Press coverage Around the World
Hearing 2002 - Accutane - Is this Acne Drug Treatment Linked to Depression and Suicide

Other Released Hearing Documents

Tab # Description of Document Date
1 Internal Roche Research report January 13, 1982
2 Lammer’s memo quoting Roche that they will encourage abortion July 29, 1983
3 Letter from Dr. Oakley recommending Accutane be removed from market February 1, 1988
4 Letter from Dr. Erickson discussing Accutane and Etretinate March 17, 1988
5 Memo from Dr. Graham on design considerations for Accutane post-marketing studies July 1, 1988
6 Dear Doctor letter from Roche on changes in product information September 1988
7 Letter from James Schlesselman saying Accutane Survey not worth doing unless changed October 14, 1988
8 Memo by Dr. Graham questioning the wording of Roche’s Dear Doctor letter and saying it implies 100% teratogenicity October 20, 1988
9 Letter from Dr. Hulka about Accutane Survey October 28, 1988
10 Memo by Dr. Graham on Roche proposed post-marketing studies April 6, 1989
11 Article from Dermatology Nursing on Accutane October 1989
12 Memo by Dr. Graham suggesting that Accutane be withdrawn from the market immediately May 7, 1990
13 Memo from Bob Nelson stating that Roche product labeling implies 100% birth defect rate February 19, 1991
14 Fax from Roche to Bob Nelson with attached tables April 3, 1991
15 Article from Columbus Dispatch quoting Dr. Graham’s memo July 14, 1996
16 Memo from Dr. O’Connell to Dr. Wilkin about suggested addition of depression to box warning May 1, 1997
17 Quote from FDA memo by Dr. O’Connell February 1998
18 Memo from Goetsch and Vega on Fatal Suicide Reports February 23, 1998
19 Warning Letter to Roche on misleading advertising March 5, 1998
20 Accutane Quarterly Report numbers on adverse events March 2000
21 Series of letters from Roche to FDA about Internet sales of Accutane and related materials April 4, 2000-December 10, 2002
22 Email from Wilkin discussing issues for upcoming Advisory Committee meeting June 20, 2000
23 Emails and letter about difference between FDA adverse event numbers and Roche’s numbers August 29, 2000
24 Woodcock’s letter reflecting advisory committee recommendations October 6, 2000
25 Emails about Lotronex and Accutane issues November 30, 2000
26 Letter from Roche to Mr. Stupak April 4, 2001
27 Editorial from Teratologists in JAMA April 4, 2001
28 Teratology article about continued occurrence of Accutane-exposed pregnancies May 7, 2001
29 Email from Woodcock on Slone survey May 20, 2001
30 Email from Ann Trontell on Slone survey May 24, 2001
31 Email from Pitts saying Accutane’s teratogenicity is equal to that of thalidomide July 16, 2001
32 Email from Beitz estimating that the number of congenital anomalies in Accutane-exposed pregnancies is between 12 and 42% July 27, 2001
33 Draft of O’Connell memo entitled “Accutane and Psychiatric Adverse Events:  The FDA Perspective” August 1, 2001
34 O’Connell and Bull’s responses to email from a dermatologist suggesting FDA has anti-abortion agenda August 3, 2001
35 Email from Trontell stating that 3% of Accutane prescribers write 20% of Accutane scripts August 31, 2001
36 Roche email celebrating the fact that have no registry which would have alienated AAD October 30, 2001
37 Letter from Waugh to FDA with accompanying internal report “General pharmacological and drug interaction studies...” January 30, 2002
38 Journal of Amer. Acad. Of Derm. article by Wysowski April 2002
39 Email string discussing underreporting of adverse events “1 in 100” April 9, 2002
40 Elle magazine article--Accutane October 2002
41 Article about Roche marketing representative who violated marketing rules November 29, 2002
42 Stupak letter to Woodcock December 6, 2002
43 Summary of Advisory Committee meetings 1988-90 No date
44 “The Dead, the Deaf, and the Dizzy” No date
45 Memorandum of Teleconferences between Roche and FDA No date
46 Letter from FDA to Roche about representative making misleading statements about Accutane at exhibit booth No date
47 Series of Roche slides No date
48 Graham memo discussing fact that HHS should withdraw Accutane from market No date
49 Table of Accutane Distribution Data No date
50 Roche Dear Doctor letter on changes No date
51 Chart on numbers of exposed pregnancies No date
52 Table on Accutane Survey numbers, post-SMART 2002
53 Acne Free Advertisement No date
54 Chart of Top 25 Territories No date
55 Roche 2001 Strategic Plan for Accutane 2000


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