The pain experienced by patients with severe illnesses is not usually the first factor to be taken account by drug and medical device producers. They can price their products and collect payment from medical insurance providers for products that prevent complications, save doctors' time or the use of other drugs, but the pain patients suffer is very difficult to price.
So when, at the beginning of the decade, medical device company TheraSense entered the market with its device that enables pain-free blood glucose testing, many diabetics simply couldn't believe their luck. The product did not actually represent a paradigm shift. It was a success because by sparing patients pain, it also achieved the other goals, which were able to be priced. Yet despite this, there are many patients who thank Prof. Adam Heller, founder of TheraSense and the inventor of the device, and his son, Dr. Ephraim Heller, every day.
A month ago, the US Administration also recognized Heller's contribution, awarding him the National Medal of Technology and Innovation, which he received from President George W. Bush in an award ceremony at the White House. He joins a most eminent list of previous winners, among them Apple Inc. (Nasdaq: AAPL) founder and CEO Steve Jobs, Microsoft Corp. (Nasdaq: MSFT) founder and former chairman Bill Gates, and Hewlett Packard co-founder David Packard.
The "financial prize" came several years earlier when TheraSense was sold, in 2004, to Abbott Laboratories (NYSE: ABT) for $1.2 billion.
A lifelong dedication to diagnosis
Heller had always been interested in chemistry. He completed his doctoral studies at the Hebrew University of Jerusalem, where he also met his wife Ilana, whom he married in 1956. "Our daughter Tali was born in the cold winter of 1958. She was ill from the day she was born until she died at the age of 24," he recalls, revealing a tragic episode in his life, one which for him, is an essential preface to the story of TheraSense.
"Tali's suffering was the result of a chain of diagnostic errors," says Heller. "A short time after she was born, she was diagnosed as being allergic to cows' milk, when the problem was actually an absence of functioning valves in the urinary tract. The misdiagnosis led to chronic kidney disease, with recurring bouts of fever, convulsions, and, ultimately, also brain damage. One particular treatment made her deaf and as a result she was wrongly diagnosed as being mentally disabled. It wasn't until she was aged seven that the problem was correctly diagnosed - several years too late."
Until Tali's death in 1982, Heller worked only when and where Tali's care allowed him, yet he still became a leading researcher in chemistry. After she died, he turned to medicine related specifically to diagnosis. "I've devoted my life to the field ever since," he says. "So has my wife Ilana, and my son, Ephraim, who founded TheraSense together with me and also founded cardiac company Angiscore. My other son, Jonathan, founded Human Impact Partners, an organization dedicated to putting healthcare at the center of public debate and preventing inequality in the distribution of healthcare resources."
Ephraim Heller left his job at Hewlett Packard in 1992 to found TheraSense on the basis of research his father conducted in conjunction with two colleagues, Dr. Yinon Degani and Dr. Brian Gregg of the University of Texas. TheraSense was founded under the auspices of the university's incubator. "The company was based on the results we achieved through the oxidation of pollutants in water and air. After Ephraim had improved the technology and sold it, he decided to focus exclusively on diabetes."
While diabetes played no part in the Heller's own family tragedy, both father and son were well aware of the grave consequences of the disease. "5% of the world now have this disease, which can result in blindness, amputation, nerve degeneration, cardiovascular disease, and even kidney failure," Heller points out. "The complications of the disease can be prevented by rigorous control of blood glucose levels, but to do that you have to carry out at least six blood tests a day. More blood sugar tests are carried out every day than all other blood tests together."
TheraSense's continuous blood sugar measuring device, the Freestyle Navigator, did something which, on the face of it, was simple - it significantly reduced the quantity of blood needed measure the level of glucose in the blood. As a result, the pain caused to patients is reduced to the minimum, enabling more tests to be carried out, which means better blood glucose control and the prevention of complications.
"This device was not the company's original dream," says Heller, surprisingly. "We set out to develop a permanently implanted glucose monitor which measures blood sugar levels continuously, and can issue an immediate alert when the level is excessively high or low." TheraSense's lead product was meant to be an interim product only, but it got the company the attention and financing it needed. "In 1996, we received our first venture capital investment, and Mark Lortz, who was formerly a VP at Johnson & Johnson, joined us as president." The product received FDA approval in 2000. TheraSense later went on to develop the continuous measurement device but did not complete this until after it was sold to Abbott. The device is currently marketed in Israeli by Geffen Medical Ltd.
Globes: What was the division of roles between you and Ephraim when you first started out?
Heller:"Ephraim was CEO, leader, strategist, and operations manager from day one, while my colleagues and I supplied him with the technology."
A partnership like this between father and son is not common in start-ups. Would you recommend it?
"The best relationships are those built on deep trust, and fields of expertise that complement each other. I believe that even if you are talking about father and son, this is a recipe for success."
What do you think of the medical device companies that have been started in Israel? Is there a chance that you could join one of them?
"In principle, I feel that some of the companies are focusing on technologies, rather than a specific product for which there is a clear need. That said, other companies focus on a need or a market, and enter it without a clear technological advantage. I'm not involved in any Israeli companies right now, but Ephraim is involved with several."
TheraSense's dream product is itself merely an interim product in the company's drive towards a crowning achievement in diabetes care - the artificial pancreas. The aim is to develop a device consisting of a glucose monitor, which will automatically transmit the patient's blood glucose level to an insulin pump, which will immediately adjust the dosage of insulin injected into the blood to control blood glucose levels, while reducing to the minimum incidences of hypoglycemia (where glucose levels are too low) and hyperglycemia (where glucose levels are too high), which lead to the side effects of diabetes.
Says Heller, "The main barrier is designing the algorithms that coordinate glucose levels and the quantity and timing of the insulin release with the amount of sugar consumed by patients in their diet. I believe that five years after the algorithms have been completed and their efficacy has been proven, we'll see products like these on the market."
What can we look forward to in diabetes care?
"The next step is the full understanding and control of the body's entire glucose control mechanism, including not only the changes in blood glucose levels and their relationship with insulin levels, but also the production and breakdown of glycogen (the method used by the body to store the necessary glucose, G.V.), which is stored in the muscles and liver, and its relationship with glucagon, the hormone responsible for converting glycogen into glucose."
Published by Globes [online], Israel business news - www.globes-online.com - on December 14, 2008
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