The undersigned submit this petition under 42 U.S.C. 263b of the Mammogram Quality Standards Advisory Act of 1992 as amended and renewed in the

Transcription

1 The undersigned submit this petition under 42 U.S.C. 263b of the Mammogram Quality Standards Advisory Act of 1992 as amended and renewed in the Mammogram Quality Standards Reauthorization Act of 1998 and 2004 to request the Commissioner of Food and Drugs: 1

2 Action Requested 1. The Plaintiffs Hallie Leighton and the Institute for Health Quality and Ethics hereby request the U.S. Food and Drug Administration to: 1. immediately and fully implement and enforce the patient notification amendment of the Mammogram Quality Standards Act of 1992, as amended in the Mammogram Quality standards Reauthorization Act of 1998 and 2004; 2. immediately terminate the unlawful practice of providing false and misleading information to women regarding their mammogram results; 3. immediately include all relevant and material information obtained from the mammogram in the report that is provided to patients as is statutorily required. Statement of Grounds 2. The Mammogram Quality Standards Act of 1992, as amended in the Mammogram Quality Standards Reauthorization Act of 1998 and 2004, was enacted by Congress to ensure that women have access to consistent and high quality breast cancer screening for the early detection of cancer. Early detection of breast cancer has a significant impact treatment success, long term chances of survival, and on the financial and personal costs of treatment. When a cancer is detected at less less than a centimeter, its impact can be minimized, and survival rates approach 100%. However, a woman s prognosis for survival decreases rapidly if the cancer begins to spread to lymph nodes and to other parts of the body. 3. Pursuant to the patient notification amendment of 42 U.S.C. 263b, a mammogram facility is required to promptly provide a patient the results of her mammogram in language that is easily understood by a layperson ( whether or not such a physician is available or there is no such physician, 2

3 a summary of the written report shall be sent directly to the patient in terms easily understood by a lay person. ) 4. The FDA s failure to adequately implement this statute has violated the rights of Ms. Leighton and other women similarly situated by denying them information necessary to make informed decisions regarding their health. 5. Ms. Leighton is one of a class of women who have radiographically dense breast tissue, which obscures the existence of cancers on a mammogram. Approximately 2/3 of women under the age of 50 and 1/4 of women over the age of 50 have breast tissue which contains enough dense tissue to obscure the existence of cancer on a mammogram. Both dense tissue and cancers appear white on a mammogram. 6. The American College of Radiology has used a four point scale, (BI-RADS (4 th ed.) scale for breast density) which categorizes a woman s breast density along a continuum as: Category 1 The breast is almost entirely fat (<25% glandular) Category 2 There are scattered fibroglandular densities (approximately 25-50% glandular) Category 3 The breast tissue is heterogeneously dense, which could obscure detection of small masses (approximately 51% - 75% glandular) Category 4 The breast tissue is extremely dense. This may lower the sensitivity of mammography (>76% glandular). 7. This information on breast tissue density has been utilized since before the patient notification requirements in 42 U.S.C. 263b were added to the MQSA Reauthorization of 1998, and it is provided to the patient s physician, but not to the patient on her mammogram results. 8. 2/3 of women under the age of 50 and ¼ of women over 50 have breast tissue that is heterogeneously dense (Category 3) or extremely dense (Category 4). For these women, the mammogram is not very effective due to the fact that both the dense tissue and cancer appear white 3

4 on the mammogram. For decades, peer reviewed scientific studies have confirmed that dense tissue masks the existence of cancers. For this significant number of women with dense breast tissue, a digital mammogram is unable to detect over 40% of cancers, and a film mammogram is significantly less effective, detecting as few as 27% of cancers. In addition to the fact that cancers may be masked by this dense tissue, density itself increases a woman s risk for breast cancer by 4-6 times. 9. The FDA has knowingly permitted the use of normal to report the results of mammograms to women in this population when no cancer is detected. The use of normal in lay language implies that no cancer is present with a reasonable degree of certainty. Most reasonable people would not categorize certainty which is slightly greater than 50% as a reasonable degree of certainty. A 27% chance of detecting a cancer is undeniably not a reasonable degree of certainty. The false and misleading application of normal in this instance is a serious violation of the public trust and a deterrent to those women who would consider using readily available supplemental screening. Furthermore, it is a direct violation of the federal statute which was designed to provide women important information regarding their own health. 10. Due to the failure of the FDA to adequately implement and enforce the reporting provision of the MQSA over a period of more than 10 years, millions of women: 1. have been provided false and misleading information regarding the results of their mammograms; 2. have been denied access to important information regarding their own bodies and their own health; 3. have been denied the right to make decisions about their own health with informed consent. 4

5 11. The purpose of this Citizen s Petition is to request that the FDA immediately terminate this practice of providing false and misleading information to patients and from withholding information which is necessary for patients to make informed decisions regarding their health care options. 12. The clear intent of the patient notification amendment was to ensure that women received full and accurate reports regarding their mammograms. It was enacted in response to inconsistent reporting and discussions between physicians and patients. The statute was enacted to leave no question that women were entitled to the information from their mammograms so that they could proactively discuss breast health issues with their physicians and make informed medical decisions. 13. The FDA clearly understood the intent of the patient notification requirement. On the FDA website, the organization provides the answers to Frequently Asked Questions: 1. Q: Must a facility provide the patient with a written lay summary even if the results are incomplete and additional imaging is needed? A: Yes. Even if the facility verbally transmits the results to the patient, the facility must provide, within 30 days of the examination, a written lay summary indicating that additional imaging is required. 2. Q: A facility performs non-mammographic breast imaging studies on the same day as the mammographic examination. Must the facility provide the patient a separate mammography lay summary, or can the facility provide a combined lay summary that represents the overall results and recommendations for all the breast imaging studies performed that day? A: The facility has the option of providing either a separate mammography lay summary or a combined lay summary. FDA recommends that, where feasible, the facility provide a combined lay summary, so as to give the patient the most complete and useful information. 14. Even in the absence of the MQSA patient notification statute, withholding material health information is a serious violation of medical ethics. Opinion of the American Medical 5

6 Association ethical guidelines states that withholding medical information from patients without their knowledge or consent is ethically unacceptable. 15. Withholding this material medical information is clearly a violation of well-established medical ethical standards. 16. Providing false and misleading information in the mammogram report is an egregious violation of the public trust which has resulted in irreparable and irreversible harm for thousands of women million women each year obtain a mammogram in the hopes of detecting breast cancer early, when it is most treatable. None of these women receive critical health information about their breast density directly from the physician who interprets their mammogram (with the exception of women in Connecticut and Texas, where legislation has been enacted to address the failure of the FDA to adequately enforce the MQSA). However, 40% of those women - 16 million women - who have dense tissue which obscures the existence of cancers receive a false and misleading mammogram report. 18. False negatives. Thousands of the women who receive these false and misleading reports actually do have an invasive breast cancer which is not detected by the mammogram. Like millions of other women, they receive a standard form letter which states We are happy to report that the results of your mammogram are normal. 19. We have estimated that of the tens of thousands of women who receive false negative mammogram reports each year, as many of 10,000 will die due to an undiagnosed cancer. (While 40 million women obtain mammograms, and 40,000 women die each year due to breast cancer, our calculations indicate that up to 25% of the deaths, (10,000 women) may be attributable to this practice of withholding information and providing false and misleading results.) 20. Petitioner Leighton received a negative mammogram report in 2006, and again in April She proactively sought breast cancer screening because all of her close relatives had been diagnosed with 6

7 breast cancer and she is Ashkenazi Jewish. Both of these factors indicate a higher risk for breast cancer. 21. Petitioner Leighton did not seek any of the readily available supplemental screening options because she was unaware that her breast tissue was dense, and she was unaware that the screening mammogram alone was not effective for her. 22. Petitioner Leighton was diagnosed with Stage IV breast cancer in April of 2010 at the age of 39. By 2010, the tumor had grown to 6 centimeters, had spread to her lymph nodes, and had metastasized to her spine. Stage IV is the most invasive stage of cancer, with the lowest rate of survival. In 2010, the National Breast Cancer foundation quoted the breast cancer five year survival rates as 98% for Stage I; 88% for Stage II; 56% for Stage IIIA; 49% for Stage IIIB, and 16% for Stage IV. 23. Had Petitioner Leighton known that a mammogram was not an effective screening tool for her, or that she could dramatically improve her chances of detecting cancer by supplementing the mammogram with a readily available ultrasound, she would have requested this from her physician. Had she known that there were other screening methods that were more reliable, she could have chosen one of these instead. 24. Tens of thousands of women every year who diligently obtain mammograms have been unnecessarily subjected to more harmful and less successful treatments for later stage breast cancer because this critical information is withheld from them. 25. Because the FDA has failed to adequately implement and enforce the MQSA patient notification statute, women have been forced to propose legislation at the state level to force radiologists to include information about breast density and the decreasing effectiveness of mammograms for the millions of women with dense breast tissue. A sample report from Connecticut has been included in this Petition, along with the false and misleading mammogram report that Plaintiff Leighton received. 7

8 26. Several organizations have lobbied extensively against legislation proposed at the state level which would address the FDA s shortfall in complying with the patient notification statute of the MQSA. None of the purported rationales for withholding material health information, or for providing false and misleading information are sound, ethical, or based in actual science. 27. There is no sound or ethical reason for withholding material health information from tens of millions of patients. Millions of women are being denied material health information in violation of the MQSA and the ethical standards of all known medical organizations. Tens of thousands suffer needlessly each year after relying on a false negative mammogram result, and an estimated 10,000 die each year as a result of their reliance on a false negative mammogram result. 28. Providing breast tissue density notification in the MQSA mandated patient letter, together with a standard warning regarding the lack of mammographic sensitivity for women with dense breast tissue, and the recommendation that women with dense breast tissue consult further with their physician(s) regarding the possible use of supplemental imaging, will further eliminate the confusion that will be the probable result of enactment of different legislation in each of the 50 states. 29. We are requesting that the FDA immediately terminate this practice and achieve compliance with the patient notification statute of the MQSA. Environmental Impact Statement 30. No environmental impact analysis is required in support of this Petition, and the granting of this Petition would not have any environmental impact. Economic Impact Statement 31. No economic impact statement is necessary. When the patient notification amendment was enacted in 1998, the FDA assessed the economic impact in the cost of additional postage and other costs 8

9 associated with mailing a notification to all mammogram patients. Each mammogram patient already receives a notification letter. 9

10 Certification 32. The undersigned certify that, to the best of their knowledge and belief, this Petition includes all information and views on which the Petition relies, and it includes representative data and information known to Petitioner which are unfavorable to the Petition. Petitioners Thomas W. Nerney Executive Director Institute for Health Quality and Ethics 75 Sprague Hill Road Chepachet, RI (401) Hallie Leighton c/o Institute for Health Quality and Ethics 75 Sprague Hill Road Chepachet, RI

11 11

12 12

13 13

14 14