27 February 2006

My fellowship begins, finally

So, the next few posts will be an attempt to describe my family's visit to Mali. Words and pictures cannot do justice to such an incredible journey, but it will be an attempt. Inshallah (God Willing).

In other news, I am happy to say that after 6.5 months of anxious waiting, I can officially say that my fellowship has started. Feb 13 we had our initial investigator meeting to discuss the protocols and processes for the upcoming Phase I/II malaria vaccine trial in children 2-3 years old in Doneguebougou and Bancoumana. Briefly, clinical trials are set up as follows:
Phase I are the safety studies, to ensure that the vaccine/drug is safe and will not cause harm to the individuals who receive the vaccine/drug. for international studies, this usually starts with giving the drug/vaccine of interest to healthy volunteers in the country from which the drug/vaccine is sponsored (in our case, the US.) If the research shows that the vaccine/drug is safe, then it is tested in people who are exposed to the illness on a continuous basis (i.e. a malaria endemic country like Mali). Here, we have already conducted Phase I studies of this vaccine in adults in Doneguebougou, and the results show that it is promising. The purpose of this Phase I study is to make sure that it will be safe for the future recipients of this vaccine, children. Typically, these studies involve few participants (30-40) so if the vaccine/drug is not safe, we will not be causing too much harm.

Phase II studies are efficacy studies, meaning we want to make sure that the vaccine/drug does what it is supposed to do. In our case, we want to ensure that the vaccine will mount a proper immune response against our particular vaccine target, which is common to all the malaria parasites that cause the most illness here in Mali, Plasmodium falciparum. These studies involve greater numbers of individuals, to ensure that the vaccine will have an effect in a larger population.

Phase III studies are really a combination of Phase I and II on a massive scale, typically hundreds to thousands of participants. In general, malaria vaccines are no where near this point yet for a variety of reasons. Typically, assuming the results are favorable, the vaccine/drug of interest can then be marketed and distributed en masse.

Phase IV studies are surveillance/follow-up/post-marketing trials to ensure that the vaccine/drug is still safe. For the most part, once a drug/vaccine passes the Phase III stage, it will remain on the market for a while. Occassionally though, the drug/vaccine may be pulled, due to deleterious side effects that where unknown or not demonstrated in earlier trials. The most notable and recent example of this invovled the pain relievers Vioxx and Celebrex, which were initially noted to be wonder drugs, and after further research (i.e. Phase IV studies) shown to be associated with cardiac arrythmias in patients who took those drugs.

so, normally there is a long gap between each phase of the process, sometimes as long as 2 years between Phase I and Phase I studies. In our case, we are combining the phases in a unique clinical trial that will piggy-back a Phase II study on top of a Phase I trial, pending favorable safety results of the Phase I trial. It is a complicated structure that I am not allowed to discuss for confientiality and security reasons, but suffice it to say that if all goes well, we will essentially have results 2 years earlier that using the traditional system. Inshallah.

So, with that boring lessone over with, let's get back to the official beginnings of my research fellowship. So, the Monday we had our investigator meeting, I was battling the beginnings of some type of cold/flu/bug, which made this 8 hour day unbearable. The next 5 days were then spent recuperating from my illness and waiting for the green light to start the consent process of the villagers who would participate in our study. In true Malian fashion, I got word Friday night that we would start the consent process Saturday morning. I quickly packed a bag and headed out to Doneguebougou early the next morning. Since my knowledge of Bambara is essentially nill, my role was really as an observer, to see the process in action. I was impressed with the teams efforts at maintaining the integrity of the consent process in a manner that is consistent with studies that I have participated in the U.S. However, the process took 45 minutes to an hour in some cases to cover the 7 page consent form. But, in the world of clinical research, all of that information sharing is necessary.

We had finished consenting our first group by Sunday afternoon, and now were waiting to start the screening process. The purpose for screening is to determine which potential participants meet our inclusion and exclusion criteria for the study. All potential participants who have given their consent must undergo a thorough past medical history and physical examination, laboratory testing, and other sampling to ensure that their general health is intact. We were told initially that this process would start that Monday. But again, this is clinical research and this is Africa, so we waited for 4 days before we were given the green light to start the process. Now mind you that this is an African village about an hour outside of Bamako. There is no internet, cell phone service that is limited to a 5 square meter area near the vaccine clinic, one television station, and no other research activities going on. So needless to say that those 4 days were spent chillin' Mali village style. I read a book, wrote some of my upcoming blog entries, listened to BBC Africa on the radio, and did not much else. So by the time Thursday rolled around, I was eager to start screening.

My role in the screening process was that of "study clinician." I was partnered with my friend Guindo, one of the Malian study clinicians. It was our job to perform the past medical history and physical examination on each potential participant. Since our vaccine will be administered to children between 2-3 years old, the examination is made more difficult with mostly uncooperative kids. Given my interest in pediatrics as a career, I was up to the task. Without getting into specifics for confidentiality reasons, I am happy to say that my medical training at Tulane was key in my diagnosis of some cardiac and intestinal maladies in the children that we screened (I plan on talking more about this later in a future blog entry). After an exhausting 2 days of screening, I was happy that my fellowship is finally happening.

The next step is vaccination. Right now we really do not know when this will start, Inshallah this week. When it does, rest assured that I will be right in the thick of things when it does. In the meantime, I will be back out in the village, chillin' Craiger in Mali style.

Conards in Bamako

So how exactly does one explain the most significant travel experience of one’s life?  I will tell you it is difficult, and I do not think that words can do it justice.  In the next series of posts, I will attempt to describe my family’s visit to Mali, which I will call the Conards in Mali 2006. . . . . .

It all started last July, right before I left for Mali.  A few days before I departed, my parents emphatically described that they would come visit me in Mali at some point during my stay here.  Initially I took that as a pipe dream, but encouraged them anyways. Over the ensuing months, their initial statement became more of a reality.  This time, they said that they would bring over my brother and sister as well.  The initial discussions included a grand African adventure, with a week in Mali, a week on safari in East Africa, and a week at the pyramids in Egypt.  Time and cooler heads prevailed, and the grand vacation was paried down to just Mali.  What happened during their visit would be up to me.  After a few months of stress, many phone calls, and many discussions with friends and travel agents alike, I came up with a pretty good itinerary.  Come the middle of December, the dates of the Family Conard visit to Mali were set (28 Jan – 9 Feb), as well as most of their itinerary.  It was then a matter of waiting until the big day they arrived.

The month of January went by a lot slower than I had imagined, partly for work reasons, and the rest for anticipation for my parents visit.  When the day finally arrived, I was beside myself.  I knew that they all would be exhausted from their roughly 30 hour journey, but nonetheless happy to be in Africa and with the Craiger.  They stepped out of the insanity that is the Bamako airport, haggard, but happy to be here.  I had arranged for a 4x4 from work to pick them up and to chauffer us around town for the next couple of days.  We went directly to my house, where thankfully there were enough beds for everyone.  After a celebratory glass of wine/beer, we toasted the upcoming 12 day journey and our family.  We then reviewed our itinerary again just to make sure everyone was on board with it.  The one idea that I tried to instill was that this was Africa, and that plans always change, and they seemed OK with the itinerary I had set up:

Conards in Mali 2006 Itinerary

28 Jan:     Arrive Bamako-Senou
     BMP villa
29 Jan:     Tour of Bamako
Museum
lunch at Maiga’s house
Gran Marche and Artisan’s Market
Dinner at Santoro
BMP villa
30 Jan: Visit to MRTC
Doneguebougou (lunch)
Visit to Mande Hotel Pool
Finalize travel plans
Dinner at Bla-bla, drinks with friends in Hippodrome
     BMP villa

31 Jan:     Fly to Timbuktu (CAM Air)
Tour of city
Colombe Hotel (223.292.14.35)
1 Feb:     Visit city
Camel tour of Timbuktu
     Possible visit to Taureg encampment
Colombe Hotel (223.292.14.35)
2 Feb:     Leave Timbuktu via 4x4, head to Mopti
     Hotel Kanaga (223.243.05.00)
3 Feb:     Explore Mopti
     Scott to Bamako via private hire 4x4
     Head to Sevare
     Mac’s Refuge (223.242.06.21)
4 Feb:     Explore Mopti/Sevare
     Possible Piroque ride
     Chill at Ambedjele
     (Scott pre-flight check in and to Airport)
     Hotel Ambedjele (223.242.08.37)
5 Feb:     Chill at Ambedjele
     Private hire 4x4 arrive from Bamako
     Drive Sevare to Djene
     Hotel Tapama (223.242.05.27)
6 Feb:     Market day in Djenne
     Explore Djenne-Debo
     Drive from Djenne to Sangha
     Gite de le Femme Dogon (223.244.20.13)
7 Feb:     Explore Sangha and Falaise
     Drive Sangha to Bandiagara
     Hotel Kambary (223.244.23.88)
8 Feb:     Explore Dogon Country near Bandiagara
     Drive Bandiagara to Segou
     Hotel Djoliba (223.232.15.72)
9 Feb:     Drive from Segou to Bamako
     Pre-flight Check in at Air France
     Last minute errands
     Dinner at Sahara
     Airport 9:00 pm

The next morning we dined on mangoes, croissants, Starbucks coffee from the states (talk about heaven!!) and Guava juice.  We then headed out to the main market here in Bamako for their first experience.  If there is one thing that quintessential Africa, it is her markets.  The sites, smells, and feel of the markets here are Africa, and most of the things I planned were around the market; Bamako, Timbuktu, Djenne, and Pays Dogon are all parts of Mali that have incredible markets.  Needless to say our first experience was unlike the others we had during our stay.  True to the Bamako market experience, we were harassed the second we arrived.  About 10 different men surrounded us, asking us what we wanted, and that they could guide us around.  Walking through the crowded cloth market (it was my idea that they could find cloth they liked to have made into shirts/pants by my friend who is a tailor), the Conard Caravan increased to roughly 15, if you included the Malians trying to make a buck or two.  In the process, we got the first of many propositions for my sister’s hand in marriage.  One Toureg man offered 30 camels for her!!  It was a tough sell, but I figured we could use the extra money and lighten our travel burden by one person.  After an hour and a half, I could tell that perhaps my desire to have my family experience the African market was too much, both for them and for me, the translator and bargainer.  Needless to say it was exhausting, and we left more or less happy for the experience.  

We then headed over to my friend Maiga’s house for lunch and a chance to experience life with a Malian family.  Granted, this was Maiga’s Uncle’s family, but one who he considers as close as his own parents.  I have described my experiences at Maiga’s before, and this is very similar to that.  Good food, good friends, and an incredible chance for my folks to recharge and get used to Africa.  My sister got one of her trip wishes (“to play with African children” as she called it) and I got a much needed nap.  My dad gave a geography lesson and my Mom played the role of Mom: playing, scolding, and laughing.  After lunch, we had the “barbeque,” aka dinner: bbq sheep, with salad and plantains.  My parents raved about it.  We left Maiga’s full and rested after a great day.  I was eager to get to our next destination, the first of many “Sunset beers” that I had planned.  The one spot I thought was perfect was closed, so we ended up going to one of the most expensive hotels in Bamako.  We somehow were able to get into the restaurant that looks over the river to open up early, and sit near the balcony, looking at the sunset over the Niger.  It was an expensive venture, but one that was necessary.  We went home that night and just chilled as a family, something I really missed in my many months away from there.  I showed them my pictures, we chatted about home and laughed.  It was truly a good night.  

The next day was the “work day,” meaning it was the day I was going to show them where I worked, meet some of the folks I work with, and then head out to Doneguebougou, my village home for the first 3 months I was here and my current home for my remaining 3 months here.  After a late start, classic Conard style, our driver arrived and we were off.  We drove by the market I by my vegetables and other foodstuffs at, and my parents almost had a heart attack.  I explained to them that I was alive thus far, so it must be good for me, no??

We arrived at Point G, the location of the National Hospital of Mali, the Medical school, and the Malaria Research and Training Center.  My friend Maiga met us there, and we took a quick tour of the facilities and the Guest House.  My parents were rather impressed by the facilities, and could not believe the flowers and tropical vegetation that was present.  I explained to them that everything there was planted by Dick Sakai, one of our administrators who hails from Hawai’i and who dabbles in horticulture.  After our tour, we headed out to Doneguebougou, my village.  Now, my parents lived in the wilds of Arkansas, New Mexico and Montana for about 10 years, so I figured they would be used to bad roads.  I think the suburban life they have lived over the past 25 years has made them soft.  Now, I will be the first to admit that the road from Kati to Doneguebougou is horrible.  You really can’t call it a road, more like a path that happens to be wide enough for a 4x4.  And to make matters worse, we had one of the more aggressive drivers with us, so the ride was even more bumpy and back wrenching.  They survived OK, I think.  The previous week I had arranged for the cook to make Tiga dega, a peanut sauce dish that is hands down the best Malian rice and sauce dish.  Well, for some reason, it tasted like shit.  Even I could not finish my whole plate.  Luckily, the freshly picked mangoes made up for it.  I then took them on a tour of the facilities here, including the vaccine clinic and the local clinic that we staff.  Needless to say, that my mom and sister, both nurses, and my dad, who helped build a clinic, were taken aback by the conditions here.  They were impressed by the vaccine clinic, but were rather surprised at the conditions of the local clinic building.  . . . .  

The best part happened next.  After our tour, Maiga had arranged for us to visit the village chief.  On our short walk to see the chief, we encountered practically every child in the village.  Needless to say that my Mom and sister were rather happy about this encounter, and passed out practically all of the bon-bons (candy) they had brought with them.  We finally reached the chiefs compound.  He was seated outside with 2 of the village elders, waiting for our arrival.  We sat down, exchanged greetings and names, and started our conversation.  In classic Malian fashion, the patriarch of the family does all of the talking.  So, my ever loquacious dad gladly was ready for the task.  He talked about his background, his desire to visit Africa (particularly Timbuktu) ever since he was a child, and his fascination with this village.  According to Bambara tradition, everything he said in English was translated in French by Maiga, who spoke to Cossa, the village guide who works at the village clinic.  Cossa then translated everything Maiga told him to Bambara to the head elder, and then the First Elder told the chief everything.  When the chief responded, the process reversed: Chief in Bambara to the First Elder, he in Bambara to Cossa, Cossa in French to Maiga, and Maiga in English to my father, and by proxy, to the rest of us.  I am sure that somethings were lost in translation along the way, much like the telephone game we play as children.  During this whole process, I could just imagine what the chief was told: My Dad would say: “You have a nice compound here,” to which the telephone-translation game might have yielded “Your wife looks like a cow.”  (I am just imagining that of course.)  The whole encounter was incredible, and one my parents later on that night said they would never forget.  One of the conversation pieces was about my parents desire to educate others back home about Africa, especially the African Americans they work with who have never had the opportunity to visit Africa, and thus my family’s desire to take pictures to show their colleagues what Africa is like.  The chief gave his permission to take as many pictures as possible.  And in true Conard style, we did.

The Family Conard left Doneguebougou satisfied with the visit.  It was easily one of the most non-touristy things they could have done.  And after a long drive back, my parents were ready for the sunset beer at the Hotel Mande, a “resort” on the Niger River.  Dinner that night was at a bar called Bla-Bla, the place with the best Grilled Capitaine (local freshwater fish) in Bamako.  Later that night, we went next door for a drink at one of my favorite bars.  The idea here was to give my folks an appreciation of the nightlife here in Bamako.  The thing that would have topped it off would have been a visit to one of the Malian night clubs, but we had an early and very important day the next day: our flight to Timbuktu, and the start of the rest of our voyage!!!. . . . .