Hydrazine Sulfate Cancer Coverup - Part 2 of 3

The debate centers around two main issues:

(1) the unique function of hydrazine sulfate, and

(2) how effective it is in performing that function.

Hydrazine sulfate is unique in that it does not work directly on tumors. Its value is in reversing the process in cancer patients, of cachexia, or wasting away, which is the actual cause of death in over 50 percent of cancer cases. Dr. Joseph Gold of the Syracuse Cancer Research Institute first proposed hydrazine sulfate as a solution for cachexia in 1969. Dr. Gold's theory was that cachexia, although related to tumor growth, was a disease independent of cancer itself, and that the emaciation of patients in the final stages of cancer was caused by a vicious cycle in which the tumor drained the body of energy. If a drug could interrupt this cycle, the tumor would stop feeding off the body itself and the body could remain in as healthy a state as possible to conquer the disease. How have Dr. Gold's theories held up? The results of many cancer studies on hydrazine sulfate in both the United States and the Soviet Union have been mixed. For instance, a recent four-year study in the Soviet Union, involving 225 terminally ill cancer patients, found hydrazine sulfate to improve effectively the overall condition of the patient in over 65 percent of the cases, while a pilot study at Sloan-Kettering Institute in 1973 showed no positive results in 29 cancer patients. The majority of the studies, however, Support Dr. Gold's theory that hydrazine sulfate can significantly halt the energy-grabbing process of cancer.

What is preventing the widespread use of hydrazine sulfate?

Certainly not its expense. "Hydrazine sulfate is a mass-produced substance, a very common chemical manufactured industrially by the carload," Dr. Gold explained. "A researcher could buy a pound jar of hydrazine sulfate for five to eight dollars, and that pound jar will contain anywhere from fifty to a hundred thousand doses." Toxic side effects are not a roadblock for hydrazine sulfate. Tests by Dr. Gold and independent researchers at the Soviet Union's Petrov Institute in over 173 patients showed that the most frequent side effects, in less than 10 percent of the cases, were nausea and vomiting. As soon as the dosage was lowered, these side effects disappeared. There was no evidence of organ damage or damage to the immunological defense system that usually occurs with conventional chemotherapy. In fact, these studies indicated that hydrazine sulfate improved appetite and increased strength and well-being in the patients. It also decreased, and in some cases eliminated, pain, fever, and hemoptysis (coughing up blood). Most important, it decreased the size of the tumor in 6 percent of the cases studied and stabilized tumors in more than 15 percent of the patients.

The chief reason why hydrazine sulfate is not being widely used is that it is on the American Cancer Society's Unproven Methods List. It was placed there in 1976 based on the largely negative results of a Sloan-Kettering Institute pilot study. According to Dr. Manuel Ochoa, chief researcher in the study. "In over 30 patients with various types of cancer, there was no evidence of objective response." The Sloan-Kettering study also reported toxic side effects other than the usual nausea, with "major neurologic toxicity ... observed in half the patients." These included paresthesia, lethargy, pain, confusion, depression, headache, vertigo, and others. Dr. Ochoa did mention that four patients had acquired a stimulated appetite and one patient had a decrease in pain, but these changes lasted "only a few weeks."

Why did the Sloan-Kettering study differ from over ten positive animal and human studies that had been completed before the report as well as from the dozen or more positive studies (including the Soviet ones) that had been conduct since then? Indeed, why did the ACS hoose the Sloan-Kettering study as the only published report upon which it based its 1976 negative ruling? It was obvious that much was hanging on the outcome of the Sloan-Kettering study, but in the beginning the Sloan-Kettering Institute could not have been cited for lack of interest. Despite its own animal studies conducted in the early 1970s, which showed very little positive response, Sloan-Kettering's initial response was quite enthusiastic.

"We were less impressed with the animal studies than we were with the concept of hydrazine sulfate," Dr. Ochoa said. "Dr. Gold's approach was rather interesting because he goes back to an old observation based on the energy of tumors. It was clearly different from most of the 'alternative suggestions.' And we thought it would be worthwhile to look at patients. Here was a concept that at least superficially could have exerted a net beneficial effect by a mechanism other than the usual toxic approaches. Dr. Gold presented something that had a rationale and also had some data to go along with it, and since we had nothing else that I would call a cure in the Department of Chemotherapy, we tested." Indeed, many researchers are looking for a "cure" or the "magic silver bullet." This attitude may nave caused hydrazine sulfate's downfall; in other words, either hydrazine sulfate was going to perform on every level of objective and subjective response for the Sloan-Kettering researchers or it was going to be no good at all.

Unfortunately, hydrazine sulfate cannot be reassured by objective results, such as tumor shrinkage. Its value can be measured only by the more subjective responses, such as an increased appetite and well-being. Such responses often evade classical scientific measuring.

Sloan-Kettering tested hydrazine sulfate in a classically scientific way. Starting with very low doses and working up to much higher ones, the Sloan-Kettering team of researchers did not, according to Dr. Gold, follow his prescribed dosage levels. It was these levels that were reported to have had a beneficial effect on many cancer patients. According to Dr. Gold's "Information Sheet for Physicians," the dosage of 60 mg, once a day for the first four days, twice a day for the next four days, and three times a day thereafter, had improved the health of cancer patients. The Sloan-Kettering study, however, started out with one mg per day, two mg per day, and then three mg per day, and continued as such (for the first patient in the study). This, according to Dr. Ochoa, was to "check for toxicity." However, subsequent patients were started on 35 mg/m2 and were given single large doses of up to 120Ð160 mg later on in the study. Dr. Ochoa explained: "In the absence of objective tumor response, our approach was to escalate the dosage until we saw some toxicity. We did see toxicity and then had to pull back. And even at the doses where we did see toxicity, we failed to see any tumor response. This is a classical way to conduct a test for any chemotherapeutic agent." Why was Sloan-Kettering conducting a classical chemotherapy study on a chemical that is not a classical chemotherapy agent, none that is known to act differently than a usual chemotherapy drug acts? Hydrazine sulfate is in fact the only agent known to act, not on the tumor, but on the body itself. Dr. Ochoa himself indicated that hydrazine sulfate was an unusual and different concept. Why then was it being tested in an experiment designed for an antitumor agent? Dr. Ochoa did say that the researchers were looking for "both subjective and objective responses," but he could not answer directly when asked if the hydrazine sulfate dosage levels were escalated when patients were actually achieving some kind of subjective response If in fact the dosage levels had been escalated, according to Dr. Gold, the positive subjective results would have been "wiped out."

Could patients' subjective responses, such as appetite stimulation, have been suddenly halted by an increase in the hydrazine sulfate dosage? Would a dosage at a particular level have kept the positive subjective responses going for a longer period of time? Could this have been the reason why patients in the Sloan-Kettering study had responses that lasted "only a few weeks"? Dr. Ochoa says, "It's a real possibility. But the appropriate thing to do then is to scientifically put together a group of patients in different subsets and treat them with different dosages to measure the effects at various optimum and suboptimum dosage levels."

Dr. Gold is amazed that hydrazine sulfate, a noncytotoxin, would be measured in terms of cytotoxic criteria. (Regular chemotherapy agents actually kill cells and therefore are known as cytotoxins.) "I'm appalled and amazed that in the oncological community people would get this mixed up. They're saying, 'Well, why shouldn't we fudge this on cytotoxic criteria because those are the only criteria we have?'

Would you believe that there are no such things in the scientific world today as indices of subjective improvement? Want to know why? Because there are no such drugs that produce subjective improvement only. Hydrazine sulfate is the first one. As far back as 1975, the Soviets indicated in their first article that there would have to be new indices set up to test for subjective improvement only. But this just hasn't happened.

Consequently, American institutions say that there is no evidence that hydrazine sulfate has positive responses because they're looking at cytotoxic criteria only, e.g., tumor regression. They're totally ignoring the high scores that hydrazine's been getting in subjective criteria."

Again, the "silver bullet" syndrome does not allow that hydrazine sulfate may be excellent for use in combination with other treatments, or even that it may only be able to help a cancer patient live a more normal life. This "cure-all-or-nothing-at-all" attitude has discouraged further research on hydrazine sulfate. But many people believe that hydrazine sulfate deserves further study. Dr. Saul Schepartz, deputy director of the Division of Cancer Treatment at the National Cancer Institute, calls the Sloan-Kettering research "a very limited study certainly not one on which one could draw conclusions. I would not call it a definitive study by any means." Dr. Dean Burk has also called for more studies to be done on hydrazine. But Dr. Gold has used much stronger terms - he's actually called the Sloan-Kettering study "invalid."

In a 1975 letter of protest to Dr Ochoa, Dr. Gold stated, "It was agreed that this project [your study] was to be a joint effort between our two institutes. . . . Failure to adhere to an agreed-upon protocol by underdosing, failure to adhere to an agreed-upon protocol by overdosing, failure to maintain objectivity in a new study by forming expressed opinions even before the study is two weeks old, weaken the results of any study, if not invalidate them completely."

Despite Dr. Gold's protests, the study was completed and readied for publication in Cancer Chemotherapy Reports. It's not hard to imagine Dr. Gold's shock and consternation when he read in a prepublication copy of the article that "the protocol for the trial of hydrazine sulfate was developed in cooperation with Dr. Gold based on the experience he has reported." Dr. Gold immediately contacted attorneys, who demanded that all references to "enjoying his cooperation" and "following his protocols" be deleted. Dr. Gold now believes that these changes were made because Sloan-Kettering Institute realized that it had made gross misrepresentations.

Dr. Irwin Krakoff, then chairman of the Department of Chemotherapy at Sloan-Kettering and a co-author of the hydrazine sulfate study, disagrees. "The protocols were followed as were set. There were a lot of phone calls, discussions, and recriminations, and rather than get into arguing about whether or not Gold participated, it wasn't relevant; it simply deleted any reference to his name." Fortunately for Dr. Gold, other studies were being tabulated at the time of the negative Sloan-Kettering report. One such study was performed by Calbiochem, a California pharmaceutical firm that provided hydrazine sulfate to interested doctors in the United States under an investigational new drug (IND) status. Using hydrazine sulfate only on terminally ill patients, the doctors then sent back their observations, which were analyzed by Dr. Gold and put into a report that appeared in Oncology in October 1975. The results showed that there was objective improvement in 17 percent of all cases and a 70 percent improvement in such subjective responses as increased appetite. weight gain, strength, and control of pain.

That's a hard thing to swallow. We're an outsider." Throughout medical history many important advances have come from outsiders, such as Galileo, Semmelweis, Pasteur, Fleming, and others, whose ideas were considered to be scandalous by the establishment. Later the value of their theories was realized, but the period between discovery and acceptance is often a long one. It is often the case that people suffer and die while the medical establishment is slow to accept positive new evidence. Today over 400,000 people die each year from cancer in the United States alone, and it is estimated that this year one in four Americans will get cancer. In an attempt to cut short the period between discovery and acceptance of hydrazine sulfate which is now in its tenth year of controversy. Dr. Gold has made unusual attempts to contact and work with both the National Cancer Institute and the American Cancer Society. His major concern is to remove the stigma of the "Unproven Methods List" from the drug so that more research will come about. Dr. Gold has been in direct contact with Dr. Frank Rauscher, executive vice-president for research at the American Cancer Society. The two men have known each other since Rauscher was director of the NCI a few years ago, and over the years they have developed a working relationship. Still, Dr. Rauscher has told Dr. Gold that he "could not guarantee" that a proposal on hydrazine sulfate would go through. But he has encouraged Dr. Gold to submit a research grant proposal for hydrazine to the ACS. Dr. Gold refuses to do so until the ACS "stops its defamatory-type actions on hydrazine sulfate." "I communicated to them by letter," said Dr. Gold in a recent interview, "that until the ACS literally 'cleans up its act' on hydrazine sulfate, I couldn't in good faith submit such a proposal. I thought good faith was the leavener of all business transactions. There's no point to my having good faith when the ACS still distributes loaded information." Although the situation with the ACS on hydrazine sulfate is at a stalemate, the National Cancer Institute seems to have a guarded, but slightly more open, attitude. Dr. Saul Schepartz of the NCI says, "Hydrazine is a rather controversial drug, but we don't care about its prior history. If there's good scientific reasons for testing it, we will. Based on the data that the Russians have presented, however, we are not initiating studies. . . . But we're willing to support grant applications having to do with hydrazine if they receive proper priority from the Grant Review Committee. The general area of research on cachexia is definitely one that we are interested in." Right now the most important research on hydrazine is obviously not being conducted at the larger research institutes, but by doctors all over the country who have been treating their terminally ill patients with this drug.

Dr. Gold maintains that he's now receiving individual case reports on hydrazine sulfate from many large U.S. hospitals despite the official foot-dragging. "Two years ago we'd never get a letter from these kinds of doctors," says Dr. Gold. "Respected oncologists were our worst enemies. Now they're calling as fast as they can." Dr. Gold cited a recent letter from a doctor in a large eastern hospital that is well known for its cancer work: "Here is a preliminary report on a patient I've been following who has documented extensive intraabdominal pancreatic malignancy. I began him on hydrazine sulfate on May 15, 1979, and have continued him to date, a period of one month. After approximately one week . . . . he had some decrease in severe abdominal pain and thereafter further pain improvement as well. Overall, during this month, there has been a remarkable stabilization of his condition. And whereas until we began the hydrazine he was steadily deteriorating with progressive pain and weight loss, he has . . . . improved in both these regards during this period. . . . The degree of abdominal mass has not increased during this period. "You've got to remember that this was a very terminal malignancy," commented Dr. Gold, "but it has been turned around, and the cancer just stopped growing. The bottom line in our fight to have hydrazine sulfate implemented on a large scale is, of course, the cancer patient himself, who in such political confrontation . . . is getting the short end of the stick."

We can only hope that the pioneering spirit of Dr. Gold and those other intrepid researchers will survive the ten-year-long battle for implementation of hydrazine sulfate. Perhaps in the next decade, cancer patients will have a painless, effective way to control their disease with a more well-informed and open attitude on hydrazine sulfate. But this can happen only when politics yields to the wisdom of science. Hydrazine sulfate is available in forms not intended and not safe for human consumption, and use of such forms or use of the drug other than as directed by a qualified physician can be highly toxic. Medicinal use of the drug should be pursued only as directed by a qualified physician.

This article and supporting research documentation are being presented to appropriate committees in Congress where a full, public investigation is being considered. Careful reporting over the past 11 years by Penthouse, by ABC's "20/20," and by this reporter on Independent Network (TV) News informed millions of Americans about hydrazine sulfate's lifesaving powers and pressured the federal government into ordering a much-needed national clinical trial. But now one-third of that massive test is over, and the net effect is to continue the almost-20-year suppression of this extraordinary drug, which stops the starvation that kills most cancer patients, shrinks some tumors, and, research suggests, may even be a long-sought "magic bullet" against a broad range of cancers. Considering the spread of AIDS and the high probability that cancer will touch you or someone you love, the unending attack on hydrazine sulfate may become very personal in your own life.

By now you are probably asking yourself questions like: How can this be true? When it comes to fighting deadly diseases, aren't we all on the same side? Who would want to stop a good drug from getting to those who are suffering? If it is true that reputable scientists in the United States and in Russia have successfully used hydrazine sulfate, why isn't it available? Where is this drug if someone you care about needs it tomorrow? We'll answer that last one first: Hydrazine sulfate is meticulously blocked from even your doctor's hands by federal regulations, and strangled by tests that make the drug look like a worthless fake. The drug's developer, Joseph Gold, M.D., director of the nonprofit Syracuse Cancer Research Institute, in Syracuse, New York, is appalled and alarmed because of what it means for cancer victims, as well as for his own efforts. Since he left the U.S. space program, Dr. Gold has devoted his life to unraveling the mysteries of cancer cachexia and its treatment with hydrazine sulfate. As the developer of this drug, he really knows how it works and what gets in the way of its curative qualities.

For over a decade, Dr. Gold has been warning that if you drink or take sleeping pills or tranquilizers, you might as well not bother taking this drug, because it simply doesn't do its thing when alcohol or any of the rest are in your blood. Simple, right? Well, naturally, Dr. Gold told the National Cancer Institute to keep those incompatible chemicals out of the nationwide clinical trials of hydrazine sulfate, the first of which was finally concluded this year. Don't worry, they told Dr. Gold, we know what we're doing, and hydrazine sulfate will receive a fair test. Right. The National Cancer Institute participated in compromising this first test by allowing alcohol, sleeping pills, and tranquilizers to be taken by dying lung-cancer patients who were being given hydrazine sulfate in conjunction with chemotherapy. That cynical act denied the 270 desperate patients who were in the group of even a fighting chance at less pain and longer life. The undermining of the first test also guarantees that the overall judgment on hydrazine sulfate will be tainted, even if the last two test groups demonstrate positive results.

The trouble with this story is that the "bad guys" all wear white coats. Having done pioneering work against cancer in some cases, on the surface they seem to be fulfilling their responsibilities as guardians of the public health. Perhaps this drug and its developer stuck so deeply in their personal and institutional craws that the high priests of cancer found every possible excuse to trash hydrazine sulfate, a drug not invented by any of them or the corporations and research centers that are members of their old-boy network. Raging egos, self-righteous turf-protection (including thousands of jobs that might be threatened if the drug got a truly fair test), and a subtle but very effective signal to researchers whose work supports hydrazine sulfate--researchers who have been forced to abandon more than a decade of carefully controlled clinical trials, their work neatly consigned to obscurity--are the apparent reasons why millions of cancer patients in our own country and around the world are presently being denied the benefits of hydrazine sulfate. In a ballroom of the Omni Shoreham Hotel in Washington, D.C., some of the nation's top AIDS researchers gathered on November 3, 1992, to develop improved strategies for helping the growing number of straight and gay Americans who are being picked off by the only lethal sexually transmitted disease of our time. During a break from the heavy work, Albert Wu, M.D., a young assistant professor of medicine at the renowned Johns Hopkins Hospital in Baltimore, walked from the AIDS conference into the nearest ballroom to check out the much less depressing scene. It was the election-night headquarters of the Democratic National Committee. As balloons and a huge victory map were being prepared for later use, Wu watched TV monitors as early returns signaled Bill Clinton's electoral-vote landslide. A reporter noticed Wu's AIDS Clinical Conference badge and asked him if he did any work with cachexia, the starvation that seizes many AIDS patients, sending them to an early and painful death. "Yes," said the research physician, "I work on cachexia.

Why do you ask?" The reporter asked the doctor if he'd ever heard of hydrazine sulfate, the only substance that has proved its ability to arrest and then reverse the terrible wasting away of body and spirit that is cachexia. Wu said he did not know anything about hydrazine sulfate, and wanted to know lots more after the reporter told him that the drug blocks cachexia in cancer patients. "Why don't I know about this?" asked the AIDS specialist. Why indeed! One reason is the long-standing and continuing hostile climate in which the medical establishment has enveloped the drug, which has resulted in a virtual purging of the medical literature of any reference to hydrazine sulfate's documented curative powers and to its even greater potential. One of the results of continuing high-level intimidation is its clear signal to the pharmaceutical industry. The principal method for bringing a new drug to the public--the one most often taken--is research and development by drug companies. But those manufacturers rely on the goodwill of the cancer establishment, and, in fact, are integral parts of it, ultimately employing many senior officials of the National Cancer Institute who--in some cases--dip in and out of the private and public sectors. In fact, the high priests in white coats created such a negative environment for hydrazine sulfate that pharmaceutical houses were discouraged from marketing it. So all doors appear to have been closed to this drug, which could be extending the lives of millions of dying people all around the world right now.
Next page: Part 3 of 3