Few people know that new prescription drugs have a 1 in 5 chance of causing serious reactions after they have been approved. That is why expert physicians recommend not taking new drugs for at least five years unless patients have first tried better-established options and need to. Faster reviews advocated by the industry-funded public regulators increase the risk of serious harm to 1 in 3. Yet most drugs they approve are found to have few offsetting clinical advantages over existing ones.
Systematic reviews of hospital charts by expert teams have found that even properly prescribed drugs (aside from misprescribing, overdosing, or self-prescribing) cause about 1.9 million hospitalizations a year. Another 840,000 hospitalized patients given drugs have serious adverse reactions for a total of 2.74 million. Further, the expert teams attributed as many deaths to the drugs as people who die from stroke. A policy review done at the Edmond J. Safra Center for Ethics at Harvard University concluded that prescription drugs are tied with stroke as the 4th leading cause of death in the United States. The European Commission estimates that adverse reactions from prescription drugs cause 200,000 deaths; so together, about 328,000 patients in the US and Europe die from prescription drugs each year. The FDA does not acknowledge these facts and instead gathers a small fraction of the cases.
Perhaps this is “the price of progress”? For example, about 170 million Americans take prescription drugs, and many benefit from them. For some, drugs keep them alive. If we suppose they all benefit, then 2.7 million people have a severe reactions, it’s only about 1.5 percent – the price of progress?
However, independent reviews over the past 35 years have found that only 11-15 percent of newly approved drugs have significant clinical advantages over existing, better-known drugs. While these contribute to the large medicine chest of effective drugs developed over the decades, the 85-89 percent with little or no clinical advantage flood the market. Of the additional $70 billion spent on drugs since 2000 in the U.S. (and another $70 billion abroad), about four-fifths has been spent on purchasing these minor new variations rather than on the really innovative drugs.
In a recent decade, independent reviewers concluded that only 8 percent of 946 new products were clinically superior, down from 11-15 percent in previous decades. (See Figure) Only 2 were breakthroughs and another 13 represented a real therapeutic advance.
Spokesmen for the pharmaceutical industry point out that therapeutically similar drugs have advantages. First, physicians need some choice within a therapeutic class because some patients do not respond well to a given drug. This is true, but after about three choices, there is little evidence to justify a 4th , 5th, or 6th in a class.
Continue reading “Pseudo Innovation”
Filed Under: THCB
Tagged: FDA, Innovation, New drug approval, Pharma, R & D, The trial journal pipeline
Jul 31, 2014
On June 18, we launched Aledade – a company built on our belief that independent primary care physicians are best positioned to lead the next revolution in health care delivery – boosting quality of care and bringing down costs. Over the past six weeks, we traveled across the country meeting doctors, discussing the future of independent primary care practice, and recruiting physician partners for our first wave of Accountable Care Organizations.
Meeting these doctors, from areas and backgrounds as diverse as the populations they serve has been a constant reminder of the reasons we founded this company. One physician, having spent decades serving the same community from the same office, lamented that in the past, he felt more involved – and more informed – about all aspects of his patients’ care. Today, he told us, fragmentation in care delivery had given him less insight into his patients’ health, and less influence in coordinating their treatment.
When we started Aledade, these were the type of doctors we wanted to empower.
Today, I am elated to announce that we have formally submitted applications to the Center for Medicare & Medicaid Services to form ACOs serving physicians in Delaware, Maryland, New York, and Arkansas for 2015. We expect this first wave of Aledade ACOs to serve tens of thousands of Medicare patients beginning January 2015.
The choice of four dissimilar states was intentional. We intend to establish a model that can be replicated across the country, and the diversity in our practices matches the diversity of our country. Each state has strengths to build on. Delaware- ‘the First State’ has been a leader in electronic health record implementation. Maryland and New York’s health reforms set the stage for alignment and collaboration with acute-care facilities. Arkansas’ tradition of independent primary care practice is strong. We’ll also be serving very different patient populations in each state – from practices that serve urban neighborhoods to those that treat folks in small towns and rural communities.
Continue reading “Meet the First Aledade ACOs”
Filed Under: THCB
Tagged: ACOs, Aledade, Delaware, Farzad Mostashari, Maryland, New York
Jul 31, 2014
President Obama has spent a lot of time defending his health law, but he appears to us to be quite ill-equipped to actually talk about health. In fact, it’s the just about the only thing he doesn’t talk about. He’s talked insurance, web sites, and funneling even more money to medical care providers. He’s talked about deadlines. He’s talked about glitches. The shocking lack of official communication about what should be the central message of any drive to make Americans healthier should tell us something.
In point of fact, no American leader since John F. Kennedy has had the courage to implore us to work for our own better health. He wrote in 1961 in Sports Illustrated:
“Thus, in a very real and immediate sense, our growing softness, our increasing lack of physical fitness, is a menace to our security…if our bodies grow soft and inactive, if we fail to encourage physical development and prowess, we will undermine our capacity for thought, for work and for the use of those skills vital to an expanding and complex America. Thus, the physical fitness of our citizens is a vital prerequisite to America‘s realization of its full potential as a nation, and to the opportunity of each individual citizen to make full and fruitful use of his capacities.”
By JFK’s clear, powerful, and time-tested standard, we are a disaster. We have no leader on health. Nobody.
If the Forest Service has Smokey Bear and local law enforcement agencies have McGruff the Crime Dog, where is our fearless leader who makes doing healthy things cool, interesting, and desirable?
Doing healthy things is not cool, and until it becomes cooler than doing unhealthy things, we are delivering to ourselves and our kids a future of misery and entrapment in a medical care system that regards us and them as widgets in its revenue cycle.
Ask any kid on any playground who’s their role model for living a healthy life, who’s teaching them the value of eating smartly, exercising, and managing their stressors, and you’ll get a blank stare For example, standard medical advice is that electronic gaming is bad and is a major contributor to inactivity and declining health in our children. But, gaming is here to stay, and we don’t see how professional finger-wagging gets kids to make better choices. Who’s their enlightened leader to tell them that getting up and getting fit will make them even better gamers? Nobody. Leaders meet their followers where their “heads” are and craft messages that connect and inspire action.
Continue reading “Ask Not What Your Government Can Do For You: JFK Speaks to Us About Health”
Filed Under: THCB
Tagged: John F. Kennedy, McDuff the Crime Dog, Medical Industrial Complex, Personal responsibility, Smokey Bear, Sports Illustrated
Jul 31, 2014
We are residents and a software developers. Before starting residency, we spent time as software developers in the startup community. We were witness to tremendous enthusiasm directed at solving problems and engaging people in their health. The number of startups trying to disrupt healthcare using data and technology has grown dramatically and every day established healthcare companies appear eager to feed this frenzy through App and Design Competitions.
When we started residency, the restrictiveness of data and reliance on decades-old technology was grossly apparent. Culturally, hospitals are an environment of budgets and deadlines that are better suited towards maintaining the status quo than promoting the creative process. Hospital IT departments harbor a deep cover-your-rear-end mentality and are incentivized for two things: first, keep systems running, and second, prevent security breaches. Perhaps rightly so–privacy and security need to be prioritized–but this environment has delayed them from facing the inevitable challenges of effectively using their own data and investing in new tools, including ones that could improve the triple aim of greater quality care with greater patient satisfaction and lower cost.
In the future, as hospitals and health systems become more accountable for the long term outcome of patients, we are optimistic that they will innovate as much out of cost-cutting necessity as for providing a better product to patients. We have little evidence that established players can power innovation solely on their own engines and expect many of the solutions will come from problem-solvers outside medicine. Doctors and patients will choose from an arsenal of apps to interact with the health information in EMRs. These healthcare apps come in three major categories: education, workflow, and decision support.
Continue reading “The Non-Physician’s Guide to Hacking the Healthcare System”
Filed Under: THCB
Tagged: Disruptors, Emmi Solutions, Hacking, iTriage, Patient Education, Visible Human Project API
Jul 30, 2014
Heart disease and stroke are two of the leading causes of death in the United States. To combat these threats, the Department of Health and Human Services (co-led by Centers for Disease Control and Prevention [CDC] and the Centers for Medicare & Medicaid Services [CMS]) has joined with private and non-profit organizations such as the American Heart Association, American Pharmacists Association and the YMCA, to launch Million Hearts®, a national initiative to prevent one million heart attacks and strokes by 2017. The initiative is working to encourage clinicians nationwide to improve the quality of care through use of the ABCS strategies – Aspirin when appropriate,Blood pressure control, Cholesterol management and Smoking cessation.
On July 7th, as we marked the halfway point in this ambitious drive to improve America’s health, the Office of the National Coordinator for Health Information Technology (ONC), in collaboration with the CDC, launched the EHR Innovations for Improving Hypertension Challenge to accelerate improvement on the Million Hearts® “B” strategy – Blood Pressure Control. The goal is to show how professionals are using health IT to improve patients’ cardiovascular health. Evidence-based treatment protocols are an essential tool for providers to use in improving blood pressure control.
What makes this ONC challenge unique? First, it taps the expertise of clinicians who care for patients with hypertension and are using health IT to improve their control. Second, the challenge is designed to promote the scalability of critical tools for maximum impact and reach. Continue reading “A Challenge to Control Blood Pressure Using HIT”
Filed Under: THCB
Tagged: American Heart Association, Blood Pressure Control, Million Hearts, ONC
Jul 30, 2014
“Then you should say what you mean,” the March Hare went on.
“I do,” Alice hastily replied; “at least–at least I mean what I say–that’s the same thing, you know.”
“Not the same thing a bit!” said the Hatter. “You might just as well say that “I see what I eat” is the same thing as “I eat what I see”!”
Alice in Wonderland. A Mad Tea Party. Lewis Carroll.
The brilliant Carroll had a field day with logical fallacies in the fictional mad world of hyper rationalism. Alice in Wonderland still passes for children’s fiction. The verdict in Halbig versus Burwell is a Tea Party no less. Alice from Dickensian London, if magically teleported to present day might have believed she had fallen in to a rabbit hole.
The DC Court of Appeals ruled in a narrow 2-1 decision that citizens who bought insurance in the individual marketplace in states where the Federal government runs the exchange do not qualify for subsidies. But in states with state-run exchanges they do qualify for subsidies. The IRS’s subsidies are unlawful in the former but perfectly lawful in the latter.
The statutory language in the Affordable Care Act (ACA) states that subsidies are available to those “enrolled in an exchange established by the state…”
Personally, I can’t see the issue. What’s the difference, in principle, between subsidizing citizens in exchanges established BY the states and citizens in exchanges established FOR the states by the Federal government?
Is this the first war between prepositions in human history?
The argument is that we must follow the rule of the law as it is written. Section 1401 (rules on who can get subsidy) applies to Section 1311 (the one about how exchanges are set up) not Section 1321 (the one about Federal government running the state exchanges when states don’t).
Continue reading “Many More Halbigs to Come”
Filed Under: THCB
Tagged: DC Court of Appeals, Gruber, Halbig, Subsidies
Jul 30, 2014
Announcing Wearables Health Tech Runway Show and New Companies, Panels, Sessions and Speakers!
Health 2.0 announces Bernard J. Tyson, Chairman and CEO of Kaiser Permanente, as a keynote alongside visionary physicians Eric Topol, Patrick Soon-Shiong, and Samsung’s President Young Sohn at the Health 2.0 8th Annual Fall Conference this coming Sept. 21-24 in Santa Clara, CA. This year, Health 2.0 is set to host the very first Wearable Tech Fashion Runway as a part of the larger session on Consumer Tech & Wearables: Powering Healthy Lifestyles. The panel will also showcase data utility layer platforms from tech giants such as Intel, Qualcomm, WebMD, and Walgreens, which are working with these trackers to provide a complete consumer health solution. Once again,Health 2.0 leads the industry with never before seen technologies, panels, and discussions based on industry classifications of patient-provider communication, consumer facing products, professional facing products, and data analytics.
Health 2.0 8th Annual Fall Conference highlights include:
- Consumer Tech & Wearables: The newest addition to the Health 2.0 agenda is The Wearable Tech Fashion Runway which features a multitude of wearable health tech in addition to data utility layer platforms from giants such as Samsung, Intel, Qualcomm, WebMD and Walgreens.
- Big Names, Big Issues, Big Solutions: Notable Industry leaders and companies bring their solutions and knowledge to tackle some of the most pressing issues within health care. Newly added to the agenda are Ryan Howard (Practice Fusion), Mike & Albert Lee (myfitnesspal), Kent Bradley (Safeway), Jonathan Bush (athenahealth), Girish Navani (eClinicalWorks), Andy Krackov (California Healthcare Foundation), Jacob Reider (ONC), Rajni Aneja (Humana), andDena Bravata, (Castlight Health). A special bonus feature includes ademo of the latest Samsung Electronics platform and product–SAMI and the SIMBand–with President Young Sohn interviewed by Indu Subaiya (Health 2.0).
- Health care Data Analytics: This topic covers the volume, velocity, variety, veracity, and value of health care data and analytics. Highlights include genomics, non-invasive diagnosis tools, and integrated data collection to uncover new discoveries, personalize medicine, and develop new care protocols with speakers from IBM Watson, Merck, Predilytics, and many more.
- Start-Ups, Entrepreneurship & Investors: This year, Health 2.0 is poised to offer new opportunities for start-ups and entrepreneurs during the fall conference. Traction: Health 2.0’s Start-Up Championship is the inaugural pitch contest enabling series A-ready start-ups to showcase their business plan in front of a judging panel of renowned venture capitalists. The Bootstrapped Basecamp will put the most innovative seed stage start-ups inside the Health 2.0 Exhibit Hall to be found by potential partners, investors and customers.
The 8th Annual Health 2.0 Conference showcases over 200 LIVE demos, 150+ speakers, and 50+ sessions across four full days with an extensive audience of 2,100+ health care professionals, health care and health tech executives, thought leaders, policy makers, and entrepreneurs. A multitude of never before seen technologies will be presented on stage,while the conference offers ground-breaking insights into the policy, tools, and solutions of new health care technology.
Registration information is available here. Prices for the conference are set to increase on Wed. 30th, July. The full agenda of speakers and companies can be found on the main conference website here.
Filed Under: Health 2.0, THCB
Jul 29, 2014
The Affordable Care Act is premised, at least in part, on the notion that competition can be harnessed to reduce healthcare costs and improve quality. This explains why insurance in the individual market has not been nationalized. Instead, consumers go to an online exchange where they customers can easily (at least in theory) compare plans offered by different firms. Unleashing competitive forces should result in lower premiums for these plans. And why not? Over the past two decades, competition has been one of the few success stories in the U.S. health economy. For example, when competition intensified in the 1990s, healthcare costs moderated. When competition weakened in the wake of provider mergers and the backlash to the narrow networks that were essential to cost containment, healthcare costs rose.
When most people think about the benefits of competition, they tend to think about prices. Monopolies charge high prices; competitors charge low prices. There is nothing wrong with this perspective, but it misses a more fundamental point. In the long run, the greatest benefit of competition is that it has the potential to fuel innovation. This is as true, in theory, for health insurers as it is for telecommunications and consumer electronics. It hasn’t always been true in practice; for several decades after the IRS made employer-sponsored health insurance tax deductible, insurers tended to offer the same costly indemnity products. But consumers eventually demanded lower premiums, and insurers responded with managed care. After the backlash, insurers developed high deductible health plans and value based insurance design. Insurers are now moving towards reference pricing. These plans offer consumers reimbursement up to a pre-specified level for treatments that can be easily broken into a treatment episode such as hip replacements or MRIs. Patients have the choice of any provider, but they bear the cost of choosing a more expensive facility.
High deductibles and reference pricing are fine, but do not always work in practice. Chronically ill patients quickly exhaust their deductibles, and reference pricing does not work well for chronic diseases. In order to complement these tactics, some insurers are once again offering narrow network plans. We commented in earlier blog posts that the ACA would catalyze the return of these narrow networks and also warned that this might fuel another backlash. Unfortunately, a recent New York Times article shows, the backlash is well underway.
Continue reading “Narrow Networking”
Filed Under: THCB, The Business of Health Care
Tagged: ACA, cost containment, Market, narrow networks, Provider Choice, reference pricing, Value-based design
Jul 29, 2014
It was 1970. I was in my laboratory at the NIH sequencing a murine myeloma protein in order to define the structure of its antibody combining region. Studies of protein conformation were at the cutting edge of science then; enthusiasm abounded. But it was clear to me that this work, in all its scientific elegance, had little to do with treating myeloma or anything else in mice or man. The reason for all the painstaking effort was the joy of pushing back the frontier of ignorance, even if only a bit. No one could foresee clinical utility then, nor would any become apparent for decades. Today such monoclonal antibodies are widely used to treat many diseases, sometimes with efficacy that justifies the costliness.
Genomics is in a bigger hurry.
Thanks to 40 years of breakthroughs, many earning Nobel Prizes, the chromosome carrying the defective gene underlying a genetic disease, Huntington’s disease, was identified in 1983 and the gene sequenced a decade later. In short order, defective genes underlying a number of single-gene diseases were defined: cystic fibrosis, hemophilia, and others. We all wait with baited breath for these elegant insights to transform into primary treatments for single allele genetic diseases. Attempts to transfect patients with normal genes are encouraging but barely so; it has proved difficult to get the right gene to stay in the right cells. Likewise, directly modifying the abnormal genetic apparatus is still largely just promising. The fallback remains working downstream from the genetic apparatus, replacing or modifying the defective products of many of these pathogenetic genes. Nonetheless, optimism regarding modifying the genetic apparatus itself is rational as is ever more boldness on the part of molecular biologists.
Continue reading “Hyping Cancer Genotyping”
Filed Under: THCB
Tagged: Affirma Gene Expression Classifier, Breast cancer, Genome screening, Human Genomme Project, NIH, Oncotype DX Breast Cancer Assay, Ovaure, Veracyte, Whole genome
Jul 28, 2014
x axis = time since prostatectomy, the y axis = predicted sexual function level,
scaled by the sexual function level. Young patients (below 55 years) reporting
poor sexual function prior to treatment
For all the advances in both medicine and technology, patients still face a bewildering array of advice and information when trying to weigh the possible consequences of certain medical treatments. But a hands-on, data-driven tool I have developed with some colleagues can now help patients obtain personalized predictions for their recovery from surgery. This tool can help patients better manage their expectations about their speed of recovery and long-term effects of the procedure.
People need to be able to fully understand the possible effects of a medical procedure in a realistic and clear way. Seeking to develop a model for recovery curves, we developed a Bayesian modeling approach to recovery curve prediction in order to forecast sexual function levels after prostatectomy, based on the experiences of 300 UCLA clinic patients both before radical prostatectomy surgery and during the four years immediately following surgery. The resulting interactive tool is designed to be used before the patient has a prostatectomy in order to help the patient manage expectations. A central predicted recovery curve shows the patient’s average sexual function over time after the surgery. The tool also displays a range of lighter-colored curves illustrating the broader range of possible outcomes.
This model not only shows people what they can expect about their recovery on average, based on their own specific characteristics, but it also clarifies the uncertainty in the shape of the recovery curve. It shows a range of possible realistic outcomes. We want to help patients who are considering this particular surgery to understand what they could expect. We can’t tell them exactly what their recovery will look like, but at least we can now forecast a personalized recovery curve and show them an informed prediction of their possible outcomes. The model can be used in an interactive way. For example, patients could adjust their reported age or reported sexual function levels to see how their predicted recovery curves change.
Continue reading “Using Big Data to Manage Medical Expectations”
Filed Under: THCB
Tagged: Cynthia Rudin, MIT, Prostatectomy, Recovery, Recovery Curve, UCLA
Jul 28, 2014