Dr Joseph Gold

THE PENTHOUSE POLITICS OF CANCER: THE PROMOTION OF HYDRAZINE SULFATE AND A MEDICAL CONSPIRACY THEORY

On September 10, 1996, an article bylined by Brian Vine -- "Is this cancer drug too cheap for its own good?" -- was published in The Daily Mail (Associated Newspapers, Ltd.). The drug in question was hydrazine sulfate, the use of which the U.S. Food and Drug Administration has not approved for any type of cancer. Vine referred to hydrazine sulfate, in quotation marks, as a cure. His article focused on one metastatic-cancer patient's belief that this drug had saved her life.

The patient was Kathy Keeton, cofounder -- with her spouse, Bob Guccione, publisher of the New York City-based Penthouse magazine -- of Omni and Longevity magazines. According to Vine's article, Ms. Keeton had begun taking hydrazine sulfate 15 months earlier, on the advice of general practitioner Joseph Gold, M.D. Dr. Gold, director of the Syracuse Cancer Research Institute, in Syracuse, New York, has promoted the drug as a cancer treatment for the last 30 years. Reportedly, other doctors had said that Ms. Keeton would live for only six weeks and had recommended chemotherapy, which she had rejected. Vine quoted her: "My recovery from cancer is all due to meeting Dr. Gold and deciding to fight it with two of his hydrazine sulphate tablets a day." She had called the results "stunning."

Montel and "Miracles"

In January 1998 I discussed hydrazine sulfate on The Montel Williams Show with Ms. Keeton, Mr. Guccione, Dr. Gold, and Ms. Keeton's Park Avenue physician, Jeffrey Mechanick, M.D. Montel called the program's topic "miracle cures." The show's associate producer had promised me that I would appear at its beginning, but I appeared last, following physicians who promoted unproven "anti-aging" treatments and, as anti-obesity agents, fenfluramine (in "fenphen" fashion) and dexfenfluramine. (After the broadcast, reports were published of heart-valve damage attributed to fenfluramine and dexfenfluramine, and manufacturers have since withdrawn them from the U.S. market.)

Ms. Keeton said she had developed stomach pains in April 1995, had been diagnosed with "advanced stage IV breast cancer" the following month, and had been advised by her doctor to undergo "classical chemotherapy, radiation, and bone marrow transplants." But, after claiming "great" knowledge of medicine, she asserted that chemotherapy "kills 25 percent of the people who get it."

According to the American Cancer Society (ACS), while the primary goal of treating patients who have metastatic breast cancer is relief of symptoms, chemotherapy may increase the median survival time of patients with metastatic cancer by as much as a year.

Said Ms. Keeton: "[D]uring the first ten weeks of my disease, during which time I was supposed to be dead, I only took hydrazine sulfate."

Dr. Gold stated that Ms. Keeton's disease had "turned around" during those weeks, but that the lymph nodes around her pancreas and common bile duct had enlarged. Therefore, he said, he had "suggested to Kathy and her doctors that she take a course of radiation to reduce and eliminate these, because we know now from 15 years of experience that the combination of hydrazine sulfate and radiation therapy will get rid of most tumors or tumor sites permanently."

Dr. Gold further stated that Ms. Keeton had "residual disease," but that her "abdominal disease, which constituted her main threat to life" was "totally gone." He said its disappearance was unquestionably the result of her having taken hydrazine sulfate. He added, however: "[W]e have blended in from time to time other nontoxic drugs, whether they be drugs [that] cancer doctors usually use or other[s] -- anything that can give hydrazine sulfate a boost, such as she's been on tamoxifen on and off."

Tamoxifen, unlike hydrazine sulfate, has beneficial effects on breast cancer that are objective and have been verified.

Dr. Gold said of Ms. Keeton: "She does fall perfectly in line with published peer-reviewed studies in the medical literature on breast cancer with hydrazine sulfate." But published studies do not validate attributing any outcome to hydrazine sulfate, whether the drug is the only treatment or is used in conjunction with other treatments. Later in the program Dr. Mechanick explained:

You really can't say that hydrazine alone had an effect objectively on the actual amount of tumor....During the ten weeks [that] Kathy was taking this medicine, there were clear signs of regression of certain areas of tumor....However, during that same period of time...we got into trouble. That's when she started to develop obstruction of...the tube that transfers bile out of the liver. That is what necessitated radiotherapy and ultimately addition of other medicines.

The Russian studies that Dr. Gold cites lacked random assignment of patients to hydrazine sulfate and placebo groups. Moreover, neither the subjects nor their caregivers were kept unaware of which patients were placebo recipients. A small, well-designed Harbor-UCLA Medical Center clinical trial of hydrazine sulfate was published in 1990. It was inconclusive.There had been no significant difference in survival time or body-weight change between those lung cancer patients who had undergone standard chemotherapy plus taken hydrazine sulfate and those who had undergone such chemotherapy plus taken a placebo. But among patients who had been in relatively good health when they'd entered the study, survival time was better for those on hydrazine sulfate. This finding made further research justifiable.

Sabotage?

In 1994 reports were published in the Journal of Clinical Oncology of three double-blind, placebo-controlled trials of hydrazine sulfate sponsored by the National Cancer Institute (NCI). In two of these trials the subjects had been lung cancer patients; the subjects in the other trial had had metastatic colorectal cancer. Hydrazine sulfate had not been deemed effective in any of these trials. Indeed, the studies raised concerns that taking hydrazine sulfate could both worsen and shorten the lives of persons these cancers.

The General Accounting Office (GAO), Mr. Guccione claimed. had described the aforementioned trials as:

deliberately sabotaged, which means to say that the National Cancer Institute, serving whatever god it serves, determined in advance that [it was] going to sabotage those studies. That is genocide. And the minute we get a hold of the families of the people who died during those tests, we will bring -- and we'll pay for -- it a class action suit against the National Cancer Institute to prove that they are determined to keep this drug off the market because nobody in the establishment is going to benefit or profit from it.

The audience applauded.

The alleged sabotage consisted in allowing subjects' use of (or giving subjects) drugs that, according to Dr. Gold, nullify hydrazine sulfate and increase morbidity in patients who take any of them and hydrazine sulfate together. Dr. Gold has said that patients on hydrazine sulfate must not take alcohol, foods high in the amino acid derivative tyramine (e.g., aged cheeses), and certain sedatives: barbiturates (e.g., phenobarbital) and benzodiazepine tranquilizers (e.g, Valium). Benzodiazepines are given to patients undergoing chemotherapy as anti-emetics (i.e., to control nausea and vomiting).

The NCI reported:

- that in one of the lung cancer studies, at least one patient had received barbiturates and that, because the subjects had been on a chemotherapy regimen that could cause severe nausea and vomiting, there had been some use of benzodiazepines;

- that in the other lung cancer study, benzodiazepines and other anti-emetics had been used, but that alcohol and barbiturates had been forbidden; and

- that in the colorectal cancer study, alcohol and barbiturates had been forbidden, but that there had been some (unprojected) use of benzodiazepines (as anti-emetics).

In rebuttal to Mr. Guccione's accusation of sabotage, I displayed, on camera, a copy of the September 1995 GAO Report to the Chairman and Ranking Minority Member, Human Resources and Intergovernmental Relations Subcommittee, House Committee on Government Reform and Oversight. I read out its title: "Cancer Drug Research: Contrary to Allegation NIH Hydrazine Sulfate Studies Were Not Flawed." ("NIH" refers to the National Institutes of Health, which includes the NCI.) Dr. Gold responded: Now, everybody knows that when one government agency investigates another, there's a deal made...."

According to the GAO report:

- in general, the anti-emetics used in the aforementioned three studies were used for short-term relief rather than continually;

- differences in survival time between those patients on hydrazine sulfate who had been given agents that allegedly are incompatible with hydrazine sulfate and those who had not been given such agents were not statistically significant;

- one of the Russian researchers Dr. Gold and Penthouse magazine cited told the GAO he had no evidence that hydrazine sulfate and tranquilizers were incompatible; and

- the NCI rejected the incompatibility concerns outlined above.

At most, data from Russian animal experiments suggested that taking alcohol and barbiturates in large amounts with hydrazine sulfate could increase overall toxicity. But in an appendix to the GAO report, the U.S. Public Health Service stated that no unexpected toxicities had been seen in the trials.

I told the audience, in effect, that conspiracy theorizing is to be expected from advocates when they lack scientific evidence that confirms their cause; that likewise to be expected are cynical allegations that those who cannot profit from the cause are trying to suppress it; and that those who devote their lives to treating and curing cancer are themselves, with their loved ones, potential victims of cancer.

Montel interrupted me:

Let's just talk about our government. Let's look at it in the last 20 years. We just now admitted to the country that we poisoned people with radiation. We just now admitted to people we did that, remember, with some of our nuclear tests. We injected radiation to people 40 years ago. We tried to kill them to see what it would do. We took a group of black men in a place called Tuskegee and injected them with syphilis -- not just allowed them to contract it, but injected them with it. So you're making it sound like our government doesn't do anything wrong. They do do things that are wrong. Will it be 30 years from now? Will it be [The audience was applauding spiritedly.] -- will it be 20 years from now when we find out this was another dupe lie?

Politicizing the Personal

As Jeff Kamen states in the most recent article in his Penthouse series on hydrazine sulfate, what prompted the GAO study was a Congressional subcommittee request that Penthouse had instigated in 1994. Mr. Kamen claims that in 1987 hydrazine sulfate had extended his mother's life after her lung cancer had metastasized, radiation therapy had failed, and her oncologist had said she would live between two and nine days. According to Mr. Kamen, the oncologist prescribed hydrazine sulfate for his mother, she lived for four months -- with "good weeks and bad" -- and died five days after "a tragic error in medical judgment [had] resulted in switching her from hydrazine sulfate to an untried chemotherapy."

Even if Mr. Kamen's account is accurate, it provides no evidence concerning whether hydrazine sulfate has therapeutic utility. That his mother lived significantly longer than her oncologist had reportedly predicted by no means warrants his conclusion that hydrazine sulfate had extended her life. Stating that she would last only days may have been the error in medical judgment. Hydrazine sulfate may have made her life shorter and less pleasant than it would have been without the drug. Discontinuing its use and undergoing the "untried chemotherapy" may have made her life longer than it would have been if she had continued to take hydrazine sulfate and had shunned the chemotherapy.

Mr. Kamen wrote that he had spoken about hydrazine sulfate on seven broadcasts of the Independent Network News. He said he had presented an account of his mother's case on four of the broadcasts.

And the publishers of Penthouse have encouraged him. In 1993, for example, the company placed a full-page ad in The New York Times and The Washington Post concerning an article of his in the April issue of Penthouse. The ad featured a photo of an emaciated person in a hospital bed and suggested that the NCI, by trying to "derail hydrazine sulfate," was to blame. In a later issue of Penthouse, Mr. Kamen wrote: "It is an understatement to say that tens of thousands of Americans will pay in bone-deep pain and premature death because of what the hydrazine-sulfate suppressors have done."

More on Keeton

For "Junk Medicine," a special report that would be published in the August 1997 issue of Self magazine, correspondent John Sedgwick interviewed Ms. Keeton nearly two years after she had been diagnosed with stage IV breast cancer in May 1995. Mr. Sedgwick wrote: "She says that all her tumors have `disappeared' except for `three microscopic spots' on her liver."

But Dr. Mechanick (who refused to be interviewed for this article) reportedly had told Mr. Sedgwick: "By CT scan she still has virtually the same amount of tumor as when we initially saw her." He had said he attributed the apparent absence of significant tumor growth to Ms. Keeton's cessation of estrogen supplement use. Indeed, according to retired oncologist Wallace Sampson, M.D., editor of The Scientific Review of Alternative Medicine, when such patients "go off the hormone, the cancer arrests in about 30 percent."

Moreover, Dr. Mechanick had said he attributed Ms. Keeton's survival for much more than the "few months" he had reportedly expected, to her "profoundly great attitude." But it is also likely that the initial prognosis for Ms. Keeton was unduly pessimistic. According to the latest published ACS estimates at the time of the broadcast, women with metastatic breast cancer had a five-year "relative survival rate" -- an estimate of the percentage of patients who live for five years after a diagnosis -- of 12-20 percent. Thus, that Ms. Keeton lived for two years after being diagnosed with metastatic breast cancer is not extraordinary. It certainly isn't miraculous. Yet, according to the August 6, 1997, edition of The New York Post, Ms. Keeton was pursuing publication of a book she called "Six Weeks to Live: How I Defied the Odds With a $3-a-Week Cancer Treatment."

The Penthouse Papers

The September 1997 issue of Penthouse featured Jeff Kamen's "The $200 Billion Scam." In a sidebar titled "Uncle Sam's Continuing Medical Genocide," Mr. Kamen cited American ground troops' ingestion of the defoliant Agent Orange in Vietnam (see "Poison of the Mind," PRIORITIES, Vol. 9, No. 1, 1997, pp. 18-21), American soldiers' exposure to chemical weapons during the Gulf War (see "Operation Illness? `Gulf War Syndrome,'" PRIORITIES, Vol. 6, No. 1, 1994, pp. 6-9), the Tuskegee syphilis experiment, the "extermination" of American Indians -- and the prescribing of tranquilizers to patients in the NCI-sponsored hydrazine sulfate trials. In the midst of the article was something that would be published in other issues of Penthouse: an invitation to relatives of persons who had been subjects in hydrazine sulfate trials between 1989 and 1993 to participate in "a class-action lawsuit under consideration" against the NCI.

In the article Mr. Kamen stated: "Kathy Keeton's successful battle against cancer is more than personal good news it has blown open a Washington scandal of astonishing proportions." The article included Ms. Keeton's diary entry of August 11, 1995: a rewrite of the Bible's 23rd Psalm. For example, Keeton had changed "The Lord is my shepherd, I shall not want" to "Joe Gold is my shepherd, I shall not die."

In a September 22, 1997, press release General Media International announced that its vice-chairman and chief operating officer, Kathy Keeton Guccione, had died at age 58 on September 19, 1997, in New York City's Mt. Sinai Medical Center. Reuters stated: "She died during surgery to remove tumorous tissue from her upper digestive system. The tissue required a surgical by-pass procedure which, due to a number of unforeseen complications, resulted in her death, according to a General Media press statement." An obituary in The New York Times described her as the author of Longevity: The Science of Staying Young and stated that she had "established the Kathy Keeton Cancer Research Foundation to encourage research in alternative and complementary cancer therapies."

Who's Covering Up?

The August 13, 1998, edition of The Washington Post included a large advertisement that featured the statement "SENATE INVESTIGATOR EXPOSES GOVERNMENT SUPPRESSION OF CANCER CURE." The ad read, in part:

It's an atrocity that brings to mind the Holocaust and the recent "ethnic cleansing" in Bosnia. We're talking about the U.S. Government's complicity in the deliberately flawed research of a wondrous treatment for cancer. A treatment so effective it's approved throughout much of the world. Now, incontrovertible evidence exists that the General Accounting Office and the National Cancer Institute, influenced by the multi-billion dollar "cancer establishment," have colluded to cover up the facts by altering the G.A.O.'s official report....For all the shocking details read September's Penthouse....The lying, and the dying, must stop....

According to the masthead of that issue of Penthouse, which appeared a year after Ms. Keeton's death, Ms. Keeton was vice-chairman. The issue featured a screed -- misleading in more respects than space limitations permit my addressing in this article -- titled "Intent to Kill: The Government Conspiracy to Destroy Hydrazine Sulfate," in which Jeff Kamen argued that alterations to a draft of the GAO report reflected dishonesty. He stated: "Lie upon lie was told to cover up the true nature of the N.C.I. trials."

According to Kamen, among the draft statements absent in the published version of the GAO report were: "NCI did not conduct adequate oversight of these trials. It did not take sufficient measures to appropriately address concerns over alleged incompatible agents [that had been administered at the same time as hydrazine sulfate]...."

But where's the coverup? The published version stated:

Nonetheless, there were lapses in record-keeping and reporting in these clinical trials. NCI did not require that complete and accurate research records be kept during one [of the three] clinical trials documenting the use of tranquilizing agents, barbiturates, and alcohol by study patients. Also, NCI-sponsored investigators did not analyze this issue until recently, and the published results did not accurately describe the use of tranquilizing agents during one of these clinical trials.

Indeed, three months before the publication of the GAO report, a letter to the editor had been published in the Journal of Clinical Oncology in which NCI-sponsored investigators has corrected and clarified details of their original report.

According to Mr. Kamen, the draft report termed the issue of alleged incompatible agents "unsettled." The published report stated: "NCI concluded that there was no objective evidence or published studies of humans addressing interactions between hydrazine sulfate and these alleged incompatible agents to support the concerns [about concurrent use]."

Say ACSH scientific advisor Saul Green, Ph.D., a former biochemistry researcher at Memorial Sloan-Kettering Cancer Institute: "Those noise [Kamen and Penthouse] are making about the GAO report itself is a coverup of the fact that three is no published evidence by Gold or anyone else that hydrazine sulfate affects the progress of cancer in a human."

On July 31, 1998, Richard M. Klausner, M.D., Director of the NCI, testified that the NCI "will prepare a detailed summary on hydrazine sulfate that will be sent for review and comment to experts in the complementary and alternative medicine community and then made available on the NCI web site." If the NCI had been conspiring to suppress the use of hydrazine sulfate, this was a strange way to proceed.

Articles backing the therapeutic use of hydrazine sulfate -- written by promoters of methods euphemistically called "alternative" and "complementary" -- are available from Kathy Keeton's website. When I visited the website on August 24, 1998, If found that it had been updated: It included the entire text of "Intent to Kill" and a memorial tribute to Ms. Keeton. But the website also included a brief biography of her with the statement: "Today, Ms. Keeton is practically cancer free and is determined to help [hydrazine sulfate] gain ANDA (Application for New Drug Approval) status so that doctors can prescribe it and thousands in need can benefit from it."

In an abstract published in the November 1998 issue of the journal Blood, ACSH scientific advisor Victor Herbert, M.D., J.D., Professor of Medicine at the Mount Sinai School of Medicine, in New York City, states:

[Bob] Guccione's lawyer, Victor Kovner, lied to me in a threatening letter on August 25, 1997, that Mrs. Guccione (Kathy Keeton) "continued to be doing very well indeed" (in her "successful battle with cancer using hydrazine sulfate," to quote Penthouse magazine). Three weeks after the Kovner letter...Ms. Keeton died in Mount Sinai Medical Center wasted away to an emaciated skeleton [and] riddled throughout her bones and body with metastatic breast cancer.

Hydrazine Sulfate...

- is commercially available for about 15 cents a gram.

- is used in the refining of rare metals, in analytical blood tests, as a component of rocket fuel, and as an antioxidant in soldering flux.

- inhibited tumors in rats in the early 1970s, according to Joseph Gold, M.D.

- interrupts abnormal glucose metabolism. Such interruption may bear on cachexia -- a condition of debility, malnutrition, and weight loss -- in cancer patients. But there are meny other possible factors in cachexia. And although food is metabolized abnormally in many cachectic patients, how cachexia develops is not well understood.

- caused marked "euphoria" in cachectic terminal cancer patients, according to a Russian research team. These researchers stated that hydrazine sulfate had made cancer patients unable to recognize the severity of their illness.

- showed mixed effects on cachexia and inconclusive effects on cancer in early, uncontrolled studies.

- did not prove useful against cancer in three double-blind, placebo-controlled clinical trials published in 1994.

- does not have any proven anticancer effects.

American Council on Science and Health, Inc.

~~~~~~~~

By William M. London


Guccione suing NCI over hydrazine sulfate

USA -- The Guccione publishing empire has launched a class-action lawsuit against the National Cancer Institute (NCI) on behalf of patients deprived of the inexpensive but reportedly effective drug hydrazine sulfate.

Publisher Bob Guccione announced the lawsuit in October after his wife, Kathy Keeton, died following a running battle both with breast cancer and the American cancer establishment.

According to the Guccione publication and The Spotlight magazine, her death was due to complications from surgery and not from cancer, which hydrazine sulfate -- a rocket fuel-derived chemical long championed by "alternative" doctors as a non-toxic drug against cancer -- had put into remission.

Ms. Keeton was the force behind Longevity magazine, a Guccione publication which has featured several articles on hydrazine sulfate.

(The Spotlight reported that patients of embattled Texas physician/biochemist Stanislaw Burzynski MD PhD, who recently won his 14-year battle with federal and state authorities over the of his "unorthodox" cancer treatment called "antineoplastons," might join the Guccione suit.)

According to The Spotlight:

"Guccione supported the work of Dr. Joseph Gold, innovator of the use of hydrazine sulfate, in helping stop the `wasting away' phenomenon associated with many cancers.

"The NCI tested hydrazine sulfate and said it was not effective, but the way the tests were conducted made it a foregone conclusion that the drug would fail. This is the basis of the lawsuit.

"Gold discovered that hydrazine sulfate could block an chin the liver and thereby prohibit malignant cells from parasitizing the host body. Many cancer patients die of the `wasting' starvation caused by the cancer robbing the body of sugar and protein.

"Russian research on hydrazine sulfate indicated the drug was all Gold claimed and more.

"Burzynski was recently acquitted of serious charges fried by the FDA. The first trial ended in a hung jury and the second trial saw the jury acquit him. Nevertheless, the State of Texas is now suing him.

"Dean Mouscher, head of Burzynski's research programs, said the FDA knows full well that `antineoplaston therapy' is both safe and effective, but the cancer establishment is on a `vendetta' the independent researcher."

Newsletter of the International Council for Health Freedom.

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