A study has found that exposure to mobile phone signals from a handset for just 5 minutes stimulated human cells to split in 2. This is a natural process during cell growth but is also central to the development of cancer.
The 6-year 'Mobile Telecommunications & Health Research Programme' is expected to present its final report in September. Official guidance that mobile phones were safe was based on the idea that human cells would only be damaged by heat from mobile phones. But the new evidence supports the position that mobile handsets can trigger potentially harmful cell changes without temperature changes.
Professor Rony Seger, cancer researcher at Weizmann Institute of Science in Rehovot, Israel, found cell damage after just 5 minutes of exposing cells to such radiation. He identified the production of Extracellular signal-regulated kinases (ERK1/2) - natural chemicals that stimulate cell division & growth. Cancer develops when the body is unable to prevent excessive growth & division of cells in the wrong places.
Are you worried about the safety of mobiles. www.telegraph.co.uk/news
Friday, August 31, 2007
Saturday, August 25, 2007
Magnetic fields detrimental to blood pressure
This article dates to about 2000 or before. Cell phones started appearing in 1985 depending on the country of use. Cell phone use has skyrocketed as has hypertension and other health problems.
In 2003 I presented a program to health care professionals discussing EMF as a cause of modern and mostly undiagnosable disease. With the accumulation of research on the impact of EMF and health, I still do not believe I am off course in my thinking.
Cells phones carried by doctors contribute to higher infection rates in hospital. EMF contributes to asthma because the non-ionizing redaction from cell phones attracts particulate matter, causing it to adhere to lung tissue.
Hands free gadgets used in cars create a very high amount of EMF radiation that can lead to accidents and poor driving decisions.
I recommend an air tube head set which can be purchased from CHI, as can our book, Blood Pressure Care Naturally.
In 2003 I presented a program to health care professionals discussing EMF as a cause of modern and mostly undiagnosable disease. With the accumulation of research on the impact of EMF and health, I still do not believe I am off course in my thinking.
Cells phones carried by doctors contribute to higher infection rates in hospital. EMF contributes to asthma because the non-ionizing redaction from cell phones attracts particulate matter, causing it to adhere to lung tissue.
Hands free gadgets used in cars create a very high amount of EMF radiation that can lead to accidents and poor driving decisions.
I recommend an air tube head set which can be purchased from CHI, as can our book, Blood Pressure Care Naturally.
Recent German research shows the magnetic fields emitted during phone use may be detrimental to those having high blood pressure.
LONDON --- Mobile phones, an essential accessory for millions of people, could increase blood pressure significantly, German researchers said yesterday.
In a letter in The Lancet medical journal, Dr Stephan Braune of the University Neurology Clinic in Freiburg, Germany said that radio-frequency electromagnetic fields (EMF) emitted by the telephones pumped up the blood pressure of 10 young volunteers who took part in a study.
Dr Braune and his team attached the phones to the right side of the volunteers' heads and switched them on by remote control at various intervals. they measured their heart function and blood pressure (BP) while they were standing and lying down.
They measured their heart function and blood pressure (BP) while they were standing and lying down.
There was no sound so the volunteers did not know when they were being exposed to the EMF.
The researchers found that 35 minutes fo radio-frequency EMF caused "increases in resting BP between five and 10 mm HG". An average good blood pressure is 136/75 mm HG.
The finding could have adverse effects on people sufering from high blood pressure or hypertension, an important risk factor for heart disease and stroke which are leading causes of death in most developed countries.
The researchers said the increase in blood pressure probably resulted from constriction of the arteries by the radio frequency electro-magnetic fields.
According to a report early this year in the Medical Journal of Australia, a sharp rise in the incidence of brain tumours there may be linked to the use of mobile telephones.
Cancer specialist Andrew Davidson of Fremantle Hospital in Western Australia said the state's cancer registry had revealed a 50 percent rise in the incidence of the disease in men and a 62.5 percent increase for women in the decade from 1982.
"It is conjectured that the rise in incidence is related to the use of analogue mobile phones in the late 80s," Dr Davidson wrote in a letter to the journal.
But former Telstra telecommunications scientist Bruce Hocking said that on the evidence so far, there was no proven risk of brain cancer from mobile phones or other communication devices.
Mobile telephones have been linked to a variety of health problems ranging from fatigue, headaches to burning skin, but there is still no proof that the gadgets pose any serious health risks -- REUTERS, AFP.
Author's comment: One way to minimize risks is to purchase an external ear-plug accessory for your phone.
The message is ready to be sent with the following file or link attachments:
Shortcut to: http://www.geomancy.net/resources/art/art-handphone.htm
Friday, August 24, 2007
Health Freedom: Beware of False Messengers
Please read this carefully and distribute widely if you values your right of access to health care of your choice.
For more information see these key sites as well,
pFAM Health
International Advocates for Health Freedom
Byron Richards
For more information see these key sites as well,
pFAM Health
International Advocates for Health Freedom
Byron Richards
ANH Rebuttal to NSF
The following is an email reply from our international affiliate, Alliance for Natural Health in response to another health freedom organization sending misinformation in regards to the recent win in Europe. We agree with ANH’s position of not contributing to the dissention in the health freedom community, but occasionally, such erroneous information is published that it needs a rebuttal. The following is ANH’s response to Dr. Rima Laibow/Natural Solutions Foundation email sent on Tuesday evening, August 21, 2007 regarding the recent ANH victory in Europe. To view NSF originial email blast, please click here.
eBLAST 23 AUGUST 2007
IMPORTANT HEALTH FREEDOM INFORMATION. PLEASE FORWARD VERY WIDELY
anh_logo.gifIt is unusual for the Alliance for Natural Health (ANH) to get involved in disputes between the many factions in health freedom. We are, above all, an alliance and are working hard at forging bonds and affiliations with other health freedom organisations in different parts of the world so that we, together, can be more effective in our work. In the USA we are formally affiliated with the American Association for Health Freedom and the Health Freedom Foundation (www.healthfreedom.net). Additionally, we work closely on Codex issues with the National Health Federation, which is the only health freedom organisation to have official observer status— and thus enabling it to speak—at Codex meetings.
However, a situation has arisen that forces us to clarify a deeply misleading commentary by one particular organisation, the Natural Solutions Foundation. Should such a clarification not be of interest to you, you of course need read no further.
Subscribers to the Natural Solutions Foundation e-list will have received an email from Dr Rima Laibow, the organisation’s founder, today about which we wish to provide important clarification. We feel compelled to make this clarification as Dr Laibow has, unfortunately not for the first time, seriously confused her facts.
What Dr Laibow of Natural Solutions Foundation Said
Dr Laibow opens her email with the title “Reading the Fine Print to Get It Right!”. Regrettably, however, there appear to be such fundamental misunderstandings in Dr Laibow’s email that we can only presume she has not taken her own advice. On a more serious note, Dr Laibow’s communication also serves to provide much greater confusion – the very thing she professes to help eliminate – and it begs the question of why she did not instruct her legal counsel to communicate with us before issuing such a distorted view of the actual circumstances in Europe with regard to our recent actions on food supplements.
In her mailing, Dr Laibow, described the recent clarification by the European Commission brought about by the ANH’s legal challenge and subsequent filing of dossiers on natural sources of vitamins and minerals, as a “nano victory”. To us that means she thinks it’s a small victory, but we suggest you make your own mind up, when you read the section beneath the next sub-heading. It is interesting that Dr Laibow does not refer to us directly, presumably because she is fearful that it might drive further interest towards our many and diverse health freedom activities in different parts of the world. Dr Laibow’s interpretation of the recent progress is that “natural source[s of] supplements are no longer in danger, now they are considered as foods” and she goes on to say “We agree with the basic [sic] principle: supplements are foods and therefore considered safe.” But is she confusing ‘safe to health’ from ‘safe from regulators’? Dr. Laibow also doesn’t appear to appreciate that food supplements in Europe are already regarded as a category of food, but the recent European Commission decision makes natural sources of vitamins and minerals food ingredients, which require no proof of safety before going to market, rather than food supplement ingredients (vitamins and minerals), which require evidence of proof of safety. Creating this evidence can be prohibitively expensive for many supplement companies.
Dr Laibow continues by outlining in a grossly inaccurately manner, the background to our case in the European Union (EU) - again making no mention of the name of our organisation - and even cites her endorsement of our December 2004 critique to the Food and Agriculture Organization/World Health Organization on planned Codex approaches to nutrient risk assessment. It seems that she might be looking for praise or credit, but she doesn’t seem to have realised that the document she endorsed has absolutely no link with our actions on natural sources. Dr Laibow’s signature on our 2004 document also represented the first time she became known to us, and we should point out that our Board subsequently requested that we remove her from the list of endorsees on the grounds of her lack of credibility and accuracy on Codex issues.
Dr Laibow’s fundamental misunderstanding of events in Europe appears be based on her apparent gross confusion over the differences between work we are doing, 1) help prevent a ban on ingredients such as natural sources of nutrients, and, 2) maintaining dosages of nutrients, which are at serious risk of being limited to non-therapeutic levels by flawed, scientifically irrational approaches to risk assessment and management.
What has ANH actually achieved in relation to natural sources of nutrients
The victory to which the ANH lays claim is that our strategy has caused the European Commission to agree that natural sources of vitamins and minerals will no longer need to go through a complex, often prohibitively expensive safety evaluation process conducted by the European Food Safety Authority. This was going to be required to get the ingredients on to an allowed (positive) list. However, the European Commission has accepted now that natural sources of nutrients don’t need to be processed in this way and can simply be used in the same way any food ingredient can be used. There remains a compulsion on the manufacturer that the product is safe, just in the same way that a baker needs to be sure his loaf of bread is safe. This position is actually quite different from many EU Member States’ interpretations of the requirements and is the exact opposite of a position made by the legal unit of the European Commission over a year ago (the legal unit now being a signatory of the reconsidered position).
Our press release on the European Commission’s altered position on natural sources of vitamins and minerals can be found at: http://www.alliance-natural-health.org/index.cfm?action=news&ID=288
Curdled milk or synthetic vitamins?
Dr Laibow refers to a quote from Gilbert & Sullivan’s HMS Pinafore: “Things are seldom what they seem, Skim milk masquerades as cream”. Having read her email, we would suggest that the milk has definitely curdled. Her confusion over natural and synthetic vitamins would be a clear example of ‘curdled milk.’
Dr Laibow says: “Natural source nutrients are safe, beneficial and extremely important to the health of people eating modern industrialized foods and living in a toxic world. Synthetic ingredients are not the same as natural ones, although our FDA has taken the unscientific position that they are the same.” ANH says: we agree, generally, with Dr Laibow on this one point – although one might assume that her previous psychiatry practice would have been rather dependent on synthetic vitamins, which have been a staple in the field of orthomolecular medicine. However, in the context of what’s going in Europe, the key point is that the European Commission was, until our recent action, treating natural sources of vitamins and minerals in the same way as synthetic ones. This meant you needed to prove that the ingredient was safe—often a prohibitively expensive process—before it could be used in a supplement. Now natural sources of vitamins and minerals will be treated as foods, rather than as food supplement ingredients, where it is assumed they are safe as these natural sources of nutrients have been part of our food supply for many thousands of years. In our book, this is a real win for nature, for natural health and, of course, for health freedom. We can only think that Dr Laibow perceives it as a “nano victory” because she does not fully understand the facts of the case, as suggested by her own description of products on her e-commerce site (see below).
Dr Laibow says: “As an aside, the Natural Solutions Foundation feels so strongly about this that we provide an online store, www.Organics4U.org , where you can access totally organic, all natural nutrients for yourself and those you care about.” ANH says: we have reviewed Dr Laibow’s e-commerce site and immediately viewed a host of ingredients in products which appear to be synthetic in origin, rather than natural sources. We suggest that unless Dr Laibow can substantiate that all ingredients selling on her site, such as ascorbic acid, pyridoxine hydrochloride, sodium selenite, L-arginine, thiamine hydrochloride, hydroxycobalamin, folic acid and vanadyl sulphate (to name but a few) are “all natural” and not synthetic, Dr Laibow might have to accept that she has ‘curdled the milk’ and is confused over the differences between natural sources of nutrients and synthetic nutrients.
Onwards and Upwards
We hope that this mailing helps to clarify a situation that Dr Laibow and her organisation has muddied. Dr Laibow has previously asked ANH as well as other organisations and Codex experts to make her aware of inaccuracies in what she has said or published. Despite several attempts at drawing her attention to specific examples of misinformation in her materials, she appears to have done little or nothing to rectify them. We therefore draw attention to this new incidence of inaccuracy publicly, in the hope that, in future, the Natural Solutions Foundation will begin to research its articles and speeches more carefully.
We are deeply committed to our work in helping to carve out a scientific and regulatory system that will allow for the expansion of natural health, so that it can ultimately become the rightful heir to mainstream healthcare. To this end, integrity and accuracy are two of our most important tools. On this occasion, we have felt compelled by the actions of the Natural Solutions Foundation to protect our integrity and the accuracy of information surrounding our recent legal activities on European food supplements. We also call on the health freedom community to be responsible in its outputs so that we can work together more effectively in our common goals.
In health, naturally
The ANH Core Team
Thursday, August 23, 2007
A bit more of an advisory please
This recent FDA alert is very important.
It is a bit late in my mind. The first thing I thought of when I read it several days ago was why is it an issue after-the-fact.
Where are the minds of the doctors and other controlled substance prescribers giving nursing mothers a script for this drug.
This clearly reinforces my recent correspondence to the FDA: too many prescribers are not participating in legally required informed consent explanations of the risks and benefits of drugs.
This almost smacks of an attempt to promote "bad mother" propaganda. The story line might be something like "Somnambulent mother on codeine trying to care for her nursing baby, both at risk of grave harm.
And what about the doctor? What about the pharmacist? Seems like mainstream medicine and Big Pharma are off the hook again.
CPS is probably drooling a this one.
Anyone ever hear of a hot water bottle?
It is a bit late in my mind. The first thing I thought of when I read it several days ago was why is it an issue after-the-fact.
Where are the minds of the doctors and other controlled substance prescribers giving nursing mothers a script for this drug.
This clearly reinforces my recent correspondence to the FDA: too many prescribers are not participating in legally required informed consent explanations of the risks and benefits of drugs.
This almost smacks of an attempt to promote "bad mother" propaganda. The story line might be something like "Somnambulent mother on codeine trying to care for her nursing baby, both at risk of grave harm.
And what about the doctor? What about the pharmacist? Seems like mainstream medicine and Big Pharma are off the hook again.
CPS is probably drooling a this one.
Anyone ever hear of a hot water bottle?
FDA Public Health Advisory
Use of Codeine By Some Breastfeeding Mothers May Lead To Life-Threatening Side Effects In Nursing Babies
The Food and Drug Administration (FDA) has issued a Public Health Advisory with important new information about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine. When codeine enters the body and is metabolized, it changes to morphine, which relieves pain. Nursing mothers taking codeine may also have higher morphine levels in their breast milk. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies.
More information from the FDA including Drug Information, Public Health Advisory, Questions and Answers can be found at thier web site, FDA.gov
Noise pollution and health
By any standard noise is annoying. I'd say the decibel level of city life is a bit more than I can take too much of since I live in a rural community of under 1000 people.
The other day a friend of mine near the Portland-Vancouver metro area suggested to a friend of hers driving to Pullman to visit his daughter at college. While her friend visits Cougarland, my friend would stay here.
In the conversation, he said, "There's nothing there!"
She replied, "That's why she (referring to me) lives there."
I guess noise is in the eye of the beholder.
Now today, for instance, I went to town, and as always, I am happy when I start heading home. It's the quiet you know.
No road rage for me amidst the 20,000 or so who inhabit that town about thirty minutes away.
Noise is a vibration. Its the vibration that constantly hack at your nervous system and lead to stress. The insidious, silent killer, about as deadly as diesel exhaust.
It could be today that it is deadlier because of the added stress caused by cell phones, cell towers, and wi-fi everywhere...
Pack up and head on out to the country, we have great home made pies at the cafe and real ice cream milkshakes.
And you will treasure the quiet, just like I do.
The other day a friend of mine near the Portland-Vancouver metro area suggested to a friend of hers driving to Pullman to visit his daughter at college. While her friend visits Cougarland, my friend would stay here.
In the conversation, he said, "There's nothing there!"
She replied, "That's why she (referring to me) lives there."
I guess noise is in the eye of the beholder.
Now today, for instance, I went to town, and as always, I am happy when I start heading home. It's the quiet you know.
No road rage for me amidst the 20,000 or so who inhabit that town about thirty minutes away.
Noise is a vibration. Its the vibration that constantly hack at your nervous system and lead to stress. The insidious, silent killer, about as deadly as diesel exhaust.
It could be today that it is deadlier because of the added stress caused by cell phones, cell towers, and wi-fi everywhere...
Pack up and head on out to the country, we have great home made pies at the cafe and real ice cream milkshakes.
And you will treasure the quiet, just like I do.
Noise of modern life blamed for thousands of heart deaths
· Stress of exposure adds to risks, says WHO report
· Light traffic is enough for chronic levels at night
* Alok Jha, science correspondent, The Guardian, Thursday August 23 2007
Thousands of people in Britain and around the world are dying prematurely from heart disease triggered by long-term exposure to excessive noise, according to research by the World Health Organisation. Coronary heart disease caused 101,000 deaths in the UK in 2006, and the study suggests that 3,030 of these are caused by chronic noise exposure, including to daytime traffic.
Deepak Prasher, professor of audiology at University College London, told the New Scientist magazine: "The new data provide the link showing there are earlier deaths because of noise. Until now, noise has been the Cinderella form of pollution and people haven't been aware that it has an impact on their health."
The WHO's working group on the Noise Environmental Burden on Disease began work on the health effects of noise in Europe in 2003. In addition to the heart disease link, it found that 2% of Europeans suffer severely disturbed sleep because of noise pollution and 15% can suffer severe annoyance. Chronic exposure to loud traffic noise causes 3% of tinnitus cases, in which people constantly hear a noise in their ears.
Research published in recent years has shown that noise can increase the levels of stress hormones such as cortisol, adrenaline and noradrenalin in the body, even during sleep. The longer these hormones stay in circulation around the bloodstream, the more likely they are to cause life-threatening physiological problems. High stress levels can lead to heart failure, strokes, high blood pressure and immune problems.
"All this is happening imperceptibly," said Prof Prasher. "Even when you think you are used to the noise, these physiological changes are still happening."
The WHO came to its figures by comparing households with abnormally high exposure to noise with those in quieter homes. It also studied people with problems such as coronary heart disease and tried to work out if high noise levels had been a factor in developing the condition. This data was then combined with maps showing the noisiest European cities.
According to the WHO guidelines, the noise threshold for cardiovascular problems is chronic night-time exposure of 50 decibels (dB) or above - the noise of light traffic. For sleep disturbance, the threshold is 42dB, for general annoyance it is 35dB, the sound of a whisper.
Ellen Mason, a cardiac nurse at the British Heart Foundation, said: "Our world is undoubtedly getting busier and noisier. Some people find noise pollution more stressful to live with than others do. Noise cannot directly kill us, but it may add to our stress. Occasionally, stressful events can trigger a heart attack in someone with underlying heart disease. We know that stressed people are more likely to eat unhealthily, exercise less and smoke more, and these can increase the risk of developing heart disease in the first place."
Mary Stevens, policy officer at the National Society for Clean Air, said of the study's results: "We welcome this because one of the problems with noise is that it's one of the areas that local authorities get most complaints about and it's a big draw on their resources. But, unlike air quality, it hasn't been taken that seriously policy-wise because there [wasn't] the link between noise and health."
Ms Stevens said that there were many options for reducing noise. Traffic could be quietened if more cars used low-noise tyres and councils installed low-noise road surfaces, for example. And coordinating roadworks by utility companies would also prevent the proliferation of potholes, another source of noisy traffic.
The EU has already issued a directive that obligates European cities with populations greater than 250,000 to produce digitised noise maps showing where traffic noise and volume is greatest. "[The research] all supports work going on at the moment to manage traffic noise, which is driven by the environmental noise directive," said Ms Stevens.
Skin Cream Alert
From Hippocrates Health Centre of Australia we received a report on the consequences of using Aldera cream for skin cancers, warts and genital warts, molluscum, actinic keratosis and related issues.
Aldera Side effects - http://www.rxlist.com/cgi/generic/imiquimod_ad.htm
We believe it is important to inform readers about the concerns with this product.
Aldera Side effects - http://www.rxlist.com/cgi/generic/imiquimod_ad.htm
We believe it is important to inform readers about the concerns with this product.
3M Pharmaceuticals are flogging ALDARA, a "cure" for skin cancer and genital warts, that can have cataclysmic side effects -- anaphylactic shock, irreversible autoimmune disease and even death.
The medical establishment and the media won't help -- Big Pharma are too rich and powerful. Only people power can stop 3M and the other multinationals in their greedy quest to dominate our fragile planet. Please help us spread the word. Click here for the truth about Aldara and send to everyone you know.
Asia urged to use vitamins and minerals to battle malnutrition
From the Flour Fortification Initiative (FFI)
"Malnutrition can cost the global economy between 180 to 250 billion dollars in healthcare costs over the next decade, the group said."
And at the same time the US FDA, Canadian Health Protection Board and other similar agencies are acting to block your access to vitamins and minerals that do protect your health.
I wonder what the cost in the US is from the nutritional deficiencies caused by prescription drugs?
Maybe you should wonder too...
"Malnutrition can cost the global economy between 180 to 250 billion dollars in healthcare costs over the next decade, the group said."
And at the same time the US FDA, Canadian Health Protection Board and other similar agencies are acting to block your access to vitamins and minerals that do protect your health.
I wonder what the cost in the US is from the nutritional deficiencies caused by prescription drugs?
Maybe you should wonder too...
Wednesday, August 22, 2007
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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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.)
Next: Risperdal - Overdosage & Contraindications »
« Previous: Risperdal - Side Effects & Drug Interactions
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.
Tuesday, August 21, 2007
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.
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!
Monday, August 20, 2007
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.
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.
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.
Saturday, August 18, 2007
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".
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".
Friday, August 17, 2007
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.
"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
Monday, August 13, 2007
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.
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.
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.
Saturday, August 11, 2007
More Folly
With flu season gearing up for another frivolus PR campaign, watch that trap that goes for the jab!
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!
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!
Friday, August 10, 2007
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.
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/
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