During the criminal trial, a postal inspector testified that she followed one of Burzynski's employees to a shipping store, where he tried to send a package containing antineoplastons to an out-of-state patient. The employee swears he did this on his own time and without Burzynski's knowledge, out of compassion for the patient. The son of an elderly Burzynski patient testified about harassing and frightening visits from FDA agents, who told them Burzynski was a fraud.
Burzynski's lawyers weren't allowed to present any evidence regarding the possible efficacy of antineoplastons. That's because the government's case has nothing to do with whether the drugs save lives, whether Burzynski's treatment is medicine or quackery. Whatever antineoplastons are, they aren't FDA-approved. Yet the agency saw enough promise in Burzynski's approach to authorize clinical trials. The act for which Burzynski might spend the rest of his life in prison--shipping antineoplastons across state lines--he is now doing openly and gleefully, because the FDA has told him it's OK in the context of the clinical trials.
Another apparent sign of flexibility came in March 1996, when the Clinton administration announced plans to speed up the approval process for cancer drugs whose tumor-shrinking potential has been demonstrated. Clinton vowed that "dozens of [new cancer drugs] will get to the market sooner."Secretary of Health and Human Services Donna Shalala swore the new system would go into effect immediately. The Dallas Morning News reported that, under the new rules, "all a company has to show is that the drug can measurably shrink the size of a tumor, even for only a short time,"and speculated that the reform might affect Burzynski's case.
Burzynski thinks the preliminary results of the clinical trials already satisfy the tumor- shrinking requirement. But when he petitioned the FDA in September for approval under the new guidelines, the agency wrote back that "[t]he Cancer Initiatives announced in March of this year by President Clinton and Vice President Gore did not set aside any laws or regulations related to approval of new drugs for cancer treatment."We have not changed or lowered our standards for the approval of such drugs."Which makes you wonder what the point of the March 1996 announcement was, aside from making Clinton seem compassionate.
All that Burzynski's patients--and potential patients--care about, of course, is whether antineoplastons work, not whether the FDA has approved them. But according to Assistant U.S. Attorney Mike Clark, who is prosecuting Burzynski, even raising that issue would be "irrelevant, emotional, prejudicial, and misleading."From the government's perspective, that's undoubtedly true. But for someone who wants or needs an unapproved treatment, the FDA's devotion to regulations is the real crime.
Young Paul Michaels is not Burzynski's only success story. There are dozens more among the 2,500 or so patients he has treated, all telling similar stories of cancer diagnoses, medical death sentences, and desperate searches in the realm of alternative therapies that ended in Burzynski's healing arms. Their dedication to Burzynski, whom they call "Dr. B,"is such that they've formed a pressure group to lobby on his behalf. The Burzynski Patient Group is run by Steve Siegel, the head of a Los Angeles-area marketing company and the husband of patient Mary Jo Siegel. "We've become another pain in the ass to the FDA--we're like a new AIDS lobby,"he says with a proud laugh. Siegel and his wife spend 100 hours a week running the Burzynski Patient Group, answering questions, referring people to other patients, lobbying Congress and the FDA. Through the efforts of the group, Barton held a series of congressional hearings from August 1995 to February 1996 to discuss Burzynski's treatment and the FDA's treatment of Burzynski.
A series of patients and their relatives appeared before Barton's subcommittee. Some said Burzynski's treatment saved them or their loved ones. (One patient who testified about the wonders of Burzynski's treatment, Doug Wagner, has since died.) Some witnesses acknowledged that antineoplastons didn't keep their relatives alive but said Burzynski should be allowed to continue his research and treatment anyway.
One subcommittee staffer who works on the Burzynski matter wonders aloud about the FDA's goals in this case. Three grand juries without an indictment, he says, is "unheard of. Ask any career federal prosecutor with no dog in this fight, and you'll learn it's extremely unusual to have a succession of grand juries without an indictment being issued. Grand juries will generally indict a ham sandwich if a prosecutor asks them to. The underlying charges are not that complicated. The drug's not approved--was the doctor distributing it? It shouldn't take 10 years to get an indictment. We still don't really know why it is that the federal government and the U.S. Attorney's Office in Houston--a large city with lots of federal criminal issues--are spending all this time going after Burzynski, what there is about this case that merits this kind of devotion of resources, when there doesn't seem to be any compelling evidence of a threat to public health. We asked the FDA when [Administrator David] Kessler testified before Barton's committee: Where's the harm? Where are injured people?"
Kessler didn't have the answer. He referred Barton to Robert Spiller--who, as the FDA's lawyer in the 1983 case, had vowed vengeance against Burzynski more than a decade earlier. Spiller related the tale of two patients he had read about in a report from the Canadian government. Both had died of a blood infection from the subclavian catheters through which some patients administer their antineoplastons. (For lower dosages, the drugs are taken in pills.) "That has nothing to do with antineoplastons per se, just the way they were administered,"the subcommittee staffer observes. "That could happen with any kind of medicine administered through intravenous catheters."
Congressional pressure, the staffer maintains, pushed the FDA into allowing all of Burzynski's previous patients to be treated in the ongoing clinical trials, even if they didn't meet the usual criteria for participating in such research. "The subcommittee broke the logjam,"he says. "Burzynski is getting farther along in the approval process. We'll soon have data on hundreds of patients under many different protocols. People want to know if this stuff works, if this is a breakthrough, or if Burzynski has nothing and is just stealing people's money. But with no accomplishments, there would be no following. If he's a con man, where [are] the victims? I've gotten a few complaints from disgruntled relatives, but I can count them on one hand. And none of them would talk to me face to face so I could question them. Even where it doesn't prove ultimately successful and the patient dies, I have relatives telling me they still swear by the guy, and their mom loved him, and they think she got some time she wouldn't otherwise have had and at least wasn't made sicker by the treatment."
The FDA isn't Burzynski's only enemy. The Texas Board of Medical Examiners has also been fighting him for years. "There's always something new going on with Burzynski," says Tony Cobos, the board's general counsel, when I ask him to sum up the story of Burzynski's troubles with state regulators. He suggests I order the relevant pile of documents. Nearly 100 pages arrive, chronicling how the medical board snatched victory from the jaws of defeat in their struggle to divest the doctor of his license. First an administrative law judge decided that all Burzynski had to do was change some of his advertising. Then the board decided to revoke Burzynski's license despite the judge's decision. The case entered the courts, where a district judge reinstated Burzynski's license and an appeals court reversed that decision, upholding the license suspension. The issue is now awaiting possible consideration by the Texas Supreme Court.
How the board got on Burzynski's case isn't clear. "Our investigative files are confidential,"Cobos says. "We don't say if people filed a complaint or where it came from. But obviously a complaint was filed."Burzynski does have some unsatisfied customers. Take Andy Cayon, a patient from Connecticut who started out as a Burzynski booster but, after six months of treatment and no apparent shrinkage of his brain tumor, now complains that the doctor's office won't even take his phone calls. Whether antineoplastons are worth a damn is still an open question; that they are not a miracle cure- all is clear to everyone, even Burzynski.
Burzynski's man in charge of managing the bureaucratic end of the clinical trials, Dean Mouscher, acknowledges that up to one-fourth of the brain cancer patients in the study so far are showing no response at all. Of course, conventional cancer treatments can't promise miracles all the time either--and often have horrific side effects to boot. The worst any user of antineoplastons can tell me about them is that they made him very thirsty all the time. In fact, the FDA let Burzynski skip Phase I of the clinical trials for antineoplastons--the test for toxicity--because there was already ample evidence of long-term safety.
Whether or not antineoplastons work, Burzynski makes it clear that he offers no guarantees. All patients sign a consent form which states that antineoplastons are "purely experimental"and that "the use of such substances as a prescriptive drug has not yet been approved by any State or Federal regulatory agency, nor has its use been approved or adopted by any single or group of Medical Institutions at this time."The form also says that "[n]either [Burzynski] nor anyone associated with him is permitted to ship his medication out of the state. Transportation of Antineoplastons out of the state of Texas by a patient or his or her agent could be viewed as a violation of the federal Food and Drug Laws. No assurances have been made to the PATIENT by anyone as to any results expected to be obtained from such treatment....[N]either success nor improvement in PATIENT's condition is warranted or guaranteed by such treatment. PATIENT understands that the reverse may be true and that PATIENT's condition may worsen as a result of the treatment....Dr. Burzynski makes no claims that Antineoplaston drugs will cure or stabilize cancer....[T]he U.S. Food and Drug Administration and the National Cancer Institute claim that this drug is not yet proven to be effective in the treatment of cancer."
The default assumption when someone jumps up claiming to have cured otherwise incurable diseases is: The guy must be a quack. Is Burzynski? The sort of rough empiricism most of us use in making these judgments (how many of us have done, or carefully studied the results of, double-blind, long-term studies of health claims on which we hold opinions?) gives evidence for both sides.
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