Category Archives: Clinical Trial

Hamburg: Society needs to weigh in

Including the patient voice in the drug approval process could produce a fundamental shift in the risk-benefit equation of a new drug. But first, the FDA has to figure out how to do it, and that may take a broader…

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Rock to the left, hard place to the right: One dilemma of compassionate use

Before its unfortunate drop in quality in its last few seasons, the medical drama House was one of my favorite shows, with its title character, a cranky, possibly drug-addicted doctor solving diagnostic riddles and saving lives with Sherlockian brilliance, and quite…

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Human germline engineering: The mom’s not in the picture

U.S. and British government agencies are moving toward enabling what would be the first clinical trials of what is, in effect, human germline engineering – genetic modifications that would be passed down through the generations. The modifications would not be…

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Patient Experience Still Undervalued in Regulating Drugs

As I write this, I’m sitting in the University of British Columbia/Vancouver General Hospital (UBC/VGH) Eye Care Centre, where my husband, Chuck, is completing post-tests at the conclusion of a six-month study on prosopagnosia, otherwise known as face blindness. The…

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Oh, Give it Iressa! Nope: ‘Bad Pharma’ Firms Need to Tell More

So urgently did I think I wanted to read Ben Goldacre’s Bad Pharma, that I ordered it from Amazon’s UK site last November, unwilling to wait for U.S. publication – which happened just as I reached the end, polishing off…

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Patients Want More than Check-the-Box Experience

Patients getting their four minutes to say how an experimental drug changed their life or gave them hope have become a routine part of nearly every FDA advisory committee meeting – as routine as the call to order or the…

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FDA’s Confusing Action Against Burzynski – What Does it Really Mean?

Last month the FDA’s Office of Prescription Drug Promotion (OPDP) issued a warning letter to the Burzynski Research Institute Inc. and the Burzynski Clinic regarding claims made for its antineoplastons A10 and AS2-1 injections that violate the Federal Food, Drug,…

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In Kidney, the Name Game not Just ‘A-Cute’ Switcheroo

I was on the phone last week with Rick Andrews, president and CEO of Thrasos, about acute kidney injury (AKI), and how it’s no longer called “acute renal failure,” the latter phrase having been scrapped in recent years. Cynics might…

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Want Better Data? Align Professional Incentives

This week, researchers are presenting their latest and greatest at the annual meeting of the American Association of Cancer Research. The excitement of all those novel findings, though, received something of an advance puncturing last week by a commentary in…

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And the Bio-Oscar Goes to . . .

I have a fondness for the movies and I perform a function in the biotechnology market, so it’s a bonus when I can combine the two. I’ve written about the correlation between the movie and drug businesses before, so indulge…

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