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The CMG Voice

A la carte medicine may be in your future

Posted Friday, April 26, 2019 by Carl-Erich Kruse

We have generally become accustomed to depending on a doctor’s prescription to acquire medications, but what if we can just order these medications online? That is the model being applied by several websites that distribute certain medications after a few clicks of the mouse. Instead of relying on a doctor’s prescription, the sites depend on something more akin to a doctor’s endorsement of a patient’s request. These platforms promise to treat, or purport to treat, things like erectile dysfunction, libido, hair loss, or anxiety. Sometimes they promote off-label (non FDA-approved) uses along the way. As with any advances in technology and medicine, they have inspired curiosity from consumers, investors, and reporters.

While these platforms tout, in part, claims of convenience for consumers, the model seems fit for exploitation. New York Times reporters navigated websites to quickly acquire medications with bare minimum interaction with medical professionals, and in some cases no counseling whatsoever about drug interactions. And on the one hand the model may seem consistent with efforts towards highly individualized medical care, but the arrangement begs questions of appropriate levels of oversight both from medical professionals and regulators. These sites distribute medications dependent on patient self-reporting and without any physical examination. It is often unclear where in the process the physician decision-making takes place.

The interaction between customer/patient and physician raises questions of whether the platforms are providing health care or simply delivering products to consumers. As health care providers, they would be subject to closer scrutiny by, for example, the FDA, and state medical commissions. While they contend they are not health-care providers, the reporters’ research demonstrated that several of the sites appear intertwined with health providers.

As the healthcare landscape continues to evolve, we can expect to see more of these types of sites. And the amount of investment being made into the sites indicates that many see a future in this model.

There are risks however. What if a consumer orders a medication that a reviewing doctor would see is clearly unsafe for one reason or another, and that consumer is harmed? Who is responsible? Would that constitute practicing medicine without a license?

To be clear, our intention is not to promote scrutiny for scrutiny’s sake; instead, close attention should continue to be paid to the societal cost and benefit of expediting segments of consumer medical care.

You can read the New York Times article here

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Recent poll confirms Americans find nurses the most honest and ethical

Posted Monday, April 22, 2019 by Tyler Goldberg-Hoss

For the 17th consecutive year, the nurses are on top. A Gallop Poll found that 84% of respondents rated nurses as having “high” or “very high” standards of honesty and ethics, besting all other included professions.

Medical doctors came in second, with 67% of respondents rating them as having such standards, and pharmacists came in third (66%).

Of note, attorneys were rated just a little lower, with only 19% of respondents believing that their standards of honesty and ethics was “high” or “very high”.

That still beats telemarketers, car salespeople, and members of Congress, who brought up the rear in the study.

For victims of medical negligence claims, particularly those involving nursing care, this study reinforces the idea that it is likely a jury deciding a medical negligence case will come into a case with similar views, already coming into court with conscious or unconscious bias in favor of medical providers, and perhaps a negative bias toward lawyers.

While that does not mean that jurors will not listen to the facts and decide the case on the merits, it does illustrate the point that most folks think highly of the medical profession, and those same folks might give the benefit of the doubt to the nurse or the doctor.

You can read the full study here:

Nurses Again Outpace Other Professions for Honesty, Ethics

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It’s now safe (enough) to transplant organs from patients with hepatitis C to patients who don’t

Posted Thursday, April 18, 2019 by Tyler Goldberg-Hoss

If you are fortunate, you are not on a waiting list for an organ transplant. Unfortunately, more than 100,000 people in the United States are not so lucky. For them, the wait for an organ to become available can be deadly. For heart and lung transplants alone, about 1,000 people a year die just waiting.

Until science comes up with a way to manufacture, grow, or otherwise create new organs, or our society decides it’s ok to buy and sell them, doctors and others in the medical community are trying to figure out ways of increasing supply. One such way is to use otherwise suitable organs from donors with hepatitis C.

In the past, doctors would only transplant such organs into patients who also already had the virus. The thinking was that they did not want to give a hepatitis-free patient that disease in addition to the donated organ.

However, with recent developments in curing hepatitis C, surgeons have started doing this: transplanting infected organs into uninfected patients. Some are waiting for the patient to successfully receive the organ and then treat them for the hepatitis C. However others are attempting to prevent the recipient from getting it in the first place by giving them medication within hours of the transplant in hopes of blocking the infection in the first place.

While the ability to prevent infection – or cure it – in recipient patients is not zero, the risk is worth many on the transplant list.

You can read more about this here:

Certain transplants safe with hepatitis C infected organs, study finds

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FDA allows for parallel, confidential reporting of medical device failures

Posted Monday, April 8, 2019 by Carl-Erich Kruse

Medical device manufacturers have been taking advantage of so-called “alternative summary reporting” to secretly report device related injuries and malfunctions to the FDA. The system is functionally “secret” in that the reports are often sent directly to the FDA without opportunity for the public, including medical providers, to later read.

The FDA has long required medical device manufacturers to report adverse device events, like malfunctions, so the events are available for public scrutiny on the Manufacturer and Used Facility Device Experience (“MAUDE”). The alternative reporting system, however, allows adverse events on exempted devices to be reported en masse, often hundreds or thousands at a time. What’s worse, getting details of these incidents is exceedingly difficult once the reports have been filed. The system appears specifically designed to omit details of device malfunctions.

Kaiser Health News discovered that since 2016, there have been 1.1 million incidents, and hundreds of thousands of injuries, from hundreds of exempted medical devices. Such exempted devices include certain models of the near-ubiquitous surgical stapler, da Vinci surgical robots, mitral valve clips, and SAPIEN 3 artificial heart valves.

This hidden reporting scheme has caused untold headaches for many actually involved in care, and those injured as a result of device malfunction. Hospitals and clinics may be relying on incorrect device failure information when making purchasing decisions on medical devices. Likewise, providers may be using devices with far higher failure rates than they have been made aware of.

In our arena, this scheme may cause medical providers to be incorrectly blamed for negligence when in fact the device, with a history of repeated, similar, failures, gets defended as “safe.” Additionally, burying this information leads to incorrect opinions from expert witnesses on device safety.

The FDA defends the obscure system as meant to streamline the reporting requirements, perhaps to improve efficiency and save cost, but as consumers we are troubled by the health and safety costs passed to the providers and consumers of medical care.

Read the entire investigative piece from Kaiser Health News here.

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The Apple Watch may help catch A-Fib

Posted Thursday, April 4, 2019 by Carl-Erich Kruse

Many of us wear fitness trackers. Since they hit the market just over a decade ago, the functions of the devices have continued to expand. Fitbit, for example, bills itself no longer simply in the business of wearable technology; instead it identifies as a “digital healthcare company.” While many who wear fitness trackers may obsess of the number of steps they have amassed in day or their quality of sleep, the evolution of these products may be offering you and me more significant health benefits.

This blog has previously discussed the possibilities of heart monitoring with the Apple Watch. Now, preliminary results from a study – sponsored in part by Apple – have shown that a fitness tracker, in this case in the form of the Apple Watch, may be effective in identifying heart conditions such as atrial fibrillation, or A-fib.

A-fib is a condition wherein the atria of the heart, the upper chambers, beat irregularly. The condition may lead to blood clots, strokes, and heart failure. Millions of Americans have A-fib. Interestingly, the most recent model of the Apple Watch, which itself features an ECG, was not part of this study.

The so-called Apple Health Study found that the Apple Watch had a 71% positive predictive value, meaning 71% of those study participants whom the Apple Watch found to have A-fib actually had it. Perhaps most importantly, the study found that, of the study participants who were notified of an irregular heart rhythm, 84% were verified by a doctor as having had an episode of atrial fibrillation. This second statistic is important if only to calm worries of overreporting and overburdening cardiologists’ offices.

Fitness trackers like the Apple Watch may be able to help consumers identify abnormalities before they are picked up on ECG at a doctors’ office, thereby improving outcomes for patients with certain conditions. We expect to see improved accuracy and functionality as these technologies continue to improve. However, it is unclear whether and to what extent the standard of care will allow for cardiologists and other doctors to rely on this data in treating their patients in the future.

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