Vanda

I thought my meeting was the only one where ethics and compliance were thrown away
But obviously this was pretty common. Vanda is just too greedy to understand what they do will result in fines that will cripple them. Sad.

 

It looks like Vanda has not changed at all. I'm so glad I got out. It is embarrassing to admit I ever worked there

 

80 percent of representatives have 3 or less intakes but are being measured against the slime that will destroy the company with their 30-80 intakes. Triage rates are low for these but that doesn't matter. Some got lucky with a doc that loves the med but the rest are just selling it as a sleep aid for bipolar or depressed patients, label be damned.

 

Compliance would have had a field day witnessing what came out of the mouths of regional and national management at meetings. Or maybe not, compliance reports to CEO and he does not seem to care about doing anything other than making money.

 

Vanda Pharmaceuticals requested FDA approval of its melatonin receptor agonist, tasimelteon (Hetlioz), as an orphan drug to treat non-24-hour sleep–wake disorder (non-24). To qualify as an orphan drug, a medication must target a rare medical condition.

Non-24 is a circadian rhythm disorder that occurs almost exclusively in patients who are completely blind without light perception. The FDA’s initial approval letter correctly stated that Hetlioz was indicated for this population, and the agency also issued a press release stating the same.

When the FDA approved Hetlioz, however, it did not specify in the product indication that the drug was solely for use in blind patients. According to consumer watchdog Public Citizen, at least 26 FDA review documents signed by 42 agency officials prior to Hetlioz 's approval explicitly stated that Vanda Pharmaceuticals was seeking approval for use in totally blind patients.

The FDA’s blunder opened the door for the drug's use in a wide range of sleep disorders in patients who are not blind. Pharmacy benefit managers and insurance companies cannot limit the use of this drug to blind patients, as these requests will be overturned. Overturned denials lead to poor member satisfaction and a lower Star rating from the US Centers for Medicare & Medicaid Services, which can result in the loss of a Medicare contract.

After discovering its error, the FDA did not ask Vanda to change Hetlioz's indication. Instead, the agency issued a second approval letter acknowledging an error in the drug's original “indications for use” section.

In a petition, Public Citizen has requested that the FDA correct the labeling by adding “in blind patients without light perception” to the indication. The Hetlioz prescribing information is still incorrect as of the publishing of this article.

-- So a clerical error (wink, wink) at the FDA set this whole thing in motion? And no Tom, we don't know how many sighted patients exist. But that's not the question; the question is how much supporting evidence can a rep show a prescriber when identifying an appropriate patient? Or is that not my job anymore? My job seems to be to create LESS certainty and evidence-based clinical decisions, not MORE. If you and the other decision-makers are so sure of the Hetlioz strategy, then send me something in writing saying,"no more Orphan Drug, Rare Disese, or Blind patient conversations with prescribers".

Vanda petitioned and received "Orphan Designation" from the FDA based on exclusively the blind population prevalence rates. Vanda submitted clinical trial information with the NDA based exclusively on blind patient trial results. Everything discussed between Vanda and the FDA leading up to the approval of Hetlioz was exclusively in the blind patient. Vanda even went so far as to request braille on the bottle because Vanda knew this was the patient who'd be prescribed Hetlioz. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=205677

So basically, we're being asked to market a serious medication with no supporting clinical information, no review by the FDA for this population, using specialty pharmacy distribution (which we do not need to be doing) at $160,000/year, WITHOUT consent by the legal entity established to verify the safety and efficacy of the proposed treatment. Right?

I'll need that in writing.

 

My whole team was Hetlioz recertified at meeting. To pass, we had to toss fair balance and indications and pride out. It was so wrong and off label and completely encouraged and endorsed by leadership.

 

TG played bully and job threatened reps with low intakes at our meeting. He showed no class. He doesn't remember that Hetlioz training clearly said "Although the majority of individuals with Non24 are blind, RARE cases have been described in sighted individuals, although the actual incidence is UNKNOWN.". Just because 5 or 6 reps have an unexplainable number of intakes ( and very low triage rates), doesn't mean that reps with low numbers are doing anything wrong other than selling on label. Non 24 is RARE in sighted individuals, remember?

 

Just be sure to document everything. Even if it is just spoken. Make a note with participants, date, location, time. Keep your field contact reports and make notes of any discrepancies between what is said vs written. Keep printed copies of emails, handouts etc. If handout, write a note of who, when and where it was provided. This way, the company, not you will be held accountable.

 

I haven't been called out as I got lucky with several early intakes. But now the well is dry. Unless I drop my call list and fanapt writers and add new offices, where will I get an intake every 2 weeks? I don't want to play Management's game of selling Hetlioz as a sleep aid for depressed patients with insomnia.

 

I don't know anyone NOT doing this. Especially older reps since MGMT obviously want to push out experience and replace with med school wannabe rejects.

 

Tasimelteon (20 mg/day) is proposed for the treatment of Non-24-Hour Disorder in blind individuals with no light perception, a circadian rhythm disorder that occurs when individuals are unable to entrain (synchronize) their endogenous master body clock to the 24-hour day-night cycle. Tasimelteon was granted an orphan drug designation for this indication. Tasimelteon was previously investigated for other indications (insomnia, Circadian Rhythm Sleep Disorders, and Jet Lag Disorder due to eastward travel).

This paragraph comes from a November 26, 2013 memo from The FDA. Reference 3413692. Link below....

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000OtherR.pdf


The following link is from the FDA website listing orphan drugs and their approval dates. Note the date and indication.

https://www.accessdata.fda.gov/scripts/opdlisting/oopd/listResult.cfm

 

Kelly and Charles ran away fast when they saw mihales setting the building on fire. Mihales and GP and Tom the gym teacher will get what is coming for torching account manager bonus's right before Christmas.

 

Wow. I didn't know Vanda had a cafe pharma thread until tonight and I only was told to check this out by 3 other reps. I should've read this back in February when interviewing. Thanks for saying what we all- most of us- every day. The fanapt promotion was always suspect but this Hetlioz bullying never seemed to make sense after training and our script says it is rare and we were asked to get ONE intake before Jan 1.

 

Which regional, altho sounds like they all did it.

 

JH but heard it was Nationwide, but east was most out of compliance

 

She is just a fish out of water and can't compete with the years of sliminess of Russell and Chris and Tom. But she showed her ability to blow off ethics at her meetings and compliance be damned. Too bad people need jobs as Master Poly will have any one complaining fired if they complain

 

Russell. He is scarred of Tom. Definitely Russell, he was so creepy at our mtg

 

Burn in hell Scott. You bragged about selling Hetlioz off label and now you are the king of Hetlioz. If it just happened accidentally, then we are ok with you. But it's not, you greedy Dr poly jr

 

this thread was hard to find, vanda needs own board