Medical Research

In People v. Privitera, 23 Cal. 3d 697 (1979), under California Health and Safety Code section 1707.1, it is a misdemeanor to sell, deliver, prescribe or administer any drug or device to be used in the diagnosis, treatment, alleviation or cure of cancer which has not been approved by the designated federal agency 21 U.S.C. section 355 or by the state board (Health & Saf. Code, section 1704).

Section 1707.1 provides:

"The sale, offering for sale, holding for sale, delivering, giving away, prescribing or administering of any drug, medicine, compound or device to be used in the diagnosis, treatment, alleviation or cure of cancer is unlawful and prohibited unless (1) an application with respect thereto has been approved under Section 505 of the Federal Food, Drug and Cosmetic Act, or (2) there has been approved an application filed with the board setting forth: (a) Full reports of investigations which have been made to show whether or not such drug, medicine, compound or device is safe for such use, and whether such drug, medicine, compound or device is effective in such use; (b) A full list of the articles used as components of such drug, medicine, compound or device; (c) A full statement of the composition of such drug, medicine, compound or device; (d) A full description of the methods used in, and the facilities and controls used for, the manufacture, processing and packing of such drug, medicine or compound or in the case of a device, a full statement of its composition, properties and construction and the principle or principles of its operation; (e) Such samples of such drug, medicine, compound or device and of the articles used as components of the drug, medicine, compound or device as the board may require; and (f) Specimens of the labeling and advertising proposed to be used for such drug, medicine, compound or device."

Defendants were convicted by jury of the felony of conspiracy to sell and to prescribe an unapproved drug -- laetrile -- intended for the alleviation or cure of cancer. (Pen. Code, section 182, subd. 1; Health & Saf. Code, section 1707.1).

Defendants contend the right of privacy is protected by the federal and California Constitutions and includes a right to obtain laetrile or, more generally, a right of access to drugs not recognized by the government as effective. Fundamental rights may be regulated only to the extent necessary to achieve a compelling state interest. Defendants argue the purported right to obtain laetrile is fundamental and therefore the regulation challenged here must be reviewed under the compelling state interest standard.

The Court held the asserted right to obtain drugs of unproven efficacy is not encompassed by the right of privacy embodied in either the federal or the state Constitutions. The appropriate standard of review is the rational basis test, rather than the compelling state interest test. Furthermore, section 1707.1 satisfies the applicable standard by bearing a reasonable relationship to the achievement of the legitimate state interest in the health and safety of its citizens.

The Supreme Court has held that regulations limiting certain fundamental rights may be justified only by a compelling state interest. Kramer v. Union School District, 395 U.S. 621 (1969) and that legislative enactments must be narrowly drawn to express only the legitimate state interests at stake Griswold v. Connecticut, 381 U.S. 479 (1965). A fundamental privacy right is not at stake here. The interest defendants allege is "the interest in independence in making certain kinds of important decisions." Whalen v. Roe, 429 U.S. 589 (1977). But the kinds of "important decisions" recognized by the high court to date as falling within the right of privacy involve "'matters relating to marriage, procreation, contraception, family relationships, and child rearing and education'" Id. at 600, but do not include medical treatment.

"The Court's decisions recognizing a right of privacy also acknowledge that some state regulation in areas protected by that right is appropriate. As noted above, a State may properly assert important interests in safeguarding health, in maintaining medical standards, and in protecting potential life. . . . The privacy right involved, therefore, cannot be said to be absolute." Roe, 410 U.S. 153-54.

Significantly, when danger to health exists Roe v. Wade indicates that state regulation shall be tested under the rational basis standard. Id. at 163. The Court held in Roe v. Wade that a state may -- without encroaching upon any right of privacy -- further its important interests "in the areas of health and safety" by requiring abortions be performed at licensed institutions which "insure maximum safety for the patient" and prohibiting performance of abortion by a person not a physician as defined by state law. Id. at 163-65. The lesson of Roe v. Wade in this case is that a requirement that a drug be certified effective for its intended use is a reasonable means to "insure maximum safety for the patient."

Laetrile advocates may yet be vindicated in the court of scientific opinion, for even as this is being written the National Cancer Institute is seeking approval from the Food and Drug Administration to test laetrile on advanced cancer patients. (Cancer Institute Seeks to Test Laetrile, L.A. Times (Sept. 28, 1978) pt. I, p. 14, cols. 1-6.) Whether cancer patients -- especially advanced cancer patients who have unsuccessfully sought relief from conventional therapy and who are fully informed as to the consensus of scientific opinion concerning the drug -- should have access to laetrile is clearly a question about which reasonable persons may differ. It is not our function to render scientific or legislative judgments. Rather, we must resolve a narrow question: Does the challenged legislation bear a reasonable relationship to the achievement of the legitimate state interest in the health and safety of its citizens? We conclude section 1707.1 does satisfy this standard and that it therefore does not encroach upon the federal constitutional right of privacy.

Andrews v. Ballard, 498 F. Supp. 1038 (S.D. TX 1980), the defendants were practicing acupuncture against the law. Acupuncture is not explicitly mentioned in the Texas Medical Practice Act. Tex.Rev.Civ.Stat.Ann. arts. 4495-4512. It is, however, included within the Act's definition of the "practice of medicine." Tex.Rev.Civ.Stat.Ann. arts. 4510, 4510a; Thompson v. Texas State Board of Medical Examiners, 570 S.W 2d 123 (Tex.Civ.App., Tyler 1978).

Article 4510, Tex.Rev.Civ.Stat.Ann. provides as follows:

Any person shall be regarded as practicing