Brainstorm Health: Digital Birth Control App, Alnylam Approval, Teen Depression

The Food and Drug Administration (FDA) has approved a digital birth control app. Yes, you read that right. So how does something like that work?

The app is called Natural Cycles. Here’s how the FDA describes it: “Natural Cycles contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily body temperature readings and menstrual cycle information, a method of contraception called fertility awareness. Designed for mobile devices, it is intended for use in pre-menopausal women aged 18 and older.”

To be clear, using this app requires user effort, too. Women who rely on Natural Cycles as a pregnancy prevention method would have to use a special thermometer to take their “basal body temperature”—i.e., the body’s temperature when it’s still at rest, upon waking up—in order to assess what part of her ovulation cycle she is in.

Regulators point out that this form of contraception requires careful monitoring, since women basically have to make decisions about refraining from sex or using protection depending on regular readings from the app, which would caution to “use protection” on days they would be more likely to be fertile.

The FDA also issued a warning: “[W]omen should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device,” said Dr. Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, in a statement.

Read on for the day’s news.

DIGITAL HEALTH

Gene therapy startup Orchard raises $150 million. Gene therapy companies are holding on to their prominent positions in the biopharma zeitgeist. On Monday, upstart Orchard Therapeutics landed an additional $150 million in funding to help the biotech go forward with gene therapy programs for a smorgasbord of immune disorders, beta thalassemia, and other rare conditions—a portfolio purchased from British pharma giant GlaxoSmithKline just four months ago. (Xconomy)

INDICATIONS

Alnylam's RNA-i therapy continues the drug pricing experiment trend. The FDA on Friday approved the world's first RNA interference treatment, Alnylam's Onpattro. The therapy is meant to treat a rare condition called hereditary transthyretin-mediated amyloidosis, or hATTR. But as is often the case with breakthrough drugs using new, expensive technologies, price will be a major factor going forward. Alnylam has plotted a system that will reportedly charge a list price of $450,000 per year for the treatment, but a net of $345,000 annually. If Onpattro doesn't wind up working, Alnylam would reportedly offer money back to the patient. (Fortune)

THE BIG PICTURE

Mental health's downstream effects. A new study presented at the annual American Psychological Association (APA) meeting suggests that treating mental health problems in teenagers could also mollify conditions like depression in their parents. "More young people today are reporting persistent feelings of sadness and hopelessness and suicidal thoughts," said Northwestern University's Kelsey Howard while announcing the results. "At the same time, suicide rates have climbed in nearly all U.S. states. This research may help health care providers as we grapple as a nation with how to address these alarming trends." (Medical Xpress)

REQUIRED READING

Google's Path Back Into China Includes a Host of Local Partners, by David Z. Morris

Apple Has Appealed Its Taxes Nearly 500 Times Since 2004, by Don Reisinger

Why Turkey's Collapsing Currency Is Tainting World Markets, by David Meyer