Target Health Presenting at Meeting on Disruptive Innovations
This meeting is a must for anyone working in data management, clinical monitoring and quality assurance, and ready for a change in the way you do your business.
Target Health Inc. will be sponsoring and presenting at the 2nd Annual Disruptive Innovations to Advance Clinical Trials for Pharma, Biologics and Devices event which is being held at The Fairmont Copley Plaza Hotel, Boston, September 13-14, 2012. The conference is designed for drug and device development innovative thinkers who are determined to reinvent clinical trials. It is an outcomes-focused program that not only delves deeply into the key strategic factors impeding clinical trial productivity, but also endeavors to connect the change-makers who will share their results and outcomes.
Dr. Jules T. Mitchel, who is on the DPharm Advisory Board of the conference, will provide an update on the collaboration between Ferring Pharmaceuticals and Target Health Inc. (eCRO) on its approach to the paperless clinical trial including the use of Target e*CTR (eClinical trial record) as an eSource tool and Target Document for the electronic Trial Master File (eTMF). Go to the meeting website and get a 25% discount off the registration fee with code SFD.
Dr. Mitchel is also speaking at a concurrent conference on Executing Clinical Trials – How to Globalize Your Study for Clinical Success. The topic of his panel is Risk-based Monitoring – What Does it Mean for Your Global Study? How Different Organizations are Adapting to a Risk Based Approach to Monitoring in Their Global Studies.
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com
Medical Robots – IBM Creates Physician’s Assistant
Watson’s avatar, inspired by the IBM “smarter planet” logo
Watson Goes to Medical School
IBM robot, Watson, is devouring the material in medical textbooks and journal articles in hopes of landing a job as a physician’s 1) ___. The trainee was sequentially presented the details of a fictitious patient: there’s an eye problem; vision is blurred; the family, living in Connecticut, has a history of arthritis. The trainee’s initial response was uveitis. More clues and the diagnosis was changed to Behcet’s disease until finally the trainee settled on Lyme disease. How sure was this seemingly hasty student of medicine 73% sure.
Medical trainees and 2) ___ are not typically in the habit of quantifying their assessments with such Commander Data-like precision, but this trainee happens to share more qualities with the Star Trek android than the rest of the medical staff. Following its resounding victory on Jeopardy!, IBM’s Watson has been working hard to learn as much about medicine as it can with a steady diet of medical textbooks and healthcare journals. The mock case described above was part of a recent demonstration to the Associated Press showing just how much Watson has learned. The robot’s diagnosis was correct and it identified a link between symptom and 3) ___ that was “not common,” as one participating physician called it. After being told the patient was pregnant and allergic to penicillin, Watson suggested treating her with cefuroxine. Its human colleagues agreed. The demonstration was a success, and it is the hope of IBM and many medical professionals that Watson will one day soon lend doctors a helping hand as they perform their daily 4) ___.
The need for efficient use of medical information becomes more pressing as the amount of 5) ___ amasses at an exponential rate. Dr. Herbert Chase, a Columbia University medical school professor, says that it has been 30 years since doctors were last able to keep pace with the growing body of 6) ___ knowledge. With only so many hours in an often overwhelming day, doctors are hopeless to keep up with a body of knowledge that doubles every 5-7 years. In addition to the struggles of keeping pace, the sheer volume of information presents a separate challenge to share that information effectively. Michael Yuan, a scientist that has worked with IBM, cites a 1999 study that found doctors field more than 1,100 questions a day and fail to answer 64% of them. The inefficient exchange of information leads to mistakes in any field. In the medical field, those mistakes could cost lives. A widely-noted – and hotly debated – report published in 2000 estimated that as many as 98,000 people die in a given year from medical 7) ___ occurring in hospitals. As the report notes, “that’s more than die from motor vehicle accidents, breast cancer, or AIDS.”
Now imagine Watson on the job. Watson’s database would be updated 8) ___ with the latest in research from potentially all online journals. The director of Health Informatics Center at the University of Southern California, Carl Kesselman, points out the need to track advances in genomics, specialized drugs, off-label uses, and the increasingly finer-grained classifications of diseases. Of course the physicians themselves can find the information, but the online searches would be labor-intensive and time-consuming. A 9) ___ assistant like Watson with realtime updates could simply be asked Jeopardy!-style questions to find answers or get second opinions. To make the interactions Jeopardy!-style, speech solutions developer Nuance is currently working with IBM to provide Watson speech recognition 10) ___ customized with medical jargon. Doctors could query Watson’s database on the go by speaking into a handheld device.
Watson is named after IBM founder Thomas Watson.
At this early stage in its medical education Watson understandably, still makes mistakes. A team of medical students are working with Watson to catch mistakes and try to identify what causes them. Its knowledge is not limited to science. Watson can also keep an eye on complex treatment guidelines that are often updated so the physician doesn’t have to. It can access medical records as well. However, for access to be completely streamlined they need to be digitized. Unfortunately the medical 11) ___ digitization seems to be a change hospitals are thus far slow to adopt. Progress is being made, however, by companies like Practice Fusion, a maker of electronic health records (EHR) systems. Combining the latest medical knowledge with the patient’s medical history would give Watson the best chance to catch those rare cases that doctors might be slow to diagnose or miss altogether.
A major break from previous practice is IBM’s plan to include patient blogs among Watson’s data set. Much as they do now on websites such as carepages.com, patients can share symptoms, drug efficacy, drug side effects, relevant family histories, etc. Like a medical wikipedia, the data cloud that amasses could be mined by Watson to pull out obscure relationships that would normally pass under the radar of doctors concerned only with their 12) ___. For example, cross-reactivity between two types of drugs that aren’t taken together very often. In essence, Watson would be conducting its own studies without a priori goals or limitations.
But the data is anecdotal, you say? Dr. Chase agrees, but argues that doctors are already using anecdotal data when they take medical histories. The patients’ descriptions are anecdotal, and the doctors don’t listen any less.
To many, the patient blogosphere is the most exciting of Watson’s resources. What sort of insights into medicine and disease will we gain simply by blogging about our own experiences? As Wikipedia shows us, there’s truth in numbers. A major challenge to mining those insightful gems is, blogs that are easily understandable to Watson. It’s one thing for a doctor to have a one-on-one conversation with Watson and refine his query when he inevitably runs up against misunderstandings. But it’s quite another thing to glean underlying facts from thousands of blogs from all over the 13) ___. A universal format for the patients would help, perhaps including a basic list of yes or no questions.
A know-it-all robotic physician’s assistant that you can talk to from anywhere with a handheld device. reminds again, of Star Trek, “Computer, across how many worlds has the epidemic spread?”.
One company would argue that it is years ahead of IBM in bringing AI to the forefront of medical diagnosis support – and her name is Isabel. Isabel Healthcare’s founder Jason Maude named the database program after his 3 year old daughter Isabel was nearly fatally misdiagnosed by her local hospital. Isabel spent two months in hospital, including a month in PICU after experiencing multiple organ failure and cardiac arrest. Isabel’s extensive suffering could have been avoided if the local emergency department and family physicians, instead of assuming her symptoms were typical of the chicken pox from which she was also suffering, had stopped to ask ‘what else could this be?’ Isabel was later diagnosed to be suffering from well-described complications of chicken pox: Toxic Shock Syndrome and Necrotising Fasciitis. Rather than suing the hospital for the error Isabel Healthcare was created, in honor of Isabel Maude
Created a decade ago, the company’s mission is to decrease misdiagnoses, and it performs essentially the same functions as Watson: symptoms are entered and the computer sifts the database to produce a list of the most likely causes. Isabel asks questions that the doctor might not think to ask, indicates the gold standard treatment, and lists relevant medical literature.
So, what do we need Watson for? IBM executives point out that 14) ___ is much faster than Isabel and much better at understanding terms that it hasn’t memorized from a textbook. Watson would know, for instance, that “difficulty swallowing” is “dysphagia.” Watson has a ways to go before it makes the grade. IBM estimates that they are still a couple years away from making a marketable Watson. Doctors, IBM execs say, should not feel threatened by their fast learning student. The clinician’s role is to practice medicine and Watson’s role is to support the clinician, to act as a library.
To learn more about medical robotics, click on the videos below:
New Medical Robot from Israel
Improvements With Medical Robotics
ANSWERS: 1) assistant; 2) doctors; 3) cause; 4) rounds; 5) information; 6) medical; 7) errors; 8) daily; 9) physician’s; 10) software; 11) record; 12) patients; 13) world; 14) Watson
Memorial Sloan Kettering, World’s Oldest Private Cancer Center, Meets IBM’s Newest Medical Robot
The original New York Cancer Hospital, built 1884-1886; now housing, at 455 Central Park West and 106th St.
IBM’s Star Robot, Watson, the Jeopardy Winner
Memorial Sloan-Kettering Cancer Center (MSKCC) is a cancer treatment, research institution and charity founded in 1884 as the New York Cancer Hospital. The main campus is located at 1275 York Avenue, between 67th and 68th Streets in New York City, with other locations in Basking Ridge, New Jersey, Long Island and Westchester County, New York. MSKCC has long been a leader in cancer surgery, chemotherapy, and radiotherapy. It was the first to develop services specifically dedicated to the psychiatric aspects of cancer, to the relief of cancer pain, and to genetic counseling.
MSKCC began in 1900 as a medical laboratory established on the campus of Cornell Medical Center and funded by John D. Rockefeller. The original Memorial Hospital building was designed by Henry C. Pelton and constructed in 1939 by a group that included John J. Astor and his wife Charlotte. Between 1970 and 1973, a new memorial hospital was built on the same site-originally donated by John D. Rockefeller, Jr.
Sloan-Kettering Institute, is MSKCC’s basic-science research arm. The research institute was established in 1945 with a US$4 million gift from the foundation of Alfred P. Sloan, Jr. Half the gift was to fund construction of a 13-story research facility and the other half to provide annual operating expenses. Charles F. Kettering, vice president and director of research for General Motors Corporation, was to organize and apply modern American industrial research techniques to cancer research. In addition to the Sloan grant, a public campaign to raise an additional $3-4 million was undertaken. Laurance Rockefeller, an important financier and philanthropist of the prominent Rockefeller family, became an important leader in donations and fundraising.
At the August 8, 1945 announcement about the research institute, Sloan and Kettering emphasized that the dramatic news of the atomic bomb, developed with a US$2 billion research program, was a graphic illustration of what can be accomplished by scientifically organized research as practiced by American industry. They said that if as much money and talented personnel were available as the government had for the atomic bomb, very rapid progress could be made in cancer research.
MSKCC is affiliated with the Weill Cornell Medical College, the Tri-Institutional MD/PhD program and the Tri-Institutional Training Program in Chemical Biology, which include MSKCC as one of its three sites (along with Weill-Cornell and Rockefeller University). MSKCC and Weill-Cornell operate a joint graduate program in biomedical sciences, the Weill Cornell Graduate School of Medical Sciences. In 2004, Memorial Sloan-Kettering also established an independent graduate school, with a Ph.D program in cancer biology: the Gerstner Sloan-Kettering Graduate School of Biomedical Sciences. The inaugural class was admitted in July 2006.
MSKCC’s new Human Oncology and Pathogenesis Program, based at Memorial Hospital, focuses on translational research, with the goal of bringing discoveries made in the lab to the patient at the bedside.
Another focus of research at MSKCC is immunotherapy, or using the body’s own immune system to fight cancer cells. In 2006 the center was one of six institutes (along with research centers at Harvard University, the Massachusetts Institute of Technology, Johns Hopkins University, the University of Chicago, and Stanford University) selected to receive a US$20 million grant for cancer research from the Ludwig Fund, created by the American billionaire Daniel K. Ludwig. The grant, one of the largest earmarked for cancer research the hospital has ever received, will be used for immunology research.
At the beginning of 2012, MSKCC, in typical “ahead-of-the-curve” strategy, took on the medical training of IBM’s star robot, Watson. Watson will continue with a residency at Memorial Sloan-Kettering to help doctors diagnose and treat cancer. IBM and MSKCC said that they will add the latest in oncology research – and the hospital’s accumulated experience – to Watson’s vast knowledge base, and keep updating it. The result should help the hospital diagnose and treat cancer more quickly, accurately and personally, they said. “The capabilities are enormous,” said Dr. Larry Norton, deputy chief for breast cancer programs at Sloan-Kettering. “And unlike my medical students, Watson doesn’t forget anything.”
Watson won fame by beating the world’s best “Jeopardy!’ players. Applying its speed and language skills to medicine was a longtime goal at IBM, and Watson went to work last year for the health insurer Wellpoint Inc. The training at Sloan-Kettering will take time, and it may be the end of next year before patients at the hospital are benefiting from Watson’s speed and depth, said Dr. Martin Kohn, chief medical scientist at IBM. If successful, the finished product could be used anywhere in the world to aid cancer treatment. Kohn said there’s a rule of thumb that it takes 15 years for breakthroughs in medicine to be disseminated around the world. “So any process that can help get valuable information about choices and treatment out into general use more rapidly obviously is an improvement,” he said.
IBM said it was still focused on the project’s development and was undecided about how to market it. It said both IBM and the hospital had invested in the plan but would not disclose specifics. Watson will be fed textbooks, medical journals and – with permission – individual medical records. Then it will be tested with more and more complicated cancer scenarios and assessed with the help of an advisory panel, Kohn said. It’s expected to speedily suggest diagnoses and recommend treatments, ranking several alternatives. The computer’s grasp of the scientific literature – and its ability to find the right passage in seconds – will help doctors keep up with the ever-expanding amount of available information, the doctors said. But Norton said it’s the patient records at Sloan-Kettering – with plain-language notations that Watson can understand – that will add “wisdom” to what the computer learns.
The hospital, founded in 1884, says it’s the world’s oldest and largest private cancer center. “Because of our size and experience, we have super-specialized physicians in every field of cancer,” Norton said. “And all of what they actually do is capturable in the language of our electronic medical records. “You boil together knowledge and sophistication and experience and what you have is wisdom,” Norton said. “No one’s ever captured wisdom before in a way that can facilitate medical decision making.” Watson can even be instructed about individual patient preferences, Kohn said. When evaluating treatments, for example, it could take into account that a patient feels strongly about not losing her hair. “Or a patient says, `My daughter is getting married in six months. No matter what, I have to live that long, “ Kohn said. “Then that influences the treatment.”
Vaccine and Antibiotics Stabilized Without Refrigeration
Vaccines and antibiotics often need to be refrigerated to prevent alteration of their chemical structures; such alteration can result in less potent or ineffective medications. Keeping medications cold from production until they are used in treatment is a costly process, accounting for as much as 80% of the price of vaccinations. The need for a cold chain has been a difficulty for health care providers, aid organizations, scientists and pharmaceutical companies for decades, especially in settings where electricity is limited. Failures in the chain result in the loss of nearly half of all global vaccines.
A research project, supported by the NIH and published online in the Proceedings of the National Academy of Sciences (9 July 2012), has developed a new silk-based stabilizer that, in the laboratory, has kept some vaccines and antibiotics stable up to temperatures of 140o F. if this can be commercialized, it will provide a new avenue toward eliminating the need to keep some vaccines and antibiotics refrigerated, which could save billions of dollars every year and increase accessibility to third world populations.
In an attempt to solve this problem, the authors have been working extensively with silk films that essentially wrap up the live bioactive molecules present in antibiotics and vaccines. This protects these essential bioactive elements, and so can greatly extend the shelf-life of the medication. Silk is used because it is a protein polymer with a chemistry, structure, and assembly that can generate a unique environment, making it an attractive candidate for the stabilization of bioactive molecules over extended periods of time.
To test their new silk stabilizers, the authors stored the measles, mumps, and rubella (MMR) vaccines for six months at the recommended 39.2 o F, as well as at 77, 98.6 , and 113 o F. The results show that encapsulation in the new silk films maintained the potency with minimal loss over time and enhanced stability, even at very high storage temperatures. Similarly, antibiotics entrapped in silk films maintained near optimal activity even at temperatures as high as 140 degrees. In addition, the authors found that these silk films had the added benefit of protecting one antibiotic against the detrimental effects of light exposure.
The silk stabilizers are likely to combine well with the authors’ previously developed silk microneedle system. These tiny needles can deliver medication directly to skin cells that contain a specified antigen. This targeted approach permits administration of lower doses of medication or vaccine and generates longer-lasting immune responses. The combination could prove to be a simple way to stabilize, distribute, and deliver the medication in one system.
According to the authors, new studies are already under way to apply the technology to all vaccines and that based on what was observed with other proteins, peptides, and enzymes, there’s no reason to believe that this wouldn’t be universal.
The Deaf Brain Processes Touch Differently – The Primary Auditory Cortex “Feels” Touch
Previous research has shown that people who are born deaf are better at processing peripheral vision and motion. Deaf people may process vision using many different brain regions, especially auditory areas, including the primary auditory cortex. However, no one has tackled whether vision and touch together are processed differently in deaf people, primarily because in experimental settings, it is more difficult to produce the kind of precise tactile stimuli needed to answer this question.
According to an article published online in The Journal of Neuroscience (11July 2012), people who are born deaf process the sense of touch differently than people who are born with normal hearing. The finding reveals how the early loss of a sense — in this case hearing — affects brain development. This observation adds to a growing list of discoveries that confirm the impact of experiences and outside influences in molding the developing brain. The authors showed that deaf people use the auditory cortex to process touch stimuli and visual stimuli to a much greater degree than occurs in hearing people. The finding suggests that since the developing auditory cortex of profoundly deaf people is not exposed to sound stimuli, it adapts and takes on additional sensory processing tasks.
The authors developed a unique apparatus that could be worn like headphones while subjects were in a magnetic resonance imaging (MRI) scanner. Flexible tubing, connected to a compressor in another room, delivered soundless puffs of air above the right eyebrow and to the cheek below the right eye. Visual stimuli-brief pulses of light-were delivered through fiber optic cables mounted directly below the air-puff nozzle. Functional MRI was used to measure reactions to the stimuli in Heschl’s gyrus, the site of the primary auditory cortex in the human brain’s temporal lobe as well as other brain areas.
The authors took advantage of an already known perceptual illusion in hearing people known as the auditory induced double flash, in which a single flash of light paired with two or more brief auditory events is perceived as multiple flashes of light. The current experiment used a double puff of air as a tactile stimulus to replace the auditory stimulus, but kept the single flash of light. Subjects were also exposed to tactile stimuli and light stimuli separately and time-periods without stimuli to establish a baseline for brain activity.
Hearing people exposed to two puffs of air and one flash of light claimed only to see a single flash. However, when exposed to the same mix of stimuli, the subjects who were deaf saw two flashes. Looking at the brain scans of those who saw the double flash, the authors observed much greater activity in Heschl’s gyrus, although not all deaf brains responded to the same degree. The deaf individuals with the highest levels of activity in the primary auditory cortex in response to touch also had the strongest response to the illusion.
There are several ways the finding may help deaf people. For example, if touch and vision interact more in the deaf, touch could be used to help deaf students learn math or reading. The finding also has the potential to help clinicians improve the quality of hearing after cochlear implants, especially among congenitally deaf children who are implanted after the ages of 3 or 4. These children, who have lacked auditory input since birth, may struggle with comprehension and speech because their auditory cortex has taken on the processing of other senses, such as touch and vision. These changes may make it more challenging for the auditory cortex to recover auditory processing function after cochlear implantation. Being able to measure how much the auditory cortex has been taken over by other sensory processing could offer doctors insights into the kinds of intervention programs that would help the brain retrain and devote more capacity to auditory processing.
A Mutation in APP Protects Against Alzheimer’s Disease and Age-Related Cognitive Decline
The prevalence of dementia in the Western world in people over the age of 60 has been estimated to be greater than 5%, about two-thirds of which are due to Alzheimer’s disease. The age-specific prevalence of Alzheimer’s disease nearly doubles every 5 years after age 65, leading to a prevalence of greater than 25% in those over the age of 90.
According to an article published online in Nature (11 July 2012), a study was performed to search for low frequency variants in the amyloid-β precursor protein (APP) gene that could have a significant effect on the risk of Alzheimer’s disease (AD). The investigation studied coding variants in APP in a set of whole-genome sequence data from 1,795 Icelanders. Results showed a coding mutation (A673T) in the APP gene that protects against AD and cognitive decline in the elderly without AD. The mutation is adjacent to the aspartyl protease β-site in APP, and results in an approximately 40% reduction in the formation of amyloidogenic peptides in vitro. According to the authors, the strong protective effect of the A673T substitution against AD provides proof of principle for the hypothesis that reducing the beta-cleavage of APP may be protective. Furthermore, as the A673T allele also protects against cognitive decline in the elderly without AD, the two may be mediated through the same or similar mechanisms.
TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area
FDA Outlines Plans to Provide Earlier Feedback on Device Product Submissions
The FDA has issued a draft guidance that outlines recommendations and procedures for medical device manufacturers and researchers who want early feedback and advice before submitting a product- or research-specific application. The draft guidance expands on the agency’s existing pre-Investigational Device Exemption (pre-IDE) program, which allows companies to obtain feedback on a product during the investigational stage and prior to the formal application process.
The new program will be referred to as the Pre-Submission or “Pre-Sub” program. It will operate within the FDA’s existing medical device premarket regulatory pathways: IDE, Premarket Approval (PMA), Humanitarian Device Exemption (HDE), Premarket Notification (510(k)), and de novo. It is intended to foster innovation by helping medical device developers identify the regulatory requirements early in the device development process.
The guidance will advise device makers how to improve the effectiveness of their pre-market submissions by:
- describing when device developers might benefit from early FDA feedback;
- describing pre-submissions package content necessary for optimal FDA feedback: and
- explaining how to best engage FDA in informal meetings to discuss the most efficient path with a new technology or planned regulatory submission
The Pre-Sub program is part of the FDA’s ongoing commitment to facilitate earlier, more transparent, and more predictable interactions between the agency and innovators during the earliest stages of product development.
The draft guidance is a commitment under the Medical Devices User Fee Amendments of 2012 (also referred to as MDUFA III) among the action items listed in FDA’s 2011 “Plan of Action for Implementation of 510(k) and Science Recommendations,” which is intended to enhance the predictability and transparency of CDRH’s regulatory pathways and to strengthen the 510(k) program.
Good News for Mental Illness in the Health Law
This following is based on an article by Richard A. Friedman MD (Professor of Psychiatry at Weill Cornell Medical College) and published in The New York Times.
Until now, people with mental illness and substance disorders have faced stingy annual and lifetime caps on coverage, higher deductibles or simply no coverage at all. This was supposed to be fixed in part by the Mental Health Parity and Addiction Equity Act of 2008, which mandated that psychiatric illness be covered just the same as other medical illnesses. But the law applied only to larger employers (50 or more workers) that offered a health plan with benefits for mental health and substance abuse.
Americans with mental illness had good reason to celebrate when the Supreme Court upheld President Obama’s Affordable Care Act. The law promises to give them something they have never had before: near-universal health insurance, not just for their medical problems but for psychiatric disorders as well. To get a sense of the magnitude of the potential benefit, consider that about half of Americans will experience a major psychiatric or substance disorder at some point, according to an authoritative 2005 survey. Yet because of the stigma surrounding mental illness, poor access to care and inadequate insurance coverage, only a fraction of those with mental illness receive treatment. For example, surveys show that only about 50% of Americans with a mood disorder had psychiatric treatment in the past year – leaving the rest at high risk of suicide, to say nothing of the high cost to society in absenteeism and lost productivity.
One of the health care act’s pillars is to forbid the exclusion of people with pre-existing illness from medical coverage. By definition, a vast majority of adult Americans with a mental illness have a pre-existing disorder. Half of all serious psychiatric illnesses – including major depression, anxiety disorders and substance abuse – start by 14 years of age, and three-fourths are present by 25. These people have specifically been denied medical coverage by most commercial insurance companies – until now.
Mental disorders are chronic lifelong diseases, characterized by remission and relapse for those who respond to treatment, or persistent symptoms for those who do not. In schizophrenia, for example, relapse is common, even with the best treatment. It makes no sense to tell someone with this condition that his lifetime mental health benefit is just 60 days of inpatient hospitalization. Psychiatric illness is treatable, but it is rarely curable; it may remit for a while, but it doesn’t go away. That is why the current limits on treatment are as irrational as they are cruel – the discriminatory hallmark of commercial medical insurance.
No more. The Affordable Care Act treats psychiatric illness like any other and removes obstacles to fair and rational treatment.
On the other hand, poor people with mental illness still have cause for concern. The new law would have expanded Medicaid to insure 17 million more Americans, but the Supreme Court ruled that states could decline to accept this expansion without losing their existing Medicaid funds. In states that opt out of the Medicaid expansion, poor people with mental illness may find themselves in a terrible predicament: They earn too much to qualify for Medicaid, yet not enough to get the federal subsidy to pay for insurance.
But on the whole, the Affordable Care Act is reason to cheer. Americans with mental illness finally have the prize that has eluded patients and clinicians for decades: the recognition that psychiatric illness should be on a par with all other medical disorders, and the near-universal mandate to make that happen.
Health Reform Status; and so it Goes
By Mark L. Horn, MD, MPH, Chief Medical Officer, Target Health Inc.
For a brief period following the Supreme Court decision on the Affordable Care Act (ACA), I was feeling a bit better about the state of health care. Despite the acrimony something had actually been resolved, and presumably we could advance towards implementation. There is clearly the potential for a change in focus and attention that can now be paid to health care delivery and quality rather than to rhetorical jousting and posturing.
Reading this week’s news, there still seem to be battles to be won. First, we have the authors of a just published paper (Cassel & Jain, JAMA. 2012; 307:2595-2596) which identified problematic elements in current programs evaluating physician performance alleging that Wall Street Journal Deputy Editorial Page Editor Daniel Henninger misrepresented their arguments in his column.
Cassel & Jain advocate for more thoughtful measurements of physician performance, measures which accurately reflect physician professionalism and the complex nature of their tasks. Henninger (in their view) interpreted their paper as critical of the ACA which, based upon their letter to the Wall Street Journal in response to his column, they very clearly support.
Physician performance and its measurement are critically important health care metrics; to maximize health outcomes we must get these metrics right. Since the ‘right’ ways to define and measure performance remain uncertain it is desirable that knowledgeable people thoughtfully engage in the process despite their inevitable disagreements. Facilitating these discussions and decisions ought to be a priority for everyone interested in health care, irrespective of their predictably differing views on the ACA. Once support or opposition to the ACA becomes the litmus test for legitimacy in promulgating health care solutions, we necessarily eliminate important perspectives and potentially creative ideas.
An additional troublesome trend is the announcement by certain states of intent to decline both funds made available to expand state Medicaid programs and the opportunity to create state based health insurance exchanges. It’s hard to escape the feeling that these decisions are motivated as much by partisan pique as by thoughtful analyses of what would best serve their citizens. We need to watch carefully for alternative proposals these states offer (if any) to provide health care for their poor and those with preexisting conditions.
Finally, there are the Congressional efforts to repeal the ACA. It is certainly should be clear to all, including the Congresspersons involved, that these efforts cannot succeed in the current Congress. Sadly for patients and society at large, the energy expended in repeal efforts is actually part of the 2012 political campaign rather than the discussion of health system reform.
So for now it seems we will simply have to wait. Happily, it’s not too long until November, but the summer may be long and very hot.