Personalized Medicine: “The Era of Classics…

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Written By Kampretz Bianca

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Berlin – The era of classic randomized, double-blind drug studies is over. This is what the impartial chairman of the Federal Joint Committee (G-BA), Josef Hecken, yesterday in Berlin at the annual congress of the German Network for Personalized Medicine (DNPM) with regard to personalized medicine. “We are entering patient groups and treatment situations where there are too few patients to do a classic study,” Hecken said. “We have a situation here in which I would consider it indecent to resort to comparative studies.”

Hecken advocated a new approach to measuring the evidence generated in personalized medicine and bringing corresponding medicines into healthcare. He suggested that every patient treated with personalized medicine should be included in a registry where all data would be automatically stored. The parameters for this therapy must be defined in advance, for example, by specialized societies. Relevant medications should only be prescribed in certain centers.

“In this way, within a few years we will have reliable data, for example on patient mortality,” explained Hecken. In this way, an orderly path can be determined to take evidence generated in the context of personalized medicine, for example in genome sequencing, to patient care. Concentrating treatment in centers ensures good diagnostic quality and good management of side effects.

Personalized Medicine Centers

For DNPM, personalized medicine in oncology means finding the right therapy at the right time for patients. At the Centers for Personalized Medicine (ZPM), molecular diagnosis is used to look for molecular peculiarities of a patient’s individual disease. Based on these individual characteristics, molecular tumor boards then look for a suitable treatment that is designed to specifically target the patient’s cancer cells.

DNPM is a cooperation of 26 university hospitals in Germany that aim to work together to improve medical care and quality of life for people affected by advanced or rare cancer in Germany. To this end, personalized medicine centers are being founded in all locations, which, together with the existing ZPMs in Freiburg, Heidelberg, Tübingen and Ulm, form the DNPM. The aim of the network is to provide affected people with transparent and standardized access to personalized medicine.

“I think it’s unethical”

Hecken emphasized that no cost savings can be expected from personalized medicine, as a highly complex therapeutic concept has a price level that is many times higher. “However, it is an ethical obligation to accurately identify patients who can benefit from personalized medicine,” Hecken said. Medical and technical progress, which leads to the chronicity of certain diseases that were previously fatal, will accelerate the trend towards increasing expenses.

There would be a discussion about whether it would be possible to offer every patient personalized medicines in last-line therapy at any price or whether it would be necessary to consider how it would be possible to generate the greatest possible benefit for all patients for a given amount of money. “I think the latter is unethical,” Hecken said.

Immense challenges

Peter Schirmacher, Medical Director of General Pathology and Pathological Anatomy at Heidelberg University Hospital, explained at the congress that much has been achieved in the field of personalized medicine in recent years and decades. However, there are still immense challenges ahead in the area of ​​diagnosis. “To be able to perform diagnostics at the current level of development, we have to invest in new equipment every 18 to 24 months,” he said. Furthermore, it is a challenge to obtain the highly specialized personnel needed for personalized medicine. The IT structures through which the generated data can be transmitted are also important.

“There will be a process of concentration on centers that have the necessary infrastructure for personalized medicine,” said Schirmacher. “This process must be supported.” Furthermore, it is important to create low-threshold study options in which registry data can be used. This will be crucial to the success of personalized medicine. © fos/aerzteblatt.de

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