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AIDS Treatment News
Congress Looks at AIDS Treatment Delays--Part II
John S. James
June 3, 1988
AIDS TREATMENT NEWS No. 058 - June 3, 1988

Issue #57 of AIDS Treatment News published part I of our interview with Dr. Steve Morin, legislative assistant to Congresswoman Nancy Pelosi. Part II continues here.

(We commented to Dr. Morin that the staffing problem could also explain the inability to investigate the suspicion that the AL 721 now being used in NIH (NIAID) trials may be seriously deficient and perhaps ineffective. After hearing the reports, NIH planned to conduct its own quality control through a government or commercial laboratory; we have heard ambiguous reports about whether it did so. And one well-informed source told us that NIH refused to allow physicians running the trials to provide samples of the material to the buyers clubs, which routinely test AL 721 substitutes and wanted to the same tests on this AL 721 at their own expense.) "We heard one after another after another of that kind of story (at the hearings). It spoke eloquently of the lack of coordination, the lack of staff to actually monitor the implementation of the studies that the scientific advisory groups were giving high priority. Fauci admitted as much in the Friday hearings.

"The next witness was Jeffrey Beal, a physician from Tulsa, Oklahoma. He's one of the primary caregivers in Tulsa, he has 80 patients who are HIV positive. He told us that the average time from diagnosis to death in Tulsa was five months--compared to about 14 months median in San Francisco.

"Apparently many people (in Tulsa) delay seeking treatment for fear of discrimination. People arrive very sick, they're fearful of losing jobs and insurance, as well as being ostracized by the community.

"There seem to be real problems in Tulsa. The nearest of the original 19 AIDS Treatment Evaluation Units is 500 miles away. They don't have the kind of information that's available on the coasts. A lot of people come home to die there, they have a lot of people who do not seek active treatment, coming from somewhere else.

"The Thursday afternoon panel was mostly activist groups from New York and San Francisco: ACT UP, Community Research Initiative, Project Inform. They told how the Community Research Initiative model had developed. People had been frustrated with FDA and NIAID. They wanted to be involved in the whole process.

"Martin Delaney (co-founder of Project Inform in San Francisco) focused on problems with the treatment INDs, how that was really more of a public-relations effort than an actual option. (The "treatment IND", a plan purportedly to speed access to drugs to persons with serious or life-threatening diseases, was implemented on paper last May, but has almost no practical effect since then.) "Day 2 of the hearings opened with Admiral Watkins, who presented in essence the recommendations of the Presidential Commission on the HIV Epidemic. He was wonderful, the recommendations were wonderful, very critical of the FDA and NIH.

Then Fauci and others (from NIAID) were questioned for about three hours. As reported in The New York Times (cited above), Fauci requested 127 new positions and got only 11 from the Reagan Administration.

"Fauci sounded completely frustrated in being able to get anything done, in a way he hasn't sounded before in interviews.

"Probably the most heat came out of the discussion of aerosol pentamidine, and their 13-month delay on that. Fauci said one of the major reasons was that they didn't have a single staff person they could assign to be on top of it. It became abundantly clear, whatever the cost of that one staff person, if you calculate the cost of Medicaid of all the hospitalizations, even aside from human suffering, how much it was costing the government not to have a person escort that drug and speed it up, it's just ridiculous.

"We also heard from LyphoMed, Inc., the manufacturer of aerosol pentamidine, on the pricing issue. I thought the LyphoMed people had a good explanation for the pricing. They showed the cost of the research that would lead to the eventual licensing of the drug for that use. They paid the cost of supplying the drug through the Community Research Initiative (which is doing a study supported by LyphoMed). Also they have people in the field, staff which drives up prices. It has to do with the hoops they have to jump through for the FDA. LyphoMed didn't have to do any of that (earlier) when pentamidine was only an orphan drug; they weren't trying to license it then.

"LyphoMed outlined exactly what they had to do, and how much it cost, and it all computed. It was a reasonable explanation.

"The corporate drama around aerosol pentamidine is a good sign, because it indicates people really believe it is going to be effective, a long-term hopeful approach.

"Frank Young (the Commissioner of the FDA) was on the entire afternoon, along with Ellen Cooper and some of the others there. That was quite a lengthy question session. A lot focused on the treatment IND issue. They basically maintained that none of the drugs they knew of were good enough to qualify." (We asked how a lay person could challenge such an argument. The FDA has secret information on the drugs. Do they simply have to say that none of the drugs is good enough to release? Must the rest of the world simply accept such statements with no criticism, no checks and balances, as an ultimate truth from on high?) "Commissioner Young had just had an operation. Ms. Pelosi asked what he would do if it turned out that he were given contaminated blood and had an HIV infection, would he take any of these alternative treatments that showed theoretical potential but had not been proven effective? He admitted yes he would take them, because they would be the only option he had.

"They tell you one thing in the official capacity, and then they tell you that they would go ahead and take the drugs (if it were for themselves personally). What kind of message is that? It's a message that the bureaucratic stuff is just that.

(We told Morin that we saw the FDA's standard dog-and- pony-show at the Presidential Commission, which did not question the FDA witnesses in any serious way, just patted them on the back. The witness sitting next to me said he had seen the same presentation time and time again, that the FDA's top officials are in the business of making a living giving this show to high-level officials. The slick, well-designed presentation simplifies the whole confusing situation on AIDS drugs--provides clean, strong, simple concepts like phase I, phase II, phase III--it wraps up everything in a nice package for officials. The FDA becomes the focus point, the nerve center, the central gateway of the whole drug development process, so all the complexity now fits into place. The officials--confused, uniformed, at sea in all the complexity--love it.) "They had all of that, the (same) graphs. It was well packaged. Linguistically it sounded very compassionate." (We commented that linguistically it also sounded very rational, to appeal also to those who think that way.) "But they (FDA) do have expedited review, they do have a lot of things that NIAID does not have, that speed things along. But they have so many hoops to go through." (They'll speed up the paperwork, yes.) "But the things they say in the paperwork that people have to go through to get to the next step are very time consuming." "To sum things up, there is a human element to this. Alternative treatments that are safe and have theoretical potential to be effective but haven't been proved effective, do give people hope. And giving people hope is very important in an epidemic like this, where there isn't that much hope in the media. The media doesn't talk much about the people who are long term survivors.

"What could be done to give people hope, was the focus. The FDA was not being a helpful participant in thinking of it that way." Morin commended Chairman Weiss for his continuing leadership on AIDS issues. "The hearings gave me new hope."

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