Healthcare Watch September 2022

Doctor Docs: Doctors Left Concerned After Roe v. Wade Overturn

A recent Sermo study of 240 U.S.-based physicians reveals that a majority are concerned and confused about what constitutes a life-threatening emergency that would make an abortion procedure legal in those 11 states where it has been banned. One thing that is clear to experts, however, is that there will be a rise in maternal deaths due to this uncertainty.

In many of the states where abortion is banned, strictly regulated, or soon to be restricted, the procedure is legal only in instances of a life-threatening situation, but no regulations define what such a situation may be, leaving 70% of physicians unclear about when to intervene for maternal safety. For example, Lisa Harris, a professor of reproductive health at the University of Michigan wrote to The New England Journal of Medicine, “Might abortion be permissible in a patient with pulmonary hypertension, for whom we cite a 30 – 50% chance of dying with ongoing pregnancy? Or must it be 100%?”

According to the Sermo survey, 79% of physicians are highly concerned that they are indeed being asked to wait until it is clear their patient will die to perform an emergency abortion. Abortion bans have made it a felony to provide or attempt to provide an abortion, meaning doctors and clinics are the ones likely to be charged and tried, rather than individual patients. This leads 89% of those surveyed to believe some doctors will err on the side of their own legal safety when making decisions about patient care and the necessity of abortion. As a result, 66% of physicians surveyed feel state abortion bans will potentially have life-threatening consequences for mothers and 68% expect more maternal deaths in states where abortion is banned.

Patient Pages: Patients Refuse Prescription Use After Recalls

Qualio surveyed 2,002 U.S. consumers of healthcare products to better understand how far-reaching quality-related product recalls are when it comes to consumer trust and healthcare-specific purchasing decisions. The survey uncovered that recalls and related quality issues have a pronounced and enduring impact on purchases of drugs, devices, therapies, and other healthcare products—more than half of U.S. adults are unlikely to use a prescription drug that has experienced a recall, regardless of whether that issue was fixed. Another 80% of consumers said that they are at least somewhat unlikely to use a specific healthcare product if they learn the FDA has issued a warning letter related to product quality issues.

The survey finds that consumers are more likely to hold the whole brand accountable than the product itself. This is especially concerning as many consumers (73%), particularly younger generations, follow news and updates about the prescriptions and healthcare products they use. Nearly half (43%) of these active consumers report they are frequently or always searching for news about the prescriptions or healthcare products they use.

Discoveries & Innovations: Hormone Could Improve Cognition in Down Syndrome Patients

Researchers believe the gonadotropin-releasing hormone may be behind the symptoms associated with Down syndrome and that hormone therapy can improve cognitive functioning.

Down syndrome effects 1 in 700 births in the U.S., according to the CDC, and yet the mechanisms contributing to the decreased sensory and intellectual functioning related to the condition are poorly understood. Now, the French Lille University Center researchers have discovered that the gonadotropin-releasing hormone, or GnRH, could be driving many of the symptoms associated with Down syndrome. In addition, restoring decreased GnRH could improve some cognitive functioning.

The idea stemmed from the fact that the researchers realized that children with Down syndrome have olfactory and intellectual abilities on par with their peers until around puberty, when they begin to decline. Down syndrome comes from a mutation on chromosome 21, which is also responsible for genes that had downstream effects on GnRH neurons. In mice, researchers found that GnRH neurons were not only present near the hypothalamus but also that they affected parts of the brain that control social and cognitive processes. In testing groups of mice with and without Down syndrome, the researchers found that these projections were the same between the two groups at birth but that they began to decrease in the experimental group after puberty. By the time they were adults, the experimental mice had lost those projections. Finally, when providing six months of GnRH gene therapy to experimental mice, there were changes in brain connectivity and cognitive function.

This allowed the researchers to set up a pilot study of seven men with Down syndrome aged between 20 and 50, who received special pumps that secreted a dose of GnRH every two hours for six months. The results were outstanding—six of the patients showed cognitive improvements of around 30%, meaning they were better able to understand instructions, had improved reasoning abilities, better episodic memory, and greater attention. However, olfactory abilities were unchanged. MRI tests pre- and post-hormone therapy showed increased signaling between visual and sensorimotor regions of the brain as well as lowered signaling between the hippocampus and amygdala—almost to the level of those without Down syndrome. More studies are needed before GnRH studies can be considered an effective treatment option.

FDA Update

Drug Approvals

The FDA approved Sanofi’s Xenpozyme (olipudase alfa-rpcp) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD). ASMD is caused by the lack of an enzyme needed to break down a complex lipid, called sphingomyelin, that accumulates in the liver, spleen, lung, and brain, and causes premature death.

Both Moderna’s COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine received an amended emergency use authorization (EUA) for an updated booster shot that contains two messenger mRNA components of the SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant.

The FDA expanded indications for AstraZeneca’s Imfinzi to include use in combination with standard chemotherapy for adults with locally advanced or metastatic biliary tract cancer. While it was first approved in 2017 to treat bladder cancer, the FDA now clears it for use in both non-small-cell lung cancer and extensive-stage small-cell lung cancer.

Zynteglo (betibeglogene autotemcel) from bluebird bio was approved as the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. Each dose of Zynteglo is a customized treatment created using the patient’s own cells that are genetically modified to produce functional beta-globin.

Med Device Approvals

BrainsWay, a company that specializes in advanced noninvasive neurostimulation treatments for mental health disorders, received 510(k) clearance from the FDA for its Deep TMS H7 Coil, a device used for treating adults suffering from major depressive disorder and depression including those with comorbid anxiety symptoms commonly known as anxious depression. BrainsWay’s coils are housed in a cushioned helmet and have been used to stimulate one portion of the brain to treat OCD since 2018. The H7 coil now addresses treatment-resistant depression.

The SBL-3 Multifocal Intraocular Lens was approved for use to provide vision correction after the eye’s natural lens is removed due to cataracts. The artificial lens, developed by Lenstec, is permanently implanted inside the eye, improving near vision.

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