Adapted from the December 2005 edition of CancerWire:
Nutritional Supplement Reported to Help Cancer Patients Undergoing First Clinical Trial was the subject of the May 2005 edition of CancerWire. The referenced supplement, Poly-MVA, was developed by Dr. Merrill Garnett, who spent over 20 years in search of a non-toxic formulation that could be used to support more orthodox treatments. [The active complex in Poly-MVA, palladium lipoic acid complex, is frequently abbreviated LAPd; Lipoic Acid Palladium.] Over the last several years a growing number of cancer patients, many with advanced, metastatic disease, have used it as a nutritional supplement. Many claim that they have derived a benefit.
James W. Forsythe M.D., H.M.D., a board certified oncologist and homeopathic physician, oversaw the first clinical study of LAPd as an adjuvant for Stage IV cancer patients. Dr. Forsythe's clinical trial began enrolling patients in January, 2004 (23 months ago). This is an independent study which has an IRB (Investigational Review Board) approval pending in the state of Nevada. CancerWire spoke with Dr. Forsythe to obtain an update regarding his clinical results.
A total of 207 Stage IV cancer patients were enrolled in the study. Some chose to take the LAPd alone while others followed the recommended protocol for the study -- taking the LAPd in addition to some form of conventional therapy (low dose chemotherapy). It should be noted that all patients with metastatic (Stage IV) disease are in danger of dying at any time. In fact an appallingly small percentage of conventionally treated cancer patients survive longer than 18 months after the disease has metastasized.
72 of the 207 patients in Dr. Forsythe's study unfortunately could not be saved, and 43 chose to discontinue within 1-2 months of enrollment. Thus there are a total of 92 evaluable patients remaining in the study at the time of this report. While the reported response rates do not include the 43 patients who left the study, it is very important to note that Dr. Forsythe's reported response rate calculations have factored in the 72 patients who died. *[See NOTE below]
There has been an overall response rate of 56% for patients who followed the recommended protocol and 50% for patients who chose to take LAPd alone. Among the 92 evaluable patients remaining in the study, none are currently experiencing a progression of disease. Every evaluable patient falls into one of the following three categories: Complete Remission (CR), Partial Remission (PR), Stable Disease (SD). The safety profile was reported as excellent. To say that these response rates compare favorably with response rates for Stage IV cancer patients who receive conventional therapy alone would be a gross understatement.
*NOTE: When patients who are enrolled in a study do not survive (die during the study period), it is quite common for clinical investigators to remove those patients from their data and report on the surviving patients only -- specfically, those patients who survive and continue to participate in the study. This rather deceptive practice of "fudging the numbers" is disingenuous at best and blatantly misleading at worst. Investigators whose reported data include only those patients who survive are clearly attempting to make the response rates appear to be much better than they actually are. The December 2005 edition of CancerWire stated that Dr. Forsythe's reported response rates would be lower if they included the 72 patients who died. We are quite sure that this editorial error was an innocent oversight and that there was no deliberate intention on the part of CancerWire editors to mislead their readers. The fact is that Dr. Forsythe's report does include those 72 patients. Thus Dr. Forsythe's reported response rates are entirely accurate -- there has been no attempt to "fudge" the numbers in any way.
So what happened after 2005? [See the editorial, A Question for Senator Clinton, on the Rick's Story page, and the CHRONOLOGY OF EVENTS that occurred during 2007 on the Additional Information page of this website.] The vicious attack on Dr. Forsythe’s study was clearly prompted by its own success. The corporate interests that were so threatened by the success of the study quickly unleashed the full force and fury of their government henchmen. The long nightmare that followed finally ended on November 1, 2007 with a unanimous jury verdict that completely vindicated Dr. Forsythe and acknowledged his status as a gifted and compassionate physician.
The continuity of the study, however, was interrupted by the repeated assaults that occurred during the “investigation” and the character assassination campaign that continued unrelentingly for well over two years. So while we know that the survival and quality of life numbers are excellent, the disruption caused by the seizure of medical records and numerous other attacks has prevented the study from gaining the respect it deserves in the medical science community; an unfortunate reality that has been extremely frustrating for those of us who were so looking forward to the data being published.
Since preventing the study from continuing and the data from being published was the FDA's grand plan all along, one might conclude that while the jury verdict was a clear vindication for Dr. Forsythe, Big Pharma and its government co-conspirators have still managed to allow their cohorts (like the American Cancer Society) to continue to blow the "no clinical data has been published" horn as they shake hands and congratulate one another for effectively muffling the truth.
The next most obvious question is: Aren't there any other studies? Yes, in fact, there are. Refusing to be intimidated by the forces that are working against him, Dr. Forsythe has continued on with his groundbreaking work in spite of the seemingly insurmountable roadblocks that have been constructed in an effort to prevent him from doing so.
The plain and simple fact is that the volume of data is enormous. If you enter the words “palladium lipoic complex” into any search engine, you will quickly see that it would take you days and perhaps weeks to click through and read all of the references. But it is not our goal to make this website a repository for volumes of data. Cancer patients have enough to deal with -- they certainly don't need to add "information overload” to their list of challenges. Cancer patients simply want to pursue a course of treatment that will give them the best possible chance for recovery with good quality of life during and after treatment. It is our hope and belief that the information provided here will assist them as they endeavor to make those decisions.
The evidence is so compelling...
Most of the FDA references that can be found on the pages of this website pertain to the "dark side" of the agency. It should be noted, however, that the FDA is not staffed by an army of Darth Vader look-alikes. Many of the people in the FDA's Center for Drug Evaluation and Research, for example, are quite removed from the world of armed raids and are quite willing to allow good science to stand on its own merits. When the facts are shining so brightly in their eyes, even the dark-siders among them cannot deny the truth. The truth is that the evidence supporting the use of palladium lipoic complexes is so compelling that the United States Food and Drug Administration (the FDA) has approved two investigational new drug (IND) applications for clinical studies designed to further evaluate the efficacy of a dietary supplement (Poly-MVA) that contains an active complex (palladium lipoic acid complex) with extraordinary properties.
NOTE: A comparable public health agency within the Mexican government has already approved (and is presently using) Poly-MVA as a nutritional aid for cancer patients in Mexico.
Why would the United States Food and Drug Administration approve, or even require, an investigational new drug application for a product that is not a drug? [Poly-MVA is currently available as a dietary supplement.] Because it is a regulatory requirement for any such product -- a drug or a supplement -- to stand up to the scrutiny of IND data reporting in order for it to be considered for an approved health claim in the United States.
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