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Why Don’t Drug Labels Make the Actual Harms and Benefits Clear?

By Jacob Molyneux, blog editor/senior editor

How can we know if a drug really works? Gary Schwitzer, publisher of HealthNewsReview.org (an incisive Website that grades the quality of health news reporting) addresses this question on his blog this week by drawing attention to a recent perspective piece published in the New England Journal of Medicine (NEJM). It’s called “Lost in Transmission — FDA Drug Information That Never Reaches Clinicians” and it states the problem clearly:

The 2009 federal stimulus package included $1.1 billion to support comparative-effectiveness research about medical treatments. No money has been allocated — and relatively little would be needed — to disseminate existing but practically inaccessible information about the benefits and harms of prescription drugs. Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles.

The most direct way that the FDA communicates the prescribing information that clinicians need is through the drug label. Labels, the package inserts that come with medications, are reprinted in the Physicians’ Desk Reference and excerpted in electronic references. To ensure that labels do not exaggerate benefits or play down harms, Congress might have required that the FDA or another disinterested party write them. But it did not. Drug labels are written by drug companies, then negotiated and approved by the FDA.

One example given in the NEJM article is the sleeping pill Lunesta:

Clinicians who are interested in (Lunesta’s) efficacy cannot find efficacy information in […]

Mid-October Rainy Thursday Web Roundup

By Jacob Molyneux, blog editor/senior editor

The nursosphere is thriving and Change of Shift, the always interesting compendium of what’s new on nursing blogs, is up over at Emergiblog.

The health care reform process creeps slowly but surely toward an end someone somewhere can surely envision. One crucial question many are still asking is whether insurance companies might serve consumers a bit more readily and agreeably if they were forced to face a little competition from a public option. After all, isn’t competition supposed to be a good thing?

Most experts don’t expect the H1N1 vaccine to pose any more danger than the seasonal flu vaccine; even so, many Americans (and nurses commenting here, or taking our poll about the mandatory vaccine) continue to be wary, prompting public health officials to engage in especially aggressive surveillance measures in order to quickly detect any possible negative reactions to the vaccine: “Government Keeps Close Eye on Swine Flu Vaccine.”

AJN clinical editor Christine Moffa posted here a while back about how meditation might help cranky or exhausted or overworked nurses stay focused on what matters during the workday. Today the NY Times has a related piece on “doctor burnout” and meditation.

The role of social media in health care is constantly evolving as we all find our way. Its use by hospital workers is at issue in a recent post at Running a Hospital, about one hospital’s decision to ban social media from all its computers. And here’s something else on this: blogger Not Nurse Ratched wonders if social media policies in […]

Nurses to Obama: “Don’t Love Us – Just Put Us at the Table”

Mason told the conference that she was disappointed in the remark because “that’s not what nurses need.” Nurses need to be respected for what they know and for what they do, and then they need to be given a seat at the policy table when strategies for changing the health care system are being discussed.

Marketers Honing In On Online Nurses

Internet Splat Map (jurvetson/via Flickr)

Nurses, you’re being watched: a marketing Website has an article on the growing influence of nurses online. Let us know what you think. Here’s an excerpt:

. . . Manhattan Research recently released a report about nurses online noting that approximately three out of four U.S. nurses recommend health websites to patients. The study notes that the average nurse spends eight hours per week online for professional purposes, which is just as much time as physicians, and almost all of them use the Internet in between patient consultations. Nurses are also proactive in researching medical product information specifically online – over eighty percent have visited a pharma, biotech, or device company website in the past year.

In addition to the prevalence of the Internet as a research and patient communication tool, nurses are continuing to find their unique voices online through a growing number of prominent nursing blogs such as Codeblog and Emergiblog which both share powerful stories of healthcare from the nurses’ point of view.

Also found today on the Web: […]
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