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FDA of Failing Act on Information About Link Between Antidepressants, Suicide Risk in Children, Say Lawmakers

27 Sep 2004
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FDA could make a decision within days on whether to adopt an advisory panel's recommendations to include a black box warning about the increased risk of suicidal tendencies that antidepressants pose for children, and any labeling changes could be implemented "in a couple of weeks," Dr. Robert Temple, director of FDA's office of medical affairs, said Thursday at a House Energy and Commerce Oversight and Investigations Subcommittee hearing, the Wall Street Journal reports (Wilde Mathews, Wall Street Journal, 9/24).

The advisory panel on Sept. 14 voted 15-8 to recommend that all antidepressants carry a black box warning -- the strongest warning issued by the government -- to inform consumers that the drugs can cause suicidal thoughts and behavior in patients under age 18. A black box warning is a black section with white writing that appears at the top of drug inserts distributed to physicians and patients.

On Sept. 13, FDA officials said that an analysis of 15 clinical trials -- some of which were not made public for years -- has found that there is a "consistent link" between the use of any kind of antidepressant and suicidal tendencies in children (Kaiser Daily Health Policy Report, 9/15).

FDA regulators are still weighing whether to require a black box warning or a bolded warning about the drugs' heightened suicidality risk in children, Temple said (Mulkern, Denver Post, 9/24).

"My guess is that we probably will" decide to use a black box warning, Temple added (Harris, New York Times, 9/24).

In addition, the agency is still considering whether to add a statement to antidepressant labels that indicates studies in children found most of the drugs are no more effective than placebos, the Washington Post reports (Vedantam, Washington Post, 9/24).

According to Temple, FDA is "clearly going to implemen[t]" all the advisory panel's other recommendations, such as a requirement that patient information guides be distributed with antidepressant prescriptions (Wall Street Journal, 9/24).

FDA Officials Asked Mosholder To Modify Documents

According to documents released Thursday at the day-long hearing, FDA officials instructed agency medical officer Dr. Andrew Mosholder to delete from records he was submitting to Congress his research material that showed an increased risk of suicidality in children who took antidepressants and told him to conceal the deletions. Panel members "repeatedly accused the agency of obfuscating the risks, slowing action and subjecting Mosholder to harassment," the Post reports (Washington Post, 9/24).

In April, FDA officials acknowledged that agency managers did not allow Mosholder to testify at a February public hearing about a report he compiled that found antidepressants may lead to suicidal behavior in children because they considered the results preliminary.

Mosholder's 33-page report, based on an analysis of 22 studies that involved 4,250 children and seven antidepressants, found that children who took the medications were twice as likely as those who took placebos to become suicidal.

However, FDA officials raised some concerns about how Mosholder classified suicidal behavior in the report. House and Senate Republican leaders at the end of March launched investigations into whether FDA managers prevented the release of the report (Kaiser Daily Health Policy Report, 9/14).

Mosholder Testimony

When Senate Finance Committee Chair Charles Grassley (R-Iowa) requested a copy of Mosholder's records for the investigation, Donna Katz of FDA's Office of Chief Counsel "urged him to delete material" from a sworn statement about his findings that also indicated he had been targeted by an internal inquiry, according to the Post.

FDA's Office of Internal Affairs, which conducts internal investigations, told Mosholder that he could be subject to disciplinary action and questioned him about whether he had leaked his findings to the news media. Mosholder declined to make the requested changes to his statement, saying that they would be tantamount to perjury.

FDA officials said the deletions were necessary because agency rules require that internal investigations remain secret (Washington Post, 9/24).

An FDA spokesperson said the revised version of the document did not "differ substantively" from the original. Mosholder at the hearing testified that in addition to suggestions that he remove the reference to the investigation, "at one point, alternative conclusions were offered to me, which I declined to incorporate into my written document" (Wall Street Journal, 9/24).

Mosholder said he was asked to lessen his recommendation that antidepressant use in children be discouraged and to suggest instead that children use such medications with caution, the AP/South Florida Sun-Sentinel reports. However, Dr. Paul Seligman, acting director of FDA's Office of Drug Safety, said it is routine for superiors to review research conclusions to ensure they are supported by evidence, adding, "There was never any pressure to change what he wrote" (Henderson, AP/South Florida Sun-Sentinel, 9/24).

FDA Criticized for Suppressing Information

Panel members accused FDA of suppressing information since 1996 on the increased risks of suicidality in children using antidepressants and of withholding information from clinical trials suggesting the drugs are not effective in children.

"FDA knew about the lack of efficacy in these clinical trials several years ago, and nothing has been done to change labels to inform doctors, patients and parents," Rep. Greg Walden (R-Ore.) said. In March 1996, FDA researcher Dr. James Knudsen wrote to an executive at Pfizer about an apparent "increased frequency of reports of suicidality in the pediatric/adolescent patients" who took the company's antidepressant, Zoloft, in clinical trials.

However, Knudsen's supervisor, Dr. Thomas Laughren, told the hearing that after reviewing the data he concluded they did not "represent a signal of risk." He added that there was no reason for a suicidality risk in children on antidepressants to be on the agency's "radar screen" between 1996 and last year (Shogren, Los Angeles Times, 9/24).

Temple added that suicidality risk in children taking the drugs "was not an issue that was prominent in our thinking," adding, "We had never seen a signal for suicidality in the adult data" (Denver Post, 9/24).

However, Rep. Peter Deutsch (D-Fla.) said, "There is something terribly rotten at the FDA. No agency charged with protecting public health should have behaved with such indifference" (Los Angeles Times, 9/24).

Hinchey Warns FDA Against Weakening Advisory

Rep. Maurice Hinchey (D-N.Y.) on Wednesday sent a letter to FDA Acting Commissioner Lester Crawford alleging that FDA reduced warnings on antidepressants after sending out an advisory in March warning doctors to look for increasing signs of depression or suicidal behavior in antidepressant takers, the Denver Post reports (Mulkern, Denver Post, 9/23).

In March, FDA issued an advisory that asked several companies that manufacture 10 different antidepressants to revise the products' labels to include detailed warnings about the potential risk of suicidal tendencies in patients who take the drugs (Kaiser Daily Health Policy Report, 9/15).

However, according to the Post, when the proposed label was later sent to the pharmaceutical companies, FDA had eliminated the line indicating that the suicidal thoughts or behavior "might be a result of drug therapy" and instead included a line that said patients can worsen "whether or not they are taking antidepressant medications." Steven Galson, acting director of FDA's center for drug evaluation and research, said, "What was added in was more precise. The overall meaning absolutely isn't different."

However, in his letter, Hinchey said that it is "important to determine why this label was weakened to ensure that it does not happen again." In an interview, Hinchey said that he is concerned that FDA's past actions indicate it could undermine a recent FDA advisory committee recommendation to require pharmaceutical companies to place black box warnings on antidepressants (Denver Post, 9/23).

Los Angeles Times Examines Parents' Role

The Los Angeles Times on Thursday examined how parents' actions helped encourage FDA to take action on the use of antidepressants by children.

The Times profiled Mark Miller, whose 13-year-old son committed suicide soon after first taking the antidepressant Zoloft. Miller's Web site, devoted to the risk of antidepressants, brought together a number of parents with similar stories, and together they lobbied Congress to act on the problem. In February, a number of parents testified at an FDA advisory panel in Bethesda, Md., and the Times reports that their stories "helped persuade the panel to urge [FDA] to warn doctors about the risk of suicide."

The parents said they feel vindicated by the black box advisory issued by FDA last week but add that they will continue to "press the FDA to extend the warnings to adults and to add a warning that the drugs cause some people to become hostile or even homicidal," according to the Times (Shogren, Los Angeles Times, 9/23).

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