Evidence-based or stock market-driven nephrology?

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I was surprised to receive the Nephrology Dialysis Trans- plantation supplement ... during the last years the American Society of Nephrology has made big steps.

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Evidence-based or stock market-driven nephrology? Sir, I was surprised to receive the Nephrology Dialysis Transplantation supplement referring to practical guidelines for the use of Novel Erythropoiesis Stimulating Protein (NESP) in treating renal anaemia, just a few days after its official approval for use in Europe, while FDA approval is still pending. This is the first time to my knowledge that our journal has published, even as a supplement, guidelines for a medication that most of us have heard a lot about but never used in

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clinical practice. It would be appropriate, if this information were given by the pharmaceutical company that has marketed NESP, in the format of a brochure, but the timing and the site of this publication as well as the title of the supplement sound rather provocative. Recombinant human erythropoietin (Epo) was introduced in nephrology in the late 1980s. It is only after more than 10 years of use and a systemic review of the literature that American and European nephrology authorities were able to set up some guidelines regarding its optimal use in patients with renal disease. We should also not forget that the initial recommendations for high Epo dosage are not applicable nowadays and we are still striving to achieve optimal haemoglobin levels for our patients. We are living at present in the era of evidence-based medicine, where full papers published in respectable medical journals are hardly criticized about their protocol design, statistical methods and power. Therefore, I was amazed to read ‘practical guidelines’ based on abstracts, except one published full report relating observations made in only 11 patients w1x. Another publication regarding the use of NESP in pre-dialysis patients was recently published, but after the publication of this NDT supplement w2x. Of course most of the authors of these guidelines have actively participated in the design and the execution of the study projects and probably have more data than was given in the supplement issue. We have just read the data in abstract form and some of us were lucky enough to know a few more details, obtained during oral or poster presentations at medical congresses. We, the Europeans, feel free to criticize our colleagues across the Atlantic for the influence that pharmaceutical companies have on them. However, during the last years the American Society of Nephrology has made big steps towards a more clear-cut policy against this kind of influence. I was lucky enough to attend the lecture given by the president of the American Society of Nephrology more than 2 years ago, at the 32nd ASN meeting in Miami in 2000 about ‘the thin line between industry and the nephrology profession’. Perhaps I was romantic or naive enough to believe that this thin line existed only on one side of the Atlantic. I have now in my hands an NDT supplement issue that looks like an advertisement product. Although NESP seems very well promising and safe, it has been tested in a rather limited number of patients compared with the total renal patients pool in Europe. It is obvious that when a new medication is tested in clinical trials the study population is well selected, by applying strict criteria that exclude a significant number of patients with other medical problems. However, I was also surprised to see recommendations for patients with failing renal grafts although to my knowledge the medication has not yet been tested in such patients w3x. As no data has been published regarding the demographics of the study population it does not seem prudent to extrapolate these initial results to the total renal patient population. The bitter recent example of glitazones should always be kept in mind before becoming very enthusiastic about new drugs. This new class of oral hypoglycaemic agents was launched in 1997 achieving blockbuster status without any clear evidence of advantage over existing therapy and troglitazone was withdrawn during the first year due to increased liver toxicity w4x. In addition the long-acting effect of NESP should also be faced with skepticism regarding possible difficulties in obtaining the correction of excessively elevated haemoglobin, by withholding it. It is obvious that titration of any drug with a longer half-life is more difficult than that of short-acting drugs. The published data refers to

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a very limited number of patients (n s 32) and it is hard to believe that haemoglobin can be reduced as rapidly as after stopping the administration of classic Epo w5x. Pharmaceutical companies are striving to publish results of new drugs as fast as possible. Their primary target is not only to influence the attitude of physicians but also the reaction of the stock market. Biotechnology companies are competing heavily in this field. Physicians should be very careful not to favour or to harm any of them, but to have in mind above all the best interest of our patients. Other studies are underway; initiated by the competitors of NESP claiming that by increasing the subcutaneous dosage of classic Epo by 30% equivalent clinical results can be achieved with a once weekly administration regimen. As the patents for classic Epo will come to an end soon, the expected reduction in the price of Epo would seem very attractive, provided that its efficacy will not be affected by these single dose regimens. Concerning NESP, we have no information regarding its commercial price. As to its place in clinical practice, I hope that in the near future more peer-reviewed publications and more hands on clinical experience will clarify the situation

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and define more precisely the patients with renal anaemia who should be given this ‘novel Epo’ rather than classic Epo. Athens Greece Email: [email protected]

Costas Fourtounas

1. Macdougall IC, Gray SJ, Elston O, Breen C, Jenkins B, Browne J, Egrie J. Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients. J Am Soc Nephrol 1999; 10: 2392–2395 2. Locatelli F, Olivares J, Walker R, Wilkie M, Jenkins B, Dewey C, Gray SJ. Novel erythropoiesis stimulating protein for treatment of anaemia in chronic renal insufficiency. Kidney Int 2001; 60: 741–747 3. The NESP Usage Guidelines Group. Practical guidelines for the use of NESP in treating renal anaemia. Nephrol Dial Transplant 2001; 16 wSuppl 3x: 22–28 4. Gale AM. Lessons from the glitazones: a story of drug development. Lancet 2001; 357: 1870–1875 5. Macdougall IC. An overview of the efficacy and safety of novel erythropoiesis stimulating protein (NESP). Nephrol Dial Transplant 2001; 16 wSuppl 3x: 14–21