Who are the main consultants
for Roche? Dr.
Douglas Jacobs, Psychiatrist & Dr.
William Cunliffe, Dermatologist
Who was involved in pretrial studies for Roaccutane in the 1980's
| The following are a list of doctors who participated in the US
clinicial trials::- Dr Strauss, Dr. Peck, Dr. Yoder, Dr. Windhorst,
Dr. Pochi, Dr. Shalita, Dr. Hazen, Dr. Frost, Dr. Harber. The findings
of the clinical trials were published in the American Academy of
Dermatology in 1982.. Clinical trials for UK were conducted by Professor W.J. Cunliffe and the findings were subsequently published in the British Journal of Dermatology in 1982 and 1983. In both articles the acknowledgments states that "we would like to thank Roche Products Ltd for providing the drug and finanical support.". |
Who was hired in the 1990's to prevent the FDA from strengthening psychiatric warnings on the Accutane/Roaccutane label
| Drs Bickers, Dr
Jacobs and Dr Jones were hired as consultants by
Roche to prevent the inclusion of suicide into the label warning
in the US. Dr. O'Connell, Medical Reviewer with the FDA, issued memorandum [click here] on the history leading up to inclusion of explicit psychiatric warnings including label warnings featuring suicide, suicide attempt introduced by the FDA for the drug in March 1998 out the reasons why the FDA rejected the representations made by Roche medical experts Dr Bickers, Dr Douglas G Jacobs and Dr Jones who had argued that the more explicit label warnings featuring psychotic illness, suicide, suicide attempts and suicide ideation should not be introduced by the FDA. Accordingly, the opinion of Dr Douglas G Jacobs and two other Roche advisors, arising from their review of literature relating to the drug conducted by them in 1997, was firmly and categorically rejected by the FDA for the reasons stated in the attached document. |
Who presented evidence on bahalf of Roche at the FDA Hearing in
2000
| Dr. Douglas Jacobs & Dr. Robert C. Nelson (former employee of the FDA) |
Who presented evidence on behalf of Roche at the Congressional Hearings in 2000 and 2002
| Congressional Hearing in 2000 - Dr. Douglas Jacobs. |
Who have Roche hired as consultants/expert witnesses to promote
Roaccutane/Accutane and dimish the psychiatric side effects of the drug
by publishing articles supporting the use of Roaccutane
| - Dr. Susan Jick - 'Jick
Study' - Publication by Dr. Douglas Jacobs |
Who have promoted Accutane/Roaccutane in media reports?
| Congressional Hearing in 2000 - Dr. Douglas Jacobs. |
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