terça-feira, novembro 27, 2012

Disease mongering/Prevenção IV

Ontem participei de atividade promovida pela Associação Gaúcha de Medicina de Família e Comunidade (AGMFC). Foi coordenada pelo médico português Luis Filipe Ribeiro de Almeida Gomes. Iniciou com uma breve apresentação do significado de Disease mongering e do conceito de Prevenção Quaternária e sua importância. Após, os participantes foram distribuídos em pequenos grupos. Receberam um texto para ser lido, e um resumo era apresentado ao grande grupo. Todos os textos eram sobre osteoporose. Haviam sido publicados em revistas de renome ou se tratavam de diretrizes portuguesas. E um se encaixava no outro, fazendo surgir naturalmente entre os participantes a conclusão que os organizadores da atividade fizeram questão de não entregar "pronta". No encerramento, Filipe apresentou mais alguns slides sobre o tema central, usando novamente muitos exemplos sobre osteoporose.

Eis as definições apresentadas:

Prevenção Quaternária - “Conjunto de acções que visam identificar os pacientes em risco de sobreprevenção, sobrediagnóstico e sobremedicalização, com o fim de os proteger de novas intervenções médicas inapropriadas e de lhes sugerir alternativas eticamente aceitáveis.”

Disease mongering - “Acção que visa alargar os limites diagnósticos de doenças pré-existentes e/ou a sua perigosidade e promovê-las publicamente, visando auferir lucro através da comercialização de medicamentos e/ou de procedimentos médicos a elas ligados.”

Sobre osteoporose, divulgou-se depoimento oficial de um dos membros do painel de peritos que criou os critérios diagnósticos:
“... durante dois ou três dias os peritos presentes andaram para trás e para a frente… tentando decidir com precisão onde é que, num gráfico de diminuição da densidade óssea, se devia traçar a linha… ao fim e ao cabo, foi uma questão de… ‘Bom... Temos que traçar a linha em algum sítio... e lembro-me que estava muito calor, e as pessoas estavam em mangas de camisa, sabem, tínhamos que andar para a frente, vocês compreendem... e, francamente, não me recordo quem é que se levantou e traçou a linha dizendo, ‘Bom, vamos lá fazer isto ”
Definida a doença em 1994, surgia em 95 uma nova classe de medicamentos – os bisfosfonatos. Os apresentadores mostraram neste ponto de um panorama histórico dados da criação, pela Merck, de uma organização não-lucrativa (o “Bone Measurement Institute”) que teria distribuído ou subsidiado máquinas de densitometria óssea mundo afora.

Sobre grupos de pacientes, apresentaram os seguintes dados: 
Cerca de 2/3 dos grupos de pacientes, como a National Osteoporosis Foundation*, recebe fundos provenientes da indústria.

* National Osteoporosis Foundation (patrocinada pela “Merck & Company”), desenha campanhas visando “… chamar a atenção para a importância de testar para a osteoporose…”
A seguir um resumo de alguns dos artigos trabalhados nos pequenos grupos:

- Bone densitometry is not a good predictor of hip fracture

The ability of bone densitometry to predict future fracture is overstated, and the data on which such claims are based are overinterpreted. Bone densitometry is a major industry (an estimated 34 000 densitometry machines were in existence worldwide in 2000), and much of the research into osteoporosis depends on it. Clinical trials test efficaciousness (can it work?) in selected groups. The clinician is concerned with effectiveness (does it work?) in unselected individuals. The challenge is to show the latter.

- Association of low-energy femoral fractures with prolonged bisphosphonate use: a case control study

We found a significantly greater proportion of patients with subtrochanteric/shaft fractures to be on long-term bisphosphonates than intertrochanteric/femoral neck fractures. Bisphosphonate use was highly associated with a unique X-ray pattern. Further studies are warranted.

- Atypical Fractures of the Femoral Diaphysis in Postmenopausal Women Taking Alendronate

Our results provide further evidence of a potential link between alendronate use and low-energy fractures of the femur. In light of the limitations of our study, a prospective study is indicated. Although many possible explanations exist, patients with the unique radiographic pattern shown here may represent a subgroup of the population that is more susceptible to the effects of prolonged suppression of bone turnover. Additional studies are needed to characterize this subgroup and to establish a clear association between atypical fractures of the femur and prolonged bisphosphonate treatment.

- Low-Energy Femoral Shaft Fractures Associated With Alendronate Use

A retrospective review was performed of patients with femoral shaft fractures admitted to a Level 1 trauma center between January 2002 and March 2007. Seventy low-energy fractures were identified. Low-energy fractures of the femoral shaft with a simple, transverse pattern and hypertrophy of the diaphyseal cortex are associated with alendronate use. This may result from propagation of a stress fracture whose repair is retarded by diminished osteoclast activity and impaired microdamage repair resulting from its prolonged use.

Deste tenho um pouco mais, pois foi o apresentado pelo meu grupo:

- Bisphosphonates and low-impact femoral fractures: Current evidence on alendronate-fracture risk 

Bisphosphonates are considered first-line treatment for postmenopausal osteoporosis. They are prescribed for millions of geriatric patients. Bisphosphonates 
– alendronate (Fosamax), risedronate (Actonel), ibandronate (Boniva), and zoledronic acid (Zometa, Reclast) – inhibit bone resorption by decreasing the activity of osteoclasts. Extensive studies have shown that therapy with bisphosphonates improves bone density and decreases fracture risk. 
...
When discontinued after 5 years, the physiologic effect of alendronate continues for at least 5 years, with no increase in morphometric vertebral fracture risk or in the risk of nonvertebral fractures compared with patients who continued to take alendronate for the full 10 years. This result is consistent with the fact that alendronate is incorporated into bone matrix and has a biological half-life of more than 10 years. Bone turnover is a natural part of maintaining bone health. When bone turnover is inhibited by bisphosphonates, microdamage that occurs regularly in bone but is normally repaired might accumulate after long-term use.
...
The reports of multiple cases of low-impact femoral fractures in patients who were taking alendronate for several years, a previously rare event, have therefore called for further study of the possible connection between alendronate and such fractures, as has been suggested by several authors. 
...
The odds ratio for this pattern was 139.33 for alendronate users, and was 98% specific to identifying alendronate users. The patients with this pattern had been using alendronate for a mean of 6.9 years.
...
The evolution of our understanding of the relationship between alendronate and femoral fractures parallels the growing understanding of the relationship between use of bisphosphonates and osteonecrosis of the jaw (ONJ), which may reflect a similar mechanism of bone injury. After numerous publications of multiple case reports, a population-based analysis of IV bisphosphonate therapy concluded that the hazard ratio of being diagnosed with inflammatory conditions or osteomyelitis of the jaw was 11.48 for recipients of IV bisphosphonates as compared with non-recipients. No randomized, controlled, doubleblind studies have been done regarding bisphosphonates and ONJ, and they are unlikely to be done in the future. Nonetheless, the case reports and population studies have led to the creation of a new syndrome in the dental world, bisphosphonate-associated osteonecrosis of the jaw (BON), and position papers on trying to prevent this disorder have been published by several organizations concerned with dental surgery. 
...
Although most cases of ONJ have occurred in patients treated with IV bisphosphonates (pamidronate, zoledronic acid), the finding of some cases related to oral bisphosphonates resulted in the recent publication by the American Dental Association of “Dental management of patients receiving oral bisphosphonate therapy
.” This document suggests that “because there is no validated diagnostic technique currently available to determine if patients are at increased risk for developing BON, it may be prudent to proceed conservatively in some cases.” 
...
the National Osteoporosis Foundation (NOF), in its Clinical Update Online of July 2008, said, “Results suggest that for most women, taking a 5-year ‘drug holiday’ after being on alendronate (5-10 mg/day) for 5 years does not increase fracture risk and might be advantageous. For women at high risk for vertebral fractures, continuing alendronate for a total of 10 years is a reasonable clinical option.”

Filipe entende que os benefícios conhecidos da estratégia global (exame + medicação) são propagandeados a partir da redução relativa de risco, e que se fosse feito a partir da redução absoluta de risco enxergaríamos tudo muito diferente. Leia mais sobre Pensamento Relativo versus Pensamento Absoluto.

Minha conclusão foi: Talvez pudéssemos adotar uma abordagem no meio do caminho entre a banalização do uso de densitometria e bisfosfonatos, e a daqueles que escutam estas coisas e saem defendendo a não solicitação do exame e a não medicalização de mais ninguém neste contexto.

Nenhum comentário:

Postar um comentário

Related Posts Plugin for WordPress, Blogger...