Gar Hildenbrand alternatives - informed consent

Informed Consent

This is an investigation of a multidisciplinary therapeutic approach, which is based on the prior labors of scientists such as Coley, Gerson, Diller, Seibert, Alexander-Jackson, Livingston, Gerlach, Knott, Sodi-Pallares, Berger, Edelson, and others. Although the individual components (mixed bacterial vaccine, dietotherapy, autologous cancer-associated microbial vaccine, PUVA-photopheresis with monocyte harvest and dendritic cell culture, hyperbaric oxygen, etc.) were developed as stand-alone anti-cancer strategies, their integration required many changes to their traditional protocols, dosages, timing, and administration. Therefore, none of the components are employed in the exact manner of the developers. No specific dangers have been identified for any of the components as they were employed by their developers, and cautious integration has produced no observed drug-drug-type side effects. Clinical investigations are a form of research that includes only patients who choose to take part. Please take your time to make your decision. Discuss it with your friends and family. You are being asked to take part in this study because you have a condition for which the available standard treatments are either inadequate or unacceptable to you.

Why is this study being done?

Standardized treatments for degenerative disease and cancer have had disappointing results, which are especially evident in the solid malignant tumors that commonly afflict people. More than 90% of all cancers are in this group. A great deal of speculation exists in the modern medical literature about the possibility of using the immune system to cure disease. Much of this discussion focuses on the curative effects of fevers and the agents which have been observed to induce curative fevers. At the heart of this animated discussion is a vaccine known as Coley’s toxins, which is thought by many to be the most effective single agent ever developed to fight cancer. It is paradoxical that, in the midst of all this excitement at the government, academic, and industrial levels of medical research, only a few isolated practitioners are actually using Coley’s toxins or similar agents.

It is widely recognized that innate immunity and extracellular-matrix function are impaired and fundamentally altered in malignant disease. Gerson referenced Pischinger on the failure of the connective tissue immunities, and demonstrated the ability of his treatment to restore resistance and immunity in far advanced infectious disease, e.g., tuberculosis. Remarkably, therapeutic reversal of advanced tuberculosis by Gerson’s treatment was marked by spiking fevers; a hallmark that Gerson observed was customary in improving cancer patients. The ability to trigger a fever associated with therapeutic benefit therefore unites the contributions of Gerson and Coley.

It has been convincingly demonstrated that a number of previously unsuspected pathogens contribute to oncogenesis, including Helicobacter pylori and human papilloma virus. With the realization that our cells are outnumbered 10 to 1 by commensal bacteria (the normal body has 10 trillion cells and 100 trillion bacteria), and the shocking recent discovery through molecular methods (e.g., PCR) that we have typed and categorized less than 0.04% of the microbial world, a probable complex role for microbes in the development of most, if not all, cancers becomes an obligatory consideration.

Cancer-associated microbes have been successfully cultivated and harvested for antigens by a number of vaccine pioneers including Gerlach, Livingston, and others. Employment of these vaccines in the context of a therapy aimed at overcoming innate immune suppression (breaking tolerance) is a logical strategy. Berger demonstrated the ability of contact abrasion to induce morphing of harvested monocytes into activated dendritic cells, the body’s most important professional antigen presenting cells. In the course of treatment with PUVA-photopheresis, many circulating microbes are killed even while monocytes are being collected. Activated dendritic cells not only take up antigen to present to lymphocytes, they can independently target and destroy invading microbes and cancer cells. Freedom from recurrence of malignant disease has been associated with high levels of dendritic cells. Employed together, these approaches provide a means to address an entire array of problems left unanswered by current standardized treatments. The purpose of this study, therefore, is to document and publish the outcomes of individuals successfully treated with the combination therapy.

What is involved in the study?

There are no new or experimental drugs or procedures in this study. What defines this investigation as a “study” is the long-term follow-up of every participant. By agreeing to be in the study, you will be helping us to define outcomes for the condition for which you are receiving treatment. The product of the study will be publications in medical journals so that others can be made aware of the efficacy, safety, and applicability of the therapy. You will receive multidisciplinary management including vaccines, nutritional immunotherapy, and other treatments to meet your individual needs. Your in-house treatment will last at least 28 days, and you may be asked to return during the course of therapy if additional treatments are deemed necessary. However, you will receive education and detailed instructions so that most of your therapy can be conducted in the comfort of your own home over its 18-to-24-month duration. During that time, you will have access to your physicians by telephone, fax, and email.

After you have completed treatment, you will continue to receive questionnaires on a yearly basis and, less frequently, occasional telephone calls from researchers who will want to know how long you continue to benefit from treatment.

How long will I be involved in the study?

The duration of medical treatment will be, for most patients, 18 to 24 months. While you will be observed during your treatment, the study itself will continue long after you have completed the therapy. Long-term follow-up will continue for many years, as noted in the previous section. You can stop participating at any time.

What are the risks of the study?

Because no new or experimental drugs or procedures will be administered, there are no pressing concerns regarding side effects. By far, the most important side effect of immune-regulatory-repair system activation, with destruction of tumors or disease lesions, is fever, with or without abdominal discomfort. No long-term side effects have been documented, and no organ damage has ever resulted from the methods and materials combined in this therapy.

What are the benefits of taking part in the study?

We hope this study will benefit other patients in the future by making medical scientists and practitioners aware of the tremendous potential of the human body to heal when the correct conditions and materials are supplied.

What other options are there?

You may receive treatment even if you do not take part in the study.

What about confidentiality?

All reasonable efforts will be made to keep your personal information confidential. The following organizations and individuals may inspect and/or copy your medical records, including research records, for quality assurance and data analysis: Gerson Research Organization, Instituto de Investigaciones Biologicas, and CHIPSA.

What are the costs?

There are no costs for participating in the study.

What are my rights as a participant?

Taking part in this study is voluntary. You may choose not to take part or may leave the study at any time. Leaving the study will not change your relationship with your doctor or the researchers.

Where can I get more information?

Additional information is available at Gar Hildenbrand Alternatives, http://www.garhildenbrand.com. You will receive a copy of this form. You may also request a copy of the protocol.

Signature

I agree to take part in this study.

Participant_______________________________________

Date_______________________

Addendum to Informed Consent

I agree to allow the use of blood samples, other body fluids, and tissues obtained during testing, operative procedures, or other standard medical practices for further research purposes.

A. I agree to the use of my specimens for research and teaching purposes.

Yes_________

No_________

B. I agree to be contacted in the future to discuss whether I will give permission for my specimens to be used for genetic research.

Yes_________

No__________

Signature

Participant _______________________________________

Date _____________________