‘If they don’t get care, they die’: the woman who runs the world’s largest kidney dialysis company
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Version 0 of 1. Helen Giza of FME is excited about the possibilities new drugs such as Ozempic could offer for renal patients New popular weight-loss drugs such as Wegovy and Ozempic come with an additional benefit: they could prolong the life of people with chronic kidney disease, says Helen Giza. For Giza, who runs the world’s largest dialysis and renal services company, Fresenius Medical Care (FME), and for the patients it serves, the new breed of weight-loss jabs promises to be transformational. Giza, originally from Wales, is beaming in via video link from Chicago, where she is preparing for the launch of an advanced dialysis treatment in the US. The £8bn company grew out of a pharmaceutical business founded by the German pharmacist Dr Eduard Fresenius in 1912, which started selling dialysis machines in 1966. FME’s core business addresses some of the growing number of problems that come as countries around the world wrestle with ageing populations. A typical patient treated by FME in the US is aged 65, male, obese, and has 10 to 12 other serious health conditions, says Giza. Among these is chronic kidney disease, a debilitating, progressive illness that occurs when the organs stop working properly. It eventually leads to kidney failure – known as end-stage renal disease – at which point people have just a few weeks to live unless they receive treatment. Other chronic conditions, such as diabetes, can also lead to kidney failure, and people have just a few weeks to live unless they receive treatment. There are estimated to be 7.2 million people in the UK living with chronic kidney disease, 13.5% of adults, and 30 million people, or 15% of adults, in the US. Worldwide, a tenth of adults are affected, with millions dying each year because they do not have access to affordable treatment. Dialysis or a kidney transplant can help people live with chronic kidney disease for many more years. Dialysis filters waste and excess fluid from the blood, and needs to be done at least three times a week for about three hours at a time. Now studies show that semaglutide, the active ingredient in Novo Nordisk’s diabetes and weight loss drugs Ozempic and Wegovy, allows people who are obese or overweight and have cardiovascular disease to live longer and in better health. US firm Eli Lilly’s drug tirzepatide, sold as Mounjaro and Zepbound, has also shown positive results from a trial in patients with heart problems. The cardiovascular benefit of weight-loss drugs could help patients with chronic kidney disease who are on dialysis live longer until their kidneys shut down, Giza says. “If these new drugs give cardiovascular benefit, which the studies say they do, people will still advance to end-stage renal disease,” she says. “It’s not curing kidney disease, but it will give more protection. These drugs will delay the onset to end-stage renal disease.” It will take a decade before the impact of the new weight-loss drugs, known collectively as GLP-1s, can be fully assessed, she says. Only about 5% of the company’s patients are taking a GLP-1 at the moment, and 75% of them quit within a year, partly due to the “tough” side effects and because they tire of having to take lots of different medicines. However, drugmakers are working on more effective treatments. Meanwhile, Giza has high hopes for the launch of FME’s advanced dialysis treatment machine in the US. The high-volume haemodiafiltration (HDF) device has been on the market in Europe for a decade, but is only now being rolled out in the US following approval from the health regulator, the Food and Drug Administration (FDA). HDF comes closer to the way kidneys work naturally, and significantly reduces mortality rates. An international study led by the University Medical Centre Utrecht showed that patients who received HDF had a 23% improvement in survival on average compared with people receiving conventional haemodialysis over a two-and-a-half-year period. Giza says it could add an extra year and a half to the average lifespan for people with end-stage kidney disease, taking it to between seven and a half and eight and a half years in the US. “That’s a real opportunity to bring this therapy to the world’s largest market and to improve life expectancy.” FME has 311,000 patients globally, including 206,000 in the US. It has 53 clinics and 4,300 patients in the UK, where it works “hand in hand with the National Health Service,” Giza says. “The commitments the Labour government has made to the NHS – it’s a challenging task, and rebuilding trust is an important one. But obviously the cost of healthcare is, whether you’re Labour or Conservative, a challenging one to manage.” FME was formed in 1996 from the merger of Fresenius’s dialysis division with the US firm National Medical Care, and it acquired a number of dialysis clinics in the US. The company is listed on the Frankfurt and New York stock exchanges, and Fresenius holds a 32% stake following FME’s demerger from the group last year. Giza says: “I wouldn’t say that we are German or American. We are truly global.” To help take pressure off hospitals and save money, the company offers home dialysis kits, which account for 16% of all dialysis it does globally. In the UK, 150 patients currently do dialysis at home. This method was “growing quite fast before Covid”, says Giza, but has “stagnated” since because of staff shortages – those needed to train home patients had to be deployed in clinics to keep them open. “Home dialysis isn’t for everybody,” she admits, but says it lends itself to younger, healthier, working-age patients. “It does mean that a patient can do dialysis on their schedule. They can do it at night and go to work and manage their dialysis far better.” She joined FME as its chief financial officer in late 2019, a few months before the Covid-19 outbreak, and was promoted to chief executive in 2022. The company battled with staff shortages to keep its clinics open during the pandemic. “If our patients don’t get the care they need, and they don’t get dialysis every other day, they die,” Giza says. “It was all hands to the pump and really navigating the crisis that ensued.” With the company reeling from a series of profit warnings in 2022, Giza embarked on a turnaround programme, including about 5,000 admin and managerial job cuts. The company has been embroiled in a series of product recalls and lawsuits over the years. It has also been criticised by unions for its labour practices in the US and the Philippines. FME said it was committed to following labour-relations laws and practices, and respects employees’ right to collective bargaining. Last October, the New York, Georgia and New Jersey attorney generals filed a lawsuit against the firm’s vascular care division for subjecting patients with end-stage renal disease to unnecessary surgery and defrauding the Medicaid programme. FME disputes the allegations made in the lawsuit and is “vigorously defending the litigation”. In April, following concerns raised by the US regulator, FME issued a recall a type of dialysis equipment, as patients who weigh less than 40kg could be at risk from chemicals leaching from silicone tubing. There are 88 children or young people using these products; no health issues have been reported. The firm is working on catheter extension sets with silicone tubing that does not leach chemicals. Giza grew up in a small town in Wales and her first job was in automotive manufacturing, which had replaced coal mining in the area. “That was a tough industry in the 90s … where the fifth decimal point on cost really mattered,” she recalls. She was headhunted by the US pharmaceutical firm Abbott in the UK because of her manufacturing experience. She went on to work for a joint venture between Abbott and Japan’s biggest drugmaker, Takeda, and worked as Takeda’s US finance chief for a decade. She became part of the deal team behind the £46bn takeover of the UK firm Shire, known for its hyperactivity drug Adderall, and led the ensuing integration. It was a “once in a lifetime experience,” she says. “We were acquiring a company the same size as us. That’s where my transformation experience really stems from.” CV Age 56Family Married, one son.Education UK chartered certified accountant; MBA from Kellogg School of Management at Northwestern University in Illinois, US.Pay €4.9m (£4.1m) in 2023.Last holiday Family trip to New York and Mexico.Best advice she’s been given “Work hard and the rest will take care of itself.”Biggest regret “No regrets – the twists and turns in the road of life, the choices we make, and how we handle them, ultimately make us who we are.”Phrase she overuses “Can we do a double click please?”How she relaxes “Running outside is my happy place; I also do power yoga.” |