AIDS TREATMENT NEWS No. 092 - December 1, 1989
John S. James
We do not know how many of the PIs oppose expanded access. But it is clear that many have strongly fought against Fauci's "parallel track" proposal, against the current system of expanded access to ddI under existing regulations (technically different from "parallel track," which has not yet been officially defined), and also against the FDA's liberalized rules for patients seeking medicines approved abroad for personal use. In short, some of the PIs have consistently fought against patients' access to treatment options--both openly, and (more importantly) behind the scenes--on the grounds that if patients have more options, they will not volunteer for their studies.
Now some patients requesting ddI are unexpectedly being denied it, and there is widespread suspicion that pressure from PIs is to blame. For example, Bristol-Myers was expected to drop the requirement for an AIDS diagnosis for access to ddI by patients who are failing AZT, allowing patients otherwise qualified to enter this program even if technically they only have ARC. Now it appears that this restriction will not be dropped, although exceptions might be considered on a case-by-case basis. We are also hearing reports of a general slowdown in the system, with patients who are eligible under all the rules being told that there is not enough drug--when before we had heard that there was no problem with supply.
Arguments against allowing wider use of the drug were stated in a much-criticized article on page 1 of The New York Times, November 21, 1989. Headlined "Innovative AIDS Drug Plan May Be Undermining Testing," this article reported that "almost 20 times as many people have flocked to free distributions of the new drug ddI than have signed up for the clinical trial, leaving researchers in despair over whether they will ever be able to complete the formal study." But with a closer look shows a very different picture:
* According to Bristol-Myers, available data on the patients who have "flocked" to ddI distribution outside of the trials show that 60 percent of them would not be allowed into any of the three ddI trials because they do not meet medical criteria, and another 30 percent live too far from the nearest trial site to participate. Well under 10 percent could possibly have entered a formal study.
Some principal investigators have dismissed these numbers by saying that doctors lie to get ddI for their patients, and therefore some of those counted as ineligible for the formal studies may really have been eligible. But they have not presented any evidence to show whether significant number of patients are lost to the study this way.
* At some of the sites where the study will be conducted, no one can enroll because the local institution is not ready for them. Often the local Institutional Review Board has not yet given its approval. The program to allow expanded access to ddI to patients ineligible for the trials cannot be blamed if low enrollment totals result from the fact that some centers are not ready.
* Some of the study sites only have enough staff to enroll a few patients a week.
For these and for other reasons, patients are on waiting lists at some of the centers--in some cases, for months. And most centers have done little or nothing to tell the public about their studies.
* In addition, there are concerns about the studies themselves. In two of the them, patients may be randomized to 1200 mg of AZT per day--the dose which is officially approved but which the medical community is rapidly coming to consider too high. Attempts to change the trial to use a lower dose have not yet succeeded. Other concerns include the appropriateness of randomizing patients to AZT when those patients were selected to be ones for whom that drug is likely to be losing effectiveness (study number ACTG 117). Such concerns about study design create disincentives for patients to enroll.
* Despite all these problems, the ddI studies have actually recruited faster than most ACTG trials in the past (when there was no system for access outside of trials), according to Jim Eigo of ACT UP/New York, who for months has been one of the principal patient advocates in the ddI negotiations.
Demonstration December 14
ACT UP/New York is planning protests on December 14 against denial of treatment to patients who have no other alternatives. Protests are also being planned in other cities. These demonstrations are being called on very short notice. For more information, ask ACT UP/New York at 212/989-1114, or call David Barr at Lambda Legal Defense and Education Fund, 212/995-8585.
If You Have Trouble Getting ddI
David Barr of Lambda Legal is collecting information about peoples' experiences when they try to obtain ddI, either by volunteering for a trial or by trying to enter the expanded access program. Anyone who has difficulty should call him at the above number. Many of the access problems have not been announced, but have been discovered by comparing notes of persons who have been turned down.
For More Information
For more information about the controversy over access to ddI, see the column by Mark Harrington and letter by Jim Eigo in Out Week magazine (New York, December 10 issue date). There is also an unpublished November 21 letter to The New York Times from David Barr and Jay Lipner of Lambda Legal, and a November 21 press statement by Project Inform, both written in response to The New York Times article of that date.
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