History and Mission of AIDSfreeAFRICA - ACS Publications

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Chapter 4

History and Mission of AIDSfreeAFRICA

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Rolande Hodel* AIDSfreeAFRICA, 125 S. Highland Ave. #3-B1, Ossining, New York 10562, United States *E-mail: [email protected]. Phone: 914-923-2073.

AIDSfreeAFRICA is a non-profit organization that is committed to supporting the nation of Cameroon in its efforts to expand local pharmaceutical drug production, while also helping to solve other health-related problems. This book chapter will cover the history of AIDSfreeAFRICA, while including potential solutions for technical and logistical challenges to working in Cameroon. In an effort to increase access to basic drugs, AIDSfreeAFRICA has been providing consultation services and networking assistance to various pharmaceutical companies in Cameroon and has partnered with health centers throughout the country to ensure the availability of medications and vitamins. The organization recently launched a Malaria Free Zone project, which aims to prevent new malaria infections in Cameroon. AIDSfreeAFRICA is also in the process of setting up a quality control laboratory to ensure drug and water safety. Inspired by the success of similar projects in other countries, AIDSfreeAFRICA is committed to the vision of Cameroon producing enough pharmaceuticals to supply the needs of its population.

The Beginning of AIDSfreeAFRICA The inspiration for AIDSfreeAFRICA came to Dr. Rolande Hodel as she listened to the story of how the president of Brazil and local Brazilian pharmaceutical companies curtailed the HIV/AIDS pandemic in their country by producing vast amounts of HIV/AIDS drugs locally. At the time, Brazil had a fully established pharmaceutical industry; however, patents protected the few available HIV drugs. The leaders of Brazil argued that HIV/AIDS was © 2017 American Chemical Society Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

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an emergency that warranted the breaking of these patents and made the bold decision to begin producing antiretroviral drugs. As a result, Brazil, as of today, is the only developing country that beat destiny and successfully controlled the AIDS crisis. Currently, the prevalence of HIV/AIDS in Brazil’s adult population is approximately 0.6%, which is similar to the rate in the United States (1). By 2003, the year of hearing of Brazil’s victory over HIV/AIDS, Dr. Hodel set her sights on empowering African countries to meet their most critical health needs, including pharmaceutical drug production. Together, Dr. Hodel and Dr. Elliott Bay founded the non-profit organization they named AIDSfreeAFRICA. Further assistance came when chemists Bill Suits and Dr. Richard Goodman joined the board of directors, leading the efforts supported by countless volunteers and donors. A team of lawyers from Kramer Levin Naftalis & Frankel, LLP offered their pro bono service to help craft the legal papers and secured the IRS approval for AIDSfreeAFRICA to be recognized as a 501(c)3 non-profit organization registered in New York and a few years later also in Cameroon. Financial assistance came from friends and family as well as by grant-giving foundations, such as the Rinehart Foundation and the New Tudor Foundation. With all the necessary components in place, AIDSfreeAFRICA was ready to help to improve health by focusing on drug production and drug access. The remaining question was which country to choose. Networking efforts resulted in invitations to Kenya and Cameroon. While Kenya is an interesting country and Dr. Hodel enjoyed a very educational four weeks, it was Cameroon that offered her the collaboration she needed to get started. The organizational goal of AIDSfreeAFRICA was originally to support Cameroon in setting up factories for the production of antiretroviral drugs, scale up production of pharmaceuticals, and formulate and repackage drugs for distribution throughout the country. However, much of the underlying infrastructure needed for such an endeavor did not exist and had to be put in place first. In 2002, the Global Fund for HIV/AIDS, Malaria, and Tuberculosis (TB) had been founded with the goal of raising donor money that would pay for AIDS, Malaria and TB drugs (2). Since it is impossible to compete by producing a product that someone else offers for free, AIDSfreeAFRICA’s focus shifted from consulting on the production of HIV/AIDS drugs to the pharmaceutical production of generic drugs, which is what Cameroonians said they needed most. In the years to follow, AIDSfreeAFRICA provided consultation services for seven start-up companies working closely with teams of local people, sourcing equipment and offering know-how. Additionally, AIDSfreeAFRICA provided networking expertise by reaching out to organizations from all over the world to find solutions, materials, and equipment. Since then, the organization’s reach again widened to include drug access/import, prevention of malaria, as well as health & Science, Technology, Engineering, and Mathematics (STEM) education. Over the years, one thing never changed, and that is the location. AIDSfreeAFRICA has worked exclusively in Cameroon. As the health needs of the Cameroonian people change, the role of AIDSfreeAFRICA will continue to evolve. At the present time, AIDSfreeAFRICA is focused on building a laboratory that will offer reimbursable quality control services for pharmaceutical drugs and for water. 50 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

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AIDSfreeAFRICA: Organizational Structure and Funding Sources AIDSfreeAFRICA is a non-profit organization and is tax-exempt on the federal and state level. The organization is also recognized in Cameroon as a non-governmental organization, specifically on the level of an “association”. Non-profit organizations are governed according to federal and state laws. Thereby, the New York State Office of the Attorney General’s Charities Bureau requires that audited financials, including disclosure of salaries and contact information of major donors, are filed. The law specifies that an organization must have policies in place such as whistle-blower policy, conflict of interest documentation, document retention policy, volunteer waiver form, bylaws, and dissolution directives. AIDSfreeAFRICA’S organizational structure consists of five board members and an advisory board of four, which includes two former board members. During the 11 years of its existence board members and advisors to the board have joined and later retired or moved on. However, each board member or advisor has left his or her imprint on the organization. Co-founders Drs. Rolande Hodel and Elliot Bay serve as the chair and vice chair, respectively, of the board of directors. Dr. Hodel works closely with the Cameroonian people and government. Twice a year she visits Cameroon, sometimes accompanied by volunteers from the USA, to deal with the majority of hands-on tasks. Dr. Elliot Bay, who also serves as the treasurer of the organization, is spearheading the building of a new quality control laboratory in Cameroon, which will be discussed later in this chapter. Additionally, Dr. Bay procures the laboratory reagents and equipment needed for drug production in Cameroon and writes all standard operating procedures that dictate how each manufacturing or testing process should be performed. The addition of a medical doctor to the board of directors became necessary as the original focus of the organization grew from producing HIV/AIDS drugs to pharmaceutical drug production and medical support. Dr. Maimunat Ahmadu, a Nigerian native, provides medical advice on new medical campaigns and provides legal and cultural advice on how best to implement programs into Cameroon while at the same time respecting local customs and cultural sensibilities. Maurice Kenny and Sherri Hutchinson, chair the Governance & Nominating Committee and the Marketing and Communications Committee, respectively. Maurice has helped to establish the governance structure of the organization and ensures that all required documents, such as conflict of interest agreements, are up-to-date. Importantly, Maurice has also been instrumental in recruiting new board members and volunteers by setting up successful recruiting campaigns on LinkedIn and Volunteer Match. Sherri is in charge of all public relations and marketing tasks for the organization, including setting up donation drives and maintaining AIDSfreeAFRICA’s website. Also volunteering as a part of the marketing committee is Atsushi Toda, who uses Google AdWords to increase website traffic and donations. This can, in part, be accomplished thanks to a generous donation of $10,000 a month from Google for advertisements. Most recently, Mary Mase joined AIDSfreeAFRICA as secretary. Mary is now in charge of communicating with volunteers and responding to any inquiries about 51 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

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the organization. Additionally, Mary brings her expertise as a skilled grant writer to AIDSfreeAFRICA. A non-profit organization cannot exist without volunteers. AIDSfreeAFRICA’s mission speaks to people and has attracted a steady flow of volunteers in the USA as well as in Cameroon. Volunteers spread the word about the organization, bring donations, and help with the packing and shipping of donations to Cameroon. Each year, AIDSfreeAFRICA ships a 40-foot ocean container with two tons of donated medical, laboratory, office and household supplies. Additionally, AIDSfreeAFRICA volunteers assist with writing, design and maintain the organization’s web site, help to maintain social media accounts, design flyers, maintain a variety databases, and offer their opinion. The latter is very important. Each individual has a unique view of the world. These views are refreshing and contribute to the success of AIDSfreeAFRICA. It is an art to understand each volunteer’s strengths and weaknesses and to be able to tailor individual jobs to harness the gifts the volunteer brings and to keep him or her interested and satisfied. Financial donors are the foundation of AIDSfreeAFRICA, and funding comes from five sources: private donors, a federal employee donation program, grants and corporate donations, in-kind donations and lastly, program income. AIDSfreeARICA’S programs in Cameroon, such as the revolving drug funds, which will be discussed later in this chapter, are designed to generate enough income to cover the cost of running the program. Since the programs create value for the participants in Cameroon, it is natural to want to have a stake in the program. There has been a steady rise in program income, which makes a convincing argument that the programs AIDSfreeAFRICA offer are valued, appreciated and successful.

Solving the Technical and Logistical Challenges to Providing Humanitarian Aid to Cameroon Lack of Infrastructure Anyone who has traveled to a developing country can appreciate the impact that poor infrastructure, such as the lack of stable electricity, high-speed internet connection, roads, refrigeration, and water can have on everyday life. Any task at hand will become more cumbersome since before accomplishing the goal numerous other problems will arise and get in the way. As each new issue is solved, more problems become evident. In real life, it feels like going one step ahead and three steps back. A major project of AIDSfreeAFRICA in 2008 was to begin large-scale production of an analytical reagent used in HIV diagnosis. The project came together because of what Dr. Hodel observed when she had first arrived in Cameroon. Dr. Hodel attended medical meetings, hospital rounds in the AIDS wards and community AIDS meetings, and saw the poorly equipped rural clinics. She kept asking: “What do you have that works? What is it that is missing that if you had it would make a pivotal impact? What is it that could impede the solution or cause the project to fail? Where is the bottleneck?” Learning that the 52 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

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first line of treatment for HIV/AIDS was free to the patients, Dr. Hodel asked to see the pharmacy. To her amazement, the pharmacy was empty, except for a few blisters with Paracetamol (Tylenol) and a box of antibiotics. However, a sizable stock of AIDS drugs remained untouched. The explanation that followed had an epic impact in AIDSfreeAFRICA’s future work. The HIV/AIDS drugs were not being used because patients were too sick with other untreated illnesses to become a candidate for antiretroviral treatment. In 2005, the available AIDS drugs still had severe side effects, and a patient had to be in good health to tolerate the drugs. However, the doctors could not cure these other infections because they lacked even the most basic antibiotics, antifungals and IV fluids needed. The second discovery came when a medical doctor, pointing at the AIDS drugs, said, “free is not free”. He meant that the donors pay for the drugs and that at some point the donors may get tired of giving. Furthermore, the AIDS drugs being free did not eliminate the patient’s entire financial burden. From a patient perspective, there were consultation fees, the cost for laboratory diagnostics, the cost for other drugs, and the cost of transportation, which in a developing country is significant. While studying these fees and costs, Dr. Hodel learned that the most expensive medical service was a laboratory diagnostic test known as a CD4 count. The CD4 count, which is an indicator of how far HIV has progressed, is a must-have diagnostic for every new AIDS patient and must be repeated every three to six months. The CD4 test was expensive because the machine used to run the test requires a consumable solution, which at the time was still under patent protection. Additionally, the solution was shipped from a pharmaceutical company in the US and sold at prices that, although normal in the US, are not necessarily affordable for a developing country. Considering that this solution was comprised of 98% water, salts, buffer and an antimicrobial, it became obvious that this bottleneck could be eliminated and the prices could be brought down by local production. AIDSfreeAFRICA would produce the solution, perform quality assurance testing, and then sell it in Cameroon under the name of Diamond Pharmaceuticals. Diamond Pharmaceuticals was a startup company AIDSfreeAFRICA had been consulting with at that time for a three-year period. Successful reagent production would give the Cameroonians an unprecedented sense of pride in the independence that comes from being able to produce their own pharmaceuticals. Production of the analytical reagent required six chemicals, distilled water, a pH meter, and a few employees. The chemicals were procured from the US and Nigeria, and AIDSfreeAFRICA hired four Cameroonians with a background in chemistry. Securing distilled water proved to be the most significant problem. During the initial stages of production, Dr. Hodel realized that the only source of distilled water at the facility in Mutengene, a village in the South West Region of Cameroon, was down and awaiting repair. The burners of the distillation equipment had burned out, and although this is a routine breakdown and could be repaired locally, no one at the plant had taken action. It was clear to Dr. Hodel that the distiller would not be fixed in the limited time of her visit to Cameroon. Working in Cameroon one has to build connections and have backup plans for each task ahead – usually more than one backup plan. Dr. Hodel made a call and instructed a technician she knew at the government hospital in the town of 53 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

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Bamenda to secure fifty liters of distilled water from the hospital’s distillery. However, that left Dr. Hodel with one small problem: this hospital was an eight-hour bus ride from the site of production. The infrastructure shortcomings were eventually overcome, but the reagent production ultimately failed because of a lack of collaborative efforts. Successful execution of a project such as this would require a team of individuals with expertise in production, quality control, and sales to come together. Dr. Hodel learned that collaborations are not welcome and that Cameroon professionals eye each other with suspicion. The above-mentioned story is a prime example of what one hoping to establish a humanitarian organization in Cameroon may face. One should keep in mind that commonplace resources may not be readily available in Cameroon, and one has to do one’s best to plan and source these items ahead of time. However, advanced planning will not always ensure smooth operation. Fast thinking and detailed knowledge of local circumstances and habits are crucial. Planning the details of a project while sitting in an office in the United States will necessarily prove unrealistic. Who in the US would imagine that the public transport system in Cameroon does not run following a timetable? How then, does it work, one may ask. To travel, people go to certain places called “bus parks”. Certain parks may offer busses going to certain destinations. Since there is no set schedule it is best to ask the locals who know because of experience. If a bus is available, which is not always the case, one can buy a ticket. However, the bus will depart only once the last seat in the bus has been filled, and this can take hours. Often circumstances arise, i.e. the bus never arrives since it broke down on the way to the car park, or heavy rain causes people to abandon their travel plans which mean the bus never fills up and thus will not leave the park. One solution is to plan travel with plenty of time. However, that also means once you arrive at your location none of the people you expect to meet are there because they want to make sure you arrived before they bother to show up. Thus, you wait another couple of hours until everyone will have been summoned to appear at the meeting. In Cameroon patience is gold. Governmental/Bureaucratic Barriers to Implementing Changes and Opening New Facilities The World Bank’s list of Ease of Doing Business lists Cameroon as 166 out of 190, just ahead and thus slightly better than Sudan (168) and Nigeria (169) (3). However, AIDSfreeAFRICA has been fortunate to enjoy a preferred status, although this status was not communicated at first. Overall AIDSfreeAFRICA has found the Cameroon government, the U.S. Embassy in Cameroon, and the Cameroon Embassy in the U.S. are all very helpful, welcoming and relatively easy to work with. The business development department of the U.S. Embassy in Yaoundé, Cameroon’s capital, introduced Dr. Hodel to the Ministry of Public Health during a meeting with all 13 heads of departments from the Ministry of Public Health. This meeting was followed by the signing of a collaboration agreement written by the technical advisor of the Department for International Collaborations of the Ministry of Public Health. This document laid down what AIDSfreeAFRICA 54 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

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would be working on and also specified what the organization is not allowed to do. For the eleven years of its existence, this document has guided all of AIDSfreeAFRICA projects. Cameroon’s Prime Minister, H.E. Philemon Yang has personally taken great interest in AIDSfreeAFRICA and ordered the organization to be classified as top priority. He makes time and arranges for opportunities to meet AIDSfreeAFRICA’S collaborators and has offered protection in the case of emergency. Interestingly, it came to light that this preferred status has its origin in the way AIDSfreeAFRICA conducts business in Cameroon. Unlike most non-profit organizations AIDSfreeAFRICA has not built its own headquarters and has not attempted to build its own factory, school or hospital. Instead, the organization’s mantra is to “support local people to succeed with their projects,” with the only limitation being that it fits AIDSfreeAFRICA’s mission and vision. As was pointed out to Dr. Hodel, most foreign foundations operating in Cameroon pull money (program income) out of the country to pay for the high salaries of staff working in their home country, such as the US. As a case in point, when Dr. Hodel mentioned to the prime minister that Cameroon has millions of dollars left untouched in approved project funding Prime Minister Yang moved mountains to enable Dr. Hodel to help. AIDSfreeAFRICA had written a proposal to help reprogram Global Fund money to get authorization for unused funds to be utilized for the purchase of HIV drugs. Prime Minister Yang ordered the reluctant Minister of Public Health to schedule a meeting on the issue. For the next two years, Dr. Hodel frequently encountered suspicions about her motives. The breakthrough came with a letter from the prime minister directing everyone to come on board and the Minister of Public Health overcoming his distrust. It took two years of persistence and hard work of cajoling everyone into working together. Success came when the Global Fund approved funding specifically to buy HIV drugs valued at 2 million dollars. Before this funding was awarded, HIV drugs had been intermittently unavailable. For years, approximately 79,000 people taking antiretroviral drugs had their treatment interrupted since Global Fund money always fell short of paying for everyone for the entire period of the grant, which is twelve months. Treatment interruptions can give rise to resistant HIV strains that are the cause of premature death and need to be avoided at all costs. The two million dollars worth of HIV drugs will go a long way to fill the gaps. AIDSfreeAFRICA has offered to help the Cameroonian government again when the reserves run low. In addition to working with the various ministries and government offices in Yaoundé, AIDSfreeAFRICA also works with local government offices, such as the various delegations for health, health district officers, directors of hospitals, government and private universities, pharmacies, and government-run drug distribution agencies called Special Drug Funds. A project that required the collaboration of local government offices, hospitals and doctor offices, to name a few, came together when the Belgian-based pharmaceutical company called Tibotec contacted AIDSfreeAFRICA for its expertise. Tibotec, a subsidiary of the US-based Johnson & Johnson, asked AIDSfreeAFRICA to register and market their antifungal drug indicated for treating oral thrush, a fungal infection of the mouth and esophagus, commonly 55 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

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found in patients with HIV/AIDS. It took Tibotec a staggering five years to register the drug in neighboring Nigeria, but it took AIDSfreeAFRICA “only” eighteen months to register the drug in Cameroon. However, it took another six months for the responsible office to print the license for import and sales to AIDSfreeAFRICA. It can be assumed that the office printer was out of ink and ordering and receiving a new cartridge may very well take six months. To accomplish the registration, Dr. Hodel reached out for support to everyone from Prime Minister Philemon Yang down to the local pharmacist. Now Miconazole is distributed through Laborex, a large well-organized for-profit drug distribution company in Cameroon. One significant challenge of working with the government is that people holding key government positions are transferred frequently, and guidelines are just as transient. Additionally, new orders and regulations can be imposed at any time and without notice. Therefore, to successfully operate an organization in Cameroon, it is necessary to stay flexible, up to date and expect changes. Need for Individuals with Specialized Laboratory/Educational Training Attempts by Cameroonians to start drug production are happening with mixed success. Of the seven startup companies AIDSfreeAFRICA had the privilege to consult with and support, the majority did not succeed and the few still trying are doing so with great difficulty. It is AIDSfreeAFRICA’s board of directors’ opinion that to establish lasting successful pharmaceutical drug production, the underlying infrastructure that is being taken for granted by their pharmaceutical companies in industrialized countries also has to be implemented. One such support that a successful pharmaceutical industry relies on is the adequate supply of skilled workers that specialize in and are experienced in the chemistry laboratory setting. The foremost complaint from people attempting to start production is the need for senior managers familiar with pharmaceutical production, supply chain management, import and quality control. These senior managers must also have experience in managing large departments. As a member of the American Chemical Society and Chemists Without Borders, Dr. Hodel constantly lobbies the industry to contribute generously to AIDSfreeAFRICA’s efforts. This has resulted in the visit of a representative from Hoffmann-La Roche to Cameroon to discuss the possibility of a technology transfer for the production of an AIDS drug. Unfortunately, the company had too many prerequisites and was not able to meet the people on their level and to bring them up from where they were to where Hoffmann-La Roche needed them to be. This is a very important issue in international collaborations, which results in many good projects never making it past the intention. We do not expect a baby to start walking before it goes through a period of crawling. Any industrialization in a developing country will have to go through all the stages of development in order to succeed. Patience is the golden key. AIDSfreeAFRICA has leveraged its own expectations and is helping out where possible. AIDSfreeAFRICA started a successful campaign to distribute donated copies of the Merck Index, which is an encyclopedia of chemicals, drugs and biological molecules, to universities and individuals in Cameroon engaged in 56 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

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drug production. This effort later mushroomed into AIDSfreeAFRICA sending forty-foot ocean containers filled with laboratory and hospital equipment and supplies to various individuals and institutions in Cameroon. Additionally, Dr. Hodel routinely discusses with university professors the availability of reagents and supplies and the items most needed to foster scientific teaching and collaboration in Cameroon. AIDSfreeAFRICA was awarded a donation of a professor’s entire scientific library, which, once it arrived in Cameroon, caused the available shelf space to overflow. The recipient, the University of Bamenda in Bambili in the North West Region of Cameroon, obliged by happily creating more shelf space. Generous donations of chemistry laboratory glassware is being given by schools such as Westchester Community College, City University of New York, Queens College, and St. John’s University and are also being made by high school and university teaching laboratories. A non-profit organization in New Jersey, USA called “S2S” which stands for “Students to Science” donated their excess laboratory equipment, which once packed for shipping, filled five large crates and was estimated to be valued at a quarter of a million dollars. One of the companies in Cameroon that was producing drugs at the time had asked for a High Pressure Liquid Chromatography machine to help with the bottlenecks in quality control, which slowed down the distribution of the produced drugs to the public. With the donation from “S2S” AIDSfreeAFRICA delivered not one, but four of these instruments plus spare parts. The company gladly paid for the transport costs. Additionally, AIDSfreeAFRICA volunteers and board members provide hands-on instructions or standard operating procedures on chemistry techniques whenever new reagent production begins or new testing procedures are introduced.

How AIDSfreeAFRICA Operates in Cameroon AIDSfreeAFRICA and Drug Funds The only government agency that procures essential drugs and exclusively all AIDS drugs in Cameroon is called Centrale Nationale d’Approvisionnement en Médicaments Essentiels (CENAME), which translates to English as National Center for the Supply of Essential Medicines. Subunits of CENAME, designated special funds, are named according to their location. For example, two such special funds are the North West Special Fund or the South West Special Fund. CENAME distributes a limited selection of approved essential drugs, which it subsidizes. Recipients of these drugs are government health facilities, church mission hospitals, approved HIV/AIDS treatment centers and university clinics that purchase these drugs via tender. This model of making drugs available only to certain types of health care providers’ forces private hospitals to buy drugs from the private market. Purchasing drugs from the private market is much more expensive, and small clinics do not have the capital to stock the variety of drugs needed on a daily basis. To avoid financial loss, a pharmacist will keep the stock of drugs low to avoid having to discard any expired products. To lower the cost, drugs are bought on the black market, which flourishes in Cameroon. Black markets are also frequented 57 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

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by individuals who self-prescribe and self-medicate. The black market seller who has no formal education or license to dispense these prescription drugs often advises the customer on what to take and how to dose the medicine. Drugs are relatively cheap in Cameroon; however, paying for the doctor and diagnosis is expensive and thus drives the black market. Privately run village health facilities and their personnel face additional obstacles, such as paying the high cost of transportation to and from the black market, if they are lucky enough to find transport. The revolving drug fund is AIDSfreeAFRICA’s response to this lack of access to drugs. A revolving drug fund works like this: AIDSfreeAFRICA donors give the initial amount of money needed that enables AIDSfreeAFRICA to buy a substantial amount of medicine, supplies, laboratory reagents and diagnostic tests. The acquired items are then given to a small rural clinic that has so far operated with few drugs and often no doctor. The clinic is then able to treat patients who pay for the service and treatment, and every week small amounts of money are deposited in a bank account controlled by AIDSfreeAFRICA. When the money in the bank reaches an agreed-upon level, AIDSfreeAFRICA takes the money and buys more drugs and supplies. The fund generates more money than what is required to keep the fund liquid. Thus, salaries can be paid more reliably, small improvements can be undertaken, and most importantly the patients come to a clinic where health providers can do more than just talk to them. AIDSfreeAFRICA’s first established revolving drug fund with the Cameroonian Christian Welfare Clinic in Limbe has shown remarkable success. The fund was established with the help of Alfred and Carole Schwedtner, members of US Servas International, an international peace organization in which Dr. Hodel has been an active member since 1989. Prior to the establishment of the revolving drug fund, the clinic saw very few patients. However, with the establishment of the fund, the number of patients has increased tenfold and the drug supply was utilized and paid for by the patients. In August 2010, a group of Cameroonians living in Maryland, USA came together to hear a proposal from AIDSfreeAFRICA to get involved in fundraising to establish additional revolving drug funds. The group agreed to focus on Mbengwi and Nkwen first. These two villages are still close to the large city of Bamenda, but in the future the group will venture further into the remote villages that are in desperate need of accessing medicine. Tibotec, the Belgium based pharmaceutical company mentioned earlier in this chapter, generously made the antifungal drug, Miconazole or MicMat, available. AIDSfreeAFRICA registered it at the Ministry of Public Health. MicMat, which is used to treat oral thrush, a painful condition affecting 25% of AIDS patients every year, was made available using a revolving drug fund. With the help of a generous grant from Tibotec, Dr. Hodel established a non-profit program selling the antifungal drug at cost. To accomplish this, AIDSfreeAFRICA hired four Cameroonians for the various aspects of the project. The employees included a sales manager, a medical delegate, a secretary, and a pharmacist who would conduct feasibility studies. The jobs were neither full time nor permanent, but they were an excellent opportunity for Cameroonians who had educated themselves, and would otherwise have to leave the country for employment. To 58 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

date, Miconazole is distributed through Laborex, a large well-organized privately owned drug distribution company in Cameroon. AIDSfreeAFRICA and Drug Production

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Diamond Pharmaceuticals AIDSfreeAFRICA’s primary mission is to support people in Cameroon to increase their pharmaceutical production capability. The first pharmaceutical start-up supported by AIDSfreeAFRICA was Diamond Pharmaceuticals. Construction of the building, which houses Diamond Pharmaceuticals, was funded by a grant by The New Tudor Foundation. In November 2005, AIDSfreeAFRICA met the investors of Diamond Pharmaceuticals and agreed to consult the group in how to succeed running pharmaceutical production of generic medicines. Since then, AIDSfreeAFRICA has been giving support in the form of expertise, technology and micro loans. However, drug production at Diamond Pharmaceuticals is currently on hold. Once they begin production AIDSfreeAFRICA will continue to offer logistical and financial assistance.

Genemark Pharmaceutical Productions In 2008, AIDSfreeAFRICA partnered with Genemark Pharmaceuticals, which is owned by Dr. Gisel Etame. Genemark, located in Douala, Cameroon’s industrial capital, has been producing malaria, cough and pain medication in the form of syrups. In 2010, Genemark added vitamins to their list of produced pharmaceuticals and began the process of producing oral tablets for malaria and to consult with the company on oral drug tablet production. The production of solid oral tablets was a big step for Cameroon; however, a pharmaceutical industry needs more than one player to become reality. Genemark’s biggest challenge is to produce drugs while adhering to international current Good Manufacturing Practices (cGMP) standards. Implementing these standards retroactively is not an easy feat. Since the factory is running full capacity and has more product orders than it can produce, the owner is left with little incentive to divert time and money to implement cGMP. At this time it is obvious that nothing short of the government inspectors instituting regulatory rules and controls will force the issue. AIDSfreeAFRICA is offering support but can only do so when invited to act.

SIPP and Cameroon Baptist Convention The production of intravenous (IV) fluids has been taking place for years in Yaoundé and Mutengene, located in the Central Region and South West Region of Cameroon, respectively. One company, SIPP, has been supplementing the government’s tender of imported IV fluids with up to 10% of the market share. They made it known that they would love to expand production but cannot due 59 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

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to the lack of capital. AIDSfreeAFRICA had considered collaborating with SIPP to produce urgently needed diagnostic reagents. Cinpharm, however, purchased SIPP before any such project materialized. Over the years, AIDSfreeAFRICA has formed an intense collaboration with the Cameroon Baptist Convention (CBC), a producer of sterile IV fluids, eye drops and ointments for internal use. More recently, they have also added drinking water/bottling capabilities to their core function. Thanks in part to Hoffmann-La Roche Technology Transfer Initiative specialist Luc Schnitzler’s visit, the main players in Cameroon’s pharmaceutical production came together. AIDSfreeAFRICA’s project to produce diagnostic reagents started at the Cameroon Baptist Convention (CBC) facility in Mutengene. Over the years the moderator of the CBC (the highest manager) and the two pharmacists stayed involved in most of AIDSfreeAFRICA’s projects concerning drug production. When the organization expanded to include drug access, the CBC was included in consultations on what drug to import and which diagnostic was useful. The CBC was the main recipient of MicMat. The CBC was also the first and only place that agreed to hold a meeting inviting all Cameroonian people involved in drug production. The CBC was the first to evaluate a dipstick test for meningitis, which does not require a spinal tap and delivers highly accurate results in mere minutes as compared to the conventional test, which requires the culturing of spinal fluid and delivering results after days. By the time the results are available by the older method it may be too late to save the patient from grave harm and maybe death.

Cinpharm Cinpharm is a high-tech production facility owned and operated by Cameroonians that began drug production in 2011. The CEO, Mr. Celestin Tawamba, is generally known as the pasta king for his success producing pasta in Cameroon and exporting pasta throughout central Africa. When the factory runs well, Cinpharm produces antibiotics, antifungals, painkillers, IV fluids and other essential drugs, including IV fluids with high capacity output. Cinpharm partnered with AIDSfreeAFRICA in hopes of securing equipment, reliable cost efficient sources for raw materials and support with maintenance and troubleshooting. AIDSfreeAFRICA has also done its best to support Cinpharm’s efforts with cGMP training and by attracting professionals from the pharmaceutical industry to volunteer their time and expertise in Cameroon. During the early phases of production, Cinpharm hired and trained people to run the complex production: the equipment, water purification, clean air, intake, storage, warehouse, quality control and quality assurance labs, and so forth. AIDSfreeAFRICA was also instrumental in securing donations of analytical equipment and delivering it to Cinpharm. In exchange, Cinpharm donates their drugs to AIDSfreeAFRICA to support its revolving drug funds. A medical clinic in the rural village called Esu was the main beneficiary of Cinpharm drugs. Cinpharm is a miniature version of India’s drug giant Cipla. Designed without the particulars of Cameroon in mind, the company was doomed to fail. The cash flow was steeply negative. Cinpharm had been built on the outskirts 60 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

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of Douala, the largest city in Cameroon. Douala is also a fast growing city and within a short time Cinpharm found itself in the midst of a lively neighborhood with markets and a large school around the corner. Cinpharm was crammed in, and besides lacking space, it also lacked access to clean water and voltage stabilized electricity. Cameroon, with its mountains and waterfalls, has plenty of hydro electricity, which it exports. However, for local consumption, electricity is expensive and its availability unpredictable. As mentioned before, skilled labor was a problem and so was the lack of mechanics and technicians who could troubleshoot and repair the unique equipment needed for pharmaceutical production. Repairs were especially problematic because the company proudly featured equipment never seen before in Cameroon. Challenges with supply chain management, difficulties in the Cameroon port with bringing goods into the country in a timely fashion and some external political/historical events, which caused the German Development Agency to delay payment of six million euro, brought Cinpharm to a grinding halt only 30 months after production had started. AIDSfreeAFRICA wrote a white paper on the situation of drug production and tried to convince Bill Gates to donate 10 million US dollars to buy the company and to run it as a vocational training center. Gates response was, “we have a training center in Ghana. We do not need another one.” The training center in Ghana is not near to Cameroon. Its activities are also limited to training regulatory issues and detecting counterfeit drugs, both topics of interest to US Pharmaceutical companies. At the time of the writing of this book, a Tunisian company bought Cinpharm and restarted production. We keep our fingers crossed for long-term and successful drug production.

AIDSfreeAFRICA’s Partnership with Health Centers In 2011, Mr. Polycarp Nji, in conjunction with AIDSfreeAFRICA, opened the Faith Health Center in his home village of Esu. AIDSfreeAFRICA has supported this project by working with the Cameroon government/Minister of Public Health and local health district officers to register the center. Additionally, AIDSfreeAFRICA has provided generic drugs and medical supplies to the Faith Health Center. More importantly, AIDSfreeAFRICA has helped by recruiting medical experts from other countries and by seeking the involvement of other international organizations. Locally, AIDSfreeAFRICA has supported the employment of nurses trained in one of many excellent schools training nurses. These schools are well known in the US. Visit the wards of any US hospital and you will find a nurse from Cameroon. Starting in June 2015, AIDSfreeAFRICA launched a new relationship with the Sirita Health Center in Ndop. Through a lucrative collaboration with Vitamin Angels, AIDSfreeAFRICA was able to donate essential vitamins to children aged 1 to 5 and lactating women in Ndop. In Ndop, Dr. Hodel also educates the local residents regarding malaria, HIV/AIDS, and other health-related topics. In addition, AIDSfreeAFRICA volunteers have, in the past, assisted the clinic with accounting and management duties to ensure that the clinic’s operations ran smoothly and effectively. 61 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

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Current and Future Projects of AIDSfreeAFRICA Cameroon had been a German colony until the end of the First World War in 1919. It was then taken over by the English and later France. Today Cameroon prides itself as being the only other French/English bilingual country besides Canada. With a landmass just a little more than the size of California and a rapidly growing population of 22 million, Cameroon has been peaceful and was never involved in a civil war. Although called the Democratic Republic of Cameroon, the dictator Paul Biya, who is only the second president since Cameroon obtained independence in 1960, rules the country. Biya is holding onto power, changes the constitution at will and to his advantage and has suppressed the opposition party, which only once rose up in 1992 but was brutally squelched. The opposition leader persuaded the population that peace is better than war, but the English-speaking minority has been suffering ever since. Civil unrest started in November of 2016 and has so far forced AIDSfreeAFRICA to relocate its headquarters from Bamenda to Buea. Since the town of Buea is also in the English speaking part of the country, AIDSfreeAFRICA is currently establishing an office in the French speaking capital Yaoundé. The office happens to be a stone’s throw away from the US Embassy – a place whose importance Dr. Hodel understood only after she experienced criminal activities and threats against her life. The US Embassy’s mission is to protect their citizens abroad – and they did. The opportunity to relocate to Buea was made possible by a chance meeting with Dr. Nde Peter Fon, a Cameroonian surgeon who owns the Solidarity Health Foundation and Solidarity Health Clinic. The doctor offered AIDSfreeAFRICA space in the new wing of the hospital he was in the process of constructing. What makes this doctor so special? He does not worry about money. He does not ask for money. He knows it will come. His hospital is also the first of its kind where women do not die in childbirth. In Cameroon it is taken as a given that some maternal death is inevitable — not, however, in Dr. Nde’s clinic. He fights for each life, and if that means performing seven hours of surgery to stop the bleeding, he does it. “No maternal death in 2016” he proudly announced. However, sometimes a baby dies in the process. Dr. Nde cares deeply. He makes sure he is available in an emergency, and so is his wife, who runs the pharmacy and is in charge of international volunteers, interns and students. Malaria Free Zone Project in Littoral, Cameroon In 2015, the World Health Organization reported 1.1 million confirmed cases and 5.3 million estimated cases of malaria in Cameroon (4). In late 2015, AIDSFreeAFRICA along with the help of the Cameroonian people launched its Malaria Free Zone (MFZ) project in the Littoral region in the western portion of the country. The goal of this ongoing project is to provide Cameroonians with the tools and knowledge needed to slow or eliminate the spread of malaria in their communities. To this end, flyers were created explaining how malaria is transmitted, how to prevent the spread, and what individuals should do if they suspect they have contracted the disease. 62 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

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The Cameroonian government has distributed new bed nets donated by the Global Fund, so previously used bed nets should now be more readily available. To create a mosquito free environment used bed nets are being permanently affixed to window frames. The netted window screenings in residential settings eliminate the need for individual bed nets, while screenings of business establishments would prevent patient, caregivers, patrons, and workers from contracting malaria while working or conducting business. In November 2015, AIDSFreeAFRICA implemented a mosquito-free environment at the Family Health Care center in Kompina, Littoral, Cameroon. In the months prior to the implementation of the Malaria Free Zone Project, the health center saw 30-60 new cases of malaria each month. Currently, data from the six months that followed the MFZ are too little to allow reasonable conclusions. Although the overall numbers of infections dropped, it could have been caused by seasonal changes. Cameroon has two major seasons, the dry season and the rainy season. Rain brings additional standing water, which is needed for the mosquito to breed and the larvae to hatch. Not all mosquitoes bite, nor do they all carry the malaria parasite. The male, noisy mosquitoes do not spread malaria. It is the female mosquito that bites humans to suck up a little blood, which is used to feed the offspring. The ensuing civil unrest has forced the MFZ program to be relocated. The project is starting anew in the rural villages close to the capital Yaoundé in the Central Region of Cameroon. Ensuring Drug Safety in Cameroon: Paper Analytical Device and Quality Control Laboratory Low-quality medications in the developing world are a major public health problem. The high cost of post-market testing and the lack of a global system for identifying substandard or fake pharmaceuticals both contribute to the above-mentioned problem. AIDSfreeAFRICA is currently spearheading two independent projects with a common goal of ensuring drug safety in Cameroon. In the long-term, data compiled from these projects should allow organizations to create a map of where standard or sub-standard drugs are commonly found. Knowing these statistics, once enough data have been collected, AIDSfreeAFRICA or other organizations can look into finding a solution to fix the problem spots. The pharmaceutical industry is paying much attention to counterfeit drugs. Non-profit organizations also focusing on detecting counterfeit drugs are likely to get attention and support.

Paper Analytical Device AIDSfreeAFRICA is currently working with Dr. Marya Lieberman from the University of Notre Dame, Indiana in collaboration with Chemists Without Borders to implement the paper analytical device (PAD) project in Cameroon. As a part of the PAD project, AIDSFfreeAFRICA will recruit faculty at colleges and universities in the US to perform analysis of pharmaceutical samples from Cameroon as a part of the university’s analytical chemistry courses. The 63 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

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pharmaceutical/drug samples are given to AIDSfreeAFRICA by hospitals or the Cameroonian government. For instance, the Ministry of Public Health may provide drug samples in cases where the identity or quality of the drug is in question. In the US, the recruited faculty members would give hands-on training to teachers and students at colleges and universities on how to perform drug testing, and each university or college would decide on the best method to use depending on equipment availability. The universities or colleges would be responsible for purchasing disposable reagents, such as solvents, standards, and columns. Ideally, the testing of the pharmaceuticals would easily fit into three or less experiments in an undergraduate instrumental analysis course. Each testing site would receive enough samples for each student (or student team) and analytical standards to use for calibration. As a part of the class, the students would be trained to prepare the samples, carry out the necessary replicates, controls, and calibration checks, and to calculate their results correctly. The data would be prepared into final reports suitable for forwarding to medical regulatory authorities, and the reports from each testing site would be compiled for a complete view of how common fake or substandard pharmaceuticals are in a given area. To ensure that the test results would be useful, each lab would have to validate its analysis procedure using blind samples. Student analyses would have to meet high quality control/quality assurance standards, and samples of drugs that fail analysis would be re-analyzed in an independent laboratory. Support and mentoring by industrial analytical chemists would be valuable to many faculty members at small colleges who need help repairing instrumentation or optimizing the HPLC methods. Any samples deemed substandard would be re-analyzed by Professor Lieberman’s research group to confirm the student work, and reports would be filed with the appropriate medical regulatory authorities. The goal of AIDSfreeAFRICA is to start the PAD project on a relatively small scale, with approximately 10 faculty members over a two-year time period. This trial period will allow adjustments to be made to the logistics, analytical and quality assurance standard operating procedures and for modes of communication and feedback to be worked out. Once the program has been established in the US, the next step will be to implement the same in Cameroon, thus building capacity where it is needed.

Quality Control Laboratory Cameroonians have recently approached Dr. Hodel, to assist in analyzing pharmaceutical drugs for their potency, composition, and possible contaminants. Due to the lack of proper supply chain management, the “health” of a drug cannot be guaranteed. In addition, infrequent rumors of “faked drugs” entering the supply chain scare the population. Cameroon has to become self sufficient in analyzing drugs, and building a good quality control laboratory is paramount. Most recently, AIDSfreeAFRICA has worked out an agreement with the University in Bamenda to establish a laboratory capable of conducting analysis of drugs as well as water samples at the university. The quality control 64 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 2 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

laboratory is being designed and setup by Dr. Elliot Bay. AIDSfreeAFRICA is currently working to procure used analytical equipment for this laboratory. The organization, working alongside Chemists Without Borders, is also seeking to partner with universities and colleges in the US to acquire sample drugs for content analysis.

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Great Things Can Be Accomplished in Cameroon Despite the technical and logistical challenges that go along with establishing and running an organization in Cameroon, there have been great local successes. One example of this is the work of Blaz Esomba. In 2010, Christopher Ekom, from the business development office of the U.S. Embassy in Yaoundé, introduced Dr. Hodel to Blaz Essomba. At the time, Blaz was concerned about drug access, and Christopher knew AIDSfreeAFRICA was working on just that. Blaz had big plans and had turned them into reality by building a large two-story hospital, in Yaoundé that is named if after his wife, Maria Nissim. Maria, who is a nurse by training, manages the facility. Once open, the Maria Rosa Nissim Foundation Hospital had a dozen staff and housed patients recovering from a variety of surgeries, such as C-sections and tumor removal. The opening and success of this hospital shows that where there is will there is a way, and a poor country, such as Cameroon, can have a state-of-the-art hospital with modern equipment and capacity to do surgery and save pregnant women and their babies. With the help of AIDSfreeAFRICA, Cameroon will in the near future produce enough pharmaceuticals to supply the needs of its population.

References 1. 2. 3. 4.

Global Health Observatory Data Repository. http://apps.who.int/gho/data/ view.main.22500?lang=en (accessed May 30, 2017). Global Fund Overview. http://theglobalfund.org/en/overview// (accessed February 9, 2017). Doing Business Measuring Business Regulations. http://www.doingbusiness.org/rankings. (accessed March 2, 2017). http://www.who.int/malaria/publications/country-profiles/ profile_cmr_en.pdf?ua=1 (accessed December 19, 2016).

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