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 negotiation.
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 choice.”
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 for.
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 years.
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 Science.
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 years.
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.
[WATCH] Confused about patents?
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 away.
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.”
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 says.
“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