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.
- 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...
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.