Taking advantage of cancer patients

How much is 10 months of your life worth? What if you only have 14 months to live?

How should we react to a doctor who takes advantage of some of the most desperate cancer patients to sell them a therapy that doesn’t work? What if, after scientific evidence shows it isn’t working, he continues to promote his therapy and offer it to patients? What if he chooses one of the most intractable cancers, pancreatic cancer, which is a near-certain death sentence, and tells patients to use his therapy instead of the one therapy that offers a small chance of working?
Is scorn a strong enough feeling for such a doctor? Shouldn’t we try to do everything we can to stop him? Well, please meet Nicholas Gonzalez, M.D., who, according to his very own website, treats pancreatic cancer with “diet, supplements (with proteolytic enzymes for cancer patients) and detoxification routines such as coffee enemas.”

Gonzalez invented the “Gonzalez regimen” nearly 30 years ago, and he claims on his website that pancreatic cancer patients in his care have experienced near-miraculous recoveries and far longer survival times than patients receiving normal care. After lobbying Congress directly (again, according to his own website), Gonzalez convinced NIH (with help from Rep. Dan Burton of Indiana) to fund a trial of his regimen, comparing it to the only available chemotherapy. The regimen is quite complicated, so I’ll reproduce it exactly here, from the NIH trials website:

”Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.”

Not an easy therapy for the patients, who had to consume over 100 pills a day in addition to the strict diet, enemas twice a day, and special baths. But does it work?

NO. In fact, the results of this trial were finally published just last month, in the Journal of Clinical Oncology – after 4 years delay – and we now learn that patients undergoing the Gonzalez regimen died in just 4 months, on average, compared to 14 months for patients in chemotherapy. Now 14 months might not seem like a good result, but when you only have 14 months to live, I’m sure you don’t want to die 10 months earlier while taking hundreds of pills and enduring twice-daily coffee enemas. This is quackery of the worst kind, killing the patients and making them miserable for the few months they have to live – according to the JCO article, patients had a worse quality of life under the Gonzalez regimen as well as having a much shorter survival time.

(Note that Kimball Atwood written extensively on the problems with the Gonzalez regimen, including links to his earlier posts on this subject, so I’ll try not to repeat too much of his excellent summary here.)

Not surprisingly, Gonzalez has had a major falling out with his collaborators on the study, who published the article without him as a co-author. So how did he react to these results? Did he have second thoughts, and perhaps consider whether he should stop selling his ineffective therapy (and offering false hopes) to pancreatic cancer patients?

Unfortunately, Gonzalez hasn’t changed his beliefs one bit, and he posted a lengthy “rebuttal” of the JCO article on his site soon after he learned about the article (which he apparently was unaware of until it appeared). In it, he boasts about how he alone was responsible for getting the study funded (“the grant was approved and awarded during a face-to-face meeting between me and the then NCI Director, Dr. Richard Klausner, held in the office of Congressman Dan Burton”), complains about being betrayed by the authors (his former collaborators), and maintains that it “implies falsely the study proves chemotherapy more effective than my treatment.” He goes on endlessly, complaining about how the scientists who ran the study at Columbia University mismanaged everything, and claiming that this is why the results didn’t show that his regimen worked. According to his diatribe, NIH, NCI, and the Columbia scientists were all part of a big conspiracy to hide the truth about his regimen. If there's any conspiracy here, it's Gonzalez's efforts to delay publication of this study and hide the results from his potential future patients (or should I say victims?). (And for those who want to blame "big pharma" for conspiring against Gonzalez, note that he proudly reports on his site that he has received millions of dollars in funding from two large for-profit corporations.)

The story of how this study got started in the first place is disturbing on many levels, and I will point readers again to a blogpost by Kimball Atwood’s for more details. Among other things, the investigators at Columbia University were warned repeatedly about violating IRB protocols on informed consent. And the basis for the study was a claim by Gonzalez – based on 11 patients whom he claims to have treated for pancreatic cancer – that he was achieving survival times substantially longer than standard therapy. It appears that he (in the most generous interpretation) chose selectively among patients to produce this claim.

Gonzalez has been investigated and put on probation in the past by the N.Y. medical licensing authorities, and has been sued successfully for malpractice, after recommending that a woman forego standard cancer therapy and take his treatment instead. (As Quackwatch documents, “he claimed that the cancer was cured even though it was progressing. It eventually damaged her spine and left her blind.”) Despite these past mishaps, he continues to offer his regimen to cancer patients, and his website today still contains claims of multi-year survival for many of his past patients.

Gonzalez is taking advantage of vulnerable, desperate patients and selling them a painful treatment that merely kills them faster. NIH deserves blame here too, as does NCCAM (the National Center for Complementary and Alternative Medicine), which funded this unethical trial, and especially Congressman Dan Burton, whose support for pseudoscience has in this case caused inexcusable harm to patients whose lives were cut short. And the physicians at Columbia who went ahead with the trial are not without blame either.

How should I react to Gonzalez? Should we give him the benefit of the doubt, and assume he’s just trying to do the best for his patients? Should we believe his claims of a conspiracy and fund more investigations into his elaborate regimen for treating pancreatic cancer? Or should we take away his license, and do anything else we can to prevent him from offering this therapy ever again? I know what I think. I am appalled.

Note: I also recommend Orac's article on this topic, titled "The Gonzalez protocol: worse than useless for pancreatic cancer."