The New England Journal of Medicine: The NIH-funded Mumbai Experiment contributed to more than 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.
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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 UNFORTUNATE 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.
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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.
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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."
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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 LEADERS 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.
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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.
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