Hydrazine Sulfate Cancer Cover Up

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Hydrazine Sulfate Cancer Coverup

The only thing worse than doing something ugly and wrong is covering it up. Especially when what you've done gives aid and support to those whose outrages are costing innocent people their lives. We are talking here about cancer, about an effective treatment called hydrazine sulfate that the government hates -- and about the layered lying and outright deception by the government that keeps this drug from the American people.

Also about the betrayal of the public trust by the General Accounting Office, a federal watchdog agency that had the information and the power to blow the whistle on the National Cancer Institute and the N.C.I.'s determined efforts to destroy hydrazine sulfate -- but instead chose to conspire with that agency to cover up its campaign to kill a drug that offends and threatens the cancer establishment.

The story, like life, is complicated. Many of the villains have solid track records of medical accomplishment. But it is their appalling conduct in this case that is our focus. 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. Caught, and angry about being forced to attend the meeting in the Dirksen Senate Office Building in Washington, D.C., late last summer, Mark Nadel, associate director of the G.A.O., was experiencing a most uncomfortable moment. And it showed -- his face was etched with controlled rage. An odd chain of events had thrown Nadel into a new and alien role. After all, his organization's audits of executive-branch agencies often make for embarrassing findings-- like the billions of dollars worth of weapons the Pentagon's bookkeepers cannot find -- and the press dutifully reports them.

In these stories the G.A.O. (the investigative arm of Congress) is always cast as the good guy, riding to the rescue of the taxpayers. Not this time, and not in this place. It was a warm, sticky day, and the pinstriped Nadel looked as though he had just swallowed a large glass of curdled milk and had nowhere to spit it out. With two other G.A.O. officials at his side, he sat across from me in a conference room of the Permanent Senate Subcommittee on Investigation. Nadel glared in my direction and told subcommittee chief counsel Jeff Robbins -- who had ordered the G.A.O. to appear at the meeting -- that his team would walk out if a reporter, namely myself, was permitted to remain in the room. (Robbins would later describe Nadel and company as "apoplectic" at being put in the same room with me.) Missing from Nadel's group -- excluded from it -- was G.A.O. assistant director Barry Tice, a 28-year veteran of probes of government agencies, who had relentlessly pursued the truth throughout a 14-month investigation of the N.C.I.'s handling of the conduct of clinical trials of the effectiveness of hydrazine sulfate. "What does Nadel have to hide? What could he have been fearing about my attendance?" Tice said to me in an interview.

There is substantial evidence that hydrazine sulfate is an effective, inexpensive anticancer agent. Then why is it on the American Cancer Society's Unproved Methods List? The young woman in the doctor's waiting room shook slightly, her emaciated hands constantly darted to the back of her head to check the knot of her kerchief. The kerchief served to conceal the fact that most of her auburn hair had fallen out. The look of desperation and confusion in her eyes expressed a pain that consumed her whole body. Most of the people in the small waiting room hoped that the doctor could help her. They didn't know that it was the doctor himself who had put the woman in such a pitiable condition. She was just one more patient undergoing chemotherapy for cancer. The toxic side effects of chemotherapy were well documented. The patient literally wastes away, his body under attack by both the cancerous growth and the cytotocic chemical agents used to kill the growth. The blood cell count drops dangerously low and the entire immunological defense system is practically destroyed. At times major body organs permanently cease normal functions. The damage often is irreversible: many times the patient cannot recover even if the cancer vanishes completely.

After surgery and radiation were found to be ineffective treatments for most cancers, chemotherapy emerged as the great hope of the 1950s and 1960s. Unfortunately the use of these "wonder drugs" put the cancer patient in an even more dangerous and painful condition. Today, 20 years later, chemotherapy has not improved the low remission rate that exists with conventional therapies; it remains between 7 and 8 percent. In addition, it is estimated that as many as 25 percent of cancer patients treated with chemotherapy will develop additional cancer as a result of the treatment. Thus, the development of new anticancer substances is a vital issue among many cancer researchers. Such a substance may already have been found: hydrazine sulfate. At least one prominent researcher has called it the "single most effective anticancer agent available." For the past ten years, hydrazine sulfate has been the subject of a heated debate among the nation's largest cancer research institutions.

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.

CANCER CONFLICTS OF INTERESTS?

Now, as to why the big guns in cancer officialdom would oppose any simple, easy-to-administer, effective, inexpensive, and safe therapy for cancer, here's the short list: The two-billion-dollar-a-year budget for the National Cancer Institute and its programs could be radically cut; other National Institutes of Health budgets could suffer similar effects. Big regional cancer centers like Memorial Sloan-Kettering in New York, M.D. Anderson in Houston, Dana-Farber in Boston, and the Mayo Clinic in Rochester, Minnesota, as well as the monies they receive, would shrink drastically. Thousands of careers could be jeopardized. There would be much less need--except for prevention programs--for the American Cancer Society, the Leukemia Society, the American Institute for Cancer Research, or any other national cancer fund-raising society. The cancer-related pharmaceutical industry's income would be severely impaired. Such drugmaking giants as Bristol-Myers Squibb would probably suffer significant contraction of income. The need for cancer specialists would vanish. Oncologists would become as extinct as syphilologists, whose ineffective treatments for syphilis bled their hapless patients of millions until the advent of the "magic bullet" penicillin. Hospital income would be significantly diminished. Hospitals with high cancer-related income could be forced to close. Thousands of smaller companies that constitute a cancer cottage industry would vanish. Thousands of physicians and researchers in America alone would lose their jobs or have to be retrained. Those are the main reasons why hydrazine sulfate--or any other potentially broad-based, easy-to-administer treatment against cancer--would draw such terrible fire from those now dining at the trough of cancer cash. Since we are not talking about a violation of law, it probably does not matter if the opponents of hydrazine sulfate have consciously considered the above consequences and acted upon those considerations. Whatever their motivations, their actions, including the apparent sabotaging of federally funded clinical trials of the drug, deny the public access to it.

SETTING THE STAGE FOR CONFLICT

Hydrazine sulfate's most recent modern use was as a military rocket fuel. The developer of its use as a drug was himself a military officer--a U.S. Air Force medical-research physician assigned to help win the space race against the Soviet Union during some of the most frightening days of the Cold War. Joe Gold, M.D., was one of a handful of elite young doctors who devised selection procedures for the first seven Mercury Astronauts from a group of 31 candidates, and helped make the critical judgments as to which U.S. test pilots were sufficiently prepared to become America's first spacemen. The world had been stunned and alarmed when the USSR orbited the sputnik and then flew Major Yuri Gagarin into orbit. President Dwight D. Eisenhower--and later John F. Kennedy--promised that the United States would follow the Russians into space and surpass them. It was up to the rocket riders of the Mercury program to accomplish that mission; it was up to the Mercury doctors to make sure that the astronauts were fit to withstand their body-pounding thunderous rides free of the earth's gravity, and then the fiery reentry of their space capsules into the earth's atmosphere.

So the medical team had to be both brilliant and bold, identifying their goals and charging unswervingly at them, tolerating no interference as they screened and tested the pilots who would dare the cold darkness of space and return. Gold was one of the doctors who certified that a Korean War Marine Corps combat veteran named John Glenn was ready for the challenge. To match the needs of the Project, Gold and his physician colleagues, like their spacemen patients, became dedicated, tough, and uncompromising--impatient with fools, incompetents, or self-serving careerists whose philosophy was: Stick with the old ways and you don't get into trouble. In short, Gold was the kind of doctor who would not tolerate anyone standing in the way of the welfare of his patient. Of course, that is exactly the kind of doctor you'd want on your team if you were sick. But it turns out that a hard-charging, nothing-is-more-important-than-the-patient approach is precisely the wrong personality to have if you want to survive in the world of the cancer establishment's research bureaucracy.

It is a largely hidden world, but sadly similar to the rest of governmental bureaucracy--self-perpetuating and self-protecting. Survival within it demands that you become meticulous about not offending those whose goodwill can make or break your access to funding. If you are an insider, you have some latitude, but God help you if you are an outsider, no matter how good your credentials, your work, or your ideas. Outsiders are inherently regarded with suspicion, distrust--and anathema. Into this spun-glass universe of ever-so-diplomatic medical men came young Joe Gold, fresh out of the Air Force. He was filled with the fervor of the Mercury program (having received a Presidential Citation from Eisenhower for his work), but his intensity was now directed at finding the answer to a single scientific question that haunted him: Is there some chemical way to block the abnormal process in the body that causes the tumor-triggered starvation called cachexia? Gold realized that if he could find the key to pick cachexia's lock on cancer patients' ability to process food, many of them would, quite literally, stop starving to death. At the very least, he thought, that would restore considerable quality of life and keep them alive longer, so other treatments might have time to cure their cancers and save them. As the idealistic doctor was developing his concepts and, ultimately, hydrazine sulfate, he had only a theoretical idea that this drug would also be found to stop tumor growth. "That," says a still enthusiastic Gold, "is the expected side effect of stopping cachexia." In the 1970s Gold published early results of his animal studies, and the prestigious Memorial Sloan-Kettering Cancer Hospital on Manhattan's wealthy East Side summoned him to make a presentation to their top scientists. Gold took another trustee of his Syracuse Cancer Research Institute with him and made a formal presentation.

As a result, Sloan-Kettering indicated that it would like to proceed with human studies. The Sloan-Kettering enthusiasm was unanimous, except from one quarter--the old-guard chemotherapists, who made clear their undisguised antipathy. Gold was nevertheless delighted, and in conjunction with members of the Sloan-Kettering executive staff, wrote a protocol for administering the drug, to which all parties firmly agreed and were committed. What followed were two collisions--of style and substance--that forever poisoned the way Gold and hydrazine sulfate were treated by the reigning medicrats of the U.S. cancer establishment:

EARLY CONFRONTATIONS

Dr. Gold is invited by telephone to a Memorial Sloan-Kettering Hospital news conference, which will announce a plan for a joint study of hydrazine sulfate with the Syracuse Cancer Research Institute. Gold advises them that he must first consult with his own board of directors. His board advises Gold to inform Sloan-Kettering that it would welcome a news conference, but that it should take place in Syracuse. The news conference never happens. (Years later Gold has a chance encounter with a former senior medical-liaison officer of the hospital, who still remembered the incident. "You cost us 16 million dollars back then," the ex-Sloan-Kettering official said. "We were going to showcase you and your work, invite a lot of wealthy donators who could have made substantial contributions to our general efforts. We may have even shared some of these funds with your institute.") Gold visits Memorial Sloan-Kettering to check on the patients receiving his experimental new drug and cannot believe what he sees.

Instead of following the jointly-agreed-on protocol of 60 milligrams of hydrazine sulfate per single dose, the hospital is engaged in underdosing and overdosing. In some cases patients are being given only one, two, three, four, or five milligrams a day. Others who have been started on the correct dose and are beginning to show anti-cachexia improvements are abruptly switched to 90 to 100 milligrams per single dose, wiping out their good responses. Gold was appalled and complains to the Sloan-Kettering physicians that they are not obeying the study protocols. They tell him that "[they] know how to test cancer drugs. [They] know exactly what they are doing," Gold recollects. Naturally, the results of the Sloan-Kettering study--the first by a major cancer hospital--are dismal. By their measure, hydrazine sulfate was "inactive," the kiss of death for a new drug. The results of the flawed study were published in a major cancer journal, and both Gold and hydrazine sulfate were permanently "marked." Almost 20 years later, that study is the one that most middle-aged physicians recall first, if they have any knowledge of hydrazine sulfate.

TIMING IS EVERYTHING

That test at Sloan-Kettering came at a curious time in the history of the U.S. fight against cancer. Only a few years earlier, a brilliant researcher named Vincent DeVita, M.D., announced to the world that he had developed a combination drug therapy called MOPP, which killed the tumors of Hodgkin's disease in 80 percent of all cases. The oncological community underwent a revolution. Dr. DeVita's work on Hodgkin's gave birth to the boom in tumor-killing, or toxic, chemotherapy. Doctors now had high hopes that chemicals could be developed that would vanquish all cancers. DeVita became the director of the federal National Cancer Institute--in effect the nation's cancer czar--and through him billions of taxpayer dollars were ultimately spread among research centers from coast to coast. Unfortunately, 23 years after DeVita's meritorious work on Hodgkin's, senior cancer researchers like Professor Jerome Block, M.D., of the University of California at Los Angeles (U.C.L.A.) Medical Center, have come to the conclusion that in most cancers, cytotoxic chemotherapy has failed to seriously improve patient survival, and that the quality of patients' lives has often been made additionally miserable by devastating side effects.

Gold and hydrazine sulfate were going in exactly the opposite direction from cytotoxic chemotherapy. Virtually no important side effects of hydrazine sulfate were produced, and when doctors followed the established protocol, 50 percent of all patients receiving the drug lived longer, higher-quality lives.

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