Hope or hoax? Unproven cancer treatments

Hope or hoax? Unproven cancer treatments – includes guide to therapy options

Lenore Gelb

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 die 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 “break-throughs” 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.

Nothing to Lose

Freedom of choice is often mentioned as a reason why cancer patients should have access to any treatment they think might be helpful, especially if no conventional treatments exist that offer much hope for prolonging their lives. However, patients may have a lot to lose.

Jarvis calls it the “Gambler’s fallacy.” He says that “patrons of questionable cancer care expose themselves to incompetent practitioners, unsanitary clinical conditions, improper clinical management that may interfere with the drugs they are taking, and more.” As examples, he cites Laetrile treatment, which exposed patients to possible cyanide poisoning, and coffee enemas, which, when used excessively, have killed patients.

In addition, many of these products are manufactured in a haphazard way without standards to ensure that the ingredients found in them and their amounts are the same each time. For example, an FDA inspection revealed that Cancell was manufactured in the back yard with kitchen utensils.

A patient’s quality of life may suffer from unconventional, untested therapies. Cassileth recently compared the quality of life of patients at the Livingston-Wheeler Medical Clinic, an unconventional cancer clinic in San Diego, to that of patients at the University of Pennsylvania Cancer Center. The Livingston-Wheeler program includes special diets, enemas, and a vaccine that is supposed to boost the immune system. None of the patients was expected to live more than a year, but the researchers thought that quality of life, as measured by a self-report scale, would be better with the unconventional treatment due to an absence of side effects from chemotherapy and other factors. Although survival times between the two groups did not differ, patients at the unconventional treatment center reported a lower quality of life at all times during treatment–the opposite of what was expected.

Cassileth points out, in addition, that even seemingly innocuous treatments like vitamin or diet therapies can interfere with the effectiveness of chemotherapy or create nutritional problems.

One of the most dangerous outcomes of some unconventional treatments is that they can discourage or prevent people from using conventional care that offers real hope. Various types of cancer may be symptomless, especially when a person is in remission, and people may feel that an unconventional treatment helped them. This can cause patients to miss the chance of effectively treating the disease with a treatment that has shown real benefit.

And questionable treatments can be very expensive. Practitioners of these treatments often charge exorbitant fees for them. But patients cannot be charged for treatments under investigation within mainstream medicine: Researchers must supply them free.

Scientific Medicine is Accountable

Another difference between scientific medicine and unconventional therapy is accountability.

Jarvis asks: “What advice can we give to a patient who is struggling with decisions about whom to trust?”

His answer is to use accountability as the criterion. People or institutions whose work is done openly and who are prominent medical specialists can be ruined if they use deceptive practices. They are required to tell patients about possible side effects and risks, not just possible benefits.

The American Cancer Society publishes information that explains in detail how proponents of unproven cancer treatments can be identified by their lack of accountability. For example, they are often isolated from established scientists and claim that mainstream medicine and the government conspire against them. Their clinical and scientific record-keeping is weak to nonexistent. They often maintain that their treatments are secrets,” or secretly prepared. They may have multiple, unusual degrees from obscure institutions. Their chief supporters are usually outside mainstream medicine.

In contrast, experimental therapies within mainstream medicine are critically reviewed within the medical community and held up to scientific scrutiny as they are being evaluated for safety and effectiveness. The results of studies are published in established medical journals after review by other scientists. The study methods are outlined in the report so that others can try to verify the results by duplicating them.

Though the burden of proof is on manufacturers to show FDA that a given drug is safe and effective, Helene Brown, at UCLA’s Jonsson Comprehensive Cancer Center, says proponents of unconventional therapies try to put the burden of proof on others to show that their therapies don’t work. They are not willing to submit data for FDA to review. As Brown says, “It’s like putting you in a dark, windowless room and asking you to prove that it’s not raining outside.”

Contrary to claims of some proponents of questionable treatments, FDA welcomes applications from product sponsors who want to investigate new drugs, and the National Cancer Institute is willing to investigate promising new therapies from researchers whether or not they are affiliated with major institutions.

Real Hope

More than ever, real hope for people with cancer exists in mainstream medicine, with increasing reports of new treatments either being approved or being studied under strict scientific conditions.

For example, in 1991 FDA approved a genetically engineered biologic product, G-CSF, that reduces the number of infections in cancer patients undergoing chemotherapy. Late in 1990, FDA gave permission for the National Cancer Institute to begin using human gene therapy for advanced melanoma, a skin cancer that is difficult to treat. And scientists announced in May 1991 a new cancer diagnostic test, developed through genetic engineering, to identify a gene in urine that, when present, may signal the onset of many types of cancer. This discovery may help in prevention and early treatment of cancer.

Under its “treatment IND” (investigational new drug) program, FDA makes certain experimental drugs available to cancer patients before final approval. For example, more than 40,000 patients received levamisole before it was approved in 1990 as a combination therapy along with fluorouracil, a drug previously approved for other conditions, as a therapy for Dukes’ C colon cancer. The combination therapy was shown by NCI clinical trials to reduce the death rate by about one-third and the recurrence rate by about 40 percent. Based on the data it had, FDA allowed die manufacturer to make the drug available to many patients before die FDA review process was complete.

A diagnosis of cancer can make people feel as if they don’t have control over their lives and bodies. Prevention and early, effective treatment often can be the key to a good outcome. Time is a precious commodity, especially for cancer patients–and it is sad when it’s wasted on unproven treatments with questionable benefits that may cause harm. Effective, safe, innovative care is best found within mainstream medicine.

Lenore Gelb is editor of the FDA Medical Bulletin, a publication for health professionals.

Get the Facts

For reliable information about therapy options for cancer patients, contact:

National Cancer Institute

Office of Cancer Communications

Bethesda, Md. 20892

Call toll-free: 1-800-4-CANCER

Upon request, NCI will send the booklet What Are Clinical Trials All About?, which explains how clinical trials work for patients considering experimental treatment. Other cancer publications are also available.

Information on currently popular unconventional treatments is available from:

American Cancer Society

1599 Clifton Road, N.E.

Atlanta, Ga. 30329

Call toll-free: 1-800-ACS-2345, or your local chapter.

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