September 1, 2009

Additional Funding Awarded for Adherence Breathalyzer

Xhale, a Gainesville, Florida-based technology company, has received a $1.7 million follow-up grant from the National Institute of Mental Health (NIMH) of the National Institutes of Health to continue developing its breath-based medication adherence system for HIV treatments. Using a small handheld device—similar to an alcohol breathalyzer—the Self-Monitoring and Reporting Therapeutics (SMART) system monitors the levels of breath-detectable versions of antiretrovirals.

The small business innovation research (SBIR) grant will allow the company to develop and further test the functionality, accuracy and usability of the SMART system. Successful completion of the research, Xhale said in a press release published by Medical News Today, will result in a commercial version of the test.

“Medication adherence has tremendous impact on patient health,” Richard Melker, MD, Xhale’s chief technology officer, said in the press release. “This is particularly true with HIV/AIDS patients where just a 10 percent change in adherence is associated with doubling of viral load and a 21 percent increase in the risk of developing full-blown AIDS. NIMH was particularly interested since non-adherence to antibiotic or antiviral regimens also poses a serious threat to public health through the emergence of resistant organisms.”

“Building on our Phase I achievements, we will design and deploy a handheld, breath-based medication adherence device,” said Donn Dennis, MD, Xhale’s chief scientific officer. “The system will first remind the patients to take their medication. After ingesting their medication, the patients will blow into the device, which will detect and document that the appropriate medication was taken at the proper time. This technology should improve adherence rates, especially in high-risk populations, and provide pharmaceutical companies and the FDA with a higher quality data set for evaluating drug safety and efficacy in clinical trials.”

This is the third time in two years that Xhale has been awarded an SBIR grant. Previous awards were SBIR Phase I awards from the NIMH and the National Institute on Alcohol Abuse and Alcoholism.

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Previous Comments:

Jeff Hammond, Carrizozo, NM, 2009-09-08 14:56:27
this smacks SOOOO much of Orwellian 1984 lore that it is scary. with the CDC power to quarantine and force inocculation with the H1N1 vaccine it is only a few steps away from any officewr of the law knocking on my dor and demanding i breath into the tube and throwing me in jail if my levels aren't up to the standards levels. or should i say heil hitler? cuz that's where we are going.

john, San Jose, 2009-09-06 20:55:25
You all point out great aspects of the potential harm and prejudice against the HIV community with this breathalizer. I know I've been pressured to adhere ad nauseum (pun intended). I don't think us HIVers mean to create a stronger virus by not adhering 100%, but I remember how sick I got on one of the PI's and after leaving several messages for my truly great dr. that I would stop and needed an emergency appt. to switch meds, I quit while waiting 4 office beauracracy to resolve.

Terry, Ft. Lauderdale, 2009-09-06 13:40:24
Reminds me of the electronic, data-emitting caps on Rx drugs that were supposed to track regimen adherence rates each time the patient "took" a pill out of the bottle when they really just opened and closed the cap. With the "SMART" system, one could just have a buddy on the same regimen blow into the system. I wouldn't worry about this system. They would need your consent. We all have a right to self-determination, which includes the right to receive and the right to reject treatment.

Matt, Seattle, 2009-09-03 19:45:03
This will keep people from getting tested.Also continues stigma about adherence vs need to stop meds when toxic.It violates my right as a patient when I should stop meds without getting someones permission.Then being told I'm not adherent.Don't be bullied by doctors and pharma they work for you!Tell them NO if they want to do this test on you.

Stephen McGILL, Monrovia, Liberia, 2009-09-03 18:42:42
Stigma fuel the wide spred of the disease in every community. Join the fight against stigma and discrimination to save lives

Mike, St. Petersburg, 2009-09-03 11:29:06
I don't get along with this project at all. Thumbs down to this, & I for one will not ever use it. What a waste of grant money on some whacked out Florida firm (figures)!

Astonished, New York, 2009-09-02 18:28:09
Take the drugs, keep taking the drugs, otherwise you'll be punished. We don't want you cured, we want you hooked on the drugs, take the drugs, keep taking the drugs...

Dave C, Santa Fe, NM, 2009-09-02 18:03:50
This is terrible, but we might as well get used to the fact that our technology can be our undoing.

D Alen, LA,CA, 2009-09-02 14:17:01
I'll say it, Screw it!

Mark, New York, NY, 2009-09-02 12:51:55
Wow, what a great new and effective way for a foreign country to screen and discriminate against HIV+ people trying to enter into a country or even returning home, for their biased government to refuse entry into the country or even being seized, tortured or even depriving them from meds until they die, eliminating the unwanted. Keep up the great work! Heads up on documented discrimination

Dave C, NYC, 2009-09-02 12:50:06
INSANITY - is this was the stimulatous money is being used for?

Greg H., Davenport, FL, 2009-09-02 11:33:40
Talk about Big Brother! This might encourage some people to just say "screw it!"

Steve, Fort Lauderdale, 2009-09-02 10:48:52
I se the value to pharma in the development cycle of new medication; however, I also see Orwelian monitoring scenarios if the device is used in the general population.

John, USA, 2009-09-02 10:29:48
How do you stop this being used to withdraw insurance coverage. When medications causes side effects and the physician does not address those issues, patients will stop taking the offensive medicines, self unmedicating. When a patient stops medicine, it's called non adherence. When a physician stops medicine, it's called a strategic treatment interruption. Is there a breathalyzer to check the physician and the insurance company for breath based patient neglect?

John, Washington D.C., 2009-09-01 21:33:38
Forgive me for being daft, but how is this going to help anyone? I mean if you already don't take your meds is this really going to help? Don't people who don't take their meds know that they aren't taking their meds?