My husband asked me the other day, “What’s Non-24?”
“Never heard of it,” I answered. “Why?”
“Oh, I just heard a commercial on the radio. Whatever it is, I think there’s a drug for it now.” He knows I like to keep track of all the new drugs being marketed to an unsuspecting public.
Interesting, I thought. I know the pharmaceutical industry’s trick of developing a drug for a condition, re-labeling the condition as a disease, giving it a catchy name, and then kicking off an ad campaign to “increase public awareness” of this horrible (and now treatable!) disease.
That’s what happened with osteoporosis in the 80s. And dry eyes in the 90s. And overactive bladder, and enlarged prostate, and so on.
So I decided to investigate Non-24. What is it, and which pharmaceutical is behind the ads? (Hint: It’s Vanda Pharmaceuticals.)
Unless you’re blind, it’s very rare
In short, Non-24 (catchy name, isn’t it?) is a sleep disorder arising from low and out-of-whack levels of the hormone melatonin. It used to be called Circadian rhythm sleep disorder.
Melatonin production in the body is influenced by light levels during the day; typically, melatonin levels increase in the evening when light levels are low, and melatonin helps our bodies fall asleep.
Related post: Lights out for better sleep
Non-24 is a condition from which some blind people will suffer for the obvious reason that their brains do not perceive light. Sleeping too much during the day and not enough at night becomes a problem for them.
But in sighted individuals, Non-24 is rare.
Standard treatment to date has been the use of melatonin supplements.
Related post: Melatonin: Not a sleeping pill for children
But enter Vanda Pharmaceuticals with tasimelteon!
Tasimelteon, or brand name Hetlioz (hmm, not so catchy), is what’s called a melatonin receptor agonist. That is, it mimics the effect of melatonin in your body.
Does tasimelteon work?
Like many drugs, that depends on what’s being measured and in how many people and over how long a time period.
On January 31, the Food and Drug Administration announced its approval of tasimelteon for treatment of Non-24.
Approval was based on results of 2 trials: . . . a 26-week study that included 84 patients, . . . and a 19-week trial that included 20 patients . . .
Really? Market approval based on 104 patients over 6 months?
And what were they testing for exactly? Patients experiencing a better night’s sleep, or less daytime drowsiness? No, something called “entrainment” or re-setting of circadian rhythm, measured by melatonin byproducts in the urine.
A market analyst skeptical of Vanda’s claims makes several good points in an article cautioning investors in the pharmaceutical (VNDA on NASDAQ):
- Not enough blind patients could be diagnosed with Non-24 to participate in the trials until Vanda “stretched” the clinical definition.
- Originally Vanda set out to prove that tasimelteon improved patients’ night-time sleep habits and improved daytime wakefulness, but when they realized the study “was likely to fail” they switched to proving “entrainment,” something they pretty much made up.
- Dr. Stephen Lockley, the Harvard sleep expert overseeing the studies, receives grant support from Vanda Pharmaceuticals.
Still the FDA has approved it, so now Vanda can sell it.
The marketing tricks
The informational website for Non-24 is classic pharmaceutical advertising.
It’s not about selling a drug—at least not directly. It’s about helping you understand what Non-24 is and why you might suffer from it. The site helpfully (and slyly) provides a sidebar of symptoms to aid self diagnosis:
- Not being able to sleep when you want
- Excessive sleepiness during the day
- Daytime napping or dozing off during the day
- Periods of poor sleep quality at night
- Sleeping through the night, but not waking up feeling alert and refreshed
- Problems with focus and concentration; trouble with memory
- Difficulty with daily tasks
- Feeling irritable
Oh my God, I’ve got Non-24!!
If you are “experiencing any of these symptoms,” you are invited to fill out your name and address and “give permission” for Vanda to send you “information about Non-24 and about medicines that treat Non-24.”
As an added incentive, when you sign up, Vanda will make a $24 donation to the “blindness community.”
Sign up to keep up with the latest Non-24 information and a great chance to support the blindness community at the same time.
There is also a “health educator” available to help you over the phone 24/7.
Perhaps Hetlioz will help some patients, hopefully with few side effects.
What I don’t like is when these drugs are marketed to more and more people in an attempt to make more money. On its website and in its radio commercial, Vanda is clearly trying to sell Non-24 and its treatment to sighted people with common sleep issues.
These drugs take a lot of time and money to bring to market. In a statement, Vanda said “research and development costs nearly tripled to $12.2 million from $4.3 million as it studied tasimelteon as a treatment for sleep disorders in people who are blind.” Now they need to recoup those costs and turn a profit.
Related story: Two Diseases Big Pharma Hopes You Get in 2014
Although Hetlioz was just approved by the FDA, it will not be available in pharmacies until this spring. I haven’t been able to discover how much treatment will cost.
But I’m sure it will be significant. Most new drugs run about $8-10 per tablet, and I don’t expect Hetlioz to be any different. According to WebMD’s drug information page, Hetlioz should be taken once a day at bedtime. Also, “It may take up to several months before you get the full benefit of this drug.” Hmm, that sounds expensive.
*Update 5/18/14* Hetlioz is now available and the price is pretty shocking. Almost $8,000 for 30 tablets! And I thought $10 per tab was expensive.
If Vanda follows a typical progression of marketing a new drug, and so far it has, expect them to offer financial assistance and coupons to those newly diagnosed with Non-24.
Up to now, Non-24 has been considered by the medical community to be rare in sighted individuals, and affecting only a small percentage of the blind. And yet Vanda seems to think it worthwhile to pay for radio advertising.
Wanna bet there will soon be many more people than ever before diagnosed with Non-24?
How about you? How have you been sleeping lately?