45 years ago, a humble man from Ohio landed on the moon

July 19, 2014- By Steven E. Greer, MD

Forty-five-years ago tomorrow (July 20th, 1969), Neil Armstrong became the first human to step onto the moon, with his poignant and profound proclamation, “That’s one small step for a man, one giant leap for mankind”. Who was Neil Armstrong and why was he chosen to be the first? Read more »

HBO’s John Oliver devotes 16-minutes on the Dr. Oz senate hearing

Atul Gawande’s surgical checklist fails in real world study

March 15, 2014- By Steven E. Greer, MD

In 2009, Atul Gawande, MD, MPH and his large international team published in the New England Journal of Medicine (NEJM) an observational study that showed a significant reduction of death and “complications” after non-cardiac surgery. The World Health Organization (WHO) created the checklist used in the NEJM paper. After this non-randomized, non-controlled, observational study was published, entire nations adopted the surgical checklist system.

Now, in 2014, a population study drawing from Ontario surgical patient data, published in the NEJM, showed no significant benefit from the widespread adoption of the same WHO surgical safety checklist that Dr. Gawande popularized. This study was also observational, but it was stronger than the 2009 Gawande study in that it included the entire population within a region.

What went wrong? Read more »

Robotic surgery and controversies

January 24, 2014- Dr. Dutson gives an update on the referral patterns and safety concerns over the Da Vinci system.

Produced, Interviewed by Steven E. Greer, MD

We interviewed UCLA’s Erik Dutson, MD, surgeon and Director of UCLA’s Center for Advanced Surgical and Interventional Technology (CASIT), about the Intuitive Surgical da Vinci robotic system, and recent safety controversies.

Occluding the left atrial appendage to prevent stroke in A-fib

Thromboembolic stroke caused by atrial fibrillation is the primary reason patients are placed on anticoagulation. However, those blood thinners also carry significant bleeding risks. As a result, various mechanical surgical approaches have been tried to prevent stroke, and obviate the blood thinners.

The newly approved Boston Scientific Watchman left atrial appendage occlusion device aims to prevent clots from forming and migrating to the brain. We interviewed Dr. William O’Neill of Henry Ford Hospital, a leading interventional cardiologist, about the Watchman, and whether it will truly allow patients with A-fib to stop warfarin or other blood thinners.

TAVI: Comparing CoreValve to Sapien

Interviewed by Steven E. Greer, MD

William O’Neill, MD of Henry Ford discusses the recent pivotal data for the Medtronic CoreValve device, soon to be approved, and how this new device will compete in the clinical arena with the Edwards Lifesciences Sapien valve.

Why the lack of outrage over smoking depicted in film and television?

To Senators Dick Durbin, Richard Blumenthal, Sherrod Brown, and Edward Markey

cc: Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration

cc: Ari Emanuel, CEO, William Morris Endeavor

January 20, 2014

Dear Senators:

Recently, two people at the Golden Globes awards show (Leonardo DiCaprio and Julia Louis-Dreyfus) were photographed smoking e-cigarettes. Then, your group of senators (i.e. Durbin, Blumenthal, Brown, and Markey) wrote a letter to NBC and the Golden Globes producers expressing concern that the images would help promote real cigarette smoking.

With such outrage over two obscure glimpses of e-cigarettes, why then is nothing being said about this pervasive film directing style that shows close-ups of actors smoking real cigarettes?

The latest example of this cinematic style is the new HBO drama “True Detectives”. Every single scene (no exaggeration) of Matthew McConaughey shows him with a cigarette in his mouth. It is repulsive. I have to look away.

More concerning than my discomfort is that this show now encourages smoking by associating one of the most admired leading men in Hollywood with chain smoking. I could list dozens of other films and TV dramas that also portray smoking the same way.

Hollywood violence, in film and video games, encourages violence. Now, Hollywood portrayals of cigarette smokers is promoting cancer.

Why is there no outrage?

Steven E. Greer, MD

Early stoppage of clinical trials

Dr. Guyatt explained in a previous post why early stoppage of clinical trials results in falsely inflated efficacy of the therapy being studied. The April 16, 2009 edition of The New England Journal of Medicine has a great example how Kaplan curves tend to converge with time and erase early efficacy differences. The study looked at the drug valsartan for the treatment of atrial fibrillation and failed to show a benefit over the comparator cohort(see graph). If it were stopped early, it would have shown that the drug was effective. Note the curves touching, or converging, as time progresses.

The finances of TAVI: do prices have to come down?

Interviewed by Steven E. Greer, MD

William O’Neill, MD of Henry Ford discusses the finances of transapical aortic valve implantation (TAVI) and why the $30,000 pricetag for the devices should be closer to $5,000. He also discusses the overall market size for TAVI.

A Bridge Too Far: Patient classifications for LVAD reimbursement

September 16, 2013- By Ashish Shah, MD, Cardiac transplant surgeon, The Johns Hopkins Medical Center

Left ventricular assist devices (LVADs) arose from the ashes of the total artificial heart era. The idea of a permanent mechanical solution was abandoned in the 80’s after very public cases involving the Jarvik 7 total artificial heart. However, a few teams utilized the same technology to temporize critically ill patients until a donor heart was available. This effectively “bridged” them to heart transplant.

Throgh the 90’s, attention turned to univentricular support rather than total replacement.  These LVADs serve to bridge the patient until they are well enough to be listed for heart transplant: bridge to transplant (BTT). After the publication of the REMATCH trial in 2001, a new class of LVAD patients were defined. Destination therapy (DT) represents the idea that a patient is actually not a candidate for transplant. The LVAD is the final therapy.

The BTT patients typically look like good heart transplant candidates but have run out of time or have reversible end organ dysfunction like renal insufficiency, malnutrition, or pulmonary hypertension that need the support period to improve their post transplant outcome. The DT patients on the other hand, may be older with a greater burden of extra cardiac organ dysfunction.

Over the last decade, Read more »