Letter to the Editor
Human recombinant EGF as a drug
EGF recombinante humano como fármaco
Pedro A. Martínez-Carpio
Unidad de Investigación Clínica, IMC-Investilaser, Sabadell, Barcelona, Spain
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"documento" => "simple-article" "crossmark" => 1 "subdocumento" => "cor" "cita" => "Med Clin. 2023;161:317-8" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "en" => array:10 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Letter to the Editor</span>" "titulo" => "Encephalopathy due to anti-GFAP antibodies in a patient with rheumatoid arthritis" "tienePdf" => "en" "tieneTextoCompleto" => "en" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "317" "paginaFinal" => "318" ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Encefalopatía por anticuerpos anti-GFAP en paciente con artritis reumatoide" ] ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Marvin Bueno, Sofia Acero, Paola Zuluaga" "autores" => array:3 [ 0 => array:2 [ "nombre" => "Marvin" "apellidos" => "Bueno" ] 1 => array:2 [ "nombre" => "Sofia" "apellidos" => "Acero" ] 2 => array:2 [ "nombre" => "Paola" "apellidos" => "Zuluaga" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2387020623003777?idApp=UINPBA00004N" "url" => "/23870206/0000016100000007/v2_202311091450/S2387020623003777/v2_202311091450/en/main.assets" ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Letter to the Editor</span>" "titulo" => "Human recombinant EGF as a drug" "tieneTextoCompleto" => true "saludo" => "<span class="elsevierStyleItalic">Dear Editor,</span>" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "318" "paginaFinal" => "319" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "Pedro A. Martínez-Carpio" "autores" => array:1 [ 0 => array:3 [ "nombre" => "Pedro A." "apellidos" => "Martínez-Carpio" "email" => array:1 [ 0 => "pmc@investilaser.com" ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Unidad de Investigación Clínica, IMC-Investilaser, Sabadell, Barcelona, Spain" "identificador" => "aff0005" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "EGF recombinante humano como fármaco" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">I read with great interest an article published in your journal, submitted by Esquirol and Herrero, on the possible therapeutic uses of human recombinant epidermal growth factor (rh-EGF).<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> It is a review of the possible indications for topical application of rh-EGF, especially for dermatological conditions (as creams or emulsions) and ophthalmological conditions (as eye drops). The heading of the introduction indicates, without providing any literature reference, that rh-EGF can be formulated in an active and stable form for clinical use, without side effects and with complete safety over prolonged periods of time.</p><p id="par0010" class="elsevierStylePara elsevierViewall">The current reality is that rh-EGF is not licensed as a medical treatment and can only be used for clinical trials. All attempts by the pharmaceutical industry to market a cream or eye drops containing rh-EGF have failed. The problem is the total instability of the molecule, which rapidly loses its tertiary structure conformation, as it is well known that obtaining a recombinant replica of 53 amino acids is not enough, but 6 cysteine residues must be correctly positioned so that 3 disulphide bridges can be formed. Without this structure it is impossible for the ligand (EGF) to bind to its receptor (EGFR).<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2,3</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The authors indicate, through a literature citation of my own authorship, that EGF eye drops are effective and safe for ophthalmological treatments.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> They referred to a meta-analysis of clinical trials that I published in 2012, which showed excellent short-term results for rh-EGF eye drops, without evaluating any mid- or long-term safety data. More than 10 years later, none of these eye drops have been successful. The rh-EGF eye drops are not available in pharmacies. It is only marketed in China, and the molecule is as inactive as the so-called sh-oligopeptide-1 that is used in cosmetics.</p><p id="par0020" class="elsevierStylePara elsevierViewall">Nor will we find any product for topical application to the skin that contains pharmaceutical-grade rh-EGF. On the other hand, many cosmetic brands boast of including EGF in their products. These are recombinant molecules synthesised in the manner described by Esquirol and Herrero, but which have not demonstrated pre-clinical efficacy and are being used, inconsistently, for clinical trials in patients. Cosmetics are being used to treat diseases, something highly disturbing and outside the medical norm. European and American legislation prohibits the identification of EGF in the composition of cosmetics. It goes by the name of sh-oligopeptide-1, which can be considered the cosmetic variant of EGF. What the authors may not be aware of is that many of the clinical trials cited in the references have not been conducted with a drug, but with a cosmetic that does not even indicate a dosage in its composition.</p><p id="par0025" class="elsevierStylePara elsevierViewall">A review of the literature published up to March 2023 reveals almost twenty inappropriate "clinical trials" conducted with the cosmetic sh-oligopeptide-1. They refer to the oligopeptide as sh-EGF (synthetic human EGF), some even indicate that it is rh-EGF, as used by the pharmaceutical industry in trials.</p><p id="par0030" class="elsevierStylePara elsevierViewall">The day a product with active and stable EGF becomes a reality, it should be studied as a drug, not as a cosmetic, and the pharmaceutical industry, not the cosmetic industry, should be in charge of developing the product. rh-EGF is not a cosmetic, it is a potent drug with potential risks, especially cancer.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> Health authorities should keep a close eye on these cosmetics, as with current developments they will end up synthesising risky molecules if they are not sufficiently monitored. Reviewers of scientific journals should not accept any studies using cosmetics to treat diseases. Ethics committees should not accept clinical trials with cosmetics because they do not meet any efficacy guarantees to be used in trials and are outside the medical standard. If any of these recombinant growth factor mimicking peptides show any kind of biological activity, they should be considered a drug of potential risk.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">Finally, the authors indicate that active and stable rh-EGF can be obtained through pharmaceutical compounding, but they do not provide any literature reference. I have been trying to find this citation for 20 years. It did not exist in 2015 when this article was published, nor does it exist today.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Funding</span><p id="par0040" class="elsevierStylePara elsevierViewall">I have not received any funding.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Funding" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Factor de crecimiento epidérmico, innovación y seguridad [Epidermal growth factor, innovation and safety]" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "J. 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Rosel" 3 => "M.A. Navarro" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/s0304-3835(99)00261-x" "Revista" => array:6 [ "tituloSerie" => "Cancer Lett" "fecha" => "1999" "volumen" => "147" "paginaInicial" => "25" "paginaFinal" => "29" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/10660085" "web" => "Medline" ] ] ] ] ] ] ] ] 3 => array:3 [ "identificador" => "bib0020" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Posology, efficacy, and safety of epidermal growth factor eye drops in 305 patients: logistic regression and group-wise odds of published data" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "J.M. Lou-Bonafonte" 1 => "E. Bonafonte-Marquez" 2 => "S. Bonafonte-Royo" 3 => "P.A. Martínez-Carpio" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1089/jop.2011.0236" "Revista" => array:6 [ "tituloSerie" => "J Ocul Pharmacol Ther" "fecha" => "2012" "volumen" => "28" "paginaInicial" => "467" "paginaFinal" => "472" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/22537292" "web" => "Medline" ] ] ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0025" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Factores de crecimiento, lesión celular, proteincinasas dependientes de ciclinas y sus inhibidores: su relevancia en la patología molecular del cáncer humano [Growth factors, cell damage, cyclin-dependent kinases and their inhibitors: relevance in molecular pathology of human cancer]" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "P.A. 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