Yes, the DEA still continues to keep cannabidiol (CBD) on the list of Schedule I drugs. I took this up in December of 2016 and the issues continue.
The new-ish bit, I suppose, is that the FDA approved GW Pharma’s cannabidiol product Epidiolex for Dravet Syndrome and Lennox-Gastaut Syndrome, which involve uncontrollable seizures. This all flows from the “Charlotte’s Web” phenomenon, which was desperate parents seeking help from a specific CBD-dominant strain of cannabis.
This meant that the DEA had to reschedule CBD as a compound with medical application. The reporting from CNBC says Schedule V:
Epidiolex will be classified as a schedule 5 controlled substance, the lowest level, defined as those with a proven medical use and low potential for abuse. Other drugs in this category include some cough medicines containing codeine.
But. However. Not so fast. Apparently the DEA has decided to re-schedule CBD ONLY in the context of FDA approved products. From the same report:
The rescheduling applies to CBD containing no more than 0.1 percent THC, in FDA-approved drug products. Though this allows GW Pharma to sell Epidiolex, it does not broadly apply to CBD.
emphasis added.
This is getting increasingly ridiculous. It is really, really, really clear that CBD does not have the fun recreational drug properties of good old delta-9-tetrahydrocannabinol. It is hard to find much effect of this compound at all*, despite all the quack remedy type products that are illegally on sale in the country at the moment.
I don’t understand how CBD got on the Schedule I list in the first place, nor why the DEA didn’t take this convenient opportunity to re-schedule it altogether.
__
*The anti-seizure properties seem solid.
N.b., As per my usual disclaimer, I may have held, hold, or be seeking to hold research funding involving CBD. Please read my comments with that in mind.
Fear of being pilloried for your past sexual misbehavior
September 21, 2018
This one is for the guys who are looking at the accusations against Trump’s latest nominee for the Supreme Court, Brett Kavanaugh. You dudes who are standard issue American heterosexual male-identifying people of at least minimal success with satisfying your sexual proclivities. You. You who are now worried that some incident in your past might have been perceived then, or eventually, as somewhat other than you perceived it by the target of your dubious affections.
Yes, you.
Please consider this is post in need of a Trigger Warning, it’s going to be about sexual assault.
Read the rest of this entry »
The R01 Doesn’t Even Pay for Revisions
September 11, 2018
Hard charging early career Glam neuroscientist Kay Tye had an interesting claim on the twitters recently.
The message she was replying to indicated that a recent request for manuscript revisions was going to amount to $1,000, making Kay’s costs anywhere from $100,000 to $10,000,000. Big range. Luckily she got more specific.
For manuscript revisions.
Let us recap.
The bog standard NIH “major award” is the R01, offered most generically in the 5-year, $250,000 direct cost per year version. $1,250,000 for a five year major (whoa, congrats dude, you got an R01! You have it made!) award.
Dr. Tye has just informed us that it is routine for reviewers to ask for manuscript (one. single. manuscript.) revisions that amount to $1,000,000 in cost.
Ex-NIGMS Director Jeremy Berg cheer-led (and possibly initiated) a series of NIH analyses and data dumps showing that something on the order of 7 (+/- 2) published papers were expected from each R01 award’s full interval of funding. This launched a thousand ships of opinionating on “efficiency” of NIH grant award and how it proves that one grant for everyone is the best use of NIH money. It isn’t.
I have frequently hit the productivity zone identified in NIGMS data…and had my competing revisions criticized severely for lack of productivity. I have tripled this on at least one interval of R01 funding and received essentially no extra kudos for good productivity. I would be highly curious to hear from anyone who has had a 5 year interval of R01 support described as even reasonably productive with one paper published.
Because even if Dr. Tye is describing a situation in which you barely invest in the original submission (doubtful), it has to be at least $250,000, right? That plus $1,000,000 in revisions and you end up with at best 1 paper per interval of R01 funding. And it takes you five years to do it.
The Office of Extramural Research showed that the vast majority of NIH-funded PIs hold 1 (>70%) or at most 2 (cumulative >90%) major awards at a time.
NIGMS (and some of my fellow NIH-watchers) have been exceptionally dishonest about interpreting the the efficiency data they produce and slippery as otters about resulting policy on per-PI dollar limitations. Nevertheless, one interpretation of their data is that $750,000 in direct costs per year is maximally efficient. Merely mentioning that an honest interpretation of their data ends up here (and reminding that the NIGMS policy for greybeard insiders was in fact to be about $750,000 per year) usually results in the the sound of sharpening stone on steel farm implements and the smell of burning pitch.
Even that level of grant largesse (“largesse”) does not pay for the single manuscript revisions that Professor Tye describes within a single year.
I have zero reason to doubt Professor Tye’s characterization, I will note. I am familiar with how Glam labs operate. I am familiar with the circle jerk of escalating high-cost “necessary” experimental demands they gratify each other with in manuscript review. I am familiar with the way extremely well funded labs use this bullshit as a gatekeeping function to eliminate the intellectual competition. I am perhaps overly familiar with Glam science labs in which postdocs blowing $40,000 on single fucked up experiments (because they don’t bother to think things through, are sloppy or are plain wasteful) is entirely routine.
The R01 does not pay for itself. It does not pay for the expected productivity necessary to look merely minimally productive, particularly when “high impact publications” are the standard.
But even that isn’t the point.
We have this exact same problem, albeit at less cost, all down the biomedical NIH-funded research ranks.
I have noted more than once on this blog that I experience a complete disconnect between what is demanded in peer review of manuscripts at a very pedestrian level of journal, the costs involved and the way R01s that pay for those experiments are perceived come time for competitive renewal. Actually, we can generalize this to any new grant as well, because very often grant reviewers are looking at the productivity on entirely unrelated awards to determine the PI’s fitness for the next proposal. There is a growing disconnect, I claim, between what is proposed in the average R01 these days and what it can actually pay to accomplish.
And this situation is being created by the exact same super-group of peers. The people who review my grants also review my papers. And each others’. And I review their grants and their manuscripts.
And we are being ridiculous.
We need to restore normalcy and decency in the conduct of this profession. We need to hold the NIH accountable for its fantasy policy that has reduced the spending capability of the normal average grant award to half of what it was a mere twenty years ago. And for policies that seek to limit productive labs so that we can have more and more funded labs who are crippled in what they can accomplish.
We need to hold each other accountable for fantasy thinking about how much science costs. R01 review should return to the days when “overambitious” meant something and was used to keep proposed scope of work minimally related to the necessary costs and the available funds. And we need to stop demanding an amount of work in each and every manuscript that is incompatible with the way the resulting productivity will be viewed in subsequent grant review.
We cannot do anything about the Glam folks, they are lost to all decency. But we can save the core of the NIH-funded biomedical research enterprise.
If you will only join me in a retreat from the abyss.
This is a highly stylized version of a communication I get in the blog email box now and again:
Dear DrugMonkey,
I love your blog, first time writer, long term reader, etc, etc.Some bastards have published a paper claiming utterly novel findings and have TOTALLY IGNORED our published paper! How can we make these assholes pay seriously for their crimes?
thanks,
Academic Scientist
…like I said, highly stylized. But it gets at the gist.
I get it.
As we all know, citations of our published papers are hella important for our careers, in the medium to longer term. And citations of our papers can have feed-forward consequences to engender even more citations. When you read a paper you tend to look at the papers it cites. If they are relevant to your work you tend to cite them in a subsequent paper. Maybe often. Maybe they become your go-to methodological or “foundational paper” citation. Do you always do an exhaustive search to make sure that you are citing the first observation*?
So when someone fails to cite you when they should** it costs you something. And particularly for people relatively early in their publishing careers, the cost seems very high. That’s because you have few papers and the insult affects a high percentage. The career implications before getting a permanent job, tenure or that first grant may seem to be extremely pointed.
I understand the anger.
I understand the desire to get your deserved credit.
I understand the desire to make those bastards pay for their crimes against you. Sort of.
But you need to sit back and think about what steps you can take, what is the likely upside and what is the likely downside for you.
The bottom line is that you cannot force people to cite you in academic work. You can’t force*** them to decide your work is most relevant or deserving of recognition in their own papers. You can’t.
The high water mark of direct action is going to be getting a Letter to Editor type of thing published. In which you say “waaah, they should have cited us” or “they claimed priority but we published some thing vaguely similar before“. Maybe, I guess, you might get an erratum or correction from the authors or the editors. If the field at large notices (and they mostly won’t) they just roll their eyes at the authors. Maybe, just maybe, it results in one or two extra citations of your prior work. Maybe.
Again, I feel you. My work has gone uncited numerous times when it should** have been. This has a material effect on my h-index. My h-index has, at times, come into play in a very direct way in the furtherance of my career and indeed my salary, benefits, retirement, etc. Citations are potentially that important.
I. Get. It.
I also understand that we all can spin this same sort of yarn. And in a lot of cases, someone else in our field can “prove” that we screwed them by not citing their papers when we should** have. It’s a normal and relatively impersonal situation in many cases. In the case of intentional bad actors, or people who feel compelled by career pressures to act badly, there is not much we can do about it.
Personally I try to take the medium road and the high road.
The medium road is the sort of semi-defensible record correcting you can take in your own papers. “As we first showed in…”. “Doe et al confirmed/replicated our prior finding…”. You can also do this any time you are presenting your work orally, from the platform or at poster sessions. In the latter, you just need to be careful about how much of this you do and how hard of a downbeat you put behind it. Don’t look like a whiny baby, is my advice.
The high road is to make sure to minimize citation offense in your own publications. Like it or not, we have a priority convention. So cite the first paper, eh? What could this possibly cost you? This leaves you plenty of room to cite 1) your own vaguely related work and 2) whatever are the best citations for the point, regardless of priority, JIF or other convention. The high road also suggests you should cite those folks who you feel have not cited you the way that you deserve. Try to take pleasure in your high-minded scholarly approach. It can be enough.
__
*the citation of pre-prints is going to be an extra fun issue with respect to proper priority citation
**”should”. Even the convention to cite the first paper to observe something relevant to your reason for citing is just an arbitrary convention.
***nope, not even in peer review. You can keep saying “reject” but that paper is eventually going to get in somewhere without citing you if the authors really don’t want to do so.
DrugMonkey 