"ETHICS" CHAOS

So nice to have governments protecting us so well -- with guesswork

Institutional review boards (IRBs) may be wildly off base in their judgments of safety or risks for children proposed for participation in clinical trials of drugs. Because of a lack of specificity in the criteria that IRBs use to assess risk, decisions are made that both overstate and understate the risk to children of therapeutic trials, according to David Wendler, Ph.D., a bioethicist at NIH, and colleagues there and at Harvard.

Current estimates are that about 75% of drugs routinely prescribed to children have only been tested in adults, which has led to an increased demand for pediatric testing, Dr. Wendler and colleagues noted in a special communication in the Aug. 17 issue of the Journal of the American Medical Association. The investigators cited as a problem of particular concern the pediatric trials that "generate vital scientific knowledge" but offer no direct benefit. Toxicity studies of vaccines such as the Dryvax smallpox vaccine are an example.

In order to protect children, federal regulations direct IRBs to approve such studies only when the risks are considered minimal or a "minor increase over minimal." The IRBs are mandated to use risks of every day life as a yardstick. "In the absence of empirical data, IRB members may assume they are familiar with the risks of daily life and with the risks of routine examinations and tests and rely on their own intuitive judgment to make these assessments," the authors wrote. "Yet intuitive judgment of risk is subject to systematic errors, highlighting the need for empirical data to guide IRB review and approval of pediatric research."

The authors said that every day life actually presents some considerable risks. For instance car trips pose the highest mortality risk encountered by healthy kids. Car trips pose an approximately 0.06 per million chance of death for children ages 14 years and younger and approximately 0.4 per million chance of death for children ages 15 though 19 years. Likewise, every day sports pose injury risks. For every million games of basketball played, 1,900 individuals are injured, including 180 broken bones and 58 permanent disabilities.

The researchers wrote that these data suggest that IRBs may be categorizing as "greater than minimal risk" procedures that don't pose a greater risk than riding in a car or playing basketball. "For example, 70% of IRB chairpersons categorize allergy skin testing as having a greater than minimal risk," they wrote, citing a previously published survey. "Yet the present analysis indicates that the risks of allergy skin testing do not exceed the risks healthy children ordinarily encounter in daily life."

The flip side is that other IRBs have ruled that procedures presented a minimal risk when the true risk of injury was one in 250. The researchers concluded that more research is needed to determine more accurate ways of assessing the real risk of research protocols.

Source

***************************

For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation. Both Australia and Sweden have large private sector health systems with government reimbursement for privately-provided services so can a purely private system with some level of government reimbursement or insurance for the poor be so hard to do?

Comments? Email me here. If there are no recent posts here, the mirror site may be more up to date. My Home Page is here or here.

***************************