Killing Us Softly (19 page)

In 1979, Gary Null, a popular critic of mainstream medicine, wrote an article in
Penthouse
titled “The Suppression of Cancer Cures.” Null told the story of a sixty-three-year-old man with lung cancer that had metastasized to his brain. After six weeks of antineoplastons, the lung cancer was gone. After a few more weeks, the brain metastases were gone, too. According to the article, forty-one patients with advanced cancers had been treated, with “definite improvement in 86 percent.” This was Burzynski's first major exposure to the media, and it dramatically increased his business.

Two years later, Geraldo Rivera, a correspondent for ABC's
20/20
, aired a show titled “The War on Cancer: Cure, Profit or Politics?” Again, Burzynski was cast as an unrecognized hero. Rivera compelled his audience with stories of hope and survival:

• “In early 1979, Steve Hipp got the dreaded news,” said Rivera. “Steve had cancer. His doctor in Michigan summed it up this way: ‘We were waiting for him to exit.' Steve's doctor recently confirmed to
  20/20
  that his tumor has shrunk.”
  
• “Al Swazeland is from Canada,” said Rivera. “In late 1978, Al discovered that he had bladder cancer. Six operations later, his only chance was removal of his bladder, which meant he would need a urine bag in his abdomen for the rest of his life. Al just informed us that as of now he has no active tumors.”
  
• “Jocelyn Chancey's inoperable breast cancer had spread to her bones,” said Rivera. “I talked to about fifteen doctors and the consensus was that she was terminal,” said her husband. But like Steve Hipp and Al Swazeland, Jocelyn Chancey had had a miraculous response to antineoplastons. “Jocelyn Chambers's bone scan shows that she is in partial remission,” said Rivera, “and a more recent bone scan shows further improvement.” “I sleep good at night,” said Jocelyn.
  

Only four years after Stanislaw Burzynski had opened the Burzynski Research Institute, he was curing patients with no hope of a cure. Still, antineoplastons hadn't entered the
mainstream. Rivera knew why. “There is a cancer establishment,” he said, “and it's basically divided into two parts. One is our most lavishly funded government health agency. It's called the National Cancer Institute. The other is our wealthiest private charity, the American Cancer Society. To critics, their combined function has a stranglehold effect, creating a kind of monopoly on cancer research and information.” According to Rivera, cancer doctors weren't sympathetic caretakers; they were ruthless businessmen. “Cancer is not just a disease,” he said; “it's a political and economic phenomenon, a $30-billion-a-year business”—one that apparently had no intention of including the likes of Stanislaw Burzynski. “If somebody were able to bring some new, innovative idea into the fight against cancer,” Burzynski told Rivera, “then finally the American public will ask the big institutions, ‘What are you doing with all this money? Where are your results?' Finally, they would have to answer to the American public!”

The Burzynski miracle marched on. Seven-year-old Dustin Kunnari received antineoplastons for a brain tumor; six weeks later, the tumor was gone. Tori Moreno's advanced brain cancer was gone in five months. Antineoplastons had also cured the brain tumors of Pamela Winningham, Crystin Schiff, Zachary McConnell, and Thomas Wellborn. And they had cured Randy Goss's kidney cancer.

In 1995, Harry Smith, of
CBS This Morning,
brought several patients cured by antineoplastons onto his show. “It's like cancer never happened to me,” said Neal Dublinsky, of Los Angeles. “Houston was the city where my life was saved.” In 2001, Thomas Elias wrote
The Burzynski Breakthrough: The Most Promising Cancer Treatment and the Government's
Campaign to Squelch It
. Elias told the story of Burzynski's persecution by the medical establishment. And he told the stories of patients who had been saved by antineoplastons despite the best efforts of cancer specialists to ignore the miracle in front of them.

In 2010, the documentary
Burzynski
aired throughout the country. Written and directed by Eric Merola,
Burzynski
featured the recovery of Jodi Fenton and Jessica Ressel from brain cancer and Kelsey Hall from adrenal cancer—all because of antineoplastons, all despite the grim prognoses of so-called cancer specialists. The movie also showed attempts by FDA commissioner David Kessler to shut down Stanislaw Burzynski. “It constitutes nothing less than one of the worst abuses of the criminal justice system I have ever witnessed,” said Congressman Richard Burr of North Carolina. Burzynski sat calmly in the midst of the maelstrom, unwavering, undaunted. He was a modern-day Semmelweis whose demonstration that hand washing could stop the spread of germs was ignored by his peers. “It is obvious that Dr. Burzynski has made the most important discovery in cancer ever,” said Dr. Julian Whitaker.

By 2011, the Burzynski Research Institute, located in Stafford, Texas, housed four chemists, four biologists, three pharmacists, and an antineoplaston production facility occupying more than 46,000 square feet—the size of a small biotech company.

S
o why haven't antineoplastons become part of routine cancer care? Surely patients haven't made up their
stories—surely people don't say they've been cured of terminal cancer when they haven't or say they're still alive when they're not. A closer look, however, shows that Stanislaw Burzynski's antineoplaston cure isn't exactly what it's claimed to be.

In November 1982, several Canadian residents who had received antineoplastons wanted to be reimbursed by their insurance company. In response, Canadian researchers Martin Blackstein and Daniel Bergsagel traveled to Houston. This was the first independent review of Burzynski's program. Blackstein and Bergsagel asked Burzynski to provide four pieces of information: (1) a biopsy proving that the patient had had cancer; (2) records of treatments before antineoplastons; (3) records of treatments with antineoplastons; and (4) radiological studies like X-rays and CT scans. Burzynski provided data from his fourteen most successful cases.

Although Blackstein and Bergsagel had been clear about what they'd wanted, what they'd gotten was disappointing. Records were scant and incomplete. Two patients had CT scans before and after antineoplastons: no change. Two other patients had been cured by standard treatments
before
seeing Burzynski. Blackstein and Bergsagel couldn't find any objective evidence that antineoplastons worked. “We were surprised that Burzynski would show us such questionable cases,” they wrote. “We were left with the impression that either he knows very little about cancer … or else he thinks that we are very stupid and has tried to hoodwink us.”

Blackstein and Bergsagel also asked to see the records of four other patients whom Burzynski had described in a medical journal in 1977. Again, the results were
disappointing. Three of the patients had died from their cancers. The fourth had been cured by surgical removal of a bladder tumor.

The second independent review of Burzynski came in 1985, again from Canada. This time investigators from the Canadian Bureau of Prescription Drugs reviewed the records of thirty-six patients. Thirty-two had died from cancer without benefit from antineoplastons. Of the four remaining patients, one had died after a slight regression of the tumor; one had died after being stable for a year; and two were still alive at the time of the survey. Of the two who were still alive, one had metastatic lung cancer and the other cervical cancer—neither had been cured.

In 1988, Sally Jessy Raphael, a popular talk show host, interviewed four patients treated by Burzynski whom she described as “miracles.” Four years later,
Inside Edition
followed up. Two of the four had died of cancer, and a third was in the midst of a recurrence. The fourth had been cured of a bladder cancer that had had an excellent prognosis.

In 1990, the United States Congressional Office of Technology Assessment reviewed journal articles published by Burzynski and concluded, “Despite a substantial number of preliminary studies, there is still a lack of valid information to judge whether this treatment is likely to be beneficial to cancer patients.”

A
s patient testimonials mounted, independent researchers offered to test antineoplastons. One was Joseph Jacobs, director of the newly created Office of Alternative Medicine
(OAM), later to become the National Center for Complementary and Alternative Medicine. Burzynski resisted. “OAM was willing to buy the research assistance for [Burzynski] to design a good protocol and to set up a data-monitoring committee,” said Jacobs. “There have been plenty of opportunities. And those clowns—his supporters—were doing everything they could to wreck those opportunities.”

In 1991, two investigators from the National Cancer Institute visited the Burzynski Research Institute and, after reviewing clinical histories, pathology slides, and radiological studies from seven patients, concluded that he might be onto something. They agreed to fund an expensive clinical trial in patients with brain tumors. This was Burzynski's single best chance to convince the FDA to license his drug.

After years of haggling with Burzynski about which patients should be included, the National Cancer Institute published its study. The collaboration involved researchers from the Mayo Clinic in Rochester, Minnesota, the Memorial Sloan-Kettering Cancer Center in New York City, and the National Cancer Institute, in Bethesda, Maryland—three of the most prominent cancer centers in the world. It was the first time a meaningful publication about antineoplastons didn't have Stanislaw Burzynski's name on it. The results were disappointing. All nine patients treated with antineoplastons died; none had had any evidence of a response to treatment. And despite Burzynski's claims to the contrary, antineoplastons were toxic: some patients suffered nausea, vomiting, headaches, and muscle pain; others, excessive sleepiness, confusion, and seizures. Burzynski was furious. Convinced that the National Cancer Institute had purposefully ruined his
work, he said, “They sabotaged the trial. They were trying to give the treatment for a very short period of time, like for instance a couple of weeks or months. And then, of course, the patient was dying after that. It was completely unethical. It was horrible.”

I
n 1992, Saul Green, a biochemist, summarized what was known about antineoplastons AS2.1 and A10 in a paper published in the
Journal of the American Medical Association
. He explained that AS2.1 was phenylacetic acid (PA), a potentially toxic substance produced during normal metabolism. Typically, phenylacetic acid is detoxified by the liver—where it becomes phenylacetylglutamine (PAG)—and is then excreted in the urine. A10 is essentially PAG. Burzynski had claimed that AS2.1 and A10 worked by inserting themselves into DNA and changing the genes that cause cancer. However, PA and PAG are too big to fit into DNA. Green concluded, “The treatment for cancer with substances called antineoplastons actually involves the use of two simple commercially available organic chemical compounds, PA and PAG. None is a peptide, none has been shown to ‘normalize' tumor cells, none has been shown to actually [insert] into DNA, and none has been shown to be active against cancer in experimental tumor test systems.”

F
urther investigations led to further disappointments.

During the 1990s, three independent reviewers evaluated 963 patients who had received antineoplastons. All three
were cancer specialists: Howard Ozer, director of Allegheny University Cancer Center in Pittsburgh; Henry Friedman, professor of pediatrics at Duke University and chairman of the brain tumor committee of the Pediatric Oncology Group; and Peter Eisenberg, a community oncologist practicing in Marin County, California. All agreed that Burzynski's protocols were poorly designed, his data uninterpretable, and the toxicities of antineoplastons potentially dangerous. Most upsetting was Burzynski's treatment of a four-year-old boy with a potentially curable brain tumor. Treated with antineoplastons only, the boy's cancer worsened.

By 1995, the FDA had had enough, charging Stanislaw Burzynski and his clinic with seventy-five counts, including criminal contempt, mail fraud, and violations of the Food, Drug, and Cosmetic Act. Congressman Joe Barton of Texas rushed to Burzynski's aid, holding a hearing that allowed others to tell their side of the story. Patients and parents carried placards proclaiming, “Say No to Chemo,” while chanting, “FDA go away! Let me live another day!” In 1997, the government failed in two attempts at conviction: one trial ended in a hung jury, the other in a not-guilty verdict.

For many cancer sufferers, Stanislaw Burzynski had become a countercultural hero. But not to everyone. “It's a travesty of everything we fought for as activists,” said Fran Visco, president of the National Breast Cancer Coalition. “If this is the type of research that is permitted to go forward, it's a threat to our lives and a threat to continued support of science. How is he getting away with it?” Ellen Stovall, executive director of the National Coalition for Cancer Survivorship, agreed: “From this moment on we are not going to let him
rest. He is insulting the intelligence of the American people by calling his therapy nontoxic and alternative. I would like to see Dr. Burzynski's congressional patrons apologize to the American people.”

D
uring the 1980s and '90s, three companies showed interest in antineoplastons: Sigma Tau Pharmaceuticals of Italy, Chugai Pharmaceuticals of Japan, and Elan Pharmaceuticals of Ireland. One by one they dropped away. The medical director of Sigma Tau wrote, “Dr. Burzynski was informed on January 31, 1991, that Sigma Tau did not intend to proceed with the development of the antineoplastons. We have studied antineoplastons A10 and AS2.1 … in human and [mouse] tumor cell lines. … On the basis of these results the project has been discontinued.” Burzynski saw the rejections as a conspiracy among cancer doctors willing to lie to save their careers. “Most of the oncologists—I'm talking about reputable oncologists—they work for pharmaceutical companies,” said
Burzynski. “They work in clinical trials; they receive various types of incentives from pharmaceutical companies. They will do everything they can to lie. … We have a lot of evidence about some of these doctors who are dishonest, who are liars, who cheat.”