Authors: Michael Palmer
Although these were encouraging signs, Brian knew that he should not make too much of them. Part of the problem with clinical medication research was the well-documented placebo effect. The more that patients, their loved ones, and treaters wanted a given therapy to work, the more the subject’s symptoms suggested that it was working—at least up to a point.
Brian longed to discuss his father’s case with Carolyn Jessup—to check on whether Jack’s response to the drug was similar to that of other patients. But disclosing to her that he was stealing beta Vasclear would teleport him immediately back to No Job, No License-land. So, in terms of experience with the drug, he would simply have to fly blind. Soon, he kept telling himself. Soon, either through improvement in Jack’s symptoms and the legalization of Vasclear, or through surgery, the secrets would end. Soon.
As good as the past week at the hospital had been, there
was
one unpleasant encounter. Brian had just set his tray on the conveyor belt to the dishwasher when he noticed Laj Randa approaching him, followed by his omnipresent pair of sycophant fellows. His turban this day was red, a color that seemed only to enhance his warrior’s visage.
“So, Holbrook, how is it with your father?” he asked.
“He’s home resting.”
“I know that. Was he put in the Vasclear study?”
“No,” Brian said, “but I’m hoping the drug will become generally available before too long.”
“Answer me something, Holbrook. Why do you think Weber and his drug company are pushing and lobbying so hard to speed this product into the marketplace?”
“I don’t know. Money?”
“No, not just money, my friend, a vast amount of money. A single dose of this medication is going to cost over one hundred dollars. That is one thousand dollars for the first two weeks per patient. A hundred thousand patients, a hundred million dollars.
In two weeks
. And a hundred thousand doesn’t begin to touch the numbers who will be taking this drug inside of just a few months.”
“So?”
“In their zeal to cash in on their product, Newbury Pharmaceuticals is making an all-out push to circumvent standard scientific practices. A limited double-blind study with no crossover at midpoint and no multi-institutional component. That’s all they have. There is always something wrong with cutting corners like that, Holbrook. Always. You took biostatistics in medical school. You know that there is a reason that a study is not statistically valid until
n
in the equations—
number of cases
—has exceeded a certain minimum.”
“Their results are very impressive.”
“Their results are meaningless until the appropriate mathematics say otherwise.”
Randa’s voice was raised now, enough to attract the attention of those around them.
“Dr. Randa,” Brian replied, “my father was in the hospital for nearly eight weeks after his last bypass. He was more dead than alive. And you know the numbers for repeat surgery as well as I do. The second time is more than twice as risky.”
“Not in my hands.”
“Tell me something,” Brian ventured. “Does your bias against Newbury Pharmaceuticals and their drug and their methods have anything to do with how much Vasclear will shift the treatment of coronary artery disease away from surgery?”
The Sikh looked at him disdainfully.
“You’re a fool, Holbrook,” he said. “Your father needs surgery. He’s not getting the operation he requires because of all the hype that has been generated over this drug. Until the scientific community gives the medication its blessing, it is only so much snake oil. You are making a mistake to wait for it to become available for him.”
Without waiting for a reply, he stalked away.
The Hippocrates Dome was perched atop the five-story Pinkham Building at White Memorial. It was an amphitheater, built on the site where one of the first operations was performed under general anesthesia, and had quickly become known as the Hippodome. The four hundred sharply banked seats, still wooden with peeling veneer, were set beneath a striking stained-glass canopy consisting of scenes depicting various significant moments in medical history. After more than a hundred years, the dome was being refurbished, with scaffolding inside and out and a huge crane hovering above it like a giant mantis.
At twenty of twelve, when Brian arrived on the sun-splashed terrace just outside Pinkham 1, Phil was waiting for him with two cups of coffee.
“Still black with an ice cube?”
“Absolutely.”
It was coffee resident-style, designed to be gulped on the way from one patient to another.
“I … um … didn’t think you’d want a cruller, so I didn’t get you one.”
“Good move,” Brian said, “as long as you didn’t get me one
before
you decided I wouldn’t want it.”
“M’lord, thou cuttest me to the quick, wherever that is.”
“So, what’s your take on this dog and pony show?”
“I don’t know. A representative from the FDA appearing on the stage alongside Ernie Pickard and Art Weber has got to be good news for the ‘V’ team.”
“I certainly hope so. It’d be good news for my dad, too.”
“How’s he doing?”
Brian hesitated, uncomfortable at withholding the real story from an old friend. But in the end, it just wasn’t worth putting Phil on the spot by telling him Jack was secretly on beta Vasclear.
“The truth is,” Brian said, “he’s not doing that great.”
“Surgery?”
“The last time I mentioned it, he didn’t refuse outright the way he usually does. I guess it depends on whether we get any indication today of when the FDA intends to move on Vasclear. Tell me something, Phil. In your experience, how long has it taken for beta Vasclear patients to start showing an improvement in their symptoms?”
“It varies. Some just a couple of days. Most within two weeks. Some a couple of months. But remember, a quarter of the cases don’t get better at all. Most of those treatment failures have ended up in the OR. A few of them have ended up in the morgue.”
Brian nodded. Phil knew as well as he did that except for simple treatments like penicillin for strep throat, almost no medication could boast that sort of success rate. Certainly no cardiac med. Brian checked his watch.
“Let’s head up there, okay? I want to get good seats for this one.”
A crowd was milling in front of the two Pinkham elevators. Protesting nearly every step of the way, Phil followed Brian up the stairs. The seats in the Hippodome were already half-occupied, and the rest were filling rapidly. Brian wasn’t the least surprised. Vasclear coverage was now appearing in the
Star
and the
National Enquirer
, as well as on various evening newscasts. The drug was becoming a national celebrity.
They found two seats on an aisle toward the right, six rows back from the stage, which was a half-circle about twenty feet across and ten deep, raised three feet off the floor. Hazy sunlight filtered through the stained glass, painting the room. The huge screen behind the stage was down. Seated between it and the narrow lectern were Ernest Pickard, Art Weber, Carolyn Jessup, and, at the end nearest to where Phil and Brian were sitting, a woman in her early-to-mid-thirties.
“She’s the FDA person?” Phil said, incredulous. “She looks like Jodie Foster on a good day.”
“What’s that disbelief in your voice supposed to mean, you sexist pig?”
“Hey, I am what I am, Bri. That woman up there not only has Jodie’s looks, she’s either an M.D., a Ph.D., or both. That impresses me as much as it intimidates me.”
“Jodie Foster graduated from Yale, Phil.”
“Well,
she
intimidates me, too. It’s genetic. My mother used to scare the crap out of me.”
Brian wasn’t sure the woman on the stage resembled Jodie Foster all that much, but he would have been lying to say that her fine features and warm coloring weren’t incredibly appealing to him. She was San Francisco to Carolyn Jessup’s Upper East Side Manhattan. And at that moment, facing a full house in one of the nation’s foremost
teaching hospitals, she didn’t look the least bit ill at ease.
At the stroke of twelve, Ernest Pickard approached the lectern.
Phil leaned over to Brian and whispered, “Distinguished Ernie, Elegant Carolyn, Leading Man Art, and Jodie. It’s like a frigging casting call up there. The only thing missing from the group is you as mild-mannered reporter Clark Kent.”
“Ladies and gentlemen,” Pickard began, “welcome. These are exciting times for White Memorial Hospital and Boston Heart Institute. As you know, for the past several years we have been involved in a joint research effort with Boston-based Newbury Pharmaceuticals. Today, we would like to share the results of our investigations with you. But first, I would like to introduce those who will be conducting these rounds with me. Dr. Carolyn Jessup, professor of cardiology and associate director of BHI; Dr. Art Weber, director of the Vasclear project and liaison from Newbury Pharmaceuticals to BHI; and finally, our special guest, Dr. Teri Sennstrom, team leader of the cardiovascular drug evaluation unit of the Food and Drug Administration.”
“Teri,” Phil whispered. “I like that name. You must, too. You’ve been staring at her nonstop.”
“Put a sock in it, Phil.”
The first half-hour of Grand Rounds told Brian nothing new. It was a coming-out party for Vasclear, complete with a glossy slide show presented by Weber that chronicled significant milestones in its life. Following Weber, Carolyn Jessup got more scientific, with a discussion of dosage schedules and clinical results, as well as before-and-after arteriogram shots from several patients. She worked the stage, lectern, screen, and audience like a symphony conductor.
Throughout the presentations, despite his reluctance to prove Gianatasio correct, Brian had trouble keeping his eyes off Teri Sennstrom. But even more unsettling was that she often seemed to be looking straight at him as well. Their connections were brief and never acknowledged by either of them with so much as a nod. But they were real. Brian was certain of it.
Jessup wound down her presentation and entertained a few scientific questions, for which she was so well prepared that Brian wondered if they had been planted. Then she reintroduced Teri Sennstrom.
“You got her phone number yet?” Gianatasio whispered as Teri approached the lectern. “She looked like she was blinking it out to you in Morse code.”
“Philip, will you grow up?”
“ ‘When the moon-a hits-a you eyes like a big-a pizza pie …’ Hey, I don’t see a wedding ring.”
Brian was too proud to admit that he had noticed the same thing. A list of his personal attributes would never have included dealing cheerfully with being teased.
“This is science,” he shot back. “Pay attention.”
Teri Sennstrom was wearing a brown gabardine suit with a cream-colored blouse. Her dark blond hair was held back in a tortoiseshell clip, revealing small pearl earrings. Facing four hundred souls in a steeply banked amphitheater, she appeared a bit more tentative than she had while sitting in the background.
Please
, Brian thought as she set some file cards of notes on the lectern.
Please tell me what to expect for my dad
.
“Well, this is quite a day,” Teri began, after thanking her hosts and conveying the best wishes and hopes of FDA chief Dr. Alexander Baird. “We appear to be at the leading edge of a miraculous advance in cardiovascular pharmacology. The data presented in brief here is a distillation of thousands of pages of reports and dozens of
arteriograms, which my team at the FDA has been reviewing for over a year. We are impressed, Dr. Weber, with the care and thoroughness of your research design. We are impressed, Dr. Pickard and Dr. Jessup, with the scrupulous manner in which the research protocol has been carried out. And mostly, we are impressed with the results to this point.
“It is Dr. Baird’s wish, as well as that of the President, that the patients in need of this drug receive treatment with it as soon as possible. To do so means that we will have to make concessions to the importance of Vasclear, just as our agency has done with other drugs in the past. Dr. Weber, Dr. Jessup, Dr. Pickard, we at the FDA believe that we are in the homestretch in our evaluation process. Dr. Baird feels that Vasclear deserves the status of a lifesaving new drug, and it is his intention to move forward with its approval for general use.”
A smattering of applause began and spread quickly throughout the hall, reverberating off the stained-glass ceiling until the Hippodome seemed to quake.
Yes!
Brian thought.
Yes!
“Our goal is to sign our approval of Newbury Pharmaceuticals’ new-drug application for Vasclear in this historic amphitheater in two weeks.”
Again there was applause. Gianatasio pumped his fist.
“You think you can keep your old man going that long?” he asked.
“We can try,” Brian replied, suddenly wondering what preexisting factors might distinguish the twenty-five-percent failures from the rest.
Two weeks
, he was thinking.
We can do two weeks
.
“Now, however,” Teri continued, “it is time for us at the FDA to ask a favor of you. As you know, our mandate is to protect the safety of the public while not unnecessarily delaying the release of any needed medication. I
would like to encourage every one of you who has questions or information on Vasclear—positive or negative—to contact me. Dr. Weber and Dr. Jessup were aware that I planned to make this request, and it is to their credit that they stand by it one hundred percent. May I have the slide, please.”
The lights dimmed, and a slide with Teri’s name, the Rockville, Maryland, address of the FDA, and an 800 phone number appeared on the screen.
“She spells it with an ‘i,’ ” Gianatasio whispered. “I like women who end their first names with ‘i.’ ”
“Even when they have an M.D. or a Ph.D.?”
“I don’t know. I don’t think I’ve ever run into that combination before.”
“Again,” Teri Sennstrom was saying, “any of you who has worked with this drug or with patients who have received it are encouraged to call my office with reports of any adverse effects or unexplained symptoms. I promise that your call will be treated with the strictest confidence. I cannot stress enough that it is much, much easier to keep a drug off the market than it is to stop its sale and recall it once it is in general use. Several times over the next two weeks, I intend to be here at Boston Heart and White Memorial. I’ll be happy to meet with any of you in person to discuss any aspect of Vasclear. Meanwhile, I think you can all share in the pride of what your institution has accomplished. Thank you.”