The federal government and academic texts as barriers to informed consent.

AuthorLanfranchi, Angela

ABSTRACT: Informed patient consent for medical treatment is required by both law and medical ethics. Yet, both federal agencies and academicians are participating in the suppression of information about the heightened risk of breast cancer posed by oral contraceptives and induced abortion. There is historical precedent in the long-delayed acknowledgement of the smoking/lung cancer link.

By law, a patient has the right to be fully informed of the nature of her medical condition and any proposed course of therapy. It is assumed that a patient will be given the complete and true scientific basis of her diagnosis and treatment, to ensure that her well-being and her autonomy in decision-making are protected.

Informed consent is the process by which a patient can participate in choices about medical treatment. It originates from the legal and ethical right of the patient to direct what is done to her body, and from the ethical duty of the physician to involve the patient in her medical care.

Our federal government has become a barrier to informed consent concerning oral contraceptive drugs and induced abortion.

NIH and NCI Violate Their Mission Statements

Both the National Institutes of Health (NIH) and the National Cancer Institute (NCI), a component of the NIH, have violated their mission statements.

The NIH has as its stated mission "science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend health life and reduce the burdens of illness and disability." It included as its fourth goal to "exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science." (1) In pursuit of its goal of improving the nation's health, it conducts and supports research in the causes, diagnosis, prevention, and cure of human diseases.

The NIH has failed to perform its mission in very significant ways: There is evidence of widespread fraud in connection with NIH-funded research. In June 2005, a study of NIH grantees by three scientists, published in the prestigious British journal Nature, documented fraud. Anonymous questionnaires revealed that a statistically significant 15.5% of scientists admitted to "changing the design, methodology or results of a study in response to pressure from a funding source," i.e. the NIH itself. More alarmingly, NIH proved to be a corrupting influence, as 9.5% of early career scientists admitted this unethical behavior, and by mid-career 20.0% admitted to it. (2)

These significant problems with scientific integrity had come to light earlier through some 2003 investigative work done by a reporter, David Willman of the Los Angeles Times. (3) In February 2005, the Alliance for Human Research Protection applauded Dr. Elias Zerhouni, director of the NIH, for acknowledging the magnitude of financial conflicts and ethical violations, and organizing an ethics summit so as not to lose public trust in all research. (4)

The NCI has also flagrantly ignored one of its major missions of "new information dissemination mandates" as required by Congressional legislative amendments to its original National Cancer Program. (5)

Estrogen-Related Risks Denied or Minimized

Well-documented literature on the carcinogenic effects of oral contraceptives had been published for more than twenty years. But NCI largely ignored it until 2006 when, without fanfare, it put on its web site a page about the carcinogenic effects of oral contraceptives. (6)

Remarkably, six years earlier, the National Toxicology Advisory Committee had placed estrogen on its lists of carcinogens (but without the addition of oral contraceptives, which contain estrogen) as a risk factor for breast cancer. (7) In 2005, the World Health Organization's International Agency on Research of Cancer met in France to review the world's literature on estrogen-progestin combination drugs, which include oral contraceptives. They then classified oral contraceptives as class-1 carcinogens. (8) It was a full year before this information appeared on the NCI web site, without any large public awareness campaign for the millions of American women who were taking these drugs and unknowingly increasing their risk for breast cancer.

There is either an effort to obfuscate, for medical personnel, the increased breast cancer risk with oral contraceptives, or incompetence at NCI. The NCI web site has both patient and health professional versions of its breast cancer (PDQ) prevention sections. In July 2007, the patient version clearly listed oral contraceptives ("the pill") as increasing the risk of breast cancer. (9) The health professional version of the same prevention information concerning oral contraceptives was, however, placed under the heading "Factors of Unproven or Disproven Associations," and downplayed by stating that there was a small increased risk in current users that diminishes over time, and then giving the reference for a "well-conducted case-control study that did not observe any increased risk" [emphasis added]. (10) This also contradicted its own web page placed May 4, 2006, which gave information on oral contraceptives increasing the risk of breast, cervical, and liver cancer. (11)

As of January 2008, both NCI PDQs had been substantially revised. The patient version listed both abortion and oral contraceptives under the heading "The following have been proven not to be risk factors for breast cancer or their effects on breast cancer risk are not known." Elaborating, the PDQ stated that "there does not appear to be a link between abortion and breast cancer," and that "taking oral contraceptives ... may...

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