Summing Up 2015

Here we are at the end of the year. A lot has happened in the world of psychiatry in 2015.

Collaborative Care is alive and scoring a 0 on the PHQ-9. The Clozaril REMS deadline was extended. Tom Insel left NIMH for Google. Mandatory E-prescribing was postponed until this coming March. EHRs continue to disappoint. Meds long past patent have had their prices jacked up 5000%. The FDA is looking to appoint a new head, and Robert Califf, a cardiologist with strong ties to the pharmaceutical industry has been nominated (See NY Times and David Healy).

On the upside, Dinah at Shrink Rap came up with a brilliant way for people to access psychiatric care in Maryland. I hope this approach is replicated more broadly.

I was perusing my posts from this past year, and I made a list of some of the major topics, and their respective posts, both general and personal:

Maintenance of Certification

I studied for:
The Montillation of MOC
Percentages

And passed:
Done
There and Back Again
Framed
Signed, Sealed, Delivered
Switching the Labels

my board recertification exam.

And I was certified by the NBPAS, as well:
Another Board

The ABPN refused to make any significant changes to MOC, especially Part IV:
I Really Should be Studying, But...
An MOC Step?
Follow the Money

Although the Part IV Feedback modules are now optional.

And I developed my own Psychoanalytic PIP Module:
Fascinating
Here Goes Nothin'
A Monkey's Uncle

The best part about all of this is that I've written enough MOC posts that I now misspell "Maintenance" only about 5% of the time.


Affordable Care Act (ACA)

The ACA has kicked in:
Out of Network Benefits in NY

And pushed me over the edge into the realm of blog ads:
Adding Ads and the ACA


Psychoanalysis

I terminated my analysis:
Termination
Blessings

And wrote some other posts about psychoanalytic evidence and topics:
Analytic Evidence
AA Brill
The Blank Screen
Narcissism, Part I
Narcissism, Part 2


Jeffrey Lieberman

His book, Shrinks was published:
"Shrinks" Review: Introduction
Shrinks: The Untold Story of Jeffrey Lieberman's Oedipal Victory over Papa Freud
Shrinks Links, Etc.

And a torrent of posts followed, culminating in the one about his fiasco of a presentation at the White Institute:
Lieberman Speaks


Addyi

The FDA approved a drug that could hurt you but can't help you:
They Caved

That was immediately sold for $1Billion:
Addyi-dendum

And then the FDA and Valeant pawned off responsibility onto the doctors who prescribe it, and the pharmacies that fill the prescriptions:
Addyi REMS-A Shanda


Paxil 329

Finally, and perhaps most importantly, the restored version of Paxil Study 329 was published, with disturbing conclusions:
329


Do I have a favorite post from the year? Not really. The Lieberman posts, especially the reviews and the one about his talk at White took the most out of me. But in terms of content, I think the Analytic Evidence and 329 posts are the most important.

On to pastures greener.

Addyi REMS-A Shanda

I seem to be on an Addyi kick lately. I got an email today about the Risk Evaluation and Mitigation Strategy (REMS) for Addyi, the newly approved medication for Hypoactive Sexual Desire Disorder.

There was a lot of fuss about this REMS, because Addyi is known to cause hypotension and syncope particularly alcohol is consumed. So the FDA created a REMS that involved special training and official certification for prescribers of Addyi (as well as pharmacies dispensing Addyi).

I mentioned in a previous post that I didn't want to do the training. I assumed it would be something along the lines of the 8 hour training required to prescribe Buprenorphine, and I didn't want to put that kind of effort into it. More importantly, I don't think the drug works, and I thought it would be easier to tell a patient I'm not certified to prescribe Addyi, than to have a long discussion about why it's not a good idea for her to take Addyi. Yeah, okay, that's a copout. I also didn't want to support this Shanda* of the FDA and Sprout (the company that makes Addyi).

*Shanda is Yiddish for something shameful or scandalous. I think Yiddish has much better words than English for expressing exasperation and outrage. Also sounds. An appropriate one here would be, Feh.

Buuuut...I got curious after I got the email. So I checked it out. What's involved is:

1. Read the Addyi Prescribing Information

2. Complete the Addyi REMS Program Prescriber and Pharmacy Training

3. Complete the Addyi REMS Program Knowledge Assessment

4. Enroll by completing the Addyi REMS Program Prescriber Enrollment Form


I want to go out of sequence for this next bit. I'll start with the Knowledge Assessment. Here it is:

Please note, this is not a section of the Knowledge Assessment. This is it. The whole shebang. I didn't need special training to answer this one.

And the training? It took me less time than reading through this post. The main point of it seems to be the Patient-Provider Agreement Form. This needs to be signed by both prescriber and patient, and states that the prescriber has counseled the patient, and the patient understands the counseling.

It's kind of brilliant. The FDA is covered for approving Addyi by the existence of  this special "training". Sprout is covered for producing and selling a dangerous drug that doesn't work by putting the burden of counseling the patient on the prescriber. And by covered, I mean legally.

This is what's required of the prescriber:

There might have been something useful in the "training" if it included recommendations for assessing a patient's ability to abstain from alcohol, or suggestions about how to encourage a patient not to drink while taking Addyi. But that would place some liability on Sprout or the FDA. So they didn't do it.

I am definitely not gong to enroll as a prescriber.

Addyi-dendum

Maker of Addyi, ‘Female Viagra’ Drug, Being Sold to Valeant for $1 Billion

Wow! That was fast! On Tuesday, the FDA approves Addyi to treat Hypoactive Sexual Desire disorder (HSDD) in women. And on thursday, the maker of Addyi, Sprout pharmaceuticals, is sold to Valeant for $1 billion.

According to the NY Times article (link above), about $100 million has been invested in Sprout since its formation in 2011. And now it gets $1 billion. Nice.

Let's look at the sequence of events here:

Boehringer Ingelheim develops flibanserin as an antidepressant, but it doesn't work.

They notice that it increases sexual desire, so they test it for that, but the FDA rejects it in 2010, and they give up on it.

Meanwhile, Slate Pharmaceuticals, run by a couple named the Whiteheads, is selling an implantable testosterone product for men. In 2010, Slate receives a warning from the FDA for making exaggerated claims about this drug.

The Whiteheads learn about flibanserin, sell Slate, and form Sprout to acquire it.

Sprout conducts 2 studies that fail to show an increase in sexual desire, change the outcome measure, keep getting rejected by the FDA, then create Even the Score to put political pressure on the FDA to approve flibanserin on the grounds that if they don't, they are guilty of gender bias.

On Tuesday, the FDA caves to this pressure and approves flibanserin, brand name Addyi.

And today, Valeant announces that it is acquiring Sprout for $1 billion cash plus a share of future profits:

Sprout is passionate about women's sexual health and has focused solely on the delivery of a treatment option for the unmet need of premenopausal women with acquired, generalized Hypoactive Sexual Desire Disorder (HSDD)

I'm sure Sprout is as passionate about women's sexual health as Slate was about men's sexual health.

Exactly as passionate.

They Caved

It's official. the FDA has approved Addyi, or Flibanserin, the drug purported to treat female Hypoactive Sexual Desire Disorder (HSDD). You can read about it in the NY Times:

FDA Approves Addyi, a Libido Pill for Women

You may recall from my previous post, Addyi, that flibanserin started life as an antidepressant, failed at that job, then tried to reinvent itself as a libido drug, with completely unclear mechanism of action. Its original developer, Boeringer Ingelheim, gave up on it and sold it to Sprout Pharmaceuticals. Sprout measured desire in its original studies of flibanserin via a diary entry. In the first trial, there was no difference between placebo and drug in the outcome measure. Neither was there in the second trial, but then Sprout tried to switch the outcome measure to a subset of questions on a response questionnaire, the Female Sexual Function Index (FSFI), which the FDA considered questionable due, in part, to a 28 day recall period. The FSFI questions were used as the outcome measure in a third trial, with small improvement in desire.

The FDA did not want to approve the drug, mainly because it doesn't work, and it also has significant interactions with alcohol, involving syncopal events. (Notably, these were seen in men, back when it was being tested as an antidepressant.) Flibanserin is a standing medication, not PRN like Viagra, so interactions with alcohol are unavoidable, short of complete abstinence.

But Sprout turned the approval process into a political issue, starting a group called, Even the Score, which claimed the FDA was unwilling to help women with their sexual problems. Sprout got a number of women's organizations involved, and the FDA agreed to a review by an advisory panel.

And now, they've approved it. This is what the FDA has to say about it:

Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring this REMS because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol. The REMS requires that prescribers be certified with the REMS program by enrolling and completing training. Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment with Addyi. Additionally, pharmacies must be certified with the REMS program by enrolling and completing training. Certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber. Additionally, pharmacists must counsel patients prior to dispensing not to drink alcohol during treatment with Addyi.

Addyi is also being approved with a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with Addyi, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment. Addyi is contraindicated in these patients. In addition, the FDA is requiring the company that owns Addyi to conduct three well-designed studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.

I'm very curious to see whether the FDA follows up on the "required" studies of risks of interactions with alcohol. I don't know what the consequences of non-compliance are, or how the FDA can enforce them.

This is really cynical of me, but I have significant reservations about a drug for women pursuing satisfying sexual interactions that makes them likely to pass out when they drink. Sounds like a new version of roofies.

On the upside, Sprout has agreed not to advertise Addyi on radio or television for 18 months, and to focus marketing on doctors, rather than consumers. Not that huge an upside. To that end, they plan to hire 200 sales reps, to cover 30,000 doctors, mainly OB/GYNs, but also some psychiatrists and primary care docs.

I tried to look up the Addyi REMS to see what's involved, but I couldn't find anything, maybe because Addyi won't be available for sale until October 17th. Personally, I'm not inclined to do the training.