Seminário Nacional sobre
Propaganda e
Uso Racional de Medicamentos
Distorções da Evidência
Científica Expressas nas
Peças Publicitárias
Andry Fiterman Costa
Salvador, 9-10 de dezembro de 2005
Andry Fiterman Costa
[email protected]
[email protected]
Declaração de Isenção de Conflito de Interesses
Resolução CFM nº 1.595/2000
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Médico pela UFRGS em 1996
Especialização em Medicina Interna 1997-99
Mestrado em Medicina-Cardiologia 2000-02
Consultor do Ministério da Saúde para Medicamentos
Excepcionais
• Consultor da Anvisa, da SES-RS e UNIMED-Porto
Alegre em Farmacologia Clínica
• Nenhum vínculo de emprego ou de interesse
financeiro de qualquer espécie com:
– Indústria de Equipamentos
– Indústria Farmacêutica
“Dosis sola facit venenum...”
Paracelsus, 1493-1541
Pai da Farmacologia
“O que diferencia o homem
dos animais é a compulsão
para usar medicamentos...”
Sir William Osler, 1849-1920
Médico
Propaganda direcionada
ao consumidor
Trata-se de um
Suplemento e não
remédio. Se o
consumidor ajudar,
diminuindo a
ingestão calórica
para cerca de 1000
kcal por dia e
aumentar as
atividades físicas,
possibilidade de
perda de peso se
torna mais concreta.
Conflito de interesses ?
Propaganda direcionada
ao prescritor
A propaganda “ética” ...
1.
44,1 % das referências de 102 materiais promocionais
dos fabricantes não justificavam as afirmativas
Lancet 2003;361:27-32.
2.
Análise de gráficos promocionais, mostrou que 36%
deles continham distorções especificamente proibidas
pelo FDA
J Gen Inter Med 2003;18:315-6
Sua Santidade, o ECR®
O RESULTADO FINAL
DE ENSAIOS
PATROCINADOS
PELA INDÚSTRIA
TEM MAIOR
PROBABILIDADE DE
FAVORECER O
PATROCINADOR
http://medicine.plosjournals.org/archive/1549-1676/2/8/pdf/10.1371_journal.pmed.0020124-L.pdf
Ten tips for the pharmaceutical
industry: how to present your
product in the best light
David Graham Digestive Disease Week Scientific Sessions
Handouts May 2003:81
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
1. Imagine um mecanismo fisiológico plausível sobre como
a droga age e que seja emblemático para apresentá-lo.
Encontre um desfecho intermediário fortemente
influenciado pela droga mesmo que ele não seja
estritamente válido
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
2. Ao delinear ensaios clínicos selecione
pacientes, aspectos clínicos e duração de
tratamento que permitam observar a máxima
resposta terapêutica;
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
3. Se possível compare seu produto somente
com placebo. Se necessário comparar com seu
competidor, tenha a certeza de administrá-lo
numa dose sub-terapêutica;
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
4. Inclua figuras de estudos pilotos na publicação
final – “Russian doll effect” assim parecerá
que mais pacientes foram estudados.
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
5. Omita qualquer fatalidade ou efeitos adversos
graves ocorridos nos grupos tratados. Se
possível não publique estes estudos.
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
6. Faça seu departamento gráfico maximizar o
impacto visual de sua mensagem. Tenha a
certeza de não mostrar dados individuais de
pacientes ou intervalos de confiança;
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
7. Torne-se um mestre na arte de fazer
comparações;
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
8. Inverta a hierarquia da evidência de maneira
que relatos de casos tenham mais importância
que ensaios clínicos;
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
9. Nomeie pelo menos 3 líderes de opinião locais
que utilizem a droga em seus pacientes e
ofereça inícios de tratamento;
Ten tips for the pharmaceutical industry: how to
present your product in the best light
David Graham Digestive Disease Week Scientific Sessions Handouts May 2003:81
10. Realize estudos de custo-efetividade que
mostre que seu medicamento, mesmo sendo
mais caro que o competidor, na prática tornase mais barato.
How to Achieve positive Results without actually
Lying to Overcome the Truth
HARLOT plc: Sackett, & Oxman
“Politics is nothing more than medicine
on a grand scale.” Rudolf Virchow,
1848
Services to Doggy-drugs
E-Zee-Me-Too Protocols
Ethics-R-Us
RATs (Research Administration Teams)
FPSU (Find the Pony Statistical Unit)
Ghost Writers in the Sky
Aftercare
HARLOT plc: Sackett & Oxman
We, the authors, are tired of being good
but poor,and have decided to sacrifice the
former to overcome the latter.
Services to Doggy-drugs
SAFE (Say Anything For a Euro)
SCUM (Sick Celebrities to Use in the Media)
SHARKS (Striking Horror And Retreat
through Killer Solicitors) squad.
RCAF (Rabid Citizens Against Facts)
HARLOT plc: Sackett & Oxman
We, the authors, are tired of being good
but poor,and have decided to sacrifice the
former to overcome the latter.
Services to Doggy-drugs
HARLOT plc: Sackett & Oxman
We, the authors, are tired of being good
but poor,and have decided to sacrifice the
former to overcome the latter.
Services to Doggy-drugs
HARLOT plc: Sackett & Oxman
We, the authors, are tired of being good
but poor,and have decided to sacrifice the
former to overcome the latter.
Services to Doggy-drugs
HARLOT plc: Sackett & Oxman
We, the authors, are tired of being good
but poor,and have decided to sacrifice the
former to overcome the latter.
Services to Doggy-drugs
HARLOT plc: Sackett & Oxman
We, the authors, are tired of being good
but poor,and have decided to sacrifice the
former to overcome the latter.
Services to Doggy-drugs
HARLOT plc: Sackett & Oxman
We, the authors, are tired of being good
but poor,and have decided to sacrifice the
former to overcome the latter.
Services to Doggy-drugs
HARLOT plc: Sackett & Oxman
We, the authors, are tired of being good
but poor,and have decided to sacrifice the
former to overcome the latter.
Services to Doggy-drugs
HARLOT plc: Sackett & Oxman
We, the authors, are tired of being good
but poor,and have decided to sacrifice the
former to overcome the latter.
Services to Doggy-drugs
O uso racional de medicamentos
inicia em uma prescrição racional.
Propaganda racional é…
… propaganda é racional ?