Billion-dollar orphans: prescription for trouble

Article Abstract:

The Orphan Drug Act, passed by Congress in 1983, allows companies exclusive rights for seven years to market drugs aimed at disorders affecting no more than 200,000 people. Tax incentives are also offered for such projects. Since passage of the Act, 333 drugs have been developed, including three for use by AIDS patients, who were initially thought to number fewer than 200,000. Now, however, a coalition of AIDS activists, biotechnology companies, and political figures want changes in the Act. They allege that loopholes make it possible for companies to make unfairly large profits. AIDS patients believe they would have access to better, cheaper drugs if several firms were allowed to market therapeutic drugs. Some companies believe that the seven-year exclusivity clause is exploited when firms use it to develop drugs they would have developed, anyway. Three drugs are of particular concern; hGH (human growth hormone); EPO (erythropoietin, used in treating blood disorders associated with kidney disease); and aerosol pentamidine, used by AIDS patients. An alternate form of the latter drug, which patients could use at home, has been developed by another company than the one licensed under the Orphan Drug Act, but it is not allowed to enter the market. Such exclusivity, say critics, keeps prices high: one year's worth of PEG-ADA (developed against a disorder affecting fewer than 40 children in the world) can cost $60,000. Congressman Henry Waxman has introduced a bill to change the Act. Under his bill, companies other than the one that introduced an orphan drug could also market it, if they could prove they had been at the same point as the first company in drug development. Furthermore, drugs against diseases (such as AIDS) that clearly affect more than 200,000 people will no longer qualify as orphans. Advocates for patients with rare diseases, however, are afraid that removing exclusivity will remove the incentive for companies to develop drugs for these relatively small markets. Most members of the Industrial Biotechnology Association support the act, but two companies recently resigned in opposition to it. Discussion of the issue is likely to continue. (Consumer Summary produced by Reliance Medical Information, Inc.)

Product development, Economic aspects, Laws, regulations and rules, Pharmaceutical industry, Orphan drugs

---

Is AIDS dementia due to increases in calcium?

Article Abstract:

Dementia is a common complication of AIDS; as many as two thirds of AIDS patients may suffer from dementia or other neurological disorders. The reason for this is still unclear. Although HIV, the AIDS virus, has been demonstrated in some brain cells, it has not been shown to infect neurons, the cells often involved in neurological diseases. Now, in the April 20, 1990 issue of Science, researchers describe an unusual observation that may account for the neurological changes seen in AIDS. The scientists showed that gp120, which is the outer protein of the human immunodeficiency virus and is responsible for attaching it to target cells, has a peculiar effect upon neural cells in tissue culture. The presence of gp120 increases the amount of intracellular calcium. So much calcium enters the cell, in fact, that it dies within a day. There is no reason to believe, however, that a similar process is occurring within the brains of AIDS patients. In fact, both the experiment and its implications are treated with a great deal of skepticism by some researchers for the simple reason that the mechanism by which such a process could work is simply not known. One of the researchers, Stuart A. Lipton, is anxious to treat AIDS patients with nimodipine, an agent which blocks calcium channels and might protect cells against calcium damage. While Lipton points out that nimodipine has already been approved for use in humans for other ailments, other researchers point out that there is not a single shred of evidence to suggest that it will do anyone any good. (Consumer Summary produced by Reliance Medical Information, Inc.)

Causes of, Complications and side effects, HIV (Viruses), HIV, Dementia, Calcium in the body, Calcium (Nutrient), AIDS (Disease), Brain diseases, AIDS dementia, AIDS dementia complex, editorial

---

Lung fossils suggest dinos breathed in cold blood

Article Abstract:

Respiratory physiology expert John Ruben has found evidence suggesting that dinosaurs could not have evolved into birds. Ruben argues that dinosaur lungs are similar to those of crocodiles and could not have evolved into the type of lungs needed for warm-bloodedness.

Dinosaurs, Evolution (Biology), Birds

Similar abstracts:

• Abstracts: Primary health for all. Ending malaria deaths in Africa. The geography of poverty and wealth
• Abstracts: The reign of trial and error draws to a close. On-line archives let biologists interrogate the genome. NIDA aims to fight drugs with drugs
• Abstracts: Marijuana receptor gene cloned. Bombesin receptor gene cloned
• Abstracts: Venture capitalists push designer drug start-ups. The pipeline is leaking women all the way along
• Abstracts: NF's cancer connections. Zeroing in on a breast cancer susceptibility gene

This website is not affiliated with document authors or copyright owners. This page is provided for informational purposes only. Unintentional errors are possible.