National Cancer Institute director Ned Sharpless to become acting FDA head
Read the announcement
FDA approves Pfizer's biosimilar to Roche's Herceptin: Biosimilar drugs are coming into increased use. They are expected to lower costs by about 20% (far less than non-organic medications). This biosimilar will have a big impact on costs because of the frequency with which it is used.
MAP4K4 Inhibition Promotes Survival of Human Stem Cell-Derived Cardiomyocytes and Reduces Infarct Size In Vivo: Interesting molecular science article. Briefly, these investigators found that a certain gene produces a toxic protein when heart cells are stressed (like in a heart attack). Blocking expression of the gene can save heart cells and lead to a greater functional status after healing. Though the research was in a mouse model it has great promise for future human trials.
FDA launches Request to Connect website:According to the website, the form : ” is intended for use by individual patients, caregivers, advocates, patient groups, and health professionals to encourage understanding and participation in FDA's regulatory work. This form is not for use by industry stakeholders. Requests may be related to a drug, biologic, device or a combination thereof.”
The Many Varieties of Universal Coverage: Confused about all the new proposals for health reform- especially those calling themselves “Medicare for all?” This interactive graphic from the Commonwealth Fund provides a really good explanation about these plans.
10 critical facts about the TPE program: This article is a really good summary about the Targeted Probe and Educate program- CMS’ audit procedure. Originally designed to help providers reduce rejected claims, it is really a sampling of bills and the medical records to back them up. This process can be conducted annually even if no problems are uncovered. If there are problems…well, read the article.
About the public’s health
Trump proposes big cuts to health programs for poor, elderly and disabled: The White House budget is out and it has a number of healthcare provisions- ranging from the opioid crisis to controlling drug costs to Medicaid funding. The overarching message is: “The 2020 Budget requests $87.1 billion for HHS, a 12-percent decrease from the 2019 estimated level. The Budget proposes $1,248.8 billion in net mandatory health savings, reducing longer-term deficits.” This article is a nice summary of these proposed changes.
Performance of human papillomavirus testing on self-collected versus clinician-collected samples for the detection of cervical intraepithelial neoplasia of grade 2 or worse: a randomised, paired screen-positive, non-inferiority trial: Human papilloma virus (HPV) is responsible for cervical cancer.; so screening for HPV has been replacing Pap smears in some settings. This study showed that self- obtained specimens were as good as clinician-obtained specimens in picking up higher grades of cancerous changes in women infected with HPV. While these self-obtained specimens are not a replacement for medical care, they would be very helpful in screening programs in places where such care is not readily available.
Health Literacy and Income Mediate Racial/Ethnic Asthma Disparities: Many factors account for health disparities. This study “suggests racial/ethnic differences in several asthma outcomes are largely due to effects of health literacy and income. Interventions to improve racial/ethnic asthma disparities should target health literacy and income barriers.”
VA Secretary Robert Wilkie announces precision medicine testing initiative with Sanford Health: Veterans will have a no-cost option to obtain genetic testing so their healthcare can be tailored to those results. “Veterans will access the test at their local VA facility, and Sanford Health will process the tests at its South Dakota-based Imagenetics facility.” Why Sanford? Because that’s where former VA Secretary Shulkin landed after he was fired.
About healthcare IT
How to ensure business associate agreements protect all parties: As mentioned yesterday, significant IT breaches are coming through business associates. This article is a reminder of and a good summary about the importance of business associate agreements and their part in security.
With lessons learned from computers, a new platform could help boost production of lifesaving biological therapies: What happens in a cell when a manufactured sequence of DNA is introduced, for examples, to help the cell produce immunity to infection or manufacture a protein missing in its host? Microsoft announced a partnership with Princeton University and two British biotech companies to develop a platform to more rapidly answer such questions. According to the company: “Microsoft’s Azure cloud infrastructure and machine learning tools can quickly analyze experimental data and improve models that predict how cells will react when a particular sequence of DNA is introduced. That could help users zero in on the best conditions for engineering a lifesaving drug, or bacteria that fix dyes onto textiles through a non-toxic process.” The venture is called Station B.