Hyvä tutkimustapa (GCP) – only English?

International Conference on Harmonisation (of technical requirements for registration of pharmaceuticals for human use) eli ICH on useiden maiden muodostama organisaatio, jonka tavoitteena on harmonisoida mm. lääketutkimusten tekotapa.  Niinpä vaikkapa meillä Suomessa tehdyn lääketutkimuksen tiedot ovat sovellettavissa Italiaan tai Etelä-Afrikkaan.   Tärkeimpiä harmonisoinnin välineitä ovat erilaiset hyvän tutkimustavan ohjeistukset, kuten ICH GCP (good clinical practice).

USA noudattaa omaa lainsäädäntöään (federal regulations) saavuttaakseen saman päämäärän eli lääketutkimusten harmonisoinnin niin, että tulokset ovat vertailukelpoiset kaikkialla maailmassa.  USA:ssa harmonisoinnista vastaa FDA, ja FDA:n ohjeet yhdessä ICH GCP-ohjeistuksen kanssa muodostavat modernin, hyvän lääketutkimustavan peruspilarit.  USA:n ja ICH:n ohjeet ovat pitkälti samanlaiset ja viisas lääkekehittelijä varmistaa, että tehtiinpä lääketutkimus missä vain, sen tekotapa noudattaa ICH CGP- ja FDA-ohjeistusta.

ICH GCP ohjeistaa mm. että potilastiedotteen tekstin tulee olla helposti ymmärrettävää ja suosittaa, että 8 – 10 -vuotias lapsi ymmärtää lukemansa tiedotteen.  Jos lapsi ymmärtää, ymmärtää aikuinenkin.  Tavoite on jalo ja siihen pitää pyrkiä.  Itse asiassa ICH GCP-teksti itse noudattaa selkeyden periaatteita.  Lauseet ovat lyhyitä tai lyhyehköjä, lauserakenne on tiukan klassinen (subjekti-objekti-predikaatti), sivulauseita on vähän; lauseenvastikkeita, adverbiaalilausekkeita ja muita kommervenkkeja saa hakemalla hakea.

ICH et consortes varmaan arvelee, että teksti on niin selkeä, ettei sitä tarvitse kääntää.  Kaikkihan osaavat basic englishiä, joten ICH GCP:n tekstihän aukeaa kenelle vain.  Eikö? No, ei kai tuohon oikeesti kukaan usko.  Kyllä niin tärkeä, etten sanoisi keskeinen, dokumentti kuin ICH GCP pitäisi olla käännettynä kaikille maailman kielille, ja joka tapauksessa suomeksi ja ruotsiksi.  Saksaksi, espanjaksi, italiaksi ja englanniksi teksti on ICH GCP:n kotisivulla, joten miksei Suomenkin kielille?  Fimean lääketutkimusohjeet ja -määräykset sekä lääkealan lainsäädäntö toki nojaavat ICH GCP:n tekstiin (EU-ratifiointi), mutta itse asiakirjaa ei ole olemassa suomeksi eikä ruotsiksi. Ja kyllä ICH:lla on paljon, paljon muutakin annettavaa kuin hyvän lääketutkimustavan ohjeet, niin tärkeitä kuin nekin ovat.

MediDocs on valmis ja innokas kääntämään ICH GCP:n ja ICH:n muutkin tärkeät teksitit  suomeksi, ruotsiksi ja venäjäksi.  Toimeksianto….anybody?

Mukavaa Myyntilupaseminaarissa

Viime viikolla pidettiin jokavuotinen Myyntilupaseminaari, tällä kertaa tiedekeskus Heurekassa n. 180 osallistujan voimin. Edellisen kerran kävin seminaarissa yli 10 vuotta sitten ja silloin esiinnyin puhujana. Muistaakseni teemana oli juuri silloin tietoinen suostumus. Mieleen jäi arkkiatri Risto Pelkosen kommentti, kun pyysin häneltä jotain evästystä luennolleni. Hän totesi, että tutkijan (ja muiden lääketutkimuksia ja potilastyötä tekevien) on annettava itselleen tietoinen suostumus ennen kuin sitä voi odottaa muilta. Viisaan miehen viisas näkemys: Ensin on itse hyväksyttävä tekemänsä ennen kuin voi olettaa ja odottaa, että potilas sen hyväksyy. No, tällä kertaa teemoja oli kolme: 1) Myyntilupa ja uuden lääkkeen markkinoille tulo, 2) Lääketurvadirektiivin implementointi (”Hyi tuota sanaa,” huudahtaa kielipuristi) ja käytännön vaikutukset myyntilupiin sekä 3) OTC – tavoiteltu status. Itse asiassa seminaari ei antanut minulle hirvittävän paljoa kotiinvietävää. Mieleen jäivät kuitenkin lääketurvadirektiivim suhteen esitetyt pelot, sillä turvaseuranta ja haittavaikutusraportointi muuttuvat ja lisääntyvät melkoisesti. Informaation määrä tulvii, eikä ole takeita että tämä lopultakaan edistää potilasturvallisuutta. Aika näyttää. Luennoitsijoista jäi mieleen kollega ja filosofi-irvileuka Fimeasta (kuka senkin nimen on keksinyt!) Pekka professorinpoika Eränkö. Oli Pekka muuttunut melkoisesti sitten vanhojen hyvien aikojen! Puhe ja ajatus juoksivat entiseen ihastuttavaan malliin ja oli riemukasta seurata Pekan viisasta ajatuksenkulkua. Oikeastaan osallistuin Myyntilupaseminaariin markkinoidakseni MediDocsia. Keskustelin muutamien toivottavasti tulevien asiakkaiden kanssa ja jaoin yrityksestä kertovan, vastavalmistuneen esitteen. Erittäin iloiseksi tulin, kun tapasin vanhoja työtovereita Novartiksen ja AstraZenecan ajoilta. Kokkareiden lomassa juttu luisti jopa niin mukavasti, että missasin Turun-junan johon olin varannut lippuni. No, seuraavaan ehdin ja pääsin hyvissä ajoin takaisin kodin lämpöön.

PILs and pillsPILS and pillsPILs and pills PILs and pills

The patient who uses pills and other medicines gets most of the information on the medicine from the patient information leaflet (PIL).  During my three decades as a clinician and medical translator I have been able to follow the changes in the softer side of the information provided to the patient.

Softer?  Well, treating sick people is part science, much art.  The PILs, on the other hand, are part science and much legalese.  Just look at the technical name of the document: product information leaflet.  A medicine is much more the “product”.  It may be the lifeline for a very sick person or the only solution for relieving aches and pains.

Of course the PIL must contain what the patient needs to know on administration, effects and side effects.  Actually, the section creating most consternation is the one on adverse effects (or”undesirable effects” as these are called in the summary of products characteristics or”adverse events” as they are called in clinical trials).  I realize that the company responsible for the medicine being on the market needs to inform the ”consumer”, i.e., the patient, of what the medicine is all about.  But where to draw the line between rare and dangerous side effects and common and not so dangerous side effects?  To cover all risks, it’s easiest to include all dangerous side effects, be it that they have occurred only a few times globally.  This is honest, but may deter innumerable patients from using the medicine and getting the treatment they need.  There is no good solution to this problem, which is a growing one.

The patient who uses pills and other medicines gets most of the information on the medicine from the patient information leaflet (PIL).  During my three decades as a clinician and medical translator I have been able to follow the changes in the softer side of the information provided to the patient.

Softer?  Well, treating sick people is part science, much art.  The PILs, on the other hand, are part science and much legalese.  Just look at the technical name of the document: product information leaflet.  A medicine is much more the “product”.  It may be the lifeline for a very sick person or the only solution for relieving aches and pains.

Of course the PIL must contain what the patient needs to know on administration, effects and side effects.  Actually, the section creating most consternation is the one on adverse effects (or”undesirable effects” as these are called in the summary of products characteristics or”adverse events” as they are called in clinical trials).  I realize that the company responsible for the medicine being on the market needs to inform the ”consumer”, i.e., the patient, of what the medicine is all about.  But where to draw the line between rare and dangerous side effects and common and not so dangerous side effects?  To cover all risks, it’s easiest to include all dangerous side effects, be it that they have occurred only a few times globally.  This is honest, but may deter innumerable patients from using the medicine and getting the treatment they need.  There is no good solution to this problem, which is a growing one.

The patient who uses pills and other medicines gets most of the information on the medicine from the patient information leaflet (PIL).  During my three decades as a clinician and medical translator I have been able to follow the changes in the softer side of the information provided to the patient.

Softer?  Well, treating sick people is part science, much art.  The PILs, on the other hand, are part science and much legalese.  Just look at the technical name of the document: product information leaflet.  A medicine is much more the “product”.  It may be the lifeline for a very sick person or the only solution for relieving aches and pains.

Of course the PIL must contain what the patient needs to know on administration, effects and side effects.  Actually, the section creating most consternation is the one on adverse effects (or”undesirable effects” as these are called in the summary of products characteristics or”adverse events” as they are called in clinical trials).  I realize that the company responsible for the medicine being on the market needs to inform the ”consumer”, i.e., the patient, of what the medicine is all about.  But where to draw the line between rare and dangerous side effects and common and not so dangerous side effects?  To cover all risks, it’s easiest to include all dangerous side effects, be it that they have occurred only a few times globally.  This is honest, but may deter innumerable patients from using the medicine and getting the treatment they need.  There is no good solution to this problem, which is a growing one.

The patient who uses pills and other medicines gets most of the information on the medicine from the patient information leaflet (PIL).  During my three decades as a clinician and medical translator I have been able to follow the changes in the softer side of the information provided to the patient.

Softer?  Well, treating sick people is part science, much art.  The PILs, on the other hand, are part science and much legalese.  Just look at the technical name of the document: product information leaflet.  A medicine is much more the “product”.  It may be the lifeline for a very sick person or the only solution for relieving aches and pains.

Of course the PIL must contain what the patient needs to know on administration, effects and side effects.  Actually, the section creating most consternation is the one on adverse effects (or”undesirable effects” as these are called in the summary of products characteristics or”adverse events” as they are called in clinical trials).  I realize that the company responsible for the medicine being on the market needs to inform the ”consumer”, i.e., the patient, of what the medicine is all about.  But where to draw the line between rare and dangerous side effects and common and not so dangerous side effects?  To cover all risks, it’s easiest to include all dangerous side effects, be it that they have occurred only a few times globally.  This is honest, but may deter innumerable patients from using the medicine and getting the treatment they need.  There is no good solution to this problem, which is a growing one.

A decade, and more, of translationA decade, and more, of translationA decade, and more, of translationA decade, and more, of translation

MediDocs Ltd (formerly Medikonsultit) will be 10 years next September.  Hooray for the company!

The languages at MediDocs are Finnish, Swedish and English (and German and Russian).  Since I work in Finland, I translate much from Finnish into Swedish and the other way.  Many of the documents must be in Swedish since Finland is, as many know, a bilingual state with Finnish and Swedish as the national languages.  Not all Finns understand Finnish.

Well, for my part this is an advantage, since there don’t seem to be very many translators around who have Swedish as their mother tongue and have decades of experience from the clinical and from the pharmaceutical world.

I have been working as a physician since 1978 – internal medicine is my home base and passion. Since then I have specialized in hematology and administration and worked for a decade with the pharma industry.  With an inborn drive for perfect communication and the well-being of people, one will by necessity gain insight into health and disease, medicine as a science and as an art.

Probably due to some genetic influence I have always loved languages; my greatgreatgreat grandfather Hermann Paul earned his living as a language editor and translator.  His magnum opus was the translation of our national epic Kalevala, published in 1885.  I became a certified translator in our national languages when I was 16, that’s before I could use my authorization stamp, since I was a minor at the time.

Since then I have done translation, first as a hobby.  Then, a decade ago I founded this company and within its realms I have been able to work professionally as a medical translator, I have given medical advice and support to pharmaceutical companies and edited medical articles and dissertations. A decade of stimulating work to the benefit of sick people, I hope, and to the support of my family.  It doesn’t end here, not at all.  The next decade is only coming along.

MediDocs Ltd (formerly Medikonsultit) will be 10 years next September.  Hooray for the company!

The languages at MediDocs are Finnish, Swedish and English (and German and Russian).  Since I work in Finland, I translate much from Finnish into Swedish and the other way.  Many of the documents must be in Swedish since Finland is, as many know, a bilingual state with Finnish and Swedish as the national languages.  Not all Finns understand Finnish.

Well, for my part this is an advantage, since there don’t seem to be very many translators around who have Swedish as their mother tongue and have decades of experience from the clinical and from the pharmaceutical world.

I have been working as a physician since 1978 – internal medicine is my home base and passion. Since then I have specialized in hematology and administration and worked for a decade with the pharma industry.  With an inborn drive for perfect communication and the well-being of people, one will by necessity gain insight into health and disease, medicine as a science and as an art.

Probably due to some genetic influence I have always loved languages; my greatgreatgreat grandfather Hermann Paul earned his living as a language editor and translator.  His magnum opus was the translation of our national epic Kalevala, published in 1885.  I became a certified translator in our national languages when I was 16, that’s before I could use my authorization stamp, since I was a minor at the time.

Since then I have done translation, first as a hobby.  Then, a decade ago I founded this company and within its realms I have been able to work professionally as a medical translator, I have given medical advice and support to pharmaceutical companies and edited medical articles and dissertations. A decade of stimulating work to the benefit of sick people, I hope, and to the support of my family.  It doesn’t end here, not at all.  The next decade is only coming along.

MediDocs Ltd (formerly Medikonsultit) will be 10 years next September.  Hooray for the company!

The languages at MediDocs are Finnish, Swedish and English (and German and Russian).  Since I work in Finland, I translate much from Finnish into Swedish and the other way.  Many of the documents must be in Swedish since Finland is, as many know, a bilingual state with Finnish and Swedish as the national languages.  Not all Finns understand Finnish.

Well, for my part this is an advantage, since there don’t seem to be very many translators around who have Swedish as their mother tongue and have decades of experience from the clinical and from the pharmaceutical world.

I have been working as a physician since 1978 – internal medicine is my home base and passion. Since then I have specialized in hematology and administration and worked for a decade with the pharma industry.  With an inborn drive for perfect communication and the well-being of people, one will by necessity gain insight into health and disease, medicine as a science and as an art.

Probably due to some genetic influence I have always loved languages; my greatgreatgreat grandfather Hermann Paul earned his living as a language editor and translator.  His magnum opus was the translation of our national epic Kalevala, published in 1885.  I became a certified translator in our national languages when I was 16, that’s before I could use my authorization stamp, since I was a minor at the time.

Since then I have done translation, first as a hobby.  Then, a decade ago I founded this company and within its realms I have been able to work professionally as a medical translator, I have given medical advice and support to pharmaceutical companies and edited medical articles and dissertations. A decade of stimulating work to the benefit of sick people, I hope, and to the support of my family.  It doesn’t end here, not at all.  The next decade is only coming along.MediDocs Ltd (formerly Medikonsultit) will be 10 years next September. Hooray for the company!

The languages at MediDocs are Finnish, Swedish and English (and German and Russian). Since I work in Finland, I translate much from Finnish into Swedish and the other way. Many of the documents must be in Swedish since Finland is, as many know, a bilingual state with Finnish and Swedish as the national languages. Not all Finns understand Finnish.

Well, for my part this is an advantage, since there don’t seem to be very many translators around who have Swedish as their mother tongue and have decades of experience from the clinical and from the pharmaceutical world.

I have been working as a physician since 1978 – internal medicine is my home base and passion. Since then I have specialized in hematology and administration and worked for a decade with the pharma industry. With an inborn drive for perfect communication and the well-being of people, one will by necessity gain insight into health and disease, medicine as a science and as an art.

Probably due to some genetic influence I have always loved languages; my greatgreatgreat grandfather Hermann Paul earned his living as a language editor and translator. His magnum opus was the translation of our national epic Kalevala, published in 1885. I became a certified translator in our national languages when I was 16, that’s before I could use my authorization stamp, since I was a minor at the time.

Since then I have done translation, first as a hobby. Then, a decade ago I founded this company and within its realms I have been able to work professionally as a medical translator, I have given medical advice and support to pharmaceutical companies and edited medical articles and dissertations. A decade of stimulating work to the benefit of sick people, I hope, and to the support of my family. It doesn’t end here, not at all. The next decade is only coming along.