Wednesday, September 27, 2006

Don't get caught in an endless loop!

I always heard the words that we should care of our health, that we should give up harmful habits to be in good health and live for a long time. But I had a lot of examples when people who did not follow advices of doctors and healthy life-style lived longer and happier than those who tried to keep special diets, go in for sport, eat vitamins and escape smoking…. So I thought that the reason for it could be auto-suggestion, and if a person visits doctor often he will discover more and more new diseases at which he will be thinking all the time and developing dismal mood.. And on the contrary when the person doesnt think about his disease he pays attention to other things and enjoys life as it is… So does it mean that we shouldnt think of our health and live not following health laws and be sure that nothing can be wrong? Not exactly…There must be a golden mean…. I started trying answering this question and understood that the following compromise may be found: a person should have as many health habits as it is necessary to have successful auto-suggestion and then if you are sure in your health you will not have to visit doctors too often and will live for a long time!

Author: Kate Anson

Wednesday, September 20, 2006

The Truth About Cholesterol

THE TRUTH ABOUT CHOLESTEROL

http://www.newswithviews.com/Howenstine/james23.htm
By Dr. James Howenstine, MD.
February 20, 2005 NewsWithViews.com


Cholesterol is not really the villain portrayed in the pharmaceutical ads. It is actually a vital substance needed in every cell of the body as it is the chemical precursor from which the body produces bile acids, provitamin D3, male and female sex hormones, and adrenal hormones (hydrocortisone and aldosterone that regulates sodium and potassium balance). Cholesterol is needed to construct the important membranes which surround cells.

The body is able to manufacture cholesterol but is unable to destroy this substance. Cholesterol is removed from the body combined with bile acids. This removal is increased by dietary fiber and diminished in the absence of dietary fiber. Up to 94% of cholesterol and bile acids are reabsorbed and reused when dietary fiber is lacking.[1] This is one reason that low fiber diets may increase blood cholesterol levels.

The body can make cholesterol whether there is any cholesterol in the diet or not. By removing all cholesterol from the diet, the blood cholesterol will only fall by about 20% to 25%.

Cholesterol is dissolved and kept in solution as a flowing liquid when there are adequate amounts of essential fatty acids. The melting point of cholesterol, where it would deposit on artery walls, is 300 degrees F. When lecithin is present, the melting point of cholesterol falls to 180 degrees where it is still insoluble. However, when the essential fatty acids linoleic and linolenic are present in sufficient quantity, the melting point of cholesterol falls to 32 degrees which is below normal body temperature. Even in the presence of an arterial injury, cholesterol will have a more difficult time depositing with fibrin and platelets on an injured artery surface because the essential fatty acids have made the blood more fluid.

After gazing at a television advertisement depicting an attractive young woman collapse on the street with a heart attack because her cholesterol was 280 mg. % you would certainly be justified in having considerable fear if your cholesterol is elevated. Massive amounts of money are being spent by pharmaceutical firms on advertisements to convince the public that their lives are in great danger if their cholesterol levels are high.

These firms have gained nearly total control over the curriculums taught in medical schools, the articles published in medical journals and who receives research grants and what they are going to be allowed to study in these grants. This control over research expenditures prevents research that might lead to cures of serious diseases (cancer, schizophrenia, HIV, Alzheimer's Disease). Conventional medical therapy uses drugs which generally have no ability to cure these diseases. Persons thinking outside the box who might discover information that would disturb the current pharmaceutical dogma about diseases will experience considerable difficulty getting funds.

Of great importance the pharmaceutical industry has established the precedent with the state boards of medical license that any therapies that do not use pharmaceutical drugs are quackery which is dangerous to the public and should be suppressed. This pressure to conform to pharmaceutical drug use has caused great personal anguish and financial loss to many innovative physicians who have dared to treat patients with alternative therapies that do cure patients. Often these physicians must spend large amounts of money defending themselves from attempts to remove their licenses.

The current dogmas about treating cholesterol are formulated by a committee named National Cholesterol Education Program NCEP. This committee is a part of the National Institute of Health within the National Heart, Lung and Blood Institute.

Their most recent recommendations (2004) included more aggressive efforts to lower blood cholesterol. The lower limit of safety for LDL cholesterol was lowered from 130 mg. to 100 mg. Cholesterol lowering drugs were recommended for all diabetics and elderly patients with high cholesterol levels. If implemented, these recommendations would add about 4,000,000 persons to the multitudes already taking statin drugs. (What a bonanza for drug company profits). Six out of the nine members[2] of the NCEP making these new recommendations are affiliated with the drug companies that manufacture statin drugs. Do you think this is a coincidence?

This 2004 call for the "aggressive and increased use of statin medication to treat high blood cholesterol values" would not be alarming if there would actually be many lives saved by these new recommendations. The disturbing part of this information is that there is little credible scientific information to support these changes and there is a large amount of valid scientific information suggesting that many persons taking statin drugs are suffering serious even fatal side effects. Obviously increasing the number of persons taking statin drugs would greatly increase the number of patients being injured by these drugs.

Two years ago Dr. Julian Whitaker proposed to the FDA that the package insert supplied with a statin drug contain information that statin drugs decrease the levels of the critical nutrient CoQ 10 in patients. He wisely suggested. that all patients taking statin drugs should also be taking 100 to 200 mg. of CoQ 10 daily to avoid complications (heart failure, muscle breakdown with potentially fatal kidney failure {myoglobulinuria}, muscle weakness, peripheral neuritis, transient global amnesia etc.) The FDA ignored Dr. Whitaker's suggestion because admitting that there was a danger from statin drugs, even if true, might hurt the sales of statin drugs.

Cholesterol Is Not A Major Cause Of Arterial Disease

Several factors appear to be of greater importance than cholesterol in causing arterial disease. Among these are deposition of toxic metals in the lining endothelium of arteries, Vitamin C deficiency, excessive amounts of lipoprotein (a), inflammation in arteries, excessive clotting of blood, homocysteine elevation (hyperhomocystinemia) and dangerous foods.

An important study by Dr. Harlan Krumholz revealed that persons with low cholesterol levels over the age of 70 died twice as often from heart attacks[3] as older persons with high cholesterol values. Most studies in old persons have shown that cholesterol is not a risk factor for coronary artery disease. Approximately 90 % of cardiovascular disease is seen in persons over 60 years of age. Almost all studies have shown that high cholesterol is not a risk factor for women.[4] This leaves cholesterol as a risk factor for less than 5 % of those persons dying of a heart attack.

High cholesterol values protect against infection. In a review of 19 studies involving 68,000 persons low cholesterol values revealed an increased risk for dying from lung and gastrointestinal diseases. Both lung and g.i. diseases are often related to infections. This information was confirmed by a 15 year study of 100,000 healthy persons in the San Francisco area. Persons entering this study with low cholesterol values were more often admitted to hospitals because of infectious diseases.[5] Patients with a history of a sexually transmitted disease or liver disease were twice as likely to develop HIV infection[6] over 7 to 8 year follow up if they had a low cholesterol value when entering the study.

Patients with severe heart failure have high levels of endotoxins and cytokines in their blood. Endotoxins are toxic substances derived from gram negative bacteria. Cytokines are hormones secreted from white blood cells responding to an inflammatory process in the body. A medical team in Germany learned that the strongest predictor for death in a patient with heart failure was the concentration of cytokines[7] in the blood. They felt that bacteria in the gut found it easier to penetrate tissues when the pressure in abdominal veins was elevated by heart failure. Endotoxins were highest in patients with edema and endotoxin levels fell significantly when heart failure improved with therapy. Patients with heart failure whose immune function is unable to respond to bacterial antigens (anergy) had a higher mortality than patients who still responded to bacterial antigens. In addition the mortality was higher in those patients who had the lowest cholesterol, LDL, and triglyceride values. The risk of dying in a group of 1000 patients with heart failure followed for 5 years was 62 % in patients whose cholesterol was below 129 mg/dl. whereas patients whose cholesterol was over 223 mg./dl had only one half this risk of death.

When arteries are examined visually, by xrays or ultrasound there has never been any correlation between changes in cholesterol values and the extent of arteriosclerosis.

Why Metal Deposition In Artery Linings (Endothelium) Is So Important

After more than 30 years of use intravenous chelation therapy (EDTA) has become an accepted form of therapy because it has been found to be an effective, safe relatively inexpensive way to reverse occluded arteries to the heart, brain, kidneys and extremities. Chelation is known to have powerful anti-oxidant effects but this may not afford a complete explanation for the benefits observed.

An important new concept about chelation relates to the inner lining of blood vessels (endothelium). This lining tissue generates the powerful arterial vessel dilator nitric oxide. The endothelium also produces prostacyclin which decreases the clotting of blood and also causes dilating of arteries. A third important endothelial product is heparin, a potent substance that helps prevent clots from forming. Excessive deposition of heavy metals in the endothelium diminishes the endothelium's ability to produce nitric oxide, prostacyclin, and heparin.[8] Chelation may restore the body's ability to create these important substances by removing these metals (iron, cadmium, lead, mercury) from the endothelial lining. Additionally removal of excess iron can decrease the risk of subsequent heart attacks.[9] By improving blood circulation, chelation may benefit patients with angina pectoris, claudication, impotence, macular degeneration, glaucoma, pancreatitis, gout, rheumatoid and osteoarthritis, chronic fatigue syndrome, fibromyalgia, dementia, multiple sclerosis, and cancer. Several of the pioneers in chelation therapy are alive in good health in their 90's after receiving thousands of intravenous chelation treatments.

The latest improvement in chelation permits this therapy to be adminstered orally. Oral chealtion obviously will not be as fast as intravenous chelation but this is not an important issue for most patients who have massive amounts of metals needing removal. Doing chelation orally is simpler and less expensive than the intravenous approach.

Lead poisons enzyme systems in the body. The bones of modern man contain 1000 times more lead[10] than the bones of men living 400 years ago. It takes 7 to 20 years for the body to completely replace the tissue in bone. Since bone is the primary storage area for lead there is clearly no necessity in most patients for rapid chelation by intravenous therapy. Nearly all health problems (learning disorders, cancer, heart disease, infections, AHHD, autism, hypertension etc.) are made worse by the high levels of lead found in our bodies. Lead is an important cause for hypertension and removal of lead from patients with hypertension often permits blood pressure values to return to normal. Recent studies have implicated lead in the genesis of cataracts. The EDTA present in chelating solutions binds lead so it can be excreted by the kidneys.

One of the leading authorities in chelation therapy, Dr. Garry Gordon, has developed an oral chelation product Essential Daily Defense EDD. EDD contains Niacin, garlic powder, Calcium EDTA, MSM (Methyl Sulfane Methane), Malic Acid, Betaine HCL, Carrageenan, Papain, Silica, dl Methionine, Beta-Sitosterol, Crataegus 6x (Hawthorne Berry), Modified Cellulose Gum, Cholesterol Free Stearic Acid, and Gelatin.

Iron is now being recognized as a health hazard. The malic acid in EDD derived from apples binds iron and decreases iron stores in the body. This does not proceed to a state where iron deficiency anemia appears but it does lead to decreased production of free radicals which is, of course, desirable.

One of the most important components in EDD is the sulfated polysaccharide derived from red algae. This polysaccharide interacts with EDTA to produce a definite decrease in the clotting tendency of blood (lower viscosity due to heparin). This decrease in viscosity permits blood to flow more freely which decreases the work load on the heart. Additionally, this heparin anti-clotting effect acquired with EDD therapy makes it nearly impossible for a patient to have a heart attack, stroke or gangrene. In this state of absent clotting and high anti-oxidant activity arteriosclerotic plaques are slowly and steadily dissolved. There is no problem with bleeding. Blood clots in arteries often occur in sites where there is no or minimal plaque formation. The anticlotting effect of heparin produced by chelation may help explain the nearly complete disappearance of strokes and heart attacks in patients receiving chelation therapy. Patients with severe arteriosclerosis may need 6 to 9 capsules daily along with other measures to improve arteries (anti-oxidants, correct diet, cessation of cigarettes etc.) The garlic, which EDD contains, binds mercury facilitating its removal from the body.

Anyone taking EDD needs to be taking a good vitamin mineral supplement because EDD over time might deplete the body of minerals. Half of all Americans are taking a daily Multiple Vitamin Mineral Supplement. The results of this supplementation are less than optimal because our bodies are being steadily poisoned by toxic substances found in our water, food, and air. Oral chelation is proving so effective in improving health that many practitioners have largely switched from intravenous to oral forms of chelation.

Oral and intravenous chelation are complex so therapy ideally should be guided by a practitioner experienced in chelation. At times the metals simply move from one site in the body to another instead of leaving the body. There is no doubt that removing metals from the endothelial membranes improves oxygenation and nutrient entry into cells resulting in improved health. Because of the toxic metal, chemical, herbicide and pesticide exposure we all are exposed to I think everyone should consider taking EDD or a similar oral chelation product and remain on it permanently. Many leaders in the natural health field are already doing so.

Essential Daily Defense can be obtained from Longevity Plus sales@longevityplus.net or 800-580-7567. and from Natural Health team at 1-800-416-2806 or www.naturalhealthteam.com

Vitamin C Deficiency

The late Dr. Linus Pauling and his associates were convinced that the arteriosclerotic plaque is formed because of a deficiency of Vitamin C. In their explanation of arteriosclerosis the structural protein (collagen) of arteries is lacking due to Vitamin C deficiency. This causes the body to supply lipoprotein (a) to these weak areas in an attempt to patch the weakness. This substance lipoprtotein (a) is very sticky and when it deposits onto an injured artery surfaces it seizes platelets, calcium, fibrin and cholesterol from the blood which causes a deposit (plaque) that narrows the opening in the artery. These narrowed openings can proceed to clot over (heart attack, stroke, or gangrene), produce symptoms (angina, leg pain with exertion, brain symptoms from lack of adequate blood flow) and small pieces of fibrin clot may break off the plaque and are thrown to arteries more distant again producing strokes, heart attack and gangrene.

In 1994 Linus Pauling and his associates announced that arteriosclerosis could be cured by a substance important in making collagen (lysine 6 grams daily) and large doses of Vitamin C (6 grams daily). The Pauling associates have never seen an individual who was taking 10 grams of Vitamin C daily who had any evidence of arteriosclerosis. Ninety five per cent of patients with advanced arteriosclerosis admitted they took no Vitamin C or less than 500 mg. daily. These findings have been confirmed by the Life Extension Foundation of Hollywood, Florida.

The Pauling associates relate that end stage arteriosclerosis patients have been completely cured by high dosage Vitamin C and lysine often within weeks. These individuals lose their anginal pain, blood pressure drops to normal, arterial blockages disappear, lipid profiles become normal, and energy increases. They become able to pass treadmill tests normally.

Human beings and guinea pigs are unable to manufacture Vitamin C. Depriving guinea pigs of vitamin C leads to the production of arteriosclerotic lesions similar to human arteriosclerosis. No plaque forms in control guinea pigs getting Vitamin C. Dr. Kilmer. McCulley has shown that guinea pigs depleted of Vitamin C get high blood levels of homocysteine whereas the control guinea pigs have normal homocysteine values.

Animals other than guinea pigs do not develop arteriosclerosis. Arteriosclerotic plaques were studied by Dr. Earl P. Benditt with an electron microscope[11] in 1977. His studies showed that plaques contain almost no cholesterol. They are actually composed of new cell growth resembling what would be seen in a tumor. The absence of cholesterol is certainly not what would expect if cholesterol circulating in the blood was the cause of the atherosclerotic plaque.

The human arteriosclerosis plaques are often located at sites where injury to blood vessels occurs from the impact of the arterial stream of blood rather than in a random fashion which should occur if a toxic material in blood i.e. cholesterol was the cause of arteriosclerosis. This explains why major plaque formation often occurs at the sites where the forceful blood stream from the aorta strikes the arteries to the heart and the arteries to the brain. Dr. Pauling's findings have been ignored by the conventional medical community because to accept such convincing insights would spell the end of the multi billion dollar coronary bypass industry and the lucrative sales of cholesterol lowering drugs.

All this evidence makes a strong argument that lack of vitamin C plays a role in causing arteriosclerosis and that taking large quantities of vitamin C along with lysine should help narrowed arteries open back up. Large dosages of vitamin C are safe but may cause loose stools.

Another aspect of Vitamin C therapy that has considerable importance is the widely acknowledged role that Vitamin C has in healing infections (polio, HIV etc.) The healing of infections might also be a reason for favorable response of arteries to high doses of Vitamin C therapy as infections are becoming recognized as a probable cause for arteriosclerosis.

High Levels Of Lipoprotein (a) Cause Accelerated Arteriosclerosis

Elevation of blood levels of Lipoprotein (a) is considered one of the best predictors of impending trouble with heart disease. Lipoprotein (a) is a substance found in the blood that has a "sticky" character. It has a strong tendency to attach to sites of artery damage. This permits a clumping together with platelets, calcium, cholesterol and fibrin derived from circulating blood at this location decreasing the size of the artery. Free flow of blood past this site is obstructed which may produce symptoms (angina, brain ischemic symptoms and muscle ischemic symptoms i.e. claudication) or actual occlusion of an artery (stroke, heart attack, gangrene).

The amino acid N-Acetyl Cysteine has been found to be the most effective agent to lower lipoprotein (a) levels in the blood. With NAC therapy lipoprotein (a) levels may decrease by up to 70 %. Obtaining lipoprotein (a) values during health evaluations is a wise idea. Patients with elevated levels of lipoptotein (a) should take N-acetyl cysteine 500 mg. twice daily. This can be obtained from Natural Health Team and health food stores.

Arteriosclerosis Caused By Elevated Homocysteine And Its Correction

Methionine from red meat, milk and milk products is converted in the body into homocysteine. When the body's stores of B6 (pyridoxine), folic acid and B12 fail to bring this homocysteine down to normal values there is a three times greater risk of heart attack in males than in males with normal homocysteine values.

Dr. Kilmer McCulley gets credit for discovering the critical role homocysteine plays in the genesis of arteriosclerosis. Homocysteine stops the production of the valuable vasodilating nitric acid, causes blood to thicken, and facilitates the oxidation of LDL cholesterol, thus setting the stage for an atherosclerotic plaque and blood clots to form. As more patients are studied it has become evident that elevated levels of homocysteine are a common cause for arteriosclerosis (at least 40 % of patients). If you have artery problems, measuring homocysteine in the blood will frequently provide clear evidence that homocysteine is causing the problem, not cholesterol.

A Norwegian[12] study discovered that in 587 patients with coronary heart disease the risk of death within four years was proportional to total plasma homocysteine level. The risk rose from 3.8 % with homocysteine below 9 micromols per liter to 24.7 % in patients with homocysteine levels above 15 micromols per liter.

The only way to be certain that you are getting the proper dosage of folic acid, Vitamin B 12, Vitamin B6 and trimethylglycine to treat homocysteine excess is to have regular blood homocysteine tests. Each 3 unit increase in HC causes a 35% increase[13] in the risk of heart attack.

Trimethylglycine (TMG) also called Glycine Betaine is the most effective[14] agent to lower homocysteine levels. The usual dose is 500 mg. three times daily. If Homocysteine levels have not fallen adequately, up to 9000 mg. daily of TMG may be needed daily.

Folic acid (800 mcg with each meal) and 1000 mcg. of B 12 daily is also needed.

B6 (pyridoxine) reduces HC by a different method than folic acid. The dose of B6 should be 100 to 200 mg. daily.

In a patient with previous bypass surgery, anginal chest pain reappeared along with new areas of blockage of heart arteries. This man was taking 15,000 mcg. of folic acid daily. His blood homocysteine (HC) level was very high risk at 18. On 6 grams daily of trimethylglycine, his HC fell to 4 in one month.

Trimethylglycine functions in treating elevated HC levels by donating methyl groups, which convert HC to the harmless aminoacid methionine. Trimethylglycine (Glycine Betaine) can be purchased in health food stores.

Inflammatory Conditions In the Body Predispose To Artery Damage

Inflammation in the body is strongly associated with the development of occlusion in arteries. For this reason blood tests that measure inflammatory reactions (sedimentation rate, C reactive protein) have been found to be of great value in detecting persons who are at higher risk of developing heart attacks and strokes.

Bacteria and viruses from inflammatory conditions in the body (gingivitis) and acute infections (cytomegalovirus, Chlamydia pneumonia (TWAR bacteria), Coxsackie, herpes, etc. appear to be responsible for 25 % of heart attacks and a similar percentage of strokes. Evidence of bacterial and viral infections in the walls of arteries have been found by electron microscopy and immunoflourescence microscopy in many patients. Two hundred reviews about infectious relationships to arteriosclerosis[15] have been published but this evidence has been largely ignored as it does not encourage the use of statin drugs which remains the prime focus of the pharmaceutical industry with their control over the media and medical community. Infectious disease causes deleterious affects on blood clotting with sludgy blood flow which promotes vascular occlusion. Discovering and treating inflammatory conditions like gingivitis may permit patients to avoid vascular occlusions.

During the weeks preceding a heart attack or stroke many patients have experienced a bacterial or viral infection. Thirty seven of 166 patients with a stroke had a bacterial or viral infection[16] within 7 days of the vascular accident. Eleven of 40 male patients below age 50 had suffered an influenza like illness within[17] 36 hours of onset of their heart attack.

During infections an inflammatory infectious reaction may be occurring in the arteries. Infections also are associated with slow sludgy blood flow which would make it easier for a clot to occlude an already narrowed artery where blood flow is already slower than normal.

There appears to be a conflict between the concept that high cholesterol causes arterial disease and the observation that high levels of cholesterol have an ability to protect against infection. The high cholesterol causing arteriosclerosis theory is damaged by the observations that:

- Persons with high cholesterol do not have any more arteriosclerosis than persons with low cholesterol values.
- Lowering cholesterol values by drugs does not cause a decrease in the amount of arterial disease.
- High cholesterol is associated with longevity in older persons. High cholesterol occurs in elderly persons with the lowest mortality rates and appears to protect against infectious illnesses.
- Less than 50 % of persons having heart attacks have abnormal cholesterol values

Measuring indices of inflammation appears to be a wise preventative health measure. There is evidence that the statin drugs have an anti-inflammatory effect and this may be the main reason for any beneficial effects seen with statin therapy rather than actual lowering of cholesterol values.

Dangerous Foods Cause Arteriosclerosis

The proper diet for patients with angina and heart attacks to follow has been a source of controversy. The two parts of the world that have the lowest incidence of arteriosclerotic heart disease are the island of Crete and the Japanese island of Kohama. People in both these places eat a diet that is high in linolenic acid, an essential fatty acid. The Cretans get their linolenic acid from walnuts and purslane, whereas the Japanese islanders are getting their linolenic acid from non genetically modified soybeans and canola oil (rapeseed oil).

Researchers in France followed 605 patients after a first heart attack, with one half receiving the American Heart Association Diet (low cholesterol) and the other half receiving the Cretan Diet (lots of whole grains, roots, and green vegetables, fish, daily fruit, chicken and olive oil). The study was terminated at 27 months and all patients were switched to the Cretan diet because of dramatic benefits from this diet (see chart)

American Heart Association Diet
Total # of Heart Attacks 33
Deaths from Heart attacks 16
Sudden Death 8

Mediterranean Diet Cretan
Total # of Heart Attacks 8
Deaths from Heart attacks 3
Sudden Death 0

Linolenic acid has two desirable qualities. It makes blood less likely to clot and prevents ventricular arrhythmias. Note the 8 sudden deaths on the AHA diet and the absence of sudden death in the Cretan diet.

Sudden death is caused by an electrical gradient being established between an area of well oxygenated heart muscle and an adjacent area of poorly oxygenated heart muscle. This gradient often permits a dangerous heart rhythm (ventricular fibrillation) to occur. This is a condition where purposeless, small, feeble muscle contractions move no blood and cause instant death. This is seen often in smokers, when the nicotine constricts a coronary artery so much a gradient is created leading to ventricular fibrillation. When smokers quit cigarettes their incidence of sudden death instantly returns to the same as a nonsmoker. Tragically, in approximately 35 % of individuals, the presence of serious coronary artery arteriosclerosis is uncovered by the occurrence of sudden death.

Linolenic acid is found mainly in seeds (flax, hemp, soybean, walnut, pumpkin). It is easily destroyed by light, air, and heat. By the end of 27 months, the blood linolenic acid levels in the French patients had reached the same range as those seen in Crete. Notice that all foods consumed in the Cretan diet will spoil (no processed food).

The processed food diet consumed by 90 % of Americans certainly contributes to promoting arteriosclerosis. The U.S. soil has been seriously depleted of nutrients with important minerals lacking. Selenium is no longer found in much of the U.S. soil. This mineral has dramatic effects in lowering the incidence of cancer when 200 mcg. is consumed daily.

Highly significant deterioration in the health of U.S. citizens was brought about by the introduction of Nitrogen, Phosphorus, Potassium NPK chemical fertilizer which has promoted the development of chronic degenerative diseases. This use of chemical fertilizer instead of manure caused the protein content of vegetables to drop. Additionally farmers no longer can afford to replace the vital soil minerals. This has lead to steadily decreasing deficiencies in the mineral content of food grown from U.S. soil. Humans lacking the trace minerals from food have failure of proper enzyme function. The trace minerals (zinc, chromium, manganese, vanadium, selenium etc) are vital to normal enzyme performance in the body. Many soil samples lack some or most of these minerals and the quantity of minerals in U.S. soil has been steadily declining since the introduction of NPK fertilizer.

Numerous foods have been genetically modified which subjects the consumer to a myriad of unnecessary dangerous problems. No testing for safety could be done on GMO foods because these GMO foods were likely to increase the incidence of cancer and degenerative diseases like arteriosclerosis. Powerful agribusiness forces wanted GMO foods released.

One of the world's leading geneticists Dr. Mae-Wan Ho states "Genetic engineering bypasses conventional breeding by using artificially constructed, parasitic, genetic elements, including viruses as vectors to carry and smuggle genes into cells. The insertion of foreign genes into the host genome has long been known to have many harmful and fatal effects[18] including cancer of the organism".

Ninety percent of U.S. families are using synthetic chemical oils to cook food. These are dangerous transfats that the body has a hard time processing. Use of this synthetic food causes massive production of free radicals and leads to the development of Type 2 diabetes, arteriosclerosis and cancer.

The substances Americans think they use in cooking (corn, saffola, canola, sunflower, and soy oils) are actually chemicals compounds manufactured at high temperatures using harsh chemicals that completely remove all nutrient value from food. These chemical oils will not spoil, have no nutritional value and are very hard for the body to process and eliminate. Prolonged usage of these synthetic chemical oils leads to arteriosclerosis, Type 2 diabetes and cancer. These synthetic oils are a major factor in the deteriorating health of the American people.

The nutrients, vitamins, minerals and fiber have been largely removed from white bread, white flour, and white rice. Non organic food consumed by most persons has heavy metals, pesticides, herbicides, chemicals and estrogenic hormones. A simple remedy would be to eat only organic food that spoils.

Increased Clotting Can Produce Heart Attacks And Strokes An increased tendency of blood to clot can have a major influence in causing vascular

Pharmaceutical Population Control

Pharmaceutical Population Control

By Joe Kress
September 2, 2006
NewsWithViews.com

The 20th Century may go down as the bloodiest era in history, but I doubt it… given the recent announcement by the Federal Drug Administration whereby the morning after pill can now be sold over-the-counter to anyone over the age of 18. If younger, but not under age fourteen, the child must have a doctors certificate. Yheee gads! Is there no end to the depths the 21st Century promoters of easy sex will reach to turn the human race against itself?

  • World War I killed between 9 million and 10 million people
  • Another 59 million died in World War II.
  • 16 smaller conflicts (not considered wars) throughout the last century cost more than a million lives
  • six other wars claimed between 500,000 and a million
  • 14 wars additional wars killed between 250,000 and 500,000.
  • In all, between 167 million and 188 million people died because of organized violence in the twentieth century- as many as one in every 22 deaths in that period.[1]

Yet, the 21 century is well on its way decreasing entire population counts though the good graces of the pharmaceutical industry. I. G. Farbin’s experiments under the Nazis to purify the races, although its cartel was forced to be dissolved after WW II, reemerges now as the giant Hoechst AG with new drugs that are accomplishing the same objective.

A hypothetical Mary Smith, single, loves recreational sex, but doesn’t want to become pregnant. Last year, before Baker Labs received approval by the FDA to market the morning after pill, her boyfriend assured her that she needn’t worry because he purchased a gross of rubbers. So they went to it. What her boy friend failed to tell her that between the first and thirtieth coupling, one of those “damn safeties” broke. About two months later, Mary missed her second period. What to do? Her boy friend, having no intention to make her an honest woman, searched the yellow pages until he found the most prominent ad with the oxymoron heading “Women’s Health Center.” Mary, with predilection to choose the wider road, once her boy friend told her he would take a walk if she didn’t have the abortion, came out of the clinic lighter by a few ounces. Problem solved.

Maybe not. Mary might regret her decision and have pangs of conscience when, for some unfathomable reason she loses a child that she really wants. But that is the untold story of regret that many women and men, may I add, carry with them until death.

Ever since Dr. Alfred Kinsey wrote “ Sexual Behavior in the Male followed up with Sexual Behavior in the Human Female (1953) and still later Alex Comfort wrote the “Joy of Sex,” (1972), all too many of their readers forgot about morality and gave themselves up to hedonism. The 60s generation set the standard of youthful behavior from then on and as that generation aged their progeny learned how free and wonderful was the Age of Aquarius that their parents enjoyed. They gleefully emulated their pot smoking, Bacchanalian reveling parents. Of course, there is the other side that never seems to be found in Hustler and Playboy magazine sex promoters. Stories of sexed up, clapped up AIDS up druggies who graduated from pot to heroin to cocaine to chemical drugs landing up finally with crack cocaine… a real bummer, much more addictive.

Added to those self-induced afflictions were an increasing number of births out of wedlock …over a million legal abortions reported every year for which a whole industry thrives and for which the Federal Government condones. When drug addicts have sex, prevention is out the window. Who knows how many non-reported abortions take place, but estimates range as high as 250,000. Rounded off, year in and year out, the reports state as a yearly average over a million and a half abortions take place, but then what about RU-486, the chemical abortion pill? Are these miscarriages reported as abortions? If not, then millions of chemical abortions are taking place in addition to those that are reported.

There were millions of underweight births and hundreds of thousands of mentally retarded, deformed children cropping up all over the United States because of self-induced attempts to abort unwanted babies. Added to the list of the on-going tragedies, we need to only go back to a time when the Chemie Gruenthal Company developed a thalidomide treatment of the cutaneous manifestations of erythema purported to be also a mild sedative or tranquilizer, depending on dosage.

The German Manufacture applied for FDA approval to sell it in the United States. According to Morton Mintz who wrote about the tragic story of FDA incompetence, wrote that had it not been for Dr. Frances Oldham Kelesy, a food and drug Administration medical officer, who refused to be hurried into approving an application for marketing a new drug - a great tragedy would have occurred. Those in Congress, primarily Republicans, even at that time, had strong links with the Pharmaceutical industry and were pressuring the FDA to approve the drug.

God knows how many children would have been born with flipper-like arms and legs. The tragedy wasn’t avoided, however, because the William S. Merrell Company gave out 2.5 million so-called experimental thalidomide pills to physicians causing infants to be born with horrible deformities especially to the limbs some had no forearms with a flipper attached to a shoulder, to the pelvis or both.

Going all the way back to 1938, it was Senator Estes Kefauver who fought to amend the Food and Drug Cosmetic Act so that it would substantially enforce more clinical studies to ensure the safety and effectiveness. He also wanted the prevention of price gouging, but it all came to nothing because the Pharmaceutical industry had at that early date powerful friends both within the Republican and Democrat Parties.[2]

When the story about the outbreak of deformed babies came out as news, it created a rush to pass the Kefauver-Harris Amendments of 1962. The senate only enacted the proposals to assure safety and efficacy, but not proposals for competitive pricing. For awhile, the FDA enforced the Kefauver-Harris amendments, but complacency set in with succeeding congressional oversight committees. The decline of overseeing the FDA began in the late ‘80s and gradually got worse until it went into a free fall in 1992. By 1995 oversight was non-existent. Elli Lilly’s anti-arthritis drug Orafax and Hoechst AG with its antidepres-sant Merital had known about many deaths, yet failed to report their cause. For ten years prior to 1992, 13 dangerous drugs were withdrawn from the market because of the number of deaths attributed to them. The wrongful death suits revealed that these drugs caused lung disorders, heart-valve damage when it was discovered that mixing certain drugs in combination resulted in these fatalities.[3]

Has the oversight of the Pharmaceutical industry finally become stricter? Well, let’s look at what RU-486, now known as the abortion pill was then, when first introduced the “morning after pill;” morning after not to prevent conception, but to kill that which was conceived. The FDA’s approval, according to Eleanor Smeal, president of the Feminist Majority Foundation declared, “At long last, science trumps anti-abortion politics. Gloria Feldt, president pf Planned Parenthood, proclaimed RU 486’s U.S. arrival marked the “beginning of a new era” for American women.

Yeah, it sure did when the two-drug abortion procedure required the patient to have administration within one hour of an emergency room because of substantial risks that could result in death. Now, most of the FDA’s restrictions have gone by the wayside because of pressure from the abortion industry. The FDA has even refused to confirm whether RU-486 is being manufactured in China. China, the communist country that allows only one child to a set of parents; two, if the second child is a female, is now helping to wipe out our population which is already in rapid decline because the white race is hardly replacing itself either here or throughout Europe. Except for the new hoard of illegal immigrant replacements from south of our border, who haven’t yet discovered the pill and still adhere to Catholic prohibition of abortion, there will exist a large class of poor, under-educated, minimum wage earners, with several different languages and hardly any loyalty to their new country, many of which produce large families and are so far, regularly dependent on emergency health care.

On August 23rd, 2006, the FDA announced the approval for the new, non-lethal “morning after pill to be sold over the counter which will in effect make sex truly recreational and without consequences. WHOOPEE! How about that! The playgirls and playboys can really indulge to a point that by the end of this generation a baby will be an oddity. Old people can look elsewhere for someone to pay for their Social Security or health benefits. The drug companies will still be selling new cure alls for those new, mutated venereal diseases that are sure to crop up as a result of all those free-lance assignations.

One thing for sure, the price for the drugs will not be cheap as long as those in congress have their own assignations with Pharmaceutical predators.

There may be a great risk for the young girl or older woman who unknowingly becomes impregnated and takes the new morning after pill. Could it kill the living fetus or maim it in some awful way? What complications are the fun lovers going to experience using this pill? There are always unintended consequences when one fools with Mother Nature.

The 21st century with all it impending wars to spread American style democracy, coupled with the losses resulting from babies not being conceived or worse… aborted, can only result in the creation of our own national apocalypse. Maybe that is the reason President Bush and the feather merchants in the U.S. Senate are not enthusiastic about closing the borders. Think of it, who would otherwise pay for their government pensions and yearly pay raises without a large number of foreign skilled and unskilled legal and illegal immigrants willing and able to replace all those babies?

Footnotes:
1. The Next War of the World by Niall Ferguson, pg 61, Foreign Affairs, September/ October issue.
2. Morton Mintz on collapse of congressional oversight, presented at a meeting of Nieman fellows. (Showcase, May 2, 2005)
3. Ibid

Organization of Mental Health Services for Disaster Victims

Organization of Mental Health Services for Disaster Victims

Louis Crocq, Marc-Antoine Crocq, Alain Chiapello and Carole Damiani

Necker Hospital, Paris, France
Rouffach Hospital, Rouffach, France
French Red Cross Society, Paris, France
INAVEM (Institut National d’Aide aux Victimes), Paris, France


INTRODUCTION

In the past, the care of disaster victims was limited to rescuing them, tending their wounds, offering shelter and material assistance, helping them to relocate and resume their previous occupation. In the last three decades, increasing attention has also been given to the victims’ psychological suffering, and to the psychosocial and moral burden of the individual and the community. Thus, programs for medical, psychological, and psychosocial intervention have been devised in various countries. They are implemented at different stages of the disaster and its aftermath. The guiding principles are: (a) to take into account psychological distress; (b) to manage the psychosocial impact on the individual and society; and (c) to prevent the development of late sequelae that would handicap individual or group functioning. Various initiatives have been proposed by governments, non-governmental organizations (NGOs), international associations, and private groups. Some of these initiatives have been quite successful. However, there is a need to integrate these various initiatives into a coherent whole. At a certain level, rescue and rehabilitation need to be coordinated by government authorities.

THE IMPACT OF DISASTERS ON INDIVIDUAL AND
COLLECTIVE MENTAL HEALTH

In 1988, the World Health Organization estimated that natural disasters had afflicted 26 million persons between 1900 and 1988. In that number, 10 million had been made homeless. A 1992 report by the International Federation of the Red Cross and Red Crescent Societies identified 7,766 disasters that had occurred in the world between 1967 and 1991, killing 7 million and affecting 3 trillion individuals [1]. Natural disasters predominantly afflict poor populations – 68 out of 109 natural disasters that occurred in the world between 1960 and 1987 concerned developing countries, and only 41 affluent countries. Furthermore, the casualty rate is higher when disasters happen in poor countries, as compared with richer countries, because of factors such as overcrowding in areas that are prone to natural (e.g., floodland) or industrial disasters (e.g., chemical plants).

Regardless of the degree of material destruction, disasters are first and foremost characterized by the intensity of human trauma. The psychosocial aspect of disasters is underlined in our definition of a disaster by a combination of five criteria: (a) the occurrence of a negative event that brings distress to the people and the community (a revolution that frees a country from a tyrant is not considered a disaster, even when it causes thousands of casualties); (b) the causation of material destruction that significantly alters human environment (an avalanche in an uninhabited mountain valley is not a disaster, contrary to an avalanche in a populated valley); (c) a great number of victims, dead, injured, homeless, who suffer significant somatic injuries and psychological suffering; (d) the overwhelming disruption of local means of rescue and protection; and (e) the interruption of services that are normally offered by society (i.e., sheltering; producing, distributing, and consuming energy, water, food; health services; transportation; communication; public order; and even . . . burying the dead). It should be remembered that victims have been threatened not only in their individual ego, but also in their collective ego, or sense of belonging to a community. Their individual misfortune is also a collective misfortune. Gerrity and Steinglass [2] developed similar hypotheses about the familial group, on the basis of Reiss’s ‘‘family paradigm’’ [3]. The family elaborates a set of beliefs about the environment. Its response to a disaster will be determined by its cognitive and emotional perception of the traumatic event and its relationship with the family’s history.

The term ‘‘victim’’ is somewhat unclear. In the broadest meaning of the term, a victim is anyone who has been affected by the disaster in his/her physical or mental health, properties, or social life. Victims are usually classified into five groups on the basis of their distance to the disaster [4]: (a) primary victims (dead, wounded, uninjured survivors), who have been directly exposed to the disaster; (b) secondary victims, who have not been directly affected, but who mourn a close relative who is part of the primary victims; (c) third-level victims, such as rescuers, health personnel, who intervened on the scene and have often witnessed traumatizing events; (d) fourth-level victims, such as government or media workers, who may have suffered emotionally when taking decisions or witnessing scenes; (e) fifth-level victims, in the general public, who were not physically present at the scene but suffered by proxy when exposed to the media coverage.

MENTAL CONDITION AND HEALTH CARE NEEDS OF
DISASTER VICTIMS

The mental state of victims should be considered at the three different stages of disaster and aftermath: (a) the immediate reaction (usually, from a few hours to less than a day); (b) the post-immediate phase, that begins on the second day and lasts from a couple of days to a couple of months; (c) the delayed and long-lasting sequelae, that may be transitory (from 2 to 6 months) or become chronic (longer than 6 months).

Immediate Phase

About 75% of victims show no mental disorder, but only short-lived neurovegetative and psychological symptoms that are transitory (a few hours) and are part of the normal adaptive stress reaction. A short period of physical and psychological exhaustion may follow, because stress depletes energy. From a psychological viewpoint, this adaptive stress reaction is characterized by an adaptive focusing of attention on the danger situation, by the recruitment of mental capacities, and by the facilitation of action. Adaptive stress leads to decision-taking, acting on a decision, and adaptive fight-or-flight reactions. However, adaptive stress is an exceptional response that has a high cost in energy and discomfort. Therefore, individuals who exhibited this adaptive response may still need psychological help afterwards.

A smaller proportion (25%) of victims may present with abnormal and maladaptive stress reactions, which may follow one of four patterns [5,6]: stupor, agitation, panic flight, automatic reaction. These maladaptive stress reactions always comprise elements of peri-traumatic dissociation [7], including confusion, derealization, fright, impression of absence of relief, and abulia. In ICD-10, such reactions are termed ‘‘acute stress reaction’’. DSM-IV proposes no diagnosis for this acute stress reaction, since the criteria of ‘‘acute stress disorder’’ require that the disturbance lasts for a minimum of 2 days, which exceeds the duration of the immediate stress reaction. Individuals who responded with maladaptive stress should be viewed as ‘‘psychological casualties’’; they have lost their capacity for autonomy and should be given psychological help.

Post-immediate Period

Either the mental state returns to normal in a few days (neuro-vegetative and psychological symptoms subside, the individual is no longer entirely preoccupied by the event and can resume his previous activities), or a psychotraumatic syndrome appears, characterized by the re-experience of the event, avoidance of stimuli reminiscent of the trauma, hyperreactivity, and constant preoccupation with the trauma. Psychotraumatic symptoms may appear only after weeks, or months. This is the so-called ‘‘latency period’’, which had been identified in traumatic neurosis by Charcot and Janet, and called period of incubation, contemplation, meditation or rumination. The duration of this period is variable: each individual needs a different amount of time to organize new defense mechanisms. Furthermore, if the individual is still hospitalized, he may wait till he recovers his autonomy to start coping with the trauma. ICD-10 and DSM-IV propose the diagnostic term ‘‘post-traumatic stress disorder’’ (PTSD) (acute type, since the duration is short) for this syndrome. In addition, DSM-IV offers the category ‘‘acute stress disorder’’ for the cases with dissociative symptoms (appearing in the immediate phase) and psychotraumatic symptoms such as re-experiencing (appearing within 4 weeks of the trauma). Individuals who presented with a maladaptive acute stress reaction are more at risk to present with acute PTSD afterwards. However, this course is not unavoidable, and there are cases of maladaptive stress reaction that recover without consequences, whereas individuals who initially responded adaptively to the trauma may later develop severe PTSD.

Delayed and Chronic Period

Cases of acute stress and post-traumatic stress that occur during the postimmediate phase may resolve – spontaneously, or with treatment – fairly rapidly (in less than 3 months). However, they may also persist, and even become chronic. The typical clinical picture of PTSD may then become manifest during the delayed and chronic period, with its key features of: (a) exposition to a traumatic event, evoking a response of intense fear or helplessness; (b) persistent re-experience of the traumatic event (in intrusive recollections, dreams, flashback episodes, etc.); (c) avoidance of stimuli associated with the trauma and numbing of general responsiveness; and (d) symptoms of increased arousal.

It is worth noting that the above criteria (c) and (d) together reproduce the personality changes that were described in the former European diagnostic category termed ‘‘traumatic neurosis’’. According to Fenichel, this personality change was characterized by the blocking of such functions of the ego as: (a) filtering of the environment; (b) presence; (c) relationship with others. Briefly, the victim no longer has the same relationship with others and the world since the traumatic event. He has developed a new way of perceiving, thinking, loving, wanting, and acting. In addition to PTSD, ICD-10 provides another diagnostic category entitled ‘‘enduring personality change after catastrophic experience’’ (F62.0), defined by criteria such as a mistrustful attitude toward the world, social withdrawal, feelings of emptiness or of being threatened, and estrangement.

Traumatic neurosis, as it was described in Europe, associated several non-specific symptoms, such as physical, psychological, and sexual asthenia; anxiety; hysterical, phobic, or obsessive overlay symptoms; somatic complaints (notably in children); psychosomatic complaints; conduct disorders, addiction, suicide attempts. Many patients still present with these symptoms, which are considered ‘‘comorbid’’ in DSM-IV and ICD-10, like the pseudo-depression that is linked to psychological numbing. These non-specific symptoms may be prominent in the clinical picture, and lead to errors in diagnosis and treatment. In clinical practice, many patients do not meet all the DSM criteria for PTSD, or the ICD criteria for ‘‘enduring personality change after catastrophic experience’’. There are many atypical cases of varying onset, duration and severity, with a diverse degree of handicap. All disaster victims who still present with symptoms at this stage should be offered psychological or psychiatric care until recovery.

Numerous surveys have shown that a substantial proportion of disaster victims still present with PTSD symptoms several years after the traumatic event. Green and Lindy [8] observed a PTSD prevalence of 44% two years after the 1972 Buffalo Creek flood disaster, and of 14% after 14 years. Bromet and Dew [9] mention a 22% rate of psychological sequelae (including 11% PTSD) after a hurricane in Honduras. In a survey of 43 terrorist attack victims, Bouthillon-Heitzmann et al. [10] reported a 79% PTSD rate 3 years after the event; one-third of subjects showed clear psychosomatic disorders.

MENTAL STATE OF THE AFFLICTED COMMUNITY

A disaster strikes a whole community, causing types of collective behavior which cannot be reduced to the mere sum of instances of individual behavior. Collective behavior is influenced by a community’s psychology, by the crowd’s state of mind, and is characterized by its own specific features. After a disaster, collective behavior may be either adaptive or maladaptive.

Adaptive collective behavior is often rehearsed and expected. Instances of adaptive collective behavior during the immediate phase are remaining at one’s post, orderly evacuation, helping others. Adaptive collective behavior is characterized by three features: (a) group structure is preserved; (b) leadership is maintained or reestablished; (c) mutual help is organized. During the post-immediate and long-term phases, adaptive collective behavior is manifested by normal mourning, regaining autonomy, reconstruction and resuming normal professional and social activities.

Maladaptive collective behavior during the immediate phase may show as: (a) collective stupor (the population remains reactionless or evacuates the impact zone in a long centrifugal exodus); (b) collective panic (headlong flight, scrambling for safety); or (c) exodus. These three types of collective behavior are characterized by: (a) the loosening of group structure; (b) the collapse of leadership; and (c) the lack of solidarity. Additionally, it is possible to observe, during the post-immediate period, the spread of rumors, and violence outbursts (riots, hooliganism, and search for scapegoats). The delayed and chronic phase may give rise to a paranoid collective mentality (hostility toward the world and demanding redress), and a dependent mentality, with feelings of being entitled to assistance, and the inability to recover autonomy.

The leaders who are responsible for organizing rescue operations must be aware of these behavior patterns, and their predisposing factors. Raphael et al. [11] identified some pathogenic factors in the social context of disaster: (a) the extent of material destruction, (b) the disturbance of the normal channels of psychosocial support, (c) a history of previous collective trauma, (d) the pre-existing state of the community (e.g., migration), and (e) the separation of families. Additional negative factors are the composition of the population (proportion of elderly, children, women), its lack of structure and preparedness, its mental state on the eve of the disaster (the ‘‘expectant attention’’, described by Le Bon, facilitates panic), rumors fostering feelings of panic or abandonment, and the presence of specific individuals who overtly spread alarmist views and will ‘‘contaminate’’ others. After a disaster, individual interventions should be complemented by collective measures aimed at restoring collective psychological health.

Juan Jose Lopez-Ibor, George Christodoulou, Mario Maj, Norman Sartorius, Ahmed Okasha. Disasters and Mental.Health (2004)

Pharmaceutical Roulette (comic)

Pharmaceutical Roulette (comic)

Counterthink Cartoons are NewsTarget parodies or satirical commentary on various matters we believe to be of public concern and are offered as Free Speech within the protection of the First Amendment to the US Constitution.

This cartoon shows what you do every time you put a pharmaceutical in your mouth, whether it's an over-the-counter painkiller or a powerful statin drug. FDA-approved pharmaceuticals kill so many Americans each year that the numbers are equivalent to dropping a nuclear bomb on a major U.S. city once each year.

As even drug companies have been forced to admit, all drugs have unintended side effects. That's because drugs are non-specific chemicals: They don't target only the tissues with "disease," they end up hijacking the biochemistry throughout the body.

Take blood pressure drugs, for example (er... don't take them, actually). When a person's blood pressure is high, it's because their blood is sludge-like and too viscous (due to diet, lack of healthy oils, etc.). Also, their arteries may be clogged due to the build up of plaque on arterial walls. With gummed-up blood and smaller arteries, the heart must pump harder to push the blood through the body, and that raises blood pressure -- it's basic physics or hydrodynamics. So when blood pressure medication comes along and artificially lowers blood pressure, guess what happens? The blood doesn't get where it needs to go, and extremities like fingers and toes start to suffer nerve damage from lack of blood.

Statin drugs are no better. While they hijack the body's production of cholesterol, they simultaneously interfere with the production of CoQ10, an essential nutrient for cellular energy, heart health, cancer prevention and much more. Those same statins also block the production of sex hormones and vitamin D, which in turn causes calcium deficiency that leads to further heart problems and osteoporosis.

The American people are being played by Big Pharma when they're told these magic bullet pills will solve their health problems. And when you take drugs -- even over-the-counter drugs -- you're literally playing with your life. More than 16,000 Americans die each year after defecating massive amounts of their own digested blood. Where did the blood come from? Gastrointestinal bleeding caused by over-the-counter painkillers called NSAIDs (the most common kind of painkillers). Aleve is one NSAID. There are many others. These drugs kill thousands of people each year.

If you enjoy playing Pharmaceutical Roulette, keep taking those drugs. You'll keep getting sicker while Big Pharma gets richer. And when you die, they'll say you died from a "heart attack" or a "stroke" when in reality, you died from taking a pharmaceutical.

But if you want to live a healthier, happier and pain-free life, just say no to drugs and start feeding your body what it really needs: Nutrition. Real foods, high-density nutritional supplements, superfoods, etc. This is what the body needs to be healthy, and it's the solution that Big Pharma and the FDA are constantly trying to discredit because it actually works! It makes people healthier and causes Big Pharma to lose a customer (and a lifelong revenue source).
http://www.newstarget.com

E-Health Care Technology Management

E-HEALTH CARE TECHNOLOGY MANAGEMENT

A Multifactorial Model for Harnessing E-Technologies

George Eisler, Sam Sheps, Joseph Tan

I. Learning Objectives

II. Introduction

III. Multidimensionality of the E-HCTM Concept

A. The Strategic Role of E-Technology

B. E-Health Care Technology Management Strategy

IV. E-Surveying Health Executives

A. Defining Health Care Technology Management

B. Pilot Test and Field Test, Using a Delphi Approach

C. Validity and Reliability Issues and the Gap Score

D. Web-Based Survey Design

E. The National Survey

V. Research Findings with Relevance for E-Health Care Technology Management

A. Factor Analysis

B. Cluster Analysis

C. The Hay Group Study

VI. Conclusion

VII. Chapter Questions

VIII. References

IX. Evidence-Based Medicine Case



Learning Objectives

1. Conceptualize e-health care technology management

2. Recognize the benefits and challenges of e-surveying health administrators and executive team members

3. Identify the perceptions of senior health care executives on technology management issues and interpretations of expert opinions and ratings

4. Understand the relationships of HCTM research findings to the results of the Hay Group Study

5. Associate HCTM research findings with an e-HCTM context



Introduction

Human history and development have always been linked dynamically to the technology inherent in tools and means of production. The survival of individuals, clans, tribes, organizations, societies, and empires depends on the power of their technology to harness nature and their environment. The evolution of human civilization from the hunter-gatherer stage to the industrial stage took almost two million years. Amazingly, the evolution of computing and automated information processing technology has taken no more than a few decades, following the Industrial Revolution, two World Wars, the Cold War, and the race to the moon. In the last decade, this trend of accelerating change has been further fueled by instant access to worldwide information, global competition, and the pervasive power of converging advances in computing, information and telecommunication technology, and biotechnology.

The e-health paradigm shift, the topic of this text, is another revolution in the human history of technological developments. The view that e-technology is just an implementation issue or just another operational requirement vying for resources may be one of the key reasons for the current poor coupling of e-technology and e-health care. This view sees e-technology merely as a tool to implement e-health care strategies. It assesses e-technology in terms of return on investment or in terms of satisfying current e-market needs, covering such aspects as identification, selection, acquisition, exploitation, and protection of e-health product or process technologies. Although such tactical e-technology plans are useful (Gregory, Probert, and Cowell, 1996), more compelling is the potential and power of e-technology to radically change clinical and business strategies in health care, not just support e-health systems that mimic traditional systems. Indeed, e-technological innovation has already shifted the competitive balance within the health care industry and is creating more new opportunities for growth, as previous chapters of this text have discussed.

Economists such as Tapscott and Caston (1993) have pointed to technology as an important change agent in the structure of industries and competition. Andersen, Belardo, and Dawes (1994) confirm that the issues are similar in the public service sector arena: “Public expectations for the level and quality of government services were formed in better economic times. Those expectations have grown while satisfaction with their fulfillment has steadily declined. In the past few years, it has become evident that cutting fat, eliminating waste, and preventing abuse is not nearly enough. Government needs to rethink its methods and restructure its approach to public services.” Around the world, countries are recognizing that the competitiveness of their health care products and services in the global marketplace depends on their focus on e-technology management. In the e-health environment, the task of managing applications and services is particularly complex. It requires that health care executives master many different skills, including government relations, community liaison, employment of human resources in e-work, financing of e-health business initiatives, e-patient care, research on e-technologies (for example, research based on linked databases), and on-line education. E-health care technology management (e-HCTM), therefore, adds one more dimension to the challenge of harnessing IT for health care in the new economy.

In recent years, e-HCTM and mainstream health care technology management (HCTM) have been receiving attention in developed countries (for example, Japan and countries in Europe and North America) as well as in developing nations (for example, Southeast Asian countries). The World Health Organization (WHO), for example, proclaimed that there were serious shortcomings in the performance of health systems in virtually all countries (World Health Organization, 2000). In the late 1980s, the WHO admitted that its attempts to introduce components of an HCTM system around the world had not been very successful (World Health Organization, 2000). The lack of a working HCTM model or framework and a shortage of technology management skills, expertise, and knowledge among workers in those countries were identified as serious limitations. Without a functioning HCTM or e-HCTM system (incorporating, for example, technology planning, technology life cycle management, and technology assessment and evaluation), long-term support for technology applications and health initiatives is unsustainable. These deficiencies with respect to the management of technology point to the crucial need to align technology strategy and e-business strategy. In other words, the strengthening, linking, and aligning of technology planning and e-business planning in the e-health care context is the essential purpose of e-HCTM. In light of this development, the discussion of this chapter will focus on drawing lessons for e-HCTM from previous research on health care technology management in traditional health care organizations—specifically, large teaching hospitals (Eisler, Sheps, Satuglu, and Tan, 2002).

Multidimensionality of the E-HCTM Concept

Transferring lessons we have gathered from technology management in other industry sectors—particularly the concept of strategic HCTM and the importance of innovation—to health care and e-health care is the beginning step in exploring the concept of e-HCTM.

The complexity of the e-health care environment, the multitude of forces that shape technology decisions, and the uniqueness of the e-health care environment are all justifications for applying e-HCTM to overcome challenges of sustainability, cost, and quality of care. Compared with other industry sectors, such as banking and transportation, the e-health care environment is not only more complex but also more turbulent. The environment is challenging not only because of the complexities inherent in the development and maintenance of a seamless system spanning the continuum of e-health care delivery but also because of the complexity of relationships among stakeholders, including providers, vendors, payers, investors, insurers, patients, the general public (consumers), policymakers, regulators, researchers, and educators.

The Strategic Role of E-Technology

The health care industry is in transition, driven by such changing factors as economic trends, technology products and services, and population demographics. These pressures have resulted in changes in the structure and process of care, financing, and human resource management. The challenge in health care can be summarized as ensuring timely access to high-quality and cost-effective health care services. Health care systems in Canada, the United States, and other developed countries are expected to continue on the road of cost reduction and quality improvement through the growth and diffusion of e-health business models and services (see Chapter Twelve). Reforms in health care have been intended to increase efficiency, flexibility, and integration, as well as to improve health outcomes, community participation, and cost control. Given these sometimes conflicting pressures, a debate about the role of technology as the problem or as an important part of the solution is taking shape. Indeed, e-technology can play a vital strategic role in health care, as it does in other knowledge-based service industries, including banking and entertainment. This is particularly true for information and communication technologies and e-technologies, which can contribute significantly to improved management, cost-effectiveness, customer service, and support. These applications can create opportunities for new e-health services or for new delivery methods for existing services. For these reasons, some governments (for example, the government of British Columbia) have maintained information and communication technologies and e-health applications on their list of priorities even during a period of severe cost reduction (British Columbia Ministry of Health Planning, 2002). Only after a thorough economic evaluation will questions about comparative costs and benefits of various e-technologies, including the status quo, be answerable.

The emergence of e-technology as a lever of economic competitive advantage has created a demand for personnel who can help enterprises take advantage of such technological innovation (Raghupathi and Tan, 2002). In the past, many industries have seen technologies such as computer and telecommunication networks as playing a supportive role, contributing to overhead costs. In other words, these technologies are not seen as central to corporate objectives. Today, e-technologies are beginning to be recognized as significant core enabling assets with major strategic implications for an organization’s survival and success. In addition, the power of converging e-technologies is blurring the boundaries between administrative and core technology tools. Many CEOs now believe that such enabling technologies, if managed appropriately, can contribute significantly to the achievement of e-business strategy and new organizational objectives. At the same time, these e-technologies may fundamentally change the way an organization functions as well as the way it relates to its industry sector, sponsors, suppliers, and, most important, its customers or clients. For example, the availability of e-health care through the Internet and related Web services is transforming mainstream health care.

From a marketing perspective, creative and rapid technological evolution generates a volatile technology push on the input side of organizations. Many companies, including giant retailers like Sears and CVS Pharmacy are going on-line to prevent their chain stores from losing customers to a growing list of on-line competitors. On the output side, customers expect reliable, consistent, safe, effective, and efficient service. The convenience of on-line shopping means that they can change their loyalties easily and quickly. They are looking for seamless technology and applications. The challenge, then, is for executives, including health executives, to enable their organization to continually transform the turbulent technology input into a customer-focused and appropriate output in the face of increasingly difficult internal and external constraints (Tapscott, 1996).

“Where change used to occur periodically, it’s a way of life now,” said Charles Webb Edwards, executive vice president of the Technology and Operations Group at Wells Fargo and executive vice president and chief technology officer at Norwest Corporation prior to its merger with Wells Fargo. “There is real value in being able to manage . . . change.” Strategic planning horizons for most companies are shortening from ten or twenty years to five and, more recently, to three years. “The new approach to strategic planning recognizes that the New World is not predictable, linear, or deterministic. Rather, it is unpredictable, nonlinear, and full of surprises.” Rapid technological change is partly responsible for this nonlinearity (McCallum, 1996). Technology strategy is an integral strand in the strategic management fabric of an organization (Badawy, 1998; Husain and Sushil, 1997).

According to McGee and Thomas (1989), what has been missing “is a comprehensive view of how technological change can affect the rules of competition, and the ways in which technology can be the foundation of creating defensible strategies for firms.” Restructuring programs, takeover campaigns, and the unprecedented trend toward joint ventures are indications of the new way of doing business, “driven by the need to compete more aggressively and efficiently in world scale markets” (Perrino and Tipping, 1989). Studies have shown that levels of companies’ investments in technology explain international differences in productivity and in shares of world markets.

Geisler and Heller (1996) argue that because of economic pressures, our health care system is in crisis. What’s more, technology, especially medical technology, has played an increasing role in creating the crisis. They claim that proper and better management of medical technology provides some hope for dealing with the forthcoming challenges.

The World Health Organization defines health as a state of total physical, mental, and social well-being, not merely the absence of disease and infirmity. It is now recognized that population and individual health has many determinants not traditionally associated directly with the health care system—for example, air quality and socioeconomic status. Accordingly, e-HCTM includes managing applications of technology that influence the environment, information dissemination, health protection, and disease prevention. It goes beyond just applications of medical technology found in modern acute care systems or for direct medical care. In this context, the term e-health care technology applies, in the broadest sense, to more than just e-health information. It includes hardware and firmware devices, software and business processes, health products such as drugs and home care health products marketed on-line, as well as e-prescription and e-home care services. E-technologies that may contribute to quality or sustainability of health care systems (see Chapters One and Two) could be associated with virtual communities (see Chapter Three), e-clinical care (see Chapter Four), e-public health systems (see Chapter Five), e-network infrastructure (see Chapter Six), various e-health domains and applications (see Chapters Seven through Eleven) or other e-health business processes (see Chapter Twelve).

E-Health Care Technology Management Strategy

In this chapter, we review the literature across several industry sectors and combine the results of that review with the findings of our research on technology management in traditional health care organizations. This approach yields general agreement about the basis for e-HCTM strategy; the characteristics of an e-HCTM-focused business; and the responsibilities and capabilities of the e-technology officer, who is equivalent to the chief technology officer (CTO) in traditional corporate settings.

E-HCTM strategy is based on the competitive and turbulent e-health environment, the nature of the e-health business, and the state of e-technology development. Other factors in e-HCTM strategy include considerations of business-specific factors, environmental factors, and customer preferences; creation of strategic advantage and differentiation; development of e-technological expertise, e-business decisionmaking and problem-solving skills, and human resource capabilities; and readiness for a comprehensive rethinking and readjustment of job descriptions, information systems, governance structure, incentives, and decision-making processes. One of the most important issues is e-health business structure and its value propositions, as has been noted throughout this text. E-health policies hold together a decentralized, virtual workplace with rapid access to global information. In addition to flexible governance structures, management of e-health systems must emphasize seamless information flow, appropriate incentives (for example, for focusing on customers), and innovative performance assessment schemes.

E-HCTM strategy needs to be characterized by managerial vision, foresight, and entrepreneurial spirit. Strong leadership is one of the most critical aspects of success. This entails commitment to knowledge acquisition rather than just product development. Management personnel must know what they want, given the difficultto- quantify costs and benefits of newer e-technologies and the need for flexibility. Managers must set realistic goals, match the supply of products and services to market demands, and be clearly aware of resources, constraints, and risks. Decisions and attitudes of management must be based on an analysis of competitive position, market intelligence, technical preferences of e-consumers (customers), and internal capabilities. The e-HCTM strategy focuses on the customer, replacing organizationcentered approaches with an emphasis on market pull rather than e-technology push.

Management systems must focus on an internally integrated enterprise. These systems must coordinate across functional boundaries; in other words, cross-functional approaches must facilitate convergence of the historically divergent views of technically oriented and market-oriented individuals. Full and meaningful worker and customer participation in the production and delivery process is key to e-health success. Moreover, process management has to replace product management; this shift in focus to flexibility, adaptability, responsiveness, and effectiveness rather than efficiency and costs is necessary mainly because competitive advantage comes from achieving greater customer satisfaction and enterprise knowledge integration by deploying the appropriate e-HCTM strategy, not just from labor cost savings. Above all, the ability of the management team to change, adapt, and avail itself of new opportunities is critical in an environment as turbulent as the e-health marketplace.

E-consumers’, e-providers’ and the government’s expectations have increased because of advances in technological capabilities. For the e-technology officer to move e-HCTM strategy forward, he or she must demonstrate thinking and visionary leadership, the ability to create new ways of funding, and a commitment to the alignment of e-technology with clinical objectives. Thus, the e-technology officer must bridge gaps between virtual team members and engage in continual planning, active resource allocation, development of standards, rapid reorganization when necessary, and adoption and implementation of fundamental changes in the e-business system. He or she must also be a steward of networked leadership, be close to the front line, and build an invisible enabling infrastructure.

The e-technology officer must ensure that promises made on behalf of e-technology applications are kept. He or she must build a viable, productive, and flexible e-technology asset base that can deliver goods and services on time and with a competitive pricing scheme. Moreover, he or she needs to take responsibility for managing technology-driven change and act as a change champion. Overall, this individual must be able to manage in an environment of decentralized decision making with a high level of interfunctional coordination; be conversant in e-business issues and challenges; have a focused commitment, empowered with applicable technical information; and have the skills to effect and manage change. Such an individual will also need relevant technical competence and an understanding of the importance of e-technologies and systems that provide a competitive edge, as well as the need for e-technologies and systems that support the goals of the virtual enterprise.

Joseph Tan. E-Health Care Information Systems : An Introduction for Students and Professionals (2005).

Cancer Organizations

Cancer Organizations

Finding the Group That Fits Your Needs
© Linda Bily

Cancer organizations devoted to specific cancers, with reliable information for the consumer.

Cancer organizations devoted to specific cancers, with reliable information for the consumer.

Alliance for Lung Cancer Advocacy, Support and Education (ALCASE) http://www.alcase.org November is Lung Cancer Awareness month. Lung cancer is still the leading death-causing cancer in the United States for both men and women.

Colorectal Cancer Network http://www.colorectal-cancer.net Colorectal cancer (which includes cancer of the colon, rectum, anus, and appendix) is the second-leading cause of cancer-related deaths in the United States. Colorectal Cancer (CRC) is one of the most treatable forms of cancer when diagnosed early, and state of the art is continually changing for advanced stages Kidney Cancer Association http://kidneycancerassociation.org The average age at diagnosis is white male - 62! Symptoms are not easily detected - but sometimes, there is lower back/flank pain. Most do not present with lumps -- Over 30,000 patients are diagnosed each year. Kidney cancer often manifests itself with painless urination of blood.

Lance Armstrong Foundation http://www.laf.org The Lance Armstrong Foundation (LAF) exists to enhance the quality of life for those living with, through, and beyond cancer. Founded in 1997 by cancer survivor and champion cyclist Lance Armstrong, the LAF seeks to promote the optimal physical, psychological, social recovery and care of cancer survivors and their loved ones. The LAF works to define, refine and improve services for cancer survivors and to facilitate the delivery of those services—with a large dose of hope—to patients, their families, and other loved ones touched by the disease.

Multiple Myeloma Research Foundation http://www.multiplemyeloma.org Multiple myeloma, a cancer of the plasma cell, is an incurable but treatable disease. While a myeloma diagnosis can be overwhelming, it is important to remember that there are several promising, new therapies that are helping patients live longer, healthier lives. There are approximately 45,000 people in the United States living with multiple myeloma and an estimated 14,600 new cases of multiple myeloma are diagnosed each year. The Multiple Myeloma Research Foundation (MMRF) is a nonprofit foundation driven by a single purpose: to accelerate the search for a cure for multiple myeloma.

National Brain Tumor Foundation http://www.braintumor.org NBTF is a national non-profit health organization dedicated to providing information and support for brain tumor patients, family members, and healthcare professionals, while supporting innovative research into better treatment options and a cure for brain tumors.

National Coalition for Cancer Survivorship http://www.canceradvocacy.org The National Coalition for Cancer Survivorship, the only survivor-led advocacy organization working exclusively on behalf of people with all types of cancer and their families, is dedicated to assuring quality cancer care for all Americans.

National Melanoma Foundation http://nationalmelanoma.org The National Melanoma Foundation was established by people genuinely dedicated to battling melanoma on all fronts. Each board member has experienced melanoma firsthand: either from being a survivor or losing a loved one to the disease. Melanoma has largely been ignored as "just skin cancer" yet the incidence is increasing at epidemic proportions, with one person dying every hour from the disease.

National Ovarian Cancer Coalition http://www.ovarian.org Our mission is to raise awareness about ovarian cancer and to promote education about this disease. By dispelling myths and misunderstandings, the coalition is committed to improve the overall survival rate and quality of life from ovarian cancer.

National Prostate Cancer Coalition http://www.4npcc.org The National Prostate Cancer Coalition (NPCC), founded in 1996, is the largest advocacy organization dedicated to ending the devastating impact of prostate cancer on men, families and society. Its goals are to increase awareness by educating the public about the disease, outreach to at-risk communities by conducting free screenings for prostate cancer, and engage citizens and associations in an effort to build an advocacy network to encourage increases in federal funding of prostate cancer research.

Pancreatic Cancer Action Network http://www.pancan.org The Pancreatic Cancer Action Network (PanCAN), works to focus national attention on the need to find the cure for pancreatic cancer. We provide public and professional education that embraces the urgent need for more research, effective treatments, prevention programs, and early detection methods.

Sarcoma Alliance http://www.sarcomaalliance.org Malignant (cancerous) tumors of the connective tissues are called "sarcomas". Although rare, there are approximately 9,800 new cases of sarcoma each year in the United States.

Susan G. Komen Breast Cancer Foundation http://www.komen.org "To eradicate breast cancer as an life-threatening disease, by advancing research, education, screening and treatment." This is Komen's mission. This organization does more for breast cancer and its patients and advocates than all others - from fund-raising, to sponsoring educational and community events to sending advocates to scientific conferences.

http://cancer.suite101.com/article.cfm/cancer_organizations

New Super Pill for Heart Disease

New Super Pill for Heart Disease

Cost of treating heart disease expected to drop by 80 percent © Annie Austin

A new pill is to be tested in Spain that combines aspirin, statins, and ACE inhibitors – the three main therapies used to fight heart disease.

New Polypill for Heart Disease

Experts in the field of cardiology announced that a new pill that save millions suffering from heart disease. They did so at the World Congress of Cardiology in Barcelona, Spain on Monday, September 4th. The new pill – dubbed polypill – will contain aspirin, statins, and ACE inhibitors. According to the World Heart Federation, which is promoting the pill, the therapy will become available with in two years and will cost approximately one fifth of taking multiple pills for heart disease.

The World Congress of Heart Disease conference ran September 2-6 in Barcelona and attracted 25,000.

The new polypill is to be tested in Spain and will be exported to other countries within the next two years.

Close to 17 and a half million people die of heart disease each year.

Design of Small Clinical Trials

Design of Small Clinical Trials


The design and conduct of any type of clinical trial require three considerations: first, the study should examine valuable and important biomedical research questions; second, it must be based on a rigorous methodology that can answer a specific research question being asked; and third, it must be based on a set of ethical considerations, adherence to which minimizes the risks to the study participants (Sutherland, Meslin, and Till, 1994). The choice of an appropriate study design depends on a number of considerations, including:

  • the ability of the study design to answer the primary research question; o whether the trial is studying a potential new treatment for a condition for which an established, effective treatment already exists; o whether the disease for which a new treatment is sought is severe or life-threatening;
  • the probability and magnitude of risk to the participants;
  • the probability and magnitude of likely benefit to the participants;
  • the population to be studied-its size, availability, and accessibility;
  • and

  • how the data will be used (e.g., to initiate treatment or as preliminary data for a larger trial).
  • Because the choice of a study design for any particular trial will depend on these and other factors, no general prescription can be offered for the design of clinical trials. However, certain key issues are raised when random- ized clinical trials (RCTs) with adequate statistical power are not feasible and when studies with smaller populations must be considered. The utility of such studies may be diminished, but not completely lost, and in other ways may be enhanced.

    To understand what is lost or gained in the design and conduct of studies with very small numbers of participants, it is important to first consider the basic tenets of clinical trial design (Box 2-1).


    KEY CONCEPTS IN CLINICAL TRIAL DESIGN

    Judgments about the effectiveness of a given intervention ultimately rest on an interpretation of the strength of the evidence arising from the data collected. In general, the more controlled the trial, the stronger is the evidence. The study designs for clinical trials can take several forms, most of which are based on an assumption of accessible sample populations. Clinical trials of efficacy ask whether the experimental treatment works under ideal condi-

    BOX 2-1
    Important Concepts in Clinical Trial Design
    Does the trial measure efficacy or effectiveness?
    A method of reducing bias (randomization and masking [blinding])
    Inclusion of control groups
    - Placebo concurrent controls
    - Active treatment concurrent controls (superiority versus equivalence trial)
    - No-treatment concurrent controls
    - Dose-comparison concurrent controls
    - External controls (historical or retrospective controls)
    Use of masking (blinding) or an open-label trial
    - Double-blind trial
    - Single-blind trial
    Randomization
    - Use of randomized versus nonrandomized controls
    Outcomes (endpoints) to be measured: credible, validated, and responsive to change
    Sample size and statistical power
    Significance tests to be used


    tions. In contrast, clinical trials of effectiveness ask whether the experimental treatment works under ordinary circumstances. Often, trials of efficacy are not as sensitive to issues of access to care, the generalizability of the results from a study with highly selective sample of patients and physicians, and the level of adherence to treatment regimens. Thus, when a trial of efficacy is done with a small sample of patients, it is not clear whether the experimental intervention will be effective when a broader range of providers and patients use the intervention. On the other hand, trials of effectiveness can be problematic if they produce a negative result, in which case it will be unclear whether the experimental intervention would fail under any circumstances. Thus, the issue of what is preferred in a small clinical study-a trial of efficacy or effectiveness-is an important consideration.

    In the United States, the Food and Drug Administration (FDA) over- sees the regulation and approval of drugs, biologics, and medical devices. Its review and approval processes affect the design and conduct of most new clinical trials. Preclinical testing of an experimental intervention is performed before investigators initiate a clinical trial. These studies are carried out in the laboratory and in studies with animals to provide preliminary evidence that the experimental intervention will be safe and effective for humans. FDA requires preclinical testing before clinical trials can be started. Safety information from preclinical testing is used to support a request to FDA to begin testing the experimental intervention in studies with humans.

    Clinical trials are usually classified into four phases. Phase I trials are the earliest-stage clinical trials used to study an experimental drug in humans, are typically small (less than 100 participants), and are often used to deter- mine the toxicity and maximum safe dose of a new drug. They provide an initial evaluation of a drug's safety and pharmacokinetics. Such studies also usually test various doses of the drug to obtain an indication of the appropriate dose to be used in later studies. Phase I trials are commonly conducted with nondiseased individuals (healthy volunteers). Some phase I trials, for example, those of studies of treatments for cancer, are performed with indi- viduals with advanced disease who have failed all other standard treatments (Heyd and Carlin, 1999).

    Phase II trials are often aimed at gathering preliminary data on whether a drug has clinical efficacy and usually involve 100 to 300 participants. Frequently, phase II trials are used to determine the efficacy and safety of an intervention in participants with the disease for which a new intervention is being developed.

    Phase III trials are advanced-stage clinical trials designed to show conclusively how well a drug works. Phase III trials are usually larger, frequently multi-institutional studies, and typically involve from a hundred to thousands of participants. They are comparative in nature, with participants usually assigned by chance to at least two arms, one of which serves as a control or a reference arm and one or more of which involve new interventions. Phase III trials generally measure whether a new intervention extends survival, or improves the health of participants receiving the intervention and has fewer side effects.

    Some phase II and phase III trials are designed as pivotal trials (sometimes also called confirmatory trials), which are adequately controlled trials in which the hypotheses are stated in advance and evaluated. The goal of a pivotal trial is to attempt to eliminate systematic biases and increase the statistical power of a trial. Pivotal trials are intended to provide firm evidence of safety and efficacy.

    Occasionally, FDA requires phase IV trials, usually performed after a new drug or biologic has been approved for use. These trials are postmarketing surveillance studies aimed at obtaining additional information about the risks, benefits, and optimal use of an intervention. For example, a phase IV trial may be required by FDA to study the effects of an intervention in a new patient population or for a stage of disease different from that for which it was originally tested. Phase IV trials are also used to assess the long-term effects of an intervention and to reveal rare but serious side effects.

    One criticism of the classification of clinical trials presented above is that it focuses on the requirements for the regulation of pharmaceuticals, leaving out the many other medical products that FDA regulates. For example, new heart valves are evaluated by FDA on the basis of their ability to meet predetermined operating performance characteristics. Another device is the intraocular lens whose performance must be satisfied in a prespecified grid. Medical device studies, however, rely on a great deal of information about the behavior of the control group that often cannot be obtained or that is very difficult to obtain in small clinical trials because of the small number or lack of control participants.

    A much more inclusive and general approach that subsumes the four phases of clinical trials is put forth by Piantadosi (1997), who defines the four phases as (1) early-development studies (testing the treatment mechanism), (2) middle-development studies (treatment tolerability), (3) comparative (pivotal, confirmatory) studies, and (4) late-development studies (extended safety or postmarketing studies). This approach is more inclusive than trials of pharmaceuticals; it includes trials of vaccines, biological and gene therapies, screening devices, medical devices, and surgical interventions.

    The ethical conduct of a clinical study of the benefits of an intervention requires that it begin in a state of equipoise. Equipoise is defined as the point at which a rational, informed person-whether patient, provider, or re- searcher-has no preference between two (or more) available treatments (Freedman, 1987; Lilford and Jackson, 1995). When used in the context of research, equipoise describes a state of genuine uncertainty about whether the experimental intervention offers greater benefit or harm than the control intervention. Equipoise is advocated as a means of achieving high scientific and ethical standards in randomized trials (Alderson, 1996). True equi- poise might be more of a challenge in small clinical trials, because the degree of uncertainty might be diminished by the nature of the disorder, the lack of real choices for treatment, or insufficient data to make a judgment about the risks of one treatment arm over another.

    A primary purpose of many clinical trials is evaluation of the efficacy of an experimental intervention. In a well-designed trial, the data that are collected and the observations that are made will eventually be used to over- turn the equipoise. At the end of a trial, when it is determined whether an experimental intervention has efficacy, the state of clinical equipoise has been eliminated. Central principles in proving efficacy, and thereby eliminating equipoise, are avoiding bias and establishing statistical significance. This is ideally done through the use of controls, randomization, blinding of the study, credible and validated outcomes responsive to small changes, and a sufficient sample size. In some trials, including small clinical studies, the elimination of equipoise in such a straightforward manner might be difficult. Instead, estimation of a treatment effect as precisely as necessary may be sufficient to distinguish the effect from zero. It is a more nuanced approach, but one that should be considered in the study design.

    Adherence to an ethical process, whereby risks are minimized and voluntary informed consent is obtained, is essential to any research involving humans and may be particularly acute in small clinical trials, in which the sample population might be easily identified and potentially more vulner- able. Study designs that incorporate an ethical process may help in reducing concerns about some of problems in design and interpretation that naturally accompany small clinical trials.

    Charles H. Evans, Jr., and Suzanne T. Ildstad. Small Clinical Trials: Issues and Challenges (2001)

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