Living tissue: Pippie’s surgeon Dr Ridwan Mia holds up a sheet of her new skin in the operating theatre.
On an icy but beautiful winter’s morning, just before 9am, Shirley Badke (36) arrived at work after dropping her youngest son (7) off at his school around the corner from her office. She was working as a secretary at a timber broking firm in Augusta, Georgia, in the United States.
As Badke was about to make a phone call, her attention was caught by “something incredible” rolling towards her through the window near her desk. She sprang to her feet and yelled hysterically.
But it was too late for her to escape the massive fireball.
A twin-engine Cessna light aircraft had exploded in the air. When it crashed into Badke’s office, blazing aviation fuel doused her. She was instantaneously transformed into a human torch. A colleague dragged her out of the office by one of her hands. Badke was beating the flames with her other hand.
No one thought she would survive. Eighty-five percent of her body had suffered third degree or full thickness burn wounds.
Drug-induced coma
For four months, Badke was in a drug-induced coma in hospital. The doctors were buying time, trying to figure out how to cover her wounds with skin without causing her excruciating pain that could have killed her.
Without skin, Badke’s body temperature would drop severely, she would lose fluids and proteins and she would have no protection against bacteria, which would lead to infections that would almost certainly result in her death.
There was not nearly enough undamaged skin on her body that physicians could use to cover the burnt areas. The only solution left was to remove two small patches of healthy skin and send them to a special laboratory in Boston. There, scientists could hopefully extract her skin cells and use them to grow the new skin Badke needed.
The technology employed, known as Epicel, is the same as that used for three-year-old South African burn survivor, Pippie Kruger, three weeks ago. More than three-quarters of Kruger’s body was severely burned when a bottle of gel firelighter exploded when her father lit a braai on New Year’s Eve. Doctors initially gave the girl a 10% chance of survival.
But there are two big differences between Badke’s and Kruger’s skin transplants: Badke received hers 17 years ago, in 1995, and her health insurance covered all the costs for the growing of the skin. Pippie’s medical aid company, on the other hand, paid for the medical-related costs of her skin grafts, such as medication, doctors’ fees and hospitalisation, but her parents had to raise more than R700 000 for the production and transport of the skin from the US to South Africa themselves.
Insurance
According to Sven Kili of Genzyme-Sanofi Biosurgery, the company that owns the patent rights to Epicel, the technology was covered by medical insurance companies in all states in the US, although actual reimbursement might vary by policy, region or hospital contract. In cases where a patient did not have insurance, said Kili, hospital managers “typically apply for state aid as soon as possible through the government’s medical scheme, Medicaid, or other channels available to the hospital for those treating patients in what is considered a high risk pool.”
But, in South Africa, medical aids are far more reluctant to cover highly priced personalised medicine, such as Epicel, which involve medicine or products that are unique to a patient.
Kili said the price of personalised medicine was at the “bleeding edge, but, because it can’t be reproduced in large quantities and benefit from efficiencies of scale, the price becomes substantially higher than the typical drugs we are used to”.
But Epicel did save both Pippie’s and Badke’s lives. “It’s a miracle that I’m still alive. I have my life because of this skin,” Badke said.
After more than a decade, the American woman’s skin has grown thicker. Pippie’s is still relatively thin and will take two to three years to take on the colour of the rest of her skin.
Thicken up
“I really can’t tell you how long it took for my skin to thicken up, but when I woke up from my coma, they told me it would take 10 years,” Badke said.
“It’s still not like normal skin. I can bump against something, the edge of something, and it will break my skin. I also have to be careful about what clothes and shoes I wear because my skin can develop blisters.”
Badke has Epicel-derived skin on both her legs, her right arm and her abdomen. She said the “Epicel areas” of her body were smooth, but those areas that healed naturally were marked by noticeable, protruding scars.
“I’ve told a lot of people that I’m a burn survivor and they say they’d never believe it from the way I look,” Badke said.
Her skin is not evenly coloured. “I have splashes of colour and, because a lot of my pigmentation cells have been burned away, I have to be wary of the sun.”
As in Kruger’s case, fire destroyed most of Badke’s sweat glands. As a result she cannot sweat, leaving her skin constantly dry, as sweat acts as a natural moisturiser and cooling mechanism. Epicel is just a top layer of skin and cannot repair the deeper skin layers that were damaged.
Skin regime
“Every day I get up and soak in a tub with special bath salts for an hour and a half to moisturise my skin. I then rub myself with a cloth with baby oil to try to seal the moisture in. I also regularly put lotion on my hands and arms.”
Badke said she could feel sensations through her transplanted skin, but that “it does feel a little like a nylon barrier between the touch and my skin. The best description I’ve been able to come up with is that it feels like I’m wearing pantyhose all the time.”
She spent eight months in hospital. For seven years after her accident she had reconstructive operations every three to four months, and she underwent intensive therapy to learn to swallow, walk and use her hands again.
“I woke up from this coma with the same mindset as I had before my accident. I thought I could get up and go and take care of my children and do my job. But, in reality, my body had undergone such trauma that it could do none of that,” she said.
Badke offered this advice to burn survivors such as Pippie and her parents: “Start every day with a prayer and only focus on that day. You can’t say, ‘What if [this never happened].’ You must only do what’s in front of you at the time. Do the therapies for that day.”
Badly disfigured
Badke has never returned to work. Initially, her hands were badly disfigured.
“I was a secretary and there was no way I could type again immediately,” she said. “But after therapy and surgery I have full use of my hands again and I have my life back with my family and my husband. There’s nothing that I’d like to do that I can’t do.”
Following treatment, Epicel technology and intensive therapy on many levels, Badke said she lived a happy, “full” life.
But, at the same time, hardly a day goes by that she does not realise how much her life changed “forever” on the morning when a blazing circle of fire engulfed her.
The painstaking procedure is labour intensive and expensive
The skin grafts used for Pippie Kruger’s transplant cost more than R700000 to produce and to transport from Boston to Johannesburg.
Although Genzyme-Sanofi Biosurgery, the company that owns the patent to Epicel, does not make any profit on the procedure, many people cannot afford it and South African medical aids are reluctant to pay for it. Each skin graft costs about R11500; 41 were produced for Pippie’s operation, although not all were used. It took three weeks to grow the skin, but almost six months to co-ordinate the entire procedure.
Kruger’s mother, Anice, has established a non-governmental organisation, that should help at least one child with 50% or more burn wounds every year to afford Epicel skin.
There are several reasons for the high cost. In Kruger’s case, more than 30% of the cost was transport. A courier company had to be paid for a courier to take the small pieces of skin cut from Kruger’s lower stomach area to to the United States. Scientists needed specific cells from them to grow her new skin.
Then two plane seats had to be booked for a special courier who accompanied the box containing her new skin to South Africa.
According to Sven Kili from Genzyme-Sanofi Biosurgery, the modified mouse cells that were used as carriers to grow the skin on were particularly expensive and required very careful maintenance and storage. The cells that were extracted from Kruger’s skin were placed on a layer of inactive mice cells and fed with special proteins and nutrients that allowed them to develop into thin layers of skin.
The mouse cells were not taken from live mice. They had to be grown in a “laboratory dish” and then had to be deactivated by removing the DNA from the cells to allow them to perform their particular function. “This is a phenomenally expensive process for which the only machine of its kind is used,” Kili said.
Clean room technology
In addition to this, “clean room technology” was required for the production of the skin – rooms that were about 100 times cleaner than operating theatres.
“The air purification systems and running costs of special machines, called Bac-T-Alert systems, that check throughout for the presence micro-organisms, is extremely expensive and time-consuming,” Kili said.
About 30 to 40 staff members worked on Kruger’s skin – they were the scientists who grew the skin, technicians involved with quality control, a large logistical team who co-ordinated the transport arrangements and import and export permits, and Kili’s medical team providing support and training to the surgeon and his team.
“All their salaries had to be paid, [and] lab space, and the media and materials used to grow the skin with also had to be covered,” he said.
Another factor was the small volumes of the skin that were produced. Kili said between 100 to 130 people received Epicel skin a year, and, as the manufacturing system was personalised, this increased costs significantly. “If you think of an antibiotic tablet, they might make 10 million of a certain tablet and then a take a few out to do quality control tests on them. The rest of the tablets make up for the cost of that. In the case of Epicel skin you have to go through the same processes, but the product can only be used on one person and that increases the cost significantly,” he said.
The production of Epicel skin would have to increase tenfold – to 1000 – for a measurable price reduction to be seen, and even then the reduction in price “won’t be more than 40%”.
Anice Kruger’s dream is to set-up a local laboratory where Epicel skin could be grown so that the transport costs could be cut out, but Kili said the cost and practicality of that could be prohibitive. “Although our company will be very keen to assist with technology transfer in that regard, the setting up of a lab will amount to billions of rands and South Africa may not have companies that produce the media and materials that are needed to grow the skin with.
“A machine that stabilises the mouse cells would also have to be built. I don’t even know how to attach a price to that,” he said. – Mia Malan
<strong>Pippie moves on</strong>
Pippie Kruger was released from the Intensive Care Unit at Garden City Hospital on Wednesday and now spends her days at a rehabilitation facility in Auckland Park, Johannesburg, where she will undergo intensive speech, occupational and physiotherapy.
She will have to learn to speak, walk and use her hands again.
After three to six months at the centre, she will receive a home therapy programme.
According to her plastic surgeon, Dr Ridwan Mia, Kruger had her first bath while she was awake on Tuesday.
Previously, she was bathed while sedated due to the intense pain and cleaning required to prevent infections taking hold.
Mia said her muscles were strengthening and she was now able to life her head for 30 seconds at a time.
Her skin grafts were thickening well, she was eating and had started to communicate with cries and sounds to indicate what she wanted, Mia said.
Kruger will have to undergo extensive reconstructive surgery until she is a teenager, including on her hands, face and ears. She will also require breast implants, as her breast tissue was damaged severely by the fire. – Mia Malan
<em>Pippie Isabella Kruger’s trust fund account is: CA Kruger, Absa Savings, Account number: 1478169228, Branch Code: 144547</em>