Welcome!

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.


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.

Abstract.
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.

Abstract
OBJECTIVE:
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.
METHOD:
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.
RESULTS:
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.
CONCLUSIONS:
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.