Healthcare Watch October 2016

Doctor Docs: The U.S. Calls for More Public Info

healthcare-watch-1In conjunction with the UN’s demand for transparency regarding drug development prices, the U.S. Department of Health issued a rule that it will require scientists and companies to publicly disclose additional details on more of their medical research studies, regardless of study results. The new rule responds to the fact that many researchers do a poor job at making additional findings available to the public when data proves unfavorable.

Francis Collins, director of NIH, says public transparency “may help inform healthcare providers and patients regarding medical decisions”—helping the public, while—“additional information may help researchers avoid duplicating studies, as well as help them to focus on areas of need and to improve trial designs”—helping budgets and future drug effectiveness.

Medical Devices: New Sensors for Placing Needles

Epidural injections and other minimally invasive procedures have become an extremely reliable way for those with chronic conditions to manage their pain. This is mostly due to their vast success and safety, but there is a small percentage of the 13 million-plus injection procedures that have adverse side effects due to incorrect placement of the needles. When puncturing through layers of tissue to reach a specific spinal nerve or area of the spinal canal, there is a risk that the needle can be inserted too far in a blood vessel, with the worst possible outcome being a stroke or spinal cord injury.

MIT researchers have developed an optical sensor based on Raman spectroscopy, which measures energy shifts with light changes to instantly tell the physician which tissue the needle has reached. The sensor proves 100% accurate at detecting each tissue layer—skin, fat, supraspinous ligament, interspinous ligament, and ligamentum flavum—before the epidural and then the actual spinal cord. MIT entrepreneurship programs hope to bring the technology out of the blind study phase and into medical facilities soon.

Sales Sector: A New Approach to Prescription Drugs

healthcare-watch-2The EpiPen controversy has made it glaringly obvious that the healthcare system is in need of reform. Dr. Spencer Malkin, CEO of Prescriber’s Choice, is addressing the problem by forming a process of customizing prescriptions to be dispensed to the patient at the physicians’ office. Because drug manufacturers are demanding a higher price for prescriptions, insurance companies are asking patients to pay larger portions, discouraging them from purchasing medicine. The result is that physicians are less able to care properly for patients.

“It’s a completely new paradigm that allows the physician and the patient greater flexibility and control,” Dr. Malkin explains. “Instead of completing frustrating and costly prior authorizations that are frequently denied, or that lead to the use of less effective medications, physicians make better use of their time, knowledge, and skills by personalizing their patients’ medications.”

Prescriber’s Choice is defying the healthcare convention in the dermatology field by cutting out third-party payers. This system allows patients to receive medicine specific to their condition while saving money and it saves the health system money as well by avoiding bills to insurance carriers.

Discoveries/Innovations: A Breakthrough with Septic Shock

A key component of what occurs during septic shock has been uncovered, giving scientists new information about how vesicles and inflammation are linked. Studies show that inflammatory signals in the blood tell the choroid plexus to form extracellular vesicles. These vesicles then communicate the inflammatory signals to the brain.

“In brief, we found a new way of blood-to-brain communication that is detrimental in septic shock,” says, study author, Dr. Roosmarijn Vandenbroucke. “One of the next steps is to investigate the therapeutic potential of changing the process of extracellular vesicle release.”

Therapeutic Talk: Connecting Depression to Cardiovascular Disease

With more than 15 million Americans suffering from depression, it’s surprising how little scientists really know about the condition. Now, it has been linked to another highly fatal condition—cardiovascular disease—by a faulty gene. Recent research has shown that genes play a large role in depression, especially those that involve regulation of the immune system. Now scientists say that they’ve identified the PXMP2 gene as an important new study subject. PXMP2 is robustly expressed during depression and may do so via metabolic pathways.

“What we saw was overlap in genetic expression between the brain and peripheral tissues that strongly implicated a link between depression and cardiovascular disease,” says lead author Bernhard Baune.

If more is understood about how faulty expression of this particular gene connects to depression and cardiovascular disease, it could open up possibilities for gene therapy for both conditions.

FDA Update

Drug Approvals

Shire got FDA approval for the only once-a-month subcutaneous treatment for patients with primary immunodeficiency. Cuvitru is the only 20% subcutaneous immunoglobulin treatment option without proline and is safe for children of two years and older. The new therapy allows for more convenient dosage option for those suffering from primary immunodeficiency, which affects up to six million people worldwide.

The first drug to treat patients with Duchenne muscular dystrophy (DMD), Sarepta Therapeutics’ Exondys 51, specifically targets the mutation of the dystrophin gene amenable to exon 51 skipping, which is present in about 13% of those with DMD. The drug received approval through the accelerated approval pathway, which gives patients access to new drugs that treat serious or life-threatening diseases before lengthy clinical trials. Data from Exondys 51 studies show a dystrophin increase in skeletal muscle.

Med Device Approvals

Bayer has introduced a new intrauterine system, which has earned FDA approval for the prevention of pregnancy for up to five years. Kyleena contains 19.5 mg of the progestin hormone levonorgestrel, and is inserted by a physician.

Medtronic’s “IN.PACT Admiral Drug-Coated Balloon (DCB), a treatment of restenosis associated with peripheral artery disease in the upper leg, recently received FDA approval. It will help the company become a top leader in the DCB market. The balloon is coated with the drug paclitaxel, which has resulted in a 7.3% clinically driven target revascularization rate. So far, the balloon has been used in 100,000 patients.


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