The government loves to tell you it’s doing one thing, like protecting you from illegal drugs, or COVID-19, when their real agenda is starkly different.
The criminalization of cannabis is, in my mind, a great crime, especially as it created a near black-out of research on the possible medical uses of cannabis. Even in 2017, the attorney general called for a crackdown on marijuana usage.
In government, it just seems you can never quite kill a bad idea. Proper regulatory oversight could have prevented these needless tragedies.
Is it any wonder that the Reagan administration’s response to the AIDS epidemic was to stick its head in the sand and not see anything from 1983 to 1987? In 1985, the administration rejected an AIDS prevention plan, telling the public health officials to basically “look pretty and do as little as you can.” As a result, by the end of 1987, sixteen thousand blood transfusion recipients and ten thousand hemophiliacs (who required Factor VIII, a clotting product made from human blood) became infected with HIV.21
Meanwhile, we were studying the effects of these retroviruses on the overproduction of immune factors in the body, which were likely involved in the pathogenesis of AIDS. Due to the extremely fragile nature of these retroviruses, the isolation of them for study can be extremely difficult. Judy was excellent in developing a two-step hollow fiber tangential flow filtration process for retroviral purification. First, a microfiltration step removed cells and large debris, and then an ultrafiltration step concentrated viral particles.
We then used this technology to publish the isolation of HIV from an ALS patient in 1985.22 Judy’s creative engineering solution to this problem was critical to our success.
It was not the only area in which she made her presence known.
***
Working on the Fort Detrick military base as a civilian employee certainly has its share of ups and downs.
Civilians like Judy and I could use most of the facilities at the base, like the excellent gym and community center. There was also a squash court where Judy taught me a variety of that great game, using a slow ball, which is more physically demanding and designed for more advanced players. On the rare occasion that I came dangerously close to winning, I would often be hit in my buttocks with the squash ball as I had taken the wrong position on the court. That is, I dared to take the command center position. She let me know in no uncertain terms what could happen if I wasn’t prepared on HER court.
At least, that was usually her explanation as to why I’d been hit by the squash ball at the most sensitive place on my upper back thigh.
The painful contusion often lasted weeks, and I was careful the next time to make certain I really had command of the court before I took that position. I knew my shot had to be precise enough to be impossible for Judy to get a racket on.
Judy also played ice hockey, and as in soccer and squash, she often played the defensive goon as if the fate of Western civilization rested on the outcome. No one was coming into her territory without paying the price. We coined our squash game “New York Islanders squash” after the professional hockey team. As when we played basketball, no referee was needed.
It was simple. No blood? No foul!
When she’d go jogging with the young, male seminar speakers, they’d often return complaining of bad knees or aching hamstring muscles as the reason they couldn’t keep up with her fast pace.
She organized and coached an annual softball team, relishing her position as catcher where she’d taunt the big, strong military men as to why they couldn’t hit an easy pitch over the fence. They’d usually respond by swinging so hard that they’d hit a simple pop-fly, for which we’d immediately call out “can of corn!” In one game we called “can of corn” ten times and one of the players challenged us as to whether that was a real expression in baseball or something we’d made up.
After the game, we went to a baseball almanac to try and find the answer. Apparently, the term came from grocery clerks who’d knock a can off a high shelf with a stick, then catch the falling item in their aprons.
One time the other team was getting so rattled by Judy’s constant stream of talking during a championship game that the umpire told Judy if she said one more word, he’d throw her out of the game. She complied, and we won the game.
I kept the trophy in my office until I retired, not because I was proud of the team, but because it was demonstrable, undeniable scientific evidence that it was physically possible for Judy to occasionally keep her mouth shut.
It was never boring to work with that woman.
Like me, she never had much patience for the constant useless challenges by some of the military authorities at the base.
Judy rode her bike to work almost every day, always before dawn, when the sleepy Frederick, Maryland traffic was non-existent. One day she forgot her helmet and the guard at the gate told her to ride home and get it. Helmets were mandatory when riding on the base.
“It’s five miles back to my place,” Judy said, “and there’s a lot of traffic. Wouldn’t it be safer to just give me a warning and I’ll remember it tomorrow?”
The guard told her she needed to go home.
Judy ignored him and quickly rode onto the base, hoping he didn’t know where she worked.
Later that morning, military police dragged Judy out of the laboratory and forced her to ride home without a helmet. It reminded me of how the military police used to come for me and march me between two guards so everybody could see, just to escort me to the barber shop because my hair was too long.
When it comes to mindless authority, Judy and I really are two of a kind!
***
In 1985, the US military created an HIV research program which was funded mainly by Anthony Fauci’s NIAID.
However, when I tried to talk to some of the scientists about their efforts, I was told I had to get permission from the military to talk to any of the scientists. Can anybody tell me why the military was interested in concealing the research they were doing on a disease which mainly affected gay men? Remember, according to the military at that time, there were no gay men serving in uniform.
While I was interested in doing basic research, and not therapies, that all changed when I met a brilliant researcher, Dr. Candace Pert. Like Judy, I felt she was a kindred spirit. Her discovery of endorphins (chemicals which provide a natural high, such as after exercise) while a graduate student was made because of an experiment she conducted, in spite of her graduate advisor telling her not to do it.
When her advisor, Solomon Snyder, was awarded the Lasker Prize for her work, without any attribution to her, she would not stay quiet.23 She became a pariah in the misogynistic patriarchal scientific community, just as Judy would become years later. When Candace reported that both insulin and endorphins were made in immune cells in the brain, her papers were roundly rejected by the scientific journals with comments like “are you washing your test tubes enough?”24
After her work was later confirmed, the journal Nature warned scientists to beware of those “radical psycho-immunologists” who would suggest that the mind and body are in communication.25 Candace Pert would later be nicknamed the “Mother of Psycho-neuroimmunology” and the “Goddess of Neuroscience.”
This connection between the neurological and immune systems was enough for Candace and her immunologist husband, Mike Ruff, to make a peptide that would mimic the part of the virus which binds to the receptor on the cell surface which allows the virus to gain entry to the cell. Candace asked Judy and I to do the HIV infection experiments with the peptide they’d dubbed “Peptide T,” which was an eight amino acid peptide within an HIV envelope, the outside portion of the virus containing the gp120 spike protein of HIV. We showed that it would block gp120 from binding to the CD4 molecule on helper T-cells and that the CD4 molecule was present in the brain, probably on microglia, not T-cells.26
Beginning in 1986, we published a series of papers in peer-reviewed journals stating that Peptide T inhibited the inf
ection of HIV viruses that used the CCR5 receptor to enter immune cells. It was not known that HIV used the CCR5 receptor to enter immune cells until 1995.27 Since Peptide T does not completely inhibit the isolation of all viral isolates, this work was roundly dismissed by the mainstream medical AIDS community. It was particularly harsh because the NIH was completely invested in pushing azidothymidine (AZT), despite its profound toxicity. Candace said many times that we did not expect Peptide T to be a cure, but it could be part of a cure. Even when we showed that Peptide T blocked HIV binding to the CCR5 receptor and did not inhibit the lab-adapted viruses which bind to the CXCR4 receptor as a cofactor, nobody was interested in Peptide T as a drug.
In 2007, twenty-one years later, an independent team confirmed our results.28 They even extended our findings to suggest that Peptide T, alone or in combination with other anti-retrovirals, could prevent infection of the central nervous system and the resulting neuronal damage that leads to neuro-AIDS.
Much of this story is memorialized in the Oscar-winning film, The Dallas Buyer’s Club, starring Matthew McConaughey.
***
A scholar’s obligation is not only to generate knowledge, but to communicate and defend the data at all costs. That is why our 2015 consulting company mission statement included the Thomas Jefferson quote, “For here we are not afraid to follow the truth wherever it may lead; nor to tolerate error so long as reason is left free to combat it.”
Judy likes to say, “God has a sense of humor.”
I think about it differently. Scientific advancement is a mysteriously beautiful thing, as the truth may be hidden for a time but can often reappear in a different form. RAP-103 is a stabilized analog of Peptide T and is being used as an inhibitor of neuropathic pain. That means its safety has been established and, given a few simple government permissions, we could use it today to start treating people for various conditions, including HIV/AIDS and SARS/AIDS, termed “Long-haul COVID.”
How else might RAP-103 (Peptide T analog) be used? In 2019, it was shown in mice that CCR5 levels skyrocket after a stroke, and it is this inflammation which causes a great deal of the damage.29 But RAP-103 (Peptide T analog) targets the CCR5 receptors, meaning it could limit the damage caused by a stroke. Isn’t it interesting that COVID inoculations have strokes and blood clots as serious side effects?
Exactly what the data would suggest would happen when expressing viral envelopes.
Another drug, Maraviroc, also targets these receptors, and was approved in 2007 as an antiviral in HIV infection. (Isn’t it curious how many of these compounds which target the immune system are also good against viruses?) However, Maraviroc also has numerous documented side effects, including liver damage and allergic reactions.30
If given a chance, wouldn’t you rather try Peptide T or RAP-103, which have been found to have little or no side effects, rather than Maraviroc?
But under current FDA pronouncements, you will never be able to make that decision.
We can only hope that someone tries to genuinely revive Peptide T as a therapy sometime in the future. We believe an immediate use for Peptide T would be for people who suffered a stroke after receiving their COVID-19 vaccine.
A final footnote to the Candace Pert story is that in 1999 she autographed my copy of her book, Molecules of Emotion. I always thought it read, “To a man with fatal integrity.”
Judy looked and it and claimed it read, “To a man with total integrity.”
We laughed about it because both claims were equally plausible. In an era of corruption in so many professions, total integrity can be fatal to your career.
Right up until her untimely death in 2013, Dr. Candace Pert was a true scholar in this age of corruption. More importantly, she did it with aplomb and humor. When Judy gets discouraged by the attacks surrounding her discoveries about XMRVs and chronic fatigue syndrome, she often recites the quote that was on the poster in Candace’s office. It read, “When they are chasing you out of town, simply run out in front and pretend you’re leading the parade!” This quote was also included in Candace’s obituary, and is a fitting tribute to a great scientist.
It matters little what people say about Judy or me. The only thing that matters is having total integrity in the interpretation of the scientific data, no matter how inconvenient those truths may be to those in positions of power.
In the summer of 1986, I thought my collaboration with Judy Mikovits would be permanently ended when she took a position with Upjohn Pharmaceuticals in Kalamazoo, Michigan. As a woman stuck in government science, which was run by tyrannical, women-hating men, she saw little chance for advancement.
But before she left, she gave me a parting gift.
I had never learned to drive, and she harangued me, gave me driving lessons, and made sure I got my license.
The job in Kalamazoo didn’t work out, as she ran afoul of tyrannical men there as well, and I welcomed her back, helping her get into a doctoral program at George Washington University.
CHAPTER SEVEN
Political and Research Struggles Continue
The true enemy of science is the substitution of thought,
reflection, and curiosity with dogma.
—Frans De Waal1
The difficulty lies not so much in developing new ideas as in escaping from the old ones.
—John Maynard Keynes2
Our son, the greatest of Sandy’s and my experiments, was born in Washington, DC in 1986.
It was a difficult delivery. After sixteen hours I was ordered out of the delivery room, just as I heard a loudspeaker announcing “Stat!” An eternity of an hour later, I was holding this tiny person in my arms. Both of us were confused by what happened next.
All seemed well, except that Sandy had not seen our new son. He had a bacterial infection (perhaps a result of being unattended in the birth canal for so long), and we had to consent to a spinal tap to judge the extent of the infection. But it all ended well, and within a few days he was given the “all clear” and our small family headed home.
While family life was headed in a delightful new direction, there was much confusion in my scientific career. It would be many years before I would be invited to an HTLV-1 scientific meeting. Ironically, scientists would ask me for invitations to HTLV-1 meetings, to which I wasn’t invited. My exile was so complete that for thirty years I never received an application from a fellow interested in studying human virology. I can only assume this was due to Gallo’s de facto fatwa against me.
In the short term, I decided to study the mechanisms by which cells communicate, primarily through messenger molecules called cytokines, which simply means soluble factors promoting communication between cells. The yin-yang model that most human systems consist of complimentary parts, one having positive effects, and the other negative, was having an increasing impact on my thinking. We became concerned because, as we tried to determine clinically the maximally tolerated dose of IL-2, we saw that the high doses usually resulted in such toxicity that many patients died. We decided to examine cytokines for their ability to stop an event (i.e., cell growth, immune reactivity, inflammation) in the presence of factors which would stimulate these events.
We searched for a molecule that was available in purified form, and for reagents, which could specifically block the activity of this molecule. A chance meeting with Larry Ellingsworth and Jim Dasch of Collagen Corporation introduced me to the reagents available for Transforming Growth Factor-Beta (TGF-beta), which turned out to be an essential regulator for most, if not all the body’s organ systems.
The late Anita Roberts, a wonderful scientist and even better human being, always said that if a cell was off, beta would turn it on.
For the next twenty years, we and many others found that TGF-beta had profound effects on every stage of hematopoiesis, from the stem cell to reactivity of the immune system.3 TGF-beta antibody Jim Dasch developed turned out to be a very valuable reagent. Jim gave the cells producing the antibody to me and the
American Tissue Culture Collection (ATCC) so that all scientists could have access to the antibodies. As usual, no good deed goes unpunished, and years later I got into trouble with the company for freely giving the reagents to other investigators.
In the interim, studying the complexity of TGF-beta was very rewarding and substantially added to our knowledge.
Meanwhile, all through the eighties, there was, generously stated, a lukewarm response to the HIV/AIDS epidemic. It was becoming more and more apparent that the public health establishment was failing to provide the required leadership. The heads of the CDC, NIAID, and the secretary of Health and Human Services (HHS) did not sufficiently share the scientific concerns about the safety of the blood supply and blood products. This laisse-faire approach greatly impacted the health of three groups: blood donors, hemophiliacs, and the gay community. The most troubling aspect of this epidemic was the number of people fatally infected because of the failures of our health-care system itself. Public health officials in other countries either lost their positions or served jail time for these failures.
But not in the good ole’ USA.
In 1995, the Institute of Medicine (IOM) produced an exhaustive 350-page study, “HIV and the Blood Supply: An Analysis of Crisis Decision Making,” which squarely placed the responsibility for the spread of AIDS through blood transfusion and blood derived products on the FDA, blood banks, and the blood products industry.4
In 1983–1984, nearly two years after several committee meetings discussed the CDC recommendation of blood testing and donor screening, the FDA was still stalling and blood industry spokesmen were still denying that AIDS was a threat to the blood supply. Privately, these administrators were saying something different about the danger, but were content waiting on an HIV blood test when several procedures were available to save lives.
Finally, on March 2, 1985, HHS Secretary Margaret Heckler announced the first AIDS test, which measured antibodies to HIV, and was licensed to Abbott Lab.5 By July 1985, the FDA recommended, BUT DID NOT REQUIRE, the use of the test, which resulted in many blood banks not testing their blood supply.
Ending Plague Page 10