In a controversial study released this week, Tufts University’s Center for the Study of Drug Development estimates that the cost to bring a new drug to market exceeds nearly 2.6 billion dollars. The study, which was 40% funded by industry has been criticized for over estimating these costs in favor of industry and misrepresenting some cost estimates. While we will not know fully the extent of the methodology of the study until later in 2015 when it is published in a peer reviewed journal, these preliminary findings were released in advance and have already begun to spur debate.
However, irrespective of these criticisms, I believe that the study does have merit and brings an important issue forward—is the FDA stifling innovation with excessive fees and paperwork? Are smaller, less well funded researchers/corporations unable to significantly contribute without partnering with big pharma? Who will ultimately bear the increased cost of drug development?
Innovation is what has always made healthcare in the US great–it is what separates us from the rest of the world. For decades, the US has been able to attract talent from throughout the world and this has resulted in numerous “game changing” breakthroughs in medicine. Through continued development of new drugs, new technologies and new ways to better treat disease, we are able to improve outcomes and reduce death from preventable disease. The US has always been a place where others from around the world have come to incubate and grow ideas. Now, it appears that innovation must come at a substantial cost–the increasing capital required for drug development as well as taxes on medical device companies only serve to squeeze out the “small guys with big ideas” and limit our ability to continue to produce new, more effective therapies and cures. In addition, these additional costs to the pharmaceutical industry are not simply added to their bottom line–they are pushed on to the healthcare consumer as well as Federally funded healthcare plans. Ultimately, the taxpayer bears the brunt of the increased cost.
The process of drug development is long and arduous. Government regulation, politics and greed have served to make it even more difficult. Physicians in academic medicine, scientists, pharmacologists and leaders in industry have learned to partner and share ideas in order to bring basic science principles from the bench to the bedside—ultimately translating ideas into cures. Certainly, big pharma is in place to make profits and increase market share. But as costs increase, many drug makers are putting less and less profit back into research and development. Growth can become stagnant and new ideas may never reach the bench or bedside. Federally funded research–such as NIH grants–face big cuts and budgets are often embroiled in political battles. Legislators use research dollars as bargaining chips and fund projects that appeal only to a particular interest group or a group of favored donors. We must find a better way to promote medical innovation and reward research. We must find better ways to choose the most promising projects for funding. We must be good stewards of the R & D dollar and make every single investment count.
As with most things in medicine, we must always pause and remember to focus on the patient. Advocating for the patient suffering with disease is the reason most of us became involved in medicine in the first place. Whether the study from Tufts over-estimates the cost of development or not, it should still serve as a wake up call to us all. We must work to control the cost of developing new therapies—we must limit excessive taxation, we must promote entrepreneurship and begin to fix the current system of FDA approval for new therapies. We must separate politics from medicine and streamline processes—eliminate paperwork and promote efficiency–if we are to continue to lead the world in medical innovation. We must continue to make room for the “small guy with the big ideas”–If we do not–ultimately it will be our patients that suffer in the end.
The practice of medicine and healthcare in general has become an electronic and increasingly mobile interaction. Patients are better informed, more engaged, more connected and have a much greater virtual presence. In fact, according to Pew Research data, the fastest growing demographic on Twitter are those who are in the 45-65 age bracket. Nearly 50% of all seniors engage online on a daily basis through at least one social media platform and many of these interactions and online engagements occur via mobile devices. Almost 75% of all adults go online within hours of attending a visit with their physician in order to gather more information about their particular medical problem. For healthcare providers—and for patients—the internet and mobile technology presents us all with wonderful opportunities to interact, engage, support and ultimately improve outcomes.
New connected devices and medical applications for mobile devices are on growing exponentially. The world responded favorably to the latest release of the iPhone 6 and the iOS8 operating system recently released by Apple. The new device has many interesting features but one in particular caught my eye early on. Apple has created a standard package for all iOS 8 devices that is called the Health Kit. This particular application allows a user to track calories, steps taken (similar to a pedometer), flights of stairs climbed and other customizable health related data points. These data can be organized into graphs and charts that allow users to track progress and adjust activity levels to achieve particular goals. More impressively, the device will allow other health related applications to organize data in the Health Kit as well. One of the biggest problems with medial applications in the past is that there has never been an easy place to organize, store, collect and view all of the data together. Moreover, this data is not easily shared with healthcare providers. The Health Kit and Apple may revolutionize this entire process of data collection, retrieval and sharing—Apple has partnered with a major electronic medical record service known as EPIC. Work is underway to allow the Health Kit data and applications to easily interact with the EPIC medical record. This would allow for easy downloads of health data during a face-to-face encounter with healthcare providers. Currently, most major hospitals and healthcare systems are moving to the EPIC platform. The data collected and downloaded at one location would subsequently be available to all providers in the system—portability of data allows for better care and less duplication of effort.
Much has been written about patient engagement and improved outcomes in the medical literature. I can think of no better way to improve engagement than through the use of real time health applications –these allow patients to receive real time feedback—both good and bad—and respond quickly in order to improve their overall health status. I think that this type of technology will only continue to grow. Apple plans to release the Apple Watch in early 2015. I expect that this will also be integrated with Health Kit and allow for the measurement of respiratory rate, heart rate, body temperature and other biologic measurements. As these tools continue to develop and applications grow, healthcare providers as well as patients must be receptive to their use. These technologies have the potential to allow clinicians to better assess patients between office visits and provide more directed and timely changes in therapy. Ultimately I believe these technologies will transform healthcare. As we continue to struggle with healthcare cost containment in the era of healthcare reform, the ability to shift care and routine interaction to mobile platforms may very well prove to be a critical piece of the puzzle.
This is an exciting time in medicine as well as in healthcare technology. Moving forward, I look to a day where biologic sensors collect data, relay data to mobile devices and then transmit information seamlessly to healthcare systems. The healthcare providers are alerted to any abnormalities and electronic responses are generated—those patients requiring timely in person visits can be identified and scheduled, while those that can be handled virtually can be managed quickly and effectively as well. Ultimately, our goal is to better manage disease and improve outcomes. I think that technologies such as the Health Kit and the Apple Watch are giant leaps forward and are just the beginning of a new age of virtual healthcare.
Posted in Doctor Patient Relationships, Healthcare Reform, Optimizing Patient Care, Outcomes
Tagged apple, Engagement, EPIC, healhcare, healthcare applications, medicine, patient care, technology