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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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How one patient's end-of-life care can affect us all Print E-mail
Written by James C. Salwitz, MD | KevinMD   
Monday, 24 October 2016 00:00

David was 42 when he died from stomach cancer. He spent the last year of his life receiving useless chemotherapy and debilitating radiation. David was in terrible pain all of the time. He stayed in bed for months as cancer destroyed his ribs, back and lungs.

Finally, David was rushed to a hospital, plugged into a breathing machine and pierced by countless IV drips. He died despite a battery of tests, drugs and several rounds of rib-cracking CPR.

His wife - previously positive, happy and successful - never recovered. She quit work, drank heavily and spun into a therapy-resistant depression. 12 months later, she used pills to take her life.

At the time of David's death, his son was 17. The teen found comfort in the kind of pharmaceutical intervention that comes from the bottle and needle.

He was high school dropout and in jail by 20. Although paroled at 23, David's son was back in prison by 26. His life had dissolved to rubble.

David's suffering, poorly controlled during that last year of life, was a direct result of a failure to plan for the inevitable and the inexcusable negligence of his caregivers to provide comfort. That misery transferred to those he loved. David's pain continued after death.

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Double booking the doctor is half-booking the patient Print E-mail
Written by A Country Doctor Writes   
Friday, 14 October 2016 00:00

Not only have we shortened medical appointments to 15 minutes. We also sometimes double book them.

I get the feeling that non-providers think of this as something fairly ordinary, and even reasonable. But it is often a very difficult and destructive thing to do.

The term "double booking" and the way it looks in an ordinary doctor's scheduling grid suggest that the physician might possibly be expected to be in two places at the same time. That is hardly ever the case for those of us who are mere mortals.

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Last Updated on Saturday, 15 October 2016 10:10
A Samurai Physician's Teachings Print E-mail
Written by FHI's Week in Review   
Monday, 03 October 2016 18:09

A Country Doctor Writes about the merits of Traditional Chinese Medicine (TCM) on 9/30/16. The author believes the value of TCM lies in "a certain enlightenment and pragmatism" and that the Chinese approach puts responsibility on the individual, rather than rely on the pharmacological effectiveness of traditional Chinese medicines. 
According to the author:

In the last hundred years, our <American> culture, with its tremendous scientific and technological advances, embraced the notion that our diseases come from invading bacteria, random gene mutations and other causes completely beyond our control. The promise of modern medicine has been that we can understand and counteract these forces through science, with more and more counteractive interventions. But as our treatments get more and more powerful, we have seen many of them cause ripple effects that cause other types of discomfort or disease.

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

Last Updated on Monday, 03 October 2016 18:25
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