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Peptide T Access Blocked




 

GMHC Treatment Issues 1991 Jan 10; 5(1): 1

We hear more about the controversies surrounding the clinical trials, patent disputes and availability of Peptide T than the actual efficacy of the drug. Since Treatment Issues last checked in with Peptide T, which has had a rather rocky history, access problems have developed. After the phase I trials in Provincetown and Boston, continued availability of the drug for trial participants became a major controversy. Trial participants were afraid they would be unable to obtain drug after the trial ended. In addition, Bristol Myers withdrew its sponsorship leaving Peptide T without a financial backer. After several rounds of sometimes heated negotiations with community health officials and activists, the National Institute of Mental Health (NIMH) picked up the funding to extend the phase I trial and to provide drug to the participants after completion of the trial. As Treatment Issues went to press, more negotiations were underway, this time regarding patent issues and sponsorship of clinical trials. In addition, recent posturing by the FDA has threatened underground sources of the drug. People who have relied on buyers' clubs to obtain Peptide T for their personal use are understandably agitated.

History Peptide T is thought to work by blocking the entry of HIV into cells bearing the CD4 receptor, a passageway into the cell to which HIV is strongly attracted. In that regard, Peptide T is similar to the drug CD4. Peptide T easily enters the brain and has been particularly associated with improvement of neurological symptoms. Several small studies claim that Peptide T reverses neuropsychiatric symptoms associated with HIV infection (1). Also, stabilization of T4 cell counts have been reported. None of the participants in these studies experienced toxicity. These interesting results prompted buyers' clubs (groups that help procure unapproved drugs for individuals) to obtain Peptide T. Buyers' clubs in Dallas and Ft. Lauderdale have been facilitating access to Peptide T for their clients. The New York PWA Health Group has considered helping people obtain Peptide T, but not much interest has been expressed in the drug, according to Derek Hodel, the group's Director.

Community Availability A source of Peptide T for buyers' clubs in the United States has been Peninsula Labs, a pharmaceutical company in California. Several buyers' clubs created a dummy animal trial, in order to gain access to the drug. Pharmaceutical companies can sell unapproved drugs to groups conducting animal research. The Food and Drug Administration (FDA) informed Peninsula that the Peptide T being sold to buyers' clubs was actually being used by people and that the commerce must stop. Recently, representatives of the FDA visited Peninsula Labs, interrogated employees of the company and searched through sales records (2). Eng Tau, a spokesperson for Peninsula Labs, claims that she would gladly supply drug to whoever requested it, if the FDA would allow her to do so.

Legal Action Ron Woodroof of the Dallas Buyers' Club filed a law suit against the FDA, requesting a temporary restraining order and an injunction against the agency's actions to stop Peninsula Labs from selling Peptide T to Dallas Buyers' Club. District Court Judge Charles Legge ruled against Woodroof and wrote in his opinion that the law does not provide unlimited access to experimental drugs for people with terminal illnesses. But Judge Legge also wrote of Woodroof, "He ought to have the right to obtain most any drug he believes would help alleviate the situation (3)." Importing Unapproved Drugs Another potential source of Peptide T is Carlbiotech, a Danish pharmaceutical company. Carlbiotech was recently awarded a contract to provide Peptide T for a trial which will take place at the University of Southern California (USC). Interestingly, Carlbiotech also received a letter from the FDA at about the same time the contract was awarded, warning them not to sell the drug to individuals in the United States who do not hold an IND (Investigational New Drug). An IND gives authority from regulatory officials to conduct human research with an experimental drug. An unnamed company employee expressed concern that Carlbiotech's contract with the FDA would be in jeopardy if it sold Peptide T to American buyers' clubs.

According to Brad Stone, an FDA spokesperson, a company cannot legally sell an unapproved drug to an individual who does not have an IND (4). If a person is in dire need he/she can apply to the FDA for a "Compassionate Use IND" for access to a drug or can try to enroll in a clinical study. A Compassionate Use IND is only possible with the cooperation of a pharmaceutical company, which is sometimes difficult to obtain. Stone said that the FDA would encourage individuals seeking an unapproved drug to apply for an individual Compassionate IND.

However, it is possible to import some experimental drugs for personal use. In July 1988, the FDA issued a paper stating its policy on importation of drugs that are not approved in the United States (5). Individuals are allowed to import such drugs according to the following stipulations: the product must be for personal use; it must be legally available in the country of origin; it cannot be resold; no more than a three month supply can be imported at one time and patients must have a prescription for the medication. In addition, the FDA retains the prerogative to disallow importation of drugs deemed to be too toxic. Buyers' clubs facilitate this process and help patients fill prescriptions for foreign drugs. A strict reading of the FDA import policy would not allow importation of Peptide T from Denmark since the drug is not licensed there, and an FDA spokesperson indicated that shipments of Peptide T could be stopped at the border (6).

Meanwhile people who are buying Peptide T from buyers' clubs are very frightened and angry that their access to the drug may be interrupted. One person who has asked to remain anonymous says: "I have less than 30 days worth of drug left and I am down to limited resources. But I will not tolerate and will not let a mindless and depersonalized bureaucracy compromise my life. I was diagnosed with AIDS six years ago and I intend to live." Planned Trials A phase II trial may soon be accruing patients to examine Peptide T's effect on neuropsychiatric symptoms. This trial will be conducted at the University of Southern California (USC). Funded by the NIMH, the trial will enroll 150 patients with moderate to severe cognitive impairment. The current protocol (trial guidelines) calls for two arms: Peptide T versus placebo for six months. Participants will also be allowed to take other antivirals. Any participant receiving placebo whose neurological symptoms worsen will be switched to drug.

As Treatment Issues went to press, the protocol had not yet been finalized. The contract for the trial was awarded to USC in September; this lethargic protocol approval process is indicative of the unhurried pace at which this drug has been developed. For further information about this trial call Charles Hovis at (212) 226-4643.

A second Phase II trial for Peptide T is currently recruiting patients at Yale University Medical Center in New Haven. This trial is for intravenous drug users (IVDUs), who are taking AZT. The study will last five years, accruing twenty-four patients a year. The National Institute of Drug Abuse is funding the trial in collaboration with the NIMH. For more information call Brenda Martini at (203) 772-0191.

What Now? It is unclear if the FDA is embarking on a general assault on the underground's providing access to unapproved drugs. The nervousness of people who have been taking Peptide T could be easily alleviated if the FDA chooses to uphold the spirit of its own import policy. Given Peptide T's apparent lack of toxicity, it is puzzling that the FDA would be vigilant about personal use of the substance outside of clinical trials. We will continue to cover this story as it unfolds.

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Copyright © 1991 -Gay Men's Health Crisis, Publisher. All rights reserved to Gay Men's Health Crisis (GMHC) Treatment Issues. Reproduced with permission. Treatment Issues is published twelve times yearly by GMHC, INC. Noncommercial reproduction is encouraged. Subscription lists are kept confidential. GMHC Treatment Issues, The Tisch Building, 119 West 24th Street, New York, NY 10011 Email GMHC. Visit GMHC

Information in this article was accurate in January 10, 1991. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.