For over twenty years, I have represented complementary and alternative health practitioners around the country. Some are medical doctors or have other types of health care licenses. Others are unlicensed with varying amounts of training. Their common bond is that they all use treatment modalities that are not currently accepted by orthodox or conventional medicine. Supporters believe that these remedies are natural, non-toxic, holistic, groundbreaking, and life-saving. Opponents claim that the very same remedies are unproven, dangerous, life-threatening, and fraudulent. Galileo fought the prevailing scientific theories of his times and was forced to defend himself and his beliefs before the ruling authority, which was the church Many of my clients have been forced to defend their theories and treatments before the modern-day inquisitions that take place before state medical boards and in state and federal courtrooms. These medical heretics are idolized by their supporters and ridiculed and reviled by their detractors. They are modern-day Galileos, defying the entrenched, benighted medical inquisitors, or they are quacks, charlatans, or modern-day Rasputins, who dupe desperately ill patients out of their money. I am Galileo's lawyer, or Rasputin's mouthpiece, depending on your perspective.

Richard A. Jaffe, Esq.
From the Introduction of Galileo's Lawyer

Richard A. Jaffe, an attorney representing some of the most eminent, high-profile alternative and complementary doctors around our nation in the past twenty 23 years, has just published a personal memoir. Titled Galileo's Lawyer and infused with sharp, often puckish perceptions of major events and players in the cases recounted, the memoir reads like a storyteller's book. Jaffe has filled the pages with important, unusual, and, up until now, publicly unreported occurrences in the most significant cases he's tried. The book is definitely not dry, like a law review article, or dense, like a history heavy with footnotes.

I met Richard Jaffe in 1985. I was serving Dr. Emanuel Revici's patients as their liaison with elected and appointed members of the New York State government and the media. Revici faced a medical licensing proceeding before the New York Office of Professional Medical Conduct (OPMC) and three malpractice suits, the only time in his medical career that he had ever fallen into such deep regulatory and legal whirlpools. Jaffe and Samuel Abady, Jaffe's law partner in those days, took over one of the malpractice cases after Revici's previous attorney had caused a default to be entered against Revici. Chapter 2 in Jaffe's memoir gives a lively account of these malpractice cases and how the first case tried (Schneider vs. Revici) established a landmark precedent in malpractice law – express assumption of risk.

I've lingered a bit here over Jaffe and his book in relation to Revici, because my acquaintance with him dates from the period in which he represented Revici. The rest of this column features an interview with Jaffe, focusing largely on various developments in federal and state law related to alternative and complementary medicine (CAM) subsequent to his Revici period. The column concludes with a summary review of all the chapters in his book.

Interview with Richard Jaffe
MC: The Office of Technology Assessment (OTA), an investigative arm of Congress (closed after 1994), consulted you for its report on unconventional cancer treatments in the US. The OTA included a chapter on law and unconventional cancer therapy, and they wanted expert guidance. The OTA report was published in 1990, almost two decades ago. Have there been developments in the law pertaining to alternative cancer therapy that stand out in your mind since then?

RJ: A number of states have adopted a statute, regulation, or board policy that more or less allows doctors to use unconventional modalities of treatment.

MC: Have these substantially protected alternative doctors?

RJ: Not completely, for a number of reasons. For example, some unconventional doctors simply don't do a good job in the basics of medical practice – like maintaining complete and accurate medical records. The statutory, regulatory, and policy changes since 1990 can't protect an alternative or complementary doctor who fails to keep good records.

Also, there are certain kinds of situations where unconventional remedies simply can't be safely given, at least from the point of view of avoiding disciplinary action. For example, it still isn't safe for doctors to use unconventional treatments as primary therapy in cases of early-stage cancer regarded by the mainstream as curable through conventional treatment. Although most states have "wiggle room" in their rules, doctors are unlikely to get away with regular use of an alternative health remedy that's seen as presenting or creating an unreasonable risk of harm.

MC: Would you say, then, there's been little remarkable change since publication of the OTA report? And little change, too, for doctors treating diseases other than cancer?

RJ: I'd have to say that more has stayed the same than has changed. The state medical boards are still investigating and prosecuting alternative and complementary doctors. The FDA is still going after companies and doctors – now for HGH [human growth hormone] and other anti-aging medications. Chelation doctors are still having a hard time. And I don't think the environmental medicine doctors have made much progress over the last ten to 20 years. The general answer to your question would be "same old, same old."

MC: My understanding of express assumption of risk, the precedent set in the Schneider v. Revici negligence case, is that the Appellate justices found no statute barring such a contractual arrangement between patients and doctors. I'm familiar with some points of law, and my pieces on the OPMC in Townsend Letter (2001-2003) were cited in one article in a law journal, but I'm no lawyer. Why don't you explain the significance of express assumption of risk? How, for instance, does it relate to the benchmark US Supreme Court decision in the late 1970s denying patients the right to choose treatment? Most important: has express assumption of risk helped protect unconventional physicians in malpractice cases?

RJ: Schneider vs. Revici is still on the books and may still help in some cases.

MC: Do I sense a reservation on your part here?

RJ: This defense was used in a couple of malpractice cases involving Nicholas Gonzales, an unconventional cancer therapist in Manhattan. It didn't work; Gonzales got hit for large malpractice judgments. It has to be done right. I have a malpractice case right now for an alternative health practitioner in New York where we will use it as part of the defense to the lawsuit. Hopefully, I'll make it work.

MC: Back to express assumption of risk: can you set this precedent in its broad judicial context?

RJ: For 30 years, people have been trying to get either a constitutional right to treatment or a right conferred by statute. In 1979, the US Supreme Court could have done this, but in U.S. v. Rutherford, the Court refused to do so.

Technically, the only issue before the Supreme Court in 1979 was whether the FDA statute applied to terminally ill patients. The Court said it did. In a footnote, the Supreme Court raised the issue of whether terminally ill patients have a constitutional right of privacy to unapproved drugs like laetrile. The Supreme Court ducked the issue by saying it wasn't before the court. But they could have asked for briefs on the issue, or they could have held there was such a right. That they didn't is significant. Thereafter, the 10th Circuit held that there was no such right, and the Supreme Court refused to hear an appeal of this issue. All other circuit courts that have addressed the issue have held that there is no such right.

MC: Might a change here be blowing in the wind (to borrow from Bob Dylan)?

RJ: Things have gotten a lot worse. The comparatively liberal Supreme Court in 1979, which created many rights, would not find a constitutional right to treatment. I think there is zero chance that the present court would create such a right.

MC: There's an interesting case working its way up through the Federal courts, Abigail Alliance v. von Eschenbach, involving the right to treatment. How does Abigail relate to previous cases dealing with this issue?

RJ: Abigail doesn't argue that terminal patients have a constitutional right to receive any unapproved treatment. It argues that terminal patients have a right to receive drugs that pass through Phase 1 clinical trials. The reasoning goes: after passing Phase 1 trials, drugs have been proven safe enough for use in humans. Since these patients are terminal, lack of proof of efficacy (determined in Phase 2 and 3 trials) should not warrant stopping them from accessing such drugs.

MC: Any other differences?

RJ: Technically speaking, the argument in Abigail was made under the due process clause rather then privacy, but I don't think that makes any significant difference.

MC: Please sum up the court results to date in the Abigail case – from the perspective of an attorney versed in cases involving the right to unapproved therapy.

RJ: The District Court held that terminal patients do not have a due process right to take post-Phase I clinical trial drugs. Two of the three judges on the District of Columbia circuit court panel reversed the district court, holding that there is, or could be, such a right. The case was then heard on en banc consideration (where all the judges of the DC circuit hear the case). In August 2007, the panel's decision was reversed. The full DC circuit held that there is no due process right to take post-Phase I clinical trial drugs.

MC: I've read that Abigail is now up for certiorari before the Supreme Court.

RJ: Yes, but don't hold your breath. I don't think the Supreme Court will take the case. There is no conflict in the circuits. No circuit holds that there is any kind of constitutional right to take non-FDA approved treatment or post-Phase 1 clinical trial drugs. And I don't believe that there are any circumstances under which today's conservative majority of the justices would agree to create such a right. As I commented earlier, even the liberal Warren court justices back in the days of Rutherford wouldn't create such a right.
Interestingly, Justice Thurgood Marshall authored the Rutherford decision, and the decision was 9-0, unanimous. Marshall was no stranger to creating constitutional rights, either as a Supreme Court Justice or previously as an attorney for the NAACP.

MC: Bottom line: you don't expect Abigail to succeed.

RJ: A noble effort, but it won't work.

MC: So what's the answer? Is there an answer?

RJ: Ultimately, the answer is legislation.

MC: No one has tried this route?

RJ: Members of Congress have introduced bills in both Houses since the early 1990s. None of these have come even close to passing.

MC: Why do you think these bills haven't passed into law?

RJ: There's simply not enough interest on the part of legislators or the public to pass such a bill. Until there is a groundswell of public support, there won't be any such right.

MC: You said in Galileo's Lawyer that you were impressed by an opinion voiced by Dr. Robert Taub, a mainstream oncologist. That's in your chapter about Revici, in the portion on the Schneider case. Taub testified as an expert for Schneider, the plaintiff. Here's what you wrote:

His job in the case was to establish that the standard of care for Stage I breast cancer was surgery and that it was a completely curable disease. He also opined that faced with a patient with this diagnosis, it was the physician's job to convince the patient to undergo surgery and that there was no other rational choice. If a patient would not follow the advice, then the doctor should turn the patient away rather than give experimental treatment.

Farther along, recalling your cross-examination of Dr. Taub, you add the following:

"But what if the patient simply refuses, and insists on unconventional treatment," I asked Taub over and over again. "Suppose the patient goes to four doctors or ten and she still refuses." And Taub kept coming back to his statement that "the doctor's job is to ensure that the patient gets the best treatment possible."

"But what if the doctor also recommends surgery, but agrees to treat the patient with medications and maybe tries to talk her into surgery later on?"

"No, that's not enough. She needs surgery, giving her anything else is malpractice."

You've subsequently advised alternative cancer doctors to do as Taub adamantly insisted they should do when a patient comes to them with a stage 1 cancer believed curable by conventional treatment.

What would you tell stage 1 patients who approached you, suspecting that the mainstreamers they'd consulted hadn't fully leveled about the prognosis? Or had let drop that authorities disagree over the cure percentages for a number of common cancers? Or had an evident bias against patients first trying a plausible alternative treatment? Or had biases against approaches foreign to allopathic physicians: Ayurvedic medicine or Chinese herbs, ancient East Asian medical traditions, which researchers in the West are beginning to investigate with less skeptical minds?

RJ: I'll first restate the advice I give to CAM doctors. From everything I've read and researched and from my discussions with competent alternative physicians who have experience in cancer, there are just some forms of cancer for which surgery is basically curative. And, painful as it is for me to say, sometimes chemotherapy is the best initial treatment. It's best for acute lymphocytic leukemia (ALL) in children (and there are very, very few diseases I would say that about).

At this stage in the game, most unconventional practitioners know to stay away from treating patients with these curable diseases, and the reason is simple and practical. A medical board will revoke the license of a doctor who treats an early-stage, curable cancer patient, especially if the patient subsequently dies. It doesn't matter what kind of CAM law, regulation, or policy the medical board has; if you treat an early-stage cancer patient and the board finds out about it, you're in big trouble.

MC: Helpful in a practical way for doctors. Still, what would you advise patients who are considering alternative therapy for early-stage cancer?

RJ: I'd tell them the same thing I told my father who wanted to try some form of alternative treatments and not have surgery for his stage 1 colon cancer: "Have the surgery."

MC: What happened with your father?

RJ: He is still alive 20 years after surgery, and he has never had a recurrence.

MC: By far, the lengthiest chapter in your book is the third, the saga of the legal woes of Dr. Stanislaw Burzynski, originator of antineoplaston treatment for cancer. Burzynski's troubles involved four federal grand jury investigations, an eight-year medical board case, a lawsuit by the Texas Department of Health, and numerous insurance company lawsuits, including two federal racketeering lawsuits – one brought by Aetna and the other brought by you, his attorney, against Aetna, its attorneys, and members of the Federal government.

Your work in all this preserved a promising treatment option for cancer patients unable to benefit from mainstream therapy. That's extremely valuable. Can you deduce any general lesson or lessons from Burzynski? Did his ordeal indicate or suggest to you how the mainstream feels about clinical trials of alternative cancer treatment?

RJ: Generalized, the basic lesson I learned from my experience with Burzynski is how unscientific, biased, and human the clinical trial process can be. Most people probably don't understand this.

MC: I must commend you for the chapter in Galileo's Lawyer (Chapter 4) devoted to children and alternative cancer therapy. By law, parents of "minors" with cancer are accountable for decisions on treatment. When parents place a child under unconventional care, seeking to spare the child from adverse effects of chemotherapy or radiation, child welfare agencies and physicians can petition in court to order treatment mainstream oncologists consider "appropriate."

In Canada, judges have leeway in custody cases involving children with life-threatening illnesses. They can refuse to turn over a child for conventional therapy. In the US, I believe it is the norm to grant such custody petitions, particularly where the child's life appears clearly at risk. (Canada's "Charter of Rights," similar to our "Bill of Rights," contains a provision that can be interpreted as allowing such denials.) And US judges are seldom swayed by promises from parents to place their children under conventional care the moment an alternative approach shows signs of failing. Would you care to comment on this subject, beyond what you've written in your book?

RJ: Chapter 4 of the book describes the FDA's attempt to stop Thomas Navarro, a young child with brain cancer, from taking Burzynski's treatment. I get livid whenever I look back at the FDA's conduct in this case. It was so outrageous to me.

Orthodox treatments for pediatric brain tumors (radiation and chemotherapy) cause severe mental retardation in virtually 100% of the patient population. Many patients die of the immunosuppressive effects of chemotherapy. The idea that FDA policy denies many of these kids an opportunity to try Burzynski's treatment first, or another reasonable alternative, greatly upsets me. I'm still haunted by the suffering of Thomas Navarro and his parents and Thomas's death. That child might have survived with Burzynski's antineoplastons, except for the FDA's roadblocks.

With pediatric cancer and alternative care, the bottom line is that parents have to have a reasonable plan. If they don't, and if their child has been evaluated at a conventional cancer center, they'll have a problem.

MC: The impact of this case on you is reflected in the first pages of your memoir. You dedicated it to Thomas Navarro and other patients who, as you expressed it, "had to fight their government before they could fight their disease."

RJ: Indeed it is! And these battles are far from over, if I have anything to say about it. My book is just the opening round of the next battle.

Summary Review of Galileo's Lawyer
Richard Jaffe's memoir, published by Thumb's UP Press (Houston, Texas, 2008), consists of an introduction, ten chapters, and a section titled "Afterthoughts." The introduction offers Jaffe's "take" on why people use CAM modalities. It also includes a scathing attack on the failure of conventional medicine to provide reasonable remedies for many chronic conditions.

The first chapter is a primer on how government entities, federal and state, regulate the health care field. It's essential basic reading, a 101 course.

Chapters 2, 3, and 6 focus on practitioners: Revici (2), Stanislaw Burzynski (3), and H.H. Fudenburg (6) (Fudenburg works with Transfer Factor).

Chapter 4 looks at the use of alternative cancer remedies in children.

Chapter 5 tells of Jaffe's successful effort to reinstate a clinical trial for terminally ill cancer patients at M.D. Anderson, Houston.

Chapters 7, 8, and 9 step into the fields of Chiropractic and Naturopathy, and the battle between nutritionists and dieticians.

The last chapter (10) recounts the first Federal criminal case of a physician providing stem cell treatment (the cells came from umbilical cords, not fetuses).

Galileo's Lawyer ends with the Afterthoughts section, in which Jaffe reflects generally about the health care field and what the government should and should not regulate or try to control.

I'll quote another passage from Jaffe's memoir, a single paragraph, which catches the quality of his mind and spirit and nails a slippery problem in alternative medicine.

Medicine, science, and legislation are human endeavors. This means they are all infused with an inherent disorder, messiness, bias, animus, and lack of objectivity. The philosophers of science have it wrong to the extent they believe that psychology, sociology, prejudice, and even sociopathology play no role in the growth of medical knowledge, (or lack thereof).

Doctors who specialize in alternative or complementary medicine (CAM) perceive the disciplinary and regulatory pitfalls attendant on unconventional practice through their eyes. Patients using CAM or desiring access to CAM glimpse related difficulties – from their vantage point. It's rare to have the perspective of a lawyer whose task for 20-plus years has been extricating CAM practitioners from the pits into which they've stumbled. Galileo's Lawyer supplies this perspective in spades.

One more quotation from Jaffe's book closes this column. It's from his chapter on Dr. Burzynski, after he's given an insightful account of a trial of Burzynski's antineoplastons, sponsored by the NCI and "sabotaged" (Jaffe's word) by investigators at Mayo Clinic, Minnesota, and Memorial Sloan Kettering Cancer Center, New York. Reminiscing about his university studies on the history and philosophy of science, he confesses that he left graduate school because he was "tired of just seeing ideas bounce off other ideas." He "wanted action." In many of his cases – Burzynski, in particular – Jaffe has gotten all that a man primed for action could wish for, plunging into various combat zones in medical politics – into battles he wryly termed "the applied philosophy of science."

"These battles," Jaffe stresses, "were not esoteric. They were brutal and fought in the trenches of life. Real patients were involved and their lives were at stake. These Burzynski NCI trials showed me up close how dirty, unscientific, and immoral medical science could be. It was a far cry from what I learned in my philosophy of science classes two decades earlier."

Richard Jaffe's memoir should be out by late February. Readers can order advanced copies at www.Galileoslawyer.com. It should also be available at Amazon.com (see below) and Barnesandnoble.com.

Marcus A. Cohen
marcusacohen@aol.com