FREEDOM OF CHOICE

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Presenters: Billy Best, Michael Cohen, J.D., M.B.A., M.F.A., Fred Smith M.D., Antonio C. Martinez, II, J.D.
Moderator: Susan Haeger
Commentator: Robert Justice, M.D.
Session: Sa11; June 12, 1999

I. Abstract

This session was designed to address the issue of freedom of choice in health care and the challenges that such freedom raises in government regulation. Presenters were also asked to propose "solutions that balance respect for individual choice and the need for public safety." Brief presentations from the four panelists were followed by questions and comments from Dr. Robert Justice of the Food and Drug Administration.

II. The Cancer-Related Issue Addressed

Billy Best

Billy Best, a cancer survivor from Massachusetts, attracted national media attention when he ran away from home to put an end to his chemotherapy treatments. Billy was diagnosed with Hodgkin’s disease in 1994 at the age of 16. His refusal of medical treatment prompted sympathizers from all corners of the world to send him and his parents information about alternative therapies. When he received reassurances that chemotherapy wasn’t going to be forced on him, Billy returned home and began his own program of natural and nutritional therapies. In March 1995, tests performed at the Dana Farber Cancer Institute showed that his cancer was gone. It has not reoccurred. Both Billy and his parents are now proponents of natural therapies.

In his opening remarks, Billy related his wish to have been given more treatment choices at the time of his initial diagnosis. He recalled that the day he learned he had Hodgkin’s disease his aunt died from breast cancer. She was receiving chemotherapy and the doctors said they see it [breast cancer] all the time and chemotherapy is what works. There wouldn’t be a problem, so she continued getting chemotherapy. She was getting more and more sick, so they increased the doses until she died while getting chemotherapy. So from the start, I had a negative look on chemotherapy.

At Dana Farber Cancer Institute Billy’s doctors gave him reassurances that echoed the ones given to his aunt. Hodgkin’s disease was common, they said, and chemotherapy, radiation, and surgery were the only treatments that cured people. Initially, Billy accepted five chemotherapy treatments. But soon he noticed that the health care professionals giving him the drug wore two layers of gloves. When he asked them why they did that, they explained that if the chemotherapy were to spill it would burn through their skin. The fact that this same substance was going straight into his heart increased Billy’s discomfort with it. But his doctors insisted that the treatments were good for him. Moreover, when his mother asked them if they recommended a change in Billy’s diet, they asserted that nutrition had nothing to do with Billy’s condition.

In October 1994, tests showed that Billy’s cancer had been contained. It hadn’t gone away, however. Against his doctors’ wishes, Billy decided that he didn’t want further chemotherapy, and he ran away from home. This attracted world-wide media attention, and many people contacted the Bests to tell them about non-toxic ways to treat Billy’s cancer. Eventually, Billy returned home, changed his diet—he stopped eating meat and dairy—and talked to his doctors about additional natural therapies he wanted to try. "They [the doctors] didn’t hear about any of the treatments we wanted to use," recalled Billy. Rather, they asserted that these treatments were not approved by the FDA and were, therefore, ineffective and potentially lethal. In addition, they emphasized that without chemotherapy and radiation, Billy would die within 6 months to 2 years. Chemotherapy and radiation "were the only choices that I had," stated Billy. When he made it clear that he wasn’t going to accept these options, his doctors reported him to the Department of Human Services in order to gain permission to treat him against his will. But because Billy was already 16 years old, the Department of Human Services stayed away from this case.

In January 1995, Billy started taking the alternative therapy 714X. Two months later, tests showed that he had been free of cancer. "I still have no cancer," said Billy. Since 1995, Billy has been researching the possible causes of cancer. His goal is to protect himself from factors that can trigger a recurrence. He spoke about the dangers of the chemical industry (i.e., the pollutants in the air, water, and earth), the food industry (i.e., the way in which foods are grown and manufactured to hold reduced amounts of nutrients), the medical industry (i.e., the way in which health care professionals are trained to treat the symptoms, but not the causes, of disease), and governmental and medical authorities who have the legal power to tell patients what they can and cannot do to take care of their health.

"I don’t hate chemotherapy," Billy said. "Chemotherapy I think is good for fighting tumors. But I don’t think that when you have cancer the tumor is the thing you should be worrying about. It’s what caused the tumors that has to be taken care of. If the tumor is blocking a main organ, then I think chemotherapy is a great thing to do. But a lot of cancers like my own, I think you can take care of easily with natural therapies. And there are hundreds of them out there, they are good for your body, so they build yourself up instead of breaking you down, so you have a better chance in the long run. Where if you get chemotherapy, it kills the tumors right away but you are still left empty with no immune system."

Billy pointed out that at the present time, finding out about natural therapies is difficult. Doctors are not allowed to talk about them or prescribe them. Patients are left on their own to gather information through word-of-mouth. Moreover, when they start using alternative treatments, they face the risk of losing their health insurance and even being persecuted. In conclusion, Billy asserted that "America is a free country." He would like to see the day when patients can find a doctor who will be able to treat disease with natural therapies.

Michael H. Cohen

Michael Cohen is an attorney and the author of numerous articles in health, law, and bioethics. Recently he authored the book Complementary & Alternative Medicine: Legal Boundaries and Regulatory Perspectives (The Johns Hopkins University Press, 1998).

Michael Cohen started his presentation by noting: "Historically medicine has not been particularly kind to people who’ve been innovators." He spoke about the trials and tribulations of the father of modern surgery and the author of one of the first books on anatomy. Although practitioners of complementary and alternative medicine (CAM) have not been burned at the stake, they have encountered numerous social and legislative challenges.

In the late 19^th century, medical licensing laws made it illegal for practitioners who didn’t meet the criteria of scientific medicine to treat patients. These laws were presented as measures to protect the public against incompetent practitioners, but they reflected no concern for patient choice. The only concern they did reflect was the protection of scientifically trained physicians. Soon enough, alternative health practitioners such as naturopaths, spiritual healers, and homeopaths were prosecuted, convicted, and jailed. "In this way," stated Mr. Cohen, "holistic health care evolved into ‘alternative medicine’ which came to define a class of healers who lacked the imprimatur and political backing of the regulatory apparatus and either practiced at their peril or received limited licensure from legislatures willing to tolerate their activities."

Mr. Cohen asserted that the stigmatization of CAM practitioners continued throughout the 20^th century. In the 1950s the American Medical Association (AMA) made official statements condemning the cooperation of physicians with unconventional health practitioners. In 1990 the 7^th Circuit found that the AMA had conspired to eliminate the profession of chiropractic. And in 1997 a draft report by the AMA Council on Scientific Affairs attributed "some of the interest in alternative medicine to New Age interest in channeling and astrology, modern witch trials concerning satanic child abuse rituals, and alleged capture by space aliens." References to CAM as "sorcery" and "voodoo medicine" continue to appear in legal documents. As a result, courts have tended to treat CAM and the people who practice it as deviant, dangerous, irrational, and anti-intellectual. In this process, they devalue the perspective of the patient. Mr. Cohen characterized the government’s claim to know what is best for American patients as "extreme medical paternalism."

In conclusion, Mr. Cohen called for a reform "of the heart" that would lead to a fundamental change in the Food and Drug Administration (FDA), the government, the law, and the whole system that robs patients of both treatment choices and their dignity. The claim that denying patients access to CAM protects them is cold and indefensible. Moreover, it does not advance people’s health. He suggested:

1) The concern for protecting patients against fraud has to be balanced against the concern for protecting personal choice in health care. Patients must have the freedom to use the treatment of their choice even if this treatment is disapproved by their physician, the AMA, government agencies, and the entire medical profession.

2) Scientific medicine and CAM need to join forces in the compassionate search for healing. Together, they must focus on the balance, wellness, and wholeness not only of physical bodies, but also of relationships and communities.

Fred Smith

Dr. Fred Smith is an oncologist at Georgetown University School of Medicine.

"I’m an oncologist, I’m a traditional physician, I use chemotherapy as my primary tool," said Dr. Smith. He then went on to applaud Billy Best’s courage. He also emphasized some of his points:

• The conservatism embedded in many physicians’ approach to health and health care;
• The fact that physicians offer no alternatives to their treatments;
• The need of many patients to be informed about alternative and complementary treatments;
• The fear that many patients experience when they realize that the only medications available to them are toxic;
• The loneliness and abandonment that many cancer patients experience when they complete the course of their treatment.

Dr. Smith acknowledged that physicians have eschewed supportive nurturing, nutritional, and immuno-augmenting therapies. But he stressed that patients who forgo conventional treatment or resort to alternative and complementary therapies must be given adequate information about the ramifications of their decisions. He recalled that when his father was diagnosed with lung cancer, he was given the option of surgery. At the same time, however, he was told that surgery could compromise his ability to breathe. With this information, Mr. Smith’s father decided to turn surgery down. Subsequently, he was offered radiation therapy, but he refused that as well. "There was an informed choice," asserted Dr. Smith. In Dr. Smith’s opinion, choice must be applauded as long as it is informed. That is, as long as it doesn’t inflict physical and emotional injury to others and as long as the complications of one’s choice are known. Dr. Smith went on to argue that it is not correct to deprive a child with leukemia—a disease for which there are curative treatments—of conventional interventions. But when someone has metastatic disease, more choices are in order. "The idea is to have that individual living for days—not dying for months. And we in traditional medicine have not offered that."

Taking issue with the comments of Michael Cohen, Dr. Smith asserted that the antagonism between conventional medicine and CAM must subside. Billy Best, he remarked, did receive several cycles of chemotherapy. Was it then the chemotherapy, his spirit, or the alternative therapies that have kept him well?, he asked. "I don’t care which of those treatments kept him that way," he said, "but I must tell you that you’ve got to be informed. Hodgkin’s disease, acute leukemia, testicular cancer are cancers that we can cure with this devastating treatment [chemotherapy, radiation, and surgery]. You must be informed." To support his point further, Dr. Smith spoke about an orthopedic surgeon in Northern Virginia who treated patients with intravenous Aloe Vera. One of this surgeon’s patients died, leaving Dr. Smith with the question, "Did that individual [the patient] have truly informed consent?"

Dr. Smith concluded his talk with a few words about his father. When his father was diagnosed with lung cancer, he was told that if he turned down conventional treatments he would die within 6 months. His father refused every conventional treatment offered to him and lived 18 months with the support of his family and hospice. Dr. Smith ended his talk with an excerpt from a poem that his father left for him. It was Alexander Pope’s "An Essay on Criticism":

A little learning is a dangerous thing;
Drink deep, or taste not the Pierian spring:
There shallow draughts intoxicate the brain,
And drinking largely sobers us again.

Antonio C. Martinez, II

Tony Martinez is an attorney and a government relations and regulatory affairs consultant. He specializes in food and drug law, health care law, and patient and health care professional advocacy.

Mr. Martinez opened his talk with a reference to his father who is a lung cancer survivor. When Mr. Martinez’s father read the labeling information on the chemotherapeutic agent his doctor recommended, he decided against chemotherapy. To examine his remaining treatment options, he turned to the informational service CanHelp which told him about an experimental vaccine available to patients with stage I and II lung cancers.

Mr. Martinez’s father underwent surgery to remove the tumors in his lungs. He then went to Canada to receive the vaccine. In addition, he used Emanuel Revici’s therapies and put himself on a health maintenance program. "My father recovered," stated Mr. Martinez. "I have to say that it was not a perfect recovery—in the sense that within a year he had another small tumor appear on one of his lungs, but that was immediately excised. This December it will be 5 years, and my father, who is 72 years old, continues to practice law in New York city, To look at him you would not know that he had cancer. I was very grateful that we were able to have access to information. Unfortunately, we had to leave the United States to get treatment. And that is really at the heart of the issue—that there’s something fundamentally wrong when we do not have that right. And you need to understand this. Because it only really hits home when you or your loved one is faced with a disease like this. You do not have the right to choose your medicine. It is not guaranteed by the Constitution and it will require an act of Congress to undo that."

Mr. Martinez urged the audience to become involved in the political struggle to guarantee patients the right to choose their own treatments. He emphasized, however, that patients who decide to take an unapproved therapy must do so with full understanding of and responsibility for the consequences. The Access to Medical Treatment Act, he said, is legislation that will allow patients to gain access to unapproved treatments following an informed-consent procedure.

Mr. Martinez’s closing remarks focused on the practices of the FDA. He said that although the FDA works hard to accommodate many kinds of patients, some of its policies have proven detrimental to people interested in complementary and alternative treatments. Mr. Martinez, who represented Dr. Stanislaw Burzynski’s patients, recalled that when Dr. Burzynski was indicted for violating the Food, Drug, and Cosmetic Act, the FDA cut off his patients from their treatment. It took an oversight hearing in Congress and many phone calls to then Commissioner Kessler to resume the treatment on which these patients depended.

Mr. Martinez gave a second example of the danger of FDA’s bureaucratic policies. It involved a patient with advanced cancer in the bowels. When this patient decided to terminate conventional treatments and turn to Dr. Burzynski’s antineoplastons, the FDA told him that he had to undergo two more rounds of chemotherapy and a bowel resection. If these interventions didn’t work, argued the agency, then he would be given permission to try his preferred treatment. The problem with this decision, argued Mr. Martinez, was that the patient wanted to prevent the need for a resection in the first place. Therefore, the FDA presented a direct threat to his goal. "After much intervention at the highest levels," recalled Mr. Martinez, "this patient was given access to the medication [antineoplastons]. You should not have to be put into that position. If you’re given information, and there’s a methodical, rational procedure that you can avail yourself easily, you ought to be able to have dominion over your body and your health care—especially when it comes to diseases for which we do not have cures for, like cancer. This is a process that’s going to require everyone to be very much involved if you care about this issue, because it affects everyone. Let’s get our right back to choose the health care of our choice."

III. Commentator’s Comments

Dr. Robert Justice is the Acting Director of the Division of Oncology Drug Products in the Center for Drug Evaluation and Research and the Food and Drug Administration.

Dr. Justice began his comments with the reassurance that he understood the issues and frustrations raised by the four speakers. He said that personally, he agreed that patients should have the right to make informed choices. However, he felt that the panelists’ criticisms toward the regulatory system were not followed by clear and specific recommendations for legislative changes. "It sounds like you want access to anything, anytime," he said, "but I haven’t heard any discussion about what safeguards you want, if any, when you have access to nontraditional or complementary or alternative medicine products. I think those are important things to think about." He noted that the members of the National Institutes of Health are empiricists. They realize that there are traditional therapies that could turn out to be effective, but they want to see that these therapies get tested in a rigorous fashion. In terms of access to investigational drugs, Dr. Justice reported that the Division of Oncology Drug Products bends over backwards to ensure patient access to them "as long as we can ensure that a drug or other therapeutic gets studied. We are concerned when there is widespread use of a drug and the studies that are needed to show that the drug is safe and effective for the treatment of a specific cancer aren’t done." Finally, Dr. Justice invited the panelists to outline the specific legislative changes they wanted to see.

Michael Cohen: Mr. Cohen replied that this conference was not the appropriate forum to give the FDA specific legislative proposals and recommendations. But he stated that he would be delighted to respond to an invitation by the FDA to do so. Briefly, however, he mentioned the Access to Medical Treatment Act, which contains numerous safeguards. At the same time he argued that if he were sick and wanted to use a drug about which he had adequate information, he wouldn’t care if it had been proven safe and effective by governmental agencies.

Susan Haeger: Ms. Haeger mentioned that Citizens for Health worked hard to try and understand why it was that for 6 years the Access to Medical Treatment Act had not moved through both houses of Congress. Her organization began to realize that the question of safety was not only important, but also complex. Concerns about safety, she stated, have to be delicately balanced against experiences like Billy Best’s. Billy was told by his physicians that the alternative treatment he wanted had shown no medical efficacy. Yet the conventional treatment offered to him was extremely toxic. "He made a choice, he’s here today. Should that choice have been denied to him?" asked Ms. Heager. Recalling the hearings on the Access to Medical Treatment Act, she stated that some of Dr. Burzynski’s patients had turned to antineoplastons after being told by their physicians that conventional medicine had nothing more to offer them. And yet, they and Dr. Burzynski suffered years of harassment. "What if, instead of waiting for the IND [investigational new drugs] trials to be done, you tracked people that made the choice on an informed basis that they wanted to use the [Burzynski] therapy and did some retrospective studies?" she asked.

Ms. Haeger asserted that many therapies which are shown to be effective in Europe and are covered by European insurance companies are not allowed in the United States. The result is that only those Americans with the financial means to travel to Europe have access to certain promising alternative therapies. In the United States, it is difficult to get information about such therapies. Information, she argued, is the key. What would be helpful, she concluded, is for the FDA to find new models for drug investigation.

Robert Justice: Dr. Justice said that he didn’t want to talk about Dr. Burzynski. He asserted that there is a model for examining highly effective traditional cancer drugs in a small number of patients and approving them. However this model has not been applied to complementary and alternative medicines. If the FDA can acquire enough data about a small number of patients concerning a) their disease prior to the treatment in question, b) other therapies they received at the time of the treatment in question, and c) documentation of their responses to the treatment in question, then, depending on the situation, such data could constitute sufficient evidence to get a drug approved. "Certainly if a sponsor of such a therapy [complementary or alternative therapy] has good, solid data that they want to bring to us, we are happy to meet with them," he said.

Fred Smith: Dr. Smith said that from the physician’s perspective what is most important is information. "We really would like to know. More than anybody, all of us as caregivers, healers, we want to take the best care of our patients and achieve the best results. And again the issue is to promote dialogue between the traditionalist and the alternative therapist and not appear to be exclusivist." Dr. Smith stated that patients do need more access to treatments. But because of society’s legal structure, the FDA sometimes approves drugs with "nonsensical restraints." He gave the example of thalidomide, which is being presented as a potentially anti-angiogenic drug. Thalidomide has been approved by the FDA under the condition that people who handle it must wash their hands, patients who use it must wear a condom during intimate contact, etc. In defense of traditional medicine, however, Dr. Smith stated that since the ground swelling public interest in laetrile in the 1980s there have been several attempts to examine unconventional therapies. Referring to laetrile, he said that "in the efficacy trial we were unable to satisfy ourselves." In his opinion, when the patient is terminally ill he or she should be granted unrestricted freedom to choose any form of therapy.

Michael Cohen: Mr. Cohen suggested that if patients have full information about a substance, they should be allowed to use it. At the same time, the government can invest resources to certify that this substance is safe and effective. He said, "If you wish to have that government certification of safety and efficacy as a patient—I’m not addressing the physician’s concern—you can have that certification. But if you don’t have it, and you choose it [the unapproved drug] anyway based on your own information, your own belief, your own sources or perhaps your own intuitive sense of what is right for your body, then you should have dominion over your body and the ability to have that substance."

He then spoke about the distinction between a food and a drug,. This makes sense in specific western contexts but collapses in the face of indigenous cultures. He argued that what is needed in the U.S. medical and regulatory systems is a radically new approach to health and healing—"not just changing one statute or one regulation, but the whole structure of thinking."

Tony Martinez: Mr. Martinez spoke briefly about the controversy surrounding the laetrile trials. He then went on to state that the legislation shaping the delivery of health care in the United States was created over 60 years ago. The Food, Drug, and Cosmetic Act was enacted in 1938. It will, therefore, take a substantial amount of work to bring it up to date. "The bottom line is this," he said. "You do not have a legal right to the health care of your choice." The Access to Medical Treatment Act is designed to enable patients and their physicians to use therapies that have not been approved by the FDA. At the same time, it requires physicians to inform the FDA that such therapies are in use and that the patients using them have given their informed consent. The FDA, stated Mr. Martinez, opposes this bill. Since the 1970s it has had full authority to decide whether a patient will be allowed to use an unapproved therapy or not. "I liken that power to really the power to play God," he said. "It’s very difficult for someone in a bureaucratic agency to be standing in the shoes of someone who faces a disease." He doesn’t think Congress ever intended to give such power to a bureaucratic agency. "We have to get this corrected," he said.

Billy Best: Going back to Dr. Justice’s call for suggestions from the speakers, Billy mentioned that the blood tests he received in Canada—which are also available in certain centers in the United States—didn’t just count blood cells, but also looked at the cells’ function and morphology. "Dana Farber would count my white blood cells," he recalled, "and say, ‘You have this many white blood cells, so you are healthy right now.’ I went to Canada and they showed me what the white blood cell was doing. It was just sitting there being eaten by bacteria. And they [health professionals in Canada] claim that they can pre-diagnose cancer up to two years just by looking at the state of your blood." Billy recommended that tests like the one he received be made available in U.S. hospitals and drug stores to help people prevent disease. Secondly, he urged medical authorities to pay serious attention to the therapeutic properties of nutrition.

Tony Martinez: Mr. Martinez asked Dr. Justice the following question: "Why can’t there be a rebuttable presumption of safety and efficacy for drugs that are already approved by G7 countries?"

Robert Justice: Dr. Justice stated that the FDA utilizes foreign studies all the time. In 1996 his agency looked at a list of all the conventional cancer drugs that are approved in Europe and found that most of them are also approved and used in the United States. "In fact," he stated, "many drugs these days get approved in this country before they ever get approved in Europe. I understand that the level of evidence for approval of cancer drugs in Europe is, in some ways, possibly becoming even tighter than it is in the United States."

Tony Martinez: Mr. Martinez clarified that his question concerned complementary and alternative therapies, not conventional cancer drugs. He stated that complementary and alternative cancer therapies used abroad are often kept in import detention in the United States. Even if you have the funds to travel abroad for treatment, when you return to the United States a) you have to show a doctor's prescription for the drugs you may be carrying, b) these drugs may not exceed a 90-day supply, and c) if your treatment requires injections, you are required to provide the name of a physician in your home area who is willing to give you your medication. Unless your physician applies to the FDA under a special treatment IND for permission to import all the medication you need, you are required to go through this process every 90 days. The process is very cumbersome.

IV. Audience Questions

Susan Haeger invited the audience to a discussion about the right of patients to make treatment choices, the frequently expressed concern that patients may not be fully informed about the unapproved treatments they choose, and the power of the government to bring legal censure and even imprisonment to physicians who try to incorporate complementary and alternative therapies into their practice. Ms. Haeger emphasized that complementary and alternative medicine is a consumer movement driven by individuals who demand that they are allowed to play an active role in their health and treatment. The public’s desire for participation and choice, she said, is coming up against the regulatory system, the medical establishment, and academic institutions.

Why is there a double-standard in which experimental drugs are used freely in hospitals while unapproved alternative and complementary treatments are banned by government regulations?

The connection between the drug companies, the AMA, and the FDA is economical. The AMA began looking at CAM when it realized that patients spend large amounts of money to avail themselves of complementary and alternative therapies. Moreover, physicians don’t give patients enough information about conventional therapies. They discuss the ability of chemotherapy to shrink or eliminate tumors, but they don’t talk about survivability after chemotherapy. How do we make a decision with this misinformation from people that we’re supposed to trust?

Why aren’t tax dollars applied to the investigation of therapies that have shown promise in other countries?

A physician who works with oncologists stated that from his experience he has come to suspect that CAM can enhance the effects of chemotherapy and reduce its adverse side-effects. He then asked Dr. Smith if he had worked with patients who received immune support in conjunction with their treatment.

Comment: A woman who works with cancer patients expressed her frustration with a new law in Texas that gives dietitians the exclusive right to dispense information about nutrition for payment.

Comment: A cancer patient said that being informed is a two-way street. Patients who are motivated to become informed often find themselves working with oncologists who are uninformed. Yet the advice that these patients received is to consult their doctor prior to using any unconventional therapy. "If your doctor is uninformed," this woman said, "they can’t help you. So I would like to encourage the oncologists to, themselves, become informed about some of the things that their patients are doing. Because I think if we worked together and sort of learned together that we will make many more strides…"

Comment: Many of the treatments that have been proven to be beneficial are not part of medical education. Nutrition, mind-body medicine, massage, biofeedback are a few examples. Such therapies need to enter medical student training.

Susan Haeger: "This panel has really brought to the fore the multiplicity of issues that confront freedom of choice. I hope everyone will continue to work together to resolve these issues."

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