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Nearly 1 in 3 Recent FDA Drug Approvals Followed By Major Safety Actions Print E-mail
Written by Sydney Lupkin | KHN   
Tuesday, 16 May 2017 15:53

The Food and Drug Administration is under pressure from the Trump administration to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of those approved from 2001 through 2010 had major safety issues years after they were widely available to patients.
Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a "black box" warning on side effects or warranted a safety announcement about new risks to the public, Yale professor Dr. Joseph Ross and his colleagues reported in JAMA on Tuesday <5.9.17>. The study included safety actions through Feb. 28.

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Last Updated on Monday, 05 June 2017 13:28
What Is the Best Way to Deliver Bad News? Print E-mail
Written by FHI's Week in Review   
Monday, 08 May 2017 17:28

Andrea Eisenberg, MD, in a 5.2.17 KevinMD post, reflects on the dilemma faced by many doctors on an all too frequent basis:

Is there a right way to give bad news? When I get a patient's pathology report of breast cancer on a Friday afternoon, should I wait until Monday to call her to let her have one more weekend cancer "free?" What if I do call and I'm transferred to voicemail? Do I leave a message to call me back? The office may be closed when she returns the call. Then she is left to ruminate over the weekend.
When I get the pathology results from a surgery, and it shows cancer, do I wait until their post op visit to tell them in person or call right away? If I tell my staff to make her appointment sooner, won't she guess it is because I have bad news?

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Last Updated on Monday, 08 May 2017 18:00
Readmission penalties don't correlate to heart attack outcomes Print E-mail
Written by FHI's Week in Review   
Monday, 01 May 2017 18:14

According to an April 26 post by

A program that penalizes hospitals for high early readmission rates of heart attack patients may be unfairly penalizing hospitals that serve a large proportion of African-Americans and those with more severe illness, a study by UT Southwestern Medical Center researchers suggests.

The study, which appears in JAMA Cardiology, looked at one-year outcomes for heart attack patients at 377 hospitals. It found no difference in one-year mortality rates and long-term readmission rates between hospitals that were judged to have an excessive readmission ratio (ERR) and those that did not.

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Last Updated on Tuesday, 16 May 2017 15:52
Chronic Disease Management - Non-Pharma Approach for Better Outcomes Print E-mail
Written by Jeffrey Herschler   
Tuesday, 25 April 2017 12:10

It’s no secret that cardiovascular disease, hypertension and metabolic disorder are among the top chronic conditions in the U.S. today ( The Western diet of carbohydrate rich, processed foods combined with sedentary lifestyles are major drivers of these diseases. Cigarette smoking, excessive alcohol consumption and obesity are also significant risk factors (  Health spending in the U.S. is currently approaching 20% of GDP and growing (The Fiscal Times). Thus, properly preventing, delaying and/or managing chronic conditions is critical for the long term health and wealth of our nation.

Despite lip service to diet, exercise and  life style modifications to address chronic disease, many practitioners are quick to reach for the prescription pad ( And why not? It's tough to persuade patients to eat right, workout, quit smoking and reign in alcohol consumption. Furthermore, a lot of the medications used to treat chronic conditions are inexpensive, effective  and widely considered safe.

However, these various drugs are not a panacea. First, although generally considered safe, many of these drugs are associated with significant Adverse Affects (AEs) ( and Second, meeting lipid profile guidelines and controlling blood pressure and blood sugar naturally (i.e. via diet and exercise) intuitively seems more healthful than artificially (i.e. via prescription meds). Western medicine appears to be in agreement with that intuitive conclusion. For example, the almost universally embraced Framingham Risk tool examines various data points to assess ten year risk of a cardiac event. In order to earn a low risk rating, a patient needs to have a systolic BP of less than 130 mm Hg. If the patient's BP is being treated with medicines, the risk increases even if the below 130 mm Hg benchmark is achieved. Finally, a patient who relies on prescription medications might be more likely to avoid important lifestyle changes. E.G. If my blood cholesterol is fine on the statin, why lose weight? If my blood pressure is under control with the lisinopril, why quit smoking?

Chronic inflammation and poor gut health are both implicated as major contributors to chronic disease ( and JAMA). Meanwhile an anti-inflammatory diet ( combined with a sensible exercise program can simultaneously address chronic conditions synergistically and deliver a host of additional health benefits with no AEs. A diet of healthy fats, lean protein and lots of fruit and vegetables united with exercise (30 minutes a day, five days a week, balanced between aerobic and anaerobic activity) will naturally reduce systemic inflammation and restore gut health ( and and WebMD). Anti-inflammatory supplements and probiotics can complement the diet/exercise treatment plan. Benefits include improved cardiovascular health (better lipid profile and reduced blood pressure), improved gastrointestinal function, reduced cancer risk as well as improved metabolic and sexual function. Such a treatment plan promotes healthy weight, reduces tobacco and alcohol cravings, lessens joint pain and supports restful sleep and general well-being.

Not every patient has the determination necessary to adopt a disciplined diet and exercise program. And not all patients will be able to completely restore their health without prescription medications. But a huge segment of our population could transform their health without drugs. Most of the remainder could benefit by relying on lower dosages of fewer medicines. Both healthcare practitioners and patients can prosper by adopting diet and exercise as a first line of defense against chronic disease.
Last Updated on Tuesday, 25 April 2017 12:36
23andMe Receives FDA Nod Print E-mail
Written by FHI's Week in Review   
Monday, 10 April 2017 16:49

According to an news release dated 4.6.17:
The U.S. Food and Drug Administration (FDA) today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual's genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional.

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Last Updated on Monday, 01 May 2017 18:12
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