Dr. Breggin Paxil Special Report

Dr. Breggin’s testimony noted, inter alia:

SKB, as this report will document, repeatedly found ways to hide or simply not to generate data about adverse effects.

Note that the rate for suicide attempts on Paroxetine approaches 1% which the FDA considers "frequent."

Also note that the rate for suicide attempts on Paroxetine 3.8 times higher than for placebo and 3.6 times higher than for the comparison antidepressants (tricyclics).

Furthermore, the suicide attempt on imipramine is listed as a “possible suicide (p. 211, stamped 306).  In regard to the onset of suicide attempts, one patient (117A-004, p. 200, stamped 291) cut himself on the third day of Paxil: “One day 3 this patient attempted to slash his wrists and abdomen and was withdrawn from the study.” Also note that case 647 002 (above) made attempts on days 1, 8, and 15.

This all-important United States Data is not presented in the text of SKB's April 29, 1991 report for the FDA, "Suicidal Ideation and Behavior: Analysis of the paroxetine Worldwide Clinical Database." To hide the U.S. data within worldwide data was extremely misleading.

2. Leaving Out Two Non-U.S. Suicide Attempts There is evidence that some suicide attempts were omitted from the calculations sent to the FDA. In the report “Adverse experienced which occurred during active treatment. Non-US Phase II-III studies” (Appendix V.1) , I located two patients that appear to have been left out of the summaries of non-US suicide attempts. Case 647 002 (Volume 420, p. 157) made three suicide attempts on days 1, 8, and finally on day 15 when the drug was stopped. The first two were considered “related” and the third “possibly related.” Also, case 1 113 120 (Volume 420, p. 157) was considered “definitely drugged related.”

These two attempted suicides do not appear in the complete list of 40 in the April 29, 1991 suicide report (pp. 17-18).

These two suicide attempts, including one patient with three attempts, are not listed in the April 19, 1991 suicide report or in any other source that we have located.

This brings the total of non-US suicide attempts to 32.

Note Until May 12, 2006 the FDA had never issued the specific warning of “increased risk of suicides in young adults ages 18-30, although this declaration was taken August 14, 2001.  The following day, May 13, 2006, Glaxo Smith Kline issued a similar warning (Id. Shipko Opinion at pp. 10-11.)