[Ip-health] Bhekisisa - Breaking bad: Cancer patients turn drug smugglers as treatment prices soar

Thiru Balasubramaniam thiru at keionline.org
Fri Feb 15 00:41:11 PST 2019


Breaking bad: Cancer patients turn drug smugglers as treatment prices soar

15 FEB 2019 00:00

When a few months of treatment costs as much as a house, some patients are
taking their lives and the law into their own hands to survive.

The “fasten seatbelt” sign switched off. Jaco Uys* moved to stand after the
more than 12-hour flight from muggy Mumbai. The greying man threw on his
backpack and joined the queue shuffling off the international flight and on
to the air bridge at Cape Town International Airport.

If this was a movie, he’d be sweating, nervously feeling his rucksack for
the tens of thousands of rands in drugs he was smuggling.

But the doting husband from George wasn’t your “typical” drug smuggler. He
was planning to ransom the pills on his back for something far more
precious than profit or a high: his wife’s life.

That is, if he made it past customs.

Fire in the blood: Blood cancer patient Retha Wessels has undergone two
stem cell transplants in the last 10 years. The medicine that could prevent
a third costs up to R75 000 per month. (Delwyn Verasamy)

Retha Wessels hates the sound of ice clinking in a glass.

She’s sitting in an armchair in her Centurion living room — 1 200km from
Uys’s hometown in George, where his wife Nadine* was waiting for the
delivery he was carrying.

The 57-year-old woman is framed by a watercolour painting of veld flowers.

“Whenever I hear the tinkling of ice in a glass,” she says. “I immediately
start shaking.” It reminds her of the sores that emerged in her mouth after
her 2013 stem cell transplant.

The procedure was supposed to stave off the complications of her multiple
myeloma — a form of blood cancer that develops in certain white blood
cells, which normally help the body to fight off infection, according to
the United States medical nonprofit Mayo Clinic.

The cancer infects these cells, causing them to stop producing the healthy
antibodies that help us to fend off disease. Instead, the cells pump out
abnormal proteins that can, for instance, damage organs and thin bones.
Steadily, hijacked cells outnumber the healthy ones in a patient’s bone
marrow, taking over.

“Your skeleton is moth-eaten,” Wessels remembers her doctor explaining.

Multiple myeloma is incurable, but stem cell transplants and chemotherapy
can help to control the condition and about half of multiple myeloma
patients who receive this treatment survive after five years, 2014 data
from the US’s National Cancer Institute found.

But transplants can also lead to painful mouth ulcers as the body’s immune
system tries to reject the transplanted cells it sees as invaders. Even
healthy cells, such as those in the mouth, can get caught in the crossfire,
the Mayo Clinic explains.

Eating ice chips is one of the ways to stave off the pain and sores.
Wessels had wrapped a floral scarf around her head.

“It’s terrible,” she says. “You’re somewhere between life and death.”

The pink detail on the carefully fashioned headwrap matches her lipstick.

“I remember watching as the litre-bag of high-dose chemotherapy emptied
into my bloodstream,” she says.

Lost in thought, she touches the headwrap where it is knotted on the side
of her hairless scalp.

“I swore I would never put myself through it again.” Wessels’ transplant
worked — for a while. But on a hot February day last year she got the news
she was dreading.

The cancer was back and she’d need another stem cell transplant. But her
medical aid refused to pay for the procedure, even after months of

The Wessels family scrambled to fundraise the R500 000 they’d need for the
operation. In the meantime, Wessels’ oncologist explained, there was a pill
that could help to stop cancer cells from growing in her bone marrow.

But that also came at a price. A month of Revlimid medication costs between
R60 000 and R75 000.

Even with help from a medical aid, Wessels and her newly retired husband
would still have to co-pay R16 000 for the pills each month.

“There was just no way we could afford it,” she says.

Wessels thought of her newborn grandchildren, the ones she feared she would
never get to see grow up.

Then she lowers her voice and explains: “I was told you can get Revlimid
for cheaper in India. It seemed completely far-fetched, but I had no

India developed its systems to try to prevent drug companies from getting
unwarranted patents. Today, its generic medicines heal the world —
including South Africa. (Reuters)

Uys had landed in Mumbai with a plan and almost as soon as his plane
touched down from South Africa, he found his way to a medicines wholesaler
in the city. The man behind the counter wasn’t interested in the
prescription Uys tried to thrust into his hands.

It wasn’t his name on the paper anyway.

The salesperson was mainly drawn by the cash in Uys’s hands. In exchange
for those rupees, he gave Uys the drugs he had travelled almost 8 000km

They were, of course, not for Uys, but for his wife, Nadine. She had just
undergone a bone marrow transplant — as with Retha Wessels, her immune
system was left in tatters. The procedure was successful, but doctors
prescribed Revlimid — also known by its generic name lenalidomide — to
maintain the new healthy blood cells in her system.

In South Africa, because Revlimid is under patent, its generic, which is
considerably cheaper, isn’t available. The cost of Nadine’s treatment could
easily run into the hundreds of thousands of rands and even medical aids
struggle to cover it in full.

Discovery Health Medical Scheme’s most expensive cover will pay for any
oncology treatment — including Revlimid — until the bill reaches R400 000,
says Noluthando Nematswerani, the company’s head of the Clinical Policy
Unit. After that, patients must pay 20% of the costs. Three other medical
aids — ProfMed, FedHealth and GEMS — did not respond to questions about
their cover.

Uys says their medical aid refused to cover Nadine’s medicine. But in
Mumbai, R30 000 had bought Nadine enough lenalidomide to last her for two

Back in Centurion, the Wessels family saved the airfare and instead, called
a family friend who was living in India and asked him to post three months’
of lenalidomide to them. What would have cost R225 000 in South Africa,
cost the Pretoria family just R7 000.

“Like many other families, there was no way I could pay for it,” Uys said.
“So I simply packed my bag and boarded a plane to India, where the medicine
is far cheaper.”

At Cape Town International Airport, Uys glided through baggage claim, with
his precious and discounted cargo still in the nondescript backpack.

Walking through the customs area, he didn’t break a sweat. He wasn’t too
worried about getting caught with Nadine’s medicine.

Uys had been told that some officials, who were also multiple myeloma
patients, might be sympathetic to his cause. After all, they’d also used
Indian pharmacies to get their drugs and might be willing to help out
someone in a similar situation if something went wrong.

But it was never necessary. He just walked straight through, got in his car
and started the four-hour drive home to his wife in George.

It was as simple as that.

Stem cell transplants and chemotherapy can help to control multiple
myeloma. So can Revlimid, if patients can afford it. (Reuters)

For such a pricey lifeline, Revlimid has a dark past. It’s a close cousin
of an older drug called thalidomide, Cape Town-based oncologist, Mike du
Toit, explains.

In the late 1950s, thalidomide was prescribed for pregnant women to ease
morning sickness. It soon became clear that something was terribly wrong,
as women around the world began to give birth to children with phocomelia,
a disease that causes babies to be born with flipper-like limbs. About 10
000 “thalidomide babies” were born worldwide before the drug was banned in
most countries by 1961, according to a 2011 article in Toxicological

In the early 2000s, the pharmaceutical company Celgene altered thalidomide
slightly and dubbed it “Revlimid” — now marketed as the only drug that
could slow the progress of multiple myeloma.

“In combination with other drugs, it is very useful in keeping patients’
healthy cell levels up for long periods of time, with very few
complications,” Du Toit explains.

Biotechnology company Celgene was duly rewarded for its fancy legal
footwork. Revlimid continues to be one of its top-selling drugs, bringing
in almost two-thirds of the company’s total revenue in 2017, its annual
report shows.

But some experts argue the company must say goodbye to its monopoly on
lenalidomide. A briefing paper compiled by the nonprofit  Initiative for
Medicines, Access & Knowledge revealed that Celgene had been granted a
total of 75 patents for Revlimid. The first unrestricted generic of
Revlimid could enter the market by 2025. But, the paper warns, there are
pending patent applications that could extend their monopoly for another 10

The combination of these patents gives Celgene unprecedented protection
from competitors for 40 years.

Catherine Tomlinson, a public health expert at local civil society’s Fix
The Patent Laws Coalition, explains: “Celgene has created a thicket of
patents around Revlimid to extend its monopoly for as long as possible.”

She says the company has used “patent evergreening” to achieve this.
Evergreening is a tactic employed by pharmaceutical companies to unfairly
prolong their patent protection by filing patents on minor changes to drugs
that already exist, a 2016 Coalition report states. In some cases, this has
meant simply adding salt to a tablet, according to a 2012 research
published in the journal PLOS ONE.

South Africa’s lax patent laws make evergreening easy, Tomlinson says.
Unlike countries such as India, South Africa doesn’t judge the patent
applications it receives based on merit, or whether companies really are
trying to patent new innovations. Without this kind of detailed review
system, South Africa grants about 93% of patent application it receives,
2017 data from the World Intellectual Property Organisation shows.

India, on the other hand, approved just 19% of the patent applications it
received in that year.

“South Africa commonly grants weak, undeserved patents that are rejected in
other countries where the merit of each application is evaluated,”
Tomlinson explains.

Neither the departments of trade and industry nor health responded to
requests for comment about this.

The country’s new intellectual property policy plans to introduce stricter
assessment of patent applications. But, Tomlinson cautions, the document
gives no details about what criteria it will use to judge future
applications, and whether it will do anything to prevent predatory tactics
such as evergreening.

South Africa’s weak patent system is how Celgene’s overlapping patents for
Revlimid have also crept on to local shores, Tomlinson argues.

Neither Celgene nor Bristol-Myers Squibb — which recently acquired Celgene
— responded to Bhekisisa’s questions.

In a separate case, the drug company Millennium Pharmaceuticals was granted
a patent on another multiple myeloma drug called Bortezomib until 2035, two
decades after the initial patent expired. The firm had made small changes
to the way the drug was packaged but these didn’t affect how it worked, a
2016 Fix the Patent Campaign Coalition report found.

The same application was made in India, but because of the country’s
substantive patent review process, the company failed to meet the necessary
criteria for a new patent. Basically, Millennium Pharmaceuticals couldn’t
prove that what it was trying to patent was very different from the
original drug it had patented more than two decades ago.

India’s patient-centred, stiffer patent laws have made it what some have
called the “pharmacy of the world”, providing affordable generic medicines
to many countries, including South Africa.

Cancer patients like Wessels and Uys are not the only ones who benefit from
the country’s legal savvy. In the past, people in need of treatment for HIV
and drug-resistant tuberculosis have also sought help from India’s
wholesalers until the drugs became available or affordable in South Africa.

This is in part because India takes advantage of public health protections
endorsed by the World Trade Organisation (WTO), which regulates trade
between nations.  The WTO’s 2001 Agreement on  Trade-Related Aspects of
Intellectual Property Rights (Trips) allows countries to override patent
protection in the interest of public health, a flexibility South Africa has
largely ignored.

South Africa’s  new intellectual property policy opens the door for a more
efficient system for the government to grant compulsory licences that allow
generics to be made or imported regardless of whether the original drug is
still patent protected.

Tomlinson explains: “South Africa could grant a compulsory licence to allow
generic use of Revlimid in South Africa, to stop excessive pricing.” But
until the policy is passed into law, applications to grant compulsory
licences still have to go through expensive litigation and could get stuck
in South African courts for years, Tomlinson argues.

Meanwhile, Celgene continues to pocket money from desperate patients.

The company expects Revlimid to earn it almost $11-billion in 2019,
according to a statement released last year. The firm argues the money is
streaming in not only because of its market monopoly but also because
patients who use Revlimid are surviving for longer — as long as they keep
buying it.

Confused about patents? Watch this short video:

Relief washed over Retha Wessels when she got a call to say her medication
had reached South African shores and was waiting for her at OR Tambo
International Airport.

Just one thing, the customs official cautioned. Without permission from the
South African Health Products Regulatory Authority (Sahpra), she would not
be able to take the drugs home. “We can only keep the medication here until
the end of the week,” an officer told a devastated Wessels.

She explains: “It’s now months later and I still haven’t heard a thing from
[Sahpra].” “My pills were destroyed.

Just three years ago, Wessels would have been able to get her drugs into
the country.

Until 2016, oncologist Mike du Toit used special applications to the
country’s medicines regulator, Sahpra, to help patients get access to
affordable Indian generic versions of Revlimid. He did this by applying for
what’s known as a Section 21 authorisation from Sahpra, which allows
doctors to import medicines that aren’t registered in the country.

“Once you had permission, you could get lenalidomide at the best price you
could find, which was about R4 000 a month,” Du Toit explains.

But three years ago, everything changed.

South African drug company Key Oncologics applied for the patent on
Celgene’s favourite cash cow, Revlimid. With a registered, patented version
of the drug now available, the ability to apply for Section 21 access fell

Now, patients could no longer get special permission from Sahpra to import
cheaper Revlimid.

Du Toit decided to take action. He wrote to the regulator, arguing that
patients who got access to generics before Revlimid was registered in 2016
should not be forced to switch medication, particularly not at such a high
price tag.

In the past, Sahpra had granted Section 21 access, on a limited basis, to
generics of high-priced patented drugs available in South Africa on the
premise that medicines were priced out of reach for patients knocking at
death’s door. For instance, Sahpra gave the medical humanitarian
organisation Doctors Without Borders (MSF) permission in 2014 to import a
significantly cheaper drug-resistant tuberculosis medicine, linezolid, to
treat its patients in Khayelitsha.

But the regulator has been inconsistent in approving the applications based
on affordability. Sahpra recently told Du Toit it does not consider price
in its judgment. Sahpra's chairperson, Helen Rees, says the regulator is
currently seeking legal opinion to help find a way to use Section 21
applications and other tools to get patients cheaper medicines.

Du Toit’s first request was denied, but he appealed the ruling and, with
legal help from Webber Wentzel lawyer Jonathan Berger, 11 patients’
requests for generic Revlimid were approved. Rees says this decision was
made because taking these patients off the medication they were responding
to would be unfair.

But a third request lodged for seven new patients has gone unanswered by
Sahpra for more than a year, leaving some cancer activists to question the
regulator’s motives.

The Cancer Alliance’s Salome Meyer argues that Sahpra is delaying its
response to avoid litigation – both from patients and Celgene. Authorising
the use of generics for the new patients while the medicine is patented is
illegal, Meyer explains.

But not authorising the applications could also spark legal action since
Sahpra previously approved the same application for Du Toit’s other
patients. Rees argues, however, that legal action is not a concern since
each Section 21 application is assessed based on the “quality, safety, and
efficacy of the product”.

Meyer warns: “Access denied for one patient is access denied [for all]. We
need to ensure affordable access to cancer medication.”

Read more: Are strong-armed tactics by Big Pharma behind the country’s
birth control shortage?

Uys and Wessels are not the only patients who have been driven to extreme
measures to get hold of Lenalidomide.

Du Toit says he has seen patients order bags of raw lenalidomide through
the post.

“This one patient was completely surprised when the package arrived at his
doorstep. He thought it would never make it through customs.”

When the patient had the material tested, it was a 100% match for
Lenalidomide. “This chap came to see me one day and said, ‘look what I’ve
got’. And he’d made 1 000 of these tablets with the raw material,” Du Toit

“He was taking the pills at his own risk and he did not share them. The
whole batch only cost R300 per month.”

But for most multiple myeloma patients, whether they live or die will
depend on how far they are willing to go — both in terms of kilometres and
in risks.

Du Toit warns: “The sheer cost of Revlimid is just [so] ridiculous that
people have to go around finding various sneaky ways to try and get hold of
it. It’s blatantly unfair.”

* Not their real names

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

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