Vas pristop je lep in idealisticen poskus pomagati pacientom, saj vam razum pove, da je izboljsanje simptomov odtehta mozne nezeljne posledice.
Ne glede na to, da antipsihotiki povzrocijo stevilne fizicne, psihicne in razpolozenjske pojave, vam “raziskave in podatki pokazejo”, da tretma z AP statisticno izboljsa simptome depresije.
Podatki seveda lahko pokazejo marsikaj.
Za ilustracijo - poskus firme Johnson & Johnson, da na trziscu plasira svoj AP, Risperdal in ga uveljavi pri zdravljenju vedenjskih motenj otrok in starostnikov.
J&J je poizkusila svoj proizvod, tipicni AP Haldol, kateremu je potekel patent, nadomestiti z “atipicnim” antipsihotikom Risperdalom ( kar jim je FDA prepovedala – would “consider any advertisement or promotional labeling for Risperdal false, misleading or lacking fair balance” if it stated or implied that “Risperdal is superior to haloperidol [Haldol].”)
Predvsem pa, J&J poskusila lansirati Risperdal v mnogo sirso uporabo, se posebej med ranljive ciljne skupine otrok in starostnikov.
Januarja 1999 je FDA ( Food & Drug Administration) opozorila J &J, da siri informacije ki se “smatrajo kot lazne ali zavajajoce”
http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/assets/documents/3/stockbridge-civ-exhibit-4.pdf?build=10011648
kakor tudi napacno navajanje stranskih ucinkov.
Septembra 2000 je FDA)prepovedala promoviraje in uporabo Risperdala za otroke z “vedenjskimi motnjami” , opozorila firmo, naj se zdravilo uporablja samo za zdravljenje shizofrenije in ne vseh “psihoticnih motenj” kakor tudi opozorila, da je firma “ zanemarila pojasniti nenavadno stevilo smrti med starostniki.
Poslovni nacrt ki je predvidel 1 miljardni promet, bi zahteval, da Risperdal uporablja na desetine miljonov uporabnikov, ne pa samo delez procenta“shizofrenicne populacije”.
http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/
Jeseni 200 je po navedah J&J 46% prihodkov od risperdala izviralo iz “off-label” ( torej mimo diagnosticnih kriterijev) receptov
Od tega 25% populacije starostnikov, 21% pa otrok in najstnikov.
http://archinte.jamanetwork.com/article.aspx?articleid=410250
The greatest disparity between supported and unsupported off-label prescription occurred among psychiatric (4% strong support vs 96% limited or no support) and allergy therapies (11% strong support vs 89% limited or no support)
Ze leta 999 je J&J najela firmo Excerpta Medica – specialista v “medicinskem trzenju”, posebej v proizvodnji “ghostwritten” ekspertnih studij, ki dokazujejo varnost in ucinkovitost klientovih zdravil, lociranju uglednih akademikov, ki so navedeni kot avtorji, in plasiranju teh studij v prestizne akademske publikacije.
Excerpta Medica specialty was producing ghostwritten, data-filled studies on the efficacy and safety of a client’s drugs, finding the right academic scholars to be listed as the authors and then placing the articles in prestigious academic journals.
http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/chapter-4.html
V letu 2000 je Excerpta Medica pricela delovati na nacrtu, da plasira clanke o Risperdalu v medicinske publikacije – planirano je bilo 39 clankov (“Awareness articles”)
in “originalnih” porocil, vsak od njih po ceni 22.000 USD, plus honorar za “avtorje”.
Splosni nacrt trzenja je bil objavljanje klinicnih podatkov in marketing ki bi podpiral uporabo Risperdala pri razpolozenjskih motnjah i.e. Sirjenje trga v tretman bipolarne motnje pa tudi sirse, torej vseh razpolozenjskih motenj.
As Excerpta later explained when it presented its plan to Janssen executives, the goal was to publish clinical data and marketing that supported the use of Risperdal for mood disorders. “Overall, the plan supports risperidone’s market expansion into the treatment of patients with bipolar disorder and, more broadly, into the treatment of patients with mood disorders,” the presentation promised.
Eno od “kljucnih sporocil” bi moral biti znanstveni clanek ki bi ovrgel tvegano povezavopri Risperdalu med dvigneno ravnjo prolaktina in klinicnimi abnormalnostmi.
V ta namen je Excerpta Medica poslala mail Dr. Robertu Findlingu, uglednemu otroskemu psihiatru, kjer ga obvseca, da so ga identificirali kot bodocega avtorja se nenapisane raziskave “ Varnost in ucinkovitost Risperidona pri vedenjskih motnjah pri otrocih z blago srednjo in mejno mentalno zaostalostjo v starosti 5 – 12 let”
Significantly, one example of a “core message” piece, according to the Excerpta proposal, would be a scholarly article that conveyed the message that Gorsky and his team had decided that they needed to fend off attacks by competitors: “prolactin elevation sometimes seen with Risperdal treatment is not (directly) linked to clinical abnormalities.”
To that end, in August 2000, Excerpta’s Michelle Daniels emailed Dr. Robert Findling, a renowned child psychiatrist at Case Western Reserve University hospital (he is now director of child and adolescent psychiatry at Johns Hopkins), to ask if he would be a lead author of an article that would be based on the results of Risperdal studies involving children taking the drug over an extended period. The data was not in yet, but the working title was “The Safety and Efficacy of Open-Label Risperidone in Conduct Disorder in Mild, Moderate and Borderline Mentally Retarded Children Aged 5 to 12 Years.”
“You have been identified as the lead author to this manuscript,” Excerpta’s Daniels wrote, noting that she had attached a “preliminary outline for your manuscript.”
Sinergisticno z agresivnim trzenjem Excerpte Medice je potekalo prikrivanje podatkov – lastnih raziskav, ki so pokazale nezeljene rezultate kot so nenormalne ravni prolaktina ali pa nezeljene kardivaskularne ucinke – in pa promoviranje napak konkurentnih zdravil.
Prodajni zastopniki, ki so ciljano obiskovali pediatre ( ti pa so bili direktno nagrajeni glede na stevilo receptov za Risperdal), so bili opremljeni s prirocnikom “Kako opraviti z najbolj obicajnimi pritozbami zdravnikov” (predpisevalcev receptov)
“Handling the Most Common Objections Voiced By Prescribers," which advised sales reps to tell doctors that “Risperdal has an excellent combination of efficacy and safety.” It referred them to the ghostwritten article that Excerpta had generated.
http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/assets/documents/4/jj-marketing-email-risperdal-to-elderly.pdf?build=10011648
Prav tako so bili poduceni, da morebitne pomisleke zdravnikov odpravijo tako, da jih napotijo na znanstvene clanke – prav tiste ki jih je “proizvedla” Excerpta Medica.
Kljub temu so utemeljeni pomisleki zdravnikov – kakor tudi lastne raziskave J&J kazale na zaskrbljujoc problem zvisanega prolaktina in s tem povezne ginekomastije – rasti prsi pri fantih.
Zato so se odlocili, da zdruzijo najbolj zaskrbljujoco raziskavo – INT41 – ki je imela najvec udelezencev in najslabse rezultate, s 4 manjsimi, bolj splosnimi raziskavami.
Stevilke so bile kljub statisticnemu zduzevanju, se vedno slabe, poleg tega pa so kazale na direktno kavzalnost – rast prsi pri fantih, ki so jemali Risperdal vec kot 8 tednov.
Tako so prisli do “briljantne odlocitve” in iz raziskave retroaktivno odstranili moteco populacijo – fante nad 10 let – in na ta nacin dosegli mnogo nizjo stopnjo ginekomastije – samo 0.8% in s tem “ dokazali” da razmerje risperdala in ginekomastije ni statisticno pomembno.
Vendar so, pri ugotavljanju procenta, moteco populacijo odstranili samo iz stevca , ne pa tudi iz imenovalca, imenovalcu pa so dodali se nerelevantno populacijo deklet.
Torej 22 ( vsi fantje z ginekomastijo) -17 ( fantje nad 10 let z g.) / 489 ( vsi fantje)+103 ( vsa dekleta) = 5/ 592
http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/chapter-5.html
Ce raziskave ne bi prirejali, bi pravilni podatki pokazali 4.5% ginekomastije pri vseh fantih in 2.0% pri fantih pod 10 let, kar je statisticno pomemben podatek.
Prav tako je studija zanemarila dejstvo – ki so ga kasneje izpostavili odvetniki – da so vsi fantje, ki so jemali Risperdal 8-12 tednov imeli dvignjene ravni prolaktina in da je cas 8-12 tednov nezadosten – ginekomastija se namrec ustanovi sele,ko ima tkivo, povzroceno s zvisanim prolaktinom, cas, da zraste.
Tako prirejena in “popravljena” studija, z osnovnosolskih napakami pri ulomkih, je bila takoj posredovana vsem J&J prodajnim zastopnikom na terenu in objavljena v spostovani publikaciji
Journal of Child Psychiatry pod naslovom , “Prolactin Levels During Long-Term Risperdone Treatment in Children and Adolescents.”
Medtem je J&J se zmeraj agresivno promoviral uporabo risperdala pri starostnikih za “sindrom soncnega zahoda” ( sundown syndrome) torej demenco, s svojim agresivnim programom ElderCare ,kakor tudi financno sponzoriral projekt TMAP
The Texas Medical Algorithm Project put together a group of doctors who recommended Risperdal as the first-choice anti-psychotic drug for Texas Medicaid prescribers even though it was more expensive than drugs. J&J would later replicate the project in other states, and many of the doctors received fees from the company.
J&J je tudi stopil v partnerstvo z Omnicare,firmo, ki zagotavlja farmakoloske storitve v domovih za starostnike,tako,da so Omnicare zdravniki predpisovali ( drazji) Risperdal, dobicek pa so si razdelili.
No, zadeva se je koncala na sodiscu,
http://www.nytimes.com/2015/09/17/opinion/nicholas-kristof-when-crime-pays-jjs-drug-risperdal.html?_r=0
Johnson&Johnson je placal 2 milijardi USD kazni, kar je seveda macji kaselj v primerjavi s 30 miljardami letnega prometa z risperdalom in "off-label” uporabo, ki se zmeraj veselo raste.
Toliko samo v ponazoritev, da niso nujno vse raziskave verodostojne in vsi podatki zanesljivi.
Lep pozdrav,