Leading Herbal Trade Association Faults Latest St. John's Wort Study in JAMA

Apr 18, 2001, 01:00 ET from American Herbal Products Association

    WASHINGTON, April 18 /PRNewswire/ -- A new study published in the April
 18th edition of Journal of the American Medical Association (JAMA), and
 underwritten in part by the pharmaceutical giant Pfizer Inc., purports to
 prove that the popular herb St. John's wort is ineffective for major
 depression.  Critics of the study, which was conducted on 200 patients
 diagnosed having major depression, say that the study has little to do with
 either the traditional use of St. John's wort or the recent modern clinical
 trials that have demonstrated conclusively that St. John's wort is effective
 in the treatment of mild to moderate depression.
     "In spite of the authors' dismissal of virtually all previous research,
 this report does not invalidate the many recent clinical studies that have
 demonstrated that St. John's wort is effective for mild to moderate
 depression," said Joseph Betz, Ph.D., Vice President of Scientific and
 Technical Affairs for the American Herbal Products Association (AHPA). Betz
 added, "This study evaluates St. John's wort for the treatment of a condition
 (major depression) for which it is not used.  It's ironic that the study's
 authors cited three recent published St. John's wort clinical trials which
 demonstrate conclusively that St. John's wort is superior to placebo, and
 equivalent to existing anti-depressants for treatment of mild to moderate
 depression but dismissed these studies merely because they were designed to
 determine the effects on mild to moderate depression."
     The study was designed and funded by Pfizer Inc., which makes sertraline
 (Zoloft)(R), a leading antidepressant medication.  Observers have criticized
 JAMA for printing an incomplete financial disclosure statement for Pfizer
 Inc., since JAMA states that the company is a St. John's wort manufacturer,
 when in fact, Pfizer did not manufacture St. John's wort when it designed and
 conducted the study.  Pfizer recently acquired Warner-Lambert, which had a St.
 John's wort product line, but discontinued the line shortly after the
 acquisition was made.
     Dr. Richard C. Shelton of Vanderbilt University led the research team.
 Shelton criticized all previous St. John's wort studies as poorly designed,
 yet experts have observed that Shelton's study suffers from some critical
 design flaws of its own.  "The study's lack of an active treatment group is a
 potential problem since it is fundamental in clinical trials for which
 effective treatment exists," said Michael McGuffin, AHPA President.  McGuffin
 added, "It is ethically questionable that the study treated patients with
 major depression, a potentially life threatening disease, for eight weeks with
 a placebo and with a treatment that is not noted for its activity in major
 depression."
     The traditional and approved use for St. John's wort in Europe is for mild
 and moderate depression and is sold in the United States as a gentle mood
 enhancer.
 
         The American Herbal Products Association (AHPA) is the leading trade
 association for manufacturers of herbal products.  AHPA serves its members by
 promoting the responsible commerce of products that contain herbs. For more
 information:  http://www.ahpa.org .
 
 

SOURCE American Herbal Products Association
    WASHINGTON, April 18 /PRNewswire/ -- A new study published in the April
 18th edition of Journal of the American Medical Association (JAMA), and
 underwritten in part by the pharmaceutical giant Pfizer Inc., purports to
 prove that the popular herb St. John's wort is ineffective for major
 depression.  Critics of the study, which was conducted on 200 patients
 diagnosed having major depression, say that the study has little to do with
 either the traditional use of St. John's wort or the recent modern clinical
 trials that have demonstrated conclusively that St. John's wort is effective
 in the treatment of mild to moderate depression.
     "In spite of the authors' dismissal of virtually all previous research,
 this report does not invalidate the many recent clinical studies that have
 demonstrated that St. John's wort is effective for mild to moderate
 depression," said Joseph Betz, Ph.D., Vice President of Scientific and
 Technical Affairs for the American Herbal Products Association (AHPA). Betz
 added, "This study evaluates St. John's wort for the treatment of a condition
 (major depression) for which it is not used.  It's ironic that the study's
 authors cited three recent published St. John's wort clinical trials which
 demonstrate conclusively that St. John's wort is superior to placebo, and
 equivalent to existing anti-depressants for treatment of mild to moderate
 depression but dismissed these studies merely because they were designed to
 determine the effects on mild to moderate depression."
     The study was designed and funded by Pfizer Inc., which makes sertraline
 (Zoloft)(R), a leading antidepressant medication.  Observers have criticized
 JAMA for printing an incomplete financial disclosure statement for Pfizer
 Inc., since JAMA states that the company is a St. John's wort manufacturer,
 when in fact, Pfizer did not manufacture St. John's wort when it designed and
 conducted the study.  Pfizer recently acquired Warner-Lambert, which had a St.
 John's wort product line, but discontinued the line shortly after the
 acquisition was made.
     Dr. Richard C. Shelton of Vanderbilt University led the research team.
 Shelton criticized all previous St. John's wort studies as poorly designed,
 yet experts have observed that Shelton's study suffers from some critical
 design flaws of its own.  "The study's lack of an active treatment group is a
 potential problem since it is fundamental in clinical trials for which
 effective treatment exists," said Michael McGuffin, AHPA President.  McGuffin
 added, "It is ethically questionable that the study treated patients with
 major depression, a potentially life threatening disease, for eight weeks with
 a placebo and with a treatment that is not noted for its activity in major
 depression."
     The traditional and approved use for St. John's wort in Europe is for mild
 and moderate depression and is sold in the United States as a gentle mood
 enhancer.
 
         The American Herbal Products Association (AHPA) is the leading trade
 association for manufacturers of herbal products.  AHPA serves its members by
 promoting the responsible commerce of products that contain herbs. For more
 information:  http://www.ahpa.org .
 
 SOURCE  American Herbal Products Association

RELATED LINKS

http://www.pfizer.com


http://www.warner-lambert.com/