Table 1.
Studies of Drugs on Bipolar Disorder on Pharmaceutical Industry Web Sites
Company | Drug | Web site visited | Ease of navigation | Results | If limited data on company Web site, findings on www.clinicalstudyresults.org | Type of information provided | # of studies on company Web site or PHRMA Web site | # of previously published studies | # of previously published negative studies | # of previously unpublished negative studies |
---|---|---|---|---|---|---|---|---|---|---|
Abbott | Depakote (divalproex sodium) | www.abbott.com | Link to “Depakote”; link to “Professionals”; link to “Proven Efficacy.” No further data. | No data | 1 unpublished positive study for Depakote ER in acute mania[38]; no data provided. No reference to 2 previously published positive studies in acute mania,[39,40] and a failed maintenance study.[41] | Only title of study | 1 | 0 | 0 | 0 |
AstraZeneca | Seroquel (quetiapine) | www.astrazeneca.com | Link to “AstraZeneca-US”; Link to “Products”; Link to “Seroquel”; Link to “Healthcare professionals.” No further data. | 4 in acute mania reported, 3 positive have been published,[42–44] and 1 negative unpublished study in acute mania;[45] 1 positive published study in acute bipolar depression[46] | NA | Full protocol with detailed summary of results. Mean ± SD length 8.6 ± 1.1 pages (range 7–10) | 6 | 5 | 0 | 1 |
Bristol-Myers Squibb | Abilify (aripiprazole) | www.bms.com | Link to “Clinical trials disclosure”; Link to “Clinical trials registry”; Link to “Therapeutic areas”; Link to “Psychiatric disorders”; | 5 studies in acute mania, bipolar depression, or mania cited by titles and listed as “Recruiting” with no further information; 3 studies cited as “no longer recruiting” and 1 as “completed.” No citations provided. | No titles or data. No reference to 2 previously published positive studies.[47,48] | Titles of studies only | 5 | 2 | 0 | 1 |
Eli Lilly | Zyprexa (olanzapine) | www.elililly.com | Link to “Products”; link to “Lilly clinical trials”; link to “Trials results by product”; link to “Zyprexa” | 6 studies of acute mania, 3 studies of relapse prevention, all positive published studies[49–57] | NA | Full protocol with detailed summary of results. Mean ± SD length 15.6 ± 8.0 pages (range 6–28) | 10 | 9 | 1 | 0 |
Eli Lilly | Symbiax (olanzapine-fluoxetine combination) | www.elililly.com | Link to “Products”; link to “Lilly clinical trials”; link to “Trials results by product”; link to “Symbiax” | 1 positive study in acute bipolar depression[58] | NA | Full protocol with detailed summary of results. Length 16 pages | 1 | 1 | 0 | 0 |
GSK | Lamictal (lamotrigine) | www.gsk.com | Link to “Clinical trial register”; link to “Lamotrigine” | See Table 2 | NA | See Table 2 | 9 | 2 | 2 | 5 |
Janssen | Risperdal (risperidone) | www.janssen.com | Link to “Our products”; link to “Risperdal”; link to “Risperdal for bipolar mania” | No data | No titles or data. No reference to four previously published positive studies in acute mania,[59–62] or one previously published negative but underpowered study in acute bipolar depression[63] | No titles or data | 0 | 4 | 1 | 0 |
Pfizer | Geodon (ziprasidone) | www.pfizer.com | Link to “Medicines and products”; link to “Geodon”; link to “For healthcare professionals”; link to “Clinical trial data”; link to “Geodon for bipolar mania and mixed episodes” | One efficacy graph from 1 published study provided[64] | 2 positive studies in acute mania, 1 published[64] and 1 unpublished.[65] No reference to another positive published acute mania trial[66] | Full protocol with detailed summary of results. Mean ± SD length 7.0 ± 2.0 pages (range 5–9) | 2 | 2 | 0 | 0 |