Prescription for Trouble

America’s fascination with alternative medicine took root during colonial times when patients longing to escape such torturous—and largely ineffective—medical practices as bloodletting and purging, turned to steam baths of botanical herbs to find a cure for what ailed them. An uneasy alliance with conventional medicine has existed ever since.

The popularity of mainstream medicine surged in the 1940s when antibiotics were used successfully to control infectious diseases, but by the ’60s and ’70s, patients rebelled against modern medicine in favor of a more holistic approach that treated the body, mind and spirit. The concept of holistic medicine morphed into two general practices: alternative and complementary.

Although often identified by the acronym CAM (complementary and alternative medicine), leaders in the field say the term is problematic based on their distinct differences. Alternative therapy refers to unproven or disproven treatments that are used instead of standard or proven therapy, and complementary therapy is used in addition to standard medicine to help improve quality of life and relieve chemotherapy and radiation side effects. The term “integrative” is now used to more accurately describe CAM therapies that complement conventional cancer therapy.

Despite the unproven claims of many integrative and alternative medicine practices, its popularity finds Americans spending up to $47 billion a year on various therapies for different illnesses—$5 billion on herbal products alone. According to the National Health Interview Survey conducted by the National Center for Health Statistics, 62 percent of Americans use some form of unconventional therapy, including a vast array of approaches, such as taking biologically based products like herbs and megavitamins; special diets; chiropractic care, acupuncture and massage; and relaxation techniques like Reiki, yoga and guided imagery.

The study of alternative medicine gained legitimacy in 1992 when the National Institutes of Health launched the Office of Alternative Medicine, now called the National Center for Complementary and Alternative Medicine, to investigate alternative and complementary medicine with the same scientific rigor as conventional therapies. Currently, NCCAM has funded more than 1,500 clinical trials, including 83 that involved cancer.

Besides determining the efficacy of alternative and integrative medicine, the NCCAM studies have the added benefit of independently proving whether they are safe. “Companies [who manufacture dietary supplements] have no incentive to pay for clinical trials themselves because they don’t have to,” says Sidney Wolfe, MD, director of the Health Research Group for Public Citizen, a consumer watchdog group in Washington, D.C. “And one after another, these studies are turning out to show these things don’t work.”

The onus to prove the efficacy and safety of herbal medicines was taken off the shoulders of the dietary supplement industry in 1994 with the passage of the Dietary Supplement Health and Education Act, which restricts the authority of the Food and Drug Administration to regulate dietary supplements, which includes vitamins, minerals, herbs or other botanicals and amino acids, among others. “There’s the pretense that because something is ‘natural’ there is no legal requirement to prove it is safe or to prove it works, and once you have a law forbidding the FDA from requiring any evidence on that, everything out there is a fraud until proven otherwise. And worse than just being a fraud, a number of these things are dangerous,” Dr. Wolfe says.

Contrary to public perception, many alternative cancer cure claims thought to be unproven have actually been disproven in clinical studies.

Just how dangerous was made clear in 2002 when the FDA removed from the market a patented herbal product called PC-SPES (PC: prostate cancer; spes: Latin word for hope), which was touted to promote prostate function and taken as an alternative treatment for prostate cancer.

“PC-SPES was shown in phase I and phase II studies to be effective in reducing PSAs in men with prostate cancer,” says David Rosenthal, MD, past president of the Society of Integrative Oncology and professor of medicine at Harvard Medical School. “But an NCI-funded randomized trial of the product found there were impurities within the product. For example, there was an anticoagulant, so people were having bleeding problems. And other batches of the product contained hormones, and we know that estrogen and estrogen-like hormones treat prostate cancer,” which likely explains the misleading effectiveness of the product in early-phase trials.

Contrary to public perception, many alternative cancer cure claims thought to be unproven have actually been disproven in clinical studies. As far back as 1955, the American Cancer Society launched a Committee on Quackery to review cancer cure claims. In the 1980s the organization investigated alternative cancer cures, such as Laetrile, high-dose vitamin C and detoxification, all of which were proven useless or harmful.

Still, a small percentage of cancer patients forego standard medical treatment in favor of alternative care. Research conducted by Barrie Cassileth, PhD, more than a decade ago found that up to 10 percent of cancer patients sought alternative treatment, though more recent research puts that figure at around 6 percent. “At the time my study was done, alternative cancer therapies were underground,” says Cassileth, chief of Integrative Medicine Service at Memorial Sloan-Kettering Cancer Center and author of The Alternative Medicine Handbook. “They had no aura of acceptance whatsoever and they were secret.”

If alternative cancer cures were underground a decade ago, the emergence of the Internet has brought them into the daylight. Thousands of websites are filled with products and testimonials from patients and doctors touting alternative or so-called “natural” cures for cancer. Besides spreading false information, the real danger of these claims, says Dr. Wolfe, is they can cause cancer patients harm. For example, he says ginkgo biloba, an herb used as a cancer cure or to reduce cancer risk, may increase bleeding disorders.

Stephen Barrett, MD, founder of Quackwatch, an organization that investigates questionable health-related claims, compares the search for alternative cancer cures with a wild goose chase. Instead, he recommends “patients follow a logic that says my doctor really wants to help me.”

Although exactly how much money is spent each year on false cancer cures is unknown, some experts put the figure at $1 billion. The hallmarks of a cancer cure scam are pretty easy to pinpoint, says Dr. Barrett, and include advertisements asking for large amounts of cash up front, testimonial evidence, the notion that the company has a product or practice that is unique, questionable clinics located outside the United States and claims that the medical establishment doesn’t want to find a cancer cure.

Although the Federal Trade Commission is in charge of prosecuting companies that make false cancer cure claims, their numbers are so high the agency doesn’t have the resources to track them all down, says Dr. Wolfe.

Cancer patients may shun conventional treatment in favor of alternative medicine for a number of reasons, from mistrust in Western medicine to believing no other options are left.

“I have patients who have been told by their oncologists that they only have a year to live and they can be given chemotherapy but it will make them sick. If somebody told you that, you would probably run away seeking something alternative too,” says Donald Abrams, MD, chief of hematology/oncology at San Francisco Medical Center and director of clinical programs at UCSF Osher Center for Integrative Medicine.

You get one shot with cancer, and that’s treating it with surgery, chemotherapy or radiation. If people delay treatment to try things that are promoted as ‘alternatives,’ what’s going to happen is that their tumors will grow and their chances of a cure are infinitely less.

The emotional impact of such a prognosis can cause distress for the patient as well as family members, making it difficult to evaluate the validity of information about unorthodox remedies. Patients should discuss with their doctor or an integrative medicine professional anything they are considering that falls outside proven therapy or that has not been prescribed, particularly since harmful drug interactions can occur.

For an alternative to alternative medicine, medical experts suggest patients consider a clinical trial testing a new therapy to combat cancer. “I’ve seen a lot of progress in our ability to treat cancer and prolong survival. I am not going to tell somebody I think you should take shark cartilage or go to Tijuana,” says Dr. Abrams.

No matter the prognosis, Cassileth says replacing conventional treatment with alternative medicine is not an option for cancer patients. “There are no viable literal alternatives to mainstream cancer care. You get one shot with cancer, and that’s treating it with surgery, chemotherapy or radiation. If people delay treatment to try things that are promoted as ‘alternatives,’ what’s going to happen is that their tumors will grow and their chances of a cure are infinitely less,” she says.

While many alternative cancer therapies, such as Laetrile and metabolic therapy, have been disproved, a lot of research is under way to study the effectiveness and safety of various integrative disciplines. One of the biggest areas of study involves the use of botanicals and herbs.

Researchers like Cassileth are investigating several botanicals looking at whether they could boost immune function during standard cancer treatment. “We’re not looking for a single-molecule pharmaceutical product,” she says. “We’re looking for interaction among the various constituents of herbs and other botanicals that might enhance immune function or that might produce some other benefit to cancer patients.”

Cassileth cautions nothing currently can replace conventional cancer treatment. “What we know right now is there’s absolutely nothing that can be used as a substitute, but as an adjunct along with mainstream cancer care, [botanicals] may be useful.”

The bottom line, say experts, is alternative medicine alone should never be considered for cancer patients. A patient’s best bet: Work with a professional health care team to develop an integrative treatment plan that incorporates the best cancer care based on medical evidence and experience.