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Burnout: Control out of Chaos in the age of COVID

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When a pattern is not seen, then chaos is perceived.

I was invited by PeerVoice, an international medical newsletter from Luxembourg, to write about the psychological pattern of adaptation to crisis and perceived chaos. While the duration of psychological stages may be different amongst individuals, there is a predictable pattern of psychological reaction to crises. You can read the details in my article.

In the mist of a crisis, anxiety rapidly rises because the circumstance are novel and unfamiliar. “We haven’t seen this before. It’s different than before.” You hear words like “unprecedented” that seem to convey we don’t know what to do because we’ve never seen this before. Crisis begets anxiety, anxiety perceives chaos, and chaos has no predictability.

To gain control and thereby reduce anxiety, one needs to see a predictable pattern in the chaos. For that predictability, I submit the premise of my article-a predictable psychological reaction to crisis. Regardless of the specific circumstances of the crisis, the stages of psychological adaptation are the same. In that way, we have a sense of what we need to do today, what we can anticipate for tomorrow, and what we need to plan for next week.

Understanding that the seeming psychological distress is simply a series of stages to be experienced in sequence, predictability is introduced to perceived chaos. With time, you emerge from the “tunnel” with a new set of psychological skills to weather the next crisis.

In my article, I reference a study from China and the psychological stages the health care workers went through when dealing with the COVID-19 patient care demands. It seems to be a universal human experience and very important to understand.

When patterns are seen, chaos is nonexistent.

David W. Goodman, M.D.

Vayarin for ADHD no longer sold in the U.S.

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This month Enzymotec, the makers of Vayarin, quietly announced on their website that they would no longer sell its product in the U.S. This leaves patients who have been taking it in a quandary without support. While the company’s announcement cites “a lack of alignment with our business strategy” as an explanation, no one gives up business that is going well.

The difficulty with Vayarin is that the research did not support its benefit in ADHD in children. Yes, I know, “They had clinical studies” that said it worked and in here lies the problem. The double blind placebo controlled study of 200 children actually showed it didn’t work on any of the 8 scales rated by teachers and worked on only 1 of 8 parent rated scales.   The company then extracted a subset of children with inattentive subtype and reviewed that data. With this data, they were able to find some positive findings. This analysis is called “post hoc” (after the fact) and is not kosher in research data interpretation. Therefore, the company went on to cherry pick positive findings and put them in promotional and advertising materials. You would have had to read the original published research with an expert’s eye to see the true “no different from placebo” findings. In December 2015, I wrote a blog reviewing this study in detail and it remains posted at www.addadult.com.

The general public has no way of discerning the quality of the research and simply relies on media stories, promotional materials and patient testimonials.  Keep in mind that the placebo effect in psychiatric trials can be as high as 25%. So, you have no way of knowing whether your friend who says “this is great” is getting a medication effect or just placebo response. Don’t feel badly. A lot of prescribers were unaware of the gerrymandering of the data being served up as clinical benefit. 

What’s the lesson for you?

While initial medication trials make headlines, the science of effective treatment is in research replication. In my opinion, the Vayarin example is illustrative of how nutriceuticals are being marketed and sold. Design a trial to optimize the outcome, manipulate the data, cherry pick positive findings, and lay out promotional materials to prescribers and the public, knowing that few will critically review the data. Research has shown the omega fatty acids can be helpful in ADHD but its contribution to improvement is about 15%. So, it may help but not a lot.

Take home messages:

  1. Moderate your hope of benefit with healthy skepticism. Use proven treatments with years of high quality clinical research.
  2. Be mindful of the marketing techniques of all nutriceuticals and medications.
  3. Read original research trial abstracts online at www.pubmed.gov
  4. Seek out true expert opinions when considerting complementary and alternative treatments (CAT) for any medical condition.
  5. If you try CAT, write down the target symptoms to change, write down any changes each month for 3 months. Then decide if it really helps.

This blog in an edited version is posted at www.Additudemag.com

David W. Goodman, M.D., FAPA

So you can’t get your ADHD medication approved by insurance? Part 2

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This is Part 2 to a previous blog:

This brings us to the next objection insurance companies will raise – the issue of safety. In citing safety as a reason for the denial of daily stimulant doses that exceed FDA daily max allowances, they deliberately and knowingly misrepresent the meaning of FDA max daily dose. For most ADHD medications, the FDA daily max dose is established on efficacy (how well it reduces symptoms), not safety. That’s to say the FDA has decided that no higher dose brings about a better reduction in symptoms. This may be because the study didn’t test higher dosing because the pharmaceutical company didn’t want the uncertainty of what would happen at higher doses (like extra side effects).

For many stimulant medications the FDA max daily dose for adults is less than the research clinical trial submitted to the FDA. One clear example, Concerta has a FDA maximum daily dose for adults of 72 mg a day, yet the adult ADHD research trial submitted to the FDA ran the dose up to 108 mg a day. In fact, in that trial, approximately 30% of the adults were at 90 mg daily or higher. This is publically available published research data. I was a prinicipal investigator (PI) on this trial some 20 years ago. The same can be said for Adderall XR with an FDA recommended daily dose for adults at 20mg yet the adult ADHD research trial submitted to the FDA ran the dose to 60 mg a day. Again, published available research on which I was also a PI.

In my previous post on this subject, I alluded to the fact of a “physicians review of medical information”, may not have even been performed by anyone. This speculation has been recently confirmed by a medical director at Aetna. He is now on the record saying that in many cases that were denied he never reviewed most of or any of the patients’ medical records.

So, all this information begs the question “what can I do to get my needed effective medication?”
First, you’ll need to follow the insurance companies procedures. Get a prior authorization, if denied submit an appeal if you are “wedded” to your medication. One secret to the appeal process is patient involvement. While I as a physician will try to submit the most relevant and supportive medical information, insurance companies may respond with more attention if the patient is very invested in the outcome. This may work best by composing a one page letter and attaching it to your doctor’s submission of medical information. Then follow this up with a phone call that will go on the record in their files.

However, if the prior authorization is denied and the subsequent appeal is denied what recourse then? I have recommended to patients to submit a complaint to the state insurance commissioner’s office. If you are comfortable, you submit a copy of the records that were submitted for the appeal process along with a cover letter from you explaining why you are filing a complaint with their office and what action you’d like them to take. The basis of your complaint can be strengthened by your physician/psychiatrist/prescriber’s reasons that justify the medical necessity for you to remain on your medication without change in compound, preparation, or dose.

What’s the likelihood that time spent on this process will yield a positive outcome? In my experience, surprisingly likely. State insurance commissioners office tend to be protective of patients’ medical care. In the state of Maryland, the insurance commissioner’s office will forward a copy of the complaint to the insurance company who is left to respond. In my experience, in about 50% of cases, the insurance company responds with a letter to the Insurance Commissioner saying they’ve reviewed the specifics of the situation, reconsidered the decision, and approve the medication and/or dose. It is worth a try. If nothing else, the commissioner’s office keeps track of compliants.

In closing, if you are on a high dose of ADHD medication and/or on an unusual combination of medications for ADHD, anticipate having to go through this process, especially with policy and pharmacy formulary changes effective Jan 1, 2018.

Understanding and planning the steps to take if your medications come under review will help you quickly get approval and/or consider other options. This planning will decrease the likelihood of a disruption in your prescriptions and treatment. Work with your health care prescriber to navigate through the stormy seas.

In future blogs on this topic, I will cite specific insurance companies and pharmacy benefit management companies who obstruct the established and effective treatment of my patients.

Hope this helps you.

David W. Goodman, M.D., FAPA

Dr. David W. Goodman Interview by NPR Morning Edition May 29, 2017

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National Public Radio recently posted my interview (click on “Heard on Morning Editon”) from April 2017 about a research publication reviewing a revised adult ADHD screener developed in coordination with the World Health Organization. What the journalist didn’t know at the time that I will share with you is that I was a pre-publication peer reviewer on this study. That means I was very knowledgeable about the details of the study and had offered my critique to the publisher prior to publication. For additional background on this screener, see my previous blog.

 

Now, let’s address the audio quotes.

Dr. Lawrence Diller says “I don’t know what ADHD is anymore” referring to changes over the past 3 decades of changes in the Diagnostic and Statistic Manual used to establish diagnostic criteria for psychiatric disorders. I’m surprised by his comment given 20+ years of international research (tens of thousands of scientific publications from around the world) that has better defined the symptoms and impairments of ADHD. It is this research that has contributed to better defining ADHD in children and the progression of ADHD into adulthood  therefore accounting for the evolution of changes in the current DSM 5. The diagnosis of ADHD is not based on a cluster of symptoms at one point in time. The diagnosis is based on the cluster of symptoms as they impair the person over the course of their life. Everyone has some inattention and distractibility at some point but few have the symptoms since childhood that have never gone away and are observed by others as a problem.

How about Alan Schwarz’s comments who disqualifies published peer reviewed science by indicting the experts and researchers who have conducted research with and without pharmaceutical support. To indict the international ADHD research community would be to suggest an international conspicacy of hundreds, if not thousands, of physicians and psychologists across 7 continents. This is a basic journalistic method (shoot the messager) to distract readers from the merits of an issue. I have personal experience with Mr. Schwarz who took to indicting me in his New York Times article when he conveyed to readers that I was advocating teaching primary care physicians how to diagnosis ADHD based on a short video clip. What he deliberately chose not to include in his article was the fact that the video was a visual representation accompanying a 2500 word, 168 scientific references, and peer reviewed article. Focused only on his agenda to act as “educator” to save the “victims” of ADHD medications from the “villians” of doctors, he deliberately misrepresented information for his self-serving purposes.

So, I’ll leave you with my saying, “The credibility of information is dependent on intent of the provider”. A salesperson gives you only information he/she wants you to have to close the sale. An educator gives you information so that your interest is best served first. You need to carefully discern this for yourself.

I will continue to present science in the halls of opinions.

Thank you for your interest….and focused attention.

David W. Goodman, M.D., FAPA

American Professional Society for ADHD and Related Disorders 2016 conference speaker videos

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American Professional Society for ADHD and Related Disorders has posted videos by many of the speakers at this year’s conference. For those professionals and others who are interested in the covered topics, we can listen the 5 min videos descriptions by the speakers of their topics. My video about ADHD in older adults is included. The conference remains the most up-to-date presentation of the science of diagnosis and treatment of ADHD across the lifespan from national and international experts in the field.

While the conference is open the professionals only, this organization and its postings help patients, family, and the general public remain informed about the state of effective treatment and evolving research.

David W. Goodman, M.D.

ADHD in older adults: First published review of world-wide literature

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On December 16, 2015, our article reviewing the world’s English scientific literature on ADHD in adults over age 50 years was published online in Drugs and Aging, an international journal. While there is a paucity of research, there are enough publications to merit pulling this literature together into one paper. Most of research comes out of the Amsterdam ADHD research group under the direction of Dr. Sandra Kooji. Some preliminary findings:

  1. Prevalence estimated at 3%. To put this into perspective, ADHD prevalence rate for children in the U.S. is approximately 8%, and 4.5% for adults. We know that for most children ADHD symptoms persist into adulthood. While we have prospective, longitudinal studies of ADHD children for 30 years, we do not have this information as the children age past 50 years old.
  2. Only 1 of 5 memory clinics actively screen for ADHD. This will leave many with ADHD misdiagnosed and likely mistreated
  3. Older adults on stimulant medication report better attention and greater ability to manage daily tasks compared to ADHD older adult not on medication.

Our paper reviews a broader range of findings and will be helpful to researchers and clinicians seeking to broaden their knowledge and polish their clinical skills as these patients present for evaluation of cognitive complaints. We look forward to participating in the expansion of this knowledge.

David W. Goodman, M.D.

FDA improves Drug Labeling for Pregnancy and Lactation

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Over the years, it has been challenging for psychiatrists to manage the risks of psychiatric medications in patients who considered childbearing, become pregnant, and chose to breastfeed. And while there is some information on many psychiatric medications, there remains little in regards to stimulant medications. Unfortunately, there is no registry for stimulant exposed pregnancy by which we can gain insight into their relative risk. The information we do have is related to animal research or people who have been active substance abusers. Very little of this research helps me in discussing evidence-based medication decisions with my patients. In my capacity as a researcher, I have had conversations about creating a stimulant pregnancy exposure registry with the pharmaceutical companies involved in ADHD but to no avail as yet.

With the proposed FDA changes in drug label for pregnancy and lactation, I hope we’ll have a better method of reviewing and evaluating relative risks and patients/families will be better informed.

The following article was distributed today, December 8, 2014 by the American Psychiatric Association, Psychiatric News Alerts.

FDA to Change Pregnancy and Lactation Labeling Information for Prescription Drugs

On Wednesday, the Food and Drug Administration (FDA) published a final rule that will set new standards for presentation of information concerning pregnancy and breastfeeding on labels of prescription drugs and biological products. The rule goes into effect June 15, 2015. “The [current] letter category system [A, B, D, and X] was overly simplistic and was misinterpreted as a grading system, which gave an oversimplified view of the product risk,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, in a press statement. “The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus, and the breastfeeding child.” The information provided under the new labeling requirements will be divided into the following categories:

Pregnancy: Containing information such as dosing and potential risks to the developing fetus and will require information about whether there is a registry that collects and maintains data on how pregnant women are affected when they use the drug.

Lactation: Containing information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed child.

Females and Males of Reproductive Potential: Containing information about pregnancy testing, contraception, and infertility as it relates to the drug.

“The new system is potentially more informative and more useful than the old grading system, … [but] a great deal will depend on the content of the information that is provided under the new requirements, particularly for psychotropic medicines,” stated Nada Stotland, M.D., a professor of psychiatry at Rush University and an expert in OB-GYN psychiatry, in an interview with Psychiatric News. “If the information provided is reasonable and clear, it should help decrease the anxiety both psychiatrists and patients may feel regarding these medication decisions.” Stotland, a former APA president, emphasized that psychiatrists must continue to inform the public about multiple treatment options—including psychotherapies and social support therapies—that can safely aid in lessening symptoms of mental illnesses during pregnancy. “If left untreated—or unsuccessfully treated—mental illness can have adverse consequences for both mother and child,” she emphasized.

David W. Goodman, M.D.

SavRx disrupts effective ADHD treatment

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With an increasing number of adults being nearly diagnosed with ADHD, the expense of ADHD medications for insurance companies has escalated. While the annual prescription increase for childhood ADHD is less than 3%, the ADHD prescription market is growing at approximately 10% per year. As a result of this change, companies are under increased pressure to reduce their pharmacy expense. While this issue is certainly not limited to ADHD medication, my patients are finding the course of the medication treatment disrupted by insurance companies obstructionistic prior approval requests for long-acting stimulant medications.

Patients and their treating physicians may struggle for some time to find the most effective individualized medication dose that produces an optimal reduction in symptoms with tolerable side effects. Patients have recently found insurance companies changing their coverage of authorized medications. That means, that despite prior approval for your current medication, the new coverage change may no longer authorize the medication and/or dose. This is becoming extremely disruptive to my patients finding themselves forced to change medication because of high deductibles, leaving them paying hundreds of dollars a month for their prior effective medication.

To give you a specific example, SavRx,  a prescription management service in Fremont, Nebraska, informed my patient who has been treated with Adderall XR  80 mg in the morning for the past six months that the coverage for this was no longer available to her, despite the fact that it had been approved by the previous pharmacy management company. Having submitted the documentation of effective treatment for months, SavRx is still not approving her optimal dose.

My recent experience indicates that this approach to medication authorization is increasing in frequency across several companies. I will continue to post blogs giving examples from other companies.

My suggestion to patients who encounter this issue with their treatment is to call your insurance company and complain about your specific case. The insurance companies may not be aware of what is happening and they certainly don’t want unhappy subscribers, let alone bad public press. We will soldier on.

 

ADD stimulant substitution by insurance prohibited in Maryland

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Step therapy is the requirement that a patient first try less costly medication before being prescribed medication a doctor thinks is best for the individual patient and specific symptoms/history. In the recent past, insurance companies had requested that adults with ADHD first be treated with a short-acting stimulant despite the fact that no short-acting stimulant is FDA approved for the treatment of adult ADHD. More recently, many insurance companies request “prior authorization”. This is a paperwork process to see if the patient can be directed to less costly medication despite the fact that the “recommended alternative” may not last long enough during the day. I’m relieved now with the passage of a new law in Maryland that will prohibit this practice. The following text appeared in the Maryland Psychiatric Society newsletter May 29, 2014. MedChi is the state of Maryland medical association.

MedChi applauds the enactment of SB 622/HB 1233, a bill that addresses a dangerous health insurance practice known as “step therapy.” Step therapy (or “fail first” policy) jeopardizes patient health by requiring them to try and fail on up to five older, less effective treatments before the insurer will cover the treatment originally prescribed. This law protects patients and keeps treatment decisions in the hands of doctors. The Maryland Health Care Commission recently studied step therapy, and Senator Middleton and Delegate Bromwell introduced this bill to codify some of its recommendations. The Middleton/Bromwell legislation, which takes effect on July 1, prevents insurers from forcing patients who are already being effectively treated on a medication to undergo the step therapy process, and also prohibits insurers from forcing patients to try medicine the FDA has not approved for treatment of a specific condition. Maryland is the first state in the country to enact the latter provision. Evidence suggests that step therapy may increase overall health care costs. Patients forced to manage multiple insurer “steps” often endure additional trips to the doctor or pharmacy, with additional time off from work or child care. When patient treatment is unnecessarily delayed, manageable conditions can devolve into more difficult to manage diseases. From May 5 MedChi News 

I encourage my patients, their family and all those for who this applies to actively pursue and receive the most effective treatment and medication that works for them. And then let your insurance company know that you are an informed patient who will advocate for your legal right to individualized treatment.

Hope this is useful to you.

 

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