FDA « Andrew's Blog

Why You Must Demand Precision Medicine for Cancer

The Human Genome Project was a really big deal, identifying the genes that make up our body. And quantum leaps in computing power, added to scientific discoveries, have been helping cancer specialists identify subtypes of disease, enabling drug developers to come up with ever more targeted therapies. More and more of these medicines for ever [...]

Considering Access to Better Treatments Through “ClinicalTrials.Andrew”

I have now been in two clinical trials. The first was for chronic lymphocytic leukemia (CLL) in 2000 and 2001. The second has been since August 2011 for blood clots in my legs or “deep vein thrombosis.” I wanted to share my experiences with you in the hope more people will consider entering a clinical [...]

An Insider’s Look at the FDA

If you’ve read my blogs for a while, or look up some past blogs, you’ll see I have been frustrated at times with the FDA. Yes, they have a tough job protecting us from medical products that are unsafe and/or ineffective. But when it comes to cancer, where we have few “homerun” therapies, I wish [...]

Does the FDA Go Too Easy on Medical Devices?

I speak to people in the pharmaceutical industry much more than folks who develop medical devices. I know how pharma researchers spend years and hundreds of millions of dollars trying to develop a useful, safe new drug that the FDA will approve for marketing. Certainly there are big payoffs, but the road is filled with [...]

The Drug Companies and Online Social Media

Imagine you’re a pharmaceutical company product manager and your specific product helps people with a chronic illness, or a cancer that can be managed by taking a pill or an injectable medicine over many years. You want to be part of the dialogue patients have with each other. You want to be part of the [...]

Resisting the Hidden, and Sometimes, Heavy Hand of Public Relations

In recent years advertising agencies and public relations firms, many of them small shops run by dedicated communications entrepreneurs, have been gobbled up by marketing communications behemoths. These are the global conglomerates that work day and night to win you and me over as friends and customers. They want us to think positively about their [...]

Does the FDA Play Fair for Patients?

Dr. Richard Pazdur, director of the Food and Drug Administration’s cancer drug office

They have a tough job, those government doctors, scientists, and bureaucrats who are charged with assessing the safety and effectiveness of proposed new medical products. As you know, they rely largely on studies presented by the applicants.

The FDA has the power [...]

The Dr. No of Cancer Drugs?

The Dr. No of Cancer Drugs? from Patient Power® on Vimeo.

Life Saving Medical Technology that Doesn’t

Here’s the scenario: You are told you have a severe heart rhythm problem. One where your heart could either stop or go into such uncoordinated contractions that you will die…unless a high tech device, a defibrillator, is implanted to instantaneously jolt your heart back into healthy pumping. You are grateful you live in a time [...]

Which Doctors and Treatments are Right?

There are two items in the news this week that caught my attention. One talks about the use of over a billion dollars from the new Federal Government stimulus package to assess which widely used medical treatments are really best (NYT 2/16/09, “US to Study Effectiveness of Treatments”). The second announces how, Zagat, the prestigious [...]

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