January 2013
Vittorio Agnoletto is a physician, the
co-founder of LILA (Lega Italiana per la Lotta contro l’AIDS) and its national
chairman from 1992 to 2001, former European Parliament member, a Professor of
Health and Human Rights at the University of Milan. Carlo Gnetti is a journalist.
Last November, they published a book together – AIDS: lo scandalo del vaccino
italiano – which tells the nearly
fifteen-year history of the
anti-Tat vaccine tested by Dr. Barbara Ensoli at the
Istituto Superiore di Sanità (ISS), Rome.
In this book the authors gather the
doubts, the criticisms, the precise and detailed objections and the countless
unanswered questions that this story has roused since its inception. And they
do so through the many articles published in the general press, the few
scientific papers closely related to the trial published in specialized
journals, the declarations, the missed declarations and the real reticence of
some of the protagonists, building what magistrate and President of the
Surveillance Court of Bologna Francesco Maisto called “a strongly marked circumstantial trail”. (For the definition given
by judge Maisto, see the interview that Emiliano Silvestri made with Vittorio
Agnoletto for Radio Radicale, min.
13:55).
The authors’ ultimate aim is to establish
the truth of a story that dominated the Italian scientific and media scene in
the last 15 years. The main theme of the book, indeed, is an urgent request for
clarification; its hope is that those who know will speak, because if the
doubts about the conduct of the trial were consistent and demonstrated real, then
people involved in the clinical trials – in Italy and especially in South
Africa – could be running serious risks.
The book is introduced by a foreword by
Robert Gallo, co-discoverer of HIV along with Montagnier and Barré-Sinoussi. Here
he summarizes the scientific concerns about a vaccine based on the Tat protein,
which was discovered by his own working group. According to Professor Gallo, by
the early 1990s and well before the start of the trials of Barbara Ensoli in
1998 it was already known that Tat could give at most a modest therapeutic
contribution, but it alone certainly could never be the basis of a preventive
vaccine. “An illogical idea for a
preventive vaccine” – writes Gallo. Indeed, “after 15 years there are no confirmed results that support this
approach, nor is it of use today as a therapeutic vaccine”.
And with combination antiretroviral
therapy available since 1995, also the therapeutic contribution of Tat seems to
Gallo now essentially useless.
The issues addressed by Agnoletto and
Gnetti range from lack of transparency to ethical concerns, from the costs of
the project to the extremely swollen times of all stages of the trial, to
familism, to media overexposure: all those issues are intertwined. In summary:
·
The lack of transparency
of the whole experimentation is highlighted especially in relation to changes
of the protocol while the trials were in progress and without notification to
the other researchers involved; to the partial publication of data and
therefore their lack of validation, with the consequent passage from one phase
of the experimentation to another without justifying and explaining the results
of the previous phases; to the confusion between trials of a preventive
vaccine, then a therapeutic one, then again a preventive one, but completely
different from the previous, coming back from a phase II trial to a phase I new
trial - with no one of the project Principal Investigators taking the burden of
saying “it was a wrong path for these and these reasons, we changed our minds”.
·
The ethical concerns are about
the way in which the monkeys were treated during the preclinical phase (which
might have distorted the data from the animal model which provided the basis for
moving to human trials), and about the fact that the volunteers enrolled in the
trials in South Africa might not obtain the same protection enjoyed by the
participants to the European trials, because the control mechanisms there, such
as ethics committees, might not always provide the same guarantees we enjoy
here.
·
The issue of the project’s
funding is complicated, because it is interwoven with the political and not
only scientific decision to allocate almost half of the total public funding
for the fight against AIDS over the past decade to research widely criticized
by leading scientists around the world and almost completely absent from the
major international scientific conferences. Further perplexity arises from the
fact that more than 20 million euros have been added by the Ministry of Foreign
Affairs to the funds allocated by the Ministry of Health, which is the ministry
that normally deals institutionally with this kind of research and finances it
through a peer reviewed mechanism of evaluation and control, in which
scientists not involved in the project judge the potential of the research
program. The Ministry of Foreign Affairs has taken these 20 million euros away
from the funds for international cooperation and allocated them to the construction
of a laboratory in South Africa for on-site
analysis of the results of the trial. But funds for cooperation are not
allocated on the basis of a peer review mechanism. To this must be added the
consideration that no pharmaceutical company seems interested in producing this
vaccine.
·
The familism might seem
like a minor problem, a “simple” scientific malpractice. But it is not, because
having the brother of the leader of the research project as the director of the
laboratory where data collected from the trial are analyzed poses a serious
threat to the interpretation of these data. And this is just one of several
cases in which controller and controlled are the same entity and a conflict of
interest arises.
A few days before the book arrived in
bookstores, Barbara Ensoli sent to a mailing list some Considerations useful to clarity, a summary of which was published in the
27 November issue of La Repubblica and which is, to date, the only (semi)official reaction by the Istituto
Superiore di Sanità.
It is a sort of “memorandum” in which
Ensoli repeats the official version of the history of the anti-Tat vaccine,
that can be read in the dedicated
website, but is careful not to respond to the criticisms
moved in the book, rather accusing the authors of having falsified and
distorted “everything”, adopting the “defamatory obstinacy” of Robert Gallo
and Fernando
Aiuti, whom Ensoli “knows very well, and she is aware of what they are able to do to gain
visibility”.
Agnoletto and Gnetti are also accused of
an “obvious” intent to defame “the vaccine, the Istituto Superiore di
Sanità (‘ISS’) and its President, Prof. Garaci, but also public institutions:
the Ministry of Health and the various ministries who have taken place over the
years, the Ministry of Foreign Affairs, the Undersecretary Letta of Prime
Minister Berlusconi, the National AIDS Commission, scientists and Italian
public research and, ultimately, the Italian system as a whole, which is
represented as unreliable” (p. 1).
According to Ensoli, the “book is so defamatory that is natural to
ask for what purpose it was written, and if there are
economic/political/international interests that could benefit from the mud the
authors throw on the Italian system” (ibid.). This induces Barbara Ensoli
to conclude her “Considerations” –
which were supposed to be “useful to
clarity”, but which do not clarify anything but a certain anxiety of their
author – wondering who “really” is
behind all of this: “Which lobbies are at
work? Where do they want to get?” (p. 8).
Where do they want to get, is a question I
thought I could ask directly to Vittorio Agnoletto. But I didn’t ask which
lobbies are behind him and if he is an AIDS denialist (according to Ensoli, the
book “contains many denialist cues”):
I would be ashamed to take seriously the rhetoric of the plots, of the lobbies
and “cui prodest?”, as well as the generic and unsubstantiated accusations
(which are all classic dialectic tricks of the denialist argumentation) that
Dr. Ensoli adopted as a defense strategy.
The following is the result of our
conversation.
•
I would like some brief clarification on controversial points of the transition
from preclinical phase in the testing of the anti-Tat vaccine to phase I and
from phase I to II. Let’s start with the problems related to animal
experiments.
Each trial, before arriving at clinical stages,
passes from a preclinical phase on animals that, in this case, was carried out
on monkeys. Among other things, it was an item
on a television program that talked about the
treatment of monkeys in October 2004 that was the first public and media opportunity
to have a look at how this vaccine was progressing, and even then there were
some controversies.
The things to say about the monkeys are
quite simple. First, there are the testimonies of two people who worked on this
project (immunologist Antonio Scardino and veterinarian Antonella Comini), who
have been able to verify directly how the trial proceeded within the animal
enclosure and have called into question the way in which the monkeys were
treated, because the animals must be kept in good health and under certain
conditions, so that their reaction to the experimentation could be free from
any risk of misinterpretation due to the conditions of life and the state of
monkeys’ organism.
The most problematic aspect is that none
of the people we tried to contact was willing to talk about two protocols – called Npt
and Id – which used the Tat protein
in various formulations. Of these protocols very little is known. It may be
that we missed an article, but we did not find a publication that describes
from A to Z the development of these protocols. But since they are presented as
crucial to the transition to phase I, there is no certainty as to how they were
performed. If we had been able to meet Dr. Ensoli, we would have asked her to
reassure us on some information that we have no chance to verify: we want to be
sure that the monkeys on which the vaccine was tested had the same response,
namely that they were not infected, while all the monkeys that were not
vaccinated became infected. Indeed, if it should turn out that some monkeys
that should not become infected got infected, or vice versa, many question
marks would weigh on these two protocols and this would call into question all
the rest of the research on humans.
How is it that, at the mention of these
protocols, we obtain total silence, everyone is afraid and no one answers? This
is a very relevant question, because we have not found any publication describing
the whole testing of these protocols. It therefore remains a mystery that could
affect the transition to the clinic, especially since the first paper on
monkeys in 1999 involved a very limited number of animals, so that other analyses
were mandatory.
Another issue that has never been
clarified regards the protocol of vaccine administration to the animals, which
had been planned in certain doses and at certain times: some researchers
reported that their impression was that the doses and the administrations to
stimulate the immunization were modified according to the reactions of
individual monkeys.
A research project cannot be performed
that way. Two associations were denied access to the ISS documentation to make
a comparison between the presented protocol and that actually realized.
If we add that some of the researchers –
veterinarians and doctors – who have worked with monkeys left the ISS and went
to work somewhere else, and if we add the scandal that followed the program Report on monkeys, then the question
marks are really many.
Therefore, already with regard to the
preclinical phase emerges a recurring question in this whole affaire: why none
of the project leaders agreed to answer? If everything has been done properly,
why not speak? Why not be proud of such an important research?
•
In this somewhat mysterious way, experimentation moved to a clinical phase I
divided into two arms: a preventive vaccine and a therapeutic one. From then
on, the preventive vaccine is lost in the mists.
The phase I studies, both of the
preventive, both of the therapeutic vaccines, ended in 2005, and both the ISS
and the Ministry in various public events claimed that everything went well and
that it was necessary to raise funds to proceed to phase II.
There are some publications on phase I,
but remains a mystery, after all the optimistic claims and a few data published
in articles – that we report in the book – that nobody speaks anymore of the
preventive vaccine, until in 2011 we find that a phase I of a completely
different preventive vaccine starts.
The key point of confusion in public
opinion is the fact that the ISS and the Ministry still say that phase I was
successful and they moved on to phase II, but in their communication to media
they do not specify that the vaccine in phase II is the therapeutic one (which
is not a vaccine, but an immunotherapy). This is confusing to those who play a
sensitive role in communication. To recall just a recent example, when our book
was published, La Repubblica
published a short interview with Dr. Ensoli. The headline of the interview says
that they are already in phase II (Completata la fase II, funziona).
Anyone who reads this, thinks that they are talking about the preventive
vaccine. I consider unethical that the communication of an institution like the
ISS is so ambiguous.
Phase I ends, the preventive vaccine in fact stops,
and from the clinical point of view the question is this: if we were told that
phase I went well, why didn’t they move to phase II and why did a new phase I
start many years later with a different preventive vaccine?
From a clinical standpoint is relevant to
know on what the expected results of phase I got stranded, because it allows us
to understand also the limitations of the research.
This was the fundamental question we
wanted to ask the project supervisors. Professor Adriano Lazzarin, responsible
for the trial here in Milan, I wished to ask why a phase II for the preventive
vaccine never started, and what are the results that have imposed a stop. It
cannot be said that this has been due to lack of funds, because money to start
a phase II of the therapeutic vaccine has been found.
There are also some clinical concerns about
phase II of the therapeutic vaccine: Tat is always administered to patients on antiretroviral
therapy and it is at best an adjuvant, a booster of the immune system, always
in the hope that it lacks side effects and toxicities, as Professor Gallo is
concerned about in the Preface to our book. Even assuming that all goes well, in
no event will Tat replace antiretrovirals.
•
What does it mean that data (always partial, ad interim) of this trial have not been validated? Indeed, to
publish in PLoS
ONE, as Ensoli did, is not the same as publishing in Nature, Immunology or AIDS. It is true that PLoS ONE is peer reviewed (although
submissions are not excluded on the basis of lack of perceived importance or adherence
to a scientific field), but this journal publishes primary research and its purpose is to create an open
access archive of news and open issues, available for scientific community
feedbacks and discussions. It is a sort of a book of dreams and hopes of the
medical research (PLoS ONE offers to its readers the opportunity to discuss
papers online, but Ensoli’s 2010 article - Therapeutic
immunization with HIV-1 Tat reduces immune activation and loss of
regulatory T-cells and improves immune function in subjects on HAART - received no comments). In order to be accepted by the
scientific community, the studies must be validated through the publication on
far different journals, with far different impact factors and greater
specialization. And also the fact that there were no reactions from the
scientific community, written replies or comments during international
conferences, says – beyond the lack of interest that this research raises in
the rest of the world – that data have not been validated, doesn’t it? I
remember that Gallo in the foreword to the book says that “there are no confirmed results that support
this approach”.
With regard to the modality of data communication,
this story does not work from the start. We live in a media society and
everything becomes entertainment, but in the world of medical science it is not
so: there are practices established at an international level.
The announcement of this project comes in October
1998, and it’s hyped at a congress on AIDS and cancer in the presence of press
and television. But nothing had been published yet in scientific journals.
The practice is that communication to public opinion
takes place after the work has been completed, at least the step you are
talking about, and the article has been sent to a scientific journal, which has
approved and published, or is going to publish, it. Here, on the contrary, more
than 8 months passed before the publication of data relating to very few
monkeys (5 of 7 monkeys that, after
being vaccinated and controlled 7 months later, would prove capable of blocking
viral replication). In this way the public announcement takes on the appearance
of a sensational ad and is, in fact, intended to try to build the image of the people
involved, and of course to facilitate the fundraising, rather than being
directed to strictly scientific aspects.
This procedure is also found in what you say about PLoS ONE, which is, in my opinion, an
absolutely respectable journal for its function and for its social value, also because
it is open access. But if you are doing research on a vaccine you must publish
these data on specialized journals, with high impact factors.
Beyond the public announcement and publication of
data, there is a third aspect in which the international scientific community
verifies a trial: the large conferences, the moment of encounter and discussion
with other scientists. Here, too, there is a minimal participation at
international conferences.
All this involves two collateral aspects: first, there
should be attention from the mass media before making high-sounding headlines
on this kind of news, because the articles are written always by the same
specialized journalists, who know that an announcement on major impact topics
must be verified. Second, the authorities funding this project know that
scientific projects must match certain criteria, for example the impact factor
of the supporting publications. Here, however, even in the absence of these
elements, they went on providing financing.
•
Immunologist Professor
Aiuti, one of the head physicians participating in the clinical phase I,
addressed three methodological criticisms to the conduct of the trial: 1) he
asked why the first phase of the trial was stopped prematurely, involving far
fewer volunteers than was established by the protocol and then exposing the
project to the risk that data collected are not verifiable; 2) he has objected
that the remarks made by the inspectors of the Agenzia Italiana del Farmaco
(AIFA) on “critical deviations” from the original protocol have not been taken
into account; 3) he was critical that phase I data might be transmitted to the press
before the researchers involved could see them, thereby exposing the project to
the risk of the failure of the double-blind. In May 2007 Dr. Ensoli sued Professor
Aiuti for libel and a few months ago she lost the case. Now, I would like to
understand the significance of this lawsuit and the meaning of a judgment
unfavorable to Ensoli: if the court ruled against her, this implies that the
scientific criticisms of the trial by Aiuti do not constitute defamation. If it
is true that the trial was conducted and communicated improperly, what could
(or should) this lead to in practice?
The judgment does not enter into the merits of the
criticisms, but simply states that those criticisms are part of a scientific
debate and that they were not aimed at creating disrepute.
•
But have these
criticisms ever been answered?
In response to the heavy remarks by AIFA, Dr. Ensoli
sent to AIFA itself a document, which we could not have access to, but which is
among the papers of the legal action, not known to Aiuti when he moved his
criticisms. AIFA has accepted some of Ensoli’s replies, while on others it said
it is still awaiting a clarification.
What is certain is that it is very odd
that in the face of a document such as that of AIFA which makes very serious
objections to the conduct of the trial the ISS and the Ministry – the sponsors
– not only have not demanded public explanations from the director of the
project, but the ISS even joined Ensoli in the suit against Aiuti.
So the criticisms of Aiuti are still waiting
for a reply. You said that the number of the volunteers in the trial has been
reduced compared to that under the protocol. But Aiuti adds that this decision
has not even been discussed with those in charge of the trial. Who decided this
variation in the protocol?
I wrote it in the book, but it is worth
underlining here: I had heavy clashes with Professor Aiuti. In the ‘90s we also
had a court case, and our political and cultural approaches are very different.
If, starting from such different cultural standpoints, we get to ask the same
questions, this strengthens our criticism.
•
It is unusual to sue someone because he makes a scientific criticism of you,
isn’t it?
It hardly ever happens in science. But to frighten
people with the threat of a civil action or with a lawsuit may be an
intimidating method, that is generally used to silence people.
I wrote it in the book: I was given
documents from a colleague who communicated to others involved in the research
the concerns of Professor Aiuti and immediately received a letter from lawyers,
threatening a defamation case. She sent me that letter, but asked not to be
named.
•
Dr. Glenda Gray too, who heads a unit at Chris Hani Baragwuanath Hospital in
Soweto, spoke of this to journalist Jon Cohen (see "Feud Over AIDS Vaccine Trials
Leads Prominent Italian Researchers to Court”, Science,
August 10, 2007). So these methods of intimidation
have not been used only against Professor Aiuti.
I think the easiest thing would have been that Ensoli
had organized a press conference or written an article saying “I was presented
those criticisms … I say on the subject …”.
In the book we tell the story that arose around the
July 1, 2005 Gala, where it was announced the success of phase I. Aiuti rose up
saying that the trial was double-blind, not even those in charge of the trial
knew the data, and it was unacceptable to communicate data to the public even
before they were known to researchers involved in the project. A press release
from the ISS specified that there had been a misunderstanding and data would be
presented to the public at a later event. But we were able to demonstrate that
a newscast
on November 7, 2004 – seven months earlier, then – had
already announced that the vaccine was safe as it had no side effects and that
this result was the outcome of phase I. Who passed this information? Or if it
was an invention of the reporter then the ISS had the duty to retract it
because it is a public institution and the announcement given had an impact on
public and social behavior. Or this information was passed to the journalist.
But in that case the problem is serious and the project director should have
been the first to rise up. The impression is therefore that the media
management prevailed over everything else.
Since we published the book, many people ask me the
reason for this ugly story. My impression is that three different things mixed
together: the desire of a group of researchers to emerge at any cost not only on
the scientific scene, but also on the public stage; the need of Italian
governments to claim a leading role of Italy in scientific research, as an
instrument of affirmation of the “grandeur” of Italy, in crisis in other areas
– hence the choice of a topic that had the biggest media impact; a political
proximity of some researchers to decision-making roles that matter.
My guess is that these mechanisms, once started,
became unstoppable.
•
We have seen that the transition from the animal model to the first phase on
humans is at the least questionable and that the progression from phase I to II
also does not seem to have been justified on the basis of validated data. What,
then, are the risks that could affect volunteers enrolled in the trials, both
in Italy and in South Africa? From what you have said, this is precisely the
reason for the urgency in publishing your book.
We have no documentation stating that this
experimentation in itself may be harmful to humans. The point is that if people
involved in the trials are told that the putative vaccine has undergone a
series of phases, it is obvious that somehow it is taken for granted the
hypothetical, possible safety of this product. On the other end, testing of a
vaccine is verified because you see that, in real life, the vaccinated do not
become infected when they come into contact with the pathogen. That is why
phase III must enroll several thousands of people and must be performed in
countries with a high prevalence of HIV.
But if this hypothetical protective
efficacy was not actually proved and if you were to question some of the
previous phases, then you would face here potential risk behaviors of those
vaccinated, which would not protect themselves because they are convinced of
being immunized. When this preventive vaccine starts again from phase I, starts
again with a different design and, what is more, it is started also in South Africa, where the health
care system works differently than in Europe, we have this concern for volunteers.
On the other hand, the agreement with
South Africa would provide also an assignment of over 20 million euros for the
construction of laboratories. Then, of course, South Africa is interested in
having this research, because it receives such funding. So our fears that
health surveillance needed in this type of trials is not guaranteed increase
even more.
We are worried about the level of “safety”
that is or is not guaranteed. If you do not shed light on the early stages of
the trial, this question mark continues to weigh on. Hence the need for the
book to be published in haste, before the trial steps to the next stages and
before they are possibly wasted other public funds to finance a project that
you must be sure that is going in the right direction.
Finally, there remain questions about the
possible toxicity of Tat used in a therapeutic vaccine for HIV positive people,
because Gallo, who has worked a lot on this protein, does not exclude that
there might be toxicity.
•
What is involved in the diversion of the few available public funds from other
research that, perhaps, if properly supported, would have been more productive?
Italy has cut funds for research. For
three years it hasn’t paid the money pledged to the Global Fund to fight AIDS,
tuberculosis and malaria. There is no serious investment in prevention. We have
160 – 180.000 people living with HIV who are living longer fortunately, but
this also increases the risks of transmission.
What results could be achieved by funding
other research, I do not know. But, potentially, we could have lost a lot. It
can be argued that the huge funding for this vaccine has diverted funds from
other projects, thus indirectly bringing damage to Italian research.
•
So we can assume that the funding for this vaccine, presented as a source of
pride, has actually impaired Italian research and community.
Yes, and I also speculate that the issue
of funds may have something to do with the unwillingness of the vast majority
of researchers to talk about this project because obviously those involved do
not want to talk - but also those who are not involved fear cuts to the little
funding they do receive.
•
I would like to explore the question of the effects, both on general population
and on people with HIV, of the communication strategy adopted by ISS in
speaking about the vaccine to the media. In particular, I would like to
understand the effects that the mistrust generated by unfulfilled promises may
have on the emotional balance of people living with a serious chronic illness
and on their adherence to treatment. And I would also like to know if a generalized
distrust towards research, formed as a result of the succession of deceptive news,
might affect the willingness of people to volunteer in clinical trials.
This communication strategy can have the
effect of making general population believe that the vaccine is already here,
and then of lowering the guard on prevention. See the recent survey
by Anlaids of
Roman students, in which we discover that more than 20% of respondents believe
that the vaccine exists and is available.
The big scandal in ISS communication is
also related to the preventive vaccine. You may ask why HIV positive people
should care for a preventive vaccine; but this is actually a very relevant
question, because if there were a
preventive vaccine the social stigmatization and every form of discrimination against
people with HIV would collapse. This would completely change the daily lives of
HIV positive people, because they no longer would be perceived, and perceive
themselves, as a threat to others.
The second point is what you say: on a
psychological level, expecially now that drugs which greatly extend lifespan are
available, it is vital to think that the extended time of your life will be
used to make new discoveries, which in turn will further lengthen your time, improving
also the quality of your life. Confidence in research and in those who conduct
it is essential, and there is no other disease like HIV/AIDS, where HIV
positive people are self-organized and sometimes even become “scientific community”
in the exchange of information about research. Often this isn’t just a
unidirectional relationship, but a mutual exchange with the scientific
community. The discovery that such an important research is conducted in such a
controversial way may certainly have an emotional impact on people living with
HIV, and this also leads to a drop of hope and, of course, to an unwillingness
to volunteer in clinical trials.
There are also many studies that show how
a situation of prolonged depression impacts on the immune system, either
directly, from the organic point of view, or indirectly, due to a worse
adherence to antiretroviral therapy.
So those who make public announcements
that are regularly proved wrong by facts bear a huge responsibility.
•
Do you have any comments about the “Considerations” sent by Dr. Ensoli to HIV
positive people, activists and associations? Don’t you think it’s paradoxical
being accused of having written a book that “contains
many denialist cues”, and this right by someone who makes a wide use of the
rhetoric of conspiracies and occult lobbies, who addresses to you generic and
unsubstantiated accusations, who avoids responding to your criticisms
preferring to shift the discussion towards the “chief systems” (the “sistema Italia”, even!), posing as a
victim of an international plot and even backbiting, someone who, in the past,
preferred to sue rather than responding to scientific allegations – all, these,
typical denialist rhetorical strategies?
From this document it is clear that she
has no remarks to disprove what we have written. What struck me most is that
there is not one refutation. There is a personal controversy with Gallo and
Aiuti, and it’s very serious that she accuses us of being AIDS denialists, very
serious. Clearly, that accusation was made to disqualify our work and, since
she says that the book is libelous, what is defamatory for me is the accusation
of denialism.
This just shows that Dr. Ensoli had
nothing to cling to. There is no reply on the topics we talked about today –
those more strictly scientific, which are the most important – but there is not
even a reply on issues like the conflicts of interest, the familism, the role
of her brother …
To me it seemed, for those who read the
book, a serious own goal.
•
The aim of the book, repeatedly stated, is a call for clarity. From who?
For example, I expected, and I still
expect, to hear a word from Professor Stefano Vella, who was the president of
the International AIDS Society, who was the one who brought to South Africa the World Conference on AIDS, and therefore has a not
just Italian perspective. He has all the means to know how a scientific
research must be performed and what is the international framework of the
research. Moreover, he is totally within the ISS, but not involved in the
anti-Tat vaccine trials, so he has all the elements to evaluate this project.
•
From the feedback received so far, do you think
that something is happening? For example, could the interview with Radio
Radicale lead to an involvement of the Radical Party and eventually to a new
parliamentary question after the elections?
I am optimistic on three
issues: I think some member of the next Parliament will be willing to resubmit
an interpellation. Some colleagues contacted me and it seems they are
discussing with their own conscience on how to intervene and provide additional
information. Finally, I hope that a magistrate will take the lead on the
matter. I am aware that it is not easy for a judge to address the scientific
aspects; it is certainly easier to deal with this matter starting from the
financial aspects and then, from there, address the experimentation. But if a
judge opened an investigation, this would facilitate a political intervention
in the Parliament and it would also give an incentive to those colleagues who
know how things turned out to resolve their crisis of conscience and decide to speak.
