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Rapid Responses: Rapid Responses published:
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Other Diseases join the List
- John A Hayman (27 July 2002)
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Facts and Figures on Sleeping Sickness
- Robert G. Geursen (12 August 2002)
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John A Hayman, A/Prof, Dept of Anatomy and Cell Biology Monash University, Melbourne, 3800
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Gavin Yamey is to be commended on his article detailing lack of research on treatments for Infectious Diseases which cause great mortality in developing countries. There are other diseases which, although not associated with a high mortality, cause considerable morbidity and result in blighted lives and a high communal economic burden. Mycobacterium ulcerans Infection, often called "The Buruli Ulcer", has now displaced leprosy in many places in west Africa to become the second most important mycobacterial infection of immunocompetent man. Thousands of patients in endemic areas are infected annually. Untreated patients develop hideous scars, contractures, loss of limbs following necessary amputation, loss of breasts in women, blindness and chronic bone infections. Treatment at an advanced stage of infection requires weeks or months of hospitalisation, repeated surgery and wound dressings with loss of schooling, as well as loss of domestic and agricultural activity. The infection responds poorly to existing antibiotic regimes and vaccine prevention (BCG) is of limited efficacy. There is lack of support for development of new drugs or vaccines to treat the disease, even lack of support for trials of existing drugs in treatment regimes which when added to surgery may be of benefit in preventing recurrences or bone infection. I ask that your Editor to consider morbidity as well as mortality when assessing the burden of Infectious Diseases in developing countries and to add Mycobacterium ulcerans Infection to the list of neglected diseases. Although they may never read it, your editorial is extremely relevant to those who suffer from these diseases. Sincerely, John Hayman |
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Robert G. Geursen, Head of Corporate Public Policy, Aventis Poseidonhaus, D-65926 Frankfurt am Main, Germany
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Dear Sir, Allow me to make some comments on your recent editorial on the world´s most neglected diseases. As my company happens to be the main provider of medicines used to combat African sleeping sickness, I would like to provide you and your readership with some precisions about the general situation and to correct some misunderstandings raised in your text. The statement that "current drugs are in scarce supply" is unfounded. Even before the agreement signed last year between Aventis and WHO, the three major drugs used against African sleeping sickness melarsoprol, pentamidine and eflornithine have been available. Pentamidine had been donated free of charge to WHO for more than ten years by Rhone-Poulenc, melarsoprol was never in shortage and marketed at an affordable price. Through WHO, even eflornithine was available to patients in need. I would also like to comment on the history of the clinical development of eflornithine, which, in the public, is sometimes presented in a misleading way. Eflornithine was discovered in the 1970's by the Merrell International Research Center. The molecule was part of the company's research program on cancer and anti-infectives. In 1981, the Merrell company was acquired by Dow Chemical, Merrell Dow Pharmaceuticals was created. In 1989, Marion Merrell Dow was formed from the merger of Marion Laboratories and Merrell Dow. In 1995, a merger between Hoechst AG, Marion Merrell Dow and Roussel Uclaf created Hoechst Marion Roussel, which, at the end of 1999, was part of the merger to form Aventis, together with Rhône-Poulenc Rorer. In 1979, Cyrus Baachi, a biochemist with Haskins Laboratories at New York´s Pace University, discovered that the molecule cured mice with trypanosome infection. The company, while pursuing the development of the product against cancer, accepted to finance the development according to FDA standards for the sleeping sickness indication, collaborating with WHO to give access to patients in African endemic countries. The product was registered as an orphan drug with the FDA in 1990, then in the endemic countries from on 1993. This achievement was publicly praised by Dr Nakajima, then Director General of WHO. Since sleeping sickness was not the target of activities of the company, it had been agreed in 1989, that, once eflornithine was registered, the company would care for a batch of product, equivalent to a two years demand, and hand over the patent rights to WHO. Meanwhile, the organisation should identify a producer for the product. Unfortunately, this approach was not successful. No other manufacturer could be identified. In order not to create a shortage at WHO, the company arranged for new batches which were produced in 1995 and 1997. When Aventis was formed, the new company happened to have the three major products to treat African sleeping sickness in its combined portfolio. It decided to propose to WHO a joint initiative on this "most neglected disease". First contacts were made in May 2000, long before an eflornithine-based cosmetic product was launched on the US market. These negotiations led to the agreement signed on May 3rd, 2001, between Aventis and the WHO. > At the end of 2000, Médécins Sans Frontières got to hear about the U.S. launch of Vaniqa, a facial cream to treat female hirsutism. They approached Bristol Myers Squibb to come to an arrangement in favour of sleeping sickness patients in Africa. However, BMS did not dispose of the technological process to make injectable eflornithine. Since Aventis was already in discussion with WHO, BMS announced to donate eflornithine active ingredient for the first year of the sleeping sickness initiative, plus a donation in cash to WHO. From the above, it should become clear that there is a difference between facts and public perception: It was not the arrival of a cosmetic product on the US market which changed the overall situation. The decisive change was the creation of Aventis, a company with a portfolio apt to propose to WHO a major program to jointly combat African sleeping sickness in the most endemic countries. The program is now in its second year, to the satisfaction of WHO, of MSF, and of Aventis. Yours sincerely, Dr. Robert G. Geursen, PhD, MD
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