Reply to: Austin et al. CytoJournal 2009;6:12 (Unfounded claims mar scientific critique)

Lessons learned from successful Papanicolaou cytology cervical cancer prevention in the socialist republic of Vietnam

“…Dr. Kochi warned that many of the world's leading malaria scientists are now “locked up in a ‘cartel’ with their own research funding being linked to those of others within the group,” and that “each has a vested interest to safeguard the work of the others.” He further warned that the BMGF's determination to have its favored research used to guide health recommendations “could have implicitly dangerous consequences on the policy‐making process in world health.” Similar warnings appear appropriate for global cervical cancer prevention efforts. Alliance leaders have provided no answers to the question of what can be learned from the controversial no‐screening arm of the Alliance India study that cannot be learned without it 84. Alliance cost‐effectiveness studies have persistently been biased in favor of non‐cytologic preventive methods,7, 26, 74, 75 and Alliance studies of HPV screening have persistently compared the performance of Papanicolaou tests analyzed in developing‐country laboratories to HC2® tests shipped to American or European reference laboratories for analysis,26, 36, 38 suggesting that an unintended consequence of the BMGF's principles of making “big bets” “driven by the interests and passions of the Gates family” may be to introduce bias into medical research.…”

“…Alliance leaders have provided no answers to the question of what can be learned from the controversial no-screening arm of the Alliance India study that cannot be learned without it. 84 Alliance cost-effectiveness studies have persistently been biased in favor of non-cytologic preventive methods, 7 , 26 , 74 , 75 and Alliance studies of HPV screening have persistently compared the performance of Papanicolaou tests analyzed in developing-country laboratories to HC2® tests shipped to American or European reference laboratories for analysis, 26 , 36 , 38 suggesting that an unintended consequence of the BMGF's principles of making “big bets” “driven by the interests and passions of the Gates family” may be to introduce bias into medical research. The widely-disputed 43 , 45 – 47 , 85 , 86 2009 conclusion from the controversial Alliance India study, which attributed improved health outcomes to nonexistent advantages in HC2® test sensitivity, 44 was nonetheless consistent with the extraordinary Alliance founding assumption and served as the basis for policy recommendations from the U.S. National Cancer Institute that “international experts in cervical cancer prevention should now adapt HPV testing for widespread implementation…low-resource countries do not need to establish large cytologic-testing (Papanicolaou) programs whose effectiveness requires repeated screening.” 87 These policy recommendations overlook observations that Papanicolaou cytology performed with both equal sensitivity and higher specificity than HC2® in the Alliance India study, that the price of HC2® precludes its widespread use in low-resource settings, and that readily affordable but incompletely validated HPV test reagents, such as those now readily available in Vietnam, 50 may create “disastrous” quality management scenarios.…”

“…Additional concerns derive from potential conflicts of interest associated with the partnership between the Program for Appropriate Technology in Health (PATH, Seattle WA), which others have characterized as a BMGF agent rather than an independent grantee, 25 and the manufacturer of the HC2® and CareHPV™ tests. 7 , 73 , 74 , 84 Others have questioned whether major public health organizations are able to effectively manage conflicts of interest. 90 …”