Purity Feinberg once owned and supervised a chain of drug stores in Georgia and South Carolina. It was her primary source of income with her internal medicine practice as a part time endeavor to maintain her skills and her medical license. She became angry and frustrated with being at the end of the healthcare chain and prescription practice with all the drug recalls, manufacturing and drug errors, and resultant patient serious adverse consequences. She wanted to do something about it rather than simply report it to the FDA who merely put a recall to the aberrant drug. Being financially solvent in her early thirties, she decided to sell her drug store chain to pursue a career with the FDA.
Her first interview was productive but only because it gave her direction and more sharply defined her goal.
“You mean it can take up to three-years to approve a drug?” Feinberg was open-mouthed. She sat opposite Dr. Phineas Adams, Associate Director of Drug Registration and Approval at the FDA office in Rockville, Maryland.
“Dr. Feinberg, as both a Physician and a Pharm D, you must realize a rush process will only bring more problems than a more intensive review of the research done by the pharmaceutical companies. There’s also verification of their statistics including the number or patients studied as being adequate to show the drug is safe and that it works. We also have to verify that the patients were real people.”
“What do you mean real people, Dr. Adams?”
“Big Pharma’s bottom line is money. Time is money. Some companies would like to get approval of their drugs by using the least amount of patients, the least powered statistical design and we’ve found over the years that many patients involved in the research studies were made up–fakes, never existed. It really isn’t the company at fault, we’ve also found, it’s certain corrupt individuals who fabricated enrollment just to make up the numbers and therefore fudge the data to show a favorable efficacious response. They get a big bonus for getting a drug approved on time and even more bucks for an earlier approval.” Adams reached for a folder. “Although these situations are few, I always show these past cases to the press and newcomers like you.”
Feinberg scanned the first few cases. “This is awful.”
“But real. It gets worse, Dr. Feinberg. The lab work, the electrocardiograms, x-rays and demographic data were all made up in the drug studies you’re looking at.”
“If it takes the FDA so long to check on the drug company submissions, how do the mistakes and sham studies get through?” She put the folder down on her lap.
“We just don’t have enough staff and we don’t have a real police force of our own.”
“Why not?” She stared at Adams.
“How many MDs, PhDs or Pharm Ds do you know who would devote a life of government service at a lower than comparative civilian pay scale to do this?”
“Well, I would, for one. I mean if the FDA had such a group, I would jump at the chance to use my medical training to safeguard the prescription users in this country.”
Purity Feinberg remembered what happened next. Dr. Phineas Adams sat back and smiled. “Ever hear of the Drug Development Enforcement FDA Section?”
And now she was on her third case and with the same partner, Lance Trumble. She only had bits and pieces of his story and he of hers. She glanced at her watch. In three-minutes there would be a knock on her hotel door and Trumble would be there. Trumble was addicted to punctuality but she didn’t consider it a liability. A dash of perfume and a last glance in the mirror was followed by the knock on the door. She looked through the peep hole and let him in.
“Your friend from the DEA wants to see us. She’s at the bar downstairs.” Trumble’s serious demeanor changed to a grin. “I guess we’ll never be alone.”
“We’re not supposed to be alone. We’re just partners remember?” She closed the door behind her.
“If I ever forget, I have you to remind me?”
“Why don’t you refer to Willy by her name rather than ‘she’ or ‘her’.” Feinberg pressed the elevator down button.
“I feel intimidated by her name–Willomena Kemos.” He walked into the vacant elevator with her and pressed the lobby button. “The truth is…Willy looks like my mother.”
“Is that bad?”
The elevator door opened. Trumble looked at Feinberg. “I’ll tell you about it sometime.” They moved to the darkened lounge down and to the right of the hotel lobby.
Willomena Kemos looked up from her tall cocktail glass at the arrival of her colleagues. Her long straight red hair seemed to straddle the drink as she focused on Trumble as he and Feinberg sat opposite her. A single candle in a light red brandy glass flickered in the middle of the small square table.
“Greetings,” Kemos kept her gaze on Trumble. The barmaid appeared as if by magic and took drink orders. Kemos added another Harvey Wallbanger to their order. “I know I haven’t even started on this one but I’ll need one more.”
“Are things so bad?” Trumble asked keeping his eyes locked on hers. They always seemed to play a game to see who dropped eye contact first.
“That’s the problem. We don’t friggin know. The DEA’s getting pressure from the FBI to get moving on this case but we can’t really define who the perpetrators are.” She sipped her Wallbanger which seemed fluorescent yellow in the dim light. “So we start with Wilson Medical Products and Legg Pharmaceuticals.”
“It was our game plan to begin with.” Feinberg paused as their drinks were delivered. “Lance could take one company and I’ll take the other.”
“The best way to do this is to let me be the bad guy here for both companies.” Kemos drummed her right fingers on the table. “Too bad you can’t smoke anywhere anymore. Whenever the stress piles up I think of how good a cigarette would taste.”
“You gave it up years ago.” Feinberg frowned.
“Yeah. It’s amazing how nicotine addiction is still there waiting for the right moment.” Kemos managed a smile. “I’m going to get into their faces. You two may have to go undercover and infiltrate or, I should say, become employees of Wilson and Legg.”
“How did the DEA come to such a conclusion?” Trumble raised his water glass with its floating lemon slice to his mouth.
“Trumble, you look troubled every time we meet.” Kemos sipped her drink.
Trumble looked at Feinberg and back to Kemos. “It seems Dear Willy, every time we meet, Purity and I have to qualify with a 9mm automatic.”
She smiled. “It’s Agent Kemos, remember. Lance, we deal with life takers and in this case with murderers who use the same automatics.” Kemos tented her fingers. “And watch the ‘dear’ stuff.”
They laughed and Feinberg continued. “So who gets which company?”
Kemos gave them each a thin file. “Porfirio Quintos is a wimp with no criminal record, no black marks with the FDA and appears to be an ethical drug developer. Mary Murphy at Wilson, on the other hand, is a vicious, corner-cutting, devious, ladder-climbing, pseudo-scientist who’ll do anything to get ahead, make more dollars and crush the competition.” She started on her second Harvey Wallbanger. “So, Purity, you get Murphy.”
“What?” Trumble’s voice shook. “I get the Don Knots of the pharmaceutical world and Purity could get herself butchered.”
“Butchered? I can take of myself Lance Trumble. Besides, a woman working with a woman like her means I’ll be thinking from my neck up and not my waist down like men often do.” Feinberg readjusted her seat.
“Sexual or impure thoughts are not part of the job, Purity. I’m talking about real danger.” Trumble stared at her.
“Are you two through? Purity is correct. A female in Mary Murphy’s midst is less threatening and less suspicious than a male presence. Besides, Porfirio Quintos could become her next target. I mean personally. Murphy’s thinking should naturally go to Quintos as being the one behind her NDA being sabotaged.” Kemos waited for them to cool down. “Anyway, it’s what the DEA’s plan includes. There are job openings in both companies each of you qualifies for. In your file, you’ll find several. Look them over and pick one and get back to me tomorrow.”
“So we got our orders?” Trumble asked.
“Your bosses are smart. They would rather you be mad at me than at them. Yes, those are the orders and the plan. However, there is also the possibility to get both of you into Wilson’s circle. We’ll see how it plays.”
Kemos finished her drink and stood up. She shook Feinberg’s hand and looked at Trumble. Trumble extended his hand and Kemos looked at it. “Remember when you said ‘Dear Willy’? That’s what I meant about from the waist down.” She accepted Trumble’s handshake.
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