Bush signed Pediatric Research Equity Act

December 5, 2003

President Bush; Mark McClellan MD; Tommy

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

http://www.ahrp.org

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare@...

FYI

Bush signed the Pediatric Research Equity Act into law, ensuring

additional income for the drug industry and for an army of physicians

who are in the drug testing business at universities, clinics,

and in private practice. This collaborative business arrangement

has put company interests above the health and welfare of children.

And this arrangement has corrupted the scientific literature.

Company paid doctors help those companies conceal clinical trial data--

they fail to disclose severe, adverse drug effects, and lend support

to false company claims about the safety and effectiveness of newly

marketed drugs.

None of those who lobbied for this legislation recommended safeguards

to ensure children are not exploited. Indeed, none of the stakeholders

in clinical trials considered the adverse impact on children who are

increasingly sought as drug testing subjects. Since passage of the

FDA Modernization Act (1997), which provided drug companies with

windfall financial incentives--such as six months additional marketing

exclusivity--children have been put at increased risks of harm and

have suffered in clinical trials. Few children have benefited from

their enrollment as human guinea pigs in drug trials.

To gain insight about how this legislation will likely exacerbate

the plight of vulnerable child subjects whose enrollement is facilitated

by cash payments to referring physicians and caregivers,

see: CHILDREN IN CLINICAL RESEARCH: A CONFLICT OF MORAL VALUES

online at: http://bioethics.net/in_focus/sharav.pdf

See also, THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF

CHILDREN FOR RESEARCH, published in Ethical Human Sciences and Services

online at:

http://www.ahrp.org/testimonypresentations/FDAmodernization03.html

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

FDA press release

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00989.html

President Bush signed the Pediatric Research Equity Act 2003 on

December 4, a legislative move that will boost pharmaceutical safety amongst

the nation’s children. The bill, formally titled The Pediatric Research

Equity Act of 2003, confers upon the Food and Drug Administration the

authority to require pediatric studies of drugs to ensure they are safe for

children. Many of today’s drugs have only been tested on adults.

“Children need access to effective drugs to treat their ailments, and those

drugs should be properly tested for pediatric use rather than just

prescribed and sold based on adult testing,” said Department of Health and

Human Services Secretary Tommy upon the bill’s passage. “This

legislation will allow the FDA to require such studies when appropriate and

will better assure doctors and parents alike that the drugs used to treat

our children are safe and will work as expected.” Added FDA Commissioner

Mark McClellan, “Prescription drugs can do more than ever to cure diseases,

including illnesses in children. But it is not good medicine to assume that

children can be treated like little adults. Parents and health professionals

deserve confidence that medicines used to treat children are safe and

effective. FDA will use this important new law to require pediatric studies,

when necessary, to give parents and doctors the confidence they deserve.”

Other sites HHS press release.

December 5, 2003

But it is not good medicine to assume thatbchildren can be treated like little

adults

Yet they give them the same dose in vaccines ....... go figure

in Illinois

sahm to 13, Chase 10 & Liam 4/3/03

Former Surgeon General Dr. Antonia Novello: " It's the lucky baby, I feel, who

continues to nurse until he is two. "