The National Cancer Advisory Board did not work in a political vacuum as it formulated the NCI recommendations on mammographic screening of women between the ages of 40 and 49.
In undisguised efforts to dictate the wording of the recommendation that was released last week, the Clinton Administration as well as members of Congress representing both parties exerted pressure on NCI Director Richard Klausner to ensure that the board’s statement supported screening.
At one point during this back-room wrangling, Sen. Arlen Specter (R-PA) threatened to call for Klausner’s resignation in the event the NCAB recommendation differed from one advocated by the Senator, sources said.
Specter, chairman of the Labor, HHS and Education Appropriations Subcommittee, said he never made the threat, and Klausner, in a recent press conference, said his conversations with the Senator were “private” and declined to discuss them.
However, the pressure from Specter prompted NCAB Chairman Barbara Rimer to defend Klausner’s leadership and threaten to resign as board chairman if Klausner were forced to step down. A copy of Rimer’s letter to the Senator was obtained by The Cancer Letter.
In addition to pressure from Capitol Hill, the White House and HHS officials urged NCI to make recommendations that would be identical to those released last month by the American Cancer Society.
The Administration wanted NCI to join ACS in its endorsement of annual mammograms starting at age 40. Despite the pressure, NCAB recommended mammography every one to two years for women in their forties who are at average risk of developing breast cancer (The Cancer Letter, April 4).
Micromanagement By Congress?
NCAB members said the data support the board’s recommendation.
“We did not make this recommendation because of political pressures,” Rimer said at a press conference March 27.
“Certainly, there has been an intense amount of activity around this issue, but we stepped back and we looked at the science, and we filtered that science through our own judgment,” she said.
The political pressure was unwarranted, said Louise Strong, president of the American Association for Cancer Research.
“I’m at a loss to understand why this issue engendered so much emotion,” said Strong, chief of the genetics section and professor of experimental pediatrics at the University of Texas M.D. Anderson Cancer Center. “It’s a mistake for Congress to get into micromanagement of this sort.
“This issue has gotten so blown out of proportion, that people who have common goals have become polarized on this issue,” Strong said. “It can have an impact on other issues, such as the relationship between NCI and Congress, and the resulting availability of funding for cancer research.
“I would like to see this issue put behind us,” Strong said. “We need to move on to other important issues.”
Senator Criticized Board’s “Delay”
Last February, soon after the NCAB met to review the NIH consensus statement on screening mammography, members of Congress began sending letters urging the board to quickly develop a statement that would support screening for women between the ages of 40 and 49.
Some members of Congress, as well as several board members, wanted NCAB to formulate a statement at its Feb. 25 meeting, sources said.
However, unable to reach an agreement at the meeting, NCAB formed a subcommittee to study the issue and make a recommendations to the full board. At that time, Rimer said the board would need about two months to complete this work (The Cancer Letter, Feb. 28).
Board members received a letter signed by 39 women Members of Congress. “We believe the only real option is to give guidance to the women in this country,” said the letter, dated Feb. 28. “We implore you to act quickly. Without definitive guidelines, the lives of too many women are at risk to permit further delay.”
Following the NIH consensus panel’s decision not to recommend regular screening for younger women, the issue had become a personal concern for Specter. During the month of February, the Senator held four hearings that explored the details of the NIH consensus conference.
In a letter to Klausner dated March 5, Specter said he was “distressed” to hear about the “two-month delay” in NCI reaching a decision.
“During the intervening 60 days, thousands of women in the 40 to 49 age category might be screened which could result in the saving of many lives,” Specter wrote.
After receiving the letter, Klausner called the Senator to reiterate that the board needed time to complete its deliberations, sources said.
“The best protection from pressure is process,” Klausner said at a press conference March 27. “We got a tremendous amount of information and pressure from all sides, [including] from the scientific community, that this is an issue that people feel very strongly about.
“We did not waiver from the process we set up,” Klausner said. “Mr. Specter had an open public meeting, and made it very clear that he wanted an answer and he wanted an answer as quickly as possible.
“In my statement [at Specter’s hearing] I made it very clear that we had a process, that we all want to reach closure as soon as possible, but we will not do it any sooner than the board felt it needed to confer, to discuss, to evaluate information and reach agreement,” Klausner said.
During the phone conversation with Klausner, Specter said he would publicly call for the NCI Director’s resignation if the process didn’t move more quickly to endorse screening for women 40-49, sources said.
In a television interview March 26, Specter said he not threaten to call for Klausner’s resignation, but he did urge NCI to make a recommendation faster.
“I did not say Dr. Klausner ought to resign or to be replaced, but I did raise a question about whether they were using their funds properly,” Specter said in an interview with NBC Nightly News. “They are funded $2.3 billion.”
Specter’s spokesman, John Ullyot, did not return a reporter’s telephone calls.
At the press conference, Klausner declined to comment on the phone conversation. “Private conversations are private conversations,” he said.
The pressure from Specter’s office prompted NCAB Chairman Rimer to write a letter to Specter defending Klausner’s handling of the controversy.
“I am distressed by the maelstrom surrounding the mammography issue and the extent to which the important scientific questions have become politicized,” Rimer wrote in a letter dated March 11 letter to Specter. “I’d like to affirm the strong, unequivocal support of the National Cancer Advisory Board for Dr. Klausner as director of the National Cancer Institute.
“Dr. Klausner has revitalized the NCI and has infused new energy into every aspect of the NCI. We believe he has handled the mammography controversy in a very appropriate, responsible way. It is distressing to hear that his leadership is being questioned in Congress.
“I personally have such confidence in Dr. Klausner’s leadership that if he were to be asked to leave his position, I would resign immediately as chair of the National Cancer Advisory Board.
“The National Cancer Advisory Board is moving quickly to develop a statement about mammography….
“I hope you will allow Dr. Klausner to do his job and continue to do so.”
“We Knew Specter Was Disappointed”
Several NCAB members said Specter’s pressure had no bearing on their ultimate recommendations.
“The fact that we didn’t have a decision at the board meeting made Specter angry,” one board member said to The Cancer Letter. “Did it have an impact? No. We felt very strongly that we had to have closure on this.
“I don’t think anyone seriously thought about Specter,” the board member said. “It was the issue that was strangling us. The feeling was, let’s move on.”
“There was political pressure, but it was not the motivating force here,” said Barbara Gimbel, an NCAB member and a former member of the board of Memorial Sloan-Kettering Cancer Center. “We knew that Sen. Specter was disappointed that at the board meeting we didn’t come to agreement.
“The value of not coming to agreement then was that we were able to make more thoughtful recommendations,” Gimbel said.
NCAB member Ellen Stovall said Specter’s prodding had unnecessarily hastened the process.
“I would have preferred to have taken a few months to come up with more thoughtful recommendations to help women with decision-making,” Stovall, executive director of the National Coalition for Cancer Survivorship, said at the March 27 press conference. “I feel that public pressure brought to bear to make us come out with this recommendation today.”
Stovall said Specter and others unduly politicized the mammography controversy.
“Where was this fervent interest in saving women’s lives during the health care reform debacle?” Stovall said to The Cancer Letter. “By enacting more responsible health care and insurance reforms, it is unlikely we would be having this intense level of debate over mammography.”
“The pressure, if any, was that our original time line was too long, and we should do it faster,” said Frederick Li, co-chairman of the NCAB subcommittee on mammography. “A lot of people seemed to be waiting for an NCI report, so we did what needed to be done.”
“There was an outcry from all different arenas,” said board member Zora Brown, president of Cancer Awareness Program Services, an organization based in Washington, D.C., that develops cancer awareness campaigns about reproductive cancers for African-American women. “There was lots of pressure on the board to do something.”
The NCAB took 30 days to weight the evidence and consider some exceedingly complicated issues. However, in Specter’s view, the board did not move fast enough.
“I am pleased that the record is now corrected that mammograms are warranted for women in their forties,” Specter said in a statement March 27. “I’m still perplexed about why it took so long to set the record straight.
“The Appropriations Subcommittee will be inquiring about this delay at a future hearing.”
Pressure To Sound Like ACS
On March 23, after the American Cancer Society released its recommendation for annual screening mammograms, the pressure on NCI intensified further.
Now, the White House and HHS decided that the Institute’s recommendations should be identical to those of ACS, sources said. The pressure from the administration did not cease until the day before the NCAB held a press conference to release its statement, sources said.
“They wanted so badly for the NCI to sound like ACS,” said a participant in the discussions who asked not to be identified by name. “They would have preferred the NCAB statement to have said annual mammography.”
Neither President Clinton nor HHS Secretary Donna Shalala requested changes in the statement, sources said. The pressure was exerted by mid-level officials, sources said.
“We really grappled with the question of whether to go to annual screening or every one to two years,” Rimer said. “As we looked at the trials, only two of them used a 12-month interval. In one of them, there was an increase in mortality. In the other, there was a decrease in mortality.
“The majority of the trials had intervals of 24 months,” Rimer said. “We really believe you cannot go beyond the evidence.”
Sources said that during the tense week, Klausner attempted to shield the NCAB from the pressure. In fact, several NCAB members said to The Cancer Letter that they were unaware of political pressure from HHS and the White House.
It was not until the night before the press conference—after it was too late to change the statement—that a small number of NCAB members were told about the pressure from the Administration.
“[Klausner] didn’t want us to be influenced,” a board member said. Had NCI changed the NCAB recommendation, at least one board member would have resigned, that board member said to The Cancer Letter.
Gimbel said she did not question whether Klausner would accept the board’s recommendation.
“Dr. Klausner had agreed to abide by the recommendations of the NCAB, whatever they turned out to be,” Gimbel said to The Cancer Letter. “He was part of the process all the way through.
“That did not happen in 1993,” Gimbel said.
In 1993, the NCAB voted 14-1 for the Institute to retain its previous screening guideline. Then-NCI Director Samuel Broder did not heed the board’s advice and decided to remove the recommendation for screening women 40-49.
A Consensus Emerges
Initially, some board members doubted that the board or its subcommittee would be able to reach a consensus. “There were heated discussions,” Stovall said. “People were terribly upset.”
However, as discussions went on, it became clear that the majority on the board was in favor of making specific recommendations for women in their forties, NCAB members said. And, just as the political interest in screening mammography peaked in Washington, the consensus was beginning to emerge.
The subcommittee co-chairmen, Robert Day, president of Fred Hutchinson Cancer Research Center, and Frederick Li, chief of the division of cancer epidemiology and control at Dana-Farber Cancer Institute, held different levels of conviction about the certainty of the scientific data. Day strongly favored screening for women in their forties, while Li seemed to take a more conservative view, sources said.
Li said he was determined to listen to all views. “Since screening is not my primary area of research, I was open to listening and learning,” Li said to The Cancer Letter.
“There was a lot of back-and-forth,” Li said. “People argued with conviction for their views.
“As we all came to understand our assignment, we were able to eventually come to a near-unanimous agreement,” he said. “We wanted to do what’s best for women who are perplexed by this controversy.”
The assignment was to make a prudent public health recommendation, based on the scientific evidence, even though the evidence was not perfect, Li said.
“For me, it was a relatively novel experience to look at scientific data which always has some level of uncertainty, and use the data to make a recommendation to 10 million people,” Li said. “It goes from a scientific judgment to a judgment regarding public policy.
“When I recognized the distinction, it was much easier to see other points of view,” Li said.
“Any set of scientific results has a certain level of uncertainty attached to it, defined as a confidence interval,” Li said. “No single study is perfect and settles the question forever.
“I think the board was faced with the situation of some level of scientific uncertainty, and feeling that for the women who needed a definitive recommendation, we ought to be able to help them.”
Key to the NCAB’s reaching an agreement was language in the document stating that the recommendations should be considered interim recommendations until more data are available, and that uncertainty is inevitable in science.
Li drafted the subcommittee’s first position paper and distributed it to the subcommittee, Gimbel said. After a two-hour conference call, the first draft was completed.
“Then we went back and forth on minutia,” Gimbel said. “We wanted to avoid a rigid stamp.”
After two more drafts, the statement was sent to the full board for comment.
The majority of the board favored screening for women 40-49, said Brown. “There were some who wanted to lean to pure science, and did not believe there was a statistical benefit,” Brown said. “But we all know mammography does find cancer. Once we stopped trying to find that mammography is the cure for cancer, then we were able to agree.
“I, for one, would have liked to see a stronger statement that was consistent with ACS, to have screening annually,” Brown said. “What we have is livable, as long as people know NCI does endorse screening for women in their 40s.”
Brown said the discussions made her understand the importance of having a wide range of representation on the board. “There was a time that I felt inadequate for the board, but now I know that you have to have someone with a common-sense view,” she said.
Statement’s Order Was Reversed
One major change from the subcommittee’s draft was the order in which the recommendations were presented, a board member said. The subcommittee favored making its statement about uncertainty and risk assessment first, while the full board urged the presentation of the screening recommendations for women 40-49 first.
It was that switch that caused board member Kay Dickersin to cast the one dissenting vote against the statement, board members said. The statement passed on a vote of 17-1.
Dickersin could not be reached for comment.
Other board members said they valued hearing Dickersin’s views and those of other board members who did not initially favor screening.
The result, board members said, was a balanced recommendation.
“The report is not an overwhelmingly positive endorsement of mammography,” said Philip Schein, chairman and CEO, U.S. Bioscience Inc., of West Conshocken, PA. “The report is well-balanced and makes very clear that this represents an interim assessment, and physicians and women must recognize that there are both false positives and negatives with current mammographic technique.”
“The process worked,” said board member Ellen Sigal, president of Sigal Environmental Inc., of Washington, D.C. “The subcommittee did a good job. They did what was right for science and for women.
“It wasn’t the political pressure,” Sigal said. “We made a decision based on information.”
“I was very comfortable with the statement, though in the beginning I would have made an even stronger recommendation,” Gimbel said. “It does assist women, it is not too rigid for all women, and we defined high risk, which is very important.
“The next step is to get women to do it,” Gimbel said.
Responsible Communication
NCI, ACS, and other organizations need to provide more accurate and responsible public education about mammography, said Robert Smith, director of cancer detection science for the American Cancer Society.
“We face the new challenge of providing a more thorough message than simply: Mammography Saves Lives,” Smith said. “We have to craft new materials that speak more clearly to the benefits and limitations of mammography.”
“This challenge will take us beyond the ‘sound-bite’ educational messages that have been overly optimistic and somewhat misleading,” Smith said. “We need to communicate the challenges we face with this disease and our disease control efforts, and what women and their doctors need to do and what they can expect. Today’s solutions are effective, but they are imperfect, which is why continued research is so important.”
However, Smith noted that long-term survival of breast cancer is significantly better for women whose tumors are found before they grow beyond one centimeter. “We have also not communicated the benefits of mammography well,” he said.
The attention to “the mammography controversy” could ultimately have a positive effect, NCAB member Stovall said.
“One agreeable result of all this attention to mammography could be a heightened public awareness of science in general and cancer in particular,” Stovall said. “Women need to be able to see the opportunity in the questions raised about mammography and insist on better information from which they can make more well-informed decisions about how to manage their health care.”
