If some of the central figures in his life—his first wife, Clara, the mother of his children, who died a suicide in 1989; or Peter, his eldest child; or, in rare moods, Helen, who left Stern a widower again two years ago—if they were present to hear Stern sing lyrics about his clients, his family would ask pointedly, ‘And what about us?’ To their implicit accusation, Stern, ironically, has no defense. The brute fact is that his energies and attention have often been entirely consumed by the courtroom, leaving less than he would have liked for the people he claims to love. All he can offer in response is candor: This is the life I needed to live. At eighty-five, he is certain that without it, he never would have known himself.
2. The Witnesses
Timeline of Critical Events
12/9/14
FDA designates g-Livia as Breakthrough Therapy
4/1/15
Eighteen-month clinical trial of g-Livia begins
9/15/16
Kiril Pafko learns of sudden deaths of clinical trial patients on g-Livia; trial database altered to omit deaths
10/27/16
PT submits altered database to FDA for g-Livia approval
1/16/17
g-Livia approved for sale by FDA
8/7/18
K. Pafko tells reporter he’s never heard of sudden deaths of g-Livia patients; sells $20 million worth of PT stock
12/12/18
Kiril Pafko indicted
In his opening, Moses was himself, methodical but brief. His great gift with juries is sticking to essentials, and he did a good job explaining a somewhat complicated case, illuminating his ‘Timeline’ on a sixty-inch monitor wheeled in front of the witness stand. Moses’s account started in 2014, when Pafko Therapeutics presented the FDA with early test results for g-Livia. Patients with non–small-cell lung cancer who’d received the medication even for a few months showed dramatic improvements compared to those on the current standard therapies. The disease spread more slowly, and in many cases tumors had actually receded.
The FDA granted g-Livia Breakthrough Therapy designation, which could speed the testing and approval process. In consultation with agency experts, PT planned an eighteen-month clinical trial of g-Livia. Assuming the product again showed the same clear benefits and extended lives, the medication would proceed to final FDA approval and become available for prescription years earlier than normal.
Days away from the completion of that trial in September 2016, troubling reports reached Kiril, through his son, Lep, PT’s medical director. Starting in the thirteenth month of the test, roughly a dozen patients at clinical sites around the world had died suddenly for unaccountable reasons that seemed to have no connection to their cancer. Instead of leaving the matter to a panel of outside experts who, by protocol, were supposed to investigate such reports, Kiril looked into the issue on his own. According to Lep, Kiril told him he had consulted the company in Taiwan administering the trial, which quickly recognized that there had been no sudden deaths. A simple coding error had mislabeled patients who had withdrawn from the study—as patients always do—as fatalities.
The database was changed—corrected, Kiril might say—and soon after submitted to the FDA. In January 2017, the FDA approved g-Livia for sale to the public. PT’s share price skyrocketed, especially after a bidding war erupted between two large pharma companies to buy the concern. But in August 2018, before the acquisition by Tolliver, the winner, was completed, a reporter from the Wall Street Journal phoned Kiril, seeking comment on a pending story. The Journal was about to publish an investigative piece stating that after more than a year on g-Livia, isolated cancer patients were dying suddenly of a suspected allergic reaction. Kiril told the reporter he knew nothing about any sudden deaths, but moments after he put down the phone, he secretly ordered the sale of roughly $20 million worth of PT stock. Once the Journal story appeared, the value of Pafko Therapeutics shares plummeted, crashing almost completely several weeks later, when the FDA publicly questioned the clinical trial data for g-Livia. Kiril Pafko’s indictment by a federal grand jury in Kindle County followed soon after.
In presenting this summary, Moses has used only forty of the fifty minutes Judge Klonsky has allotted to each side for opening statements. His brevity is meant to signal to the jurors that despite the foreign world of drug testing, the crime is clear. But the US Attorney’s simplifications create some opportunities for the defense. Stern asks Moses to bring the Timeline back up on the monitor, a request the prosecutor may not refuse but which causes obvious consternation at the prosecution table, where nine investigators and lawyers are seated. Aside from Moses, the only other person there who will address the jury is a lean young assistant US Attorney with a glossy mop of black hair named Daniel Feld, presently typing on his laptop with the passion of a concert pianist.
“As always,” Stern says now to the jury, after elaborating on Kiril’s presumption of innocence and the government’s heavy burden of proof, “there are two sides to the story and some vital facts Mr. Appleton chose not to mention to you. At the very heart of the charges that the government must prove beyond a reasonable doubt”—Stern, as ever, speaks the last four words with slow weight—“is their claim that Kiril Pafko is responsible for altering the results for the clinical trial of g-Livia in September 2016, erasing evidence of a dozen sudden, baffling deaths. Despite all the fanfare—testimony from Dr. Pafko’s colleagues, forensic analysis of Kiril’s office computer, records of his phone calls—after all of that, you will learn that”—Stern pauses before again laying emphasis on the next words—“Dr. Kiril Pafko altered nothing. Not in September 2016 or any other time. Nothing.”
With that, Stern nods to Pinky, who is triggering her laptop to display slides on the giant monitor, emphasizing Stern’s principal points. The Timeline fades out and the phrase “Kiril altered nothing” appears on-screen. Pinky, who is also at times her grandfather’s roommate, is a frequently infuriating employee. Marta would have fired her sister’s daughter long ago, but Stern continues to hold out hope. Still, he could not contain a swell of relief that Pinky actually showed up at work this morning, or again now when it appears she’s kept the slides in the correct order.
“But didn’t Mr. Appleton say the results were altered? Yes. But not by Kiril. The changes were made in Taiwan, by Dr. Wendy Hoh, who works for the company that was conducting these trials for PT. You will see Dr. Hoh as a witness, and you will have an opportunity to listen to her. The evidence will show you that her reasons for altering this database were not as the government describes.
“In point of fact, you will see that the motives the government imagines are often just that—imaginary. For example, Mr. Appleton suggested that Dr. Pafko committed this fraud in order to become a megamillionaire. Yes, the value of PT’s stock rose steeply once g-Livia was approved by the FDA. g-Livia is a remarkable medication, and it was no surprise that big pharma companies immediately wanted to buy PT. But since g-Livia was first given Breakthrough Therapy designation, from that day until today, Kiril Pafko has not grown a penny richer personally by selling PT stock. Mr. Appleton did not think it was important to tell you that.”