permission as to the tenth and eleventh, one of whom was David Smith. The letter noted that Smith had not received chemotherapy and concluded: "The administration of Antineoplastons to patients with Hodgkin's disease who have not received potentially curative chemotherapy is not acceptable. The administration of Antineoplastons in this patient should not be continued." This conclusion was consistent with FDA regulations relating to the use of investigative drugs to the exclusion of recognized curative therapy, 21 CFR 312.42(b)(1)(i).
Smith, through counsel, sought reconsideration of FDA's decision to disallow the single patient exception. By letter of May 27, 1996, Exhibit 11 to the Verified Complaint, FDA adhered to its earlier decision.
On June 5, 1996, his supply of Antineoplastons having been exhausted, Smith sought emergency relief in this Court.
To be entitled to a preliminary injunction, Smith must demonstrate (1) that he is substantially likely to succeed on the merits of its suit; (2) that he would suffer irreparable harm in the absence of an injunction; (3) that the injunction would not substantially harm other parties; and (4) that the injunction would not substantially harm the public interest. See, e.g., Taylor v. Resolution Trust Corp., 312 U.S. App. D.C. 427, 56 F.3d 1497, 1505-1506 (D.C. Cir. 1995); Wagner v. Taylor, 266 U.S. App. D.C. 402, 836 F.2d 566, 575 (D.C. Cir. 1987). Preliminary relief may be granted after balancing these factors if plaintiff demonstrates a high probability of success and some injury, or vice versa. Cuomo v. United States Nuclear Regulatory Commission, 772 F.2d 972 (D.C. Cir. 1985).
1. Irreparable Harm
Smith asserts that he will suffer and eventually die without the Antineoplastons treatments, but, of course, that proposition cannot be proven. The efficacy of Antineoplastons in the treatment of Hodgkin's disease, or any cancer for that matter, has not been scientifically established. According to Dr. DeLap at FDA, the reported changes in Smith's symptoms and on his bone scan since he began receiving Antineoplastons do not establish that the treatments are benefitting Smith. Smith's refusal to undergo chemotherapy, a proven treatment for his illness, undermines his argument that it is the FDA's actions, rather than his own election, that will cause the injury of which he complains.
Smith has also failed to demonstrate a substantial likelihood of success on the merits of his claim, or any likelihood, for that matter. While there are decisions recognizing that competent adults have a fundamental right to refuse medical treatment, Cruzan v. Director, Missouri Dept. of Health, 497 U.S. 261, 111 L. Ed. 2d 224, 110 S. Ct. 2841 (1990), and to determine the time and manner of their death, free from governmental interference, Compassion in Dying v. State of Washington, 79 F.3d 790 (9th Cir. 1996), nothing in those decisions suggests that the government has an affirmative obligation to set aside its regulations in order to provide dying patients access to experimental medical treatments. On the contrary, where courts have been presented with claims like Smith's they have refused to find a "right" to receive unapproved drugs. See Rutherford v. United States, 616 F.2d 455 (10th Cir.), cert. denied, 449 U.S. 937, 66 L. Ed. 2d 160, 101 S. Ct. 336 (1980); accord Carnohan v. United States, 616 F.2d 1120 (9th Cir. 1980). The constitutional rights to privacy and personal liberty "do not give individuals the right to obtain [unapproved drugs] free of the lawful exercise of government police power." Carnohan, supra, at 1122.
Even if this court were persuaded that Smith had a fundamental right to "choose among available medical treatments," as he puts it, Antineoplastons are not "available" as a matter of law. Antineoplastons have not been approved for general use by FDA. See 21 U.S.C. § 355(a) (prohibiting distribution of new drugs without agency approval). Their use has been approved only for limited clinical trials under agency supervision. See 21 U.S.C. § 355(i) (exemption from premarketing approval solely for investigative use). Dr. Burzynski's administration of Antineoplastons treatments to Smith was in contravention of the FDA protocols specified in the IND, and, at least after the Fifth Circuit's ruling on April 15, 1996, in direct violation of a federal court order.
Smith also claims that the FDA's decision to exclude him from the Antineoplastons IND amounts to a denial of his right to equal protection under the law. Where an equal protection claim involves no fundamental right or suspect classification, however, a plaintiff must demonstrate that the government's decision or its classification is not rationally related to a legitimate purpose. See e.g., Williamson v. Lee Optical, 348 U.S. 483, 99 L. Ed. 563, 75 S. Ct. 461 (1955). Smith has not attempted to sustain that burden and cannot do so.
The FDA based its decision to exclude Smith from the Antineoplastons IND on the fact that Smith had not tried an available, proven treatment for his illness. That decision is supported by FDA's regulations, which require the agency to consider whether "another drug under investigation or approved for the same indication and available to the same patient population has demonstrated a better potential benefit/risk balance." 21 CFR § 312.42(b)(4)(v).
The FDA's decision with respect to Smith is manifestly related, and rationally related, to furthering the agency's interest in protecting the public from the risks of medical treatments that have not been proven safe and effective. That interest is present and, if anything, heightened in cases of patients who suffer from serious, life-threatening illnesses. "If an individual suffering from a potentially fatal disease rejects conventional therapy in favor a drug with no demonstrable curative properties, the consequences can be irreversible." United States v. Rutherford, 442 U.S. 544, 556, 61 L. Ed. 2d 68, 99 S. Ct. 2470 (1978).
Smith has no fundamental right to receive Antineoplastons treatments, and FDA's decision to exclude him from its experimental treatment program is entirely rational. Smith has failed to demonstrate any likelihood that he will succeed on the merits of his claim.
The court does not doubt the sincerity of Smith's desire for, or belief in, Dr. Burzynski's Antineoplastons treatment. Smith's decision to refuse chemotherapy is his decision to make. Smith has not, however, demonstrated that he is entitled to judicial intervention on his behalf and, for that reason, his application for preliminary injunction must be denied.
An appropriate order accompanies this memorandum.
United States District Judge
June 7, 1996
For the reasons given in the accompanying memorandum, it is this 7th day of June, 1996, ordered that plaintiff's application for preliminary injunction is denied.
United States District Judge