An alternative cancer cure testimonial, mistletoe, and Johns Hopkins University

Ever since the beginning of this blog, there’s one topic I’ve explored many, many times, mainly because of its direct relationship to my profession as a cancer surgeon. That topic is, of course, the question of why people fall for alternative medicine cancer “cures.” It started with one of my very earliest posts and continued right up to deconstructing Presidential candidate Ben Carson’s very own alternative medicine cancer cure testimonial last fall. It continues again now.

Regular readers, particularly long time readers, have already come to recognize common themes in these alternative medicine testimonials. At least I hope so. It is with this hope that I take a look at yet another one of these cancer cure testimonials. One of these common themes, of course, is that frequently those who’ve pursued alternative medicine have also undergone treatment with conventional medicine that was effective. A key characteristic of testimonials for whatever woo these people used to treat their cancer is that they attribute their good fortune to the quackery they’ve chosen, not the conventional medicine or surgery they had undergone before switching to quackery.

This confusion takes multiple forms, the most common of which is confusing chemotherapy used as the primary treatment for breast cancer with chemotherapy used in the adjuvant setting. The former is chemotherapy administered by itself with curative intent; the latter is chemotherapy administered after successful surgery to remove the primary tumor given with the intent to reduce the chance of recurrence. These sorts of testimonials are most common with breast cancer in my experience because surgery is so successful in eliminating most breast cancers, but they certainly are not limited to them. For instance, take a look at the case of Ivelisse Page, who is portrayed as having “refused chemo” and as instead having decided to be injections of “this plant” (not cannabis).

This case is not an unusual alternative medicine cancer cure testimonial. It caught my attention, though, because of its link to Johns Hopkins University and quackademic medicine, an unusual feature given that most alternative cancer cure testimonials stay as far away from anything resembling science as you can imagine.

Let’s see if you can tell where the fallacy lies:

Ivelisse Page’s family has a history of colon cancer. Her father died from the disease in his late thirties. Knowing that she was at higher risk for developing the illness, she followed a healthy lifestyle of organic food and exercise and got regular colonoscopies, yet she also developed colon cancer at the age of 37.

After the diagnoses, she had 15 inches of colon with 28 lymph nodes removed, and later 20% of her liver removed, she writes on her website. But there was one important part of the mainstream oncology treatment that she declined to do – after researching her disease and treatment options herself, she completely refused chemotherapy.

Instead Ivelisse turned to homeopathic remedies and supplements, as well as mistletoe injections – a popular alternative cancer treatment in Europe. Seven years later, she is complete cancer free and is happy to say that she beat IV stage colon cancer that only 11% of patients survive.

This particular testimonial would appear to be particularly convincing to those who don’t know much about colon cancer. I mean, wow! She had stage IV colon cancer, and stage IV colon cancer, as is the case with most stage IV solid tumors, is basically incurable. Well, not quite. There’s a reason why colon cancer also shows up a lot in these testimonials is because there is a certain subset of stage IV colon cancer that can be cured with surgery. That subset is colon cancer that has metastasized to the liver, as long as the metastases are few enough, close together enough, and small enough to be encompassed in a liver resection. Now let’s look at the story as told on her website:

A week after diagnosis, Ivelisse had 15 inches of her colon removed along with 28 lymph nodes. The pathology report would later show that the tumor had perforated the colon wall and that the cancer was present in one of the 28 lymph nodes, “a very good sign” according to the doctors. Obviously the presence of cancer outside the colon wall necessitated further treatment. Jimmy and Ivelisse consulted a variety of doctors, did much reading and research, and bathed the whole process in prayer. They concluded that conventional chemotherapy did not offer the best success rate. In her case chemotherapy would only increase her survival rate by only 10-13%. Instead they chose a complementary and alternative approach. Surprisingly, her oncologist agreed to continue to monitor her despite refusing chemotherapy.

Unfortunately, my favorite tool for estimating recurrence rates, Adjuvant! Online, is down for updating. I can’t determine Ivelisse’s exact stage, but I can say that, because she had a positive lymph node, she is at least stage IIIA. Specifically, she is probably stage IIIA or IIIB, although she could be IIIC if her tumor had invaded through the wall of her colon and into adjacent structures. I’m going to assume that’s not the case because I’m sure she would have mentioned something like that if it were the case, because patients remember if their surgeon has to remove parts of adjacent organs in order to remove the cancer. In any case, five year survival for stage III cancer ranges from 44% (stage IIIC) to 72% (Stage IIIB) to 83% (Stage IIIA). Of course, these figures assume adjuvant chemotherapy was administered, which means that surgery alone produces cure rates roughly 10-13% lower than these numbers. What that means is that chemotherapy reduces the risk of dying in patients like Ivelisse by about a third.

Now here’s the thing. Ivelisse chose an bunch of alternative therapies instead of adjuvant chemotherapy. She recurred, and, worse, she recurred in her liver as stage IV disease. Now, it’s possible that she might have recurred anyway, but by refusing adjuvant chemotherapy she did not maximize her chances of going recurrence-free and surviving at least five years. Let’s say she had Stage IIIA cancer. If that were the case, then she decreased her five year survival by more than one-third.

So, at this point she had at least one liver metastasis. We know that her metastasis/metastases must have been resectable, because she underwent liver resection:

Ivelisse was about a week into her immune therapy when she went in for her 5 week post operation appointment. Her oncologist gave them the shocking news that the cancer had spread to her liver. This put her at stage IV colon cancer. Ivelisse went in for surgery once again to remove the tumor. They removed about 20% of her liver. After surgery, Ivelisse began her prescribed protocol by her complementary and alternative doctor which included daily alternating injections of mistletoe and thymus, cimetidine, homeopathic remedies and additional supplements. The great news is that six years later, Ivelisse beat the 8% survival rate of stage IV colon cancer and is COMPLETELY CANCER FREE! She is still following her protocol under the care of her complementary and alternative doctor, and monitored by her oncologist, GI doctor and OBGYN.

This is a rather interesting combination of woo. For one thing, cimetidine is a pharmaceutical drug, whose trade name is Tagamet. Why it’s in there, I’m not sure. (Note added afterward: Oops. Forgot about this. So there is evidence for antitumor effects from cimetidine; it’s just not compelling to the point where it is routine standard of care.) As for homeopathic remedies, given that homeopathy is The One Quackery To Rule Them All, we know that it wasn’t doing any good. Here’s the other thing. While it’s true that the five year survival for stage IV colon cancer is around 8-10%, that includes all comers, including patients with a lot of metastatic disease and patients with resectable liver metastases. It is this latter category that has a much higher chance of surviving five years. For instance, in the case of a solitary liver metastasis successfully resected, five year survival is around 45%, and in the case if isolated liver metastases (liver metastases that are close together and can be removed as a group), five year survival is around 38%. OK, these are not great numbers, but they do indicate that low volume metastatic disease to the liver is associated with a reasonable chance of survival; it’s not a guaranteed death sentence.

But what about the mistletoe? While it’s true that mistletoe extract has shown some promise against various cancers, I must admit that I was puzzled by this part of Ivelisse’s story:

Suzanne Somers, a well known actress, singer, and author of Knockout, a book about alternative cancer therapies, utilized mistletoe extract injections as part of her natural healing protocol for cancer. But it hasn’t caught on in the U.S. the way it has in Europe just yet.

In 2011, Ivelisse and Jimmy Page founded Believe Big, a nonprofit aimed to educate people on “bridging the gap between conventional and complementary medicine for fighting cancer.” The site also provides resources about mistletoe treatments and how to find physicians who are trained in this therapy.

In 2013, Believe Big started to raise the funds for mistletoe clinical trials at Johns Hopkins Medicine’s Sidney Kimmel Comprehensive Cancer Center. The trials would take 5-8 years to complete and would study patients with different types of cancers. The cost of the trials is high, and the cancer center is still holding fundraisers and a GoFundMe campaign to collect enough money to start the process.

I’ve discussed Suzanne Somers’ Knockout before. It’s a load of cancer quackery. To get an idea of how bad it was from a scientific standpoint, consider that one chapter was all about how fantastic Stanislaw Burzynski’s antineoplastons are.

In any case, this story puzzles me. The whole thing smells fishy. Look at the webpage of her doctor Paul Hindenberger, for instance, where he lists his practice as including Anthroposophic medicine, homeopathy, and salutogenesis. Now, I know that Anthroposophic medicine and homeopathy are quackery. I’ve written about both before more than once. (Use the search box for examples.) However, I had never heard of salutogenesis before. This introduction reveals it as a philosophy of how to maintain health that immediately drew my suspicion because it involves health continuum or as he said the fully appropriate term “the ease/dis-ease continuum” as a horizontal line between total absence of health (H-) and total health (H+)and explained that all people are positioned somewhere on this line. Any time I see the word “dis-ease” instead of disease, my skeptical antennae start twitching mightily and my quackery detector starts beeping. In any case, I was underwhelmed by what I found, but someone intrigued, if only because I had never heard of salutogenesis before. Maybe I’ll revisit it.

In the meantime, I noted that Dr. Hinderberger is not on the faculty at Johns Hopkins; rather he’s in private practice in “integrative medicine” in Baltimore. I also learned that this particular mistletoe extract is “not approved by the federal Food and Drug Administration (FDA)” and “falls under the category of homeopathy and is paid for out-of-pocket, at a cost of $100 to $150 per month, depending on the extract intensity and number of injections.” Also, a search of ClinicalTrials.gov for “mistletoe” and “Johns Hopkins” failed to turn up a single clinical trial last night, while a search for just “mistletoe” turned up only a few open trials, only one of which was for colorectal cancer, a trial in Switzerland that didn’t use the same mistletoe extract, viscotoxin.

So what I found was that Jimmy and Ivelisse Page are raising money for a trial of mistletoe with Johns Hopkins but that the GoFundMe page for the trial shows it far short of its target of $1.3 million, apparently to be run by Dr. Luis Diaz, an associate professor of oncology at the Sidney Kimmel Cancer Center at Johns Hopkins. My next question learning this was: Why, if mistletoe extract is so promising, isn’t Diaz applying to the NIH for funding for a clinical trial? If it’s not FDA-approved, why didn’t he submit an IND (investigational new drug) application to the FDA?

Instead, this happened:

Page has been cancer-free since the operation on her liver and attributes her turnaround to a combination of surgery, diet and exercise, and the mistletoe. Now she’s made it her mission to bring the extract from its European manufacturers to the United States, where the Food and Drug Administration has yet to issue its stamp of approval. She knew Diaz could help establish the necessary clinical trials. “I told her that the trials would cost millions of dollars, which I thought would subdue her a bit, but it didn’t,” Diaz says. “Instead, she went into overdrive.” Page and her husband, Jimmy, formed a nonprofit called Believe Big to connect cancer patients with doctors who use nonconventional therapies and also to raise funds for the three-stage clinical trials. Through benefit dinners, fundraising walks, and donations, Believe Big has raised most of the $300,000 required for stage 1 testing, which could begin this summer. While Diaz says it’s not uncommon for a nonprofit to fund clinical work, it’s highly unusual for an individual to be the driving force.

This article is from 2014. Searching PubMed for Luis Diaz and Channing Paller (another faculty member said to be involved) failed to find any active clinical trials at Hopkins on mistletoe extract—or any clinical trials on mistletoe extract at all. So what’s going on? who knows? Whatever is going on, progress towards clinical trials has clearly been a lot slower than expected, given that I found stories dating back to 2013 about this fundraising effort. Does mistletoe extract have any value in colorectal cancer? Again, who knows? Results in ther cancers have been conflicting. It might be a natural product with anticancer activity, but even if it is it’s no panacea.

In the end, it almost certainly wasn’t the mistletoe extract, the homeopathy, or any of the other woo chosen by Ms. Page that saved her. It was the good, old-fashioned application surgery to her tumors, because, after all, nothing heals like surgical steel. The question I have is: What the heck is Johns Hopkins doing here, and why would it allow itself to be associated with a woman who also used homeopathic remedies? Money alone can’t explain it, because the amount of money raised thus far (approximately $300,000) just isn’t that much in the grand scheme of things for a major academic medical center.