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Styles of Judicial Opinion Writing

May 28th, 2013

Not Enough Original Words

You copy a little,
But not too much.
Some people say it’s degrading.

In Cojocaru v. British Columbia Women’s Hospital and Health Centre, the Supreme Court of Canada confronted an interesting question whether a litigant may challenge an adverse judgment on grounds that the trial judge plagiarized from the plaintiffs’ submissions. Cojocaru (May 24, 2013).

In this complex medical malpractice case, the trial court issued its written judgment in 368 paragraphs, of which only 47 were discernibly original. The overwhelming majority of the paragraphs, 321, were plagiarized from the plaintiffs’ submissions, without attribution. The Supreme Court agreed that this degree of plagiarism raises a serious question whether the trial judge’s judgment should be set aside as not a truly independent evaluation of the facts and law. Id. at para. 10-11.

The Court proceeded to note that trial court judgments are “entitled” to a presumption of integrity and impartiality. The defendants argued that any such presumption was vaporized by the “the extent of the copying, the quality of the copying, the lack of attribution for the copying, the nature of the case and the failure to fulfill the basic functions of reasons for judgment.” Id. at para. 52.

Although acknowledging that the trial court had copied over 87% of its judgment from the plaintiffs’ briefs, the Supreme Court held that the defendants had failed to rebut the presumption of judicial integrity and impartiality. Id. at para. 73. Judicial plagiarism is, according to the Supreme Court, “a longstanding and accepted practice.” Id. at para 30. The Court, however, acknowledged that excessive plagiarism “may raise problems.” Id.

The Supreme Court rejected the notion that judges should express themselves in their own language, and that their reasons should be their “original” work product. Id. at 31. Copying, according to the Court, does not mean that plagiarist judges have failed to think about and resolve the issues before them. Id.

The Court conceded that it was not “best practice for judges to bulk up their judgments with great swaths of borrowed material.” If the carried the copying to excess (presumably much greater than 87%), the copying “may raise problems.”

Rules and prohibitions against plagiarism do not apply to judges, say the Canadian Supreme Court judges. Id. at para. 32. According to the high court, lack of originality is a virtue in a system that depends upon precedent. “Judges are not selected, and are only rarely valued, because of their gift for original expression.” Id. (quoting, with attribution, thankfully, Simon Stern, “Copyright Originality and Judicial Originality” 63 Univ. Toronto L. J. 1 (2013)).

The Supreme Court cited precedential support of its judgment that judges are too busy to think and write in their own words. See id. at para. 37, 38 (citing English v. Emery Reimbold & Strick Ltd., [2002] EWCA Civ 605, [2002] 3 All E.R. 385 (holding that copying does not invalidate a court’s decision); id. at para. 41 (citing United States v. El Paso Natural Gas Co., 376 U.S. 651, 656 (1964) (noting that when trial judge “adopt[s] verbatim” the findings of fact submitted by counsel, “[t]hose findings, though not the product of the workings of the … judge’s mind, are formally his; they are not to be rejected out-of-hand, and they will stand if supported by evidence”).

The majority of the intermediate appellate court, the Court of Appeal, had held that the extent and nature of the plagiarism was “cogent evidence” of lack of the trial judge’s judicial integrity. Although the Supreme Court rejected the conclusion that the trial judge had failed to make an independent decision, the Supreme Court did display some original, independent thought in upholding the defendants’ assignments of error. The Supreme Court reversed the judgment for plaintiffs on the merits. Id. at para. 76.

Judicial Verbosity – Too Many Original Words

There is a tradition in New Jersey appellate cases to never issue a short, succinct opinion when a long one is at hand. Plaintiff Alison Rosenberg took Merck’s drug, Fosamax, for osteoperosis. After undergoing a tooth extraction, Rosenberg developed bone complications of her jaw. She claimed that she developed osteonecrosis of the jaw (ONJ), and that this condition was caused by her use of Fosamax, and by Merck’s negligent failure to warn that Fosamax causes ONJ. Rosenberg et al. v. Merck Sharp & Dohme Corp., No. A-5271-10T3, 2013 WL 1187916 (N.J. Super. Ct. App. Div. Mar. 25, 2013) (per curiam).

Merck defended and affirmatively sought to show that Rosenberg did not have ONJ. Its expert witness, Brent Ward, D.D.S., M.D., an expert in ONJ and in maxillofacial surgery, testified that Rosenberg suffered from osteomyelitis, not from ONJ.

At the end of the case, the trial judge instructed the jury to make findings:

“(1) whether plaintiff proved it was more likely than not that plaintiff had ONJ;

(2) whether plaintiff’s development of ONJ was a result of taking Fosamax; and

(3) whether Merck negligently failed to adequately warn about the risks of ONJ from Fosamax.”

The jury resolved the first question by finding that the plaintiff had not suffered from ONJ, and pursuant to the trial court’s instructions, ceased deliberations and notified the court of their final verdict, upon which judgment was entered. The jury thus never reached the questions about ONJ and Merck’s liability.

Rosenberg, et vir., appealed, contending that the trial judge erred in excluding evidence of Merck’s 2010 change in its warning label, which impeded her attempt to impeach Dr. Ward on the relationship between Fosamax and ONJ. The problem is that the excluded evidence was relevant only to an issue that the jury never reached. Somehow the New Jersey Appellate Division managed to draw out its per curiam opinion to eleven pages, in its own words.

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High, Higher, Highest Quality Research Act

May 25th, 2013

“The High Quality Research Act” (HQRA), which has not been formally introduced in Congress, continues to draw attention. See “Clowns to the left of me, Jokers to the right.” Last week, Nature published an editorial piece suggesting that the HQRA is not much of a threat. Daniel Sarewitz, “Pure hype of pure research helps no one, ” 497 Nature 411 (2013).

Sarewitz suggests that “the problem” is the hype about the benefits of pure research and the let down that results from the realization that scientific progress is “often halting and incremental,” with much research not “particularly innovative or valuable.” Fair enough, but why is this Congress such an unsophisticated consumer of scientific research in the 21st century? How can it be a surprise that the scientific community engages in the same rent-seeking behaviors as do other segments of our society? Has it escaped Congress’s attention that scientists are subject to enthusiasms and group think, just like, … congressmen?

Still, Sarewitz believes that the HQRA bill is not particularly threatening to the funding of science:

“In other words, it’s not a very good bill, but neither is it much of a threat. In fact, it’s just the latest skirmish in a long-running battle for political control over publicly funded science — one fought since at least 1947, when President Truman vetoed the first bill to create the NSF because it didn’t include strong enough lines of political accountability.”

This sanguine evaluation misses the effect of the superlatives in the criteria for National Science Foundation funding:

“(1) is in the interests of the United States to advance the national health, prosperity, or welfare, and to secure the national defense by promoting the progress of science;

(2) is the finest quality, is ground breaking, and answers questions or solves problems that are of utmost importance to society at large; and

(3) is not duplicative of other research projects being funded by the Foundation or other Federal science agencies.”

HQRA Section 2(a) – (c). These superlatives set up most research proposals to fail because of the scientific community’s inability to predict in advance which studies will be truly “ground breaking” and will “answer questions .. that are of utmost importance….” Congressmen will thus be able selectively to target research grants to embarrass the NSF Director in public hearings. The Director will hardly be able to defend a particular grant with the assertion that, “well, we have many other grants that are also very fine, although not of the “finest quality”; we have other grants that are really important to society, but also not of the “utmost” importance.

Certainly, there is a good deal of wasted research funding, on grants that are frivolous. Directing funding to worthwhile research is not an easy task, but it almost certainly beyond the ken of congressional committees.

What the HQRA attempts to set up is not another layer of peer review by the NSF Director, but by Congress itself, with a line-item veto for research that offends particular Congressional sensibilities. Sarewitz is naive to believe that this bill poses little threat or change to the funding of science in the United States. The HQRA is a particularly serious threat, not to NSF funding of scientific research, but to the selection of grants that to be funded.

Congress should be looking at the NSF budget for waste, but the best way to ensure that the NSF triages funding of truly important research is to limit the funds appropriated. Contrary to the current wisdom, neither right nor left has a monopoly on stupidity when it comes to science. The history of federal funding of alternative medicine in this country (e.g., National Center for Complementary and Alternative Medicine (NCCAM), and previously the Office of Alternative Medicine.) illustrates all too well how ideological funding and Congressional “oversight” works. See, e.g., Eric Boyle, “The Politics of Alternative Medicine at the National Institutes of Health,” Federal History online 16 (2011).

Posted in Scientific Evidence | Comments Off on High, Higher, Highest Quality Research Act

Two Schools of Thought

May 25th, 2013

In litigation of claims of professional malpractice, the “two schools of thought doctrine” is a complete defense. Jones v. Chidester, 531 Pa. 31, 40, 610 A.2d 964 (1992).

As explained by the Pennsylvania Supreme Court, physicians may defend against claims that they deviated from the standard of care, or of professional malpractice, by adverting to support for their treatment by a minority of professionals in their field:

“Where competent medical authority is divided, a physician will not be held responsible if in the exercise of his judgment he followed a course of treatment advocated by a considerable number of recognized and respected professionals in his given area of expertise.”

Id. at 40. See also Fallon v. Loree, 525 N.Y.S.2d 93, 93 (N.Y. App. Div. 1988) (“one of several acceptable techniques”); Dailey, “The Two Schools of Thought and Informed Consent Doctrine in Pennsylvania,” 98 Dickenson L. Rev. 713 (1994); Douglas Brown, “Panacea or Pandora’ Box: The Two Schools of Medical Thought Doctrine after Jones v. Chidester,” 44 J. Urban & Contemp. Law 223 (1993).

Perhaps the two schools doctrine is an interesting anomaly that harkens back to a legal epistemology founded in authority rather than evidence. In the law of expert witnesses, the criterion for admissibility of opinion has shifted from “general acceptance” to epistemic warrant, but malpractice law still allows custom and practice to dictate the standard of care. The two schools doctrine ameliorates the practice of basing standard of care on authoritative, non-evidence based practices and opinions. If standards of care were truly evidence based, then there might still be situations in which the available evidence was inconclusive between two approaches to patient care. In situations of inconclusive evidence between two approaches, the two schools doctrine would provide a defense.

Products Liability

In products liability cases, failure-to-warn theories are often predicated upon claims that defendants should have known of a risk of harm posed by their products. Plaintiffs will cite past pronouncements made by authors as evidence that the harm was “known” to others, and thus the defendants should have known of the harm, and thus should have warned about the harm. This species of claiming often takes place, however, without any analysis whether the past pronouncements were made with good and adequate scientific bases.

If products liability law persists in treating past, putative knowledge uncritically, then it should, at least, allow defendants to defend on the ground that there were contrary pronouncements made. Juries should be told that the existence of contrary pronouncements from a respectable minority of writers is a complete defense. The two schools of thought doctrine should thus be given wider play in tort law than just professional malpractice. Products liability should honor the basic underlying principle of malpractice law that the opinions of even a respected minority of experts fully answers the claim of negligence. The existence of the contrary opinions should bar punitive damage claims altogether.

Consider what happens in the typical failure to warn case. The plaintiff goes trash picking through the dustbin of medical history to find some prescient writer who argued that the product in question causes disease. Defendant points to other authors who disputed the relationship. The court instructs the jury that they may find defendant negligent for failing to warn if they believe the plaintiffs’ evidence. The jury makes its decision, thoroughly infected with hindsight bias.

This scenario is unsatisfactory and unduly restrictive. Applying the two schools of thought doctrine, the court should instruct the jury to find for the plaintiff only if there was not a considerable number of recognized and respected professionals and experts, who had opined that the product caused the specific injury in question. The existence of such a minority should defeat claims for punitive damages as a matter of law.

United States v. Harkonen

On May 7, 2013, the Ninth Circuit of the United States Court of Appeals denied, Dr. Harkonen’s petition for rehearing in United States v. Harkonen. No data or analyses were false or fabricated in the Harkonen case. The government’s prosecution was predicated on a statistical orthodoxy that is opposed by a large number of recognized and respected statisticians. This fact would have been a complete defense to a claim of professional negligence. The two schools doctrine should completely bar a prosecution for fraud.

Remarkably, expert witnesses commonly testify to causal associations on lesser evidence than Dr. Harkonen relied upon in a press release for his judgment of causal efficacy, but the trial court believed the jury could infer scienter and falsity from conversations between an “orthodox” statistician and Dr. Harkonen about the propriety of drawing a casual inference from a given dataset.

Perhaps civil litigants should start counterclaiming for fraud when they receive expert witness reports.

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Asbestos Litigation Blues

May 22nd, 2013

Mr. Curtis Geatz alleges that he has mesothelioma as a result of asbestos exposure, including exposure to crocidolite from having smoked Kent Micronite filtered cigarettes for nine months, in 1955-56. Geatz v. Benjamin Moore & Co., File No. 62CV124946, Minn. D. Ct. for Ramsey Cty. (2d Jud. Dist.). See “Lorillard Executive Admits Asbestos Once Included in Kent Filters” (April 23, 2013) (misleadingly suggesting that testimony about filter content was something other than very old news).

Crocidolite is clearly the most potent cause of mesothelioma. In a published cohort study of workers at Hollingsworth & Vose, a company that made the filters for the Kent cigarette, over 15 percent of all deaths were due to mesothelioma. James Talcott, et al., “Asbestos-Associated Diseases in a Cohort of Cigarette-Filter Workers,” 321 New Engl. J. Med. 1220 (1989).

Despite the high potency of crocidolite in causing mesothelioma, the late Irving Selikoff worked hard to advance his opinion that all asbestos fiber types were comparable. Selikoff also propagandized the view that crocidolite was not widely used in the United States, although he and his colleagues documented the use of “blue” fiber at Johns-Manville factories in the United States. See “Selikoff and the Mystery of the Disappearing Amphiboles” (Dec. 10, 2010).

In Mr. Geatz’s case, Lorillard moved for summary judgment on grounds that crocidolite fibers in the cigarettes plaintiff smoked were not a substantial contributing factor of his mesothelioma. The trial court denied Lorillard’s motion, apparently on the strength of unidentified exhibits attached to an attorney affidavit (Tiffany Dickenson).

Mr. Geatz’ claim is not implausible on its face, but the trial court’s refusal of Lorillard’s motion for summary judgment is a conclusory black box. It may be right or wrong, but it fails to describe the defendant’s evidence or arguments as to why potent crocidolite in the Kent filter could not have been a substantial factor, or the plaintiffs’ evidence as to why the jury should be allowed to say otherwise. Lorillard may have argued that the fibers did not leave the filter, or that the exposure would have been too low, even to the extremely potent crocidolite fiber. Apparently there was no threshold issue of admissibility of each side’s expert witnesses, but still, the scientific issues, the plaintiffs, and the defendants deserve some explanation of the court’s decision.

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As They WOE, So No Recovery Have the Reeps

May 22nd, 2013

Late last year, Justice York excluded Dr. Shira Kramer’s WOE-ful opinion that gasoline fumes from an alleged fuel-line leak caused Sean Reep to be born with cerebral palsy. Reeps v. BMW of North America, LLC, 2012 NY Slip Op 33030(U), N.Y.S.Ct., Index No. 100725/08 (New York Cty. Dec. 21, 2012) (York, J.). Kramer’s opinion was a parody of science, pieced together from case reports, animal studies, and epidemiologic studies that looked at exposures utterly unlike that of Mrs. Reep’s exposure.

Justice York saw through the charade. The animal studies were largely exonerative. The case reports were of birth defects quite different from those sustained by Sean Reeps. The epidemiologic studies were of different chemicals or chemicals at levels very different from those experienced by Mrs. Reeps. Plaintiffs’ expert witnesses ignored established principles of teratology in claiming late-term birth defects to have been causally related to early term exposures. Plaintiffs’ expert witnesses gave a convincing presentation of how not to do science, and why judicial gatekeeping is necessary. See “New York Breathes Life into Frye Standard – Reeps v. BMW” (Mar. 5, 2013).

Justice York clearly articulated that the “plaintiff’s burden to prove the methodology applied to reach the conclusions will not be rejected by specialists in the field.” Reeps, slip op. at 11. The trial court recognized that under the New York state version of Frye, the court must determine whether plaintiffs’ expert witnesses are faithfully applying a methodology, such as the Bradford Hill criteria, or whether they are they are “pay[ing] lip service to them while pursuing a completely different enterprise.” Id. Justice York recognized that the court must examine a proffered opinion to determine whether it “properly relates existing data, studies or literature to the plaintiff’s situation, or whether, instead, it is connected to existing data only by the ipse dixit of the expert.” Id. (internal quotations omitted).

Plaintiffs were unhappy with Justice York’s decision, and their counsel moved for reconsideration, positing only 15 supposed errors or misunderstandings in the opinion. On May 10, the trial court denied the motion for reconsideration and further explicated the scientific deficiencies of plaintiffs’ witnesses’ opinions.

The trial court was unimpressed:

“In general, attorney for plaintiffs misrepresents the substance of this court’s Decision. The court did not prefer conclusions of defendants’ experts to that of plaintiffs – disagreement among experts is to be expected, since causation analysis involves professional judgment in interpreting data and literature. An expert opinion is precluded when it is reached in violation of generally accepted scientific principles. The court determined that Drs. Kramer and Frazier did not follow generally accepted scientific methodology.”

Reeps, 2013 NY Slip Op 31055(U) at 2 (Opinion on Motions to Reargue, to Renew, and for Oral Hearing) (May 10, 2013).

The court noted that the plaintiffs’ witnesses’ novel claim that low-level gasoline vapor inhalation causes birth defects, a claim that had escaped the attention of all other scientists and regulatory agencies, cried out for judicial intervention. Id. at 3.

The court also rebuffed the claim that plaintiffs’ witnesses, Shira Kramer and Linda Frazier, had followed the Bradford Hill guidelines:

“These guidelines are employed only after a study finds an association to determine whether that association reflects a true causal relationship.”

Id. at 5 (quoting Federal Judicial Center, National Research Council, Reference Manual on Scientific Evidence at 598-599 (3d ed. 2011)) (emphasis in the original). Kramer and Frazier never got off the dime with the Bradford Hill guidelines.

In considering the plaintiffs’ motions, the trial court also had occasion to revisit the assertion that “weight of the evidence” (WOE) substituted for, or counted as, a scientific basis for a conclusion of causality:

“The metaphorical use of the term is, if nothing else, ‘a colorful way to say the body of evidence we have examined and judged using a method we have not described but could be more or less inferred from a careful between-the-lines reading of our paper’.”

Id. at 5 (quoting Douglas Weed, “Weight of Evidence: A Review of Concept and Methods,” 25 Risk Analysis 1545, 1546-47 (2005).

Unmoved by the sophistical hand waving, the court emphasized that Kramer and Frazier had confused “suggestive” evidence with “conclusions,” and they had misrepresented the meaning and significance of threshold limit values. All in all, a convincing demonstration of the need for, and the judicial competence to carry out, gatekeeping of expert witness opinion testimony.

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Where Are They Now? Marc Lappé and the Missing Data

May 19th, 2013

The recrudescence of silicone “science” made me wonder where some of the major players in the silicone litigation are today. Some of the plaintiffs’ expert witnesses were characters who gave the litigation “atmosphere.”

Marc Alan Lappé was an experimental pathologist, who testified frequently for plaintiffs in toxic exposure cases. He founded an organization, The Center for Ethics & Toxics (CETOS), to serve as platform for his advocacy activities. Lappé was a new-age scientist, and an author of popular books on toxic everything: Chemical Deception: The Toxic Threat to Health and the Environment, and Against the Grain: Biotechnology and the Corporate Takeover of Your Food. When the silicone-gel breast implant litigation went viral, or immunologic, Lappé was embraced by the silicone sisters and their lawyers as one of their leading immunology guys. Lappé, a revolutionary, obliged and produced another pop science classic: Marc Lappé, The Tao Of Immunology: A Revolutionary New Understanding Of Our Body’s Defenses (1997).

Lappé jumped in to the silicone litigation early. He supported autoimmune claims, as well as the dubious claim that polyurethane-covered breast implants caused or accelerated breast cancer. Livshits v. Natural Y Surgical Specialties, Inc., 1991 WL 261770 (S.D.N.Y. Nov. 27, 1991). In depositions and in trial testimony, Lappé was combative and evasive, but when he wanted to be clear, he could be clear enough:

“It’s my opinion that silicone directly or indirectly can precipitate an activated immune state in such women that can lead to an autoimmune condition.”

Lappé Dep. 44:19-22 (Aug. 21, 1995), in Roden v. Medical Engineering Corp., No. 94-02-103, in District Court of Wise County, Texas, 271st Judicial District.

Plaintiffs also offered Lappé as an ethicist, in what was an obvious attempt to turn personal injury cases into passion plays and to raise the emotional temperature of the court rooms. Plaintiffs were able to get away with such nonsense in some state court cases, but the federal judges generally would not abide expert witnesses on ethics. See, e.g., Switzer v. McGhan Medical Corp., CV 94-P-14229-S, Transcript at 96-98, N.D. Ala. (Jan. 4, 1996) (Pointer, J.) (noting that Lappé would not be permitted to testify that the defendant’s conduct was unethical or unconscionable). Ironically, Lappé would become ensnared by an article, the publication of which was surrounded in ethical controversy.

Although Lappé had some experience in experimental immunology, he had no background in silicone. Undaunted, he set about to publish a work of science fiction. Marc Lappé, “Silicone-reactive disorder: a new autoimmune disease caused by immunostimulation and superantigens,” 41 Medical Hypotheses 348 (1993). Lappé went on to find some researchers with whom he could join forces, and in 1993, he and his co-authors published an article based upon what was ostensibly bench research on silicone immunology. Alas, Lappé did not really know the other authors, who were pitching their immunological screening test to plaintiffs’ support groups and to plaintiffs’ lawyers. Lappé signed up as a co-author without knowing the authors’ marketing plan, and without ever having seen the underlying data and statistical analyses. Given his credentials as a bioethicist, the lapse was remarkable. Lappé learned only through his involvement as an expert witness that his coauthors had been warned by the Food and Drug Administration about unlawful marketing of their “test,” and that some of his co-authors were involved in litigation against Bristol-Myers Squibb. Although the article was clearly intended to support both the marketing of the test, the litigation that would have benefited his coauthors directly, as well as Lappé’s testimonial adventures, the article contained no conflict of interest disclosures. Laurence Wolf, Marc Lappé, Robert Peterson, and Edward Ezrailson, “Human immune response to polydimethylsiloxane (silicone): screening studies in a breast implant population,” 7 Faseb J. 1265 (1993).

Lappé was an advocate, but he was not stupid. The late Chuck Walsh took some of Lappé’s early depositions in the breast implant litigation, and pressed him on whether he had seen or had access to the underlying data. Lappé Dep. Roden at 94:4 -21 (Aug. 21, 1995). Lappé also acknowledged that he had been unaware that the data presented in the published paper was truncated from the data originally obtained in the study. Id. at 108:19 – 109:7. Lappé bristled, as well he should, at these challenges to his ethical bona fides. He apparently requested the underlying data on more than one occasion, but his colleagues would not share the data with him:

Question: I want to ask you, did you ever get the basic raw data?

Answer: That was asked and answered as recently as three weeks ago. And the same answer applies today: No. I had asked for it. It was not give[n] to me. I have asked for it again. It’s not been given to me.

Lappé Dep. at 172:9-14 (Mar. 21, 1996), in Wolf v. Surgitek, Inc., No. 92-60186, 113th Judicial District, District Court of Harris County, Texas.

In early 1998, before Judge Pointer’s neutral expert witnesses delivered their reports in the multi-district proceedings, I traveled to Gualala, California, to take Lappé’s deposition in Page v. Bristol-Myers Squibb Co., No. JCCP-2754-03740, California Superior Court, County of San Diego (Jan. 19, 1998). I recall the little coastal town of Gualala well. The hotel, restaurant, and even the deposition room were infested with fruit flies, no doubt because pesticides were banned under Lappé’s influence. When I asked Lappé whether he had changed his views in any way, he gracefully backed away from his previous testimony:

“I believe that the current evidence, the weight of evidence suggests that the antibodies that are formed in women, perhaps in excess of their background levels for IGG antibody, may not have a specificity towards silicone itself as an antigen but may bind preferentially to silicone and therefore given nonspecific binding results such as those as the Emerald Labs detected in their plate bioassay. I think their evidence does not presently weigh in favor of considering silicone by itself as an antigen.”

Lappé Dep. Wolf at 100: 5-18. Later that year, 1998, Tim Pratt extracted further concessions from Lappé, in a Mississippi case. Lappé acknowledged that the MDL court’s neutral expert witnesses had done a “reasonably good job,” and that he agreed with them that there was not consistent evidence to support the claim that silicone caused autoimmune disease. Lappé Dep. at 26:1-9 (Dec. 17, 1998), in Brassell v. Medical Engineering Corp., Case No. 251-96-1074 CIV, Hinds County Circuit Court, Mississippi.

The litigation faded away, and so did Lappé. He died in 2005. Douglas Martin, “Marc Lappé, 62, Dies; Fought Against Chemical Perils,” N.Y. Times (May 21, 2005). Few other expert witnesses for silicone plaintiffs had the intellectual integrity to confess error. I hope he has found his missing data.

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Biopersistant Silicone

May 18th, 2013

From the late 1980’s until the late 1990’s, a cadre of public health zealots waged war against various silicone medical devices, but especially against silicone gel breast implants. Their charge was that silicone degraded in vivo to silica, and that it caused autoimmune disease. Their supposed method: weight of the evidence.

I recall sitting next to Professor Carl Cranor at a meeting in Washington, D.C. When the subject of silicone gel breast implants came up, he started trash talking the exonerative epidemiology. When I introduced myself and told him that I represented one of the defendants in that litigation, he got up and moved. Thankfully.

In 1999, the Institute of Medicine issued its consensus report that debunked the plaintiffs’ attempts to draw a causal connection between silicone and autoimmune disease. Stuart Bondurant, et al., Safety of Silicone Breast Implants (1999). The phrases “weight of the evidence” or “weight of evidence” are never mentioned in the report, over 500 pages long.

Recently, the silicone plaintiffs’ causal theory has resurfaced. There has been no new important evidence, but with the scientific community’s attention drawn elsewhere, some old zealots and some new have wandered back into the field to recycle the claims and hypotheses that consumed lawyers and scientists in the last century.

Last year saw a review by Yehuda Shoenfeld and his Israeli colleagues, who describe a “new” syndrome that manifests with various immune-system disturbances. These authors call their syndrome ASIA (autoimmune syndrome induced by adjuvant). M. Lidar, N. Agmon-Levin, P. Langevitz, and Y. Shoenfeld, “Silicone and scleroderma revisited,” 21 Lupus 121 (2012).

Shoenfeld, who has dabbled with this theory for 20 years, acknowledges that the epidemiologic studies fail to support the ASIA notion. Despite the lack of support from controlled, observational studies, these authors proceed to describe “the mechanisms by which silicone may mediate autoimmunity in general, as well as the evidence for causal associations with more specific autoimmune syndromes in general, and scleroderma in particular.” Id. at 121.

Last month, an article was published online with a collection of case reports from the Netherlands. Jan Tervaert & R. M. Kappel, “Silicone implant incompatibility syndrome (SIIS):A frequent cause of ASIA (Shoenfeld’s syndrome),” 56 Immunologic Research (2013), published online, April 2013. The authors employ Shoenfeld’s criteria for ASIA, and postulate a causal relationship between silicone implants and the syndrome in 32 cases.

This month, the assault has stepped up. Yehuda Shoenfeld, “Video Q&A: what is ASIA? An interview with Yehuda Shoenfeld,” 11 BMC Medicine 118 (2013). The video of Dr. Shoenfeld is also available for those who may find it hard to believe that article has found its way into print.

Silicone. It never goes away.

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IARC and Cranor’s Apologetics for Flawed and Fallacious Science

May 13th, 2013

In his recent contribution to the Center for Progressive Reform’s symposium on the Milward case, Professor Cranor suggests that the International Agency for Research on Cancer (IARC) uses weight of the evidence (WOE) in its carcinogenicity determinations. See Carl F. Cranor, “Milward v. Acuity Specialty Products: Advances in General Causation Testimony in Toxic Tort Litigation,” PDF 3 Wake Forest J. L. & Policy 105 (2013)[hereinafter cited as Cranor] Cranor’s suggestion is demonstrably wrong.

The IARC process is described in several places, but the definitive presentation of the IARC’s goals and methods is set out in a document known as the “Preamble.” World Health Organization, IARC Monographs on the Evaluation of Carcinogenic Risks to Humans — Preamble (2006) [cited herein as Preamble]. There is no mention of WOE in the Preamble.

The IARC process consists upon assessments of carcinogenicity of substances or exposure circumstances, and categorization into specified groups:

IARC Category	Verbal Description	IARC “Findings”
Group 1	[Known] Carcinogenic to humans	111
Group 2A	Probably carcinogenic to humans	65
Group 2B	Possibly carcinogenic to humans	274
Group 3	Not classifiable as to its carcinogenicity to humans	504
Group 4	Probably not carcinogenic to humans	1

The IARC operative definitions that a substance to a category are highly stylized and unique to IARC. The definitions do not coincide with ordinary language definitions or general scientific usage. Only one substance is categorized as “probably not carcinogenic to humans” is Caprolactam.

Alas, oxygen, nitrogen, carbon dioxide, sugar, table salt, water, and many other exposures we all experience, and even require, do not make it to “probably not carcinogenic.” This fact should clue in the casual reader that the IARC classifications are greatly influenced by the precautionary principle. There is nothing wrong with this influence, as long as we realize that IARC categorizations do not necessarily line up with scientific determinations.

Cranor attempts to exploit IARC classifications and their verbiage, but in doing so he misrepresents the IARC enterprise. For instance, his paper for the CPR symposium strongly suggests that a case involving a Group 2A carcinogen would necessarily satisfy the preponderance of evidence standard common in civil cases because the IARC denominates the substance or exposure circumstance as “probably carcinogenic to humans.” This suggestion is wrong because of the technical, non-ordinary language meanings given to “probably” and “known.” The IARC terminology involves a good bit of epistemic inflation. Consider first what it means for something to be “probably” a carcinogen:

“Group 2.

This category includes agents for which, at one extreme, the degree of evidence of carcinogenicity in humans is almost sufficient, as well as those for which, at the other extreme, there are no human data but for which there is evidence of carcinogenicity in experimental animals. Agents are assigned to either Group 2A (probably carcinogenic to humans) or Group 2B (possibly carcinogenic to humans) on the basis of epidemiological and experimental evidence of carcinogenicity and mechanistic and other relevant data. The terms probably carcinogenic and possibly carcinogenic have no quantitative significance and are used simply as descriptors of different levels of evidence of human carcinogenicity, with probably carcinogenic signifying a higher level of evidence than possibly carcinogenic.”

Preamble at 22, § 6(d). So probably does not mean “more likely than not,” and “possibly” means something even less than some unspecified level of probability. An IARC classification of 2A will not help a plaintiff reach the jury because it does not connote more likely than not.

A category I finding is usually described as a “known” carcinogen, but the reality is that there may still be a good deal of epistemic uncertainty over the classification:

“Group 1: The agent is carcinogenic to humans.

This category is used when there is sufficient evidence of carcinogenicity in humans. Exceptionally, an agent may be placed in this category when evidence of carcinogenicity in humans is less than sufficient but there is sufficient evidence of carcinogenicity in experimental animals and strong evidence in exposed humans that the agent acts through a relevant mechanism of carcinogenicity.”

Preamble at 22, § 6(d).

Again, the precautionary nature of the categorization should be obvious. Knowledge of carcinogenicity is equated to sufficient evidence, which leaves open whether there is a body of contradictory evidence. The IARC’s definition of “sufficiency” does place some limits on what may affirmatively count as “sufficient” evidence:

“Sufficient evidence of carcinogenicity: The Working Group considers that a causal relationship has been established between exposure to the agent and human cancer. That is, a positive relationship has been observed between the exposure and cancer in studies in which chance, bias and confounding could be ruled out with reasonable confidence. A statement that there is sufficient evidence is followed by a separate sentence that identifies the target organ(s) or tissue(s) where an increased risk of cancer was observed in humans. Identification of a specific target organ or tissue does not preclude the possibility that the agent may cause cancer at other sites.”

Preamble (2006), at 19, § 6(a). This definition hardly helps Cranor in his attempt to defend bad science. Scientists may reasonably disagree over what is sufficient evidence, but the IARC requires, at a minimum, that “chance, bias and confounding could be ruled out with reasonable confidence.” Id. Ruling out chance, of course, introduces considerations of statistical significance, multiple comparisons, and the like. Ruling out bias and confounding with confidence is an essential part of the IARC categorization process, just as it is an essential part of the scientific process. Reviewing the relied upon studies for whether they ruled out chance, bias, and confounding, was precisely what the Supreme Court did in General Electric v. Joiner, and what the current statute, Federal Rule of Evidence 702, now requires. Failing to review the extant epidemiologic studies for their ability to rule out chance, bias, and confounding is exactly what the district court judge did in Milward.

IARC and Conflicts of Interest – Nemo iudex in causa sua

Holding out the IARC process as exemplifying scientific method involves other controversial aspects of the process. IARC’s classifications are determined by “working groups” that review the available scientific literature on an agent’s carcinogenicity. Members of these of groups are selected in part because they have “have published significant research related to the carcinogenicity of the agents being reviewed… .” Preamble at 5. See also Vincent Cogliano, Robert A. Baan, Kurt Straif, et al., “The science and practice of carcinogen identification and evaluation,” 112 Envt’l Health Persp. 1269, 1273 (2004).

While the IARC tries hard to avoid apparent financial conflicts of interest, its approach to selecting voting members of the working groups invites a more pervasive, more corrupting influence: working group members must vote on the validity of their own research. The prestige of their own research will thus be directly affected by the group’s vote, as well as by the analysis in the resulting IARC monograph. Many writers have criticized this approach. See, e.g., Paolo Boffetta, Joseph McLaughlin, Carlo La Vecchia, Robert Tarone, Loren Lipworth, and William Blot, “A further plea for adherence to the principles underlying science in general and the epidemiologic enterprise in particular,” 38 Internat’l J. Epidemiol. 678 (2009); Michael Hauptmann & Cecile Ronckers, “A further plea for adherence to the principles underlying science in general and the epidemiologic enterprise in particular,” 39 Internat’l J. Epidemiol. 1677 (2010).

Notably absent from Cranor’s defense of using bad science and incomplete evidence is his disregard of systematic reviews and meta-analysis. Although “agency” science is a weak shadow of the real thing, even federal agencies have come to see the importance of using principles of systematic reviews in their assessments of science for policy purposes. See, e.g., FDA, Guidance for industry evidence-based review system for the scientific evaluation of health claims (2009). Currently underway at the National Toxicology Program’s Office of Health Assessment and Translation (OHAT) is an effort to implement systematic review methodology in the Program’s assessments of potential human health hazards. That the NTP is only now articulating an OHAT Evaluation Process, incorporating principles of systematic review, suggests that something less rigorous has been used previously. See Federal Register Notice , 78 Fed. Reg. 37 (Feb. 25, 2013).

No one should be fooled by Cranor’s attempt to pass off precautionary judgments as scientific determinations of causality.

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Cranor’s Defense of Milward at the CPR’s Celebration

May 12th, 2013

THE RISE OF THE UBER-EXPERT

One of the curious aspects of the First Circuit’s decision in Milward was the court’s willingness to tolerate a so-called weight of the evidence (WOE) assessment of a causal issue by toxicologist Martyn Smith, when much of the key evidence did not involve toxicology. In defending WOE, Professor Cranor argues that scientists (such as those in an International Agency for Research on Cancer (IARC) working group) evaluate evidence from different lines of research into a single, evaluative judgment of the likelihood of causation. The lines of evidence may involve animal toxicology, cell biology, epidemiology or other disciplines:

“In drawing conclusions from the data to a theory or explanation, it is necessary for scientists to evaluate the quality of different lines of evidence, to integrate them and to assess what conclusion the lines of evidence most likely supports and how well they do so in comparison with alternative explanations.”

See Carl F. Cranor, “Milward v. Acuity Specialty Products: Advances in General Causation Testimony in Toxic Tort Litigation,” PDF 3 Wake Forest J. L. & Policy 105, 117 (2013)[hereinafter cited as Cranor].

Presumably, the scientists will come to the table with the training, experience, and expertise appropriate to their discipline. The curious aspect of Cranor’s defense is that Martyn Smith’s expertise did not encompass many of the lines of research advanced, in particular, the epidemiologic. Of course, in the real world of science, the assessment of the “lines” of evidence is conducted by scientists from the different, relevant disciplines. In the make-believe world of courtroom science, the collaboration breaks down when a single expert witness, such as Smith, offers opinions outside his real expertise. Because the law is not particularly demanding with respect to the extent and scope of expertise, Smith was able to hold forth not only on animal experiments, but on human epidemiologic studies. The defense was able to show that Smith disregarded basic principles of epidemiology, but the First Circuit agreed with Cranor, that consideration of Smith’s disregard should be kicked down the road, to the jury for its consideration.

As a practical matter, in today’s world of highly specialized scientific disciplines, it is simply not possible for an expert witness to address evidence from all the fields needed to evaluate the multiple lines of evidence relevant to a causal issues. We should rightfully be skeptical of a single expert witness who claims the ability to weigh disparate lines of evidence to synthesize a judgment of causation. Of course, this is how science is practiced in a courtroom, not in a university.

REJECTION OF EVIDENCE HIERARCHY

Another salient feature of Cranor’s argument is his insistence that there is no hierarchy of evidence. Cranor’s argument is ambiguous between rejecting a hierarchy of disciplines or a hierarchy within epidemiology itself . Cranor never actually argues directly for a leveling of all types of epidemiologic studies, and as we will see, his one key citation (repeated three times) is for the hierarchy of disciplines: epidemiology, molecular biology, genetics, pathology, and the like.

Clearly there are instances of causation determined without epidemiology. The Henle-Koch postulates after all were developed to assess causation by infection biological organisms. And in some instances, very suggestive evidence of viral causes of cancer has been attained before confirming epidemiologic evidence. If there is a meaningful population attributable risk, however, epidemiology should be able to confirm the suspicions of virology or molecular biology.

Cranor repeatedly cites a meeting report of a workshop held in Washington, D.C., in 2003. See also Michael Green, Michal Freedman, and Leon Gordis, “Reference Guide on Epidemiology,” in Reference Manual on Scientific Evidence 549, 564 (3d ed. 2011) (citing same meeting report). Cranor’s citations and quotations misleadingly suggest that the report was an official function of the National Cancer Institute (NCI), and that the published report was an official pronouncement of the NCI. Neither suggestion is true.

Cranor praises the Circuit’s Milward decision for adopting his argument and citing the meeting report for his claim that there is no hierarchy of evidence:

“Citing National Cancer Institute scientists, [the Circuit] also added that “[t]here should be no such hierarchy” of evidence for carcinogenicity as between epidemiological and some other kinds of evidence.¹⁰⁰ These scientists and many distinguished scientific committees would not require epidemiological studies to support claims that a substance can cause adverse effects in humans or place certain other a priori constraints on evidence.¹⁰¹”

Cranor at 119 (citing Milward, at 17, citing Michele Carbone, et al., Modern Criteria to Establish Human Cancer Etiology, 64 Cancer Research 5518, 5522 (2004)).

Given the emphasis that Cranor places upon the Carbone article, it is worth taking a close look. Carbone’s article was styled “Meeting Report.” See also Michelle Carbone, Jack Gruber, and May Wong, “Modern criteria to establish human cancer etiology,” 14 Semin. Cancer Biol. 397 (2004). The article was a report of a workshop, not an official NCI publication. The NCI hosted the meeting; the meeting was not sponsored by the NCI, and the published meeting report was not an official statement of the NCI. Notably, the report appeared in Cancer Research as a paid advertisement, not in the Journal of the National Cancer Institute as a scholarly article.

In assessing the citation, readers should consider the authors of the meeting report. Importantly, the discipline of epidemiology was not strongly represented; most of the chairpersons and scientists in attendance were pathologists, cell biologists, virologists, and toxicologists. The authors of the meeting report reflect the interests and focus of the scientists in attendance. The lead author was Michele Carbone, a pathologist at Loyola University Chicago. Some may recognize Carbone as one of the proponents of Simian Virus 40 as a cause of mesothelioma, a hypothesis that has not fared terribly well in the crucible of epidemiologic science. Other authors included:

George Klein, with the Microbiology and Tumor Biology Center, Karolinska Institute, in Stockholm,

Jack Gruber, a virologist with the Cancer Etiology Branch of the NCI, and

May Wong, a biochemist, with the NCI.

The basis of the citation to Carbone’s meeting report is an informal discussion session that took place at the meeting. Those in attendance broke out into two groups, one chaired by Brook Mossman, a pathologist, and the other group chaired by Dr. Harald zur Hausen, a famous virologist who discovered the causal relationship between human papilloma virus and cervical cancer.

The meeting report included a narrative of how the two groups responded to twelve questions. Cranor’s citation to this article is based upon one sentence in Carbone’s report, about one of twelve questions:

“6. What is the hierarchy of state-of-the-art approaches needed for confirmation criteria, and which bioassays are critical for decisions: epidemiology, animal testing, cell culture, genomics, and so forth?

There should be no such hierarchy. Epidemiology, animal, tissue culture and molecular pathology should be seen as integrating evidences in the determination of human carcinogenicity.”

Carbone at 5522. Considering the fuller context of the meeting and this report, there is nothing particularly surprising about this statement. It is not clear that the full question and answer even remotely supports the weight that Cranor places upon it. Clearly, Cranor’s quotations are unduly selective. For instance, Cranor does not discuss the disagreement among those in attendance over criteria for different carcinogens:

“2. Should the criteria be the same for different agents (viruses, chemicals, physical agents, promoting agents versus initiating DNA-damaging agents)?

There were different opinions. Group 1 debated this issue and concluded that the current listing of criteria should remain the same because we lack sufficient evidence to develop a separate classification. Group 2 strongly supported the view that it is useful to separate the biological or infectious agents from chemical and physical carcinogens due to their frequently entirely different mode of action.”

Carbone at 5521.

Perhaps Cranor did not think a legal audience would be interested in the emphasis given to epidemiology. The authors of the meeting report noted that the importance to epidemiology for general causation, but its limitations for determining specific causation:

“Concerning the respective roles of epidemiology and molecular pathology, it was noted that epidemiology allows the determination of the overall effect of a given carcinogen in the human population (e.g., hepatitis B virus and hepatocellular carcinoma) but cannot prove causality in the individual tumor patient.”

Carbone at 5518. The report did not state that epidemiology was not necessary for confirmation of carcinogenicity in the species of interest (humans). The meeting report emphasized the need to integrate the findings of epidemiology and of molecular biology; it did not urge that epidemiology be ignored or disregarded:

“A general consensus was often reached on several topics such as the need to integrate molecular pathology and epidemiology for a more accurate and rapid identification of human carcinogens.”

Carbone at 5518.

“Ideally, before labeling an agent as a human carcinogen, it is important to have epidemiological, experimental animals, and mechanistic evidences (molecular pathology). Not all of the evidence is always available, and, at times, it may be prudent to identify a human carcinogen earlier rather than later.”

Carbone at 5519 (emphasis added). Unlike Cranor, the authors of the meeting report distinguish between instance when they are acting on a scientific determination of causation, and a precautionary assessment that proceeds prudentially “as if” causation is determined.

Against this fuller context, Cranor’s characterization of the meeting report, and his limited citations and quotations can be seen to be misleading:

“The First Circuit wisely followed the Etiology Branch of the National Cancer Institute, which sponsored a workshop on cancer causation that concluded ‘there should be no . . . hierarchy’ among epidemiology, animal testing, cell culture, genomics, and so forth.¹⁶⁴”

Cranor at 129. The suggestion that the informal workshop statement represented the views of the Etiology Branch is bogus. Not content to misrepresent twice, Cranor comes back for yet a third misleading citation to this report:

“A further conclusion, already noted, is that scientific experts in court should be permitted to rely upon all scientifically relevant evidence in nondeductive arguments to draw conclusions about causation.²⁰⁹ “There should be no such hierarchy” of evidence, as the Milward court put it, following scientists conducting a workshop at the National Cancer Institute.²¹⁰ This decision stands as an important corrective to the views of some other appellate and district courts concerning the scientific foundation for expert testimony in toxic tort cases.”

Cranor at 135 (emphasis in original) (citing Carbone for a third time). To see how misleading is Cranor’s suggestion that scientists should be permitted upon all scientific relevant evidence, consider the meeting report’s careful admonition about the lack of validity of some animal models and mechanistic research:

“Moreover, carcinogens and anticarcinogens can have different effects in different situations. As shown by the example of addition of β-carotene in the diet, β-carotene has chemopreventive effects in many experimental systems, yet it appears to have increased the incidence of lung cancer in heavy smokers. Animal experiments can be very useful in predicting the carcinogenicity of a given chemical. However, there are significant differences in susceptibility among species and within organs in the same species, and differences in the metabolic pathway of a given chemical among human and animals could lead to error.”

Carbone at 5521. Obviously relevance is conditioned upon validity, a relationship that is ignored, suppressed, and dismissed in Cranor’s article.

The devil, or the WOE, comes from with ignoring the details.

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Clowns to the left of me, Jokers to the right

May 11th, 2013

Both the left and the right are infused with hypocrisy when it comes to accepting science and evidence-based evaluations. The source and cause of the antagonism should be obvious. A scientific worldview requires a commitment to changing positions if and when new evidence develops, models are refined, and theory deepens. A political (or a religious) worldview places core commitments above empirical data, as was so clearly revealed in the case of The Vatican v. Galileo Galilei. The left wants scientists to practice science for the redistribution of wealth. The right wants scientists to practice science for the Ad maiorem Dei gloriam.

The latest assault on science comes from the right, and has the name “The High Quality Research Act” (HQRA). The text of the bill provides:

SEC. 2. HIGH QUALITY RESEARCH.

(a) CERTIFICATION

Prior to making an award of any contract or grant funding for a scientific research project, the Director of the National Science Foundation shall publish a statement on the public website of the Foundation that certifies that the research project—

(1) is in the interests of the United States to advance the national health, prosperity, or welfare, and to secure the national defense by promoting the progress of science;

(2) is the finest quality, is ground breaking, and answers questions or solves problems that are of utmost importance to society at large; and

(3) is not duplicative of other research projects being funded by the Foundation or other Federal science agencies.

(b) TRANSFER OF FUNDS

Any unobligated funds for projects not meeting the requirements of subsection (a) may be awarded to other scientific research projects that do meet such requirements.

(c) INITIAL IMPLEMENTATION REPORT .

Not later than 60 days after the date of enactment of this Act, the Director shall report to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Science, Space, and Technology of the House of Representatives on how the requirements set forth in subsection (a) are being implemented.

(d) NATIONAL SCIENCE BOARD IMPLEMENTATION REPORT

Not later than 1 year after the date of enactment of this Act, the National Science Board shall report to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Science, Space, and Technology of the House of Representatives its findings and recommendations on how the requirements of subsection (a) are being implemented.

(e) IMPLEMENTATION BY OTHER AGENCIES

Not later than 1 year after the date of enactment of this Act, the Director of the Office of Science and Technology Policy, in collaboration with the National Science and Technology Council, shall report to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Science, Space, and Technology of the House of Representatives on how the requirements of sub-section (a) may be implemented in other Federal science agencies.

Although the Bill applies by its terms to the National Science Foundation, the Congressional mandate envisions implementation by other Federal science agencies such as the National Institutes of Health. The heart of the Bill is the required certification from the Director of the NSF under Section (2)(a)(1), (2), and (3), above.

The proposed statutory criteria for the Director’s certification virtually ensure that no research will be funded; indeed, the criteria are inimical to the very idea of research.

The first criterion, the general welfare and defense of the country, is an utterly vacuous standard. The Director could certify any research under this criterion.

The second criterion, which I call the criterion of hyperbolic research can virtually never be met. Funded research must now not only be of good or excellent quality, it must be of “the finest quality.” The research must be “ground breaking.” Of course, no honest researcher knows in advance that the research will be ground breaking. There are no guarantees of success in research. If there were, then the research would be unnecessary because the grant proposal would suffice. I suspect that every researcher believes his or her research will “answer questions or solve problems that are of the utmost importance to society at large,” but the bill is written to suggest that the Director must certify success in advance, as justification for the funding. Of course, the NSF Director, if honest, will never be able to satisfy this criterion for most research even when the research is relatively successful in advancing scientific understanding of some phenomenon. If this is the standard, nothing would or should be funded. Why not just say government should not be a funding resource because political processes can never ensure the highest quality research.

The third criterion for certification by the Director, which requires that the funded research not be duplicative of other federally funded research projects, is the hardest to understand. A crucial part of the scientific process is replication and demonstration of consistency. Furthermore, non-duplication is a vague and contested criterion at best. If a previous cross-sectional study suggested an association between an environmental exposure and a particular disease, would NSF funding of a case-control study be duplicative because it would looking at a possible association between the same exposure and outcome as studied in the previous study? I would think not, but the language of the bill invites an attack on the Director for certifying the case-control study.

I would be the first to agree that there is some poor science conducted at the public’s expense (and some very good science too), but the certification is poorly designed to advance the quality of federally funded scientific research. No doubt, the sponsors of the bill see the certification requirement as an opportunity to haul the Director of the NSF (and ultimately of the Director of the National Institutes) into Congressional committee meetings to be publicly dressed down for research that the committee members disapprove of.

Dylan Walsh of the New Yorker has reported about the introduction of the HQRA bill by Representative Lamar Smith, chairman of the House Committee on Science, Space, and Technology. Dylan Walsh, “Not Safe for Funding: The N.S.F. and the Economics of Science,” The New Yorker (May 9, 2013).

Among the distinguished members of the House Committee on Science, Space, and Technology is scientist Congressman Paul Broun. Back in September 2012, at a church-sponsored event in Georgia, Dr. Broun declared that “all that stuff I was taught about evolution and embryology and the Big Bang theory” are “lies straight from the pit of hell.” These lies, according to Broun, are no casual deviation from the truth; they are part of a conspiracy to “to try to keep me and all the folks who were taught that from understanding that they need a savior.”

This is the same Representative Broun who declared:

“You see, there are a lot of scientific data that I’ve found out as a scientist that actually show that this is really a young Earth. I don’t believe that the earth’s but about 9,000 years old. I believe it was created in six days as we know them. That’s what the Bible says.”

The proposed HQRA is all about turning control of science funding to politicians, people like Representative Broun, and his colleagues.

There is an interesting discussion of the HQRA at Professor Deborah Mayo’s blog, “If it’s called the ‘The High Quality Research Act’, then ….” (May 9, 2013).

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