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Friday, May 23, 2014

Blind Date With Vanda's Hetlioz

An American friend of mine sent me an email the other day. She told me how she had seen an ad aired on TV for a drug called Hetlioz (tasimelteon). Apparently, it's a pill to help those who suffer with Non-24-hour Disorder.

I admit I had to look this disorder up. My first thought was, Christ! They want to treat people who refuse to watch Kiefer Sutherland's character Jack Baur in FOX TV's 24?

Alas, I was wrong.

Non-24-hour Disorder, according to Hetiloz manufacturers, Vanda Pharmaceuticals, is...

... a chronic circadian rhythm disorder that occurs when individuals are unable to synchronize their endogenous circadian rhythm to the 24-hour day. Non-24 is most commonly found in blind individuals lacking the ability to perceive light, the primary environmental cue for synchronizing the circadian system daily. In general, individuals with Non-24 suffer from a variety of clinical symptoms as they cycle in-to and out-of phase resulting in disrupted nighttime sleep patterns and/or excessive daytime sleepiness.

Vanda had to convince the American drug regulator, the FDA, that their drug worked and was safe through a series of clinical trials. These trials have been slammed.

For instance...

  • The design of Vanda's primary phase III study changed numerous times, including a complete replacement of the primary endpoint just one month before study results were announced


  • The replacement primary endpoint installed to assess tasimelteon's benefit was created by Vanda and has never been used before in sleep-drug clinical trials, nor was it endorsed by the FDA.

  • Vanda was forced to cut in half the patient enrollment into the tasimelteon clinical trials because totally blind patients with non-24 could not be identified. Even then, Vanda was only able to enroll patients by stretching the clinical definition of non-24.

  • Tasimelteon was only able to demonstrate a benefit for non-24 patients by combining data from two phase III studies. Despite Vanda's claims to the contrary, the phase III studies may have actually failed on their own.


Despite all of the above, Hetiloz was approved by the FDA earlier this year.


Now there's a word.

Astroturfing is the practice of masking the sponsors of a message or organization (e.g. political, advertising, religious or public relations) to make it appear as though it originates from and is supported by grassroots participant(s). It is a practice intended to give the statements or organizations more credibility by withholding information about the source's financial connection.

Step forward The National Sleep Foundation.

Trawling through their website I learned that their Non-24-Hour Sleep Wake Disorder section is sponsored by Vanda Pharmaceuticals. I flicked the following email to Vanda...

Dear Sirs,
Many pharmaceutical companies are now suggesting that they are going to be more transparent in regard to clinical trials and sponsorship's etc.
I noticed that the sleep foundation have a section on their website that is sponsored by Vanda Pharmaceuticals.
As a matter of public interest could you tell me if this was a financial arrangement, if so, how much?

In typical Pharmafia fashion Vanda did not reply, opting instead to check me out [fig 1] - Click image to enlarge.

Fig 1

I posed pretty much the same question to the National Sleep Foundation via their Twitter page. [Fig 2]

They had the decency to answer me but didn't really answer the question I put to them.

Fig 2

Not related in any way to Vanda?

Here's the sponsored section on the Sleep Foundation's website [Fig 3] - Click on image to enlarge and read the bottom left of the image.

Fig 3

Alternatively, click here.

I pressed the Sleep Foundation for an answer - to date, they have failed to respond.

I dug a little deeper regarding Vanda's drug Hetiloz.

In July 2013 it was reported that Vanda Pharmaceuticals Inc. were facing at least one shareholder lawsuit surrounding late-stage trials for the company's sleep disorder drug Hetiloz.

In one class-action complaint, Small v. Vanda Pharmaceuticals Inc. et al., it's alleged that Vanda and its officers issued materially false or misleading statements about Tasimelteon’s efficacy and the results of its Phase III clinical trials. Specifically, it is alleged that Vanda changed the design of the  primary Phase III study several times, including a complete replacement of the primary endpoint  one month before results were announced, because the company was in possession of data suggesting that the original primary endpoint was not going to be met; used a replacement primary endpoint that had never been used before in sleep-drug clinical trials and was not endorsed by the FDA; enrolled patients in the Phase III trials by “stretching” the clinical definition of Non-24; and combined data from two Phase III studies in order to demonstrate a benefit for Non-24 patients, where the two Phase III studies failed individually.

The full complaint can be read here.

Amazing that the FDA went ahead and gave a licence to Hetlioz... then again, the FDA are basically an extension of the pharmaceutical industry.

Non-24-hour Disorder is a new one on me. As for the treatment of it, Hetiloz, experiments with rodents revealed fertility impairments, an increase in certain cancers, and serious adverse events during pregnancy at dosages in excess of what is considered the "human dose". [1] [2]

I can only presume that these warnings will be printed in braille for expectant blind mothers?

Then again since when have pharmaceutical companies protected their patients?

Bob Fiddaman 

Blind people need all the facts too


[2] Side Effects Drug Center: Hetlioz Warnings and Precautions". RxList. February 10, 2014. "In animal studies, administration of tasimelteon during pregnancy resulted in developmental toxicity (embryofetal mortality, neurobehavioral impairment, and decreased growth and development in offspring) at doses greater than those used clinically."

You can follow the National Sleep Foundation on Twitter here.


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