Blessings

City Bakery Melted Chocolate Cookie-Part Cookie, Part Chocolate Bar

I've gone back and forth on whether to write about the termination of my analysis, after the fact. I did write about it in Termination, before it happened. Somehow, this is harder.

So, my analysis ended. The last session was difficult and confusing, and probably will remain confusing for a long time.

First, there was the cookie saga. I decided to get my analyst a parting gift, and since it's impossible to encompass the entirety of an analysis in one object, I decided on cookies. I wanted a specific kind of cookie from a specific bakery (the melted chocolate cookie from City Bakery), but then I wasn't sure I'd be able to get that kind of cookie, so I baked my world-famous-awesome brownies (see This Post for the recipe), but then I felt uncomfortable giving her something I baked myself so I went back to the original cookie idea. And all of this got experienced, acted out, and narrated in the last few days of my analysis.

Another thing I did in the last few sessions was talk about all the things that made me uncomfortable about the process of terminating. Like which words my analyst would choose to end the last session, and how I felt about the intimacy of shaking her hand when I left.

Yet another thing I did, as a larger gesture, was make a blessing. Having been raised as an Orthodox Jew, many, if not all of my fundamental references are Judaic. And one thing observant Jews do is make blessings, which follow the specific formula of, "Blessed are you, lord our God, king of the universe, who is/does something." The italics are the part that varies.

There are blessings for all kinds of things, from rainbows to acknowledging scholarship to thunder to hearing bad news. There is a blessing for every type of food, categorized in very specific ways, of course, but pretty much everything is covered: bread, wine, potato chips, strawberries, and yes, cookies. And even though I'm not as observant as I was growing up, I still make blessings over food. It's a way of reminding myself that I am privileged enough to have food.

In the last few weeks of my analysis, I tried to think of a suitable blessing to make over termination. It was tough. One idea I had was the blessing parents make when a child becomes a Bar or Bat Mitzvah, which goes something like, "Blessed are you....who has removed this one's punishment from me." It sounds awful in translation, but simply means that the child has attained an age at which one begins to take responsibility for ones own actions. That has something of the right idea for a termination, but I told my analyst it seemed more suitable for her to say about me, than for me to say about her.

A friend suggested a blessing about healing a broken heart, which was pretty good, but not quite right.

In the end, I invented my own blessing. It's based on the prayer that's said at funerals and other types of memorial events, such as a Yahrzeit (anniversary of a death), which seemed suitable, since termination has an element of death to it. The end of the prayer translates to something like, "...May he rest in his resting place in peace..."

The Hebrew word that's translated as "resting place" is Mishkav, which literally means, lying-down place. Like a couch. So I used the same word but tweaked it a little to, "Blessed are you, lord our God, king of the universe, who raises (me) up from the couch in peace."

For me, it captures the idea that I leave not "cured", but in more peace than I was in when I started.

So the last session went something like this:

I came in and handed my analyst a bag with the gift. She laughed and asked if these were the brownies or the cookies. I told her they were the cookies, but then I felt bad. Maybe she really wanted to try my world-famous-awesome brownies, and I could have brought both those and the cookies. Oh well. There went that opportunity.

I felt like I should say something momentous that encapsulated the entirety of my analytic experience, but all I could think to say was that my analyst had been very kind. I felt like she should say something broad to summarize our work together, but she just said she'd enjoyed working with me. She also said the door is always open, should I wish to return. I felt like that was decent of her, but it made me wonder if she thought I might not be able to manage on my own.

In the middle of the session, I silently made my blessing, then told her I had made it.

All the old doubts were right there. Have I done enough? Can I manage on my own? Does she like me? Can I share the things I'm inclined to keep to myself? Is she disappointed that I didn't bring her brownies? Can I tolerate the pain of this separation?

It was like a miniature version of my whole analysis, reliving all these feelings that I had grappled with over the years, and made some kind of peace with, only to re-experience them right at the end.

There was a lot more laughing than I had expected, on both our parts. I felt like my preemptively bringing up my discomfort with her final wording, or with shaking her hand, had lessened the pain of those experiences, but also lessened their power. They became more awkward than sad, and I wondered if she was feeling sad too, but was uncomfortable showing it, or felt it was inappropriate to let me see her feeling that way, and maybe the laughter was more nervous than fun. I was disappointed that she wasn't obviously sad. I might have been more disappointed if she had been.

In the end, she said, "We do have to stop." And she laughed. I smiled. I got up, walked to the door, and we shook hands with a quiet, nervous laughter. And then I left.

It wasn't our best session. It wasn't our worst session, either. It was just one of many sessions. I'm grateful for my whole analysis, and I'm also glad, and sad it ended.

So, cookies for closure, discussion for honesty, and a blessing for peace.

Amen.

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.

You Don't Say

There's a fascinating article in The Atlantic, The Coddling of the American Mind, that has been blogged about and tweeted by Dinah at Shrink Rap. The gist of it is that on college campuses, students and faculty who say things that are offensive are castigated and accused of microaggressions. Offensive comments include, "Where are you from?" if asked of someone Asian, and, "I believe the most qualified person should get the job.” One Harvard law professor was asked not to use the word, "violate", and others were asked not to teach rape law. Professors are supposed to issue trigger warnings for content that might be offensive or upsetting to someone.  

The article uses the phrase vindictive protectiveness to describe the phenomenon of shielding students from anything that might be upsetting. It then goes on to promote the use of CBT to prevent phobic avoidance and encourage mental health.

I'm not so hot on that last part.  To me the issue seems less about phobic avoidance than about the notion that students can only function under ideal conditions, and that everyone's ideal condition needs to be accommodated- a kind of emotional Ponzi scheme.

You can check out the article if you're interested, as well as Dinah's post, which gives a lot more detail than I do. But the reason I'm bringing it up is that it's such a stark contrast to another recent article in the NY Times, FDA's 'Off Label' Drug Policy Leads to Free-Speech Fight. 

The FDA currently has a policy that prevents drug Manufacturers from promoting a drug for off-label use, even if the content of the promotion is true, but this policy is being challenged under first amendment rights.


Amarin Pharma, a small drug manufacturer, challenged the F.D.A. when it sought to promote the off-label use of its cardiovascular health drug, Vascepa, for patients with a different condition. An F.D.A.-approved study showed that the use of the drug was effective, but the agency had denied approval for use by those patients.

The company and four doctors sued the F.D.A. after it threatened to bring civil charges against them if they used the study to help sell off-label use of Vascepa. They claim that the agency's rule on off-label promotion violates their First Amendment right to free speech...


Judge Paul A. Engelmayer of the Federal District Court in Manhattan found in favor of Amarin. This is tricky. It may well violate someone's freedom of speech to prevent them from stating something true, or that they believe to be true, without intent to defraud. But if a drug rep believes the conclusions of the article he enthusiastically shows to the doctor, that doesn't make those conclusions true. The FDA's policy may exist to prevent drug companies from bypassing the approval process for a new use by producing manipulated, shoddy, not to mention cheap research that they can call "true".

But think about it. On college campuses, the supposed bastions of creative ideas and innovative thought, censorship of speech is rampant. But pharmaceutical companies can say anything they want about their products, as long as they can generate the statistics to support their statements. That can't be the intention of the first amendment.