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The Animal Rule: Animal v. Human Studies as Scientific Evidence

Can animal studies substitute for human studies in approving drugs destined for human use?  Read the sound science evidence in  our January 2004 issue.

SBS--House on Haunted Hill II

Viagra & Aggression                

 Reference Manual On Scientific Evidence                                   
 10 Myths About Expert Witnesses
 

Viagra & Aggression

Read the groundbreaking research on the possible link between sildenafil citrate and aggressive behavior.  Write to us about your own experiences with sildenafil and contribute to this important ongoing research.

Neurological, Psychological, and Aggressive Disturbances with Sildenafil by Harry A. Milman and Suzanne B. Arnold.

Ann Pharmacother. 2002 Jul-Aug;36(7-8):1129-34.

BACKGROUND: Anecdotal reports and case studies have described psychological disturbances and aggressive behavior in some men taking sildenafil. In the course of assisting the defense in a trial in which a man was alleged to have committed rape and in which sildenafil was implicated, a mechanistic hypothesis was formulated by the first author for central nervous system (CNS) adverse effects associated with the use of sildenafil. OBJECTIVE: To examine whether there was any scientific information available to suggest a possible mechanism for or an association between exposure to sildenafil and aggressive behavior. METHODS: The scientific literature on sildenafil, nitric oxide (NO), and the NO-cyclic-guanosine monophosphate (cyclic-GMP) signaling pathway was reviewed. Adverse event reports that referenced sildenafil and were filed with the Food and Drug Administration Adverse Event Reporting System between January 4, 1998, and February 21, 2001, also were examined. RESULTS: Published studies reported that sildenafil crosses the blood-brain barrier, that it exerts various biochemical and physiologic effects in the brain, and that it affects information processing. Other published reports indicated that phosphodiesterase type 5 (PDE-5), NO synthase, and guanylyl cyclase are present at highest activities in areas of the brain responsible for behavior, sexual drive, and emotion, and that NO modulates aggression and sexual behavior in male mice. In addition, 274 adverse event reports designated sildenafil as the primary suspect of various neurologic disturbances, amnesia, and aggressive behavior. DISCUSSION: Evidence has been presented for an association between sildenafil and various CNS adverse effects, including aggressive behavior. Whether sildenafil causes these effects by inhibiting PDE-5 in the brain, accumulating cyclic-GMP, decreasing NO, and affecting cell-cell signaling and modulation of aggressive behavior requires further investigation. CONCLUSIONS: It is recommended that, before prescribing sildenafil for erectile dysfunction, clinicians should caution their patients and their partners on the possibility of neurologic, emotional, or psychological disturbances; amnesia or loss of consciousness; or aggressive behavior.

 

Reference Manual on Scientific Evidence

The Federal Judicial Center in Washington, D.C. has published the revised, second edition of its Reference Manual on Scientific Evidence. The Manual, as Fern Smith, Director of the Center, notes in the preface to this new edition, assists "federal judges in recognizing the characteristics and reasoning of ‘science’ as it is relevant in litigation." This is not merely a re-printing of the 1994 Manual; several new chapters have been added. In a concise and very readable Introduction, U.S. Supreme Court Justice Stephen Breyer reviews the increasingly important role scientific evidence plays in litigation and the corresponding challenges trial courts must meet if science is to "find a warm welcome . . . in our courtrooms." The first edition of the Manual was published in 1994 largely as a result of the landmark 1993 Supreme Court case on expert testimony, Daubert v Merrell Dow Pharmaceuticals; in a new chapter by Margaret Berger, law professor at the Brooklyn Law School, "The Supreme Court’s Trilogy on the Admissibility of Expert Testimony," she helpfully summarizes Daubert as well as two subsequent cases, 1997's General Electric Co. v Joiner and 1999's Kumho Tire Co. v Carmichael. A likewise welcome addition to this revised Manual is "How Science Works" by David Goodstein, a professor of physics at the California Institute of Technology, who discusses the philosophy and practice of Science. New reference guides on medical testimony and engineering are also included, which should assist judges in their review for cases involving nonscientific expert testimony. One of the more requested portions of the first edition--the Reference Guides--remain but have been updated with new cases and additional material. The Reference Guide on DNA Evidence, however, has been completely revised to take account of the rapid changes that the last six years have seen in this field. To make room for these changes and additions, some of the material in the first edition on court-appointed experts has been condensed and rearranged into a new chapter, "Management of Expert Evidence," written by William W. Schwarzer, U.S. District Judge for the Northern District of California, and Joe Cecil, director of the Judicial Center’s Scientific Evidence Project.

The Reference Manual on Scientific Evidence is a welcome resource for a firm grounding in the complexities of science in the courtroom. An electronic version of the Manual may be downloaded off the Internet by pointing your browser to:

http:///www.fjc.gov

MTI REVIEW INDEX

Hypoglycemia: Driving Under the Influence

Read how low blood sugar can lead to an unjustified DUI --with sound science in easy to understand language and actual case reports

Crime and Prescription Drugs

Psychological Autopsies: Can the Dead Testify?

Scientific Misconduct: Science and Lies Without the Video Tape

Carcinogens: Living With Cancer Causing Agents

DUI and .08 BAC: It's in the Blood?

Of Mice, Men and Genomics: New Technologies and Toxic Testing

Sick Building Syndrome: A House on Haunted Hill?

Cosmeceuticals:..The Make-up of an Uncertain Future?

The NAAQS Particulates: Running on Toxic Fumes?

Toxic Rx: Prescription for Error?

Water Toxins: ... Pfiesteria Hysteria

Toxic R&R: Relevance and Reliability...

Multiple Chemical Sensitivity

Endocrine Disruptors: To Be or Not To Be

Pesticides & the FQPA of 1996

The Quest for Toxic Truth

Toxic Testing: The Evidence

 

Mistake not further than you should: 10 Top Myths About Expert Witnesses

The noted physicist Wolfgang Pauli was once asked to respond to the findings reported in a scientific paper. Specifically, he was asked to comment on the correctness of the conclusions, to which he caustically replied, "That paper isn’t even good enough to be wrong!" Similarly, many mistaken notions about what it is to be an expert witness, or, indeed, what constitutes Sound Science In The Courtroom permeate both criminal and civil law today. When applied to the legal profession, however, conceptions that are "not even good enough to be wrong" go far beyond academic concerns; what goes on in a courtroom creates ripple-effects throughout society. For example, a number of commonly held myths about expert witnesses are not only incorrect, but many are so removed from reality that belief in them affects not only the outcome of a specific case, but also the lives of millions of Americans not directly involved. What follows is an examination of the more common myths about experts. All of these are sentiments which we frequently encounter at MTI in our work as medical and scientific information consultants.

 1. "Real experts don’t have to do any research to prepare for this case; they already know the answer, hence the name, expert."

 At MTI, we are confronted with this reaction from attorneys frequently. Actually, the other common myths about experts and science in the courtroom follow from this flawed mode of thinking. When one considers the flood of medical and scientific articles written per year (more than two million are catalogued annually by MEDLINE alone), the patent absurdity of this notion becomes obvious. Beyond the sheer impossibility of knowing everything, even within the narrow confines of a scientist’s area of specialization, such a belief that "expert" signifies someone who has no need to perform research to prepare for a specific case is both a mistake of what the word means and what it really means to be an expert. "Expert" comes from the Latin term experiri, meaning "to try, or to put to a test." Significantly, experiri is also the root of "experiment," probably the most important ingredient in our modern notion of science: "an action or operation undertaken in order to discover something unknown or to test a hypothesis; a method, system of things, or course of action, adopted in uncertainty whether it will answer the purpose; the action of trying anything, or putting it to proof; a test, trial." As these various glosses of experiment from the Oxford English Dictionary indicate and as everyday practice makes clear, a scientist who conducts an experiment does not "already know the answer." In fact, as reports of numerous instances of junk and fraudulent science in recent years have illustrated, if a scientist crafts the science to fit what he previously "knows," he is guilty of scientific misconduct. A true expert in the courtroom, then, "puts to the test" the available scientific literature as applied to the circumstances at hand. To ensure that the expert has all of the available literature at a minimal cost to our attorney clients, MTI does the investigative research at rates much lower than the more costly hourly fees generally charged by our doctors and scientists. This makes it possible for the attorney to "know the answer" to questions of science upon going to trial--at affordable expense.

 2. I only need an expert for the day of the trial.

 This is a tack often taken by attorneys wishing to spare expense but it quite often spells disaster for both the attorney and the client. Attorneys who contract "hired guns" frequently report that the gun backfires. Each case and individual are unique, regardless of the type of expertise needed, and it is essential that the consultant be given as much information as possible on which to base a sound science opinion well before the day of the trial. This requires telephone consultation, review of medical records and other pertinent scientific documents, and perhaps even meeting individually with the attorney and/or client to collaborate on the best use of the science involved. Again, MTI can perform much of the time-consuming portions of this necessary phase by collecting the intelligence and other information and putting it into succinct form so that the attorney’s resources and the expert’s time are most efficiently used.

 3. Experts charge too much. I can prepare the medical or scientific research myself using the Internet and save the client’s money.

 The Internet is certainly proving itself to be a wealth of information but also of misinformation and even, at times, disinformation. What is most positive about the Internet is that anyone can publish anything on the Internet. Unfortunately, this is precisely what is most negative about the Internet as well. Consequently, one needs to be very cautious about the credence one gives to information found online. Using an expert consulting service like MTI can save you thousands of dollars in lost time and money. By engaging professionals who are both thoroughly familiar with the credible medical and scientific resources available and who can selectively target and narrow the information to that which is material, you can have confidence that your evidence will pass the strictures of relevance and reliability which all scientific cases must meet as a result of the landmark Daubert v Merrell Dow Pharmaceuticals Supreme Court decision.

 4. I only use experts that are on faculty at universities; they are the best.

 Unfortunately, this approach all too often limits you to a choice that may not be in the best interests of the client. As with many of the common myths regarding experts, this notion sounds good on the surface. Certainly the C.V. of a faculty member at a university usually looks more impressive than that of a doctor engaged in private practice who does not have the time to amass the publications that a university professor does. If you look carefully at what "expert" means, one can see the proximity not only to experiment as discussed in myth #1 above, but also to the word "experience." The root word again is experiri and involves "trying something and putting it to the test." Many doctors in private practice have years of hands on experience and bring years of experiments to a case rather than years of inhabiting the milieu of "publish or perish." Simply put, many doctors in private practice may be entirely too busy saving lives to publish articles and flesh out their resumes. At MTI, we work with our doctors and employ a team approach that guarantees that you can make the absolute best use of their expertise and at the same time they can be sure that they have the most up-to-date medical and scientific literature available on which to base their opinion.

 5. Using only articles from peer reviewed journals as evidence ensures that we will get past the gatekeeper judge.

Recognizing the value of peer-review journals is, of course, laudatory and is certainly a step in the right direction to ensure that your case is grounded in sound science; however, as with relying on information on the Internet, you need to be wary here. Just because an article was published by a peer-reviewed journal does not mean that the science will meet the relevance and reliability standard set by Daubert. Part and parcel with the explosion in medical and scientific literature in recent years has been the growth in peer-reviewed journals. Most are trustworthy repositories of scientific information. However more than a few have been judged to have ideological agendas driving the "peers" on the journals’ review boards and, consequently, often feature dubious science. Having expert help that involves a team-generated, carefully prepared, documented opinion based not only on sound science but on an understanding of the workings of the contemporary scientific community is the best way to ensure that the keeper of the gate will accept your evidence.

 6. Using a consulting firm instead of an individual doctor will cost you more.

As with any human endeavor, cost in a criminal or civil case is always a concern. And there is no getting around the fact that science is expensive. However, in most legal cases, the reverse of the notion that consulting firms are more costly than individual doctors is closer to the truth. It has been our experience (and those of attorneys and firms for whom we have worked) that as expensive as the work we do at MTI may at times be, it is less costly than contracting with an individual expert who must then, by necessity, do everything himself. Almost without exception an attorney can save money by using a full-service consulting firm such as MTI. Many of the time consuming services that you would be forced to pay top dollar for in order to have a doctor perform on his own can be done by professional researchers with a high level of expertise for much less money. Engaging MTI’s scientific professionals also ensures that you have more expertise available to make your case even stronger.

 7. Consultants always over-bill.

In general, this is as untrue as is the canard that attorneys always over-bill. Science is, as we noted above, expensive, and the amount billed by our doctors for legal cases involving scientific issues can be considerable. Consequently, it has been our experience that many experts actually bill fewer hours than the hours of work they actually perform out of a conscientious desire to hold costs down as much as possible. We seldom have to caution our doctors about putting in excessive hours for cases in which they serve as experts; more often than not we have to remind them to bill for all of the hours they work on the case, especially the MDs in private practice for whom time is at a premium.

 8. Real experts need ample trial experience to be effective.

This myth is often held by those who believe that university experts are superior to doctors who are in private practice. Here again, one needs to look beyond the superficial. When it comes to a case that involves scientific evidence, what is most important is having a seasoned expert, not necessarily a seasoned witness. Generally, it is more crucial that a legal case have an individual who is adept in his field and has been thoroughly prepared for the exigencies of the specific case. At MTI, our extensive experience with Science in the Courtroom allows us to prepare our experts thoroughly by providing them with the most up-to-date scientific information as it bears on the case and getting the experts ready for their testimony by consulting with them and the attorney frequently in the weeks, days, and even hours leading up to the trial.

 9. I want an expert from the same geographic location as the client; then I won’t have to pay exorbitant travel expenses.

With firms and attorneys trying to cut costs, this is a frequent assertion. However, it is shortsighted. First of all, this myth assumes the expert has to be present on a number of different occasions. With all of the new technologies, especially videoconferencing and taped depositions, there are ample opportunities to reduce travel costs and still avail yourself to high-level expert services. More importantly, however, the attorney who takes this position could be performing a grave disservice to the client in restricting expert options to only an in-state expert. Because of the collegial nature of the medical profession and the adversarial nature of the courtroom, medical doctors are frequently unwilling to testify against doctors from their state.

 10. I want one all around medical expert, so he can address a variety of issues.

This is an appropriate myth with which to conclude our examination of misconceptions about experts for it brings us back to where we began. Curiously, this request is often made by the same people who want an expert who does not have to research but "already knows everything." If "knowing everything" about just one narrow specialization is impossible, expecting an expert to have this facility about more than one subject of medicine and science or to be a modern day Leonardo Da Vinci is even more unrealistic. Requiring the expert to be a "jack of all scientific trades" does a disservice to the doctor and, ultimately, the client inasmuch as it spreads the expertise too thin to be of any real value for the case at hand.

U.S. Supreme Court justice Stephen Breyer, in the introduction to the second edition of The Reference Manual on Scientific Evidence, published by the Federal Judicial Center in 2000, wrote that the legal disputes that confront the highest court in the land "increasingly involve the principles and tools of science." Consequently, Justice Breyer added that "in this age of science, science should expect to find a warm welcome, perhaps a permanent home" in U.S. courtrooms. This, however, has not always proven to be the case, often as a result of the persistence of the above myths about Science in the Courtroom in general and about expert witnesses in particular. The discarded bones of arguments and testimony that have been disallowed by gatekeeper judges has littered the legal landscape in the eight years since the Daubert decision was handed down. If anything, the problem has only exacerbated itself since the Joiner (1997) and Kumho (1999) decisions which strengthened Daubert and provided judges with even more power in the exclusion of testimony which they deem to be "not even good enough to be wrong." The best defense to assure you that you will not fall victim to the evidentiary gatekeeper is to engage the services of a full-service medical and scientific information consulting firm. Not only will doing so improve the likelihood of your evidence being accepted, but you will also find that the sound science-grounded expertise a quality firm can bring to bear will make your case stronger. At Medical & Toxicological Information, we stand ready to help you with the sound science your complex cases require. We look forward to serving you.

SBS--House on Haunted Hill II   October 2003

It is that time of year when the air gets a bit of a chill and our thoughts begin turning to the cozy comfort of indoors. However, sometimes the comfort we hope to receive turns into medically unexplained symptoms of Sick Building Syndrome that can indeed haunt us forever. In October of 1999 you may recall our article entitled Sick Building Syndrome: House on Haunted Hill or Chicken Little Goes to Washington in which we covered some of the basics of this haunting syndrome. Since 1999 we believe much has happened in this area to warrant an update for our readers.

Sick Building Syndrome (SBS) is one of many syndromes that are defined largely on the basis of unexplained symptoms rather than specific medical signs. In fact, scientists are still trying to sort out and categorize the various syndromes such as SBS, chronic fatigue syndrome, multiple chemical sensitivity (MCS), Gulf War Syndrome, and the like. Some of these conditions overlap with explained conditions such as asthma, which often leads to sharp debate over the relationship of such symptoms and syndromes to environmental exposures. And yet in some areas such as toxic molds some progress has been made in linking the symptoms to the syndrome. For example, last year HR 5040 The United States Toxic Mold Safety and Protection Act (now HR 1268) was introduced in Congress, which may become law at some future date.

Of course, it is not only scientists that have difficulty identifying some of these syndromes; it is often even more difficult for attorneys to know if they have a real case of SBS. At MTI this is one of our specialty areas and by using sound science we can help our clients identify a legitimate case of SBS. Additionally, in our research occasionally we run across an article that goes beyond the medical jargon that we believe can be especially helpful to our attorney readers. One such article, Identifying and managing adverse environmental health effects: Taking an exposure history describes the issues involved in terms of the needs of physicians who are treating patients who complain of a myriad of symptoms and uses an example of an actual SBS case. This timely and informative article is available free online at http://www.cmaj.ca/cgi/content/full/166/8/1049.

After rereading our newsletter and this very helpful article we hope you will think of MTI for your next case involving SBS or any of the chemically -related syndromes. Our professional staff, made up of researchers, doctors, and scientists, is the absolute best and we have many years of experience in providing sound science to our attorney clients, regardless of which side of the toxic tort spectrum their case falls.

Contact us. We would like to hear from you!

 

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