Fwd: Senate Passes Pediatric Research Equity Act

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DARocksMom wrote:DARocksMom

Tue, 29 Jul 2003 16:57:53 EDT

Senate Passes Pediatric Research Equity Act

undisclosed-recipients:;

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

 

http://www.ahrp.org

 

Contact: Vera Hassner Sharav

 

Tel: 212-595-8974

 

e-mail: veracare

 

 

FYI

 

 

Congress and the Bush Administration both are eager

 

to test pharmaceutical products on children who cannot

 

refuse to be test subjects.

 

 

We at AHRP are in full agreement that medications used in

 

children be thoroughly tested for safety, effectiveness

 

and appropriate dose. However, AHRP endeavors to protect

 

children from harmful medical experiments.

 

 

We note that the proposed legislation does not include

 

safeguards to protect child test subjects from harm.

 

There are No prohibitions on the recruitment of children with

 

financial incentives to their parents and guardians. No limits

 

on the risks of harm or pain that child subject might be made

 

to endure.

 

 

AHRP asks: Whose children will be conscripted to serve

 

as " risk bearing children " ? (The phrase was used by the Dept.

 

of Health and Human Services in 2001 memo).

 

 

On October 21, 2002, AHRP proposed 10 recommendations for the

 

protection of children in clinical trials. See below

 

http://www.ahrp.org/ahrpspeaks/altclinton.html

 

 

Without such safeguards to protect children from exploitation

 

the Pediatric Research Equity Act (PREA) is NOT equitable.

 

Without safeguards for child subjects, the PREA is as reckless

 

and ill-conceived as is the Pentagon's aborted Plan for s Futures

 

betting Market on Terror.

 

http://www.nytimes.com/2003/07/29/politics/29WIRE-PENT.html?pagewanted=print

 

& position=

 

 

The difference is that children are not represented on any policy

 

making bodies--Not in the administration and its advisory committees,

 

Not in Congress. Children don't have a chance vis a vis the powerful

 

pharmaceutical / medical research lobby and their deep pockets.

 

Congress failed, once again, to ask the Administration for a detailed report

 

about the adverse effects suffered by children who were used as test

 

subjects in

 

pediatric drug trials. Congress receives such a report annually about

 

laboratory

 

animals who serve as test subjects. Are our legislators afraid of what

 

that pediatric record may show?

 

 

This legislation is not equitable because those most likely to be affected

 

are disadvantaged poor children whose parents don't have the knowledge or

 

resources to protect them from harm.

 

 

 

~~~~~~~~~~~~~~~~~~

 

News Release

 

FOR IMMEDIATE RELEASE

 

Thursday, July 24, 2003

 

Contact: HHS Press Office

 

(202) 690-6343

 

 

STATEMENT BY TOMMY G. THOMPSON

 

Secretary of Health and Human Services

 

and

 

MARK B. McCLELLAN, M.D., Ph. D.

 

Commissioner of Food and Drugs

 

Regarding Passage of S. 650, The Pediatric Research Equity Act of 2003

 

 

We commend the Senate for today's action in passing the Pediatric Research

 

Equity Act of 2003. This legislation is another step toward closing the gaps

 

that have existed in guaranteeing proper testing of pharmaceutical products

 

for children. Under the President's leadership, HHS agencies have already

 

taken important steps toward assuring the safety and efficacy of drugs when

 

given to children. But an important action that is still needed is clear

 

legislative authority for the Food and Drug Administration (FDA) to require

 

pediatric testing for appropriate products. The Senate has taken us another

 

step toward that goal.

 

 

Many of the innovative pharmaceutical products now being developed are

 

likely to be used in children. But medicines to be used by children should

 

undergo specific pediatric testing, and not simply rely on adult tests. This

 

testing is needed both for new drugs and also for already-approved drugs

 

that may be prescribed for children but still lack pediatric testing.

 

 

Congress took one important step toward addressing this need with enactment

 

of the Best Pharmaceuticals for Children Act (BPCA) in January 2002. This

 

legislation authorized HHS' National Institutes of Health and the FDA to

 

undertake pediatric testing of already-approved drugs that do not benefit

 

from other types of pediatric development incentives. We are carrying out

 

this mandate. Earlier this year, HHS identified an initial list of 12

 

already-approved drugs that urgently need pediatric testing. We are making

 

up to $25 million available this year to begin this process, and the

 

President has proposed to double the amount to be available in the coming

 

fiscal year.

 

 

At the same time, the BPCA also extended incentives for pharmaceutical

 

companies to provide pediatric testing for new products, and this action has

 

also helped ensure that appropriate testing takes place for many new drugs.

 

 

However, it remains important for FDA to have clear authority to require

 

pharmaceutical manufacturers to conduct pediatric clinical trials on

 

appropriate drugs and biologics. The Senate's action takes us a step closer

 

toward enactment of a law to make that authority clear. We thank HELP

 

Committee chairman Gregg and Ranking Member Kennedy for their leadership in

 

shepherding this legislation, and we express the hope that the House of

 

Representatives will also act soon on this important issue.

 

 

###

 

 

AHRP Recommendations for the protection of children in clinical research

 

 

(1) Federal regulations are predicated on our moral responsibility to

 

protect children — who are not volunteers — from being subjected to medical

 

or behavioral experiments that are not in their best interest. Thus, federal

 

regulations — 45 CFR 46 Sub-part D — restrict the use of children in medical

 

experiments involving greater than minimal risk, if there is no potential

 

medical benefit for them or their condition.

 

 

(2) Inasmuch as drugs have unwanted side-effects, and medical research

 

involves risks of harm, only children whose narrowly defined currently

 

diagnosed medical conditions can potentially be helped, should be recruited

 

to test drugs or other medical devices or procedures.

 

 

(3) Legislation for the protection of children’s health and welfare should

 

put the burden of proof on those seeking to conduct research on minors under

 

the age of eighteen (18), to establish the existence of " compelling

 

circumstances " that justify such research on children. Investigators must

 

provide the criteria for demonstrating that the benefits of the research

 

outweigh severity, duration, frequency and likelihood of the risks. Children

 

must be assured that current " best medical practice " standards of treatment

 

will be compared to any new or experimental treatment, and that those

 

consenting on their behalf can be held accountable for making research

 

decisions that are in the child's best interest.

 

 

(4) Children should not be recruited for experiments involving greater than

 

minimal risk on the basis of vague speculations about them being " at risk "

 

of some unproven condition that may or may not ever materialize. Rigorous

 

standards must be established for each study involving children so that the

 

level " of risk " can be objectively defined by demonstrable, existing

 

factors. Investigators must demonstrate that the nature, severity, duration,

 

and frequency of the risk is greater than the intervention proposed.

 

 

(5) All clinical trials involving the use of children, as previously

 

defined, should provide no-fault insurance coverage for both short-term and

 

long-term adverse effects that may arise from or in the course of

 

participation in the stated clinical trials. [1]

 

 

(6) The pool of child subjects must not constitute an unfair burden on

 

disadvantaged families who may not have access to current " best practice "

 

standards of treatment in their community. Thus, care must be taken to

 

ensure that the population from which sick children shall be recruited

 

represents families from diverse socio-economic strata. When children are

 

sought from a specific ethnic or socio-economic population, evidence must be

 

provided demonstrating that the condition under study disproportionately

 

affects that specific population.[2]

 

 

(7) The recruitment of children with financial enticements to their parents

 

and caregivers should be prohibited.

 

 

(8) The record demonstrates that the current system of review of both the

 

scientific and ethical components of research protocols involving sick

 

children, have failed to protect children such as nine-month old Gage

 

Stevens or eight year old Jennifer Munger from harmful experiments that

 

killed them. [3] Therefore,

 

 

A. There is a need for oversight by a " Children Protection Committee " in

 

addition to review by an institutional review board (IRB) that would serve

 

as the child subjects’ advocates, monitoring their selection, assessing the

 

reasonableness of their parents’ consent, the adequacy of disclosure in the

 

informed consent documents, and monitoring their continued willingness to

 

participate in the research. [4]

 

 

B. The majority of the Children Protection Committee (51%) should be drawn

 

from the community, among them representatives from the same socio-economic

 

strata as the children in the specific clinical trial.

 

 

(9) All of the members of the ethics review board and the Children

 

Protection Committee should be vetted for complete absence of conflicts of

 

interest.

 

 

(10) The expenses for the process of safeguarding children's best interest

 

in research — including community members who are involved in implementing

 

the research review and monitoring process — should be paid from a

 

government fund established for that purpose. The government should, in

 

turn, be authorized to recapture its costs, including oversight of all

 

pediatric research, by way of reimbursement from the drug or medical device

 

manufacturers who are eventually licensed to market such drugs or medical

 

devices that result from approved pediatric research.

 

 

[1] This is the identical phrasing of the language of state and federal

 

workers' compensation laws that provide such no-fault insurance coverage to

 

virtually all employees of U.S. businesses.

 

 

[2] This requirement reflects the ethical principle articulated in the

 

Belmont Report relating to justice; namely, equal sharing of the burden and

 

benefit of research.

 

 

[3] Willman, D. Los Angeles Times, Dec. 20, 2000, front page; Moss, M. Wall

 

Street Journal, June 12, 1996, front page.

 

 

[4] The recommendation for a Children Protection Committee had been proposed

 

by the Department of Health Education and Welfare in 1973 but never adopted.

 

See 28 Fed. Reg. 31, 738 (1973)

 

 

 

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