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Fred A. Baughman Jr., MD comments: 

 Lawmaker: FDA Resisting Antidepressant Probe 
  
 1 hour, 49 minutes ago 
  
 By Lisa Richwine 
  
 WASHINGTON (Reuters) - A top Republican lawmaker on Thursday charged the 
 U.S. Food and Drug Administration (news - web sites) with hindering a 
 congressional investigation into whether the agency suppressed a possible 
 link between antidepressant use and suicidal behavior in youth.  

[Fred A. Baughman Jr., MD:
the fundamental
character of the FDA has changed since the early 60's when they stopped the marketing of
thalidomide in the US and largely protected us from the epidemic congenital
amputations. Today we would, I am sure, have an immense population of such newborns
with the FDA and this administration standing strong, claiming there was no causal link.
We are worse off for the FDA today, believing in the least they protect us. Clearly, the
FDA with all of the government is on the payroll of big pharma]


 Rep. Joe Barton (news, bio, voting record), chairman of the U.S. House 
 Energy and Commerce Committee, said the FDA (news - web sites) has been 
 uncooperative during the committee's inquiry, which began as a general probe 
 into the risks of the mood-enhancing medicines in children and teens. 

[Fred A. Baughman Jr., MD:
all of
whom are normal, though the psycho-pharm-gov cartel says each with troubled behavior
or emotions has a brain disease; always a lie]


 "Unfortunately, over the last several months, the committee has been met 
 mostly with stonewalling, slow-rolling and plain incompetency from the FDA," 
 said Barton, of Texas. 
  
 The committee asked the agency to supply lawmakers with all related 
 documents, but an FDA employee decided to limit the number of records it 
 sent, Barton charged. 
  
 If necessary, "we will send committee staff to the FDA with the (U.S.) 
 Capitol Police ... and we will go through the files ourselves," he said. 
  
 Dr. Janet Woodcock, FDA's acting deputy commissioner for operations, said 
 the agency had supplied the requested documents and the "FDA will make every 
 effort to cooperate with the committee." 
  
 She also said committee investigators had declined invitations to review 
 documents at the FDA but were still welcome to do so. 
  
 Seven months ago, the committee began probing whether the widely used drugs 
 would increase the risk of children and teenagers committing suicide, 
 prompted by the agency review of the medicines. 
  
 One FDA reviewer, Andrew Mosholder, concluded there was a link, but other 
 agency officials disagreed and decided Mosholder should not present his 
 views at an advisory committee meeting held earlier this year. 
  
 Questions about a possible link first arose last year when regulators 
 reviewed clinical trials of children who took GlaxoSmithKline Plc's Paxil. 
 Only Eli Lilly and Co.'s Prozac, sold generically as fluoxetine, is approved 
 for treating pediatric depression. 
  
 The agency review also includes Pfizer Inc.'s Zoloft, Forest Laboratories 
 Inc.'s Celexa, Wyeth's Effexor, Bristol-Myers Squibb's Serzone, Solvay's 
 Luvox, Akzo Nobel's Remeron, and two other GlaxoSmithKline drugs -- 
 Wellbutrin and Zyban. 
  
 The FDA has not reached a final decision about any link, but last month said 
 it would update antidepressant labels to include information from various 
 studies. 
  
 It also called for a separate analysis from Columbia University that 
 Mosholder has said echoes many of his concerns. 
  
 A panel of outside experts convened by the FDA meets next week to discuss 
 the new analysis and other information. 
  
 The antidepressant controversy has prompted calls for better disclosure of 
 clinical trials that yield unfavorable results. Manufacturers did not 
 publicize studies that raised safety questions and that failed to show the 
 effectiveness of most of the drugs in treating pediatric depression. 

[Fred A. Baughman Jr., MD:
not safe and
not effective. The risk vs. benefit analysis does not add up to reason or justification to
use in children]


 To forestall future similar problems, major medical journals said this week 
 they would not publish results from any clinical trials that are not 
 registered in a national database. 
  
 "The bottom line is that physicians and researchers who formulate treatment 
 guidelines for patients must be able to trust the information that they 
 use," Dr. Ronald Davis, an American Medical Association trustee, said at the 
 hearing. (Additional reporting by Susan Heavey) 
  

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