Friday, October 26, 2012

The Silence of the Lamb Chops

Item: Beef Products, Inc. is suing ABC News and others for $1.2 billion for allegedly defaming their product, Lean Finely Textured Beef.  

"Say 'compensatory damages'
and I'll let you up. Say it!
“Boys! Break it up! Break it up, ya hear?!

“Land sakes, look at the both of you, fightin’ and scrappin’ like a couple of wild monkeys. You should be ashamed of yourselves!

Eldon Roth, what on Earth possessed you? You, the CEO of a successful beef supply company.”

“It’s not so successful anymore, is it, Eldon?”

“Quiet, Jamie Oliver. I’ll get to you in a minute. Eldon, what would your mamma say if she caught sight of you filing that $1.2 billion lawsuit against ABC News, Diane Sawyer, and what all? Why, she’d tan your hide, sure as I’m standing here.

“Young man, you can’t go running to the courts just because someone calls you names or bad mouth’s your company. Just ain’t right.”

“But Jamie called our beef products pink slime, and it’s just not true!”

“Is SO!!”

Is NOT!!”

“Hush up, the both of you!

“Jamie, you are in no position to be declaring what’s true and what ain’t. You know darn well Eldon’s company don’t use household cleaning products and washing machines to make that pink sl-- … er, that, uh, finely textured beef product. That was a flat-out fabrication, Jamie Oliver, and you know it.

"You say to-MAY-to, I say
to-MAH ... Wait, what?!
“And Eldon, you shouldn’t be trying to hush people up by draggin ‘em before a judge. The First Amendment allows all of us to speak our minds, even people who say dumb and hurtful things. Especially them people, come to think of it.

“The problem ain’t that some folk are telling made-up stories about your company. The problem is that you didn’t tell your own story your own self. You knew three years ago that some of the kids was saying mean things about Beef Products Incorporated, but you didn’t hardly lift a finger to set them right. You can’t let other people tell your story for you and expect everything’s gonna work itself out. You got a responsibility to tell your own story.

“Now, this whole mess has gotten clean outta hand. I want you two to shake hands and make up.

“Jamie, no more fibs outta you.”


“And Eldon, I appreciate how you feel. There was a whole bunch a dog-piling-on-the-rabbit and not much truthin'. But trying to silence people with lawsuits ain't right and it ain’t good for your reputation. It starts tongues a waggin’ and rekindles the untruths for Lord knows how long.

“Now you boys go on and skedaddle. You’re prolly late for supper.”

Wednesday, October 24, 2012

Compounding the Problem

Just a few more questions, Mr. Miller.

The tragic fungal meningitis outbreak that killed 23 people triggered numerous federal investigations, including a criminal investigation. While these may be among the most serious inquiries the compounding industry has had to endure, they are not the first.

Exactly one year ago today your organization, the International Academy of Compounding Pharmacists, sent a memo to its members offering advice on how to sidestep a Food and Drug Administration analysis of a compound drug that they suspected might be substandard.

The FDA was concerned that the drug—used to reduce the risk of premature birth, called 17P—might be made with unapproved Chinese ingredients, so they were calling compounding pharmacists and requesting samples of the drug to test. As CEO of the trade association representing compounding pharmacists, whose Code of Ethics is “designed to … advocate acceptance of a personal obligation to the highest ethical and professional standards of conduct,” wouldn’t it have made more sense to help rather than hinder the FDA in this matter?

 There was no evidence that any of the calls pharmacies received were coming from a genuine governmental official.”

But the title of the memo was “F.D.A. Calling Compounders about 17-P.”

Regulators do not ‘call around’ asking for information. They come to a pharmacy with an official inspection form.”

But I’m reading the actual memo—I can send you the link if you’d like—it says:

“On Friday afternoon, IACP found out that the Food and Drug Administration is calling compounding pharmacies and asking questions about 17-P. … In some instances, the FDA representative has asked for ‘samples’ or if you have any 17-P already compounded and on your shelves.  … It is absolutely critical that you manage these calls and conversations carefully.”

The memo goes on to offer “some suggested responses” to “some of the questions we know have been asked of compounders.” Here, let me read you a few of the recommendations.

Do you compound 17-P?
Yes, upon receipt of a valid prescription from a prescriber.

If we give you a prescription, can you compound 17-P for us to test?
Even if our pharmacy received a prescription from a prescriber licensed in our state, we would not consider it a valid prescription because it would not be for a specific, legitimate patient.

Do you have samples of 17-P?
A dose of reality: If you write it,
it will appear on the Internet.
We do not compound or distribute "samples" of any of our prescription medications to anyone.

Do you have pre-made 17-P available? We would like to pick some up and test it.
We do not maintain compounded 17-P in stock because our pharmacy prepares 17-P upon receipt of a prescription from a patient or prescriber. If we have any 17-P prepared currently, it is awaiting pick-up for one of our patients.

Weren’t you concerned that the memo makes it look like you are encouraging your members to stonewall the FDA inquiry?

“There is not one word in that document that says do not comply with a regulator.”

That may be technically accurate. But there aren’t many words encouraging your members to be helpful either.

One last question, Mr. Miller. Have you ever heard the expression, “If you don’t want it on the front page of The New York Times don’t put it in print”?

Friday, October 19, 2012

Hit “send” then “forehead”

Admit it. You cringed when you read about the soon-to-be-unemployed flack who fat fingered Google Inc.’s quarterly earnings report three hours early yesterday. You cringed because you’ve done it. We all have, although maybe not so spectacularly. 

RR Donnelley, the top SEC filing agent in the country and the alleged culprit in this caper, submits thousands of reports every year for their many clients. But this low-tech premature explication involved Google. And while we should have delighted in the delicious irony of a keyboard malfunction triggering a tummy-flipping $22 billion free fall for the tech giant, it just struck too close to home for us to really savor it. 
Artist's rendering of the
cliff that the flack was
thrown from after
hitting "send."

So if you want to avoid future embarrassment, just remember this one simple tip: When drafting a sensitive email—or any email for that matter—do not fill in the “To” line until you have edited and approved the final draft. This is particularly important when replying to emails with multiple recipients. 

When hitting “Reply,” simply cut the recipients from the “To” and the “Cc” lines, paste the names to the bottom of your email, and replace them when you’re ready to hit “Send.” Trust me. You’ll be glad you did.