Antidepressant Makers Withhold Data on Children By Shankar Vedantam Washington Post Staff Writer Thursday, January 29, 2004; Page A01 - Commentary by Fred A. Baughman Jr., MD

 Fred A. Baughman Jr., MD comments on:

  Antidepressant Makers Withhold Data on Children
  By Shankar Vedantam
  Washington Post Staff Writer
  Thursday, January 29, 2004; Page A01
 
  Makers of popular antidepressants such as Paxil, Zoloft and Effexor have
  refused to disclose the details of most clinical trials involving
  depressed children, denying doctors and parents crucial evidence as they
  weigh fresh fears that such medicines may cause some children to become
  suicidal. 

[Fred A. Baughman Jr., MD:
this should be, is, criminal. ]

  
  The companies say the studies are trade secrets. Researchers familiar
  with the unpublished data said the majority of secret trials show that
  children taking the medicines did not get any better than children
  taking dummy pills.
 
  Although the drug industry's practice of suppressing data unfavorable to
  its products is legal, doctors and advocates say such secrecy distorts
  the scientific record.  

[Fred A. Baughman Jr., MD:
that such is still within the law, is an
anomaly, that can only have been bought, paid for]

  "Conflicts of interest and the company control of the data have thrown
  out the scientific method," said Vera Hassner Sharav, a critic of the
  drugs and a patients' rights advocate. "If hundreds of trials don't work
  out, they don't publish them, they don't talk about them."
 
  "We need a journal of negative findings," agreed Darrel Regier, director
  of the American Psychiatric Association's division of research, who
  believes the drugs save children's lives. "The probability of those
  negative findings being published is far less than the chances of
  positive studies -- -- the companies. "They have a legitimate right to
  do what they want with the data," he said.
 
  But David Healy, a Welsh psychiatrist and author of "The Antidepressant
  Era," rejected the notion that the safety information could be treated
  like any other private property. 

[Fred A. Baughman Jr., MD:
This is information pertaining
to the true efficacy and to the morbidity and mortality rates in
children/humans, and should be disclosed to the public]

Healy
prescribes the medicines but has
  campaigned for more cautious use and more accurate labeling.
  "On a pressing issue like this," he said, "there is no reason these data
  could not be put into the public domain in their entirety."
 
  The FDA said it is evaluating 20 studies in all, but agency officials
  have declined to identify them.
 
  In the end, some scientists believe, the only way to ensure that science
  is conducted in the public interest is for it to be funded with public
  dollars. The National Institutes of Health is therefore ramping up
  funding for clinical trials.
 
  "We have been dependent on the pharmaceutical industry to provide the
  answers," said Thomas R. Insel, director of the National Institute of
  Mental Health. "The questions they want answered are different than the
  public health questions."