an unanticipated consequence of
Jack M. Balkin
Jack Balkin: jackbalkin at yahoo.com
Bruce Ackerman bruce.ackerman at yale.edu
Ian Ayres ian.ayres at yale.edu
Mary Dudziak mary.l.dudziak at emory.edu
Joey Fishkin joey.fishkin at gmail.com
Heather Gerken heather.gerken at yale.edu
Abbe Gluck abbe.gluck at yale.edu
Mark Graber mgraber at law.umaryland.edu
Stephen Griffin sgriffin at tulane.edu
Bernard Harcourt harcourt at uchicago.edu
Scott Horton shorto at law.columbia.edu
Andrew Koppelman akoppelman at law.northwestern.edu
Marty Lederman msl46 at law.georgetown.edu
Sanford Levinson slevinson at law.utexas.edu
David Luban david.luban at gmail.com
Gerard Magliocca gmaglioc at iupui.edu
Jason Mazzone mazzonej at illinois.edu
Linda McClain lmcclain at bu.edu
John Mikhail mikhail at law.georgetown.edu
Frank Pasquale pasquale.frank at gmail.com
Nate Persily npersily at gmail.com
Michael Stokes Paulsen michaelstokespaulsen at gmail.com
Deborah Pearlstein dpearlst at princeton.edu
Rick Pildes rick.pildes at nyu.edu
Alice Ristroph alice.ristroph at shu.edu
Neil Siegel siegel at law.duke.edu
Brian Tamanaha btamanaha at wulaw.wustl.edu
Mark Tushnet mtushnet at law.harvard.edu
Adam Winkler winkler at ucla.edu
[The following is the text of the Keynote Address for the Conference on Public Health in the Shadow of the First Amendment, delivered at Yale Law School on October 18, 2014, byJoshua M. Sharfstein, M.D., Secretary, Maryland Department of Health and Mental Hygiene]
Thank you for inviting me to speak at this important and timely
conference. As a pediatrician and state public health official, I especially
appreciate the chance to talk with you today.
I’d like to start by setting expectations.
My legal training is limited to two courses in health law and an
introductory class in administrative law…which I audited.
So I am not angling for an honorary degree ... as much as I might like
to show it to my brother, who did graduate from here and now teaches at
Vanderbilt Law School.
Instead, I will speak from my judgment and experience.
Before I get into the substance of the topic, however, and as the only
public health doctor speaking at this conference, I would like to clear the air
of a misconception about people who work in my field ... specifically, that we
are dour and humorless killjoys.
I recently spoke to public health graduates who had just earned their
degrees in one of the many diverse fields, including epidemiology,
environmental health science, laboratory investigation and immunology.
I had to remind them that each had passed the core curriculum.
Public Health 101 -- How to take all the pleasure out of eating and
Public Health 201 -- How to turn a conversation on any topic into a
discussion of antibiotic resistant sexually transmitted disease.
And Public.Health 301 -- How to take all the pleasure out of eating and
drinking … by talking about antibiotic resistant sexually transmitted disease.
The truth is that public health is a field full
of people who enjoy life. Our premise is that the well-being of individuals,
families, and communities has fundamental moral value. When people are healthy,
they are productive, creative, and caring. They spend time with their friends and
families, they strengthen their neighborhoods, and they help others in need.
In short, they get to live their lives.
When I think of who works in public health, I do not picture nanny-like
functionaries sitting in cubicles.
Rather, I have in mind Dr. Albert Sommer, the ophthalmologist from my
neighborhood in Baltimore who recognized that Vitamin A deficiency causes not
only blindness but also early death among children in the developing world.
This insight was proven through extensive clinical investigation in the field.
Dr. Sommer’s work has saved millions of lives.
As a public health official in this country, my job has operated at a
different scale. But the premise is the same -- to use tools of science to
identify ways to reduce suffering and improve health.
In Baltimore, for example, after we identified a large number of babies
dying in unsafe sleeping conditions … we designed and implemented a campaign to
address the problem.
Working with experts in behavior change and communications at the Johns
Hopkins Bloomberg School of Public Health, the city developed hard-hitting
advertisements in which parents who lost babies to unsafe sleep told their
stories. We showed these videos across the city, including in jury rooms, and
in social services offices.
Safe sleeping increased, unsafe sleep deaths declined, and now more
children in our city get to live their lives.
In this context, I would like to share my concern that recent court
decisions involving the First Amendment are undermining the health and
well-being of the American people.
The issues under discussion at this conference are not abstract
questions of law; they are matters of life and death.
About 25 years ago, the Institute of Medicine defined public health as
“what we, as a society, do collectively to assure the conditions for people to
I would like to discuss several “conditions for people to be healthy”
that recent court decisions have put at risk … as a result of an ideology that
gives tremendous weight to commercial speech but provides little deference to
professional speech and public health expertise.
A condition for people to be healthy: integrity in the doctor-patient
As a pediatrician, I speak with parents about their deepest fears for
their children and discuss ways to avoid all sorts of threats to their health
-- from HIV to teen pregnancy. I have confidential discussions with young
children and teens, on complicated matters that may include abuse, sexuality,
and risky behavior.
Effective medical care requires a special kind of trust between doctor
Unfortunately, recent decisions are undermining this trust.
For example, the 8th Circuit Court of appeals has upheld a South Dakota
law requiring physicians to tell patients that abortion is related to a risk of
suicide, after conducting its own extensive analysis of whether the language
required was factual. The court got it totally wrong, with the New England
Journal of Medicine stating flatly that the law requires physicians to tell patients
information that is “false and misleading.”
The Journal’s editors asked, “[C]an a patient trust any interaction
with his or her physician knowing that the physician’s very words have been
mandated by the state? Patients should not accept, and our profession should
not allow, physicians to become a mouthpiece of state sponsored ideology.”
The 11th Circuit Court of Appeals recently upheld a Florida law that
makes physicians subject to discipline for asking about gun ownership in many
circumstances -- including in circumstances recommended by professional
In dismissing the idea that this censorship violated a physician’s
First Amendment rights, the Court found that First Amendment protections
“approach a nadir … when professionals speak privately, in the course of his or
her professional judgment, to a person receiving the professional’s services.”
And then cited a case involving professional financial advisers.
The contrast between the Court’s low regard for the speech of
physicians and the high regard for commercial speech is striking.
In Sorrell vs. IMS Health,
the Supreme Court blocked a law from Vermont to protect the doctor-patient
relationship by prohibiting the sale of data to pharmaceutical companies that would
identify which doctors wrote which prescriptions. The Court applied a
heightened form of scrutiny, treating the sharing of prescribing data for
marketing to physicians among the most protected speech in our nation.
A condition for people to be healthy: An effective regulatory
framework for drugs, devices, and biologics.
This means a regulatory framework that protects the public from unsafe
products and incentivizes the private sector to develop products that really
At the turn of the 20th century, companies sold “patent” remedies with
hidden ingredient lists and all sorts of outlandish claims. There was little
incentive for research on safety or effectiveness.Starting with the Pure Food and Drug Act of
1906, the agency that would become the FDA slowly asserted itself. One tragedy
after another led to change. FDA began to require testing for safety, then
effectiveness, before marketing.After
legislation to require this evidence passed Congress in 1962, the Institute of
Medicine found insufficient evidence for two-thirds of grandfathered products,
thousands in total, which were removed from the market.
FDA’s regulatory structure gives companies a strong incentive for
rigorous testing, which has led to better data, more therapeutic options, and
leaps forward in patient care.
It is now widely acknowledged that the foundation of restrictions on
off-label promotion is at risk. Most recently, on the basis of several lower
court decisions, six companies have asked FDA to substantially loosen its
restrictions on off-label promotion, citing “important constitutional concerns.”
The logic of this view appears to be that companies have First
Amendment Protection under the doctrine of commercial speech to promote their
products with any statements that are technically true -- such as, in a survey,
four out of five doctors recommend a particular drug for a particular
indication; or this one specific study found that a handful of patients
Such communications can be highly misleading. Peer review of scientific
papers does not come close to the scrutiny applied by FDA to data. Publication
bias means that positive studies are far more likely to be published; the FDA
can insist on getting all studies, whether published or not.
This trend in First Amendment law also undermines the key incentive for
companies to produce compelling data for their products. Every one of us here
is likely to be a patient someday, and when that day comes, the consequence of
inadequate research will not be a theoretical legal concern.
A condition to be healthy: effective tobacco control policy.
Tobacco is the nation’s leading cause of preventable death, and it
kills nearly 6 million people around the world each year. Tobacco companies are
also convicted racketeers who use the tools of advertising, marketing, and
product manipulation to addict young people.
The history of the 20th century illustrates the danger of inadequate
tobacco regulation. Among other problems, cigarette manufacturers marketed
their products using a series of dubious claims and inferences, all designed to
provide reassurance on the health question.
These included that doctors preferred certain brands and that light and
low tar brands were safer -- what some have justifiably called the largest
fraud ever perpetrated on U.S. consumers.
Finally, nearly 50 years after the U.S. Surgeon General linked
cigarettes to lung cancer, Congress passed and President Obama signed
legislation that would provide for significant restrictions and oversight of
the tobacco industry. I would venture to say that this is a law arguably better
designed to “promote the general welfare” than virtually any other on the
The First Amendment challenges, ironically, not only could block key
progress on tobacco, but they could create a legal right to the very kind of
marketing that created the public health disaster in the first place.
In 2012, the D.C. Court of Appeals struck down FDA’s effort to put
graphic warning labels on cigarettes --despite evidence of their value from leading public health authorities around
the world … and despite the fact that these warning labels represent the
standard for tobacco control in the world under the Framework Convention on
In reaching this decision, the Court took commercial speech to a place
so ideological … that there is no legitimate role for public health to protect
against cancer, heart disease, lung disease, and low birthweight from
tobacco.The judges actually wrote in a
footnote, “We are skeptical that the government can assert a substantial
interest in discouraging consumers from purchasing a lawful product, even one
that has been conclusively linked to adverse health consequences.”
FDA has gone back to the drawing board in order to try to thread the
needle and find a path that the courts will find acceptable. Even if
successful, however, the delay will be measured not only in years but also in
years lost to addiction and illness.
The First Amendment looms over other possible tobacco regulation,
including plain packaging, other marketing restrictions, and even the FDA’s
ability to review evidence and control marketing messages that certain products
may be less addictive or pose less of a health risk. The result could be a
legal right to conduct the same kind of advertising that deceived the nation
for decades around light and low tar cigarettes.
One challenge with all these cases is that the legal decision and
public health harm can be separated by years.
In 2002, the Supreme Court decided Thompson
vs. Western States, finding that FDA’s bar on pharmacies advertising
compounded medications violated the First Amendment. This decision had the
effect of undermining FDA’s oversight of compounding.
Despite the far greater risk of compounded medications ... particularly
sterile compounded medications … particularly sterile compounded medications
injected into the spinal fluid …. compared to medications that have passed
through the approval process, the agency was forbidden to keep pharmacies from
advertising their products nationally. One of those that marketed aggressively
was called the New England Compounding Center, which sold a contaminated
product that led to dozens of deaths, and hundreds of cases of meningitis.
As the Secretary of the Department of Health and Mental Hygiene in
Maryland, I was responsible for tracking down these contaminated products
across our state. Marylanders suffered from meningitis and other complications.
This outbreak harmed the people I am responsible for.
Many factors contributed to the outbreak, including failures of
oversight. However, as in a hospital seeking to avoid a catastrophic medical
error, multiple, redundant levels of protection are important to protect
consumers. Had FDA’s approach been allowed to stand, the scale of the suffering
could only have been less.
In the case of compounding, there is little dispute that FDA has the
authority to ban the practice altogether. Permitting small amounts of
compounding without massive, national marketing was a reasonable way to
proceed. By striking down this balance, the Supreme Court shares responsibility
for the suffering and death that ensued.
“What we, as a society, do
collectively to assure the conditions for people to be healthy.”
So far, I’ve been talking about the “conditions for people to be
I’d like to turn to the first part of the definition.“What we, as a society, do collectively …”
It is this first part that reflects the fact that public health is a
choice. We, as a society, have the ability to adopt an extreme view of
commercial speech and the First Amendment, tie our own hands on public health,
and accept the consequences.
But in the United States of America, we have not made this choice.
Such a choice would require the explicit understanding and
acknowledgment that we are trading our health for an ideological view of
But this tradeoff is rarely, if ever, conceded in court opinions.
For example, the Sorrell
decision essentially ignored evidence of the impact of data-driven pharmaceutical
marketing on patient care. The 8th Circuit came up with its own medical judgments
on abortion and suicide.
The DC Circuit in its decision on graphic warning labels conducted its
own “scientific analysis,” which I put in quotation marks. Spewing sarcasm, the
Court managed to reach the opposite conclusion of the world’s leading medical
and public health authorities.
It is much easier for a Court to assert there is no evidence of benefit
from warning labels that admit a genuine tradeoff between an ideological view
of commercial speech and health.
So the violation of public health is twofold. Courts are not only,
through their decisions, undermining the conditions for people to be healthy.
Courts are, by the way they are making these decisions, undermining collective
process by which we can act together to create the conditions to live longer,
happier, and more fulfilling lives.
This failure to acknowledge the consequences of their legal theories is
an intellectual weakness. It is cowardly.
It also suggests a way to respond.
Journalists, public health officials, and their legal colleagues must
work to connect court decisions to their human consequences. It should be
embarrassing for judges to ignore the evidence and judgment of professional
authorities and write screeds masquerading as scientific reviews. We should be
especially critical of evasions and denials that allow the courts to avoid responsibility
for their actions.
I know that in the national security context, it has been argued that
the Constitution is not a suicide pact.
I would argue in the public health context, the First Amendment is not
a suicide pact.
As law review articles by Dean Robert C. Post and others have set out,
there is plenty of room in the U.S. Constitution for the courts to support
freedom of speech without undermining the health and well-being of the American
There is plenty of room for courts to defer to medical and public
health professions on important questions of medicine and public health.
Success will require re-legitimizing public health. In my view, it is
too easy now for judges to look past public health judgment and evidence. We
must work hard to earn greater popular support for science-based decisionmaking
and policy and counter ridiculous myths about our field.
For motivation, we need only glance at the photos in our wallets and on
our phones, think of the friends and neighbors in our communities, and consider
the vital need for a strong and healthy United States of America into the
Thank you again for inviting me to this conference, and I look forward
to your questions.
M. Sharfstein, M.D., is Secretary of Health & Mental Hygiene for
the State of Maryland. You can reach him by e-mail at joshua.sharfstein
at maryland.gov and follow him on Twitter at @DrJoshS