The FDA’s Law Enforcement Arm: The OCI

I’m excited to host Bette Lamb today as she blogs about her latest medical thriller, The Bone Pit. Sounds right up my alley. Plus, she shares about the law enforcement arm of the FDA. Did you know about them? Let the conspiracy theories begin.

Welcome back, Bette!
At some point in your life you might find yourself at odds or in some kind of trouble with the police. And a real nightmare? Getting involved with the FBI. Maybe the CIA.
Very scary stuff! If you’re a movie buff, as I am, there are too many scenarios to paste yourself into once you get your imagination going in that direction
But the OCI? Who the heck are they? And what do they have to do with you, or me?
When I was digging out information about fraudulent clinical drug trials for our latest medical thriller, Bone Pit, I discovered that the Food and Drug Administration (FDA) has its own law enforcement unit: the Office of Criminal Investigations (OCI).
Maybe you’ve heard of them, but I hadn’t.
OCI began operating a little more than twenty years ago; it was tailored to enforce the FDA’s many areas of responsibilities. Since opening six field offices in 1993, OCI has become operational throughout the US and Puerto Rico. It hires experienced agents from the FBI, Immigration and Customs Enforcement, the Secret Service, and other law enforcement agencies – real, tough lawmen and women who bring prior experience in traditional law enforcement methods and investigative techniques. These are not necessarily sit-in-the-office types — they obtain and execute arrest and search warrants, carry firearms, and gather evidence to support prosecutions through the federal and state court systems.
They are not people to mess with, because if you do—if  you break the law—they will hunt you down and bring you before the Department of Justice for prosecution.
In other words, OCI is the FDA’s teeth. And they will bite anyone who tampers with food or over-the-counter drugs, importation of unapproved drugs or devices, biological products (such as blood supplies), new drug application fraud, and fraudulent schemes involving AIDS, cancer, and Alzheimer’s.
They also oversee clinical investigator fraud – something that drew my interest. For example: An investigation by OCI and the Veterans Affairs (VA) resulted in a conviction of a VA physician who falsified documentation of a clinical drug study and enrolled patients who did not qualify under the study protocol. The physician’s criminal negligence caused the death of one patient by falsely documenting the results of a blood chemistry analysis. The guilty physician was prosecuted and sentenced to 71 months in the federal slammer.
Each year, OCI investigates about 1,200 criminal cases that result in the arrests of some 300 criminal suspects. From 1993 through November 2010, agents made 5,702 arrests that resulted in 4,748 convictions and more than $11 billion in fines and restitutions. Significantly, OCI agents are charged with protecting $1 trillion worth of food, drugs, cosmetics, and other FDA-regulated products from theft, counterfeiting, fraud, tampering, and false advertising, as spelled out in federal laws covering the United States and Puerto Rico. That means the FDA regulates approximately 25 cents of every dollar spent annually by American consumers.
The latest in scientific methodology sits smack in OCI’s corner supporting their investigations: an experienced staff of investigative analysts, technical equipment specialists, polygraph examiners, and specialists in computer forensics are just some of their tools they have to catch the bad guys.
Police, FBI, CIA, and now OCI.
I don’t think I’ll mess with any of them. 
**************************************************************************
    
Bette Golden Lamb is unmistakably from the Bronx – probably why she loves to write dark and gritty novels. Being an RN explains her intense interest in medical thrillers. Sisters in Silence, is about a female serial killer on a noble mission to save barren women from a life of despair. The RN Gina Mazzio series, Bone Dry and Sin & Bone, and the new release, Bone Pit, feature a gutsy nurse who can’t ignore life-threatening situations. In another direction, Heir Today, starts out as a treasure hunt and takes you on a suspense/adventure romp.
All four books were co-authored with husband J.J. Lamb.

Assisted Reporduction is not for Whimps

Today, I’m pleased to host Bette Lamb who discusses her research into infertility clinics. I was certainly surprised by what she found. Are you?

Welcome, Bette!

“You and I know that without babies we are nothing.
A hiss of surprise escaped Petra’s lips. “Dr. Vesey–“
“Oh, I say what’s expected to my patients. But you’re not my patient anymore, are you? We’re just two barren women facing a meaningless future.”
This interchange comes from our new novel, Sisters in Silence, where a fertility counselor takes on a ”noble mission” to save her barren sisters from suffering —  by killing them.
That’s probably not what actually happens when you go to a fertility clinic for Assisted Reproductive Technology (ART). I mean you don’t end up dead, but you do end up with a murdered bank account and a pummeled ego hovering around zero.
Consider this: For women over thirty-five who want a baby, the news is not good. That’s no matter what they do — with technology or without it. To me, that alone was a surprising piece of information. BTW, every time I blink, the age that determines whether your eggs are too old keeps getting younger. The last figure I heard, off the record, was 27 years old.
When I started researching our medical thriller (the novel is co-written with J. J. Lamb), the media buzz was all about women pursuing their careers and waiting to have babies later – sometimes well into their fifties. And women buy it – I mean, against all reason, they believe it.
 I’ve talked to intelligent, savvy women in their mid-forties who say, “I’m just beginning to think about having a baby.” And many might as well keep right on thinking about it. Because no matter how young you look or how much you’re into Pilates, or how many vitamins you take, or whether the forties are the new thirties, you’re in for a surprise when you take that first trip to a fertility specialist who you’ll probably have to end up seeing. You’ll be floored.
When I started delving into this specialty for our book, the statistics for success knocked me over. My day job, for most of my career, was as an RN in Ob/Gyn. I thought I knew exactly the kind of information I would find. After all, these clinics are everywhere. They have to deliver the goods to keep the doors open. Right?  Wrong.
Most women seeking professional help DO NOT SUCCEED. That means they do not walk away with a baby that they carry to term and deliver. In fact, the odds of success are pretty grim: From about 4% for women older than 42, to a high of 37% for women under 35. (After a woman reaches her mid thirties, success rates start to tank dramatically.).
Put yourself in the skin of a 42-year-old woman who has a successful career, a stable relationship, and some money put away. Watch her after starting down the ART runway. In the first steps, she looks like a million – she’s confident, she knows she’ll be in that winning percentage of women coming home with a baby.
And I’ll bet she doesn’t even want to hear about surrogacy (using some other people’s eggs) or adoption. Babies are not that available and who wants some older kid? After several cycles of hormones that make her feel like she’s losing her mind, a love life that is based on her cyclic ticking clock, a significant other who’s now having ED because of the scheduled sexual demands that have nothing to do with lust, life becomes hell in a toaster.
This is the world of our fictional fertility counselor. A world of disappointments, lost love, and unfulfilled expectations day after day. That might drive you off your rocker, too.
*****************************************************************************

Bette Golden Lamb is unmistakably from the Bronx – probably why she likes to write thrillers. When she isn’t writing crime novels, you can find her in her studio playing with clay.  Her artistic creations appear in juried regional, national, and international exhibitions. She sells through galleries, associations, and stores. She’s also an RN, which explains, Bone Dry, a medical thriller, and Heir Today, an adventure/thriller which also has a medical aspect to it. And just released at Amazon .com, Sister in Silence, a medical thriller about barren women — available as an ebook or trade paperback. Both books were co-authored with husband J.J. Lamb. You can learn more about Bette here: