The Last Trial Page 12

  “Dad, you look like the weekend in Florida with Aunt Silvia did you good. How was Dr. McVie?”

  “Innis is an interesting person,” he says.

  “Oh, ‘Innis,’” says Marta, and smiles as she turns her face askance.

  “Please,” her father answers, although the truth is that she has recurred in Stern’s thoughts more frequently than he might have guessed. “At any rate, she does not seem especially eager to put a knife into Kiril.”

  He goes downstairs to the Cadillac with Ardent. Marta is right that he enjoyed the weekend with his sister. Stern’s love for Silvia is unlike his feelings, no matter how deep, for anyone else in his life—there is something purer and less burdened in it. She had been seventeen when their mother died, and Stern, five years the elder, had assumed that his role toward her would become somewhat parental, but their needs proved less predictable. They have looked after one another. Stern and his sister, by the habit of a lifetime, speak each day. Occasionally they are on the phone for an hour, but most often their conversations last barely a minute. ‘So, busy?’ ‘Yes, of course. You?’ Silvia, too, has been widowed now for the second time.

  Never having had children of her own, Silvia is very close with each of Stern’s kids and their offspring. That means Stern often learns details from Silvia, which have not been confided to him, especially about his son. Peter is living with his husband and an infant daughter in San Francisco and is still often snarky or combative with his father.

  At home, Pinky informs Stern that she is going out for the night, which is obvious from her attire. Very often she dresses in outlandish colors, fuchsia and neon greens to match her tattoos, but tonight it’s a darker look: Huge slashes of mascara like the Nike swoosh darken the area under her eyes, and she wears a nose ring on each side dangling from the nail. She has on a leather skirt, black tights, a heavy belt decorated with a silver watch chain, a skimpy bustier, and a black leather vest studded with what appear to be the heads of armor-piercing bullets. Around her neck is a black leather dog collar.

  She gives her grandfather a full inventory of the frozen dinners and puts one he likes into the oven. She is clearly eager to leave, but suddenly snaps her fingers, recalling something.

  “The Malibu! How about that? What’d you think?”

  “I am not sure what to think, Pinky. Did you contact the Greenwood Sheriff’s Police to find out how many white 2017 Malibus are registered in the county?” If there are thousands, the significance of her sighting diminishes, but as Stern might have predicted, Pinky hasn’t gotten around to that yet.

  “But I haven’t finished telling you the whole story,” she says. “You know, I saw that white Malibu out the window. As soon as I had Dr. McVie’s file, I ran out to the parking lot to grab a couple photos and text them to you. And just as I finished, this security guy comes along in his golf cart and asks if I need something.”

  “I hope you did not explain,” says Stern. He would not want Kiril hearing about this from the PT staff rather than from his lawyer.

  “I just told him I forgot where I parked my car.” She smiles. “I’m good at fooling people, Pops.”

  That is probably the case, Stern thinks, but largely because Pinky is so off-center that most people would have a hard time guessing what she has in mind.

  “So he’s, like, driving me back to visitor parking, and, whoa, there’s another white Malibu. I asked him—his name is Oscar, and I’m, like, ‘Oscar, like really, everybody here got a ’17 Malibu for a ride?’ and he laughs and says they’re pool cars.”

  “Pool cars?”

  “PT owns them. They’re trying to be all green and crunchy, so they pay for people to take the light rail out there, but, like, if a salesperson has to go see a client, or the researchers have got a meeting at Easton, they sign a car out. Oscar says PT owns six white Malibus. Hybrids.”

  Pinky is sure she’s onto something. But she’s also ahead of herself.

  “Pinky, are you remembering what our friend Detective Swanson told us? She walked through the PT lot while I was in the hospital and saw no car there with serious body damage.”

  “Yeah, but Pops, that’s always seemed pretty lame to me. Somebody nearly wipes you out and runs for it, they’re not gonna bring some wrecked car back to the PT lot, are they? Oscar is bound to ask questions. I say whoever hit you took the Malibu to a body shop straight off. What kind of detective is Swanson not to figure that out?”

  A detective who was trying to humor an old man, Stern could answer.

  “Well, certainly, Pinky, someone must keep track of these vehicles. They would notice if one of them was missing for several days, no?”

  “Maybe. Maybe they sign cars out for a week at a time. I mean, we should investigate a little, right?”

  He wonders if experience with Pinky is causing him to give less credence than he should to her suspicions. He believed he’d seen the PT parking decal in the back window of the car that hit him. And it was paint from a white Malibu on his Cadillac.

  “I mean, Pops, I was wondering if I could ask Janelle to see if they have sign-out records for that week when you got hit. For the pool cars?”

  “Pinky, I am obliged to mention this first to Kiril. We must tell him before we try to prove that someone from PT committed a felony.”

  “Okay, but you’ll ask him, right? To see the records?”

  “I shall.”

  Pinky, as usual, is happy to be indulged. She reminds Stern about his dinner in the oven and with that departs, leaving him with the customary knot of feelings his granddaughter engenders. He could ask where she is going—especially so early on a Monday night—but she is not likely to answer. On the occasions she has, Stern would have been happier not to know. S&M tonight? Possibly, from her getup, but he’d rather not imagine. And there is no point in asking who she’s meeting, since he is unlikely to recognize the names. Pinky does not really have old friends. Most of the kids from high school, for example, with whom she often got into trouble, have straightened out, paired off, even started families. Many probably regard Pinky as a relic of a troubled time to which they don’t want to return. When Pinky goes out she generally seems headed to some kind of group mash at a club. Pinky is on the curvier side—no swimsuit model but a pretty girl with even features and lovely eyes, and when she goes out clubbing she seems to have no trouble finding someone to sleep with. No matter how upside down it seems to Stern, sex appears to be her principal means of connecting to other people.

  Pinky had been christened—literally, to please her father’s Lutheran family—Clarice in memory of Clara, but Stern’s daughter Kate could not bear to utter something so much like her mother’s name when she was still in deep mourning. Instead, while Kate waited to hit on something better, her husband’s dotty ninety-six-year-old grandmother, who could never remember the baby’s actual name, had started calling her ‘Pinky’ because of her coloring.

  Pinky was indeed a beautiful rosy baby, but trouble from the start—colicky, sleepless, always bawling as an infant, then later a problem in school, where she tended to isolate herself. Within the family, there is constant conversation about what is wrong with her. ‘Wrong’ is never said aloud, but everyone over the years has freely conceded to being infuriated by the young woman. Kate, who coexisted for decades in grudging silence with John, that useless lunkhead of a husband she’d finally kicked to the curb a decade ago, regularly points out that her eldest child is the only human on earth with whom Kate has ever gotten into screaming battles. After years of visits to a counselor, Kate has taken to calling Pinky ‘oppositional.’ Peter, Stern’s son, who can be severe, once called Pinky a ‘dimwit.’ Marta refers to Pinky as ‘somewhere on the spectrum.’ Even Stern sometimes cannot find the words for her judgment. No more than a year ago, he became aware of an uproar Pinky was causing in the office by posting photos of her sexual encounters on Snapchat. Pinky, it should be said, has her own way of explaining her frequent social mishaps. ‘After a while,�
� she once told her grandfather, ‘I just find everyone annoying.’

  He is worried that Pinky, now about to turn thirty, is on the verge of becoming a permanently lost soul. But this concern, like so many others, is tamed by the knowledge that he will not be here to see how the story plays out.

  He had never been so divorced from reality as to fail to anticipate getting old. He foresaw many parts of this—the fingers that seem like stone, the way he has become the old man who holds up everyone behind him. But he did not guess at how natural it would feel to be retreating from the world. Caring goes on, but you accept more and more that you have limited time and, thus, effect. Your connections in the present dwindle, as peers die, as you lose your spouse. You are at a distance and it requires more effort to understand what everyone else is saying—not least of all because he can barely hear, even with an aid in each ear. (Last week, he stared at Marta in his office doorway and asked, ‘Why are you talking about frying tuna?’ She was exasperated immediately. ‘I said, “We should try this opportunity.”’)

  While studying the scientific aspects of Kiril’s trial, he had a startling and sudden recognition of Nature’s plan: We mix and mate as part of her goal to combine and recast DNA. She is eternally looking for a better set of chromosomes. From her perspective, humans are essentially a race of shape-shifters, present temporarily before leaving our genetic material behind. We are all Nature’s fools, tricked by instinct into believing in the importance of The Self.

  14. FDA

  Dr. Alexandra Robb’s title virtually breathes the word ‘bureaucrat’—director of the FDA’s Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research. On the stand, however, she is the image of professional competence. In her late forties, she is well kept, wearing a pinstripe suit and shoulder-length dark hair with a natural wave. Seeing her across the courtroom, Stern thinks she may have some African ancestry, or a grandparent from somewhere on the Indian subcontinent. Her look, these days, is blessedly best identified merely as ‘American.’

  As a sign of her importance to the prosecution case, Dr. Robb is questioned by Moses. He goes first through her background. Her education, like that of every other health professional who has testified, seems to have taken forever. She has both an MD and a master’s in public health and is board certified in oncology. She spent years as a professor before joining the FDA. After a few more questions, Moses asks the court to qualify Dr. Robb as an expert, meaning she will be allowed to offer opinions about the clinical trial process for cancer drugs.

  “Dr. Robb,” he says, “does the Food and Drug Administration do any pharmaceutical testing on its own?”

  “No. That is very expensive. Makers of medications are principally responsible for testing their products.”

  “What is the FDA’s role in pharma testing?”

  “We establish standards aimed at ensuring that those tests are objective and complete. We then analyze the results to determine if a particular medication has been shown to be safe and effective.”

  “In the United States, may a pharmaceutical product be sold without the approval of the FDA?”

  “No drug or biologic product may be transported across state lines without the FDA’s approval. Effectively that means they cannot be marketed to the American public without our say-so.” A biologic, Stern has learned, is a medication derived from naturally occurring living material rather than something synthesized in a test tube. g-Livia is a biologic, since the medicine originates from a mouse antibody, which has been bioengineered to be identical to the proteins humans deploy against foreign cells.

  “Are you familiar with a medication trade-named g-Livia?”

  “I certainly am.”

  “What was your first professional contact with the product?”

  “I attended a meeting in August 2014.”

  “Who was there?” She names three doctors from PT, including Kiril and Lep, and a small crowd from the FDA, including the project manager; the medical officer who evaluates trial data; a statistician; a pharmacologist; a pharmacokineticist, who traces how a medication is absorbed; a chemist; and a microbiologist. Even then a buzz about g-Livia was starting among cancer specialists and on Wall Street, thanks again to Olga Fernandez.

  “And when you refer to Kiril Pafko, do you see that gentleman in the courtroom today?”

  “Stipulated,” says Marta immediately without looking up from her notes. She will cross Dr. Robb for the defense. Most judges insist that only the lawyer who will examine the witness may address issues raised by the testimony. In this case, Marta is trying to avoid an uncomfortable moment for their client. Custom would call for Kiril to rise and to be pointed out by Dr. Robb, just to be certain that he is the same person she is talking about. Both Sterns find that finger-pointing demeaning to the defendant. To avoid that, Marta has agreed—stipulated—that Kiril is who Dr. Robb means.

  Sonny does not allow Moses to answer and says, “Record will reflect stipulated identification of Defendant Pafko.” For his part, Moses appears slightly perturbed, but he goes on to the substance of the meeting in 2014 in DC.

  “Well,” says Dr. Robb, “the project manager wrote out a memo, which I know both sides have, but the sum and substance was that we had approved the Investigational New Drug Application for the product at the end of 2013. The PT people wanted to tell us—”

  “Excuse me,” says Marta, standing quickly. “May we know who spoke?”

  “I’m sorry,” says Dr. Robb. “The principal speaker for PT was the medical director, Dr. Lep Pafko, although Dr. Kiril Pafko said a few words to start. He told us that even in the early phases of clinical testing on animals, and some very limited dosage studies on humans, they had seen what they regarded as remarkable results.” It was his cancer, Stern knew, along with a couple of other cases, that Kiril and Lep had spoken about in DC. “A prominent lawyer” is how he’s described in the documents. Again, for a second, he is drawn back to that time in his life when a bad death seemed so close.

  “And did the team from Pafko Therapeutics have any requests?”

  “Yes. They were going to file an additional application, asking to have g-Livia designated as a Breakthrough Therapy.”

  “And what is Breakthrough Therapy designation?”

  “It means the FDA has agreed to an established process to expedite the development and review of a medication.”

  “And what is required for a medicine to be designated a Breakthrough Therapy?”

  “The drug or biologic must be for a serious condition, and preliminary clinical evidence must indicate that it may constitute a substantial improvement over available treatments.”

  “And how is the approval process for Breakthrough Therapy sped up—or expedited, as you put it?”

  “FDA staff will work more closely with the manufacturer, to design clinical trials, for example, that meet our criteria. In addition, the drug or biologic is eligible for expedited review, including a process called accelerated approval.”

  With Moses prompting, she then goes on to explain accelerated approval, which means the FDA will allow a medication into the marketplace with less than the three to four years of clinical testing usually required. Instead, the drug is approved based on a so-called surrogate endpoint, a shorter period when, for similar medicines, the benefits are normally clearly established.

  Dr. Robb is probably the most polished and effective witness the government has called yet, treating a mass of technical material with clarity, and the jury appears to be following her closely. That is not good for Kiril but, in Stern’s view, just as well. The saying is that a stupid jury is a prosecution jury. Jurors who can’t understand the evidence can only fall back on their native prejudices, which usually include a belief that defendants are ipso facto guilty. On the other hand, Stern has seen instances when a jury’s confusion led to reasonable doubts. But theory is beside the point. In the last six decades, Stern has learned that you can only be who you are. A
jury that prefers style over substance is not likely to be wowed by Sandy Stern. For him, an appeal to jurors’ innate intelligence has always been the best approach. At this stage, after a week and a half, he can usually get a good sense of what is going on in the jury box, even though he does his best not to study them for prolonged periods, which Stern knows makes some jurors feel like animals in the zoo. This bunch seems extremely alert, and several smile whenever he gets to his feet. Either they like him—or find him ridiculous.

  “And after granting Breakthrough Therapy designation, did the FDA and PT arrive at a plan for a clinical trial that would support accelerated approval?”

  “We did.”

  “Can you explain what a double-blind clinical trial is?”

  “Yes. The most objective way to test a medication is to compare it against another treatment whose effectiveness has already been well documented. That kind of comparative trial means some patients will receive the new medication that is being evaluated, while others receive the therapy that is within the current standard of care. A trial is double blind when neither the patients nor the physicians and their site staff know which medication the patient is receiving. In order to ensure that that veil of ignorance is maintained, usually the manufacturer and others directly involved in the testing don’t know either.”

  Dr. Robb then details a series of meetings between her and her staff on one side and Lep and his chief deputies on the other. Kiril was not at any of these conferences, a point Marta emphasizes by popping up and asking each time for Dr. Robb to name who was present. As a result of these discussions, PT and the FDA agreed on a double-blind clinical trial designed to last eighteen months and involving two hundred patients receiving g-Livia and another two hundred receiving an established form of chemo. The test protocol, the size of a dictionary, is marked as an exhibit by Moses and entered into evidence.

  “And with regard to that clinical trial, did PT intend to conduct this test itself?”