Sent via USPS Express Mail
/13; Resent Electronically 1/17/13
Drug Enforcement Administration
Attn: DEA Federal Register Representative/ OD
8701 Morrissette Drive
Springfield, VA 22152
Re: Docket No. DEA
Schedules of Controlled Substances:
ent of Lorcaserin Into Schedule IV
January 14, 2013
Dear Sir or Madam:
On December 19, 2012, the Drug Enforcement Agency (DEA) published a notice of
proposed rulemaking regarding the placement of lorcaserin into Schedule IV (C
IV) of the
stances Act (CSA). As you are aware, lorcaserin is a novel serotonin 2C
receptor agonist, which was recently approved by the Food and Drug Administration (FDA)
at a dosage of 10 mg, twice per day (BID), as an adjunct to a reduced calorie diet and
d physical activity for chronic weight management in obese (BMI 30 or greater)
and overweight (BMI 27 or greater) adults, in the presence of at least one weight
comorbid condition, (e.g., hypertension, dyslipidemia, type 2 diabetes). Eisai, Inc. p
market lorcaserin under the trade name, Belviq, upon the effective date following the DEA’s
publication of its final ruling, which is generally not less than 30 days from its date of
publication in the Federal Register (under Federal Regulations, T
itle 21, Section 1308.45
entitled “Final Order”). However, Eisai, Inc. requested special consideration from the DEA
(in a letter written by Mark J. Taisey, and dated December 19, 2012
allow the effective date to be the same date that the
final rule is published.
I am a licensed, actively practicing physician
in the United States
writing to express
my strong support for the scheduling of lorcaserin as a controlled substance.
However, I am concerned with the DEA’s proposed Schedule IV des
ignation for this
medication and feel strongly that, prior to making a final ruling, the DEA should give
further consideration that lorcaserin might instead be more appropriately placed
into a more string
one quick point. the anonymous letter is headed
Sent via USPS Express Mail
1/14/13; Resent Electronically 1/17
not totally sure but i do not think DEA accepts written submissions, just direct e-postings to the FR page. so i think the #### re USPS mail is intended to create the illusion that a signed copy was formally submitted, when it is actually only an anonymous posting. now, why would anyone do that...
Something has been bugging me about this particular letter, and its Anonymous poster. I first commented on it on about Jan 18, the day after it came out. And then a poster named 'Jason' tried to persuade me that it was signed after all, and was a legitimate post from a physician. I can't find his post, but my reply is below. The question is this: Is 'Jason' a known VVUS long, and was that letter written by people from the VVUS board. Of note is that it was electronically posted on the FR page about a day or so after AF's taunting article drew attention to that page.
DEA Comments board (update)
by iago4466 •Jan 18, 2013 3:47 PM
iago4466 • Jan 18, 2013 11:12 PM
Jason, I agree it's possible that the post was signed but the name is not accessible. It's also possible it was from a real physician. But I have serious doubts. I would have to read it again very carefully, and alongside the Mannsbach letter, to be sure, but I think the one begat the other. Frankly, at this point I can't be bothered to spend the time... I had thought the Mannsbach letter was objective scientific evidence when I first read it, but now that Rckings has pointed out Mannsbach's links to VVUS, I doubt even that letter was written without an agenda.
I like the way he tries to make the case of a more strngent scheduling for Belviq because of 90 million obese could abuse it but then again 90 million obese isn't an urgent unmet medical need enough to waive the 30 day waiting period.
Kind of a oxymauron isn't it?
Yes, I read it at the time it was posted. It's one of the better written derivatives of the Mansbach letter, in the sense that it draws heavily (but not exclusively) on that source. It also contains other "attack information" and "alarm bells" designed to raise red flags at the DEA. Of note is, that unlike the Mansbach letter, it's unsigned. And I do not believe the claim that it comes from an objective licensed physician concerned about public safety. One reason I don't believe that is that the comment tries too hard to be too destructive in too many ways. In other words, the writer over eggs the pudding. The most obvious "tell" for the writer's real agenda is the demand that the Eisai request for the final 30-day waiver be turned down, again to protect the public. Yeah, sure, that would be right on the radar screen of a genuine physician... They are really concerned about the niceties of administrative law, aren't they? Again, the comment is too "obvious" to be anything other than what it is - an attack letter put together by someone with a stake in delaying the marketing of Belviq. How seriously would DEA take the comment? Well, perhaps on a par with the Mansbach's, although a savvy reviewer would see the agenda pretty quickly (it's far more disguised in the much subtler Mansbach letter). As to the contents, I would want to see what Dr Daniel thought as his expertise in this area of science is greater than mine.
I'll say again, the reason for the DEA delay is the cumulative effect of the comments, and the controversy created. The many attack comments posted in the few days after AF's counter-strike on the ARNA longs' spam are less sophisticated than Mansbach's and this one. But they increase the perception of a controversy and, legally, need to be scrutinized and responded to. For letters like this and Mannsbach's, the work involved is substantial. For the spam, less so. But the ARNA longs' spam was unnecessary and a mistake, as it triggered the counterstrike.
Iago, thanks for the input. I have read many of your post and I think you are correct about this whole debacle (for sanity purposes, lets don’t go there). Do you think the person/persons reviewing the schedule have as much insight as you do? I sure as hell hope so. I have also, in the past, seen drugs that a required a restricted label following DEA (ARIA comes to mind). Do you see any chance of this, no matter how small? I am beginning to wonder in all honesty. I might be coming off a bit naïve or incorrect on my terminology, I am somewhat new to the biopharma arena. Thanks for any input you might have.
I am not concerned about the spam so much as it is easily identified. I am more concerned about letters such as the one stated above as well as the Mansbach letter, which are well written, fairly well documented and referenced, with an almost unreasonable but deliberate attention to detail. Of course, detail of which the DEA must respond to. For a government pencil pusher, I am certain they are absolutely overwhelmed at the complexity of such comments and are looking to defer their response to each and every point to a more qualified, more senior adviser. As an investor this has been an incredibly frustrating experience no doubt. I understand now the increase in short position, the request by my broker to lend out my shares just prior to the drop from $8.65. It has been a well orchestrated attack. To recover back to $11 would require a 45% gain roughly.