Tag: Pharmaceuticals

Vice President Mike Pence is a supporter of right-to-try, having signed Indiana's right-to-try bill into law when he was the Governor of Indiana.

The cruel sham that is right-to-try raises its ugly head at the federal level again

Ill-advised right-to-try bills are spreading like kudzu through state legislatures. Now federal legislators want to insert right-to-try language into the bill that funds FDA drug approval. Given the support of powerful Republicans like Vice President Mike Pence for right-to-try, is it too late to stop this juggernaut and protect patients?

/ April 17, 2017
Translational research and preclinical data

Donald Trump versus the FDA: Is the standard of evidence for drug approval actually too low rather than too high?

All of the candidates being considered by President Trump for FDA Commissioner believe that the FDA is too strict in its standards for approving new drugs. In a commentary in Nature last week, two bioethicists argued that, at least in terms of preclinical data, the standard of evidence is actually too low. Which is correct?

/ February 6, 2017
Emergency Room sign

Drug therapy is still sending too many people to the emergency department

Prescription drugs continue to send thousands to the emergency room every year. Many of these adverse drug events are predictable and avoidable.

/ December 1, 2016
Randomized controlled clinical trial

Whither the randomized controlled clinical trial?

With the rise of precision medicine and genomics, the conventional randomized clinical trial appears more and more outdated. Fortunately, clinical trials are evolving, but will it be enough to incorporate the numerous advances in "-omic" medicine in a rigorous scientific manner to benefit patients?

/ June 20, 2016

Legislators want “pharmaceutical cost transparency”. Are they asking the wrong question?

If science-based medicine is unaffordable, then your care won’t be science-based. Prescription drug costs are one of the biggest concerns in health care today. There seems to be no upper limit on prices, with some new treatments costing over $1,000 per day. The arrival of new drugs to treat (and cure) hepatitis C has created a perfect pharmaceutical storm: highly effective treatments,...

/ May 21, 2015

Cancer prevention: The forgotten stepchild of cancer research?

The New York Times has been periodically running a series about the “40 years’ war” on cancer, with most articles by Gina Kolata. I’ve touched on this series before, liking some parts of it, while others not so much. In particular, I criticized an article one article that I thought to be so misguided about how the NIH grant system leads researchers...

/ November 16, 2009

All Medicines Are Poison!

That’s the title of a new book  by Melvin H. Kirschner, M.D. When I first saw the title, I expected a polemic against conventional medicine. The first line of the Preface reassured me: “Everything we do has a risk-benefit ratio.” Dr. Kirschner took the title from his first pharmacology lecture in medical school. The professor said “I am here to teach you...

/ November 3, 2009

Wyeth vs. Levine: Should Drug Label Standards Be Determined By Juries?

It is with some degree of trepidation that I enter the fray on the Wyeth vs. Levine case. I’ve been watching the media frenzy about the lawsuit with interest – mostly because (for the first time in a while) I think that the pharmaceutical company is in the right on this one – and that most journalists (and even medical journal editors)...

/ November 6, 2008

Polypharmacy – Is It Evidence-Based?

Polypharmacy essentially means taking too many pills. It’s a real problem, especially in the elderly. A family doctor gives an elderly patient one pill for diabetes, another for high blood pressure, and another to lower cholesterol. The patient sees a rheumatologist for his arthritis and gets arthritis pills. Then he sees a psychiatrist for depression and gets an antidepressant. He takes a...

/ August 12, 2008