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Should the FDA Approve Experimental Treatment for Severe Diseases? Print E-mail
Written by MD Whistleblower   
Monday, 09 May 2016 00:00

I've never had the pain and agony of having a kid who is truly sick. Broken bones and minor surgeries don't count. Even one of my kid's bouts with malaria doesn't rate, as this illness was easily cured.
Parents of kids with chronic illnesses would sacrifice anything to help their kids get better or to suffer less. In the news recently is a conflict between families of kids with Duchenne muscular dystrophy and the Food and Drug Administration (FDA). A very small study of an experimental drug called eteplirsensuggested some benefit. Understandably, the families want the FDA to grant approval so that their kids and others could have access to this drug that will fight a dreadful disease that is fatal. Families argue that these kids have nothing to lose and can't wait another 5 years waiting for more definite evidence of efficacy to emerge.
The FDA is legally required to approve drugs that are safe and effective. Obviously, the definitions of safe and effective are subjective, but the agency requires that a reasonable threshold be crossed for both of these parameters. Gray areas create agonizing conundrums for agency officials and patient advocates.

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Pfizer's Chantix not linked to serious psychiatric side effects: Study Print E-mail
Written by FHI's Week in Review   
Monday, 02 May 2016 00:00

In a FiercePharma post by Emily Wasserman on Apr 25, 2016:

A large international study <a randomized controlled trial, called EAGLES included 8,144 smokers in 16 countries> of <Pfizer's> Chantix and GlaxoSmithKline's Zyban found that the meds do not increase patients' risks of neuropsychiatric side effects. The meds also beat a nicotine patch and placebo at helping people quit smoking, according to results recently published in The Lancet.

According to Ms. Wasserman:

Pfizer is hoping that the results get the FDA to change its tune about Chantix's safety. Back in 2009, the agency slapped the drug with a black box warning amid reports "changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions" in people taking the med.

Read more in the current issue of Week in Review>>

Last Updated on Tuesday, 03 May 2016 17:13
Urgent Care Centers Changing Healthcare Landscape Print E-mail
Written by Naseem S. Miller | Orlando Sentinel   
Monday, 02 May 2016 00:00

Dr. Alejandro Badia started an orthopedic urgent care center out of frustration.

"Every patient that came to see me had already been somewhere, and that somewhere didn't do much for them," he said. "I said to myself, 'Why can't somebody reach me more directly?'"

Badia, who's based in Miami-Dade County, established OrthoNOW orthopedic urgent care in 2010, and by 2014 he turned it into a franchise.

"Our mission is to change the way expert orthopedic health care is delivered. It's a simple mission. Like Uber. It's a simple concept," said Badia, a practicing hand surgeon.

He has sold 10 practices so far, one of which is slated to open in Winter Park this summer.

OrthoNOW and its franchisees...are capitalizing on one of the fastest growing segments of healthcare in the United States: urgent care, which took shape in the 1980s but has taken off in the past decade.

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Last Updated on Tuesday, 24 May 2016 17:17
Engaging the Patient With a Support Network Print E-mail
Written by Accountable Care Options, LLC   
Wednesday, 27 April 2016 17:38

It's time to form a community network, not just with other physicians, to provide resources for the psychological, social and financial well-being of your patients. It’s the future of health care.
Physicians are taught to apply protocols, but they need to consider all aspects of life, not just the disease state. Often, a decline in health status is correlated to financial burdens, caregiver exhaustion and other needs. That requires a new way of thinking.
Where should doctors look? Local governments have organized information on resources such as caregiver support, support groups for specific disease states, Meals on Wheels, housing and financial assistance and certain pharmaceutical groups. Their centers have phone numbers of organizations that provide home health care and sometimes a little bit of cleaning and light housekeeping. In South Florida, those resources are as close as dialing 211.
The physician must do more than hand a patient a phone number. He or she must first identify the problems because patients will often say everything's fine when it’s not. Staff can identify issues while they chit-chat with patients about their spouses and children; family members can provide insights.
A lot of innovative health care models are not only adjusting to this form of care -- they're requiring documentation of the go-to person for patient support, whether it's a spouse, family member or friend. Some models encourage physicians to tell patients, "Bring somebody who can help motivate and support you to stay well.”
That person can be a friend, a neighbor or a family member; anyone can be a health care champion. Physicians may find it counter-intuitive to include that individual because they’re accustomed to keeping everybody out in order to focus on the patient's needs and wants, and sometimes for some legal reasons. But physicians will achieve better results by involving people who are near and dear. And let's face it, patients will listen to a friend, they'll listen to their family member. They won't necessarily listen to a team of professionals who are going to tell them what they'd like to see happen.
Physicians can close the loop on a patient’s use of community services by asking questions such as “What do you like about it?" and "What do you wish you had?" Sometimes, matching patients to services takes a little fine-tuning. The doctor can say, “If it didn't work for you, well, let's try something else.” Ultimately, what matters most is what works for the patient.

Last Updated on Wednesday, 27 April 2016 17:45
How to destroy a great ER: A step by step guide Print E-mail
Written by Thomas Paine, MD | KevinMD   
Tuesday, 19 April 2016 00:00

I took a fantastic emergency medicine (EM) job when I finished residency. There was no question in my mind that it was the best job within a hundred mile radius, maybe more. When I first started, my expectations were met. My group held a contract to staff a busy but well-staffed suburban emergency department, and had held that contract for almost 20 years when I signed. The hospital was independent, locally administrated, and not part of a mega healthcare system. Its atmosphere was collegial and clinician-friendly.

The ER was well-staffed with all-star nurses and techs with experience. Everyone who worked in the hospital wanted to get a job in the ER. There were three nurses per nine-bed zone with a float nurse (gasp!) in each zone. Sure there were snags and busy days, but it ran about as efficiently as an ER could. The patients were well-cared for and generally pleased.

About a year after I took this job, a large regional health care system bought our hospital. It was called a merger, but we all knew otherwise.

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Last Updated on Wednesday, 20 April 2016 08:38
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