Tag: Food and Drug Administration

It’s time for true transparency of clinical trials data

What makes a health professional science-based? We advocate for evaluations of treatments, and treatment decisions, based on the best research methods. We compile evidence based on fair trials that minimize the risks of bias. And, importantly, we consider this evidence in the context of the plausibility of the treatment. The fact is, it’s actually not that hard to get a positive result...

/ November 8, 2012

No, sugar pills won’t repel insects, and other consequences of regulating nonsense

As a group blog, Science-Based Medicine brings a variety of perspectives to issues of science in medicine. However we align around a few core principles which define what science-based medicine is, and how it should be practiced. One principle we emphasize is the importance of subjecting the evaluation of all health interventions and treatments to a single, science-based standard. One of the...

/ June 21, 2012

Who’s to Blame for Drug Shortages?

All the best effort to practice science-based medicine are for naught when the optimal treatment is unavailable. And that’s increasingly the case – even for life-threatening illnesses. Shortages of prescription drugs, including cancer drugs, seem more frequent and more significant than at any time in the past. Just recently manufacturing deficiencies at a large U.S.-based contract drug manufacturer meant that over a...

/ September 1, 2011

Breast implants and anaplastic large cell lymphoma (ALCL): Is there a link?

I must admit that I have a bit of a love-hate relationship with breast implants. On the one hand, as a breast cancer surgeon, I see them as a major benefit to my patients who are unfortunate enough to require mastectomy in order to control their disease. The armamentarium of techniques for reconstructing breasts after mastectomy generally falls into one of two...

/ January 31, 2011

Avastin and metastatic breast cancer: When science-based medicine collides with FDA regulation

Not all drugs that prevent progression of cancer prolong the patient's survival. The case of Avastin and metastatic breast cancer reminds us of that simple, unfortunate fact once again.

/ August 30, 2010

Off-Label Use of Prescription Drugs

A recent survey of 599 primary care physicians and 600 psychiatrists found that: The adjusted response rate was 47%, respondents were similar to non-respondents, and physicians commonly prescribed the drugs examined. The average respondent accurately identified the FDA-approval status of just over half of the drug-indication pairs queried (mean 55%; median 57%). Accuracy increased modestly (mean 60%, median 63%) when limited to...

/ August 26, 2009

Is Tylenol Safe?

Tylenol (acetaminophen, also known as paracetamol outside the US) has been in the news recently. Most of the stories I’ve seen have been accurate, but I’ve run across a couple of people who misunderstood what they read. I thought I’d try to put the record straight. An FDA advisory panel has recommended reducing the maximum allowed single dose from 1000 mg to...

/ July 21, 2009

Tactless About TACT: Critiques Without Substance Should Be Abandoned

In May 2008, the article “Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned” was published online in the Medscape Journal of Medicine. The authors included two of our own SBM bloggers, Kimball Atwood and Wallace Sampson, along with Elizabeth Woeckner and Robert Baratz. It showed that the existing evidence on treating heart disease with IV chelation did not...

/ June 23, 2009

Counterfeit Drugs: A Growing Global Health Crisis

A resistant strain of bacteria –created by partially effective counterfeit antibiotics – doesn’t need a VISA and passport to get to the U.S. –    Paul Orhii, National Agency for Food and Drug Administration and Control, Nigeria I attended a conference in DC yesterday called, “The Global Impact of Fake Medicine.” Although I had initially wondered if homeopathy and the supplement industry would...

/ June 11, 2009

FDA approval of drugs and transparency in clinical trial results

Note: The reason that I am posting today rather than my usual Monday slot is because the article I discuss here was embargoed until last night. Consequently, I asked Harriet if she would trade days with me this week, and she was kind enough to do so. One thing that science relies on almost absolutely is transparency. Because one of the most...

/ September 23, 2008