Monday, August 17, 2015

The POLY[]PILL

Technology and the pressure of cost containment and improving patient compliance are resulting in an interest in developing a pill with 3,4, or even 5 drug combinations.  There are however some obstacles for this advance in poly-pharmacology.


Patients often are not compliant with treatment recommendations, even for one medication.  As more medications are prescribed compliance deteriorates further.


If a safe, inexpensive, once-a-day pill could substantially reduce the risk of myocardial infarction (MI) or stroke, would people want it? Most would probably say yes because MI and stroke are the first and third leading causes of death, respectively, in the United States.1 It is likely that many employers, health plans, and payers would also say yes because MI and stroke cost the US economy more than $300 billion annually in health care expenditures and lost productivity.2



Improving adherence by simplifying drug regimens and reducing their cost could have far-reaching consequences. In 2003, Wald and Law3 proposed to combine 3 half-dose antihypertensive agents, an intermediate-dose statin, low-dose aspirin, and folic acid into a once per day polypill for primary and secondary prevention of cardiovascular disease. Based on epidemiological models, they estimated that daily use by individuals aged 55 years or older could reduce the incidence of MI and stroke by more than 80%.3
The 4 drugs in the current version of the polypill have long histories of safe use. Although all 4 are frequently prescribed in the United States, the US Food and Drug Administration (FDA) has not approved combining them in a single pill. It has, however, authorized approximately 50 two-drug pills for hypertension.4 Recently, an FDA advisory committee expressed cautious support for using the polypill for secondary prevention of MI and stroke in patients who are unlikely to be closely monitored by a physician. It did not address the larger question of primary prevention.5
Although the polypill could produce substantial public health benefits, people in the United States are unlikely to find out anytime soon. This is because the pill’s price is so low (≤$1 per tablet) and the cost of the large clinical trials required for FDA approval is so high, it is unattractive to investors. The inventor’s dilemma is that creating a product that improves health is not enough; the product must also be able to generate a healthy return on investment. In the United States, the surest way to generate a healthy return on investment is to increase health care spending, not reduce it.
In reality advances in drug delivery systems will be very important for pubic health reasons, compliance and cost reduction.  It will require some creative and innovative for financing drug development costs.  The technology is ready, can we afford it ?  We need innovative venture capitalists.  It is doubtful whether the Affordable Care Act will nourish this embryonic technology.  What can be done?


First, to inspire innovators, federal agencies and philanthropies should commit a larger share of their research budgets to high-risk, high-reward science. Second, to entice inventors to address challenging problems, there could be greater use of prizes (eg, cash for the first inventor who creates a drug or device that meets a specific need).

Third, to ensure that low-cost, high-value discoveries reach the market, patent buyouts could be offered. This could increase the likelihood that these products are commercialized and offered at prices sufficiently low to encourage widespread adoption.

Fourth, to give inventors access to the capital required to bring a cost-lowering technology to market, a public-interest investment fund could be established. The public-interest investment fund would seek out promising products that are not attractive to conventional investors, and replenish its coffers with shared savings from successful inventions.

Fifth, to streamline the regulatory approval process, the FDA could be authorized to use existing mechanisms, such as fast-track or breakthrough therapy authority, to expedite review of cost-lowering technologies. This would require expanding the FDA’s mission beyond safety and efficacy to address costs.
What is the actual cost to develop a new medication ? The California Biomedical Research Association outlines the process
The studies are spread out from 2010 to 2015 and the increases have been substantial during this period. Keep in mind that reports from pharma are used to justify the high costs of drugs.
In addition the costs vary greatly among disease categories and the category of the drug.  Some drugs are a variation of one already approved, while others are in new classes such as oncology drugs designed as antibodies to cancer cells.  Variations in cost estimates suggest that policymakers should not use a single number to characterize drug costs. It is important to also be aware that different drug types might have substantially different actual costs of clinical trials. Therefore, the estimated variation in drug costs could be higher or lower, depending on whether the correlation between actual costs, success probabilities, and durations is positive or negative. As discussed below, recent work suggests that HIV/AIDS drugs have high clinical costs.


Poly drug combinations are made of already approved drugs for single use, and development costs may be far less. 





JAMA Network | JAMA | Effects of a Fixed-Dose Combination Strategy on Adherence and Risk Factors in Patients With or at High Risk of CVD:  The UMPIRE Randomized Clinical Trial

Saturday, August 15, 2015

About the AMA’s STEPS Forward™

Health Care is changing so rapidly that physicians and hospitals need "a little help from our friends"  If you are old enough you may remember that as title song from the era of The Beatles. At that time we all thought the times were tough. Well we did not envision that we would  once again need help from friends.  In this case I am surprised and pleased to see a  well orchestrated plan from the American Medical Association.

Health care is changing rapidly. Physicians are transforming their practices into organizations that can achieve the Quadruple Aim — better patient experience, better population health and lower overall costs with improved professional satisfaction. To navigate this environment, we leveraged the findings from the AMA-RAND study, "Factors affecting physician professional satisfaction and their implications for patient care, health systems and health policy," to develop the STEPS Forward™ practice transformation series.
Yes, despite the opinions of naysayers that the AMA represents  only 25% of physicians, it is the best 25% that I have encountered in the past ten years.

About the AMA’s STEPS Forward™ most or all of the modules contain CME credits. STEPS Forward™ is a practice-based initiative designed to provide you with proven strategies that can improve practice efficiency and help you reach the Quadruple Aim — better patient experience, better population health and lower overall costs with improved professional satisfaction.

STEPS Forward™ offers innovative strategies that will allow physicians and their staff to thrive in the new health care environment.

STEPS FORWARD provides modules includes a set for adopting electronic health records.   Complete electronic health record (EHR) implementation toolkit zip file
And there are many other modules:

ICD Conversion

Starting Lean Health Care
Improving physician resiliency
These are just three examples of modules which outline each topical issue.

Redesign Your Practice is the starting point for the overall program.


EHR AMA MEANINGFUL USE ICD10 INTEROPERABILITY


It’s no secret that many physicians are unhappy with their electronic health record (EHR) systems, thanks in large part to cumbersome processes and limited features that get in the way of patient care. Now a panel of experts has called for EHR overhaul, outlining the eight top challenges and solutions for improving EHR usability for physicians and their patients.
Introduction
Much of this post is taken from an AMA symposium on the use of EHR in July 2015.  All of you who are already using EHR know about the strengths and weaknesses, and even outright failures of electronic health records.

Electronic Health Records, AMA Townhall, Atlanta Georgia


8 top challenges and solutions for making EHRs usable
1. Enhance physicians’ ability to provide high-quality patient care.
2. Support team-based care. 
3. Promote care coordination.  
4. Offer product modularity and configurability. 
5. Reduce cognitive work load
6. Promote interoperability and data exchange
7. Facilitate digital patient engagement.  
8. Expedite user input into product design and post-implementation feedback. 
The The Affordable Care Act posits affordable care, improved access, formation of accountable care organizations, patient centered care, medical homes and more.
The Patient Protection and Affordable Care Act is made up of the Affordable Health Care for America Actthe Patient Protection Act, and the health care related sections of the the Health Care and Education Reconciliation Act and the Student Aid and Fiscal Responsibility Act. It also includes amendments to other laws like the Food, Drug and Cosmetics Act and the Health and Public Services Act. 
Despite the lofty goal of providing excellent care, The Affordable Care Act and HHS the incentivization program has had the diametrically opposite effect on unifying clinical practice.
The addition of EHR does nothing to really enhance communications between providers. The paper silo has become a digital silo.  Physicians and patients assume that the EMR connects physicians when most physicians do not have time to read and entire EHR.  Physicians used to communicate directly with each other, but in many cases they no longer do so, assuming the referral physician and the consultant have spoken.
Meaningful use  III challenges physicians and patients to use portals for a certain percentage of patients. Many medicare patients already chose between necessity of life (food, shelter, medications) and do not have internet access. Yes, there still are many that do not "live the dream".
The data elements will continue to increase, with wearables, such as fitbits, blood pressure and/or blood sugar monitors, and remote monitoring.  Will these too be incorporated, seaminglessly into the EHR ?  
It is far better to anticipate these changes than to wait for it to happen.
CMS needs to realign it's mission to patient care, and provider efficiency. CMS Bureaucratic bloat has not so silently increased. Much of it's resources are to distribute the social program for medical care and to prevent fraud.

Tuesday, August 11, 2015

Alphabet Google takes Deeper Dive into Med Tech with Health Tracking and Life Sciences X-Lab

The news that Google was forming it's own holding company this week overshadowed important developments in Google's LifeSciences Xlab.

Google ($GOOG) has not wasted any time since launching its life sciences division group a couple of years ago, sinking funds into med tech projects to expand its reach in wearable health. Now the company is charging full speed ahead with one of its initiatives, developing a health-tracking wristband device with its eye on FDAapproval.

The product, which is being developed through the company's Google X research unit, measures pulse, heart rhythm and skin temperature and gauges environmental information like light exposure and noise levels, giving doctors and researchers minute-by-minute data on patients' physical states,  Google already offers health-monitoring smartwatch features through its Android Wear software platform, but its health-tracking wristband will not be marketed as a consumer device, Andy Conrad, head of the company's life sciences team, told the news outlet. "Our intended use is for this to become a medical device that's prescribed to patients or used for clinical trials," he said.

Google's wristband could offer an advantage over other health-tracking methods, which often rely on patient compliance and visits to the lab to amass data. The company's wristband would collect information continuously, allowing drugmakers, physicians and scientists to track patients' vital signs outside of a lab setting. If all goes to plan, the device could be used as a prevention tool to catch early signs of disease, Conrad said.
"I envision a day, in 20 or 30 years, where physicians give it to all patients," he said (as quoted by Bloomberg). "Prevention means all the time."

Next up, Google plans to team up with academic researchers and drugmakers to test the wristband, kicking off its first trials over the summer, company spokeswoman Jacquelyn Miller told Bloomberg. And the company could also be in the market for a manufacturing partner, Conrad said, echoing last year's deal with Novartis ($NVS) to license and commercialize its smart contact lenses for diabetes.



Meanwhile, Google continues to roll out new projects and strike deals with industry heavyweights to beef up its presence in life sciences. In October, Google X revealed a project to design tiny magnetic particles that screen for cancer and other diseases. Earlier this year, the company said it would team up with Johnson & Johnson ($JNJ) to create a robotic-assisted surgical platform for minimally invasive procedures.

Google and Google Ventures have deep pockets,,already investing In 2014, Google investing more than one-third of its $425 million venture fund into healthcare and life sciences companies, 

Four years ago when Google pulled its personal health record everyone thought they had lost interest in health care.  Far from it, Google saw early on the lack of enthusiasm on the part of consumer/patients.  They don't want to populate their own PHR....they want it done for them.

 For one, Google sees an explosion of potential in the space thanks to the rise of genomics and availability of patient data

Google Ventures isn't getting into specifics on its life sciences strategy, but if the group's existing portfolio is any indication, it'll have a genomic bent. Among Google's beneficiaries are 23andMe, Foundation Medicine ($FMI), DNAnexus andFlatiron Health, companies that sequence, analyze and index genomic data. But the company has placed plenty of bets on more traditional biotech outfits, as well, including antibody specialist Adimab, large-molecule developer Rani Therapeutics and iPierian, since acquired by Bristol-Myers Squibb ($BMY) for up to $725 million.

Google's deeper dive into life sciences goes beyond its venture arm. Last year, the company expanded its secretive, R&D-focused Google X unit to include a dedicated life sciences team, spurring rumors that the tech giant is planning to make major waves in the field of wearable health devices.

And then there's Calico, a Google-funded biotech with the vague mission of battling aging and a star-studded staff to lead the effort. Short for California Life Company, the startup got off the ground last year with Genentech veterans Art Levinson and Hal Barron leading a team of well-regarded researchers, and Calico has since inked a research deal with AbbVie ($ABBV) to get rolling on an R&D operation that could cost up to $1.5 billion.

And then there is this:
Google signs on Harvard doc to lead bioinformatics study


Jessica Mega M.D. Associate Clinical Professor of Cardiology at Harvard Medical School,  a physician and  at Boston, MA-based Brigham and Women's Hospital, joined Google's Google X research arm to head up its Baseline study, which aims to collect a broad swath of information from hundreds of samples to find disease biomarkers and provide a comprehensive map of the human body, Forbes reports. Researchers will use software algorithms and computing to sift through the data, allowing scientists to more easily access medical information and potentially identify diseases sooner. She is an authority on blood coagulation disorders, a major component of coronary artery disease and acute coronary syndrome.

"Dr. Mega has all the skills and temperament to lead this effort for Google, which will break new ground for precision medicine and complement the Precision Medicine Initiative," Dr. Robert Califf, vice chancellor at Duke University's School of Medicine and a researcher on the study, told Forbes. "Her scientific knowledge, experience in clinical trials and positive personality are a great fit."

Meanwhile, Google continues to forge ahead with new initiatives through its Google X arm. The company teamed up with pharma giant Novartis ($NVS) last July to develop smart contact lenses for continuous glucose monitoring for diabetes patients. In October, Google X revealed a project to design tiny magnetic particles that screen for cancer and other diseases. The company plans to develop a wearable device with a magnet to attract and count the particles, providing a new monitoring tool for physicians.

"Every test you ever go to the doctor for will be done through this system," Andrew Conrad, head of the Life Sciences team at the Google X research lab, told theWSJ at the time. "That is our dream." But the company could face some technological challenges along the way, such as identifying coatings that help the particles bind to specific cells and creating a small, battery-friendly device that doesn't need frequent recharging.














Google takes deeper dive into med tech with health-tracking wristband - FierceMedicalDevices