The Billion Dollar Patent

Source: DailyBruin

10/01/2020

 

Nearly 8,000 miles from the polished offices of Murphy Hall sits a black stone slab the size of Chancellor Gene Block’s office bookshelf.

Maroon, white and orange flowers dress the upper surface in ornate polygonal patterns. A bronze lamp stands at the slab’s head, a small flame burning inside the rectangular glass casing. Pristine green grass surrounds the site and sandstone-colored tiles snake around the exterior to form a walking path.

Mahatma Gandhi was cremated at that site 71 years ago.

The champion of “satyagraha,” or peaceful political resistance, is celebrated worldwide for his nonviolent advocacy against the British colonial empire. Be it in the hallowed rooms of Moore, Bunche and Dodd halls or the open air of Bruin Walk, Block and his counterparts have touted the freedom fighter’s virtues as the foundation of civil rights movements in the United States and abroad.

But those remarks ring hollow in a courthouse just 3 miles southwest of Gandhi’s memorial grounds. In that pale brownish-white building, decked with numerous pillars and countless clay planter pots, lawyers representing UCLA have argued with Indian officials about how it should be able to increase the cost of a potentially lifesaving medicine by more than eightfold, rendering it outrageously out-of-budget for many.

Thousands of Gandhi’s heirs struggle every day to treat their ailing loved ones, shoving tinted currency slips stamped with his smiling face – their life savings – into pharmacists’ hands in exchange for treatments. Hundreds more die in the streets of New Delhi, outside brimming hospitals. Millions die each year across the subcontinent because of treatable conditions.

Chief among those illnesses is prostate cancer, an insidious disease with growing prevalence among Indian men. More than 25,000 new cases popped up in 2018, with more than 17,000 people dying and nearly 48,000 having lived with the disease for upward of half a decade. Curative treatments are few and far between, and the available market demands that family members abandon their financial futures to keep their loved ones alive. Countless resort to simply letting their relatives die, and doctors can only sit idly by.

That prospect seemed to change in 2005, when UCLA researchers partnered with a pharmaceutical company to manufacture a compound called enzalutamide that could help treat late-stage prostate cancer. U.S. regulatory agencies fast-tracked clinical trials, claiming it was a miracle medicine.

If UCLA gets its way, it’s going to have blood on its hands.

In a cruel twist of fate, though, that compound will be dangled outside the reach of nearly 1.4 billion people because the university is fighting a legal battle to monopolize the drug’s production in India.

Indians are upset and the university hardly seems to care. It stands to make billions in other pharmaceutical deals if it wins.

But if UCLA gets its way, it’s going to have blood on its hands.

A subcontinent’s worth.

Enzalutamide should have been the quintessential story of scientific discovery.

The compound came about from a conversation in 2003. Michael Jung, then a 55-year-old distinguished professor in the Department of Chemistry & Biochemistry at UCLA, was asked by his wife one day whether he was content doing more of the same for the rest of his life. The New Orleans native pondered the idea of continuing his theoretical research into synthesizing organic compounds.

Michael Jung

Michael Jung COURTESY OF PENNY JENNINGS/UCLA

He wanted to do more, though, and set out to somehow pursue something else: creating compounds to cure human diseases.

That dream turned into a plan when, according to a UCLA Newsroom account, Charles Sawyers, a professor of medicine and molecular pharmacology at UCLA, approached Jung with an ambitious idea.

“Let’s stop prostate cancer,” Sawyers said.

Two years later, UCLA – on behalf of the duo – licensed enzalutamide to a San Francisco-based company called Medivation Inc. The resulting drug, Xtandi, was a pill meant to treat castration-resistant prostate cancer, a late-stage form of the disease with few treatments.

Xtandi didn’t disappoint. The compound was so effective, the Food and Drug Administration cut short clinical trials and offered the medicine to all participants. Xtandi quickly became a popular drug on the market because it allows patients to resume a number of their daily activities – walking in the park, taking care of grandkids, attending family gatherings – during their treatment. Medivation was eventually bought over and the drug’s licensing agreement began being managed by Pfizer Inc. and Astellas Pharma Inc., two massive pharmaceutical corporations.

The companies made ​nearly $1.9 billion off Xtandi in 2015 alone. UCLA sold its royalty interest in the drug for $1.14 billion and has invested a portion of that amount in its other research endeavors. Jung now researches anti-tumor and antiviral treatments at UCLA, while Sawyers studies cancer pathways at the Memorial Sloan Kettering Cancer Center.

And that’s about all the university’s idealistic PR account will include.

People wait at a pharmacy in the All India Institute of Medical Sciences.

LIZ KETCHAM/PHOTO EDITOR

The reality is that a patient takes about four Xtandi pills daily for 28 days, each pill costing more than $100 by some estimates. Depending on insurance coverage, patients can cough up copayments ranging from $3,300 to the full price of more than $12,000 a month. Even with Medicare, the typical Xtandi patient can end up spending upward of $12,000 a year on the drug – almost a fifth of the median U.S. household income.

Oh, and the companies’ plan only got worse.

Pfizer and Astellas sought to patent enzalutamide in India and charge the same obscene prices to one of the poorest countries in the world. When the Indian Patent Office rejected their application in 2016 on the grounds that it wasn’t inventive, considering generic versions of enzalutamide exist on the Indian market, the companies called on UCLA to appeal the rejection.

That’s the crux of this tale: how a scientific breakthrough now has one of the nation’s top public universities selling out to a pair of multibillion-dollar companies.

The bastion of public higher education and research responded in true form: by taking California taxpayer dollars almost 8,000 miles overseas to the High Court of Delhi to patent a compound already patented in the U.S., so Pfizer and Astellas could bankrupt millions in a nation rank with poverty, starvation and inequities. The university has enlisted the help of everyone from corporate savvy Indian lawyers to an ex-minister now in jail for corruption charges.

And that’s the crux of this tale: how a scientific breakthrough now has one of the nation’s top public universities selling out to a pair of multibillion-dollar companies.

Leena Menghaney, South Asia head for Doctors Without Borders’ Access Campaign

Leena Menghaney, South Asia head for Doctors Without Borders’ Access Campaign LIZ KETCHAM/PHOTO EDITOR

“I’ve always associated academic institutions with some kind of principals, so it’s shocking to see they’re so commercialized,” said Leena Menghaney, the South Asia head for Doctors Without Borders’ Access Campaign. “It shows that academic institutions have lost their independence.”

That kind of characterization flies in the face of the University of California’s mission of public research.

“Just as we are doctors without borders, scientists should be without borders as well,” Menghaney said. “Your science should cross boundaries and should be able to benefit people.”

Jung and Sawyers’ science now stands to kill hundreds.

India’s medical market largely consists of generic medicines, mass-produced at significantly cheaper prices than their branded counterparts across the world. This system came into place because many Indians lack medical insurance and are forced to pay costs upfront and out-of-pocket. Xtandi, for example, has at least four competing generic products roughly priced between 30,000 and 40,000 rupees – between $429 and $572 per packet of 120 tablets.

Granting the Xtandi patent would illegalize these existing drugs and replace them with the same medicine priced at around 825% more. In effect, Pfizer and Astellas would monopolize an already expensive market and get away with charging Indians more than 30 times their average salary.

Rajeev Kumar, associate dean of the All India Institute of Medical Sciences

Rajeev Kumar, associate dean of the All India Institute of Medical Sciences LIZ KETCHAM/PHOTO EDITOR

The results of that could be devastating. Indian doctors are already forced to consider patients’ financial statuses when prescribing drugs and advising treatments, said Rajeev Kumar, associate dean of the All India Institute of Medical Sciences in New Delhi, the nation’s premier government-run medical facility. Kumar, a urologist, said he almost never prescribes Xtandi because it is much more expensive than its generics and even more so than chemotherapy.

But enzalutamide has shown promising results when introduced earlier in prostate cancer treatments. And per oncologists, like Sainath Bhethanabhotla of the Krishna Institute of Medical Sciences in Hyderabad, India, enzalutamide has fewer side effects than chemotherapy and other prostate cancer treatments on the market.

UCLA’s legal win would force Indian doctors to make the impossible choice between offering patients Xtandi at the risk of plunging them into financial ruin and pursuing other treatments knowing they may not be as effective.

So much for stopping prostate cancer.

Before my colleagues and I traveled to New Delhi this summer, I spent a month in Hyderabad laying the groundwork for our reporting trip.

While reaching out to oncologists and pharmacists, I ran into a relative of my mom’s colleague: a fourth-year computer science student preparing to take the GRE. The student knew some local medical professionals and offered to help me visit them. One day, while his suspensionless minivan creaked along the congested road, I asked him what he wanted to do after graduating.

He answered, almost instinctively, that he wanted to pursue a master’s degree at UCLA. He told me about the name recognition of the university and how its groundbreaking research is something many Indians and national institutions look up to. UCLA, as he saw it, was an authority on science and public education.

He’s not wrong. Be it doubling down on the need for an egalitarian, open access to research or assembling hundreds of scientists across the globe to discover a cure for depression, UCLA is an academic authority worldwide.

But the university is using that same amassed status to also demand that Indian patients pay two multinational pharmaceutical companies they hardly know of. Some of those patients could be relatives of students or professors.

The dichotomy only dismantles UCLA’s image as an international research stalwart. And that doesn’t just hurt faculty and administrators – it hurts students and alumni, too.

Enzalutamide was hailed as a grand medical achievement in treating cancer and restoring patients’ quality of life. Now it has become such a fraught compound that Jung and Sawyers didn’t even respond when the Daily Bruin reached out for comment.

That’s understandable, given the antics UCLA has resorted to when defending itself. The Union for Affordable Cancer Treatment wrote an open letter in 2017 – signed by 56 academics and civil society organizations, including Menghaney, Third World Network, the All India Drug Action Network and Yale Global Health Justice Partnership – requesting UCLA and the UC Board of Regents withdraw their patent litigation in New Delhi.

John Mazziotta, CEO of UCLA Health, responded in a letter, asserting that while UCLA held the patent, it ceded numerous legal rights to Medivation because the company – now owned by Pfizer – agreed to take up the full cost of producing enzalutamide.

“Importantly, this life-saving drug would not currently be available for patients at all were it not for Medivation’s significant investment and diligent efforts,” Mazziotta wrote, italics included.

It takes some gall to justify using taxpayer dollars to sue a foreign government.

UACT isn’t the only one speaking up, though. The Universities Allied for Essential Medicines and the American Medical Student Association have lobbied the UC for nearly two years, sending a petition with nearly 3,500 signatures to UC President Janet Napolitano and meeting with UCLA administrators to convince them to drop their lawsuit against the Indian Patent Office.

In addition, Knowledge Ecology International, a nonprofit that advocates for, among other things, accessible medicine, submitted a proposal in February to make enzalutamide part of the World Health Organization’s Essential Medicines List to pressure Pfizer and Astellas into allowing for generics of the drug.

There’s a reason for all this opposition: UCLA’s patent battle is fundamentally a show of superiority.

That a public university can partner with pharmaceutical giants, hire multiple lawyers familiar with India’s patent system, secure a spot on a higher court’s docket and sue the world’s largest democracy to charge debilitatingly high prices for a lifesaving drug is only possible because Block and his fellow administrators are blessed with financial and administrative power few Indians – and even Americans – have.

Instead of using that authority for the public good, UCLA has sold its soul for a couple of Ben Franklins.

“Why don’t you just leave the developing world out of your licenses? … What are you going to earn out of us?” Menghaney said. “You didn’t create this drug for us. How many Indians can buy it at Pfizer’s price?”

According to KEI, it costs between 50 cents and $1 per milligram to produce enzalutamide in most countries. Pfizer and Astellas are charging nearly triple that. And lawyers representing the UC were fighting in the High Court of Delhi as recently as May.

Administrators have couched these actions as a contractual obligation. We’re supposed to believe the university is incapable of persuading its pharmaceutical partners to not make some chump change off India – or, dare we say, lower their prices.

That’s remarkably elitist – blaming inaccess for millions on a bad contract.

Enzalutamide was discovered in a lab funded by taxpayer dollars, made possible by grant money from the National Cancer Institute at the National Institutes of Health and the U.S. Army Prostate Cancer Research Program, in a university founded by the state of California to advance the public’s interest. Yet millions – in India and the U.S. – will be expected to fork over their life savings to share in this collective medical achievement.

UCLA succeeded, all right. Its authority is being heard loud and clear.

What surprised me most about my reporting wasn’t how upset Indians were with UCLA. Rather, it was how many threw their hands up and ruefully accepted their fate.

Patients await care at the All India Institute of Medical Sciences

LIZ KETCHAM/PHOTO EDITOR

Inaccessible medical treatments aren’t a novelty for them. Dozens of families sit on the ground outside the AIIMS facility, waiting in the unrelenting sun and smog for their minuteslong doctor consultations. Patients toil in hourslong outdoor lines in front of the pharmacy just to get their medicines, clamoring for space under the sparse ceiling fans. Some sleep on dusty sidewalks, with children beside them.

What surprised me most about my reporting wasn’t how upset Indians were with UCLA. Rather, it was how many threw their hands up and ruefully accepted their fate.

Xtandi is just another inaccessible brand name to millions of Indians. Prostate cancer is just another ill-fated condition they hope to not contract. And UCLA’s patent battle is just another obscure piece of trivia. Western powers colonized the nation for nearly a century, so the exploitation – now from multinational companies – isn’t new.

“You can’t take any action on these companies. It’s not that irregular. … It’s something of business as usual,” Bhethanabhotla said. “As a doctor you can’t do anything, … it’s not something where you can act. So you just go with the flow.”

And many Indians do. Horns blow in the distance outside the AIIMS campus and yellow, three-wheeler rickshaws speed by. Grainy brown smoke clouds the air, while pedestrians trudge over the dirt edges of the road, their leather slip-ons navigating the dusty terrain.

India will tread on, as it always has. The nation that produced the likes of Gandhi and boasts a population of nearly 1.4 billion can surely produce a handful of decisive challengers to its colonial powers.

Be they a western empire or a bankrolled university.

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