Author Archives: Mark Senak

What Do Patients Want?

Thirty years ago, HIV advocates elevated the notion of patient involvement in the development of new medicines to entirely unprecedented levels by demanding input into multiple aspects of clinical development of HIV treatments.  That included not only in the way … Continue reading

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Healthcare Reform – Where Are We? – An Invitation

Over the past three decades, we have gone from Hillarycare to Obamacare to Trumpcare. The mere fact that healthcare is characterized by the names of public figures is testament to the extreme politicization of an important public policy issue. The … Continue reading

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A Memoriam and A Reckoning

Thirty years ago today, the man seated at the left died of complications from AIDS. The man standing on the right is me. This photograph was taken six weeks before he died. We were just 31 years old. Last week, … Continue reading

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OPDP Sends First Letter of 2017

To put it mildly, enforcement by the Office of Prescription Drug Promotion (OPDP) has been lagging. Warning and Untitled letters from this office numbered in the triple digits twenty years ago. In the past three years, it did not break … Continue reading

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How Much Change Does a Commissioner Make?

For the second time in as many years, we have been going through the ritual of getting a new FDA Commissioner appointed. The last one – Dr. Robert M Califf served from February 2016 until January of this year. Dr. … Continue reading

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