We are writing about the Pediatric Research Equity Act of 2003 (S 650). We are in full agreement that children should have the same safeguards as adults; that medications used in children be thoroughly tested for safety, effectiveness and appropriate dose. However, S 650 does not do this. Instead, it requires that children be used to test all drugs as a condition of licensure by FDA – unless a waiver is obtained from the Secretary of the department of Health and Human Services under section 505B.
Recent public and professional debate about smallpox vaccine and its risks provides the framework for evaluating the ethical justification for conducting clinical trials on children. Dryvax is a particularly impure product made of live vaccinia virus harvested from the pustules of calves infected with (it is believed) cowpox. Although the vaccine, which is scratched on the skin, only causes mild infections in most people, in a small but significant number the infection caused serious adverse reactions similar to the complications of the disease they were designed to prevent: painful, disfiguring skin disorders, blindness, neurological impairments and death.
Dr. Meryl Nass
An estimated 500,000 first responders, lab and hospital workers will receive smallpox vaccine, the DHHS announced yesterday.
This is an interesting announcement, because to my knowledge there exist no FDA-licensed smallpox vaccines.
There are three vaccine candidates whose safety and efficacy are uncertain at this time.
The first vaccine made available was Wyeth’s Dryvax, which was pulled out of storage after approximately thirty years.
 THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) https://ahrp.org 142 West End Ave. Suite 28P New York, NY 10023 Testimony by The Alliance for Human Research Protection Committee on Ways and Means Hearing on Protections for Foster Children Enrolled in Clinical Trials May 18, 2005 On March 10, 2004, The ALLIANCE…
Today’s New York Times Magazine cover story, Planet of the Retired Chimpanzees By Charles Siebert, reports that chimpanzees who have served as subjects in biomedical research can look forward to being set free in one of 12 specially built chimp sanctuaries the prettiest places in all of Florida. This is…
Posted by Meryl Nass, MD In the last few days there have been multiple news articles and testimonies in the Maine and Vermont legislatures about the need to impose vaccine mandates to protect immunocompromised children.[1] [2] I attended the vaccine bills’ hearing in Augusta, Maine on May 11, which lasted…
