THE GLOBAL CERVICAL CANCER PREVENTION PROJECT
OUR MISSION IS TO PROMOTE THE MORAL IMPERATIVE OF SAVING AS MANY LIVES AS QUICKLY AS POSSIBLE WHILE FIGHTING CORRUPTION IN THE MEDICAL PROFESSION
Our Story
Pap screening in lower-income countries is a moral imperative because saving as many lives as quickly as possible is a moral imperative.
CERVICAL CANCER is a leading cause of death in lower-income countries. Today, approximately 90% of the world's cervical cancer deaths occur among women in lower-income countries.
Pap screening prevents cervical cancer by detecting and eradicating pre-cancerous cervical lesions before they progress to life-threatening cervical cancers. The US Preventive Services Task Force has determined that Pap screening reduces cervical cancer rates by 60% to 90% within 3 years of implementation, and that these reductions in suffering and premature death are "consistent and dramatic across populations."
The Head of Cancer Screening at the World Health Organization has emphasized that "good-quality Pap screening can be implemented even in a rural setting of a lower-income country with reasonable investment."
Pap screening in lower-income countries is a moral imperative because saving as many lives as quickly as possible is a moral imperative. However, moral imperatives lack relevance if they are not supported by sufficient political will.
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FOUR TECHNOLOGIES prevent cervical cancer: Pap screening, visual screening, human papillomavirus (HPV) screening, and HPV vaccination.
Chronic infection of the cervix by HPV, which is sexually acquired, causes cervical cancer. Nearly everyone will get HPV at some point in their lives. HPV vaccination is recommended for girls because it does not prevent cervical cancer among women who have previously gotten HPV. Therefore, HPV vaccination does not offer protection against cervical cancer for most women in lower-income countries. Pap screening can offer protection for all women in lower-income countries.
HPV vaccination, if implemented without cervical screening, will require decades to reduce cervical cancer rates by 50%. In contrast, the US Preventive Services Task Force has determined that Pap screening reduces cervical cancer rates by 60% to 90% within 3 years. HPV vaccine expert Diane Harper observes “Combining cervical screening with HPV vaccination does not significantly lower the number of women getting cervical cancer every year, but does decrease the number of women with abnormal screening tests.”
HPV tests cannot be used to screen women under the age of 30, due to unacceptably high false-positive rates of HPV tests among younger women. Visual screening tests cannot be used to screen older women, due to anatomical changes that occur in the cervix as a woman approaches menopause. Pap screening protects women of all ages from developing cervical cancer.
Even in expert hands, quality control for visual screening has failed catastrophically. HPV screening, which remains too expensive for routine implementation in lower-income countries, requires a pre-existing Pap screening infrastructure and can readily be phased in to pre-existing Pap screening programs should prices for HPV tests fall into an affordable range.
If our objective is to honor the moral imperative of saving as many lives as quickly as possible, then Pap smear screening is the appropriate technology to promote for cervical cancer prevention in lower-income countries. Competing imperatives -- such as corporate profit-making, non-profit corporate fundraising, and academic advancement -- involve promoting technologies other than Pap screening for lower-income countries.
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WE LEARNED in 1994 that the burden of cervical cancer in Vietnam was a legacy of the Vietnam War. That knowledge generated sufficient political will to honor the moral imperative of saving as many lives as quickly as possible. Working as unpaid volunteers, we subsequently participated in the establishment of Pap screening in southern Vietnam, which led to 50% reductions in cervical cancer rates between 1998 and 2003. We delayed publication of data linking war to disease until 2004 in an attempt to ease the process of reconciliation by presenting what most would acknowledge to be a remedy in advance of what some would perceive to be an accusation.
At the start of the 21st Century, Vietnam had provided a model for successful cervical cancer prevention in lower-income countries. Vietnamese and American colleagues were preparing to replicate Vietnam's success by, together, implementing Pap screening in other lower-income countries.
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UNFORTUNATELY, since the start of the 21st Century, two developments have decimated political will for the moral imperative of Pap screening in lower-income countries:
1. In 1997, the US National Institutes of Health (NIH) launched an experiment in Mumbai that contributed to the preventable cervical cancer deaths of at least 500,000 Indian women. As part of the cover-up of that catastrophe, NIH-funded physicians have broadcast the unfortunate falsehood that Pap screening is not feasible in lower-income countries.
2. In 1999, the Bill & Melinda Gates Foundation established the Alliance for Cervical Cancer Prevention. The non-transparent and incorrect founding assumption of the Alliance was that novel technology, instead of Pap screening, was the most likely solution for cervical cancer in lower-income countries. That unfortunate assumption has corrupted medical science and decimated political will for Pap screening in lower-income countries. In 2002, the Alliance formally dismissed our suggestion that Pap screening be implemented in lower-income countries.
Because of NIH and the Gates Foundation, one of the world's big, fixable problems is being fixed far too slowly -- with catastrophic, lethal consequences .
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THE GOAL of this website is to avert further human catastrophe by encouraging NIH leaders to start telling the truth.
Eric J Suba MD
President and Executive Director
The Global Cervical Cancer Prevention Project
(formerly named The Viet/American Cervical Cancer Prevention Project)
The New England Journal of Medicine: The Mumbai Experiment Contributed To At Least 500,000 Preventable Cervical Cancer Deaths
CERVICAL SCREENING prevents cervical cancer by detecting and eradicating pre-cancerous cervical lesions before they progress to life-threatening cervical cancers.
From 1997 until 2015, the US National Institutes of Health (NIH) funded an experiment in Mumbai that used premeditated, preventable death as the yardstick to compare the effects of a discredited cervical screening test to the effects of no screening at all.
The Mumbai experiment has been condemned because physicians deliberately withheld cervical screening from women who subsequently died from cervical cancer. As documented in the video clip above, the Mumbai experiment displayed frightening similarities to the Tuskegee Syphilis Study, which President Bill Clinton condemned as being "clearly racist."
In 2021, the Journal of the National Cancer Institute formally confirmed that the Mumbai experiment evaluated the effects of a cervical screening test that had been discredited before the experiment began.
The reasons for NIH funding such a pointless, deadly evaluation – and renewing that funding continually for 18 years – remain important unsolved mysteries. In an effort to solve them, we submitted a US Freedom of Information Act (FOIA) request for the initial NIH grant application for the Mumbai experiment.
NIH responded that “all documents related to this grant number were destroyed in accordance with applicable records retention policies.”
Other documents obtained through FOIA show that scientific data may have been falsified to create an appearance that the discredited cervical screening test had saved lives.
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THE ABSURD SCIENTIFIC DESIGN of the Mumbai experiment required that a pre-determined number of women would die from cervical cancer without ever having been screened for pre-cancerous cervical lesions. To guarantee they would obtain that pre-determined number of preventable cervical cancer deaths, physicians had to persuade 151,538 low-income women of color to risk dying from cervical cancer without ever having been screening for pre-cancerous cervical lesions.
Predictably, the US Office for Human Research Protections (OHRP) – the bioethical oversight agency of the US Government – discovered duplicity in the methods used to convince women to join the experiment.
Low-income women in Mumbai understand Marathi, but not English. OHRP discovered critical differences between English-language and Marathi-language versions of the informed-consent form used for the Mumbai experiment. The English-language version, which was submitted with NIH funding applications, included life-saving information about cervical screening that was missing from the Marathi-language version used to recruit experimental participants.
Without such duplicity, NIH could not have launched the Mumbai experiment.
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US Government-funded physicians who conducted the Mumbai experiment “applied the principle that whenever a new intervention is evaluated, it is compared to the standard care existing in the country and only subsequently should it be implemented as a public health policy.” That unfortunate principle delayed the implementation of Pap screening throughout India for the duration of the experiment. During that 18-year delay, at least one million women died from cervical cancer in India.
The US Preventive Services Task Force has determined that Pap screening reduces cervical cancer rates by 60% to 90% within 3 years of implementation, and that these reductions in suffering and death are "consistent and dramatic across populations."
As we reported in 2022 in the New England Journal of Medicine, the Mumbai experiment thereby contributed to the preventable cervical cancer deaths of at least 500,000 Indian women. In their published response, NIH and WHO colleagues did not dispute the number.
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DOCUMENTS we obtained through the US Freedom of Information Act show that NIH physicians Edward Trimble and Clifford Lane participated in a cover-up of the catastrophe in India. Dr Trimble reported to Nobel Laureate Harold Varmus. Dr Lane reported to Dr Anthony Fauci. During the course of the cover-up, false statements were made to Congressional staffers Anne Morris Reid, who reported to Representative Henry Waxman, and Wendell Primus, who reported to Representative Nancy Pelosi. Those false statements left the staffers “gratified to learn that the Mumbai experiment has had such positive impacts.” Subsequently, Dr Trimble announced to the global public "We looked at the ethics [of the Mumbai experiment] very carefully and felt them to be sound."
It is legal for physicians to lie to the global public. However, making false statements to Congress, even when not under oath, is a criminal offense punishable by fine and/or imprisonment.
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NIH leadiers should put an end to the cover-up conducted by NIH physicians by telling the truth about the Mumbai experiment.
NIH leaders should formally acknowledge that OHRP determinations were accurate, and that the Mumbai experiment was unscientific and unethical. Because NIH funded the Mumbai experiment for 18 years, NIH leaders should apologize for the needless suffering and death it caused.
Until NIH physicians admit the Mumbai experiment was a mistake, they will be unable to conduct the root cause analysis needed to prevent catastrophes like the Mumbai experiment from happening again.
The Mumbai Experiment and Its Cover-Up Have Corrupted Global Health Policy
"Our results clearly show that good-quality Pap screening can be implemented even in a rural setting of a developing country with reasonable investment, while HPV screening does not give any better detection of pre-cancerous cervical lesions, despite the higher investments."
Rengaswamy Sankaranarayanan MD
Head of Cancer Screening at the World Health Organization (WHO)
and
Surendra Shastri MD
Principal Investigator of the Mumbai Experiment
[writing in 2005 in the International Journal of Cancer]
THE MUMBAI EXPERIMENT contributed to the preventable cervical cancer deaths of at least 500,000 Indian women because it delayed the implementation of Pap screening throughout India from 1997 until 2015.
However, if the moral imperative of Pap screening in lower-income countries is discredited, then the number of preventable cervical cancer deaths attributable to the Mumbai experiment drops to zero.
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THE COVER-UP of the Mumbai experiment has required publicizing the politically expedient falsehood that Pap screening is not feasible in lower-income countries.
As documented in the video clip above, the principal investigator of the Mumbai experiment, Dr Surendra Shastri, has promoted that falsehood to the United Nations and to other influential groups. As noted at the top of this page, Dr Shastri himself, together with the Head of Cancer Screening at WHO, have both convincingly refuted that falsehood.
Nevertheless, that falsehood has been incorporated into WHO policy guidelines, which falsely state "In low- and middle-income countries, because of the high cost of setting up screening programmes based on Pap screening, coverage of screening is very low and alternative screening methods are needed.”
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THE US NATIONAL INSTITUTES OF HEALTH (NIH) funded the Mumbai experiment for 18 years. Perhaps by coincidence, NIH physicians refuse to endorse Pap screening for lower-income countries.
NIH physician Mark Schiffman has acknowledged the success of Pap screening in Vietnam, yet persistently
refuses to endorse Pap screening for other lower-income countries. Instead, since at least 2009, Dr Schiffman has promoted HPV screening for lower-income countries. Simultaneously, Dr Schiffman concedes that HPV screening is too expensive for routine implementation in lower-income countries.
NIH physicians also promote HPV vaccination for lower-income countries. As explained on the first page of this website, HPV vaccination does not prevent cervical cancer among most women in lower-income countries, and HPV vaccine expert Diane Harper observes “Combining cervical screening with HPV vaccination does not significantly lower the number of women getting cervical cancer every year.”
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PERHAPS BY COINCIDENCE, NIH shares profits from HPV vaccine sales with HPV vaccine manufacturers Merck
and GlaxoSmithKline, both of which have pled guilty to criminal marketing policies and brushed off billions of dollars in fines. Merck has attempted to inappropriately influence US HPV vaccination policies. The clear conflicts of interest between NIH and HPV vaccine manufacturers are entirely legal, yet are difficult to manage, because terms of the profit-sharing arrangements among NIH, Merck, and GlaxoSmithKline are exempt from disclosure under the US Freedom of Information Act.
It is correspondingly difficult to estimate how much income NIH stands to earn from global, perennial HPV vaccination.
NIH scientist Phil Castle has acknowledged the success of Pap screening in Vietnam, yet warns that reports of successful Pap screening in lower-income countries “raise an important ethical concern” because such reports may reduce demand for HPV-based technologies.
Because of the NIH-funded Mumbai experiment and its cover-up, one of the world's big, fixable problems is being fixed far too slowly -- with catastrophic, lethal consequences -- while income is transferred from lower-income countries to NIH and to corporations that market HPV vaccines and HPV tests.
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FURTHER HUMAN CATASTROPHE may be averted if Dr Schiffman tells the truth and formally acknowledges the 2005 determination by WHO that “good-quality Pap screening can be implemented even in a rural setting of a developing country with reasonable investment, while HPV screening does not give any better detection of pre-cancerous cervical lesions, despite the higher investments.”
That acknowledgement will be an important step toward encouraging WHO and other organizations to change course and to promote the moral imperative of Pap screening for lower-income countries.
The Bill & Melinda Gates Foundation: "Implicitly Dangerous"
WORLD HEALTH ORGANIZATION (WHO) malaria expert Arata Kochi MD has warned that the Bill & Melinda Gates Foundation "was stifling debate on the best ways to treat and combat malaria, prioritizing only those methods that relied on new technology." Dr Kochi warned that the determination of the Gates Foundation to have its favored research used to guide policy ‘‘could have implicitly dangerous consequences on the policy-making process in world health.’’
Dr Kochi's warnings regarding the Gates Foundation also apply to global cervical cancer prevention efforts.
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IN 1999, the Gates Foundation established the Alliance for Cervical Cancer Prevention. Seattle-based PATH, a non-profit corporation, was the organizing partner of the Alliance. PATH receives half of its budget from the Gates Foundation and is considered an agent of the Gates Foundation, rather than an independent grantee. The cancer research branch of the WHO was also an Alliance partner organization. The self-serving yet incorrect founding assumption of the Alliance was that novel technology, rather than Pap screening, is the most likely solution for cervical cancer in lower-income countries.
That unfortunate assumption has decimated political will for the moral imperative of Pap screening in lower-income countries.
In 2002, the Alliance formally dismissed our suggestion that Pap screening be implemented in lower-income countries.
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FROM 1999 UNTIL 2009, the Alliance and the cancer research branch of the WHO conducted an experiment in Osmanabad, India. The Osmanabad experiment used premeditated, preventable death as the yardstick to compare the effect of Pap screening to the effect of no screening at all. That experimental design was every bit as absurd as using death as the yardstick to compare the effect of “No-Smoking” to the effect of smoking cigarettes.
The Osmanabad experiment has been condemned by public health experts and ethicists because physicians deliberately withheld cervical screening from women who subsequently died from cervical cancer. The US Office for Human Research Protections, which determined the Mumbai experiment was unethical, has no authority to investigate human research funded by the Gates Foundation. It is uncertain whether anyone has such authority.
Shockingly, the Osmanabad experiment concluded that high-quality Pap screening does not prevent cervical cancer. That shocking conclusion is every bit as absurd as an experimental conclusion that “No Smoking” does not prevent lung cancer.
A subsequent re-analysis of the Osmanabad data set showed that scientific data may have been falsified to create the appearance that Pap screening did not prevent cervical cancer in India. Concerns have also been raised about financial partnerships among PATH, the Alliance, and HPV test manufacturers.
However, because the WHO conducted the Osmanabad experiment, it is politically mandatory for the WHO to accept the experiment’s absurd scientific conclusion that Pap screening does not prevent cervical cancer.
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NIH PHYSICIAN Mark Schiffman praised the Alliance experiment without questioning the scientific plausibility of its conclusions or the ethics of the barbaric methods used to obtain them.
The scientific absurdity that Pap screening does not prevent cervical cancer is politically expedient in several ways:
- It increases the marketability of HPV tests and HPV vaccines.
- It provides an illusion of vindication for the incorrect founding assumption of the Alliance.
- It provides an illusion of vindication for delaying the implementation of Pap screening throughout India for 18 years or more.
As exemplified in the chilling video clip above, that absurd conclusion has also provided an illusion of ethical justification for deliberately withholding Pap screening from women who subsequently die from cervical cancer.
Because of the Bill & Melinda Gates Foundation, one of the world's big, fixable problems is being fixed far too slowly -- with catastrophic, lethal consequences -- while income is transferred from lower-income countries to PATH and to other corporations that market HPV tests and HPV vaccines.
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FURTHER HUMAN CATASTROPHE may be averted if Dr Schiffman formally acknowledges that Pap screening actually does prevent cervical cancer; that the results of the Osmanabad experiment were scientifically absurd; and that the methods used to obtain those results were unethical.
Those acknowledgements will be important steps toward encouraging the WHO and other organizations to promote the moral imperative of Pap screening for lower-income countries.