Today's News and Commentary

About pharma

Bristol-Myers bulks up cancer portfolio with $74 billion Celgene deal: The new year is only three days old and a blockbuster acquisition has been announced. You can read the details about what the companies said were strategic reasons for the purchase. Historically these combinations have made financial sense because of the economies of scale gained by the business functions of each company. Products lose patent rights and economies of scale do not apply to R&D… So what is the attraction of megamergers/acquisitions other than “short term” revenue enhancement?

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About the public’s health

How the government shutdown affects health programs: As previously noted, because HHS and VA programs had been funded, the budget impasse has left governmental healthcare programs largely unaffected. Now that the the problem is dragging on, it is worthwhile to look at the areas where healthcare is affected because lack of financing :
Insuring food safety falls under the FDA, but a large part of that effort is funded by the Agriculture Department.
HHS oversees The Indian Health Service, but funding comes from the Interior Department.
”The Department of Homeland Security’s Office of Health Affairs assesses threats posed by infectious diseases, pandemics and biological and chemical attacks.”
The Environmental Protection Agency is likewise on the list of Departments whose funding is being withheld.

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Sex differences in GBM revealed by analysis of patient imaging, transcriptome, and survival data:
STOP and read!
I know this article seems really esoteric (it comes from Science Translational Medicine) but I include it to highlight a problem. By and large, clinical research has under-represented women. It was originally assumed that what was found true in men also applied to women. Many studies have shown the incorrectness of this supposition. Hormonal differences have been given as the cause of this variance. However, according to the study’s authors: “Sex differences play a role in patient outcomes, and… in the case of the brain tumor glioblastoma, these go beyond hormonal influences and appear to be intrinsic to the tumor cells themselves… the sex of the patient correlates not only with prognosis but also with responses to different treatments, suggesting that it may be an important factor to consider when optimizing the therapeutic regimen for each patient.” With the increased focus on individualized medical treatment, the patient’s sex must also be considered a biological variant.

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How far Americans live from the closest hospital differs by community type: The focus on costs and quality (including patient experience) often overshadows the problems with access to healthcare. This study highlights the access problems faced by those living in rural areas. Note the figures are averages, so many people face longer distances to get to care. Remember that not all access issues involve transportation- for example, scheduling delays also contribute to this problem.

About Information technology

Health Industry Cybersecurity Practices:Managing Threats and Protecting Patients: HHS has made cyber security a top priority for the coming year. As a result of The Cybersecurity Act of 2015 (CSA) (Public Law 114-113), a task force was convened that looked at this growing problem. This document is the culmination of this effort. It is an excellent summary and resource.

Read the task force report

11 best practices for protecting connected medical devices:This article draws on the above report to highlight the issue of peripheral device vulnerability. Diagnostic equipment as well as implantable electronics (like pacemakers) are more easily hackable than, for example, electronic records. We need to pay more attention to this oft-overlooked security exposure.

Read the list with brief explanations

HL7 Releases FHIR Version 4.0 for Healthcare Interoperability:Other than security, the biggest IT problem is interoperability. HL7 is supposed to be a platform for aiding seamless communication among different IT systems. but there are several versions of this product. One advance is Fast Healthcare Interoperability Resources (FHIR). This version claims to be a large step forward in enabling this connectivity. The reading gets technical very quickly but at some point a cursory knowledge for all healthcare management professionals is necessary.

Read the announcement

Read more about FHIR 4.0

About pharma

Aurobindo Pharma USA recalls 80 lots of blood pressure drug from America:The specifics of this article are less important than the overall message. Last year a number of drugs were pulled from the US market because of impurities. This announcement highlights the fact that a large majority of chemicals used in manufacturing of pharmaceuticals for the US market come from India and China. Further, there are large numbers of generic medicines sourced from abroad. The FDA does not have the resources to inspect all these foreign plants and so relies on local enforcement- which is often inadequate.. Until local authorities can be trusted and rapid analytic devices are developed for use at point of inspection, this perennial problem will inevitably recur.

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FDA says certain antibiotics could rupture main artery:In the mid 1980s, the quinolones came on the market as a new class of antibiotics. Use rapidly increased for such conditions as urinary tract infections and community acquired pneumonias. As early as 1983, an association between quinolone use and Achilles tendon rupture was reported. Recognition of this problem has been growing as use of this class of drugs has continued to increase. In 2008, the FDA mandated that all these products have a black-box warning. Now it appears that connective tissue in general is at risk— aortic ruptures or tears have been associated with quinolone use. The obvious message: no drug is always safe and use must include consideration of risk/benefit tradeoffs and informed patient participation in decision making.

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Give it to us straight, doctors tell pharma advertisers—but being funny is OK, too: Have you ever read an advertisement or seen a commercial on TV and asked yourself either: What was that about? or Why don’t I understand the message? The problem of understandability is also prevalent in pharma advertising. According to a recent study: “More than one-third (39%) of doctors said they are sometimes confused by messaging, and another 35% reported being overwhelmed on occasion by the language used in the ads.” Despite all the regulatory requirements advertisers face, 76% of doctors recommend the Keep It Simple strategy. Humor helps as well.

Read about the study

About quality

Merit-based Incentive Payment System (MIPS):As providers enter another year of Quality Payment Program requirements, this link provides a great resource for understanding and complying with the MIPS.

Connect to the resource

About insurance

House Democrats seek authorization to intervene in ACA lawsuit:The Democrats in the House of Representatives have crafted rules giving that body the authority to participate in appeal of the recent ACA ruling in Texas. If it passes, they will join Democratic state attorneys general in that effort.

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