Penthouse's Promotion of Hydrazine Sulfate

William M. London, Ed.D., M.P.H.

In 1995, Kathy Keeton, wife of Penthouse magazine publisher Bob Guccione, achieved widespread publicity with claims that hydrazine sulfate had enabled her to recover from stage IV metastatic breast cancer after doctors gave her only 6 weeks to live. This article discusses the publicity surrounding her experience and what happened when I challenged this claim in a televised discussion with Keeton, Guccione, Jeffrey Mechanick, M.D. (Keeton's Park Avenue physician), and Joseph Gold, M.D., who has advocated hydrazine's use since the 1960s.

"Miracle Cure" Claims

On September 10, 1996, The Daily Mail (Associated Newspapers, Ltd.) published a report by Brian Vine titled "Is this cancer drug too cheap for its own good?" Referring to hydrazine sulfate as a "cure," Vine reported that Keeton had begun taking it 15 months earlier, on the advice of Gold, a general practitioner who directs the Syracuse Cancer Research Institute in Syracuse, New York. The article stated that other doctors had predicted that 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 Gold and deciding to fight it with two of his hydrazine sulphate tablets a day." She had called the results "stunning."

In January 1998, I appeared on The Montel Williams Show with Keeton, Guccione, Gold, and Mechanick. 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 the anti-obesity drugs fenfluramine (in "fen-phen" fashion) and dexfenfluramine. (Reports of heart-valve damage subsequently caused these drugs to be withdrawn from the U.S. market.)

Keeton said she had developed stomach pains in April 1995, had been diagnosed with advanced stage IV breast cancer the following month, had been advised by her doctor to undergo "classical chemotherapy, radiation, and bone marrow transplants." She said, however, that during the first ten weeks of her disease—during which time she was "supposed to be dead"—she only took hydrazine sulfate. Gold claimed that 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 . . . 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."

Gold further stated that 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: "We 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 have been verified. Thus any improvement in Keeton's status was most likely due to the effect of tamoxifen.

Gold alleged that Keeton's course fell perfectly in line with published peer-reviewed studies in the medical literature on breast cancer with hydrazine sulfate. But the weight of medical evidence does not support the any claim that hydrogen sulfate can cause tumor regression, whether the drug is the only treatment or is combined with other treatments. In fact, later in the program Dr. Mechanick said:

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 Gold cited 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 published in 1990 showed 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 [1]. This finding was inconclusive but justified doing further research.

Sabotage?

In 1994, the Journal of Clinical Oncology published reports of three double-blind, placebo-controlled trials of hydrazine sulfate sponsored by the National Cancer Institute (NCI). In two of these trials, the subjects were lung cancer patients; the subjects in the other trial had metastatic colorectal cancer. The researchers found no benefit and raised concerns that hydrazine sulfate could both worsen and shorten the lives of persons with these cancers. Hydrazine sulfate has been proposed for treating the progressive weight loss and body deterioration characteristic of advanced cancer [2-4].

During the Montel Williams show, the audience applauded when Guccione claimed that the General Accounting Office (GAO) had described the three 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 alleged sabotage consisted in allowing subjects' use of (or giving subjects) drugs that, according to Gold, nullify hydrazine sulfate and increase morbidity in patients who take any of them and hydrazine sulfate together. Gold has said that patients on hydrazine should avoid 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).

To rebut the sabotage claim, I displayed a copy of the September 1995 GAO report "Cancer Drug Research: Contrary to Allegation, NIH Hydrazine Sulfate Studies Were Not Flawed." [5] The report indicated that some patients had used the aforementioned drugs or alcohol, but:

Gold commented: "Everybody knows that when one government agency investigates another, there's a deal made . . . ." I responded that conspiracy theorizing is common among advocates when no scientific evidence supports their cause. Montel interrupted and said:

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?

The reasons why hydrazine sulfate is not FDA-approved are quite simple. It has not been proven effective; and it has not been proven safe. In fact, it has been reported to cause cell mutations or cancers in at least a dozen studies of laboratory animals [6], and the National Toxicology Program considers it "reasonably anticipated to be a human carcinogen." [7]

In December 2000, the Annals of Internal Medicine published a case report of a 55-year-old man with cancer of the sinus near his left cheekbone. Instead of undergoing recommended medical treatment, he obtained hydrazine sulfate through a Web site and, for four months, followed the regimen published on the kathykeeton-cancer.com Web site. Two weeks later, he was hospitalized with signs of kidney and liver failure. Despite intensive hospital care, he died within a week [8,9]. In another case, a 76-year-old man with esophageal cancer who treated himself with hydrogen sulfate for five weeks developed severe mental confusion and other symptoms of brain toxicity that required hospital treatment that included mechanical ventilation and intensive care [10].

Politicizing the Personal

Jeff Kamen, who wrote a series of articles about hydrazine sulfate for Penthouse, stated that the GAO study was prompted by a Congressional subcommittee request that Penthouse had instigated in 1994. Kamen claimed 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 Kamen, the oncologist prescribed hydrazine sulfate for his mother, she lived for four months—with "good weeks and bad,"and she died five days after "a tragic error in medical judgment [had] resulted in switching her from hydrazine sulfate to an untried chemotherapy." However, even if Kamen's account is accurate, living longer than a doctor predicts does not prove that a treatment works. In fact, hydrazine sulfate could have made her life shorter and less pleasant, and undergoing chemotherapy sooner might have prolonged her life.

Kamen wrote that he had spoken about hydrazine sulfate on seven broadcasts of the Independent Network News and discussed his mother's case on four of the broadcasts. The publishers of Penthouse certainly welcomed and supported his advocacy. In 1993, for example, the company placed a full-page ad in The New York Times and The Washington Post concerning an his article 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, 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 in the August 1997 issue of Self magazine, correspondent John Sedgwick interviewed Keeton nearly two years after she had been diagnosed with stage IV breast cancer. Sedgwick wrote: "She says that all her tumors have 'disappeared' except for 'three microscopic spots' on her liver." But Dr. Mechanick, who subsequently refused my request for an interview, reportedly told 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 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%.

Moreover, Mechanick had attributed Keeton's survival for much more than the "few months" he had expected, to her "profoundly great attitude." But it is also likely that the initial prognosis for 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% to 20%. Thus, Keeton's survival for two years after being diagnosed with metastatic breast cancer was neither extraordinary nor "miraculous." Yet, according to the August 6, 1997, edition of The New York Post, 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 a Kamen article called "The $200 Billion Scam." Referring to hydrazine sulfate, the article alleged: "If you or someone you love should come down with cancer or AIDS, you will probably be denied the one drug that may offer the best possibility of an effective treatment with the least side effects." In a sidebar titled "Uncle Sam's Continuing Medical Genocide," Kamen cited American ground troops' ingestion of the defoliant Agent Orange in Vietnam, American soldiers' exposure to chemical weapons during the Gulf War, 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 and on Keeton's Web site: 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, 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 Keeton's diary entry of August 11, 1995, a rewrite of the Bible's 23rd Psalm:

Joe Gold is my shepherd, I shall not die,
He leadeth me thru green pastures.
Yea, though I walk through the valley of
the shadow of the Crab, his care and
his calls shall comfort me, and I shall
dwell in the house of Hydrazine forever.

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. The Foundation's federal tax returns indicate that it gave $10,000 to Gold's institute in 2002 but performed no charitable activities and had negligible assets during 2003 and 2004.

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. . . .

That issue featured a screed titled "Intent to Kill: The Government Conspiracy to Destroy Hydrazine Sulfate" in which Kamen asserted that a draft of the GAO report had been dishonestly altered and that "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]. . . ."

In reality, there was no cover-up. The published GAO report 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 had corrected and clarified details of their original report. Yet according to 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]." Commenting on the situation, Saul Green, Ph.D., a former biochemistry researcher at Memorial Sloan-Kettering Cancer Institute, astutely noted that the noise that Kamen and Penthouse were making about the GAO report was itself "a coverup of the fact that there is no published evidence by Gold or anyone else that hydrazine sulfate affects the progress of cancer in a human."

In July 1998, NCI director Richard M. Klausner, M.D., testified that the NCI would send a detailed summary on hydrazine sulfate 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.

Kathy Keeton's website contained articles written by several hydrazine sulfate promoters. When I visited the site on August 24, 1998, I found that it had been updated with the entire the entire text of "Intent to Kill" and a memorial tribute to Keeton. But the website still contained a brief biography of her with the statement: "Today, Keeton is practically cancer free and is determined to help [gain FDA approval] so that doctors can prescribe it and thousands in need can benefit from it."

In an abstract submitted to the American Society of Hematology, Victor Herbert, M.D., J.D., Professor of Medicine at the Mount Sinai School of Medicine in New York City, stated:

Guccione's lawyer . . . 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 . . . letter . . . Keeton died in Mount Sinai Medical Center wasted away to an emaciated skeleton . . . riddled throughout her bones and body with metastatic breast cancer.

For Additional Information

References

  1. Kosty MP et al. Cisplatin, vinblastine, and hydrazine sulfate in advanced, non small-cell lung cancer a randomized placebo-controlled, double-blind phase III study of the cancer and leukemia group B. Journal of Clinical Oncology 12:1113-1120, 1994.
  2. Loprinzi CL. Randomized placebo-controlled evaluation of hydrazine sulfate in patients with advanced colorectal cancer. Journal of Clinical Oncology 12:1121-1125, 1994.
  3. Loprinzi CL. Placebo- controlled trial of hydrazine sulfate in patients with newly diagnosed non small-cell lung cancer. Journal of Clinical Oncology 12:1126-1129, 1994.
  4. Cheblowski RT. Hydrazine sulfate influence on nutritional status and survival in non-small-cell lung cancer. Journal of Clinical Oncology 8:9-15, 1990.
  5. Nadel MV. Report to the Chairman and Ranking Minority Member, Human Resources and Intergovernmental Relations Subcommittee, House Committee on Government Reform and Oversight. Cancer Drug Research—Contrary to Allegations, Hydrazine Sulfate Studies Were Not Flawed. Document No. HEHS-95-141. Washington, D.C.: U.S. General Accounting Office, September 1995. [PDF format]
  6. Hydrazine sulfate. CAS Registry Number: 10034-93-2. National Toxicology Program Web site, accessed July 22, 2006.
  7. Hydrazine and hydrazine sulfate CAS No. 302-01-2 and 10034-93-2. Report on Carcinogens, Eleventh Edition. Triangle Park, NC: National Toxicology Program, Jan 31, 2005.
  8. Hainer MI and others. Fatal hepatorenal failure associated with hydrazine sulfate. Annals of Internal Medicine 133:877-880, 2000.
  9. Black M, Hussain H. Hydrazine, cancer, the internet, isoniazid, and the liver. Annals of Internal Medicine133:911-913, 2000.
  10. Nagappan R, Riddell T. Pyridoxine therapy in a patient with severe hydrazine sulfate toxicity. Critical Care in Medicine 28:2116-2118, 2000.

Dr. London is associate professor and chair of the Department of General Studies and interim director of the Master of Public Health in Urban Public Health Program at Charles R. Drew University of Medicine and Science in Los Angeles, California. When he appeared on The Montel Williams Show, he was Director of Public Health for the American Council on Science and Health.

This article was revised on July 23, 2006.

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