Evaluation of the proteome analysis by IQWiG is scientifically irrelevant

[Press release]

The German Institute for Quality and Efficiency in Health Care (IQWiG) has carried out a study of the “proteome analysis for the detection of diabetic nephropathy”. The point here is that researchers are now able to use the protein molecules in the urine to identify at an extremely early stage whether there is a risk of kidney disease. In contrast to the methods still used up to now, this means that diabetics can be protected from kidney loss, dialysis, transplantation and impending premature death. The German Federal Joint Committee (G-BA) commissioned the investigation, as various worldwide studies and statements from leading medical professionals show that this type of diagnostics has long been ready for the market.

After two and a half years of investigation, IQWiG has now come to the conclusion that “the patient-relevant benefit or harm of a proteome analysis for detecting diabetic nephropathy is just as unclear due to a lack of studies”, “as is its diagnostic or prognostic quality”. The institute justifies this with the fact that no references to studies have been received that are relevant to the question.

Researchers and doctors are appalled by the way the institute works in collaboration with the G-BA. Seven studies and ten statements by internationally renowned scientists were available. Furthermore, IQWiG is obliged to research the relevant material carefully. The IQWiG examinations are paid for by the G-BA. This in turn is supported by the funds of the statutory insured, for whom such new procedures should ultimately be evaluated to the best of our knowledge.
The investigation during the proteome analysis, including its conclusion, violates the international criteria for evaluating diagnosticians and the statutory provisions. In fact, the IQWiG has excluded all study evidence of the proteome analysis from its own assessment. The neutral study evaluation by Cristelis / Heersprink with three studies with the highest level of evidence according to the international EBM standard was rejected as irrelevant.

Diagnostics are assessed according to the international levels (EBM or SORT). However, IQWiG uses an evaluation that is customary for evaluating drugs and requires a randomized study on the endpoint such as death / dialysis / myocardial infarction from the diagnostic test. Such a study is arbitrarily required for the first time for a diagnosis and does not provide any information about the diagnosis and its value and benefit. Diagnostics can only be checked in comparison to previously used diagnostics or with the disease comparison.

Everything else, especially how the disease develops after the diagnostic detection, depends exclusively on the effect of the drug. This is also stated in the international standards.

As medical researchers, we find that IQWiG ignores basic medical knowledge. Diabetic nephropathy develops and exists exclusively at the molecular level. The proteome analysis depicts this with the protein pattern at a very early stage. All drugs also only work on a molecular level - namely on the body's proteins. Since the proteome analysis is the first to recognize a developing diabetic nephropathy at the molecular level, the corresponding drugs can be used in good time for the first time. This is crucial, medical and biochemical basic knowledge, which the IQWiG rules out as "negligible" in the assessment and the studies carried out for this purpose.

This working method of IQWiG not only violates the internationally applicable criteria, but also significantly violates the G-BA's rules of procedure.

The IQWiG thus approves of the fact that more and more people are entering the kidney complication phase and increasingly reaching renal replacement therapy. So far, DN can only be recognized with albuminuria and the kidney filtration rate (glomular filtration rate - GFR-). But then the organ reserve of the kidney is used up to approx. 60% and the DN is well advanced. A dynamic decay of the remaining kidney filters is initiated.

Obviously, the increase in the number of patients requiring dialysis is knowingly accepted. So far, only 0.9% of diabetics are on dialysis. Up to 30 to 40% of diabetics develop diabetic nephropathy. In the last few years, the age of entry for diabetes has decreased to around 43 years. After about 10 to 15 years, late-reporting diagnosticians develop diabetic nephropathy. Dialysis occurs after a few years. In mathematical terms, this means that 80 to 150 billion euros will be incurred in this area alone in the next 10 years. The same is due to the cardiovascular diseases that develop at the same time, but which could also be treated through timely detection.

But these possibilities of the latest early diagnosis are still denied to the thousands of statutory health insurance patients in Germany. At the same time, however, they must - without being asked - finance institutions such as the G-BA and thus unscientific studies by IQWiG.

Interviews with scientists and researchers are possible at any time.

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