Good morning, one and all. Damian Garde here, filling in for Ed Silverman on what looks like a dreary day, at least weather-wise, on Pharmalot’s satellite campus to the north. Here, please find your as-expected handful of headlines to begin what we hope will be a day as productive as it is painless. And if you hear something particularly head-turning along the way, do drop us a line.
Johnson & Johnson (JNJ) is breaking the law to protect its blockbuster anti-inflammatory Remicade, according to Pfizer, which is suing in hopes of improving sales for its biosimilar. Pfizer (PFE) argues that J&J is using rebates and contracts to illegally maintain a monopoly, pulling strings with pharmacy benefit managers to keep Inflectra, the biosimilar, from getting the insurance coverage it needs to gain market share.
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Stupid CVS is running our life. Yes I agree Drs need to stop giving opioid to young people. Only for a short term after a surgery. Looks like it’s time to legalize marijuana. If we can’t get pain relief with pills anymore I will smoke weed.
Any pharma biostatistician will tell you that the efficacy trials with the greatest chance of success ask one question, with one primary endpoint, with sample size sufficient to answer the single question with adequate statistical power to do so with significance level set at P = 0.05. The sponsor is free to have as many secondary endpoints as it wants, but the umpires (FDA) will tell you that efficacy data from secondary endpoints is not allowable for claims even if prespecified. Where there are no prespecified analyses any data derived therefrom is called data dredging, and is also not allowable notwithstanding the pleadings of Marketing to use these data.
I discuss in some detail because this system is far from broken. The only “problem” is that this is an axpensive way of doing clinical development. Woodcock is favoring what is favoring the idea of a Master Protocol, which asks multiple questions with multiple endpoints. When referring to “innovative statistical designs” this would imply that the agency will start accepting secondary endpoint outcome measures, and other types of non traditional analyses that depart from 55 years of historical precedent.