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SMITH v. SHALALA

June 7, 1996

DAVID B. SMITH, Plaintiff,
v.
DONNA E. SHALALA, SECRETARY, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Defendants.


James Robertson, United States District Judge


The opinion of the court was delivered by: ROBERTSON

Plaintiff David Smith suffers from an advanced stage of Hodgkin's lymphoma. He brings this action seeking an injunction "restraining the Department of Health and Human Services and the Food and Drug Administration from prohibiting" the Burzynski Cancer Institute from treating him with Antineoplastons, an experimental anti-cancer agent. Smith posits "the right of a competent terminally ill cancer patient to choose among available treatments that he or she can accept and endure," and he claims that the FDA's refusal to permit his treatment with Antineoplastons interferes with his rights to due process, equal protection, and privacy.

 The court heard oral argument on plaintiff's application for a temporary restraining order on June 5, 1996. Because this matter was presented as a life-or-death emergency, the court has undertaken to decide plaintiff's preliminary injunction motion on an extremely expedited basis. For the reasons set forth below, plaintiff's motion for a preliminary injunction will be denied.

 Facts

 Smith was diagnosed with Hodgkin's disease in 1993. He underwent radiation treatment, after which the cancer was in remission until it reappeared in February 1996. In March 1996, his treating physician recommended chemotherapy. Fearing the potentially severe side effects of the treatment, Smith refused.

 Smith then sought out Dr. Stanislaw Burzynski of the Burzynski Cancer Institute in Houston, Texas. Dr. Burzynski recommended a course of treatment with Antineoplastons, an investigational new drug (IND) being administered in FDA-approved clinical trials pursuant to the Food, Drug and Cosmetics Act, 21 U.S.C. ยง 355(i). Smith began receiving experimental treatments on April 1, 1996. He and Dr. Burzynski both now claim that the Antineoplastons treatment has been effective. Dr. Burzynski reports encouraging changes in Smith's bone scans. Smith states that he has experienced a reduction in bone pain and itching.

 At the time Dr. Burzynski began treating Smith with Antineoplastons he had been charged in a seventy-five count federal indictment for mail fraud, introducing an unapproved drug into interstate commerce, and violating a court order. United States v. Burzynski et al., H-95-290 (S.D. Tex. 1995). The district judge required, as a condition of Dr. Burzynski's pretrial release, that he stop administering Antineoplastons except with FDA approval, but he stayed that requirement pending review by the court of appeals. On April 12, 1996, in a per curiam order, the Fifth Circuit affirmed the district court's order imposing conditions, No. 96-20209, observing that the administration of Antineoplastons without approval of the FDA and outside FDA-approved clinical trials was unlawful, see Trustees of the Northwest Laundry and Dry Cleaners Health & Welfare Trust Fund v. Burzynski, 27 F.3d 153 (5th Cir. 1994), cert. denied, 130 L. Ed. 2d 1075, 115 S. Ct. 1110 (1995).

 On May 17, 1996, Dr. Burzynski notified the FDA that he was treating Smith with Antineoplastons but outside the protocols of the approved IND and requested permission to continue Smith's treatment under a "single patient exception." Such exceptions are frequently permitted to allow the administration of unapproved new drugs to patients who are not eligible for treatment in any of the clinical study protocols under an IND, but they are not granted if a patient would be subjected to an unreasonable and significant risk of illness or injury, 21 CFR 312.42(b).

 By letter of May 23, 1996, Exhibit 9 to the Verified Complaint, the Acting Director of FDA's Division of Oncology Drug Products, Office of Drug Evaluation, wrote to Dr. Burzynski, expressing concern about "the large number of new patients that you have now revealed were started on Antineoplastons between February 24, 1996 and April 15, 1996 outside your INDs . . . ." The letter responded to Dr. Burzynski's requests concerning eleven patients, granting permission to continue treatment for eight of them, seeking further information as to a ninth, and refusing 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.

 Analysis

 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 ...


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