Independent Advisors Prove Independent
Journalist-turned-stock-analyst Ramsey Baghdadi of Concept Capital, who formerly wrote for the RPM Report , tells TheStreet.com that Food and Drug Administration Advisory Committee recommendations are down to 52 percent "yes" votes this year, "the worst year since 2007." He compares that unfavorably to 2009 and 2008 when the advisors gave positive nods 75 and 80 percent of the time. Reasons for the tougher regulatory environment, according to Baghdadi? "First, the FDA is bringing more drugs in front of advisory panels due to changes in FDA law that require most new drugs to be reviewed by outside experts," the article notes. "Second, stricter conflict of interest rules implemented by FDA (in the wake of the 2007 reformr law) have made it more difficult for the agency to recruit experienced panel members." If inexperienced members without conflicts of interest are more prone to voting no, how does that explain 2007, when the current rules weren't in place and there were still 50 percent "no" votes? Here's my analysis: Generally speaking, the FDA calls advisory committees for two reasons: either its staff is internally divided or uncertain of its analysis of the safety and efficacy of a particular new drug application; or, it is looking for the outside panel to ratify what is going to be a controversial decision. In the former case, one would expect votes to go about 50-50. It's like a well designed clinical trial where the observers truly don't know what the outcome will be. You'd expect success -- or failure -- about half the time. As for "ratification" votes, I'd look to the shifting political environment for an explanation. The FDA serves two constituencies: people and organizations primarily concerned about bringing new drugs to market (industry, many clinicians and patient advocacy groups) and those primarily concerned about drug safety and overutilization. FDA decisions generate controversy whenever they alienate either side. In the wake of the Vioxx scandal, safety advocates have recouped some ground lost during the 1990s and the first half of the last decade, when the agency became overly industry friendly. These days, I would put their influence at the FDA about on par with industry, i.e., the odds of the FDA making a controversial decision requiring advisory committee ratification are about 50-50. The 2008 and 2009 high approval numbers marked the end of an era when advisory committees served as rubber stamps for an industry-friendly FDA. Let's hope this year's votes mark the beginning of a new, more scientific era. (Hat tip to FDAWebview - subscription required - for alerting me to TheStreet.com story.)
Make your small private practice thrive in 4 steps
by Susan Giurleo, PhD Health care is changing at lighting speed. If you don’t know this, or worse, don’t accept it you’re doomed. No. Really. It’s change or close shop. Whether you like it or not, health care reform is going to change the way we practice from now on. Many physicians are choosing to work for large group practices to buffer themselves from directly dealing with change. Mental health providers could do the same, I suppose. But is that what you want for your career? Do you want to work for someone else for a Relative Value Unit? How about your patients and clients? Do you think they would prefer to receive care in a small practice where they are known by the staff and cared for with dignity? (...) Read the rest of Make your small private practice thrive in 4 steps No comment | Tags: Health reform | Category: Physician practice
Categories: 2010, CES, Change, DEA, General, Patients, Physicians, VA, twitter Tags: 2010, CES, Change, DEA, health reform, Patients, physician practice, physicians, twitter
All Things in Moderation Except . . .
A new study says moderate drinkers live longer than teetotallers or people who go on occasional benders, even if they are moderate drinkers the rest of the week/month. More proof, as if any were needed, that nothing is bad for you and may even be good for you if done in moderation.
Root beer bonds a chemotherapy patient with his oncologist
by Krupali Tejura, MD I am treating a patient for head and neck cancer — which can be one of the most harrowing therapies. To receive chemotherapy and radiation concurrently can be pretty debilitating. Swallowing foods can be next to impossible, and the taste changes and saliva changes are brutal. It’s one of the harshest areas to treat … and I warn the patients beforehand: they are in for a battle. (...) Read the rest of Root beer bonds a chemotherapy patient with his oncologist No comment | Tags: Cancer , Specialist | Category: Diagnosis and treatment
Categories: 2010, Change, General, ONC, Patients, VA, twitter Tags: 2010, Change, diagnosis and treatment, ONC, Patients, twitter
Converting from paper chart to an EMR: Keep daily use in mind
by Rosemarie Nelson, MS Maybe you’ve been assuming that when it comes time to go live on your EMR, you’ll simply scan each patient’s old paper chart into the electronic system. Maybe you haven’t given it much thought because you’re focusing on the change in your work flow when you start to use the EMR to document patient encounters. Well, it’s time to pay attention to the transfer, because the conversion of the paper chart can significantly ease your transition to using the EMR at the point of care if you plan it with daily use in mind. And simply scanning the paper chart isn’t the answer. (...) Read the rest of Converting from paper chart to an EMR: Keep daily use in mind No comment | Tags: Health IT | Category: Health IT and EMR
Categories: 2010, Change, EMR, General, MU, Paper Chart, health it, twitter Tags: 2010, Change, EMR, health it, health it and emr, Paper Chart, twitter