Grassley, Drugmakers And Whistleblower Protection

Rules of Pharma whistleblowing:

1) Don't tell ANYONE what you are doing & that includes family, friends, coworkers...

2) NEVER reveal your identity no matter what the company says.

3) Only submit evidence that could possibly come from multiple people, not just you.

4) NEVER use company computers to report whistleblowing.

5) Backup evidence offsite in digital and hard copy.

6) Be specific as possible. Names, dates, time etc.

7) Sign up for anonymous email and web browsing so that nothing can be traced back to you.

Good stuff, Ed -- I see Merck made the poison pen letter list. Heh.

In February 2008, Old Merck signed what amounted to a felony plea agreement, but called it a "corporate integrity agreement", in which it agreed to -- among other things -- enhance its protections for whistleblower employees, and improve its processes for investigating and reporting potential violations of federal False Claims Act, among other laws. Here is the background on that.

One irony resulting from the woeful February 2008 chapter is that Merck will now be in a pretty good position to explain to Senator Grassley all the "enhanced procedures" it has in place -- and likely thus avoid the considerable ire of at least this one Iowa Republican.

This morning, I openly wondered whether Merck would explain -- with precision -- to Sen. Grassley's staff, WHY it is NOW so close to the "state of the art" on FCA compliance measures. That will be interesting, and worth looking out for.

Namaste

P.S.: I think the advice of "Anonymous" is solid above -- but the rubber always meets the road when it is time to collect the bounty.

Actually, it all comes out a long while before then, when -- as is typical -- the company forces the whole process into a posture that requires filing suit, or an administrative proceeding -- and then (if one is lucky) the U.S. Attorneys' office will offer to do what it can to help protect identities, but cannot promise to do so, indefinitely. Eventually, under our system, even a company has the right to face its accuser. And so, eventually, the whistler's identity outs. Just FYI.

Wonder what Pfizer will say to Chuck about Peter Rost?

I'm intrigued by the idea that some whistleblowers do it "only for the money." First, how would anyone know? And second, if someone is risking career suicide, what's wrong with getting rewarded for it? Finally, does it really matter why someone reports a wrongdoing? The idea that anyone would have to explain, let along justify, such a thing strikes me as very screwy.

Chuck should look under the rocks at the old Schering-Plough as well as the old Pharmacia. There is a pattern here. Go get 'em.

If these companies were not concerned about illegal activity being reported by whistleblowers, things would be much worse than they are.

Whistleblowers deserve every penny they get - the patient life they save may be yours or a family member's.

Senator Grassley is to be congradulated for keeping these corporations on notice that they are being monitored for how they treat whistleblowers.

Chuck rules! Go get 'em!!

I hate to play spoiler here, but every company on that list already has a 'compliance program' in place.

No doubt that all are prepared to send the senator exactly what he wants to see. And I can tell you from experience that these co.s are pros at putting on aires.

They can say what they want and produce all the documentation they can, but it isn't worth the paper it's printed on.

Anybody, and I mean everybody, who is in this position should do one thing and one thing only, call a WB Attorney. They will let you know where you stand. Your company will stand on YOU till you quit or create reasons to let you go.

So please forgive me if I don't get all giddy at the honest senator's intentions. It's just I know these guys, they will tell you what you want to hear, but behind closed doors, well that's an entirely different story.

If I were the senator, I would ask the people on the front lines, the wb's themselves. I bet you would get to the truth then. He is asking great questions, just allowing the wrong people to answer...

Shytown is dead on. Asking Pharma CEOs about whistleblower protection is like asking the SS about fair treatment under the Third Reich.

Of course the companies will spin their response back to the senator. But that will put them on record. Maybe then the senator will compare that response to actual documentation in the possession of whistleblowers that may show otherwise.

Good Point Doc, I didn't think about that angle.

If you ever give up medicine, you would make a good lawyer.

Just like when FDA Commish Andy said in a public luncheon to Pharma Execs "Whistleblowers will not be tolerated"

Thank you NJ StarLedger for reporting.

Or when his replacement sent an e-mail to all FDA staff warning them against revealing tradesecrets. Which of course the Food Drug and Cosmetics Acts specifically allows for individual FDA employees to report on their own to members of Congress (as part of whistleblowing). (Think of JNJ pediatric OTC manufacturing issues.)

Or the current FDA policy that allows employees to be fired if they say ANYTHING negative about the agency even if it's legal for them to do so. (Think of the letter to President Obama from Medical Devices.)

Imagine what this country would be like if we still lived with the same sort of laws and policies against citizens and crown officials from congregating and discussing the practices and policies of King George.

With the Fourth of July Weekend approaching I think I will re-read the declaration of independence. I particularly like the part where Jefferson states "But when a long train of abuses and usurpations, pursuing invariably the same Object evinces a design to reduce them under absolute Despotism, it is their right, it is their duty, to throw off such Government, and to provide new Guards for their future security."

I do not believe that we anywhere close to needing to resort to revolution. I however believe that the First Amendment IS our most important "new guard" for our security and it must be strengthened for government employees. For as the preamble to the constitution states it's to "secure the Blessings of Liberty to ourselves and our Posterity".

For myself I believe those blessings of liberty include my unalienable rights to life and the liberty to petition congress.

For what do I do when I see things that endangers my own life and my child's life.

Do I have the truly have the right to petition congress?

And if I do exercise that right, because you don't have a right unless you exercise it, what happens to my unalienable right to the pursuit of happiness and to continue to have a career I worked so hard for or to even being able to continue to make living.

Thank you Senator Grassley for fighting.

iTouches can be used, for your protection, to capture the illegal crap thrown at you. Be aware and assume your company probably has policies that are against that, but then again, the same should apply for defamation. Especially in this industry. Things go wrong, and the corrective action is firing someone for a false reason.

Yes, be as anonymous as possible. An iTouch actively recording from your pocket works well. Test it out.

And keep a running list daily in spreadsheet format:

Who said What to Who at What time. What type of Actions did they Threaten you with? Were you pulled off any assignments? Were you demoted? Most important, do you BELIEVE that what you told to do was ILLEGAL or UNETHICAL. Who asked you to do what, did you listen to the instruction, what was the retaliatory action taken?

If you are Physically threatened (as in "you should watch Joan of Ark and see what happened to her), there are a number of ways to "handle" that situation.

Godspeed

Go here:

www.badreferences.com

MB

Thanks for the last 2 e-mails.

As for an iTouch the FDA is located in Maryland. The papers here have recently reported how when a motorist videorecorded a police officer harassed someone in public, that when the video was distributed via YouTube the vidographer was prosecuted under wiretapping laws, which covers the audio portion of the recording. This is becomming more common and it's not unusual for them to find something to send a whistleblower to jail especially if the whistleblower was correct. Think of the UBS whistleblower as probably the most famous example.

Why is it that letters from Senators don't make it a point to contact the perpetual middleman (their contracted manufacturing plants?). After all, most of the "guts" of a products lifecycle actually occurr there (i.e. manufactring, facility engineering, QA / QC obligations occurr there?

Unless these middlemen are hired with a wink ;-) as scapegotes if push ever came to shove.

This does happen. Contracted manufacturers and labs (to upper management) doesn't :: really :: get hired to do what they do all the time. They get hired to provide acceptable results in order to get product to market ASAP. Plausible deniablaty runs this industry. We are digging with the right tools, but a different plot of land. We need to tear down the fence seperating the two. In fact, contracted firms should be under a microscope far more than the parent company itself.

This is where well thought ideas by very intelligent people should be applied. The longer this happens, the more precidents are sent as examples where company Y tells auditors "well, you let company X do it - you are discriminating. Then, a whole bunch of time and money wasted on attorneys, and they spend months, if not years bickering. On the wrong plot of land, as products keep flowing to market as if nothing happened. ~ M. Black

Thanks FDA-er

Solution (at least on an iPhone) is to obtain the app HD Recorder. Have your IPhone set to have a password applied so that when you "awaken" it, to have to provide a password. Become familiar with the app. Stick it halfway down your pants, or even your pocket. Play with it and become accustomed to its abilities.

Open the app, set your options, hit the record button, and put it in it's recording place of your choice. There are very few reasons that one could have to justifying confiscating your phone. If they do, 1) they will not know the passcode, and if they ask you to unlock it. If so, use a wrong password. Three times. Then the phone assumes it's stolen, and you have to dance a jig with apple to unlock it.

It is unlikely that probable cause would be established. When recording, you let the screen goes blank, but it keeps on recording unless you unlock it and press stop. It will automatically save the file with a timestamp, but you could add to or modify.

The program will provide you with instructions to transfer the file to your PC. Then transfer it thrice. One in your posession, send one to your uncle Louie, and a third place if you'd like in the place of choice.

When stories like this break through to the media, awareness will grow, and those bastards will have FAR more reasons to threaten you, and to follow the rules of the industry without putting you in the middle, with head on chopping block, to be used to explain their foul-ups if they ever need to.

Technology will cause these dispicabicable, sorry excuses of human beings, to keep their mouths shut.

Go to that website above too.

~ M. Black

Make that FAR more reasons NOT to threaten you.

Aplogies, MB

If you are a WB you need to be absolutely sure your actions or statements all conform to WB status. You can't bootstrap the mantle of WB onto actions if they do not show you were trying to report something to a proper authority.

I've seen people burn their careers and money trying to claim WB status that wasn't there.

On the other hand, what exactly is the follow up for Sen. Grassley? THe letter goes out, the spin comes back. Sure the company is on record. So what? They are on record for their policies anyway.

Aside from a muscle flex, I don't know what this will accomplish.

Even if actions conform to WB status, that does not mean that you have any protection.

Prosecution is becoming the norm.

http://www.washingtonpost.com/wp-dyn/content/article/2010/07/06/AR2010070602330.html

http://www.whistleblower.org/blog/31-2010/640-spying-101-which-state-secrets-make-a-spy-

http://www.washingtonpost.com/wp-dyn/content/article/2010/07/01/AR2010070104054.html

You do know there is a major distinction between whistleblowers involved in National Security and classified information in the military or intelligence field, and a pharmaceutical employee telling law enforcement about deceptive business tactics at the company they work for, yes?

Two completely different worlds.

Please don't draw any analogies between violating an oath of duty in the military or intelligence field and divulging classified information risking national security to busting out a drug company for fudging their clinical safety data to make a few bucks.

My earlier post had to do with pharma execs who have loose lips and find themselves under the corporate microscope, who then want to claim they have WB protection because they have some moral or legal justification - only they didn't actually blow the whistle until their job was in trouble. You can't backdate it - either you went to the authorities and told them information that is WB, or you didn't.

and I sound way more snarky than I meant to. Sorry for that = didn't mean to attack you!!

You need not be absolutely sure that the action, etc. is illegal or unethical. I'm by far not condoning you act like a drunken Mel Gibson with a sawed off shotgun. Do all you can to professionally handle the situation. Heck, even give them the benefit of the doubt. Maybe consider not getting involved with things you are responsible for, or otherwise touches upon what you're doing. But if and when it does, you'll know it.

Then, start you're little Black book ON THEM.

~ M. Black