Michael Palmer - Side Effects

"Anything's possible, " she said. "I suppose Ian Toole and his spectrophotometer are no more exempt from error than… Redding Pharmaceuticals."

"Do you have more of a sample? Can we have the findings rechecked at another lab?"

Kate shook her head. "It was an old prescription. There were only half a dozen left. I think he used them all."

Zimmermann tried picking at his meal but quickly gave up. "I don't mean to sound doubtful about what you are saying, Kate. But you see what's at stake here, don't you?"

"Of course I do. And I understand your skepticism. If I were in your position and the Omnicenter were my baby, I'd want to be sure, too. But Bill, the situation is desperate. Two women have died. My friend is lying up there bleeding, and I have been unknowingly taking a medication that was never prescribed for me. Someone in or around Redding's generic drug department has made an error, and I think we should file a report with the FDA as quickly as possible. I spoke to the head pharmacist at Metro about how one goes about reporting problems with a drug."

"Did you mention the Omnicenter specifically? " Zimmermann asked. "I may be nervous and frightened about all this, Bill, but I'm neither dumb nor insensitive. No. Everything I asked him was hypothe ical."

"Thank you."

"Nonsense. Grandstand plays aren't my style." She smiled. "Despite what the papers and all those angry Red Sox fans think. Any decisions concerning the Omnicenter we make together." Kate nibbled on the edge of a piece of garlic bread and suddenly realized that for the first time since returning home to Jared's note, she had an appetite. Perhaps, after the incredible frustrations of the week past, she was feeling the effects of finally doing something. She passed the basket across to Zimmermann. "Here, " she offered, "have a piece of this before it gets cold."

Zimmermann accepted the offering, but deep concern continued to darken his face. "What did the pharmacist tell you?"

"There's an agency called the U. S. Pharmacopia, independent of both the FDA and the drug industry, but in close touch with both. They run a drug-problem reporting program. Fill out a form and send it to them, and they send a copy to the FDA and to the company involved."

"Do you know what happens then?"

"Not really. I assume an investigator from the FDA is assigned to look into matters."

"And the great bureaucratic dragon rears its ugly head."

"What?"

"Have you had many dealings with the FDA? Speed and efficiency are hardly their most important products. No one's fault, really.

The FDA has some pretty sharp people-only not nearly enough of them."

"What else can we do? " Absently, Kate rolled a black olive off its lettuce hillock and ate it along with several thin strips of prosciutto.

"I need help. As it is, I'm spending every spare moment in the library.

I've even asked the National Institutes of Health library to run a computer cross on blood and ovarian disorders. They should be sending me a bibliography tomorrow. I've sent our slides to four other pathologists to see if anyone can make a connection. The FDA seems like the only remaining move."

"The FDA may be a necessary move, but it is hardly our only one. First of all I want to speak with Carl Horner and our pharmacist and see to it that the use of any Redding products by our facility will be suspended until we have some answers."

"Excellent. Will you have to bring in extra pharmacists?"

"Yes, but we've had contingency plans in place in case of some kind of computer failure since… well, since even before I took over as director. We'll manage as long as necessary."

"Let's hope it won't be too long, " Kate said, again thinking of Beverly Vitale's lifeless, blood-smeared face. "If we go right to the FDA it might be."

"Pardon?"

"Kate, I think our first move should be to contact Redding Pharmaceuticals directly. I think the company deserves that kind of consideration for the way they've stood up for orphan drugs and for all the other things they've done to help the medical community and society as a whole. Besides, in any contest between the bureaucratic dragon and private industry, my money is on industry every time. I think it's only fair to the Omnicenter and our patients to get to the bottom of matters as quickly as possible."

Kate sipped pensively at her wine. "I see what you mean… sort of," she said. "Couldn't we do both? I mean contact Redding and notify the FDA?"

"We could, but then we lose our stick, our prod, if you will. The folks at Redding will probably bend over backward to avoid the black eye of an FDA probe. I know they will. I've had experience with other pharmaceutical houses-ones not as responsive and responsible as Redding. They would go to almost any length to identify and correct problems within their company without outside intervention."

"That makes sense, I guess, " she said. "You sound uncertain, Kate.

Listen, whatever we do, we should do together. You said that yourself.

I've given you reasons for my point of view, but I'm by no means inflexible." Zimmermann drained the last half of his glass and refilled it. Kate hesitated and then said, "I have this thing about the pharmaceutical industry. It's a problem in trust. They spend millions and millions of dollars on giveaways to medical students and physicians.

They support dozens upon dozens of throwaway journals and magazines with their ads. I get fifty publications a month I never ordered. And I don't even write prescriptions. I can imagine how many you get."

Zimmermann nodded that he understood. "In addition, I have serious questions about their priorities-you know, who comes first in any conflict between profit and people."

"What do you mean?"

"Well, look at Valium. Roche introduces the drug and markets it well, and the public literally eats it up. It's a tranquilizer, a downer, yet in no time at all it becomes the most prescribed and taken drug in the country. Unfortunately, it turns out to be more addicting than most physicians appreciated at first, and lives begin to get ruined.

Meanwhile, a dozen or so other drug houses put out a dozen or so versions of Valium, each with its own name and its own claim. Slower acting. Faster acting. Lasts all night. Removed more rapidly. Some busy physicians get so lost in the advertising and promises that they actually end up prescribing two of these variants to the same patient at the same time. Others think they're doing their patients a big favor by switching.

Some favor."

"Pardon me for saying it, Kate, but you sound a little less than objective."

"I'm afraid you hear right, " she said. "I had some emotional stresses back in college, and the old country doctor who served the school put me on Valium. It took a whole team of specialists to realize how much my life came to revolve around those little yellow discs. Finally, I had to be hospitalized and detoxed. So I just have this nagging feeling that the drug companies can't be trusted. That's all."

Zimmermann leaned back, rubbed his chin, and sighed. "I don't know what to say. If speed is essential in solving this problem, as we both think it is, then the route to go is the company. I'm sure of that."

He paused. "Tell you what. Let's give them this coming week to straighten out matters to our satisfaction. If they haven't done so by Friday, we call in the FDA. Sound fair?"

Kate hesitated, but then nodded. "Yes, " she said finally. "It sounds fair and it sounds right. Do you want to call them?"

Zimmermann shrugged. "Sure, " he said, "I'll do it first thing tomorrow.

They'll probably be contacting you by the end of the day."

"The sooner the better. Meanwhile, do you think you could talk to some of your Omnicenter patients and get me a list of women who would be willing to be contacted by me about having their medications analyzed?"