The latest draft guideline by the U.S. Preventive Services Task Force is part of a 50-year controversy over the appropriateness of screening women between the ages of 40 and 49.
In this controversy, which often engulfed NCI, Congress usually intervened, claiming that “common sense” dictates that mammography is efficacious in younger women.
The Cancer Letter first published a version of this timeline in the Nov. 20, 2009, issue and has been updating it since.
May 1977
NCI first adopts guidelines for mammography for use in breast cancer screening (The Cancer Letter, May 13, 1977). This was not a guideline for all women, just those women under 50 who were participating in the NCI-American Cancer Society study called the Breast Cancer Detection Demonstration Project. Younger women in the study were to receive screening only if they had a previous history of breast cancer or a mother or sister with the disease.
Later that year, the very first NIH Consensus Development Conference examined the issue of screening mammography and whether to continue the BCDDP. The panel concluded, based on data from the study, that screening mammography should be available for women over 50. Women 40-49 with a personal history of breast cancer or whose mothers or sisters had breast cancer should continue to be screened within the study (The Cancer Letter, Sept. 23, 1977).
1987
The results of the BCDDP came in. Though it was not a randomized trial, the results seemed to infer that younger women would benefit from screening to the same degree as older women. About this time, NCI, ACS and about 18 other organizations got together to establish a consensus on screening mammograms.
The Health Insurance Plan of New York trial showed a 30 percent mortality reduction in women over 50, but could not demonstrate a benefit for women between 40 and 49.
Still, NCI, ACS and the other organizations recommended annual clinical breast exam beginning at age 40, with screening mammography at one- to two-year intervals; and beginning at age 50, annual CBE and mammography. The statement also advised all women to perform a monthly breast self-exam, and suggested “special surveillance” for women with a history of breast cancer or breast cancer in her mother or sister.
1988
A new analysis of the HIP trial, by Kenneth Chu, was published in the Journal of the NCI. Women screened at ages 40-49 and followed for at least 18 years after trial entry had 24 percent fewer breast cancer deaths than the controls. However, the benefit didn’t show up until nine years later.
According to a 1988 story by The Cancer Letter on these results, “the researchers said they hope that this study will help settle the under-50 screening debate.”
The results did strengthen what became known as the “consensus guideline,” and though the guideline was not accepted by every health organization, it was publicized widely by NCI, ACS and the groups that signed onto it. Plastic shower cards with the mammography screening recommendations and pictures of how to perform breast self-exams became ubiquitous.
1992
The results of the National Breast Screening Study of Canada were published in the Canadian Medical Association Journal. This was supposed to be the trial designed specifically to answer the question about screening mammography for women in their 40s. The study showed that women 40-49 who received mammograms did no better than women were weren’t screened. In fact, the trial found that the women who were screened did worse than the control group.
More advanced cancers were found in the screened group in the first round of screening than in the control group.
Radiologists claimed that this demonstrated that the Canadian trial was biased. Something must have gone wrong in the randomization, they said. Stephen Feig, of Thomas Jefferson University, and Daniel Kopans, of Massachusetts General Hospital and Harvard University, in a report for the American College of Radiology, identified all the things they found objectionable in the Canadian trial.
Letters and rebuttals between the Canadian investigators and Feig and Kopans, and others, filled various journals during 1992.
To deal with this imbroglio, NCI officials decided to hold a conference.
February 1993
The NCI Workshop on Breast Cancer Screening developed a report that became known as the Fletcher report after the panel’s chairman, Suzanne Fletcher of the American College of Physicians. This report didn’t make any recommendation, but reviewed the available data.
If there is no agreement on the science, how can we change the policy?
Ellen Sigal
For the 40-49 age group, “there is no reduction in mortality from breast cancer that can be attributed to screening,” the report said. “There is an uncertain, and, if present, marginal reduction in mortality at about 10 to 12 years.
Only one study provides information on long-term effects beyond 12 years, and more information is needed.” The report also called these 10-year age groupings “arbitrary and without biologic justification.”
Radiologists attacked the report—and questioned Fletcher’s qualifications. “Women and physicians should be aware of the fact that there are strong inferential data that screening can reduce mortality for women 40-49,” Kopans wrote in a letter to The Cancer Letter.
“Inferential” benefit—rather than statistically significant benefit—was what NCI had based its original guideline on for women in their 40s. Many organizations, clinicians, and radiologists took the view that there was no need to change the guideline.
But maintaining the status quo didn’t sit well with then NCI director, Samuel Broder. In his public remarks, he seemed to view it as a moral issue: How can you claim that screening mammography saves lives if you don’t have statistically significant evidence that it save lives?
This represented a seismic shift at NCI. The institute was changing the rules of the game.
This change was alluded to when, in September 1993, the NCI Physician’s Data Query database stopped referring to screening guidelines, instead issuing “summary of evidence statements” about cancer screening methods (The Cancer Letter, Sept. 17, 1993).
Having made that change, the institute had no choice but to back away from the 1988 guideline. The result was a brutal political battle.
September 1993
Broder presented NCI’s proposed revised statement on screening mammography to the National Cancer Advisory Board.
The board was informed rather late in the game about the change of rules. PDQ had already made its changes.
The proposed guideline recommended that women 40-49 “discuss with a health professional the advisability of screening with mammography, taking into account family history of breast cancer and other risk factors. NCI also recommends annual clinical breast examination as a prudent practice for this age group” (The Cancer Letter, Sept. 24, 1993).
“Our job is only to convey scientific knowledge,” Broder said. “The best course is to acknowledge where we are. We can’t protect the public from the fact that science may change things.”
But the NCAB wasn’t ready to back the proposed new guideline, and instead passed a resolution on a 14-1 vote asking NCI to delay action on the guideline. The prevailing view was stated by then NCAB member Ellen Sigal. “If there is no agreement on the science, how can we change the policy?” she said. “I went to all of those meetings. I heard those scientists say, ‘We don’t know.’ Then I heard the scientists and physicians say they will continue to get mammography for themselves and would have their family members get it. How can we possibly change the guidelines?”
Proponents of screening alleged that NCI had to toe the line because the Clinton health care reform plan didn’t include a screening mammography benefit for women in their 40s. Some NCI officials were intimating behind closed doors to some participants that there was pressure from the administration to make the changes, perhaps as a way of trying to push the board to support the change.
December 1993
NCI issued a “summary of scientific fact,” not a guideline. The three-sentence statement: “There is a general consensus among experts that routine screening every one to two years with mammography and clinical breast examination can reduce breast cancer mortality by about one-third for women ages 50 and older. Experts do not agree on the role of routine screening mammography for women ages 40 to 49. To date, randomized clinical trials have not shown a statistically significant reduction in mortality for women under the age of 50.”
Early 1994
NCI was called to answer for this at Congressional hearings. Several members of Congress believed NCI’s actions confused women and took away hope, and they were eager to browbeat those Bethesda scientists. At one hearing, Rep. Edolphus Towns (D-N.Y.) called NCI racist, sexist, and callous. Rep. Bernie Saunders (I-Vt.) called for kicking the rascals out.
Broder stated at Congressional hearings that the change had nothing to do with the Clinton health reform plan, and that NCI’s movement away from the 1988 guideline was set in motion the year before the Clinton plan emerged.
Meanwhile, ACS and the American College of Radiology and others acknowledged that the data aren’t in. However, while waiting for conclusive data, it would be prudent health practice to screen, they said.
The pressure to reach a consensus, to speak in a single voice and “avoid confusion” continued.
1996
New data were coming out of trials in Sweden, claiming a mortality reduction for women 40-49. NCI’s new director, Richard Klausner, said it was time to re-examine the 1993 statement.
Time for another conference. The Swedish data had not been published yet in scientific journals, but had been presented at an international meeting, just one step on the road to validation. Was the institute under political pressure to quickly change the statement back to supporting mammograms for younger women? Certainly, the lashing by Congress was a recent memory.
This time, in an attempt to head off accusations of institutional bias, NCI decided against sponsoring the necessary conference. Instead, NIH would hold a Consensus Conference with a panel not selected by NCI.
January 1997
The NIH Consensus Conference statement said that the evidence was insufficient to determine the benefits of mammography among women aged 40-49. The panel recommended that women aged 40-49 should be counseled about potential benefits and harms before making decisions about mammography.
So, what does this mean if you are a woman in your 40s? You should talk to your doctor and make an informed decision about whether a mammography [sic] is right for you based on your family history, general health, and personal values.
Diana Petitti
The statement didn’t provide much further information. When the statement was released at the conference, even some scientists who had been neutral on the subject of screening for women in their 40s attacked it for not addressing the Swedish data in a more detailed fashion.
According to a story in The New York Times, Klausner came running out of the conference auditorium to use the telephone. Klausner said he was “shocked by the conclusions and disliked their negative tone.”
Klausner later claimed he was misquoted, and actually had been shocked by the level of anger that erupted at the end of the conference.
Be that as it may, the quote, as well as Klausner’s comments at the press conference after the meeting, served to immediately trample the panel’s conclusions.
At the press conference, Klausner said: “I am concerned that women are not being given, with the report, all the evidence that they actually need…. [M]y evaluation is that these studies have reached a statistical significance and that there is now evidence that we didn’t have previously.”
As NCI distanced from the panel’s report, the NCAB began work on a separate statement.
February 1997
The Senate passed a “sense of the Senate” resolution in a 98-0 vote, urging the NCAB to consider recommending screening for women 40-49 or to direct the public to consider guidelines issued by other organizations. NCI officials were brought to Congress again to explain why scientists can’t agree.
Pennsylvania Sen. Arlen Specter, then the Republican chairman of the Labor, HHS appropriations subcommittee, held four hearings in four months on this issue. It seemed that members of Congress this time had determined that screening in younger women saves lives.
NCI’s role should be to “help us get a clear message, tell us what the risks are, tell us what the advantages are. There is no question,” she said at a hearing, “that the advantages outweigh the risks.”
March 1997
As Congress and the Clinton administration exerted pressure on the institute to act immediately, the NCAB endorsed screening mammograms for women 40-49 every one to two years if they are at “average risk” for breast cancer. In a demonstration of solidarity, NCI and ACS released a joint statement saying that the two groups agreed that screening women in their 40s is “beneficial and supportable with current scientific evidence.”
In a White House press briefing, President Bill Clinton praised the NCAB’s recommendations for providing “consistent guidance to women” (The Cancer Letter, April 4 and 11, 1997).
November 2009
USPSTF published a screening guideline that gives a “C” to breast cancer screening for younger women (The Cancer Letter, Nov. 20, 2009).
HHS Secretary Kathleen Sebelius almost immediately rebukes the recommendation. “There is no question that the U.S. Preventive Services Task Force recommendations have caused a great deal of confusion and worry among women and their families across this country,” Sebelius said in a statement Nov. 18. “I want to address that confusion head on. The U.S. Preventive Services Task Force is an outside independent panel of doctors and scientists who make recommendations. They do not set federal policy, and they don’t determine what services are covered by the federal government.” (The Cancer Letter, Nov. 20, 2009).
In a matter of days, the text of the one-page summary of USPSTF recommendations on the task force’s website has been altered to clarify the recommendation against routine screening for younger women.
The clarification, set off in a pink box, quotes what appears to be a press interview by USPSTF Vice Chair Diana Petitti:
“So, what does this mean if you are a woman in your 40s? You should talk to your doctor and make an informed decision about whether a mammography [sic] is right for you based on your family history, general health, and personal values.” The statement is dated Nov. 19, three days after the release of the guideline.
Though the clarification is consistent with the guideline recommendation, resorting to postscripts containing expert opinion is an obvious, embarrassing break with tradition for the task force, whose purpose is to rise above opinion of a single expert by relying on a panel of experts charged to apply pre-specified criteria for systematic, comprehensive review of scientific evidence.
As the controversy continued to develop on Capitol Hill, the Senate Dec. 3 approved an amendment that would give the HHS Secretary authority to cover additional preventive services for women and specifically nullify the breast cancer screening recommendations.
The amendment, introduced by Sens. Barbara Mikulski (D-Md.) and Olympia Snowe (R-Maine), covers a wide range of preventive services and doesn’t mention mammography specifically. These services would make these services available without copayment. The measure passed 61-39.
The Mikulski-Snowe amendment was further amended by Sen. David Vitter (R-La.) to disregard “the current recommendations of the United States Preventive Service Task Force regarding breast cancer screening, mammography, and prevention shall be considered the most current other than those issued in or around November 2009.”
Under the Vitter amendment, these recommendations would not be used in setting coverage requirements. The amendment was passed without a roll-call vote.
In other developments on Capitol Hill:
- Rep. Frank Pallone (D-N.J.), held a hearing of the Health Subcommittee of the House Committee on Energy and Commerce to get the task force to explain its recommendations.
- Sen. Tom Harkin (D-Iowa), chairman of the Senate Health, Education, Labor and Pensions Committee, is similarly planning a hearing. The investigation follows up on a letter from 22 members of the Senate, who claimed that the guideline “could prove devastating for women at risk of breast cancer” and urged Harkin to focus the investigation on the task force.
“The American people deserve to know more about how this task force came to its controversial findings,” the senators wrote (The Cancer Letter, Dec. 4, 2009).
April 2015
USPSTF proposed screening recommendations that were essentially unchanged from the 2009 version. The recommendations proposed at that time were so controversial that they could have jeopardized the passage of the Affordable Care Act. For that reason, the ACA specifically excluded the task force’s 2009 recommendation on mammography.
The 2015 guideline, published April 20, resurrected the controversy—and if anything, the situation today has even greater thermonuclear potential: while the 2009 guideline is specifically excluded from ACA, the 2015 document was still in place. This meant that the low grade—in this case a “C”—for mammography screening among younger women meant that private insurers may not have felt obligated to cover mammography for women between ages of 40 and 49.
Congressional supporters of mammography quickly mobilized to fight the 2015 guidelines. On April 20, then Sen. Barbara Mikulski (D-Md.) sent a letter to then HHS Secretary Sylvia Burwell, urging that the 2015 guideline be overruled in the same way as the previous version.
“We know that early detection of breast cancer offers women their very best chance at a cure and at survival,” Mikulski wrote to Burwell. “Mammograms are essential for that early detection. I am requesting that your Department take swift action to reassure the American public that you will do everything within your power to ensure the continued availability of free mammograms for all women aged 40 and older.
There is more to screening than finding more, smaller cancers. An effective screening test, within a screening program, needs to be shown to reduce mortality from that cancer without creating a large, false positive pool of patients.
Peter Boyle
“Further, should the USPSTF’s recommendations be finalized, I would strongly urge that all appropriate actions be taken by the Department of Health and Human Services to ensure patients’ previous access to breast cancer screening is not impeded, discouraged, or eliminated. Finally, should the draft recommendation be finalized, I will actively and aggressively pursue all legislative options available to ensure that women aged 40 and older are able to continue receiving free annual mammograms.”
Ultimately, the stakes were higher than breast cancer screening. If some of the USPSTF recommendations could be disregarded while others got implemented, then why pretend that evidence-based medicine has a role in determining U.S. health policy?
“So why does it appear to be the situation in the ongoing polemic about breast cancer screening guidelines that an evidence-based approach is abandoned when it does not result in guidelines which are those which are not liked or welcomed?” Peter Boyle, president of the International Prevention Research Institute, professor of global public health at Strathclyde University, said to The Cancer Letter in 2015.
“Is this just a U.S. phenomenon?” said Boyle, who died last year. “Guidelines for breast cancer screening in Europe have changed little in the last 25 years. Some things are clear. There is more to screening than finding more, smaller cancers. An effective screening test, within a screening program, needs to be shown to reduce mortality from that cancer without creating a large, false positive pool of patients. Lack of a consistent reduction in mortality from large trials, and a large over-diagnosis rate, has led to moves against the widespread use of PSA testing for prostate cancer” (The Cancer Letter, April 24, 2015).
