So you have a great idea for an app. Not so fast: it took two years and over half a million dollars to get ours cleared for marketing by the US Food and Drug Administration (FDA).
Our app, DANA uses a mobile phone to records peoples’ reaction time during game-like tests. It also provides questionnaires that help clinicians evaluate brain health. Commissioned from AnthroTronix by the Department of Defense, the app will help diagnose concussion, depression and Post-Traumatic Stress Disorder (PTSD).
For something so important, a serious investment of time and money for clearance may not sound extravagant, but few small companies can afford a two-year go-to-market delay, not to mention the significant investment and heartache that goes with it. And although the FDA has tried to facilitate regulation by providing guides like the Mobile Medical Applications Guidance Document and the Mobile Medical Applications website, the regulatory process remains confusing.
Here are five simple lessons from our own experience that will help other entrepreneurs to do the right thing and engage with the FDA: Continue reading “The FDA & Me (or How to Explain Your Test Isn’t a Game)”
Filed Under: Health 2.0, THCB
Tagged: brain health, Brain Injury, FDA regulations, Mental Health, Mobile
Mar 6, 2015
Would allowing patients to read their mental health notes provide more benefits than risks?
In a recent article in JAMA my colleagues and I argue that it would. While transparent medical records are gaining favor in primary care settings throughout the country through the OpenNotes initiative, there has been reluctance to allow patients to see what their treaters say about their mental health issues. While this reluctance is understandable and deserves careful consideration, we suggest that several benefits could result from patients reading their mental health notes.
First of all, accuracy would be enhanced by allowing patients to cross-check what their clinicians say about their symptoms, medication doses, and so forth. Second, allowing patients to review assessments and treatment decisions privately might help to promote a richer dialogue between patient and clinician. Third, patients might learn that their clinician sees them more as a complete person, rather than as a collection of symptoms.
Many patients silently fear that their treater “will think I’m crazy/whining/lazy/boring”; seeing in print that the treater does not see them that way—and in fact recognizes and documents their strengths—can be an enormous relief and might therefore enhance the therapeutic alliance.
Clinicians have their own worries about transparent mental health notes that must be considered. Will patients feel objectified by the medical language commonly used in documentation? Will they break off treatment if they don’t like what they read? Will too much time be spent wrangling over details of what has been documented? Will vulnerable patients be psychologically harmed by reading their notes? Although our article briefly addresses these issues, only a trial of transparent mental health notes will provide the data needed to assess them.
Such a trial has just begun at the Beth Israel Deaconess Medical Center in Boston. Culminating many months of careful planning by my colleagues in the ambulatory psychiatry clinic, the Social Work department, as well as the OpenNotes team, we began a pilot project of transparent notes in our psychiatry clinic on March 1. So far almost all clinicians have chosen to participate in the project, and have identified 10% of their caseloads to be included. It’s too early to gauge results yet, but we hope to more fully evaluate the effects of making mental health notes fully transparent to our patients.
Michael W. Kahn, MD is an assistant professor of psychiatry at Harvard Medical School and Harvard Medical Faculty Physician at Beth Israel Deaconess Medical Center (BIDMC).
Filed Under: THCB, The Vault
Tagged: BIDMC, Clinical Documentation, doctor/ patient relationship, FutureMed, Mental Health, Michael Kahn, Open Notes, patient engagement, personal health records, practice of medicine, Psychiatry
Apr 11, 2014
The Obama administration announced on Friday that it will require parity for mental health insurance coverage. That means that health insurers must apply the same copayments, deductibles, and visit limits to mental healthcare as they do for physical health care treatment. Call it fair, call it political, but please don’t call it a good economic or health policy.
The story about how this is fair, or at least politically popular goes something like this: Health insurers are evil and powerful firms that can and will do whatever they want. On the other hand, patients with mental health problems are politically weak and must be protected from the powerful insurers that have no interest in taking care of them.
In this story, the Obama administration rides in on its white stallion and rights the wrongs being perpetrated by the villainous insurance companies. All we need is a damsel in distress, an evil step-mother, and a catchy tune and Disney will sign the movie rights.
The problem with this simplistic story line is that you can replace “mental health” with nearly any other condition and the story would sound just as plausible.
Continue reading “Mental Health Parity and the Affordable Care Act”
Filed Under: OP-ED
Tagged: Costs, Craig Garthwaite, David Dranove, insurance coverage, Mental Health, mental health care, The ACA
Nov 11, 2013
The Navy Yard shooting in Washington, D.C. has once again confronted us with the issues of guns and mental illness, but what we really should address is the inadequacy of mental health care in the United States. Since 2009 there have been 21 mass shootings and the perpetrators in over half of these were suffering from or suspected to have a serious mental illness like schizophrenia, bipolar disorder and depression. (The other killers with no signs of mental illness were ideological zealots, disgruntled employees and disaffected loners.)
After each incident there is a great hue and cry, and calls for action but no substantive action is taken. Our reflexive approach has repeatedly failed to provide care in a timely fashion to individuals in need. As a country, we continue to ignore the growing public health need for greater access and a more proactive approach to mental health care. It is time that we say enough is enough and do something to prevent future tragedies.
When you strip away the hype and politics, the causal factors in these horrific incidents are clear and solvable. Yet we’ve lacked the social and political will to fashion and apply the solution.
The plain truth of the matter is that we do not provide adequate services to the 26% of the U.S. population with mental illness. The scope of and access to mental health services available to most people are limited and fragmented. Moreover, insurance coverage is all too often lacking and discriminatory. Consequently, we do not provide the level and quality of care of which physicians and health care providers are capable. It is the equivalent of knowing that a woman has breast cancer but not offering the indicated treatment options of surgery, radiation and chemotherapy. The result is that many people go untreated or inadequately treated.
Continue reading “After the Navy Yard Shooting: A Call to Action On Mental Illness”
Filed Under: OP-ED, THCB, The Vault
Tagged: American Psychiatric Association, Jeffrey Lieberman, Mental Health, mental health care access, Navy Yard Shooting, Psychiatry, public health
Sep 27, 2013
The American Psychiatric Association recently published a new version of the Diagnostic and Statistical Manual (DSM). The DSM-5 is what medical, mental health, and chemical dependency professionals use to diagnose developmental, mental health, substance abuse and dependence, learning, and personality “disorders.” Now in its 5th edition, the DSM was first published in 1952. At that time, the DSM was 129 pages containing 106 diagnoses.
Now, 61 years later, the DSM-5 consists of approximately 950 pages and roughly 375 diagnoses. The DSM-5, while researched far more than previous editions, is based on the medical model or the model of disease. Simply put, the medical model finds the causes of disease and illness and then prescribes a treatment to cure the disease or illness. This means a person has a pathology or pathogen that needs to be treated and cured.
The questions that eat at me during my day as a psychologist and at night as a person searching for answers are:
- Is it possible to accurately identify mental health “issues,” “illness,” or “disorders?” versus extreme ranges within the sphere of the human condition?
- Even if it is possible to identify these conditions, does it determine the course of “treatment” or “intervention?”
- If so, is there a “treatment” for every identified “condition?”
- Does it mean there is a treatment that works?
- Do you need a diagnosis to get help?
Over the years, many have been critical of this approach to mental “health” issues. Referring to mental “health” is actually a newer name as people have historically been thought to have mental “illness.” This makes more sense for people who are unfortunately compromised by severe conditions termed schizophrenia, bi-polar (manic-depressive), and severe depression and anxiety. But does this make sense for children, adolescents, and adults who are challenged with some other, and possibly less severe, aspect of their functioning and development? Do all human problems warrant a medical or mental health diagnosis? When did a weakness become a “disorder” that requires “intervention” and/or “treatment?”
To be fair, the DSM provided structure and guidelines for approaching the complicated business of determining who had a “problem” that required help. However, it seems things have gone too far. Critics of the DSM believe that this latest edition has taken the business of diagnosing to a new level, one where approximately 50% of the population can be diagnosed with something. Critics also believe that this pathology finding approach supports the continued trend of medication prescribing as the number one mode of treatment, and continued trend of increased health care costs and premiums with increased utilization of individuals who need a “diagnosis” to meet “medical necessity” to receive services. What does that mean? It means if you don’t have a diagnosis, you don’t get help. It means you have to have a problem (pathology) to get help (treatment and intervention).
Without going into detail about some of the changes in the newest edition of the DSM, some diagnostic categories have been added and some diagnosis “thresholds” have been lowered. This means that you need fewer symptoms to “meet diagnostic criteria.” Here are some examples of concerns with the new DSM-5:
- Temper tantrums will now be diagnosed as Disruptive Mood Dysregulation Disorder
- Normal forgetting will now be diagnosed as Minor Neurocognitive Disorder
- Gluttony will be diagnosed as Binge Eating Disorder
- Grief will be diagnosed as Major Depression
- First time substance users and college partiers will get a diagnosis of Substance Use Disorder
- Everyday Worry will be diagnosed as Generalized Anxiety Disorder Continue reading “Pathologizing the Human Condition”
Filed Under: THCB, The Vault
Tagged: American Psychiatric Association, Dan Peters, Diagnosis, DSM-5, Mental Health, practice of medicine, public health
Sep 1, 2013
We have become a pill popping society. It makes absolutely no sense that twenty percent of our population regularly uses a psychotropic medicine and that the United States has more deaths each year from overdose with prescription drugs than from street drugs.
The causes of excessive medication use are numerous- the diagnostic system is too loose; some doctors are trigger happy in their prescribing habits; the drug companies have sold a misleading bill of goods that all life’s problems are mental disorders requiring a pill solution; and the insurance companies make the mistake of encouraging quick diagnosis on the first visit.
My purpose here is to advise individuals on how best to deal with the risks of overdiagnosis and overtreatment.
Elsewhere I have suggested the things government needs to do. A diagnosis, if accurate, can be the turning point to a much better life. A diagnosis, if inaccurate, can haunt you (perhaps for life) with unnecessary treatments and stigma.
Spend at least as much effort ensuring you have the right diagnosis as you would in buying a house. Become a fully informed consumer, ask lots of questions, and expect clear and convincing answers from any clinician who offers a diagnosis and recommends a treatment. If the diagnosis doesn’t seem to fit, get second or third opinions.
Never accept medication after receiving only a brief diagnostic evaluation, especially if it has been done by a primary care physician who may not be expert in psychiatry and may be too influenced by drug salesmen.
Don’t believe drug company advertisements that end with, ‘Ask your doctor.’ Drug companies profit if they can convince you that you have a psychiatric disorder and need medication. They portray the expectable problems of everyday life as mental illnesses due to a chemical imbalance because this sells pills and makes money- not to help you.
Continue reading “Getting Back to Normal”
Filed Under: THCB
Tagged: Allen Frances, DSM-5, Mental Health, over-medicalization, overdiagnosis, Patients, Physicians, Psychiatry
Jun 28, 2013
A couple of weeks ago, President Obama launched a new open data policy (pdf) for the federal government. Declaring that, “…information is a valuable asset that is multiplied when it is shared,” the Administration’s new policy empowers federal agencies to promote an environment in which shareable data are maximally and responsibly accessible. The policy supports broad access to government data in order to promote entrepreneurship, innovation, and scientific discovery.
If the White House needed an example of the power of data sharing, it could point to the Psychiatric Genomics Consortium (PGC). The PGC began in 2007 and now boasts 123,000 samples from people with a diagnosis of schizophrenia, bipolar disorder, ADHD, or autism and 80,000 controls collected by over 300 scientists from 80 institutions in 20 countries. This consortium is the largest collaboration in the history of psychiatry.
More important than the size of this mega-consortium is its success. There are perhaps three million common variants in the human genome. Amidst so much variation, it takes a large sample to find a statistically significant genetic signal associated with disease. Showing a kind of “selfish altruism,” scientists began to realize that by pooling data, combining computing efforts, and sharing ideas, they could detect the signals that had been obscured because of lack of statistical power. In 2011, with 9,000 cases, the PGC was able to identify 5 genetic variants associated with schizophrenia. In 2012, with 14,000 cases, they discovered 22 significant genetic variants. Today, with over 30,000 cases, over 100 genetic variants are significant. None of these alone are likely to be genetic causes for schizophrenia, but they define the architecture of risk and collectively could be useful for identifying the biological pathways that contribute to the illness.
We are seeing a similar culture change in neuroimaging. The Human Connectome Project is scanning 1,200 healthy volunteers with state of the art technology to define variation in the brain’s wiring. The imaging data, cognitive data, and de-identified demographic data on each volunteer are available, along with a workbench of web-based analytical tools, so that qualified researchers can obtain access and interrogate one of the largest imaging data sets anywhere. How exciting to think that a curious scientist with a good question can now explore a treasure trove of human brain imaging data—and possibly uncover an important aspect of brain organization—without ever doing a scan.
Continue reading “A Case for Open Data”
Filed Under: Uncategorized
Tagged: data sharing, Human Connectome Project, Mental Health, NIH, open data, Psychiatric Genomics Consortium, Research, Thomas Insel
Jun 17, 2013
My sister and I took our positions in the funeral home’s family room and greeted hundreds of mourners who had come to pay their respects. Everything seemed as it had four months earlier at our mother’s funeral. The ubiquitous tissue boxes. My navy pinstriped suit. The ripped black ribbon, a Jewish tradition, affixed to my lapel.
But this time, we were accepting condolences after the death of our dad, who stood next to us such a short time before.
It’s hard enough to lose one parent. Losing two within months is incomprehensible. When I left my parents’ Michigan apartment last month, I couldn’t believe it would be for the last time. I’ve replayed phone messages so that I could hear their voices again. And each morning, I look at Dad’s watch on my wrist, thinking it should be on his.
Two days before my dad died, I celebrated the first Mother’s Day without my mom. Now, I’m marking the first Father’s Day without my dad.
As I’ve mourned my parents, I’ve been struck by how many stories I’ve heard about husbands and wives dying soon after their spouses. One of my high school teachers lost both parents within a year; so did a journalist friend in Los Angeles. My rabbi told me his parents died only months apart.
My mom buried both of her parents within the same week in April 1979, when I was 5. My zaydee died first, unable to fathom life without his wife, who lay dying in the hospital. My bubbe died during his funeral two days later.
I wondered whether there was more to this than coincidence, and sure enough, there’s a well-documented “widowhood effect.” Those who lose a spouse are about 40 percent more likely to die within six months than those with living spouses. The effect has been found in a host of countries, across a range of ages, in widows and in widowers – though men are more likely to die soon after losing spouses than women are.
S.V. Subramanian, a professor of population health and geography at Harvard University, co-wrote a review published in 2011 that looked at more than a dozen studies on the effect. “We never say that grief is a disease,” he told me. “But what some of this research is showing is that at older ages, grief can make you more vulnerable to mortality.”
Subramanian said his uncle’s parents died within days of one another.
Continue reading “How My Parents’ Death Changed My Thinking About End-Of-Life Care”
Filed Under: OP-ED
Tagged: Charles Ornstein, End of Life Care, Father's Day, grief, Mental Health, Senior Care, widowhood effect
Jun 15, 2013
In a few weeks, the American Psychiatric Association will release its new edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). This volume will tweak several current diagnostic categories, from autism spectrum disorders to mood disorders. While many of these changes have been contentious, the final product involves mostly modest alterations of the previous edition, based on new insights emerging from research since 1990 when DSM-IV was published. Sometimes this research recommended new categories (e.g., mood dysregulation disorder) or that previous categories could be dropped (e.g., Asperger’s syndrome).1
The goal of this new manual, as with all previous editions, is to provide a common language for describing psychopathology. While DSM has been described as a “Bible” for the field, it is, at best, a dictionary, creating a set of labels and defining each. The strength of each of the editions of DSM has been “reliability” – each edition has ensured that clinicians use the same terms in the same ways. The weakness is its lack of validity. Unlike our definitions of ischemic heart disease, lymphoma, or AIDS, the DSM diagnoses are based on a consensus about clusters of clinical symptoms, not any objective laboratory measure. In the rest of medicine, this would be equivalent to creating diagnostic systems based on the nature of chest pain or the quality of fever. Indeed, symptom-based diagnosis, once common in other areas of medicine, has been largely replaced in the past half century as we have understood that symptoms alone rarely indicate the best choice of treatment.
Patients with mental disorders deserve better. Continue reading “Transforming Diagnosis”
Filed Under: THCB
Tagged: DSM-5, Mental Health, National Institute of Mental Health (NIMH), Thomas Insel
May 3, 2013
There aren’t many who would quibble with an argument that those with severe mental illness—specifically, individuals “who have been involuntarily committed to a mental institution, found incompetent to stand trial or not guilty by reason of insanity. or otherwise have been [legally judged] to have a severe mental condition that results in the individuals presenting a danger to themselves or others“—should not be able to purchase firearms. Right? Right.
Making that law isn’t actually the trouble (expanding background checks is, of course, a different story). It’s already law, and has been on the books for awhile. The trouble is enforcing it.
The federal government maintains the National Instant Criminal Background Check System (NICS), a database of people who are federally prohibited from purchasing guns, including felons, people convicted of domestic violence, and individuals who meet the extreme mental illness criteria above. Except:
Federal law does not require State agencies to report to the NICS the identities of individuals who are prohibited by Federal law from purchasing firearms, and not all states report complete information to the NICS.
To recap: We have federal criteria that prohibits certain individuals from buying firearms. The feds maintain a database of known individuals for background checks (which take 30 seconds, per the regulation). But states aren’t required to offer the names of “prohibitors” to the database.
Continue reading “What Does HIPAA Have to Do With Gun Control? Maybe More Than You Think.”
Filed Under: Uncategorized
Tagged: Adrianna McIntyre, Gun Control, HIPAA, Mental Health, National Instant Criminal Background Check System (NICS), Patient privacy
Apr 25, 2013