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Lawmaker Seeks Clinical Trial Data

Antidepressant makers, including Eli Lilly, asked to submit results of tests on children

Aug 5, 2004 |

The chairman of the Senate Finance Committee has asked drug makers including Indianapolis-based Eli Lilly and Co. to turn over their clinical trial data on antidepressants.

The request by Republican Sen. Chuck Grassley of Iowa is part of an ongoing congressional review into whether children are more likely to have suicidal thoughts and actions when taking antidepressants.

Congress is also looking into whether drug makers and the Food and Drug Administration have withheld safety information from the public.

"I am concerned that some drug companies may not have provided the FDA with all information at their disposal," Grassley wrote in letters sent Wednesday to eight companies.

An Eli Lilly spokesman said the company will give Grassley the information he wants on antidepressants, which the company has already given to a House committee and made public.

But spokesman Ed Sagebiel said Lilly is seeking clarification from Grassley's office on his additional request for clinical trial information for other drugs.

Eli Lilly's Prozac is the only modern antidepressant that has been specifically approved by the FDA to treat depression in children and adolescents.

But doctors routinely prescribe other antidepressants. Children under 18 took about 7 percent of the most popular antidepressants dispensed in 2002, according to the FDA.

Lawmakers got involved in the issue after the FDA announced in March that it wants drug makers to put labels on antidepressants cautioning doctors to watch for signs of worsening depression or suicidal behavior in both adult and pediatric patients.

The British government last year advised doctors that only Prozac should be given to children with depression.

Critics felt the U.S. warnings didn't go far enough, and Grassley started investigating whether the FDA blocked an internal review that found a link between the use of antidepressants by children and suicidal behavior.

Dr. Andrew Mosholder, a child psychiatrist who works for the FDA's Office of Drug Safety, concluded that a child taking an antidepressant other than Prozac was twice as likely to have a "suicidal event" as a child taking a placebo, according to Grassley.

Mosholder's conclusions were not made public. The FDA has instead contracted with researchers at Columbia University to re-examine the data.

Both Mosholder's review and the Columbia University study are based in part on data submitted by the drug companies. Grassley said he is asking the drug manufacturers to give him their clinical data by Aug. 27.

"My position is, and continues to be, that doctors and patients need to be given the fullest picture possible," Grassley said.

In addition to Grassley's investigation, the House Energy and Commerce Committee is planning a September hearing on the subject of children and antidepressants.

The government's increasing scrutiny of drug trials has prompted several drug makers to start revealing more clinical trial results.

Lilly this week announced one of the industry's most sweeping disclosure plans, pledging to post results of all its human clinical trials on a public Web site as early as October.

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