Azelaic acid

Cancer -- Its Final Defeat?

Editor:

Past and present patients of Stanislaw Burzynski, MD, PhD share a mixture of cynicism, irritation, and amusement when they hear the frequent funding appeals to "find a cure for cancer in our time." We already have a cure, at least for most cancers. It's available at Dr. Burzynski's Houston clinic.

Dr. Burzynski does not brashly claim to have discovered the cure science has been seeking for generations. Characteristically, he gently admits to being able to "help people with cancer; many, but not all." The fact remains that many people are alive today who, without his therapy, would otherwise be dead. Many of his successful cases involved patients who had been considered terminal by conventional medicine.

He is particularly successful in cases of brain tumors, which kill many children, and of prostate cancer, the second most common cancer-killer of adult men. It has been guesstimated that, had his therapy been made readily available, under insurance protection, since its initial development, it could have prevented three-quarters of a million prostate cancer deaths in this country alone.

One wonders if cancer has not been our deadliest medical scourge since people first trod the earth. Dr. Burzynski's therapy, (which he calls "antineoplaston," meaning "against cancer"), appears the giant breakthrough that we have awaited so long. Its discovery was exciting, and reflective of Dr. Burzynski's brilliance, and both medical and moral tenacity.

Stanislaw Burzynski tacked "MD" after his name in 1967 when, at age 24, he graduated at the top of his 250-student class from the Medical Academy in Lublin, Poland. A year later he added a PhD in Biochemistry, one of Poland's youngest candidates ever to earn both doctoral degrees. Perhaps unknown even to himself at that time, his quest for cancer's defeat had already begun.

It was between his two doctorates that the young Dr. Burzynski identified peptides which occur naturally in the human body. Their deficiency in cancer patients aroused his suspicion of an association between the peptides, and cancer's growth. In a mind such as Dr. Burzynski's the step from suspicion to reasoned investigation -- to research -- is but a short one. Thus began the research career of a deeply caring doctor destined to be remembered as a towering giant in the annals of medical history.

It is believed that cancer represents a defect in a cell's genes, notably "oncogenes," which accelerate cell growth and reproduction by division, and "tumor suppressor genes, which suppress such growth. Normally, these two functions are in balance. When defective, and out of balance, normal cells turn into cancer cells.

Dr. Burzynski's antineoplastons, (which are peptides and amino acid derivatives), take aim at defective genes in rogue cells. They "switch off" the oncogenes, and "switch on" the tumor suppressor genes. In response to this restoration, cancer cells stop multiplying, and then die.

Dr. Burzynski's next step was to discover the technique of synthesizing his antineoplaston peptides in the laboratory, so that they might be administered to patients. Thus was born his non-toxic therapy, capable of knocking out cancer cells.

The next several years were relatively tranquil for Dr. Burzynski. His research flourished, and his reputation began to grow. At the 1976 meeting of the Federation of American Societies for Experimental Biology, (FASEB), the world's largest regular scientific gathering, his paper was selected by Associated Press as its lead story from among the 3,700 papers submitted. He received flattering publicity, and began to be noticed. He was invited to membership in several distinguished medical societies. He received prestigious awards.

The problems first arose in 1978, disguised as FDA agents. For more than 20 years this agency of the US government has persecuted Dr. Burzynski in an attempt to shut him down. Fortunately, he was allowed to conduct clinical trials, and through the intervening years has treated many patients.

Why would an agency of the US government try to throttle a doctor who, day after day, was amassing an unequaled record of success in the treatment of cancer? Many believe the answer relates to the astronomic profits of drug companies. (See The Cancer Industry, by Ralph W. Moss, published by Equinox Press). It's the other side of the "tobacco" coin. The government conveniently overlooks tobacco's linkage with cancer because shutting the tobacco industry down would wipe out millions of tobacco-taxation dollars. Like so many of the less-honorable facets of our society, it's all a sordid matter of money.

In retrospect it is curious, to say the least, that the FDA strove mightily for 20+ years to close Dr. Burzynski's doors, yet put no stop to the sale of ephedra diet aids, despite their infliction of brain-related side effects which, between 1993 and 2000, caused hundreds of "adverse event reports," including some 70 deaths. These official reports are believed to be only a fraction of the real totality.

On the one hand the FDA tries to shut down a doctor of impeccable qualifications who has achieved astonishing success in curing cases of cancer, many of which were considered terminal by conventional medicine. Drug company profits are indisputably threatened by the success of Dr. Burzynski's therapy. On the other hand the FDA chooses not to remove a profitable product from the market, despite the fact it causes serious -- sometimes fatal -- brain damage.

On one occasion FDA agents confiscated 200,000 documents from Dr. Burzynski's patient-records files. To reference them thereafter he had to visit the FDA's office and photocopy them on a machine he was required to install at his own expense. These records have never been returned. The FDA tried time and time again to haul Dr. Burzynski through the courts, at one time bringing a handful of spurious charges which, upheld, could have led to his imprisonment for 300 years.

The FDA seemed to scrape "the bottom of the barrel" in the matter of four-year-old Thomas Navarro. This little boy had a brain tumor and was subjected to surgery, to no lasting avail. His parents, Jim and Donna Navarro, resisted the proposal to subject him to the potential horror of radiation and chemotherapy. Learning of Dr. Burzynski's unparalleled success at treating this kind of tumor in particular, they chose to take him there instead. The FDA refused to allow this. "Thomas must first be treated with radiation and chemotherapy, and have these treatments fail, before we will allow his treatment by Dr. Burzynski." This barbaric stance was backed up by the Arizona Child Protection office, which threatened to remove Thomas from his parents' custody if the FDA ultimatum was not obeyed. The Navarros fled to Texas to escape this tyranny.

The family's heartbreak continued throughout their months-long sojourn in Houston. They were so near to Burzynski's clinic, yet the FDA persisted in keeping them nonetheless, so far.

The saga of now five-year-old Thomas Navarro continues. The child has finally been subjected to chemotherapy, and is having severe adverse reactions. If this little boy eventually succumbs to this disease, it is the feeling of many that he would be less a victim of cancer than of bureaucratic murder.

My personal experience with Dr. Burzynski is yielding a happier outcome. At age 72, and just four months before retirement, I was diagnosed at Group Health Co-Operative, (GHC), a Seattlebased HMO, as having prostate cancer. A second opinion obtained at the famous Northwest Prostate Institute in Seattle, (where seed implantation was developed), confirmed that I had an "advanced case of highly aggressive cancer." The fact that my GHC diagnosis was, in my opinion, at least two years late proved a disguised blessing. GHC's proposal was that I receive four months' hormone treatment, then radiation, then another three months' hormone treatment. (For the uninitiated, "hormone treatment" may be freely translated as "chemical castration.")

It was after my chemical castration had been started that my wife and I learned about Dr. Burzynski through the Health and Healing newsletter of Alternative Medicine's Dr. Julian Whitaker. I applied for consideration as a patient, and was accepted. In January, 2000, Diane and I began our new millennium by taking the first step towards healing my cancer. We did so at Dr. Burzynski's clinic. The treatment is still in progress, and producing encouraging results.

I have not yet been discharged as another of Dr. Burzynski's cured cases, but believe this happy ending now looms close. My tumors are shrinking and, to date, my formerly sky-high PSA is holding at a safe level. When my discharge arrives, however, I shall not merely know myself to be cancer-free. There are two ancillary aspects of our overall experience that shall also accompany me, and which may prove helpful to others. They are as follows:

1) I shall forever regard as myth one of the little fictions I grew up with, namely that "doctor knows best." I have long believed that, as in any other calling, the medical profession's practitioners range from laudable to lousy. The elasticity with which I now view this range has increased. At one end of the scale we find Dr. Burzynski, whose patients think he should be canonized. Well, almost. At the opposite end are doctors who should never again be allowed to treat a patient. The vast majority of doctors, of course, fall at the "laudable" end between these two extremes.

It appears that, to some extent, half the US population must share this view, whether consciously or subliminally. This is reflected by the number of people who have turned for health-care to the practitioners and products of alternative medicine.

My own situation is a case in point. Shortly after taking up residence in this country in 1966,1 discovered that I had hypertension. I'd probably had it, unknowingly, most of my life. In 1997 this diagnosis was expanded to include angina, one heart artery by then proving to be totally clogged. I do not have a medical degree, but it's my heart, and I believe this in itself gives me a certain awareness of its condition, and of its need.

From this perhaps naive vantage point I now believe that the approximately 20,000 toxic high blood pressure pills that have been shoveled down my unsuspecting gullet since I became a GHC member have wreaked damage on my cardiac mechanism. "Oh yes," I can imagine some MD reader expostulating, "and what if you'd not taken this medication? Would you prefer the alternative? You'd probably be dead." That too, perhaps, is true.

Since learning my cancer is under control however, Diane and I have adjusted our aim somewhat, to focus instead on my heart problem. We have turned for help in this effort to alternative medicine, with the objectives of lowering my blood pressure to acceptable limits, shaking free of conventional b.p. medication, and hopefully of even de-clogging my one blocked artery. Our five-pronged attack involves diet, exercise, vitamin and mineral supplementation, lots of filtered water, and lifestyle adjustments. So far, our plan seems to be working.

We have also been fortunate in that Dr. John Crocker, our family physician at GHC has been generously supportive in all our efforts, even though GHC as an entity would not cover the cost of my stay at Dr. Burzynski's clinic to obtain the treatment which GHC itself could not provide.

Dr. Crocker's open-minded attitude however, helps reinforce our conviction that conventional medicine's resistance to alternative medicine must eventually crumble. The latter's more appropriate label of "complementary medicine" will, we believe, become recognized to the extent that it will be added to the list of services offered by lIMO's. Personally, of course, we would like Seattle's GHC to lead the way in this regard. Only then, we believe, could the medical protection they offer be considered truly comprehensive.

Supplemental to this improvement, we forecast that complementary medicine would promptly become the HMO's most popular service, and that the HMO in total would become considerably more cost-effective.

2) At first glance the second "side effect" of our total cancer experience might seem at odds with the first. Thoughtful introspection, however, suggests this notion to be misleading.

Take our personal case-history as a 'for instance'. I first joined GHC when I came to Seattle at the beginning of 1966. Our membership presently costs us some $450/month, plus co-payments and drugs.

Assuming an average monthly cost of $300 throughout these years, we have thus paid some $150,000 in total membership dues and ancillary costs. We have considered the medical care provided by GHC to be of excellent quality, and of course it has been comforting to know it was there whenever needed.

In reality, however, we have been fortunate in not having been beset by major medical problems, and our "dues" have exceeded the cost of the services we have used. These latter have involved a couple of childbirths, (both Cesarean), plus annual check-ups and, of course, blood pressure reviews and medication. Our real-need medical costs have probably averaged no more than $50/month.

Then came cancer. Our first major medical disaster and expense! GHC's battery of anti-cancer weapons include surgery, hormone treatment, radiation, and chemotherapy. It's a fair guess that going this conventional way would have cost GHC, (thence Medicare), a total of some $100,000 or so.

We chose to avoid the side-effects of these treatments, and their questionable success at knocking cancer out for keeps, and turned instead to Dr. Burzynski. Twenty years of much higher success and no side effects, his high reputation among authorities like Dr. Julian Whitaker, the fact he has been besieged by the bureaucracy and lied about and denigrated by part of the medical establishment (notably Radiation Oncologists), we felt, all pointed to his being the doctor with the most to offer.

GHC could neither provide his therapy nor pay for its cost, we learned, and thus we would have to pay its cost ourselves. Neither did Medicare offer any financial assistance, therefore, our total medical care package for the past 35 years will have cost us a total of some $200,000.

I wondered what the financial outcome would have been had I, 35 years ago, elected not to join GHC, but instead had chosen to invest the equivalent of its premium, say in a mutual fund. If I had spent an average of $50 each month on medical costs, and had my investment fund earned an average income of 12%, I wondered, what would my comparable financial status now be?

The answer was startling. Instead of having spent approximately $200,000 on medical costs, and now be facing the prospect of continuing monthly premiums of $450 and climbing, I would have invested a net total $126,000 into a fund which, today, would show a balance of $1,583,817 - after paying off Dr. Burzynski in full!

Since an average growth rate of 12% would cause an account value to double every six years, the balance in my hypothetical account would have exceeded $6 million, had I launched it at age 26, rather than at my 1966 age of 38! The conclusion seems obvious.

Derek V. Baker

18339 Wallingford Avenue North

Seattle, Washington 98133 USA

Email: baker3d@foxinternet.com

"Zappers" and Rife Technology Not Gimmicks

Editor:

I just noticed the letter from Dr. Yurkovsky in the May issue. To label 'zappers' and Rife technology instruments as 'gimmicks and naive solutions' is kind of a shame. No doubt there are some junk instruments out there but to denigrate Dr. Clarke or Dr. Beck or the many other viable instruments is a disservice and does nothing positive.

Dr. Yurkovsky must imagine that all the many thousands, yes thousands of people being helped by these technologies must all be imagining their health improvements. A powerful placebo effect. I don't think so. Other researchers such as Professor Rochlitz report that the 'Zappers' built to the Beck specifications work very well, particularly with viruses.

Dr. Curt Maxwell

P.O. Box 1075

Winterhaven, California 92283 USA

520-341-7048

Fax 011-526-517-7519

Washing Hair Samples

Editor:

Thank you for the article on hair analysis in the June 2001 issue. In 20 years of practice with over 10,000 patients, hair analysis has proven to be an extremely reliable and useful tool.

I would like to add that the JAMA study actually confirmed the reliability of hair analysis, provided the hair is not washed at the laboratory. In the study, if one looks only at the results of the two laboratories that do not wash the hair, (labs A and E in the study), the reliability is superb. Six of the nine nutrient mineral levels were identical, and the others very close. The correlation is far better than any of the other labs.

Far from discrediting hair analysis, the JAMA study showed that labs that do not wash the hair provide very reliable results. This confirms a 1986 study by Dr. R. LeRoy (J. Orthomol. Med., Vol. 1, #2). He found that 1) washing hair samples with just deionized water removed minerals erratically from sample to sample, 2) the longer hair was washed, the more minerals were washed out, and 3) samples from females lost more minerals than samples from males.

Hair is not "inert" as the author of the Townsend article contends. It is a complex tissue, with secondary, tertiary and quatrenary protein structures. It is known to be 10-15% porous. Women s hair is more porous than men's, which may explain why washing removes more minerals from women's hair.

Labs that wash the hair say they must remove 'exogenous' minerals from the hair, often with harsh solvents and detergents. Leroy, Robbins and others, however, contend the minerals that are washed out are "highly soluble compounds...which are required by our body chemistry, and these losses constitute an integral part of the hair fiber."

Leroy concluded, "based on the studies, I believe washing of the hair before analysis should be discontinued as a common practice until we can positively state where mineral contamination stops and endogenous mineral starts."

I would suggest that a dirty hair sample is like a contaminated urine or blood sample. It needs to be resampled properly. Redoing the occasional contaminated sample is far better than allowing the laboratory to damage the biopsy material by washing it, especially with harsh chemicals.

The author of the Townsend article also says that to determine "metabolic rates" from a hair analysis is clinically unproven. I refer readers to a study in the Journal of Orthomolecular Medicine. Vol. 1, #2, 1986, pp.126-131. Confirming research indicates that Oriental pulse and tongue diagnosis correlates well with the oxidation type as revealed in unwashed samples of hair (Int. J. of Acupuncture and Oriental Med., Vol. 6, #1-4, 1995). This is a fascinating correlation, considering the divergent origins of hair analysis and acupuncture. In my 20-year experience, oxidation types are very accurate and

Medical Journals Need to Stop Exaggerating Study Results

Editor:

It is time to set standards in medical journal reporting. We constantly hear criticism of the lay press and TV media regarding how they exaggerate reports appearing in medical journals. Hardly a week goes by without quotations in both the NY Times and the Wall Street Journal from a clinical article appearing in either the New England Journal of Medicine or the Journal of the AMA about some dramatic breakthrough in medicine. We have grown to accept this medical hype in the lay media, but it is critical that we put a stop to this exaggerated journalism in our own recognized medical publications.

On the front page of the May 1, 2001 issue of Internal Medicine News the headline reads: Incidence Fell 20% -- Adding Clopidogrel to Aspirin Sharply Curbs CV Events.

The first paragraph of the report states that "Clopidogrel and Aspirin look like the best thing since Aspirin alone for patients with unstable angina or mild myocardial infarction." The article explains that this drug combination reduced the incidence of cardiovascular events by 20%.

The language throughout this article is exaggerated hyperbole. For example, the article states that this drug combination "sharply curbs CV events," and refers to the study as being "...a major trial...." The study's author states that "...the combination should be adopted now for patients with unstable angina...." The results are called "statistically significant," and the study is hailed as a "landmark," with one surgeon quoted as calling it "a hugely important study."

However, when you carefully examine the results, the following becomes evident:

1. Virtually all of the patients also received the standard treatment of heparin.

2. Many were also treated with a [beta]-blocker or angiotensin-converting enzyme inhibitor.

3. Many were also treated with. lipid-lowering drugs.

No explanation was given as to whether any of the above medications in any way contributed to the study results.

The reported advantage of the Clopidogrel-Aspirin combination, when compared with aspirin alone, was a reduction in the incidence of cardiovascular death, myocardial infarction or stroke by 20%-11.47% for the aspirin alone group vs. 9.28% for the Clopidogrel-Aspirin combination group. The 20% reduction was actually a difference of little more than 2% between the two groups.

The article acknowledged that the drug combination caused more major bleeds, and reported that the combination had "nearly a 1% increase in the incidence of major bleeds." This is a scientific publication and consistency should be mandatory. When the report compares the advantage of the combination it avoids using the 2% difference between the two study groups, referring to it instead as a 20% reduction. However when the report deals with the combination's disadvantage, it chooses to say there was nearly a 1% hike in the incidence of major bleeds, instead of reporting that 33% more patients taking the combination product suffered from major bleeds. We need to use the same measures throughout. The difference between the 3.6% incidence of "major bleeds" among the combination's users, and the 2.7% among the Aspirin users is actually 33% more major bleeds among the Clopidogerol-Aspirin grup!

This is a plea to require that our scientific publications be held to a high standard of non-exaggerated excellence, Doctors reading these publications need to have the facts reported fairly, accurately and without the taint of hyperbole. Comparisons need to be consistent in the way data is presented.

We have already heard accusations that the academic community and professional media bend over backward to cooperate with the drug industry. The last thing we need are examples of what can be construed as collusion.

Jack O. Scher

4026 River Road

Faber, Virginia 22938 USA

804-361-1130 / Fax 804-361-9199

Email: jscher@leelapress.com

Peppermint for IBS May Cause Adverse Effects

Editor:

The use of enteric-coated peppermint in children with irritable bowel syndrome (Literature Review by Dr. Gaby May 2001, p. 22) warrants comment.

I have encountered a number of severe disorders attributable to mints and other products (toothpaste, antacids, sauce) flavored with oil of peppermint (Southern Medical Journal Vol. 76:1331, 1983). They include inflammation of the lips, esophagitis, irritation of hiatus hernia, gastritis, diarrhea and recurrent pancreatitis. Diabetic patients with slower gastric emptying seem more vulnerable. One "dietetic" mint containing both peppermint and sorbitol widely used by diabetics proved particularly irritating. There also have been systemic allergictype reactions, including atrial fibrillation.

The current corporate emphasis on greater concentrations of peppermint deserves close scrutiny by physicians and the FDA, especially in the case of children.

H. J. Roberts, MD, FACP

6708 Pamela Lane

West Palm Beach, Florida 33405 USA

Rochlitz' Applied Kinesiology is Useful for MCS

Editor:

Thank you for the excellent May issue on Allergies. I must say I was a little disappointed with your earlier January issue on Multiple Chemical Sensitivities (MCS) because after becoming very ill in 1996, I tried most of the modalities mentioned therein with little success. Before I became sick, I was considered by many to be one of the healthiest teachers in our building. I was a former NCAA All-American athlete, I did not smoke, drink or use recreational drugs, and I did not eat sugar, ate strictly organic food and used filtered water. I thought I was living a fairly healthy lifestyle as I exercised on a regular basis and stayed in good physical and emotional health. I seldom saw a doctor and hadn't used prescription medication for almost 10 years.

Initially, I believed my symptoms were a result of working too hard, though later it became evident I was teaching in a sick classroom: blocked ventilation system and water-damaged roof and walls, which actually caused mushrooms to grow from my carpet! At the time, I knew nothing of chronic fatigue, MCS, or the many other chronic illnesses affecting so many people, nor did I know of the dangers of poorly maintained buildings. I first lost my voice, started gaining weight and later my throat started to drain. I became allergic to everything and was termed a universal reactor. I even left the sick school and moved 200 miles away hoping that a drier climate would improve my health, even though I had no problems previously with a wet climate. The move didn't bring me better health. My adrenals were shutting down and I could no longer produce testosterone. I saw a myriad of health care practitioners from an acupuncturist who prescribed herbs, to a "famous" ortynlaryngologist who wanted to prescribe drugs. I compr omised my body more by taking antibiotics after several MD's failed to properly diagnose my problem. I spent an entire summer doing voice therapy, only to return to school, to that same sick classroom in the fall and see my symptoms return. Later, I had some residual tonsil tissue removed to stem the draining after the antibiotics failed. A month after the surgery the other side of my throat started to drain and my chemical sensitivities worsened, probably due to the drugs from the general anesthesia. Nothing seemed to work. However, I did get some relief by doing a cleanse and taking DHEA.

My MCS persisted to a degree that made my life as a teacher almost intolerable. I could no longer tolerate chemicals of any kind in my classroom. Perfumes, whiteboard markers and glues left me almost totally debilitated. I was told my main problem was Candida. I became allergic to Nystatin after taking it to combat the Candida yeast overgrowth. I even created a chemical-free house and minimized chemical exposure in my new classroom, thinking avoidance could be the solution. At the time, I didn't know that I would have to fix the cause of my permeability to all of these toxins.

Finally, after almost 3 years, my chiropractor gave me a book he had read 10 years before. He said my story and symptoms reminded him of the book and its author. It was a 1988 edition of Allergies and Candida by Steven Rochlitz. At this point nothing had worked to improve my health. Both my DC and environmental MD encouraged me to try Rochlitz's methods. After my wife read the introduction about the author, she told me, "this guy sounds just like you." Unbeknownst to me, Steven Rochlitz, PhD had suffered a similar health crisis almost 20 years earlier. Out of desperation, I called Steven Rochlitz, took all of his seminars and did a private session with him in Arizona. At the time, I was so allergic and financially broke, I had to set my tent up and sleep in the desert.

In the 1-hour private session, he found the root cause of my MCS with Applied Kinesiology methods: chronic viruses and Protozoan parasites. Rochlitz then found what my body needed to counter these microorganisms and shortly thereafter I was finally well. And that was the end of my chemical sensitivities and other complaints. I was astonished to find my problem so quickly resolved and equally surprised were my MD and DC. I went from seeing health practitioners 3-4 times per week to relieve symptoms to going almost a full year without any appointments.

I was disappointed with the January issue because it was missing a very important approach when it comes to ecologically ill people. I am pleased to finally find Professor Rochlitz' research cited in the May issue. I urge everyone - sick people and physicians alike - to take his October Seminar and to read his books. Don't be like me and spend thousands of dollars with minimal results. I highly recommend that you do his work first, not last, as I did. I am so convinced that Rochlitz's methods will work for others, I recently coordinated Rochlitz to lecture and teach a class to health practitioners and lay people, including a few sick teachers in my region. Incidentally, my DC who originally gave me his book, attended the class. I am grateful to him and my MD for the encouragement to try something different when so many things had failed to alleviate my health problems.

Today, without environmental problems, I am a strong advocate of improving indoor air quality (IAQ) in schools. At present, I serve on the WEAIAQ State Task Force that tries to educate and prevent IAQ problems in schools throughout the state. If you have any questions or may be interested in hearing more of my account with Rochlitz or perhaps attending one of his classes, please call me.

Chip Halverson, MEd

Ephrata, Washington USA

509-754-1848

More Good News for Alternatives

Editor:

The amendment to the B.C. Medical Act as finally passed, mandated one representative on the investigating committee, rather than requiring an equal number as first introduced.

I wish to make it clear that I was only one out of a large number of women and men who worked so hard for this amendment. One of the key people was Mr. Hugh Pearson, who died last year at age ninety. I think it should be called the Pearson Amendment.

A. Hoffer, MD, PhD, FRCP(C)

Suite 3 - 2727 Quadra Street

Victoria, BC V8T 4E5 Canada

250-386-8756

Fax 250-386-5828

Compounding Controversy Another Threat to CAM Providers

Editor:

Regulators are becoming more and more focused on the business practices of compounding pharmacies. Though protected by law, compounding pharmacies (CP) must not become a manufacturer. As we know, CPs are often the only source of certain compounds used by CAM providers. But the FDA and at least one state have taken action to limit or even prohibit the practice.

New Florida Regulations

Florida amended its pharmacy regulation in April 2000 to prohibit pharmacists from dispensing to third parties. This change in practice presents several problems. Though doctors may order the prescribed substances from the pharmacies, the patients must receive them and take them to their physician for administering. Physicians may not inventory such drugs for patients. The new policy limits how the physician practices medicine. The new regulations have the resulting effect of penalizing both patients and their physicians by restricting how physicians furnish treatments.

Ninth Circuit Court of Appeals Decision

The Ninth Circuit Court struck down Section 353a of the Food and Drug Administration Modernization Act of 1997 ("the Section") which prohibited advertising and promotion of compounded drug products. The decision strikes a blow to the FDA, which the Court criticized for not addressing the real problems concerning pharmacy compounding. The Court describes the problems with compounding pharmacies. The Court tells the government to construct regulations that deal with the problems directly.

The case was brought by a group of licensed pharmacies that challenged the promotion and advertising subsections of the Section, alleging it violates the Constitutional guarantee of free speech under. the First Amendment. Western States Medical Center v. Donna E. Shalala, 238 F. 3d 1090(9th Cir. 2001).

The Ninth Circuit recently concluded: The government asserts that increased distribution of compounded drugs is dangerous because of the health risks associated with large numbers of patients taking such drugs. Western States v. Shalala @ 1097.

The government, in the Western States Medical Center case, failed to show how restricting advertising and promotion would protect patients from the health risks involved in compounding. The Court, in so many words, laid out a roadmap for the FDA to address the compounding problems and related dangers in future regulations. Though the decision wipes out the Section, it reinforces the point that the government will place additional restrictions on compounding pharmacies in the future.

The FDA restricts the percentage of compounding business a provider/pharmacy may dispense or distribute. If a state such as Ohio, chooses not to enter into a Memorandum of Understanding with the FDA, pharmacists, pharmacies. and physicians in that state must not distribute or dispense compounded drug products out of State equaling more than 5% of the total prescription orders they dispense or distribute. (See pgs. 4,5, Guidance for Industry, Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug and Cosmetic Act, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, November 1998.)

Remember the law has not changed the basic procedure. Providers must write a prescription; the pharmacy sends the filled prescription to the patient. The provider may not receive it directly. Unused prescriptions cannot be used for another patient. Providers may not inventory the compound for patients or future patients.

Physicians who now compound drug products for their patients must carefully monitor state and federal laws to determine if and how they are restricted in providing such products. We recently learned that at least one pharmacy has sent notice to physicians in Florida indicating they will no longer supply bulk drug products to physicians in the state due to Florida's regulatory change. Physicians should not count on the knowledge or integrity of the compounding pharmacies to protect them from potential risk or possible state action.

Gregory D. Seeley, Esq.

Susan M. Biebelhausen, Paralegal

Seeley, Savidge & Ebert Co., LPA

800 Bank One Center

600 Superior Ave. East

Cleveland, Ohio 44114 USA

216-566-8200

Fax: 216-566-0213

E-mail: gdseeley@sse-law.com

Fiber Benefit Questioned in Preventing Colon Cancer

Editor:

For the past 40 years we have been hearing the orthodox medical establishment tell us that a high fiber content in diet is a protection from colorectal cancer. Now on TV, I am hearing of a reported study of some group in the medical establishment saying that adding fiber to diet will offer little if any protection from colorectal cancer. To that I say -- at long last!

I have one concern about adding large amounts of wheat bran to diet. I refer to a report in The Lancet in the May 29, 1982 issue, pp. 1202-1206. The study was done by a group from the Imperial Cancer Research Fund in London and the Chinese Academy of Medical Sciences with the title "Silica Fragments from Millet Bran in the Mucosa Surrounding Oesophageal Tumors in Patients in North China."

There are areas in two parts of the world, North Iran and North China, where the death rate from oesophageal cancer is 50 times as high as in England. These are areas where diet is largely grain vegetarian. In the North of China the grain is millet and in North Iran, the grain is wheat. In this study, it was found that in the brans of many grains there are sharp fragments of silica. These silica fibers occur as sharp needlelike fibers. This group examined tissue removed during surgery for oesophageal cancer. They found a heavy load of these sharp silica fibers in the aesophageal mucosa in patients in North China. In England following similar surgery very few of the silica fibers were found.

It was presumed that these sharp silica fibers would lodge in the oesophageal mucosa making small wounds that never heal and that the constant irritation of the silica needle-induced wounds will give rise to aesophageal cancer.

We got the fiber boom due to the near absence of colorectal cancer among the black population in Uganda and the author of it was Denis Burkett.

He took note that the black population of Uganda were free from colorectal cancer. These people are grain vegetarians and the grains are millet, corn and sorghum. In their whole grain diet, they get a great lot of nondigestable fiber. This makes for very big stools that pass through the intestinal tract much faster than with the population in England. Burkett suggested that this high fiber in diet was causing this population to be free from colorectal cancer. This brought about the fiber boom throughout our Western World which was much more intense then than it is now.

There was a best-selling book published here written by a doctor with the title The Save Your Life Diet. The idea was to add fiber to the American diet and presto -- no more colorectal cancer.

It would seem that Burkett did not look to see what was happening to oesophageal cancer in the Ugandan population. In the April 27, 1974 issue of The Lancet there was an editorial with the title "Beware of the Ox." The thrust of this editorial was that colorectal cancer worldwide is proportional to beef in diet. There is no place in the world, the editor wrote, where there is very little beef in diet and a high death rate from colorectal cancer. The black population in Uganda had almost no beef in diet.

Then there is the vitamin D connection to colorectal cancer. Cedric and Frank Garland, epidemiologists at the University of California at San Diego gave an example of Norway. The Garland brothers hold that vitamin D is protective against both breast and colorectal cancer. They say that 45 years ago the catch of herring off Norway was more than a million tons a year. Herring is a fine source of vitamin D. Now the herring catch had dropped to under 4,000 tons a year and over this 45 year period the death rate from both colorectal and breast cancer has nearly doubled.

In 1985 a group headed by Cedric Garland examined records of 2,000 utility workers in Chicago. Over a 19-year period the ones who had in diet 150 iu a day of vitamin D had the death rate from colorectal cancer reduced by 50% as compared to those with less than half that much vitamin D in diet.

The Garland brothers then did a study of over 25,000 in Maryland. Here the 20% of this population with the highest vitamin D in blood was having the death rate from colorectal cancer reduced by 80% as compared to the 20% with the lowest vitamin Din blood. This report was in The Lancet in the November 18, 1989 issue.

Then there was a report from Scotland in The Lancet in the January 13, 1990 issue telling of the near freedom from colorectal cancer of a vegetarian Indian population of 15,000 there. Scotland has the highest beef consumption in the world along with the highest death rate in the world from colorectal cancer. It was noted that this Indian population had a very low level of vitamin D in blood. The point was being made that vegetarian populations can have low vitamin Din blood and still be nearly free from colorectal cancer.

Now that the medical establishment here seems to be turning away from the concept that a high fiber diet is protective from colorectal cancer, it would be great if they would do the obvious and tell people to avoid beef in diet and to take about 500 iu a day of vitamin D as supplements.

Wayne Martin

25 Orchard Drive

Fairhope, Alabama 38532 USA

334-928-3975

Fax 334-928-0150

Reversal of Total Arterial Occlusion

Editor:

When an artery has been totally occluded, rational thinking would dictate that no medication, oral or intravenous, could open it.

Sodium salts of edetate, together with vitamins/minerals (ACAM Protocol) infused intravenously can indeed open totally occluded arteries.

Mr. C.H., a 77 year-old retired circuit judge, was diagnosed by his vascular specialist as having total occlusion of a vertebral artery. A series of infusions at this clinic reopened the artery. This was confirmed by his physicians when comparing before and after imaging test results.

Mr. C.H. is the third patient we have been able to document. Previously our clinic has published a successful reopening of a totally occluded LAD coronary artery of an airline pilot. [1] His before and after coronary angiograms are quite dramatic. We also published the case of a patient with total renal artery occlusions. [2] Again, results were confirmed by before and after imaging at the patient's hospital.

How is this possible? We postulate that other ingredients of the IV solution (magnesium, vitamin C, B complex, etc.) effect a dampening of inflammatory swelling at the site of occlusion resulting in a slight dilating effect, allowing the EDTA-blood to slip in between the dilated arterial segment and the occlusive plug, gradually wearing it away, and thus eventually opening the vessel. There may be other unknown mechanisms.

Surely chelating physicians have similar cases in their files. I feel it is of great importance to gather together as many of these as possible. If physician readers have documented cases of reopening plugged vessels, please send them to me.

The finished document will be important to all of us, physicians and patients, and we'll make a very powerful argument for EDTA infusion therapy.

E.W. McDonagh, DO

McDonagh Medical Center

2800A NE Kendallwood Parkway

Kansas City, Missouri 64119 USA

816-453-5940

Fax 816-453-1140

References

(1.) E.W McDonagh, DO & C.J. Rudolph, DO, PhD; Noninvasive treatment for sequellae of failed coronary blood circulation; 100% occlusion of left anterior descending coronary artery, 30% stenosis right coronary artery, and left ventricular contractility deficit. J. Neural Ort hop Med Surg (1993) 14;169-173.

(2.) C.J. Rudolph, DO, PhD, FACAM and E.W. McDonagh, DO, ACGP, FACAM, Renal artery stenosis reversal in a hypertensive individual, using a combination of EDTA chelation and multiple vitamin and trace mineral therapy, Journal of Advancement in Medicine, Volume 12, Number 3, Fall 1999.

The NutraSweet Company Responds

Editor:

The article, "Carpal Tunnel Syndrome Due to Aspartame Disease," by H.J. Roberts [1] that appeared in your November 2000 issue represents the most recent, and arguably one of the most outrageous, unsubstantiated allegations about aspartame made by this author. Once again Roberts cites abbreviated "case reports" as "evidence." As in his previous anti-aspartame writings, Roberts has not conducted even one randomized controlled trial (RCT) to verify his allegations, while failing to acknowledge the dozens of RCTs that have appeared in the peer-reviewed literature over the past 20 plus years which have documented the safety of aspartame. [2,3] His literature citations, typically, contain many of his own articles, plus those carefully selected to support his thesis.

Like many other statements in the article, his comments about "methanol toxicity due to aspartame," are contrary to scientific fact. He ignores the seminal work of Tephly, a world expert on methanol, and his coworkers [4] which established that even an abuse dose of aspartame (i.e., the amount in about 75 cans of beverage consumed all at once by a 70kg person!) does not significantly increase blood formate levels over predosing levels. It is formate that is the toxic element in methanol metabolism. Thus, the body is able to handle the methanol derived from even enormous doses of aspartame quickly and efficiently. Further, fruits, fruit juices, beer and wine are also sources of methanol in much greater amounts than from aspartame in products. For example, a 12-ounce can of beverage sweetened 100% with aspartame provides about 20 mg of methanol whereas the same volume of tomato juice provides about 6 times that amount. [5] It is also of some concern that Roberts quotes a study by Trocho [6] to support his cont entions, but he neglects to mention the criticism of that paper by Tephly, [7] published in the same journal, outlining the flaws of the research and conclusions of the authors. Tephly concluded that "the normal flux of one-carbon moieties whether derived from pectin, aspartame, or fruit juices is a physiologic phenomenon and not a toxic event." 7 Thus, there is no "methanol toxicity" associated with aspartame ingestion.

This latest collection of anecdotes by Roberts is similar to those discussed in a book he published in 1990, [8] which was reviewed in the New England Journal of Medicine by Dr. Arturo Rolla. [9] Dr. Rolla stated, "Dr. Roberts did not apply a rigid scientific method to test his hypothesis, but presents it as a fact to the general public without previous scrutiny by his peers. He quotes the Wall Street Journal and other newspapers as often as the scientific press." [9] He goes on to conclude, "This type of book raises many questions for the medical community. Is it right for a physician with a hypothesis to write a book of this nature without first seeking scientific proof and presenting the data to a medical journal or society? I appreciate the concern and effort of the author, but my reaction to his book is as negative as it is strong. There is no place for a publication such as this one. It only adds to public misinformation, confusion, and mistrust. There are many other medical and scientific avenues avai lable. I hope the author will continue his effort using more rigid scientific methods, in order to present it to his peers. He has a right to write, but he also has a responsibility as a physician. Freedom of the press relies as much on the honesty and responsibility of the writer as on the government that supports it." [9] Unfortunately, ten years have gone by since that book was published, but Roberts has still not adapted rigorous scientific methods to evaluate his claims.

Aspartame has been on the market for over 20 years and is enjoyed by over 100 million Americans. It is one of the most exhaustively studied food additives ever approved by the Food and Drug Administration (FDA). Well over 200 scientific studies in animals and humans have established the safety of aspartame. These include numerous studies in both adults and children, as well as special subpopulations: obese persons, diabetic persons, lactating women, patients suffering from chronic renal failure, patients suffering from alcoholic liver disease, and those individuals who bear one gene (carriers) of the genetic disease phenylketonuria (PKU). [2,3]

Aspartame has been reviewed and found to be safe by the US FDA, [10] the Council on Scientific Affairs of the American Medical Association, [11] the World Health Organization, [12] and regulatory agencies of more than 100 nations (see website: www.aspartame.org for additional organizations which support the safety of aspartame).

It is unfortunate that the Townsend Letter for Doctors and Patients has, since 1994, published several of Robert's unfounded allegations about aspartame. Such anecdotes, hearsay, and personal opinions do not constitute "scientific evidence." On the contrary, there is an overwhelming body of scientific evidence in the peer-reviewed scientific literature demonstrating aspartame's safety. [2,3]

References

(1.) Roberts H.J. Carpal Tunnel Syndrome Due to Aspartamo Disease. Townsend Letter for Doctors and Patients 2000; 82-84.

(2.) Stegink LD Filer Jr LJ eds. Aspartame: physiology and biochemistry. New York: Marcel Dekker; 1984.

(3.) Tschanz C, Butchko HH, Stargel WW, Kotsonis FN, eds. The clinical evaluation of a food additive: assessment of aspartame Boca Rataon FL: CRC Press; 1996.

(4.) Stegink LD, Brummel MC, McMartin K, Martin-Asnat, G, Filer. LJ Baker, G L, and Tephly TR. Blood methanol concentrations in normal adult subjects administered abuse doses of aspartame J Toxicol Environ Health 1981;7;281-90.

(5.) Butchko HH, Kostonis FN. Acceptable daily intake vs. actual intake: the aspartame example. J Am Cell Nutr 1991;10:258-66.

(6.) Trocho C, Pardo R, Rafecas I, Virbili J, Remesar, x, Fernandez-Lopez JA, and Alemany, M. Formaldehyde derived from dietary aspartame hinds to tissue components in vivo Life Sci 1998;63:337-49.

(7.) Tephly TR. Comments on the purported generation of formaldehyde and adduct formation from the sweetener aspartame. Life Sci 1999;65:157-60.

(8.) Roberts HJ. Aspartame (NutraSweet[R]) Is it safe? Philadelphia. The Charles Press, 1990.

(9.) Rolla AR. Aspartame (NutraSweet[R]): Is it safe? by HJ Roberta (book review). NEJM 1990; 323(21):1495.1496.

(10.) Food and Drug Administration. Aspartame: commissioner's final decision. Fed Regist 1981;46:38285-308.

(11.) American Medical Association. Council on Scientific Affairs. Aspartame: review of safety issues. JAMA 1985;254:400-2.

(12.) Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives. Evaluation of certain food additives. (WHO Tech Rep Ser No. 653). Geneva: WHO; 1980:20.I.

Anticancer Effect of Azelaic Acid

Editor:

This is about the anticancer effect of azelaic acid. This is an utterly harmless substance that costs very little and has a vast potential in cancer treatment.

It has now been 20 years since the first hopeful report on the anticancer effect of azelaic acid was in the Lancet, (May 24, 1980 pp. 1109-1111). In this report, azelaic acid was shown to be effective in treating melanoma. There were seven authors to this report from the University of Turin, the University of Rome and the Saint Mary's Hospital Medical School in London. One of the authors was Dr. A. Breathnach of St. Mary's Hospital so we will call this the A. Breathnach et al. report. Here melanoma patients with various degrees of progression were treated with 10 to 15 grams of azelaic acid per day and a topical cream with a 15% azelaic acid. Treatment was up to 16 weeks. There were no complete regressions but there were abundant signs of partial regressions.

It has only been in recent years that it has been understood that cancer colonies progress by expressing proteolytic enzymes. In the above-mentioned 1980 report in the Lancet, the anticancer effect of azelaic acid was said to be that it is an inhibitor of tyrosinase. While there was no further discussion of this subject, it is now felt that melanoma cells along with other kinds of cancer cells, foster their own progression by producing the proteolytic enzyme tyrosinase.

In Medical Hypotheses (1999, 52 (3) pp. 221-228) there is another report on the anticancer effect of azelaic acid. This new report is by Dr. Breathnach, now with St. Thomas Hospital in London. Here it is suggested that not only is azelaic acid an inhibitor of tyrosinase, but that it inhibits anaerobic glycolysis, the energy system of malignant cells. It is also suggested that azelaic acid can limit the metastatic potential of cancer cells.

In this latter Breathnach report, it is suggested that azelaic acid may be effective against forms of cancer other than melanoma. There is the possibility of using it in treating squamous cell carcinoma as in bronchial carcinoma and bladder cancer, also breast cancer and leukemia. It is also suggested as treatment for both benign hyperplasia of the prostate and prostate cancer. Also mention is made that azelaic acid will cross the blood/brain barrier and as such may be effective against brain metastases. It seems to be both anti-inflammatory and germicidal. Being anti-inflammatory could be useful in treating brain metastases. Cancer patients who have had chemotherapy and/or radiation often are beset with bacterial infections. The germicidal quality of azelaic may be important to these patients. The obvious and simple way to use it in treating cancer is with 15 grams a day per os. Much higher concentrations in blood and tissue can be had by the intravenous infusions of the disodium salt of azelaic acid.

What is being suggested here is that it is both harmless and inexpensive so patients with the above-named kinds of cancer may want to take azelaic acid 15 grams a day and hope for the best. A good way to take it is to mix it with peanut butter.

Wayne Martin

25 Orchard Drive

Fairhope, Alabama 36532 USA

334-928-3975

Fax 334-928-0150

COPYRIGHT 2001 The Townsend Letter Group
COPYRIGHT 2001 Gale Group