of the F.D.A.’s center for drugs, explained at a news conference after the meeting that the split within the agency resulted from the “complexity” of the issue.

The F.D.A. usually follows the advice of its advisory committees, especially when the votes are so lopsided. Agency officials said they did not know when they would come to a decision and refused to characterize the form that any new Avandia warning might take.

The open disagreement within the F.D.A. reflects a fierce debate that has occurred among diabetes experts across the country since The New England Journal of Medicine published a study in May suggesting that Avandia increases the risks of heart attacks.

In the revelations since then, F.D.A. officials have said that GlaxoSmithKline told the agency about these risks nearly two years ago, but that because of fierce internal disagreements, the agency never warned patients about them. In Europe, regulators required that the drug’s label reflect some concerns about these risks.

The agency’s lack of action helped persuade some lawmakers to support legislation that has since passed both the House and Senate that provides the agency with more money and power to police drug safety issues. That legislation is expected to be sent to President Bush within days.

About a million patients in the United States took Avandia last year, and a nearly identical number took Actos, a similar pill made by Takeda that may be safer. Avandia’s global sales last year totaled $3.4 billion, but its sales have plunged since May.

The Avandia controversy largely revolves around whether several highly complex statistical analyses of dozens of studies show that Avandia increases the risks of heart attacks. Separate from this argument, there is considerable evidence that both Avandia and Actos worsen the condition of heart failure.

Dr. Murray Stewart, a GlaxoSmithKline vice president, said that in recent months the company has examined data from several large managed care companies in the United States that included 1.35 million patients with diabetes. The company’s analyses, he said, showed that patients who took Avandia suffered no greater risk of heart attack or death from heart problems.

The committee disagreed, with most members saying that while GlaxoSmithKline should continue to market Avandia, the F.D.A. should place strict warnings on its label.

“I also think there needs to be a stiffening of the warnings,” said Dr. Peter J. Savage, a committee member from the National Institutes of Health, echoing the comments of others.

Dr. Steven Nissen, a Cleveland Clinic cardiologist who authored the study in The New England Journal of Medicine in May, said in an interview after the hearing that he would have voted to remove Avandia from the market. But he said he was encouraged that the committee “affirmed the finding that there was an increased cardiovascular risk from the drug.”

He predicted that Avandia’s sales would plunge with the new warning.

The disagreements within the F.D.A. affected almost every aspect of the hearing. In their presentations, Dr. Graham and his boss, Dr. Gerald Dal Pan, both referred to studies that suggested that Actos is safer to the heart than Avandia. But the Actos studies have not been thoroughly reviewed by the F.D.A., and the underlying data from them were not given to committee members.

When asked why, Dr. Graham said that “we were promised that that would be done for this meeting.” Officials eventually explained that the agency did not enough resources to get the analysis done for the meeting, he said.

“So then I’m faced with a dilemma,” Dr. Graham said. “Do I keep silent about that and not breathe a word of it, or do I present it?”

Dr. John R. Teerlink, a committee member from the University of California in San Francisco, said that the agency should “either have the political will to either schedule the meeting when we had the data or not to present data that we couldn’t look at.”

The public debate about Avandia has brought about a remarkable number of independent examinations of the drug’s safety, and several researchers shared their findings with the committee during the hearing’s open public comment period.

Executives with both Tricare, a managed care company that serves active and retired military personnel, and WellPoint, a huge health insurer, said they had found no evidence in their records that patients given Avandia had suffered more heart attacks.

Dr. Sidney Wolfe of the drug safety advocacy group Public Citizen, said F.D.A. records show that Avandia has a lot more problems associated with it than just heart risks.

“If Avandia were up for approval today, based on what we know now, it would be rejected,” he said.

Multiple speakers reminded the committee that few diseases have a greater public health impact than diabetes. Each day in the United States, there are 4,100 new diabetes cases and 810 deaths from the disease, said Dr. Robert E. Ratner of the MedStar Research Institute in Washington. Also every day, about 230 diabetes patients suffer amputations, 120 suffer kidney failure and 55 go blind.

He said that while controlling blood sugar levels has proven health benefits in the short term, no study has proven that diabetes drugs extend lives.

“We’re not keeping people alive with our drug therapy because our drug therapy isn’t adequate,” he said. And he said that no diabetes medicine has conclusively proven that it helps protect the heart. He also noted that diabetes patients often fail to take their medicines properly, and that doctors often fail to treat the disease aggressively enough.

“Why do we need new therapies for type-two diabetes?” Dr. Ratner asked. “We have an epidemic of diabetes and its complication that will soon swamp our medical delivery system.”

Most diabetics die from heart disease, since the disease has severe effects on the heart. If Avandia actually increases the risks of heart attacks, that “denotes a serious limitation” of the drug’s usefulness, an F.D.A. reviewer concluded in a report before the meeting.

It's Drug Pushers and Junque Science Again...or Menstruation key to bone rebuilding

So with the mass marketing of Gardasil in timing with the push for a pill to stop your menstrual cycle, this report shows something close to normal human physiology.

Gee, maybe there is a way back to truth in labeling, or, as it were, scientific research without pre-determined outcomes.

My alarm went off with Gardasil, as readers of this BLOG well know. It also went off when the big ad campaign came out to get you to buy into how great life is without that part of being a woman that they want to deny you next.

One pill, no period.

Sounds easy, but did they forget to include in the ad all the problems you'll encounter because of the pill's nutrient depletions? Not!

And of course they probably forgot to mention that as you age, you just might be forced into a category of those swallowing TIDE.

Yes, bisphosphonates are made from by-products of laundry detergent. And, yes, they do destroy bone and increase your risk of developing esophageal cancer.

Aren't these baby boomers going to be a lucky bunch, while Merck, Pfizer, and P & G laugh all the way to the bank.

And then those natural types, like yours truly, will do what she can to educate others on the positive health benefits of menstruation.

This is also something your Taoist teacher will tell you if you listen.

Menstruation key to bone rebuilding in anorexics

Adequate nutrition can rebuild bone mass in women with anorexia, but the restoration of normal menstrual periods appears to be necessary for fully normal bone metabolism to be recovered, a new study shows.

"Our observations may be important to an understanding of the mechanism of possible reversal of osteoporosis in anorexia nervosa, for which there is as yet no effective treatment," Dr. Jennifer Dominguez of Columbia University Medical Center in New York City and her colleagues conclude.

Studies in which anorexic women have been given oral contraceptives or estrogen to help restore bone mass have had mixed results, Dominguez and her team note, while the process by which bone thinning occurs in these patients is not fully understood. Further, they add in the July issue of the American Journal of Clinical Nutrition, "the role of nutrition in the recovery of bone has been underestimated."

To better understand bone loss and rebuilding in these patients, the researchers followed 28 women with anorexia nervosa who were undergoing treatment to help regain weight, comparing them to a control group of 11 healthy young women.

After just over two months on nutrition therapy, the anorexia nervosa patients showed significant increases in bone mineral density, the researchers found. Patients' levels of the protein osteocalcin, which is secreted by bone cells and is a key marker of bone formation, also rose. But levels of N-telopeptide, a marker for bone breakdown, remained abnormally high, except among eight women who began menstruating normally after recovering 90 percent of their ideal body weight.

The average bone mineral density among women who didn't begin menstruating after treatment was lower than the bone mineral density for the women who started menstruating and the healthy controls.

The findings suggest, Dominguez and her colleagues note, that women with anorexia have normal to increased rates of bone formation, but that bone breakdown outpaces bone building, resulting in loss of bone mineral density.

"Our data suggest that nutritional therapy is critical and necessary for optimal effect of other therapies," the researchers write. These drugs include antiresorptives -- drugs that block bone breakdown - and estrogen replacement therapy. In fact, they add, such treatment may not be effective until nutritional therapy has restored normal bone formation.

SOURCE: American Journal of Clinical Nutrition, July 2007.