Unproven Cancer Treatments

by Food and Drug Administration (FDA)

People who have just been told they have cancer must decide quickly what to do about treatment — their lives may depend on it. When conventional, mainstream treatments don't promise total cures, thousands of cancer patients turn to questionable, untested, possibly fraudulent treatments.

The promises of the practitioners of these treatments can be seductive, not unlike the pitch of the used car salesman offering the "deal of a lifetime." But the stakes are much higher.

Unproven cancer treatments may sound good at first to patients faced with the possibility of side effects from conventional cancer treatments, including chemotherapy, radiation and surgery. In contrast, promoters often describe questionable, untested treatments outside mainstream medicine as natural, nontoxic and noninvasive. However, while some — such as herbal treatments and some diets — may sound "natural," others are not, and are made up of unknown substances and possibly toxic contaminants. Others may appear harmless, but, because they are ineffective and cause people to delay or forego beneficial treatments, they, too, are dangerous. Manufacturing standards typically do not exist. Theories underlying the treatments vary widely, but one thing they have in common is the absence of scientific proof that they work.

The Office of Technology Assessment, an agency that serves the U.S. Congress, recently published a report on questionable (or, as OTA calls them, unconventional) cancer treatments, defining them as those treatments that fall outside the bounds of mainstream medicine and have not been proven safe or effective by scientific standards that balance benefit and risk.

This is in contrast to experimental therapies within mainstream medicine, which are new products under investigation or approved products being tested for new uses. These products are tested in a way that allows duplication of the results by others and that controls for other factors that may influence the results. FDA does not test products itself, but permits the human testing of new therapies. Before such testing can begin, the product's sponsor (a pharmaceutical company, private organization, government agency, or individual) needs to show scientific evidence that the product may work and that precautions will be taken to protect patients on whom it is tested.

Once the results of the clinical trials have been submitted to FDA by the sponsor, FDA must decide whether a treatment's benefits outweigh its risks. For example, cancer drugs often have serious side effects. But the condition they treat is also serious, as cancer patients well know. FDA wants to make sure that new treatments provide benefits outweighing their risks before permitting them on the market. As part of the review process, FDA also approves a labeling insert that accompanies approved products and allows physicians to prescribe the drug safely and effectively at the appropriate doses.

All reviews of new products for cancer (as well as other life-threatening diseases) are done as quickly as possible, with most approval decisions taking a year or less.

Promoters of questionable treatments rarely submit information to FDA about their products, let alone reliable and accurate data. Marketers or promoters of questionable, unconventional treatments for cancer can be prosecuted for violating federal and state laws.

According to Barrie R. Cassileth, Ph.D., of Chapel Hill, N.C., a researcher in the field of unproven cancer treatments, current popular treatments are often lifestyle-oriented remedies with a "do-it-yourself" quality. These treatments may especially appeal to consumers who want an active role in their own care. They include the popular so-called metabolic therapy, which, depending on the practitioner, may combine special diets, "detoxification" by internal cleanings or enemas, spiritual or emotional "healing," and high-dose vitamins and minerals. Other questionable therapies have names that sound like current mainstream cancer treatments. For example, one questionable treatment is called "immuno-augmentive therapy" (IAT), which sounds like immunotherapy, a mainstream treatment that manipulates a patient's immune system to fight cancer.

OTA Report

Because of the popularity of many unconventional treatments, Congress commissioned OTA to study them. After four years of research, OTA concluded in a 300-page report that "effectiveness [of unconventional treatments] is unknown, and relevant information on adverse effects is nonexistent." According to OTA, certain psychological and behavioral approaches may have some benefit when they are used in addition to mainstream treatments. For example, psychological support groups can benefit those patients who want to try them.

People frightened by a diagnosis of cancer may want to believe in the existence of "a miracle cure." Extravagant claims for questionable cancer treatments are often found in testimonials in the media. These messages can be quite convincing to someone facing the life-and-death issues of cancer. But people should view claims for questionable cancer treatments with the following in mind: - If it sounds too good to be true, it probably is. - Don't believe you have nothing to lose. - Scientific medicine is accountable. - Real hope is found in mainstream cancer treatment.

If It Sounds Too Good to Be True

A recent Wall Street Journal cartoon pictured a hiker encountering a guru on top of a hill who tells him, "I found the secret to happiness, but the FDA won't let me release it."

The punchline might have had him say he found a cure for cancer. Such extravagant claims are common for treatments for cancer and other chronic and sometimes fatal diseases for which medical science has yet to find a cure. But real "breakthroughs" in medicine are few and far between, and when they do occur, the medical community is quick to take advantage of them.

An example of a claim "too good to be true" is found in the promotional literature for Cancell, a currently popular cancer treatment that looks like a dark brown liquid and is made up of ordinary chemicals including nitric acid, sodium sulfite, potassium hydroxide, sulfuric acid, and catechol. The literature for Cancell states that the product is nontoxic and has no side effects. Although the Cancell booklet says no claims are made for the treatment, it also says that the treatment "digests" cancer cells and then, "the cancer no longer exists." No scientific evidence supports the use of Cancell for any disease, and no data have been submitted to FDA on Cancell's safety or effectiveness. FDA has conducted numerous regulatory investigations of Cancell, and has taken its promoters to court to try to stop its distribution.

William Jarvis, M.D., professor of Preventive Medicine at Loma Linda University and president of the National Council Against Health Fraud, Inc., says that advocates of unconventional therapies have one major characteristic in common: They exude self-confidence about their treatments. In his opinion, they offer an illusion of effectiveness, like a magician's act.

Testimonials may seem convincing, but many times, according to Jarvis, the patients quoted never had cancer in the first place. Another important fact is that physicians can't predict with certainty how long a cancer patient will live. When people live longer than expected, they may attribute their survival to an unconventional treatment, just as people who live to be 100 may claim that a glass of wine a day kept them alive. In reality, the cancer patients may have tried many different treatments, including mainstream therapies, and no one knows why they lived longer than expected. A certain number of people do beat the odds. The people who don't aren't around to refute the testimonials.

The choices in conventional cancer medicine — most often involving surgery, chemotherapy and radiation — do involve risk and discomfort, but in return, the patient has a chance of real, proven benefit.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.