Excerpt 4 – The Experiment on Myself – 1994
My Journey to a
Next Generation Treatment
Donald E. Moss, Ph.D.
[Setting and Summary by Jim Summerton, Ph.D.]
[ Setting and Summary: Key small-scale clinical trials to provide a preliminary assessment of safety and efficacy of MSF in humans could be conducted outside the USA for something like $50,000. In sharp contrast, FDA-compliant (US Food and Drug Administration) studies to assess safety and efficacy in humans would cost tens to hundreds of millions of dollars. Because Moss had no access to many millions of dollars, he had no alternative but to focus on an affordable clinical trial on MSF to be conducted outside of the USA.
Moss' first attempt to carry out affordable clinical trials outside the US was in Argentina, but that was a complete bust for two reasons. One reason was an interminable delay by an Argentine bureaucrat. The other reason was that because Moss had not yet tested MSF on himself, the normal individuals Moss needed for the Phase 1 safety study were unwilling to be his first "guinea pigs".
Subsequently, a possibility for affordable clinical trials in Mexico was suggested by Dr. Pedro Barrera, who was on the faculty of a major university in Chihuahua. And through the unstinting goodwill of Dr. Barrera in Mexico and multiple colleagues at the Univ. of Texas in El Paso this possibility matured into a real opportunity. But to grab hold of that opportunity, as described in this chapter Moss concluded that he must first test MSF on a human subject (himself) in order to avoid a repeat of the "guinea pig" fiasco that, in combination with bureaucratic delay, had derailed the previously-attempted clinical trials in Argentina. ]
…………………………………. I paused by the door, watching Mary’s back until she finished injecting her sample. I didn’t want to distract her and she ignored me, keeping her gaze glued to the chromatograph screen. When the glowing green line began to jump upward, showing that her sample was being analyzed, she turned her attention to me.
“Mary,” I said watching her eyes for a reaction, “I’m starting an experiment. I’ll need you to help me draw blood several days each week. I’ll have to see how it goes before I know how long it’ll take.”
“I’ve never drawn blood. I’ve seen you hit thin, rolling veins in old ladies with Alzheimer’s disease. You don’t need my help.” She raised her eyebrows and then glanced back at the display on the chromatograph to check her sample.
She was right. Years earlier I’d learned phlebotomy at a local hospital. “You don’t understand,” I said. But before continuing I went to the door and checked the hallway. “I need samples of my own blood, lots of them. I don’t like to stick my own vein. Besides, if I use my right hand to stick my left arm and hold the needle in place, I can’t handle the tubes to collect the blood and do everything else. I need someone to help.”
“What kind of an experiment are you doing?” she asked with furrowed brows over eyes that were now locked onto mine.
“I’m going to start taking MSF, see if it’s toxic to humans and measure its effect on my red blood cells,” I said.
“Are you crazy? Is that even legal?” she asked.
“Taking it is legal.” I paused before going on. “Learning anything is what’s illegal.”
“What do you mean, ‘it’s illegal to learn from it?’”
“To see what MSF does to me, after I take it, I’ll have to use our lab to analyze my blood. I haven’t asked the Institutional Review Board – the human subjects committee – to see if they’ll let me do it. Using university equipment for a human experiment that hasn’t been approved is where I get into trouble.”
“Why don’t you just get approval?” she asked. She looked at me like she was talking to a child who couldn’t figure out how to pour pee out of a shoe.
“They’ll start worrying about liability. What if I kill myself or make myself into a drooling idiot? And then they’ll argue about what I can learn if only one person takes it. They’d never approve it. And then if I did it anyway, after getting turned down, they’d take about ten minutes to fire me, even as a tenured full professor. I have to do it, though, with or without approval.”
“What’ll happen if they find out?” she asked. At that moment the chromatograph beeped, her sample had finished. Mary didn’t move to check it or start another. She still had that look on her face. I was surprised that she didn’t like the idea.
“They’ll probably fire me,” I said. “I might get off if I just play dumb. A lot of people, including the president of the University, wouldn’t think that being an idiot was an act for me. What would be bad is if some bureaucrat at NIH found out about it. They could pull federal funding, research grants and all, from the whole university. Anyway, let’s not tell anybody about this, just keep it between us.”
“Does Jo Anne know about this?” she asked.
“She wants my doctor to check me out and know what’s going on. Besides, I’m going to start at really low doses and work up. It’ll be safe. The only people who know about this are Jo Anne, my doctor, me, and now you.” She didn’t need to know any more.
“How about the chairman of the department, don’t you think he should know?”
“Come on, Mary, all I’m asking you to do is help me draw some blood. And, you’re right, Dr. Whitworth should know about it and he does. He’s the one that’ll witness my notebook to make the data credible.”
“Why do you want to do this now?” she asked. At this point she got a look that combined surprise and indignation. I had a sinking feeling that she wasn’t going to do it.
“I have a friend, a colleague in Chihuahua who’s going to introduce me to a doctor who might help me test MSF in real Alzheimer’s patients. I have to have some human data before I can start anything.”
“You need to have data before you start? Isn’t that what you do with the people in the trial?”
“I triggered a fiasco in Buenos Aires. All I heard was ‘conejillos de Indias.’ If I have a chance to run a trial in Mexico, I have to be able to tell them that I’ve taken the drug.”
“Why can’t you do it on somebody else?” she asked as she turned her back for a moment to inject another sample into the chromatograph.
“That’s the problem of ‘somebody else.’ I once talked to a lady that had been married to a man for fifty years before he slipped into the abyss of dementia. She complained about not having a treatment right then, the magic bullet. I asked if she would give permission for her husband to take a new drug if it might help him. She told me she didn’t want her husband to be a ‘guinea pig.’ I asked her whose husband should be the guinea pig so that her husband could get better. She said she didn’t care. The point is that I can’t ask somebody else to test my drug. If I want it tested, I have to do it myself.”
“Okay,” she said with a long sigh. “I’ll do it. I’ll help you but I won’t stick your vein. You’ll have to do that yourself.”
A few minutes later, we had our first run-through with our blood-draw routine to get a sample before I took my first MSF capsule. Mary helped me put the tourniquet on but she absolutely refused to stick the needle in my arm. She watched me poke around until I found my vein. Once I got the blood flowing, she helped me switch collection tubes, something I couldn’t do with the one hand I had free.
After collecting the baseline sample, I took the MSF capsule in my hand and looked at it for a long time, debating if it was really such a good idea to put it in my mouth. Did my brain really want to put this in my stomach? What was I doing to myself? Finally I popped it onto my tongue, sipped a little water, and swallowed it. I hoped that I wasn’t making the biggest mistake of my life.
In the first four hours after taking the pill, I studied every heartbeat, checked the way I felt with each breath, and waited to see if could feel anything change. I still felt fine. It was also finally time to poke around again at my own vein, bulged below the rubber tourniquet, until my warm blood surged up into the glass tubes, holding the answers I needed.
* * *
After taking MSF in higher and higher doses for two months, the results from my blood answered two important questions. The first was that MSF worked when it was given orally. Secondly, my blood showed that I was taking big doses, not as large as I’d given my monkeys but more than enough to treat dementia, and I wasn’t sick.
Where I ran into trouble was when I also wanted to test MSF on dogs. Shortly after finishing the MSF test on myself I confided to a friend in a big drug company what I had done. He raised his eyebrows and told me, “That’s fine. But whatever you do, never use dogs in toxicity tests. They are very sensitive to these types of drugs. It’ll make them sick and make MSF look too toxic, ruining your chances of getting it into humans.”
After hearing that advice, I decided that I had to test MSF in dogs. After all, wasn’t the purpose of this whole exercise to find truth? If it’s too toxic, I could understand it. But I wanted to know, not cover it up. I had to do some tests in dogs and see what happened.
The problem was that I didn’t have any dogs. The only candidate was the two-year old, eighty pound, bright-eyed yellow Labrador, Frankie, that Jo Anne and I had raised and trained from a puppy. She would be perfect for an MSF test. She was smart and absolutely compliant, doing anything we asked with a trusting heart. She readily accepted pills, gulping them down. I knew that I could easily train her to let me draw blood from a vein in her ear so I could do the same analysis I’d done on myself. I thought it would be a good idea.
Doing a test on Frankie introduced some extra complications. First of all, doing an experiment on animals without university approval was a more egregious violation of regulations than taking MSF myself. Although there was no university committee for the protection of humans from their own stupidity, there was a committee charged with protecting animals from human stupidity.
Giving MSF to a dog without the animal committee’s approval would be against the regulations. In addition to the special problem of using a dog, it was illegal to use my lab equipment to analyze the results just as it had been for my own MSF experiment.
The biggest challenge with doing an experiment with Frankie was that I’d have to get
Jo Anne’s permission. Her approval was important.
Over dinner one night, I brought up the idea of giving MSF to Frankie.
“I’ll do the same experiment on her that I did on myself,” I said, passing the hamburgers like I’d done nothing more than suggesting that we should go to a movie sometime.
Jo Anne looked up at me and froze, her eyes burning holes in me. “Absolutely not. Frankie can’t understand and give consent.”
“But I won’t do anything to her that I haven’t already done to myself,” I protested.
“I won’t let you do it,” she said and I knew by the steely look on her face that the conversation was over.
That night I learned a little more about how much Jo Anne loved that dog, especially as compared to me. She’d let me take MSF.
Jo Anne’s refusal to let me give MSF to Frankie turned out to be a stroke of luck. At five years of age, as a beautiful young adult, Frankie got a rare type of bone cancer in her face and we had to euthanize her. As we walked away from the vet hospital that awful day, I realized that if I had given her MSF, I’d have always wondered if it might cause bone cancer.