Science

Legal Laetrile: but does it work?

LEGISLATION now awaiting Gov. James R. Thompson's signature would delete one of the reporting provisions of the law legalizing the controversial anti-cancer drug Laetrile, which was passed over the governor's veto in 1977. The bill, sponsored by Sen. Donald Totten (R., Hoffman Estates) would remove the requirement that the Illlinos Department of Public Health (IDPH) file annual statistical reports on Laetrile use in the state with the governor and the General Assembly

Under current Illinois law, a physician who treats a cancer patient with Laetrile must fill out an IDPH-provided form entitled "Report of Treatment with Amygdalin-Laetrile," and return it to IDPH within 30 days of the termination of Laetrile treatment. The form asks: name, age and sex of patient; the type of malignancy; what, if any, prior treatment was administered; whether Laetrile was the sole means of treatment or was used in conjunction with more conventional treatment; the dates on which Laetrile treatment was begun and terminated; and the results of the treatment. These forms are analyzed by IDPH which in turn submits to the governor and the legislature a report which is supposed to give some idea of the extent and efficacy of Laetrile use in the state.

But the scientific value of the reports is compromised: physicians don't often provide much quantified information in them, and responses are frequently vague, inconsistent, incomplete or based on subjective judgments. According to a pharmacist at IDPH's division of food and drugs, "in terms of statistical data . . . [the report] is completely worthless. [It is] just not a practical means of providing data."

Totten said he introduced the bill to remove the reporting requirement at the request of IDPH. S.B. 1205 would remove the requirement that annual reports on Laetrile use be submitted to the legislature and the governor. If the legislation is signed, physicians would still be required to submit Laetrile treatment reports to IDPH; the agency simply would not report on them to the legislature. Physicians would also still be required to submit with their reports physician-patient affidavits. These are signed before Laetrile treatments begin to certify that the patient has terminal cancer, has been informed of all other forms of treatment and told that the U.S. Food and Drug Administration (FDA) and other medical experts do not consider Laetrile effective in combating cancer.

Redesigning the Laetrile treatment forms would not necessarily improve the data since it still would not be data collected under controlled scientific conditions.

Even data collected under controlled scientific conditions on this subject are not immune to criticism or disbelief. After conducting Laetrile studies in cancer patients, the National Cancer Institute (NCI) announced last April that it found Laetrile to be ineffective as a treatment for cancer. Many Laetrile advocates have since denounced the NCI findings.

Spurred by public pressure and concern over the growing number of cancer victims who delayed or abandoned conventional cancer therapy for Laetrile, the NCI began its clinical trials in July of 1980 — an apparent precedent, as generally a purported anti-cancer drug must demonstrate anti-tumor activity in animals before testing can be conducted in humans. NCI had run a series of laboratory experiments on animals for 20 years without finding any convincing evidence of Laetrile effectiveness.

For the NCI study, 156 cancer patients were selected. All were in good general condition, and represented the spectrum of cancer types, such as lung, breast and colorectal. The patients had tumor masses that could be regularly measured, but for which no other treatment had been proven effective. According to NCI information, the study protocol (treatment plan), developed by four cancer research centers, was modeled after the Laetrile usage espoused by some Laetrile practitioners. For 21 days Laetrile was administered at a daily intravenous rate of 8 to 9 grams which was then continued by oral doses of 0.5 grams three times daily. Concurrently, the patients participated in the "metabolic program" some Laetrile proponents espouse: a diet concentrating on fresh fruits and vegetables and whole grains, enzymes and vitamins, and limited animal products and alcohol.

One patient was removed from the program when cyanide levels in the blood became dangerously elevated, a danger the FDA has identified with Laetrile use. Another patient did exhibit a partial reduction in tumor size for 10 weeks, after which the tumor progressed despite continued Laetrile use.

Results of the study show that within a month of initial Laetrile treatment, 50 percent of the patients had signs of disease progression, a figure which jumped to 90 percent within three months. By the end of five months, 50 percent of the patients had died; by eight months only 20 percent of the patients were still alive — a survival rate consistent with that expected when no treatment was administered. The NCI's verdict: Laetrile is ineffective in treating cancer.

But if it had been thought that the study would resolve the Laetrile controversy, that expectation now seems overly optimistic. Many Laetrile advocates are disdainful of the NCI study, and in some instances have accused researchers of using the wrong form of amygdalin or not following the appropriate Laetrile therapy (proponents feel a Laetrile metabolic program should be custom-made for each individual's circumstances).

According to a spokeswoman from American Biologies (a major distributor of amygdalin and other metabolic products) the researchers in the study "do not address themselves to the fact that the patients were stable" at three weeks, and the patients' condition deteriorated only after the dosage was significantly reduced. She also objected to the use of chemotherapy criteria (tumor size) to evaluate the performance of Laetrile, noting that Laetrile is not purported to reduce tumor size, but instead controls cancer and relieves discomfort. The spokeswoman was certain that "this thing is far from over."

In contrast, S.B. 1205 is not viewed as controversial, with Totten reporting that he "has not heard one way or another from anybody." The bill, which passed easily through both chambers, was sent to Gov. Thompson on June 19.

Julie A. Dutton is a research associate with the Illinois Legislative Council's science unit.

August 1981 | Illinois Issues | 21