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Feature

Having Both Too Much,
and Too Little, Free Speech

EBy Gordon Hull, PhD, Director, Center for Professional and Applied Ethics, UNC Charlotte
vidence-based medicine sounds like a good and also sponsoring a large number of meta-analyses currently. Again,
straightforward thing. It’s the idea that clinical they get their desirable conclusions” (internal citations omitted).
medicine should aspire to base its practice on the best In a follow-up interview in Retraction Watch, the author added

available scientific evidence of what works and what that part of the problem is declining public funding for research,

does not, and that clinicians should have such information readily which puts that research in the hands of industry, which has to

available to them when working with patients. I want to suggest answer to sales and marketing departments.

here that creative judicial interpretations of the First Amendment None of this is a new complaint, but it generates very

are making it hard to practice such medicine. There are two halves specific problems for off-label marketing, because it pulls the

to the worry: one is based on too much free speech and the other rug out from under the reasons given not to ban it. How can

on too little, but both make it difficult to use evidence in a clinical one possibly identify correctly which claims are “truthful and

setting with patients. non-misleading?” All the “truth” has been manufactured, and

For too much free speech, consider that the growth of corporate evidence going the other direction never gets funded or published.

free speech rights (especially post Citizens United), now is being So what about the too little free speech argument? Let’s

applied to pharmaceutical advertising. In a 2012 case, an appellate set aside the complications of reproductive health debates, and

court overturned the conviction of a pharmaceutical representative look at firearms. Florida’s statute banning doctors from asking

All the “truth” has for marketing the drug patients – including those with children – about firearms in
Xyrem for off-label use, the house, absent specific reasons to think “that the patient is

been manufactured, as long as his speech suicidal or has violent tendencies,” was upheld by an appellate
was “truthful.” In court last summer. The appellate court overturned a lower court

and evidence going early March, the FDA opinion finding that the law “aims to restrict a practitioner’s
reached a settlement ability to provide truthful, non-misleading information to a

the other direction with Amarain that the patient.” Are guns in the home clinically relevant? A recent
company is free to New York Times analysis concluded that hundreds of children die

never gets funded or “engage in truthful and – usually accidentally – because adults leave unsecured, loaded
non-misleading speech” firearms where children can access them. The children then

published. about potential uses for its unintentionally shoot themselves or each other. The Times cites
product, even if those are CDC statistics to the effect that gun accidents were the ninth-

unapproved. The product leading cause of unintentional deaths of children ages 1-14 in

in question is fish oil, 2010; applying evidence of inconsistent and under-reporting, gun

and the debate was over accidents would make the top five or six. One could be forgiven

if it could be advertised to reduce the risk of cardiac events and for thinking that these deaths are almost entirely preventable.

not just as an intervention for patients with very high triglyceride Despite this, the gun lobby is sponsoring more such laws.

levels. In the abstract, this might sound perfectly reasonable; only There are two situations in which selective judicial

doctors can actually prescribe off-label, and surely they should be application of the First Amendment is being used to undermine

able to use the best evidence available to make those decisions, the ability of clinicians to responsibly exercise evidence-based

right? The problem is that in the world we live in, it is not clear if medicine and their own professional judgment in the context of

the free speech in question is “truthful and non-misleading.” The doctor-patient relationships. In one, the problem is generated by

research Amarin cited in support of the off-label marketing was too many free speech rights on the part of Pharma companies

clearly paid for by Amarin. This is a common phenomenon, and to peddle their products in off-label ways that are not backed by

it led one of evidence-based-medicine’s early champions, John even a scintilla of objective evidence. In the other, the clinical

Ionannidis, recently to publish a piece in the Journal of Clinical relation is undermined by prohibiting speech on guns, despite

Epidemiology called “Evidence-Based Medicine Has Been the presence of clinically-relevant evidence that gun-owning

Hijacked,” which argued, among other things, that “the industry parents need to be very, very careful to control access to their

runs a large share of the most influential randomized trials. They firearms, and many aren’t. Again, the doctor’s ability to use his

do them very well. … It is just that they often ask the wrong or her professional judgment is undermined in ways antithetical

questions with the wrong short-term surrogate outcomes, the to any sort of evidence-based medicine. When the evidence

wrong analyses, the wrong criteria for success (e.g., large margins doesn’t exist, you nonetheless have to use it; when it’s solid, you

for noninferiority), and the wrong inferences. … The industry is have to ignore it.

6 | July/August 2016 • Mecklenburg Medicine