What the doctor ordered?

James Forsythe has been practicing medicine for more than half a century.

He received his medical degree from the University of California, San Francisco in 1964. After a residency in pathology at Tripler Army Hospital in Honolulu and a tour in Vietnam, he returned to San Francisco for an internal medicine residency and an oncology fellowship.

Forsythe started practicing oncology in Reno in 1974. Thereafter, his names appears often in local newspaper archives—for board appointments to the Washoe County arm of the American Cancer Society in the 1970s, for a local AIDS hotline he started in 1985, as an occasional contributor of letters to the editor, and as an expert voice on health-related stories.

Today, though, Forsythe claims he’s unable to even gain an audience with the staff of the Renown Institute for Cancer to present the results of a seven-year study he’s been conducting with stage IV cancer patients.

Why would a hospital ignore requests from a longtime local doctor to present his data to its team? According to Forsythe, it’s at least partially related to the type of medicine in which he specializes.

Forsythe isn’t just certified in internal medicine and oncology. In 1995, he earned a homeopathic certificate from the British Institute of Homeopathy and was certified by the Nevada State Board of Homeopathic Medicine the same year. Since then, he’s been practicing what’s known as integrative oncology—a mix of conventional medicine and homeopathy. Forsythe says he’s using this blend to successfully treat cancer. However, his approach is condemned by many in scientific and medical communities.

Steven Novella—a clinical neurologist at the Yale University School of Medicine and executive editor of the blog Science-Based Medicine—wrote in 2015 that alternative medicine practitioners are “actively trying to weaken and muddy the scientific and academic standards of medicine and the regulations that maintain them.”

In September, when it was announced that the University of California, Irvine had accepted the largest gift in its history—$200 million from Susan and Henry Samueli for the establishment of an integrative health program—Novella wrote:

“When confronted with claims of integrative medicine, you have to always ask yourself, what exactly are they integrating? If mainstream medicine, by its own standards, uses interventions which have been shown to be safe and effective, the only things left to integrate are treatments that have not been shown to be safe and effective. Some of these unproven treatments are also highly implausible, sometimes to the point that they are essentially magic potions and witchcraft.”

To the letter

In a May 10 letter to Dr. Steven Althoff, chief of staff at Renown, Forsythe wrote, “I am requesting from you an opportunity to present my report and data to Renown’s Cancer Staff or even the General Medical Staff. I have tried numerous times with the Cancer Center but have always been met with rejection and stonewalling.”

Forsythe said he also made several calls to Althoff but received no response. He said he was eventually able to schedule a meeting with two high level administrators at the hospital but claims that—after speaking with them about his study—he was told the cancer center is the “economic engine that drives the hospital,” and there would be no incentive to change its operations.

Renown declined to acknowledge Forsythe’s accusation or, indeed, whether or not it has any record of such a meeting having taken place. The hospital also declined requests for interviews with its doctors. It did, however, issue a statement concerning its procedures for the identification of new treatment protocols and noting that the hospital “has no involvement in independent investigations or drug trials conducted outside the oversight of Renown Research Office. Community physicians conducting clinical trials can share promising results with fellow physicians for peer review or submit those results for publication by medical journals to advance the field.”

In his letter to Althoff, Forsythe noted that he’d reported the results of his study at the International Organization of Integrative Cancer Physicians in San Diego on April 29.

“I had an audience of over 500 doctors and cancer patients present and reported on 1,000 patients accrued since [June 2010] now nearly seven years into a prospective study achieving a 64 percent survival rate,” he wrote. “My competition for this study was reported in the Clinical Journal of Oncology 2004 in which 5 years of survival on Stage IV disease was a dismal 2.1 percent.”

The “competition” to which Forsythe refers is traditional chemotherapy. And according to him, the widely discredited study he cites showed only a 2.1 percent survival rate for chemotherapy recipients. (The study is discussed in greater detail later in this story.)

Forsythe may not have found an audience for his study results at Renown, but his integrative treatment practices certainly aren’t a secret. He’s the author of numerous books on the topic, including The Forsythe Anti-Cancer Diet and The Human Genome Playbook for Disrupting Cancer—both self-published through Century Wellness Publishing. (Until recently, the doctor’s clinic was also called Century Wellness. It’s now the Forsythe Cancer Care Center.)

He’s also been featured in two books by celebrity-turned-author and cancer survivor Suzanne Somers—Breakthrough: Eight Steps to Wellness and Knockout: Interviews with Doctors who are Curing Cancer and how to Prevent Getting it in the First Place. Somers’ books on health issues often generate headlines like “Breaking: health author Suzanne Somers mostly wrong about science, medicine,” and “Suzanne Somers Reveals That Science Is Hard, Even With A Thighmaster’s Degree.”

Furthermore, several aspects of Forsythe’s integrative oncology approach mirror those of other doctors in the field, as do some of his talking points when addressing conventional cancer treatments; many adherents of integrative oncology have made variations on the claim of 2.1 percent survival among chemotherapy recipients.

Renown declined to answer questions regarding the numbers cited or treatments employed by Forsythe and others in his field. However, many practitioners of conventional medicine are familiar with both the treatments and the statistics; in fact, some have taken to the internet in recent years specifically to rebuke them—often beginning with the 2.1 percent claim.

Dead wrong

David Gorski is the managing editor of Science-Based Medicine. He’s a surgical oncologist at the Barbara Ann Karmanos Cancer Institute in Detroit, where he specializes in breast cancer surgery and serves as the medical director of the Alexander J. Walt Comprehensive Breast Center. He’s also a professor of surgery and oncology at the Wayne State University School of Medicine.

Gorski refers to the 2.1 percent survival claim as the “2 percent gambit.” In 2013, he wrote that it “is based on a fallacious cherry picking of data and confusing” the different types of chemotherapy—primary, meaning it’s used as the main treatment for the cancer; and adjuvant, which means it’s used in addition to a treatment like surgery.

In a 2011 blog post, Gorski took aim at the study from which variations of the 2.1 percent claim arise. It’s titled “The contribution of cytotoxic chemotherapy to 5-year survival in adult malignancies” and was published in the Journal of Clinical Oncology in 2004. Of it, Gorski wrote: “It turns out that this is not such an impressive study.”

The research methods are described in its abstract as “a literature search for randomised clinical trials reporting a 5-year survival benefit attributable solely to cytotoxic chemotherapy in adult malignancies.”

So, basically, the researchers were looking to see to what extent chemotherapy contributes to five-year survival rates in adult cancer patients. To that aim, their review included more than 150,000 cases of cancer in the U.S. and another nearly 73,000 in Australia. These were all in adults who were diagnosed in 1998 with one of 22 types of malignancies.

For each type of cancer, they determined the number of cases in which chemotherapy was attributed with survival and divided it by the total number of cases to arrive at a “percentage of 5-year survivors due to chemotherapy.”

Then, the researchers extrapolated the outcomes to all cancers. In their review of U.S. cases, they determined “the absolute number of 5-year survivors due to chemotherapy” was 3,313. Dividing this by a total of 154,971 cases, they arrived at 2.1 percent as chemotherapy’s overall contribution to survival.

However, when considered independently, the survival rates attributed to chemo were much higher for certain types of cancer included in the study—37.7 percent for testicular cancer and 40.3 percent for Hodgkin’s lymphoma, for example. And according to Gorski, the study “appears almost intentionally designed to have left out the very types of cancers for which chemotherapy provides the most benefit.” He pointed to the fact that leukemia cases were not included, even though it “is one type of cancer against which chemotherapy is most efficacious.”

A letter to the editor attributed to four Australian doctors was published in the journal a year after the study and noted other problems, including that the researchers did not address the benefits of chemotherapy in treating advanced cancer.

“Many patients with cancers such as lung and colon present or relapse with advanced incurable disease,” the doctors wrote. “For these conditions, chemotherapy significantly improves median survival rates, and may also improve quality of life by reducing symptoms and complications of cancer.”

Of course—all potential issues concerning scientific rigor aside—there’s an arguably larger problem with study, and that’s the way it is misrepresented by alternative medicine adherents. Nowhere in the study does it suggest that only 3,313—or 2.1 percent—of the U.S. cancer patients surveyed survived. Yet, somehow that is the claim that most often arises.

By the numbers

The National Cancer Institute (NCI) runs the Surveillance, Epidemiology, and End Results (SEER) program, from which the Australian researchers drew their U.S. data. It’s a resource for information on the incidence and survival rates of cancer in the United States—which vary by type and stage.

Information from the SEER program for people diagnosed with breast cancer between 2007 and 2013 reveals a five-year relative survival rate by stage. For people with stage 0 and stage I cancer, the survival rate is nearly 100 percent. For those with stage II cancer, it drops to about 93 percent. For stage III, it’s 72 percent. In cancers that have metastasized—spread to other parts of the body—the five-year relative survival rate is much lower, around 22 percent.

According to the nonprofit Breastcancer.org, chemotherapy is frequently employed to “treat all stages of breast cancer, including cancer that has come back in the breast area and breast cancer that has spread to other parts of the body.”

With such high survival rates, it is clear breast cancer patients are not being killed by chemotherapy. Yet some women refuse it anyway.

In a November 2017 blog post on Science-Based Medicine, Gorski explained that in the case of breast cancer (among some other types) “surgery is the primary treatment and can be curative by itself.” What chemotherapy and other adjuvant treatments like radiation therapy or hormonal therapy do is decrease the chance of cancer recurring after surgery.

According to Gorski, “All a woman does by refusing recommended chemotherapy after surgery is to refuse a relative decrease in their risk of dying of a recurrence of breast cancer.” That relative reduction is between 25 and 30 percent—a benefit, which Gorksi said, “is, in absolute terms, much greater for more advanced but still curable breast cancers.”

He has also written often about the number of women who turn down chemotherapy—or other adjuvant treatments—in favor of alternative therapies, which he alternately refers to as “woo” and “quackery.” Over the years, Gorski has taken particular aim at Suzanne Somers—calling her a “celebrity know-nothing” and her book Knockout “dangerous misinformation about cancer.” A week after it was published, he wrote in a blog post, “Let’s get one thing straight here. It is most definitely not, as implied by various articles about Somers, in any way amazing that Somers is still alive after having ’rejected chemotherapy.’”

In the post, Gorski explained that Somers had stage I breast cancer and underwent surgery followed by radiation. With those two treatments, he estimated she “had an 88.6% chance of living 10 years without any chemotherapy” or hormonal therapy.

Somers has several times credited her survival to the refusal of chemo and hormonal therapy. Like other alternative medicine adherents, she uses the terms, “cut, burn and poison” in place of “surgery, radiation and chemotherapy.” In truth, though, many of the alternative treatments Somers has endorsed—including some of Forsythe’s—have come under heavy fire from the scientific community.

Breaking with protocol

Forsythe calls his cancer treatment blending conventional and alternative medicine the Forsythe Immune Protocol. A part of the protocol is the use of low-dose, insulin-potentiated chemotherapy—which Forsythe said is 10 percent of a normal dose.

This type of chemo is often called insulin potentiated therapy. According to a page on the Memorial Sloan Kettering Cancer Center website, it involves, “administering insulin at the same time as chemotherapy drugs, with the idea that lower chemotherapy doses are then needed because insulin lets more of the drug enter cells. However, this has never been proven experimentally.” The page warns that, in general, insulin shouldn’t be taken by people who are not diabetic as “it can decrease blood sugar to dangerously low levels, causing symptoms such as headache and delirium.”

Forsythe also utilizes a product called Poly-MVA (sometimes called Polydox), which he says contains lipoic acid, palladium, minerals, vitamins and amino acids. According to Forsythe, “By using the palladium and lipoic acid complex, it forces the cancer cell into an apoptosis cycle—cell death.”

But according to the Sloan Kettering website, “Polydox (Poly-MVA) has not been shown to treat or prevent cancer, lupus, asthma, HIV, or any other medical condition,” and its inventors and promotors make many claims about it “that are not supported by any scientific evidence.”

In 2012, the Food and Drug Administration issued a warning letter to Poly-MVA’s creator, AMARC Enterprises, Inc., concerning its marketing of the product as a treatment for cancer. The letter noted that Poly-MVA is “not generally recognized as safe and effective” in treating the condition for which it was advertised, meaning that it would be classified as a new drug and would need to undergo FDA approval before being legally market in the U.S. Poly-MVA is still not an FDA approved drug but is available, including online, as a supplement.

Other therapies Forsythe endorses—like alkalization therapy, detoxification and the use of essential oils in treating cancer—have also been widely criticized. But Forsythe maintains that the treatments are effective and that criticisms of them by conventional doctors and the scientific community are often related to influence from the pharmaceutical industry.

“I think it is very important that your readers know that they should look for options,” Forsythe said. “They shouldn’t just rush in and start chemo or get under the knife the next day without thinking about it, or just go under the radiation beam. With the internet now, they can find out so much information.”

Of course, he’s right about the amount of information that can be found online regarding cancer treatments. Take, for example, laetrile. Also known as amygdalin, it’s a naturally occurring chemical compound found in plants like apricots—famous for being promoted as a cancer cure. Forsythe said it’s an example of an effective treatment that’s been shelved by big pharma.

Laetrile hasn’t received a lot of mention since a 1980 National Cancer Institute study documented its inefficacy—and the drug was being condemned by medical professionals for years prior to that. In fact, Forsythe was among the doctors to decry its use. In a November 1979 letter to the editor published in the Reno Evening Gazette, he criticized the parents of a boy who had died after receiving a mix of laetrile and chemotherapy in Mexico, writing, “The sad fact is that as parents, we can certainly understand the desire to protect a child against some of the distressing toxicities of chemotherapy, i.e. hair loss, nausea, vomiting, loss of appetite, etc.; however, when the end result is cure over certain death, then it is mandatory that there be laws to protect the child from the ignorance of his parents.”