Unproven Cancer Treatments : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

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 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 the manufacturer to make the drug available to many patients before the 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.

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.