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"This is taking a long time," Goldberg told the Press in an e-mail. "Sure, drug approval is a technical, time-consuming and costly process. Nonetheless, thousands of anticancer compounds have been shown to be effective — or dismissed as ineffective — over the decades since Dr. Burzynski initiated his experiments."
Henry Friedman, a neuro-oncologist at the Duke University Medical Center, was one of the independent doctors who reviewed the data for Goldberg. He doesn't say that antineoplastons don't work — only that Burzynski has failed to prove otherwise.
"Despite thousands of patients treated with the antineoplastons, no one has yet shown in a convincing fashion, [through] the rigorous requirements for peer review, that the therapy works," he says, adding later, "You have to understand how incredible that is. Because normally, you can do a cancer study of as few as 30 [or] 40 patients...and begin to get an idea of whether there is activity or not. And then you can do larger studies, and you can really prove the merits or the lack of merit of the therapeutic strategy."
When asked why, if Burzynski's protocols were so lacking, he received orphan status from the FDA, Friedman says, "It is a Grand Canyon's distance between somebody getting orphan disease status and getting approval for the drug."
Moreover, he says, Burzynski "has been making a fortune...on patients he's treated with antineoplastons. I find that of questionable ethics."
"If there were something there, it would be fairly easy to prove," he says. "And you don't have to do it in any unique way other than a routine, careful Phase II trial, or, with thousands of patients, he could have done a randomized study."
"He's selling hope at a high price," Gorski says.
But what about all those patients who credit Burzynski with saving their lives? Don't they count for anything?
"How many people are there who feel like [televangelist] Benny Hinn saved their lives?" he says, adding that "People who are dead do not get up and say, 'Burzynski did nothing for me.'"
Also, Gorski says, bold and unproven claims are "a problem for cancer in particular, because as soon as you get cancer, you've got a big target on your back [for] quacks to come and get you."
So while mainstream oncologists might believe that Burzynski orbits the quackosphere, he has achieved near-messiah status among journalists, pseudoscientists and armchair oncologists who believe in an omnipotent Cancer Industry determined to quash any treatments that threaten the standard regimens of surgery, radiation or chemo. Often, the cornerstone of their belief is that every oncologist in the country is absolutely fine with children dying gruesome deaths because they are somehow making money off standard treatments.
And while Burzynski's patients say the antineoplastons worked where other treatment failed, these patients — or their surviving family members — often operate under the belief that any success is attributable to antineoplastons alone, and any deaths are strictly the fault of previous chemo or radiation.
While speaking with these family members, or reading their testimonies, is often heartbreaking, Burzynski has not been able to translate these anecdotes into sound science.
This may be because Burzynski doesn't seem interested in persuading colleagues, only patients. And on that level, he's wildly successful.
Patient testimonies almost always contain the phrase "treated like family." His warm bedside manner, and that of his staff, is often in stark contrast to patients' experiences in mainstream hospitals. Also, his CV is long, and, depending on what you consider relevant to the practice of medicine, contains the vital information that Burzynski is a "hereditary count" and the fact that he holds hundreds of patents in dozens of countries. (According to the U.S. Patent Office, these include a patent for a cancer-fighting toothpaste, as well as antineoplaston treatments for patients with AIDS, Parkinson's disease and neurofibromatosis. The 1991 patent for AIDS treatment describes remarkable results achieved with three patients, but Burzynski doesn't appear to have continued this research.)
Burzynski can also point to the hundreds of articles he's published, which also reassures patients and makes them comfortable enough to write big checks. Some of these articles are interesting reading, such as the 2004 one titled "Antineoplastons in Dairy Products," which revealed the dramatic finding that the level of antineoplastons in whey is greater than that found in feta cheese. (Caveat, per the study: "The analysis of feta cheese was more difficult to perform due to the high content of fat.")
This feta cheese revelation unfortunately occurred after the publication of the Burzynski bible, i.e., The Burzynski Breakthrough: The Most Promising Cancer Treatment and the Government's Campaign to Squelch It, but there's no telling if it will make future editions. But the book's author, syndicated columnist Thomas Elias, remains convinced that the FDA persecuted Burzynski because he threatened the livelihood of the doctors on the agency's review boards.