TY - JOUR
T1 - Progress against solid tumors in danger
T2 - The metastatic breast cancer example
AU - Corteś, Javier
AU - Calvo, Emiliano
AU - González-Martín, Antonio
AU - Dawood, Shaheenah
AU - Llombart-Cussac, Antonio
AU - De Mattos-Arruda, Leticia
AU - Gómez, Patricia
AU - Silva, Orlando
AU - Perez, Edith A.
AU - Rugo, Hope S.
AU - Lluch, Ana
AU - Hortobagyi, Gabriel N.
PY - 2012/10/1
Y1 - 2012/10/1
N2 - The high prices of drugs and the worldwide economic and financial crisis are concerning. Of course, additional research might elucidate the subgroup of patients who will experience greater benefit, but as scientists and physicians, we should clearly separate value and price. Asurvey to assess the perception of health care workers involved in the management of women with MBC on the FDA's decision to ascertain how it will affect practice and to determine how bevacizumab is commonly used in the community for MBC was conducted. These survey results highlight the discord between the opinion of community oncologists and the FDA's recent decision to withdraw the indication of bevacizumab for MBC.33 Apositive trial is based on a statistically significant P value, which should not be confused with clinical meaning. In addition, the concept of clinicalmeaningis closely related with costs. IfOSis the primaryend point of first-line trials, only the prognosis of a few tumors will be improved, and only over the course of a few years. This controversy is not only relevant to bevacizumab in MBC. The lack of consistency and transparency in the drug approval process is dangerous and likely to discourage pharmaceutical companies from developing new drugs. Progress in our fight to cure cancer will be jeopardized if we confuse value and price.
AB - The high prices of drugs and the worldwide economic and financial crisis are concerning. Of course, additional research might elucidate the subgroup of patients who will experience greater benefit, but as scientists and physicians, we should clearly separate value and price. Asurvey to assess the perception of health care workers involved in the management of women with MBC on the FDA's decision to ascertain how it will affect practice and to determine how bevacizumab is commonly used in the community for MBC was conducted. These survey results highlight the discord between the opinion of community oncologists and the FDA's recent decision to withdraw the indication of bevacizumab for MBC.33 Apositive trial is based on a statistically significant P value, which should not be confused with clinical meaning. In addition, the concept of clinicalmeaningis closely related with costs. IfOSis the primaryend point of first-line trials, only the prognosis of a few tumors will be improved, and only over the course of a few years. This controversy is not only relevant to bevacizumab in MBC. The lack of consistency and transparency in the drug approval process is dangerous and likely to discourage pharmaceutical companies from developing new drugs. Progress in our fight to cure cancer will be jeopardized if we confuse value and price.
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U2 - 10.1200/JCO.2012.41.9580
DO - 10.1200/JCO.2012.41.9580
M3 - Comment/debate
C2 - 22927522
AN - SCOPUS:84867042331
SN - 0732-183X
VL - 30
SP - 3444
EP - 3447
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 28
ER -