Drug legislation: Drug companies divided
Article Abstract:
The Orphan Drug Act provides pharmaceutical companies with grants, tax credits, and the sole marketing rights in the United States for a period of seven years, as incentives for the development of drugs for rare diseases that affect less than 200,000 people. However, in April 1990, proposals were brought forth to Congress to limit this act. Because of the lack of competition, some of the drugs that have been developed under this act, are very expensive and the companies are making a large profit. In February 1990, hearings were held concerning three drugs in particular: human growth hormone; aerosol pentamidine, used to treat pneumonia in AIDS patients; and erythropoietin (EPO), used to treat anemia in patients with chronic renal failure. The new bill would allow more than one company to market the drug if it can be shown that development occurred simultaneously. EPO has been the most profitable product that has come out of the biotechnology industry. Sales of EPO are estimated at approximately $450 million dollars for 1990, and it is felt that this drug should no longer be considered an orphan drug. The new amendments to the bill would require that the growth of the population affected with the disorder be estimated before a drug is designated an orphan drug. This would affect the stasis of drugs developed for treatment of AIDS. A second amendment would extend tax-credits to include testing in animals and human clinical trials. The Industrial Biotechnology Association and the Pharmaceutical Manufacturers Association oppose the changes, but the executive director of the National Organization of Rare Disorders supports the bill. However, others feel that without the Orphan Drug Act, there would not be enough investment by pharmaceutical companies to develop drugs to treat rare illnesses. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: Nature
Subject: Zoology and wildlife conservation
ISSN: 0028-0836
Year: 1990
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Compound Q: AIDS drug trial resumes
Article Abstract:
Studies have shown that Compound Q (a protein also known as trichosanthin which is derived from a cucumber-like plant from China) kills cells that are infected with the human immunodeficiency virus type 1 (HIV-1) which causes AIDS (acquired immunodeficiency syndrome). Project Inform, an advocacy group from San Francisco, coordinated a trial to test the drug's efficacy that was not authorized by the Food and Drug Administration (FDA). The trial was criticized for being poorly designed, yielding inconclusive results, and causing unnecessary suffering to AIDS patients. The trial was stopped in August 1989 by the FDA, but soon will be resumed with the FDA's approval. This will be the first time the FDA has given an Investigational New Drug license to a community-based research group. Pharmaceutical companies are becoming involved in the testing of this drug. Genelabs is donating a highly purified form of Compound Q, known as GLQ223, and Sandoz is providing $250,000 for the trial, with the stipulation that the patients who were in the trial before it was stopped be retreated. Genelabs, which holds the patent for GLQ223, is also testing the drug in FDA-approved trials. The findings of these phase I trials will be completed in the mid-1990s. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: Nature
Subject: Zoology and wildlife conservation
ISSN: 0028-0836
Year: 1990
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Immune response looks healthy
Article Abstract:
Issues are presented concerning the financial donations which are being directed towards drug and vaccine development by philanthropists and science foundations. Vocational guidance for immunologists is included.
Publication Name: Nature
Subject: Zoology and wildlife conservation
ISSN: 0028-0836
Year: 2001
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