The Antidote: Inside the World of New Pharma (46 page)

“A well-meaning physician at the time told me I would not see my son graduate from high school,” Mann-Hester said. “He had just started kindergarten. I walked out of that doctor’s office that day and told my family that wasn’t an option, obviously . . . I’ve done interferon, interferon with ribavirin, pegylated interferon with ribavirin at half strength, pegylated interferon with ribavirin at full strength, and now with the telaprevir. Telaprevir gave me the clear.”

For seventeen years, Mann-Hester had expected to die young. She didn’t plan for retirement. Now she needed to. Standing at a microphone in the center of the room, she went on: “I did get the telaprevir rash. I had it on my hands, my legs, and my feet. But it was of very little consequence to me, and would it have made a difference if you were telling me it would save my life? Absolutely not. I would do everything in my power to save my life.

“I was in a place where I was living to die. In my mind, I thought this was going to be the thing that would take me. I had already accomplished my goal, which was to see my son not only graduate from high school but from college. And so I had no hope left, that I thought I was going to live with this disease to die. Now I’m living
until
I die, which is a whole new concept for me, because now I have many windows and many avenues available to me that I did not have before. So I wholeheartedly am asking you to please approve this drug for the general public so that other people can tell my story at some point in time.”

As the panel finished its questioning throughout the afternoon, the mood lifted, markedly. Lawrence Friedman, a gastroenterologist who had written more than one hundred textbook chapters and who teaches at both Harvard and Tufts medical schools, saw telaprevir in historic terms, and he went on record to lavish high praise on Vertex even before the voting, which was conducted by secret ballot, with panelists afforded time afterward to comment. As part of its presentation, the FDA provided a reinterpretation of Vertex’s SVR rate, raising it from 75 percent to 79 percent. Friedman hailed the revised figure. “Considering where we started with non-A, non-B hepatitis, I think that it’s a stunning achievement that we will be able to cure nearly eighty percent of naïve patients and probably the same number of relapsers, two-thirds of whom
will only have to take treatment for twenty-four weeks,” Friedman said. “We’ve almost completed a transformation of genotype one into genotypes two and three, which I think is just a remarkable success story.

“The other important aspect of this drug is that the protocol for using it is relatively simple, and it’s familiar because what we’re doing is basically using the same milestones we’ve used for peginterferon and ribavirin and grafting the new protocol onto that. And the drug that is causing us concern in terms of its side effects is only used for twelve weeks. And there’s some wiggle room because if you have to stop it a little early, you might not sacrifice success.

“So I think there are so many positive aspects of this drug, and for those of us who have been in the field, this is a very exciting moment.”

John Alam’s determination to shorten treatment, sparked nearly a decade earlier by his dying father’s illness, as much as any one factor drove Vertex’s clinical strategy. Friedman’s point-by-point endorsement many years after Alam himself had disappeared into the mist of what Ken Boger called “the ghosts of Vertex executives past” testified to his efforts and his urgency. A chorus of accolades built swiftly as the first seven panelists explained their “yes” recommendations. One by one, they thanked Vertex for the thoughtful elegance of its presentation and praised telaprevir—a “tremendous advance,” as Dr. Doris Strader, a Vermont gastroenterologist, called it. Patrick Clay, sitting impassively, was the lone question mark.

Clay explained that he too voted yes, but he downplayed his endorsement, reminding the panel of what he saw as the larger imperative: a better cocktail, soon, while other lives depended on it. “The benefits far outweigh the risk in this, and it is yet another step,” he said. “And that’s all it is. There’s still a long way to go. This is a marathon, not a sprint.”

Nearly all the other committee members effused. Lynda Marie Dee, the patient advocate who’d chided Merck for its purposeful obscurity, raved about Vertex’s careful attention to clarity, transparency, and clinical utility. As Kauffman, Pace, and the company’s image-making team had anticipated, a drug is one thing, a drugmaker’s actions another. Dee said: “You know, there’s a discussion often among activists about whether drug companies should ever get A’s; we do a report card in one
of my groups . . . I won’t say that this is an A, but it’s very close to it. I’m very grateful for such clear data, for such concise rules about how to do this, such manageable toxicities. It was a great, really, really excellent application.”

At about four o’clock in the afternoon, an enthusiastic 18–0 vote granted Vertex all it needed and more: a final, unimpeachable seal of approval; the guarantee of a strong label at launch; official parity with Merck; a sense that the last line of the blockade was down and that the ships, at last, after more than twenty years and a total investment of nearly $3.6 billion, could start steaming through. Goldman Sachs immediately sent a note to investors, raising its estimate of Vertex’s chances of approval to 100 percent.

For Vertex, the AdComm was a coronation—its most visible benediction yet, in the arena that mattered most. As for the world beyond, Clay’s point, though voiced begrudgingly, was real. Now that there would soon be available a type of drug—a protease inhibitor—that in combination with the standard medicines could double the cure rate and halve the treatment time for patients with hepatitis C,
what then?
Dr. Debra Birnkrant, FDA’s director of antiviral products, posed the question, asking panelists to consider what impact the advent of a dramatically improved standard of care would have on the scores of molecules, singly and in myriad combinations, already in human testing. Having to face the rest of the industry, she seemed to want both guidance and cover. Birnkrant:

“Thinking about phrases we’ve heard based on the data we’ve seen over the last two days—that this a game changer, a paradigm shift, and a new era—can you comment on the impact of these drugs on current and future clinical trials with regard to standard of care or control arm? . . . The future is here. It’s not really that far away, and we have to make some tough decisions. And that’s why I wanted to get some input, so that when we go back to companies, we can state the obvious but then have the backing of this committee.”

Two hours later, the team was back in Bethesda, crowded into the wine bar at the Doubletree. Mueller, hoisting a flute of champagne, delivered a long, grateful toast, recognizing one by one the people
in the room for their contributions, including the group from Tibotec. Not normally this generous with praise, he was magnanimous, laughing heartily, plainly moved. “Usually I say just something is pretty good,” he said. “This was stellar.”

One of Cumbo’s first decisions after becoming interim vice president of sales was to reschedule Launch Week, moving the traditional sales meeting/pep rally up to the beginning of May even though telaprevir wouldn’t be approved for several more weeks. The chief risk was that Vertex’s field force would train without knowing what was in the final label, but Cumbo wanted his representatives to be ready to start calling on doctors—and outhustling Merck—on “Day One.” Meant both to educate and energize, launch meetings combine the intensity of a maximum-stakes pre-exam crash course with the high-octane buzz of a casino. A recent Hollywood comedy,
Love and Other Drugs
, included its own version of a Pfizer launch meeting, featuring go-go dancers, the Macarena, and sales leaders who sleep with their trainees.

The commercial purposes of the daylong events—informational sessions, role-playing, KOL lectures, compliance training—were self-evident. Vertex needed to align its reps with the rest of the commercial team, which was rolling out, in waves, a broad educational campaign about hepatitis C and HCV testing; a twenty-four-hour patient hotline; an assistance program to help patients get and, if necessary, pay for its drug; and a city-by city marketing campaign for telaprevir under the trade name Incivek (In-see-veck). Yet, as ever, questions of identity, of values and vision, predominated. Now that Vertex had a drug and a sales force, it could ill afford to have its reps act like, as someone commented, “coin-operated machines.”

Ken Boger planned to retire as general counsel in September—ten years after joining Vertex during the upheaval after 9/11 and the crash of the immunosuppressant VX-745. Standing on the low stage in the America Ballroom at the Westin Copley Place hotel in Boston’s Back Bay in a seasoned sports coat and tie, in front of the undulating digital backdrop that a few reps half-joked might induce seizures, he looked like a hologram of someone’s tough but affectionate uncle, lovable but not to be
messed with. He cushioned himself against the pounding rock music that the audiovisual team cranked up to introduce new speaker segments by concentrating on his terse, five-hundred-word speech. Smiling broadly, he began:

“I’m actually very happy to be here today . . . even at eight in the morning. I mean, at this podium, in this city, and at this company, which is on the verge of beginning to achieve a dream that was twenty years in the making. I say ‘beginning’ because our founder—and I understand you heard from him yesterday, and he’s my little brother, and that’s okay—he said, with characteristic hyperbole, that in starting this company that he wasn’t just interested in making drugs, he wanted to change the world. I’m gonna get back to that, but it is, in fact, part of our goals at Vertex. It’s fundamental to our corporate identity, and it’s fundamental to our brand.

“But let me digress for a minute. Who do you suppose was the most admired company in America in 1987, according to a
Fortune
magazine poll. Any guesses? Right, Merck. I’m not going to pick on Merck—actually I am; it’s gonna be a lot of fun. So who do you suppose was the most admired company in America in 1988? Merck. In ’89? Merck. In 1990? Merck. In ’91? In ’92? In ’93? All Merck. In 1993
BusinessWeek
called Merck a ‘national treasure.’ ”

For those like Ken who had been with Vertex from its earliest days, the specter/example of that Merck still burned—a sustaining inner flame. Boger’s decision to leave Merck in 1989, at the height of its glory, was their shared backstory for everything since.

“So now let’s fast-forward to 2011,” Ken continued. “Neither Merck nor any other pharmaceutical company was in the
Fortune
magazine top
fifty
most admired companies, other than J&J, but people who make powder and Band-Aids don’t count in this analysis. That was despite the same language you see from 1993 about integrity, transparency, and patient focus being used by Merck executives throughout the two decades leading up to the present. An integral part of Merck’s corporate brand was trust, and they lost it, even though they spent a lot of time talking about trust and patient focus.

“The patient wasn’t there when Merck launched a phony journal in 2002 to 2005 in a format designed to convince people it was a real peer-reviewed journal—just to pump their drugs. The patient wasn’t there when Merck made a hit list of doctors to be discredited or intimidated for raising issues about Vioxx, and withheld that data about Vioxx-related adverse events. There are a lot of other examples, not just from Merck, but across the industry over the last two decades.”

Post-Vioxx, Boger’s desire to differentiate Vertex from Merck had taken on a deeper moral gravity, and Ken had been both the company’s wise man and its enforcer. He felt the salespeople needed to understand what Vertex had at stake, not just reputationally, but in what it could become.

“So going back to the founder, who said he wanted to make drugs
and
change the world, that doesn’t mean that personal goals don’t play a role. One of our earliest advertising slogans was ‘Ambition will cure AIDS before compassion will.’ I really loved that. It wasn’t necessarily the most effective ad, but I loved it. It said a lot to me.

“It doesn’t mean that financial goals don’t play a role. The first part of George Merck’s famous slogan from the 1950s was to never forget that medicine and the drug business are for the patient. The second part of that slogan said that if you remember the first part, profits will follow. What the founder meant was that we focus on serious disease, and significant unmet medical need, with the principal objective of transforming patients’ lives. It’s a fundamental part of our corporate identity, it’s a fundamental part of our corporate brand.”

Vertex prides itself on having zero tolerance for legal and ethical lapses. Ken’s twin brother, Jack, dean of the University of North Carolina Law School and a renowned anti–death penalty champion, tells a story that Ken says illustrates how companies should handle violators. An old political grandee at the school advised Jack on his first day on the job that he should grab the first person he saw and throw him down the stairs: after that, there would be no more trouble. Ken wanted the company’s newest hires—in what had become a disreputable business of bribing doctors with cash and favors, practices both government and industry
were now cracking down on—to understand just how their actions would reflect on Vertex.