SSRIs: Dr. Andrew Mosholder's suppressed report [to FDA on Feb. 2nd] is posted {URL for Report is toward the end of this article}

[Guest guest]

> StopTheInsanity

> Mon, 26 Jul 2004 22:16:21 -0400

> [sSRI-Research] SSRIs: Dr. Andrew

> Mosholder's suppressed report [to FDA on Feb. 2nd]

> is posted {URL for Report is toward the end of this

> article}

>

> Dr. Andrew Mosholder is but the most recent example

> to come to light, of an

> FDA medical officer whose expert analysis and

> recommendations were

> suppressed by the agency because the recommendations

> might affect the

> financial interests of a drug manufacturer.

>

> Dr. Mosholder was asked to analyze the Paxil data in

> Sept. 2003, after the

> British regulatory agency examined the clinical

> trial data and found a

> suicidal risk for children / adolescents prescribed

> Paxil / paroxetine. The

> British issued a prohibition on the use of Paxil for

> children (June 2003).

>

> Dr. Mosholder then analyzed the suicidal behavior

> data submitted by drug

> manufacturers of 9 different antidepressants to the

> FDA from 22 randomized,

> placebo-controlled clinical trials. In these trials,

> 4,250 children /

> adolescents participated: 2,298 were given an active

> drug, and 1,952 were

> given a placebo.

>

> Dr. Mosholder found that 108 child-patients suffered

> suicide-related events:

> 74 were on active drug, and 34 on placebo. Of

> these, 78 were serious

> adverse events--54 occurred in children taking an

> active drug, compared to

> 24 on placebo. Children on an antidepressant were at

> greater than twofold

> increased risk of drug-induced suicidal behavior.

>

> Inasmuch as the drugs--with the possible exception

> of Prozac*--have failed

> to demonstrate a benefit in clinical trials, these

> serious risks are not

> offset by any scientifically proven benefit for

> children. Therefore, a

> minimal precautionary action would require prominent

> warnings to physicians

> and families.

>

> Dr. Anne Trontell, Director, Div. Of

> Neuropharmacological Drug Products, and

> Dr. Mark Avigan, Director, Div. Drug Risk

> Evaluation, concurred with Dr.

> Mosholder's analysis and conclusions, but disagreed

> that physicians and

> families should be warned about these risks.

>

> Dr. Mosholder's medically responsible, science-based

> recommendation:

>

> " Given the strength of the association shown by the

> present data, the

> clinical importance of the apparent effect...and the

> fact that the

> additional analyses are likely to take several more

> months to complete while

> considerable numbers of pediatric patients are being

> exposed to these drugs,

> I favor an interim risk management plan regarding

> the use of these drugs in

> the pediatric population. This might be of value to

> physicians, patients

> and families who are faced with the need to make a

> decision regarding

> pharmacotherapy at the present time. Specifically, I

> propose a risk

> management strategy directed at discouraging the

> off-label pediatric use of

> antidepressant drugs, particularly the use of drugs

> other than fluoxetine in

> the treatment of pediatric MDD [major depressive

> disorder]. Conceivably,

> this might include discouraging the initiation of

> treatment of drug-naïve

> pediatric MDD patients with off-label drugs, in the

> absence of some

> over-riding clinical consideration. "

>

> Dr. Mosholder's embargoed report and the

> accompanying Trontell and Avigan

> memos are posted on the AHRP website at:

> http://www.ahrp.org/risks/SSRImosholder/index.html

>

>

> Of note: FDA's chief counsel, Daniel Troy, is the

> architect of the

> administration's aggressive intervention in court on

> the side of drug and

> medical device manufacturers. Troy is one of over

> 100 top government

> regulators appointed by the Bush administration, who

> were identified as

> advocates for the industries they are supposed to

> regulate.

>

> See: Anne Mulkern, When Advocates Become Regulators.

> Denver Post, May 14,

> 2004. http://www.ahrp.org/infomail/04/05/24.html

>

> See also: Jeanne Lenzer, FDA's counsel accused of

> being too close to drug

> industry BMJ, July 24, 2004

>

>

http://bmj.bmjjournals.com/cgi/reprint/329/7459/189?maxtoshow= & HITS=10 & hits=

>

10 & RESULTFORMAT= & fulltext=Troy & searchid=1090843404662_4568 & stored_search= & FI

> RSTINDEX=0 & volume=329 & issue=7459

>

> Examples refuting the basis of FDA's pre-emption

> argument: FDA's decisions

> about drug safety are not always based on scientific

> evidence. All too often

> FDA decisions result in preventable deaths:

>

> REZULIN:

>

http://www.latimes.com/news/nation/reports/fda/lat_fda001220.htm

>

> PROPULSID:

>

http://www.latimes.com/news/nation/reports/fda/lat_propulsid001220.htm;

> webmd.com/content/article/22/1728_55973

>

> FEN-PHEN: http://www.redux-settlement.com/

> Phenylpropanolamine (PPA):

>

http://www.latimes.com/news/nationworld/nation/la-na-ppa28mar28-1,1,2552623.

> htmlstory?coll=la-home-left1

>

> RISPERDAL (risperidone); ZYPREXA (olanzapine):

> http://www.ahrp.org/infomail/0702/12b.html

>

> *It should be noted that in Dec. 2003, Eli Lilly,

> manufacturer of Prozac,

> issued a label change in the UK stating, Prozac is

> NOT recommended for

> children. See:

> http://www.ahrp.org/risks/ProzacKids1203.html ;

>

> Contact: Vera Hassner Sharav

> Tel: 212-595-8974

> e-mail: veracare

>