National Academy of Sciences Challenges the "Special Status" of National Cancer Institute
Chicago, IL 60612 September 30, 2003
A July 29 National Academy of Sciences (NAS) report on the
National Institutes of Health (NIH) will be the subject of October 2 bicameral
hearings by the House Energy and Commerce, and Senate Health, Education, Labor
and Pensions Committees.
The NAS study, requested by Congress, stressed the need to re-examine the "special status granted the National Cancer Institute (NCI) by the 1971 National Cancer Act;" this legislation was responsive to a heavily promoted PR campaign by NCI and American Cancer Society (ACS) representatives. The Act authorized the President to appoint the director of NCI and to control its budget, thus bypassing the authority of the overall director of all other 26 National Institutes of Health (NIH) and Centers. As a result of this anomaly, NCI's current $4.6 billion budget, 17% of the NIH, is beyond control of NIH's director.
The NAS expressed further concerns that NCI's "special status" could cause "an unnecessary rift between (its) goals and mission, and the leadership of NIH." As seriously, NCI's independence has led to its virtual isolation from the public health and general scientific communities.
Beyond the broad scope of the NAS study, and the focus of its Cancer Policy Board on quality health care, NCI's "special status" has resulted in more serious and generally unrecognized problems. These are largely responsible for losing the war against cancer, and include:
·Contrary to NCI's exaggerated claims and misleading public assurances, overall cancer incidence rates, and those of childhood and a wide range of non-smoking adult cancers, have escalated over recent decades. Meanwhile, overall mortality rates have remained unchanged and high.
·The leadership of NCI, and its major Centers, is marred by pervasive conflicts of interest, and a revolving door with industry, particularly the cancer drug industry.
·NCI policies and priorities are imbalanced. They are fixated on damage control—screening, diagnosis, and chemoprevention ("secondary prevention"), treatment and related research—with minimal priorities for prevention.
·Contrary to requirements of the 1971 Act, the NCI has failed to inform the public of a wide range of avoidable causes of cancer. This denial of the public's right to know has even extended to the suppression of information.
·Since 1998, and in close collaboration with the American Cancer Society (ACS), the National Cancer Program is being surreptitiously privatized.
EXAGGERATED CLAIMS OF PROGRESS IN THE WAR AGAINST CANCER
For over the last two decades, the NCI has made a series of highly publicized and misleading claims of major advances in the "War Against Cancer." These include:
·NCI's 1984 announcement, in its "Cancer Prevention Awareness Program," that cancer mortality would be halved by 2000.
·The same assurance in NCI's 1986 "Cancer Control Objectives" report.
·The 1998 NCI and American Cancer Society (ACS) "Report Card" announcing a recent reversal of an almost 20-year trend of increasing cancer incidence and deaths.
·The February 2003 "pledge" by NCI director Andrew von Eschenbach, former ACS President-elect, to "eliminate the suffering and death from cancer by 2015."
In a September, 2003 "Annual Report to the Nation on the Status of Cancer, 1975-2000," the NCI, ACS, and the Centers for Disease Control and Prevention claimed that "considerable progress has been made in reducing the burden of cancer in the U.S. population," particularly from 1995-2000; "burden" is defined as the number of people with cancer. However, this claim is inconsistent with NCI's own data, as detailed in its SEER Cancer Statistics Review, 1975-2000:
·The overall cancer burden and incidence rates increased by 18%; rates for Blacks increased by 20%.
·There has been a dramatic increase in the burden and incidence rates of a wide range of non-smoking cancers. These include: liver (104%); prostate (88%); non-Hodgkin's lymphoma (71%); thyroid (54%); testes (54%); breast (29%); acute myeloid leukemia (15%); and brain (14%). These increases have more than offset the 11% decline in lung cancer rates in men, due to decreased smoking.
·The burden and incidence rates of childhood cancer have increased as follows: acute lymphocytic leukemia (59%); brain (48%); kidney (43%); and bone (20%).
·Overall cancer mortality rates have remained high, 199 per 100,000, and unchanged; rates for Blacks have increased by 6%.
·Mortality rates for prostate cancer, one of the major cancer killers, have decreased by only 1%.
·Mortality rates have increased by 46% for non-Hodgkin's lymphoma, and 10% for brain cancer.
This increasing burden and incidence of cancer is in striking contrast to the 30-fold escalation of NCI's budget, from $220 million in 1971 to the current $4.6 billion. Paradoxically, it seems that the more we spend on cancer, the more cancer we get.
·The overall burden and incidence rates have remained virtually unchanged, decreasing by under 1%.
·There have been increases in the burden and incidence rates of the following cancers: childhood kidney (43%); testes (24%); thyroid (19%); prostate (5%); acute myeloid leukemia (5%); brain (3%); and breast (2%).
·Mortality rates have decreased as follows: overall (5%); prostate (18%); breast (13%); colorectal (8%); non-Hodgkin's lymphoma (6%); brain (4%); and lung (4%). This reflects improved diagnosis, treatment and longer survival.
CONFLICTS OF INTEREST AND A REVOLVING DOOR WITH INDUSTRY
Benno C. Schmidt, the first chairman of President Nixon's NCI three-member Executive Cancer Panel, was an investment banker and senior drug company executive, with close ties to oil, steel, and chemical industries. He was followed in the 1980's by Armand Hammer, the late oil magnate, and Chairman of Occidental Petroleum, one of the nation's largest manufacturers of industrial chemicals, with major responsibility for the Love Canal disaster. Schmidt and Hammer showed no interest in cancer prevention. Instead, they focused on the highly profitable development and marketing of cancer drugs.
The late Dr. Frank Rauscher, appointed NCI director by President Nixon in 1971 to spearhead his "War on Cancer," resigned in 1976 to become Senior Vice President of the American Cancer Society (ACS). In 1988, he moved on to become Executive Director of the Thermal Insulation Manufacturers Association, which promotes the use of carcinogenic fiberglass, and fights against its regulation.
A 1993 analysis of conflicts of interest by board members of NCI's Memorial Sloan-Kettering Comprehensive Cancer Center revealed extensive ties to cancer drug companies, and oil, steel, fiberglass, and tobacco industries, apart from $4 million institutional holdings in drug companies.
Dr. Samuel Broder, NCI director from 1989 to 1995, frankly admitted the reality in a 1998 Washington Post interview. "The NCI has become what amounts to a government pharmaceutical company." Taxpayers have funded R & D, and expensive clinical trials for over two-thirds of cancer drugs on the market. These drugs are then given, with exclusive rights, to the industry, which sells them at inflated prices. Broder resigned from the NCI to become Chief Scientific Officer of Ivax, and later Chief Medical Officer of Celera Genomics, both are major manufacturers of cancer drugs.
Dr. Vincent DeVita, NCI director from 1980 to 1988, and Dr. John Mendelsohn, President of NCI's University of Texas MD Anderson Comprehensive Cancer Center, were both consultants and board members of ImClone Systems, Inc., which had been seeking FDA approval of its targeted cancer drug, Erbitux. Neither DeVita nor Mendelsohn disclosed these interests in media interviews promoting targeted cancer drugs.
In October 2002, DeVita published an article, "The War on Cancer," in The Cancer Journal, of which he is co-editor, claiming major progress in cancer drug treatment. However, he failed to disclose his commercial interests in targeted drugs, and in his CancerSource.com web site. This is contrary to the Journal's disclaimer: "No benefits in any form have been or will be received" by any authors. The Journal has failed to respond to a request to publish evidence of this conflict.
NCI'S IMBALANCED PRIORITIES
The research policies and priorities of the NCI remain dominated by professional mindsets fixated on damage control—screening, diagnosis, chemoprevention, treatment—and treatment-related research. High priority for screening persists in spite of long-standing challenges as to its questionable effectiveness for cancers such as prostate, lung, pre-menopausal breast, and childhood neuroblastoma. Minimal emphasis, and even indifference, remains directed to the prevention of a wide range of avoidable causes of cancer, other than lifestyle factors, smoking, inactivity, and fatty diet, without consideration of carcinogenic contaminants.
In sharp contrast to predominant expenditures on treatment and related basic research, NCI's prevention budget has been and remains minimal. A published, and unchallenged, analysis of its 1992 budget revealed that less than 2.5% of a $2 billion budget, in contrast to a claimed 20%, was allocated to research on avoidable carcinogens in air, water, food, the home, and the workplace.
In May 1998 exchanges between Congressman David Obey (D-WI) and former NCI Director Klausner, he claimed that 20 percent of NCI's $2.5 billion budget was allocated to research on environmental causes of cancer. Following Obey's request for further information, Klausner failed to respond, other than increasing his 20 percent estimate to 40 percent.
NCI's limited comprehension of prevention is revealed in the "Highlights" of its 2001 Cancer Facts. The opening sentence states: "Cancer prevention is a major component and current priority—to reduce suffering and death from cancer." This was followed by the claim that 12 percent of NCI's $3.75 billion budget is allocated to prevention. However, this was defined in exclusionary terms of tobacco and faulty diet, without any reference to environmental and occupational carcinogens.
Not surprisingly, in February 2003 Congressman John Conyers (D-MI), ranking Member of the House Judiciary Committee, warned that so much cancer carnage is preventable. "Preventable that is, if the NCI gets off the dime and does its job."
In view of NCI's exaggerated and inconsistent claims for its prevention budget, in February 2003, Congresswoman Jan Schakowsky (D-IL) requested the General Accounting Office (GAO) to investigate NCI's "fight against cancer." Specifically, she requested the following budgetary information:
"1. Funding for Research on Prevention: For programs whose primary objective is focused on prevention, rather than research in which prevention is incidental to other primary objectives.
"2. Funding for Outreach: Providing the public, and also Congress and regulatory agencies, with a scientifically documented comprehensive registry of avoidable causes of cancer, and avoidable exposures to carcinogens in: air, water, the workplace, and consumer products (food, cosmetics and toiletries, and household products); prescription drugs; and diagnostic radiation."
GAO's response is pending.
FAILURE TO INFORM THE PUBLIC OF AVOIDABLE RISKS OF CANCER
With the exception of smoking and faulty diet, the NCI has failed to inform the public of published scientific information on a wide range of avoidable causes of multiple cancers, particularly from involuntary and unknowing exposures to chemical and radioactive industrial carcinogens. These fall into three major categories: (1) environmental contaminants in air, water, soil, the workplace, and food; (2) carcinogenic ingredients in consumer products, particularly pesticides; (3) carcinogenic prescription drugs and high-dose diagnostic medical radiation, particularly pediatric CAT scans.
As critically, NCI has failed to inform Congress and regulatory agencies of such avoidable exposures to industrial and other carcinogens, incriminated in standard rodent tests and in epidemiological studies; such information could have enabled the development of corrective legislative and regulatory action. This silence has also encouraged petrochemical and other industries to continue manufacturing carcinogenic products, and corporate polluters to continue polluting unchallenged.
NCI's silence on cancer prevention is in flagrant violation of the 1971 National Cancer Act's specific charge "to disseminate cancer information to the public." This silence is in further violation of the 1988 Amendments to the National Cancer Program (Title 42, Sec. 285A), which call for "an expanded and intensified research program for the prevention of cancer caused by occupational or environmental exposure to carcinogens."
In May 1998, Congressman David Obey addressed the following question to NCI director Dr. Richard Klausner. "Should NCI develop a registry of avoidable carcinogens and make this information widely available to the public?" Dr. Klausner responded, "Such information is already available from NCI's Cancer Information Service." However, there is no basis whatsoever to support this claim.
NCI's silence on avoidable causes of cancer has even extended to suppression or denial of such information, as illustrated by the following examples.
In 1983, the Department of Health and Human Services directed NCI to investigate the risks of thyroid cancer from I-131 radioactive fallout following atom bomb tests in Nevada in the late 1950's and early 1960's. NCI released it report in 1997, based on data which had been available for over 14 years, predicting up to 210,000 thyroid cancers from radioactive fallout. These cancers, whose incidence has almost doubled since 1973, could have been readily prevented had the NCI warned the public in time, and advised them to take thyroid medication. At a September 1999 hearing by the Senate Subcommittee of the Committee on Government Affairs, former Senator John Glenn (D-OH) charged that the NCI investigation was "plagued by lack of public participation and openness." Senator Tom Harkin (D-IA) charged that NCI's conduct was a "travesty."
As serious is NCI's frank suppression of information. At a 1996 San Francisco "Town Hall Meeting" on breast cancer, chaired by Congresswoman Nancy Pelosi (D-CA), former NCI director Richard Klausner insisted that "low level diagnostic radiation does not demonstrate an increased risk." However, this was contrary to NCI's long-term studies on patients with spinal curvature (scoliosis), which showed that such radiation was responsible for 70 percent excess breast cancer mortality.
PRIVATIZATION OF THE NATIONAL CANCER PROGRAM
In 1998, ACS created and funded the National Dialogue on Cancer (NDC), co-chaired by former President George Bush, and Barbara Bush. Included were a wide range of cancer survivor groups, some 100 representatives of the cancer drug industry, and Shandwick International PR, whose major clients include R.J. Reynolds Tobacco Holdings.
Without informing NDC's participants, and behind closed doors, ACS then spun off a small Legislative Committee. Its explicit objective was to advise Congress on the need to replace the 1971 National Cancer Act with a new National Cancer Control Act, which would shift major control of cancer policy from the NCI to the ACS. The proposed Act would also increase NCI funding from this year's $4.6 billion to $14 billion by 2007. The ACS was assisted by Shandwick in drafting the new Act, besides managing the NDC.
However, with the February 2002 appointment of ACS President-Elect von Eschenbach as NCI director, the National Cancer Program has been effectively privatized. As a condition of his appointment, von Eschenbach obtained President Bush's agreement to continue as Vice-Chairman of NDC's Board of Directors, a position he has held since 1998 as a key founder of the Dialogue.
Subsequent to von Eschenbach's appointment, NDC was spun off into a non-profit organization. NDC then hired Edelman, another tobacco PR firm, following a pledge that it would sever its relations with the industry. Edelman represents the Brown & Williamson Tobacco Company, and The Altria Group, the parent company of Philip Morris, the nation's biggest cigarette maker; Edelman also represents Kraft and other fast food and beverage companies now targeted by anti-obesity litigation. Edelman is also a Board member of the Centers for Disease Control and Prevention Foundation, which fosters relations between the Centers, ACS, and the NCI. Edelman has thus become firmly embedded in national cancer policy making. In July 2003, it was discovered that Edelman had reneged on its pledge, and was continuing to fight tobacco control programs from its overseas offices. Attempting damage control, Edelman claimed that this was just an oversight. Once more, it agreed to terminate tobacco support programs, and to donate this income to charity.
Equally disturbing is the growing secretive collaboration between the NCI and the ACS-NDC complex, as revealed in the August 2003 Cancer Letter. The latest example is the planned privatization of cancer drug clinical trials, together with the creation of a massive tumor tissue bank. This would cost between $500 million and $1.2 billion to operate, apart from construction costs in the billions. This initiative would be privatized, rife with conflicts of interest, exempt from the provisions of the Federal Advisory Committee and Freedom of Information Acts, and free from federal technology transfer regulations.
Samuel S. Epstein, M.D., Professor emeritus Environmental & Occupational Medicine, University of Illinois at Chicago School of Public Health; Chairman, Cancer Prevention Coalition; email@example.com; 312-996-2297
Peter Orris, M.D., M.P.H., Professor Internal and Preventive Medicine, Rush University Medical College, Chicago; 312-864-5550
Quentin D. Young, M.D., Chairman of the Health & Medicine Policy Research Group; past President of the American Public Health Association; 312-372-4292
Nicholas A. Ashford, Ph.D., J.D., Professor of Technology and Policy, Massachusetts Institute of Technology; 617-253-1664
For supportive documentation, see the Cancer Prevention Coalition's February 2003 report, "The Stop Cancer Before It Starts Campaign," endorsed by some 100 leading experts in cancer prevention and public policy, and representatives of consumer and environmental groups; see www.preventcancer.com.
Samuel Epstein (firstname.lastname@example.org)
Professor emeritus; Chairman
Cancer Prevention Coalition
UIC School of Public Health
Chicago, IL 60612
Phone : 312-996-2297
Fax : 312-413-9898