Government Reform and Oversight Committee February 4, 1998 Mr. Ralph Moss, Ph.D.

Mr. Chairman and Members of the Committee.

Congress was deceived when the war on cancer was launched in 1971. Experts swore under oath that they would deliver a cure for cancer in time for the Bicentennial (1976). That is ancient history. But Congress continues to be fooled by a new generation of experts" who testify that the war on cancer is being won, and that all we need to do is trust them to conquer this terrible disease.Recently, Dr. Richard Klausner, M.D., director of the National Cancer Institute (NCI), appeared before this Congress and claimed that we have turned the corner in the fight against cancer. He promised that advances in genetics were ushering in a golden age of research. However, I believe that the rosy picture he paints is misleading.

Back in 1962, 278,000 Americans died of cancer.

Last year, cancer deaths were over 560,000, double the figure of 35 years ago. Certainly, part of this increase is due to the growth and aging of the population. But even when one adjusts for these factors, the overall U.S. mortality rate from cancer increased over 10 percent from 1950 to 1991. And the incidence rate during that time increased nearly 50 percent.

There has been a leveling off in recent years. But we have still witnessed a tremendous worsening of the cancer situation throughout this century. In particular, the rates of lung cancer have risen astronomically, more than 500 percent among women. There has been a tripling in the incidence of melanoma, and nearly a doubling of cases of prostate cancer and multiple myeloma.

BREAST CANCER STATISTICS
Many of us are understandably alarmed at the prevalence of breast cancer in America today. When President Nixon launched the war on cancer in 1971, a woman's lifetime risk for contracting breast cancer was one in fourteen. Today, it is one in eight. Between 1973 and 1992, the incidence of breast cancer rapidly increased by 34 percent, and among black women by 47 percent. And the chances of being cured have not improved very much. Since 1960, nearly one million American women have died of breast cancer. Dr. Klausner has made much of the recent leveling off or even downturns in some of the cancer statistics. These are encouraging.

However, a slight downturn in mortality does not make up for millions of personal tragedies.

WHEN THE DIAGNOSIS IS CANCER
Let us consider what happens to a person who is diagnosed with cancer.

First of all, there are the so-called "proven" methods, surgery, radiation therapy and chemotherapy. Sometimes these are brutal methods, that involve the loss or damage of body parts and functions. Surgery is an ancient approach, known to the Egyptians, Greeks and Romans. It is a sad commentary that this is still the mainstay of therapy. New ideas are urgently needed in the treatment of even so called "curable" cancers.

But what about those patients whose tumors are inoperable or widespread at the time they are discovered? Similarly, what about the patients whose tumors have returned after being "successfully'' treated with "curative" therapies?

Such cancers are, by and large, incurable with today's conventional methods. The best that conventional medicine has to offer is palliation. And despite the war on cancer about half of all cancer patients will eventually find themselves in this deplorable position.

What are they supposed to do?

THE PITFALLS OF CLINICAL TRIALS
If you read the statements of the NCI, they urgently appeal to cancer patients to join their clinical trials. This message is picked up and amplified by all the beneficiaries of the war on cancer. You can even see it on billboards in airports. A "clinical trial" is made to sound very attractive to cancer patients. However, as the President's Commission for the Study of Ethical Problems in Medicine stated (in 1983), "Patients who are asked to participate in tests of new anticancer drugs" should "not be misled about the likelihood (or remoteness) of any therapeutic benefit they might derive."

In fact, there is little chance of therapeutic benefit to patients in such trials. Studies in both the United States and Japan have shown that only about one percent of patients in Phase I clinical trials have a complete response to the treatment, and only about 5 percent have any response at all.

You may think that five percent is not bad odds when you are in a desperate situation. But here you have to understand some of the peculiar terminology of the field. For a "response" is not a "cure." Far from it. The FDA defines a response as the shrinkage of 50 percent or more of the measurable tumors for a period of one month or more.

It is a change in size of a mass. This might be important, if the tumor is painfully pressing on a nerve or another vital structure. But usually such shrinkages are absolutely meaningless to the patient. It is essentially a numbers game played among oncologists - who can shrink tumors the most. In the majority of cases, these temporary shrinkages do not correlate with an increase in median overall survival, which is the most meaningful measurement of patient benefit in such trials.

Sometimes, in fact, a high response rate actually correlates with a lower period of survival. It may do more harm than good.

"TREATMENT DEATHS"
I want to call your attention to the fact that these trials can be very dangerous for patients. The drugs approved by the FDA for treating cancer are all toxic. Some of them have astonishing toxicity, especially when given in combination. In one clinical trial of drugs on patients with the leukemia-like myelodysplastic syndrome, 42 percent of participants were killed by the treatment itself.

In another study, of a three-drug regimen called "ICE," 13 patients (8 percent of the total) died as a consequence of the treatment itself, so-called "treatment deaths." But the scientists in charge had the nerve to conclude that this regimen was "well tolerated, with acceptable...side. effects and predictable organ toxicity."

Acceptable to whom? Not the patients who died after contracting raging bacterial infections, capillary leak syndrome, bleeding inside the brain, and irreversible kidney failure - all caused by these drugs. And certainly not their families.

This is the "scientific" approach of the NCI. Not surprisingly, there is tremendous resistance among patients and doctors to such trials. Only three to five percent of cancer patients go into them. Many oncologists want nothing to do with them. In fact, just 10 percent of all oncologists enroll 80 percent of the patients in clinical trials.4 In New York oncologists have given their patients small doses of standard chemotherapy to make them ineligible for useless clinical trials.

LOOKING FOR ALTERNATIVES
Drugs that don't work clinical trials that measure meaningless shrinkages, doctors who think that horrible side effects are perfectly acceptable...no wonder cancer patients today are desperately looking for alternatives. They are exploring the realm of un-approved, complementary, non-toxic treatments in record numbers.

You can be sure that one of the reasons the NCI and FDA so hate these alternative treatments is that they siphon away "adventurous" patients who might otherwise go into clinical trials.

Historically, all of the agencies involved in the war on cancer have lied about the nature of these alternatives. They have painted a distorted picture of them as quackery. They have prejudged them, refusing to carry out the most basic tests that could evaluate their efficacy. Tests were only performed under duress (often because the Congress insisted) and these tests were at best ill-conceived and at worst marked by outright fraud.

Yet the history of medicine tells us that many treatments and techniques once considered"alternative" or "fraudulent" later became an established part of the mainstream. Radiation and chemotherapy themselves started out on the fringe. Acupuncture was derided as "quackupuncture" for decades. But a recent Consensus Conference of the National Institutes of Health endorsed its use for such conditions as pain and nausea related to cancer. The Office of Alternative Medicine (OAM) was established by Congress at the National Institutes of Health precisely because of the historic failure of the NCI to fulfill its mission and examine all possible options in the fight against cancer. But little progress has been made because of the intransigent attitudes of the cancer establishment.

Are there frauds among the alternatives? Certainly. How can we separate the wheat from the chaff ? We need good research, with open-minded attitudes and adequate funding, to carry out studies of these alternatives. The OAM is ready to perform these studies. But the NCI stands in the way. Along with its police partner, the FDA, it is the great roadblock to the examination of promising new ways of treating cancer.

GREAT PROMISE

Dr. Klausner is betting on the genetic revolution to produce a cure for cancer. Even some geneticists warn that cancer breakthroughs, if they do come from this field, may be decades away. I believe there is enormous potential in the various alternative and complementary approaches to cancer.

In my book Cancer Therapy (1992), I discuss over 100 such methods. One could add another hundred or so of promise. These include vitamin and mineral regimens, herbal formulas, unusual drugs from land and sea, immunological techniques, electromagnetic treatments, and utilization of the mind-body connection.

On a recent trip to Germany I was astonished to see the scope and freedom with which many progressive oncologists treat cancer. They use a combination of the conventional approaches with such things as tumor vaccines; mistletoe therapy; local, regional and whole-body hyperthermia; thymus and other organ extracts; fever therapy; orthomolecular and antioxidant therapies; psychoneuroimmunology; music and art therapy; sports and physical therapy; and many, many others. Their government not only allows such approaches, but encourage and pay for them as well.

It is astonishing that the average American oncologist knows little or nothing about any of these approaches. The FDA has done everything in its power to block their development over here. The NCI has not seriously examined a single one of these. Our war on cancer has fallen woefully behind developments in other parts of the world, not just Germany but Japan, China, and many other countries as well.

The approach of the war on cancer has been relentlessly that of chemotherapy. Reliable estimates put the sales of cancer therapeutics at over S 12.3 billion this year. 5 Most of that is controlled by American firms. And so it has been a big business success story, with double-digit growth rates every year for over a decade. But it has done little for the cancer patient.

The FDA has approved approximately 40 drugs for the treatment of cancer. But it has never approved a non-toxic agent or one that was not patented by a major pharmaceutical company. The approved drugs are all toxic and many of them cause second cancers in those who are lucky enough to survive the treatment. And the NCI, FDA, and comprehensive cancer centers are tied by a thousand strings to the multi-billion dollar pharmaceutical industry. Recently, a top FDA official went to work for Elan Pharmaceuticals. But this is nothing new. Two past directors of the FDA became drug company officials, as did Dr. Klausnerps predecessor at the NCI. It is a time-honored tradition, the "revolving door."

Meanwhile, the FDA spends a good deal of its resources hunting down and harassing those who use innovative methods in treating cancer.

They have carried out a vendetta against Dr. Stanislaw R. Burzynski, MD, PhD, a Texas physician who has used non-toxic peptides in the treatment of brain cancer and other kinds of malignancy. They have repeatedly raided his clinic, seized his records, harassed his patients. In 1995, they instigated charges that would have put him in federal prison for life. Luckily, the jury saw otherwise and Dr. Burzynski is a free man. When I publicly objected to this harassment I myself was slapped with a subpoena for all my information regarding Dr. Burzynski. When I pointed out the illegality of this request, and indicated my willingness to fight the FDA, the subpoena was just as suddenly quashed by the U.S. Attorney.

FDA has also impeded the work of Dr. Georg Springer of the Finch Medical School, who has developed a promising vaccine for breast cancer. It has hindered the work of Arnold Eggers, M.D., of Downstate Medical School, who has a promising treatment based on concepts first proposed by William B. Coley a century ago. And it has used its resources to attack the distributors of non-toxic medications. The most recent victim was a distributor of the non-toxic drug hydrazine sulfate, who was raided by FDA enforcement agents on January 16, 1998.

The approach of the NCI and FDA is overwhelmingly in support of toxic chemotherapy. They have abrogated their duties as the defenders and protectors of the cancer patients. They function today on behalf of the industry they were supposed to challenge and oversee. They are the drug testing and law enforcement arms of a vast $100 billion a year business, the cancer industry.

C.I.S. FIASCO
The promotion of toxic treatments and the venomous hatred of alternatives is not restricted to court battles. Both FDA and NCI are active in the court of public opinion, trying to destroy confidence in any non-toxic or less-toxic treatment.

Their main vehicle in this regard is the Cancer Information Service of the NCI. Their reckless attacks on alternative and complementary treatments are disseminated at taxpayer's expense via print, fax, and especially the Internet.

Their statements are filed with prejudice, errors and innuendo. Each one contains an "advertisement" for NCI's clinical trials. When I was an advisor to the Office of AlternativeMedicine, I tried to find out exactly who wrote these erroneous statements and what sort of "peer review" they possibly could have undergone before being released. I never could find out. It is clear that no bona fide experts were involved in their creation, and that the proponents of such methods were not consulted or even interviewed before these statements were drawn up and released.

These harmful, hateful statements have become an integral part of the "war on cancer" which, quite frankly, more often looks like a "war on alternative practitioners" than a war on any disease. Treatment approaches that threaten the hegemony of the drug industry are prone to vicious attack.

The NCI's statements on alternative and complementary cancer treatments should be immediately withdrawn. New statements that are factual and unbiased, should be drawn up for release by the Cancer Information Service.

The statements that have already been prepared by Dr. Mary Ann Richardson and her group at the University of Texas School of Public Health could provide a good starting point for these new statements.

REFORM OF FDA
In addition, the FDA should be reformed so that it no longer exerts a stranglehold on innovators in cancer treatment and diagnosis. That is why I strongly support passage of the Access to Medical Treatment Act and urge you all to cosponsor this important legislation.

The FDA does little to protect citizens from the ravages of chemotherapy, which is overwhelmingly given without any proof of patient benefit. In the past, FDA at least paid lip service to the idea that anticancer drugs should extend life or improve quality of life. But in 1996, they caved in and agreed that new drugs could be approved based on partial remissions in clinical trials. Such partial remissions are nothing but the shrinkages of tumors. As we have shown, such temporary and partial shrinkages do not necessarily lead to improvements in survival or quality of life.6

POMES
Finally, Mr. Chairman and members of the committee, I have an urgent request.

In August, 1997, the Office of Alternative Medicine (OAM) in conjunction with the National Cancer Institute (NCI) convened a meeting in Bethesda, MD to consider how they could evaluate the practices of doctors who use unconventional methods to treat cancer. The name of this meeting was POMES, which stands for "Practice Outcomes Monitoring and Evaluation Systems. Over 100 leaders of the cancer field attended, including not just alternative researchers and practitioners, but the director of the Comprehensive Cancer Center of the University of Wisconsin, the president of the American Health Foundation, two department chairs from Memorial Sloan-Kettering Cancer Center, representatives from major food companies, and many others.

There were great hopes for this meeting, since we were told that it was funded by Dr. Klausner's office at the NCI. Perhaps this signaled a change in attitude at NCI, the change we have all been waiting for. But not only was Dr. Klausner unable to attend, but his key deputy, Robert Wittes, M.D., Director of the Division of Cancer Treatment, Diagnosis and Centers, also failed to put in an anticipated appearance. The FDA and NCI scientists who did appear lacked decision-making power in this area.

After several days of heated discussion, the participants finally hammered out statements that could lay the basis for future evaluations of alternative cancer treatments. It felt like history in the making. These guidelines called for the creation of an Oversight Board, a body of experienced people who could guarantee a "level playing field" in the evaluation of alternative practices. No longer would NCI have complete power to serve as lawyer, judge and jury in every case.

Most of the participants left that meeting excited by the prospects before us. Then, silence. Since August, we have not received a single official communication regarding POMES. Has POMES died a natural death...or did someone kill it?

I know for a fact that the problem does not lie with the Office of Alternative Medicine, whose leaders remain enthusiastic about the prospect of fairly evaluating such treatments. I can only conclude, therefore, that the roadblock is the top leadership of the NCI and possibly the NIH as well.

You have to ask yourself why these high-placed medical leaders so fear an impartial test of unconventional approaches to cancer? Why do they hate the idea of an impartial Oversight Board, which could detect fraud or malfeasance on either side of the cancer controversy?

Perhaps they are afraid of the competitive threat such non-toxic and less-toxic methods might pose to the cancer industry? Do they fear the ridicule of prejudiced colleagues? Or perhaps they fear the repercussions in Congress, if it turns out that an effective treatment for cancer was overlooked - or even suppressed - by NCI and FDA?

Mr. Chairman, I urgently appeal to you to help revive POMES.

I am sure you agree that patients and their caregivers need reliable information about the safety and potential effectiveness of alternative and complementary cancer treatments.

Many American citizens are impatient with the foot-dragging at NCI and the obstructionism of the FDA. Yet we as individual citizens have no way to force these agencies and individuals to act properly or fairly. It is up to you, our elected representatives, to do that. There is no time to waste. Since August, another 270,000 Americans have died of cancer. Many of them were desperately seeking reliable scientific information on alternatives at the time they died.

The Congress created the CAM to bring about the fair evaluation of alternative methods. Weappreciate the fact that you have increased OAM's funding to $20 million this year. It is a heartening vote of confidence in the future of this field. And, in some respects, under the leadership of Wayne Jonas, M.D., it has done a brilliant job. But OAM by itself does not have the political clout to force the testing of alternative cancer treatments. That is the main reason that OAM has not carried out a single evaluation of a controversial cancer treatment. It has not and it will not, because at every turn, the NCI has been there, insisting on a major role. It now turns out that the role NCI wanted was to block and obstruct such trials from taking place.

BLOCK NCI'S APPROPRIATIONS!
Just one month ago, Dr. Klausner appeared before the Appropriations Committee and requested S2.2 billion for his agency for fiscal year 1998. This is an increase of $61 million over last year. I am here to ask you to do everything in your power to block that appropriation until NCI changes its attitude towards alternative and complementary treatments. As a first step they should actively implement the POMES process.

In his speech to Congress, Dr. Klausner stated that "there is no one intervention or even one type of intervention that will successfully conquer the many diseases we call cancer. Our approach must be open and broad-based.

Fine words! But it happens to be the exact opposite of the course that NCI is actually pursuing. It is only an aroused Congress that can make Drs. Klausner and Wittes open the doors of NCI to alternative treatments. They must not be allowed to serve as a branch of the pharmaceutical industry, but must be convinced to test a wide variety of treatments, as they are currently practiced around the world. If these individuals will not comply, they should be replaced by open-minded scientists who will.

Mr. Chairman, for the 1.2 million Americans and the 9 million people worldwide who will develop cancer this year, such reforms cannot come a moment too soon.

1 Ries, LAG, et al. SEER cancer statistics review. 1973- 1991, Tables and Graphs, Bethesda,NCI, 1994.
2 J Clin Oncol 1996;14:287.
3 J Clin Oncol 1995;13:323
4 J Clin Oncol 1994;12: 1796
5 Frost & Sullivan, World cancer therapeutics markets [executive summary]. Mountain View,CA: Frost & Sullivan, 1993. Cited in Moss, Questioning Chemotherapy, p.75.
6 Stout, H and McGinley L. Cancer drugs to get speedier FDA review. The Wall Street Journal,March 29, 1996.

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