DC Dispatch: U.S. Insulin Costs Could Benefit Canada

Congressman Peter Welch introduced a bill that would make it legal for patients, wholesalers, and pharmacists to import insulin from Canada.

As part of the drug price inflation frenzy gripping the U.S., insulin is a top subject of debate in Congress as well as among consumers. The cheaply made drug has been available since the ’80s from Sanofi, Eli Lilly, and Novo Nordisk. These companies still have a hold on the patent for the fairly simple drug that costs only a few dollars to produce, allowing them to increase the price, seemingly conjunctively, steadily over the years to its current rate of around $400 to $500 for a monthly supply.

Congress is reacting to the inflation as the pharma companies, insurance companies, and pharmacy benefit managers all claim the other is to blame for the high pricing that 100 million diabetic and prediabetic Americans now face.

Democrat Peter Welch introduced a bill that would make it legal for patients, wholesalers, and pharmacists to import insulin from Canada, and eventually other countries with acceptable safety standards. “This commonsense legislation bypasses big pharma’s pricing monopoly by making safe, lower-cost insulin available to patients,” Welch said in a statement. He added that insulin prices “have gone through the roof and are hammering” patients.

Previously, the House Energy and Commerce Committee and Oversight and Investigations Subcommittee, of which Welch is a part, sent letters asking the three companies to explain the rising insulin prices and whether they had struck any deals over the last 10 years to limit the availability of generic equivalents.

Should this law pass, patients with insulin prescriptions could import low-cost insulin and have it covered by their insurance plans, a loss of market Welch hopes will push transparency and negotiations out of the pharma companies.

Discoveries/Innovations: Improving Artificial Heart Valves with 3D Printers

CT scans and a custom parametric modeling process were combined to create multi-material physical models of patients’ aortic heart valves to test for the proper artificial valve size.

3D printing may be the key to perfecting the common procedure of replacing heart valves in patients with aortic blockages. One in eight elderly patients in the U.S. develop moderate-to-severe blockage of the aortic valve in their hearts, usually caused by calcified deposits that build up on the valve that prevent them from fully opening and closing. Many of these older patients cannot sustain open heart surgeries and need to instead undergo transcatheter aortic valve replacement (TAVR), during which a doctor implants an artificial valve via a catheter. Despite the commonality of the procedure, it is still challenging for surgeons to choose the appropriately sized heart valve without ever actually looking at the patient’s heart. If the valve is too small it can dislodge or leak around the edges, and if it’s too large it can rip through the heart, risking death.

Researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University developed a unique 3D printing workflow to address this problem, allowing cardiologists to evaluate how different valve sizes will interact with each patient’s unique anatomy. “Our integrative 3D printing and valve sizing system provides a customized report of every patient’s unique aortic valve shape, removing a lot of the guesswork and helping each patient receive a more accurately sized valve,” said James Weaver, PhD, a Senior Research Scientist at the Wyss Institute and coauthor of the research. CT scan data is used to produce physical models of individual patient’s aortic valves, and a “sizer” device determines the perfect replacement valve size.

Medical Devices: Portable Virus Detector Revolutionary for Remote Locations

Jacqueline Linnes of Purdue University holds a paper-based device capable of testing for infectious diseases.

A small, battery-powered device has been developed by Jacqueline Linnes, an Assistant Professor of Biomedical Engineering at Purdue University, that is capable of performing lab-quality tests for many infectious diseases, particularly viruses. The technology has the power to bring RNA amplification and testing to remote regions where this has not been possible due to infrastructure limitations, considering the previously available equipment is typically kept in special laboratory environments and requires well-trained staff to operate.

But this paper-based device has been proven to detect HIV nucleic acids from the blood of a finger prick within 90 minutes. People in any location can use the device to test themselves. Much like a pregnancy test, the paper strip moves the drop of blood along itself while being heated by the battery-powered tool. The device can specifically address challenges to faster disease detection in countries such as Kenya and Haiti, where HIV outbreaks have begun and spread rapidly and healthcare can be as much as 10 miles away with little transportation.

And if an affordable and accurate device can run on low power while detecting diseases in these countries, it could also prove useful to communities in the U.S. with limited staff and far apart facilities. “The idea is to more quickly detect what’s causing an infection for patients both in areas of the world that have the lab facilities close by and those that don’t,” Linnes said in a statement.

Brand Beat: Janssen to List Drug Pricing in TV Commercials

Johnson & Johnson has reported it will advertise its drug prices in TV commercials before being forced to by the Trump Administration. Their subsidiary, Janssen, will include the list price and potential out-of-pocket costs of its most prescribed drug, the anticoagulant Xarelto. The pricing follows guidelines set by the Department of Health & Human Services’ list price mandate along with the pricing principle plan that members of the trade association PhRMA agreed upon earlier this year. The company plans to record patient and consumer feedback on the Xarelto changes as it prepares to follow suit with its other medications.

“We spoke with many consumers and patients to understand what pricing information would be most relevant to them,” Scott White, J&J’s Group Chairman of North America Pharmaceuticals, said in a statement. “Their input not only shaped how we responded to the Administration’s DTC TV advertising proposal, it also suggested a common-sense path forward that we believe will give patients clearer, and more valuable, information about the cost of the medicines we advertise on TV.”

Doctor Docs: Vocal Cord Cancer on the Rise in Teens

New research shows teens and young adults are testing positive for vocal cord cancer at an accelerated rate in recent years. While traditionally linked to smoking, this high incidence of vocal cord cancer in a younger generation seems to be linked to human papillomavirus (HPV) infection, according to research led by Steven Zeitels, MD, a head and neck surgeon at Harvard Medical School and Massachusetts General Hospital.

Prior to the 2000s, the rare disease of the larynx was most present in older adults with a history of smoking. In fact, the American Academy of Otolaryngology – Head and Neck Surgery suggests 95% of people with the most common type of vocal cord cancer are smokers. But Dr. Zeitels’ 2016 research is revealing a turn in the medical trend where 31% of vocal cord cancer sufferers are nonsmokers and 70% of oropharyngeal cancers may be linked to HPV infection.

“We’re right at the cusp of an accelerated change because we’re seeing this in younger people and nonsmokers,” Dr. Zeitels told Everyday Health. “We were seeing a disproportionate number of younger people with vocal cord cancer. Of that group, a disproportionate number were nonsmokers.”

In the paper published in the Annals of Otology, Rhinology & Laryngology, Dr. Zeitels says, “It isn’t surprising that alternate malignant pathways may have a different timeline. Malignant pathways, such as high-risk HPV, may have a different and shorter timeline.”

Dr. Zeitels has also compared vocal cord cancer patients diagnosed in two time periods: 1990 to 2004 and 2004 to 2018. In the first time period, 112 people were diagnosed with vocal cord cancer, none of them 30 or younger. From July 2004 to June 2018, 241 people were diagnosed, 11 of whom were 30 or younger. Ten of the 11 people 30 or younger tested positive for high-risk HPV, such as HPV 16, which is one of the more common strains linked to cancer. None of these young patients had a history of smoking, except one. This study helps to alert doctors to the rising possibility that younger nonsmokers may be at risk for the disease when in the past they were taught that young people and nonsmokers do not develop vocal cord cancer.

FDA Update

Investigational Application

The FDA approves IntraBio’s Investigational New Drug Application for Clinical Trial for IB1001-202, designed for the treatment of Tay-Sachs and Sandhoff Disease. There are currently no drugs available to combat these fatal, pediatric diseases.

Breakthrough Designation

The FDA grants Breakthrough Drug Designation to Amicus Therapeutics’ AT-GAA for the treatment of late onset Pompe disease, an inherited lysosomal storage disorder caused by the deficiency of an enzyme known as acid alpha-glucosidase.

Drug Approvals

Novartis received approval for Egaten (triclabendazole) for the treatment of fascioliasis in patients six years of age and older. This is the only FDA-approved drug for this disease and is expected to facilitate broader access to this drug not only in the U.S., but also worldwide.

Cablivi (caplacizumab-yhdp) injection from Ablynx is the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP).

Medical Devices

The German-based BIOTRONIK earned FDA approval for the Orsiro drug-eluting stent (DES) system. The device delivers sirolimus, which helps to prevent restenosis, through a proprietary bioabsorbable polymer coating, which is infused with the drug and releases it as it breaks down.

The FDA grants 510(k) clearance for the use of the Cellvizio AQ-Flex 19 Confocal Miniprobe, manufactured by Mauna Kea Technologies, to detect lung cancer. The device is used with existing bronchoscopes, transbronchial needles, and other bronchoscopic accessories as a laser endomicroscopy platform.

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