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Civil War Over Opioids Print E-mail
Written by FHI's Week in Review   
Monday, 23 January 2017 19:24

In a STAT Special Report by Bob Tedeschi on January 17, 2017:

Two years after the United States saw a record 27,000 deaths involving prescription opioid medications and heroin, doctors and regulators are sharply restricting access to drugs like Oxycontin and Vicodin. But as the pendulum swings in the other direction, many patients who genuinely need drugs to manage their pain say they are being left behind.

Read more in the current issue of Week in Review>>
Is 'Physician Engagement' Code for Physician Control? Print E-mail
Written by Michael Breen, MD | KevinMD   
Monday, 09 January 2017 00:00

Are physicians unruly children?

That's the attitude I see at hospital C-suite meetings. As in, "Our doctors are protesting our new unproven proton beam therapy center. How cute! They think they know how hospitals work. Even cuter, they think their opinion matters." Chuckles all around.

That smiling dismissiveness doesn't surprise me. Call me cynical, but when people have power over other people, they become contemptuous. And in today's world hospital executives have that power over their interchangeable, expendable physicians. Their ridicule is regretful, but almost fitting. After all, many physicians they patronize once took that same attitude toward their patients.

At least, though, that behind-the-scenes contempt is sincere. What I resent more is articles like one I just read: "The best way hospitals can engage physicians, nurses, and staff."

Engaging physicians is very much in vogue these days. The purpose is to tactfully bring physicians around to the institution's way of doing things.

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Last Updated on Tuesday, 10 January 2017 20:24
Why doctors are rebelling against saving lives Print E-mail
Written by Michael Breen, MD | KevinMD   
Wednesday, 28 December 2016 00:00

When I was in medical school, "real" doctors saved lives. Period.

Specialists who focused on a patient's quality of life, (the plastic surgeons, bariatric surgeons, holistic practitioners, infertility experts, etc.) were considered sellouts. (We won't even consider the med school status of future psychiatrists.)

We disparaged these doctors because they could be saving lives and chose not to, because they were often paid (God forbid) out-of-pocket by their patients, and because they actively self-promoted themselves to the public (another doctor no-no). These "greedy" docs were scorned as entrepreneurs in a profession too sacred to be tainted by money. (This as traditional docs plundered third party payers. Don't get me started.)

Fast forward. Many future doctors now choose "quality of life" specialties.

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Who the FDA is really protecting: FDA says more studies needed and orders strict warning on Bayer’s Essure device, yet leaves product on market Print E-mail
Written by Marcus Susen   
Wednesday, 14 December 2016 00:00

A black box warning will now accompany Bayer’s Essure permanent birth control device. The FDA recently ordered that such warning be placed on Bayer’s Essure device.  Although a black box warning is the strictest and strongest warning that the FDA requires, the FDA did not stop there. They also recommended that the device include a patient-doctor checklist and ordered Bayer to conduct more studies. However, notwithstanding these actions, the FDA and Bayer chose to leave the product on the market.
These measures were taken after thousands of adverse events and medical device reports had been filed with the FDA which included reports of the inserts migrating out of the fallopian tubes, breaking, and perforating internal organs. Other reports note allergic reactions (teeth and hair falling out), ectopic pregnancies, still births, and even death.   
Essure is a birth control device manufactured by Bayer Healthcare. The device was developed to prevent pregnancy through the insertion of micro-inserts into the fallopian tubes that then expand and anchor, causing tissue growth and, in turn, bilateral occlusion (blockage) of the fallopian tubes. It was intended to be a gentle, permanent, and non-surgical procedure. 
However, the black box warning and patient-doctor checklist now warn of risks such as persistent pain and the need for surgical removal and advise patients of other symptoms being reported to the FDA, such as headaches, fatigue, weight changes, hair loss, and depression.
These actions taken by the FDA raise serious questions for patients and doctors alike, such as why is the product still on the market if more studies are needed? How can doctors inform their patients of the risks of allergic reactions to the metals (nickel, titanium, iron chromium, platinum and silver-tin) when Bayer and the FDA acknowledge that there is no reliable test to predict who may develop such reactions? How are physicians supposed to surgically remove the “permanent” device? It appears as though the FDA and Bayer’s actions leave women with more questions than answers.
During the FDA approval process for Essure back in 2002, where the safety and efficacy of Essure was analyzed by the FDA and the manufacturer, these exact concerns were raised, but ignored during a panel meeting of experts convened by the FDA. Something all doctors and patients should know of, not communicated in the black box warning and doctor-patient checklist, is the context of how this device was “conditionally approved” by the FDA.  

According to the transcript of this panel meeting, when the issue of sensitivity to the metals in Essure was brought up, one expert responded: “I don’t know what happens to people with metal sensitivity when you implant metals in them.” Another expert joked that the only metal she was not sensitive to was “14k (laughter)” and “18k” gold. The joking did not stop there. In fact, the Chair of the meeting referred to the Essure patient population in Iowa as “those corn fed girls (laughter).” However, most concerning of all was a statement by a panel doctor who was concerned that, if the device was approved, someone would eventually “find each of us, bring us back here, and ask us why we approved this (laughter).” 
Well, that time has come Doctor and no one is laughing.   

Marcus Susen is a partner with the law firm of Koch Parafinczuk and Wolf based out of Ft. Lauderdale, FL.  Mr. Susen was the author of the Citizens Petition/Trade Complaint which was filed with the FDA requesting that the Essure device include a black box warning and be taken off the market. He currently represents hundreds of women who have been injured by the Essure device in courts across the country. 
Lean Methodology and Patient Safety Print E-mail
Written by Skeptical Scalpel   
Tuesday, 06 December 2016 18:31

A recent story in U.S. News & World Report described how a Seattle hospital is taking a systems approach in improving healthcare quality and cutting costs. It said, "Virginia Mason Health System...has looked to adopt many of the much-admired and often-emulated business philosophies from Toyota."

The best-known of those philosophies is the so-called "lean methodology" which is based on eliminating waste and focusing on things that add value.

Attempts to incorporate lean into healthcare have met with varying degrees of success. I blogged about this six years ago and pointed out that a literature review done back then found "significant gaps in the [lean and six sigma] health care quality improvement literature and very weak evidence that [lean and six sigma] improve health care quality."

Randomized prospective trials of lean in medicine are lacking. A recent paper from the Journal of the American College of Radiology found...

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Are Doctors the New Drug Dealers? Print E-mail
Written by Michael Kirsch, MD | KevinMD   
Thursday, 24 November 2016 00:00

I have written about pain medicine, previously on this blog, and it generated some spirited responses. Let me be clear that I am completely against all forms of pain, whether foreign or domestic, physical, spiritual, psychic or even phantom. The medical profession has superb tools to combat and relieve pain, and physicians should utilize them, within the boundaries of appropriate use. We now have an actual specialty - pain management and physicians with special training in the science and treatment of all varieties of pain. I utilize these specialists when necessary, and I am grateful for the help they provide to my patients.

There are two forms of drug abuse in our society - legal and illegal.

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JAMA Forum: How Would the Next President Ensure Competitiveness in the Health Care Marketplace? Print E-mail
Written by Ashish K. Jha, MD, MPH   
Thursday, 03 November 2016 00:00

Recently, 10 health care experts were asked to state 1 question they would ask the presidential candidates. Although they offered a variety of responses, 1 topic seemed dominant: what the next president would do to ensure competitiveness in the marketplace.

The next president must choose between dealing with the symptoms of an increasingly dysfunctional marketplace or dealing with one of the key underlying causes, namely, the market power of hospitals and health systems. If the Affordable Care Act (ACA) is to thrive under the next administration, the most important federal agency to ensure its success may not be the one that everyone focuses on, the Centers for Medicare & Medicaid Services (CMS). Instead, it may be the Federal Trade Commission (FTC), whose work to monitor and regulate the consolidation frenzy that has taken hold among physician practices, hospitals, and hospital systems that will likely have the biggest impact on the future viability of the ACA.

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