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.)
Hollywood, take notice of this primary care doctor
Doug Farrago is a family physician in Maine, and the editor of the entertaining Placebo Journal . He uses his Placebo Journal media platform to show his audience what primary care is all about. In this video, Doug Unplugged , he gives us a little taste of that journey. Hollywood, take notice. Placebo Television #19: President Obama makes an offer you can’t refuse How Twitter and blogging helped a patient with cancer Medscape op-ed on how to help today’s tense, frustrated doctors No comment | Tags: Media , Primary care | Category: Health in the media
Categories: 2009, 2010, AMA, ARRA, General, twitter Tags: 2009, 2010, AMA, ARRA, health in the media, media, primary care, twitter
What’s new on KevinMD.com
I want to thank you all for reading KevinMD.com . The conversation sparked by the posts has been sometimes controversial, but always insightful. A special thanks to the regular contributors, now numbering over 125 health care professionals and patients who add their own distinct voice to the health care discussion. Here’s what’s new on the site. 1. KevinMD.com on LinkedIn. In addition to the 23,000 who follow on Twitter , and 3,800 Facebook fans, you can now continue the health conversation on LinkedIn . In addition to my topics, you can follow a few other, hand-picked blog feeds and ensuing discussion on my LinkedIn group. 2. Social media button. Click the Connect button in the lower left corner, and sign in with Twitter or Facebook. This enables easy sharing of KevinMD.com content on your social network. 3. Speaking. I am available for a limited number of speaking engagements each year, discussing the health care intersection with social media. I am currently booking dates into 2011. 4. Guest posts. I continue to welcome guest columnists who want to be heard on social media’s leading physician voice. Find out how . 5. Speed and stability. For technical aficionados, Javascript and CSS were minified, database caching was optimized and KevinMD.com is now served from a content distribution network. Page load times have improved by 30% or more over the past month, with measurable gains in both traffic and site stability. Once again, I sincerely appreciate your readership and support. Thank you for making KevinMD.com the web’s leading source for influential health care commentary. Can Twitter and Facebook help prospective medical students? Doctors who are not on Facebook, Twitter and blogs risk becoming irrelevant; my USA Today op-ed KevinMD Twitter and Facebook Thanksgiving Drive 2009 No comment | Tags: Facebook , Twitter | Category: Medical potpourri
Categories: 2009, 2010, Connect, GEM, General, NIST, ONC, Patients, Physician Voice, VA, facebook, twitter Tags: 2009, 2010, Connect, facebook, gem, medical potpourri, NIST, ONC, Patients, physician voice, twitter
KevinMD at BlogWorld Expo 2010 Social Health track
I’m honored to be invited back to BlogWorld Expo’s Social Health track on Thursday, October 14, 2010. I’ll be joined on a panel with my esteemed blogging colleagues, Kim McAllister of Emergiblog , Bryan Vartabedian of 33 Charts , and Kerri Morrone Sparling of six until me . We will discuss whether social networks are compatible or competitive with the medical blogosphere. Dave deBronkart, otherwise known as e-Patient Dave and regular contributor to KevinMD.com , will give the opening keynote. I want to thank our sponsors, Johnson & Johnson (presenting sponsor), MedPage Today and Campaign for Nursing (supporting sponsors), and WEGO Health (associate sponsor). There’s plenty more, including breakout sessions discussing patient blogging and disease awareness, industry issues and how people are using social media to improve their health. I invite you to visit the Social Health track’s site, and hope to see everyone in Las Vegas in October. Medical bloggers at Blog World Expo, October 15th, 2009 When a health care professional gets diagnosed with breast cancer The medical home in health reform’s attempt to fix primary care No comment | Tags: Social media | Category: Social media
Categories: 2009, 2010, DEA, General, Las Vegas, MU, VA, twitter Tags: 2009, 2010, DEA, Las Vegas, social media, twitter
10 top health blog posts, July 2010
Here are the top posts from this past month, based on the number of times they were viewed. 1. iPhone, Android or Blackberry? The right smartphone for doctors 2. What residents and medical students should wear in the hospital 3. Why doctors run late and how patients can help 4. Florida EMTs may go bankrupt because of a malpractice lawsuit 5. Unnecessary testing needs more than tort reform to cure 6. Ranking prestige of medical diseases 7. The way we practice primary care doesn’t make sense 8. Customer service needs to be a priority in health care 9. Best free Android medical apps 10. The grief men face when their wives undergo mastectomies Health blog posts of the week, ending July 14, 2010 10 top health blog posts, March 2010 10 popular health blog posts, December 2009 No comment | Tags: Cancer , Health IT , Malpractice , Medical school , Patient , Primary care , Residency | Category: Medical potpourri
Categories: 2009, 2010, Android, Blackberry, CES, Florida, General, MT, Patients, Smartphone, health it, iPhone, twitter Tags: 2009, 2010, blackberry, CES, Florida, health it, malpractice, medical potpourri, medical school, Patients, primary care, residency, Smartphone, twitter