VAARA: mitä hoitosuositus(ryhmä) EI saisi sisältää? Moniko suomalainen KANSANTAUTIEN hoitosuositustyöryhmä läpäisisi tämän seulan?

Transkriptio

1 VAARA: mitä hoitosuositus(ryhmä) EI saisi sisältää? Moniko suomalainen KANSANTAUTIEN hoitosuositustyöryhmä läpäisisi tämän seulan?

2 VAARA: hoitosuositusryhmän kasautuminen (stacking) Moniko suomalainen KANSANTAUTIEN hoitosuositustyöryhmä läpäisee tämän kriteerin?

3 Miten hoitosuosituksia pitäisi tehdä (Suomessa)?

4 Miten hoitosuosituksia pitäisi tehdä (Suomessa)? Yhtäläinen huomio kaupallisille ja intellektuaalisille eturistiriidoille ja yksiselitteiset kriteerit molemmille Riippumaton menetelmäasiantuntija (methodologist) vastaamaan suosituksista Substanssiasiantuntijat voivat kerätä ja tulkita näyttöä, mutta suosituksista vastaavat riippumattomat paneelit Guyatt et al. Ann Intern Med 2010

5 Stacking: vastalääke löytyy! Hoitosuosituspaneelin jäsenten ei lähtökohtaisesti tarvitse olla samaa mieltä tasapainoinen suositus syntyy kompromissina

6 Riittääkö sidonnaisuuksien ilmoittaminen? Maailmalla ilmoittaminen ei riitä, vallitse trendi on yksiselitteinen: nollatoleranssi Pienellä maalla ei ole varaa huonoihin hoitosuosituksiin; lopetetaan selittely Panostetaan näytön arviointiosaamiseen, ei substanssiasiantuntijuuteen Lainataan rohkeasti isommilta; sekä suosituksia että toimintatapoja Kuka on keskiössä, kenen asialla tässä ollaan? Potilaat? Luottamus on lääkäreille ensiarvoisen tärkeää (vrt. poliitikot/vaaliraha)

7 Sidonnaisuuksien ilmoittaminen ei riitä, ne tulee ELIMINOIDA!

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9 previously deemed approved for that use. The for treating depression in the same time got inflated and paid kickbacks to n the last few years pharmaceutical companies have agreed to pay over $13 billion to resolve U.S. Department of Justice allegations of fraudulent marketing practices, settlement also resolved patients under 18, even prices from government physicians and to the cluding the promotion of medicines for uses that were not approved by the Food and Drug Administration. Here are summaries of some recent large settlements. was pulled from the market allegations that Merck though the drug had never programs by submitting nation s largest long-term In in the 2005 last due few to years safety pharmaceutical made companies false or misleading have agreed to pay been over approved $13 billion for that to resolve age U.S. false Department price reports, of Justice alleged allegations care pharmacy of fraudulent provider, marketing practices, including concerns. the The promotion government of medicines statements for uses about that the were not approved group. by GlaxoSmithKline the Food and Drug Administration. the United States. Here are summaries Omnicare of some Inc. recent As part large of the settlements. alleged that Pfizer also drug's heart safety to also pled guilty to failing to Medicare and other agreement, Johnson & promoted three other increase sales. disclose safety information government health care Johnson admitted that it Pfizer Merck GlaxoSmithKline Sanofi-Aventis Johnson & Johnson drugs illegally: the about the diabetes drug programs "paid millions of promoted Risperdal for SEPT antipsychotic 2009 Geodon, an See NOV Merck 2011 in Dollars For Docs Avandia JULY to 2012 the FDA. dollars in DEC kickback-tainted 2012 treatment of NOV psychotic 2013 antibiotic Pfizer Zyvox, and the Merck GlaxoSmithKline claims for Sanofi-Aventis Hyalgan," symptoms Johnson in nonschizophrenic Pfizer & Johnson antiepileptic was fined drug $2.3 Lyrica. Merck agreed to pay a fine See GlaxoSmithKline in agreed to according Sanofi-Aventis to the DOJ agreed to Johnson patients, & Johnson agreed billion, SEPT 2009 then the largest of NOV $ million related to Dollars pay JULY For Docs a 2012 fine of $3 billion to DEC 2012 NOV 2013 announcement. pay $109 million to resolve although the to drug pay a was $2.2 billion fine to health See Pfizer care in Dollars fraudfor Docs the illegal promotion of the resolve civil and criminal allegations that the approved only resolve to treat criminal and civil Pfizer was fined $2.3 Merck agreed to pay a fine GlaxoSmithKline agreed to Sanofi-Aventis agreed to Johnson & Johnson agreed settlement and the largest painkiller Vioxx, which was liabilities regarding its company gave doctors schizophrenia. free allegations relating to the billion, then the largest of $950 million related to pay a fine of $3 billion to pay $109 million to resolve to pay a $2.2 billion fine to criminal fine ever imposed withdrawn from the market promotion of drugs, as well units of Hyalgan (an prescription drugs Risperdal, health care fraud the illegal promotion of the resolve civil and criminal allegations that the See J&J in resolve criminal and civil in the United States. Pfizer in 2004 after studies found as its failure to report injection to relieve knee Invega and Natrecor. The settlement and the largest painkiller Vioxx, which was liabilities regarding its company gave doctors Dollars free For Docs allegations relating to the pled guilty to misbranding the drug increased the risk safety data. This is the pain) to encourage those government alleged that J&J criminal fine ever imposed withdrawn from the market promotion of drugs, as well units of Hyalgan (an prescription drugs Risperdal, the painkiller Bextra with of heart attacks. The largest health care fraud doctors to buy their promoted these drugs for in the United States. Pfizer in 2004 after studies found as its failure to report injection to relieve knee Invega and Natrecor. The "the intent to defraud or company pled guilty to settlement in the United product. Sanofi lowered uses not approved as safe pled guilty to misbranding the drug increased the risk safety data. This is the pain) to encourage those government alleged that J&J mislead", promoting the having promoted Vioxx as States to date. The the effective price by and effective by the FDA, the painkiller Bextra with of heart attacks. The largest health care fraud doctors to buy their promoted these drugs for drug to treat acute pain at a treatment for rheumatoid company pled guilty to promising these free targeted elderly dementia "the intent to defraud or company pled guilty to settlement in the United product. Sanofi lowered uses not approved as safe dosages the FDA had arthritis before it had been misbranding the drug Paxil samples to doctors, but at patients in nursing homes, mislead", promoting the having promoted Vioxx as States to date. The the effective price by and effective by the FDA, previously deemed approved for that use. The for treating depression in the same time got inflated and paid kickbacks to drug to treat acute pain at a treatment for rheumatoid company pled guilty to promising these free targeted elderly dementia dangerously high. Bextra settlement also resolved patients under 18, even prices from government physicians and to the dosages the FDA had arthritis before it had been misbranding the drug Paxil samples to doctors, but at patients in nursing homes, was pulled from the market allegations that Merck though the drug had never programs by submitting nation s largest long-term previously deemed approved for that use. The for treating depression in the same time got inflated and paid kickbacks to in 2005 due to safety made false or misleading been approved for that age false price reports, alleged care pharmacy provider, dangerously $1.42B high. Bextra $2.3B settlement $520M also $950M resolved $1.5B patients under 18, $3B even $95M prices $109M from government $762M $2.2B physicians $193M and to the concerns. The government statements about the group. GlaxoSmithKline the United States. Omnicare Inc. As part of the was pulled from the market allegations that Merck though the drug had never programs by submitting nation s largest long-term alleged that Pfizer also drug's heart safety to also pled guilty to failing to Medicare and other agreement, Johnson & in 2005 due to safety made false or misleading been approved for that age false price reports, alleged care pharmacy provider, promoted three other increase sales. disclose safety information government health care Johnson admitted that it concerns. The government statements about the group. GlaxoSmithKline the United States. Omnicare Inc. As part of the drugs Eli Lilly illegally: the AstraZeneca Abbott about the diabetes Boehringer drug programs Amgen"paid millions of Endo promoted Risperdal for alleged that Pfizer also drug's heart safety to also pled guilty to failing to Medicare and other agreement, Johnson & antipsychotic JAN 2009 Geodon, an APRIL 2010 See Merck in Dollars For MAY Docs 2012 Avandia to Ingelheim the FDA. dollars DEC 2012 in kickback-tainted FEB 2014 treatment of psychotic promoted three other increase sales. disclose safety information government health care Johnson admitted that it antibiotic Zyvox, and the OCT 2012 claims for Hyalgan," symptoms in nonschizophrenic patients, Eli drugs Lilly illegally: was finedthe AstraZeneca was Abbott was fined about the diabetes drug programs "paid millions of promoted Risperdal for antiepileptic drug Lyrica. See $1.5 GlaxoSmithKline in Amgen agreed to pay Endo Health antipsychotic Geodon, an See Merck in Dollars For Docs according to the DOJ $1.42 billion to fined $520 million to billion in connection Dollars Avandia For to Docs Boehringer the FDA. Ingelheim dollars a $762 in kickback-tainted million fine to Solutions treatment Inc. and of psychotic its announcement. although the drug was See resolve antibiotic Pfizer a in government Zyvox, Dollars For and Docs the resolve allegations to the illegal Pharmaceuticals Inc claims resolve for criminal Hyalgan," and subsidiary symptoms Endoin nonschizophrenic Inc. patients, antiepileptic drug Lyrica. See GlaxoSmithKline in approved only to treat investigation into the that it illegally promotion of the agreed to pay $95 according civil charges to the that DOJ the Pharmaceuticals off-label promotion of promoted the antipsychotic drug Dollars For Docs million to resolve schizophrenia. announcement. company illegally agreed although to pay the $192.7 drug was the See antipsychotic Pfizer in Dollars For Docsantipsychotic drug Depakote. Abbott allegations that the introduced and million approved to resolve See J&J in only to treat Zyprexa. Zyprexa had Seroquel. The drug admitted to having company promoted promoted several criminal and civil schizophrenia. been approved for was approved for trained a special several drugs for nonmedically accepted Aranesp, a drug to Endo s drugs including liability Dollars arising For Docs from the treatment of treating schizophrenia sales force to target See marketing J&J in of certain psychotic and later for bipolar nursing homes, uses. These drugs treat anemia. Amgen the prescription drug Dollars For Docs disorders, but Lilly mania, but the marketing the drug included the stroke- pleaded guilty to Lidoderm. As part of dangerously high. Bextra Big Pharma s Big Fines

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11 Lääkäri on paitsi potilaan, myös terveyden asialla. Jälkimmäinen vastuu tarkoittaa käytännössä sitä, että hyvä lääkäri ei voi olla vaatimassa yhteiskunnalta lisää voimavaroja, ellei hän samanaikaisesti pysty osoittamaan, että juuri hänen käytössään ne tuottavat suuremman rajahyödyn kuin mitenkään muuten kohdenneuttuina.

12 Kansalliset (Käypä) hoitosuositukset?

13 Leinonen & Järvinen. HS/Vieraskynä,

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15 Sidonnaisuuksilla on RAHALLISTA merkitystä Mitä enemmän lääketieteen opiskelijat olivat opiskeluidensa aikana tekemisessä lääkemarkkinoinnin kanssa, sitä liberaamimpi he määräsivät uusia lääkkeitä (joilla ei osoitettu olevan terapeuttista etua vs. vanhat).