ALLIANCE
FOR HUMAN RESEARCH PROTECTION (AHRP)
Tel. 212-595-8974
Fax: 212-595-9086
142 West End Ave. Suite 28P
New York, NY 10023
Co-founders:
Vera Hassner Sharav, President
John H. Noble, Jr., PhD, Treasurer
David Cohen, Ph.D., Secretary March 27, 2003
March 27, 2003
Senate Committee on Health,
Education, Labor, and Pensions
Dear Senator Judd Gregg
and Senator Edward Kennedy:
The Alliance for Human Research
Protection (AHRP) is a grassroots organization of professional and lay
citizens, one of whose missions is to protect children from harmful
medical experiments.
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.
As you know, no drug is
perfectly safe. Drugs are prescribed by physicians using a risk-benefit
equation. Certain drugs are highly toxic, for example some antiarrhythmics
and chemotherapy agents. Other drugs lead to severe, idiosyncratic reactions
in a small percentage of recipients. These reactions may include bone
marrow failure or life-threatening anaphylaxis.
Furthermore, many drugs
are unlikely to be used in children, and these are often the most toxic
drugs, for instance, chemotherapy agents for tumors that only occur
in adults, or certain cardiac drugs. There is no reason to test these
drugs in children, particularly as they have significant toxicities.
S650, however, requires that this be done.
Instead, in accordance with
The Belmont Report and existing federal regulations that had been adopted
in 1983 for the protection of children - 45 CFR 46 Subpart D -
The Alliance for Human Research Protection recommends that drugs be
tested in children only when a role for the drug in the pediatric population
is anticipated by the manufacturer, and only children who have the condition
for which this drug is a treatment may be used in clinical trials.
Using children as subjects
in clinical research is currently limited for a very good reason: they
are unable to give voluntary, informed consent. Current regulations
do permit children to serve in clinical trials that investigate treatments
for conditions the children have. We believe this legal regime balances
the need to investigate new therapies with the need to protect vulnerable
members of society who cannot consent to being experimental subjects.
It allows drug manufacturers
to test pediatric drugs in the appropriate population. But there is
no benefit to either children or society when children are used to test
drugs for illnesses they do not have, or to test drugs that will be
used solely for adult conditions.
If a physician wishes to
use an adult drug for a child, he/she still may use the drug off-label,
using available information on the drug in adults, and his/her professional
judgment regarding its benefit in children.
We wish to further express
our concern about the lack of adequate safeguards to protect children
from research that is likely to put their health at risk of harm.
Children are incapable of
exercising the adult right to informed consent—they should not be made
to bear the burden and risks of research, unless they have a condition
that would stand to benefit from a specific drug trial.
It is surprising that you
need training and a license to drive a car, but no comparable training
or licensing requirements exist for researchers who conduct medical
experiments on people. It is surprising as well that Congress could
pass legislation that would subject children to risk without a commensurate
benefit. By the FDA's calculation, the law will expose as many as 30%
of the child subjects to needless risk.
Instead, The Alliance for
Human Research Protection proposes the following guidelines for all
clinical research in which children are experimental subjects:
- Restricting the use
of children in research to studies involving no greater than minimal
risk - unless the potential benefit to their condition justifies
the risk.
- Prohibiting conflicts
of interests, such as paying a fee to physicians who recruit children.
- Establishing a registry
of all pediatric clinical trials and requiring mandatory reporting
of serious adverse effects.
- Imposing stiff penalties
when foreseeable risks have not been disclosed or informed consent
requirements have been violated.
- Assuring every child
who participates in clinical trials will be protected by no-fault
insurance coverage against possible adverse effects that may arise
from or in the course of participation in such research.
- Assuring every child
who participates in clinical trials no greater risks than the child
would incur if given the currently available "best standard"
of medical treatment.
- Prohibiting use of financial
enticements to induce parents or guardians of children to enroll
them in research.
- Mandating long-term
monitoring for adverse effects.
- Requiring all researchers
who conduct research on human subjects to be trained and certified
as proficient in the knowledge of medical ethics and the best standards
of medical care.
- Restricting children
from being used as subjects in trials of therapies that are not
intended for children.
Testing, unfortunately,
does not always assure drug safety. Experimental subjects can be harmed,
and patients who receive approved drugs can also be harmed. Rare, but
severe adverse effects will often not emerge in pre-marketing studies,
but only later, when the drug is in wide use. We agree with the Association
of American Physicians and Surgeons that adults, not children, should
bear the brunt of unavoidable drug testing risks whenever possible.
Sincerely yours,
Meryl Nass, MD, AHRP board
member
Vera Sharav, President,
AHRP
John H. Noble, Jr., Ph.D.,
Treasurer, AHRP
Cc: Congressional Human
Rights Caucus ;
Senate
Children's Caucus |
