The facts about Antonio Regalado’s MIT Technology Review article
I provide here the text of the letter I sent to MIT’s legal department after the publication of the MIT Technology Review article on myself. I affirm here, under penalty of perjury, that the facts stated in this letter are true and correct to the best of my ability. Certain doxxing information has been redacted.
I was introduced to Mr. Regalado by George Church at Harvard†, who asked me if I had an interest in being interviewed. I had a partnership with George’s lab for my gene therapy, which was intended to be used to treat late stage HIV/AIDS and had a second application in treatment of aging.
Epilogue: This MIT Technology Review article has dogged me, and it had a severe impact on my professional life. The article and its tabloid intent and tone affected potential academic appointments, probably affected funding, and also probably affected reception of other significant work of mine. Based on timing of its appearance and the writing style, I believe that Antonio Regalado created the Wikipedia page on myself, and I strongly suspect that Tony has continued over the years to make sure that my page is focused solely on his article. My page’s editing discussions included a Sept 2022 fake rule, “Wikipedia pages are not supposed to be resumes” as grounds for wholesale removal of all material on other topics. Note that a standard part of any actor’s page, for example Rupert Grint is complete listing of their work. After I complained to Jimmy Wales, my page was flagged.
My work includes other peer reviewed scientific articles of greater public interest: 2010 (epidemiology) a study of influenza transmission conditions during a pandemic; 2011 (human biology) article on human chimerism as the basis for transgender and homosexuality; 2012 (monetary economics) article on a cause of the 2008 financial crisis; 2013 (biodefense) article detailing how the NSABB only makes biosecurity worse; 2019 (bioethics/law) a major review of ethics and law pertaining to self-experimentation;
2020 (pandemic policy) a joint editorial on handling of the COVID-19 pandemic by immediate release of vaccines; 2021 (political economics) an article on the potential for tyranny contained in modern monetary theory;
2022 (climate economics) an article critical of the absurd nonsense that is the basis of the Nordhaus school of climate economics.
† George Church https://wyss.harvard.edu/team/core-faculty/george-church/ https://patents.justia.com/inventor/george-m-church
_____________________________________________________________
Office of the General Counsel
Massachusetts Institute of Technology
77 Massachusetts Avenue
7–206 and 10–370
Cambridge, MA 02139–4307
April 26, 2017
Regarding article in MIT Technology Review: One Man’s Quest to Hack His Own Genes [1]
Dear Counsel:
This letter addresses certain issues with the article published in January of 2017 about my work. After email and discussion with the editor in chief, Jason Pontin, and the journalist, Antonio Regalado, about the article, followed by discussions with my counsel, it is with reluctance that I formally protest certain representations in the article that are not factual, as well as the overall article’s tone of misrepresentation. Some degree of misrepresentation is the price paid for publicity. It is normal to see minor facts being wrong. However, some of these misstatements and the overall presentation could have significant legal repercussions in the future if I do not diligently attempt redress. I wrote balancing comments to the article laying out certain issues and posted them under my name. However, this may not be sufficient record. Comments are not prominent and it has come to my attention that all parties who have contacted me who read this article failed to notice them. Thus, this letter, which is written because MIT Technology Review is a periodical with significant credibility and reach. It is usually considered a “periodical of record” similar in kind to the New York Times. Thus, the statements contained in this article are not necessarily innocuous. They carry weight. And I have fiduciary duty regarding Butterfly Sciences. I will not belabor such basic elements of law given the audience.
First, there is the statement that, “The effort is the second case MIT Technology Review has documented of unregulated gene therapy”. Antonio knew I had an approved IRB protocol. That was above and beyond my requirement for conformance with regulation, as will be discussed in more detail later. It was not required. This statement is, therefore, false. Antonio also lumped me together with Liz Parrish, whose background is housewife, hairdresser, and injecting herself with things she bought online. This latter is libelous in its import.
Second, the article states, “Hanley took the technique in a different direction, poring over decade-old studies by a company called VGX Animal Health that had tried zapping plasmids into the muscles of cows, dogs with kidney disease, and baby piglets.” This is false, and I did not say this to Antonio. I did not mention VGX to Antonio. I found the VGX company, of course, when I was doing competitive analysis prior to presenting to venture capitalists. I believe Antonio found VGX himself and jumped to conclusions. I initially did my own work, and read journal articles. I did find the work of Ruxandra Draghia-Akli which is what VGX used. You may consult the granted patent from 2013 to see how this developed and you can see that there is no similarity with Ruxandra’s work [2]. The sequences in this patent were all realized in practice. You can review the Singh decision in patent law to clarify why.
Some years ago I had a phone conversation with Ruxandra of approximately an hour to resolve certain questions I had on one of her papers. She was, at the time, the Director of Health for the European Commission (I think I have her title right) and was most generous with her time [3]. I doubt very much that Antonio failed to find her. I believe I mentioned her to him. The tone of the article suggests strongly that Antonio deliberately failed to do so in order to put across the prejudicial and sometimes libelous slant.
I laid out to Antonio how this project developed. This effort of mine had its roots when I was in grad school and happened to find out that gp120, which is the attachment protein for HIV, had high affinity for GHRH. I realized that if all one did was to scavenge a large fraction of GHRH from the bloodstream, one would cause an immune decline and wasting syndrome similar in some ways to aging. In late stage, there can be 500,000 to 1 million copies of HIV per milliliter of blood. Normal GHRH decline results in levels at 70 that are roughly 15%-20% of those at 20 years of age. So this GHRH part of the HIV therapy was designed to help rescue people from late stage AIDS. This HIV therapy is also discussed on the company web site [4].
The other part of the therapy was to pair it with genes coding for micro-antibodies based on camelid single-chain antibodies, or else RNAi. I had to drop this aspect when it became clear that the market was so small that there was little chance of obtaining funding for it.
I was aware that the GHRH part of the therapy had other targets. I thought from the beginning that ailments of aging were also a worthwhile target.
Third, while this is not as serious a concern as the first and second, which could potentially come back to bite me in civil court, the story about how I came to “nominate myself as lab rat” is not correct. I did not do this because nobody would back my plan. I decided that I was going to test it from the beginning, and I told Antonio this. The reason I did so is that developing things with the idea that they will be used on oneself should generate best effort. And, I needed to know for this protocol what it was like. There was no worthwhile literature or standards that I could find on use in humans. I am glad that I did, as I found out that what literature existed was extremely understated. As a result of my experience with it, the protocol has been modified and it is now virtually painless. Antonio used some of that material from the interview when he discussed the protocol. This appears to be another deliberate falsification in order to maintain the tone he chose.
Fourth, the article states that I spent $10,000 ordering DNA, implying this is the cost of development, I believe this was to encourage the idea that “anybody could do this”. That is a gross misrepresentation, akin to suggesting that Gilead created Harvoni for the cost of synthesis of the drug molecules. By that measure, developing Harvoni cost a few thousand dollars. I made it clear that I had spent over half a million all told, and that it wasn’t possible to break out meaningful costs that way. I regret that he badgered me into giving him some figure. I have not repeated this error with other journalists. However, it remains a misrepresentation, one that Antonio was quite aware of.
Fifth, the matter of FDA approval and regulation is misrepresented. Testing on oneself is a fairly common thing in science [5], and most of those don’t bother to go through the IRB process [6]. Investigational New Drug (IND) applications are not necessary at this stage. I did contact the FDA to ask if there was a way to register intent to self-experiment, but there was not. Other scientists have used themselves as guinea pigs and submitted that data in support of their IND application.
The IRB is a body established by law under the FDA’s jurisdiction [7]. The chain of regulation development starts with the Nuremberg code [8], then the Helsinki Declaration9 and the Belmont Report [10], and ends with current Good Clinical Practices (GCP) guidance [11]. In that chain of regulation there is no objection to qualified scientists experimenting on themselves (and a statement of approval in Nuremberg code #5). I did appraise Antonio of this before and after the article was published. There was, you see, an “incident”.
Antonio asked me early on for documentation to prove that I had IRB approval. He agreed that any such documents were strictly confidential, and that if I supplied them, he would ensure that this was all they would be used for. Consequently, I did not redact the documents I sent. My interview was in summer of 2016, and I heard nothing from Antonio for some time. In late December, I got a call from the attorney for my IRB, the Institute of Regenerative and Cellular Medicine (IRCM) [12]. She had just received a phone call from Antonio in which she said he raised his voice to her repeatedly, insisting that either she was committing fraud or I was, because I hadn’t told them I was a subject in the study. She wanted to know if I had given the phone number to Antonio, and what I had said relative to permission. From her end, since all these documents filed with the IRB are confidential, she could not say anything about it.
Needless to say, I contacted Antonio. He wrote me back that he had not used “the f word” in this phone call but would not say what phrase he had used instead. After a few days we spoke on Skype and I did my best to clarify matters. Antonio acknowledged that he should not have used the phone number he got from my IRB protocol. This was the first indication I had that Antonio had an adversarial orientation. Please note that this went against the tone of every MIT Technology Review article I had read, and Antonio had given me no significant indication of adversarial intent prior.
This action taken by Antonio caused significant disruption in my business relationships. Not only did I have to patch things up with the IRB [redacted], but I had to inform the surgeon of the adversarial nature of Antonio’s interest, and this affected that relationship somewhat. Most scientists consider the magazine to be a friendly publication.
The part of the article about regulation was published with Hank Greely’s statements. Mr. Greely is free to make the statements he did, but he is not familiar with the literature, as his statement that it’s a serious bias problem does not hold up to scrutiny [13]. That idea is the opposite of Altman’s conclusion that such was very rare. There are areas of medicine where the placebo effect is strong, however, the factors I am looking at are not amenable to modification by placebo. I talked to Antonio about that. It’s curious that no other articles by MIT Technology Review on a scientist [take] that kind of stance, including the one about Philip Kennedy. I think it is also worth noting here that in my dealings with Antonio (and with other journalists) I was forthright, and made no attempt to hide any effect of the therapy, whether apparently positive or negative. In fact, I took some pains to disclose elements such as the dream I related to him, which is above and beyond what most would do.
I noted also that Antonio was oddly incurious about the effects or my documentation of them in blood work. I offered to send him my IRB report with findings and he was uninterested. I ascribed that to journalistic lack of familiarity with science. But, since then, I have spoken to quite a few others and every other journalist is very interested in what the effects were.
Sixth, the article states, “In planning his study, Hanley skipped some steps that most companies developing a drug would consider essential. In addition to … he never tested his plasmid in any animals.” It is true that I did not test these particular plasmids on animals. However, there are reasons that I went over. This kind of gene therapy had been done on many animals already, with plenty of published literature. The animals it was tested on comprise dogs, cats, pigs, horses, and cattle. In addition to IRB’s that have the task of protecting human subjects from unprincipled investigators, the Institutional Animal Care and Use Committee (IACUC) protects animals from unwarranted suffering [14]. Yes, I could have done such studies. I got approval to do so from IACUC. But the IRB accepted my application and reasoning. One has to ask why 50 or 100 more rabbits must be killed just to to tell us what we already know. To me, deciding not to kill more animals is ethics in action.
Seventh, the article states, “The doctor can be seen placing a plexiglass jig built by Hanley onto the biologist’s thigh. The doctor leans in with a hypodermic needle to inject the sticky solution of GHRH plasmids into the designated spot. He also uses the jig to guide the two electrodes, stiff sharp needles the size of fork tines, into the flesh. The electrodes — one positive, one negative — create a circuit, a little like jump-starting your car.”
(Redacted)
Figure 1: Right leg inoculation screen shot.
Unfortunately, the video of the first injection (there were two, one in each thigh) is corrupted and not playable now. However, figure 1 that was captured from it August 16, 2016, shows me holding the jig in place.
The primary issue here is that I directed the procedure from A to Z. I trained the surgeon, and he assisted me in this procedure. He was required to be there by the terms of my IRB approved protocol. (e.g. I was, thereby, in conformance with the regulatory regime I had agreed to.) Antonio had a copy of this protocol and clearly he had read it. The physician was named in that set of protocol documents. This is a crucial difference and I spoke that way to Antonio about it. I made a point of saying this. It is the difference between the surgeon doing it as his experiment, and me doing it to as mine. I am quite sure that Antonio knows this, and yet, he went out of his way to try to create the impression that there was something illegal or against regulations going on, even after I made it clear this was nonsense on multiple occasions. Again, I am the only scientist I am aware of to be singled out for anything remotely like this level of serious innuendo by MIT Technology Review. This has had a significant impact on my business relationships.
The article also states, “The U.S. Food and Drug Administration could get involved, intervening with warning letters or site visits or auditing his ethics board. The plastic surgeon — whose name Hanley wished to keep confidential — could face questions from California’s medical board.” The fact that this was a plastic surgeon Antonio got from the protocol document I sent him, and he published that even after agreeing again not to use any information from it without my express permission.
In addition, these statements cross over into the realm of libel about myself, the surgeon, and the IRB. I don’t think that Antonio can take the position that he wasn’t properly informed that there was nothing nefarious happening. I did so inform him quite clearly, and the law and history are on my side in this. I made it clear to him that there was no law and no regulation requiring me to even do an IRB. I did tell Antonio that other startups have submitted IND applications with their own human data and this helped them get approval for the IND. I also challenged Antonio to find any such regulation. He did not find it any such thing. I sent him to the FDA’s human subjects training web site, which he indicated in conversation he did not visit. Antonio found Mr. Greely, whose issue appeared to be concern about bias, not any problem with regulation. I am rather sure that had Antonio found significant support for his position, that he would have put it into the article. But he did not, and yet he maintained his unsupportable position.
Eighth, the article says, “It also let him play in a big scientific pond alongside people doing “real science,” like those in the Church lab.” When I told Antonio that to be in the research game seriously, you need to be hooked into NIH or have Google’s billions, that was in the context of teaching him the difference between research and translational science. A large gap exists in translation into products that people can use. This is a well recognized and very serious problem in medicine [15]. It is such a serious problem that congress passed legislation for 2011 funding a dedicated section for translational medicine [16]. Note that this was 2 years after I started Butterfly Sciences in 2009. I discussed this translational problem with Antonio and told him that there is a large amount of IP that never sees the light of day because of it. Also in that context, I talked to him about the vaccines I created. He mentioned DNA vaccines in his article, but he didn’t indicate I told him. I discussed an Ebola and a West Nile vaccine I have in the refrigerator. I told him the story of why those were developed as other examples of translational science. I told him this is what pharma does. Translational science is what big pharmaceutical companies do as well, and even they don’t have the budget to do much basic research. This Battelle report diagrams the flow into product and does not show significant money going from pharmaceutical companies into basic research [17]. This, like the rest of the writing, deliberately portrays me as if I were an amateur, a hack, someone lacking in ability and skill. This was unwarranted and a continuation of the libelous portrayal of the article.
In conclusion, the article overall contains one major and minor misstatement after another. I won’t burden you with the nits not mentioned unless you want to know them. Taken individually some of these items could be considered to be accidents, or perhaps florid writing. I considered the hypothesis that Antonio was in the early stages of age-related dementia. I have rejected that idea, at present, because he has demonstrated quite good memory when it appears to suit him. Thus, when one puts everything together it shows that Antonio intentionally misrepresented virtually everything about what I’ve done, including elements that are quite serious. Unfortunately, this goes beyond acceptable limits of reporting and requires redress.
Sincerely,
Brian Hanley, PhD Butterfly Sciences [redacted]
1 Regalado, A. One Man’s Quest to Hack His Own Genes. 2017 https://www.technologyreview.com/s/603217/one-mans-quest-to-hack-his-own-genes/
2 Hanley, B. Methods and compositions for gene therapy and GHRH therapy. 2015 https://www.google.com/patents/US8993316
3 Ruxandra Draghia-Akli. Curriculum Vitae. Retrieved April 3, 2017 http://ec.europa.eu/civil_service/docs/directors_general/draghia_akli_ruxandra_en.pdf This position held by Dr. Draghia-Akli in the EU is equivalent to the position of director of NIH in the USA held currently by Francis Collins.
4 Butterfly Sciences web site. http://bf-sci.com/ For HIV project information go to ‘Gene Therapy R & D’.
5 There are 10 Nobel prizes awarded to scientists who experimented on themselves in the area of their award. At least 15 are documented to have experimented on themselves. There are over 500 scientists documented for their self-experiments, and it’s not hard to find those references.
Weisse, AB. Self-Experimentation and Its Role in Medical Research. 2012 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3298919/
6 Wingfield, J. I, Robot. 2011 http://www.wmagazine.com/story/kevin-warwick-cyborg-scientist Kevin Warwick is the Deputy Vice-Chancellor for Research at Coventry University.
Piore, A. To Study the Brain, a Doctor Puts Himself Under the Knife 2015 https://www.technologyreview.com/s/543246/to-study-the-brain-a-doctor-puts-himself-under-the-knife/ Philip Kennedy is a neurologist in practice in the state of Georgia.
7 Public law 93–348 National research service award act of 1974.
8 The Nuremberg Code. 1949 https://history.nih.gov/research/downloads/nuremberg.pdf
9 World Medical Association–Declaration of Helsinki. 1964, 1975,1983, 1989. Note: There are later versions of Declaration of Helsinki. This is the one recognized by NIH/FDA. https://history.nih.gov/research/downloads/helsinki.pdf
10 The Belmont Report. 1979 https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/
11 Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance. 1996 https://www.fda.gov/downloads/drugs/guidances/ucm073122.pdf
12 Institute of Regenerative and Cellular Medicine. Retrieved April 3, 2017 http://ircm.org/
13 Altman. Who Goes First? The Story of Self-Experimentation in Medicine. University of California Press. 1989
14 NIH-OLAW. The Institutional Animal Care and Use Committee. 2011 https://grants.nih.gov/grants/olaw/tutorial/iacuc.htm
15 Meslin, et al. Mapping the translational science policy ‘valley of death’. 2013 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3729667/
16 National Center for Advancing Translational Sciences (NCATS). Mar 1, 2017 https://www.nih.gov/about-nih/what-we-do/nih-almanac/national-center-advancing-translational-sciences-ncats
17 Battelle. US Biopharmaecuticals Sector: Economic Contribution to the Nation. 2011 http://phrma-docs.phrma.org/sites/default/files/pdf/2011_battelle_report_on_economic_impact.pdf
_________________________________________________________
