INHALED DIGITAL THERAPY AND THE AMERICAN CLINICIAN - GERALD C. SMALDONE MD PHD STATE UNIVERSITY OF NY AT STONY BROOK - IPAC-RS
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Inhaled [Digital] Therapy
and the American Clinician
Gerald C. Smaldone MD PhD
State University of NY at Stony Brook
25 May 2019 Digital Health in Inhaled Drug Delivery 1
A brief history of the development of the
American Drug Industry
Why is Medicine So Expensive? D.J Kevies NY Review of Books, February 21, 2019
1800- 1865 drug monopolies were prevented by patents, and
ethical codes
Plant extracts could not be patented [made by nature] but sold as
“patent medicines”
AMA indicated in 1847 that patenting a medicine was
inconsistent with beneficence and professional liberality”
25 May 2019 Digital Health in Inhaled Drug Delivery 2
1870 Parke Davis and Eli Lily used trademark law to preserve brand
names and kept ingredients secret [condemned by ethical firms and
physicians for secrecy and high prices]
Entry of chemical firms [Bayer], no ethical limitations and patents the
basis for business
Research, Innovation and patent protection took over, allowed
protected disclosure
Pure Food and Drug act 1906, 1912, must list ingredients
1912 AMA, revised ethical position-patents OK as long as one does not
profit! But led to University involvement, person reputation and
ultimately profit
1980 Bayh Dole Act Universities patent federally funded research-
alliance with drug industry
25 May 2019 Digital Health in Inhaled Drug Delivery 3
SG1
Over the last 30 years new relationships evolved. The Insurance Game
INSULIN WARS by Danielle Ofri Jan. 18, 2019
Dr. Ofri practices at Bellevue Hospital in New York
“My patient’s ‘preferred
insulin’ changed three times
in a year, so each time she
went to the pharmacy, her
prescription was rejected.”
25 May 2019 Digital Health in Inhaled Drug Delivery 4
Slide 4 SG1 Smaldone, Gerald, 3/23/2019
Modern Times
Drug Companies
+
Insurance Companies = ACRIMONY
+
Physicians
25 May 2019 5
Drug Companies and Patients 25 May 2019 Digital Health in Inhaled Drug Delivery 6
SG3
The Aura of Adherence and Inhaler Therapy, Perri Klass MD March 11, 2019
USING AN ASTHMA INHALER CORRECTLY
A new study suggests that
many patients aren’t waiting
between puffs on their
inhalers and may not be
deriving he full benefits of
the drugs.
25 May 2019 Digital Health in Inhaled Drug Delivery 7
Slide 7 SG3 Smaldone, Gerald, 3/23/2019
25 May 2019 Digital Health in Inhaled Drug Delivery 8
Blame the patient 25 May 2019 Digital Health in Inhaled Drug Delivery 9
QVAR RediHaler
Nothing to shake or prime
Nothing to press
A spacer-free design
[do not use a spacer]
A built-in dose counter on the back
DON’T SHAKE IT!
NO PRIMING PUFF!
DO NOT USE A SPACER!
25 May 2019 10Confuse the patient 25 May 2019 Digital Health in Inhaled Drug Delivery 11
Blame the doctor
Most health care professionals use
incorrect asthma inhaler technique
Plaza V, et al. J Allergy Clin Immunol Pract. 2018;doi:10.1016/j.jaip.2017.12.032.June 18, 2018ADD TOPIC TO
EMAIL ALERTSMyrna Dolovich
Health care professionals incorrectly used an asthma inhaler
almost 85% of the time, according to a systematic review
recently published in The Journal of Allergy and Clinical
Immunology: In Practice.“The correct use of inhalers has been
an issue for a number of years,” Myrna B. Dolovich, BEng,
PEng, of the faculty of health sciences within the division of
respiratory medicine at McMaster University, told Healio Family
Medicine, adding that a different systematic review conducted
more than 30 years ago showed an overall error rate of 31%
25 May 2019 12DRUG ~ COST
Atrovent $50
Ventolin $60
QVR $200+
Spiriva $400+
Anoro Ellipta $400+
Trelegy $500+
25 May 2019 Digital Health in Inhaled Drug Delivery 13Does Adherence really matter?
NO SIGNIFICANT DIFFERENCES IN EFFICACY BETWEEN DEVICES
25 May 2019 14Perspectives
Why Don’t Our Patients with Chronic Obstructive Pulmonary Disease Listen to Us?
The Enigma of Nonadherence
Felicity C. Blackstock1, Richard ZuWallack2,3, Linda Nici4, and Suzanne C. Lareau5
Annals ATS Volume 13 Number 3| March 2016
ADHERENCE
COMPLIANCE
CONCORDANCE
25 May 2019 15Enter Technology 25 May 2019 Digital Health in Inhaled Drug Delivery 16
“New” Technology
The Dose Counter
25 May 2019 17The Smartmist
Aradigm's innovative AERx pulmonary drug delivery platform
demonstrated performance that is highly efficient and precise
compared to other inhalation systems
DELIVERING THE DOSAGE
For more than 30 years, asthmatics have walked around with
portable inhalers in their pockets. Taking a puff of medication from
an inhaler, patients can stifle an asthma attack. If they inhale
medicine daily, they may even prevent asthma attacks entirely. But
there's a problem. Studies suggest that many asthma patients use
inhalers incorrectly and end up with less medicine than they need.
They might inhale their medication too quickly.
25 May 2019 1825 May 2019 Digital Health in Inhaled Drug Delivery 19
It’s a tough World out there
Collusion between Drug and Insurance Companies
Concordance between caregiver and patient
Complexity of delivery systems
Rebranding of old molecules
Lack of real data
Limited comparison studies between products
25 May 2019 20Digital Drug Delivery/Telemedicine
RISKS
• Must overcome the Office Environment
• MD buy-in is not guaranteed
• Patients easily confused by myriad of systems
• Could be viewed as another way to brand old molecules
• An excuse to jack up prices
• No real evidence that they work
BENEFITS
• POTENTIAL TO SUPPLY REAL DATA IN THE REAL WORLD
25 May 2019 2125 May 2019 Digital Health in Inhaled Drug Delivery 22
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