This is the first of two stories on monitoring the safety of new drugs — read the second here


hen a new remedy for rheumatoid arthritis arrived, ads called it a “unique” breakthrough that would “transform expectations” for patients and doctors. “If I knew then what I know now about rheumatoid arthritis, I would have been more proactive,” said one young woman, pictured happily kayaking.

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  • Bread, specifically na’an, gave me arthritis. Took 6 months of abstaining for my finger joints to feel normal again.

  • Well researched indeed. But at the risk of labelled a Roche stooge, I find this too one-sided and biased. For e.g., you could have delved deeper to see what percentage of Actemra patients who suffered these severe AEs were recipients of Humira/Enbrel in previous lines of therapy? May be they carried the risks flagged for those drugs? And may be that is why if Actemra is no worse than Humira/Enbrel in heart AEs or pulmonary AEs, that shows that they are not increasing the threats?

    Obviously the caveats of statistical analysis notwithstanding, it will be a “definitive” proof of your claims if you show how many of the SAEs/deaths happened when patients took Actemra in first-line, compared to later lines of therapy. You have to consider the disease progression by the time patients end up getting Actemra.

  • Hello I have been on this medication every 4 weeks for 3 years reading this I am worried I do get palpitations I have a enlarged liver but the side effects are not addressed I am in uk

  • Excellent research and reporting, thank you. Please consider a similar series monitoring the safety of medical and dental devices, which receive even less scrutiny by the FDA than pharmaceuticals.

  • We feel we have a Fix/prophylactic for Alzheimer’s Please GOOGLE Jack William Schultz, presented there.
    Our most recent profound finding: Alzheimer’s patients that have reached a state/stage of Severe Agitation (requiring multiple caregivers 24/7) better than 80% of those patients STOP those symptoms in 5 days or less. No longer needing multiple caregivers 24/7.
    Pharma not happy with a cost effective drug to address this and other issues noted in my patents.
    What do you suggest to avoid bankrupting Social Security,Medicare and Medicaid in the next 15 years?
    404-697-5353 404-803-5409

    • Have you tried marketing/studies in the usual manner. You are selling!
      If you truly have magic drug, go through proper channels. Can you cite publications? Thx

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