FDA Conspires with Cold Medicine Manufacturers to Keep
Selling Dangerous Products to Four Year Olds
by David Gutierrez, staff writer
(NaturalNews) The FDA admits that it negotiated a deal with pharmaceutical
companies to recommend that over-the-counter cold-and-cough medicines should not
be given to children under the age of four -- rather than six, as recommended by
"The analysis that led to the under-four cutoff was performed by FDA," agency
spokesperson Rita Chappelle said. "We suggested it, and then it was voluntarily
adopted by industry. [They] did not come up with the proposal themselves."
Pediatricians had petitioned
the FDA to impose a ban on the use of cold-and-cough drugs in children under
the age of six, citing lack of scientific evidence that the products work at all
in children, as well as a high risk of adverse effects. Advocates of such a
measure point to studies finding that 7,000 children in the United States visit
emergency rooms every year due to cold-and-cough drug overdoses.
An independent panel commissioned by the FDA to review the doctors' suggestion
concluded that the recommendation was sound and should be adopted as a rule by
the agency. Instead, the FDA ignored both groups and came up with a new rule.
The agency claims that its conclusions were based on a review of emergency room
data on cold-and-cough overdoses in children, but it has refused to release the
data it used in its analysis.
"There was no data suggesting that the drugs were effective in kids under 12,"
objected FDA advisory panel member Sean Hennessy of University of Pennsylvania.
"I don't see how [the new policy is] a fully rational approach to the problem."
Baltimore Health Commissioner Joshua Sharfstein, one of the
initially asked the FDA for a new rule, agreed that the agency's actions in the
case are questionable.
"There is a delicate dance between how much legal authority the FDA has and
their use of the bully pulpit for getting some sort of compromise," he said.
The FDA has yet to impose any compulsory regulations regarding cold-and-cough
drugs in children.
Sources for this story include: ap.google.com.