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| DECISION TO SCREEN FOR PROSTATE CANCER SHOULD INCLUDE PATIENTS, AMERICAN CANCER SOCIETY PANEL SAYS |
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Similar language was included in the prostate cancer screening guidelines published by the American College of Physicians, and another similar clause is expected to figure in the final National Institutes of Health consensus document on mammographic screening for women in their forties.
Sources said the ACS draft guideline was compiled as a result of a meeting of about 30 experts who gathered in Phoenix last week to review the 1992 screening guideline. Though all those present at the meeting ultimately agreed on the language, the draft still requires approval by the ACS Prostate Cancer Advisory Group, the Detection and Treatment and Medical Affairs committees, and the Societys board of directors. The approval process is expected to be completed in June, sources said.
A copy of the preliminary document was obtained by The Cancer Letter. The proposed guideline statement reads:
"Both Prostate-Specific Antigen (PSA) and Digital Rectal Examination (DRE) should be offered annually, beginning at age 50 years, to men who have at least a 10-year life expectancy, and to younger men who are at high risk. Information should be provided regarding the potential risks and benefits."
By contrast, the 1992 guideline states:
"DRE and PSA should be performed on men 50 and older. If either is abnormal, further evaluation should be considered."
The differences between the two statements do not represent a "major or essential change" in the Societys position, a document that summarized the workshop conclusions states. "Rather, these are clarifications or modifications which reflect our present knowledge," the document states. However, the differences between the two documents appear substantial: PSA is mentioned first in the draft guideline, a change that reflects the importance of the test. The words "should be offered annually" in the draft replace the more categorical "should be performed." The draft guideline recommends considering a mans age, life expectancy and his risk factors when deciding whether to screen. The draft guideline refers to "risks" as well as "benefits" of prostate cancer screening, thereby acknowledging a downside of the procedure. Several observers said that the most far-reaching change is the draft guidelines recommendation that men should be provided information on screening.
The complete text of the narrative that accompanies the draft guideline follows:
"The annual screening of men for the detection of early prostate carcinoma should begin by age 50 years. However, men in high-risk groups, such as those with a strong familial predisposition (e.g., two or more affected first-degree relatives) or African Americans may begin at a younger age (e.g., 45 years). More data on the precise age to start prostate carcinoma screening are needed for men at high risk.
"Screening for prostate carcinoma in asymptomatic men detects tumors at a more favorable stage (anatomic extent of disease). There has been reduction in mortality for prostate carcinoma, but it has not been demonstrated that this is related to screening. An abnormal PSA test result has been defined as a value of above 4.0 ng/ml. Some elevations in PSA may be due to benign conditions of the prostate.
"DRE of the prostate should be performed by health care workers skilled in recognizing subtle prostate abnormalities, including those of symmetry and consistency, as well as the more classic findings of marked induration or nodules.
"DRE is less effective in detecting prostate carcinoma compared with PSA."
The American College of Physicians Guideline: Introducing its guideline on prostate cancer screening, the American College of Physicians cautioned against routine screening of all men for prostate cancer. The organizations recommendations, published in the March 15, 1997 issue of the journal Annals of Internal Medicine state:
"Recommendation 1: Rather than screening all men for prostate cancer as a matter of routine, physicians should describe the potential benefits and known harms of screening, diagnosis, and treatment; listen to the patients concerns; and then individualize the decision to screen.
"Recommendation 2: The College strongly recommends that physicians help enroll eligible men in ongoing clinical studies."
The ACS draft guideline and the College guideline differ in their recommendations for men considered to be at a higher than average risk for developing the disease. While ACS recommends that these men start screening before age 50, the College doesnt. The American College of Physicians represents 100,000 health professionals.
| ACS PANEL URGES ANNUAL MAMMOGRAMS FOR WOMEN AGE 40-49 |
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The panel, reporting at an ACS Breast Cancer Screening Guidelines Review Workshop, concluded that annual mammography could result in a greater mortality benefit than the present one-to-two year interval recommended by ACS.
At the meeting, follow-up data from major clinical trials were presented, reporting significant reduction in the breast cancer mortality rate in women under 50 who were regularly screened. "The evidence strongly suggests that the time that it takes a breast cancer to move from a pre-clinical phase when it can be found through mammography, not physical examination, to evolve to a clinical phase when it is larger, palpable, and may have spread to a number of lymph nodes, is shorter in younger women," said Marilyn Leitch, a surgical oncologist from the University of Texas Southwestern Medical Center. "The current average two-year interval between screens may be too long for this age group and their faster-growing cancers."
The panels recommendation follows an NIH consensus conference held last January, which found insufficient evidence to recommend regular screening for women in their forties. The NIH panel recommended that women in their forties should weigh the risks and benefits as they decide whether to undergo mammographic screening. The conclusions, reached after a day and a half of scientific presentations, stunned and angered the proponents of screening. The American Cancer Society said it was "disappointed" by the consensus statement.
The consensus conference was convened on request of NCI director Richard Klausner. Last spring, following a review of new data from randomized trials in Sweden, Klausner decided that the Institute needed to re-examine its 1993 decision to cease recommending routine screening for women in their forties.
| RAISING NIH APPROPRIATIONS IS HIGH PRIORITY, HOUSE SUBCOMMITTEE CHAIRMAN SAYS |
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Porters counterpart in the Senate, Arlen Specter (R-PA) has pledged at least a 7.5% increase for NIH. Another Senate measure, Resolution 15, seeks to double medical research funding over the next five years.
As recent hearings in the House and Senate indicate, by proposing a less-than-spectacular increase for NIH, the President has given the Republican-controlled Congress a viable political issue. The mood on Capitol Hill is all the more favorable for biomedical research because in recent years NIH has been extraordinarily effective at presenting its story. One fundamental element of the NIH case is the promise to apply the new understanding of genes to improving the health of Americans.
Thus, after NIH Director Harold Varmus delivered his prepared remarks, Porter asked the kind of question most government officials only dream of hearing from appropriators: How much money can you use? The NIH professional judgment budget, which summarizes the scientific opportunities for fiscal 1998 was $13.88 billion, about $800 million more than the Presidents final proposal, Varmus replied.
Asked to comment on the increase proposed by Specter, Varmus said the money could be spent usefully. "We could have over $500 million extra under the proposal made by Senator Specter, compared to the Presidents request," Varmus said. "Obviously, with that money we could afford a large number of additional grants that would otherwise not be funded." Varmus said NIH has established a list of new efforts that could be undertaken with additional funds, an approach that first appeared in the Bypass Budget.
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