September 2005 Newsletter - Why is Nutritional Information Hard to Get from your Doctor?; Glutathione and Parkinson’s Disease; Success Stories with Fibromyalgia and Depression/PMS
Dear Friends and Patients:
You’ve all heard the saying, knowledge is power. I recently had a new patient ask me during her interview prior to entering the practice why there were not more doctors who were knowledgeable about nutritional therapies so that they could combine them with traditional drug therapies. She told me that in her home country of Germany integrative medicine was a common practice and patients were given choices whether to take a drug or a natural herb or supplement. Let me give you my opinion of what is going on.
It all starts with medical schools, where future doctors are educated. When I attended the University of Florida College of Medicine a course in nutrition was never offered. A survey in the 1990′s showed only 6% of medical schools offered a single course in nutrition. The attitude has been to delegate nutritional responsibilities to the dieticians. Medical schools today are homogeneous. Most of what is taught in one school is taught in the rest of the schools. Since there is only one kind of medicine accepted (“established medicine” = drug based medicine), all medical schools and medical literature teach basically the same things. Medical research in these schools is certainly encouraged, but since funding is often provided by drug company grants, the research is within the framework of accepted ideology. There is little financial incentive to fund research on food or natural supplements as these cannot be patented.
Evidence-based Medicine
“Evidence-based medicine” is a fairly new term that allopathic medicine now uses to justify drug based therapies. It dictates that any drug or medical research today should be conducted by randomized, double-blind, placebo controlled studies, usually in medical centers. Treatment protocols are based on conclusions drawn from statistical analyses of this research or meta-analyses of previous trials. “Evidence-based medicine” does not allow for testimonials or even clinical observation of treatment outcomes by a physician, but must be measured by a lab test, X-ray result, etc. On the surface this would appear to be a very scientific way of practicing medicine. Alternative therapies are summarily dismissed as “unproven” as most have not gone through this type of research and statistical analysis. So if a patient feels better after taking vitamins or receiving an acupuncture treatment, or pain is relieved after seeing his or her chiropractor for an adjustment, under the evidence-based system it doesn’t count. “Unproven” is not the same thing as “doesn’t work.”
One problem with the “evidence-based medicine” model is agreeing on what constitutes evidence. The same data can be interpreted in various ways giving different results. Statistical associations are used to justify drug therapies. But this is not the same thing as causation and often (up to 20% in some reports) a latter study will refute the findings of an earlier study. For instance, one study found that people who took aspirin had lower cancer rates, with the conclusion aspirin prevents cancer. A latter study found this to be false. In a recent associated press article over one fifth of all new drugs that were deemed to be “safe” during the clinical trials of the drugs where later found to have major, potentially life-threatening side effects. The good news in this is that the evidence is at least being re-examined. Another problem is that it does not take into account the biochemical individuality of humans. Living systems are complex and the interpretation of data from studies is often difficult or biased. People are not like automobiles, where parts in one car are interchangeable with parts in another car of the same make and model. There are millions of genetic variables that make each person unique. This is why the same drug can cause some people to have an adverse drug reaction, help others, and have no benefit at all in others. Yet another problem is how do you measure health? Health is not the absence of symptoms or having normal lab tests. Traditional medicine is focused on the treatment of disease whereas alternative or complimentary therapies, for the most part, are intended to improve physiological functioning and health. These are not the same things.
Problems with the FDA
Another problem is the suppression of information by the FDA (Food and Drug Administration). The FDA will celebrate its 100th birthday next year and was initially known as the Bureau of Chemistry. Dr. Harvey W. Wiley was founder and head of this agency and his job was to enforce the Pure Food and Drug Law. When a sugar-water concoction filed with chemical additives and cocaine was introduced, he filed suit against Coca-Cola to keep this artificial product off the market and prohibit its interstate transport. Commercial interests caused his ouster in 1912 and he was replaced by Dr. Elmer Nelson, who was pro-commercial interests. Within several decades the foods of commerce took over. Dr. Bernard Jensen and Mark Anderson pointed out in their book Empty Harvest, the food supply became “bleached, refined, chemically preserved, pasteurized, sterilized, homogenized, hydrogenated, artificially colored, defibered, highly sugared, highly salted, synthetically fortified, canned, and generally exposed to hundreds of new man-made chemicals.” And what has followed is the epidemic of cancer, heart disease, obesity, and diabetes we see today.
In 1962, the Kefauver Law was passed which basically placed natural supplements in the same category as drugs. This law states that if a claim is made that a substance is intended to diagnose, cure, mitigate treatment or prevent disease, it is a drug. And to suggest any such substance for a complaint, illness or treatment constitutes medical prescribing. Forget that we’re talking about natural foods or plant products. Hence, the disclaimers today on every bottle of vitamins, herbs, or natural supplements and the prohibition by the FDA on manufacturers and suppliers of natural products in advertising the truth about what their products can do to treat illness or disease.
Former FDA commissioner Herbert Ley stated in 1970 “People think the FDA is protecting them – it isn’t. What the FDA is doing and what people think it is doing are as different as night and day.” The recent rash of problems with drugs approved as safe like the arthritis drug Vioxx (causing heart disease) , the synthetic estrogen Premarin (causing breast and uterine cancers) and the anti-depressant drugs (causing increased suicidal risks and violent behavior in children) have made headlines and raised public alarm. These drugs were left on the market long after evidence of their danger was presented to the FDA.
A USA TODAY analysis of financial conflicts at 159 FDA advisory committee meetings from January 1, 1998, through last June 30 found more than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies . Federal law generally prohibits the FDA from using experts with financial conflicts of interest, but the FDA has waived the restriction more than 800 times since 1998. In addition, at 92% of the meetings at least one FDA member had a financial conflict of interest.
What hasn’t been in the headlines is the FDA bias against vitamins and natural supplements. An FDA Dietary Supplements Task Force Final Report, released in 1993 stated “. . . the task force considered many issues in its deliberations including: to insure [that] the existence of dietary supplements on the market does not act as a disincentive for drug development.”
Is “Alternative Medicine” Alternative?
Those of you reading this newsletter know “alternative medicine” is actually the health choice of planet earth and is a combination of every good health idea invented by mankind, in every country and culture on this planet accumulated over thousands of years of experience. There is nothing “alternative” about it. The Centers for Disease Control reported that 62% of 31,000 adults surveyed in 2002 had used some form of CAM (complementary and alternative medicine) in the previous 12 months. In 1999, more than half the US health dollar was spent on “alternative medicine” and it was all out-of-pocket. Conventional medicine, on the other hand, is being paid for and is surviving only because insurance and Medicare pay for it – and if it weren’t for this, the public would not pay out-of-pocket. There is a place for drug therapy, especially in acute, emergency situations, but drugs are not a panacea and they all have side-effects. People want kinder, gentler, more cost effective therapies. They want to improve their health rather than wait until they have a disease. This attitude is becoming more evident as the baby boomers reach retirement and want to continue active lifestyles.
A study conducted at Columbia University Integrative Medicine Department found that 70% of the cardiac surgery patients surveyed were using some form of CAM therapy. Only 20% of these patients had reported this use to their physicians and almost half of these patients stated they specifically did not want to discuss this issue with their physicians. “Embarrassment” and physician disapproval are most frequently reported as the main reasons patients withhold information about CAM therapies from their doctors (JAMA 1998; 280:1569-1575). Lack of knowledge about CAM is one of the greatest reasons healthcare providers do not discuss CAM with their patients. However, more and more physicians, naturopaths, and allied health professionals around the globe are communicating with each other and are joining organizations such as ACAM (American College for the Advancement of Medicine) and ICIM (International College of Integrative Medicine) which promote integrative medicine. These healthcare providers realize the optimal treatment of their patients demands that they be aware of and better understand all the therapies patients are using. The conferences these organizations sponsor are a blend of basic science, breakthroughs in medical research, and clinical applications where both drug and natural therapies are presented. Evidence-based complementary and alternative medical journals that are peer-reviewed, such as eCAM and Alternative Therapies have emerged. In 1998, recognizing the need for study of CAM and dissemination of this information, the National Institutes of Health established the National Center for Complementary and Alternative Medicine. This is an exciting time of change. For the first time in the history of medicine, this change is consumer driven.
Finally, the State of Florida Patient Bill of Rights guarantees the right of all Florida citizens access to not just one type of heath care, but to alternative types of care as well. It requires that all physicians provide unbiased information (informed consent) about both traditional and CAM types of treatments and allows the patient a choice of therapies. Unfortunately this information and treatment choice is rarely given. This puts the burden and responsibility of information gathering, and also decision-making, on the patient. So these are some of the facts and issues, and I let the readers draw their own conclusions as to why nutritional information is so hard to come by.
An Introduction to Neurotransmitters
Most of our readers have seen commercials on TV or in magazines by drug companies touting anti-depressant medications that are supposed to correct “chemical imbalances” of the brain. These brain chemicals are called neurotransmitters . Neurotransmitters relay signals between nerve cells and are required for proper brain function. They function in conjunction with hormones. It used to be thought that neurotransmitters are in the “brain” and hormones are in the “body”, but the truth is that both function as a unit in the central nervous system and also the periphery of the body. As a result of poor diet, chronic stress, increased workloads, genetics, and other factors, people suffer from neurotransmitter imbalances. Think about this – every organ in your body is connected to the brain via a vast network of neurons and receptors for neurotransmitters. It is estimated that there are 100 billion neurons in the human brain. The brain uses the neurotransmitters to signal the lungs to breathe, the intestines to digest, the heart to beat. For instance, epinephrine is released in a “flight or fight” response to a stressful situation or injury. Epinephrine is a neurotransmitter and a hormone. Epinephrine is also used as a drug and is in injectable glass ampules on every hospital emergency cart. If epinephrine is too low in the brain, a person may feel tired or depressed. If it is too high, a person may feel anxious or have a sleep disturbance. So in a sense, neurotransmitters affect the functioning of the entire body.
The problem is how to determine what the imbalance is due to and how to measure it in a lab test. We all know that depression is not a Prozac or Paxil deficiency. I attended an American College for the Advancement in Medicine meeting a few years ago where I was introduced to Dr. Kellerman. This gentleman is a Ph.D. researcher who was studying neurotransmitters, how to measure them in the urine, and how to correct imbalances with targeted amino acid therapy rather than using drugs. Back then he had developed a technology to measure 5 different neurotransmitters in the urine and currently he is able to measure 12 different ones. Dr. Kellerman is working on identifying others. When I was in medical school, the only neurotransmitter testing that was available was collecting urine for 24 hours for epinephrine and norepinephrine to screen for a rare type of tumor that could cause rapid heart beat and elevated blood pressure. Traditional lab testing hasn’t come much further to date, unfortunately.
Prescription anti-depressant drugs are supposed to correct a biochemical imbalance. What they do is work with existing neurotransmitter supplies at the synapse between neurons. Most of the drugs affect only one neurotransmitter such as serotonin, and according to Dr. Kellerman, the drugs will eventually deplete neurotransmitters. What if there are multiple neurotransmitters that are out of balance? Or what if there isn’t a sufficient supply of a neurotransmitter to work with? The drug then doesn’t work. Anti-depressant drugs all have side-effects and are not truly correcting the underlying problem(s) that caused the imbalances. In 2004, the FDA required that all antidepressant drugs carry “black-box” warnings (the highest warning level for a prescription drug), alerting doctors and consumers that the antidepressants increase suicidal behavior in children and adolescents with depression and that the risk of using antidepressants must be carefully balanced with the need. The box also carries warnings that patients who use antidepressants must be closely monitored for “clinical worsening, suicidality, or unusual changes in behavior.”
Neurotransmitters are divided into 2 general categories: inhibitory and excitatory. Serotonin and GABA are the main inhibitory neurotransmitters. Epinephrine, norepinephrine, histamine, glutamate, PEA (phenylethylamine), and acetylcholine are the main excitatory neurotransmitters. Dopamine can be either inhibitory or excitatory. Dr. Kellerman believes there are over 50 different neurotransmitters, and many of them have not been identified to date.
Besides depression and anxiety, neurotransmitters participate in the regulation of other essential bodily functions. Appetite control and cravings are affected by brain chemicals, and when the messaging system is not functioning properly, the stomach and appetite control center may not tell you that you are full. So a person continues to eat when he or she is not really hungry. ADD and ADHS have reached epidemic proportions in the US. Both in children and adults we find that neurotransmitters are out of balance. Multiple factors can affect brain chemistry, especially that of children. Some factors include toxic metals or other chemicals, food allergies, food preservatives or dyes, electromagnetic stress from electrical sources such as TV’s, cell phones, computers, etc., and high sugar diets. Hormone levels and balance are affected by neurotransmitters as well. We find as people age, hormone levels decline and neurotransmitters are also out of balance.
For more information on this topic, go to neuroscienceinc.com.
Success Story – Patient with Osteopenia
Mrs. B is 65 years old and saw me for the first time in 1991. She was concerned about a bone density study that showed moderate osteopenia (thinning of the bones) in her hips and back. She came into the practice taking black cohosh and various types of calcium supplements. Her gynecologist had previously placed her on Premarin and Provera, but she had a bad experience with these synthetic hormones with bleeding and recurrent urinary infections, so she stopped them. She was told to go on Fosamax to prevent further deterioration of her bones into osteoporosis. She wanted to know if there were any alternatives to taking the Fosamax but her gynecologist told her that this was the only treatment available. I discussed natural bio-identical hormonal replacement therapy with her to build up bone mass in conjunction with proper nutrition, supplements, and an exercise program. She was placed on compounded natural biestrogen (a mixture of estradiol and estriol) and also on bio-identical natural testosterone and progesterone. It took several months to adjust doses to where she felt comfortable. We were then able to combine all four hormones into a small trouche that she took twice daily under the tongue for convenience.
Mrs. B also was placed on a combination of Osteo B Plus (calcium citrate, magnesium, various minerals such as manganese, silica, boron, copper, etc. that are also needed for bone health) and vitamin D and vitamin K. She was encouraged to exercise and also to do light weight training. She had a bone density study done this year that is now completely normal, documenting the increase in her bone mass. Mrs. B feels healthy and remains active.
Another Success Story – Patient with Anxiety and Sleep disturbance
Mrs. C is 35 years old and came to the Center with chronic anxiety, depression and sleep disturbance. She had a young child at home and found it stressful trying to be a stay-at-home mom and also help her husband with his business at the same time. She stated she felt fatigued all the time and was not sleeping well. She was also having PMS symptoms around the time of her period where she would become very moody and irritable. After a comprehensive exam and nutritional assessment Mrs. C was found to have a vitamin B12 deficiency and was started on both oral B12/folate lozenges and compounded Methylcobalamine (activated form of B12) shots. She was also placed on targeted amino acid therapy to help restore a low serotonin level after urine testing of neurotransmitters found this level to be very low. This was in spite of taking Paxil, an anti-depressant medicine. Within a month she was feeling a major improvement in energy and was sleeping through the night with a good quality sleep. Within two months her PMS was no longer an issue and she was taken off her anti-depressant medication. She continues to do well at present on the combination of B12 replacement and targeted amino acid therapy.
Update on Intravenous Glutathione Therapy and Parkinson’s Disease
In December 2003, I published an article about Glutathione on our website. If there ever was a “miracle” substance that occurs naturally in your body, glutathione gets my vote. Glutathione is one of the body’s most powerful antioxidants and is a mediator of detoxification and immune function. Glutathione is not well absorbed orally although there are a lot of oral glutathione products on the market. Large concentrations of glutathione naturally occur in the organs of excretion (liver, lungs, kidneys). IV glutathione therapy enhances the function of these organs when they are under stress from the toxic effects of drugs or heavy metals. Glutathione also has a beneficial effect on the immune system and improves conditions such as chronic fatigue, immune dysfunction states, and macular degeneration.
Largely through the work of Dr. David Perlmutter, we now have access to impressive clinical and laboratory data that shows marked improvement in Parkinson’s disease patients with the use of intravenous glutathione. Dr. Perlmutter measured both glutathione and oxidized glutathione levels in the portion of the brain most affected by Parkinson’s disease and in normal control groups. Glutathione levels were reduced by about 40% and oxidized glutathione increased by about 30% in the patients with Parkinson’s. Nine patients were given IV glutathione twice daily for one month. All 9 patients in the study improved significantly with a 42% decline in disability and the improvement was sustained for 2 to 4 months. This treatment was in addition to medications the patients may have been on, such as Sinemet. Dr. Perlmutter and other integrative physicians have since treated many other patients with success.
Our experience at the Center has likewise been dramatic, and not just in Parkinson’s patients. I recently saw a 79 year old lady who became profoundly fatigued after a coast to coast airplane trip to visit her family. She became toxic during the airplane ride from inhaling the myriad of perfumes, chemicals and other substances in the recirculated air during the 5 hour flight. A simple IV glutathione infusion corrected this problem within 12 hours. (Glutathione levels decline with age). Another patient had a severe reaction to medication he was given elsewhere, causing severe inflammation and hepatitis of the liver, requiring hospitalization. A series of twice weekly glutathione infusions helped this patient’s liver heal from the toxic effects of the drug. Most of our toxic metal patients find their fatigue improves dramatically with the addition of IV glutathione therapy, and this also acts as the body’s “natural chelator” to remove most heavy metals such as lead or mercury (these metals deplete glutathione reserves). We have also used Glutathione IV in cancer patients undergoing chemotherapy to lessen the toxic effect of the chemotherapy on liver and kidneys, and to improve well-being.