Category Archives: Clinical Trial

Ignoring the science for a bigger box of crayons

Once upon a time in the days before enlightenment, we tried to use science to develop our drugs. Believe it or not, researchers actually had to come up with a hypothesis of how a drug might work, what disease it…

Share

Listening to the voice that matters

Since being diagnosed with cancer a few months ago, I have been in an unwanted crash course on the patient perspective of everything I’ve been writing about biopharma for the past several years. It’s an eye-opener. Genetic testing, lack of…

Share

Old dogs and new tricks: The real-world consequences of excluding older adults from drug trials

How much time do you spend with old people? That’s a loaded question, of course. Age is a relative term, since we age every day and so does the world’s population. Even though the global median age was estimated at…

Share

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…

Share

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…

Share

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…

Share

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…

Share

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…

Share

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…

Share

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,…

Share