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Tuesday, April 05, 2011

Psychedelic Drugs

Drugs that produced unusual experiences have been called “psychedelics” or “hallucinogens”. A hallucination is an experience originated within the brain that is similar to or indistinguishable from an experience originating from outside the brain. Deeply imbedded in the nature of consciousness is the ability of the brain to project and internal event into the world outside. Indeed, in the final analysis, all events internal and external are brain events. If a person takes a known psychedelic agent, LSD, he or she expects to have unusual experience and will report these experiences appropriately as, for example, an “acid trip.”

If a psychedelic chemical is produced in the brain or is present as an unknown entity in food or drinks, then the unusual experiences will be reported as real experiences, happening out there in the real world. One theory of "schizophrenia" is that unknown psychedelics act on the brain to cause psychotic mind activity. Drugs used to treat this “illness” counter the brain disturbance created by endogenous psychedelic chemicals.

I am convinced that the diagnosis of schizophrenia acts against the best interests of teenagers, their parents and their community. Schizophrenia is meaningless term that can be applied such a variety of brain dysfunctions, that the focus should be on discovering the root cause of the brain dysfunction and not this antiquated diagnosis. Drug use and abuse is so prevalent among teenagers that any brain dysfunction (aka mental illness) in an adolescent should be attributed to drug use until proven otherwise. If not drug use, then the cause is eating too much of the wrong food and exercising too little.

Psychedelic drug use flourished in the 60’s in the US and Canada, along with rock and roll, folk music and protests against racial discrimination and the Vietnam war. LSD was popular in the sixties with researchers who were excited about the therapeutic possibilities of a drug that “opened the doors of perception and the gates of heaven and hell.” For many, LSD was a deep and spiritual drug that appeared to be a key to understanding brain function. Research into the action of LSD in the brain revealed a profusion of activity that defied easy understanding, however. LSD research was outlawed and psychedelic use subsided in the 1970’s and 80’s only to increase again in the 1990’s.

Cannabis (marihuana) is perhaps the most available and widely used psychoactive plant. It contains the psychoactive drug, tetrahydrocannabinol (THC). In the best case, THC induces mild euphoria, feelings of general well-being, relaxation with increased appreciation of humor, music and food with increased sensuality and creative or philosophical thinking. In the worst case, disorientation, memory deficits, paranoia, agitation, and anxiety produce bad experiences and antisocial behaviors. Cannibis use can produce any and all the symptoms of psychiatric illness. Combine cannabis with other drugs, malnutrition and punk rock, you can reproduce  the major mental illnesses in the psychiatric textbook.

Other natural psychedelics include  psilocybin (magic mushrooms), mescaline (peyote), LSA (Morning Glory Seeds) and Ayahuasca found in teas brewed from plants containing dimethyltryptamine and harmine. Synthetics such as MDMA (ecstasy), 2C-B (nexus), DOM (STP), and 5-MeO-DIPT (Foxy Methoxy) are common street drugs. LSD and psilocybin are based on tryptamine. Mescaline and 2C-B. are based on phenethylamine. Psychedelic effects include sensory distortions, such as the warping of surfaces. 2C-B produces dose sensitive effects: a small dose increase is the difference between no activity and a disconnection from “reality”. Empathogens are phenethylamines such as MDMA and MDE that induce feelings of openness, euphoria, empathy, love, and heightened self-awareness. MDA (unlike MDMA) is neurotoxic.

Alkaloids of the ergoline family produce a variety of compounds that can be psychoactive or have medicinal value. Ergine was discovered by Albert Hofmann working at Sandoz laboratories where ergot alkaloids became big business. Hofmann administered new compounds to himself to assay psychoactive effects. A 500 microgram dose by injection led to a tired, dreamy state, with an inability to maintain clarity of consciousness. After a short period of sleep these effects ended. Ergine is a precursor to LSD, and is listed DEA schedule III drug in the United States. Hoffman was the first to synthesize LSD and appreciate its psychedelic effects. Many drugs have been derived from ergot alkaloids such as Bromocriptine, Cabergoline, Ergine, Ergonovine, Ergotamine; Lysergic acid, Lysergol, LSD, D-Lysergic acid hydroxyethylamide, Lisuride, Methergine, Methysergide, Pergolide.

From Children and the Family by Stephen Gislason MD

Thursday, March 10, 2011

Medical Thinking

Medicine has become an eclectic assortment of activities, loosely connected to a variety of scientific disciplines. While MDs study science, they are not usually scientists. They are technicians with a special mandate to care for other humans who are sick and injured. A short time ago, physicians were conspicuous members of communities with well defined social status and social responsibilities that were often more important than their technical abilities. The community recognized the limitations of its physician and accepted caring and concern in place of therapeutic efficacy. Physicians continued the traditions of shamans, performing in front of audiences who needed their reassurance or who shared their grief.

As human populations grew, societies became multilayered complexes of interacting groups and technologies. Universities and medical societies clung to the old ideas of the community physician while teaching medical students an odd assortment of technologies, hoping that somehow these bright people would figure out how to retain their humanity while they practiced increasingly abstract and impersonal techniques. Hospitals collected machines for diagnosis and treatment and hospital communities involved increasingly diverse groups of people who interacted in increasingly complex ways. Specialized physicians stayed in the hospital where high technology equipment and teams of technicians were available.

Many complications have arisen in recent years in the application of increasingly expensive technologies. Both physicians and patients complain that they have become disenfranchised and alienated. The media feature medical news everyday, creating a feeding frenzy for good news --- everyone wants to believe claims that a common disease is about to be cured. Although progress in basic science is marvelous, progress in medical treatments is slow and often disappointing. Media claims tend to misleading, creating inflated expectations and stampedes towards cures that are more fantasy that reality or are frankly fraudulent.

Medical practice is now under scrutiny from many directions. The idea of practice guidelines and problem-solving algorithms have been around for many years, but now are the subject of heated debate. Many scholars have realized that research findings do not get incorporated into medical practice - indeed with the proliferation of information, there is less formal direction in the selection and application of knowledge. Practice guidelines are now so numerous that a front-line physicians could not possibly follow them. Astute observers notice that medical practice goes with fads and fashions. The most important source of modern illness such as the negative effects eating too much of the wrong food and the toxicity of polluted environments are too complicated and are usually ignored in medical practice.

There are different approaches to the study of medical practices. One approach is to examine how physicians think and react. In the best case, physicians are objective, rational problem solvers who follow standard algorithms to arrive at correct diagnoses and who prescribe the safest, least expensive, most efficacious treatments. In the worst case, physicians are prejudiced, irrational technicians who are unreliable problem solvers and often fail to make correct diagnoses and often prescribe treatments that are expensive, unsafe and fail to solve the problem at hand.

You can argue that physicians are just like everyone else. They have likes and dislikes and limited ability to understand complex issues. Physicians can be as irrational as anyone else. For example, physicians often divide illness into two broad categories, the organic and the non-organic. The distinction is used universally by physicians when they talk to one another but there is no biology to support the irrational belief in "non-organic illness." In dismissing a patient’s symptoms, a physician will remark to a colleague, for example, that the origin of the abdominal pain is "supratentorial." This is a neuroanatomical remark without much understanding. The tentorium is a membrane that forms a floor for the cerebral hemispheres inside the skull. A supratentorial event would involve any part of the brain above the midbrain and for many physicians, brain function at this level is indeed a mystery.

Physicians continue to rely on patient’s stories and medical students are still taught to take a history as an essential part of their examination of the patient. However, all story telling is imperfect; patients lie, both deliberately and inadvertently. Physicians tend to be impatient and biased listeners who want to hear a simplified story that fits their preconceptions of diagnostic categories. They often ignore the patient's report and invent their own story.

Medicine is afflicted with descriptions, categories and generalizations that are confusing or misleading. The popular notions of cancer, for example, are misleading. Slogans such as "Cure for Cancer" are nonsensical. There is no disease called cancer, rather there are diverse expressions of cell growth gone wrong. Aberrant cells are created in everyone. Abnormal cells can occur in any tissue of the body - one at a time or in groups. The first tumor discovered is described as a local disease, but malignant cells enter the blood and are carried through the body. "Cancer" is a whole body, chronic disease. The incidence of mutated cells increases with age and increases as more carcinogens are introduced to the environment. Fortunately, most abnormal cells fail to grow. Some growth abnormalities are pre-programmed, but most are induced by carcinogens that are optional features of environments. Most often, carcinogens are man-made radiation or chemicals, distributed in the air, water and food. MDs add carcinogens to their patients' burden with XRays and chemotherapeutic drugs; attempts to kill one population of mutated cells, creates other populations of mutated cells and, at the same time, suppresses immune activity that might destroy the new mutations.

Recently, stories about individuals and their unique experiences have been replaced by reports from studies of large anonymous groups whose fate is interpreted with statistics, as if these studies were better than understanding the experience of individuals. The results of studies are analyzed statistically which creates an abstract, virtual reality of doubtful value. I believe that medicine based on large "clinical studies" is flawed at fundamental level of wrong assumption, but evidence-based medicine is the new dogma of medical practice. Drug companies use studies as part of their marketing strategy; good results are released to the media and bad results are forgotten. The ideals of science and medical ethics are also forgotten. See Confusing Study Results

You can argue that the education of physicians is flawed; modest attempts have been made to improve medical school teaching, but the same old stuff usually gets repeated with little or no review. Medical school tends to be a hectic tour through a variety of disciplines that contribute to the medical view of the word. Medical students are challenged to learn too much too quickly and have little time to reflect.

Medical education has a friendly surface, that invites you to study anatomy, biochemistry, physiology, pharmacology and pathology, all noble disciplines that reveal life processes in health and disease. There is also a somewhat hidden curriculum that transforms smart and free individuals into obedient servants of the system. Conformity is the highest value in medicine and some students have trouble adjusting to their new status as obedient robots.
See Indentured Doctors

The system includes many wealthy and powerful players who have little or no tolerance for idealist students who want to innovate and change the way the system works. Wealth means vested interest which translates into a desire to control medical school curricula, post-grad medical education and government policies.

New insights into human interactions, the environment and better understanding of the actual and real causes of disease might in the future transform medical education. Universities will have to re-examine their assumptions and methods. Strategies that involve disease prevention and interventions at early stages of disease should take precedence over futile attempts to fix end-stage disease.

In a New Times editorial, physician Zuger described a number of books written by other physicians. She identified Dr. Jerome Groopman and Dr. Atul Gawande, both clinicians at Harvard and writers for The New Yorker as articulate commentators on the state of medical practice. Zuger stated: "Instead of speeding along in double time, Groopman and Gawande, like the frustrated coaches of a losing team, are slowing the motion of medicine down to half-speed, examining each play, then each frame and image, trying to figure out where the glitches lie."

Groopman describes errors and uncertainty in medical care. Groopman said he wrote his book from dissatisfaction that is common among physicians. He analyses errors in assumptions and reasoning. MDs, like all humans, jump to conclusions quickly and then seek evidence that supports their first impressions. They tend to be dogmatic and resist change. Physicians are encouraged to think in terms of categories and link diagnoses with prescriptions. MDs should understand pathophysiology and think in terms of disease-causing processes that act over time. They should always want to know what causes the process and how to intervene in the early stages of disease to prevent progression.

Groopman describes some of his own experiences with other Doctors: "One of my first experiences with the problem came in 1983, during the first week in July as it happens, when my wife, Pam, also a doctor, and I were traveling to Boston from California with our son Steven, then 9 months old. Steve had developed a low-grade fever, had dark and loose stools and was irritable, refusing to nurse. Stopping in Connecticut to visit my in-laws, we consulted the town pediatrician. The doctor quickly dismissed Pam’s concerns. “You’re overanxious,” he told her. “Doctor-parents are like this.” By the time we arrived in Boston, the baby was ashen and he was jerking his knees to his chest and wailing in pain. We rushed to the emergency room at Children’s Hospital, where a new surgical resident examined him, ordered X-rays and blood tests and made the correct diagnosis: an intussusception, an intestinal obstruction. It was a hectic night, and the novice doctor was being pulled in many directions. He told us there was no urgency to operate and left us alone with our flailing child. I had worked one year in a research lab at this hospital and phoned the senior hematologist who had been my mentor. He contacted an attending surgeon, who came to the emergency room and whisked Steve to the operating room. “It was fortunate that we operated when we did,” the surgeon told us later. The intestine was at the point of bursting, spilling its contents into the abdomen, precipitating peritonitis and possibly shock."

Zuger, A. Doctors Who Wield the Pen to Heal the Profession. NYT. May 15 2007.
Groopman Mental Malpractice, NYT. July 7, 2007

See Medical Care and Planet Ecology

Monday, November 15, 2010

No Environment in Medical Practice

Most of us need little convincing that the air in urban environments is
polluted. Climates are changing. The belief that the food chain is contaminated with toxic chemicals is universal and readily validated. But, what branch of the medical sciences will responsible for the diagnosis and treatment of patients who suffer environmental disease? Who is studying and documenting the new patterns of illness that emerge from our deteriorating circumstances? Where do sick people with ill-defined illness get help? Who is changing the curricula of medical schools and teaching medical students what is really going on out there?

The underlying idea of medical practice is to receive the sick and injured, patch their wounds and alleviate suffering when there is no effective treatment.Whatever the determinants of injury and disease are, the doctor and the hospital are ready to attempt rescue you. It is up to you, dear reader, to investigate the causes of disease and to change your food and environment so that you are less likely to become injured and ill.

Physicians who work in occupational medicine develop expertise in the
toxicology of work environments. Government agencies such as NIOSH in the USA developed standards for limiting toxic chemical exposures and provided information about work hazards. The US EPA set standards intended to reduce air and water pollution but its policies and powers have been constrained by political interference.

Not much progress has been made in bringing knowledge of the environment into community medical offices and hospitals; in this regard medical practice reveals itself to be out-of-date and often irrelevant to the real needs of many patients. Instead the environment has come to hospital in the form of  destructive winds, floods and sudden unexpected changes in environments that people often assumed to be more stable and enduring. No medical specialty has assumed the responsibility of applying knowledge of environmental principles, ecology, or toxicology to all citizens. It is difficult for anyone suffering any sort of environmental problem or chemical toxicity to get even a cursory hearing from public health authorities or individual physicians. Lung disease is usually treated as an individual problem with little or no reference to the environment that people with lung disease share.

The only physicians directly involved in toxicology issues work in
occupational medicine and supervise working conditions in industries that expose workers to dust, molds,  toxic chemicals and other hazards. Here the emphasis is on preventing acute exposures to toxins in concentrations that are known to be harmful. Little is known about the long term effects of chemical exposure at low doses and there is a tendency for authorities to deny illness caused by chronic exposure.

Allergists intend to deal with some of the medical problems caused by the environment, but often limit their knowledge and practice to a few selected environmental problems, such as hay fever and asthma. Even though asthma receives considerable research attention, the contribution of indoor and outdoor air pollutants and allergy to food proteins is not well understood and ignored in medical practice. By narrowing the definition of allergy to type 1 hypersensitivity, allergists leave patients without help. Some physicians perceive the shortcoming of the medical system and begin to move toward a new methodology. Many years ago, Knicker, a prominent Allergist and Immunologist, stated many years ago, in a challenge to his colleagues: "The estimated group of 40 million citizens with classical allergies is possibly the most underserved of all diseases in the U.S; medical marketing surveys suggest that many atopic individuals are not yet diagnosed or are poorly treated. In addition, there are millions of other individuals who have unrecognized adverse reactions to various antigens, foods, chemicals, and environmental or occupational triggers." (Knicker WT. Deciding the Future for the Practice of Allergy and Immunology 1985 Annals of Allergy.55;106-113 )

Selner and Staudenmayer stated: "...Allergists typically have focused exclusively on the respiratory system, the skin, and the gastrointestinal tract, to the exclusion of other body systems. They are generally not familiar with the toxologic literature which suggests that attention must be paid to symptoms other than those characteristically anticipated with IgE-mediated allergic response. Allergists must broaden their interests to include all body systems other than those traditionally associated with immunological phenomenon if they are to appropriately respond to patients needs and society's expectations."

They referred to the need for a whole systems approach - a comprehensive approach to the interactions of food, air, and water with human bodies. While Knicker and others urged allergists and immunologists to emerge from the practice of narrowly defining their specialty, into the real modern world, with all its unsolved medical problems, the American and Canadian Allergy associations moved to further limit the scope of their practice and focused on skin tests for allergy and asthma as an allergic disease related to pollen and dust allergy. The needs of sick people were neglected while professional debates and methodological arguments continue to this day.

More Biology is Needed In Medicine

A biologist sees living creatures connected to and interacting with their environment. It is normal for a biologist to think in terms of populations, food supply, seasons, weather, and social-behaviors, and to do field studies which reveal patterns of adaptation to specific environments. Anyone who has worked with animals or fish in closed environments knows how critical environmental conditions and diet are in determining both the behavior and the physical status of the residents. When a fish in an aquarium displays disturbed behavior, you do
not call a fish psychiatrist; you check the oxygen concentration, temperature, and pH of the water. You have to clean the tank and change the fish diet.

A proper biological method of medicine recognizes and solves problems in food, air, and water supplies. A steady flow of molecules from the environment enters the body of each individual through the air breathed and the food and liquids ingested. This body-input determines health and disease in whole populations over the long-term and the moment to moment functional capacity of the individual. The quality and composition of air, food, and water changes continuously. The illusion of food continuity in the supermarket conceals changes in the growth, contamination, storage, spoiling, transportation, and merchandising of food products.

Air Quality Inside Buildings

Air pollution, both indoor and outdoor, is a significant cause of health problems worldwide. Home environments contain airborne allergens, infections, irritants and toxins that can reduce the quality of life and cause disease. Indoor work and living environments concentrate air contaminants and create "sick buildings."

Every year, approximately 1,000 new chemicals are developed and added to the 70,000 chemicals, 9 million mixtures, formulations and blends of chemicals already in commercial use. Some of these chemicals are purchased for home use, others pollute work environments. Workers contaminated with industrial and agricultural chemicals bring some home on the clothing and skin. Few of these chemicals have been adequately assessed for their potential toxicity, either individually or in combination with other chemicals. Indoor air is often more polluted than outdoor air.  A decrease in indoor air quality is the result of reduced ventilation and efficient construction practices, sealing homes and office buildings from the outdoor environment. Reduced ventilation contributes to the "Sick Building Syndrome" (SBS) with symptoms such a headache, fatigue, malaise, mental confusion, eye and throat irritation, coughing and wheezing.

Air inside buildings contains local aerosols that are more concentrated than outdoor air. The term "dust" refers to the larger particles in the aerosol that settle on walls and furniture. A smoker in the living room of a house produces a toxic aerosol that permeates the rest of the house. Smoke particles settle on walls and every object in a room so that a smoker leaves a trail of contamination that non-smokers smell as soon as they enter the room. Indoor air contains a living aerosol of microorganisms that infect or trigger allergic reactions. Spores of bacteria and fungi are microscopic and may persist for months or years. The abundance of microorganisms, even in a very clean house, surprises most people who have tests done to assess air quality. Insects and their excretions and body parts form part of the aerosol. Allergy to dust mites is often recognized. Other insects are common and are usually not recognized.

See Airborne Fungal Diseases

Chemicals Found in Indoor Air

Hazardous chemicals are used at home. Studies have shown that cancer risks from airborne chemicals can be higher for home environments than for hazardous waste disposal sites. The concentration of chemicals is determined by the airflow (or lack of it),heating appliances, the use of chemcials such as cleaners, perfumes, paints, adhesives, furnishings and the smoking habits of the inhabitants.

Common Indoor Airborne Chemicals

  1. 1,1,1-Trichloroethane Benezene
  2. Formaldehyde Alipthatic Hydrocarbons
  3. Chlordane Chloroform
  4. Styrene Trichloroethylene
  5. Toluene Xylene
  6. Dichloromethane Tetrachloroethylene
  7. Alcohols N-Hexanol
  8. Ethyl Acetate Acetone
  9. Radon 4-Phenylcyclohexene
  10. Carbon Monoxide Carbon Dioxide
  11. Polycyclic Aromatic Hydrocarbons

There are 80 or more main chemical components found in cigarette smoke and a wide variety of toxins created from the degradation and out-gassing of synthetic and treated materials and plastics. Indoor air is often a greater source of exposure to hazardous chemicals than is outdoor exposure according to a study by the US EPA. They looked for 20 chemicals in a variety of locations and found 11 chemicals at all locations -
1,1,1-trichloroethane, p-xylene, ethylbenzene, tetrachloroethylene, o-xylene, p-dichlorobenzene, chloroform, trichloroethylene, and carbon tetrachloride.


See Learn More About Air Quality

Wednesday, May 05, 2010

Brain Drug Warnings: Antipsychotic Drugs For Seniors

There is growing problem with inappropriate and excessive drug prescription to people over the age of 65. Physicians routinely prescribe anti-psychotic drugs to their aging patients; the benefits are doubtful and the negative effects are well established. In a review of physicians’ attitudes and prescribing practices, Damestoy et al stated: “The inappropriate use of medications by elderly patients has become a public health concern because of its prevalence and its potential impact on patient autonomy…physicians were unanimous in their view of the aging process as a very negative experience.”

In April 2010, the drug company, AstraZeneca, agreed to pay $520 million to settle US government allegations that it illegally promoted the anti-psychotic drug Seroquel (quetiapine fumarate) as a treatment for medical conditions for which it had not received approval — such as Alzheimer's disease, depression and sleeplessness. AstraZeneca's total sales of Seroquel reached $4.87 billion in 2009.

Fick et al stated: “A literature search will uncover articles that describe the toxic effects of medications and drug-related problems for older adults. It has been conclusively demonstrated that the toxic effects of medications and drug-related problems can have profound medical and safety consequences for older adults, with enormous economic consequences on the healthcare system…. If medication-related problems were ranked as a disease by cause of death, it would be the fifth leading cause of death in the United States. Therefore, the prevention and recognition of drug-related problems in elderly patients is one of the principal healthcare ( aka medicalcare) quality and safety issues for this decade… An extensive survey of the literature was conducted of all relevant medications used in elderly patients…This study identified 48 individual medications or classes of medications to avoid in older adults and their potential concerns and 20 diseases/conditions and medications to be avoided in older adults with these conditions. Of these potentially inappropriate drugs, 66 were considered by the panel to have adverse outcomes of high severity. “

Some of the drugs prescribed are tranquillizers and sleeping pills that add to memory loss and confusion, effects that are easily ignored in the elderly.  More potent mind drugs harm elderly patients. These drugs will not correct aberrant behavior, improve cognition or memory but almost inevitably will disable and further damage an already compromised brain. Patient demand has always driven the prescription drug industry to produce more chemicals and physicians are encouraged to prescribe these chemicals for "off-label indications". A well–trained physician will understand that psychotropic drugs are mostly useful for brief interventions and that long-term use is usually not desirable. Patients become dependent on psychotropic drugs and many demand renewed prescriptions over many years. Damestoy stated: “Many of the (elderly) patients had been using psychotropic medication for a long time, some for as long as 20 years. Patients with a strong attachment to anxiolytic drugs… become demanding and difficult when their use of psychotropic drugs was questioned.”

The path of least resistance for physicians is to enquire little and renew prescriptions automatically. In a study of 224 patients with a diagnosis of probable Alzheimer's disease, that risk of deterioration was significantly higher among patients who were taking antipsychotics or sedatives compared with those who were not on any drugs. Patients who were taking both antipsychotics and sedatives had the highest risk of rapid deterioration.

Antipsychotic drugs were developed to treat schizophrenia, a disease of young people. The “atypical antipsychotics,” clozapine, olanzapine, quetiapine and risperidone have all been used to treat elderly patients, especially those with dementia. There is no evidence that any of these drugs will alleviate dementia in any way. They are used, for example, as “chemical straight jackets” to immobilize nursing home residents. Among the problems created by these drugs are Parkinson’s disease, weight gain, and diabetes.  Janssen-Ortho, the company that markets Risperdal (risperidone), issued drug safety information bulletin linking the drug to increased risk of strokes in elderly patients. Since there is significant doubt that this drug should be used in any elderly patients, the increased risk of diabetes and stroke is a definitive contraindication. The strength of the association between antipsychotics and diabetes varies. A number of reports implicate chlorpromazine, clozapine, and olanzapine. An Ontario study involving 20,000 patients in nursing homes revealed that 25% of the residents are prescribed antipsychotic medications within the first year of admission. I would suggest a more appropriate use would be less than 1% of residents.

The Institute for Clinical Evaluative Sciences, in Toronto, Ontario, Canada carried out a surveillance study of antipsychotic drug use in adults with dementia 66 years of age or older. The records of 20,682 adults living in the community and 20,559 adults living in a nursing home were examined. The most commonly prescribed atypical antipsychotics were risperidone, olanzapine, and quetiapine, and the most common conventional antipsychotics were haloperidol, loxapine, and thioridazine hydrochloride. They found that patients given antipsychotic drugs were up to 4 times more likely to be hospitalized or die within 30 days. They warned that serious side effects occur shortly after starting the therapy.

From the Human Brain in Health and Disease by Stephen Gislason MD

Friday, April 23, 2010

Mental, Neurological IIlness and Diet

While neurological diseases and “mental illnesses” appear to be a vast pool of suffering with diverse causes, mostly unknown, I continue to propose a simple and obvious approach to prevention and treatment of disease. I have written about nutritional programming (NP), an ambitious approach to diet design that addresses all the complicated issues of resolving health problems related to food intake, a form of molecular engineering or programming. Good, Fernandes and West stated in their review of Nutrition and Immunity many years ago: “We look forward to the time when the prophylactic and therapeutic potential of scientifically controlled diet, along with cellular, molecular, and hormonal engineering, may be realized and applied. Freedom of many disorders which have historically deprived us of our genetic legacy of a long and healthy life is certainly a worthwhile objective."


The food supply is critically important to brain function. There are many ideas which link food ingestion and the environment to brain dysfunction and disease. We can ask some simple questions to inspire further inquiry, such as: Are mental and neurological diseases diet related?


Are the victims deficient in critical nutrients, or poisoned by excesses of nutrients? Are some dementias caused by the toxicity of food additives, pesticides and/or food contaminants? Do these diseases combine food toxicity and food allergy and emerge slowly in complex combinations? Do the most afflicted people drink more alcoholic beverages, tea, and coffee; eat more fast foods, cheese, bread, or meat? Where do they live? What environmental toxins are common in their food, water and air?

These and related questions about diet and disease have never been answered in terms of meaningful research; however, there are a thousand clues in the research literature which point to diverse problems and many potential solutions . My experience with food-related psychopathology suggests that modern diets are probably responsible for cerebrovascular disease, most strokes, all diabetic neuropathies, some learning and behavioral problems in children, some mental illness, some depressions, some dementias and some neurological disease of unknown origin. The mechanisms are of these disorders are multiple and complex.

You can imagine an alternative world. For example, what if no-one ate too much of the wrong food and everyone did physical work every day? What if the consumption of tobacco, caffeine and alcohol disappeared suddenly? Would you expect humans in general would feel and function better? Would babies be born healthier? Would babies’ brains work better?

What if packaged, processed, fast foods disappeared tomorrow and every child ate more fruits and vegetables? What if children took a balanced vitamin-mineral supplement everyday? Would all those children feel and function better? Would their IQ scores be higher? Would they do better in school? What if combustion engines were replaced by fuels cells converting hydrogen to water? There would be no toxic hydrocarbons, less carbon monoxide and less carbon dioxide.

What if vehicular traffic vanished from cities and paved areas were replaced with walking and cycling paths, gardens, orchards, and flowers? What if vegetables were grown in market gardens within cities where parking lots used to be? Would human brains work better? Would urbanites be healthier, happier and more productive?

Why not continue imagining how you would construct an ideal world? You cannot imagine an ideal world without imagining an ideal diet and an ideal environment to live in.

Nutrition can be thought of as an idealized, abstract look at the possible (but not real) outcomes of eating food. The role of foods themselves, as objects of behavior and regulators of internal body dynamics, are relatively ignored. The possibility of things going wrong with digestion, absorption, and metabolism and with immune surveillance of these processes, while considered in medical science, is seldom a concern in medical practice. The dietitian often assumes that nothing will go wrong with food-body interactions - nutrients that are in the food are available to the body without complications. A physician generally assumes that nothing will go wrong during the processing of food or will consider a small number of adverse effects ignoring a number of pathological possibilities that may be the key to enigmatic disease.

To pursue a strategy of nutritional therapy, you assume that things routinely go wrong with food-body interactions. Since food ingestion creates dysfunction and disease by a variety of mechanisms, nutritional therapy is based on removing the causes of illness by correcting a faulty food supply. The supreme technique of nutritional therapy is, therefore, diet revision, a strategy of correcting disease by modifying food choices and eating behaviors.

Proper diet revision restores control over a confusing, chaotic set of circumstances and symptoms. A systematic method of diet revision with full participation of the patient in evaluating and selecting foods has never been included in medical practice.  Efforts to change a patient’s food supply also encounter the irrational elements of eating behavior. Diet revision often turns into a struggle with fast foods, compusive eating, emotional issues, family and societal issues.

The Alpha Nutrition Program evolved as a standard method of diet revision. The program should be viewed as a prototype that encourages the development of nutritional therapy as a systematic study. Since resolving delayed patterns of food allergy in common disorders such as eczema, migraine, asthma, and irritable bowel were priorities, this method of diet revision was influenced by allergy practice. The basic idea is to reduce or eliminate problem foods first. Once a patient clears their original symptoms, they have heightened reactivity and food challenges are more unpleasant, risky, and obvious.

Read the Human Brain in Health and Disease by Stephen Gislason MD

Monday, April 05, 2010

Weight Loss Fantasy and Fraud

Thousands of weight loss schemes have been marketed -some sincere but flawed, others frankly fraudulent. Some estimates of cost suggest over 40 billion dollars a year is spent in the USA alone on retail products and schemes offered for weight loss while increasing numbers of people are becoming obese. Diet Plans such as the Atkins diet and the South Beach variants are pitched by persistent advertising and many people join the parade of followers. Some lose weight, but almost all regain the weight they lost.


Infomercials, shown on cable TV promise that you can lose all the weight you want while you eat everything you want are false and not to be believed. This is what everyone wants of, course, a quick cure, but there is no easy path. It doesn't matter what they are trying to sell you - crab shells (chitin), fat absorbers, fat burners, magic mushrooms, wonder bark from Brazil, magic cellulite pills, pyruvate, creatine, garcinia cambogia, green goop, algae, magic genies in a bottle - it's all a great fantasy that will not come true.

There is no magic diet. The medical community, food industry, dietitians government health and regulatory agencies, magazine publishers and diet businesses are all helpless as Americans and Canadians consume excessive amounts of food and become increasingly obese. This epidemic of obesity threatens to bankrupt the health care system in both countries. Weight loss products and claims appear to be out of control as regulatory agencies in the USA and Canada only made token attempts to stop fraud.
A new wave of "reality" shows on TV show people attempting to lose weight and reveal how difficult it is to lose, how hard you have to work, how much you have to change your food choices and how much you will depend on other people to support your effort. The simple truth is – it's easier to gain weight than to lose it. Research has shown several important features of body weight management. There are powerful biological controllers of eating behaviors, appetite and weight regulation. There are genetic tendencies toward excess weight and obesity-causing gene mutations have been discovered. European and North American diets are flawed. There is excess fat and sugar in "normal" foods and food is too abundant. Eating has become entertainment. This is a bad idea if you want to stay slim. The modern lifestyle is flawed. There is too much sitting, too much convenience and too little physical work. Recreational eating must be abandoned in favor of recreational exercise

Weight issues are usually discussed as individual problems. The reality is that obesity is an expanding global problem. Because overeating causes many diseases, this global problem is often described as a disease epidemic that spreads like an infectious disease. An intelligent approach to each individual who is overweight is to recognize that this one person is a member of a group whose members all participate in creating dysfunction and disease. Obesity can only be understood as a family problem and then a societal problem. Remedies do involve changes in the behavior of individuals but these changes depend on a supporting group that changes the way the community operates.

Fat storage has a purpose and offers benefits. Everyone stores some white fat to provide insulation and body shape. Our facial contours are constructed from fat. The shape of women’s bodies differ from men’s bodies because of carefully designed fat deposits in the breast, abdomen and buttocks. Extra fat is a good insulator and keeps you warm. Extra fat is buoyant and helps you float in water. Marine mammals are all fat because they swim in cold water. Eskimos are fat so that they can survive cold winters when food is scarce. Brown fat is a source of heat; calories are burned in brown fat to warm the body.

Children hear stories about prudent animals who prepare for the future and do well and imprudent animals who only live for the present and perish. The child knows that squirrels store nuts for the winter and bees survive the winter by eating the honey they made during the summer. Bears get fat in the summer so that they can hibernate during the winter. The challenge of a seasonal food supply is expressed in acquisitive behavior, gaining weight and hoarding food. Most humans seem to have an odd mixture of prudent and imprudent behaviors and only a small number appear to be good at long-term planning. 
Humans are relatively tolerant of short-term food deprivation and take advantage of surplus by feasting and celebrating. The party aspect of human behavior links us strongly with carnivorous predators who gorge when they have made a kill and then rest. All overweight people would become slimmer if they hibernated over the winter and did not eat food for 4 months. All overweight people would become lean people if they as trained hard and long as an endurance cyclist. Long-distance athletes are the leanest people in town because sustained exertion causes muscle cells to use fat as fuel. If you train long enough and hard enough, most of your stored body fat is burned as fuel.

Diets Don't Work

Most therapists who have worked with overweight patients have stories of spectacular initial successes, with equally spectacular relapses weeks or months later. Obviously, there are unsolved problems in the weight-loss business. Carbohydrates are often blamed for weight gain and high fat, high protein diets have been promoted for 50 years and books proclaiming weight loss success are re-issued year after year without any reassurance that these diets are healthy or safe. Research in the 20th century showed that diets rich in plant foods and low in animal fat and proteins are the best diets for health from all points of view. The long-term consequences of high protein, high fat diets are well known; you get all the bad diseases that characterize modern civilization such as cancer, heart disease, strokes, diabetes and obesity.

This is not to argue that you could not lose weight on a high protein, high fat diet. You can lose weight by any method of reducing caloric intake, but that weight loss is not be relevant to your long-term success. It is to argue that you would be making a mistake if you lived on a high protein, high fat diet for many years. Pittas et al, for example, compared a high glycemic index, high-carbohydrate diet with a low-GI/low-carbohydrate diet resulted in comparable weight loss and increase in insulin sensitivity in 34 overweight participants. Both diets in the randomized, double-blind trial were designed to achieve 30% calorie restriction and followed recommendations for "healthy eating." The high carbohydrate diet was 60% carbohydrates, 20% protein, and 20% fat. The low-carbohydrate diet was 40% carbohydrates, 30% protein, and 30% fat. Both groups achieved a 10% reduction in BMI and 20% increase in insulin sensitivity. Dansinger et al. compared 4 popular diets (Atkins, Zone, Weight Watchers, and Ornish) for weight loss and cardiac risk factor reduction. and found that each diet modestly reduced body weight and several cardiac risk factors at 1 year. Overall dietary adherence rates were low. Increased adherence was associated with greater weight loss and cardiac risk factor reductions for each diet group.

Appetite and weight regulation are complex and vary from person to person. While there are some general rules, there are many exceptions to the rules. The solution to obesity, diabetes, high blood pressure, coronary artery disease lies more in the choice what foods you eat, how they are cooked, and how much you eat. The idea that you can predict the outcome of eating specific foods by the knowing the carbohydrate, fat, protein ratios is wrong. No matter what other argument seems appealing, the single enduring fact of healthy nutrition is that a diet rich in plant foods works best. Some plant foods such as wheat, however, may cause severe disease in people who are susceptible (as I am), so that no generalization will work for everyone.

Read More in Eating and Weight Management by Stephen Gislason MD

http://www.nutramed.com/AlphaBooks/EatingWeight_Managment.htm

Wednesday, December 23, 2009

Depression is Big Business

What is Depression ?


The term "depression" is descriptive and vague. I believe the whole concept of depression is flawed and needs to be revised. The term “depression” does not point to one discrete disorder but to a variety of unpleasant experiences common to all humans. When the term “depression” is used without qualification, it is usually misleading. Since antidepressant drugs have become a big business, the promotion of "depression" as a widespread illness, treatable with drugs has become a scandalous marketing enterprise with little or no merit. Although the term “depression” was an invention of psychiatry the use of the term is pervasive in medicine, the media and in folk psychology. Writers, TV journalist and MDs  have been talking about “clinical depression” as if “clinical” increased the credibility of this dubious term. The best use of the term “depression’ is to point to someone who is unusually and chronically sad, critical and angry; a person who withdraws from work, play and close relationships with other humans.

There are eight circumstances that cause sadness, anger and sustained dysphoria:

1. The inhalation, ingestion and injection of bad chemicals

2. Chronic illness

3. Oppression and abuse

4. Wrong food

5. Too little exercise

6. Noise, clutter and poor living conditions

7. Information noise and confusion

8. Loss of persons, property and prestige

All humans are involved in competition and negotiation with other humans. If you are losing a competitive struggle, you feel, sad and angry, sometimes with a terrible sense of loss; you want to withdraw, hide, cry and sometimes you want to die. If you habitually lose competitions or have an effective oppressor close by, you often feel dysphoric. We can call this social inhibition, oppression or suppression rather than depression.

Physicians have routinely prescribed drugs to patients who were sad, discouraged and thought of suicide. None of the drugs prescribed have reduced the overall suicide rates and new evidence suggests that some antidepressants increase the risk of suicide. For patients who died of an overdose, the prescriptions took on the ominous aspect of tools of self-destruction. The prescribing physician becomes an accomplice in the patient’s death.

Antidepressants

Antidepressants were a hard sell until recently. Although many drugs in this class modified the behavior of patients, their slow action and many side effects were negative features. The introduction of a “new class” of antidepressants that increase serotonin activity, led by Prozac changed the market for psychotropic drugs. The effects of Prozac on “personality” were widely publicized and drug companies advertise indirectly and, more recently directly to the consumer, relegating physicians to the role of middleman. The patient now demands the prescription and the doctor complies. The consumer hopes that Prozac and related drugs can increase energy, confidence and assertiveness. “Shy” people were added to list of potential customers.

Although writers such as psychiatrist Peter Kramer (Listening to Prozac) suggested that the patient's interest in personality changing drugs was a new market force, nothing new really happened; it is the same old interest in psychotropic drugs but the names, the players and the prices changed. Cocaine outsells Prozac, but the profitability of prescription antidepressant drugs is outstanding.

Goodman, Chair of the US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee made a public statement in 2006 that claims in drug monographs and advertising that selective serotonin reuptake inhibitor (SSRI) antidepressants work by normalizing serotonin levels are not based on scientific evidence and should be prohibited. Moynihan and Cassels described the drug industry's marketing tactics. With obscene profits from drug sales; a drug company can afford to control the naming and perception of diseases by physicians, government, and consumers. They create drug demand by advertising to consumers and doctors at the same time. For example, Cohn & Wolfe Healthcare, SmithKline's PR firm created “social phobia disorder” treatable with Paxil, which became the world's best-selling antidepressant, earning US$3 billion annually.

Brain Drugs -- Benefit or Harm?

A review of data, just published, from the US Women's Health Initiative study (involving 136,293 postmenopausal women) revealed that , 5496 women taking drugs from the two major antidepressant groups, tricyclic antidepressants (TCI) and selective serotonin-reuptake inhibitors (SSRI), had increased all-cause mortality; SSRIs users had a 45% increased relative risk of incidence stroke and a 32% increased risk of death with a higher incidence of hemorrhagic strokes. The incidence of stroke per 1000 person-years with no antidepressant use was 2.99; the incidence for SSRI users was 4.16 for. Death rates for per 1000 person-years were 12.77 for SSRI users and 14.14 for TCI users, compared with 7.79 for non–antidepressant users. Studies of this nature cannot differentiate the negative effects of dugs from the underlying disease processes. In medical talk, depression has assumed a false reality, becoming a malevolent agent that acts upon its victim. While sad, tired and angry people are real, depression is not real and is not a cause of something else such as a stroke. My conclusion is that antidepressant drugs are potentially harmful and can add to the existing pathologies that they pretend to treat

Antidepressants are chemicals that are added to a dysfunctional chemical mix that caused dysfunction and dysphoria in the first place. Few patients make any effort to alter their disease-causing lifestyle and few physicians make any effort to investigate and improve the patient’s chemistry overall. Psychotropic drugs are added to the dysfunctional chemical mix and its effects merge with coffee, alcohol, the chemistry of food additives, and contaminants, sugars, food allergy and airborne neurotoxins that act on the brain.

New problems added by the prescription chemical may suddenly emerge such as unexpected bursts of anger and aggression or increased tendency to have violent suicidal thoughts. One young woman reported to me that after taking Prozac for two weeks, she had threatened her live-in boyfriend with hammer, chased him into the bathroom and attacked the closed door, smashing holes in the door until she more or less recovered composure. Her boyfriend fled the apartment and never returned. The boyfriend was domineering and verbally abusive, as boyfriends sometimes are, but the pre-Prozac young woman was usually compliant and never had a violent temper. Her Prozac rage is an example of chemically triggered behavior. Prozac may provoke agitated preoccupation with suicide or violence directed against others. The drug facilitates the rage response, as do most of the drugs that suppress appetite. Up to 73% of patients taking antidepressant report sexual dysfunction, such as diminished sexual desire, delayed sexual arousal, and muted or absent orgasm.

Fisher suggested that these drugs blunt emotions and interfere with forming and maintaining meaningful relationships. When men and women take serotonin-enhancing drugs and fail to achieve orgasm, an important feature of pair bonding fails. You would not be surprised to learn that a woman taking Prozac decided to divorce her husband, stating that she no longer loved him. After she stopped taking the drug, she loved him again and stayed married.

Prozac can facilitate the rage response and may lead to acts of aggression and violence that otherwise would not occur. Prozac also inhibits appetite for food and sexual appetites; sometime useful effects, but not always. In Canada, three similar antidepressants were among the top-selling drugs; these are Prozac, Paxil, and Zoloft. Lauren Slater called Prozac the "Big Mac of Medicine" because of its popularity and the faddish consumer appeal based on the futile hope that a drug could resolve human suffering. She described the dramatic and brief benefits of taking Prozac: "those first few mornings were fairy tales, tall tales, replete with all the bent beauty of a New World." Her story is not simple, however and the long-term effects of taking the drug are mixture of benefits and negative effects. The initial recovery from depression is not sustained and a three or four phase sequence can often be discerned, beginning with an initial improvement that occurs in the first 2 to 4 weeks. The statement “the first time was the best time" applies to most, if not to all psychotropic drugs.

In Slater's experience, Prozac removed her sexual drive, blunted her creativity and reduced her appetite. The underlying problems are many and begin with the lack of specificity of the drug. Prozac blocks Serotonin re-uptake and in stage 1 of its activity, probably increases serotonin receptor activity in all areas of the brain. Serotonin synapses are not all conveniently arranged just to alleviate depression and a whole complex of unrelated functions are affected. The brain is not passive and changes to offset or accommodate the drug activity; the effects then shift to an adapted state, different from the initial drug-dependent state. The person taking the drug has also shifted in terms of behavior and learning and may be learning new skills and, at the same time, coping with new problems such increased anger, loss of libido and blunted feelings.

Martin Enserink reviewed the development of antidepressant drugs and stated: ‘Antidepressants have evolved through several generations since the 1950s, each a “huge improvement” over its predecessor--or so advocates have claimed. But a government-sponsored study published last month confirmed what other analyses had shown before: The fashionable antidepressants of the 1990s are no more effective than those of previous generations. The study, a meta-analysis commissioned by the Agency for Health Care Policy and Research (a part of the Department of Health and Human Services, USA) and carried out by the Evidence Based Practice Center in San Antonio, Texas, looked at 315 studies carried out since 1980. It focused primarily on the hottest pills that have hit the market since 1987, the "selective serotonin reuptake inhibitors" (SSRIs), a group that includes such brands as Prozac, Paxil, and Zoloft. The study found that on average, about 50% of patients in SSRI treatment groups improved, compared to 32% in placebo groups. But in the more than 200 trials that compared new drugs with older ones, the two classes proved equally efficacious. Because the newer drugs appear to have less severe side effects, however, patients may be able to stay on them longer. The failure to find evidence of progress is disappointing, scientists admit. And one of the biggest disappointments is that researchers still don't understand what causes--or relieves--depression. Most antidepressant drugs are based on the assumption that depression results from a shortage of serotonin or norepinephrine in the brain. Both are neurotransmitters, chemical messengers that cross the synapse, the cleft between two nerve cells. The first generation of antidepressants, discovered during the early 1950s, the MAO inhibitors, block monoamine oxidase, an enzyme that breaks down serotonin and norepinephrine. This allows the neurotransmitters to linger in the synapse, increasing their effect. Another type of drug discovered in the late 1950s, the tricyclics, prevents the nerve cells that excrete the neurotransmitters from mopping up these compounds shortly after they are released. Blocking "reuptake" also prolongs their effect. Because studies pointed to serotonin shortage as the main culprit in depression, industry developed the selective reuptake inhibitors, which now dominate the market.”

Data from United Kingdom's General Practice Research Database of 6.4 million patients were used to discover a relationship between antidepressant use and diabetes 2: 165,958 patients were identified who received at least 1 new prescription for an antidepressant between January 1, 1990 and June 30, 2005. The researchers conclded that taking moderate to high daily doses of antidepressants for more than 2 years is associated with an 84% increased risk for diabetes.The increased risk was particularly notable for the selective serotonin reuptake inhibitor (SSRI) paroxetine and the tricyclic antidepressant amitriptyline. Another study, the Diabetes Prevention Program (DPP) trial found that antidepressant use over an average of 3.2 years was associated with an increased risk for diabetes of 2.60 in the placebo group and 3.39 in the lifestyle-intervention group, but there was no increased risk in the metformin group. Paroxetine caused a 4-fold increased risk for diabetes above 20 mg/day. Related drugs, fluoxetine, citalopram, or sertraline did not increase the risk.

From the book: The Human Brain in Health and Disease by Stephen Gislason MD

Saturday, November 28, 2009

Impermanence & Plasticity

Everything changes. The largest chunk of uncertainly is impermanence. There are constant paradoxes and contradictions built into our brain function. We must be alert to notice and respond to changes but, at the same time, attempt to be stable and consistent. Our visual system is designed to notice minute changes but ignores most of the movement around us to create the illusion of a stable world in consciousness. Growth, development, and aging are the main expressions of predetermined impermanence that combines DNA programming with environmental opportunities and hazards.

You could argue that brain growth and development changes are most vigorous in the first 20 years of life; later, after a brief period of relative stability, degenerative changes take over, accelerating with advancing age.

A big problem we have is that while the world around us changes, we also change and the biggest changes occur in our brain. The idea of one personality remaining stable over many years is actually absurd, but we are tempted to believe in an enduring self. An astute observer will notice that each day brings forward a series of different personalities within one body. I call these personalities eigenstates. The self is not one entity but rather consists of a collection eigenstates that serve different needs, roles and capabilities. Some eigenstates are built it others are learned and remain open-ended, evolving with changing circumstances.

Learning, in the best case, is adaptive impermanence that requires changes to brain structure and function. We will consider, for example, that learned movements are generated from dynamic cortical maps based on fields of activity that converge and diverge in complex patterns. Over time, the pieces of the map change with learning and practice, so that the construction of cortical connections is always in flux. This impermanence allows us to learn at all stages of life, to adjust to changing environments and, to some extent, to work around disabilities that arise from brain injury and disease.

Among affluent self-indulgent humans, there is conspicuous age denial and much promotion of anti-aging products and procedures. While, in the best case, humans can continue to learn into old age, the facts are not so encouraging. All brain functions decline with age and degenerative brain diseases appear with increasing frequency as the years advance. Slogans such as use it or lose it may contain some truth, but it is never obvious that high functioning elderly humans are doing well because of brain exercise with crossword puzzles rather than by luck, cleaner air, better DNA and superior diet. It is more obvious that sustained physical activity, reduced caloric intake and good nutrition are the keys to high functioning aging.

Too often, I am an unwilling victim of television news nonsense and plasticity is a current favorite topic. Brain damaged survivors are shown with plausible mental abilities, as if their example refuted neuroscience beliefs. The term plasticity has crept into neuroscience jargon and should be erased from the vocabulary. I am not aware of the source of plastic metaphor and can only assume that it refers to a material that can be coaxed into different shapes by heat and pressure using a variety of machines. I cannot see any connection between the malleability of plastic and the constant flux that characterize brain function.

Even smart, educated humans participate in these media delusions. For example, I was surprised to read a report by Allison Gandey from a meeting of the American Academy of Pain Medicine that revealed basic ignorance among a group of smart professionals. She stated: " Some suggest the discovery of neuroplasticity is the most important breakthrough in neuroscience since the revelation of the brain's basic anatomy. Proponents say the brain is pliable and can alter its structure and function. " One MD even admitted:" We used to think the brain was wired after about the first 3 years and what you had was what you got and you work within that because there was no chance of changing it. If on top of that the brain was damaged, you had to live with that damage. Neuroplasticity says that's not so — the brain is changing all the time."

It is true that the brain is changing all the time, but it is not true that this is a discovery or a breakthrough. It is also not true that lost function is easy to recover. While it might be true that limited recovery of function is possible after brain injury, it is more true that loss of function tends to be permanent after the initial recovery in the first few months. You might consider that some physicians are just like everyone else, entertaining erroneous assumptions and unrealistic fantasies, but then, I also read rather naive comments about plasticity in the neuroscience literature.

Let me restate what should be a basic premise of neuroscience: All learning is adaptive impermanence that requires changes to brain structure and function. Another premise is that if learned skills are not refreshed through practice, skilled performance deteriorates.

You can fantasize opportunities to intervene with new technologies in the future to compensate for lost brain function, but progress to date is minimal. While there are limited populations of stem cells in the brain, their proliferation presents a hazard (aka cancer)more than a solution for degenerative brain diseases.

There is a growing body of knowledge about the growth and development of the brain from conception through adolescence; one important feature of childhood and adolescence is the pruning of synaptic connections. To make real sense from the facts as we known them is that brain structure and function is in turbulent flux with abundant opportunities for things to go wrong for 20 years. In the best case, a confused, rebellious adolescent will become a responsible adult who is a little more stable for the next 20 years and then begins a descent into cognitive decline. To believe that the brain is a finished organ at any age is nonsense. At the same time, you need to know that neurons are long lived cells that can survive from their origins in the fetus through old age. The cell body of the neuron must endure for its synaptic connections to change. The most dynamic structures are spines on dendrites and the synapses themselves. Damaged axons can regenerate if the cell body is still alive.

One basic idea in neuroscience is that the old brain is preprogrammed with maximal automaticity and stability whereas the neocortex is built to be modified. Survival depends on the stability of neuronal circuits in the oldest part of the brain. The critical controllers of respiration and cardiac function must be reliable or you die. You might compare the neocortex with dynamic random access memory in a computer that is programmable, stores memory, and can be erased.

There are time critical episodes in early development that leave no opportunity for recovery if things go wrong. Knudsen stated:" during a critical period, a neuronal pathway awaits specific instructional information encoded by impulse activity to continue developing normally. This information causes the pathway to commit irreversibly to one of a number of possible patterns of connectivity. There are critical periods for the development of form vision and stereopsis and for the development of appropriate social responses to members of the same species. "

See Neuroscience Notes by Stephen Gislason MD

Wednesday, September 23, 2009

Naproxen Wins the Best NSAID Award.

I have followed the saga of nonsteroidal anti-inflammatory agents (NSAIDs) since Vioxx was withdrawn from the market in 2004. Rather intense reviews of NSAIDs followed with uncertainty about which drugs were the safest to use. As of Sept.2009, the winner is Naproxen, in doses less than 1000 mg per day.

A large retrospective study examined the medical records of 48,566 adults between the ages of 40 and 89 years who were admitted to hospital with coronary artery disease. The databases used came from Canada, the United States, and the United Kingdom. The study found that naproxen was not associated with a higher risk for coronary heart disease events or cardiac death in patients with a history of coronary heart disease. However, ibuprofen; high-dose celecoxib; high-dose rofecoxib; and, diclofenac, did increase this risk.

Relative to naproxen, current users of diclofenac had increased risk of serious coronary heart disease x 1.44 and serious cardiovascular disease/death x 1.52; ibuprofen had increased risk x 1.25; coronary heart disease risk increased for rofecoxib >25 mg x 2.29; celecoxib >200 mg x 1.61.

Recall that in September 2004, Merck & Co announced a voluntary withdrawal of Vioxx from the U.S. and worldwide market due to safety concerns of an increased risk of heart attacks and strokes, according to an alert from MedWatch, the U.S. Food and Drug Administration (FDA) safety information and adverse event reporting program. Vioxx was one of several selective COX-2 inhibitors that were marketed aggressively as the best drugs for pain relief. Because they were prescription drugs and more expensive, patients believed they were better than ASA, ibuprofen, diclofenac or naproxen but this was not true.

The claimed advantage of the COX-2 inhibitors, slightly lower incidence of gastrointestinal bleeding was supported by some but not all studies Cox-2 inhibitors that offered no advantage in terms of pain relief and anti-inflammatory effects. The fate of COX-2 inhibitors has been dismal. A growing controversy surrounded the use of Cox-2 inhibitors since their introduction in 1999. The drug companies involved were competing to secure a large share of the multi-billion-dollar-a-year market for pain-relieving anti-inflammatory drugs. A news report in 2002, for example, warned people that: "Elderly patients taking Vioxx, the most popular arthritis drug in Canada, were twice as likely to be hospitalized with major gastrointestinal bleeding than those taking its pharmaceutical competitor, Celebrex. In 2002, 3.4 million prescriptions for Vioxx were filled across Canada; 3.1 million for Celebrex.

The Therapeutics Initiative Newsletter in BC issued the following COX-2 inhibitors update in 2002: “Based on FDA data from the CLASS and VIGOR studies, COX-2 selective inhibitors are associated with an increased incidence of serious adverse events as compared to non-selective NSAIDs."

Reference: Ray WA, Varas-Lorenzo C, Chung CP, et al. Cardiovascular risks of nonsteroidal antiinflammatory drugs in patients after hospitalization for serious coronary heart disease. Circ Cardiovasc Qual Outcomes 2009; 2:155-163.

From the 2009 book, Heart and Arteries by Stephen Gislason MD

Wednesday, July 29, 2009

Mental Illness

When someone's brain is not working properly others describe them as "mentally ill." Mental health and mental illness are poorly chosen terms that obscure the medical and social issues that arise whenever human dysfunction is examined. The hospital in my community has a separate building described on a sign as “Mental Health and Addiction Services.” I suspect that the staff and the patients that use this building do not understand what “mental health” means. I am certain that the juxtaposition of the words “health” and “addiction” is a mistake.

Kurt Vonnegut described the cause of mental illness as “bad chemicals.” Humans are unrealistic about what substances they can safely ingest, inhale and inject into their bodies. Humans are most unrealistic about how easily and how profoundly small amounts of external chemicals can affect their mind. They believe that they are tougher than they are. Modern psychiatric theory imagines bad chemicals or good chemicals in the wrong amounts manufactured by mistake inside the brain of each victim. Physicians often view the brain as a black box with no chemical input except the drugs they prescribe. A neurobiologist will recognize that numerous chemicals arrive from the outside to interact with brain chemistry. Bad chemicals in the food supply can disturb brain function in entire populations with endemic brain dysfunction as the result.

The World Health Organization claimed that one-fourth of the world’s population is affected at any time by depression, other mental disorders or substance abuse problems. According to the WHO report: "Women are more often affected then men. The higher prevalence of mood disorders in women may include the frustration of relying on the role of housewife for identity and self-esteem; lack of personal income; and for those who do work lower pay and more labor-intensive jobs than men." In addition, violence against women has been recognized as a growing problem. Some studies show that as many as half of all women living on planet earth have been physically abused at some time in their lives. Their abusers are mostly men and most of those men are boy friends, spouses, family members or close “friends.”

Kessel et al suggested that half of all Americans will have a mental illness during their lifetime, with symptoms beginning in the teen years for many. They favored diagnoses such as mood disorders, anxiety, impulse control and substance disorders. Rather than using fuzzy terms such as “anxiety, mood disorders or depression,” we can recognize “mental illness” as a variety of interacting maladaptations caused by bad genes, bad chemicals, bad food, infections, malnutrition, poverty, oppression and abuse.

Mental disturbances are the first symptoms of bad environments that substitute disease-causing conditions for healthy conditions.

Mental illness is often self-inflicted by overeating the wrong foods, drinking alcohol to excess, using and abusing drugs obtained from both legal and illegal sources.

Social Chaos

Common effects of erratic brain function are conflict and chaos. Two people living together with erratic brain function increase chaos by more than a factor of two. More people interacting erratically increase chaos exponentially until family structures, community structures, and national structures become dysfunctional.

Bad chemicals entering human brains from polluted air and water, wrong foods, alcoholic beverages, legal and illegal drugs is a recipe for a society's dysphoric disintegration. We might better appreciate the folly of "fighting a drug war" when we realize that most chemical demons live at home. Unfortunately, in terms of substances that can impair brain function, “drug sellers" include every corner store, fast food outlet, pop vendor, pharmacy and supermarket. Local bars and liquor outlets generate a continuous stream of social and health problems at an enormous cost to society.

We must be smart enough to see the connections among food materials which influence brain function: alcoholic beverages, nicotine in tobacco, teas, coffee, chocolate, spices, food additives, sugar excess, wheat, milk, eggs, prescription drugs and street drugs. We should be very concerned about the prescription drug problem with drug addiction and dependency that is supported by all our institutions. Unfortunately, the practice of medicine has become a drug-pushing affair. An addicted society will better tolerate the social pathology and diseases caused by tobacco smoke, alcoholic beverages, air pollution, bad food, sedatives, antidepressants, tranquilizers, and sleeping pills but displaces its dysphoric energy in a "drug war" against cocaine, heroin and a few other "drugs of abuse".

Humans are seldom consistent in setting goals and priorities so that societal confusion about the use and abuse of food chemicals and drugs is more or less predictable. Smart policy makers will, however, understand that most citizens are under the influence of one mid-altering drug or another. The daily use and abuse of several brain chemicals produces mentally disabled people who are neither reasonable nor correct in their thinking and conduct. When physicians intervene and prescribe more chemicals, they add to the chaotic mix, not realizing there is there is little hope of benefit. To my way of thinking, this “drug psychotherapy” has become a perverse enterprise with no happy endings in sight.

Read the Human Brain in Health and Disease by Stephen Gislason MD

Tuesday, July 21, 2009

Pandemic Viral Illnesses Occur Every Year.

A Perspective

What interests me and other science philosophers is how nonsense routinely overwhelms reliable knowledge. Humans appear to have an endless capacity and need to generate nonsense. Nonsense is generated, in part, as nominal fog that obscures a simple truth - we do not know what will happen next. "Experts" are just as limited as the most ignorant and opinionated nonsense generator. You could, without any hesitation, award television news media with the Oscar for the best nonsense generators of the year. Their nonsense spreads worldwide with speed and penetration that would make any virulent virus envious.

There are a host of current examples of noumenal fog generators under titles such as Health Care, Economy, National Security, Terrorism and most recently, Pandemic. Whenever these key words appear, have a look, you will not be disappointed -- the ratio of nonsense to sense will be at least 9 to 1.

I have chosen today to do a brief review of the Swine Flu Scare of 2009 - a great pile of nonsense that seem to have overwhelmed even the most cautious of scientists. This is not to argue that H1A1 viruses are innocuous, but to develop a perspective on the relative threats of viruses in general and to reveal that the evidence for swine flu as a special threat is lacking.

In the Northern hemisphere, viral epidemics cause up to 80% of all respiratory illnesses. The most common infections are caused by six viral groups: rhinovirus (RVs), respiratory syncytial virus, influenza virus, parainfluenza virus, corona virus, and adenovirus. In one study of 285 children admitted to hospital with lung infection, viruses were identified in 125 - respiratory syncytial virus (107), influenza (9) and parainfluenza type 3 (9). Clinical and radiologic diagnoses included bronchiolitis (127), interstitial pneumonia (47) and lobar pneumonia (91).

Rhinoviruses often referred to as “cold viruses” cause the majority of respiratory illnesses. Other viruses contribute to waves of colds, coughs, bronchitis, asthma and pneumonia that pass through every human population in epidemic patterns. Colds are rhinovirus infections that are usually mild and self-limiting but are more serious in premature babies and children with chronic diseases or immunosuppression. The average child can expect to have four to eight rhinovirus infections per year, and adults have three to five infections.

Respiratory Syncytial Virus is spread by coughing and sneezing; by close contact with sick patients or by hand contamination. Infection develops in care -givers who touch their eyes or nose with contaminated fingers.

Adenoviruses While Influenza viruses are well-known and epidemics of more virulent influenza strains are feared, other less known viruses, especially adenoviruses, tend to be common and can produce severe illnesses. For example, adenoviruses are the second most prevalent cause of acute lower respiratory infection of viral origin in children under four years of age in Buenos Aires, Argentina. Pneumonia was observed in 71% and bronchiolitis in 29% of children admitted to hospital with adenovirus infection. Wheezing occurred in 58% of the children. Four children died (a fatality rate of 16.7%). Adenoviruses have emerged as important pathogens in immunocompromised patients, in whom disseminated disease occurs frequently and is associated with a high mortality rate. For over 25 years, the US military controlled adenoviral respiratory infections through immunization of its members. A group of Navy physicians reported a “large epidemic of respiratory illness due to adenovirus in healthy young adults” after adenovirus vaccine supplies were depleted.

The US military medical services are perhaps best equipped to diagnose and treat adenovirus infection which cause outbreaks of disease among military recruits. A National Surveillance for Emerging Adenovirus Infections system includes military and civilian laboratories at 15 sites in the USA. Fifty-one adenovirus serotypes have been identified. In 2007 the emergence of a virulent Ad14 variant spread through the United States with some deaths. Ad14 infection was described initially in 1955 and was responsible for an epidemic acute respiratory disease in military recruits in Europe in 1969. In 2001-2002, Ad14 was associated with approximately 8% of respiratory adenoviral infections in the pediatric ward of a Taiwan hospital, with approximately 40% of Ad14 cases in children aged 4-8 years manifesting as lower airway disease. During the years, 2004-2007, the US surveillance system detected 17 isolates of Ad14 from seven sites. During March-June 2007, a total of 140 additional cases of confirmed Ad14 respiratory illness were identified in Oregon, Washington, and Texas. Fifty-three (38%) of these patients were hospitalized, including 24 (17%) who were admitted to intensive care units (ICUs); nine (5%) patients died

Influenza viruses cause epidemic respiratory illness every winter in most countries on the planet. New virus strains spread globally and cause prolonged illness and some deaths. The routine death toll in the US and Canada every year has been estimated to be 32,000 people.
Since the exact cause of fatal pneumonia is seldom correctly diagnosed, the fatality rate for influenza ( and other viral infections) is not really known. Other viruses also cause illnesses that spread globally with substantial morbidity, cost and some deaths. Influenza often begins with cold symptoms and progresses to involve the lungs. Most patients develop a chronic cough that can last for weeks. Pneumonia can develop and is a common cause of death.

Much publicity has been given to the possibility of an especially virulent strain emerging that will increase the death toll from thousands per year in the US and Canada to millions. Some virologists were concerned that influenza virus epidemics in birds would produce a newly virulent human virus. The World Health Organization warned that the world was not prepared for the next pandemic ( true). As of January 2006, the strain of avian influenza, A (H5N1), has been identified in only 148 human, 79 of them fatal, from direct contact with infected birds. The strain was first detected in Hong Kong in 1997 and has spread through Southeast Asia and then in Russia and Turkey. So far, bird flu has not become a major threat to human survival.

In 2009 a H1N1 variant ("swine flu") emerged and caused another media frenzy; the WHO declared a "pandemic" and despite reports of a relatively mild illness with a low mortality rate, news anchors began to refer to a "deadly virus" (false). The positive aspect of the scare tactics was increased international cooperation in monitoring the spread of the virus and increased funding of vaccine development.

Some of the fear was generated by comparison with the 1917 flu pandemic caused by another H1A1 virus. The truth is that speculations adn predictions based on very limited knowledge of that pandemic are likely to be wrong. While you can argue that every year, influenza and many other types of viruses create pandemics and every year more virulent strains could emerge, there is no reliable knowledge that allows experts to predict what will happen next.

Airborne causes of illness are discussed in the 2009 book,
Air and Breathing by Stephen Gislason MD

Monday, May 11, 2009

Who knows how to treat high blood pressure

We might wish that all the effort in hypertension research over several decades had determined an optimal approach for the treatment of hypertension. Instead, the proliferation of often-conflicting study results creates confusion and less certainly about an optimal approach. A public health approach would change the nation's diet, encourage exercise and launch a vigorous assault against obesity. Diet changes require less sodium, less sugar, less fat, more fruits and vegetables. Taking drugs is more popular since it requires no effort and no change in habits.

MDs are willing to prescribe several drugs to achieve “normal” blood pressure. In contrast, the US, the National Heart, Lung and Blood Institute the sponsor of the ALLHAT study, launched a High Blood Pressure Education Program in 2006. They hoped to encourage patients to adopt healthier lifestyles and to influence physicians’ drug prescribing habits. They stated that the basis for the program is the ALLHAT conclusion that " diuretics are more beneficial than calcium channel blockers (CCBs), angiotensin converting enzyme (ACE) inhibitors, or alpha-blockers as initial treatment to lower blood pressure and to protect against adverse effects of high blood pressure."

American Society of Hypertension issued Diabetes Guidelines 2008

ASH called for patient-centered management and early, aggressive treatment of hypertension in diabetics. Their advice might apply to everyone. The ASH urged physicians to adopt a more integrated, individualized approach to treating hypertension by treating the intricacies of each patient rather than focusing on the disease in isolation. Goal blood pressure in hypertensive diabetic patients remained 130/80 mm Hg. All patients should reduce weight reduction, improve diet, increase physical activity, limit alcohol consumption, never smoke and limit salt intake to less than 2.4 g/day. The report stressed a reduction to glycated hemoglobin [HbA1c] to less than 7% mantaining finger test fasting glucose levels in the range of 70-130 mg/d. Low-dose ASA (aspirin) 80 mg/day was recommended. Lipid leves in the blood should be: low-density lipoprotein cholesterol <> 40 mg/dL in men and > 45 mg/dL in women. Potassium levels should be kept to < 5 mEq/L.

2009 Update

In a best evidence review Vega stated:”Angiotensin-converting enzyme (ACE) inhibitors are some of the most commonly prescribed medications for hypertension. This enthusiasm for ACE inhibitors is somewhat inconsistent with current recommendations, which prefer thiazide diuretics as first-line medication for uncomplicated cases of hypertension. With the popularity of ACE inhibitors in mind, investigators conducted a systematic review of published studies to determine how effective the drugs actually are in reducing blood pressure.”

The conclusions: ACE inhibitors (benazepril, moexipril, ramipril captopril) were associated with an average reduction in systolic blood pressure between 6 mm Hg and 9 mm Hg and in diastolic blood pressure of 4-5 mm Hg; all drugs in this class are similar and achieved most of their power in reducing blood pressure at half of the maximum recommended dose, or less. Related drugs, angiotensin receptor blockers (ARB), provide similar modest reductions in blood pressure; 46 randomized controlled trials examining 9 ARBs, and found that average reductions in systolic and diastolic blood pressure were 8 mm Hg and-5 mm Hg, similar to ACE inhibitors. ARBs were effective at one eighth to one half of the manufacturers' recommended doses.There is no strong evidence that ACE inhibitors can prevent diabetes or heart failure.

An analysis of the Treating to New Targets (TNT) study was presented at the American Society of Hypertension 2009 Scientific Meeting. Messerli et al published did an analysis of the INVEST study, a trial comparing two antihypertensive regimens in 22 576 patients with hypertension and coronary artery disease, and found that excessively lowering diastolic blood pressure was harmful. Messerli stated: "It stands to reason that when you lower blood pressure too much, you can do harm. After all, if blood pressure is zero, mortality is 100%. So somewhere there must be a nadir, below which the lowering of blood pressure becomes counterproductive."

Compared with the reference blood pressures -- systolic >130 to 140 mm Hg and diastolic >70 to 80 mm Hg -- patients with systolic blood pressure <110 mm Hg had a threefold increased risk of cardiovascular events, whereas those with diastolic blood pressure <60 mm Hg had a 3.3-fold increased risk of events. Messerli suggested that lowest point of inflection on the morbidity and mortality curves was 140.6 mm Hg for systolic blood pressure and 79.8 mm Hg for diastolic blood pressure.

References

Bakris GL, Sowers JR; on behalf of the American Society of Hypertension Writing Group. ASH Position Paper: Treatment of hypertension in patients with diabetes -- an update. J Clin Hypertens (Greenwich). 2008;10:707-713.

Charles P. Vega .How Effective Are ACE Inhibitors for Hypertension? A Best Evidence Review. Posted Medscape Online 03/13/2009

Heran BS, Wong MM, Heran IK, Wright JM. Blood pressure lowering efficacy of angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2008;(4):CD003823.

Bangalore S, Messerli FH, Wun CC, et al. J-curve revisited: An analysis of blood pressure and cardiovascular events in the Treating to New Targets (TNT) trial. American Society of Hypertension; May 7, 2009; San Francisco, CA.

Tuesday, April 28, 2009

Swine Flu and Infection Risk

The emergence of a new influenza virus has created a frenzy of misinformation and panic. TV news shows people wearing paper face mask, the latest signal that the world is a dangerous place. While I have broadcast my concern for many years that infection surveillance is inadequate and promoted a new ethic of social responsibility, I find the frantic media reports this week to be offensive if not absurd. Social responsibility means -- don't spread infections you have acquired; if you are sick, stay at home.

There are real dangers in the world. Infectious agents evolve continuously. Increasing populations and increasing urban density are ideal for infection transmission. Transportation of people and goods all over the world means that infections become worldwide in a matter of days, not localized. I continue to meet physicians who think they are living in the nineteeth century and refer to localized, "endemic" infection.

Solutions can only be found by well-informed, calm methodical people. Turn off CNN and let us proceed with caution and appropriate concern. In my business, we have looked at air quality issues for several decades. Here is a response to a typical question we addressed:

Question: I do a lot of international flying, from North American to Asia, several times a month. I have gotten, many times, upper respiratory infections, bronchitis, bad coughs that my physicians, as well as my common sense, tells me comes a great deal from the poor air quality on airplanes. In addition, just the past week, with the outburst of some kind of Asian virus with serious symptoms, I want to protect myself as much as possible, while at least on the airplanes. What masks do you suggest, and any other comments or suggestions you might have?

Answer: We have looked at this problem repeatedly over 2 decades and not arrived at a satisfactory method of personal protection except for canceling the flight. You have to accept that traveling involves exposure to thousands of strangers who may infect you with microbes most of which, you have not encountered before and you will lack protective immunity. This increased exposure begins when you leave home and continues even after you arrive back.

You have to disinfect everything, including yourself, before you are free of foreign microbes. It’s easy to focus on the in-flight conditions, but exposure in the aircraft is only a small component of the overall risk of infection when you travel. Biological agents infect through the respiratory mucosa; ingestion; contact with the mucous membranes of the eyes, or nasal tissues; by penetration of the skin through scratches, small cuts and abrasions Organic airborne particles share the same characteristics in air or on surfaces as inorganic particles from hazardous dusts.

Here is a quick summary of the basic strategies you can use:

Disposable paper face masks provide minimal protection against dusts, fungal spores and bacteria, but not viruses. These are obviously the cheapest, most available and probably most acceptable to wear in public including in airports and perhaps on a flight. The protection rating is hard to assess, but is probably very low in the range of 5-10. Paper masks with a NIOSH protection rating of 100 offer better protection against viruses, if you wear them properly.

The mask has to be changed often and you must wash your hands after handling the mask. For more serious protection you can use half-mask or full-face air-purifying respirators with particulate filter efficiencies ranging from N95 (for hazards such as pulmonary tuberculosis) to P100 (for hazards such as viruses). The protection rating is somewhere between 50-200, depending on the filter chosen and degree of proper utilization.

The best protection against airborne infectious agents (as well as all airborne toxins) is provided by self-contained breathing apparatus (SCBA) respirators with a full facepiece operated in a positive pressure mode. This reduces the hazard from most sources -- airborne particles, microbes, chemical vapors and gases. The National Institute for Occupational Safety and Health (NIOSH) suggests that the proper use of SCBA reduces the user’s exposure by at least 10,000.

Decontamination of clothing is a precaution against particles that have settled on the outside. Use detergent, hot water, and 0.5% hypochlorite solution (one part household bleach to 10 parts water) to wash clothes and baggage. You should wash your hands frequently and shower ASAP after a flight using generous quantities of detergent and water. Shampoos contain detergents that tend to be better cleansers than regular soap. Use a basic shampoo as a whole body wash.

Until more people wear APRs and everyone is used to them, we can assume that if you strap one on to go to work, travel in an airplane or walk the dog, most people will think " you look weird!" We are not sure how new security regulations will treat the use of APRs on airplanes… it will controversial.

See the book, Air and Breathing by Stephen Gislason MD

Sunday, April 26, 2009

Unsafe? Avandia for Diabetics

There have been a succession of disappointments about drug therapy in recent years. One drug, Avandia, became a popular diabetes medication. It took several years and a brave MD to uncover evidence that it is not such a good drug, after all.

Avandia is rosiglitazone, a popular diabetes 2 drug. Doubts were raised about the safety of this drug and there are arguments for and against it. The arguments and concerns will not be resolved quickly. Avandia is marketed by Glaxo, which, like all drug companies, vigorously defends its big money drugs. Sales of Avandia reached $3.2billion per year in the US.

Our perspective for 2 decades is that the drug treatment of diabetes lacked convincing long-term efficacy and there were important concerns about side effects and long-term adverse effects. Oral medications should not be considered as primary treatment. However, MDs tend to be drug prescribers, drug companies are interested in making money and patients are obedient consumers who like to believe there are simple solutions for complex problems.

Dr. Steven Nissen and colleagues from the Cleveland Clinic reviewed more than 40 studies and concluded that Avandia increased the risk of heart attacks by 43 percent. Psaty and Furberg recalculated Nissen’s analysis using interim results of the Record study in addition to the studies that Nissen used. They found that Avandia increased a patient’s risk of having a heart attack 33 percent. Nissen is an experienced but independent FDA advisor who has become an ombudsman for the American people.

In the US where Avandia was developed and concerns were announced, questions about the safety of Avandia and how regulators have dealt with its risks were asked at Congressional hearing in June 2007. Glaxo had an ongoing study, REPORT, and rushed to submit favorable interim results for publication in advance of the government hearing.

In his New England Journal editorial, Dr. David M. Nathan, a Harvard diabetes expert, doubted the value of the REPORT study because of the high number of patients who dropped out and the study design which compared Avandia to a combination of metformin and sulfonylurea. While this combination is popular, doubts about its safety were raised and never resolved in another study that showed a 96 percent increase in diabetes-related mortality. Metformin alone appears to be relatively free of cardiovascular risk. Nathan concluded that the interim results of the Record trial do not provide any assurance of the safety of treatment with rosiglitazone and suggested that doctors should use medications other than Avandia.

A series of drug adverse effect withdrawals in recently years have generated criticism, that the US Food and Drug Administration fails to protect the public. In the Avandia case, critics say that the US FDA should have warned about the potential heart risks years ago. A supervisor in the drug safety office at the agency said in an interview that she was rebuked after calling for a stronger warning label on Avandia and a competing drug, Actos.

November 20, 2007: A US Senate Committee on Finance released a report describing what it terms the "intimidation" of Dr John Buse by GlaxoSmithKline (GSK) over his concerns about the cardiovascular risks associated with the company's antidiabetes drug rosiglitazone (Avandia). The committee stated: "According to documents provided to the committee by, among others, GSK and the University of North Carolina, it is apparent that the original allegations regarding Dr Buse and GSK’s attempts at silencing him are true. According to relevant emails, GSK executives labeled Dr Buse a 'renegade' and silenced his concerns about Avandia by complaining to his superiors and threatening a lawsuit."

The main problem for a growing number of patients is the false belief that a drug or combination of drugs can rescue an individual from a disease-causing lifestyle. While there may be benefits to be had with medications, a person with diabetes 2 should learn expert self-management skills and exercise all the therapeutic and preventative options available before taking drugs.

From the Book Managing Diabetes 2 by Stephen Gislason MD

See further discussions of medical biases and limitations

Also See Diabetes Drugs