PERT: It will lead immediately to a large scale trial. If it continues to work, that would lead to registration of the drug within months.
REDWOOD: In what ways would it be an improvement over current AIDS medications in terms of safety and efficacy?
PERT: The problem of the virus becoming resistant has never gone away. And by using the [currently recommended] triple drug combination, you’re assaulting several different mechanisms of action of the virus. It helps, it's great. You’re able to keep resistance from developing for a while. But resistance eventually develops, and what's happening now is that many of the people who have been on the triple drug cocktail for three years are starting to fail, because the virus has mutated and the virus levels have come back up. In response, doctors are switching the drugs around. Plus, the toxicity profiles of the drugs are pretty serious.
REDWOOD: What is known about the toxicity profile of Peptide T?
PERT: We know that it is virtually completely nontoxic in hundreds of man/woman years of testing. The other thing is that people in the mainstream AIDS establishment have been crying out for a drug that would work by a new mechanism. The new mechanism they want is called a "viral entry inhibitor," something that blocks the receptors that the virus uses to get into the cell. And, of course, we were the first ones to talk about that mechanism years ago.
In the last three years we’ve realized that Peptide T actually works through the chemokine-5 receptor, which is the main receptor that's used by the virus to infect in the earlier stages of the disease. We published this last year in the journal Clinical Immunology. This is classical pharmacology. If a drug works by a new mechanism, then it can be highly effective because it's synergistic with the other mechanisms.
REDWOOD: Is it possible that in response to Peptide T treatment the AIDS virus would mutate in such a way that it would learn to dock at a different location?
PERT: Theoretically, anything's possible. But experimentally, people haven't seen that. What people have seen is that there’s a change where the HIV virus goes in the early stages from the C-5 (chemokine-5) receptor to the late stages of the disease where it goes to the C-4 receptor. So there is some shifting of which subreceptors in the family it uses, but it doesn't have the ability to manufacture a brand new receptor, as far as we can see.
REDWOOD: The scale of the AIDS epidemic in Africa dwarfs anything we’ve seen in North America or Europe. One of the big problems has been that the expense of industrially manufactured medications is far too high for people in Africa to pay. If the new Peptide T treatment is shown to be valid in the upcoming studies, is there the possibility that it would get to those large numbers of people in need?
PERT: Yes there is, because we're behind it.
REDWOOD: How would it be done?
PERT: It will be made available somehow. If it can really help the situation, then we will do our best to introduce the drug and use our technology to find ways to manufacture it as inexpensively as possible to get in there and do the job. As to making it available to people in Africa, perhaps there will be an act of Congress or perhaps the World Health Organization. I don't know. You’re asking me hard questions, because I'm just a scientist, not a political scientist.
I want to add that Peptide T has already been shown in a $10 million government trial to be effective in neuroAIDS [where AIDS affects the nervous system]. That was a trial that started in 1989 and went on for seven or eight years.
REDWOOD: So the hope now is that Peptide T will have a more global effect on AIDS in its many forms.
PERT: It was originally designed to block the virus. I'm an expert on peptides and receptors (endorphins are a peptide), and the idea was to find the exact chemical structure, the exact sequence of amino acids, on the part of the virus that bound to the receptor. We did that by a computer-assisted database search, and then we showed that in the test tube it did block the virus from entering and infecting the cells, and decreased the amount of infection in the test tube. So Peptide T was designed to block the virus from entering the cells. It’s also kind of an antidote to the envelope protein of the virus. So there’s an interesting twist that could explain the Peter Duesberg debate.
REDWOOD: This is the controversial hypothesis where Duesberg asserts that AIDS is not actually caused by the HIV virus?
PERT: Yes. Of course it is really the virus, but just a part of the virus. That’s why the presence of AIDS doesn’t correlate exactly with the virus levels. The viral envelope, the part that goes around the outside, is the part of the virus that actually binds to the receptors. It turns out that for each perfect little virus that gets spit out of a cell, there are millions of copies of the loose envelope protein that circulate, and almost act like an ectopic hormone, acting at a distance and binding to the natural receptors, the chemokine receptors and VIP [vasoactive intestinal peptide] receptors. It causes disease in that way. We’ve published many papers over the years showing how it’s possible to actually block the binding of the envelope protein. So it’s a whole other mechanism of action. It is more global and it’s been shown to alleviate many of the symptoms of AIDS. People feel better when they’re on the drug.
REDWOOD: What are your views about the potential good and potential harm from biotechnology and genetic engineering?
PERT: I am getting more and more concerned about it. I have been dragged kicking and screaming from a very old paradigm point of view, which says that everything’s cool, everything’s great, and technology is wonderful. I can remember arguing 30 years ago with a friend who was telling me why an egg from a free range chicken that was allowed to be having sex is much better. And I thought she was, like, totally crazy. [Laughter]. It’s been a process of slow education, but I actually joined a board yesterday of people who are concerned about issues like this.
You know, it's the same old hubris. It's very similar to what we were saying about vaccines, or giving psychiatric drugs to children. It's based on an assumption that Mother Nature can be just arbitrarily changed and that everything will be cool and nothing’s going to happen. Without testing! Without long term safety testing. It's the hubris factor. So while I'm not an expert on the genetically engineered food issue, I’m really concerned. I heard that something like 70 percent of our food has now got some genetic engineering in it. We don’t even know what it is because it's not even labeled.
REDWOOD: In Molecules of Emotion, you mention your strong interest in alternative and complementary medicine. What areas of this field interest you most? Which do you use personally?
PERT: I guess the answer is that I'm interested in all of it. There's this debate about how if you call it "alternative," then it’s too political and antagonizes people, so instead we’ll call it "integrative" or "complementary." Actually, I like to call it alternative paradigm medicine. This new paradigm says that consciousness, mind, and spirit really matter. That they’re real and that they’re scientific if people bother to look at the scientific literature.
Over the years I’ve used acupuncture and chiropractic. Just last night I had a much-needed chiropractic treatment which cleared up some very bothersome back pain from a fall earlier in the week. I also meditate daily with TM [Transcendental Meditation] and Ayurveda works very well for me.
REDWOOD: So alternative paradigm medicine has had both theoretical and practical meaning for you.
PERT: Absolutely practical. It's been a gradual transition. My first foray into "alternative medicine" was when I started to critically look at my childbirth experiences. I started to research this when I was pregnant with my second child, who’ll be 25 on Saturday. I was just astounded in reading the literature about the negative effects of drugs that are taken shortly before birth, and whether you should break the amniotic sac, and alternative methods for pain relief. To study that, see that, and experience that myself, and to see again the hubris where they say, "Oh, it can't hurt to do this or do that." The whole interference with the natural process which has been there for millions of years and has evolved and serves it purpose. That always concerns me.
REDWOOD: What is your vision for the Institute for New Medicine which you founded in affiliation with Georgetown University Medical School?
PERT: My vision for the Institute for New Medicine is that it will become the Howard Hughes of the new medicine.
REDWOOD: Howard Hughes had many aspects to his life. [Laughter]. I am assuming you’re not talking about manufacturing airplanes or becoming a strange recluse. What is it about Hughes that you wish to emulate?
PERT: I'm talking about having incredibly large amounts of revenue. That way we can give serious attention to researching the ancient wisdom-modern science link and to really research alternative paradigm medicine, not just at Georgetown but all over the world. We’d like to fund labs so that alternative paradigm medicine can be brought up to the level of respect and attention that it deserves in the culture, to set things right with it. And then, of course, we want to have a Ph.D. program at Georgetown.
REDWOOD: In integrative medicine research?
PERT: Yes, exactly. That’s what we’re planning to do. I think the whole thing can withstand scrutiny. I don’t believe you need to do a different kind of science for this. I think the normal rules of science apply and I’m excited about researching it. The only thing that’s lacking is the money.
REDWOOD: Best wishes on finding it. Or earning it.
PERT: The plan is for the money to come from Peptide T. I think that’s why Peptide T took so long, because the universe had to be at the place where the institute was on line. I also had to reach a certain stage of my development to be able to realize the importance of Peptide T in the master plan, to fund and catalyze the transformation to what I call vthe new medicine." But, of course, it’s really old in some ways and new in others.
REDWOOD: Do you own the rights to Peptide T?
PERT: Yes, the rights were licensed by the NIH, where Michael Ruff and I worked when it was invented. It’s had a long and unusual history in both the licensing and business aspects of it.
REDWOOD: Where is it now?
PERT: It's now in a company called Advanced Immunity, a small company in which Michael and I are partners.
REDWOOD: There was recently a well-publicized scandal at The New England Journal of Medicine, because dozens of articles evaluating new pharmaceuticals had been published in the journal by authors who failed to disclose their financial ties to the manufacturers of the drugs they were evaluating. What steps have you taken to ensure the integrity of current and future studies on Peptide T?
PERT: We have taken great care to follow all the appropriate guidelines. The San Francisco study follows all standard FDA protocols and is being administered under the auspices of Georgetown Medical School. Probably the key point is that neither Michael Ruff nor I will have any role in gathering or handling the raw data. And, of course, there will be full disclosure at the time of publication.
REDWOOD: If Peptide T does what you believe it can do in treating AIDS, the potential for funding the Institute for New Medicine is substantial.
PERT: It is very substantial. And I should mention that Peptide T has the potential to work for more than AIDS. By the terms of the license, as well as by any moral terms and our own intentions, we have to spend the funds on AIDS and have the breakthrough before spending the funds for the other uses. But the other uses include Alzheimer's disease, multiple sclerosis, psoriasis, and a number of neuro-inflammatory diseases.