Report Issued on Use of Science in Regulatory Decisions

Scientists and policy experts from industry, government, and various nonprofit sectors worked on a report released recently by the Research Integrity Roundtable, designed to offer ways to improve the scientific analysis and independent expert reviews which underpin many important regulatory decisions. The primary audience for the report is federal agencies and their scientific advisory committees, but the ideas in the report may be relevant to others who work at the intersection of science and regulatory policy, including in Congress, the judiciary, and readers of MassTortDefense.  These issues can have important implications for persons interested in issues associated with chemicals, energy, land use, natural resources, agriculture, pharmaceuticals, and other areas in which science informs public policy.

Critics of the manner in which science is used in regulatory decision-making processes tend to raise two kinds of concerns. They question the composition of committees that are empaneled to recommend or review the science behind a possible regulatory decision and they question the way an agency or committee has reviewed the relevant scientific literature, charging that the reviewers used or omitted the wrong studies, and/or that the studies were not appraised appropriately. Obviously, some disputes over the "politicization" of science actually arise over differences about policy choices that science can inform, but not determine.

With that in mind, this report attempts to lay out some broad principles, guidelines, and practices designed in the view of the authors to limit the battling over conflict of interest and bias, and systematic reviews.  Accordingly, this report focuses on:

 How should panels be composed and the qualifications of prospective advisory panelists be vetted?
 How should concerns about biases and conflicts of interest of advisory panelists be handled?
 Which studies should agencies review when examining the scientific literature related to a regulatory policy issue?
 How should contending views regarding the relevance of particular scientific results to a regulatory issue and the credibility of those results be addressed?

For panel formation, the report concludes that a reasonable balance must be established between transparency and privacy. In the realm of qualifications, for example, balancing how much personal information should be revealed to the public by a prospective panelist who may be willing to serve in an advisory capacity, but may not want every aspect of his or her personal life or financial status released to the public.

In dealing with scientific studies, the report suggests a balance must be established in developing and applying objective and transparent criteria for establishing data relevance and reliability between the desire for complete data-sets and the reality that the relevant scientific literature is populated with studies from a wide variety of sources with varying degrees of data availability. In some cases, when proprietary information is involved, an appropriate balance must be struck between the public’s right to know and the legally based need to protect proprietary formulas, production processes, and related intellectual property. 

Junk Food Junk Science Exposed

Much of the litigation our clients confront on a daily basis seems predicated on the philosophy that all predicaments, all injuries, must be the fault of someone else.  There is no such thing as personal responsibility; individuals need not face the consequences of choices they make. Why change your risky behavior when you can sue someone else for it?

This same approach is the foundation of the effort to remove all soda and so-called “junk foods” from our schools.  But, is the mere availability of such products in schools actually the cause of  childhood obesity -- certainly an important public health concern?

Readers may want to note a recent study published in the journal Sociology of Education.  See VanHook & Altman, Competitive Food Sales in Schools and Childhood Obesity: A Longitudinal Study, 85 Sociology of Education 23 (January 2012).

The study followed  nearly 20,000 students who started kindergarten back in 1998. The researchers recorded the students’ BMI (body mass index) in fifth grade and again in eighth grade, and correlated these data points with the availability of  junk food at their schools (like snacks, candy, and soda).  (The researchers did factor in race and ethnicity, socio-economic status, and other factors that might affect weight gain.)

Surprise, surprise?  They found no link between children’s weight and the sale of these foods in the nearly 1000 schools.  About 1/3 were overweight in schools with and schools without. This actually makes compete sense, and follows on other studies that showed when students couldn’t buy soda at school, they simply compensated by drinking more at home, before and after. See Taber, et al., Banning All Sugar-Sweetened Beverages in Middle Schools, Arch. Pediatr. Adolesc. Med. 2011; 0: 20112001-7.

Bashing food companies may make some feel better, and banning sales in schools may allow some to pat themselves on the back for a job well done, but selling these foods in school has little or nothing to do with whether children will become overweight.  The real issue is parental responsibility --  how, what, and how much parents are feeding their children at home; what eating patterns they instill, and what exercise parents encourage in their kids. Admittedly, changing parental behavior is a lot harder than banning the soda machine, but it is also the only approach likely to make a significant impact on this issue.  Regulation and litigation are not the answers.

Observations from Judges on Scientific Evidence

I spoke last week at a CLE seminar on "Chemical Products Liability and Environmental Litigation."  One of the panels included an array of federal and state court judges who offered their thoughts on a number of interesting topics, including Daubert/Frye issues.

No surprise for the savvy readers of MassTortDefense, but one clear takeaway is that judges have differing views and approaches on a variety of expert-related issues, including when they hold a hearing vs. deciding on the paper, and when they want the experts to appear live vs. argument.

There were a few areas of consensus. 

  • The panel agreed you need to know your judge, learn his or her preferences, and know how busy their docket is. 
  • In Daubert or Frye hearings, don't waste time on Rule 56 or Rule 702 black letter law.
  • In filings, always cite to the record so the judge or clerk can find the basis of factual assertions. This was called a "lost art."
  • A stipulated joint glossary of key terms is appreciated when possible.

The judges agreed that they are not overly impressed with arguments noting the expert was excluded by other courts on other cases.  If the facts are nearly identical, and they respect the other judge, and there is an opinion or order with some reasoning, they may give it some weight.  But if the expert opinion was also admitted in some other cases, this may cancel out the influence of prior exclusions.

Finally, while many lawyers talk about filing an iffy or uncertain motion to "educate" the court as to important science issues, the panel suggested this often doesn't help. There may be a time lag between the motion and trial; and the loss of momentum from losing a motion may have carry-over effects in the litigation.

 

British Journal Finally Retracts Autism Article

The British medical journal "The Lancet" has  finally issued a full retraction of a study it ran in 1998 purporting to link the measles-mumps-rubella (MMR) vaccines to autism.  Wakefield, et al., "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children," Lancet 1998; 351: 637-641.

The journal noted that following the judgment of the U.K. General Medical Council's "Fitness to Practice Panel" concerning the lead author, it had become clear to the journal that several elements of the 1998 paper by Wakefield, et al., were "incorrect," and contrary to the findings of an earlier investigation. Therefore, the journal "fully retracted" this paper from the published record.

Readers of MassTortDefense know how one article purporting to link a drug to a side effect, a chemical to an adverse effect, a product to an illness, can spawn significant products litigation, and even a mass tort.  Here, the study not only influenced a decade of litigation, it spurred a public health crisis by sending parents in the U.K. and the U.S. into confusion over the safety of having their children vaccinated.  The overwhelming scientific evidence shows vaccines to be safe, but The Lancet stuck by its article even when it was revealed that the study was connected to plaintiff lawyers' pursuit of litigation. In the meantime, all children were put at risk as Great Britain's child vaccination rates plummeted to below 70% in some areas, and by 2008 there were more than 1000 cases of measles, including fatalities, in  England and Wales.

The Lancet article issues demonstrate how even reputable publications can become conduits for plaintiffs' junk science and political junk science.  It's hard to fathom why it took so long for the retraction.  It calls again for an overhaul of the peer review process, which the Supreme Court in Daubert noted as a hallmark of good science.  Most importantly, it reminds the defense bar and their clients how important it is to have a thorough, searching examination of the science that plaintiffs rely on for general or specific causation.  Nothing can be taken at face value, and sometimes only a dogged pursuit of discovery will uncover the many flaws in a seemingly well-regarded study.

Autism and related developmental disorders are an extremely challenging medical issue, deserving of time and resources.  But the questions cannot be answered by junk science.