October 26

Risk Bearing Children

Risk Bearing Children

February 27, 2001

Would you volunteer your child to be a "risk-bearing" subject in drug experiments?

When Jonathan Swift published A Modest Proposal in 18th century Ireland, he offered a sure solution to the country’s hunger and economic ills: The poor could sell their year-old children as food to the rich…. God-fearing citizens were aghast at the suggestion that in a civilized society, the young of the less fortunate might be viewed as the solution to hunger by the more fortunate….

In "compassionate" America today, God-fearing citizens are unaware that Government ordinances are sealing the fate of thousands of poor children who are being recruited to assume the risks and burdens of commercial drug testing–so that the more fortunate stakeholders of the biomedical industry, may prosper.

In 2001 to The Boston Globe reported that 45,000 children were participating in medical experiments that year, compared to 16,000 in 1996.

Researchers are getting $5,000 referral fees to recruit children for drug trials. And parents-who are uninformed about the actual risks involved– are being offered financial incentives–$200 to $1,000–to volunteer their children.

The U.S. Department of Health and Human Services (DHHS), its agencies and advisory committees have embarked on an aggressive strategy aimed at increasing the recruitment of healthy children for drug trials involving risks of harm.

Until now, Federal regulations have somewhat protected children from exploitation in invasive medical experiments that are not in their own best interests. Children have been protected by regulatory restrictions that ensured children would be recruited for medical experiments that offered them a potential benefit. Under current regulations, children may not be used in experiments that put them at "greater than minimal riskä if there is ãno prospect of direct benefit to individual subjects." [45 CFR 46.406] Since there is no potential benefit for healthy children to be exposed to risk in research, federal regulations have until now protected them from such experiments. The FDA acknowledges that in the past, phase I safety studies (those involving highest risk) "had been primarily limited to life threatening diseases and children who had the disease for which the new drug was being proposed."


These minimal protections are being stripped away by government policy makers as they re-interpret federal regulations.

On April 19, 2000, the FDA adopted a new policy broadening the regulatory definition of "potential benefit" to include virtually all healthy children, by claiming: "any child has the potential to benefit from a treatment for otitis media" (i.e., ear infection). http://www.fda.gov/cder/pediatric/ethics-statement.htm

The goal of this policy change is to legitimize the unethical exploitation of helpless children. Parents would be encouraged to "volunteer" their healthy children on the theory that the children may, sometime in the future, benefit from new treatments that may be discovered!

The FDA acknowledges on its website, that this recent policy "has led to an increasing number of proposals for studies of safety and pharmacokenetics, including those in children who do not have the condition for which the drug is intended."

The Federal government is facilitating the recruitment of thousands of healthy children to become drug- testing subjects so that the pharmaceutical industry can extend their patents.

Federal policy makers are also attempting to legitimize non-therapeutic experiments in which children are put at risks of harm without a potential direct benefit that would justify such risks. Children are being sought by drug companies who have a financial incentive, a six -month extension on patent exclusivity, thanks to the FDA Modernization Act of 1997. For drug companies that incentive can mean between $284 million and $975 million.

In March 12, 2001 DHHS distributed a draft of proposed changes in its policy regarding the protection of children as research subjects: "Policy and Procedures for DHHS Research Involving Children–45 CFR 46.407."

The proposed policy redefines the terminology of current federal regulations by broadening the criteria under which healthy children would be recruited into research that may cause them pain, and put them at risk of serious harm.

The DHHS Draft indicates that "for the purposes of sec. 46.406" the term "condition" is redefined to include non-medical "conditions." The DHHS Draft would allow "a demographic [sic ] descriptor" to qualify as a "condition."

Does this legitimize racial profiling for research purposes?

Thousands of healthy but helpless, younger and younger children are being recruited to serve as human drug testing subjects–even before their safety is known in adults.

According to The Boston Globe, 45,000 children are participating in medical experiments in 2001–up from 16,000 in 1996. Researchers are getting $5,000 referral fees to recruit children for drug trials. And parents–who are uninformed about the actual risks involved– are being offered financial incentives–$200 to $1,000–to volunteer their children.


WHOSE CHILDREN will be exposed to risks of harm and pain for the benefit of others?

This direction is made clear in a statement Dr. Koski made in his article in the Journal of Law, Medicine & Ethics (2000) 28:330-331: "as we understandably increase the extent to which needed research is conducted on vulnerable populations, such as children, it may well be necessary to redefine our notions of consent and assent for purposes of recruiting subjects." According to this policy the U.S. Government will be exploiting the vulnerability of children to serve the interests of the pharmaceutical industry by violating the Hippocratic Oath, "first, do no harm," the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report.

WOULD YOU VOLUNTEER YOUR HEALTHY CHILD to be a ãrisk-bearingä child in a medical experiment without a potential benefit to your child?

Is your doctor volunteering his own children (or grandchildren)?

Are research team members volunteering their children?

Are the executives of the big pharmaceutical companies volunteering their children?

Are any of those who stand to make millions from successful experiments volunteering their children?

It is important for parents who are approached to volunteer their children for research to ask this question before they sign them up.


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