Eng.fiu.edu

"The Problem with Hoodia"
“Hello, I'm Roger. So, what takes you to Africa? Work or pleasure?” Angela Bingham turned to her seatmate and tried to muster a genuine smile. Although she was proud of her work, Angela thought it odd that a stranger would try to start a conversation by asking such a personal question. Nevertheless, she was stuck sitting next to this man for the remainder of the 11-hour flight to Cape Town, so she decided to open up and try to be friendly. A little small talk might even make the time pass more quickly. “I'm Angela," she replied, shaking Roger's hand. "I'm going to Africa for work. My company, Pharmedics, is involved in pharmaceutical drug development. The medicines we work on are used to treat asthma, Parkinson’s disease, Alzheimer’s disease, AIDS…you name it." "Sounds interesting. So, are you going to Africa to find a cure for a disease?" Roger asked. "Well, sort of.my latest project involves an extract from a plant called Hoodia gordonii. It grows in the wild all over southern Africa and has been used by the San, or the Bushmen of the Kalahari, for thousands of years. The San are the first human inhabitants of Africa. They take Hoodia to diminish hunger and thirst on long hunting and gathering expeditions and during times of drought. Hoodia's extract, called P57, may turn out to be an anti-obesity wonder drug.” “That sounds like very good work. Obesity is a terrible health problem, an epidemic, especially in the States. Are you a scientist?” “No, I’m a manager. Actually, Pharmedics is a virtual company—there are very few of us who are employed directly by the company itself. I work with outsourced field researchers, clinicians, and lab scientists all over the world. It's a British company, but I'm based in New York. I develop a communications strategy between the stakeholders and I coordinate feasibility studies for research and production. Pharmedics only works on initial isolation of extracts, though. We leave the actual drug development and commercialization up to the big boys." “The ‘big boys’?” “Yeah, Pfizer, Unilever—big multinational pharmaceutical firms. They’ve got the money and the power to create the drugs and push them through the American Food and Drug Administration and such. But tell me, what do you do, um.I can’t believe I forgot your name already…” Angela’s seatmate smiled graciously. “Roger. Don’t worry about it—I’m an artist, a sculptor. I’m bringing a commissioned work to Cape Town to be placed in front of the headquarters of a shipbuilding company. I work with metal. The pieces of the sculpture are all down in the baggage compartment. I’m going to South Africa to put them together.” “Well, well,” beamed Angela, “that’s basically what I’m going to Cape Town to do. I’m no artist, though. I'm supposed to figure out how a whole bunch of puzzle pieces fit together, even though I have no idea what the end product is supposed to look like.” Temporarily saved by the impending arrival of the dinner cart from having to explain further, Angela leaned back in her seat and decided to close her eyes for a moment. She recalled the conversation she’d had the previous week with her company’s president, David Campbell, when she was initially dispatched on this mission. “Angela, I want you to know that you’ve done incredible work coordinating the clinical trials of P57. It has enormous commercial potential for the development of weight loss drugs and Pfizer is very interested in taking it to the next level. But Angela, we've hit a major roadblock. We can't sell P57 to Pfizer until we work things out with the San. They are claiming that they have rights to the extract because they originally discovered its medicinal qualities. I’ve got their lawyer, reporters from the International Herald Tribune, a bunch of human rights organizations, and the governments of Namibia, Botswana, and South Africa breathing down my neck…it’s an unbelievable mess. I didn’t even know that Bushmen existed anymore. I need you to go over to South Africa, meet with the different groups, and make everybody happy.” Angela’s heart pounded. She was used to bringing diverse people together from multiple countries to work as a drug development team, but this sounded much more complicated than what she usually did. “David, I’m not sure I understand what you want me to do. Why do we have a problem with the San? They don’t have a license to P57, we do.” Taking off his glasses, David Campbell stood and began pacing the room. “We purchased the license to develop an extract from the initial patent holder for Hoodia gordonii plant, the Council for Scientific and Industrial Research (CSIR). Although it is a government institution sponsored by Namibia, Botswana, and South Africa, the CSIR did not consult with the San, who live in those countries, before applying for the patent. Even if they had approached the San, they may not have cooperated because they don't trust the government. The San’s nomadic way of life has been seriously endangered by development in southern Africa. The San are poverty-stricken and they lack education and access to information, so they have little power to negotiate or profit from developing their knowledge of medicinal plants such as Hoodia gordonii…anyway, a South African non-governmental organization called BioWatch found out about the CSIR agreement with Pharmedics and leaked it to the San and to the press. That's how this whole problem started.” Angela was starting to catch on. “So do the San believe they are the true owners of Hoodia? Do they want some sort of monetary compensation for their knowledge of Hoodia?” “I wish it were that simple. To tell you the truth, the San find the very idea that anyone should pay them for their knowledge morally abhorrent. The San value knowledge as a collective resource. What’s more, the whole patent process makes little sense to them. They don’t see how life—even plant life—can be ‘owned.’” Sitting back down at his desk, Campbell went on to explain how matters were made even more complicated by the fact that the San are not a single community, but a group of multiple far-flung nomadic communities that travel throughout South Africa, Namibia, and Botswana. Although the San decided not to pursue their ‘no patents on life’ beliefs in court, they did want to negotiate a benefits-sharing agreement, with Hoodia royalties being used to alleviate poverty and sustain endangered aspects of San culture. The distribution of such benefits was problematic. Even if an agreement could be reached between the CSIR, Pharmedics, and the San, how could a system be created to fairly compensate multiple nomadic San groups across three countries? Angela was overwhelmed but determined. “David, I can’t believe what a puzzle you’ve placed in front of me. There are so many groups involved.I’ll go to Cape Town, but I can’t promise I’ll make everyone happy. I'll try to help everyone see how complicated this is and work out some sort of compromise." David sighed. "That's what we need, Angela, a compromise. Just remember, P57 could change a lot of lives for the better, but if we don't put the pieces together no one will benefit." “Well good morning, sleepyhead, just in time for breakfast! You passed out without even taking a bite of dinner. I didn’t want to wake you—I hope that’s o.k. We’ve only got a few more hours before landing.” “Oh yes, of course. I didn't intend to fall asleep.Roger, can I ask you something? You said you are going to Cape Town to put the pieces of your metal sculpture together. How exactly are you going to do that?” “Well, you choose your method depending on the types of metals you are working with. If the metals are the same, you can weld them together. It takes a lot of heat and it’s dangerous, but if you are careful the joining will last a long time. If the metals are different, it’s very difficult to force them together with welding. You generally have to use some sort of fastener like bolts or rivets. You pick the process to match the parts.” Angela took a moment to consider this. "'Pick the process to match the parts.' Maybe I should think of my job in South Africa more as a sculpture than as a puzzle. Thanks, Roger. You’ve helped me a lot.” Angela leaned back in her seat. She was grateful Roger had asked her what she did for a living; moreover, she was glad she’d chosen to open up to him. She smiled to herself, and this time it was genuine.

Source: http://www.eng.fiu.edu/mme/robotics/EML4551SeniorDesignOrg/GL/CaseStudy-ProblemwithHoodia.pdf

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SOAH DOCKET NO. 515-09-2498 TEXAS STATE BOARD OF BEFORE THE STATE BOARD PHARMACY, Petitioner OLUWAFEMI AWE, LICENSE NUMBER 30310, Respondent ADMINISTRATIVE HEARINGS PROPOSAL FOR DECISION Staff of the Texas State Board of Pharmacy (Staff/Board) seeks to suspend the pharmacist license of Oluwafemi Awe (Respondent), impose probationary conditions, and asse

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