Senate HELP Committee Votes to Send Children to Front Line of Drug Tests

Sat, 22 Mar 2003

Washington Post columnist, Al Kamen, writes about the difficulty the Center for Disease Control (CDC) is having convincing its own staff members to be inoculated with the smallpox vaccine, despite (or perhaps because of) the appeal by Dr. Julie Gerberding who suggested Workmen’s Compensation may be available to some, should the vaccine cause disabling adverse effects.

This is interesting in light of the fact that the CDC had sought to expose 40 healthy children to the risks of this same vaccine in a clinical trial. The children would not have qualified for Workmen’s Compensation. This particular children’s trial was averted, in large measure due to the efforts of the Alliance for Human Research Protection to alert the public about this travesty.

However, on the day America went to war in Iraq, the Senate Health, Education and Labor Committee (HELP) passed The Pediatric Research Equity Act of 2003 (S 650), attempting to codify the “pediatric rule” that a U.S. court had overturned.

If this legislation were passed, it would open the door to the recruitment of thousands of children to be used to test the safety of unproven, potentially hazardous drugs–even before they have been tested in adults. Children who cannot protect their own best interests would bear the burden, be exposed to risks of harm, to fill the unmet recruitment needs of a burgeoning drug testing industry. The Bureau of National Affairs (BNA) reports (below): “The American Academy of Pediatrics endorsed the passage of the legislation, stating that it would be a huge step in advancing children’s health.” On the contrary, as written, this legislation would put an increased number of child subjects’ health at risk of harm. However, the bill would be a huge step in advancing the financial interests of the members of the Academy of Pediatrics (and the other pediatric research stakeholders), not to mention advancing the interests of the pharmaceutical industry.

Whereas adults have the right to make informed choices, children do not–this bill puts children at risk of being harmed by drugs of unproven safety, much like canaries sent to the mines to test air safety.

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http://www.washingtonpost.com/wp-dyn/articles/A1179-2003Mar20.html

THE WASHINGTON POST

Fringe Benefits

By Al Kamen

The Centers for Disease Control and Prevention is looking for hundreds, maybe thousands, of employees to volunteer for smallpox shots, director Julie L. Gerberding announced in an e-mail this week.

Various categories of employees, including quarantine officers, veterinarians, information technology specialists, industrial hygienists, public health advisers, nurses and medical officers, “will be asked to consider volunteering to receive the smallpox vaccine,” she said.

As everyone knows, there are possible side effects, including at least a 14-in-a-million chance of life-threatening reactions and one-in-a-million chance of buying the farm, for those vaccinated.

But consider, “if an employee has an adverse reaction to the vaccination,” Gerberding wrote, “they are entitled to file for worker’s compensation coverage.” Active-duty Commissioned Corps personnel aren’t covered, so they should go to “emergency rooms, primary care providers or military treatment facilities.”

Also, employees who claim an injury because of contact with someone who was immunized may be covered, provided, among other things “that they were in the performance of duty when the event(s) leading to the claim occurred.”

But those “who feel too ill to report to work should take appropriate leave,” she most helpfully suggests. Got smallpox? Take the whole day off.

Remember, “participation . . . is completely voluntary,” Gerberding wrote.

It’s unclear how many employees are being asked to volunteer because the CDC wouldn’t say. One would like to think this is secret so the terrorists won’t find out. But CDC communications specialist Curtis Allen said the agency was concerned that a low percentage of volunteers would lead some to conclude the program — much like the one for emergency workers — was a flop.

Got that right.

Henderson Reprieve

D.A. Henderson, the heaviest hitter on the Health and Human Services Department’s bioterrorism team, is hanging it up after 18 months, saying he’s exhausted from the 80-hour-plus weeks. Henderson, credited with his leading role in eradicating smallpox worldwide in the 1970s, is heading back to the Johns Hopkins Center for Civilian Biodefense Strategies, which he founded.

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Bureau of National Affairs (BNA)

PHARMACEUTICAL LAW & INDUSTRY REPORT

Pediatric Testing

Senate HELP Committee Votes in Favor Of Bill Requiring Testing of Drugs for Children

A bipartisan bill that would grant the Food and Drug Administration the authority to require drug sponsors to test medications for their safety and efficacy in pediatric populations was approved unanimously March 19 by the Senate Health, Education, Labor and Pensions Committee.

The Pediatric Research Equity Act of 2003, S. 650, was reported favorably with the inclusion of one amendment introduced by the chairman of the HELP committee, Sen. Judd Gregg (R-N.H.). The amendment, which received a vote of 11-10, essentially includes in the original text of the bill a sunset provision that would end the protections provided in four years and would subject the bill to reauthorization.

Gregg co-sponsored the legislation with Sens. Chris Dodd (D-Conn.), Hillary Clinton (D-N.Y.), and Mike DeWine (R-Ohio).

Codifying Pediatric Rule S. 650 is the reintroduction of a bill originally introduced in April 2002 by Clinton, DeWine, and Dodd. The bill aimed to amend the Federal Food, Drug, and Cosmetic Act to require labeling containing information related to pediatric patients. The measure was unanimously passed in August 2002 by the Senate HELP Committee but no further action was taken on it.

S. 650 would codify the Food and Drug Administration’s Pediatric Rule, which was invalidated in October 2002 when the U.S. District Court for the District of Columbia ruled that the agency overstepped its authority by implementing the rule (Association of American Physicians and Surgeons Inc. v. FDA, 226 F. Supp. 2d 204 (D.D.C. 2002).

The Pediatric Rule became effective in April 1999 and required that drug sponsors conduct trials on the effects of medications in children and include those assessments in all new drug applications, biologic license applications, and certain abbreviated new drug applications submitted after December 2000.

At the hearing, DeWine labeled the court’s decision on the rule as a “troubling step backward for children’s health.” Noting that only 75 percent of medications currently sold on the U.S. market are tested and labeled for pediatric use, he told the committee that, in the absence of the pediatric rule, new medicines and biologics are being approved without knowing whether they are safe to use in the pediatric population.

“We are introducing this bill so that our children are no longer a therapeutic afterthought,” he said. “[B]ecause most drugs lack adequate pediatric safety information, every year millions of American parents are forced to play Russian roulette with their children’s health–they reach in the medicine cabinet and hope for the best. Our children deserve better.”

The American Academy of Pediatrics endorsed the passage of the legislation, stating that it would be a huge step in advancing children’s health. “Parents deserve the peace of mind that comes with knowing that the medicine their children are taking has gone through rigorous testing,” AAP President Dr. E. Stephen Edwards said in a March 18 release. “This legislation guarantees it.” Adding Sunset Provision

Gregg introduced an amendment that would place a time limit on the safeguards provided by the bill and subject it to reauthorization in 2007.

The amendment was not readily accepted by the bill’s cosponsors. Clinton, who voted against its passage, noted that the protections of the bill lapse and that she is in favor of more “reliable, permanent protections for children, just as we expect for adults.”

Dodd, who also voted against the amendment, added that, if anyone suggested that a rule requiring testing of medications used in adults include a sunset provision, it would be overwhelmingly rejected by the committee.

DeWine said that he would vote for its inclusion in the bill, but only because he felt it would give the bill a much better chance of passage into law. “The bill should become law the way it is written now, but we need to move,” he said.

The committee was split on whether to include Gregg’s amendment, but ultimately it was approved, with 11 of the 21 members voting for its passage.

The Elizabeth Glaser Pediatric AIDS Foundation released a statement immediately after the committee markup saying that it was disappointed with the inclusion of a time limit in the bill. “Adults are not required to lobby Congress every four years for the right to safe drugs,” the release said. “Children should not have to either.”

Copyright © 2003 by The Bureau of National Affairs, Inc., Washington D.C.

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