– The paradigm dispute in medicine (H. L. Coulter)

Stages I and III: Emergence of the Minority Paradigm; Separation and Expulsion; Professional Coercion Stanislaw Burzynski, M.D. , Ph.D.  (biochemistry), was born and educated in Poland, receiving his degrees by the age of 24 from the Medical Academy of Lublin. While searching for a Ph.D.  dissertation topic he discovered that human blood contains certain unidentified substances regarded as intracellular debris, and he decided to identify these substances.
 He concluded that they were new varieties of the metabolites known as peptides. When he emigrated to the United States in 1970, and obtained a position as researcher and assistant professor at the Baylor College of Medicine in Houston, he continued to isolate and identify these peptides.
 After discovering that cancer patients had lower than normal levels of certain of them (2 percent of normal, for instance, in prostate cancer), and that some of them exhibited pronounced anti-tumor activity, he called them Antineoplastons. He later concluded that they suppress the oncogenes which are hypothesized to cause cancer while at the same time stimulating the tumor-suppresser genes that are hypothesized to stop cancer. It followed that cancer patients could be successfully treated by bringing their blood levels of Antineoplastons up to normal.
 Eventually he isolated 119 Antineoplastons from human blood and urine, some with general anti-tumor activity, others with specific action on certain types of tumor cells. He published articles on them in the scientific journals, obtained a number of scientific awards, and became a member in good standing of the American Medical Association and the American Association for Cancer Research.
 In 1976 he was offered a promotion to the Baylor Cancer Research Center, but this would have meant abandoning the private practice of medicine and losing the intellectual and professional independence which this entailed. Perhaps it was his earlier years dealing with the bureaucracy of communist Poland which inclined him against the offer, but, in any case, he rejected it and resigned from Baylor.
 He started treating cancer patients as an independent physician and, according to testimony by himself and his associates, with fair, or better than fair, success. Using these data he was able to persuade the institutional review board of Houston’s Twelve Oaks Hospital to allow Antineoplastons to be used there. In 1977 he reported on a clinical trial at that Hospital in which Antineoplastons were administered to 21 advanced cancer patients: “Chronic intravenous administration of Antineoplaston A to these patients showed pronounced anti-tumor effect without any significant toxicity.”
 At this point the Twelve Oaks Hospital withdrew his permission to treat patients with Antineoplastons, demanding that Burzynski first get permission from the Baylor College of Medicine or the M. D. Anderson Clinic in Houston. While these two organizations had no legal right to block Burzynski’s treatment, they were major centers of political power in the Houston medical establishment.
 Burzynski was thereby forced to strike out on his own. He opened his own clinic and used patient fees to finance the further development of Antineoplastons. Thus he avoided the usual approach of selling his invention to a pharmaceutical manufacturer and letting this company battle with the FDA-a course which takes an average of ten years and costs an average of over $100 million.
 His determination to pursue his own course in life aroused hostility of the sort discussed above in connection with homoeopathy and Krebiozen. In 1978 he was investigated by the local medical society “board of ethics” for using “unapproved” medicines of his own devising. He was ordered to cease giving interviews to the press (i.e. , to stop appealing from the profession to the public at large). He was denied research funds from the American Cancer Society. He was also cut off by the National Cancer Institute, which had helped finance him in the past. And the 1978 meeting of the American Association for Cancer Research actually refused his abstract-which rarely occurs to a recognized researcher (by this time Burzynski had 28 publications to his name).
 Because of the medical society’s gag order Burzynski could not complain about this treatment, but the press blackout was broken in 1979 by Gary Null, a New York health crusader, in a 1979 article in Penthouse-“The Suppression of Cancer Cures.” In 1981 Burzynski was featured in an episode of ABC’s 20/20, “The War on Cancer: Cure, Profit, or Politics?”
 Interest in Antineoplastons was mounting, patients were flocking in for treatment, and a Canadian physician impressed by the treatment persuaded Burzynski to apply for IND (“investigational new drug”) status in that country. For a while it appeared that Canada would be the first country to license this new anti-cancer substance, but in 1982 the Ontario Health Insurance Plan stopped paying for Antineoplastons and declared them , “experimental.”
 The Ontario Deputy Minister of Health asked the Ontario Medical Association to appoint experts to review Burzynski’s treatment.
 Thus the stage was set for orchestrating a damaging report of no probative medical value but of great public-relations significance. Drs. Martin Blackstein, chief of oncology at Mt. Sinai Hospital in Toronto, and Daniel Bergsagel, head of medicine at Princess Margaret Hospital in that same city, flew to Houston the morning of November 15, 1982. Burzynski first showed them his manufacturing facility and then took them to the Clinic to review patient records. They spent 2 hours and 15 minutes on this latter task and then flew back to Toronto. Their report (prepared within a day or two) stated, inter alia, “After reviewing 20 case reports …we were unable to identify a single case in which therapeutic benefit could be attributed to Antineoplastons.”
 This report, eerily similar to the treatment meted out to Ivy and Benveniste, was the turning-point in Burzynski’s relationship to the medical establishment and the beginning of a downhill slide in his fortunes. It was steadily cited as the reason why Burzynski’s results could not be taken seriously and why his treatment should be considered fraudulent. The two doctors strongly recommended against insurance reimbursement for the Burzynski therapy, and their report became the touchstone of opposition to Burzynski. They stated: “Dr. Burzynski does harm by misleading patients and giving them false hope. Furthermore, some patients may be diverted from standard curative therapy by the lure of a false siren.”
 Thereafter Burzynski was shunned and blacklisted; other physicians stopped referring patients, and he was clearly being marginalized.
 The attitude of other oncologists to Burzynski can be judged by the comments of Patrick Kelly, MD, head of pediatric neurosurgery at the Mayo Clinic in Minnesota, later chairman of the Department of Neurosurgery at the New York University Medical Center. He was interviewed by Julian Whitaker, MD, a physician sympathetic to Burzynski, who showed Kelly before-and-after X-rays of a young boy whose inoperable brain tumor had virtually disappeared after treatment with antineoplastons. Kelly himself had diagnosed this boy nine years earlier, stating that the tumor was one of the largest he had ever seen, and calling the case “terminal.” States Whitaker: “Dr. Kelly was emotional and, in my opinion, irrational. He knew nothing about the therapy but felt that Burzynski was “out in left field”, and likened a concern with Burzynski’s plight to “jousting at windmills” or trying to solve “the hunger problem in Ethiopia.” He said that he “would like to see the scans, but they wouldn’t change his mind about Burzynski.” He then asked, “Dr. Whitaker, you do not treat brain cancer, but I do. Why are you so interested in what Dr. Burzynski is doing, when I’m not?” He ended this unpleasant conversation with, “Dr. Whitaker, I am just not interested.” Whitaker goes on,”Without exception, all the oncologists I talked to about Dr. Burzynski were scornful and hostile …Delving into the attitudes, actions, and beliefs of modern oncologists was like opening a box of cereal and finding it full of worms….”
 Stage II: Ideological Warfare
 This report, and another in January, 1983, by the American Cancer Society, contained the same factual distortions and omissions and the same evidence of bad faith which have been evident in the other paradigm disputes.
 At the top of the list is the venerable “secret remedy” charge. Blackstein and Bergsagel stated, “the preparation of human urinary antineoplastons is not known, and the structure of the synthetic compounds is secret.”
 In fact, the manufacture of these peptides was at the time covered by five US patents, and many more in other countries, all of which revealed details of the manufacturing procedures. Burzynski had licensed Taiwanese and Filipino companies to manufacture Antineoplastons, so they could hardly be “secret remedies.”
 The “secret remedy” charge was just medical flim-flam. Burzynski himself wrote later that Blackstein and Bergsagel appeared not to comprehend, and were not even interested, when he attempted to explain how Antineoplastons were manufactured.
 Next came the “previous treatment” chestnut: “The commonest problem we encountered [sic] was the fact that the patients had received effective treatment before they were referred to Houston, and were responding slowly to this treatment. Dr. Burzynski started antineoplaston and falsely credited the antineoplaston with the therapeutic response that was observed.”
 This argument has already been examined in the case of homoeopathy and Krebiozen. Here the two Canadians were dead wrong about the facts. Seven of the nine patients had not received any standard treatment. One had had chemotherapy and radiation. One other had received a small dose of radiation. But even in the two latter cases, how could they determine a priori what treatment had benefited the patients?
 The Canadians then complained about the dearth of animal studies. Burzynski’s answer was that Antineoplastons are “species specific,” meaning that medicines made from human sources do not work, or do not work well, in animals. In particular (as Burzynski had already warned), they do not work well in the standard NCI mouse leukemia study test.
 However, in animals the Antineoplastons seem to possess a preventative effect. Burzynski had shown that their inclusion in the diet of mice subject to spontaneous breast cancer significantly delayed the onset of such breast cancers, but this was ignored by the Canadians, who suggested that Burzynski was using the species-specificity argument in bad faith-to evade the requirement for animal studies.
 But species-specificity is a recognized factor in any medicines made from animal or human sources, and this charge by Blackstein and Bersagel (later repeated by the National Cancer Institute) was evidence of their own bad faith, not of Burzynski’s.
 The Canadian report contained further instances of bad faith. They claimed, for instance, that the slides they saw indicated no improvement in the patient’s status.
 About a patient whose colon cancer had metastasized to the lung and caused nodules in that location they concluded: “The Xrays that we were shown demonstrated no significant change in the size of the pulmonary nodules over a 4 to 5 month period.” But earlier Burzynski had sent these same X-rays to an independent Houston radiologist, not associated with his Institute, who had concluded: “there is considerable improvement with almost complete resolution of the nodules in the right lung …The nodule in the left suprahilar region which was seen on the previous radiographs has also completely regressed.”
 In general, the two doctors seemed incurious about Burzynski’s data, giving the distinct impression that their minds were already made up.
 As with the committees condemning Krebiozen, the Canadians saw no live patients, and it is not clear how many records they examined. At one place in their report they wrote “20,” at another “12. ” According to Burzynski, they only examined 9 case reports. He wanted to show them others, but they were in a hurry to get back to Toronto. He offered them some files to take along, but they refused. Finally he sent them 16 more reports by mail, most showing complete remission with no treatment other than Antineoplastons.
 So the two Canadians flew all the way to Houston and back to examine the records of 9 patients!!
 Stage IV: Administrative and Judicial Coercion
 In January, 1983, the American Cancer Society announced that it “does not have evidence that treatment with Antineoplastons results in objective benefit.”
 But, like the Stoddard-Cole Report on Krebiozen, the body of the announcement contradicted the conclusions. The ACS noted that in a 1977 study by Burzynski, “twenty-one far-advanced cancer patients were treated with Antineoplaston A” and “some degree of clinical improvement was noted in 18 of the 21 patients (86 percent).” It also repeated without comment Burzynski’s claim that there were “minimal or no side-effects” and presented a chart showing complete remission in four cases (19 percent), partial remission in another four cases. Thus Antineoplastons were, in fact, effective in treating cancer.
 The ACS announcement was thus a confused bureaucratic maneuver, and not a scientific conclusion.
 What is the public supposed to think when the American Cancer Society contradicts its own conclusions in this way? In a court of law such misconduct would taint the prosecution’s case and could even involve criminal penalties.
 Whatever the public may have been thinking, the FDA, in April of the same year, filed suit against Burzynski and his associates to “force the permanent cessation of all their scientific and medical work on the development, manufacture, and administration of antineoplastons.”
 But the trial judge ruled against the FDA on grounds of insufficient evidence to warrant such a sweeping measure. She did, however, agree on an injunction against shipping Antineoplastons in interstate commerce until Burzynski filed an IND with the FDA, while specifically allowing the medicines to be sold inside Texas.
 On May 6, 1983, Burzynski applied for an IND for one of the Antineoplastons. At the end of the month, however, the FDA turned him down, putting the drug on what is called “clinical hold.” The reason given was that Burzynski had failed “to furnish information indicating that Antineoplaston A-10 …has activity against malignant cells of animal or human origin or against animal tumors.”
 This statement, as we have seen, was an outright lie. But the “clinical hold” remained in effect, symbolizing the treatment which Burzynski was to receive from the FDA thenceforth. He attempted to comply with the FDA’s IND demands three more times in 1983, once in 1984, once in 1987, and once more in 1988 but was turned down each of the six times.
 In their denial of an IND of May 31, 1983, the FDA wrote that Burzynski did not have the “training or experience” to conduct cancer trials, dismissing the fact that he had conducted NCI-funded cancer research center at the Baylor College of Medicine for seven years.
 By 1988 his IND application contained over 6000 pages and was more than six feet thick. That the FDA was not allowing him an even playing field is seen from a public statement made by FDA Commissioner Frank Young, January 4, 1989, that cancer drugs had been approved by the FDA on extremely small databases (well under 100 patients), with “responses” in less than ten patients, and on the basis of studies “whose design was anything but classic.” In one case, he said, a cancer drug was approved on the basis of only six “responses.” So, like Krebiozen, Burzynski was being held by the NCI to a much higher standard than other applicants.
 By the date of Commissioner Young’s statement Burzynski had treated an estimated 1500 patients.
 The reason for the discrimination against Burzynski was, of course, that drug applications submitted by pharmaceutical manufacturers whose operations are within the accepted paradigm are approved rapidly, while Burzynski’s work was well outside the accepted paradigm.
 Visceral disapproval of drug research outside the dominant paradigm seems central to the FDA philosophy of regulation. Bureau of Drugs Director Richard Crout stated in 1976 that when anyone other than a large institution requests permission to conduct a clinical trial, “You want harsh regulation …sometimes we say it is proper to hinder research.” In 1982 he stated: “I never have and never will approve a drug to an individual, but only to a large pharmaceutical firm with unlimited resources.”
 The story of FDA harassment of Burzynski could be extended ad nauseam. On September 31, 1983, FDA agents made an unscheduled visit to his clinic and questioned him for several houses. The next day they returned and again harassed him while cancer patients had to wait hours for treatment.
 In 1994, when a UCLA professor wanted to conduct clinical trials of Antineoplastons, the FDA delayed approval by nine months, by which time the professor had left the university.
 On July 17, 1985, FDA agents raided Burzynski’s clinic and seized 200,000 pages of documents, including all patient records. To continue to treat these patients Burzynski had to install a copier at the FDA office in Houston and request permission in advance to copy records. These documents have never been returned.
 On October 24, 1985, the Federal judge in Houston ordered the FDA to stop releasing misleading and inappropriate information about Burzynski, especially to insurance companies.
 On April 17, 1986, the FDA denied Burzynski’s request to ship Antineoplastons to a university in Japan which wanted to test them in cancer. In 1989, however, after Japanese studies demonstrated anti-cancer activity of Antineoplastons, the FDA allowed Burzynski to start clinical trials of one preparation.
 Despite these clinical trials, the FDA instigated Grand Jury investigations of Burzynski in 1985, 1990, and 1994. These required submission of thousands of documents by Burzynski and subpoenas of Burzynski himself and his employees to testify. In the 1994 investigation the US Attorney was removed from the case by the judge for “prosecutorial misconduct.”
 On March 23, 1995, FDA agents without a warrant attempted to search the home of a Burzynski brain-tumor patient, telling the family that they had been trying to “get” Burzynski for years. They were barred entry because the daughter, herself a lawyer, happened to be at home.
 The next day, March 24, the FDA raided Burzynski’s Houston clinic for the second time, hauling off boxes of records, including patient files.
 From April to November, 1995, the Government conducted a fourth Federal Grand Jury investigation, subpoenaing more and more of Burzynski’s files and Burzynski’s employees. In November, 1995, FDA Commissioner Kessler was questioned harshly by a congressional investigating committee on FDA abuse of its authority.
 In November, 1995, Burzynski (like Ivy before him) was indicted for interstate commerce in an unapproved drug-specifically for giving drugs not only to residents of Texas (legal) but also to persons from other states in the knowledge that they would take these drugs back home with them (illegal).
 In January, 1996, the Government sought a court order to prevent Burzynski from treating patients who did not qualify for a clinical trial, calling the potential deaths of some patients an “irrelevant” detail. The US House of Representatives scheduled another hearing on FDA abuse of authority, and under this pressure Burzynski was allowed to continue treating his current patients and to expand his limited ongoing clinical trials.
 On September 15, 1996, the FDA refused to meet Burzynski to discuss with him the safety and efficacy of Antineoplastons. The FDA, echoing Richard Crout, stated that it never accepts data from a single investigator, knowing quite well that Burzynski had, and has, numerous collaborators and co-investigators.
 On October 11, 1996, Government lawyers filed motions to keep all evidence of efficacy out of the forthcoming trial, stating that allowing jurors to see such evidence “is a thinly-veiled effort to expose the jury to the specter of Dr. Burzynski in the act of saving lives. Permitting it will certainly infect the jury’s consideration of the real issues with irrelevant, emotional and prejudicial and misleading concerns regarding whether antineoplaston works and the unfortunate fate of Dr. Burzynski’s patients.”
 By this point Burzynski had treated about 3000 extremely ill cancer patients, the bulk of them with brain tumors which do not respond to any conventional cancer therapy.
 This detailed account is given to bring home the degree of vindictiveness manifested by the Government against this person whose only real sin has been to contest the existing paradigm of cancer treatment.
 Burzynski was brought to trial on January 6, 1997. On March 3 the jury declared itself deadlocked-with six jurors for acquittal on all counts, 5 for conviction on all counts, and one undecided. The judge dismissed all points of the indictment dealing with “insurance fraud,” stating that the Government had not come close to proving these charges. The prosecution announced its intent to bring Dr. Burzynski to trial again in May, 1997. 

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