October 26

Drug Testing Debate – Parenting Mag 4 Pt. Series

Drug Testing Debate – Parenting Mag 4 Pt. Series

Tue, 22 Oct 2002

Parenting Magazine published a 5-part report about the impact on children of FDA’s “The Pediatric Rule.” That Rule provides drug companies six month patent extension on drugs tested in children. This financial windfall could translate into some $30 billion in added revenue over the next 20 years. According to Parenting Magazine., there are currently about 500 clinical trials involving children who are testing drugs approved for adult drugs. The Pediatric Rule has been thrown out by a federal court on Oct 18, but Senator Clinton is reported to lead the charge to legislate the Pediatric Rule into law. [See AHRP’s reasons for opposing mandatory pediatric drug testing and our alternative to the proposed Clinton-DeWine legislation.]

Parenting Magazine reported that “even though some 60,000 kids were enrolled in drug studies last year, pharmaceutical companies need far more. This has left the medical-testing industry in a bit of a crisis, resulting in zealous recruiting tactics, such as promises of gift certificates to Toys “R” Us, Tower Records, and the Gap, to name a few.”

Those who promote and those who lend their seal of approval to aggressive recruitment of (mostly) disadvantaged children for drug tests expect these children to undergo pain and risks for others. Rosemary Roberts, M.D., Deputy Director, Pediatrics, FDA’s Center for Drug Evaluation and Research, would absolve those who approve and oversee pediatric trials of their responsibility to protect children. Dr. Roberts would have us shift that responsibility to the children themselves, stating: “In a trial, there are risks, but hopefully they will be properly outlined to the patients.”

In September, the Center for Disease Control (CDC) announced plans to test the controversial, and much dreaded smallpox vaccine on children. Yesterday’s Wall Street Journal reported that the CDC acknowledged in a briefing that “As many as 50 million Americans, including babies, pregnant women, people with the common skin rash eczema, as well as those with weakened immune systems, may be vulnerable to the vaccine’s risks.”

“Gasps erupted from an audience of microbiologists as one of the government’s top smallpox experts displayed slides of children covered with disfiguring pockmarks at a meeting in San Diego last month.” [See: http://phil.cdc.gov/Phil/results.asp?page1

Paul Offit, chief of the infectious diseases section of Children’s Hospital of Philadelphia, who is also a member of the CDC advisory committee, said of the smallpox vaccine: “I would never give that vaccine to my children because right now there is no disease out there.”

[See: Ugly Side Effects of Smallpox Vaccine Color Terror Plans, by Marilyn Chase and Greg Hill, WSJ, Oct 21, 2002, front page]

WHOSE CHILDREN ARE BEING RECRUITED in Cincinnati for smallpox vaccine trials?

Senator Clinton and those who would rush to legislate mandatory drug tests on children seem not to recognize the double moral standard being applied–one for privileged children, the other for underprivileged children.


http://www.parenting.com/parenting/article/article_general/0,8266,7765,0 0.html

The Drug-Testing Debate (part 1)

By Jennifer Wolff

Dan’s* blond hair grazes his eyes as they fill with tears. “Take it out! Take it out!” the 9-year-old begs, turning away from the needle in his arm. His dad holds his shoulders flat against the hospital exam table. “You have a birthday party coming up, don’t you? Let’s think about that,” he whispers into his son’s ear.

Beneath the glaring lights of this examining room at Children’s Mercy Hospital, in Kansas City, MO, the nurse grows frustrated trying to find a plump vein beneath Dan’s pale and obviously sensitive skin. She pokes him a couple of times before giving up. Teary-eyed, Dan hops onto the floor and nibbles the Rice Krispies Treat that was to be his reward for lying still.

Chris*, Dan’s little brother, climbs up onto the exam table. Although two years younger, he braves the blood draw without so much as a whimper. Then his dad tells Dan to try again. The boy reluctantly gets into position, but this time he starts to cry before the needle even gets close to his arm.

The nurse tells him to take a deep breath, but he squirms and flaps his leg. “I don’t want this,” Dan whispers to no one in particular. His face reddens as the needle hones in. “I don’t want to do it,” he screams. “I don’t want to…”

The needle is in. Three tubes of blood are quickly drawn.

It’s hard for any parent to think of his child suffering at the end of a doctor’s needle, however necessary. But there’s no pressing medical reason for Dan to be enduring this procedure, because he isn’t sick. Nor is Chris. Rather, the brothers have been admitted for the day to Mercy’s Pediatric Clinical Research Unit because they both are in good health and meet the criteria of a particular study — thus making them perfect human subjects in the burgeoning business of pharmacological drug testing on children.

Their parents have consented for them to lend their bodies to medical science, in this case to test a heartburn drug long approved by the Food and Drug Administration (FDA) for use in adults, but never for the kids who are nonetheless treated with it regularly. The trial is part of a controversial FDA incentive program that hopes to achieve more accurate labeling for products that children use. By testing this drug in kids like Dan and Chris, its manufacturer will be able to include the correct dosage for children of different ages on its label. And, of course, it stands to make hundreds of millions of dollars.

“They’re using my blood to test if this medicine can save someone’s life,” Chris says through a wide, gap-toothed grin, not really clear on the fact that heartburn, which this medication treats, isn’t fatal. “But also ’cause Mom said we’re going to get money.” For participating in the trial, each of the boys will be paid $190.

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