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.

Sunday, March 1, 2015

Father Disappoints Again

Here's a link to an article from a couple days ago in the NYTimes, about Vyvanse for Binge Eating Disorder (BED).

The article claims that Shire promoted awareness of the "relatively rare" Binge Eating Disorder, including giving $100K to the Binge Eating Disorder Association last year, before finally marketing Vyvanse to treat the disorder.

It also claims the FDA should have been more cautious about approving a drug with a high potential for abuse.

In addition, it points to the fact that, "Shire appeared to be following a familiar drug industry playbook by promoting awareness of a disorder, in this case binge eating, before more directly marketing its treatment. A company website, BingeEatingDisorder.com, makes no mention of Vyvanse but provides detailed information about how to talk about the disorder with a doctor, including a printable symptom checklist and sample opening lines to start the conversation. The site also tells patients “don’t give up” if a doctor initially resists."

Here are the recommendations for speaking to ones doctor about BED:

So here are some of my thoughts:

Shire is sleazy. It already paid $56.5 million to settle federal charges for improperly promoting drugs. And $56.5 million is nothing to a drug company.

The NYTimes is sensationalist, and conveniently points a finger at the FDA. Seriously, Vyvanse was already FDA approved for ADHD, so it didn't suddenly become unsafe, or more prone to abuse than it already was.

The first labeling change was on January 30th. It looks like this:

The label from November of 2014 only includes an indication for ADHD. Also note, Vyvanse is only approved for Moderate to Severe BED, and NOT indicated for weight loss. There's also a warning about abuse:

It bothers me that the Times is intent on pointing to the FDA. The FDA has a job to do, and sometimes it screws up, but I think we often attribute almost magical powers to it. Stepping away from the fact that the F stands for "food", and that it's a pretty big responsibility to oversee all the drugs AND foodstuffs in the country, so of course there are going to be mistakes, and stepping away from the fact that any large organization is going to have some graft, the FDA's job is just its job. Companies that want a drug approved have to submit applications, run studies, prove safety, and prove efficacy against placebo, but that's it. Sure, there is a fast track program that was legislated into effect by the ACT UP movement, and it's sometimes abused, but it exists for a good reason.

I'm not trying to defend the FDA. I just don't think it needs to be defended. It's not its job to determine the morality of a drug with potential for abuse, and it's not its job to determine the validity of a diagnosis. And it's not its job to make decisions for physicians about their prescribing practices, or for patients about how and whether they abuse their medications.

We never really lose the wish for an omnipotent parent who will have the wisdom and ability to protect us from harm, both from without and within. And we continue to be disappointed when we don't find that parent where we expect to.


  1. This is a consistent pattern for the FDA, not an isolated screw up. This happens with both stimulants and opioids. In the case of Vyvanse, I am not aware of them disclosing what the vote of their scientific committee was, but in the case of opioids (Zohydro) the scientific committee voted overwhelmingly against releasing a high dose hydrocodone derivative during an opioid epidemic and it was approved anyway. Despite the political rhetoric about barriers to approving and marketing drugs there appears to be little resistance on the part of the FDA as far as I can tell. They certainly are not manipulated by pharmaceutical companies when the regulators ignore the results of their own scientific advisors. I could also find only one study on this application of Vyvanse.




    1. They do screw up. I happen to think a lot of the problems with the FDA are legislative, or perhaps judicial. For example, there need to be consequences for companies that don't do follow-up studies on drugs that were fast-tracked. And by consequences I mean large sums of money.