Welcome to my blog, a place to explore and learn about the experience of running a psychiatric practice. I post about things that I find useful to know or think about. So, enjoy, and let me know what you think.

Wednesday, April 26, 2017

Opioid Training Requirement

New York State recently decided that in order to address the problem of opioid abuse, all physicians (and non-physician prescribers) with a DEA number need to be trained in pain management, palliative care, and addiction. By July 1st of this year. I found out about it in the middle of March.

And it needs to be repeated once every 3 years.

The required course work covers the following eight topics:

(1)        NYS and federal requirements for prescribing controlled substances;
(2)        Pain management;
(3)        Appropriate prescribing;
(4)        Managing acute pain;
(5)        Palliative medicine;
(6)        Prevention, screening and signs of addiction;
(7)        Responses to abuse and addiction; and
(8)        End of life care.

I. Don't. Prescribe. Opioids. Period.

What I'm saying is, this training has no relevance for me, and is another example, aside from MOC, of taking time away from educational or clinical experiences that are useful to me, to do someone else's busywork.

I think whoever came up with this idea is trying to create the impression that something is being done about the opioid problem, without thinking it through. A more reasonable, and respectful approach would have been to say, "If this is relevant to your practice or work setting, then you must get this training. And if you don't have the training and you do prescribe opioids, you're in big trouble."

Here's an indication of just how poorly thought out this program was:

Providers will be required to attest to completion of the required course work or training.  The Department of Health has not yet released instructions for submitting an attestation, but has indicated that more information is coming soon.  

As I mentioned, this was back in March. There is now a way to attest, by going to the HCS portal, then "My content" --> "All Applications" --> "N" --> "Narcotic Education Attestation Tracker (NEAT)".  This is where the directions come from.

And for reference, this is the actual announcement.

There are two currently available courses that satisfy the training requirements (that I know of):

The New York Chapter of the American College of Physicians offers a three-hour online course on the required eight topics in conjunction with the Boston University School of Medicine.  This course is available free of charge to all providers.  You can view the course announcement by clicking here.

The Medical Society of the State of New York is also offering three 1-hour online courses covering the required eight topics.  The courses are free to MSSNY members and will be made available to non-members for a fee of $50 per module.

I couldn't figure out how to access this course without paying dues and logging in to the MSSNY site. But why would I want to pay $150 for a course I can take for free elsewhere?

The statute does provide an exemption from the course work or training requirement for DEA registered providers, but it's not clear to me under what circumstances, or how it can be done:

...The DOH may grant an exemption to the required course work or
training to an individual prescriber who clearly demonstrates to the DOH that there is no need to complete such training. Exemptions shall not be based solely upon economic hardship, technological limitations, prescribing volume, practice area, specialty, or board certification.

When I was making my attestation, there was a button you could press to ask for an exemption, but I didn't press it since I wasn't asking for one, so I don't know what happens when you do.

Now about the course. This is an aside, but one thing that pissed me off is that while the course provides CME credit for everyone who takes it, those certified by the ABIM can use it as SA credit, while those certified by the ABPN cannot. If that's not a scam on the ABPN's part, I don't know what is.

The first two modules were completely useless to my practice, although I found the content interesting. They cover how to:

Determine when opioid analgesics are indicated
Assess for opioid misuse risk
Talk to patients about opioid risks and benefits
Monitor and manage patients on long-term opioid therapy

One thing that struck me is that the course seems to be intended mainly for primary care providers, and it's hard to imagine when someone who is responsible for everything involved in primary care would have time to deal with pain management and potential for misuse.

The third module was useless as well as boring. It was basically just someone rattling off NY State laws governing the safe prescribing of opioids, and how to, "Appropriately document communication with patients about health care proxies and advance directives and describe the appropriate use of advance care planning CPT codes."

I dozed off several times. I still managed to pass.

So if the topic is relevant to your practice, or you're looking for some free CME credits, or if neither of these is the case but you have a DEA number in NY State, then by all means, take these classes.

Monday, April 17, 2017

House Calls

The other day, I was scooting around a Google map of Manhattan, trying to find The Doughnut Plant, which makes the best coconut cream yeasted doughnut ever. And as I was virtually strolling along 23rd street, I saw this:

House Call Psychiatrists. Hmm. I couldn't help checking out their website.

From their home page:

House Call Psychiatrists is a network of board certified and licensed psychiatrists with extensive experience making psychiatric home visits.  They are available 24 hours a day, 7 days a week for convenient and private house calls within Manhattan, Brooklyn, Queens and North Jersey.

House Call Psychiatrists offer a unique and high level service in the convenience of your home, office or hotel room. They are able to address most psychiatric issues in a timely and private manner avoiding other urgent care centers and hospital emergency rooms.

There's an interesting idea. It's a bit different from TalkSpace, a texting therapy service which I posted about previously. Some of the things I didn't like about TalkSpace were that it's not in-person treatment, and there's no delayed gratification like there is when you have to wait for your appointment.

But these are house calls. So you do have to make an appointment, even if it happens to be in the middle of the night. And it is in-person.

Here's some more information.

There are 7 psychiatrists on the team, all men. A general psychiatrist, two addiction psychiatrists, a bipolar specialist, a geriatric specialist (who doesn't seem to be board certified in gero-psych, so I guess that's why they don't call him a geropsychiatrist), a community psychiatrist, and an anxiety specialist.

Thinking about the "extensive experience making psychiatric home visits," I'm skeptical. How would they get that extensive experience? I can remember my pediatrician coming to my house, but nothing since then-who makes house calls anymore?

"Our psychiatrists have been making house calls for many years on Assertive Community Treatment (ACT) teams which are home-based psychiatric outreach programs.  They are also psychiatric emergency room physicians with admitting privileges to..."

ACT house calls seem very different to me than the house calls they're talking about here. For one thing, ACT is a team, and sees patients as such. Here, my impression is that this is 1 to 1 care. For another, most patients in ACT treatment can't afford the $500 fee that House Call Psychiatrists charge. Or $1000 from 8pm to 8am.

I'm trying to understand the model. I assume they cover for each other, and that someone is always on call.

All the the psychiatrists seem to have separate private practices that provide more typical office visits. Some of their websites indicate that they will also make house calls, but at the $500 rate, rather than their regular rates, which are less. Does this mean that the House Call Psychiatrists only see established patients? I don't get that impression.

They also offer to see patients in their hotel rooms, which implies that they may be visiting NYC, and therefore not established patients.

The house call services provided are:

This makes me wonder about liability. If they provide crisis intervention and safety checks, then they may end up seeing a patient they don't know who is suicidal. What if that patient needs to be hospitalized but refuses to go? One of the individual psychiatrist's websites states that he does make house calls, but that, "A home visit should not replace calling 911 if you are having an emergency." That confuses me.

My fantasy about this model is that some wealthy person feels like he needs to see a psychiatrist, but he is either visiting NYC, or lives here but doesn't want to go to anyone's office. I imagine this as happening in the middle of the night, with patients who suffer from insomnia (they state they treat sleeping difficulties), or who are having panic attacks. Or maybe it's during the day, but it's some CEO who wants his shrink to come to him.

I'm really not sure what to think about this model. I know I wouldn't make house calls with my patients, but my practice has a certain nature that doesn't lend itself to this model. Also, I don't fancy wandering into a stranger's hotel room in the middle of the night, knowing that there's a psychiatric problem.

Home visits are a great idea for patients who function poorly and would be lost to care if they weren't followed by an ACT team, for example. But patients who can afford $500 fees presumably function fairly well. (Incidentally, no insurance is accepted, and the fee is prepaid at each visit via credit card.)

I think that for one-off panic attacks, home visits are probably not a good idea, because they maintain the message that the patient can't manage on his own and tolerate some delayed gratification, similar to TalkSpace.

For naltrexone injection or genetic testing, maybe it does make sense for the shrink to come to your office.

For ongoing therapy, I don't know. Is there some benefit to making time during the day to travel to the shrink's office? Is there a power struggle that gets settled by default when the shrink comes to you? Does it violate the important frame of a treatment to have it in your home, or does it just create a different frame?

I have a lot more questions than answers. What do you think?

Monday, March 13, 2017

Manualized Treatments

I'm sorry I've been gone so long. There, I got that out of the way. I have been exquisitely busy, with mostly good things, so no complaining. But really no time to blog. I have missed it, though, and I've also felt strangely guilty, as though having embarked on this journey, I need to see it through, whatever that might mean.

I assumed no one would be reading the blog, once I stopped posting regularly. I haven't even checked in much to see the stats. But when I did, recently, I was shocked to discover how many hits the site is getting on a regular basis. It's a nice feeling.

So now that I'm back, there's the question of what to post about. I've decided, at least for this return post, to ignore the Republican in the room. With my apologies to those who voted for Trump, I find the current political situation in this country very disturbing. And that's all I'm going to say on the subject, for now.

Why manualized treatments? Lately I've been involved in some committees that are debating the nature of an analytic curriculum, and whether it should include psychotherapy training. This goes to the question of what the difference is between psychodynamic psychotherapy and psychoanalysis (these days, I believe the therapy is referred to as psychoanalytic psychotherapy). That's a very tough question, with lots of controversy about a spectrum of treatment, the use of the couch, the frequency of sessions, goals of the treatment, whether analytic training makes for better therapists, the theoretical bases, overlap in technique, the list goes on.

At a recent meeting, one suggestion was to include courses in Transference Focused Psychotherapy (TFP) and Panic Focused Psychodynamic Psychotherapy (PFPP), both manualized treatments, in the first year of training, and the point was made that it may be helpful early on in ones training to have this kind of framework for thinking about what one is doing, rather than just learning to sit with the chaos and confusion.

Oh, this was funny. I got to that meeting a couple minutes late, and everyone was sitting around in a big circle, and it was crowded, so I went and grabbed a chair from a stack and just plunked it down in the outermost circle. Then I started to look around for my analyst so I could figure out how uncomfortable I should feel. At first I didn't see her, then I realized I was sitting directly behind her. About five minutes later I started to laugh because I thought, "Well this is backwards."

I disagree with the framework point for several reasons. First, it's not the only way to create a framework. The current trend in teaching psychotherapy is to use a book by Cabaniss, Psychodynamic Psychotherapy: A Clinical Manual. The idea behind it is that there are now core competencies in psychotherapy that residents have to meet, and it's structured in a way that fulfills those competencies. It's brilliant in the way it breaks things down into simple pieces, but it's very algorithmic, and in my opinion, it infantilizes the residents for whom it's intended.

I've been teaching in a psychotherapy program for several years, and we don't use that book. Instead, we use Rosemary Balsam's, Becoming a Psychotherapist: A Clinical Primer. It's a bit outdated (it includes a section about whether you should have an ashtray in your office), but when it comes to teaching newbies how to work with patients, it's brilliant. Completely non-algorithmic, it still manages to create a solid framework for how to think about what one is doing in terms of technique. Every time I read it I think, "I wish I had had this when I was a resident."

Second, teaching beginning psychodynamic psychotherapy with manualized treatments is analogous, for me, to using a GPS to get someplace new. This happens to me all the time. I use the GPS, I have no problem getting where I'm going, and I have no idea where I am. Not a chance that I could get home without the GPS. I just did as I was told, (drive 158 miles, then turn left) but I'm clueless. Whereas back in the days before GPS's, I had to look at a map, and maybe I got a little lost and had to pull over and look at a map again. It was more of a struggle, but by the time I reached my destination, I could get home on my own.

That said, I think manualized psychotherapy treatments are good things. I just don't think they're the first way one should learn to do psychodynamic psychotherapy. So let's go over the two I mentioned above. Please note that I'm writing about manualized psychodynamic psychotherapy treatments, which is why CBT is not included in the discussion.

Transference Focused Psychotherapy (TFP):

TFP is a manualized evidence-based treatment for borderline and other severe personality disorders. It is based on psychoanalytic concepts and techniques that have been modified and organized into a systematic approach to address severe personality pathology. TFP posits that the specific symptoms of borderline personality disorder (BPD) stem from a lack of identity integration, corresponding with a lack of coherence in the individual’s experience and understanding of both self and others. This unintegrated psychological state, referred to as “identity diffusion,” is associated with reliance on defensive strategies involving dissociation of conscious aspects of experience that are in conflict (“splitting-based defenses”) and with a vulnerability to experiencing cognitive distortions in the setting of affect activation.  (Yoemans, et al)

TFP meets twice weekly for an indefinite period. Its objectives include improved behavioral control, and an increase in reflection and affect regulation, both of which ultimately promote identity integration. The success of TFP rests on three central tasks for the therapist: setting and maintaining the frame; containing and making use of the therapist's own affective responses (countertransference); and interpretation.

The frame is set via a collaborative negotiation of a treatment contract-how frequently they will meet and why that's important, what happens if sessions are missed, etc. The therapist needs to be flexible and open, and to address any concerns the patient might have. This creates a safe environment for the patient, and allows for later discussion and exploration of deviations from the contract.

Work with Borderline patients can produce intense affective reactions in the therapist. The goal is for the therapist to recognize and accept those affects, rather than denying their presence, and to use them to help understand what the patient is feeling. For example, Borderline patients can project a lot of their own negative and aggressive feelings onto others, so the therapist's awareness of his own affective reaction can help him recognize an affective state which the patient may be experiencing, but unable to recognize in herself.

The interpretive process includes the triad of clarification, confrontation, and interpretation, itself.

"Clarification involves drawing attention to an area of psychological conflict by tactfully and specifically exploring the patient’s conscious experience."

Confrontation calls attention to the, "...patient’s verbal and nonverbal communications that are in contradiction with each other and that represent internal states that are segregated from each other." An example would be pointing out her own aggressive behavior to a patient who frequently feels mistreated by others.

As for interpretation, itself, "In the advanced phases of the interpretive process, the TFP
therapist continues to support reflection, while calling attention to the dissociation of positively and negatively colored aspects of affective experience and ultimately exploring the patient’s motivations
for keeping them apart. In the process of interpretation, TFP emphasizes a persistent focus on the here-and-now and an empathy with the total internal experience of the patient, which is to say, with the patient’s identifications with both the persecutory as well as the persecuted object, and with the idealized as well as idealizing object." Much of this work takes place in the transference, i.e. in the therapist's interpretation of the patient's reactions to the therapist, whether idealizing or demeaning.

Empirical studies of TFP have shown decreased suicide attempts, ER visits, and hospitalizations, as well as increases in global functioning. (all significant, see this summary)

One study comparing TFP with DBT and supportive treatment found significant improvements in depression, anxiety, global functioning, and social adjustment in all three groups, at one year. TFP and DBT showed significant improvement in suicidality. TFP and supportive treatment were associated with improvements in anger and impulsivity. Only TFP was significantly predictive of change in irritability and verbal/direct assault.

The difference in approach of TFP vs. DBT seems to be that DBT is good at getting Borderline patients to function, despite their affective and cognitive tendencies, while TFP tries to shift those tendencies.

Panic Focused Psychodynamic Psychotherapy (PFPP):

I actually wrote a post about PFPP a couple years ago, Panic Disorder Study. Unfortunately, the link I used to the article doesn't seem to work anymore, so here's a new link, with the full text.

As a quick recap, PFPP is a manualized treatment for Panic Disorder that runs for 24 sessions over the course of 12 weeks (2/week). It assumes that panic symptoms have psychological meaning, often related to conflicts surrounding separation, autonomy, and anger. There are three phases of treatment.

In phase 1, the meanings behind the panic symptoms are explored, with the goal of some initial symptom relief. Phase II involves addressing transference to examine the way the conflicts causing the panic can play out in real time. Phase III addresses termination, including the reliving of central separation and anger themes in the transference.

One of the impressive things about PFPP is that it managed to develop a manual for doing psychoanalytic psychotherapy. I haven't seen the actual manual, but presumably, it was able, "... to maintain the essential features of a psychoanalytic treatment (free association, elucidating unconscious meanings and conflict, developmental exploration, interpretation, use of the transference) with adequate flexibility, while focusing on the specific underlying meanings of symptoms of panic disorder." (Discussed Here).

I couldn't find a trial testing PFPP against CBT, since the original, 2007 study, which tested PFPP against something called, Applied Relaxation Training. There does seem to be a trial in progress, as well as one about PFPP in adolescents. I guess they were satisfied enough with the results of the original trial that they continue to offer training in PFPP.

That's about it for my return post. Hope to post again soon.

Published on Psych Practice March 13, 2017

Tuesday, October 18, 2016

Finally! Building a Website-The Website

I know, I know, I started writing about building my practice website months ago, and I've completely dropped the ball. But only the blog ball. I've actually been working very hard on my own website, as well as that of my analytic institute, and on other tech-y advances we're adopting. More on that later.

For now, I have finally chosen SquareSpace as my site host, and I'm diligently shoveling away at everything I need to do to get the site up and running.

Why SquareSpace? I know that in my last post on this matter, it looked like I was going to go with Duda. Since then, I've traveled further along the convoluted paths of website-building research, and one of the things I discovered is that SquareSpace is a solid company in many ways, including staying power. I really wasn't sure I could say that about Duda-that a couple years from now, they'll still be around.

In the end, it was a competition between Squarespace, and a hosted site using Wordpress. I'll tell you a little bit about that.

I like Instagram. My interests fall into a few main categories: dogs, crochet/yarn, design, food, and museums. They have targeted ads, which I sometimes look at. One day, an ad came up for SkillShare, where you can take mini-courses taught by whoever. Some are free. Some require a premium subscription. I found a premium class called, Mastering Wordpress: Build the Ultimate Professional Website. So I paid the 99 cent three month trial fee, and started taking the class. It was pretty bad. It was boring, and the guy was describing how to make his EXACT site. But it did make it clear to me that I could do this.

Then I found another course, How to Properly Make a Website with Wordpress-Beginner's Tutorial. This one was helpful. You can check it out on SkillShare, but the guy has his own site called, Websites Made Easy.

Basically, you use HostGator.com to host your site. You can also buy a domain name through them.

To review briefly, the domain name is the name of your site, i.e. its address, like alfredeneumanmd.com. (I actually got a .org domain name). The hosting site is where your site "lives" online. Hosting sites usually have several pricing plans that vary by what's offered.

Once you buy your domain name and pick your hosting plan, you hook up Wordpress to it, and you build your Wordpress site.  Wordpress has a ton of plugins, which are little extra functions that someone else wrote the code for, and which do great things for your site.

I didn't go this route because I actually tried to go this route, and something happened with the billing, and then it somehow got canceled. The problem wasn't on my end, so I started reading reviews of HostGator, and apparently they used to be pretty good, but not so much anymore. So I gave up on it.

It's also not clear to me why this is a better way to go than simply hosting your site through Wordpress.

But here's what it came down to with SquareSpace. It's a one-stop shop. You can buy a domain name through them, and host on their site, and use their software to build your site.

The domain name has an annual fee (no matter where you get it), and SquareSpace charges $20/year, which is more than many of the other hosting sites. But they lock you in at your initial rate. Other sites don't tell you what they'll charge after the first year.

SquareSpace also doesn't give you a hard time about transferring your domain name, if you decide you don't want them to host anymore, as long as you've had your site for at least two months. According to reviews, other hosting sites do give you a hard time. I think it's indicative of SquareSpace's trust that you'll like their product, and want to continue with them.

The pricing is middle of the road. I got the "personal" plan, as opposed to the business plan. It boasts:

and costs $16/month, or $12/month if I pay annually. It includes Domain Privacy, which removes your personal contact information from the public WhoIs internet record of your domain name, which can be crawled by spam marketers for your email address.

The business plan has a few more items that I don't need right now. But you can switch between plans whenever you like. They also require  a 14 day free trial, so you're sure SquareSpace is what you want.

The design software took a little getting used to, but it's powerful, and really quite beautiful. They have excellent online tutorials, and lots of them.

In case you're interested, I chose the Keene template:

I changed the font and ditched the toothbrush, and I really like it. It's clean, uncluttered, and attractive.

The new font looks like this:

Finally, SquareSpace has exceptional customer service, which I came to realize is very important when you're DIY'ing your own site. Every review I read about SquareSpace was impressed by the customer service. I've already made use of it, and the turnaround time was faster than I expected, and they were genuinely helpful.

Next up, the ACTUAL building of the site, or, "How do I introduce myself to the world and describe what I do? What DO I do? Why do I do it that way?" I never realized how philosophical building a website can be.

Sunday, October 2, 2016

Rosh Hashanah 5777

Tonight is the start of the year 5777, on the Jewish calendar. Regardless of when you mark the beginning of the year, whether it's tonight, or January 1st, or some other day, the new year is a time for reflection on the past, and hope for the future. May it be a year of happiness, health, and peace.

(It's traditional to celebrate Rosh Hashanah by eating an apple dipped in honey, to symbolize a sweet new year). 

Saturday, October 1, 2016

There IS Something You Can Do

On September 16th, The Department of Health and Human Services (HHS) released a final regulation about clinical trials submitted to the FDA, and the National Institute of Health (NIH)issued a new policy regarding the same subject. These are the basics:

The HHS regulation, also called the "Final Rule", states that a responsible party, such as a pharmaceutical company submitting a phase 2, 3, or 4 clinical trial for review by the FDA, with the purpose of getting a new drug approved, or a new indication for an existing drug, must register the trial at clinicaltrials.gov within 21 days of enrolling the first participant. Registration involves providing, "1) descriptive information, 2) recruitment information, 3) location and contact information, and 4) administrative information."

In addition, "The Final Rule requires a responsible party to submit summary results information to ClinicalTrials.gov for any applicable clinical trial that is required to be registered, regardless of whether the drug, biological, or device products under study have been approved, licensed, or cleared for marketing by the FDA."

The, "...results information must be submitted no later than one year after...the date that the final subject was examined or received an intervention for the purpose of collecting the data for the primary outcome measure. Results information submission may be delayed for as long as two additional years...," for a few complicated reasons we won't get into here.

Results need to include, "1) participant flow information, 2) demographics and baseline characteristics of the enrolled participants, 3) primary and secondary outcomes, including results of any scientifically appropriate statistical tests, and 4) adverse events."

Importantly, "The Final Rule also adds a requirement to submit the clinical trial protocol and statistical analysis plan at the time of results information submission."

Information needs to be updated on clinicaltrials.gov at least once a year. And any errors, deficiencies, or inconsistencies that the NIH (which runs clinicaltrials.gov) identifies need to be addressed by the responsible party.

That's the HHS final rule. Trials need to be registered on clinicaltrials.gov, information needs to be kept relatively current, and results have to be posted.

The NIH policy broadens the scope of which trials they consider subject to these requirements.

These are good things for trial transparency and honesty. We'll get to the catches in a bit.

Let me backtrack and try to explain why I'm writing about this. Currently, pharmaceutical companies submit drug trials to the FDA, to get approval. They're supposed to register these trials on clincialtrials.gov, but they often don't, it's not policed, and the data they do submit isn't checked. Note that clincialtrials.gov is run by the NIH, not the FDA, so there's a built in disconnect right from the start.

While a study is being reviewed by the FDA, the pharmaceutical company can publish anything they want about that study in peer reviewed journals. They can do this even if the drug ends up not being approved. They often mis-report data and results. And there is no way of knowing if they are staying true to their original study protocol, or if they're messing around with the stats in ways that benefit them. The journals have no way of knowing what's true and what isn't. The whole "peer review" part is also a sham, because the "peers" are given whatever information the pharmaceutical company feels like giving them.

And the FDA does nothing to prevent any of this from happening.

This is not me being paranoid. Here's an article that describes a disturbing example:

The citalopram CIT-MD-18 pediatric
depression trial: Deconstruction of medical
ghostwriting, data mischaracterisation and
academic malfeasance

 Jureidini, et al.

OBJECTIVE: Deconstruction of a ghostwritten report of a randomized, double-blind, placebo-controlled efficacy and safety trial of citalopram in depressed children and adolescents conducted in the United States.
METHODS: Approximately 750 documents from the Celexa and Lexapro Marketing and Sales Practices Litigation: Master Docket 09-MD-2067-(NMG) were deconstructed.
RESULTS: The published article contained efficacy and safety data inconsistent with the protocol criteria. Procedural deviations went unreported imparting statistical significance to the primary outcome, and an implausible effect size was claimed; positive post hoc measures were introduced and negative secondary outcomes were not reported; and adverse events were misleadingly analysed. Manuscript drafts were prepared by company employees and outside ghostwriters with academic
researchers solicited as ‘authors’.
CONCLUSION: Deconstruction of court documents revealed that protocol-specified outcome measures showed no statistically significant difference between citalopram and placebo. However, the published article concluded that citalopram wassafe and significantly more efficacious than placebo for children and adolescents, with possible adverse effects on patient safety.

International Journal of Risk & Safety in Medicine 28 (2016) 33–43
DOI 10.3233/JRS-160671

And this is the abstract from the original article, for comparison:

A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents.

Wagner KD1, Robb AS, Findling RL, Jin J, Gutierrez MM, Heydorn WE.

Open-label trials with the selective serotonin reuptake inhibitor citalopram suggest that this agent is effective and safe for the treatment of depressive symptoms in children and adolescents. The current study investigated the efficacy and safety of citalopram compared with placebo in the treatment of pediatric patients with major depression.
An 8-week, randomized, double-blind, placebo-controlled study compared the safety and efficacy of citalopram with placebo in the treatment of children (ages 7-11) and adolescents (ages 12-17) with major depressive disorder. Diagnosis was established with the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version. Patients (N=174) were treated initially with placebo or 20 mg/day of citalopram, with an option to increase the dose to 40 mg/day at week 4 if clinically indicated. The primary outcome measure was score on the Children's Depression Rating Scale-Revised; the response criterion was defined as a score of < or =28.
The overall mean citalopram dose was approximately 24 mg/day. Mean Children's Depression Rating Scale-Revised scores decreased significantly more from baseline in the citalopram treatment group than in the placebo treatment group, beginning at week 1 and continuing at every observation point to the end of the study (effect size=2.9). The difference in response rate at week 8 between placebo (24%) and citalopram (36%) also was statistically significant. Citalopram treatment was well tolerated. Rates of discontinuation due to adverse events were comparable in the placebo and citalopram groups (5.9% versus 5.6%, respectively). Rhinitis, nausea, and abdominal pain were the only adverse events to occur with a frequency exceeding 10% in either treatment group.
In this population of children and adolescents, treatment with citalopram reduced depressive symptoms to a significantly greater extent than placebo treatment and was well tolerated.

Am J Psych. 2004;161(6):1079-83

In the end, the FDA did not approve citalopram for use in children. But the study has been cited over 160 times, putting it in the top 5% of cited articles in medicine from 2004. Between 2005 and 2010, nearly 160,000 children under age 12 received escitalopram, despite the FDA's lack of approval.  (There was a switch at some point from off-patent citalopram to on-patent escitalopram, in this time period.) It's hard not to conclude that the published study had impact on prescribing practices.

There's a much fuller description of this here, by Bernard Carroll. And a lot more about this whole topic on 1BoringOldMan.com.

Getting back to the Final Rule, there are some problematic loopholes. There are allowances for delays in reporting. There is also the crazy idea that the study protocol doesn't have to be reported until the results are submitted. This leaves room for dinking around with the protocol, changing outcome measures after the trial has started, etc.

Here's what you can do. Take a look at this petition, and if you're on board, sign it. It's entitled, "Stop False Reporting of Drug Benefits & Harms by Making FDA & NIH Work Together". The main point is this:

We now petition Congress to require the FDA and NIH to coordinate their monitoring and sharing of key information through ClinicalTrials.gov. Working together, the two agencies could enable stakeholders to verify whether purported scientific claims are faithful to the a priori protocols and plans of analysis originally registered with the FDA. Publication of analyses for which such fidelity cannot be verified shall be prohibited unless the deviations are positively identified (as in openly declared unplanned, secondary analyses). This prohibition shall include scientific claims for on-label or off-label uses made in medical journals, archival conference abstracts, continuing education materials, brochures distributed by sales representatives, direct-to-consumer advertising, and press releases issued by companies or their academic partners. It shall extend to FDA Phase 2, Phase 3, and Phase 4 clinical trials. By acting on this petition, Congress will create a mechanism for stakeholders independently to verify whether inferences about clinical use suggested by the unregulated corporate statistical analyses can be trusted.

Please think about it. Thanks.

Friday, September 30, 2016

PA Victory?

I know everyone has problems with prior authorizations. The Byzantine bureaucracy and obscure explanations for denials are maddening.

I'm suddenly reminded of the DMV scene in Zootopia, except I think insurance companies do it on purpose.

Today I had a minor and unexpected victory, and I think I might know why it worked, so I thought I'd share it.

Unfortunately, I have to mask any clinical information, so you'll have to take my word on a number of points. Some things may sound peculiar or not-thought-out, but like most cross-sectional views of a patient's medication regimen, if you knew the full history, it would make sense.

Here's what happened. I needed to get a PA for a new medication, M. The patient had had trials of multiple cheaper covered medications, and had either failed them, or had been unable to tolerate them. The insurance company's criteria seemed to be having failed a 4 week trial of, or been unable to tolerate, two medications.

A number of months ago, I had tried to get a PA for a new med for this patient, and the application was rejected, despite the fact that the criteria were obviously met. I didn't have the energy to pursue it then, and there were one or two more covered meds left to try.

The difference now seems to be that I've since had a Genesight test done on this patient. As I've described in the past, I have my doubts about the whole genetic testing business, but I used the test results as documentation to support my rationale. M was in the "Green Column", and the other meds in that column had already been tried.

It worked! Who knew? I'm only guessing that that's the reason, but I can't think of any other difference. Same patient, same insurance company.

It wasn't a pure victory, though. This medication has a starter pack that's used to titrate gently. THAT wasn't approved. And using a single dose form, starting lower, and then increasing the number of pills per day, well, that wasn't covered, either, because it involved too many pills. What I needed to do was skip the recommended titration, and go straight to the next dose up. Not dangerous, but possibly hard to tolerate.

To me, it feels like a punishment for asking the insurance company to cover the medication.

I guess with insurance companies, you take what you can get.