The U.S. Preventive Services Task Force (USPSTF) would seem as unlikely a target for attack as Santa’s elves. For a quarter-century, this squeaky-clean, underappreciated group of doctors and nurses who are specialists in preventive medicine has toiled away in obscurity in the selfless service of public health.
Appointed by the Agency for Healthcare Research and Quality, the task force panel is independent and does not take costs into consideration; it evaluates only the risks and benefits of preventive medicine strategies. The task force must be reeling over the vicious reaction to its latest recommendations regarding screening mammography.
The guidelines are based on an exhaustive analysis of recent studies from Sweden, the United Kingdom, and the U.S. Breast Cancer Surveillance Consortium involving a total of more than 830,000 women, and a specially commissioned study funded by the National Cancer Institute in which six separate teams studied the risks and benefits of 20 screening strategies through mathematically modeling.
The panel recommended against routine screening mammograms for women 40-to-49 years old, and screening every two years for women 50 to 74. These not-exactly-radical recommendations are almost identical to the World Health Organization guidelines, which recommend screening every one-to-two years between ages 50 and 69.
Because mammography is less effective at distinguishing cancers from normal breast tissue in premenopausal women, mammograms miss cancers in some younger women and raise a false alarm in others. This can cause real harm; one woman may ignore a cancerous lump because her mammogram was normal; another may undergo an unnecessary surgical procedure because her mammogram was suspicious. As Cornelia Baines, a physician-epidemiologist at the University of Toronto once pointed out, “… A benign biopsy is not a benign experience”; a statement supported by the medical literature.
A Carcinogenic Test
Unlike Pap smears and prostate exams, mammography is not a benign screening technique. Mammograms utilize x-rays and are known to increase the lifetime risk of breast cancer, especially in younger women. A case-control study in 1,742 women under the age of 50 with breast cancer found that, compared to 441 controls, multiple mammograms five or more years prior to diagnosis almost doubled breast cancer risk. A U.K. study estimated that annual breast cancer screening starting at age 40 would increase radiation-induced breast cancer mortality by 0.5 per 100 women screened. That’s five times the increase in radiation-induced breast cancer mortality when annual screening started at age 50 (0.11 per 100 women screened).
Mammograms are far more accurate in women over 50, and so the benefits outweigh the risks. Mammography is also a useful tool in younger women with suspicious lumps or a family history of breast cancer.
So who most vociferously attacked the task force? The themes and terms used by the critics are eerily similar.
Carol H. Lee, chair of the American College of Radiology Breast Imaging Commission, said to Reuters that the recommendations "ignore the valid scientific data and place a great many women at risk of dying unnecessarily." In the same article, Daniel Kopans, a Harvard professor of radiology, said the new guidelines "are scientifically unjustified and will condemn women ages 40 to 49 to unnecessary deaths from breast cancer." W. Phil Evans, president of the Society of Breast Imaging, told Reuters, “These recommendations are inconsistent with current science and apparently have been developed in an attempt to reduce costs. Unfortunately, many women may pay for this unsound approach with their lives."
In the American College of Radiology press release, James H. Thrall, chair of the group’s Board of Chancellors, said “…we are moving toward a new health care rationing policy that will turn back the clock on medicine for decades and needlessly reverse advances in cancer detection that have saved countless lives". The Access to Medical Imaging Coalition warned in a statement to the Washington Post that the task force recommendations will "turn back the clock on the war on breast cancer.” Otis Brawley, chief medical officer of the American Cancer Society, wrote in a Washington Post op ed, “Turning back the clock will add up to too many lives lost”.
In the same op ed, Brawley said the task force “took a step backward in the fight against breast cancer.” Evans said in a statement, "The USPSTF recommendations are a step backward and represent a significant harm to women's health".
Some critics apparently believe that avoiding “confusion” is a rationale for rejecting facts. James H. Thrall, quoted in the Washington Post, called for rescinding the task force’s recommendations "to avoid confusion as health-care reform moves forward." Robert Schmidt, a professor of radiology at the University of Chicago Medical Center told the Chicago Tribune that, “It’s wrong to keep changing recommendations and give conflicting messages to women.” In the Washington Post, Kopans cites “the confusion and anxiety that this has created.” Len Lichtenfeld, the American Cancer Society's deputy chief medical officer, told the Associated Press, "Our concern is that as a result of that confusion, women may elect not to get screened at all."
Conflicts of Interest
Are you starting to wonder whether these players are reading from the same script book? Vague, fact-free, emotionally charged statements are the language of public relations, not scientific discourse. The striking similarities in word choice among these critics could be entirely coincidental. Perhaps the congruence in their conflicts of interest is coincidental as well.
U.S. Preventive Services Task Force members are not allowed to have “substantial conflicts of interest, whether financial, professional, or other conflicts, that would impair the scientific integrity of the work of the USPSTF." Organizational or personal conflicts of interest, however, are common among critics.
Donors to the American Cancer Society Cancer Action Network (ACS CAN), the “nonprofit, nonpartisan advocacy affiliate of the American Cancer Society”, include Hologic, which makes breast imaging products, and Johnson and Johnson, which makes an image-guided breast biopsy product. Donors to the American College of Radiology Imaging Network (ACRIN) Fund for Imaging Innovation include Siemens, GE Healthcare, Phillips, Hologic, and many others that make mammography machines or related products.
According to the American College of Radiology Web site, “the leaders of the ACR and ACRIN have been meeting with industry leaders from key donors to the ACRIN Fund to strengthen the relationships between the organizations and better determine how both parties can maximize this relationship.” The Society of Breast Imaging is an organization managed by the American College of Radiology.
The Access to Medical Imaging Coalition is run by Tim Trysla, who works for the Alston and Bird law firm and is counsel to the “largest complex diagnostic imaging manufacturers, physician groups and providers regarding Medicare reimbursement.” He directs the “Coalition of Diabetic Providers and Manufacturers opposing Medicare competitive bidding for durable medical equipment.” Daniel Kopans holds patents on imaging systems. Robert Schmidt reports receiving royalties from, and being a shareholder in Hologic.
Absent any actual scientific basis for opposition, critics combine fact-free fear-mongering with general attacks on the task force. “It’s arrogant and irresponsible,” said Schmidt in the Chicago Tribune. "It's crazy – unethical, really" said Kopans.
The bogeyman of rationing is raised. Lee said to Reuters, “These new recommendations seem to reflect a conscious decision to ration care”. Kopans said in the same article, “…I am afraid their decision is related to saving money rather than saving lives."
None of these conflicts of interest have been mentioned in news coverage. Unnecessary mammography leads to unnecessary surgical procedures – and exposes women to radiation that can increase breast cancer risk. Current breast cancer detection methods are not safe or effective enough to justify their use in millions of younger women.
Fear-mongering from organizations with vested interests is preventing a public dialogue stressing that what we really need are better detection methods, especially for young women who have more time to develop radiation-induced cancers. Rather than touting an ineffective, possibly dangerous screening method, we need better diagnostic methods for younger women. As Cindy Pearson, executive director of the National Women’s Health Network (one of the few national health advocacy groups that takes no money from industry) said, “We need a Pap test for breast cancer.”
In the meantime, a clear-eyed scientific assessment of what works and what doesn’t work is needed not only for breast cancer screening but for all diagnostics and therapeutics. Mammography makes money for the people and organizations that have created this sham of a controversy. When critics with conflicts of interest are banned from the argument, the controversy vanishes.
Adriane Fugh-Berman, M.D., is an associate professor in the department of physiology and biophysics at Georgetown University Medical Center, and director of PharmedOut, an independent project based at Georgetown that educates physicians about inappropriate pharmaceutical company influence on prescribing practices. Alicia M. Bell is the project manager and research assistant for PharmedOut, as well as a member of the board of directors of the National Women's Health Network.