As someone who has spent the last several years promoting the development of a comparativeness effectiveness center that would encourage the production of more objective information about what works medically, for whom, and under what circumstances, it is hard not to feel discouraged by the reaction to the breast cancer screening guidelines recently announced by the U.S. Preventive Services Task Force.
To be sure, there are a variety of lessons that should be learned from this experience about how to present to the public information that goes against current “conventional wisdom, ” how to explain why current recommendations may differ from past recommendations or current practice, how to reach out to the media, and how to handle issues of timing, task force composition and so forth. But all of these considerations aside, the outrage expressed by various groups, the charges that the government was putting money and economics above the lives of women and the rush by the Department of Health and Human Services to distance itself from the task force recommendations were important reminders about the difficulty of changing existing behavior patterns and belief structures.
The U.S. Preventive Services Task Force
The group that made the recommendations is the U.S. Preventive Services Task Force—a group that most people have probably not known much about before the November release. Although its recommendations were frequently characterized as reflecting recommendations of “the Government”, the USPSTF is an independent panel of experts in primary care and prevention, primarily from academia but also with other private sector representation as well. The task force is charged with reviewing the evidence on the effectiveness of various types of clinical services and developing recommendations for clinical preventive services. The group grades the services being reviewed on the strength of the evidence. It does not consider costs as part of its deliberation but rather the gains, risks or potential harm of the service being considered.
As HHS Secretary Sebelius has made clear in subsequent statements, the USPSTF is not a decision-making group. It makes recommendations. However, its recommendations are normally regarded as reflecting the best information available and therefore something of a “gold standard”. Not surprisingly, its recommendations are frequently used as a basis for coverage decisions.
The health care reform bill passed by the Senate in December, for example, requires that there be coverage with no copayments for all preventive services that are recommended with a grade of A or B by the USPSTF. However, as the Congress is sometimes wont to do, the Senate passed an amendment that would allow the health secretary to require coverage of additional preventive services, and in case that wasn’t enough, it passed a second amendment specifically exempting recommendations regarding mammography.
The USPSTF was first convened by the Public Health Service in 1984 and since 1998 has been sponsored and funded by the Agency for Healthcare Research and Quality (AHRQ). Individuals are nominated by their colleagues, by themselves or by professional organizations. While they are vetted by HHS for conflicts and the names reported in the Federal register, several of them were quoted in the New York Times as saying that they didn’t regard themselves as political appointees and doubt that former President George W. Bush would have appointed them. For the few I know that were on the task force, this characterization definitely seems true. Hopefully, whenever new members are appointed, the sense of being apolitical appointees will continue.
Among several issues that have been raised in the aftermath of the mammography guidelines flap is whether the inclusion of only primary care and prevention experts is the most appropriate composition when the services being reviewed involve specialists—in this case oncologists and perhaps radiologists as well At the very least, the suggestion that recommendations be reviewed for comment before publication by relevant experts as CMS does with its new coverage decisions is an idea worth considering.
The 2009 Recommendations for Breast Cancer Screening
As most people now know, the USPSTF recommended biennial screening mammography for women aged 50 to 74 years. It recommended against routine mammograms for women in their forties who are not at high risk. The task force updated its recommendations in early December, a few weeks after the initial release, indicating that the decision to start regular biennial screening mammography before the age of 50 should be an individual one between patient and physician that takes into account the patient’s values regarding benefits and harms. The update occurred in an attempt to clarify the recommendation after what had been a clearly unexpected outcry from the public as well as dissent from some physician groups. In the somewhat arcane language that the task force uses to indicate the strength of the evidence, the specific recommendation indicated that there is moderate certainty that the net benefit of screening mammography for women aged 40-49 is small — thus the recommendation against routine screening.
The task force concluded that the current evidence about benefits and harms for screening mammography for women 75 years and older is insufficient to make a judgment. Similarly, it concluded there is insufficient evidence to assess benefits and harms of clinical breast examination beyond screening mammography in women 40 and older or to assess the additional benefits and harms of digital mammography or MRI compared to film mammography.
The 2002 Recommendations for Breast Cancer Screening
The 2009 guidelines were an update of recommendations that had been in 2002 to update a 1996 recommendation. In 2002, the USPSTF suggested screening mammography every 1-2 years for women aged 40 and older. It also indicated that the evidence is strongest for women aged 50-69 and that the evidence that screening mammography reduces mortality from breast cancer for women aged 40-49 was weaker and the absolute benefit smaller.
As was true for the more recent recommendations, the task force reported that the absolute benefit was smaller because the incidence of breast cancer is lower among women in their 40’s, not that the screening itself is less effective. Also, the USPSTF commented that the delay in observed benefit for women younger than 50 made it difficult to determine the incremental benefit of beginning screening at age 40 rather than at 50. Nonetheless, the task force recommended screening every one to two years for women aged 40 and older. So while the rationale and discussion was very similar for the recommendations provided in 2002 and 2009, the bottom-line recommendation was quite different—a distinction apparently lost on the members of the USPSTF although this is not the first time there has been controversy surrounding mammography screening guidelines.
Why the Difference in Recommendations?
The explanation provided was that there was one new trial and that evidence was updated from an earlier trial focusing on the screening of younger women. While the additional information appears to have just nudged the group over the edge of where the previous group had been, incredibly the task force seemed to be surprised by the reaction that the recommendation produced. Two who were quoted in the New York Times — the vice chair,Dr. Diana Petitti, and a task force member, Dr. Michael LeFevre — said they were “caught off-guard” by the reaction to the guidelines. The focus of the recommendation was to encourage women to make their own decisions with the advice of their physicians—a focus that was made clearer in the December update to the recommendations. Nonetheless, the take-away message was clearly different in 2009 than it had been in 2002.
A History of Controversy….
The recent political firestorm is hardly the first time that there has been controversy concerning the value of screening mammography (that is, mammography for asymptomatic women), although little attention to past controversies was reported during the present controversy.
In 1997, the National Institutes of Health held a consensus conference regarding the value of screening mammography and concluded that the scientific evidence did not support their use for women in their forties. Despite this, the National Cancer Institute and the American Cancer Society continued to encourage screening mammography for women in their forties. The cancer society has made annual screening central to its campaign against breast cancer since 1983. It has also criticized the use of randomized trials only and the exclusion of substantial amounts of observational data that have suggested better results from screening mammography.
Studies reported in the 1990’s involving randomized control trials in the U.S. had indicated a statistically significant 30 percent reduction in the risk of dying from breast cancer for those who were screened. However, a critical review of these randomized trials by the Cochrane group that was published in the British journal Lancet in 2001 indicated that six out of eight of the studies had been very flawed and that the pooled data from the remaining two studies provided no evidence supporting the use of screening mammography. The USPSTF reviewed the same studies as the ones in Lancet and decided to only eliminate one of the previously removed six studies. Doing this produced a 16 percent reduction in cancer mortality in the screened group and was used by the USPSTF to developing its 2002 guidelines.
The same studies along with the newer randomized trial data and modeling by the Cancer Intervention and Surveillance Modeling Network (CISNET) available after the 2002 guidelines formed the basis of data used in 2009.
Although in many ways the current period is an unusually highly politically-charged environment because of the intense focus on health care reform, it is important to learn what we can from the controversy over screening mammography guidelines so that we can avoid repeating this kind of public response to new empirical findings in the future.
Many groups behaved badly during the recent controversy. Some Republicans cited this as an example of the kind of rationing that would occur under Obama’s health reform plan. Several other groups, including the American College of Radiology and to some extent, the American Cancer Society, said or suggested that the recommendation reflected the Administration’s interest in saving money. The fact that cost and cost effectiveness was not a consideration in the deliberations did not deter these charges. The comment by Secretary Sebelius that the USPSTF was appointed by President Bush, thereby attempting to impugn their conclusions as somehow being politically motivated, was very disappointing and put a political tinge on what has previously been regarded as an apolitical group of medical experts.
The political naïveté of the task force is incredible—almost breath-taking in its innocence. Had the task force members never heard of the death panel charges made earlier in 2009 as well as the concerns, charges and counter-charges about whether a move to evidenced-based medicine would lead to rationing? Were they not aware that they were moving away from a previously established recommendation—somewhat muted though the previous recommendation had been? Did they not think that the release of their recommendations between the House’s passage of its bill and the last throes of the Senate’s deliberations might be an inauspicious time to change screening guidelines for a disease as emotionally charged as breast cancer? Having at least one or two appointees who are recognized for their expertise in preventive and clinical care but who are not completely politically tone-deaf might be an important consideration in the future.
Finally, it’s well worth considering the suggestion of adding one or two members to the task force on a rotating basis who represent the specialty or specialties involved in the disease under review or allowing experts to review recommendations prior to their release.
Editor’s Note: For more on issues surrounding cancer screening, see Cancer Screening And Age In The United States And Europe, by David H. Howard, Lisa C. Richardson and Kenneth E. Thorpe, in the November/December issue of Health Affairs.