August 31st, 2017

By Zachary Barnett

I founded Abzyme Research Foundation (ARF) to help advance the eradication of HIV/AIDS. New ideas that shift prevailing paradigms inevitably create conflicts with the status quo. Galileo dared assert that the Earth revolves around the Sun, but as his empirical observations were the first indication that the prevailing dogma was wrong, there was intense opposition. Such is the case with the field of HIV vaccine research, and more specifically our own promising abzyme-based HIV vaccine candidate.

We have regrettably fallen victim to some unfounded criticisms from Dr Carl Dieffenbach, Director of the Division of AIDS at National Institutes of Health (NIH) in a blog interview in June (imstilljosh.com). “We” refers to these parties – ARF, a non-profit that wants to help accomplish a functional cure for HIV/AIDS; Dr Sudhir Paul, originator of our vaccine candidate; and Covalent Bioscience, a for-profit charged with doing further work needed to develop the vaccine. ARF believes that further research on our HIV vaccine candidate for preventing and curing HIV/AIDS is essential, and that the misinformation caused by Dieffenbach’s comments could short-circuit the process of scientific invention and discovery, a result that neither the HIV/AIDS community nor the broad scientific communities want.

ARF, Paul and Covalent Bioscience have invited Dieffenbach for a panel discussion with HIV/AIDS experts – open to the public – where questions raised by his comments can be answered honestly and in a straightforward way. Such a discussion would permit the public to look at the real facts related to the vaccine research ARF is supporting. I hope that Dieffenbach accepts the invitation.

We have also sent our rebuttal of Dieffenbach’s comments to the NIH and formally requested a retraction. The retraction request is based on a detailed fact-check of Dieffenbach’s comments about our abzyme-based HIV vaccine research using the available public records of peer-reviewed scientific publications and funding. Our fact-check revealed a different conclusion than Dieffenbach’s.

NIH itself has continuously funded Dr. Sudhir Paul’s research on abzymes and vaccination after multiple peer review cycles for over 30 years. During this period of time, as is customary in every human endeavor, a minority of peers were “naysayers,” but he consistently ploughed on, first discovering abzymes, then documenting the rules under which abzymes are produced by humans, and then identifying and solving long-standing problems in HIV vaccine research. Now, with this innovative and disruptive research coming close to medical realization, the NIH should not be discouraging the public from supporting ARF’s mission. We are determined that ARF’s mission to develop our innovative vaccine approach for possible cure and prevention of HIV/AIDS will not be quashed by NIH.

Taxpayer-funded organizations like NIH do the public a disservice by interfering with promising, peer-reviewed research such as ours. Do we know for sure if our abzyme-based HIV vaccine approach will succeed to cure and prevent HIV/AIDS? Of course not, but we are compelled to conduct further tests because that is what the scientific process and urgency of our mission demands. Dr. Paul’s tests of the HIV vaccine candidate in mice generated broadly neutralizing antibodies that suppressed HIV infection. Monkeys responded similarly. No other vaccine candidate in which NIH has invested billions of dollars has accomplished this objective, and ARF believes that the extraordinary response to its novel vaccine is the best hope thus far to eradicate HIV/AIDS world-wide. That is the reason we sought and successfully obtained support funding from NIH, non-profit groups, private sector investors and philanthropically-minded celebrities. We must test our vaccine approach rigorously in monkeys, and, assuming we meet FDA’s exacting manufacturing standards, we will advance the vaccine to human clinical trials. For success, we require significant funding to complete vaccine manufacturing, stability tests, safety assessments, and the associated regulatory, legal and infrastructure procedures.

Millions of human lives are at stake. NIH’s stated goals are “to foster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health….and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.” There is consensus among scientists and policy makers that an effective HIV vaccine is needed urgently if we are to eradicate HIV/AIDS. We urge NIH to fund ARF’s plans to develop the vaccine candidate. At a minimum, we ask that NIH get out of our way and ensure that its employees do not impede progress in our vaccine approach.

The research over several decades has not resulted in a preventive vaccine or a cure for HIV infection, and the available HIV drugs remain out of reach for most of the world’s population. Now more than ever, public and for-profit agencies with genuine concern for human welfare should be encouraging new approaches to vaccine discovery and development. Impeding this worthy goal is simply wrong. We hope that NIH and Dieffenbach will join us in full transparency to discuss the contribution of our approach to developing a truly effective HIV/AIDS vaccine. The HIV/AIDS community, the American taxpayer and the world deserve no less.

Street-Lighting HIV Vaccine Research and Funding

Researchers often try to solve difficult problems by searching within established scientific concepts, akin to looking under the streetlight for a wallet that was lost elsewhere. Most HIV vaccine funding has been used up without a breakthrough to obtain “easy” insights to ─ virus coat mutability, coat protein trimers, transient coat changes during infection, physical masking of virus vulnerability, reverse engineering vulnerable regions, deep sequencing and mining of the infection-induced antibodies, and last-resort immunological ideas such as deficient antibody adaptation and deficient inherited antibody genes.

Paul’s research group has provided evidence that the lost wallet, reversing active HIV suppression of the correct antibodies, has been hiding in plain sight, in –  Paul et al J Biol Chem 2003,278:20429; Nishiyama et al J Biol Chem 2009,284:30627; Planque et al J Immunol 2012,189:5367; Planque et al AIDS 2014,28:2201

We will continue to fund research to support this viewpoint.  Stay tuned for a new study announcement next week.