Excerpt 6 – The Trip to Mexico – 1995
My Journey to a
Next Generation Treatment
Donald E. Moss, Ph.D.
[Setting and Summary by Jim Summerton, Ph.D.]
[ Settings and Summaries: The clinical trial in Mexico had required approval from the Institutional Review Board at the Univ. of Texas, and various approvals from Mexico, including approvals from an ethics committee, a research committee, and the Dean of Faculty at the Medical School in Chihuahua. In addition, in the case of an "international" study such as Moss would be running, an approval from the Director of Control of Medications in Mexico City was also required. Before the Phase 1 safety component of the study was begun, the first four written approvals had been received, and Dr. Berlanga (Pati) had received verbal assurance that the last approval was routine if the other four authorizations had been given. With this final verbal approval, and assurance that the written approval would follow by mail in a few days, the clinical trials team began the initial safety phase of the clinical trial.
Then as the 2-week safety phase of the trials was nearing completion, disaster struck. This came in the form of a letter from the office of the Director of Control of Medications in Mexico City stating: "Permission to begin and conduct your project 'sulfonyl fluoride in the treatment of Alzheimer's disease' is denied.". It turned out the person who had given approval was on vacation and would be retiring immediately after that vacation, and so a new person, Dr. Sergio Zwinovsky, was now in charge and was apparently hell bent on derailing the MSF clinical trials. To attempt to resolve this problem Dr. Moss and Dr. Berlanga flew down to Mexico City, where they were joined by Dr. Roberto Prado-Alcala, a professor at the Universidad Autonoma Nacional de Mexico.
This chapter details this near disaster and its eventual successful resolution. ]
Pati and I sat in adjoining seats as the Aeroméxico plane made its final approach to the Mexico City airport. Evening sun illuminated the sprawling city below and glinted off the buildings that poked their way up through the layer of smog that hung close to the ground. Pati seemed calm for the duration of the flight from Chihuahua, laughing and talking with me about what she thought would happen at the meeting scheduled for ten o’clock the next morning.
I thought that getting the appointment was a major feat, either because of the Magic of Pati or by divine intervention, I didn’t know which. And I was afraid that getting the appointment might not be anything but an opportunity for Dr. Zwinovsky to turn us down in person, make it really official. The one fragment of hope I felt was that Roberto had not only cleared his schedule so he could go to the meeting with us, but he would also meet us in the terminal so we could go to dinner together.
Once on the ground, Pati and I grabbed our carry-on baggage and launched ourselves into the sea of people flowing in and out of Mexico City on a Sunday evening. It was rush time in one of the busiest airports in the western hemisphere. After a delay of about an hour because we couldn’t find each other in the more than seven million square feet of Terminal One, Roberto had us in his car headed out into the gathering night.
Over the empty dishes of dinner, we got down to business. Slightly younger than me, Roberto had a kind round face, lots of black hair that bordered on curly, and a quick smile. But he also had an intensity and energy characteristic of an accomplished scientist who was earning his way to the top of one of the world’s great universities. He had read and digested all the information about MSF and had dedicated his whole day tomorrow to helping Pati and me. We discussed the whole protocol and answered his questions. We were ready.
Roberto kindly drove Pati and me to a home located in a quiet quarter near Chapultepec Park. Ceci, a friend of Pati’s from grammar school, had welcomed the chance to put us up but she wouldn’t be home until late that night. One of her neighbors was expecting us and had the key to let us in.
It was almost ten o’clock when we got settled but we were both too keyed up to sleep so we decided to take a walk around the neighborhood. The July night in the high thin air of Mexico City was still warm but the temperature was dropping as we strolled along.
After several blocks, we turned a corner and found ourselves in front of a massive Catholic church built from blocks of black lava. The doors were open and light spilled out of the vestibule onto the sidewalk. We could see that there was a service going on inside.
Pati took my sleeve. “I want to go inside. Just for a minute. Will you come in with me?”
Among all the things that Pati and I had discussed, religion had not come up as one of them. I didn’t know how religious she was and I am sure that she didn’t know that I was not particularly religious. But if she wanted to go in and see what service was going on, I would go with her. We climbed the steps and slipped in the door and took our seats in one of the back pews, being as unobtrusive as possible.
After a minute there, Pati leaned over to my ear and whispered, “I will be right back,” and she left the pew and joined a line of worshippers waiting at a confessional. I was unaccustomed to being in a church. I didn’t know what to do while I waited. I hoped I wouldn’t embarrass myself. Finally, I put my head down and reflected on the long string of improbable events that had come together like a gathering wave to put me in the nave of a church constructed of black stone in Mexico City.
When Pati came out of the confessional, she followed the other parishioners to the front and took communion. When she came back down the aisle, she motioned for me to join her and we left the church and went back out onto the dark street. Within a few more blocks, we came upon a café that was still open and we stopped and reviewed our hopes for the upcoming day over a final cup of coffee.
It was after midnight when we found our way back to the dark house and let ourselves in. I went to bed to sweat out the night in alternating fits of doubt and hope for the next day. Pati stayed up to greet her friend.
* * *
The next morning I awoke to the smell of coffee and I could hear Pati talking with someone. When I entered the kitchen I was introduced to Ceci, a tall woman with a round face, wide smile, and dark eyes. They put some coffee and orange juice in front of me and Ceci made a light breakfast. As soon as I finished, we all left for the city.
The first stop on our agenda was a tour of Ceci’s clinical laboratory. She had agreed to run the clinical hematological analyses of the blood samples we would collect during Phase Two, if we got approval. The modern equipment on the benches and the variety of instruments impressed me as one of the best labs I had seen anywhere. After the short tour, Ceci drove us to the front entrance of a gray stone building in the Colonia Casa Blanca of the Federal District in downtown Mexico City where Roberto was waiting.
Dr. Zwinovsky’s secretary welcomed us as we arrived promptly at ten o’clock at his windowless office on the fourth floor. She hugged Pati and said she felt like she knew her from all the telephone conversations the two had shared. After Pati introduced Roberto and me, the secretary showed us into a cramped conference room that contained a heavy wooden table surrounded by six chairs. Within moments, Dr. Zwinovsky burst into the room and introduced himself. He wore a starched open neck white shirt, and dark slacks. He had a pale fleshy face and black hair that he had combed straight back.
Dr. Zwinovsky took a seat at the head of the table and Pati introduced herself, Roberto, and me. Dr. Zwinovsky showed special deference to Roberto when he was introduced as a member of the faculty at UNAM.
“Well,” Dr. Zwinovsky said, “tell me about your project.”
I noticed that he had all the papers we had sent in a pile next to his right hand but I didn’t have any idea whether or not he’d read them. I guessed that he had not so I started with the basics of MSF.
“No,” he said abruptly putting up his hand and stopping me midsentence. “What I want to know is who gets to buy the Lexus.” He looked around the room, peering at each of us.
At first I thought he was joking. What did he mean? Then I had the awful realization that he was serious. After I got over the shock, I started explaining how none of us would make any money because of the patent situation. I had that discussion down pat because I’d given it so many times but my Spanish annoyed him.
“You can speak English here,” he interrupted. “Go on.”
So I continued in English, outlining the disastrous patent situation and comparing it to the good that MSF could do for patients. Pati and Roberto added to the discussion as I went along, especially with regard to the plight of patients and the absence of any other treatments. I also explained that we were in Mexico exactly because nobody could make money. The costs in the United States prohibited doing any evaluations there.
“See what happens when we have a gringo here,” he interrupted me again, “we all end up speaking English.”
That remark left me at a complete loss of words. This guy was by far the biggest jackass I’d ever met. I felt like a mouse being played with by a cat, getting flipped in the air as a temporary release from its jaws, only to be caught and rolled around before being trapped again in its teeth. The cat wasn’t hungry. It was all entertainment for the cat, but in the end the mouse would die in earnest.
While I tried to gather my wits, Pati picked up the torch in a kind and patient voice and reiterated the hopeless situation of demented elderly in Mexico. She talked about how the project had been reviewed and approved by the University of Texas at El Paso and the Universidad Autónoma de Chihuahua and that it was an opportunity for international cooperation that would benefit both countries.
Although Dr. Zwinovsky had shown special respect for Roberto during the introductions, he hadn’t asked him any questions and ignored Roberto’s remarks. I was embarrassed that I had entangled Roberto, an internationally recognized scientist who had other things to do that day, in this misadventure and that he had gone to so much effort to help us. After the debacle had been going on for twenty minutes, Dr. Zwinovsky pulled up his shirt sleeve to look at his Rolex.
“When your project is approved in the United States, we will be proud to join hands and move forward to test MSF in Mexico as a joint project.” He gave us a wide toothy smile and the farce had come to an end.
* * *
The three of us descended the four flights of stone steps in silence. This was the one and only time I ever saw Pati flustered and angry. Her jaw was set, muscles worked along the side of her face, and veins stood out on her forehead.
When we stepped out into the sunshine on the plaza in front of the building, Pati took out her cell phone and looked at it a moment. Before she dialed the number she turned to Roberto and asked, “Can you come with us to another meeting, if I can get it arranged?”
* * *
Less than an hour later, Pati, Roberto, and I entered another imposing stone building a few blocks away. Pati led us up to an office on the top floor.
Gold leaf lettering at the entrance announced Secretaria de Salud de México. Pati pulled the heavy glass door open and we entered an office adorned with thick carpet and polished wood furniture. Light streamed through big windows that looked out over the city.
Having just had our collective butts handed to us at our encounter with Zwinovsky, I had a lot of trepidation about another meeting. But I trusted Pati. If she thought this was a good idea, I’d follow. I felt like the Cowardly Lion following Dorothy and the Tin Man going into the castle for an audience with the Wizard of Oz.
A gracious older woman dressed in a white blouse and dark skirt waiting for us greeted Pati with a hug before showing us into a spacious conference room with rows and rows of books lining the walls. Big comfortable looking chairs surrounded a gleaming table twenty feet long.
Within moments, an older man with salt and pepper graying hair and an unmistakable air of authority strode in through a side door and embraced Pati. During the introductions, Pati explained that the man was a family friend and that he was the Secretary of Health of Mexico. As she spoke, he shook hands with Roberto and me and asked us all to take seats at one corner of the sprawling table so we could sit close to one another and talk.
Pati took the lead in this meeting which was conducted entirely in Spanish. She smiled and in a calm, smooth voice, sketched out the MSF patent problem and why I was in Mexico to collaborate with them. She noted that the study had been approved both in El Paso and Chihuahua but that Dr. Zwinovsky blocked it by saying that Mexico would approve the project only when it had also been approved in the United States. Such a requirement was an unnecessary and arbitrary condition that might keep a new treatment away from millions of patients in Mexico who currently had nothing. This study was also a chance for Mexico to take the lead in an international race to find something that could help.
The Secretary listened to Pati without interruption, never taking his eyes off her. When she finished, he asked me some questions about MSF and then turned and asked Roberto about his opinion. Roberto’s comments became the anchor for the meeting.
“Mexico is a sovereign country,” the Secretary said at the end of the questions, smiling warmly. “We can conduct a clinical trial without approval from the United States. You will get a letter from
Dr. Zwinovsky confirming this within a week.”
After we all shook hands again and we were leaving the office, I felt psychological whiplash. Within two hours I’d been pushed to the bottom of a pit, pulled out of hell, and thrust back into a fairy tale. With the key help of Roberto and, again, by the Magic of Pati or divine intervention, and I didn’t know which, we were back on track.