partlycloudy
Thursday November 23rd, 2017 11:56AM

US regulators approve first digital pill to track patients

By The Associated Press
Related Articles
  Contact Editor

WASHINGTON (AP) — U.S. regulators have approved the first drug with a sensor that alerts doctors when the medication has been taken, offering a new way of monitoring patients but also raising privacy concerns.

The digital pill approved Monday combines two existing products: the former blockbuster psychiatric medication Abilify — long used to treat schizophrenia and bipolar disorder — with a sensor tracking system first approved in 2012.

The technology is intended to help prevent dangerous emergencies that can occur when patients skip their medication, such as manic episodes experienced by those suffering from bipolar disorder.

But developers Otsuka Pharmaceutical Co. and Proteus Digital Health are likely to face hurdles. The pill has not yet been shown to actually improve patients' medication compliance, a feature insurers are likely to insist on before paying for the pill. Additionally, patients must be willing to allow their doctors and caregivers to access the digital information.

These privacy issues are likely to crop up more often as drugmakers and medical device companies combine their products with technologies developed by Silicon Valley.

Experts say the technology could be a useful tool, but it will also change how doctors relate to their patients as they're able to see whether they are following instructions.

"It's truth serum time," said Arthur Caplan, a medical ethicist at NYU's Langone Medical Center. "Is the doctor going to start yelling at me? Am I going to get a big accusatory speech? How will that interaction be handled?"

The technology carries risks for patient privacy too if there are breaches of medical data or unauthorized use as a surveillance tool, said James Giordano, a professor of neurology at Georgetown University Medical Center.

"Could this type of device be used for real-time surveillance? The answer is of course it could," said Giordano.

The new pill, Abilify MyCite, is embedded with a digital sensor that is activated by stomach fluids, sending a signal to a patch worn by the patient and notifying a digital smartphone app that the medication has been taken.

The FDA stressed however that there are limitations to monitoring patients.

"Abilify MyCite should not be used to track drug ingestion in 'real-time' or during an emergency," the statement said, "because detection may be delayed or may not occur."

Patients can track their dosage on their smartphone and allow their doctors, family or caregivers to access the information through a website.

In a statement issued last May at the time the FDA accepted submission of the product for review, the companies said "with the patient's consent, this information could be shared with their health care professional team and selected family and friends, with the goal of allowing physicians to be more informed in making treatment decisions that are specific to the patient's needs."

While it's the first time the FDA has approved such a pill, various specialty pharmacies and hospitals in the U.S. have previously "packaged" various drugs and sensors. But the federal endorsement increases the likelihood that insurers will eventually pay for the technology.

Drugmakers frequently reformulate their drugs to extend their patent life and to justify raising prices. For instance, Otsuka already sells a long-acting injectable version of Abilify intended to last for one month. The patent on the original Abilify pill expired in 2015.

The Japanese drugmaker has not said how it will price the digital pill. Proteus Digital Health, based in Redwood City California, makes the sensor.

___

Merrill Hartson in Washington contributed to this report.

  • Associated Categories: U.S. News, Associated Press (AP), AP National News, Top U.S. News short headlines, Top General short headlines, AP Health, AP Business, AP Business - Corporate News, AP Business - Industries, AP Business - Financial Services, AP Business - Health Care
© Copyright 2017 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
Russia drafts legislation targeting foreign media
Russian lawmakers say they have drafted legal amendments that would allow the government to register international media outlets as foreign agents
9:41AM ( 6 minutes ago )
Recreational marijuana rules rile pot-friendly San Francisco
The San Francisco Board of Supervisors will take up legal cannabis regulations Tuesday after weeks of wrangling over where to allow new recreational stores come January 1
9:37AM ( 11 minutes ago )
Boston Red Sox great Bobby Doerr dies at 99
Bobby Doerr, the Hall of Fame second baseman of the Boston Red Sox and teammate of Ted Williams, dies at 99
9:34AM ( 13 minutes ago )
Associated Press (AP)
Trump Jr. faces calls to publicly explain WikiLeaks contacts
President Donald Trump's oldest son has released a series of direct messages he received from the Twitter account behind the WikiLeaks website
9:11AM ( 36 minutes ago )
Trump faces new challenges in tax overhaul, Alabama race
President Donald Trump is headed home following an Asia tour he called "tremendously successful."
8:43AM ( 1 hour ago )
10 Things to Know for Today
Among 10 Things to Know: Trump Jr. messaged with WikiLeaks during 2016 campaign; Rescuers search debris after Iran-Iraq earthquake killed more than 400; Republicans continue abandoning Alabama Senate candidate Moore after new accusations
7:28AM ( 2 hours ago )
AP National News
US producer prices rise 0.4 in October on higher food prices
US producer prices rise 0.4 percent in October, post biggest annual gain since 2012
8:39AM ( 1 hour ago )
Global stocks mostly slide after disappointing Chinese data
Global stocks are mostly down as investors watched for tax reform developments in the U.S. and digested weak manufacturing data from China
7:46AM ( 2 hours ago )
Boeing inks $1.3B Ethiopian Airlines deal for 777 freighters
Boeing inks deal to sell four 777 freighters to Ethiopian Airlines, purchase valued at $1.3 billion
7:36AM ( 2 hours ago )
AP Business
Sessions open to idea of Clinton Foundation special counsel
Attorney General Jeff Sessions is leaving open the possibility that a special counsel could be appointed to look into Clinton Foundation dealings and a uranium deal during the Obama administration
1:53AM ( 7 hours ago )
Bipartisan analysis: Senate bill would hike taxes for 13.8M
A bipartisan analysis of the Senate GOP tax bill finds that it would increase taxes for some 13.8 million moderate-income American households
8:01PM ( 13 hours ago )
The Latest: Trump to meet with House GOP ahead of tax vote
White House official says Trump plans to meet with House Republicans on Thursday ahead of an expected vote on tax overhaul legislation
7:03PM ( 14 hours ago )
AP Business - Corporate News
UN agency report shows Iran meeting nuclear commitments
A new review by the United Nations agency monitoring Iran's compliance with a treaty that restricts its nuclear activities has not identified any violations by Tehran
5:47PM ( 16 hours ago )
Protesters disrupt US fossil-nuclear event at climate talks
Protesters drown out speeches by White House advisers and business representatives Monday at an U.S.-sponsored event promoting the use of fossil fuels and nuclear energy
5:09PM ( 16 hours ago )
Trump turns to drug industry for his new health secretary
President Donald Trump picks former top drug company and government executive to be his next health secretary
3:46PM ( 18 hours ago )
AP Business - Industries
Trump names former drug exec as new health secretary
President Donald Trump picks former top drug company and government executive to be his next health secretary
11:31AM ( 22 hours ago )
US stocks on two-day losing streak as health stocks fall
US stocks fall for second day as medical device makers take sharp losses
5:17PM ( 3 days ago )
US stocks slip as health care device companies stumble
US stocks are mostly lower as health care device and equipment companies take sharp losses as investors consider Amazon's potential to compete with them
3:00PM ( 3 days ago )
AP Business - Health Care
Russia drafts legislation targeting foreign media
Russian lawmakers say they have drafted legal amendments that would allow the government to register international media outlets as foreign agents
9:41AM ( 6 minutes ago )
Recreational marijuana rules rile pot-friendly San Francisco
The San Francisco Board of Supervisors will take up legal cannabis regulations Tuesday after weeks of wrangling over where to allow new recreational stores come January 1
9:37AM ( 11 minutes ago )
Boston Red Sox great Bobby Doerr dies at 99
Bobby Doerr, the Hall of Fame second baseman of the Boston Red Sox and teammate of Ted Williams, dies at 99
9:34AM ( 14 minutes ago )
Trump Jr.'s WikiLeaks exchange adds intrigue to Russia probe
President Donald Trump's oldest son has released a series of direct messages he received from the Twitter account behind the WikiLeaks website
9:25AM ( 23 minutes ago )
Nations press panel to raise annual Bluefin tuna quotas
Nations from around the Atlantic and Mediterranean start assessing how much more of the prized Bluefin tuna can be caught in the next years amid signs stocks of the iconic fish continue to recover
9:23AM ( 25 minutes ago )