Here is yet another facet of the complicated story about possible suppression of research data about selective serotonin uptake inhibitor (SSRI) anti-depressants.
The British Medical Journal just received documents from an anonymous source about adverse effects of fluoxetine (Prozac) that went missing for 10 years from the files of the Wesbecker case. Joseph Wesbecker shot and killed 8 people, wounded 12 more, and then commited suicide. He had been taking fluoexetine for one month for his depression. The plaintiffs against Eli Lilly, the manufacturer of Prozac, claimed the company withheld data unfavorable to fluoxetine from the FDA, and that the drug caused Wesbecker's homicidal rage. Lilly apparently won the case, and used the results to argue that Prozac had been proven safe and effective in a court of law. However, the judge later ruled the case "dismissed as settled with prejudice" because he discovered Lilly had secretly settled the case before the jury verdict.
Among the newly found documents was an internal company report that showed that fluoxetine lead to a 19% absolute risk increase for activation symptoms. Such symptoms included agitation, panic attacks, and aggressiveness. This information was never provided to the FDA.
The increasingly complex story of suppression of SSRI research seems to be part of a growing epidemic of suppression of medical research.
Let's say it again. Withholding data from clinical research is unethical because:
1. it breaks the promise to research subjects that their voluntary participation has scientific or social value, but undisseminated research has no value; (See Emanuel EJ et al. What makes clinical research ethical? JAMA 2000; 283: 2701-2711.)
2. it impedes scientific progress;
3. it prevents patients from receiving the best possible medical care.
But until this unethical behavior starts having negative consequences for its perpetrators, the epidemic of research suppression is likely to continue.
Links 8/25/16 - [image: sleeping cat links]
37 minutes ago