Whenever you read about some high profile drug company trial where the smoking gun is some incriminating email, do you shake your head and wonder, "How could they have written that in an email?" There are two ways for a drug company to protect itself from being nailed by these kinds of emails. The best is not to do things that if written anywhere would incriminate them. The other way is to teach your employees not to leave documentary evidence of your company's misdeeds. Guess which route the drug companies are taking?
Want to avoid those embarrassing internal emails containing concerns that an important product may be harmful, or documents that could attract the attention of an ambitious prosecutor?
The Medical Technology Learning Institute and Compliance-Alliance is offering: "Dangerous Documents: Avoiding Land Mines in Your FDA Records and Emails" -- a course tailor-made for the drug industry and medical device company executive anxious to cut down on pesky multimillion-dollar legal settlements.
Dangerous Documents offers such helpful tips as: Instead of writing, "We'll meet on Thursday to destroy the documents," it's better to say, "We'll meet on Thursday to implement our document retention policy." (Bill Berkrot, Reuters)
Sounds like a grand course. At least it cost a grand (well, $995) to take it, but you'll be learning from an expert, Nancy Singer, a former prosecutor who litigated on behalf of the FDA. Now she's working the other side, teaching the minions of Big Pharma "the latest thinking on what it takes to achieve and maintain compliance with FDA and CMS requirements." Or, if you don't, how not to get caught. From the syllabus:
- Who can be held criminally liable under the Federal Food, Drug and Cosmetic Act
- 18 words that will attract the attention of prosecutors or plaintiffs' lawyers
- 8 common practices that are sure to get you in trouble
- The dangers in not monitoring employee emails
Never use words like illegal or negligent when you can instead say, "It could be argued that that doesn't comply with requirements" or "perhaps we haven't been as careful as we should be," Singer said.
Don't ever say something is illegal or negligent. Even if it's true.
A common problem is what Singer calls the Cover Your Ass memo, where the employee writes a memo to the file as evidence they raised the issue. Possibly good for the employee. Bad for the company. Singer teaches the employee it won't protect them (I'm not sure this is true, but it's good for the companies that hire her). Engaging in questionable activity won't protect them either, nor will lying about it.
If caught. The whole point of this course seems to be, don't get caught. What a way to make a living.
My friend and colleague over at FluTrackers, AlaskaDenise, has just posted this http://www.flutrackers.com/forum/showthread.php?t=91118 and I would be interested in your take - I suspect you may have some thoughts on the subject.
There are moments like these when I really, really wish my employer approved of my speaking on their behalf without the prior approval of a team of lawyers, because on this particular point I am quite proud of them for being, apparently, way more ethical and decent than other Big Evil Pharmas. They do other nice stuff that I'm proud of too, our new Head Honcho is dumping a wagon-load of cash into drugs for Third World diseases and stuff, but on this documentation stuff, we are pretty darn good.
We have our own training and do not hire outside consultants for this purpose. No consultant could be better than our longtime in-house people who have experienced and survived many many audits, restructurings, lawsuits and filings. The mandatory classes on compliance paperwork and documentation start by answering Ms. Singer's question as follows:
"Who can be held criminally liable under the Federal Food, Drug and Cosmetic Act?"
YOU. Everyone who works here, down to the janitors. Everyone. The drugs we make go into people, including you and your family, so by FSM you better be good at all times and not just when Santa comes around. FDA regs say, even minor demons and souls in limbo at Evil Big Pharma are responsible for doing the right thing, and not merely right but also ethical.
"18 words that will attract the attention of prosecutors or plaintiffs' lawyers"
What, 'Senator Whatshisnuts was happy to receive our bribe campaign donation and looks forward to working with us soon'?
'Be sure to order the Iranian Sevruga and Veuve Clicquot, not the salmon and Brut we had Thursday'?
Our general rule is, if you don't want it on the front page of the NYT, don't say/do it. I mean, isn't context everything? If you're just looking for the keywords money, bad and dead, you can certainly write "we realize that the Phase I study had unexpected cardiac explosive decompressions, but we made sure to extirpate all instances in the final report by means of financial generosity." Who the hell can't use a thesaurus?
It'd take hours to deconstruct everything that is wrong with Ms. Singer's syllabus, but bloody hell. Our in-house course spends hours upon hours lecturing us about the importance of eating business lunches at Burger King because money doesn't grow on trees, sort of thing--imagine your Depression Era grandparents telling you to save string, that's how cheap they are when it comes to anything that might be vaguely thought of as an inappropriate bribe. And then we end with, "Here are two magnets to stick on your file cabinet/lab bench. One is the phone number for the Anonymous Ethics Hotline, where you can report any violations you see anonymously or ask any questions. The other is the Legal/Quality department hotline, where they will investigate any questions you may have about compliance. Call them if you ever have something you can't go to your boss about, especially if the problem is your boss." You sure as fuck aren't going to get an on-call legal staff, ethics hotline and quality bulldogs backing your ass up against an unethical prick who happens to be the VP's Assistant Shoe-Shiner when you take Ms. Singer's course.
Oh, and actually the CYA memo DOES work. I've seen it save folks from the debar list, actually.
Sorry about the double post, but this has been annoying me all day.
This is exactly the sort of "training" that gets small startups and academics seeking to enter/work with industry in big, big trouble.
See, the Mega Big Pharmas don't need this class. Like I said, we've all got our own in-house people who are awsum. We've done filings and our cGXP qualifications many, many times and we're damn good at it. When we need to expand, we've got full time employees who do nothing but scale-ups and site qualifications.
When a startup or an academic lab has finally gotten a drug through preclinical experiments, and is ready to put it into humans, they need to make a giant leap in $$$, facilities, staff, etc. and they are leaping into a world that grad schools and postdocs really do not prepare them for. They often hire consultants (such as Ms. Singer) or contractors to shepherd them through their growing pains. This is all well and good, as there are some excellent contractors who can help them in this regard: Lonza, Elan, Baxter, there are many more, and they are quite good at what they do. They will hold your little hand and explain things to you using quite small words. They will even let you set up an office in their place and hang out with them at lunch to pick their brains.
There are also a lot of asshats like Ms. Singer, who lead the small, unwitting startup executives and academics along the path of iniquity. I just met one at a conference a couple of months ago, actually, attempting to drum up business. The startup executives take these overpriced training seminars, without realizing that a seminar is not what they need. They think they've now got the keys to the kingdom, when in fact they haven't got so much as a coupon packet from the Welcome Wagon. No, what they NEED is a team of ferocious lawyers, blood dripping from their fangs, a bunch of Quality auditors who can make egomaniacal researchers widdle in their pants with a single glance, a hive-mind's worth of extremely patient and resilient engineers, and a clinical data contractor who does this sort of thing daily. A big pile of money helps, too.
Shorter version of Ms. Singer's seminar: When the FDA auditor asks how you're handling documents, you say, "We have (NuGenesis, Elan Software, VelQuest, etc.) electronic notebooking system, and the archives are all handled by Iron Mountain." The auditor says, "oh" and you move on to the next question on the pop quiz.
Seriously, I tell you this for free. Because I would hate for the small startups and academics of the world to be led astray by this sort of seminar thingy. There would be many more startups for my employer to purchase if all academics and small business executives understood that a seminar is not an appropriate solution for a growing business ready to enter the fun-filled world of cGXP medicine, science and engineering.