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Archive for the ‘Medical communications’ Category

The seasons change fitfully, the employment sagas churn [although, fortunately, the gods and sea monsters have not yet made appearances], and for each unplanned technology purchase there are several ancillary items which abruptly become needful.

I have told many a student not to change operating systems or software editions before a major project begins [much less, in media res], and not to let their skills get out of sync with workplace technology. Oh, and how the boots chafe when they are suddenly on your own feet!

From Snow Leopard to Mavericks in an afternoon was a bit of a shock, but doing the new Keynote on a new hand-held device was even more exciting.  Does it do new, useful, things?  Yes, but try and find a dongle at a conference when the default is still VGA or a USB remote?

Breathe, breathe, breathe.  These will be here, even if at the moment they’re under the snow (again).

Snowdrops-2014

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One of the upsides of freelancing is getting to learn new topics and have economic justification for researching all kinds of things.  But if a client fails to tell you where you should be, who you will be meeting, their area of interest, and what the dress code is, it’s hard to be ready to do your best work.

[sigh] Yes, yes, it builds character.  Onward!

Time for another phone call, methinks.

And, because I shouldn’t leave y’all without some eye candy, let’s see what’s in the cue….. Ah, yes — here’s a lovely Stewartia pic:

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…but I must say, their bandages have been very good to my wounded knees.  From raw weeping dermis to nice fresh pink skin in under two weeks.

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I wish I hadn’t had to get back on the train north; I wish I could have wandered the center of town for most of the evening, maybe stopping back at the conference hotels to catch up with other friends, or maybe taking the bus south to see Purlewe and company.

I love Philly in the evening....But what I got to do was lovely…

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Today, I’m working on some scripts, and as I start drafting the next one, I name the first character “Smith” as a placeholder.  I sternly tell myself I am not allowed to call the other character in the skit “Wesson”. Even if William would have loved it.

Cue music: “Just Give ’em Whiskey“, by Colourbox

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TubularArtCarOne of the things I tell students is that you can learn a lot about document requirements by back-engineering from failed documents or from situations where people run afoul of the law [or simply common sense: those endless “stupid” instructions about not taking a bath with your curling iron clearly indicate that some fool out there did exactly that, with Darwin-award-winnng results].

So, if you look at the FDA Enforcement summaries for 2008, you can learn a lot about what ridiculous things people try, and what you would need to do differently in order to land on the right side of the law. One outrageous example is as follows:

Internet Selling of Illicit Street Drug
__________________________________
On January 31, 2008, the FDA sent a Warning Letter to Ms. Jennifer Gulla of Laguna Niguel, California, for marketing the product “Blow” on her Website. “Blow” is marketed as an alternative to an illicit street drug and is intended to affect the structure or function of the body. “Blow” is well known street drug terminology for illicit cocaine, and the term may suggest that the product has effects on the body similar to cocaine.

The FDA had become aware of the proliferation of various products that were being manufactured, marketed, or distributed as alternatives to illicit street drugs. FDA is concerned that these products pose a potential threat to the public health. Some street drug alternatives are being marketed as dietary supplements. FDA does not believe that street drug alternatives are intended to be used to augment the diet, to promote health, or to reduce the risk of disease.

Accordingly, street drug alternatives do not qualify as dietary supplements. In March of 2000, FDA made available guidance for industry on street drug alternatives. This document contains additional information and is available at:
http://www.fda.gov/cder/guidance/3602fnl.htm.

FDA considers “Blow” a drug because it was intended to affect the structure or function of the body of man or other animals. Moreover, this product is a new drug because it was not generally recognized as safe and effective for its labeled uses. The sale of “Blow” without an approved application violates the law.

To view the full text of the Warning Letters:  http://www.fda.gov/foi/warning_letters/s6674c.htm

Source: FDA Enforcement Story for 2008, Chapter 3, pages 17-18

Now, as you may have noticed, we have a bonus hairpin turn in this example: the FDA says that faux street drugs cannot be sold as “dietary supplements”, but since they are being sold as something to affect the function of the human body, they are “drugs”, and therefore must undergo years of testing to demonstrate that they are

  1. A consistent chemical formulation
  2. Formulated in a safe, clean manufacturing environment
  3. Safe for humans to use in established doses
  4. Effective at doing what they claim to do

And, of course, if they _are_ effective, they will be banned as purposless intoxicants anyway, unless you happen to be a celebrity or anyone with more money than sense.  Whee!

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The new method, Mendelian randomization, “is changing the way we think about causality,” Dr. Lauer said.

[see here]

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