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Date: Fri, 23 Aug 2002
Posted by: Lois Levitan (lcl3@cornell.edu)

FDA APPROVES TRIAL FOR INTERFERON TO TREAT WEST NILE VIRUS  [edited]

      By LAWRENCE K. ALTMAN, News York Times, Aug 21 2002

      [Additional information inserted in square brackets from AP story by ULA ILNTZKY]

The Food and Drug Administration said yesterday that it had approved a national trial of a drug to determine whether it could become the first specific therapy against the West Nile virus.

The drug is alpha interferon, which Schering-Plough sells as Intron A. It is licensed [and used in treatment] for hepatitis C and a few other conditions.

No patient has entered the trial, which the F.D.A. allowed on Monday [Aug 19, 2002], said Dr. James Rahal, the chief of infectious diseases at New York Hospital Queens and a leader of the study. Dr. Rahal was one of the first American physicians to study West Nile virus in 1999, when the illness, which is carried by mosquitoes, was first detected in this hemisphere. [Patients across the country can enroll, but the trial most likely will focus on Louisiana and Mississippi. Rahal said the length of the trial will depend on the results.]

...SNIP...

Under federal rules, doctors may prescribe a licensed drug for unapproved uses. Some doctors have prescribed Intron A for West Nile patients. But the effectiveness of the drug has not been documented in a scientific trial.

[Rahal said Wednesday that he treated 15 Louisiana patients with the drug in a study to make sure it was safe for people with West Nile. He said the results were promising enough to get the FDA to approve the new trial.]

Researchers running the Intron study hope to enroll at least 40 patients who have been hospitalized with the virus. Cooperating doctors can enroll any West Nile patient 50 years and older within four days of hospital admission. Patients younger than 50 will be eligible if they have meningitis and encephalitis. Outpatients are not eligible.

[The study will target patients whose virus is still in the blood, where it circulates before entering the brain, Rahal said. Therefore patients must begin treatment within the first four days of being admitted. ]

["Once damage has occurred in the brain, it's not likely to be reversible, at least not by a drug. What we want to do is increase the body's defence against the virus, and decrease the amount of virus that ultimately enters the brain or the nervous system." ]

[The protocol calls for two weeks of interferon, whose side effects include a decrease in the white blood count and inflammation of the liver--both reversible once the drug is stopped. Rahal said long-term use could cause depression, confusion and fatigue.]

In such a randomized controlled trial, half the patients will receive Intron A injections and the other half will receive standard care without Intron A. To enroll, a patient has to agree to allow the choice to be made by the statistical equivalent of a coin toss. The doctors and patients will know who is receiving Intron A.

Participants will be treated at the hospital where they initially sought care. Schering-Plough will pay for the drug.

[The National Institute of Allergy and Infectious Diseases at the National Institutes of Health is also funding research on three West Nile virus vaccines and said this week that one may be ready for human trials next year.]

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The Ilnytzky article appeared in the Ithaca Journal, my hometown paper, on Thursday Aug 22, side-by-side with an AP story from the World Summit for Sustainable Development in Johannesburg, South Africa. The other article is headlined DISEASES OF THE POOR FOCUS OF WORLD SUMMIT, by Ravi Nessman, and begins:

AIDS killed 3 million people last year. The year before, tuberculosis killed 1.7 million and malaria more than a million others. Millions more died from diarrhea and other easily preventable diseases. A decade ago, world leaders at the Earth Summit in Rio promised to tackle diseases of the poor.

[Snippets from the rest of the article:]

But with so many of the world's most vulnerable still dying in droves..."You really have to think twice about whether this health revolution that is being talked about it the West is any way benefiting the people that need it the most," said spokeswoman from Medeccins Sans Frontieres, the medical aid group known in English as Doctors without Borders.

In some cases, rich countries have damaged the already weak health care systems in many poor countries. Countries including Canada, Great Britain and the United States have tried to solve their nursing shortages by recruiting health workers from countries such as South Africa, which have shortages of their own.

According to Oxfam, global drug research and development spending is about $70 billion, but only 10 percent of that money goes to research on diseases that account for 90% of the world's infections.

-- 
Lois Levitan, PhD       Program Leader
Environmental Risk Analysis Program
Center for the Environment
213 Rice Hall, Cornell University
Ithaca, New York USA 14853-5601

Phone:   (607) 255-4765     Fax: (607) 255-0238
Email:	LCL3@cornell.edu

Program Email: envrisk@cornell.edu
Web:http://www.cfe.cornell.edu/ERAP

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