[Ip-health] The Daily Bruin: When UCLA Sold Its Soul - The Billion Dollar Patent

Thiru Balasubramaniam thiru at keionline.org
Wed Jan 8 05:18:06 PST 2020


https://features.dailybruin.com/2020/travel-grant/#/when-ucla-sold-its-soul
https://features.dailybruin.com/2020/travel-grant/

WHEN UCLA SOLD ITS SOUL


THE BILLION DOLLAR PATENT


BY KESHAV TADIMETI

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.

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.

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.

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.

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.

“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.

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.

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.

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.


-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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