British Medical Journal: Secret US report surfaces on antidepressants in childre

[Guest guest]

> ImmediateAttention

> Fri, 06 Aug 2004 02:17:09 -0000

> [sSRI-Research] British Medical Journal:

> Secret US report surfaces on antidepressants in

> childre

>

> BRITISH MEDICAL JOURNAL - AUGUST 7, 2004

>

> BMJ 2004;329:307 (7 August),

> doi:10.1136/bmj.329.7461.307

>

> Secret US report surfaces on antidepressants in

> children

>

> Jeanne Lenzer

> New York

>

>

http://bmj.bmjjournals.com/cgi/content/full/329/7461/307?ehom & eaf

>

>

>

> Internal memos and a secret government report about

> the negative

> effects of antidepressants in children—suppressed by

> the US Food and

> Drug Administration—have surfaced publicly.

>

> The Alliance for Human Research Protection, a

> national network

> dedicated to ensuring ethical standards in medical

> research,

> published the documents on 26 July.

>

> The published documents confirm earlier news

> accounts that a

> government expert with the FDA's Office of Drug

> Safety, Dr Andrew

> Mosholder, found that children taking

> antidepressants were twice as

> likely to become suicidal as children taking

> placebo. He reportedly

> urged the agency to follow the lead of British

> health authorities by

> warning doctors that the risks of the newer

> antidepressants, except

> fluoxetine, might outweigh the benefits when used in

> children.

>

> The leaked documents show his data and conclusions.

> The FDA has

> subsequently acknowledged to the BMJ that Dr

> Mosholder was prevented

> from presenting his report at an advisory committee

> meeting on 2

> February and was told that if he was asked any

> questions during the

> meeting he could respond to queries only by using a

> prepared script

> approved by his supervisors.

>

> Dr Mosholder had evaluated data from 22 studies

> using nine drugs in

> 4250 children and found that 74 of the 2298 children

> taking

> antidepressants had a " suicide related event "

> compared with 34 of the

> 1952 children taking placebos.

>

> When questioned about the decision to suppress Dr

> Mosholder's report,

> Dr Robert Temple, associate director for medical

> policy in the FDA's

> drug evaluation centre, defended the agency's

> actions. " We thought

> the analysis was premature, " he told the BMJ.

>

> Both the raw data and Dr Mosholder's interpretation

> were " imperfect "

> said Dr Temple, adding that some of the behaviours

> labelled " suicidal " were highly suspect and could

> have been

> accidents, such as a child " who hit her head with

> her hand. " FDA

> officials acknowledged, however, that some cases

> classified

> as " accidental injury " could be suicide related.

> Because of this, the

> FDA has contracted with Columbia University to

> further study and

> classify events that might be considered to be

> suicide related.

>

> Some of these events, he added, such as superficial

> cutting, " might

> be due to anxiety " and not represent true suicidal

> intent.

>

> Dr Thomas Laughren, the FDA's team leader for

> psychiatric drug

> products, told the BMJ that he had reported the

> relative risk ratios

> of all the drugs evaluated at the advisory meeting

> and that it was Dr

> Mosholder's conclusions, and not the data, that were

> withheld.

>

> Responding to critics who say studies of

> antidepressants other than

> fluoxetine show little or no efficacy in children,

> Dr Temple said

> absence of proof should not be interpreted to mean

> the drugs are

> ineffective.

>

> Dr Jerome Hoffman, an epidemiologist and professor

> of medicine at the

> University of California at Los Angeles, told the

> BMJ that the flip

> side of Dr Temple's claim that antidepressants in

> children could be

> life-saving is that they could be life

> threatening—as suggested by Dr

> Mosholder's report.

>

> " Most Americans undoubtedly believe that the FDA

> demands reasonable

> evidence that a drug is safe before it is allowed to

> be used, " said

> Professor Hoffman. " But this episode suggests that

> they reject this

> `precautionary principle' in favour of the idea that

> no drug is

> dangerous unless it is `proven' to be so. "

>

> " The FDA... attempted to silence Dr Mosholder [but]

> repeatedly

> claimed to `support his concern' for the safety of

> children, " added

> Professor Hoffman, " but this apparently didn't

> extend to supporting

> his desire to express that concern publicly. That

> may be the most

> dangerous aspect of this entire affair. "

>

> The FDA has launched a criminal investigation to

> find out which

> employees leaked Dr Mosholder's report. Meanwhile

> the suppression of

> the report has triggered Congressional

> investigations by Senator

> Charles Grassley, who has interviewed employees in

> the agency's

> Office of Drug Safety, where Dr Mosholder worked.