September 10, 2008
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Looking for a cancer cure in all the wrong places

Patients are often willing to try unproven ‘cures,’ but may not disclose that information to their physician.

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Many patients being treated for cancer hold an apparently unshakeable belief that the medical establishment must be suppressing cheap “natural” cancer treatments out of ignorance or greed. Some turn to websites that promote products such as shark liver oil or mistletoe, convinced by claims that such remedies can cure their cancer quickly and painlessly — unlike the regimen proposed by their oncologist or hematologist.

“It’s been an age-old problem, back to the snake oil salesman in a travelling wagon,” Gary Coody, the FDA’s National Health Fraud Coordinator, told HemOnc Today. “When there is no effective cure, people are looking for an easier cure, one that doesn’t have the side effects. And especially for incurable diseases, they’re looking for hope. They are so vulnerable to these false claims.”

Mark Moyad, MD, MPH
Mark Moyad, MD, MPH, says if pharmaceutical companies had a cure for cancer they would be cashing in on it, not hiding it.

Photo by University of Michigan

For this report, HemOnc Today looked at the most current research about the use of complementary and alternative medicine related to oncology and talked to several experts who were asked to comment on why patients are turning to these alternatives — and what to do about it.

A 1998 editorial in The New England Journal of Medicine described alternative medicine as “distinguished by an ideology that largely ignores biologic mechanisms, often disparages modern science and relies on what are purported to be ancient practices and natural remedies, which are seen as somehow being simultaneously more potent and less toxic than conventional medicine.”

A decade later, and despite the best efforts of the federal government and skeptical physicians, these often disproven or unproven alternative treatments — such as black cohosh and mega-vitamins — remain popular alternatives to mainstream cancer therapy and lucrative for those who tout their purported healing powers to desperate patients.

The most recent estimate from the Department of Health and Human Services released in 2004 said Americans spent between $36 billion and $47 billion on complementary and alternative medicine, or CAM, in 1997. The Nutrition Business Journal issued a report in 2007 saying that the complementary and alternative services market was worth $39.5 billion.

DISCUSS IN OUR FORUM What do you say to your patients about alternative therapies?

The National Center for Complementary and Alternative Medicine has reported that rates of CAM use are “especially high among patients with serious illnesses such as cancer.” According to the results of a study published in the Journal of the American Medical Association in 2000, 83.3% of patients with cancer had used CAM in some form, and 62.6% had taken vitamins or herbal supplements. The National Cancer Center reported in 2004 that 72% of patients do not tell their oncologist that they are using an alternative or complementary therapy.

Complementary medicine usually refers to therapies such as yoga or medical marijuana that are used along with mainstream treatments to relieve the symptoms of disease or the side effects of treatment. Alternative medicine, on the other hand, is used as a substitute for mainstream treatments, according to the NCCAM, and is often not reported to a patient’s physician.

Patients want to believe there is a cure out there that even their doctor does not understand. David H. Gorski, MD, PhD, a surgical oncologist specializing in breast cancer and an associate professor of surgery at the Wayne State University School of Medicine in Detroit, said the attitude surrounding alternative therapies is “more religion than science. A lot of the ideas that come from a lot of these alternative medical therapies are based on an understanding of disease that a prescientific society had.”

Some patients believe that pharmaceutical companies and doctors are conspiring to withhold information about alternative products that could help cure their disease. Alternative therapies are often promoted as “secret” cures, and supporters use unverifiable anecdotes as “proof” that they or their loved ones were cured by these secret remedies.

John Russo, PharmD
John Russo

The notion that valuable information about these so-called cures is being withheld from patients is “insane,” said John Russo, PharmD. Russo writes for a blog called The C.A.M. Report, a website he described as “an objective and dispassionate source of information” on the latest developments in complementary and alternative medicine.

“I’ve been teaching or working in medical communications since 1976,” he said. “I have never seen any evidence there is somebody holding something back for political reasons or because it would hurt sales of another drug.”

Mark Moyad, MD, MPH, is the Jenkins/Pokempner Director of Preventive and Alternative Medicine at the University of Michigan Medical Center and maintains an oncology consulting practice. He is editor-in-chief of Seminars in Preventive & Alternative Medicine and has written more than 100 papers on the use of CAM in cancer.

He also scoffs at the notion of a conspiracy, pointing out that pharmaceutical companies already make millions of dollars selling the most common dietary supplement, vitamins.

“If I was smart enough to come up with a cure, I would have done it,” he said. “It is like saying you don’t want to cure erectile dysfunction. The first company that came up with something that was close to a cure has now made billions. There’s actually a lot of money in a cure because it is probably something that has to be maintained or taken on a regular basis, so that argument to me has never been able to fly.”

FDA targeting fraudulent treatments

David H. Gorski, MD, PhD
David H. Gorski

The FDA took steps in June toward combating online sales of fraudulent cancer “cures.” The agency sent letters to 23 merchants selling 125 so-called cancer cures, warning that they were in violation of the Federal Food, Drug, and Cosmetic Act by claiming their products could cure, mitigate, treat or prevent cancer.

Punishment could include “the seizure of illegal products and injunctions against manufacturers and distributors of those products.”

“It’s our responsibility to get those drugs off the market,” said FDA spokeswoman Rita Chappelle. “We have prioritized the drugs we will go after first, based on our Compliance Policy Guide. Those drugs are the ones that pose the most harm.”

The FDA’s action follows a similar move by the Federal Trade Commission, which earlier this year sent letters to 112 companies selling various products that supposedly cure cancer. Coody said more enforcement action is coming.

“The concern is that people aren’t getting truthful, substantiated information,” he said. “They may be taking these products in lieu of approved drugs. They may be taking them along with their approved drugs. Most of these ingredients — virtually all of them — have not been studied for drug interactions with prescribed drugs,” Coody said.

Gorski said that the FDA should be more aggressive about uncovering fraud among some of the companies and websites promoting alternative therapies for cancer. “I was actually quite amazed that the FDA [took this step], but whether it follows through remains to be seen.”

FDA list

The FDA has sent warning letters to several companies that sell fake cancer cures online, including Best on Earth Products, Precision Herbs and VitaPurity. HemOnc Today looked at the websites of these companies to see which claims were still being made.

As of August 4th, Black Salve Bloodroot Capsules were available at bestonearthproducts.com. The ingredients in the compounds are listed but no claims are made about what the products do. At precisionherbs.com, some of the products the FDA had labeled fake were removed, but the company was still selling least one product called Amorph. The company no longer claims that Amorph can specifically treat cancer, but that the remedy promotes cellular health and was “(h)istorically used with tumor shrinking combinations to keep tumors from morphing from one type to another.”

VitaPurity has drawn FDA attention in the past. Based in Central Point, VitaPurity received a warning letter in 2005 for making false claims about its supplements Ellagic Ultra, Lycopene 25 with Tomato Powder, Buffered Vitamin C Powder and Miracle Mushroom Blend. At press time, these products were still available at vitapurity.com. The company touts its lemon grass supplement Citral as preventive of cancer and recommended by doctors, while concurrently dubbing chemotherapy as a “19th century treatment.”

On a page promoting the anticarcinogenic power of a supplement called Lycopene 25, VitaPurity refers to a study titled “Prostate Carcinogenesis in N-methyl-N-nitrosourea (NMU)–Testosterone-Treated Rats Fed Tomato Powder, Lycopene, or Energy-Restricted Diets.” In that study, researchers from the University of Illinois and the Ohio State University wrote, “Consumption of tomato powder but not lycopene inhibited prostate carcinogenesis, suggesting that tomato products contain compounds in addition to lycopene that modify prostate carcinogenesis.”

The results of that trial demonstrated an anticarcinogenic effect only in rats, not humans, and did not attribute that effect specifically to lycopene. There are study results that suggest lycopene and/or other compounds found in tomatoes may have an anticarcinogenic effect, but to claim Lycopene 25 has the same or similar effects would require FDA approval. In a disclaimer on the site, the company acknowledges that the FDA has not evaluated its claims.

Moyad agrees that the FDA needs to go after companies selling fake cures. After 21 years of researching and teaching CAM, however, he believes the problem lies less with companies that sell these alternative “cures” than with physicians, especially those who sell unproven supplements from their offices.

Companies that received warning letters from the FDA

CAM on trial

NCCAM is currently sponsoring 10 open trials examining the use of CAM to treat cancer and the adverse events associated with treating the disease. Four other NCCAM-sponsored studies, including a phase-3 study exploring the power of selenium and/or vitamin E to prevent prostate cancer, are active but not recruiting.

Researchers in one phase-1 trial are looking into the efficacy of mistletoe combined with gemcitabine at treating patients with advanced solid tumors.

Researchers at Roswell Park Cancer Institute are recruiting postmenopausal women into a study comparing the efficacy of flaxseed vs. the aromatase inhibitor anastrozole (Arimidex, AstraZeneca) to treat ER-positive breast cancer. The phase-0, randomized, double blind study is scheduled for completion in 2010.

The agency is also sponsoring a phase-2 study titled Effects of Energy Healing on Prostate Cancer. Researchers at the Cleveland Clinic Foundation are trying to determine whether Reiki energy healing affects anxiety and disease progression in patients with localized prostate cancer.

There are two ongoing phase-3 studies exploring whether a selected vegetable and herb mix (SV, Sun Farm) can improve survival time for patients with advanced non–small cell lung cancer, one for patients undergoing chemotherapy and one for those who have refused chemotherapy but will receive supportive care.

What to tell patients

Convincing patients to stop using complementary or alternative therapies can be difficult. Gorski said he does not try to convince them if they also agree to maintain their precribed treatments.

“If they just want to use some herbal extract to relieve symptoms and they’re not giving up the normal course of medicine, my tendency is just to make sure it doesn’t cause any interactions,” he said. “I’m honest in saying I don’t think it’s going to work and why, based on science, but I’m not going to tell them not to do it so long as they keep coming back for what I know to be effective.”

Telling patients that most alternative treatments have little value can be counterproductive, Gorski said. “That’s about the surest way I can think of that you’re going to chase such a patient out of your office and have them totally discount what you have to say.”

Moyad said that patients deserve a fuller explanation than that. “I walk them through why I believe an alternative therapy doesn’t work. I walk them through why the product being recommended doesn’t work.”

His consults can last as long as an hour, time he acknowledges that most clinicians cannot devote to a single patient. He recommends that doctors educate themselves about CAM so that they can give patients informed advice.

“As doctors become more educated, the patient is 10 times more likely to listen to the doctor vs. the quack,” he said. “Nine out of 10 times, the patient wants an answer from his primary care physician or his oncologist. And if that doctor can’t provide the answer, the patient will go to a less credible source.

“We’ll always have snake oil salesmen; we’ve had them for 200 years. I don’t feel like we have to go after those guys. I feel like the solution is within.” – by Jason Harris

Issues at Hand

POINT/COUNTER
What should oncologists tell their patients who are interested in complementary and alternative medicine?

For more information:

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