The State of the Planet - 2050

Abstracts and comments attached the Science Magazine series, November 14-December 5, 2003, VOL 302

For a number of years now I have argued that our natural environments and resources and their various ecologies have been seriously abused in terms of both how better use would serve us and how ongoing abuse can only but disserve posterity -which, if one thinks about it, necessarily includes anyone younger than -and therefore, ourselves. 'Fortuitously' then, The State of the Planet, a current, heavily detailed series in the weekly magazine, Science (VOL 302), supports much of what I have written -but not without problem. Democracy, for example, is an artifact of thus-far evolution (freshman anthropology); ours, and all thus-far governments, in this respect, are still fundamentally 'pecking-order-based' and essentially aristocratic in nature and deed.

The situation then, is that the very scientists that develop such analyses are themselves part of the problem: they conjecture 'What may happen if we do or not do this or that', but they are not, almost universely, proactively engaged in any reformation of government offsetting the 'negatives' in their findings -in anything, that is, that compromises their own positions of 'well-being and quality of life' in the aristocracy. -Or to put it another way: why should anyone properly calling himself a scientist today expect his 'lifestyle and quality of life' to be compatible with the earth's carrying capacity for a billion or more others of even profoundly lesser 'lifestyle and quality of life'?
[Those interested in a measure of this 'aristocracy' should consider taking The Ecological Footprint Quiz by Redefining Progress.]
Appendixed below are-
1 - Sustainability and the Commons(*8) - a short editorial by Science Editor-in-Chief, Donald Kennedy, on Garrett Hardin's Science Magazine essay, The Tragedy of The Commons, the first such properly encompassing the nature and magnitude of 'sustainable resource use'.
2 - The State of The Planet - 2050(*9) - abstracts and last paragraphs from the Science Magazine series.
3 - This writer's response(*a) to series analyst/authors.
4 - 'The Tragedy of The Commons' Reexamined(*b) - an etiological analysis accounting for the existence of 'the tragedy'.
5 - Zerhouni Pledges Review ... (*c) - a Science Magazine news article reporting NIH practices representative of 'tragedy propagation in today's thus-far aristocratic civilization'.
6 - Stealth Merger(*d) - the Los Angeles Times, basic, investigative article reporting those NIH practices.
7 - A Word on Dirigiste Heurism and The Inevitable Transcendency of Science - two appendices from other essays on the inevitability of a single, overall government thru and by science (only if on-line or already properly saved).
8 - (Extra 'goody'!) Long-Term Ecosystem Response to the Exxon Valdez Oil Spill(*e)

Back to downloaded Home Page or Download the Home Page or back to Complete list of Essays and Appendices

Posted January 18, 2004; last modified June 20, 2004

December 12, 2003 Science Magazine vol 302 (p1861)
Sustainability and the Commons

Thirty-five years ago, Science published a remarkable essay by Garret Hardin entitled "Tragedy of the Commons". I knew Hardin at the time and admired his paper, but had no idea whatsoever of the influence it and its author would have on how we think about population and the environment. That influence has spawned several successor strands. One, evident almost immediately, was an enhanced concern about the impact of population growth on resource utilization. The second was a delayed argument about how to consider population growth in policy terms -an argument to which Hardin later added combustible material with a piece called "Lifeboat Ethics" that struck many as elitist or hard-hearted. The third, much later, is a recent social science literature revising Hardin's hard choice (either a coercive consensus to limit breeding or repressive government controls) by showing that groups often evolve fair social arrangements that limit exploitation and conserve shared resources.
   The population/resource collision has only grown more important since Hardin's Science essay. Earth's population then was about 3.5 billion; it has since grown by a factor of nearly 2, to 6.3 billion. That growth, amplified by global increases in affluence and the power of technology, has brought escalating pressures on "common-pool" resources such as air, fresh water, and ocean fisheries that are accessible to many potential harvesters who can extract marginal personal benefits at a cost that is low because all other harvesters share it. Decades of depletion of these resources, whose status was explored in the past four issues of Science, have led to new concerns and new terms: "sustainability" and "sustainability science." The loss of value compels us to undertake more careful analyses; first, of what values we actually take from nature's resources, and second, of how science can contribute to maintaining such resources sustainably.
   We obtain value from our environment in various ways: We may use it for timber or for hunting, we may enjoy it for various nonuse values such as birdwatching, and we may extract pleasure from merely knowing that it's there. In Man and Nature, perhaps the first environmental classic, George Perkins Marsh provided a meticulous 19th-century account of what had happened to the world's woods, waters, and fields. In Marsh one finds a kind of outrage over environmental damage, but there is little of the sense of wonder about nature that one finds in modern writers such as Wallace Stegner. Marsh is all about use values, Stegner about nonuse. A modern convergence defines sustainability as requiring that the average welfare of the successor generation, with respect to the total of all these values, be as high or higher than that of the current generation.
   That begs some important questions. What about equity? Most, I think, would insist that the condition of the majority of people, if not of everybody, should either stay the same or improve. And what about history? If welfare has been improving for several generations, is there a built-in expectation that historical rates of improvement will continue? Our welfare detectors, after all, are exquisitely sensitive to disparity.
   Once we find agreement about what sustainability really means, we can ask what science might contribute. It is surely encouraging that science is focusing increasing attention on resource problems, but the success rate is not high. At small scales, where science is applied in limited societies where property rights can be made clear, there have been some real winners, such as managed preserves that blend conservation objectives with recreational values. But at large scales, ranging from ocean fisheries to global climate, good science often fails the implementation test because the transaction costs are too high or because political and economic factors intervene. A recommended target stock size for managing a marine fishery fails, although its stability makes it desirable, because to harvesters it looks too large to leave alone. Models and climate history tell us that global warming is likely to reach damaging levels, but the cost of controlling carbon emissions is high and there is always the mirage of a hydrogen economy.
   The big question in the end is not whether science can help. Plainly it could. Rather, it is whether scientific evidence can successfully overcome social, economic, and political resistance. That was Hardin's big question 35 years ago, and it is now ours.

Donald Kennedy

The State of The Planet - 2050
Abstracts and last paragraphs from the Science Magazine series.

Human Population: The Next Half Century(*1) by Joel E. Cohen [et al]
Prospects for Biodiversity(*2) by Martin Jenkins
The Future for Fisheries(*3) by Daniel Pauly [et al]
Global Freshwater Resources:(*4) by Peter H. Gleick
Energy Resources and Global Development(*5) by Jeffrey Chow [et al]
Global Air Quality and Pollution(*6) by Hajime Akimoto
Modern Global Climate Change(*7) by Thomas R. Karl1 and Kevin E. Trenberth2

November 14, 2003 Science Magazine vol 302 p1172
Human Population: The Next Half Century
Joel E. Cohen [et al]
[abstract: first and last paragraphs]

By 2050, the human population will probably be larger by 2 to 4 billion people, more slowly growing (declining in the more developed regions), more urban, especially in less developed regions, and older than in the 20th century. Two major demographic uncertainties in the next 50 years concern international migration and the structure of families. Economies, nonhuman environments, and cultures (including values, religions, and politics) strongly influence demographic changes. Hence, human choices, individual and collective, will have demographic effects, intentional or otherwise.
Three factors set the stage for further major changes in families: fertility falling to very low levels; increasing longevity; and changing mores of marriage, cohabitation, and divorce. In a population with one child per family, no children have siblings. In the next generation, the children of those children have no cousins, aunts, or uncles. If adults live 80 years and bear children between age 20 and 30 on average, then the parents will have decades of life after their children have reached adulthood and their children will have decades of life with elderly parents. The full effects on marriage, child bearing, and child rearing of greater equality between the sexes in education; earnings; and social, legal, and political rights have yet to be felt or understood.

November 14, 2003 Science Magazine vol 302 p1175
Prospects for Biodiversity
Martin Jenkins
[abstract: first and last paragraphs]

Assuming no radical transformation in human behavior, we can expect important changes in biodiversity and ecosystem services by 2050. A considerable number of species extinctions will have taken place. Existing large blocks of tropical forest will be much reduced and fragmented, but temperate forests and some tropical forests will be stable or increasing in area, although the latter will be biotically impoverished. Marine ecosystems will be very different from today's, with few large marine predators, and freshwater biodiversity will be severely reduced almost everywhere. These changes will not, in themselves, threaten the survival of humans as a species. ...
This does not mean, of course, that we can continue to manipulate or abuse the biosphere indefinitely. At some point, some threshold may be crossed, with unforeseeable but probably catastrophic consequences for humans. However, it seems more likely that these consequences would be brought about by other factors, such as abrupt climate shifts (24), albeit ones in which ecosystem changes may have played a part.

November 21, 2003 Science Magazine vol 302 p1359
The Future for Fisheries
Daniel Pauly [et al]
[abstract: first and last paragraphs]

Formal analyses of long-term global marine fisheries prospects have yet to be performed, because fisheries research focuses on local, species-specific management issues. Extrapolation of present trends implies expansion of bottom fisheries into deeper waters, serious impact on biodiversity, and declining global catches, the last possibly aggravated by fuel cost increases.
Examination of four scenarios, covering various societal development choices, suggests that the negative trends now besetting fisheries can be turned around, and their supporting ecosystems rebuilt, at least partly. These scenarios describe what might happen, not what will come to pass. Still, they can be used to consider what we want for our future. We have noted, however, that many of the fisheries we investigated, e.g., in the North Atlantic (27) or the Gulf of Thailand (28), presently optimize nothing of benefit to society: not rent [taxable through auctions (29)], and not even gross catches (and hence long-term food and employment security). It is doubtful that they will be around in 2050.

November 28, 2003 Science Magazine vol 302 p1524
Global Freshwater Resources:
Soft-Path Solutions for the 21st Century
Peter H. Gleick
[abstract: first and last paragraphs]

Twentieth-century water policies relied on the construction of massive infrastructure in the form of dams, aqueducts, pipelines, and complex centralized treatment plants to meet human demands. These facilities brought tremendous benefits to billions of people, but they also had serious and often unanticipated social, economical, and ecological costs. Many unsolved water problems remain, and past approaches no longer seem sufficient. A transition is under way to a "soft path" that complements centralized physical infrastructure with lower cost community-scale systems, decentralized and open decision-making, water markets and equitable pricing, application of efficient technology, and environmental protection.
Ultimately, meeting basic human and ecological needs for water, improving water quality, eliminating overdraft of groundwater, and reducing the risks of political conflict over shared water require fundamental changes in water management and use. More money and effort should be devoted to providing safe water and sanitation services to those without them, using technologies and policies appropriate to the scale of the problem. Economic tools should be used to encourage efficient use of water and reallocation of water among different users. Ecological water needs should be quantified and guaranteed by local or national laws. And long-term water planning must include all stakeholders, not just those traditionally trained in engineering and hydrologic sciences.

The transition to a comprehensive "soft path" is already under way, but we must move more quickly to address serious unresolved water problems. We cannot follow both paths.
Pacific Institute for Studies in Development, Environment, and Security, Oakland, CA 94612, USA.

November 28, 2003 Science Magazine vol 302 p1528
Energy Resources and Global Development
Jeffrey Chow, Raymond J. Kopp, Paul R. Portney
[abstract: first and last paragraphs]

In order to address the economic and environmental consequences of our global energy system, we consider the availability and consumption of energy resources. Problems arise from our dependence on combustible fuels, the environmental risks associated with their extraction, and the environmental damage caused by their emissions. Yet no primary energy source, be it renewable or nonrenewable, is free of environmental or economic limitations. As developed and developing economies continue to grow, conversion to and adoption of environmentally benign energy technology will depend on political and economic realities.
If fossil fuel depletion occurs more rapidly than we expect, or if governments enact policies that artificially increase fossil fuel prices, renewables and alternative energy sources may come online more quickly. The requisite political will and financial support to enact such changes will occur only when societies and their governments decide that the benefits of fossil fuel consumption do not make up for the negative effects on environmental health and human welfare of fossil fuel dependence.
Resources for the Future, 1616 P Street, N.W., Washington, DC 20036, USA.

December 5, 2003 Science Magazine vol 302 p1716
Global Air Quality and Pollution
Hajime Akimoto
[abstract: first and last paragraphs]

The impact of global air pollution on climate and the environment is a new focus in atmospheric science. Intercontinental transport and hemispheric air pollution by ozone jeopardize agricultural and natural ecosystems worldwide and have a strong effect on climate. Aerosols, which are spread globally but have a strong regional imbalance, change global climate through their direct and indirect effects on radiative forcing. In the 1990s, nitrogen oxide emissions from Asia surpassed those from North America and Europe and should continue to exceed them for decades. International initiatives to mitigate global air pollution require participation from both developed and developing countries.
Finally, the importance of megacities as sources of regional and global pollution is worth noting. Megacities may be defined as metropolitan areas with over 10 million inhabitants, although there is no precise accepted threshold, and population estimates are not necessarily based on the same areas of reference. In 2001, there were 17 megacities according to United Nations statistics (47). With rapid growth of the world's population, particularly in developing countries, and continuing industrialization and migration toward urban centers, megacities are becoming more important sources of air pollution from associated mobile and stationary sources. Air quality in megacities is thus of great concern, as illustrated by a study in Mexico City (48). Although the health effects of air pollution on the inhabitants of megacities are a serious social problem, its regional and global environmental consequences are also of great concern. Therefore, local, regional, and global air-quality issues, and regional and global environmental impacts, including climate change, should be viewed in an integrated manner. ~~~~~~~~~~~~
Frontier Research System for Global Change, 3173-25 Showa-machi, Kanazawa-ku, Yokohama 236-0001, Japan.]

December 5, 2003 Science Magazine vol 302 p1719
Modern Global Climate Change
Thomas R. Karl1 and Kevin E. Trenberth2
[abstract: first and last paragraphs]

Modern climate change is dominated by human influences, which are now large enough to exceed the bounds of natural variability. The main source of global climate change is human-induced changes in atmospheric composition. These perturbations primarily result from emissions associated with energy use, but on local and regional scales, urbanization and land use changes are also important. Although there has been progress in monitoring and understanding climate change, there remain many scientific, technical, and institutional impediments to precisely planning for, adapting to, and mitigating the effects of climate change. There is still considerable uncertainty about the rates of change that can be expected, but it is clear that these changes will be increasingly manifested in important and tangible ways, such as changes in extremes of temperature and precipitation, decreases in seasonal and perennial snow and ice extent, and sea level rise. Anthropogenic climate change is now likely to continue for many centuries. We are venturing into the unknown with climate, and its associated impacts could be quite disruptive.
We are entering the unknown with our climate. We need a global climate observing system, but only parts of it exist. We must not only take the vital signs of the planet but also assess why they are fluctuating and changing. Consequently, the system must embrace comprehensive analysis and assessment as integral components on an ongoing basis, as well as innovative research to better interpret results and improve our diagnostic capabilities. Projections into the future are part of such activity, and all aspects of an Earth information system feed into planning for the future, whether by planned adaptation or mitigation. Climate change is truly a global issue, one that may prove to be humanity's greatest challenge. It is very unlikely to be adequately addressed without greatly improved international cooperation and action. ~~~~~~~~~~~~
1 National Oceanic and Atmospheric Administration, National Climatic Data Center, Satellite and Information Services, 151 Patton Avenue, Asheville, NC, 28801–5001, USA. 2 National Center for Atmospheric Research, Post Office Box 3000, Boulder, CO 80307, USA. *To whom correspondence should be addressed. E-mail:

(*a - This writer's response to analyst/authors)

Date: January 9, 2004
From: PS Bezanis
William Adams et al , Joel E. Cohen , Klaus Hasselmann et al , Oliver Houck , Martin Jenkins , Thomas R. Karl et al , A J McMichael et al , C G Nicholas Mascie-Taylor et al , Daniel Pauly , Jules Pretty , Mark Rosegrant et al , Paul Stern et al , Robert Watson ,
(apologies to those whose email addresses were not specified in
Science Magazine)


'The State of the Planet' (Science VOL 302) and related follow-ups
(Abstracts: The State of the Planet)

First, I thank everyone for an excellently thorough 'State Of The Planet' series. I must say, nevertheless, that what I see is the continuing unwillingness of scientists in general to engage government in more than warning of 'dire what-if consequences'. The explanation for this is that free-enterprise democracy is profoundly profitable and seductive to the well-educated, thus inspite of their findings, scientists in general find little reason or incentive to argue for any intrusion which diminishes their quality of life. The situation then, is that scientists are themselves part of the 'resources and environment' problem they identify.

Be that what it be, scientists should consider that it is they and they alone who will eventually inherit the job of determining the nature and course of human existence by determining 'the state of the planet' as follows.

1 - Nations today generally reflect the economic interrelationships of the individual people of those nations, essentially those of the individual's ownerships, habits, dispositions, consumerisms and 'the right to earn a living'.
2 - It is safe to say that classical evolutionary mechanics of 'a new life-form invading and saturating an econiche' are likely to continue to obtain for human existence on earth -except as guided or modified by scientific knowledge.
3 - It is further safe to say that the momentum residing in the institutionalized habits and dispositions of children today (above) will carry into their 2050 adulthood -and therefore past that too.
4 - Democracy is an artifact of thus-far evolution (freshman anthropology); ours, and all thus-far governments, in this respect, are still fundamentally pecking-order-based and therefore essentially aristocratic in nature and deed (above).
5 - There is, therefore, little reason to believe that any change of momentum 'meliorative to the projected dire 2050 state of the planet' should be expected -except as might be proactively brought about by knowledgeable scientists.
6 - The scientist working alone is intrinsically unhampered by 'pecking order' (likewise the mathematician), and working together too, then, scientists tend to keep pecking order out of their work -except as influenced by potential financial gains outside the laboratory ('Zerhouni' and 'Stealth Merger' below).
7 As we discover how 'screwing up The State Of The Planet affects our continuing existence upon it', it is the scientist to whom the task of 'heuristic optimization' will naturally, solely, and inevitably default.

Related and attached (browser format) are two articles from current periodicals and two from this writer's website, Godel's Proof and The Human Condition
8 - Zerhouni Pledges Review ... (*c) - news article reporting NIH practices representative of 'tragedy propagation in today's thus-far aristocratic civilization' -from the December 19, 2003 Science Magazine VOL 302 p2046
9 - Stealth Merger(*d) - the basic, investigative article reporting those NIH practices from the December 7, 2003 Los Angeles Times (pA1).
10 - A Word on Dirigiste Heurism - Appendix 1 of Evolving Society's Issues and Variables
11 - The Inevitable Transcendency of Science - Appendix 1 of The 'Black Box' Nature and Course of Human Existence

PS Bezanis

Garrett Hardin's 'Tragedy Of The Commons' Reexamined

Hardin's Tragedy of the Commons is, without a doubt, an excellent first identification of a problem unique to human evolution. It has not been moved along however, because its 'arena of resolution' is more or less stuck in time. The reason, quite simply, is that it is hard to address this kind of problem without knowing something about its etiology. There is, in fact, such a thing, and it develops out of the nature of general evolutionary process. Further and better still, it says more than a little about 'economics and the quality of life' in that continuing human course.

Following is a progression of this material, the bottom line of which is that any and all 'melioration of the tragedy' must eventually and inevitably default to scientists alone for properly heuristic, timely manipulation -it is they who are not 'moving resolution along'.

1 - Nations today generally reflect the economic interrelationships of the constituent individuals of those nations and peoples -habits, dispositions, consumerisms, 'the right to earn a living' et cetera.

2 - These are, in general, properties come into existence out of natural, evolutionary process, those of 'the classical diasporation and invasion of an econiche by an organism new to it' -here, the whole earth, and an organism of deliberative capability in particular.

3 - The thus-far 'autonomy of distinct peoples and nations', in this respect, reflects the sub-speciation inherent of diasporation and the variability of econiche/environment natural resources and properties.

4 - All thus-far autonomy however (diasporation), is fundamentally pecking-order-based in origin and -unless otherwise driven, therefore also fundamentally aristocratic in nature regardless of governmental form.

5 - It is, in other words, a 'world democracy of autonomously aristocratic nations' -of peoples of 'variously autonomous, institutionalized pecking-order-based expression' -habits, dispositions, 'natural rights and freedoms', ethnicities, religions, consumerisms, 'power' et cetera.

6 - 'The tragedy of the commons' exists, in other words, because of a relative impossibility of identifying and convening argument that favors 'best continuing well-being and viability for the lifeform-whole' without compromising 'national autonomy' and the personal pecking-order-based expression it more or less assures.

7 - 'The real tragedy of the commons' then, is that it identifies a lifeform that it is genetically driven to supercede its 'autonomous self' -and knows it, but is loathe to deliberate any compromise of its aristocracy however inevitable that be.

PS Bezanis

December 19, 2003 Science Magazine vol 302 p2046
Zerhouni Pledges Review of NIH Consulting in Wake of Allegations
by Eliot Marshall

A newspaper report on apparent conflicts of interest among National Institutes of Health (NIH) scientists has shaken the $27 billion biomedical research center to its core. Following the publication of a four-page article in The Los Angeles Times on 7 December, detailing how a handful of employees earned millions of dollars in outside income over a decade, both Congress and NIH Director Elias Zerhouni launched reviews of how the agency oversees staffers' outside deals (Science, 12 December, p. 1875).
   The article did not directly accuse NIH officials of wrongdoing, but "our community is surprised ... and angry" about the allegations, says David Korn, a former dean of Stanford University School of Medicine who is now at the Association of American Medical Colleges in Washington, D.C. "We're getting a lot of e-mail traffic," adds Korn: People are expressing "the sort of shock you might feel on hearing that the pastor of the church was dallying with parishioners' wives."
   Zerhouni said in a telephone interview this week that he is setting up two review groups, one to examine the allegations and produce an inventory of outside relationships going back to 1999, and a second to recommend policies for the future. He said: "There will be no stone unturned; I am going to review it from A to Z. This is too important for us not to be completely responsive."
   The Times report focused on a memo that former NIH Director Harold Varmus issued on 3 November 1995. In it, Varmus told top NIH staff that he was removing some limits on outside activities because the Office of Government Ethics had decided that NIH's rules were then "more restrictive" than the federal norm. For example, his memo removed a $25,000 cap on permitted outside income, allowed officials formerly prohibited from consulting--such as institute directors--to do so, and gave staffers permission to take company stock as payment for work. Every outside activity was still subject to prior approval by an ethics officer.
   In an editorial, the Times argued that Varmus "demolish[ed] private-public firewalls that had served the agency well." Varmus, who left NIH in 1999 to become president of the Memorial Sloan-Kettering Cancer Center in New York City, strongly disagrees, but he concedes that "the issues addressed by the article are very important." NIH loosened consulting rules in large part, he says, to make working at NIH more appealing to top researchers. "I was trying to improve the intramural program and strengthen our ability to recruit" people who could earn "a hell of a lot more" from consulting if they were at a university. The aim was to encourage "useful interactions between government employees and outside groups" so NIH scientists would be "in the loop ... and competitive," Varmus says, adding: "I'm proud of it."

December 7, 2003 Los Angeles Times pA1
Stealth Merger:
Drug Companies and Government Medical Research Some of the National Institutes of Health's top scientists are also collecting paychecks and stock options from biomedical firms. Increasingly, such deals are kept secret.
By David Willman, Times Staff Writer

BETHESDA, Md. — "Subject No. 4" died at 1:44 a.m. on June 14, 1999, in the immense federal research clinic of the National Institutes of Health.
The cause of death was clear: a complication from an experimental treatment for kidney inflammation using a drug made by a German company, Schering AG.    Among the first to be notified was Dr. Stephen I. Katz, the senior NIH official whose institute conducted the study.
   Unbeknown to the participants, Katz also was a paid consultant to Schering AG.
   Katz and his institute staff could have responded to the death by stopping the study immediately. They also could have moved swiftly to warn doctors outside the NIH who were prescribing the drug for similar disorders. Either step might have threatened the market potential for Schering AG's drug. They did neither.
   Questioned later, Katz said that his consulting arrangement with Schering AG did not influence his institute's decisions. His work with the company was approved by NIH leaders.
   Such dual roles — federal research leader and drug company consultant — are increasingly common at the NIH, an agency once known for independent scientific inquiry on behalf of a single client: the public.
   Two decades ago, the NIH was so distinct from industry that Margaret Heckler, secretary of Health and Human Services in the Reagan administration, could describe it as "an island of objective and pristine research, untainted by the influences of commercialization."
   Today, with its senior scientists collecting paychecks and stock options from biomedical companies, the NIH is no longer an island.
   Interviews and corporate and federal records obtained by the Los Angeles Times document hundreds of consulting payments to ranking NIH officials, including:
   • Katz, director of the NIH's National Institute of Arthritis and Musculoskeletal and Skin Diseases, who collected between $476,369 and $616,365 in company fees in the last decade, according to his yearly income-disclosure reports. Some of his fees were reported in ranges without citing exact figures. Schering AG paid Katz at least $170,000. Another company paid him more than $140,000 in consulting fees. It won $1.7 million in grants from his institute before going bankrupt last year.
   • Dr. John I. Gallin, director of the NIH's Clinical Center, the nation's largest site of medical experiments on humans, who has received between $145,000 and $322,000 in fees and stock proceeds for his consulting from 1997 through last year. In one case, Gallin co-wrote an article highlighting a company's gene-transfer technology, while hiring on as a consultant to a subsidiary of that company.
   • Dr. Richard C. Eastman, the NIH's top diabetes researcher in 1997, who wrote to the Food and Drug Administration that year defending a product without disclosing in his letter that he was a paid consultant to the manufacturer. Eastman's letter said the risk of liver failure from the drug was "very minimal." Six months later, a patient, Audrey LaRue Jones, who was taking the drug in an NIH study that Eastman oversaw, suffered sudden liver failure and died. Liver experts found that the drug probably caused the liver failure.
   • Dr. Ronald N. Germain, deputy director of a major laboratory at the National Institute of Allergy and Infectious Diseases, who has collected more than $1.4 million in company consulting fees in the last 11 years, plus stock options. One of the companies collaborated with his laboratory on research. The founder of another of the companies worked with Germain on a separate NIH-sponsored project.
   • Jeffrey Schlom, director of the National Cancer Institute's Laboratory of Tumor Immunology and Biology, who has taken $331,500 in company fees over 10 years. Schlom helped lead NIH-funded studies exploring wider use for a cancer drug — at the same time that his highest-paying client was seeking to make the drug through genetic engineering.
   • Jeffrey M. Trent, who became scientific director of the National Human Genome Research Institute in 1993 and, over the next three years, reported between $50,608 and $163,000 in industry consulting fees. Trent, who accepted nearly half of that income from a company active in genetic research, was not required to file public financial-disclosure statements as of 1997. He left the government last year.

Hidden From View
Increasingly, outside payments to NIH scientists are being hidden from public view. Relying in part on a 1998 legal opinion, NIH officials now allow more than 94% of the agency's top-paid employees to keep their consulting income confidential.
   As a result, the NIH is one of the most secretive agencies in the federal government when it comes to financial disclosures. A survey by The Times of 34 other federal agencies found that all had higher percentages of eligible employees filing reports on outside income. In several agencies, every top-paid official submitted public reports.
   The trend toward secrecy among NIH scientists goes beyond their failure to report outside income. Many of them also routinely sign confidentiality agreements with their corporate employers, putting their outside work under tight wraps.
   Gallin, Germain, Katz, Schlom and Trent each said that their consulting deals were authorized beforehand by NIH officials and had no adverse effect on their government work. Eastman declined to comment for this article.
   Dr. Arnold S. Relman, the former editor of the New England Journal of Medicine, said that private consulting by government scientists posed "legitimate cause for concern."
   "If I am a scientist working in an NIH lab and I get a lot of money in consulting fees, then I'm going to want to make sure that the company does very well," Relman said.
   Relman and others in the field of medical ethics said company payments raised important questions about public health decisions made throughout the NIH:
   • Will judgment calls on the safety of individual patients be affected by commercial interests?
   • Can study participants trust that experimental treatments are chosen on merit and not because of officials' personal financial interests?

   • Will scientists shade their interpretations of study results to favor their clients?
   • Will officials favor their clients over other companies that seek NIH grants or collaborations?
   Conflict-of-interest questions also arise in the potentially lucrative awarding of patents.
   Thomas J. Kindt, the director of in-house research at the National Institute of Allergy and Infectious Diseases, accepted $63,000 in consulting fees from a New York biotechnology company, Innovir Laboratories, and wound up an inventor on one of its patents.
   Asked why the government received no consideration, Kindt said that he had contributed to the "basic idea" while using vacation time.
   "No work was done on it as a government employee," said Kindt, whose annual salary at the NIH is $191,200. His consulting with Innovir was approved by NIH officials, Kindt said.
   Others worry that the private arrangements can undermine the public interest.
   "The fact that paid consulting is happening I find very disturbing," said Dr. Curt D. Furberg, former head of clinical trials at the National Heart, Lung and Blood Institute. "It should not be done."
   Private consulting fees tempt government scientists to pursue less-deserving research and to "put a spin on their interpretation" of study results, he said.
   "Science should be for the sake of gaining knowledge and looking for the truth," Furberg said. "There should be no other factors involved that can introduce bias on decision-making."
   Dr. Ruth L. Kirschstein, who as the deputy director or the acting director of the NIH since 1993 has approved many of the top officials' consulting arrangements, said she did not believe they had compromised the public interest. "I think NIH scientists, NIH directors and all the staff are highly ethical people with enormous integrity," she said. "And I think we do our business in the most remarkable way."
   In response to The Times' findings, Kirschstein said, she would "think about" whether administrators should learn more about a company's ties to the NIH before approving the consulting arrangements.
   "Systems can always be tightened up," Kirschstein said on Oct. 29. "And perhaps, based on this, we will do so."
   On Nov. 20, NIH Director Elias A. Zerhouni told agency leaders that he would form a committee to help "determine the appropriateness" of employees' consulting and other outside arrangements.
   "I believe we can improve our performance by subjecting ethics deliberations to a more transparent process," Zerhouni said in a memo.
   In a brief telephone interview last week, Zerhouni said he wanted the NIH "to manage not just the reality, but the perception of conflict of interest."
   "If there is something that could be viewed as improper, I think we need to be able to advise our scientists not to get into these relationships," he said. "My sense is our scientists are people of goodwill."

Temptations Abound
The NIH traces its beginnings to the Laboratory of Hygiene, founded in 1887 within a Navy hospital on Staten Island in New York. It became the federal government's first research institution for confronting such epidemic diseases as cholera, diphtheria, tuberculosis and smallpox.
   The laboratory's success convinced Congress of its value in seeking cures for diseases.
   In 1938, the renamed National Institute of Health moved to its present, 300-acre headquarters in Bethesda, about nine miles north of the White House.
   The agency's responsibilities — and prominence — have grown steadily.
   In 1948, four institutes were created to support work on cardiac disease, infectious diseases, dental disorders and experimental biology. "Institute" in the agency's name became "Institutes."
   President Nixon turned to the NIH in 1971 to lead a war on cancer. The agency has led the government's fight against AIDS. Two years ago, President Bush enlisted the NIH to help counter biological terrorism.
   Republican and Democratic administrations have boosted spending for the 27 research centers and institutes that compose today's NIH. Since 1990, the annual budget has nearly quadrupled, to $27.9 billion this fiscal year.
   Senior NIH scientists are among the highest-paid employees in the federal government.
   With billions of dollars in product sales potentially at stake for industry, and untold fortunes riding on biomedical stock prices, commercial temptations abound:
   Researchers poised to make a breakthrough in their NIH labs can, the same day, land paid consulting positions with companies eager to exploit their insights and cachet. Many companies cite their connections to NIH scientists on Web sites and in news releases, despite an agency rule against the practice. Selection of a company's products for an NIH study can provide a bankable endorsement — attracting investors and boosting stock value. If the study yields positive results, the benefits can be even greater.
   Conflicts of interest among university medical researchers have received wide attention in recent years. U.S. Rep. W.J. "Billy" Tauzin (R-La.) also raised questions recently about cash awards that several nonprofit institutions made to a previous director of the National Cancer Institute.
   The consulting deals between drug companies and full-time, career employees at the NIH, however, have gone all but unnoticed.
   The wide embrace of private consulting within the NIH can be traced in part to calls from Congress for quicker "translation" of basic federal research into improved treatments for patients.
   And for decades industry has pressed for more access to the government's scientific discoveries.
   As the number of government-held patents soared, companies sought legislation encouraging commercialization of federally funded inventions. The proponents said the changes also would make U.S. firms more competitive with foreign companies whose research and development programs were subsidized by their governments.
   Laws enacted in the 1980s for the first time authorized formal research collaborations between companies and scientific arms of the government, including the NIH. Starting in late 1986, in-house researchers at the NIH were permitted to arrange cooperative research agreements with companies. The agreements were intended to benefit both sides while advancing scientific discovery.
   Other changes in law permitted the government agencies, and the researchers, to share in future patent royalties for inventions.
   The new laws said nothing about government employees being hired by the companies.
   Yet by the end of the 1980s, more companies were putting NIH researchers on their payrolls, albeit within limits imposed by the NIH.
   Agency leaders in the 1990s began weakening those restrictions.
   In November 1995, then-NIH Director Harold E. Varmus wrote to all institute and center directors, rescinding "immediately" a policy that had barred them from accepting consulting fees and payments of stock from companies.
   The changes, he wrote, would bring the NIH ethics rules more in line with new, less stringent, executive branch standards. Loosening of restrictions on employees' outside pursuits was occurring throughout the government. And with biomedical companies ready to hire, few were better positioned to benefit than employees at the NIH.
   Varmus' memo — which until now has not been made public — scuttled other restraints affecting all employees, including a $25,000 annual limit on outside income, a prohibition on accepting company stock as payment and a limit of 500 hours a year on outside activities.
   His memo also offered a narrowed definition of conflict of interest:
   Employees had been barred from consulting for any company that collaborated with their NIH lab or branch. But Varmus said the ban would be applied only if the researcher was personally involved in the company's collaboration with the agency.
   Furberg, the former NIH official, said Varmus' actions invited, at minimum, appearances of conflict of interest.
   "I'm amazed at what he did," said Furberg, a professor at Wake Forest University. "And to do it in secrecy I find very objectionable. This is a critical change in the NIH policy."
   In 1999, Varmus wrote a letter to the institute directors that cautioned them to "avoid even the appearance of a conflict of interest." But in an attachment to the letter, he told them that employees "may briefly discuss or mention current work" to outsiders, in effect giving agency scientists permission to reveal their unpublished, confidential research.
   Varmus, now president and chief executive of the Memorial Sloan-Kettering Cancer Center in New York, declined to be interviewed for this article. His spokeswoman, R. Anne Thomas, said that Varmus, who in 1989 shared a Nobel Prize for research into the genetic basis of cancer, believed that NIH employees should take personal responsibility for avoiding conflicts of interest, regardless of what agency rules allow.
   Kirschstein, after taking over as Varmus' interim successor at the NIH three years ago, said in a May 2000 speech to medical researchers that conflicts of interest posed "a major concern."
   "While the federal government was once the dominant force for supporting clinical research, today we share the arena with biotechnology companies, pharmaceutical firms and many others — all interested in the possibility of financial gain from their research.
   "Profit raises issues of public trust," she said. "When scientific inquiry generates findings that can make a profit for the researcher and the institution, their images become clouded."
   Yet officials have lifted controls on consulting even as industry's stake in NIH research has deepened. When Zerhouni, the current NIH director, appeared before the House Subcommittee on Environment, Technology and Standards last year, he cited 274 ongoing research and development agreements between the federal agency and industry.
   At the same time, NIH leaders have moved to what they describe as "managing" conflicts of interest. Employees are allowed to consult if they receive prior clearance from an administrator at their institute or, in the case of most institute directors, from NIH headquarters.

An Honor System
Potential conflicts are typically addressed by allowing employees to sign "recusals." Under these agreements, NIH employees pledge not to participate in decisions affecting an outside client. Agency officials, Kirschstein said, rely on an honor system to enforce recusals and other conflict-of-interest rules.
   The Times found instances in which the recusals did not work as intended.
   In the mid-to-late 1990s, Eastman, the diabetes researcher, participated in a series of decisions affecting the drug company employing him as a consultant, despite having signed a recusal. Separately, Katz, the director of the arthritis institute, signed a recusal involving his client, Schering AG, which nevertheless supplied the NIH with the drug involved in the kidney patient's death in 1999.
   Katz said that he did not know at the time that Schering AG was the maker of the drug his institute was testing.
   Compliance with the recusals can, itself, undercut the interests of the NIH and taxpayers, who support the agency. When heads of institutes and laboratories recuse themselves, they sometimes constrain their ability to carry out their government duties.
   Kirschstein, who for the last eight years has personally reviewed requests from the institute directors to consult privately for pay, said she tended to approve the deals, unless she saw "real conflict."
   "I've disapproved some — and I've approved many," she said.
   In her view, recusals have worked "extremely well" in avoiding conflicts of interest.
   Other present and former officials say it is difficult, if not impossible, for researchers to keep separate their confidential government information when they consult for companies.
   "You can't police the thing," Philip S. Chen Jr., a senior advisor in the NIH director's office who has served as an agency scientist or administrator since the 1950s, said in an interview last year. "The rules are there — whether they follow the rules is another thing."
   A former NIH director voiced surprise at the agency's loosened approach to conflicts of interest.
   "There has been a lot of relaxation," said Dr. Bernadine P. Healy, who served as director from 1991 to 1993. Before, Healy said in an interview, "there were very strict ethics rules for NIH scientists. You couldn't have virtually any connection with a company if your institute was in any way doing research involving their products."
   At least one vestige of the old days remains.
   During last year's holiday season, workers were advised to refuse gifts from outsiders worth more than $20.
   "Just a reminder," ethics coordinator John C. Condray wrote, introducing a five-page memo, "that sometimes gifts and events can create the appearance of a lack of impartiality."

Fewer Public Filings
While making it easier for scientists to cut consulting deals, the NIH has made it harder for the public to find out about them.
   The Ethics in Government Act requires yearly financial-disclosure reports from senior federal employees. This year, employees paid $102,168 or more generally must disclose outside income by filing a "278" form, which is available for public review. Other employees may file a "450" form — which does not specify the amount of money received from an outside party and is kept confidential.
   At the NIH, 2,259 employees make more than $102,168, according to data provided by the NIH. Those records show that 127 of the employees — about 6% — are filing disclosure forms available to the public.
   From 1997 through 2002, the number of NIH employees filing public reports of their outside income dropped by about 64%, according to the agency records. Most of those employees have switched to filing the confidential 450 form.
   At the National Institute of Allergy and Infectious Diseases — which researches treatments for AIDS and other life-threatening maladies — only three officials file public reports revealing their outside income, according to NIH records.
   Officials at the NIH said that an advisory legal opinion from the U.S. Office of Government Ethics gave them the discretion to bypass public disclosure.
   Issued in 1998, the opinion said that the threshold for public disclosure was to be set, not by a federal employee's actual salary, but by the low end of his or her pay grade. If the minimum salary in an employee's grade is beneath the $102,168 threshold, he or she is exempt from filing a public report.
   The NIH has shifted many of its high-salaried employees into pay plans with minimums that dip below the threshold.
   For instance, two prominent NIH laboratory leaders, Schlom and Germain, make $180,400 and $179,900, respectively. Within roughly the last year, NIH changed each of their pay plans, and they now are exempt from public disclosure.
   They file confidential forms, which instruct employees to not specify the dollar amounts they receive from outside parties.
   Asked why the NIH has assigned highly paid staff to plans that eliminate public disclosure of employees' outside income, an NIH spokesman, John Burklow, provided a written response:
   "The primary benefit of the alternate pay plans is to attract and retain the best scientists in a highly competitive environment."
   Said Donald Ralbovsky, another NIH spokesman: "What it really boils down [to] is that fewer people are filing 278s because of changes in pay plans."
   The shift imparts an implicit message to employees, said George J. Galasso, a former NIH researcher and administrator who retired in 1996:
   "If you've got something to hide, you file a 450. If you don't, you file a 278."

Make-or-Break Grants
As director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Katz is one of the few at the NIH who still must file public financial-disclosure reports.
   Katz, 62, is paid $200,000 a year — more than members of Congress, justices on the Supreme Court and the vice president.
   His institute leads the government's research into the causes, treatment and prevention of disorders of the joints, bones and overall muscle-skeletal system.
   With a yearly institute budget of $485.4 million, Katz's decisions are watched closely by industry. The director's office decides how much of the budget will be spent on grants and contracts coveted by companies.
   And Katz has been available for outside consultation: From 1993 through 2002, Katz took between $476,369 and $616,365 in fees from seven biotech and pharmaceutical companies, according to his annual disclosure statements. He consulted while chief of the dermatology branch at the National Cancer Institute and continued after becoming arthritis institute director in 1995.
   Katz said that his private consulting broke no rules and that he relied in part on Varmus' 1995 memo while entering arrangements with companies.
   "The consultations provided my global knowledge as a dermatologist and research scientist," Katz said in written responses to questions from The Times. "I have always received official permission to perform these consultations and have performed these consultations outside of my normal NIH work schedule and according to strict government guidelines and rules."
   One of his clients was Advanced Tissue Sciences Inc.
   The struggling biotech company in San Diego hired Katz as a consultant in 1997, a year after he had announced a new NIH research initiative for bone and connective-tissue repair.
   Advanced Tissue installed Katz on its scientific advisory board and paid him fees between $142,500 and $212,500 from 1997 through 2002, according to his income-disclosure reports.
   During that time, Katz's institute pledged $1.7 million in small-business research grants to the company. The company announced nearly every grant in a news release; Advanced Tissue's president termed the grants "an endorsement by the government."
   In his written response, Katz said that he had signed a recusal "withdrawing myself from any interactions between Advanced Tissue Sciences and the government to remove any real or potential conflict of interest." The grants were awarded following evaluations by NIH reviewers outside of Katz's institute.
   Responsibility for administering the grants to Advanced Tissue was delegated to one of his subordinates, Katz said.
   The NIH policy manual says officials may not take fees from companies seeking or receiving agency grants "if the employee is working on or involved in these matters" or "supervising others who work on these matters."
   Katz said his subordinate "handled all decisions regarding these grants without informing me."
   However, Advanced Tissue kept him apprised as NIH grants were obtained, a company executive said.
   "He was informed," said Anthony J. Ratcliffe, the firm's vice president for research until its collapse a year ago. "We would have made a written report to the SAB [scientific advisory board] members twice a year. There would have been a report to the SAB meetings on all grants, all grant activities."
   Ratcliffe said the company dealt with Katz's potential conflict of interest by paying him in fees alone, and not stock options. Both men said Katz did not advise the company on the NIH grants.
   His consultations, Katz said, were limited to his scientific expertise and "never involved, directly or indirectly, the preparation or discussion of material which could relate to any financial dealings between [Advanced Tissue] and the NIH."
   Kirschstein, the senior NIH official who each year approved Katz's consulting with Advanced Tissue, said she did not learn the company held grants with the arthritis institute until The Times inquired.
   "I didn't even know there were grants," Kirschstein said.
   As it turned out, the grants would be among the few positive financial developments for Advanced Tissue.
   By December 2001, its cumulative net operating losses were approximately $292.7 million. Barely a year later, the company entered bankruptcy and shut its doors, having collected about $1.5 million of the $1.7 million in small-business research grants.

Life-and-Death Decisions
While Katz was consulting for Advanced Tissue, he also was on the payroll of Schering AG, which made Fludara, a drug that his research staff was using as an experimental treatment for autoimmune diseases.
   From the time he began consulting for Schering AG in 1996 through 2002, Katz collected between $170,000 and $240,000 in fees from the company, his disclosure reports show.
   In his responses to questions, Katz said that he "first became aware" that Fludara was a Schering AG product when The Times made inquiries.
   Fludara had been approved by the Food and Drug Administration in 1991 to treat leukemia, but the company wanted to expand its use to other diseases, a goal the NIH studies could advance.
   Two people died in the studies conducted by Katz's institute.
   In one study using Fludara to treat muscular disorders, a patient suffered what agency researchers reported in July 1998 as a "sudden death … not thought to be drug related."
   The second fatality, indisputably, resulted from the treatment. It involved "Subject No. 4," who had enrolled in a separate study, designed to treat kidney inflammation related to lupus, a disease of the immune system.
   Schering AG provided Katz's institute with a supply of Fludara and with analyses of patients' blood samples through its U.S. affiliate, Berlex Laboratories, records and interviews show. The company also contributed a total of $60,000 to the institute to support the research, eliciting a July 1, 1998, thank-you letter from Katz.
   Participants entering the study were warned of some risks. The NIH advised them that Fludara might cause damage to their blood cells and that, as a result, "blood transfusions may be required."
   That is what befell Jamie Ann Jackson, identified in NIH documents as "Subject No. 4."
   Jackson, a registered nurse, lived with her husband, their two daughters and a son in Plainville, Mass., about 37 miles southwest of Boston. She received four transfusions between March and May of 1999, yet grew sicker.
   On June 1, trembling with chills, Jackson was admitted to the NIH Clinical Center in Bethesda. Within days, lab results confirmed that she was in the grip of graft-versus-host disease. The graft of outside material — in this instance, blood from a transfusion — attacks and overwhelms the immune system and organs of the new host.
   Fatal in about 90% of cases, the malady had been documented in leukemia and other cancer patients who took Fludara. For that reason, the risk of graft-versus-host disease was noted in the product labeling — as was a warning about irradiating transfusions as a prevention.
   But the NIH doctors did not specify that transfusions should be irradiated for patients in the lupus study. In an interview, Dr. John H. Klippel, then the institute's clinical director, said he could not recall whether he or his colleagues took stock of the label warning.
   In Britain, authorities were more cautious, recommending that blood transfusions for all patients taking Fludara be irradiated. The British recommendations were described in 1996 in The Lancet, a medical journal with an international circulation.
   Two weeks after being admitted to the NIH Clinical Center, 42-year-old Jamie Ann Jackson died.
   "Steve Katz was notified almost immediately," Klippel said.
   Katz's subordinates warned the remaining patients and their personal doctors about the death and, for the first time, advised them to irradiate any transfusions. The FDA was informed.
   But the NIH office responsible for conducting an inquiry into research deaths was not promptly notified.
   And while Katz's institute stopped enrolling recruits, the treatment of those already in the study continued for nine months after Jackson's death.
   After five of the other 12 patients given Fludara experienced abnormal changes in their blood, increasing their risk of infection, the experiment was stopped, 20 months before its scheduled conclusion.

'Absolutely No Role'
While Fludara's use for anything other than leukemia remained experimental, an increasing number of doctors were prescribing it "off-label" for diseases of the immune system, including rheumatoid arthritis.
   Yet the NIH was slow in warning them about the lethal, but preventable, problem of graft-versus-host disease.
   It was not until October 2000, 16 months after Jackson died, that doctors from the NIH briefly summarized the death in Transfusion, the journal of the American Assn. of Blood Banks.
   Meanwhile, three articles written by NIH doctors and published from March 2000 through May 2001 referred to the agency's work with Fludara without mentioning the risk of graft-versus-host disease or the death in their study.
   In an article published in the May 2001 issue of the journal Pharmacotherapy, the doctors, three from Katz's institute, wrote that Fludara "was well tolerated" and thanked the company for providing the drug and "analytical support."
   Not until last week — 4 1/2 years after the event — did the same doctors appear as authors of a full-length article describing Jackson's death. It was published in Transfusion.
   In his responses to The Times, Katz said that, to his knowledge, "all matters concerning the adverse event were handled according to standard operating procedures."
   Katz said that he had signed a recusal, pledging not to participate in matters involving Schering AG. He said he had nothing to do with initiating the study, "was not advised that it was ongoing and had absolutely no role in overseeing its conduct."
   The Times documented three instances in which he discussed the study: The July 1998 letter acknowledging the company's first half of the $60,000 donation; the June 1999 phone call from Klippel notifying him of the death; and a meeting in April 2000 with Kirschstein to discuss the fatality and his institute's response to it.
   Katz confirmed all three incidents in a series of e-mail exchanges.
   He said he wrote the letter without realizing that Berlex Laboratories was the American arm of Schering AG.
   "At that time, I was unaware of any relationship between Berlex Laboratories and Schering AG and was, therefore, unaware that my sending the thank you letter might present any conflict of interest."
   Katz declined to identify when he learned that Berlex was the U.S. affiliate of Schering AG.
   The relationship between Schering AG and Berlex has not been a secret. News articles describe Berlex as Schering AG's U.S. business unit. The Berlex and Schering AG Web sites make clear the affiliation. In 1998 — two years after Katz was hired — Berlex accounted for 17% of Schering AG's net global sales.
   Oliver Renner, a spokesman in Berlin for Schering AG, said: "Berlex Laboratories is a fully owned subsidiary of Schering AG. We are distributing our products under the name of Berlex in the United States. We also conduct research and development work through our Berlex entities."
   Katz, asked about the phone call he received when Jackson died, said he did not then realize what company made the study drug. Although the study was ongoing, he said he did nothing in response to being notified of the death.
   "No further action was required or undertaken by me," Katz said.
   He said he remained uninformed about Schering AG's connection to the study when he met with Kirschstein in April 2000.
   "The reason that I did not exclude myself from any contact regarding the lupus [clinical] trial was that I was unaware, and no one on the staff brought to my attention, that the trial had any relationship to Schering AG," Katz said. He noted that the arthritis institute first used Fludara for lupus in 1993, before he arrived as director.
   Representatives of Schering AG said the company did nothing out of the ordinary in collaborating with the NIH — and in hiring Katz.
   "The discovery and development of new pharmaceuticals often involves a combination of government and private industry efforts," the company said in a statement. "It is also a common practice for pharmaceutical companies to work with many leading external experts…. In keeping with this practice, we have a consulting agreement with a Dr. Stephen Katz from the NIH involving his expertise in the field of dermatology."
   Schering AG is no longer pursuing development of Fludara as a treatment for autoimmune diseases.
   Kirschstein, the NIH official who approved Katz's consulting for Schering AG, said she had not known its drug was being tested by his institute.
   Kirschstein said she did recall being visited by Katz and his top aide in April 2000. The NIH's human protection office had just opened an internal review of the lupus-related study, questioning the researchers' failure to protect against graft-versus-host disease, as well as their failure to report the death to agency investigators in a timely fashion.
   "Dr. Katz and his scientific director came to me … to tell me about a study in which a drug was used and there was a death," Kirschstein said. "They did not tell me the name of the drug, and did not tell me much about the study, but told me that they and the [department] were looking into it."
   In a follow-up letter two years later, the internal review absolved the institute of responsibility for Jackson's death. Her husband has filed a wrongful-death lawsuit against the government in U.S. District Court. The lawsuit does not refer to Katz.
   Jackson's mother, Carmella Tarte, said time had not eased her grief.
   "We all went to the hospital, but we never even got to talk to her," Tarte said in an interview. "It's been four years and, well, Thanksgiving was just another day, you know? She has children she didn't see graduate."

*About This Report
In late 1998, the Los Angeles Times began examining payments from drug companies to employees of the National Institutes of Health and the agency's research collaborations with industry. This report is based on records from the federal government and from companies, as well as scores of interviews.
   In early 1999, the newspaper first sought income-disclosure reports for all eligible employees of the 27 research institutes and centers of the NIH. The newspaper, as of this month, had filed 36 requests with the NIH for documents under the Freedom of Information Act.
   According to NIH staff, the agency has provided documents totaling 13,784 pages, including annual financial-disclosure reports, memos and internal e-mails.
   A significant number of NIH employees had by this year stopped filing yearly income reports that are open to public inspection. To assess the relative extent of public financial disclosure at the NIH, The Times in July queried dozens of other federal agencies under the Freedom of Information Act.
   Other documentation, describing products and hundreds of research collaborations between the NIH and industry, was retrieved from company and NIH Web sites, from filings with the Securities and Exchange Commission, and from lawsuits filed in federal and state courts. Other related documents were obtained from the Food and Drug Administration under the Freedom of Information Act.

Times researcher Janet Lundblad in Los Angeles assisted in this report. Researchers Robert Patrick and Christopher Chandler in Washington also contributed.
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Science Magazine Dec 19 vol 302 p2082

Long-Term Ecosystem Response to the Exxon Valdez Oil Spill
Charles H. Peterson et al

The ecosystem response to the 1989 spill of oil from the Exxon Valdez into Prince William Sound, Alaska, shows that current practices for assessing ecological risks of oil in the oceans and, by extension, other toxic sources should be changed. Previously, it was assumed that impacts to populations derive almost exclusively from acute mortality. However, in the Alaskan coastal ecosystem, unexpected persistence of toxic subsurface oil and chronic exposures, even at sublethal levels, have continued to affect wildlife. Delayed population reductions and cascades of indirect effects postponed recovery. Development of ecosystem-based toxicology is required to understand and ultimately predict chronic, delayed, and indirect long-term risks and impacts.

Before the Exxon Valdez oil spill, information available for constructing risk assessment models to predict ecological impacts of petroleum hydrocarbons was limited to selective, largely short-term monitoring after previous oil spills and to tests of acute toxicity in laboratory-tolerant taxa (1). After the tanker Exxon Valdez grounded on Bligh Reef in northern Prince William Sound on 24 March 1989, the magnitude of the spill, extent of shoreline contamination, and evident high mortality of wildlife prompted an evaluation of ecological impacts of unprecedented scope and duration extending now for more than 14 years (2–5). The release of 42 million liters of Alaskan North Slope crude oil contaminated to some degree at least 1990 km of pristine shoreline. Prince William Sound was most severely affected, but the oil spread more than 750 km to the southwest along the Kenai Peninsula, Kodiak archipelago, and the Alaska Peninsula (Fig. 1). Years of study provide a new understanding of long-term biological impacts and recovery processes in a coastal ecosystem populated by abundant marine mammals, seabirds, and large fishes (2–5).
Fig. 1. Map of the spread of oil and the shorelines (indicated in black) contaminated to some degree after the grounding of the Exxon Valdez at Bligh Reef in northern Prince William Sound. Oil was transported to the southwest, striking Knight (KN) and other PWS islands, the Kenai Peninsula (KP), the Kodiak Island archipelago (KI), and the Alaska Peninsula (AP). [View Larger Version of this Image (41K GIF file)]
Delays in recovery and emergence of long-term impacts are understood by bringing an ecosystem perspective to ecotoxicology (6). The ecosystem framework extends ecotoxicology to include interactions among multiple abiotic and biological components rather than treating each species separately and restricting assessment to acute short-term impacts (7). Disagreements exist between Exxon- and government-funded scientists (8), and unknowns persist, especially in understanding how multiple processes combine to drive observed dynamics. Nevertheless, these uncertainties do little to diminish the general conclusions: oil persisted beyond a decade in surprising amounts and in toxic forms, was sufficiently bioavailable to induce chronic biological exposures, and had long-term impacts at the population level. Three major pathways of induction of long-term impacts emerge: (i) chronic persistence of oil, biological exposures, and population impacts to species closely associated with shallow sediments; (ii) delayed population impacts of sublethal doses compromising health, growth, and reproduction; and (iii) indirect effects of trophic and interaction cascades, all of which transmit impacts well beyond the acute-phase mortality.

Acute-Phase Mortality
After the release of crude oil from the Exxon Valdez into Prince William Sound (PWS), acute mortality followed a pattern largely predictable from other oil spills. Because marine mammals and seabirds require routine contact with the sea surface, these taxa experience high risk from floating oil (2, 6). Oiling of fur or feathers causes loss of insulating capacity and can lead to death from hypothermia, smothering, drowning, and ingestion of toxic hydrocarbons. Accordingly, mass mortalities of 1000 to 2800 sea otters (9) and unprecedented numbers of seabird deaths estimated at 250,000 (10) were documented during the days after the spill. An estimated 302 harbor seals, a short-haired marine mammal, were killed not by oiled pelage but likely from inhalation of toxic fumes leading to brain lesions, stress, and disorientation (2). Mass mortality also occurred among macroalgae and benthic invertebrates on oiled shores from a combination of chemical toxicity, smothering, and physical displacement from the habitat by pressurized wash-water applied after the spill (5, 7).
Persistence of Oil: Ecosystem Sequestration Only early phases of transport and transformation of the petroleum hydrocarbons followed expectations (11). About 40 to 45% of the oil mass grounded in 1989 on 787 km of PWS beaches; another 7 to 11% was transported to contaminate 1203 km of Gulf of Alaska shoreline (11, 12). About 2% remained on intertidal PWS beaches after 3.5 years (11); this reflected an exponential decay rate of –0.87 year–1, which in turn produced a loss of 58% over a year. Unexpectedly (3), rates of dispersion and degradation diminished through time, as most oil remaining after October 1992 was sequestered in environments where degradation was suppressed by physical barriers to disturbance, oxygenation, and photolysis (12). A 2001 survey of intertidal PWS shorelines revealed 55,600 kg of often little weathered, Exxon Valdez oil in intertidal subsurface sediments and a perhaps equal mass of high-intertidal degraded surface oil and lower-intertidal, minimally weathered subsurface oil (13). This represents a decay rate from 1992–2001 of only –0.22 to –0.30 year–1 (20 to 26% loss over a year) from the 806,000 kg estimated to be present on PWS beaches in 1992.
Sedimentary refuges inhibited degradation and sequestered persistently toxic oil in the intertidal zone of coarse-grained gravel shores where geomorphologic armoring by boulders and cobbles inhibited disturbance by waves (12). Some of this oil was similarly trapped under mussel beds providing an enduring route of entry into many food chains (14). The subsurface cobbles and gravels of stream banks (15) harbored biologically available oil, exposing and killing pink salmon embryos through at least 1993 (16). Thus, heavily oiled coarse sediments formed and protected subsurface reservoirs, sequestering oil from loss and weathering in intertidal habitats containing fish eggs and invertebrate predators (sea otters, seaducks, and shorebirds).

Long-Term Population Impacts
Chronic exposures of sediment-affiliated species. Chronic exposures for years after the spill to oil persisting in sedimentary refuges were evident from biomarkers in fish (17), sea otters (18), and seaducks (19) intimately associated with sediments for egg laying or foraging. These chronic exposures enhanced mortality for years. In 1989, prediction of oil risk to fishes was based largely on testing acute toxicity in short-term (4-day) laboratory exposures to the water-soluble fraction dominated by 1- and 2-ringed aromatic hydrocarbons (8). After the spill, fish embryos and larvae were chronically exposed to partially weathered oil in dispersed forms that accelerate dissolution of 3-, 4-, and 5-ringed hydrocarbons largely missing from the traditional laboratory toxicity assays (15). Laboratory experiments showed that these multiringed polycyclic aromatic hydrocarbons (PAHs) from partially weathered oil at concentrations as low as 1 ppb are toxic to pink salmon eggs exposed for the months of development and to herring eggs exposed for 16 days (20, 21). This process explains the elevated mortality of incubating pink salmon eggs in oiled rearing streams for at least 4 years after the oil spill (16).
After 1989, sea otter recovery of about 4% per annum (averaged throughout western PWS) has fallen far short of the 10% expected from earlier population recovery after termination of trade in sea otter pelts (22). At heavily oiled northern Knight Island, sea otters have remained at half the estimated prespill numbers with no recovery initiated by 2000, whereas an unoiled Montague Island population doubled just in the period from 1995 to 1998 (23). Spring carcass collections in 1976 –85 and again in 1989–98 produced age-at-death data, which allowed population modeling to demonstrate that sea otter survival in the oiled portion of PWS was generally lower in the years after the spill and declined rather than increased after 1989 (24). This response surprisingly included higher mortality of animals born after the spill, implicating a substantial contribution from chronic exposure. Persistent exposure to oil in 1996–98 is confirmed by higher levels of the detoxification enzyme CYP1A in individuals from northern Knight than from Montague Island (18). Abundance of sea otter prey (clams, mussels, crabs) did not differ between Knight and Montague during this period, so prey availability fails to explain suppression of population recovery (23). Suspension-feeding clams and mussels concentrate and only slowly metabolize hydrocarbons, which leads to chronically elevated tissue contamination that persisted in one prominent prey of sea otters, the clam Protothaca staminea, until at least 1996 (7). Sediments in protected areas, including oiled mussel beds and shallow eelgrass habitats (25), also retained contamination, with recovery to background in oiled mussel beds estimated from repeated sampling to require up to 30 years (14). Thus, foraging sea otters suffered chronic exposure to residual petroleum hydrocarbons from both sediment contact and ingestion of bivalve prey. In contrast, piscivorous river otters showed little evidence of chronic oil exposure even along heavily oiled shorelines, implying that foraging in sediments entails greater risk (18).
Among marine birds, harlequin ducks exhibited the most unanticipated chronic impact. Radio tracking of adult females revealed higher mortality rates while overwintering in 1995–96 through 1997–98 on heavily oiled Knight and Green Island shores (22%) than on unoiled Montague Island (16%), a difference with significant implications for population trajectories (26). Harlequin ducks, which prey on intertidal benthic invertebrates, showed induction of the CYP1A detoxification enzyme in 1998, which in the absence of corresponding patterns in other potential inducers like polychlorinated biphenyls (PCBs) indicates ongoing exposure to oil 9 years after the spill (20). Body mass of harlequins in late winter was negatively related to CYP1A levels in 1998, which suggests that a mechanism involving energetics led to the observed elevation in over-winter mortality rates (27). Reflecting the sensitivity of harlequin duck population dynamics to adult female survival, fall PWS densities of harlequins on oiled shores declined at an annual rate of about 5% in 1995-97, as compared with stable numbers on unoiled shores (26).
Other marine birds that forage in shallow sediments showed evidence of persistent exposure to residual oil after the spill. Barrow's goldeneye, a seaduck that overwinters in coastal Alaska and forages in intertidal mussel beds, declined in abundance in oiled relative to unoiled bays immediately after the spill with no evidence of recovery through 1991 (28). Along oiled Knight Island shorelines, Barrow's goldeneye showed chronic exposure to oil into winter 1996–97, as evidenced by induction of CYP1A (19). The association between foraging on littoral benthic invertebrates and chronic exposure to residual toxins from the oil is illustrated by differences among age classes in pigeon guillemots. This seabird, which restricts its foraging to the near- shore environment, suffered acute mortality during the spill (10). In 1999, 10 years after the oil spill, the chicks of pigeon guillemots, which are fed only fish, showed no evidence of ongoing exposure to toxics, whereas the adults, which include shallow-water benthic invertebrates in their diets, had elevated CYP1A in their livers (29).
Sublethal exposures leading to death from compromised health, growth, or reproduction. Several studies documented cascades of events indirectly affecting individual survival or reproduction after sublethal exposures. Oil exposure resulted in lower growth rates of salmon fry in 1989 (8), which in pink salmon reduce survivorship indirectly through size-dependent predation during the marine phase of their life history (30). After chronic exposures as embryos in the laboratory to less than 20 ppb total PAHs, which stunted their growth, the subsequently marked and released pink salmon fry survived the next 1.5 years at sea at only half the rate of control fish (21). In addition, controlled laboratory studies showed reproductive impairment from sublethal exposure through reducing embryo survivorship in eggs of returning adult pink salmon that had previously been exposed in 1993 to weathered oil as embryos and fry (31). These definitive experimental demonstrations of compromised survival and reproduction from sublethal dosing conform with a growing understanding of how exposure to xenobiotics at sensitive early stages in vertebrate development can lead to enhanced mortality and reproductive impairment later in life through endocrine disruption and developmental abnormalities (32). Abnormal development occurred in herring and salmon after exposure to the Exxon Valdez oil (14, 20).
Support for the inference that sublethal effects of chronic exposure to toxics through ingestion of oil led to population-level impacts on shorebirds comes from studies of the black oystercatcher. In summer 1989, pairs of black oystercatchers with foraging territories on heavily oiled shores showed reduced incidence of breeding and smaller eggs than those that bred elsewhere (33). Chick mortality was enhanced in proportion to degree of shoreline oiling in both 1989 and 1990. Subsequent study (34) revealed that black oystercatchers indeed consumed oiled mussels and that parents gathering prey on oiled shores in 1991 and 1992 fed chicks more to achieve less growth than on unoiled shores, which implies energetic or developmental costs and reproductive impairment from ingestion of toxics 3 years after the spill. Fledging late or at small size has negative implications for chick survivorship.
Cascades of indirect effects. Indirect effects can be as important as direct trophic interactions in structuring communities (35). Cascading indirect effects are delayed in operation because they are mediated through changes in an intermediary. Perhaps the two generally most influential types of indirect interactions are (i) trophic cascades in which predators reduce abundance of their prey, which in turn releases the prey's food species from control (36); and (ii) provision of biogenic habitat by organisms that serve as or create important physical structure in the environment (37). Current risk assessment models used for projecting biological injury to marine communities ignore indirect effects, treating species populations as independent of one another (7, 8), even in rocky-shore systems, where basic community ecology would indicate otherwise (38).
Indirect interactions (Fig. 2A) lengthened the recovery process on rocky shorelines for a decade or more (7). Dramatic initial loss of cover by the most important biogenic habitat provider, the rockweed Fucus gardneri, triggered a cascade of indirect impacts. Freeing of space on the rocks and the losses of important grazing (limpets and periwinkles) and predatory (whelks) gastropods combined to promote initial blooms of ephemeral green algae in 1989 and 1990 and an opportunistic barnacle, Chthamalus dalli, in 1991. Absence of structural algal canopy led to declines in associated invertebrates and inhibited recovery of Fucus itself, whose recruits avoid desiccation under the protective cover of the adult plants. Those Fucus plants that subsequently settled on tests of Chthamalus dalli became dislodged during storms because of the structural instability of the attachment of this opportunistic barnacle. After apparent recovery of Fucus, previously oiled shores exhibited another mass rockweed mortality in 1994, a cyclic instability probably caused by simultaneous senility of a single-aged stand (5, 39). The importance of indirect interactions in rocky shore communities is well established (38), and the general sequence of succession on rocky intertidal shores extending over a decade after the Exxon Valdez oil spill closely resembles the dynamics after the Torrey Canyon oil spill in the UK (40). Expectations of rapid recovery based on short generation times of most intertidal plants and animals are naοve and must be replaced by a generalized concept of how interspecific interactions will lead to a sequence of delayed indirect effects over a decade or longer (7).
Fig. 2. Marine interaction webs of the Pacific Northwest known to generate strong indirect effects. Heads of arrows point to the taxon receiving the negative effect of predation or competition or the positive effect of habitat provision. (A) Rocky intertidal shore community (5, 7). After acute mass mortality in 1989 of (i) Fucus, (ii) herbivorous limpets and periwinkles, and (iii) predatory Nucella, a bloom of ephemeral algae occurred after 0.5 to 1.5 years as a delayed indirect effect of release from all interaction arrows marked by 1. With a lag of 2.5 years, chthamaloid barnacles later increased far above reference densities as an indirect effect of release from all interaction arrows marked by 2 (4, 7). (B) Subtidal kelp forest community (36, 41). Despite acute loss of over 50% of the sea otters at heavily oiled northern Knight Island, there exists only limited evidence of initiation of this potentially strong trophic cascade. Some patches of larger sea urchins have appeared but no explosion of their abundance and no evident overgrazing of kelp have been seen even in the absence of sea otter recovery to date (22, 23). [View Larger Version of this Image (25K GIF file)]
Indirect interactions are not restricted to trophic cascades or to intertidal benthos. Interaction cascades defined broadly include loss of key individuals in socially organized populations, which then suffer subsequently enhanced mortality or depressed reproduction. After exceptionally high mortality of 20% between September 1988 and spring 1989 and another 20% during the following year in the AB pod of resident (fish-eating) killer whales that had been observed to swim through the spill, losses of adult females from these matriarchially organized family groups led to suppressed reproduction (2). In another pod (AT1) of transient (mammal-eating) killer whales, the 40% loss during the spill is leading to likely disintegration (2). Furthermore, the most compelling example in all of marine ecology of a trophic cascade radically modifying a marine community comes from the Gulf of Alaska kelp ecosystem (36). Unless eliminated by killer whales that have lost their traditional, larger marine mammal prey (41), sea otters control sea urchin populations, preventing them from overgrazing kelp and other macroalgae, and thereby retaining structural habitat for fishes and invertebrates (Fig. 2B). Given the spill loss of about 50% of the sea otters from PWS, there is potential for this cascade to influence recovery dynamics, but evidence of its operation to date is limited to reduction in otter foraging and increase in urchin sizes (18). Nevertheless, should sea otters be eliminated from an area by an oil spill, the repeatability of the otterurchin-kelp cascade is sufficiently strong that risk assessment models can confidently include its implications. In contrast, limited understanding of the importance of behaviorally mediated indirect effects in driving community dynamics (42) still prevents their inclusion in risk modeling.

Implications of Changing Paradigms of Oil Ecotoxicity
It is well known that acute tests of toxicity in the laboratory are insufficient for ecotoxicological risk assessment (43). It has also been clear that tests of chronic exposures are needed to fully understand impacts of petroleum and other toxins in the marine environment (6). Support grows for inclusion of a range of physiological, biochemical, and histopathological evaluations of toxicity, facilitated by rapid development of molecular tools. Furthermore, ecologists have long acknowledged the potential importance of interaction cascades of indirect effects. Now synthesis of 14 years of Exxon Valdez oil spill studies documents the contributions of delayed, chronic, and indirect effects of petroleum contamination in the marine environment (Table 1). Expanding the scope of the fundamental basis of ecotoxicology beyond reliance on short-term acute toxicity to include delayed, chronic, and indirect effects operating over longer periods is analogous to developing ecosystem-based management of forest (44) and fisheries (45) resources to embrace the nexus of ecosystem interactions. Our synthesis implies necessary modifications of environmental standards for water quality, stormwater control, chronic low-level oil releases, and many other human activities. Vague concerns about the role of poor water quality in the steady declines of estuarine-dependent fisheries may now find renewed focus on a specific class of contaminants, the multi-ringed PAHs, in physically protected sedimentary spawning and nursery habitats. In light of delayed impacts of the Exxon Valdez (Table 1) and the San Cristobal oil spill in the Galapagos Islands during 2001 (46), the growing role played by risk assessment modeling in a priori environmental decision making and a posteriori estimation of natural resource injury needs reconsideration. Much incentive exists for advancing the predictive capacity of ecology to allow more confident modeling of chronic, indirect, and delayed effects of stressors through ecosystem-based frameworks.

Table 1. Changing paradigms in oil ecotoxicology, moving from acute toxicity based on single species toward an ecosystem-based synthesis of short-term direct plus longer-term chronic, delayed, and indirect impacts.

Old paradigm   Emerging appreciation  

  Physical shoreline habitat  
Oil that grounds on shorelines other than marshes dominated by fine sediments will be rapidly dispersed and degraded microbially and photolytically.   Oil degrades at varying rates depending on environment, with subsurface sediments physically protected from disturbance, oxygenation, and photolysis retaining contamination by only partially weathered oil for years.  
  Oil toxicity to fish  
Oil effects occur solely through short-term (4 day) exposure to water-soluble fraction (1- to 2-ringed aromatics dominate) through acute narcosis mortality at parts per million concentrations.   Long-term exposure of fish embryos to weathered oil (3- to 5-ringed PAHs) at ppb concentrations has population consequences through indirect effects on growth, deformities, and behavior with long-term consequences on mortality and reproduction.  
  Oil toxicity to seabirds and marine mammals  
Oil effects occur solely through short-term acute exposure of feathers or fur and resulting death from hypothermia, smothering, drowning, or ingestion of toxics during preening.   Oil effects also are substantial (independent of means of insulation) over the long term through interactions between natural environmental stressors and compromised health of exposed animals, through chronic toxic exposure from ingesting contaminated prey or during foraging around persistent sedimentary pools of oil, and through disruption of vital social functions (care giving or reproduction) in socially organized species.  
  Oil impacts on coastal communities  
Acute mortality through short-term toxic exposure to oil deposited on shore and the shallow seafloor or through smothering accounts for the only important losses of shoreline plants and invertebrates.  

Clean-up attempts can be more damaging than the oil itself, with impacts recurring as long as clean-up (including both chemical and physical methods) continues. Because of the pervasiveness of strong biological interactions in rocky intertidal and kelp forest communities, cascades of delayed, indirect impacts (especially of trophic cascades and biogenic habitat loss) expand the scope of injury well beyond the initial direct losses and thereby also delay recoveries.  

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