The Volokh Conspiracy
Mostly law professors | Sometimes contrarian | Often libertarian | Always independent
My last two posts summarized the extent to which the First Amendment should constrain the government when it seeks to censor weak scientific claims. To the extent that the government uses advertising restrictions in order to promote good science, free speech doctrine has already begun to get in the way.
This could nudge federal agencies and other lawmakers to use other means to promote research and consumer knowledge. That's a good thing. The government could do much more than it currently does using its own powerful voice and by using other non-censorship regulations. Here are a few examples:
1. Funding and supporting more independent research.
One of the greatest drawbacks to our current system of food and drug testing is that we rely on self-interested companies to produce the bulk of research that regulators and consumers must use to make important decisions. This is so in part because randomized controlled trials – the "gold standard" for research – are very costly. The companies that are likely to profit from positive research findings are the most eager to fund it.
But for the company, the research is only worth its costs if it comes out the right way. Randomized controlled trials can be gamed, and often are. Although controlled trials are supposed to avoid the selection effects that can mar studies of observational data, they can be distorted if researchers put conditions on study participants that ensure all the research subjects are unusually healthy, and therefore unusually likely to respond well to medicines and to avoid side effects. Independent researchers would have more interest in selecting the pool of research subjects in a way that better represents the future users of the product.
It is unrealistic to expect that the National Institutes of Health and other federal research organizations will receive large enough budgets to run all clinical trials themselves. But more can be done with post-market observational data. While observational studies will always raise questions about whether there are sufficient controls to ensure that an effect is truly causal, they do have the virtue of coming from the real world and reflecting what has happened in the field. Randomized controlled trials, by contrast, reflect the population of patients who happened to come down the pipeline and are willing to consent to an experiment. Controlled trials also tend to be quite small because of their costs, and they may lack the power to detect rare but important therapies or side effects.
Compared with controlled trials, analysis of observational data is cheap. The federal government should encourage researchers to access medical data and link them to other consumer databases in order to uncover latent health benefits and risks. Instead, federal privacy and research law tends to do the opposite, discouraging data collection and erecting barriers to access.
2. Publicizing or certifying the findings of independent or well-conducted research.
The government can also use its voice to promote the research that meets its favored scientific standards. Rather than using censorship rules, the government could certify health claims that meet its evidentiary standards, and allow manufacturers to proudly mark that certification in its advertising. The government can also contribute to consumer education more actively through its websites or through public service campaigns in the mainstream media.
3. Using ex-post liability and safe harbors.
Regulators could also rely more heavily on ex-post enforcement than the modern regulatory state typically does. Strict liability and ex-post fines for products that prove to cause harm can do a lot to motivate research and caution by manufacturers. The government could also create strong incentives to engage in pre-market research using safe harbors from the fines and liability that would otherwise apply if a product turns out to be dangerous for its anticipated use.
4. Mandating disclosures about the evidence base (or lack thereof.)
The government could also make better use of rules requiring companies to provide disclaimers or other information. The compelled speech doctrine seems to be more forgiving than the free speech rules that apply to censorship, at least when compelled disclosures are used to provide relevant, purely informational content. Thus, the state could require companies that choose to make scientific or health claims in their advertising to provide the evidence supporting and contradicting each of their claims on a website or through a central clearinghouse.
Mandated disclosures have a tendency to proliferate quickly, though, and they don't always have salutary effects. In the next post, I will address some serious limits to the ability for mandated disclosure to effectively educate consumers.