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
"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
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
"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
(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
"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
"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
"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
"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
Morin commended Chairman Weiss for his continuing leadership on
AIDS issues. "The hearings gave me new hope."