Case No: 4183/98
In the matter between:
PHARMACEUTICAL MANUFACTURERS’ ASOCIATION OF SOUTH AFRICA AND OTHERS
THE PRESIDENT OF THE REPUBLIC OF SOUTH AFRICA AND OTHERS
The Treatment Action Campaign
The difference in data is easily explained. Clinical trials for orphan drug candidates nearly always involve far fewer patients. The reason, of course, is there are fewer patients available with rare diseases and they are often geographically dispersed. Also, it is clear that FDA applies a more lenient standard to approval of orphan drugs, in some cases, granting approval on the basis of existing literature.
New York Times, September 28, 1989Global benefits of generic competition in Brazil
Credit Government Scientists With Developing Anti-AIDS Drug
To the Editor:
The Sept. 16 letter from T.E. Haigler Jr., president of the Burroughs Wellcome Company, was astonishing in both substance and tone. Mr. Haigler asserts that azidothymidine, or AZT, was essentially discovered and developed entirely by Burroughs Wellcome with no substantive role from Government scientists and Government-supported research. This will be a surprise to the many men and women who have devoted their lives to working for the viral cancer program and developmental therapeutics program of the National Institutes of Health over the last 25 years.
We (associated with the National Cancer Institute and Duke University) make this statement as co-authors of the first publications describing AZT as a drug for treatment of acquired immune deficiency syndrome (Mitsuya, et al., Proceedings of the National Academy of Sciences, 1985, and Yarchoan, et al., The Lancet, 1986). There are few drugs now approved in this country that owe more to Government-sponsored research. In the interest of brevity, perhaps this point can be summarized most efficiently by stating what Mr. Haigler's company did not do.
All of these were accomplished by the staff of the National Cancer Institute working with staff at Duke University. These scientists did not work for the Burroughs Wellcome Company. They were doing investigator-initiated research, which required resources and reprogramming from other important projects, in response to a public health emergency.
- The company did not perform the first synthesis of AZT. This was done by Dr. Jerome Horowitz at the Michigan Cancer Foundation in 1964, using a Government grant.
- The company did not conceive or provide the first demonstration of an effect against animal retroviruses. This was done by Wolfram Ostertag at the Max Planck Institute in 1974, using a mouse retrovirus in a test tube. Mr. Haigler's implication that his staff “discovered" the antiretroviral potential of AZT in 1984 is noteworthy. What he did not say was that his staff repeated the Ostertag mouse experiments. You cannot discover" something published by someone else 10 years earlier.
- The company specifically did not develop or provide the first application of the technology for determining whether a drug like AZT can suppress live AIDS virus in human cells, nor did it develop the technology to determine at what concentration such an effect might be achieved in humans. Moreover, it was not first to administer AZT to a human being with AIDS, nor did it perform the first clinical pharmacology studies in patients. It also did not perform the immunological and virological studies necessary to infer that the drug might work, and was therefore worth pursuing in further studies.
Indeed, one of the key obstacles to the development of AZT was that Burroughs Wellcome did not work with live AIDS virus nor wish to receive samples from AIDS patients.
In a number of specific ways, Government scientists made it possible to take a drug in the public domain with no medical use and make it a practical reality as a new therapy for AIDS. It is unlikely that any drug company could have found a better partner than the Government in developing a new product. We believe that the development of this drug in a record two years, start to finish, would have been impossible without the substantive commitment of Government scientists and Government technology. It does not serve anyone's interests to nullify the importance of Government-sponsored research in solving problems of American public health.
HIROAKI MITSUYA, M.D.
ROBERT YARCHOAN, M.D.
SAMUEL BRODER, M.D.
Bethesda, Md., Sept. 20, 1989
Thus sworn to and signed before me at ____________________________ on this ________ day of April 2001.