The Orange Man

While I am on vacation, I'm reprinting a number of "Classic Insolence" posts to keep the blog active while I'm gone. (It also has the salutory effect of allowing me to move some of my favorite posts from the old blog over to the new blog, and I'm guessing that quite a few of my readers have probably never seen many of these old posts.) These will appear at least twice a day while I'm gone (and that will probably leave some leftover for Christmas vacation, even). Enjoy, and please feel free to comment. I will be checking in from time to time when I have Internet access to see if the reaction to these old posts here on ScienceBlogs is any different from what it was when they originally appeared, and, blogging addict that I am, I'll probably even put up fresh material once or twice.




The first thing that struck me about him was that he was orange.

It wasn't a shade of orange I had ever ever encountered before in a patient. It was a yellowish orange, an almost artificial-looking color. At first I wondered if he was suffering from liver failure with jaundice, but this orange was not the right color, and his sclerae were not yellow. I also considered whether he was suffering from renal failure, but the orange color of his skin didn't quite match the rather coppery color that some patients suffering longstanding renal failure necessitating dialysis sometimes acquire. I was puzzled. His chart said that he was being admitted for surgery for rectal cancer. So I sent the intern in to get the story, do the history and physical, and get him all plugged in for his bowel prep. (Yes, believe it or not, there was a time when it was not all that uncommon for patients to come into the hospital the night before their surgery in order to undergo a preop bowel prep, rather than being forced by their insurance companies to undergo the torture of drinking four liters of the purgative known as Go-Lytely--a misnomer, if ever there was one!--at home and spending the next several hours having to rush periodically to the toilet, waiting in vain for the liquid exploding out of their hind end to run clear.)

Ten years ago, I was in my chief resident year in general surgery. I was doing a rotation as chief of one of the general surgery services back at the mothership (the University Hospital). This particular service had a lot of colorectal surgeons on it. Consequently, we saw a lot of good, solid general surgery involving the colon, one of the organs a lot of general surgeons like to operate on the most. Naturally, a lot of this surgery was colorectal cancer, given how common this variety of cancer is. It was while I was doing this rotation that I first encountered the Orange Man, as I dubbed him in my mind (although I never called him that out, not even to the other residents, who might have found it amusing).

When rounding with one of my surgery attendings, I learned the sad tale of the Orange Man. He was a man in his early 50's, who had first seen my attending over a year before. He had suffered BRBPR (which, non-medical types, stands for "bright red blood per rectum") and been referred to a gastroenterologist, who examined him and did a colonoscopy. This revealed a rather low-lying rectal cancer. He was referred to my attending, who evaluated him, found that there was no evidence of metastasis to the liver or elsewhere on CT scans, and recommended surgery. Although the tumor was relatively low, the attending thought there was a very good chance he could do a sphincter-sparing procedure, known as a low anterior resection, possibly with either a very low anastomosis or a coloanal anastomosis. However, the patient would have to be prepared for the small possibility that it might require an abdominoperineal resection (APR) to remove the tumor. (An APR involves taking not just the rectum, but the anus as well. It necessitates sewing the anus shut and leaving the patient with a permanent colostomy. APRs are necessary for very low-lying cancers or cancers that can't be removed with an adequate margin of normal tissue between the tumor and the anus or tumors low enough to involve the anal sphincter mechanism.

Scary news indeed. I can only imagine the reaction of the Orange Man upon hearing the news. He was probably terrified. Certainly, I'd be scared if it were me. Certainly, I wouldn't want to have a permanent colostomy if it wasn't possible to get the tumor out with a clean margin and still save my anal sphincter. No one, and I mean no one, does. But, if it had been me, I'd still have undergone the surgery, because I know it would be my best shot at long-term survival. I'd take the small chance that it might be necessary to have a permanent colostomy.

The Orange Man, unfortunately, made a different choice. Convinced that he could find another way, he sought "alternative" medical treatments. He somehow ended up in New York City, where he undertook a regimen that involved coffee enemas and megadoses of carrot juice. There he returned periodically for over a year, all the while purging himself with coffee enemas, consuming megadoses of carrot juice and vitamin supplements, and undertaking various other "alternative" treatments for a potentially curable cancer (and, I guess, trying to ignore the increasingly orange tint his skin was developing).

Coffee enemas? I couldn't believe it. I had never heard of such a therapy before. What possible use could coffee enemas have against cancer, I wondered. The only use for them I could imagine at the time was possibly as a more rapid (and highly disgusting) method of delivering caffeine into the bloodstream.

I didn't know about it at the time, but now I can speculate that the "therapy" the Orange Man had chosen was very likely some variation of the Kelley/Gonzalez treatment. The basis of this "therapy," developed first by Max Gerson, MD back in the 1940's and 1950's, then continued by William Kelley, DDS in the 1960's, and still practiced today by Nicholas Gonzalez, MD, is a belief that all cancers come from a deficiency of pancreatic enzymes, which supposedly allows cancer cells to grow. By the "concept" behind this, cancer grows and metastasizes because there is lack of cancer-digesting enzymes in the body. The solution is, supposedly, is to get pancreatic enzymes to the place where cancer is growing, in a concentration high enough to stop growth, but not so high as to cause too rapid production of "toxins" from tumor breakdown. Consequently, the treatment consists of "detoxification" with coffee enemas, which supposedly help flush the waste products of tumor cell breakdown out of the body; dietary manipulations; ingestion of pancreatic enzymes; and megadoses of supplements and vitamins, like carrot juice. The original Gerson diet required more than a gallon a day of juices made from fruits, vegetables, and raw calf's liver, but there are many variants.

Looking back on the incident, I now wonder if the Orange Man was treated by Gonzalez himself, given that New York is where Gonzalez has operated.

The Orange Man was finally forced to return to my attending when it became clear that the coffee enemas and megadose carrot juice therapy were not working. His rectal tumor continued to bleed intermittently but with increasing frequency. It continued to grow slowly and started to interfere with his ability to defecate. Finally, it began to produce a horrible sensation of tenesmus (the intractable sensation of having to move one's bowels that rectal cancer patients sometimes get and which can at times be almost unbearable). Finally, the Orange Man had had enough.

Unfortunately, the cancer hadn't yet had enough the Orange Man. By the time he returned to "conventional" doctors and surgeons, his tumor had grown considerably. It was now intermittently bulging out of his anus and may have been growing into his anal sphincter. Fortunately, CT scans showed that it did not appear to have metastasized to the liver or elsewhere yet. Fortunately for him, the tumor still appeared to be operable. But he would require an APR and a permanent colostomy for the tumor to be excised with curative intent. There was no chance of sparing the anal sphincter and no chance that he would avoid a permanent colostomy. There was also a very high chance that the Orange Man would be left permanently impotent, as well.

The Orange Man was the first to teach me that alternative medicine that is ineffective is not harmless.

I still remember his operation. It was one of the last ones I did before I had to move on to another service. The Orange Man had a bulky rectal tumor that was very difficult to remove. He had numerous hard, suspicious lymph nodes in the mesentery, going all the way up to the root of the aorta. He clearly had node-positive disease, a negative prognostic factor. The tumor had clearly invaded all the way through the wall of the rectum, another negative prognostic factor. All I can remember thinking is: How on earth could this guy have chosen not to undergo surgery a year before, back when his tumor would have been much more easily removed, and he would have had a good chance of not needing an APR (with its attendant permanent colostomy), not to mention a much better shot at long-term survival? Why? What did the "alternative" medicine practitioner tell the Orange Man to convince him to forsake proven effective therapy? Did the practitioner promise him he could be "cured" without surgery, radiation, or chemotherapy, without pain? Did the practitioner scare him with horror stories of the complications from such therapies? Did he or she do a little of both?

I don't know what ever happened to the Orange Man. I felt very sorry for him. He had clearly been taken in by a quack and was very likely to pay the ultimate price. And he knew it. A few days later, before the Orange Man was discharged, I had to move on to another service in another hospital. I never saw Orange Man again. Given the extent of his disease, there's certainly less than a 50-50 chance that he is still alive today. If he is still alive, however, there is a 100% chance that he has a permanent colostomy that he probably didn't have to have.

Alternative medicine that is ineffective is not harmless.

When I hear advocates of alternative therapies claim that their therapies are harmless, I think of the Orange Man. When I hear advocates of alternative therapies claim that their therapies are harmless, I also think of women like Patti Davis, who underwent a breast biopsy and was told that she had breast cancer. Her cancer would have had a high probability of being cured (oncologists hate to use that word, but in this case it is not entirely inappropriate) with conventional therapy, but instead she, like the Orange Man, opted for a variant of the Gerson therapy, driving to a clinic in Tijuana, undergoing "detoxification, and eating 7-8 pounds of carrots a week at one point. Her mother, who had had breast cancer at age 47 and survived 22 years after surgery, radiation, and chemotherapy, urged her daughter to finish her surgical therapy and a course of conventional therapy, to no avail. Mrs. Davis ultimately did return to conventional therapy when she felt a lump under her arm that had developed while she was undergoing the Gerson therapy and finally realized her mistake.

By then it was too late. She later died at the age of 39.

And she has company: Debbie Benson, who eschewed conventional therapies for a treatable cancer; Lucille Craven, who went so far as to hide her diagnosis from her husband for many months while she sought treatment from various "alternative" practitioners; and many others.

Alternative medicine that is ineffective is not harmless.

I think of the Orange Man and Patti Davis, when I read or hear alties crowing about how the Gonzalez regimen is being tested by an NIH-funded trial. Although I support the rigorous testing of alternative medicine therapies in clinical trials to determine whether they have any efficacy, as I have said before (see here and here), dubious trials like the Gonzalez trial highlight the problems of the National Center for Complementary and Alternative Medicine (NCCAM), too many of whose studies are based on pseudoscience and supported by preliminary data that is shaky, at best. A prime example, the Gerson/Gonzalez therapy trial was funded on the basis of a single uncontrolled and poorly designed clinical study of 12 highly selected patients with pancreatic cancer. R01 grant applications for conventional medical therapies usually require considerable preliminary data from basic science, preclinical animal experiments, and often preliminary clinical trials if they are to have a shot at being recommended for funding. Where was the in vitro data to support the Gonzalez protocol, showing activity against pancreatic cancer cell lines? Where were the preclinical animal studies showing activity in models for pancreatic cancer (or any cancer)? Where were the animal studies that support the supposed mechanism by which the therapy is postulated to work? Not in the scientific literature or in the grant application, as far as I can tell. If I were to submit a grant application to the NCI for funding for a clinical trial based on so little data, the study section would deposit my application in the circular file; that is, if they didn't pass out from laughing so hard first! Yet NCCAM funded this one for over $1.4 million. That's $1.4 million that could have gone to fund a trial that might actually have taught us something, just like the more than $1 million that has gone to funding a trial to test chelation therapy, despite randomized clinical trials showing that it does no better than placebo for atherosclerotic cardiovascular disease. Worse, both of these studies lend credibility to these dubious therapies, because they have the imprimatur of the NIH. Because I still believe that some alternative therapies that show promise need to be tested by rigorous science (green tea as a chemopreventative agent for cancer, for example), I wouldn't go so far as Dr. Sampson, who believes that NCCAM should be completely defunded. On the other hand, it is unclear to me why NCCAM's budget continues to rise, while the NIH budget proposed by the administration for fiscal year 2006 is the tightest in more than a decade. With paylines for NIH grants falling like a rock last year and poised to fall just as much farther next year, I have to ask: Are these sorts of dubious studies the best use the NIH can find for the increasingly limited pool of taxpayer money for biomedical research?

Alternative medicine that is ineffective is not always harmless. It's not just the patients who choose them in preference to proven treatments who suffer. It's their families friends, who watch them die from potentially curable diseases (often draining their life's savings along the way), and all of us, who fund these ineffective treatments or end up paying more through taxes and insurance when a patient who might have been treated more effectively and inexpensively requires much more difficult and expensive treatment because of a delay caused by the pursuit of ineffective therapies and false hopes.

This post originally appeared on April 13, 2005 on the old blog.