Christopher T. Robertson

The Novel New Jersey Eyewitness Instruction Induces Skepticism but Not Sensitivity

In recent decades, social scientists have shown that the reliability of eyewitness identifications is much worse than laypersons tend to believe. Although courts have only recently begun to react to this evidence, the New Jersey judiciary has reformed its jury instructions to notify jurors about the frailties of human memory, the potential for lineup administrators to nudge witnesses towards suspects that they police have already identified, and the advantages of alternative lineup procedures, including blinding of the administrator. This experiment tested the efficacy of New Jersey’s jury instruction. In a 2×2 between-subjects design, mock jurors (N = 335) watched a 35-minute murder trial, wherein identification quality was either “weak” or “strong” and either the New Jersey or a “standard” instruction was delivered. Jurors were more than twice as likely to convict when the standard instruction was used (OR = 2.55; 95% CI = 1.37–4.89, p < 0.001). The New Jersey instruction, however, did not improve jurors ability to discern quality; rather, jurors receiving those instructions indiscriminatingly discounted “weak” and “strong” testimony in equal measure.

The Money Blind: How to Stop Industry Bias in Biomedical Science, Without Violating the First Amendment

The pharmaceutical and medical device industries use billions of dollars to support the biomedical science that physicians, regulators, and patients use to make healthcare decisions—the decisions that drive an increasingly large portion of the American economy. Compelling evidence suggests that this industry money buys favorable results, biasing the outcomes of scientific research. Current efforts to manage the problem, including disclosure mandates and peer reviews, are ineffective. A blinding mechanism, operating through an intermediary such as the National Institutes of Health, could instead be developed to allow industry support of science without allowing undue influence. If the editors of biomedical journals fail to mandate that industry funders utilize such a solution, the federal government has several regulatory levers available, including conditioning federal funding and direct regulation, both of which could be done without violating the First Amendment.

The Federal Right to Try Act of 2017—A Wrong Turn for Access to Investigational Drugs and the Path Forward

In 2017, President Trump said that “one thing that’s always disturbed”1 him is that the US Food and Drug Administration (FDA) denies access to experimental drugs even “for a patient who’s terminal...[who] is not going to live more than four weeks [anyway.]”1 Fueled by emotionally charged anecdotes recirculated by libertarian political activists, 38 states have passed Right to Try laws. In 2017, the US Senate approved a bill that would create a national law (Box).2 As of December 2017, the US House of Representatives was considering the bill. Although the FDA has an expanded access option for utilizing experimental drugs outside of clinical trials, Right to Try laws create an alternative pathway that bypasses the agency. Moreover, the term “Right to Try” is a misnomer: the legislation creates a right for a patient to ask a company to provide a product, the same right that currently exists.3 As is the case with the FDA program, companies are not obligated to provide access. The proposed federal Right to Try legislation2 sets the threshold for patients to access investigational drugs at the completion of phase I (dosage-determination) trials, grants companies and physicians broad immunity from liability, and largely blinds the FDA to safety or efficacy data from these therapeutic attempts. Such changes would upend the agency’s expanded access program, which has worked successfully for decades to provide patients who are seriously ill and without therapeutic options access to investigational drugs and still assure the safety and efficacy of new drugs before these products gain marketing approval. The legislation does not solve actual concerns, such as lack of knowledge that the program exists and the very limited supply of many investigational products. A 2016 review4 of 10 years of FDA records found that the Center for Drug Evaluation and Research receives over 1000 expanded access applications per year. The FDA reviews such requests in days—or hours when an emergency so requires—and approves over 99%.5 This is no mere rubber stamp of proposals: unlike individual physicians, the FDA has access to proprietary data about the risks and benefits of the investigational product or others in the same class. In some instances, the agency can improve the proposed treatment via modifications of drug dosage, dosing schedule, or other aspects.6 Eliminating the FDA’s review of expanded access requests is perilous, because most of the drugs that succeed in phase 1 trials turn out to be too unsafe or ineffective for clinical use. Phase 1 trials are intended to find a reasonable dosage of a drug in a small number of subjects, who may not even have the disease in question. About two-thirds of successful phase 1 drugs will fail as they proceed to phase 2,7 and even more will fail at phase 3. Given the low odds that an investigational drug will succeed, patients benefit from the agency’s review. Under expanded access, the FDA does not set a threshold for when patients may access investigational drugs: the agency has permitted access to products that are in phase 1 testing, and well as in preclinical (nonhuman) testing. Such a case-by-case approach is appropriate and should be retained. The federal Right to Try legislation2 creates immunity for physicians who prescribe investigational agents and companies that dispense them even if they act negligently in certain circumstances or if their actions may have been influenced by financial conflicts of interest. In our view, such broad liability protection is not needed. If Congress, nonetheless, seeks to provide immunity, it should be premised on FDA review of the protocol and the patient having received independent advice from a physician who has no economic or reputational stake in the investigational drug. Under the expanded access option, pharmaceutical companies can only charge shipping and manufacturing costs for their investigational products. The Senate bill2 has no such restrictions, opening the door for companies to profit from selling unproven drugs. The FDA policy of limiting what companies can charge for their investigational products provides an important incentive for companies to complete clinical trials. In addition, the bill includes no mechanisms or incentives for insurance coverage, which would be essential if companies were to charge, as private and government health insurance plans generally exclude coverage for experimental treatments. Instead, the Senate bill creates a very real opportunity for vulnerable patients to be taken advantage of financially. Furthermore, 19 state Right to Try laws specifically allow insurers to deny hospice coverage to patients who try investigational products via the Right to Try pathway: 5 of those laws also allow denial of coverage for home health care (as does the law of an additional, sixth state, which does not have the hospice provision). Three of the 19 state laws allow, in addition to denial of both hospice and home health care coverage, denial of insurance coverage altogether for up to 6 months after treatment with the investigational product ends. One state law allows denial of home health care and insurance coverage without mention of hospice coverage.8 If investigational products are to be treatment options—as advocates of Right to Try laws intend—then federal law should prohibit insurers from VIEWPOINT

New DTCA Guidance — Enough to Empower Consumers?

In new draft guidance, the FDA recommends using evidence-based formats for conveying risk information about drugs in direct-to-consumer advertising but gives companies more discretion about which risks to disclose and how. But is disclosure an effective regulatory tool?

Medical Causes and Consequences of Home Foreclosures.

The objective of this study was to elucidate the medical causes and consequences of foreclosure. We surveyed 90 households undergoing foreclosure in 2013–2014 in Maricopa County, Arizona on two occasions approximately five months apart. At baseline, median monthly household income was

Heterogeneity in IRB policies with regard to disclosures about payment for participation in recruitment materials.

3,000, and median mortgage payment

Blinding Prosecutors to Defendants’ Race: A Policy Proposal to Reduce Unconscious Bias in the Criminal Justice System

1,350. Only 10% of respondents lacked health insurance when surveyed, although 28% had experienced a gap in coverage within the past two years. Fifty-seven percent identified a medical debt or another medical cause of their foreclosure, and 54% had taken on new debt to pay medical bills; 10% had mortgaged their home for this reason. Although 57% of respondents had a chronic condition requiring ongoing care, more than half reported delaying or skipping a needed medical visit. At follow-up, one-third of respondents had been unable to afford food, and 3 respondents reported becoming homeless; 46% said foreclosure had worsened their health; and 63% had already incurred new medical debts. Medical debt and medical problems frequently contribute to foreclosure, even among insured families. Foreclosure compromises access to care and basic necessities like food and shelter, and worsens self-reported health.

Why Courts Fail to Protect Privacy: Race, Age, Bias, and Technology

Although the Federal Common Rule requires that informed consent documents include all material information, it does not specify the content of materials used to recruit human subjects. In particular, there is no federal regulation relating to how payment for research participation is to be advertised. Rather, the FDA has issued guidance, advising researchers not to emphasize payment information. In order to determine how IRBs have interpreted this guidance, we coded the policies of the top 100 institutions by receipt of NIH funding, in order to determine whether they require, permit, or forbid researchers to disclose the amount of compensation in their recruitment materials. We found that the vast majority of institutions implicitly or explicitly permit such disclosures; however, there are a significant number of IRBs at each extreme, some discouraging or forbidding with others encouraging or mandating such disclosures. Such heterogeneity in local regulations suggests that IRB discretion may be imposing costs on human subjects and the scientific enterprise that outweigh the benefits. We suggest that this heterogeneity should be resolved towards a national consensus on permissibility.

An Assessment of the Human Subjects Protection Review Process for Exempt Research.

Summary: Racial minorities are disproportionately imprisoned in the United States. This disparity is unlikely to be due solely to differences in criminal behavior. Behavioral science research has documented that prosecutors harbor unconscious racial biases. These unconscious biases play a role whenever prosecutors exercise their broad discretion, such as in choosing what crimes to charge and when negotiating plea bargains. To reduce this risk of unconscious racial bias, we propose a policy change: Prosecutors should be blinded to the race of criminal defendants wherever feasible. This could be accomplished by removing information identifying or suggesting the defendant’s race from police dossiers shared with prosecutors and by avoiding mentions of race in conversations between prosecutors and defense attorneys. Race is almost always irrelevant to the merits of a criminal prosecution; it should be omitted from the proceedings whenever possible for the sake of justice.

Why Blinding? How Blinding? A Theory of Blinding and Its Application to Institutional Corruption

The Fourth Amendment protects against unreasonable “searches and seizures,” but in the digital age of stingray devices and IP tracking, what constitutes a search or seizure? The Supreme Court has held that the threshold question is supposed to depend on and reflect the “reasonable expectations” of ordinary members of the public concerning their own privacy. For example, the police now exploit the “third party” doctrine to access data held by email and cell phone providers, without securing a warrant, on the Supreme Court’s intuition that the public has no expectation of privacy in that information. Is that assumption correct? If judges’ intuitions about privacy do not reflect actual public expectations, it may undermine the legitimacy of the criminal justice system and exacerbate social unrest. Although prior research has shown that the police disproportionately target younger people and minority communities, judges tend to be male, white, educated, affluent, and older than the general population. Their intuitions may thus be systematically different. Even worse, cognitive science suggests that judges may have difficulty putting themselves into the shoes of the searched person or considering the reasonableness of the police tactics from an ex ante perspective, without knowledge about the fruits of the search. With 1200 respondents, we conducted a large-scale survey experiment to test whether, and if so, why, contemporary Fourth Amendment jurisprudence diverges from the societal norms it purports to protect and reflect. We identify a range of privacy expectations for 18 different police practices. We use oversampling, reweighting, and randomization to investigate particular causes of this disparity between judicial and public expectations. We conclude by suggesting better ways forward, so that social science evidence can replace judicial speculation.