Cancer Ideas

 

Volume 50. I Keep Finding Cancer Ideas/ How Much is Real or Bull?  When Does it Go to Common Health Sense?

 

Chapter 1. I Keep Finding Cancer-Healing  Ideas 1

 

American College for Advancement in Medicine: Professional Doctors’ Organization for Holistic Doctors

 

American College for Advancement in Medicine

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linkedin.com/groups/4594521

twitter.com/ACAM_ORG

youtube.com/channel/UC1jmGhbXs6foR5sQA6ejhRg

 

Honokiol and Cancer

 

Honokiol prevents a cancer enzyme called PLD (phospholipase D) from performing.

 

PLD keeps cancer cells from dying in a process known as apoptosis.

 

Honokiol blocks it, hence, cancer cells in many parts of the body die.

 

It causes no harm to healthy cells.

 

It only hurts cancer cells.

 

Injections of honokiol on mice with cancer blocked tumor growth.

 

cancerresearchsecrets.com/membership/hanokiol

 

rollupoursleeves.blogspot.com/2012/10/honokiol.html

 

cancerfightingstrategies.com/immune-system-and-cancer.html

 

naturalmedicinejournal.com/../honokiol-research-review

 

sciencedaily.com/releases/2015/06/150625145320.htm

 

en.wikipedia.org/wiki/Honokiol

 

Essential Oils and Cancer

 

Essential oils are the nueturing, medical part of concentrated flowers.

 

Many have anti-bacterial-pathogenic properties.

 

Some types are:

 

Organic Black Cumin Oil

Organic Cinnamon Oil
Organic Lemon Oil
Organic Lime Oil
Organic Orange Oil
Organic Peppermint Oil

 

They can be very expensive.

 

People also use mushrooms and herbs both topically on the skin where you feel inflammation and orally.

 

I’ve seen ads for supplements touted as cancer-fighters with essential oils and the following ingredients in them:

 

Black Cumin

Muscadine Grape Seed

the Native American Sacred herb Tsi-Ahga

Allicin-Release Product (ARP) from garlic.

blackberries

black raspberries

blueberries

cranberries

red raspberries

strawberries.

 

Healing Sounds and Cancer

 

Go to youtube.com.

 

Type in:

 

healing sounds

healing music

music to cure cancer

cancer healing frequencies

Listening releases healing endorphins.

 

Another Approach to Healing Cancer is to Shut Off the Poisons

 

Most cancer approaches are about doing something positive like take a drug, eat this food, listen to this music, etc.

 

There are many negative things that harm the body from junk food to polluted air to wifi to smart electric meters.

 

Get rid of all this stuff that causes free radical damage, toxin damage, radiation damage, etc.

 

Get rid of your microwave oven.

 

Don’t Trust Anyone Hyping any Supplement with Gobs of Flowery Junk

 

I read a few articles by some company hyping up their anti-cancer supplement formula.  I typed the name into a search engine.  I got nothing back except references to that company.  There is no independent corroboratation.  Don’t buy into anyone’s hype.

 

Many articles are ads made to look like research studies.

 

Another thing is acronyms.  People make up stupid acronyms to make something sound cool but it’s just a stupid word like PSX-60, GTA, BT 5600, Omni 6300.   It’s all B.S.

 

Enzymes Eat Cancer Cells/ Kelley Enzyme Therapy

 

Enzyme therapy goes back to Dr. Beard in 1910 then Dr. Krebs and Dr. Kelley.

 

Kelley enzyme therapy cancer protocol has been hyped up with a high cure rate.

 

Papaya Enzymes break down fibrian coating of cancer cells so immune system can attack and kill these cells.

 

Papain is the principal active enzyme in papaya powder.

 

Citrus Pectin kill cancer cells.

 

Dr. Kelley found that people produce enough enzymes but the blood supply to a cancer area is so poor the enzymes are not carried to the area.

 

It could be that the blood is so oxygen-poor that it doesn’t carry enzymes to cancer cells or we don’t have enough minerals to release the enzymes fully.

 

Celtic sea salt and Himalayan salt contain all the essential minerals the body needs.

 

Infection can also interrupt enzyme activity.

 

Take megadoses of enzymes by taking enzyme pills in natural juices.  Blend them with a blender.

 

Eat a lot of citrus and colored fruits.

 

Chapter 2. Cancer-Healing Ideas 2

 

Vitamin D Kills Cancer

 

Dr. Lorraine Day was saying in the 1980s that outdoor sunshine is good for health and to fight cancer at the same time the entire medical industry was saying stay out of the sun and sun-taan lotion companies were making big company.  It was paranoia.

 

I was raised as an outdoor person with Polish parents who had a summer cottage.  We ran around outdoors in shorts all day long.

 

Don’t believe all the hype you hear from mainstream medicine.  Somebody who stood to make money by telling people to stay out of the sun stood to make a lot of money so they hyped this lie up. 

 

In general, staying out of the sun therefore not getting much vitamin D is bad for health overall.  The medical industry makes money off sickly people not healthy ones.

 

You don’t need vitamin D pills.  Just walk around outside for about fifteen minuyes a day.  Even when it’s cloudy, the UV rays get through,

 

Cedric Garland, professor at the UC San Diego School of Medicine wrote, in the Annals of Epidemiology, that raising the minimum year-around serum 25(OH)D [vitamin D] level to 40-60 ng/ml would prevent approximately 58,000 new cases of breast cancer and 49,000 new cases of colorectal cancer each year.

 

Garland also said, "The first event in cancer is loss of communication among cells due to, among other things, low vitamin D and calcium levels. “

 

Dr. William Grant, found that about 30 percent of cancer deaths could be prevented each year with higher levels of vitamin D.

 

Sunbathing is the best way to increase Vitamin D production in the body.

 

The causes of skin cancer are:

 

putting chemical suntan lotions on your body

 

staying out in the sun too long

 

Don’t get a sun burn, just a tan.

 

Diet is a major contributor to all cancers.

 

Beryllium Formulation/ Remedy from Homeopathy Reduces Cancer Tumors

 

Homeopathic literature states that a beryllium formulation reduces the size of cancer tumors.

 

This is what people observed.

 

Any Type of Sweating/ Sauna is Easiest

 

Cancer cells die in heat.  Toxins in the body go out with sweat like the heavy metals.

 

I sweat through exercise.

 

If you’re old or weak, you can either buy a sauna (infrared sauna) or use one at a fitness center that has one.

 

Coffee Enemas to Clean the System Out

 

I read the idea of a coffee enema in an article on cancer.

 

I saw Jeff Berwick on his youtube channel talk about it and he did it on air.  You buy the kit and shove the nozzle into your asshole.  I would never do it.  I think certain things aren’t natural.  They go too far. 

 

I eat a lot of fiber and exercise.  My colon is clean enough.

 

An alternative is to go to a health food store and ask for liver cleanse supplements or powder.

 

en.wikipedia.org/wiki/Coffee_enema

 

curezone.com/forums/fm.asp?i=331385

 

sawilsons.com/library/basic-coffee-enema-procedure-and-recipe

 

draxe.com/coffee-enema

 

healthline.com/health/coffee-enema

 

UK enema kits

manifesthealth.co.uk

 

Use Cayenne and Pepper and Turmeric/ Curry Powder in Your Food

 

There are lots of articles and books praising cayenne pepper, curry powder and garlic powder as supreme health agents so I sprinkle some on every time I eat a hot meal.

 

Hyperthermia Therapy/ Create a Fever to Detox the Body and Kill Cancer Cells

 

Parmenides, a Greek physician (540-480 B.C.) said, “ive me a chance to create a fever and I will cure any disease.”

 

Before the Flexnor Report in 1910 and the modernization of medicine to chemical drugs, inducing a fever was a common way to try to cure a disease.

 

The body pasteurizes harmful bacteria and destroys it.

 

Healthy tissue can handle high temperatures but not cancer cells can’t.

 

A fever creates thermal damage to the cancer cell and stimulates the immune system to kill off poisonous cells.

 

The simple ways to do it are to take a hot sauna or do something to give you a fever like get a minor infection or eat some rotten food to get food poisoning and a fever.

 

There is hyperthermia equipment at some medical centers and spas.

 

Heat the body or parts of it to get very hot.

 

Some doctors use lasers, microwaves, etc.  It’s called local hyperthermia treatment.

 

Try the term Pulsed Electro Magnetic Therapy  in a search engine.  Dr. C. Andrew L. Bassett, used pulsed electromagnetic fields at  Columbia University's Orthopedic Research Lab.

Orthop. Review 15(12)1986 781-795.

 

Chapter 3. I Keep Finding Cancer- Healing Ideas 3

 

The PAP-IMI Machine/ Pulsed Magnetic Therapy

 

The PAP-IMI machine is an electromagnetic therapeutic device
invented Dr Panos Pappas.

 

The PAPIMI creates a pulsed electromagnetic field applied to different parts of the body.

 

It helps stimulate and activate healing and the repair of tissue.

 

The FDA approved Pulsed electromagnetic fields/ PEMF use in 1982.

 

Deep Photon Infrared Light Therapy

 

The idea is that Deep Photon Infrared Light Therapy increases energy in the cells which speeds up healing and kills cancer cells.

 

Thet use light waves via  light-emitting diodes or LEDs.

 

LEDs boost energy to the cells and speed up healing.

 

Hydrochloric Acid Therapy To Cure Many Ills

 

A weak solution of hydrochloric acid taken orally or by injection into the blood or muscles clears out the poisonous waste acids from the lymph channels, increases elimination of CO2, restores pH and desensitizes the tissues to disease proteins.

 

HCL is good for health, especially if combined with potassium.

 

When used with potassium, it boosts the immune system and increase red cells in their ability to transport oxygen.

 

Hydrochloric acid can clean out the poisons in cancer cells.

 

There is a supplement called Betaine HCL.

 

Trampoline Rebounding Exercise

The idea is that when you jump up and down on a rebounder (a small trampoline), the lymphatic system is freed from gravity and eliminates toxins.

 

A Massage Gets the Lymphatic System to Relax and Eliminate Toxins into the Blood which are then Flushed out in Waste

 

The lymphatic system is a network of vessels that transport nutrients and drain toxins from tissues.

 

It does not have its own pump

 

You help it expel toxins by massaging the body, expecially the areas where the lymph nodes are.

 

Massage stimulates lymph movement and oxygen-rich blood to circulate.

 

It feels good too.

 

Massaging the lymph nodes is like milking them to expell the toxins.

 

You get good lymphatic drainage through exercise.

 

Chapter 4. Cancer-Healing Ideas 4

 

Give up Past Negative Beliefs

 

I don’t believe in the psychobabble psychoanalytical therapy that your past affects who you are now.  I believe that’s the way so-called therapists suck people into coming back for repeat sessions talking about their past but I just read an article where the guy says if you were criticized as a child and never good enough, it weighs heavy on you as an adult.

 

For me, I am my true nature.  I create my life as I live it.  I don’t give a crap what anybody says to me about me or anything.  To me, almost everything except for math, science, logic and practical skills is someone else’s bullshit.

 

Live like I do.  Don’t buy into this crap that your past determines who you are now like my wimp relative who blames his alcoholism on his father who he says was an alcoholic even though he quit drinking.

 

I can’t stand wimps.

 

I can’t stand people who try to put you down by saying stupid things in order to bring themselves up a notch.  I know somebody like that right now which is why I don’t answer his phone calls, etc.

 

I feel good.

 

My self-talk is good.  I think the world is screwed and I’m one of the few sane people here.

 

I don’t buy this bit about being loyal to your blood relatives even if they‘re scumbags.  Some of my relatives are selfish, disgusting pigs.  They want sympathy and guilt from me or something.  I even caught one of them stealing food from me. 

 

If you got cancer or any disability, don’t compound it by staying around these scumbags.

 

A Clean Living Space

 

I don’t get shocked very often.  I downloaded the following book:

 

huldaclark.com/cure-for-all-diseases.pdf

 

I started reading it.  At first I thought she was a neurotic clean freak focusing too much on the normal stuff we’re surrounded by in regular life but then it hit me.  All this chemical stuff everywhere from our foods to stuff in carpets contains poisons that might not hurt us piece by piece but taken all together, they wear us down and cause diseases.

 

Then almost by coincidence, as I was writing this article, I was listening to the youtube channel:

 

SGTreport

 

and this video came on:

 

KILL GRID: 5G Networks And Frequency Warfare

 

She talked about wifi hurting your eyes.  My wifi device was near my bed.  I got a longer cable and moved it further away:

 

stopthecrime.net

 

Almost everything in the modern world is a poison.

 

Most cleaning products are loaded with toxins.

 

Soap has chemicals in it.

 

Look for alternatives.

 

Not all toxins can be avoided but try to avoid exposure.

 

A List of Carcinogenic Substances

 

lead
mercury
zinc
nickel
cadmium
as well as alcohol
nicotine
sodium
sulfuric acid lead
copper
aluminum
pesticide residues
petroleum-based toxins
chloride
fluoride
fat and cholesterol

 

Chapter 5. Cancer-Healing Ideas 5

 

 

It’s a Comprehensive Fight: Destroy As Many Cancer Cells As Possible In The Shortest Time Possible.

 

If you’re diagnosed with cancer, you don’t just listen to Doctor A say you got stage four, it looks bad, we’ll get you on chemotherapy right away.

 

You probably have a limited amount of money.

 

Use whatever ideas of the many out there to fight your cancer.

 

Fight it from all angles possible.

 

The idea is to purge your body of cancer cells and strengthen your immune system.

 

Radiation, EMFs, WIFI, etc.

 

 I listened to some stuff at rense.com, then at stopthecrime.net.

 

All these waves everywhere poison us despite what their trade organizations and companies say.

 

Smart meters are wireless meters pulsating through our houses, going through our bodies.

 

The National Council on Radiation Protection and Measurement said we’re being exposed to radiation all over the place.

 

Minimize the use of medical imaging scans such as CT scans.

 

One CT scan exposes the body to a lot of radiation equal to several hundred X-rays.

 

jmbblog.com/americans-exposed-to-atomic-bomblevels

 

healthycommunications.com/mammograms_cause_breast_cancer.htm

 

 

Microwave Ovens and Microwaved Foods

 

Microwave ovens release harmful waves as they cook food.

 

Microwaved food is damaged somehow.

 

Reports say it damages anything from vitamin B-12 to a general  degradation of all microwaved foods.

 

It releases potentially toxic particless  into the food.

 

A guy said when he fed his plant microwaved water, it died.

 

Amalgam Mercury Fillings are Toxic

 

Mercury in dental fillings could be the cause of many diseases.

 

Mercury is the second most toxic substance next to plutonium.

 

It disrupts cell function.

 

Get the fillings removed.

 

Find a holistic dentist.

 

Find products to cleanse the body of mercury and heavy metals.

 

Use ceramic resin type material for fillings.

 

Gold is better but no metals of any kind should be put into fillings.

 

Toxic Food Additives like MSG

 

MSG is a neurotoxin that can cause reactions like:

 

migraine headache
asthma
nausea and vomiting
fatigue
disorientation
depression

 

MSG kills brain cells in laboratory animals.

 

These substances and foods contain MSG:

 

Glutamate
Monosodium glutamate
Monopotassium glutamate
Glutamic acid
Calcium caseinate
Textured protein
Hydrolyzed protein

Yeast extract
Yeast food
Autolyzed yeast
Yeast nutrient

 

curezone.com/foods/enumbers.asp

 

Cinnamon Reduces Cancer

 

According to some studies, cinnamon reduces cancer cells increasing in number.

 

Cinnamon also combats insulin resistance.

 

Cinnamon extract stopped cancer growth.

 

You Need Iron When You Have Cancer

 

Cancer patients get weak and tired.

 

It could be an iron deficiency.

 

Iron is important for red blood cell function.

 

Haemoglobin carries oxygen to the tissues from the lungs then returns with carbon dioxide from the cells for energy production in the muscles.

 

Iron is in most vegetables.

 

You could use an iron supplement.

 

These fruits and vegetables contain iron:

 

Spinach
Green peas
Celery
Bell Peppers
Green beans
Green onions
Potatoes
Squash
Apples
Peaches
Nectarines
Pears
Cherries

Strawberries
Blackberries

Raspberries

 

Iodine Deficiency and Cancer

 

All cells need iodine for proper functioning.

 

Iodine deficiency is a cause of breast cancer and other diseases.

 

Iodine levels in soil have fallen.

 

Eat lots of vegetables.

 

Possibly take an iodine supplement.

 

Salt is Good

 

 

A body is 75% water.

 

The blood in a body is a salty water solution.

Salt has many important functions like:

 

regulating the water content of the body.

lowers blood pressure

stabilizing irregular heartbeats

antihistamine.

release asthma.

stop persistent dry cough

clear the lungs of mucus

strong antiseptic

extracting excess acidity from inside the cells
without it the body will become acidic.

preserving serotonin, melatonin and tryptamine levels in the brain

prevention and treatment of the cancer.

 

Cancer cells cannot live in an oxygenated environment.

 

When the body is hydrated and salty blood reaches all parts of the body, oxygen and active immune cells in the blood destroy cancer cells.

 

Salt at the supermarket is salt that has had most of the minerals sucked out of it.

 

Celtic Sea Salt is raw salt with the minerals still in it.

 

healthfree.com.

 

Don’t overdo salt.  If you drink a lot of water, you flush out excess salt.

 

Psychobabble Ideas on Cancer

 

They say people who express anger and people who keep it in are more likely to get cancer.  This is a contradiction.  You either express anger or you don’t.  It’s all a bunch of psychobabble.  Here are personality traits they say cancer patients tend to have:

 

worrier

 

keeps emotions pent up

 

dangerous person, seeks conflict to solve problems

 

negative emotions

 

Loss/ Grief

 

Unfulfilled passion

 

Unworthiness

 

anxiety

 

compulsive neatness

 

Volume 51. Holistic Cancer Treatments Guide/ 1990 American Government Report (Public Domain Book)

 

Introduction

 

I found an article from 1990 that looked pretty extensive so I edited it down for this book.

 

If you want to find the original, go to scribd.com or buzzle.com and type in Unconventional Cancer Treatments.

 

This book was scanned on a scanner from print to get it to e-form so there are a lot of mistakes in it.

 

Holistic Cancer Treatment Knowledge

 

Several of the unconventional treatments include a spiritual or religious component.

 

In macrobiotics, for instance, the dietary guidelines are one aspect of a much larger philosophical and spiritual system.

 

Similarly, Anthroposophic medicine, which includes the use of the herbal preparation Iscador for cancer patients, is based on a complex religious philosophy and "spiritual science" developed by Rudolph Steiner in the late 19th and early 20th centuries.

 

Other unconventional treatments that were designed specifically for cancer patients include a spiritual component.

 

Spiritual aspects of the original Kelley regimen, for example, reflected the developer's strong religious beliefs.

 

A physician who founded the first clinic in Tijuana offering laetrile to cancer patients, Ernesto Contreras, includes a strong spiritual orientation in his regimen and often leads services for patients at a chapel he built at his clinic.

 

Patients may also seek care from traditional healers (outside their own culture), e.g., Native American healers, curanderos, shamans and others, who use a strong spiritual component in their approach to treatment.

 

Although the extent of use of traditional healing methods by U.S. cancer patients is undocumented, the popular literature suggests that some approaches have become relatively common in recent years.

 

The 'New Age' movement in the United States has popularized a number of mystical practices, such as crystal healing, channeling and 'neo-shamanism,' as well as some traditional healing practices involving curanderos, herbalists and others.

 

While most spiritual approaches treat cancer as any other disease or misfortune, some techniques with spiritual or mystical components are often associated specifically with cancer.

 

"Psychic surgery" refers to a procedure involving removal of spirits or physical manifestations of spiritual pathology from a patient.

 

Some Americans travel to the Phillipines for "psychic surgery," where it is practiced in its original context of religious and traditional healing.

 

Psychic surgeons from the Phillipines have also come to the United States, holding treatment sessions as they travel around the country.

 

They have often been pursued by legal authorities and some have been convicted of practicing medicine without a license.

 

Psychic surgery is considered by many in the unconventional community to be afringe' treatment.

 

The treatments are grouped into four general categories:

 

psychological and behavioral nutritional herbal pharmacologic and biologic.

 

These categories are not the only ones that could be devised and the groupings do not connote commonality among their elements beyond the basic nature of the treatment.

 

Since many of the treatments include a variety of components, however, assignment to certain categories was not straightforward and could have been done differently in a number of cases.

 

In general, assignment to the categories was based on the nature of the central or unique element of each approach.

 

The mainstream medical literature contains very few substantive articles for physicians and patients who want to find out about unconventional cancer treatments.

 

Very few scientific studies of these approaches have been done.

 

Most reports that make their way into medical journals concern adverse effects of particular treatments or are generally negative.

 

Some patients become frustrated when they discover there is so little concrete information about the effectiveness and safety of specific unconventional treatments.

 

Many will have been told, perhaps by a clinic itself, perhaps by other patients or advocates, that the treatment will improve their quality of life and will cause their cancer to regress and possibly disappear.

 

They may have been told by prominent national groups (e.g., ACS, FDA) that, at best, the treatment is untested and therefore unproven, or worse, that it also has dangerous side effects.

 

Based on the work done for this assessment, a common situation is that effectiveness is unknown and relevant information on adverse effects is nonexistent.

 

Patients often decide to go ahead with unconventional treatment because no reliable information confirms that the treatment doesn't work or that it would likely be harmful.

 

They may feel they have nothing to lose by trying it.

 

Since most health insurance policies-public and Private-do not cover charges for unconventional cancer treatments, patients generally pay for them directly.

 

Insurance coverage under the Federal Medicare program (for people 65 and over) is limited to care that is "reasonable and necessary,' which for drugs generally refers to those that are FDA approved and in some cases to drugs designated by NCI as "Group C" (Group C drugs have been found to have some therapeutic value in clinical trials, but have not yet been approved by FDA).

 

Most Blue Cross/Blue Shield and private insurance plans have similar restrictions.

 

Most health insurance contracts contain general language that excludes coverage of unconventional treatments and some specify particular treatments by name.

 

Chapter 1. Holistic Cancer Behavioral and Psychological Approaches

 

INTRODUCTION

 

Over the past two decades, the role that personal characteristics and behaviors might play in recovery from serious illness has become a widely discussed topic, both in the scientific and popular literature.

 

In self-help books geared toward cancer patients, for example, certain attitudes and characteristics, such as having a "cancer-prone personality," are commonly linked with hastening the course of illness or allowing it to develop in the first place.

 

Other characteristics, such as a strong "will to live" and a good coping style, are often credited with preventing illness, reversing the course of existing disease, or prolonging life.

 

Newspaper and magazine accounts of spontaneous remissions and of individuals who outlived their physicians' predictions lend widespread support to these ideas.

 

Recently, reports of spontaneous remissions from cancer have begun to be collected in an annotated bibliography intended for researchers studying psychosocial factors and interventions in cancer treatment.

 

Several popular books on the role of emotions and behavior in recovery from serious illness have helped bring this subject into the foreground of cancer treatment.

 

Some of the best known examples include Norman Cousins' Anatomy of an Illness and Head First, Bernie Siegel's Love, Medicine and Miracles and Peace, Love and Healing and the Simontons' Getting Well Again.

 

From various points of view, these books encourage patients to combat feelings of hopelessness, passivity and depression that may accompany life-threatening illness and to develop positive outlooks and effective coping strategies.

 

Along with a number of other available books on the subject, these books support the view that patients' efforts to promote physical, emotional, psychological and spiritual well-being, or healing, can enhance the environment for medical care, improve psychological and physical adjustment to the disease and in some cases tip the balance toward recovery.

 

Guided imagery, meditation, psychological counseling, support groups and other approaches are often used to help patients achieve these goals.

 

Increasingly, psychological and behavioral methods are becoming a regular part of cancer treatment, whether included explicitly as part of conventional regimens or sought out independently.

 

For the most part, the aim of these methods is to enhance quality of life.

 

In some cases, however, claims of tumor regression or prolonged survival are made, based largely on case reports and uncontrolled studies.

 

Although initial attempts at controlled studies evaluating psychosocial interventions have recently been made, the efficacy of psychological and behavioral approaches in improving the course of cancer is still uncertain.

 

This chapter focuses on the use of psychological and behavioral methods for modifying the disease process itself-in other words, as unconventional cancer treatment.

 

Conventional uses of psychological interventions in enhancing quality of life are summarized first, followed by a brief discussion of current research on relationships among emotions, immunity and cancer.

 

The next section of this chapter describes three of the most popular psychological interventions for which claims of tumor regression or life extension have been made.

 

The final section summarizes the available information from studies attempting to evaluate the efficacy of various psychological and behavioral interventions in altering the course of cancer.

 

PSYCHOSOCIAL SUPPORT FOR CANCER PATIENTS

 

In the past decade, demand by cancer patients and survivors for psychosocial support services has grown.

 

Community organizations, patients, treatment centers and professional societies have worked together to develop support services for an estimated 5 million U.S.

 

cancer patients and survivors.

 

A variety of psychological and behavioral interventions are being used to address physical and psychosocial needs of cancer patients and long-term survivors.

 

Some of these interventions are incorporated into conventional treatment programs, while others are offered outside of medical settings, e.g., as part of cancer support group activities.

 

For the most part, these interventions are designed to help patients reduce pain, control nausea and vomiting associated with chemotherapy and cope with other physical or mental disorders that the disease and its treatment may bring about.

 

Examples of interventions used to reduce distress associated with cancer and chemotherapy include hypnosis, progressive muscle relaxation training with guided imagery and systematic desensitization.

 

Increasingly, psychological approaches are also being used to address broader emotional and social issues among cancer patients and their families.

 

Patients may seek help in changing their lifestyles, in reducing stress, in reexaminingg their relationships with others, or in planning for the future.

 

There is a wide variety of hospital-based and independent support groups and peer support programs for patients and their families.

 

These groups differ in scope, components and approach.

 

Some are sponsored by the American Cancer Society (ACS), including CanSurmount, Reach for Recovery and Candlelighters Childhood Cancer Foundation.

 

Patients calling ACS's Cancer Response System telenumber can be referred to local ACS support groups, hospital-based groups, or affiliated groups.

 

A number of others are associated with the National Coalition for Cancer Survivorship, an Albuquerque- based organization that encourages the development of local support groups, provides information for patients and researchers and assists patients with problems in job discrimination, insurance coverage and doctor-patient communication.

 

The psychosocial support offered by the groups described below is based on the idea that cancer patients can improve the quality of their lives and perhaps contribute to their treatment and recovery by becoming actively involved in the fight against their cancer.

 

Unlike self-help groups that also act as advocates of either mainstream or unconventional cancer treatments, these groups are relatively autonomous.

 

They are not affiliated with facilities or organizations that provide medical care or advocate particular types of cancer treatment.

 

They all, however, see their programs as complementary to ongoing medical care.

 

While there is a growing population of cancer patients who wish to become actively involved in the fight against their illness through these sorts of programs, it is estimated that only about one in ten patients follow this route.

 

It is possible that more cancer patients will choose to pursue these approaches if they become more widely known and readily accessible (e.g., through oncologists or hospitals).

 

One of the best known programs offering psychosocial support is the Wellness Community, which was founded by Harold Benjamin in 1982 in Santa Monica, California and is expanding, through patient demand, to other parts of the country.2 The Wellness Community's program, which is free to participants, is intended to encourage cancer patients and their families to participate actively in the fight for recovery, thereby improving the quality of their lives and possibly enhancing their chances of long-term survival.

 

Since its beginning, it has attracted more than 8,000 cancer patients and family members.

 

The Wellness Community explicitly states that its approach to patient care is in support of, not a substitute for, mainstream medical care.

 

Many cancer patients are reportedly referred to the program by their oncologists.

 

Oncologists also serve on the centers' Professional Advisory Boards, which have direct input to the staff of State-licensed psychotherapists at each center.

 

The size of the staff at each facility varies according to the community; as of 1987, the program in Santa Monica was staffed by seven psychotherapists and seven psychotherapy interns.

 

The central elements of the Wellness Community are the mutual aid groups that focus on cancer patients' feelings and that teach self-help techniques with the idea that "positive emotions and positive mental activities may improve the possibility of recovery from cancer".

 

Other group activities include lectures for patients (on topics ranging from self-esteem to nutrition), potluck dinners, charade nights, joke festivals, picnics and other group activities designed "to bring smiles and laughter into the lives of cancer patients".

 

In addition, members may also have one-on-one sessions with the staff psychotherapists.

 

Another widely known support group is the Exceptional Cancer Patients (ECaP) program founded in 1978 by Bernie Siegel, M.D. in New Haven, Connecticut.

 

The program is said to be based on "care frontation," described as a loving, safe, therapeutic confrontation, which facilitates personal change and healing.

 

Siegel's program includes individual and group support that makes use of patients' dreams, drawings and images in an effort to "make everyone aware of his or her own healing potential" and to become anexceptional cancer patient,' which Siegel defines as one who gets well unexpectedly.

 

Patients are charged for an initial, intensive, intake session and for group and individual sessions thereafter.

 

ECaP states that its psychotherapy is in addition to, not in place of, mainstream medical care and that no medical advice is offered to participants.

 

ECaP also seines as an information resource; according to its patient literature, more than 750 people from all over the country write or call ECaP each week seeking information.

 

It can supply books, audio- and videotapes and reading lists.

 

ECaP also keeps track of other centers that offer similar services and may refer callers to facilities in their vicinity.

 

In an effort to further expand the availability of its services, about once a month ECaP offers intensive, 2-day training sessions for people interested in setting up similar groups (which can be called ECaP-like groups, as there is only one ECaP center).

 

As of early 1990, approximately 160 people had received this training.

 

Another model support program is the Commonweal Cancer Help Program, which was started in 1985 in Bolinas, California.

 

Michael Lerner, Ph.D., Commonweal's President and Rachel Naomi Remen, M.D., medical director, organize groups of 8 to 12 patients for intense, week-long sessions aimed at helping patients cope with stress and resolve fears and anxieties (particularly about pain, illness and death) and improve the quality of their lives.

 

The main purpose of the sessions is to help cancer patients "discover those inner and outer conditions under which they may best maximize their health and wellbeing".

 

Commonweal retreats are held in a rustic ocean- side center about an hour drive north of San Francisco.

 

The retreat staff includes the director, a co-director who is a psychologist trained in cancer work, a yoga teacher, a vegetarian cook and art teacher and a massage staff.

 

The program includes a cognitive or informational component and a multifaceted lifestyle component.

 

Commonweal offers participants access to its library of books and articles from the medical and popular literature dealing with cancer treatment and research.

 

The remainder of its program offers patients a daily regimen designed to release stress and encourage personal expression of feelings.

 

The program includes small group sessions, lectures, massage, yoga, training in relaxation and stress reduction techniques, meditation, imagery, walks in nature, journal and dream work, reflection and other forms of artistic expression and personal exploration.

 

Commonweal's directors believe that these activities- exercise, healthful diet, deep relaxation, opportunity for personal expression, access to information and caring support-release fear and stress and enable patients to identify lifestyle and healing path that is best for them.

 

The majority of the participants in the program have been women and the relatively low cost of the retreat has allowed people from varying backgrounds to attend.

 

Generally, participants have heard about the program through physicians, other health care providers, or previous participants.

 

People interested in the program are screened by the coordinator to ensure that they understand the nature of the program, can work well with a small group and ace able to take care of themselves.

 

Participants must also be under the care of a physician and understand fully that the program is not itself a complete treatment.

 

PSYCHONEUROIMMUNOLOGY

 

It is often suggested in the popular literature that various types of behavioral intervention designed to reduce stress or to promote positive mental images act by enhancing the immune system.

 

Since the immune system is the body's primary defense against many diseases, its enhancement is commonly linked with reducing the susceptibility to cancer or with enhancing the ability to fight cancer.

 

Unfortunately, the actual relationships among emotions, immunity and disease are still poorly understood, despite a large body of literature on the subject spanning several decades.

 

Within the last 10 years, however, new evidence has emerged concerning the biological basis of interrelationships among personality, emotion, behavior, immune alterations, neuroendocrinology and the onset and progression of disease.

 

The relatively new interdisciplinary field of psychoneuroimmunology (PNI) encompasses these diverse areas of research.

 

One of the catalysts for the recent interest in PNI research was the discovery by Ader and colleagues that immune functions in experimental animals could be altered by behavioral changes (13).

 

That observation provided evidence that the immune system did not function completely autonomously, as was previously thought, but that other biological processes, e.g., necrologic and endocrine factors, could directly modulate immune function.

 

Recent PNI research has revealed a number of biochemical and neurological connections between the immune system and the central nervous system.

 

Their clinical significance, however, is still unclear.

 

For many years, certain types of cancer have been thought to be influenced by immune processes, although the nature and extent of these influences are still only partially understood.

 

Experimental animal data suggest that tumors induced by viruses or ultraviolet radiation appear to elicit immune responses (via antigen-specific T-lymphocytes) that act against those particular tumor cells.

 

However, the majority of cancers of internal organs (not induced by viruses or ultraviolet radiation) are apparently not affected by T-cell-mediated immunity, although they could be susceptible to other immune processes in ways that are also poorly understood.

 

Burnet's widely known immune surveilance theory, which proposes that one function of the immune system is to recognize and destroy malignant cells as they arise, has gradually been modified and expanded to take into account broader possibilities for additional types of immune action against malignant cells.

 

Attempts to measure and interpret alterations in immune function are central elements of many current PNI studies.

 

Investigators have tried various ways of testing the hypothesis that the immune system mediates among emotions, personality, behavior and disease onset and progression.

 

However, a major difficulty in interpreting the significance of alterations in particular immune functions is that the clinical implications-benefit or impairment with regard to disease-are not yet known.

 

A statistically significant increase in circulating levels of disease-fighting cells could, for instance, reflect normal variability, or could have only short-term effects, or could be compensated for by changes in other immune processes.

 

The critical associations needed to interpret immune system alterations and changes in cancer onset or progression have not been demonstrated.

 

For the most part, PNI research has focused on correlations between psychosocial characteristics, such as personality, emotions and stress and specific biochemical measures of immune function, or between psychosocial characteristics and disease onset and progression.

 

A handful of studies have been carried out to assess possible effects of psychological interventions on immune function or on disease onset and progression.

 

So far, PNI research on links between psychosocial characteristics and disease has suggested that stress, or the ways in which individuals cope with stress, may influence immune function.

 

It is not known if stress acts directly, via physiologic processes, or indirectly, via altered health-related behaviors, such as alcohol drinking, a poor diet, lack of exercise, etc.

 

Of critical importance, it is not known whether these altered immune responses are directly linked to the onset or progression of cancer.

 

Other studies have examined effects of psychosocial factors on the risk of disease onset.

 

There are conflicting data on relationships between psychosocial factors, e.g.

 

"cancer-prone personalities and cancer onset and progression.

 

For instance, clinical depression has been found to have little or no effect on the risk of developing cancer in large segments of the population.

 

A recent review of these studies concluded thatthe results of prospective studies [on psychosocial risk factors and cancer onset] do not yet permit firm conclusions about the cancer-prone personality.

Many studies have examined effects of psychosocial factors on the course of cancer, with mixed results.

 

In general, four types of factors have been examined: adjusting to illness, emotional expression, will to live and emotional stress.

 

A number of studies have reported correlations between one or more of these factors and cancer outcome.

 

A recent study of 36 women with recurrent breast cancer found that signs of joyful attitudes were associated with longer disease-free intervals.

 

Two other recent studies did not find a correlation between psychosocial factors and length of survival or time to relapse in patients with advanced disease.

 

At present, one of the most controversial areas of PNI research concerns effects of behavioral interventions on immune function and cancer.

 

Preliminary evidence suggests that some psychological or behavioral interventions, such as hypnosis and relaxation, can alter immune function in healthy individuals.

 

Another study in progress is examining effects of relaxation and imagery techniques on immune function in cancer patients.

 

Whether psychological and behavioral methods may influence the onset or progression of cancer is still an open question.

 

Studies that have approached this issue are discussed in the last section of this chapter.

 

UNCONVENTIONAL USE OF PSYCHOLOGICAL AND BEHAVIORAL APPROACHES IN CANCER TREATMENT

 

Psychological and behavioral interventions for which an assertion of tumor reduction or life extension is made involve relatively few techniques.

 

As discussed above, these same approaches are also used for helping patients reduce pain or distress and inmost of these cases are not claimed to have a direct anticancer effect.

 

Given the popularity of psychological interventions for a wide range of purposes, the unconventional use of these methods appears to be a relatively small, but quite visible, part of the overall field.

 

This section summarizes information on the psychological approaches that are most prominently associated with direct anticancer claims in the popular and professional literature.

 

Three techniques are discussed: the psychotherapeutic method developed by Lawrence LeShanj meditation as described by the late Ainslie Meares and imagery and visualization as developed by the Simontons.

 

These approaches are the best documented examples and are the ones cancer patients are most likely to hear about, even though many other practitioners have adopted and modified them.

 

There is overlap in practice among imagery, meditation and a variety of other self-regulation techniques, such as relaxation, hypnosis and biofeedback.

 

Hypnosis, for instance, is probably very similar to meditation and imagery in its effect on consciousness.

 

It is commonly stated in the popular literature that these psychological techniques facilitate the achievement of a particular state of consciousness and thereby enhance the immune system and the body's natural healing abilities.

 

As discussed in the previous section, PNI research is just beginning to address this issue.

 

LeShan's Psychotherapy

 

One of the most prominent examples of an unconventional psychological approach is a form of one-on-one psychotherapy developed by Lawrence LeShan, a researcher and clinical psychologist, as an adjunct to conventional treatment for cancer patients.

 

LeShan's two most prominent books explain the basis for his view that patients with advanced, metastatic disease can sometimes undergo tumor regression and can sometimes increase the length and quality of their lives under his psychotherapeutic regimen.

 

His conclusions are based on personal experience over several decades with patients he has treated.

 

LeShan received his Ph.D. from University of Chicago and began clinical research in 1952 at the Institute for Applied Biology in New York.

 

He has published widely in psychological literature.

 

For many years, his research focused on relationships among personality factors, traumatic life events and cancer onset and progression.

 

In his earlier research, he focused on the notion of a "cancer-prone personality" and concluded that the interplay between personality and events can so weaken the body's cancer defense mechanism that a cancer is likely to appear.

 

The approach LeShan describes in his 1989 book, Cancer as a Turning Point, is a psychotherapeutic process used to identify the creative potential and self-healing ability of each patient.

 

LeShan attempts to develop "the perception and the expression of the individual's special song to sing in life" andthe cause of his or her loss of contact with enthusiasm and joy'.

 

He describes his method as a process of self-examination and growth that delves deeply into the patient's past in order to "analyze the blocks that keep the patient from being able to live out his or her true nature".

 

Rejecting a traditional Freudian psychoanalytic approach early on in his career, LeShan chose instead to find ways of helping cancer patients make their disease a "turning point" in their lives, an opportunity to fulfill their dreams.

 

LeShan explains this guidance toward inner development and fulfillment in the following way:

 

What is right with this person? What are his (or her) special and unique ways of being, relating, creating, that are his own and natural ways to live? What is his special music to beat out in life, his unique song to sing so that when he is singing it he is glad to get up in the morning and glad to go to bed at night? What style of life would give him zest, enthusiasm, involvement?

 

How can we work together to find these ways of being, relating and creating? What has blocked their perception and/or expression in the past? How can we work together so that the person moves more and more in this direction until he is living such a full and zestful life that he has no more time or energy for psychotherapy?

 

Leshan believes that some cancer patients have undergone tumor regression and have increased the length of their lives as a result of his psychotherapeutic approach.

 

He states his conclusion this way:

 

Ever since I learned how to use this approach some twenty years ago, approximately half of my "hopeless, terminal," patients have gone into long-term remission and are stiIl alive.

 

The lives of many others seemed longer than standard medical predictions would see as likely.

 

Nearly all found that working in this new way improved the "color" and the emotional tone of their lives and made the last period of their lives far more exciting and interesting than they had been before starting the therapeutic process.

 

Speculating that the psychotherapy might bring about changes inpatients' immune function, LeShan writes that his treatment is often "sufficient to halt or reverse the direction of growth of a serious neoplasm." He believes thatif we recover our hope for the ability to live our own life our "cancer-defense mechanism [will] recover its strength and come to the aid of the medical program."

 

As we move toward living this life, [our] own self-healing powers [will] act more strongly and raise our 'host-resistance' to the cancer.

 

Meditation

 

Meditation can be defined asany activity that keeps the attention pleasantly anchored in the present moment.

 

Although there are many forms of meditation, one common feature is the absence or near absence of logical thought and emotional experience.

 

Different approaches to meditation may consist of quieting the mind, concentrating on a single subject such as breathing or a repeated word, observing passing thoughts, or visualizing active healing processes (a Process similar to the practice of imagery, described below).

 

The purpose of meditating is not primarily to relax, although relaxation may be a side effect of meditating, but to raise awareness, which is seen as the prerequisite togetting the mind back under control (92).

 

By calming the body and fixing the mind through 'dropping the anchor of attention,' meditation is believed to be an important tool of self- healing and self-regulation.

 

In the 1970s and early 1980s, meditation directed against tumors received public attention as a result of the work of the late Ainslie Meares, an Australian psychiatriSt.

 

Meares used a form of meditation aimed at producing a profound stillness of mind.

 

He characterized the practice as one of simplicity and naturalness.

 

Cancer patients reportedly experienced "a profound and prolonged reduction" in anxiety and a nonverbal understanding of life and death.

 

Meares believed that intensive meditation "enabled the immune system to function more effectively by inducing changes in blood supply to particular parts of the body and in endocrine function and neural activity".

 

Based on his experience treating 73 patients with advanced cancer who attended at least 20 sessions of intensive meditation, Meares believed his treatment reduced anxiety, depression, discomfort and pain in about half his patients.

 

Meares believed that intensive meditation was associated with tumor regression in at least 10 percent of the advanced cancer patients he treated.

 

He also published a number of case reports of regression of cancer after intensive meditation and in the absence of conventional treatment.

 

Imagery and Visualization

 

Imagery refers to various psychological techniques that involve the creation and interpretation of mental images.

 

It has been described as a tool for communicating with the subconscious mind.

 

Imagery can be used as a tool for articulating ideas, beliefs and experiences and for replacing fears and negative expectations with positive ideas and beliefs.

 

In cancer treatment, guided imagery often consists of visualizing the symbolic destruction of cancer cells and has been used to reinforce patients' beliefs in their ability to recover.

 

Other imagery techniques used in cancer treatment, e.g., gentle imagery, focus on imagining peaceful, pleasant scenes.

 

Imagery is often used along with relaxation, meditation, or hypnosis.

 

A broad psychological approach to cancer treatment centering on the use of imagery was popularized in the 1970s by O. Carl Simonton, a radiation oncologist and Stephanie Simonton-Atchley, a psychotherapist.

 

The Simontons' best-selling 1978 book, Getting Well Again, described their clinical experience treating cancer patients with imagery and other psychological approaches at the Cancer Counseling and Research Center in Dallas (continued now at the Simonton Cancer Center in Pacific Palisades, CA).

 

Their regimen was described as awhole-person approach to cancer treatment' and included interventions designed torestore the physical, mental and emotional balance so that the whole person returns to health'.

 

The rationale was reportedly based on theories concerning the role of personality characteristics and psychological factors in the etiology of cancer.

 

Relaxation and mental imagery were presented as tools for cancer patients to motivate themselves to recover their health and to make creative changes in other areas of their lives.

 

overall, the regimen was presented as an adjunctive approach to conventional cancer treatment, but claims for direct antitumor effects were also made.

 

The process of imagery, as outlined by the Simontons, begins with a period of relaxation.

 

The patient is then instructed to visualize the tumor as a weak, disorganized, soft mass of cells.

 

Conventional treatment is visualized as powerful and effective, capable of shrinking tumors and helping the patient overcome the disease.

 

The patient is encouraged to visualize defending himself or herself against cancer through a strong and aggressive immune system, a symbol of the body's natural healing processes.

 

White blood cells are visualized as a vast army of defenders easily overwhelming the weak malignant cells.

 

Dead and dying cells are visualized as being flushed out of the body by natural processes, until no more tumor cells remained.

 

The patient is then instructed to imagine himself or herself as healthy, energetic and fulfilled.

 

The Simontons recommended that cancer patients repeat the process three times a day.

 

According to the Simontons, the process of relaxation and imagery reportedly helped patients lessen fears, tension and stress; change attitudes; strengthen the will to live; confront depression, hopelessness and helplessness; and gain a sense of confidence and optimism.

 

It was also believed that relaxation and imagery could effect physical changes, enhancing the immune system and altering the course of a malignancy.

 

The Simontons claimed significant life extension as a result of relaxation and imagery techniques.

 

The claim was apparently based on a preliminary analysis of their patients compared with national statistics, as explained in the following excerpt from Getting Well Again:

 

In the past four years, we have treated 159 patients with a diagnosis of medically incurable malignancy.

 

Sixty-three of the patients are alive, with an average survival time of 24.4 months since the diagnosis.

 

Life expectancy for this group, based on national norms, is 12 months.

 

A matched control population is being developed and preliminary results indicate survival comparable with national norms and less than half the survival time of our patients.

 

With the patients in our study who have died, their average survival time was 20.3 months.

 

In other words, the patients in our study who are alive have lived, on the average, two times longer than patients who received medical treatment alone.

 

Even those patients in the study who have died still lived one and one-half times longer than the control group.

 

In a 1980 paper describing an uncontrolled, exploratory study, the Simontons used a similar approach to describe outcomes in another, possibly overlapping, series of cancer patients.

 

Out of 130 patients with breast, lung, or colon cancer, 75 patients with advanced disease were included in the analysis.

 

Median survival time (the time at which half have died and half are still alive) since diagnosis was 35 months for the 33 breast cancer patients, 21 months for the 18 colon cancer patients and 14 months for the 24 lung cancer patients.

 

These survival times were compared to published data on other groups of metastatic breast, colon and lung cancer patients: 16, 11 and 6 months, respectively.

 

The Simontons noted that their patients lived twice as long as those reported in the literature and speculated that better patient motivation, greater confidence in the treatment and overall positive expectancy as a result of their regimen may have contributed to the results.

 

The design of the Simontons' study was such that valid conclusions could not be drawn from it about increased survival as a result of relaxation and imagery, since other possible intervening variables were not accounted for.

 

It is not known how the Simonton patients might have differed in physical and psychological characteristics from the patients with whom they were compared.

 

Chapter 2. Holistic Cancer Dietary Treatments

 

Dietary Introduction

 

A specified diet is the primary component of some unconventional cancer treatments.

 

This chapter reviews three examples of unconventional treatments with dietary regimens as the primary or central component: the treatment regimen developed by the late Max Gerson, M.D currently offered at a clinic in Tijuana, Mexico; the treatment regimen developed by William Kelley, D.D.S and recently modified by Nicholas Gonzalez, M.D who treats patients in New York; and the macrobiotic regimen, whose educational resources and specialized food products are widely available to patients in the United States.

 

Coffee enemas are included in two of these regimens.

 

In other chapters of this report, treatments are described that also include dietary elements, but in those cases, the diet may be one of several major elements in the approach, with a non-nutritional treatment usually considered primary in the regimen.

 

In the Livingston-Wheeler regimen, dietary guidelines are specified, but the regimen is centered on its original anti-infective treatment.

 

In addition, many of the clinics in the United States and Mexico that promote "metabolic" treatment for cancer specify particular foods to include or avoid as part of a regimen that also includes pharmacologic and biologic agents, exercise and spiritual and psychological components.

 

Other dietary approaches used in unconventional cancer treatment for which more limited information is available are not covered in detail in this chapter.

 

One of these is wheatgrass, a component of a regimen that has been available for several decades in the United States.

 

Originally developed by Ann Wigmore, the wheatgrass regimen is advocated for prevention and treatment of a variety of conditions and for general health maintenance.

 

Individuals attending one of three U.S. centers that offer instruction in following the wheatgrass regimen are taughtan enlightened approach to the understanding of health and various cleansing and rebuilding techniques to restore and/or maintain a vigorous life, according to promotional literature.

 

One of the centers, the Hippocrates Health Institute in Florida, describes itself as a health resort offering "a multi-dimensional program for the serious health seeker".

 

The wheatgrass diet is described as a "nutritional lifestyle that embraces an all natural way of eating".

 

Using books and products commonly available in health food stores and through mail order houses, patients can also follow the wheatgrass regimen on their own.

 

The wheatgrass regimen eliminates all meat, dairy products and cooked foods from the diet, while emphasizing "live foods" including uncooked sprouts, vegetables, fruits, nuts and seeds, wheatgrass juice, "detoxification" enemas and high colonies, enzyme supplements and chlorella (green algae tablets.

 

Proponents believe that wheatgrass is the key element of the program and claim that it bolsters the immune system, kills harmful bacteria in the digestive system and rids the body of waste matter and toxins.

 

Anecdotal case reports of tumor regressions and life extension among cancer patients who followed the wheatgrass regimen have been published in the proponent literaturesee, e.g, but thus far, no studies of its clinical role in the treatment of cancer have been reported.

 

By relying for the most part on vegetarian, low-fat, high-fiber foods, the dietary regimens described in this chapter share certain characteristics with the kinds of foods currently recommended by mainstream groups for lowering the risk of developing cancer and heart disease.

 

Recent American Cancer Society ACS guidelines for cancer prevention, e.g suggest reducing the intake of fat, alcohol and salt-cured and smoked foods, while increasing the intake of fruits, vegetables and whole grains.

 

One way they differ, however, is that the unconventional cancer treatment diets may emphasize a few particular foods and limit or totally eliminate others.

 

The macrobiotic regimen, e.g advises against consuming vegetables and fruits that are not grown locally, such as bananas and other tropical fruit and against certain types of vegetable, such as those in the nightshade familyincluding tomatoes, green peppers, eggplants, e.g.

 

The wheatgrass diet excludes all cooked vegetables and fruits in favor of raw foods exclusively.

 

The Kelley regimen emphasizes certain categories of food, e.g vegetables or red meat, over others, on an individual basis.The Kelley diet does not necessarily conform to current mainstream dietary recommendations.

 

It has been noted that in some circumstances, cancer patients who follow overly restrictive diets of any kind, whether unconventional or not, maybe at risk for malnutrition and uncontrolled weight loss.

 

It has also been noted that diets that may be useful in preventing cancer are not necessarily effective in treating cancer, since substances in food that may play a role in the initiation of cancer may be different from those that may contribute to tumor progression.

 

The goals of the unconventional dietary treatments also overlap with the goals of conventional nutritional support for cancer patients in that both try to counteract the metabolic and nutritional effects of the disease and of some forms of treatment.

 

The unconventional treatments go beyond the conventional support measures, however, by claiming to reverse the course of the disease, to enhance host function and to improve quality of life.

 

The fact that the unconventional treatments particular dietary regimens for cancer patients at all, regardless of their condition, stage of disease, or type of tumor, separates them from mainstream cancer treatment.

 

Nutritional support has a well- established place in conventional cancer treatment, but generally does not include dietary recommendations for patients with cancer.

 

At present, no diet is recommended publicly by NCI or ACS for use in cancer treatment.

 

In practice, patients are not commonly given nutritional advice at the time of diagnosis or initiation of treatment by mainstream physicians.

 

Nutritional support in mainstream oncology focuses instead on the provision of nutrients under special and usually more extreme circumstances.

 

Nutritional support given in conjunction with conventional cancer treatment often involves the use of total parenteral nutritionnutrient solutions given intravenously or enteral nutritionnutrient solutions provided.

 

These measures are normally limited to cachexic patients in advanced stages of disease, to patients who have particular cancer- or treatment- related nutritional problems that prohibit normal intake of food, or to malnourished patients undergoing major surgery.

 

It is well accepted that cancer and its treatment can cause malnutrition and that malnutrition itself predicts a poor outcome.

 

A number of physiologic factors associated with cancer are believed to contribute to malnutrition, including the metabolic state of the tumor and its effects on the body's metabolism, catabolic effects of conventional treatment and physiologic stress associated with rapid tissue growth and cell destruction, although the ways in which these factors influence nutritional status are still poorly understood.

 

The issue of how to ensure that patients obtain an optimal daily intake of nutrients and calories in order to preserve lean body mass without stimulating tumor growth is considered unresolved.

 

Total parenteral nutrition has been found to be of limited use and in some cases even detrimental.

 

In general, oral dietary treatments have not been evaluated for possible prevention of malnutrition or for possible effects on the course of the disease in cancer patients, although the initial stage of a multicenter study involving a low fat dietary intervention in patients with breast cancer was recently begun.

 

The unconventional dietary treatments for cancer described in this chapter are also distinct from the adjunctive use of dietary treatment in other contexts, e.g in the more numerous and diverse practices where physicians and other practitioners offer what is often referred to as "alternative" or "holistic" health care.

 

The issue of dietary treatment in conjunction with conventional treatment by these practitioners is commonly raised in the popular literature, but detailed information is scarce.

 

The actual dietary regimens, their rationales and the outcomes have not yet been reported, so the extent and nature of their use cannot be characterized precisely.

 

A program developed over the past years by Keith I. Block M.D illustrates one approach to nutritional treatment that can be used in conjunction with mainstream cancer care.

 

The program, as described by its developer, is intended to be used adjunctively and not as a substitute for medical treatment.

 

At present, it is used in Block's private medical practice in Evanston, Illiniois and at an independent medical center in Chicago.

 

According to Block's protocol, individualized dietary guidelines and nutritional treatment are used in combination with mainstream cancer treatment, exercise and psychosocial support strategies for stress reduction.

 

Overall dietary guidelines are made on the basis of nutritional assessments, including the use of body composition analysis, blood and laboratory studies, determinations of nitrogen balance and other biochemical and clinical evaluations.

 

Patients are given a range of food choices within an overall framework that covers five food groups cereal grains, vegetables, fruits, fats and proteins.

 

Foods are divided into exchange lists so patients can select foods according to their tastes while still satisfying the overall nutritional requirements of the program.

 

The semivegetarian diet Block recommends consists of high-fiber, low-fat, protein-restricted foods along with specific items such as soybean products, shiitake mushrooms and sea vegetables.

 

In general, Block recommends that 10 percent of calories be derived from complex carbohydrates, 10 percent of calories from fat and the remainder from protein sources.

 

The diet, which is modified on an individual basis, emphasizes foods high in vitamins, trace minerals and substances thought to reduce cancer risks.

 

Developed in part from macrobiotic principles, the diet has been modified to incorporate information from other sources, primarily experimental data from the scientific literature on substances that maybe active in inhibiting tumor growth or stimulating immune responses.

 

Nutritional analysis has reportedly shown Block's nutritional program to be nutritionally adequate; the Recommended Daily Allowances RDAs were met or exceeded for almost all nutrients for which RDAs have been established and for which nutrient analyses are available and the diet reportedly exceeds requirements for vitamins A, C and B, calcium, iron, magnesium and several other elements.

 

Block's use of an adjunctive dietary program for cancer patients has several goals, some of which he believes have been met in many cases, based on observations of patients treated with this regimen.

 

One goal is to maintain adequate nutritional support through oral feeding as much as possible, in order to improve patients' quality of life and help them retain 'a sense of self-empowerment and clinical autonomy.He notes that few of the cancer patients on his program experience weight loss, except those with anorexia in late stages of disease, or experience hair loss during chemotherapy.

 

Another goal is to enhance patients' resistance to the disease by focusing on improving immune function and inhibiting tumor growth through the provision of a low-fat diet, which may decrease the intake of tumor-promoting substances.

 

The high intake of vitamin A-containing vegetables in the diet is believed to enhance patients' responses to conventional cancer treatment.

 

Overall, Block believes his program to be of benefit in diminishing the side-effects of conventional treatment and in improving patients' quality of life.

 

The treatment protocol has been described in some detail in unpublished manuscripts, but thus far, it has not been studied systematically so that its effects on patients cannot be judged adequately.

 

The Gerson Treatment

 

The Gerson treatment, consisting of a low sodium, high potassium, vegetarian diet, various pharmacologic agents and coffee enemas, is one of the most widely known unconventional cancer treatments.

 

As one of the first unconventional approaches now commonly referred to as ''metabolic," it may have spawned the development of many other currently used unconventional dietary and pharmacologic approaches.

 

Max Gerson, M.D a German-born physician, spent the last years of his medical career in the United States.

 

He died leaving no apparent system in place to continue his treatment program.

 

Gerson's daughter, Charlotte Gerson Straus, co-foundedwith Norman Fritz the Gerson Institute now based in Bonita, California.

 

The Institute oversees a clinic in Tijuana, Mexico, where the Gerson treatment is offered.

 

According to one outside report, that clinic treats approximately patients per year.

 

Background and Early Use

 

Max Gerson was born in Germany and graduated from the University of Freiburg medical school.

 

He practiced medicine in Germany, Austria and France before emigrating to the United States.

 

He received his New York medical license and his U.S. citizenship.

 

He opened a private medical practice in New York City and also began treating patients at nearby Gotham Hospital.

 

Gerson was a member of the American Medical Association (AMA, the New York State Medical Society and the Medical Society of the County of New York.

 

After a long investigation, the Medical Society of the County of New York suspended Gerson's membership.

 

The Society charged that Gerson's participation in a radio broadcast, during which the show's commentator, Raymond Gram Swing, described beneficial results of Gerson's treatment for cancer, constituted personal advertising.

 

Gerson reportedly also lost his hospital privileges and malpractice insurance (although no details of these actions are available.

 

During a hearing on a proposed bill to authorize increased Federal support for cancer research in general, Gerson testified before a subcommittee of the Senate Committee on Foreign Relations.

 

In his statement to the subcommittee, Gerson described his background, the development of his treatment for cancer and submitted written case histories of patients treated with his regimen,

 

of whom were questioned in person at the hearing.

 

Gerson claimed that these patients were cured of advanced cancer as a result of his treatment.

 

Both Gerson's testimony and radio appearance drew national attention.

 

The same year, an editorial appeared in The Journal of the American Medical Association in response to numerous requests for information about Gerson.

 

The editorial criticized Gerson and his sponsors at the Robinson Foundation, New York, for promotion of an unestablished, somewhat questionable method of treating cancer.

 

The editorial stated AMA's view that Gerson had provided only clinical impressions as to benefits secured but nothing resembling scientific evidence as to the actual merit of the method.

 

A report of the AMA Council on Pharmacy and chemistry reiterated AMA's view of the Gerson treatment, concluding thatthere is no scientific evidence whatsoever to indicate that modification in the dietary intake of food or other nutritional essentials are of any specific value in the control of cancer.

 

The American Cancer Society's Committee on Unproven Methods of Cancer Management published its first statement on the Gerson treatment.

 

While certain aspects of Gerson's regimen-e.g the intake of fresh fruits and vegetables and the reduction or elimination of sodium and fat-are consistent with current knowledge about reducing the risk of contracting certain types of cancer and other illnesses, Gerson's thesis that regression of cancer can result from dietary treatment and "detoxification" is unconfined.

 

Rationale for the Treatment

 

Gerson developed his dietary treatment over the course of several decades.

 

His approach was largely empirical.

 

By his own account, he tried variations and combinations of foods and other agents on his patients, noted the ones that reacted favorably and adjusted subsequent patients' regimens accordingly.

 

All along, he reasoned why some agents seemed to work while others did not and developed hypotheses to account for his observations.

 

Gerson described the development of his treatment regimen and presented case histories of patients he believed were treated successfully in his

 

book, A Cancer Therapy: Results of Fifty Cases and in a number of published articles in German and in English.

 

By the late s, Gerson had produced an overall approach and rationale for treating cancer that diverged significantly from conventional medical thought and practice.

 

It is unknown whether Gerson's formal medical training included study of the therapeutic use of diet.

 

Early on in his medical career, he devised a dietary regimen to treat his own severe migraine headaches.

 

After reported success with his condition, he used his diet in the treatment of a variety of other disorders, including skin tuberculosislupus vulgaris, asthma, pulmonary tuberculosis and arthritis.

 

In, he began treating cancer patients with the diet he used on tuberculosis, at the insistence of a patient with cancer of the bile duct, who reportedly recovered following Gerson's treatment.

 

By the time he established his practice in New York in the mid-s, he concentrated on treating cancer patients.

 

His frost paper published in English on dietary treatment for cancer appeared in.

 

In that paper, Gerson outlined his high potassium, low sodium,' fatless diet regimen, which included foods, mineral and vitamin supplements and crude liver injectionspreparations of raw calves liver.

 

He reported on patients treated with the regimen in whom he observed improvements in "general bodily health" and, in some cases, tumor reduction.

 

In a subsequent publication, Gerson described other agents that he added to the regimen, including an iodine solution Lugol, thyroid extract, potassium solution, pancreatic and vitamin C.

 

Gerson noted that in six additional patients his treatment appeared to reduce inflammation around tumors, relieve pain, improve psychological condition and provide at least temporary tumor regressions.

 

Gerson first published explanations of the components of his regimen and the rationale for their use, along with some of the clinical outcomes he observed.

 

Gerson described cancer as a ''degenerative disease," fundamentally similar to many other disease states; he believed that an "impaired metabolism" was the underlying problem in degenerative disease and that proper liver function was critical to maintaining metabolic order.

 

He believed that several physiologic functions were impaired in cancer patients, including the metabolism of fats, proteins, carbohydrates, vitamins and minerals; the activity of oxidative enzymes; and the activity of intestinal bacteria.

 

Gerson believed that the impairment in these functions created an internal climate favorable to the growth of malignant cells.

 

Gerson believed that his treatment regimen reversed the conditions he thought necessary to sustain the growth of malignant cells.

 

He attached great importance to the elimination of 'toxins' from the body and to the role of a healthy liver in recovery.

 

Gerson noted that if the liver were damaged, e.g by cancer or cirrhosis, the patient had little chance of recovery on his treatment regimen.

 

He observed that patients who died showed a marked degeneration of the liver, which he presumed was due to unspecified toxic factors released into the bloodstream by the process of tumor regression.

 

He believed that these toxic tumor breakdown products poisoned the liver and other vital organs.

 

According to this view, Gerson believed that detoxification-preventing patients from dying of self-poisoning -was the most important frost step in treatment.

 

In support of detoxification, he cited a passage from Hippocrates that described drinkmg a "special soup" and administering enemas.

 

Gerson prescribed coffee enemas as part of his cancer treatment regimen.

 

He maintained that the coffee enemas helped to stimulate the flow of bile, thereby increasing the rate of excretion of toxic products from the body.

 

Gerson believed that the need to detoxify resulted not only from the internal generation of poisonous substances but also from the external supply of toxins created by the use of insecticides and herbicides in commercial agriculture.

 

Accordingly, his dietary regimen emphasized the use of food grown organically.

 

He reasoned that treatment for cancer must replenish and detoxify the entire body to allow its innate healing mechanisms to be restored.

 

Another central component of Gerson's approach concerned the balance of potassium and sodium in the body.

 

An imbalance in the concentration of these substances contributes to the internal environment supporting the growth of tumors, Gerson believed.

 

He sought to eliminate sodium in patients' diets and to supplement with potassiumin the forms of potassium gluconate, potassium phosphate and potassium acetate.

 

Several papers published since Gerson's death have elaborated on Gerson's ideas regarding physiologic implications of the potassium-sodium balance in cancer states.

 

Those papers suggest various biological and theoretical rationales for Gerson's theory that potassium supplementation and sodium restriction act against tumor formation (.

 

The role of oxidation in the treatment of cancer was another central element of Gerson's theory.

 

He believed that tumor cells thrive in an environment depleted of oxygen and can be destroyed when oxidative reactions occur.

 

He believed it was essential to supply intact oxidative enzymes in the diet, in the form of vegetable and fruit juices prepared by a stainless steel grinder and pressrather than by centrifugal juicers or liquefiers, which he believed destroyed the foods' oxidative enzymes.

 

He also recommended avoiding food that had been canned, processed, bottled, powdered, frozen, or cooked in aluminum pots.

 

The combined effect of these treatment components was intended tonormalize the biological function of damaged cells.

 

Gerson wrote:

 

the end result is to return the body to its physiologic functions as they existed before the development of malignancies.

 

In this state of the normal metabolism, abnormal cells are suppressed and harmless again.

 

Current Gerson Treatment Regimen

 

Current patient literature from the Gerson clinic states that the treatmentrestores the patient's healing mechanism so that the body can heal itself and overcome degenerative disease.

 

In addition to treating patients with cancer, heart disease, diabetes, arthritis, multiple sclerosis and other diseases, the clinic also treats some people with no apparent serious disease [who] come to the Center simply to detoxify and build themselves up in order to feel good, to improve their health and to prevent disease.

 

The regimen is said to have two main components: "an intensive detoxification program to help the body eliminate toxins and waste materials which interfere with healing and metabolism" and an intensive nutrition program which floods the body and its cells with easily assimilated nutrients needed for improving the metabolism and healing.

 

After a period of treatment at the clinic, each patient is instructed to continue the regimen at home ''until the liver, pancreas, oxidation, immune and other systems have been restored sufficiently to prevent the recurrence of cancer and other degenerative diseases".

 

At present, the dietary part of the Gerson treatment offered at the clinic consists of low-sodium, low-fat, low-animal protein and high-carbohydrate foods, with vitamin and mineral supplements.

 

The diet relies on large amounts of fresh and raw fruits and vegetables.

 

Until late, raw fresh calves liver juice was included in the regimensee discussion below.

 

The current patient brochure lists the dietary components as: glasses daily of various fresh raw juices prepared hourly from organically grown fruits and vegetables and three full vegetarian meals, freshly prepared from organically grown vegetables, fruits and whole grains.

 

The Gerson treatment also consists of a variety of other substances, including potassium supplements, thyroid hormone, Lugol's solutionan inorganic solution of iodine plus potassium iodide, injectable crude liver extract with vitamin B, pancreatic enzymes and enemas of coffee or chamomile tea.

 

Other treatments, beyond the ones Gerson specified, have been added to the current protocol in recent years.

 

According to materials distributed by the Gerson Institute, these substances include:

 

ozone treatment given by enema

 

or via infusion in autologous, heparinized blood or directly into patients' blood vessels;

 

hydrogen peroxide topically, rectally, or orally.

 

intravenous ''GKI drip" glucose, potassium and insulin solutions;

"live cell therapy";

 

castor oil;

 

clay packs;.

 

Lincoln bacteriophagea vaccine made from killed Staphylococcus aureus bacteria and influenza virus vaccine, both reportedly to stimulate allergic inflammation, a process Gerson believed contributed to healing;

 

laetrile.

 

The Gerson treatment is time-consuming and restrictive and can be difficult to follow in areas where fresh fruits and vegetables are not widely available.

 

To assist with the rigors of the treatment, the clinic advises patients to have a helper since patients need time and energy and rest to heal and if they do the therapy alone it will reduce their chances of healing.

 

Potential and Reported Adverse Effects

 

Two aspects of the Gerson treatment have attracted attention as possible causes of adverse effects-the use of raw calves liver juice and coffee enemas.

 

Ingestion of raw calves liver juice has been associated with infection with Campylobacter fetus subspecies fetus, an organism that is carried in the intestinal tract of cattle and sheep.

 

Infection with C.

 

An outbreak of C. fetus subsp.

 

fetus infection among cancer patients, some of whom were thought to have been treated with the Gerson regimen, was reported.

 

Patient with sepsis were reported to the San Diego County Department of Health Services.

 

C. fetus subsp.

 

fetus was isolated from blood cultures from nine patients and from peritoneal fluid from one patient.

 

Upon admission to the hospital, five of the patients were comatose and all had severe electrolyte abnormalities.

 

The nine cancer patients died shortly after admission.

 

After learning of the outbreak from a newspaper article, members of the Gerson staff contacted the San Diego Department of Health Services to discuss the problem, assuming from the description of treatments taken that at least some of the

 

patients had been treated at the Gerson clinic.

 

Acknowledging the possible link between the raw liver juice and the Campylobacter infection in these patients, Gerson staff subsequently improved the handling and storage of the calves liver to reduce the likelihood of contamination and instituted routine tests for C.

 

fetus among their patients at the first sign of infection; patients testing positive would then be treated with an appropriate antibiotice.g erythromycin.

 

No further reports of this type of infection in Gerson patients have been published in the literature.

 

The clinic discontinued the use of raw liver juice in late, however, because of potential problems with infection.

 

Coffee enemas have been associated with serious fluid and electrolyte abnormalities, although none have been reported specifically in patients undergoing the Gerson regimen.

 

One report in the literature noted the death of two Seattle women, one of whom had cancer, due to fluid and electrolyte abnormalities following coffee enemas.

 

One of these women reportedly took a coffee enemas in one night and continued at a rate of one per hour, while the other woman took them four times daily; in both cases, the enemas were taken much more frequently than is recommended in the Gerson treatment.

 

Another report of serious adverse effects associated with coffee enemas cited three cases.

 

The overall risk of fatal electrolyte disturbance associated with coffee enemas is unknown and may depend to some extent on frequency and conditions of use.

 

Claims of Effectiveness

 

Gerson wrote (and rewrote, after the original was lost) A Cancer Therapy: Results of Fifty Cases to show thatthere is an effective treatment of cancer, even in advanced cases.

 

In testimony before a Subcommittee of the Senate Committee on Foreign Relations in 1946, Gerson estimated that about 30 percent of 'hopeless cases' of cancer he treated showed a favorable response.

 

In a lecture Gerson gave in 1956 (published posthumously in 1978) and in a paper published in 1954, he estimated that his treatment produced "positive results in about 50 percent of so-called generalized, regrowing or final cases" (334).

 

The current practitioners of the regimen also claim success with the treatment.

 

Patient literature from the Gerson Institute claims:

 

the Gerson Therapy is able to achieve almost routine recoveries in early to intermediate cancers.

 

Even when the disease is advanced and incurable by conventional standards (i.e., involves the liver or pancreas or multiple internal sites) excellent results are possible.

 

The Gerson Therapy has cured many cases of advanced cancer in man.

 

(329) Emphasis in original.]

 

Further, the patient literature states that even for patients with both cancer and other diseases (e.g., arthritis, heart disease and diabetes), the Gerson treatmentusually heals the body of all diseases simultaneously' (329).

 

This claim is reportedly based on Gerson's belief that the body will not heal cancer and yet leave arthritis or arteriosclerosis or diabetes unimproved and that when the body's ability to heal is restored, the 'physician within' will set about to mend and restore the whole patient (329).

 

The vice president of the Gerson Institute, Norman Fritz, republished a book by S.J.

 

Haught (the pen name for Robert Lichello, a writer for the National Enquirer in the 1950s), which was originally titled Has Dr.

 

Max Gerson a True Cancer Cure? (1962), renaming it Cancer? Think Curable! The Gerson Therapy (1983).

 

In his introduction to the revised edition, Fritz claims that the Gerson treatmentcan save about 50 percent or more of advanced 'hopeless' cancer patients' and thatthe percentage who recover can exceed 90 percent for early cancers and some 'early terminal' cancers.

Fritz's claims are apparently not made by others in the Gerson Institute, but the Haught book is still widely available to patients and is one of the most easily accessible sources of information about the treatment (401).

 

The Gerson Institute's newsletter often describes case histories of patients believed to be cured through the Gerson treatment (see, e.g., a description ofcure of a partially removed, inoperable, radiation-resistant, adult astrocytoma through the Gerson Therapy (327)).

 

Attempts at Evaluating the Gerson Treatment

 

Since the 1940s, there have been several attempts by a number of groups and individuals to assess the effects of Gerson's regimen and at least one attempt is currently in progress.

 

Gerson's Case Presentations

 

In 1947, Gerson submitted 10 case histories of cancer patients treated with his regimen to the National Cancer Institute (NCI) for review (332,822).

 

The only available information about that review comes from a current NCI statement on the Gerson treatment, which states that the NCI review found no convincing evidence of effectiveness, particularly since the patients were also receiving other anticancer treatments (893).

 

It was also noted that Gersonwas invited to submit additional data but did not do so." Further information about the nature of the 1947 review is unavailable, since NCI cannot locate any records concerning it (766).

 

In 1959, NCI reviewed 50 case histories presented in Gerson's book A Cancer Therapy:Results of Fifty Cases.

 

NCI concluded that, in the majority of cases, the basic criteria for evaluating clinical benefit were not met.

 

These criteria were the following:

 

The patient must have histologic verification of the presence of a malignant neoplasm and the diagnostic sections must be available for independent review to verify Gerson's diagnosis.

 

If the patient had surgical resection or other previous treatment for a proven malignant neoplasm, the presence of a recurrence or metastasis also must be verified histologically and the sections made available for review.

 

If the patient had been previously treated, he must be completely reevaluated and observed for a long enough period of time to verify that this treatment was ineffective and that the neoplasm is indeed advancing (60).

 

NCI concluded overall that Gerson's data provided no demonstration of benefit (60,897).

 

In an undated rebuttal, members of the Gerson Institute disputed NCI'S 1959 findings, taking issue with almost every case assessment and charging that NCI dismissed legitimate evidence on the basis of technicalities (330).

 

No independent assessment of the review has been made.

 

The Austrian Study

 

An exploratory study of the clinical effects of some components of the Gerson regimen is currently under way in Austria.

 

According to an unpublished interim report (522), Peter Lechner, M.D., of the Second Department of Surgery of the Landeskrankenhaus in Graz, Austria, is conducting a study using a modified Gerson regimen as an adjunctive treatment.

 

The modified regimen is described as a high fiber, low sodium, high iodine and potassium, lactovegetarian diet with regular coffee enemas.

 

It reportedly omits certain elements of the original Gerson regimen, such as liver juice, thyroid supplements (unless the patient is hypothyroid) and niacin supplements.

 

It also limits the number of coffee enemas to two per day; Lechner noted in previous experience with patients following the Gerson regimen that a higher frequency of enemas was associated with the development of colitis (inflammation of the large intestine, often leading to diarrhea) in some patients.

 

Twenty-nine patients who chose to follow the modified Gerson regimen were included in the study.

 

An equal number of non-participating patients, matched for tumor type and stage of illness, were paired with the patients following the regimen.

 

Nineteen pairs of patients with breast cancer, eight pairs with colorectal cancer and four pairs with malignant melanoma were studied.

 

All patients reportedly had previous mainstream treatment (surgery and possibly other treatments) and some of them were taking them concurrently (chemotherapy, radiation, or interferon).

 

While some of the patients are described as having metastatic disease and in advanced stages of illness, the report does not indicate whether all patients had measurable disease at the start of the study or whether previous or concurrent treatment was considered to have had an antitumor effect in any of the patients.

 

Lechner reported that patients following the modified Gerson regimen showed no side-effects attributable to the treatment and did not become malnourished.

 

One of the patients with inoperable liver metastasis who followed the Gerson treatment showed a temporary regression.

 

In Lechner's opinion, there were subjective benefits from the modified Gerson regimen: patients needed less pain medication, were in better psychological condition and

 

experienced less severe side-effects of chemotherapy than did the patients with whom they were compared.

 

Without claiming definitive results, Lechner stated that the patients with breast and colon cancer with liver metastasis benefited more than others in the study.

 

According to the report, those patients "seem to live longer and their quality of life is apparently better" than patients with whom they were compared, although he noted that his conclusions were subjective andof no statistical relevance at all.

 

Lechner's description indicates that the study was not designed to generate definitive conclusions about changes in survival or in quality of life among patients following the modified Gerson regimen.

 

The fact that the patients following the regimen chose to undergo a relatively rigorous and demanding program suggests that there may well be differences between those patients and the ones who did not participate in the program.

 

In this case, the comparison between participating and nonparticipating patients does not provide a legitimate basis for judging differences in turner response, survival, or quality of life.

 

In addition, based on the information provided in the report, it is impossible to separate the effects of the modified Gerson regimen from the effects of previous or concurrent treatments.

 

The study does, however, provide preliminary qualitative information on the experiences of the 29 patients who followed a modified Gerson regimen along with conventional treatment.

 

It is unclear from the report how much longer the study would continue or what endpoints were being measured.

 

The British Review

 

In 1989, three British researchers visited the Gerson Clinic on behalf of a British medical insurance company (805) to assess its basis as a claimed dietary cure for cancer (459).

 

The investigators observed patients and their treatment freely and were offered information from the clinic's files on a group of patients considered by the Gerson staff to represent best responses to the Gerson treatment.

 

They conducted two studies: the first was a review of the best responses and the second was a psychological study of patients at the clinic at the time of the visit.

 

For the review, the investigators were presented with 149 cases from among all patients treated at the clinic since it opened in 1977.

 

Of those, 27 were alive and well and had sufficient documentation for assessment.

 

Nearly all had had mainstream treatment of some kind before beginning the Gerson regimen and a number continued to receive it in addition to the Gerson treatment.

 

The investigators reported that nine of the patients had melanomas and the course of their diseasefell within what we would consider the limits of the 'natural history' of this disease.

 

Two patients reportedly had early stage prostate cancers which had been removed surgically and their survival was also judged to be consistent with what would have been expected without further treatment.

 

Another patient with prostate cancer havingclinically significant disease' had survived beyond the expectation of the investigators, given his disease and prior treatment.

 

Two patients with breast cancer and two with endometrial cancer were considered to have had disease courses consistent with their cancer and other treatment.

 

A third patient with biopsy-proven endometrial cancer who had had no conventional treatment subsequently underwent a hysterectomy, at which time no evidence of malignancy remained, representing a case of tumor regression.

 

One patient with non-Hodgkins lymphoma (NHL) had extensive radiation treatment, which could have accounted for a favorable outcome and another had no followup scans, so tumor status could not be determin ed.

 

In another patient with low-grade NHL, a biopsy-confirmed mass regressed with no other treatment.

 

The remaining patients were described as having slowly progressive disease.

 

The investigators concluded:

 

Although several of these cases would have been expected to have a poor prognosis on the basis of their histology and stage.

 

a proportion of poor prognosis patients do fare better than the average.

 

Any large series of 6,000 poor prognosis patients treated conventionally would produce similar results.

 

A small number of the patients appear to have had disease regression that cannot be explained as being an extreme of the natural history of the disease.

 

There may thus be a small antitumor effect in some patients.

 

However, it must be stressed, if the anticancer effect of the Gerson Therapy was substantial, we would have expected to find evidence of a larger number of responses-if an effective new anti-cancer treatment had been given to 6,000 patients we would expect it to have been easier to find successful cases to present.

 

In the second study, 15 patients completed a questionnaire that elicited information about their background and disease history and their feelings about their physicians, their physical and mental health, the Gerson Clinic and their interpersonal relationships.

 

It was found that, in general, the patients had very positive feelings and experiences; they felt well supported by family and other patients at the clinic, had a high degree of control over their health and had high mood and confidence scores.

 

The investigators noted particularly that none of the patients was taking opiates for pain, though several had taken them previously and they had low "pain" scores.

 

The investigators concluded overall that there was a "significant subjective benefit" to patients and their families from the treatment:

 

The nature of the therapy requires a positive contribution to be made by the patient to his or her health and meets a need not satisfied by conventional therapy.

 

There are therefore lessons for oncologists to learn in the management of desperate cancer patients and their families.

 

Gerson Institute Case Review

 

An effort to document possible tumor remissions among patients treated at the Gerson clinic in Tijuana is currently being conducted under the direction of Gar Hildenbrand of the Gerson Institute (402).

 

Since 1987 (400), a "best case" review has been in progress to assemble relevant data from Gerson patients believed to have benefited from the treatment.

 

As planned, the review would include patients who either had no previous treatment or who failed previous treatment and would collect details from each patient's medical records (including all cancer-related discharge summaries, pathology reports, slides, radiology summaries, films, laboratory reports and surgery summaries).

 

Provision was made for blind reevaluation of the pathology material by the U.S.

 

Armed Forces Institute of Pathology and of the medical records by experts at the University of California at Los Angeles.

 

Where necessary, followup evaluations on patients would be conducted (including scans or other evaluative procedures).

 

The collected data would then be reviewed by an expert panel to determine whether objective responses to the treatment had been documented.

 

As of August 1989, OTA had no further information on the status of the Institute's review.

 

Chapter 3. Herbal Treatments

 

Herbal Introduction

 

The therapeutic use of plant products-herbal medicine-is among the oldest of medical practices.

 

It is a central feature of many current forms of folk and traditional medicine, e.g., traditional Chinese medicine, Native American healing and curanderismo and is used in the treatment of a wide range of disorders, including cancer, More than 3,000 different plant species have reportedly been used to treat cancer in cultures worldwide, according to a survey of the international literature (through 1971) in scientific and folk medicine (382).

 

Herbal products are also used in unconventional cancer treatment in the United States, drawing from traditional practices in most cases, but generally offered outside of the overall context of traditional medicine and folk healing.

 

Plant products are also the source of much of the mainstream pharmacopeia.

 

The use of botanical products in drug development involves the identification and extraction of active components of whole plants or crude extracts and, in some cases, synthesis of equivalent active compounds.

 

The rationale for this approach is that by reducing or eliminating the variability of chemical composition and concentration that exists in crude plants, precise doses of known compounds can be given to patients.

 

Several chemotherapeutic drugs used in conventional cancer treatment were developed from botanical sources.

 

One of the best known examples is Etoposide, derived from the mayapple plant (Podophyllum peltatum).

 

Prompted by a 1942 report of the treatment of venereal warts using a constituent (podophyllotoxin) of mayapple, Jonathan Hartwell and colleagues at the National Cancer Institute's (NCI'S) Drug Research and Development Program identified the chemical structure for podophyllotoxin and isolated other constituents of the plant (719).

 

NCI conducted tests of the constituents for antitumor activity in a mouse tumor model (the Sarcoma 37 test) and found that all were highly active in that test system (384).

 

NCI initiated clinical trials of podophyllotoxin, which were later discontinued because of its toxicity.

 

Clinical trials of the substance were continued by a private company (Sandoz Limited) in the 1960s and semisynthetic compounds (etoposide and teniposide) were later developed from the substance.

 

Etoposide was approved by the Food and Drug Administration (FDA) in 1983 for use in patients with refractory testicular tumors, small-cell lung cancer, nonlymphocytic leukemias and non-Hodgkins lymphoma (424).

 

Two of the most important chemotherapeutic drugs currently used were originally developed from a folk remedy containing the rosy periwinkle plant (Vinca rosea), which was used in Madagascar for treatment of diabetes.

 

Chemical constituents with antitumor activity were isolated from the plant and tested for antitumor effects in animal systems.

 

The constituents were later approved as vinblastine, used to treat Hodgkins disease and vincristine, used to treat acute childhood leukemia (826).

 

Traditional herbal practices, in contrast, involve the use of whole plants or crude extracts of whole plants, rather than purified active components.

 

One of the central tenets of herbal philosophy is that constituents in botanical preparations other than the predominant active component may modify physiologic effects of the active component in beneficial ways (945).

 

The effects of crude preparations are generally slower in onset and less dramatic than those of the purified active ingredient, which maybe considered advantageous in some instances (946).

 

In recent years, some aspects of traditional Chinese medicine involving herbal medicine, acupuncture, Qi gong and other practices, have become more popular in the United States and are used to treat a wide variety of conditions.

 

U.S. cancer patients who use traditional Chinese medicine do so mainly for pain control, reduction in side-effects of conventional treatment and enhanced quality of life, in the opinion of several members of the Advisory Panel for this project (8).

 

Some of the herbal products used in traditional Chinese medicine are sold in U.S.

 

health food stores and by specialty supply companies (948).

 

In China and Japan, where traditional chinese medicine and, particularly, herbal medicine, is used in primary antitumor treatment, herbal products are the subject of much scientific research concerning their role in host support, e.g., as enhancers of immune function (207).

 

Most of the recent scientific literature on immune-stimulating effects and adjunctive therapeutic use of herbal medicine in cancer treatment has been published by researchers in China, Japan and Korea.

 

Higher fungi, including both edible and inedible mushrooms, are some of the major sources of polysaccharides and other substances that have been studied for antitumor and immunologic activity and as potential sources of new anticancer drugs.

 

Many types of fungus are used medicinally in China and Japan to stimulate host defenses and to enhance patients' overall health.

 

One of the most extensively studied mushrooms is the shiitake (Lentinus edodes), a popular edible mushroom in Japan.

 

Lentinan, a polysaccharide isolated from extracts of the shiitake, has shown antitumor activity in a variety of animal tumor tests and has shown a variety of immune-altering functions, e.g., as a restorer or potentiator of T-lymphocyte activity, with no direct cytotoxicity (182).

 

Another example includes extracts from the underground tuberlike growths (sclerotia) of Polyporus umbellatus, an edible mushroom that grows wild on tree stumps.

 

Studies have shown that a polysaccharide found in extracts of Polyporus umbellatus increases cellular and humoral immunities in experimental animals, is active in experimental tumor systems and may potentate the effects of chemotherapy (375).

 

Other fungi studied for immunologic and antitumor effects include Coriolus veriscolor, from which the polysaccharide Krestin is derived and the enokidake fungus (Flammulina velutipes).

Clinical studies in Japan and China have also examined the potential for using extracts of some fungi in conjunction with conventional cancer treatment (207,375).

 

A small number of botanical preparations are currently being used to treat cancer in a way that is distinct both from the context of traditional herbal practices and from conventional drug development.

 

Some of them may have had roots in traditional practices, but have since been removed from that context and offered independently or in conjunction with conventional cancer treatments by practitioners untrained in traditional medicine.

 

These few herbal treatments can be included in this report, since in their present form, they are neither a part of conventional cancer treatment nor of traditional or folk medicine.

 

This chapter summarizs the available information on five of the most widely used unconventional treatments based on herbal substances (presented in alphabetical order).

 

These include single agent treatments, such as teas brewed from chaparral and Pau d'Arco and mixtures of herbal products sold as proprietary treatments-Hoxsey products, preparations of mistletoe and Essiac treatments.

 

CHAPARRAL

 

Chaparral is an herbal product commonly available in health food stores.

 

There is little systematic information available on its use, but it is often singled out, along with Pau D'Arco and several others, as a widely used unconventional treatment for cancer.

 

Chaparral tea has reportedly been used in folk remedies for leukemia and cancers of the kidney, liver, lung and stomach (382).

 

It is reported to have been popular among American Indians of the Southwest as a remedy for a wide variety of disorders in addition to cancer, such as arthritis, venereal disease, tuberculosis, bowel cramps, rheumatism, colds and bronchitis (266).

 

Chaparral tea is claimed to have a variety of medicinal qualities- it has been described as an analgesic, an expectorant, an emetic, a diuretic and an anti-inflammatory substance (861).

 

Chaparral tea is prepared from the leaflets and twigs of Larrea divericata Coville and/or Larrea tridentata Coville, also known as the creosote bush (520), which is indigenous to the desert areas of the Southwestern United States.

 

According to one report, the tea is made by steeping about 7 to 8 grams of dried leaves and stems of chaparral per quart of hot water (809).

 

A number of chemicals, e.g., gums and resins, have been isolated from the creosote plant.

 

Studies of its biological activity have focused on one of its main components, nordihydroguaiaretic acid (NDGA), a chemical with antioxidant properties that has been used widely in the food industry as a preservative.1 A 1969 report by Smart and colleagues (809) summarizing the available scientific data on NDGA noted that in vitro tests revealed a virtual complete inhibition of aerobic and anaerobic glycolysis and as the rationale for the food industry's using NDGA as a food additive to prevent fermentation and decomposition of commercial foods.

 

In 1968, the FDA removed NDGA from its "generally recognized as safe" (GWS) list after the results from long-term feeding studies in rats showed that NDGA induced lesions inmesenteric Iymphnodes and kidneys.

 

The U.S. Department of Agriculture, however, still permits the use of NDGA in lard and animalshortenings (861).

 

respiration with dilute suspensions of Krebs 2 ascites, Ehrlich ascites and leukemia L121O cells.

 

' Some in vitro studies reported that NDGA was associated with stimulation of tumor cell growth and stimulation of respiratory enzyme activity at low concentrations, though those same processes were inhibited at higher concentrations of NDGA (810).

 

It has also been reported that under certain conditions, NDGA can bind to DNA (932) and can suppress certain immune responses in cultured mouse cells (783).

 

NDGA had sigificant antitumor activity in one animal tumor model (Ehrlich ascites tumor) when given with high doses of ascorbic acid (vitamin C), but has shown no activity in several other animal tumor models (S180, mammary adenocarcinoma 755 and leukemia L121O in mice).

 

Additional tests of extracts of the crude chaparral plant and of NDGA for antitumor activity in animal models showed no significant antitumor effects, with thepossible exception of a flavonoid fraction of L.

 

divaricata which had marginal activity in P388 (383).

 

According to NCI, additional animal tumor tests carried out at the University of Utah reportedly showed that NGDA was active in the ependymoblastoma test system but not in Melanoma S91 tumors (810).

 

NDGA has also been reported to inhibit the development (59 1) and promotion (57) of certain carcinogen-induced tumors in rodents.

 

Based on a 1969 case report (809) of a patient with recurrent malignant melanoma whose cancer reportedly regressed following treatment with chaparral tea and on some of the experimental data cited above, NCI sponsored a clinical study of NDGA (810).

 

It was reported that over a period of 1 year (November 1969 to November 1970), 59 patients with 'advanced incurable malignancy were treated with chaparral tea or NDGA at the University of Utah.

 

The treatment examined in the study included both chaparral tea as used by cancer patients and its component, NDGA: some patients drank two to three glasses per day of chaparral tea, while others received oral doses of pure NDGA (250 to 3000 mg per day).

 

It was not noted in the analysis which patients took which form of the treatment.

 

The outcomes of 45 of these patients were considered evaluable (defined as having received at least 4 weeks of treatment or as having undergone a tumor regression of at least 25 percent or more), although few clinical details were given in the published report.

 

Tumor remissions were reported in four patients in that study.

 

One was the case previously described of the man with recurrent melanoma (his inclusion in the results indicates that the study was not entirely prospective) (see ch. 3).

 

Another was a second patient with melanoma (in these two cases of melanoma, the duration of response was noted as 3 months and 20 months).

 

The third was a patient with choriocarcinoma of the testicle with pulmonary metastasis, whose regression lasted 2 months and a fourth was a patient with lymphosarcoma, whose regression lasted 10 days.

 

Little additional clinical information about these patients, e.g., previous treatment or stage of illness, is given in the report.

 

It was noted that 27 of the patients had "subjective improvement" during the course of their treatment with chaparral tea or NDGA.

 

While the authors concluded that chaparral tea was not an effective anticancer agent (defined in the report as a substance that caused a significant regression of 20 percent of a specific cancer type lasting a minimum of 2 months), the report indicates that there could have been evidence of some antitumor activity.

 

The lack of clinical detail in the published report makes the results difficult to interpret, but the observation that several patients with advanced disease had tumor regressions suggests that chaparral tea and NDGA as given were not necessarily inactive.

 

ESSIAC

 

Essiac is an herbal preparation developed in Canada as a treatment for cancer, which is reported to have originated in Indian folk medicine.

 

From the 1920s until the late 1970s, Essiac was made available to cancer patients by Rene M.

 

Caisse, a nurse who developed the treatment while working at a medical clinic in rural Ontario and who became its sole proprietor.

 

Shortly before her death in 1978, Caisse turned over the Essiac formula, along with rights to its name and manufacture, to the Resperin Corp.

 

of Ontario, the company currently providing Essiac to patients in accordance with a special agreement with Canadian federal health officials.

 

Background and Early Use

 

Rene Caisse began her career as a public health nurse in Haileybury, Ontario.

 

In 1922, one of Caisse's patients told her that she had recovered from breast cancer some 20 years earlier after taking an Indian herbal tea.

 

Caisse obtained the recipe for the herbal tea and began administering it to cancer patients in 1924 following a reportedly successful treatment of a relative with cancer using the tea.

 

She named the treatment Essiac, her name spelled backwards.

 

She gradually modified the herbal formula, producing an injectable and an oral form of the treatment.

 

One of the constituent herbs, which Caisse believed had antitumor effects, was used in the injectable form, while three other herbs, which she believed contributed to improvements in overall health rather than to tumor reduction, were used in the oral form (303).

 

She never revealed the names of these herbs, nor any others she may have used.

 

Throughout her career, Caisse insisted that the ingredients and formula remain secret, despite pressure from the public and medical profession to reveal the information (303).

 

From the late 1920s until 1942, Caisse operated a clinic in Bracebridge, Ontario (303), where she treated hundreds of cancer patients with Essiac (388).

 

From the 1950s until her death in 1978, she provided patients with Essiac from her home in Bracebridge, except for a period of unknown duration beginning in 1959 when she worked at the Brusch Medical Centre in Boston (303).

 

OTA research did not turn up any papers by Caisse in the scientific or popular literature.

 

Most of the available written information on Essiac comes from the press, which, since the 1920s, has periodically described certain aspects of Caisse's career, her advocacy of Essiac as a cancer treatment and testimonials of patients treated with Essiac.

 

Most of these articles have appeared in local Ontario newspapers.2 In 1977, an investigative article entitled ''Could Essiac Halt Cancer?' was printed in Homemaker's, a popular Canadian magazine (303).

 

More recently, the identity of herbs used in Essiac has been reported (388,981), but few additional treatment details have come to light.

 

No substantive information about the treatment regimen is available in the Archives of Ontario (Ministry of Culture and Communications, Toronto, Ontario), where copies of some of Caisse's personal correspondence between 1938 and 1959 are kept.

 

The description provided here is based on these few sources; most of these are secondary sources, since neither Caisse nor her supporters have apparently provided any primary materials.

 

OTA's requests for primary written information from the Ontario company currently supplying Essiac and from Canadian health officials now coordinating the provision of the treatment were refused.

 

Rationale for the Treatment and Claims for Efficacy

 

The 1977 Homemaker's article briefly described Caisse's view of how she thought Essiac affected the cancer process, based on her observations of patients who took the treatment:

 

Often patients would report an enlarging and hardening of the tumor after a few treatments; then the tumor would begin to soften and if it was located in any body system with a route to the exterior, the patient would report discharging large amounts of pus and fleshy material.

 

After this, the tumor would be gone.

 

Rene reasoned that Essiac somehow caused all the cancerous cells to retreat to the site of the original tumor, then to shrink and discharge-often to vanish altogether.

 

Caisse claimed that even in what she referred to as ''hopeless" or "terminal" cases, Essiac benefited patients by relieving pain, reducing tumor size and increasing survival.

 

She claimed generally positive results with many types of cancer with no harmful side effects (303).

 

She reportedly also believed that treatment with Essiac would reduce the risk of metastasis following surgery to remove tumor tissue (303).

 

In a letter to the Deputy Minister of Health in Canada dated October 6, 1958, Caisse wrote:

 

My treatment consists of an intermuscular injection of herbs which causes the growth to localize.

 

If there are secondaries, they recede into the primary growth, causing it to become larger, until it is all localized; then the mass starts to reduce in size.

 

(148)

 

According to a current patient information sheet distributed by a cancer support group, Essiac increases appetite, alleviates and can eliminate pain and gives a wonderful feeling of well-being.

 

It is claimed to be nontoxic and to have no side-effects.

 

There is no available information to indicate how Caisse applied Essiac in specific cases, e.g., whether she gave all patients the same doses of the same formula or whether she modified the treatment

 

@lanyof these are collected by Stan Darling, Member of Parliment,Ottawa, Ontario.

 

One recent newspaper example is: J.

 

Lun&"The OjibwayWonder Drug, Can EssiacCure Cancer?" Norrh Buy Nugget, Apr. 9, 1988 (570).

 

regimen (ingredients, treatment schedules, oral v.

 

injectable forms, etc.) for different patients.

 

At present, Essiac is sold in 16 oz.

 

bottles, with recommended doses of 2 oz.

 

diluted in 2 to 3 oz.

 

of warm water to be taken once a day for the first 10 days, later reduced to 1 oz. in the same dilution per day.

 

This dose is recommended for 1 to 2 years or longer, with amounts eventually being further reduced to two or three times per week (449).

 

The patient information advises that no other treatment, including chemotherapy and radiation, should be used while taking Essiac.

 

It states thatany other treatment which causes change in the human immune system will prevent Essiac from doing its job.

 

If other medication must be taken, however, Essiac will not conflict, it just won't work as fast (449), according to current patient information.

 

Components of Essiac

 

Several reports specify four herbal ingredients in Essiac: Indian rhubarb (Rheum palmatum), sheepshead sorrel (Rumex acetosa), slippery elm (Ulmus fulva),and burdock root (Arctium lappa) (388,392,981).

 

None of these reports indicate how or when these ingredients were identified, although one (98 1) cites personal communication from the Resperin Corp.

 

No information is available on the amount of each ingredient or the method of preparation, since Resperin considers the formula proprietary.

 

Some experimental antitumor data are available on the individual herbal ingredients reportedly present in Essiac mixture.

 

As with the Hoxsey data described later in this chapter, OTA obtained information about antitumor testing of the Essiac ingredients from the Natural Products Branch at NCI (232)3 and from the published literature (as collected by the NAPRALERT database,4 various books and scientific articles).

 

The details are summarized below:

 

Burdock-Two studies reported antitumor activity of burdock in animal tumor systems (257,296), while two others reported no significant activity for this herb (451,969).

 

NCI tested burdock 14 times, with one sample showing activity, though not considered significant, in the P388 mouse leukemia system.

 

Benzaldehyde, which has been isolated from burdock, has shown antitumor activity in some animal tests.

 

Indian rhubarb-This herb was found to have antitumor activity at one dose level in the Sarcoma 37 animal system but not at a higher dose in the same test system (72).

 

Another group found Indian rhubarb inactive in two other animal tumor systems (485).

 

NCI tested two samples of Indian rhubarb from Poland and found no antitumor activity in mouse leukemia systems.

 

Another type of Indian rhubarb, Peltiphyllum peltatum, was tested three times at NCI using samples from California and none was found active in mouse leukemia systems.

 

Components of Indian rhubarb, e.g., aloe emodin, catechin, emodin and rhein, have shown antitumor activity in some animal test systems.

 

Sorrel-NCI tested one sample of sorrel from Taiwan and found no activity in mouse leukemia systems.

 

The compound aloe emodin and emodin have been isolated from sorrel and have shown activity in some animal test systems.

 

Slippery elm-NCI tested slippery elm seven times using samples from various parts of the United States and found no antitumor activity in mouse leukemia systems.

 

Slippery elm contains betasitosterol and a polysaccharide, both of which have been reported to have antitumor activity in animal tumor models.

 

Unlike the Hoxsey treatment (see below), which has not been tested as a mixture for antitumor activity in animals, the presumably complete Essiac mixture has been tested for antitumor activity in a variety of experimental mouse tumor systems.

 

These experiments were conducted at Caisse's request by the Memorial Sloan-Kettering Cancer Center (MSKCC) in the mid- 1970s and again at MSKCC at the request of the Resperin Corp.

 

in the early 1980s ((427).

 

In 1983, Canadian federal health officials requested that NCI test Essiac for antitumor effects in animals (359,602).

 

Caisse submitted three samples of Essiac (two dried samples used to make an extract and one liquid sample), which MSKCC tested in the S-180 mouse sarcoma test system.

 

This test is intended to detect immunotherapeutic effects (indicated by the occurrence of tumor regression) or chemotherapeutic effects (indicated by a diminished tumor growth rate) (427).

 

The results of six immunotherapy tests and two chemotherapy tests of Essiac samples using the S-180 system all showed no activity.

 

MSKCC tested Resperin's sample of Essiac in a variety of other animal leukemia and solid tumor test systems in 17 separate chemotherapy experiments and found no antitumor activity in any of these tests.

 

No evidence of acute toxicity was found in any of these tests, although some evidence of subacute toxicity (slight weight loss in treated animals) was found (427).

 

In 1983, the Resperin Corp. submitted a liquid Essiac sample to NCI, following a request from the Health Protection Branch, Health and Welfare Canada, that Essiac be tested in animal systems.

 

The results of NCI'S tests with Essiac showed no antitumor activity in the mouse lymphocytic leukemia P388 tumor system.

 

In contrast to the MSKCC tests, however, NCI found lethal toxicity in the highest concentrations of Essiac given to the animals in these tests.

 

It is not known how the composition of MSKCC's samples compared with NCI's samples, or how the concentrations used in the animal tests relate to those in the treatments given to patients.

 

Attempts at Evaluating Essiac in Cancer Patients

 

There have been no prospective clinical trials of Essiac to determine its safety and efficacy as a cancer treatment.

 

In the early 1980s, however, Canadian health officials conducted a retrospective review of Canadian patients treated with Essiac using case summaries submitted voluntarily by the patients' physicians.

 

In 1982, when the review began, about 150 physicians in Canada had reportedly requested supplies of Essiac on behalf of their cancer patients.

 

On request from the government, approximately half of these physicians submitted summaries on a total of 86 patients to the Canadian federal health department (Bureau of Human Prescription Drugs, Health Protection Branch, Health and Welfare Canada).

 

According to the former director of the Bureau of Human Prescription Drugs (392), the Bureau reviewed the physicians' reports and concluded the following:

 

47 patients received "no benefits" from Essiac treatment;

 

8 of the patient reports were unevaluable;

17 patients died;

 

1 had a "subjective improvement";

 

5 required fewer analgesics;

 

4 had an "objective response" to the treatment;

 

4 were instable condition.

 

The Bureau's judgments were based on the written summary comments physicians submitted, not on a review of the original patient charts.

 

The Bureau did solicit additional information on the four patients who reportedly had an objective response and the four who were in stable condition.

 

Among these eight patients, three were then found to have had progression of disease, two had died and three were still in stable condition.

 

The latter three patients had received previous conventional treatment that, in the Bureau's judgment, was probably responsible for their stable condition.

 

The Bureau concluded that this review provided no evidence that the progression of cancer in these patients had been altered by taking Essiac.

 

It noted, however, the possibility that some of these patients might have benefited from the treatment psychologically or emotionally.

 

The Bureau's summary of the safety data collected in that review noted that "with occasional batches there was some nausea and vomiting" and suggested that these reactions were probably due to a variation in composition of the herbal preparation.

 

However, few patients reportedly experienced any serious side-effects from the treatment.

 

Current Status of Essiac in Canada

 

In 1978, Resperin filed a pre-clinical new drug submission 5 with the Health Protection Branch (HPB), Health and Welfare Canada.

 

HPB officials allowed Resperin's application to proceed, authorizing the distribution of Essiac toqualified medical investigators' for clinical trials designed to obtain scientifically valid data on Essiac's safety, dosage and effectiveness in cancer treatment (392).

 

In addition, it was expected that the Resperin Corp.

 

''would maintain adequate manufacturing and quality control of the drug" and would "undertake appropriate scientific investigations to isolate and identify any active substances] in Essiac" (392).

 

In September 1982, HPB suspended Resperin's preclinical new drug submission.

 

An HPB official stated that Resperin had not fulfilled its commitment under the agreement "to maintain adequate manufacturing, to investigate the pharmacology of Essiac and to arrange appropriate clinical trials" (392).

 

During the same period in which the Canadian preclinical drug submission was in effect, Resperin applied to FDA for an NDA-permission to market Essiac in the United States-but this application was turned down (554).

 

Details of the NDA submission are confidential, according to FDA rules, so no details on this application are available unless Resperin chooses to make them public.

 

Although Essiac is currently unapproved for marketing in Canada and cannot be used in clinical trials without a valid preclinical new drug submission, the Canadian Government allows Essiac to be manufactured and sold and to be used by cancer patients under certain circumstances.

 

A cooperative arrangement between Resperin and HPB authorizes the distribution and sale of Essiac to cancer patientson compassionate grounds, i.e., when no other treatment is appropriate in the particular case (392).

 

Patients who wish to obtain Essiac ask their physician to make a request to the Bureau of Human Prescription Drugs, which relays the order to the company and the company ships Essiac directly to the patient.

 

Physicians are asked to report to HPB the clinical details on each patient using Essiac.

 

OTA requested details from HPB about its procedures for distributing Essiac and monitoring its use (e.g., the type of data collected, how many patients have requested and received Essiac from Resperin via HPB over the past 5 years, how many of these are

 

U.S. patients and the types of cancer for which treatment with Essiac is being sought), but was told that no more information could be given (480).

 

THE HOXSEY TREATMENT

 

The Hoxsey treatment involves several herbal preparations, all of which are made from combinations of herbs and inorganic compounds.

 

At present, this treatment is offered only at a clinic in Tijuana, Mexico, although from 1924 until the late 1950s

 

(188) it was offered at a number of clinics in the United States under the direction of the late Harry Hoxsey (1901-1974).

 

Awareness of the treatment was recently renewed by the release of Hoxsey: Quacks Who Cure Cancer? (59), a documentary film on the history of the Hoxsey treatment and on Harry Hoxsey's personal role in its development and promotion.

 

According to Hoxsey's autobiographical book You Don't Have To Die (418), the herbal formula for the Hoxsey treatment was developed in 1840 by John Hoxsey, Harry Hoxsey's great-grandfather.

 

It was derived from grasses and flowering wild plants growing in a pasture where one of John Hoxsey's horses, afflicted with a cancerous growth, grazed daily.

 

The horse's cancer reportedly disappeared and John Hoxsey surmised that the wild plants had caused the recovery.

 

He gathered some of the plants from the pasture and later added ingredients from old home remedies for cancer.

 

He used the resulting herbal mixture to treat similarly afflicted horses near his farm in southern Illinois (418,938).

 

The herbal formula was bequeathed to John Hoxsey's son, then to Harry's father John and finally to Harry Hoxsey in 1919, whose father charged him with using it to treat cancer patientsif need be, in defiance of the high priests of medicine' (418,984).

 

Although Harry's father, a veterinary surgeon, was the first to use the formula to treat people with cancer, it was Harry Hoxsey who made it famous.

 

The first clinic offering the Hoxsey treatment opened in the early 1920s and by the 1950s, the Hoxsey Outpatient Clinic in Dallas was reportedly one of the largest privately owned cancer centers in the world (188), with branches in 17 States (58).

 

By Hoxsey's account, the clinic had at its peak of operation 10,000 patients under constant treatment or observation (418,582).

 

Hoxsey was widely known for his flamboyant and confrontational style (59,938,984).

 

His reluctance to disclose the treatment formulas and his bold claims reportedly led Morris Fishbein, then editor of the Journal of American Medical Association (J.A.M.A.),

 

to publish articles labeling Hoxsey and his late father as charlatans (938).

 

Hoxsey sued for libel and won (984).6 In 1956, the FDA Commissioner ordered that aPublic Beware! warning against the Hoxsey treatment be posted in U.S.

 

Post offices and substations across the country (518,984).

 

Repeated clashes with FDA over violations and a number of arrests eventually prompted Hoxsey to close his main Dallas clinic in the late 1950s.

 

Since 1963, the Hoxsey treatment has been offered at a clinic in Tijuana, Mexico, under the direction of Hoxsey's longtime chief nurse, Mildred Nelson (58).

 

The herbal preparations Nelson uses to treat cancer patients are reportedly based on Hoxsey's herbal formulas and method of preparation (78,188).

 

Rationale for the Treatment

 

In 1956, Hoxsey described his belief that cancer was a systemic disease, however localized its manifestations might appear to be.

 

Although he did not ''pretend to know its fundamental cause, ' he believed thatwithout exception it occurs only in the presence of a profound physiological change in the constituents of body fluids and that it leads to achemical imbalance in the organism (418).

 

Hoxsey summarized the theory behind his approach this way:

 

We believe that the organism's attempt to adapt itself to the new and abnormal environment produced by the chemical imbalance causes certain changes (mutations) in newly born cells of the body.

 

The mutated cells differ radically in appearance and function from their parent cells.

 

Eventually a viciously competent cell evolves which finds the new environment eminently suitable to survival and rapid self-reproduction.

 

These cells are what is known as cancer.

 

It follows that if the constitution of body fluids can be normalized and the original chemical balance in the body restored, the environment again will become unfavorable for the survival and reproduction of these cells, they will cease to multiply and eventually they will die.

 

Then if vital organs have not been too seriously damaged by the malignancy (or by surgery or irradiation) the entire organism will recover normal health.

 

(418)

 

He also did not claim to know how or why his herbal cancer treatment worked, but he maintained that itcorrects the abnormal blood chemistry and normalizes cell metabolism bystimulat[ing] the elimination of toxins which are poisoning the system (418).

 

There are three external forms of the Hoxsey treatment used for tumors in or near the skin to 'halt the spread of the disease and speed the necrosis (death) of cancer cells (418).

 

Hoxsey reported that his yellow powder ishighly selective for malignant tissue, leaving normal tissue undamaged.

 

The paste and liquid forms, however, were not, by his account, selective.

 

He applied vaseleline or zinc oxide around the perimeter of the affected area, a practice which he believed contained the corrosive action of the preparations (418).

 

Hoxsey summarized the observed outcomes of his external treatment this way:

 

In practice we have found that a small amount of our compounds, when placed on a large cancerous mass, cause a chain reaction which extends an inch or two beyond the point of application.

 

The mass dies, dries, separates from normal, healthy tissue and falls out.

 

(418)

 

Nelson believes that the Hoxsey tonicnormalizes and balances the chemistry within the body, a process she believes results in tumor regression.

 

In a 1984 interview, Nelson said:

 

When you get everything normalized, the abnormal cells-the tumor cells--cease to grow.

 

And very slowly the tumor is absorbed and excreted and it's gone.

 

(188)

 

In that same article, it was noted that the Hoxsey tonic is intended to helpeliminate toxins from the body.

 

In addition, the Hoxsey powder and paste were described asescharotic agents' that were commonly used by conventional physicians to treat cancer before radiation and chemotherapy were developed (188).

 

Components of the Treatment

 

Hoxsey's treatment regimen included his internal and external preparations andsupportive treatment,' although the components of the latter are not specified in his book (418).

 

His preparations included a paste or salve applied topically for external cancers; a powder, pills and a dark brown herbal tonic taken orally.

 

Hoxsey adjusted the composition and dose of each patient's formula, depending on the individual patient's general condition, the location of the cancer and the extent of previous treatment.

 

The internal treatment was taken by mouth as a liquid tonic or in pill form (418).

 

Hoxsey's 1956 book You Don't Have To Die lists the ingredients of his internal treatment given inall cases of cancer, both internal and external (418) as potassium iodide combined with some or all of the following substances, on a case-by-case basis: licorice, red clover, burdock root (Arctium lappa), stillingia root (Stillingia sylvatica), berberis root (Berberis vulgaris), pokeroot (Phytolacca americana), cascara (Rhamnus purshiana), Aromatic USP 14 (artificial flavor), prickly ash bark (Zunthoxylum americanum) and buckthorn bark (Rhamnus frangula) (418).

 

The last two substances in this list are not specifically mentioned in Mildred Nelson's list of ingredients used in the Hoxsey treatment she currently offers.

 

Hoxsey's escharotic preparations, which were applied locally inexternal cases, included a yellow powder, a red paste and a clear solution.

 

He reported that his yellow powder contained arsenic sulfide, talc, sulfur and what Hoxsey called ayellow precipitate (664).7 The caustic red paste reportedly contained antimony trisulfide, zinc chloride and bloodroot (Sanguinaria canadensis).

 

The clear solution contained trichloroacetic acid (418).

 

The current Hoxsey treatment offered by Mildred Nelson at the Bio-Medical Center in Tijuana includes a liquid tonic, a salve and a powder, all of which are reportedly based on Hoxsey's formulas.

 

The current patient literature from Nelson's clinic lists the components of the liquid herbal tonic as:potassium iodide and herbs, licorice, red clover, cascara, burdock root, barberis root (sic), poke root and stillingia root' (78).

 

The ingredients of the salve and powder are not given.

 

In addition, Nelson's treatment regimen specifically includes nutritional supplements and dietary restrictions.

 

Nelson advises before-mealtri-tabs, after-meal tablets, yeast tablets, vitamin C, calcium capsules, laxative tablets, antiseptic douches and antiseptic washes.

 

She also recommends that patients exclude certain foods thatnullify the tonic (663), such as pork, tomatoes, pickles or other products with vinegar, salt, sugar, artificial sweeteners, alcohol, carbonated beverages and bleached flour.

 

All patients are tested for systemic infection with the fungus Candida albicans before treatment is initiated, although the reasons for such testing are not given in the patient literature (78).

 

Treatment lasts up to 3 days at the clinic, with followup visits within 3 to 6 months after the initial visit.

 

Antitumor Effects of the Hoxsey Components

 

Many of the constituent herbs in the Hoxsey treatment have a long history of folk use in the treatment of cancer, as well as for a variety of other conditions (266,382).

 

One of the constituents of the external treatment, bloodroot (Sanguinaria canadensis), was used by Native Americans to treat cancer, warts and nasal polyps.

 

The ingredients used in Hoxsey's external paste-zinc chloride, antimony trisulfide and bloodroot (418)-were used by Frederic Mohs, M.D., of the University of Wisconsin Medical School in the 1930s and 1940s to treat nonmelanoma skin cancer, e.g., invasive basal cell carcinoma.

 

The Mohs chemosurgical technique, as it came to be known, used the caustic paste to permit serial microscopic examination of excised tissue (625).

 

Mohs' preparation, which he referred to as a zinc chloride fixative, reportedly contained 40 grams of stibnite (antimony trisulfide in a metallic base), 10 grams of powdered sanguinaria and 34.5 cc of a saturated solution of zinc chloride (624).

 

In this method, dichloroacetic acid was first applied to the skin covering the tumor, followed by application of the caustic paste to kill and fix the tissue and left in place under a bandage for 24 hours, during which time the patient was given analgesics for pain.

 

Twenty-four hours later, a layer of tissue approximately 5 millimeters thick could be excised with a scalpel, a procedure involving no pain or bleeding and then examined microscopically.

 

Several successive applications of fixative, excisions and microscopic observation were performed until the tumor was removed.

 

Mohs reported high rates of success with this method-e.

g., a 99 percent cure rate for all primary basal cell carcinomas he treated (625).

 

He noted that the reliability of the method was due to the microscopic control that ''makes it possible to follow out the irregular and unpredictable extensions from the main tumor mass (624).

 

In a 1948 paper in J.A.M.A., he contrasted his use of the fixative paste with that of unconventional practitioners, who, according to Mohs, used the same fixative without microscopic control of excision, a procedure Mohs considered unreliable and excessively mutilating (624).

 

In the early 1950s, Mohs and others abandoned the use of the fixative paste in this method and replaced it with surgical excision of fresh tissue specimens, which are then examined microscopically as before.

 

This latter form of Mohs' method is currently used in conventional surgical treatment of some types of skin cancer, particularly basal cell and squamous cell carcinomas (845).

 

Its advantages over the fixed tissue method reportedly include the avoidance of pain associated with tissue fixation, the ability to perform multiple stages of excision in one day and the elimination of 'postfixation tissue slough, ' permitting immediate reconstruction of the surgical wound when needed (845).

 

Over the past several decades, many of the botanical products reported to be present in the Hoxsey internal treatment have been tested individually for antitumor activity in animal systems (see ch. 12 for discussion of animal test systems).

 

The complete Hoxsey tonic currently given to cancer patients has apparently not been tested for antitumor activity in animal systems.

 

OTA obtained results of testing for antitumor activity of the constituent Hoxsey herbs used in the internal tonic from NCI's Natural Products Branch,the NAPRALERT database,9 an OTA contract report reviewing the history of the Hoxsey treatment (938) and other published sources.

 

Details of the results in animal test systems are summarized below, giving results for NCI and non-NCI tests separately:

 

Burdock-Two studies reported antitumor activity (257,296) in animal tumor systems, while two others reported no significant activity for this herb (451,969).

 

NCI tested burdock 14 times, with one sample showing activity, though not considered significant, in the P388 mouse leukemia system.

 

Benzaldehyde, a constituent isolated from burdock, has been reported active in two test systems in rats (848).

 

Buckthorn-Antitumor activity of a component (aloe-emodin) of buckthorn has been reported in the P388 tumor system (495) and in the Walker 256 system (summarized in (384)) (the Walker 256 test was later withdrawn from use because of problems with its validity).

 

Two other components, emodin and dihydroxyanthroquinone, may also have antitumor activity in animal systems.

 

NCI tested buckthorn in animal systems three times, with no antitumor results.

 

Cascara-Also contains aloe-emodin and emodin, which have shown antitumor activity in animal test systems.

 

No antitumor activity was found when a powdered plant suspension of cascara was tested in the Sarcoma 37 system (72).

 

NCI tested cascara 16 times and found no antitumor activity.

 

Barber~Two studies have reported antitumor effects of substances isolated from barberry (415,702).

 

NCI reported one test of barberry, which showed no antitumor activity.

 

Licorice-one study reported that licorice was inactive in the Sarcoma 37 test system (72).

 

NCI tested licorice 19 times, with one sample showing activity that was not considered significant.

 

Benzaldehyde and a number of other components (e.g., fenchone, glycyrrhizin, indole, quercetin and betasitosterol) have been isolated from licorice and found to be active in animal test systems.

 

Red Clover-Red clover showed no activity when tested in the P388 system (254).

 

NCI tested red clover 94 times, with one test showing activity that was not considered significant.

 

Pokeroot-One published study reported no significant antitumor activity of pokeroot in three animal test systems (Ehrlich ascites, Leukemia SN36 and Sarcoma 180) (969).

 

A component of pokeroot is well-known, however, for its ability to induce the proliferation and differentiation of lymphocytes in the blood (720), a property that might be relevant to an immunologic response to cancer but which might not be picked up as positive activity in these animal tumor models.

 

NCI tested pokeroot for antitumor activity 43 times; in one of these tests, activity was reported in the Walker 256 system, but this test system was later withdrawn because of problems with its validity.

 

Prickly Ash-No tests for antitumor activity of prickly ash have been reported in the literature, although some of its components (e.g., chelerythrine and nitidine) have tested positive in animal systems.

 

NCI tested this plant for antitumor activity five times, with no positive results.

 

Stillingia-No tests of stillingia have been reported, although one of its constituents (gnidilatidin) has tested positive in animal systems.

 

NCI has no record of testing it for antitumor activity.

 

Taken together, the data indicate that many of the herbs used in the Hoxsey internal tonic or the isolated components of these herbs have antitumor activity or cytotoxic effects in animal test systems.

 

The complete Hoxsey herbal mixture has not been tested for antitumor activity in animal test systems, with human cells in culture, or in clinical trials, however.

 

It is unknown whether the individual herbs or their components that show antitumor activity in animals are active in humans when given in concentrations used in the Hoxsey tonic.

 

It is also unknown whether there might be synergistic effects of the herbs used together.

 

Adverse Effects

 

Hoxsey's medical director stated in a 1952 publication that no toxic reactions had been seen in patients treated with the Hoxsey tonic, but he added that 'the growth of a cancer can be stimulated if the treatment is used improperly (664).

 

No further information about this possibility was given.

 

No side-effects or toxicities specifically resulting from the Hoxsey treatment have been reported in the medical literature.

 

Side-effects of some of the individual herbs taken alone, often in massive doses compared to the amounts present in the Hoxsey treatment, however, have been reported (67,179,487, 671,881).

 

Pokeroot, a reported component of the liquid tonic, contains toxic mitogenic substances (agents that induce cell division and proliferation) and has been linked with poisoning, including some fatal episodes, in children and adults (266).

 

The relevance of these reports to possible toxicities of the Hoxsey mixture depends on the amount of each herb present in the mixture (which maybe unknown) and the total amount taken (which varies with each patient).

 

Claims

 

Nelson claims that about 80 percent of the cancer patients who take her herbal treatment are cured (59).

 

She believes that abad attitude is usually responsible for her20 percent failure rate (663) and that she can tell who is going to get well and who is not from their attitude when they first arrive at the clinic; a patient's strong belief that the treatment is going to lead to recovery is the best predictor of success, she says.

 

Hoxsey's public claims of his treatment's effectiveness were similar to Nelson's present-day claims.

 

Hoxsey presented numerous case histories of patients treated at his clinic in his 1956 book (418).

 

Additional case histories supporting his claims are described in a 1954 publication by Defender Magazine (251).

 

In his book, Hoxsey noted that cancer patients sought his treatmentas a last resort.

 

He wrote:

 

We don't pretend to cure all of them.

 

The vast majority are advanced and even terminal cases by the time we get them.

 

Many come to us after the disease already has spread through the body; after surgery or irradiation has so impaired circulation of the blood to the affected areas that our treatment cannot reach them.

 

Nevertheless we believe we cure a far greater percentage of cases treated than is cured by any other method at present known to science.

 

(418)

 

In 1947, the medical director of Hoxsey's clinic stated it more specifically: he claimed they had been curing '85 percent of external cancers and approximately 25 percent of internal cancers' (664).

 

In particular, it was noted that the outcome of treatment was 'dependent to a great extent upon the lymphatic system and our best results are in cancers that have a large lymphatic supply.

 

He stated that many of their patients had hadthe limit of X ray and radium andin many of these, we cannot hope to cure the cancer itself because of the extensive prior destruction, but that the Hoxsey treatment mightlimit the further extension of the cancer and keep the patient free from pain thereafter.

 

This director noted,in almost every case that the general health of the patient improves' as a result of the treatment.

 

He concluded thatwe know that the Hoxsey treatment cures cancer and it is only reasonable to believe that we have within our grasp the cause and eventually the complete solution, of the cancer problem (664).

 

Attempts at Evaluating the Hoxsey Treatment

 

No clinical trials of the Hoxsey treatment have been reported.

 

Several record reviews, initiated in the 1950s, have been discussed in the literature, however.

 

The first was based on a site visit in 1954 by a group of physicians, who, by Hoxsey's account, spent 2 days inspecting the clinic, reviewing patient records and talking to patients.

 

Although the data on which they made their conclusions are not given in Hoxsey's book where an excerpt of their statement appears, the group concluded that the Hoxsey Clinic wassuccessfully treating pathologically proven cases of cancer, both internal and external, without the use of surgery, radium or x-ray (quoted in (418)).

 

Criteria for such successful outcomes reportedly included patients who remainedsymptomfree in excess of five to six years after treatment.

 

They concluded thatthe Hoxsey treatment is superior to such conventional methods of treatment as x-ray, radium and surgery.

 

In 1957, a committee of faculty members of the University of British Columbia conducted a review of the Hoxsey treatment and facilities (582).

 

After visiting Hoxsey's Dallas clinic, the committee described the overall treatment regimen, along with various other aspects of the treatment (the history of the treatment, Hoxsey's claims for efficacy and the history of Hoxsey's litigation concerning the treatment).

 

They were particularly interested in following up on patients from British Columbia who were treated at the clinic.

 

The clinic gave the committee members records for 78 patients from their 'active' fries (unbeknownst to the clinic, however, some of these patients had died).

 

The committee was able to follow up on 71 of these patients, using British Columbia's cancer registry, death registry and physician records.

 

Their detailed findings were summarized as follows:

 

For over one-half of the [cancer] patients from British Columbia, the result [of treatment with the Hoxsey method] has been either death or progression of the disease.

 

In nearly one-quarter there was no proof that the patient ever had cancer.

 

Nearly one in ten of the patients had curative treatment before going to the Hoxsey Clinic.

 

In only one case, an external cancer, was there any evidence at all that the Hoxsey treatment had an effect on the disease; in that case, better results could have been obtained by orthodox means.

 

(582)

 

The latter case to which they refer reportedly involved a woman with aslow-growing cancer of the ear who refused surgery and was treated with one of Hoxsey's external treatments.

 

The committee reported that the treatment ''did, in fact, remove the cancerous growth, along with a good deal of normal tissue.' It did so ''with needless pain and disfigurement, given that it could have been treated with radiation or surgery, in the committee's opinion (582).

 

They also reported that of the 32 patients who died,two-thirds were dead in less than six months, 90 per cent were dead within a year and none survived two years (582).

 

Hoxsey made attempts (in 1945 and 1950) to have NCI review his patients' records.

 

On both occasions, NCI determined that the records Hoxsey submitted did not meet NCI'S previously established criteria at that time for documenting treatment effects.

 

In summary, these criteria required that Hoxsey:

 

explain the composition of his herbal treatments and his regimen for treating patients;.

 

submit complete clinical and laboratory records of at least 50 patients with internal cancer to show conflation of the diagnosis by biopsy and objective evidence of regression of primary growth and metastasis by measurement, photographs and x-rays; and.

 

provide proof that these patients had survived &least 5 years following treatment (418,582,984).

 

In 1945, Hoxsey reportedly submitted records for 60 patients, 40 of which were for cases of external cancer and the remaining 20 were reportedly unevaluable by NCI's criteria (582,984).

 

In 1950, Hoxsey submitted an additional 77 case histories, all of which, he claimed, werefully documented with clinical records and pathological reports and some of which includedactual microscopic biopsy slide[s] or details of where NCI could obtain such material.

 

He added that all but a few of the cases we sent in had been cured more than five years and those few were of a deadly type of cancer where survival for even three years was considered little short of miraculous (418).

 

According to a discussion of the documentation Hoxsey submitted to NCI by the University of British Columbia committee, however, Hoxsey's 77 records reportedly included only 6 biopsies; 2 of these were from patients with internal cancer and neither of these 2 biopsies confirmed the existence of malignant cells (582,984).

 

It was also reported that 31 of the 77 patients were dead within 5 years of treatment and ''in the remaining 46 cases, the criteria would have been met by 12 patients if suitable sections had been submitted (582).

 

According to several sources, NCI concluded on the basis of Hoxsey's data that no assessment of his treatment could be made (418,582,984).

 

Hoxsey believed, however, that it was NCI's responsibility to verify his case records; their failure to do so was deliberate, he believed, resulting from a widespread conspiracy organized against him by the AMA (418).

 

Attempts were made to initiate investigations into Hoxsey's treatment and his allegations against NCI and AMA, but the investigations were never conducted.

 

In 1947, Senator Elmer Thomas of Oklahoma asked the U.S. Public Health Service to investigate Hoxsey's treatment and the Surgeon General refused the request (294,582,984).

 

In 1951, Senator William Langer of North Dakota sponsored a resolution under which a subcommittee would have been authorized to study Hoxsey's treatment and claims for effectiveness, but this resolution was never reported out of committee (582,984).

 

Hoxsey's point of view was echoed by a 1953 report to the Senate Interstate and Foreign Commerce Committee by Benedict Fitzgerald, an attorney who examined records of Hoxsey's litigation with the AMA and the Federal Government.

 

After reading about the circumstances of these attempted case reviews, Fitzgerald wrote that NCI ''took sides and sought in every way to hinder, suppress and restrict [the Hoxsey Cancer Clinic] in their treatment of cancer (294).

 

To date, no independent, comprehensive assessment has been made to resolve the many allegations and issues raised by Hoxsey's tumultuous career.

 

MISTLETOE

 

Mistletoe has long been used in the treatment of a variety of acute and chronic conditions (302).

 

It was not widely used for treating cancer, however, until the 1920s, during the early development of Anthroposophy, a modernspiritual science applied to medicine and a variety of other disciplines.

 

At present, mistletoe is given to patients either as the central component of a complex, broader treatment regimen in the practice of Anthroposophic medicine mainly in Europe (277) or as a single agent partially or completely removed from the overall context of Anthroposophic care (e.g., in the United Kingdom and other countries).

 

At present, mistletoe preparations are advocated mainly by Swiss and German physicians practicing Anthroposophic medicine, but are also used by other European physicians not necessarily associated with Anthroposophy.

 

A larger group of researchers in Europe and to a lesser extent in the United States, has focused on the study of mistletoe's biological properties in various experimental systems.

 

Mistletoe preparations are available in a variety of forms (413,753), including a preparation by the trade name Plenosol (208), but the oldest and most widely used is a product marketed by Weleda AG (Switzerland and West Germany) under the trade name Iscador, which consists of fermented extracts of mistletoe, some forms of which are combined with small amounts of various metals (e.g., silver, copper and mercury).

 

Iscador is listed in the German Rote Liste (1989) and is registered with the Swiss Inter-Cantonal Office for drug control (847), but is not listed in the Swiss Compendium of pharmaceutical drugs (224).

 

Some commercial preparations of mistletoe are licensed in West Germany, but are not held to the same standards of efficacy as other medical drugs (422), according to a 1976 West German drug law (789) allowing for different standards for unconventional treatments.

 

Approximately 40,000 patients worldwide were receiving Iscador treatment in the early 1980s, according to the Society for Cancer Research, a Swiss Anthroposophic organization (8 16).

 

Mistletoe treatment is reportedly available in Switzerland, West Germany, the Netherlands, the United Kingdom, Austria and Sweden, at clinics and private practices specializing in Anthroposophic or in various types ofholistic medicine.

 

Commercial preparations of mistletoe can be legally prescribed by licensed physicians in these countries (726).

 

The Weleda company, which makes a range of drug and household products, also has branch operations in several other European countries, as well as in Canada, the United States, India, South Africa, Argentina and Brazil (746).

 

Although Iscador is not commonly used in the United States, some U.S. physicians have been trained in Anthroposophic medicine and incorporate aspects of its practice into patient care (953).

 

The U.S. branch of Weleda does not sell Iscador, as the product is not approved for sale in the United States, but U.S. physicians can order Iscador directly from European manufacturers (952).

 

Some U.S. patients may also travel to specialized clinics or hospitals in Europe to receive Iscador treatment.

 

Mistletoe achieved prominence as a cancer treatment through the work of Rudolf Steiner, Ph.D. (1861 -1925), who founded Anthroposophy (598).

 

Working with Ita Wegman, a Dutch physician, Steiner applied the principles of hisspiritual science,' which combined spiritual and scientific thought, to the practice of medicine and to the treatment of cancer in particular.

 

In the decades since Steiner's death, physicians and researchers have continued developing his ideas (423) and have established a network of clinics and hospitals in Europe, North America and South Africa designed to put his principles into medical practice.

 

The first Anthroposophic clinics opened in Arlesheim, Switzerland and Stuttgart, West Germany, in 1921.

 

A group of physicians following Steiner's philosophy founded the Society for Cancer Research in 1935.

 

In 1949, that group founded the Hiscia Institute, whose main purpose WaS to develop Iscador for therapeutic use and to conduct research.

 

The Lukas Klinik, specializing in the Anthroposophic treatment of cancer, was opened in 1963 in Arlesheim.

 

At present, the Society for Cancer Research supports two research institutes (the Hiscia Laboratory, where Iscador is manufactured and the Widar Research Center, where biochemical studies of mistletoe are carried out), in addition to the Lukas Klinik and a postgraduate training facility for physicians specializing in Anthroposophic medicine.

 

Steiner's Approach to Cancer Treatment

 

Steiner's work led him to believe that cancer results from imbalances in certain forces affecting the human body.

 

He believed that some of these forces are responsible for cell division, growth and expansion (lower organizing forces) and others (higher organizing processes orformative forces' are responsible for limiting and organizing that growth, controlling cell differentiation and producing overall body form; it is the balance of these two types of force that influences the strength or weakness of one's individuality.

 

Steiner believed that in healthy people, such forces are balanced and act in harmony, whereas in people with cancer or in peoplesusceptible to cancer, the higher organizing forces are weak, relative to the lower organizing forces.

 

The resulting imbalance would lead to excess proliferation of cells, loss of form and eventually tumor production (477).

 

Steiner believed that cancer involved not only physical disorder in the body, but also disruptions amongdifferent levels of matter, life, soul and spirit (726).

 

In the early 1920s, Steiner proposed mistletoe as a therapeutic agent capable of correcting the imbalance he believed was ultimately responsible for the development of cancer.

 

In general, his proposal was based on the process of what he calledspiritual science,' in which he combined spiritual and scientific thought ascomplementary modes of insight.

 

Anthroposophic literature refers to his reportedly extraordinary mental capabilities (higher faculties of perception,' extrasensory perception, or inner knowledge) as the key element underlying his novel proposal to use mistletoe therapeutically in cancer (277).

 

Contributing to Steiner's proposal to use mistletoe were his detailed analyses of the plant's botanical characteristics, which are described in many Anthroposophic accounts of the origin of this treatment.

 

Steiner examined the growth and development of the semiparasitic mistletoe plant and noted, e.g., that its morphology is spherical rather than vertical; its growth is not influenced by the force of gravity; it grows on different species of host trees, taking water and minerals from the tree sap and supplying the tree with sugars made via photosynthesis; it avoids direct contact with the earth and makes no roots in the ground; it produces berries all year long; and it flowers in the winter.

 

Steiner concluded from these characteristics that mistletoe develops independently from earth forces (e.g., gravitational, electromagnetic, chemical) and from seasonal cycles, opposite to the way in which he believed tumors develop (94,477).

 

Steiner concluded that these characteristics made mistletoe uniquely valuable as a therapeutic agent.

 

He believed that mistletoe could stimulate 'higher organizing orindividualistic forces which he felt were relatively inadequate in cancer patients.

 

He suggested that by taking mistletoe, such forces would be transferred from the plant to the patient and would result in an enhancement of host inflammatory defense mechanisms against cancer.

 

The mistletoe treatment was named Iscador (94) and Steiner recommended that the mistletoe be combined with certain metals in high dilution that he believed would enhance the activity of the mistletoe preparation (847).

 

With Iscador as the central element, Steiner's cancer treatment regimen consisted of various medical and nonmedical interventions.

 

Steiner developed and advocated specific artistic activities that he believed also contributed to recovery from cancer, such as clay modeling, eurythmy (or movement treatment) and speech formation.

 

The overall aim of the regimen was to strengthen patients'formative forces ororganic self-supportive systems and provide an opportunity for individuals to undergo inner change and to develop the soul and spirit (533).

 

The current Anthroposophic treatment for cancer consists of a similar, but expanded, combination of inverventions intended to be used adjunctively with conventional care (726).

 

Conventional medical treatment is recommended for some patients, although at the Lukas Klinik in Switzerland, patients are generally referred to other centers to obtain it.

 

Treatment at the Lukas Klinik consists of some combination of the following, according to each patient's condition: conventional and homeopathic preparations for various medical problems associated with cancer (e.g., for hemorrhages, bone metastasis, effusions, pain, etc.); a vegetarian diet with restrictions on the consumption of mushrooms, hardened fats, refined sugars, new potatoes and tomatoes; avoidance of alcohol and cigarettes; artistic activities such as eurythmy, painting, speech formation, light and color therapy and music; light exercise; and hyperthermic baths, oil baths and massage (277,533,534).

 

Preparation and Administration of Iscador

 

Iscador is made from a species of European mistletoe, Viscum album, which differs from mistletoe commonly found in the United States.

 

The different preparations of Iscador are classified according to the type of tree on which the mistletoe grows and are chosen for use according to the sex of the patient and the location of the primary tumor.

 

For instance,Iscador M refers to the preparation made from mistletoe growing on apple trees and is used to treat women with cancer; ''Iscador Qu,' from oak trees, usually for men;Iscador p, from pine trees, for men and women; andIscador U, from elm trees, for men and women (726,746).

 

The preparations are also distinguished by the type of metal added, e.g., silver, mercury and copper, in concentrations ranging from 10-8g silver/ 100 mg mistletoe to l0-5g copper/100 mg mistletoe (746).

 

The addition of these metals is believed to enhance the action of Iscador on particular organs and systems.

 

An Iscador preparation with copper is used for primary tumors of the liver, gallbladder, stomach and kidneys; Iscador with mercury is used to treat tumors of the intestine and lymphatic system; Iscador with silver is used to treat cancers of the urogenital system and breast; and Iscador without any added metals is used to treat tumors of the tongue, oral cavity, esophagus, nasopharynx, thyroid, larynx and extremities (746).

 

The rationale for inclusion of metals with mistletoe preparations is not explained in the Iscador literature OTA reviewed.

 

Some aspects of the method by which Iscador preparations are made are proprietary, but it is known that the whole plant is used to make an aqueous extract, which is then fermented with the bacterium Lactobacillus plantarum.

 

The fermented saps ofsummer and winter extracts of mistletoe are mixed and then undergo sterile filtration (413,955).

 

It is packaged in small ampules containing different concentrations of mistletoe, ranging from 0.0001 mg mistletoe/ampule to 50 mg mistletoe/ampule, designed to be administered by subcutaneous injection at or near the tumor site.

 

In some cases, Iscador is administered orally, e.g., in cases of primary tumors of the brain and spinal cord.l0 A typical course of Iscador treatment consists of 14 injections given in increasing concentrations.

 

It is usually given in the morning, when body temperature is rising.

 

According to a report of the Swiss Cancer League (847), fermented Iscador products contain large numbers of both dead and live bacteria (mainly Lactobacillus) and some yeast (847).

 

Proponents contest that assertion, noting that Iscador is filtered to eliminate bacteria and that routine testing is conducted for microbial contamination, as required by the Swiss International Office for Drug Control (723).

 

Iscador preparations are also tested for endotoxin contamination (367).

 

No cases of serious infection have been reported in the literature as a result of subcutaneous injection of Iscador.