Nov. 21 - 30, 2011 - Spent hours on the phone trying to address the
Diary Prequel Package, pp.263-267 · diary_prequel:entry:00721
Page text: p.263, p.264, p.265, p.266, p.267 · original PDF
- Date
- 2011-11-21 00:00 (day precision)
- Type
- diary entry · diary
- author
- Anthony S. Fauci
Nov. 21 - 30, 2011 - Spent hours on the phone trying to address the
ADAP waiting list since we (HHS/PEPFAR) felt that if the POTUS
announces a scale-up of treatment for PEPFAR, then the logical question
is what are we doing about the ADAP waiting list? Tom Frieden
suggested that we engage the drug companies. Since I know Jim Rooney
from Gilead, I made the initial contact which led to many phone calls
involving Jim and people from Gilead; people from HHS - me, Tom
Frieden, Mat Wakefield (HRSA), Sally Howard (chief-of-staff to
Sebelius), Dora Hughes as well as people from NASTAD and Welvista.
Important issues is the Gilead agreed to greatly lower their prices for
people on ADAP waiting list
Dec.1, 2011 - World AIDS Day (WAD). A very special day. The White
House has decided that the venue for the POTUS statement on WAD would
be George Washington University in a program sponsored by One and RED,
Bono's organizations. Sanjay Gupta was the MC. We had Presidents
Bush and Clinton by live video conference and President Obama delivered
the speech that Eric Goosby, Tom Frieden and I and others wrote for
him. As expected, he went with Option #2 (see above - Nov. 8, 2011).
In addition, he included an additional $15 million (for Clinics) + $35
million (for States) = $50 million for ADAP total. Again, Tom Frieden
and HHS people (see above) have been working on the "domestic option"
for the past couple of weeks to offset criticism that we were paying
attention to global, but not domestic AIDS.
Following the POTUS speech, there was a panel moderated by Sanjay
consisting of Bono, Alecia Keys, Kay Warren, Rep. Barbara Lee, Sen.
Marco Rubio and a few others. I was told a few days prior that Sanjay
would turn to me with a question sometime during the program. Right
after Pres. Clinton's live video speech, Sanjay said that you cannot
have a discussion about HIV/AIDS without including Tony Fauci (who is
in the audience) and his perspective on the science and he turned to me
to speak. I spoke for a few minutes about the fact that the
scientific data were overwhelming (circumcision; treatment as
prevention, etc.) and the task now was to implement the science. The
statement was similar to what I had said at the IAS meeting in Rome in
July. Right after my comment, Bono said that he must tell a funny
story and he proceeded to describe the night when he came to my house
for dinner to discuss what we could do to push the global AIDS agenda.
He was cute. He said that his friend Bobby Schriver told him that the
only person that could break the logjam on Global AIDS programs was
Tony Fauci. He finished by calling me a "proper hero". A YouTube
record of this statement by Bono is available for Dec. 1. Also, I had
a chance to say a few words to Pres. Obama as he was "working the line"
following his speech. He congratulated me for the great work that we
were doing and that he has been hearing about. All in all, a really
good day!!
Of note, Gregg Gonsalves wrote a scathing letter to Raj Shah (that went
viral on the internet) scolding him for obstructing the treatment as
prevention initiative (see above discussions re: Raj). Unclear to me
how Gregg found out about all of this.
Dec. 2,, 2011 - Finishing off WAD activities, went to Harvard on a
beautiful crisp clear December day and participated in the AIDS@30
International Symposium. I gave the keynote "Perspective" on vaccines
and participated in a panel Chaired by Bruce Walker and consisting of
Bob Gallo, Nelson Michael, Jerry Sadoff, and Julie McElrath. Flew up
to Boston with Eric Goosby and flew back to DC with Nelson Michael.
All good.
Dec. 2 thru 21, 2011 - Significant issues regarding dual use research.
Check press from Dec. 20-21, 2011. Briefly, NIAID funded 2 studies -
subcontract via CEIRS (Centers of Excellence for Influenza Research and
Surveillance) to Erasmus University in Netherlands (Ron Fouchier) and
grant to Yoshi Kawaoka at Wisconsin to study feasibility and mechanism
of getting the highly lethal (60%), but poorly transmissible H5N1 (bird
flu) that has been smothering in SE Asia since 1997 to become
transmissible and maintain lethality in a mammal model (ferret).
Rationale for the study was to determine - Can it happen (in mammals)
since many people reasonably assume that it cannot since it has not
done this in nature despite being around in chickens and rarely in
humans since 1994? Also, if it does become transmissible by point
mutations followed by passaging in ferrets (the experimental
methodology), then what is the signature of it so that health officials
in the field could do better surveillance and also design better
diagnostics, therapies and possibly vaccine. Both papers (with slight
differences found that relatively few mutations (~5) followed by serial
passage in ferrets led to virus that had better transmissibility and
kept virulence. Kawaoka paper showed increased transmissibility but not
maintenance of virulence, while Fouchier paper showed both. Papers
submitted to Nature (Kawaoka) and Science (Fouchier). Program staff
(NIAID), Fouchier and editors asked (because of possibility of dual
use) the NSABB to examine the results and advise if it was OK to
publish. Kawaoka was asked by NIAID to do the same. To everyone's
surprise, the NSABB recommended that the papers be published with the
conclusions, but with redaction of the key results, mutations and
methodologies. I believe that this was group think and "cover your
ass". Decision was to do this and provide a link in the paper whereby
people (health officials, legitimate scientists, PHARMA, etc) who have
a need to know can have access to the data. This was a precedent
setting recommendation that was virtually impossible to ignore even
though I disagreed with it since the complexity of influenza
adaptability is extremely complex and it is unlikely that terrorists
could replicate this work largely because it is unlikely that if that
this model just simply predicts that it will maintain these
characteristics if taken from ferret to human. Furthermore and more
importantly, since the data had already been presented (by Fouchier) at
an international meeting in Malta and the papers were reviewed by
several reviewers and known by many, the data are already "out their"
and would be virtually impossible to "restrict" the access to the full
papers by a "vetting" mechanism of people who "apply" for the
unredacted papers. Journal editors were disappointed (Bruce Alberts -
Science and Phil Campbell - Nature) as were many flu scientists.
However, we heard the usual hysteria from people like Ebert and
Ingelsby who complained that the experiments should never have been
done in the first place. Also, Mike Osterholm who is a member of the
NSABB was practically hysterical that the NSABB recommendations should
go out right away so that he could "answer all of the press calls" that
he was getting. In reality, the only press that was agitating was -
you guessed it - Laurie Garrett. Of note, Mike Osterholm is the Head of
the CIERS group that subcontracted through the Mount Sinai group to
Fouchier to conduct these experiments. Osterholm now (incredibly)
says that he never thought that this situation would arise when he knew
about the contract and actually was given updates through the CIERS on
the actual data. Yet, he is the loudest one saying we should now lock
down all experiments and treat this like BSL-4. Problem here is that
as I predicted, the White House is now involved and they want the USG
to examine all research that is ongoing and that is proposed for its
dual use potential and to put restrictions on it if it has such
potential. What they do not understand it that in the "discovery of
science" you cannot always predict what will be dual use and the danger
is that scientific work and importantly the normal open discourse of
science will suffer because some uninformed people who live for
"intrigue" are acting out their own agenda. More later.
Dec.22, 2011 to Jan. 7, 2012 - Situation has escalated with wall-towall conference calls with HHS and a variety of WH folks about what to
do. Major issues are that Bruce Alberts and Phil Campbell are willing
to publish a redacted version of the papers in Science and Nature,
respectively; however, they insist that the USG have in place a link or
some mechanism that they can publish with the redacted versions of the
paper that would allow legitimate scientists and Public Health
officials to have access to the entire manuscript. I found out
through painful probing that recommendations from NSABB guidelines
USG policy should have been in place years ago to deal with the
upstream (prior to the start of experiments) and downstream (progress
reports and communication of results) issues of Dual Use Research of
Concern (DURC). Problem is that the recommendations of the NSABB as to
the "7 deadly sins" of DURC never got "clearance" from the multiple
agencies to which NSABB officially reports (DoD, DHS, DoS, DoJ,
intelligence community) in order for it to get the Public Comment in
the Federal Register to give the scientific community the opportunity
to weigh in on the feasibility of controlling or not such research at
the same time a preserving the fundamental basis of open scientific
discourse. I believe that Amy Patterson should have shown some
greater strength of leadership to make sure that this process moved
along, when in fact it just froze. The NSABB sent in their
recommendations in 2007 (NSABB started in 2004) that should have become
guidelines USG Policy that ultimately could guide the local
institutional Biosafety Committees (IBCs) to monitor this at the local
level. Irony is that now the papers have been reviewed, the Fouchier
paper was presented in an international meeting in Malta and multiple
people have seen the data. BTW, Fouchier has been acting like a jerk in
his cavalier attitude about disseminating the results. Now NSABB and
the journals above all want a mechanism is a few days (to coincide with
the publication dates of the papers (Jan. - Feb. 2012) that they have
not been able to do in 4-5 years. All of the demagogues have weighed
in. People thinking that the world is not in danger of a terrorist
making a "killer virus" that spreads easily. What is at stake is the
proper balance of doing microbial research that has DU potential with
security issues. Of, note, I wrote an opinion piece in the Dec. 31,
2011 issue of the Washington Post on the value of the science. The
security people do not understand the scientific enterprise, although I
can understand their concerns. This whole thing has destroyed my
Christmas Holidays. It still is not over. Divergent opinions in the
scientific community ranging from 1) this work should never have been
done in the first place (Ebright; Ian Lipkin) to 2) we should not
restrict publication of any of the data and should just let it out
(Racaniello; Peter Palese) to 3) we should publish only redacted
version (which is ridiculous since the data are out already) to 4) we
should destroy the virus (D.A. Henderson). Please note that the
complexities of species adaptability to virus transmission and
lethality is so complex that just because multiple induced mutations
followed by passaging in ferrets of 1 strain of H5N1 does not mean that
this virus would do the same in humans or that anyone else could
replicate the experiment. Of great importance is the fact the Fouchier
found out (but DID NOT submit it with his paper to Science - he wants
to put it into a second paper)that if you take these 5 mutations and go
back and put them into the wild-type H5N1, you do not get increased
transmissibility, which proves my point (and that of Jeff Taubenberger)
that transmissibility is a multi-genic process that is strongly
"context-dependent". In other words, just knowing these 5 mutations
may have little impact on someone's ability or not to repeat these
experiments. Let me be clear, I believe that we need to now once and
for all get the process going of a SOP for evaluating dual use research
of concern (DURC) before the experiments are performed to evaluate the
risk/benefit of even doing the experiments and to periodically look at
the data to determine whether the data should be shared (presented or
published) before one presents it or submits it to a journal. I think
that there was major multifaceted failure here of NSABB covering their
asses with the recommendation; researchers wanting attention for their
work; failure of Amy Patterson's shop to get their job done over years;
panic and hubris on the part of USG agencies who know nothing about
science. I can go on and on. The problem that we are facing now is
that we (USG) is being put in an untenable position of be involved in
and associated with restricted (or as some say "censoring") scientific
information when it is already out there. The process sets a bad
precedent and it evokes all kinds of conspiracy theories and makes us
look foolish. My choice at this point would be to admit that it is
too late in the process - we should publish the unredacted papers and
make this an "Asilomar moment" to make sure that we are not in this
position again.
Of note, on Jan. 7, 2012 a NY Times (written by Phil Boffey -
unsigned - I know because he called me about it) came out with an
inappropriately alarmist editorial entitled "Engineered Doomsday"
calling into question the rationale for the research and asking for
lock down of virus in BSL-4 and ultimate destruction of virus. He got
most of his information from Ian Lipkin (my good friend) who feels
strongly about this and was nice enough to tell me that he was going to
do this. This editorial has only inflamed the hysteria and posturing.