• The Quest for Toxic Truth
• Selected Bibliography
• Glossary of Research Terms
• Toxic Notes

THE CURRENT STATE OF BIOMEDICAL PUBLICATION

2,000,000
1,500,000
1,000,000
500,000
0
	1995
	Published Articles
	Medline, # Indexed
	Embase, # Indexed
	Biosis, # Indexed
	Unpublished, Approximate

However, if we wanted to answer the question posed to Dr. Asclepius "Can Trykillum cause Stryasipus?" could a definitive answer be gleaned from research of the literature? Several problems immediately come to mind.

PROBLEM 1

One is the enormous amount of unpublished information available. It has been estimated that over 2,000,000 published articles are added each year to just the biomedical literature and many of these are not indexed, and therefore are not that easily retrievable. Estimates vary on the amount of actual indexed articles, but the figure probably would fall somewhere between 40 and 60 percent of those published. Some contend the majority of the published material from peer review journals is indexed, which helps to offset this large gap.

PROBLEM 2

The second problem is the large amount of unpublished studies and trials. Some estimate this to be as high as a third of the published ones. Many factors enter into this complex problem. However, most agree publication bias in its myriad forms is the major culprit. To illustrate this point, let's suppose that one tablespoon a day of Trykillum had been fed to 600 rats for one year in a controlled clinical trial. At the end of the trial, no differences were observed in rats fed Trykillum and the 600 control rats fed a normal diet. Findings that conclude with "no effect" are not particularly glamorous and chances are a report of this trial would not be published. However, this finding would be of considerable importance to our expert witness for the defense.

PROBLEM 3

A third major problem to giving a definitive answer to our Trykillum question is an outgrowth of the first two--a lack of consensus in the scientific community. It is not unusual for a special conference to be held with hundreds of experts meeting to decide a single question and when the symposium ends they are not any nearer an answer than before they met and therefore there are no published proceedings. Touted as a new way to reach consensus, meta-analysis, which aggregates the results of several trials, has proved to be at times very helpful and at other times very controversial and often investigators are not able to agree on the methodology, much less the results. An even more dramatic problem stems from the scientific method itself. Because science progresses incrementally, not rapidly, seeming contradictions creep into the literature when it is taken study by study.

These three problems are very formidable. In order to answer our Trykillum question, we will have to undertake an exhaustive search of the scientific literature, locate the unpublished findings and allow for the lack of consensus in the scientific community. We are frequently asked just such a question and at MTI this is how we proceed:

SUGGESTION FOR PROBLEM 1

After formulating our search strategy, the first step in our quest is an online search. We would probably begin with a cursory search of MEDLINE, TOXLINE, and EMBASE. Then our investigation would proceed with a manual search of INDEX MEDICUS and SCIENCE CITATION INDEX materials prior to 1996 that are not indexed online. Additional references are found by checking the bibliographies of key articles, monographs, and important reference works. This would take care of a large portion of the published literature.

SUGGESTION FOR PROBLEM 2

The next phase is more difficult, locating the unpublished information. The best place to start is to check the material unearthed in phase one. Authors often mention unpublished clinical trials, case control studies, or single case reports. A second source is clinical trial registries that exist for several research areas; one example is the Oxford Database of Perinatal Trials, that covers the years 1940-1984. A third possibility is to examine the published literature for names of scientists and research institutions and then personally contact them to discuss unpublished findings. You may even be able to obtain a written statement from them regarding the trial or study.

SUGGESTION FOR PROBLEM 3

The third problem, lack of consensus in the scientific community, is not insurmountable, but almost. Your best hope for finding a composite view of the lack of consensus may be the popular press. Many researchers are quite "media-savvy" and write their own press releases or when no symposium consensus has been reached the Society will issue a press release or post a statement on its internet home page. This will help to confirm that there is no consensus or may identify the owners of the various dissenting opinions and give you some additional leads.

After all is said and done and we have a three-foot mountain of paper, have we answered the question "Can Trykillum cause Stryasipus?" We're not sure but we are certain once our client's expert witness wades through this treasure chest of trials, studies, review literature, and documents, an expert opinion will be forthcoming and we will be closer in our quest for toxic truth.

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1. Angell, Marcia, and Kassirer. "Clinical Research: What Should the Public Believe?"New England Journal of Medicine 331, no. 31 (21 July 1994): 189-190.
2. Dickerson, K., Chan, Chalmers, Sacks, and Smith. "Publication Bias and Clinical Trials." Controlled Clinical Trials 8 (1987): 343-353.
3. Hutchison, Brian G."Critical Appraisal of Review Articles." Canadian Family Physician 39 (May 1993):1097-1102.4. Knipschild, Paul. "Some Examples: Reviewing the Literature." BMJ 309 (17 September 1994): 719-21.
4. Lock, Stephen, and Smith. "What Do Peer Reviewers Do?" JAMA 263, no. 10 (9 March 1990): 1341-1343.
5. Oxman, Andrew D. "Checklist for Review Articles." BMJ 309 (1994): 648-51.
6. Rubin, Robert J. Personal Interview. Baltimore MD: Johns Hopkins University School of Public Health, 11 July 1996.
7. Seglen, Per O. "From Bad To Worse: Evaluation By Journal Impact." Trends In Biochemical Science 14, no. 8 (August 1989): 327-328.
8. Sharp, David W. "What Can and Should Be Done To Reduce Publication Bias." JAMA 263, no. 10 (9 March 1990): 1390-1391.
9. Shprintzen, Robert J. "Fallibility of Clinical Research." Cleft Palate Craniofacial Journal 28, no. 2 (April 1991): 138-40.
10. Sleight, Peter. "Publication of Clinical Trial Results: A Clinical Investigator's View." Journal of the Royal Society of Medicine 88, no. supp 24 (1995): 17-19.
11. Taubes, Gary. "Epidemiology Faces Its Limits." Science 269 (14 July 1995): 164-169.

Complete Bibliography Available Upon Request

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CASE REPORTS:

Reporting of a single case by a practitioner in his specialty that illustrate: (1) an important or historic event; (2) potential mishaps or disasters; (3) bizarre curiosities that will never be encountered in every day practice; (4) slightly unusual cases that provide a tiny thread in the enormous tapestry of the human condition. JRS Med 88:298, 1995.

CASE CONTROL STUDIES:

Studies which start with the identification of persons with a disease of interest and a control (comparison, referent) group without the disease. The relationship of an attribute to the disease is examined by comparing diseased and non-diseased persons with regard to the frequency or levels of the attribute in each group. Medline.

CLINICAL TRIALS:

Pre-planned studies of the safety, efficacy or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable effects. This concept includes clinical trials conducted both in the U.S. and other countries. Medline.

META-ANALYSIS:

A quantitative method of combining the results of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new studies, etc. with application chiefly in the areas of research and literature. Medline.

PEER REVIEW:

The evaluation by experts of the quality and pertinence of research or research proposals of other experts in the same field. Peer review is used by editors in deciding which submissions warrant publication by granting agencies to determine which proposals should be funded, and by academic institutions in tenure decisions. Medline.

PUBLICATION BIAS:

Any influence that reduces the amount of good science appearing in the literature, and it takes place as early as the inception of a project, continues through what actually achieves printed status, and appears finally in reactions to data after publication. JAMA 263 (10):1392, 1990.

RESEARCH:

Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions or laws. Webster, 3d edition.

REVIEW LITERATURE:

Published materials which provide an examination of recent or current literature. Review articles can cover a wide range of subject matter at various levels of completeness and comprehensiveness based on analysis of literature that may include research findings. The review may reflect the state of the art. It also includes reviews as a literary form. Medline.

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The U.S. Environmental Protection Agency has released the final report titled Air Quality Criteria for Particulate Matter which evaluates the latest scientific information pertaining to health and environmental effects associated with airborne particulate matter. The complete document is available on the internet at: http://www.EPA.gov/ORD

The American Petroleum Institute (API) has recently made available their report titled Summary of Produced Water Toxicity Identification Evaluation Research, June 1996. The report summarizes the results of a three-part study to evaluate the ability of EPA proposed toxicity identification evaluations (TIEs) to determine the potential toxicants in produced water from oil and gas production operations in various locations. Factors affecting the results were identified as well as potential toxicants. Suggestions for improving TIE procedures are included. 102 pages. Contact Suzanne Covello at API for ordering information; phone: (202) 682-8319 or fax: (202) 682-8270.

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