Tag: Food and Drug Administration
Now that Burzynski has gotten off in 2012, Burzynski The Movie will spawn a sequel in 2013
About a year ago, I became interested in a physician named Stanislaw Burzynski who has been treating cancer with compounds that he calls “antineoplastons” for over three decades without, in my opinion, ever having ever produced any compelling evidence that antineoplastons have significant anticancer activity. Although I had been vaguely aware of Burzynski and his activities, it was the first time that...
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...
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...
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...
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...
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.
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...
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...
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...