On the FDA’s Decision To Withdraw Avastin’s Breast Cancer Indication

Merrill Goozer

Posted 11/18/11 on Gooz News

They did the right thing. Two clinical trials showed no improvement in mortality among women with metastatic breast cancer. Those trials didn’t even replicate the delay in progression of disease that had been shown in the original trial that led to accelerated approval in 2007.

Now comes the firestorm from patient advocacy groups, who will use anecdotal stories to claim the drug works for some women. The drug industry’s flaks and sycophants will suggest the FDA’s overweaning regulatory apparatus is stifling innovation.

Continue reading “On the FDA’s Decision To Withdraw Avastin’s Breast Cancer Indication”

An Unbalanced and Harmful Approach to Quality Measurement: Is Life Expectancy Enough?

Jaan Sidorov

Posted 10/12/11 on Disease Management Care Blog

Sei Lee and Louise Walter, in this Commentary published in the Oct 5 issue of JAMA, argue that the current  approach to measuring health care quality often leads to unintended harm for many older adults.  That’s because the guidelines-driven and evidence-based measures are “unbalanced.”

The Disease Management Care Blog agrees that the state-of-the-art is unbalanced, but it’s even worse than Drs. Lee and Walter describe.

First, the Commentary…..

Right now, standard methods for assessing the degree of blood pressure control (typically defined as being less than 140/90) doesn’t account for some elders being prone to getting low blood pressure and dizzy when they’re upright. Blood sugar control is a good idea among most persons with diabetes, but for many reasons, older persons are more prone to having dangerously low dips in their glucose levels.  Last but not least, there’s also the questionable wisdom of screening for cancer when the likelihood of death from other causes is far greater.
Continue reading “An Unbalanced and Harmful Approach to Quality Measurement: Is Life Expectancy Enough?”

Peter Pronovost is a liar. He must be.

Click to toggle image sizePeter Pronovost and his subversive friends are at it again.  Imagine, first they assert that implementation of a standard protocol and checklist could reduce the rate of central line associated bloodstream infections.

“It wouldn’t work here.  Our patients are sicker.”

Then, to make matters worse, they go and contend that reducing the rate of central line infections saves money.  Here’s the abstract from the American Journal of Medical Quality:

This study calculates the costs and benefits of a patient safety program in intensive care units in 6 hospitals that were part of the Michigan Keystone ICU Patient Safety Program. On average, 29.9 catheter-related bloodstream infections and 18.0 cases of ventilator-associated pneumonia were averted per hospital on an annual basis. The average cost of the intervention is $3375 per infection averted, measured in 2007 dollars. The cost of the intervention is substantially less than estimates of the additional health care costs associated with these infections, which range from $12,208 to $56,167 per infection episode. These results do not take into account the additional effect of the Michigan Keystone program in terms of reducing cases of sepsis or its effects in terms of preventing mortality, improving teamwork, and reducing nurse turnover.

“No, it can’t work that way unless we get rid of fee-for-service payments and go to capitation.  We all know that nobody will act to reduce infections because they will get paid less.”

Continue reading “Peter Pronovost is a liar. He must be.”