How to Survive a Plague: Going Rogue

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Unable to get his hands on a promising AIDS pill that could save his dying lover, Tom Blount set off on a wild and illegal quest to knock off the drug himself

It seems a lifetime ago that a diagnosis of AIDS was a certain death sentence. Now that advanced therapies and sophisticated medical regimens have transformed HIV/AIDS into a chronic, manageable condition for those able to afford them, it’s easy to put those dark days out of mind.

       For anyone who lived through the devastating early years of the epidemic, though, the fear, hatred, and violence with which people with AIDS were treated is a memory that won’t soon fade.

            In those years, an extraordinary coalition of LGBT activists and allies sprung up to battle a killer virus (and the virulent response to those affected by it) by manning the front lines: investigating, organizing, and refusing to die without a fight—or let their friends and loved ones die. Journalist David France documented that unprecedented battle in his Oscar-nominated 2012 documentary How to Survive a Plague. Now, with a much-anticipated new book of the same title, France unveils the inside story of a how an unlikely group of people with little in common but a shared enemy triumphed against enormous odds, both scientific and human.

            The remarkable story of Tom Blount is just one example. In the early nineties, Blount, an architect whose lover was dying of AIDS, sat on the community board of Merck, a giant pharmaceutical company heavily involved in the search for a cure. After producing countless drugs to combat the epidemic, to often fruitless or dangerous effect, in 1992 Merck finally lit upon a promising new discovery—an experimental compound called Crixivan. Unfortunately, Blount’s fast-declining lover was not eligible to take it. Unwilling to take no for an answer, Blount quit his job and embarked on a wild mission to produce the pill himself. This is his story.

 

Three of the most vocal members of Merck’s group of community advisers—Bill Bahlman, Marty Delaney, and Tom Blount—were obsessed not with the large sample trials of the company’s new med, nor with the eighteen thousand patients who were taking it. Instead their attention was fixated on a single test subject: Patient 142.

A year after he started on Crixivan, Patient 142 remained at undetectable viral levels, the only person in the world who had held HIV at bay in such a dramatic manner.

Hoping to learn 142’s secrets, the company obtained permission to break the study code to find out who the patient was. It turned out to be a young man from San Francisco.

A Merck executive who reached him by phone found the patient to be smart, engaged, and, perhaps significantly, a stickler for taking his doses at precise intervals. When he first joined the study, he was in quite good health, though his viral load was very significant, with substantial CD4s. And he had never taken any previous medicine for his HIV infection.

In the following weeks, the company began enrolling patients in a small study, attempting to replicate its success with Patient 142.

Among the activist advisers, Tom Blount was the most enthusiastic about the research. He had quit his job as an architect and founded the Atlanta Buyers Club to acquire every experimental compound he could locate in his effort to save his partner, Jim Straley, who was quite sick and getting sicker by the day. None of the country’s buyers clubs had access to more medication than the Atlanta group, but nothing made a difference for Straley. Blount, born into a prominent and wealthy Republican family—his father had been Nixon’s postmaster general—saw Crixivan as his lover’s last hope.

The study criteria were strict. Merck was looking for patients a lot like Patient 142: healthy upon admission, with high CD4s, and a heavy burden of viral activity. Straley met some of those criteria, but not the final requirement—that the test subject be treatment naive. Straley had tried nearly every available drug, experimental or not. He was rejected from the test in June 1994.

Blount ran an appeal all the way up to the principal investigator at the Birmingham, Alabama, enrollment site, an infectious disease specialist named Michael Saag, pleading for an exception to the rules or, at the very least, access to the drugs on the parallel track. It didn’t work.

“I can’t believe that Jim’s life has such little value to everyone but me,” Blount wrote in a bitter fax to Saag. “[T]he decision to not allow at least some compassionate use is completely immoral.”

When the trial began that September at a handful of hospitals around the country, Blount tried a different tack. He flew from one participating hospital to another, hunting down the patients who had been accepted and begging them for a few of their large, unmarked white capsules. Everyone donated some—such was the camaraderie in the plague’s trenches. In total, he had amassed, perhaps, a month’s supply. If he repeated his tour, he might be able to double his cache, but he knew he was unlikely to contribute meaningfully to his lover’s health as a beggar.

So he took a handful of the capsules to a shady outfit in Brooklyn that specialized in bootlegging prescription medication as unlicensed generics. Tom Blount was going rogue. He liquidated various portfolios and sold one of his homes, plowing $300,000 into his campaign to illegally replicate one of the most complex pharmaceutical compounds ever invented. He was prepared to do whatever it took.

When the preliminary results for Crixivan were in that winter, [Merck’s head of vaccine research] Emilio Emini convened the company’s community advisory board, inviting a dozen or so activists to the company’s modest conference room in Rahway, New Jersey. About fifteen company officials joined them. Emini spoke cautiously. There was no exact repeat of Patient 142, but the results were still impressive. For a small subset of fifty patients in the study, his team initiated combination therapy, adding in one of the nucleoside analogues like AZT or DDI.

Both approaches led to excellent results, at least for the short duration of the test. But the two-drug combination was better in every measure, especially in patients who hadn’t taken one or the other of the drugs as monotherapy in the past. It was just as [activist]Mark Harrington had speculated years earlier: HIV mutated less when two different drug types were combined. Emini couldn’t be sure resistance wouldn’t eventually develop to cause the drug combinations to lose effectiveness. But the snapshot today was better than anything they had seen before.

Bahlman felt a chill of raw excitement. The other activists present felt similarly. This was the juncture that Jules Levin, a member from Brooklyn, had only dreamed of. A straight man with the disease, he hadn’t been in the ACT UP trenches, so he hadn’t ridden the unhappy roller coaster of dashed hopes. This news looked like a gift from the heavens. His first thought was urgency. “We need a parallel-track program right away,” he said.

“We can stop the dying!” agreed Bahlman. “You have to implement those procedures as quickly as possible. And get the drug approved as quickly as possible. It’s a humanitarian necessity.”

Emini shook his head. The small study wasn’t enough; the company needed to conduct a very large phase 2 trial in order to know how well Crixivan performed. With a late-fall start date in mind, they gave sixty-seven medical centers in the US, Canada, Australia, and seven European countries approval to begin enrolling patients. But the drug was fiendishly difficult to make. It would be another year before Merck could produce enough, and then a year for the trial to reveal its secrets. If the results were good, then Merck would have to build a new plant to produce Crixivan in commercial quantities.

Emini didn’t reveal that there was already a secret race to get the plant built. Joseph Vacca, a senior chemist, personally pressed the company’s new chief executive, Ray Gilmartin, to check on Patient 142 himself. The experience moved him to give preliminary construction approval, a move the board of directors would be right to question. The plant would have a technically difficult task. Crixivan’s complex production required fourteen painstaking steps, considerably more than any other drug. It took four months for Skip Volante, the unflappable head of process chemistry, and his team to manufacture enough for fifty patients. Hoping to cut production time, they devised a process for making the molecule in three prefabricated segments, then “snapping them together” like Lego pieces, but it was still painfully slow. Each patient in the phase 2 study would need about one kilogram of Crixivan a year—fifty to one hundred times the dose of a typical drug. To make that much, the company was running the Rahway plant at full capacity.

Emini told the CAB members it would be years before Crixivan could be released on a parallel track.

“It’s my job to advocate for people with AIDS,” Bahlman said after a long silence. “We need this drug. How can I know that what you’re telling me is true?”

Tom Blount was not so polite. “You’re lying,” he told the Merck officers.

Paul Reider, the company’s VP, had listened to the pleadings silently. “Tom, you don’t believe us? Why don’t you come in and look? As long as you sign a secrecy agreement, we’ll show you everything.” No one could recall a time when a drug maker had opened its doors to scrutiny from its customers. “Bring an expert with you,” Reider insisted. “And if you can help us do it any better, let us know.”

That afternoon, Blount was on the telephone with his Brooklyn contact asking him to recommend an expert. He knew just the man, an industry consultant in process chemistry based in London named Trevor Laird. Blount sent Laird an airline ticket.

“Blout’s spy met them at Merck’s parking lot, dressed like an eager graduate student. The three were allowed inside without questions.”

Tom Blount’s efforts to clone Crixivan progressed at an excruciatingly slow pace. The Brooklyn compounder, an orthodox Jew, lost some time around the Jewish high holy days. But he was able to break apart the three prefabricated segments of the molecule. One of them, the simplest, had already relinquished its secrets; he was halfway toward decoding the second. His methods were nefarious. He and his colleagues would dispatch agents around the country anytime a Merck scientist gave a technical presentation, scribbling notes and asking sharply detailed questions. They had been nearly discovered at Harvard recently. Dr. Reider was there to discuss the molecular properties of the HIV protease when a scruffy man in a trench coat caught his eye. The man slid into a front-row seat, “a place where nobody in their right mind sits,” Reider said later, as the seating convention at Harvard was sacrosanct. No one but Nobelists and full professors took the front row. But this guy hunkered down there conspicuously, hunching over his notebook. Following his talk, Reider wanted to ask the intruder who he was, but he vanished without a trace.

Blount, meanwhile, was monitoring the official Merck trial through his sources at the various testing sites. By January, patients in Birmingham and Philadelphia fared so well in the phase 2 trials that officials were hurrying to enter phase 3 and quietly gave all final approvals to build large-scale production facilities. It looked as if Crixivan would be available by the end of the year. But this would be of no use to Jim Straley, who was now so weak he barely left bed. Blount pressed his man in Brooklyn to perform miracles. In a phone call in January, he reported that his team of chemists was getting close, but they still lacked key information. He wanted to talk about the upcoming meeting at Merck where the outside expert would evaluate the company’s plant capacity.

“You have to take another person with you,” said the bootlegger, in a thick Brooklyn accent.

This didn’t seem possible. Merck had asked the activists to sign a nondisclosure agreement before returning to the facility. He worried about discovery.

“I don’t know if we can,” Blount said. He offered to get the information himself, but his compounder believed the task was too technical.

“Listen, there are some specific questions I have to ask in a specificway,” he said. “I need to [send a specialist], and he’s going to be wearing a wire,” the drug cloner said.

To which Blount replied, “Oh.”

When the day came, January 11, it was clear that Jim Straley could no longer wait for Crixivan. Blount went to the refrigerator to retrieve the thirty-day supply he had begged and borrowed. He had to help lift Straley’s head onto a pillow so he could swallow his first capsule, not worrying for the moment what they would do when the supply was exhausted.

Blount tucked Straley back into bed and raced to the airport for a 6:50 flight. Jules Levin, his fellow [community advisory board]member, met his plane in Newark and drove him to the Merck plant, thirty minutes away. Along the way, Blount took Levin into his confidence for the first time. He confessed to his secret bootlegging work and revealed that a person with a wire would be joining them. Levin was furious at first, but he knew there was no stopping Blount. He agreed to stay silent.

“And I thought you were this simple architect from down south,” he said finally.

“‘You are so full of bullshit!’ he screamed, slamming a fist on the boardroom table. ‘I know what happened in Birmingham. I know what happened in Philadelphia.'”

Blount’s spy met them at Merck’s parking lot, dressed like an eager graduate student; the three were allowed inside without questions. Trevor Laird, the London expert Blount had hired to advise the activists, joined them in Merck’s boardroom. John Doorley, the head of Merck’s public-relations team, opened the meeting with a few words meant to lower expectations about the tour and the drug itself. Until that moment, Blount hadn’t realized how raw his emotions were. He exploded, slamming a fist on the boardroom table. “You are so full of bullshit,” he screamed. “I know what happened in Birmingham. I know what happened in Philadelphia.” He glowered at the entire Merck team. “Not only do I know this is it. I know that you know this is it.”

Nervously, Merck’s Skip Volante, a short man with a stutter, talked fast and openly about the company’s limits. Work was set to begin in March to retrofit two Merck plants in Elkton, Virginia, and in Flint River, Georgia, even without FDA approval. None of the company’s other facilities was capable of producing Crixivan. The pilot plant in Rahway was operating at full capacity to meet the needs of the ongoing trials.

Volante explained each stage of the manufacturing process and demonstrated how the prefabrication had saved time. It remained an onerous process, he said; it took seventy-seven pounds of thirty raw materials to produce just 2.2 pounds of the drug, enough to supply one patient for a year. The company had to find a way to cut the time and increase yield dramatically.

Trevor Laird saw that one of the fourteen steps, coming toward the end of the syndication chain, was creating a bottleneck. This was not news to Merck. “We had been working on that step for four months, trying to improve the yield and the productivity of that step,” Volante explained.

Laird was satisfied that Merck was doing all it could.

This upset Blount. He was near tears when he turned to Paul Reider. “Currently, how much can you make for an expanded-access program?”

“Tom, we’re doing more than is possible already,” Reider said. The pilot plant was running hard, from 8:00 a.m. to 4:00 p.m. every day. “If we did any more, we’d jeopardize the whole program. Think about the risk. If we go back to the small equipment and run double shifts, that’s nothing. That’s, like, four hundred kilos.”

Blount did a quick calculation. “Four hundred kilos is enough for four hundred people,” he said bitterly. Tears filled his eyes as he turned to leave, stunned that Merck wouldn’t automatically run the plant in multiple shifts. At the door he spun to fire a finger at the executives from Merck. “Four hundred people? That’s like a fully loaded 747. You have the ability to save it, and you’re not doing it!” He was crying violently. “Every one of them is a human being,” he said, then slammed the door behind him.

The room fell silent. Nobody said it, but it was impossible not to think of the 747 that had fallen from the sky over Lockerbie all those years ago, taking the life of Irving Sigel, their former team leader, and the man who first hypothesized the power of protease inhibitors. Emilio Emini would later say that this was the first time he clearly saw the end users for his products as individuals rather than market segments.

The next morning, Paul Reider called Blount.

“We’ll do it,” he said. “We’ll get your four hundred kilos.”

“There would be no back-channel access for the rich or connected. If Magic Johnson wanted Crixivan he would have to go through the same lottery.”

Over the next few weeks, Tom Blount witnessed a miracle in Atlanta. His lover’s turnaround was breathtaking, “like watering a wilted plant.” Now he had to find pills to replenish his supply. At the pilot plant in New Jersey, frantic efforts were under way to add the necessary shifts for a parallel-track distribution. Some four hundred employees were assigned to the task, a risky undertaking that had already cost Merck over a billion dollars. Skip Volante tried again to streamline the bottlenecked manufacturing process. It took another chemist, a young PhD whose mother ran a Greek diner in Queens, New York, to break the bottleneck. He did this by adding a dash of baking soda at a key point, changing the pH and doubling the output. (“Every cook knows you add baking soda,” his proud mother boasted.)

Meeting again with Levin and Blount a few weeks later at a hotel near Newark Airport, Merck’s people committed to supplying enough Crixivan for 1,100 people in just a few weeks.

How to select the recipients became an immediate problem. Thousands and thousands of people were literally on the brink of death. Levin suggested a national lottery. The proposal revolted Bill Bahlman. He thought it was inhumane to make people with AIDS to scramble for lifesaving pills as if they were candies spilled from a piñata. But as nobody had a better alternative, he accepted it with a proviso: that there would be no back-channel access for the rich or the connected. If Magic Johnson wanted Crixivan, he would have to go through the same lottery. The same for Jim Straley, whose secret stash was now gone.

“I could never ask you for a supply just for him,” Blount told Reider. “That’s good,” Reider replied, relieved.

At Merck’s request, Bahlman and Levin agreed to set up the lottery mechanism and monitor it closely. Two million copies of a simple black-and-white brochure went out trying to identify patients with extremely low CD4s, under fifty. An 800 number was set up for people seeking registration forms, which needed to be signed by a doctor. In just six weeks, doctors submitted the names of twelve thousand critically ill patients for inclusion in the lottery.

To avoid any appearance of favoritism, an outside company was retained to manage the selection process. Each patient was assigned an identifying number, and those numbers were sent to the Boston office of Ernst and Young, the same firm that counts secret ballots for the Oscars. A computer program was used to randomly select the lucky patients. Selections would be announced by the summer.

While awaiting word if Jim Straley would make the cut, Blount was on the telephone almost daily with his contractor in Brooklyn. Using a clumsy but working formula, he had produced a small number of samples. Just then the underground team hit a wall. Manufacturing more of the compound required an ingredient that was sold by a single manufacturer, Nippon Soda, in Japan, and Merck had cleaned them out.

By coincidence, Paul Reider was scheduled to give another technical briefing late in February at Emory College in Atlanta. The lab in Brooklyn was sending a secret representative. Blount decided to go along as well—and beg for the hoarded ingredient.

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Inside the meeting, Reider was again shaken by a feeling of being followed. A technician in the audience pestered him with questions and then vanished before Reider could inquire about his interests in Crixivan. “That was eerie,” he complained to Blount later that evening over dinner at a Japanese restaurant in Atlanta. He was beginning to suspect corporate espionage. “The only way to ask those questions is if he actually had run the chemistry in his own hands.”

Blount, who had had a little too much to drink, took another sip and turned to face Reider. He knew he would have to come clean sooner or later. Now he had no choice.

“Paul,” he said. “Every now and then life brings you to a watershed. You come to the point where you realize it’s all or nothing. Sometimes it’s in a form where I’m in right now, where I have to trust you with something you can kill me with.”

Reider smiled warmly. Over the previous year or more, he had developed great affection for Blount and the other activists. “You can trust me, Tom,” he said.

“Paul, it’s me.”

Reider caught his breath.

“It’s me, Paul. I’m knocking off the drug.”

A broad smile came across Reider’s face. “I can’t believe it,” he said.

“Now there are two things I need from you. I need this element you’ve locked up at Nippon Soda. And I need you to test what we’ve made because I don’t want to [have]a bad drug out there. That’s my nightmare.”

Reider shook his head in disbelief and begrudging admiration. “Send it to me,” he said.

“You won’t try to stop us?”

Reider waved away Blount’s concerns. “It’s unlikely you’ll get the mix,” he said. “It’s more important you don’t hurt anybody.”

And in a day or two, the Brooklyn compounder called Blount with news. “I don’t know what happened, but we have access to all this element now.” With the chemical in hand, they quickly finished the assembly, breaking Crixivan’s secret code.

“Good,” Blount said. “Now I need you to send some of our compound anonymously for Paul Reider to test.”

In a few weeks, Reider gave his opinion. “It’s good,” he said.

By this time, though, Blount was beginning to see the impossibility of his undertaking. Making Crixivan was one thing; making it in large-enough batches even for one patient to maintain his dosage over time, relying on the erratic appearance of various ingredients, seemed like folly. He kept his doubts to himself, anxious to maintain pressure on Merck.

“I’m going to call it Stralevir,” he said, an homage to Jim Straley.

“How much do you plan on making?” Reider asked.

“I figure about thirty thousand the first year,” he said. “My estimated cost is around $2,000 per person.” Reider did the math: Blount’s knockoff Crixivan could take away $60 million a year from Merck’s bottom line. Reider couldn’t let that happen—which was just the reaction Blount hoped for.

Michael Seggev, Merck’s junior community-affairs specialist, was focused on enrolling the lottery winners as rapidly as possible. He received an onslaught of letters, many from mothers or lovers, that changed his plans. They began, “I am so grateful for what your company is doing. But sadly, he has passed away. I know that he would want someone else to get his medicine, so can you please pick the next person on the list?” Seggev was impatient. “Hurry up,” he urged the fulfillment company. “Get the next person on the list. I mean, we have the drug—we’d better use it.”

By summer, the 1,100 recipients had been chosen. Among them was a CAB member, Linda Grinberg, who had thirty CD4 cells left and was months past the date her doctors had predicted her demise. Too weak to travel, she had missed most of the board meetings in the past year. The drugs hit her like something from science fiction. Her immune cells shot up with Crixivan, and her viral load plummeted. She felt marvelous for the first time in years. She discovered an inner peace that made her the envy of her friends. She even started dating again, in her forties, cautiously. Crixivan had brought Grinberg back to life.

When the letter for Jim Straley came, on August 18, Blount was relieved he had made the cut. But it was too late. Jim Straley died two days later, too far gone for the miracle pills. His relationship with Blount had lasted eighteen years, thirty days, and twelve hours. Blount was bereft. “I wanted twenty years,” Blount said some time later. “I would have been satisfied with twenty.”

From the book HOW TO SURVIVE A PLAGUE: The Inside Story of How Citizens and Science Tamed AIDS by David France, Copyright 2016 by David France, Reprinted by permission of Alfred A. Knopf, an imprint of the Knopf Doubleday Group, a division of Penguin Random House, LLC

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