Making America Healthy Again: Analyzing Trump's Take on the Social Determinants of Health [from Health Affairs Blog]

George Consortium member and Northeastern University professor Patricia Illingworth concludes on the Health Affairs Blog that the Trump administration shows "little interest in addressing the social determinants" of health, such as "education, socioeconomic status, poverty, the physical and social environment, employment, and discrimination, among others..."  

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Access to health care is critical for the health of individuals and for the well-being of the community, but health depends on more than medical care. Studies show that the social determinants of health, including education, socioeconomic status, poverty, the physical and social environment, employment, and discrimination, among others, are at least as important for health as is medical care. It is worth considering where the new administration stands with respect to the social determinants of health. President Trump’s budget, perhaps the best indication we have of his administration’s priorities, unfortunately appears to show little interest in addressing the social determinants.

The President’s Fiscal Year 2018 budget request, proposed back in May, targeted many of the social factors that impact health, slashing funding for education, energy, the environment, housing and urban development, among other social sectors. If the social determinants of health are underfunded, however, people’s need for health care will increase. As a result, these cuts would hurt the health and well-being of people living in the United States and would drive up the cost of health care. Take, for instance, the connection between education and health. According to economists David Cutler and Adriana Lleras-Muney, four extra years of education reduces the risk of heart disease by 2.16 percentage points and the risk of diabetes by 1.3 percentage points. People with more education are also less likely to smoke, drink excessively, use illegal drugs, or be overweight.

In a recent study published by the Brookings Institution, Princeton University economists Anne Case and Sir Angus Deaton show that “deaths of despair”—those associated with drugs, alcohol, and suicide—have risen significantly among middle-aged white non-Hispanic Americans without a college degree. In this respect, the United States is unique among the affluent nations Case and Deaton compare. They largely attribute this rise to a decrease in work opportunities for people with lower levels of education. Trump’s proposed budget, rather than boosting education and training, cuts funding for the Department of Education by 13 percent and for the Department of Labor by 21 percent. It also reduces funding for before-school, after-school, and summer programs by over $1.2 billion.

Living conditions also impact health. Asthma has been found to be the leading cause of children’s visits to emergency rooms, hospitalizations, and school absenteeism. Exposure to parasites and infectious agents, air pollution from vehicles, and the construction of buildings with poor circulation and little fresh air are among the causes of asthma in children. Not surprisingly, asthma is more prevalent in poor and minority communities. There is also evidence that public housing is itself a risk factor for asthma. Instead of increasing support for housing, Trump’s budget proposes a 15.2 percent reduction to housing assistance over a 10-year period.

The burden of the proposed budget’s assault on the social determinants of health will be borne primarily by the poor, but not only by them. Because people are social, the health of one person can impact the health of many people in a community. Health has some of the qualities of a public good. People are social; they flourish in the company of others. Their health is affected by the health of others and it affects the health of others. Contagious diseases are one example of how the poor health of one person can affect the health of others. Herd immunity demonstrates how the good health of some confers health benefits on others. To put it differently, health has a spillover effect.

Studies show that people are healthier when incomes are relatively equal, when early education is high-quality and accessible, and when poverty is low. For better or for worse, our health depends upon the health of other people, and their health upon ours. Unless we are prepared to live solitary lives, policy that affects the social determinants of health must contend with the inextricable connection between our health and the health of others.

Given the social dimensions of health, failure to ensure the health of all people with, for example, enriched educational opportunities and adequate housing and social programs, puts everyone’s health at risk. There are important social justice reasons for promoting the social determinants of health. But one need not care about justice and ethics to want to provide for the health of others. Self-interest speaks for itself. In this case, the message is loud and clear: ignore the health of others at your peril.

American Beverage Association v. San Francisco: When the First Amendment Jeopardizes Public Health

By Micah Berman, Wendy E. Parmet, and Jason A. Smith

Last week, while the health law world focused on the Republicans’ renewed attempt to repeal and replace the ACA, the Ninth Circuit struck an ominous blow to public health. As we have noted previously, federal courts in recent years have relied on an increasingly expansive interpretation of the First Amendment to prioritize the rights of commercial speakers over the health and safety of the public.  This new-found appreciation for commercial speech has resulted in decisions striking down a wide-range of public health regulations and has led food and beverage companies to make “ever-bolder arguments aimed at limiting longstanding government authority to protect the public’s health.” In American Beverage Association v. City and County of San Francisco, those bolder arguments were accepted by the court, putting public health regulations in greater peril.

American Beverage Association concerned a challenge to a 2015 San Francisco ordinance requiring certain advertisements of sugar-sweetened beverages (SSBs) to display over at least 20% of the area of the advertisement a warning stating: “Warning: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San Francisco.”  

In support of the mandate, the city cited recommendations by the World Health Organization, the American Dental Association, and the American Heart Association that people limit their intake of added sugar, and noted that “sugar-sweetened sodas and fruit drinks containing less than 100% juice by volume, are major sources of added sugars in American diets…” The city further noted that the USDA had concluded in 2015 that consumption of added sugars was associated with obesity, type 2 diabetes, cardiovascular disease and dental caries.

Before the ordinance could take effect, the American Beverage Association (ABA), the California Retailers Association and the California State Outdoor Advertising Association, brought a First Amendment challenge in federal court. In May 2016, Judge Edward Chen rejected the plaintiffs’ request for a preliminary injunction, finding that they were not likely to succeed on the merits. As the district court noted, under the Supreme Court’s decision Zauderer v. Office of Disciplinary Counsel of Supreme Court, laws that compel commercial speakers to disclose factually accurate information are subject only to rational basis review. Responding to the plaintiff’s argument that Zauderer as well as Ninth Circuit precedent permitted rational basis review only when regulations were not controversial, the district court explained that “the ‘uncontroversial’ requirement should not be read expansively to mean something beyond accuracy. …” The court then went on to review the extensive evidence establishing the health dangers of SSBs, and determined that the warning was factually accurate and rationally related to protecting public health.

On appeal, the plaintiffs argued that the district court misinterpreted the Zauderer test and that under the correct approach, the court must consider whether warnings are controversial, non-factual, and unduly burdensome. Plaintiffs further argued that the lower court read the requirement that warnings not be controversial too narrowly. The Ninth Circuit agreed with the ABA on all three points – all of which are deeply problematic for public health.  To briefly summarize:

Controversial:  At the outset, the court (correctly) recognized that “‘uncontroversial’ in this context ‘refers to the factual accuracy of the disclosure…’”—i.e., whether or not the facts are reasonably in dispute.  There is no real scientifically valid dispute that sugary beverages do indeed “contribute to obesity, diabetes, and tooth decay.”  Thus, this issue should have been easily resolved in the City’s favor.  But, the court instead concluded that the City’s message was “controversial” because added sugars do not contribute to obesity or diabetes in all cases.  It accepted the ABA’s argument that only “overconsumption” is problematic.  Such nitpicking is perhaps explained by a failure to understand basic epidemiology (what “contributes to” means).  More broadly, though, the decision seems to accept the argument that the warning was “controversial” merely because beverage companies objected to having to carry it.  Thus the “uncontroversial” requirement is no longer limited to inaccurate statements, but rather applies as long as there is any objection to a warning. If this were the standard, of course, every warning or disclosure that a manufacturer did not want to convey would be “controversial.” 

Factual:  The court next concluded that the required warning was not “factual” because it implicitly suggested that “sugar-sweetened beverages are less healthy that other sources of added sugars … and are more likely to contribute to obesity, diabetes, and tooth decay than other foods.”  Thus, it concluded that the required warning was “misleading, and, in that sense, untrue.”  It used this example, supplied by the ABA:

If car dealers were required to post a warning only on Toyota vehicles that said: “WARNING: Toyotas contribute to roll-over crashes,” the common-sense conclusion would be that Toyotas are more likely to cause rollovers than other vehicles.

Putting aside the issue that added sugars in beverages may well be less healthy than other sources of added sugars, this is an inapposite example.  The City’s warning does not apply to a particular brand; it applies to all sugar-sweetened beverages.  A better analogy would have been a warning on cars that says “WARNING: Operating the audio system while driving increases the risk of an accident.”  Such a warning would not suggest that doing other things—like texting while driving—do not also pose a risk of distraction, or that engaging in other dangerous actions while driving would not also increase the risk of an accident. The First Amendment certainly surely does not require that compelled warnings be carefully contextualized and compared to all other hazards.   

Undue Burden:  Finally, the court ruled that the ordinance was “unduly burdensome” because the warnings would “overwhelm[] other visual elements in the advertisement.”  This decision is troublesome for public health, since other required warnings—such as those on smokeless tobacco products—are even larger.  The court went on to note that some beverage companies had suggested that they would stop advertising in San Francisco if the warnings went into effect, and that this “supports the [plaintiffs’] position that position that the disclosure requirement is unduly burdensome because it effectively rules out advertising in a particular medium.”  But the cases cited by the Ninth Circuit involved instances where it would have been literally impossible to comply with a warning required and still advertise in a particular medium.  Choosing not to advertise because one would rather not carry a warning is something entirely different, and—like the court’s reading of “controversial”—such a rule would effectively give regulated entities a veto over warning requirements. 

We have argued elsewhere that courts must consider the health impact of laws that regulate commercial speech in the name of public health. In making that assessment, professional expertise and scientific evidence should play an important role. Experts are often uniquely positioned to identify whether or not a law regulating speech may benefit or protect public health. As result, as the Third Circuit explained in a professional speech cases, legislatures “are entitled to rely on the empirical judgments of independent professional organizations that possess specialized knowledge and experience concerning the professional practice under review”.

American Beverage Association underscores the importance of allowing legislatures to rely on expert opinion, as well as the need for a more robust approach by courts for handling expert opinions.  Courts must be able to distinguish between scientific debate and established consensus. In finding that San Francisco’s proposed warning was controversial and factually misleading, the Ninth Circuit relied on statements by the FDA that added sugars are “generally safe” and “no more likely to cause weight gain in adults than any other source of energy.” The court also cited technical comments issued by the American Dental Association which stated in part “the evidence is not yet sufficient to single out any one food or beverage product as a key driver of dental caries.”

In relying on these comments to conclude that the warning was misleading and controversial, the Ninth Circuit failed to give respect to the city’s own health officials. The court also failed to appreciate he broad scientific consensus that SSBs contribute to the diseases cited in the warning, as well as the function of evidence within the regulatory process.  Equally troubling is the role that the food industry has in influencing both scientific evidence and regulatory systems. The food and beverage industries have been working consistently to fund scientific research that shifts blame from their products and have also been tireless in their efforts to hinder the FDA.  Given the Ninth Circuit’s conclusion that mandated warnings are unconstitutional as long as they are controversial, industry has yet more reason to fund and produce evidence that exonerates their products. In effect, the mere production of such evidence, no matter how scientifically questionable, may now restrict the state’s right to compel warning labels.

Although the court in American Beverage Association recognized that the protection of public health is a substantial state interest that may warrant restricting commercial speech in appropriate cases, its analysis placed new and possibly insurmountable obstacles on the regulation of commercial speech. By describing well-established scientific facts as “disputed policy views” or as “one-sided [and] misleading messages”—the court offered industry a blueprint for producing false controversy and striking down public health laws that are based on the weight of the evidence. The decision may yet be reviewed and reversed by the full Ninth Circuit en banc. The state’s ability to regulate commercial speech to protect public health may depend on what the full court does.

"Graham-Cassidy" Provides Zero Funding to Address the "Opioid Crisis"

By Elisabeth J. Ryan

One of the few positive provisions of the summer’s Senate “health care” bills was the inclusion of funding to states to “support substance use disorder treatment and recovery support services.”  With more than 30,000 people dying from heroin and painkiller overdoses in the United States every year, sufficient funding to address and effectively treat this issue is crucial.  Yet the latest Republican version of the “health care” bill has omitted this funding entirely.

The original Better Care Reconciliation Act included a $2B fund to distribute grants to states for fighting the “opioid crisis” and other substance use disorder issues; the “Cruz amendment” version significantly increased that amount to nearly $45B over nine years.  While even that amount would likely not have been sufficient to cover needs, the increase was hailed as a key provision aimed specifically at some Republican Senators still wavering in their support.  Yet the latest iteration – “Graham-Cassidy” – includes absolutely no such funding.  This glaring omission has received little attention, but it contributes to the bill’s overall potential to actually harm public health.  The bill would also make alarming cuts to Medicaid (which is one of the top insurers for substance use disorder services) and would also allow states to waive the current requirements that insurance companies not only cover substance use disorder treatment but also that they cover it without charging people higher premiums.  One analysis estimates that a person with "drug dependence" could face a premium surcharge of $20,000 per year.  

Without any funding added to the bill to offset those potentially devastating losses, treatment for substance use disorder will become either financially or practically impossible for the millions of people who may need it.  This lack of adequate, evidence-based, available treatment already constitutes a public health crisis - Congress may be poised to make it even worse.  

Briefly: Rescinding DACA Will Harm Public Health

By Elisabeth J. Ryan

In the New England Journal of Medicine, Atheendar S. Venkataramani and Alexander C. Tsai point out that the Deferred Action for Childhood Arrivals (DACA) program has proven to have a quite remarkably positive effect on the health of "dreamers":

“A recent quasi-experimental study compared changes in mental and physical health outcomes among persons who were eligible for DACA with those of a similar group of noncitizens who did not meet at least one of the eligibility criteria. The study showed that rates of moderate or severe psychological distress in the DACA-eligible group fell by nearly 40% relative to rates in the DACA-ineligible group after DACA’s passage. Similarly, descriptive studies of DACA beneficiaries have revealed remarkable improvements in psychological well-being after the program’s implementation. The most recent contribution to this literature has shown, using data on Emergency Medicaid beneficiaries in the state of Oregon, that the mental health benefits of DACA extended across generations: among the children of DACA-eligible mothers — the majority of whom are U.S. citizens by birth — rates of adjustment and anxiety disorders fell by more than half after DACA was implemented.”

Rescinding DACA - as Trump has announced he will do, despite some recent indications that maybe he won't, who knows - "will have profound adverse population-level effects on mental health.

Federal 'Right to Try' Legislation - perpetuating a misguided skepticism towards the FDA [From CRITical Thinking]

George Consortium member Jeanie Kim, with the Collaboration for Research Integrity and Transparency (CRIT) at Yale Law School, has written a detailed look at the proposed federal "right to try" legislation.  Wendy Parmet and Elisabeth Ryan wrote about the Senate bill on PHLW a few months ago; Jeanie's commentary serves as a great companion piece, emphasizing the potential dangers of making an end run around the FDA.

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Federal “Right to Try” Legislation – perpetuating a misguided skepticism towards the FDA

September 8, 2017

By Jeanie Kim

This blogpost provides a commentary on the federal “right-to-try” bills. For a succinct primer on “right-to-try,” see this article in Vox.

The “right to try” (RTT) movement presents a narrative that pits patients against the FDA. Supporters of RTT, powered by the libertarian Goldwater Institute, have pushed for laws that let terminally ill patients bypass regulators to access unapproved treatments.

As of September 2017, 37 states have enacted RTT laws. Earlier this year, the Senate and the House introduced federal RTT bills, and on August 3, 2017, the Senate unanimously passed an amended RTT bill without an opportunity for debate. There is pressure on the House to follow suit, but it is unclear whether the House will consider the originally introduced RTT bill(1) (“RTT 1.0”) or the Senate’s amended version(2)(“RTT 2.0”), or even take up the legislation at all.

Despite the recent legislative backing, RTT is not a new concept.(3) It is a variation on an age-old skepticism towards the FDA that has been around as long as the agency’s inception. At the core of RTT is the previously rejected, yet persistent argument that the FDA’s approval standards for safety and efficacy should not matter for terminally ill patients who have nothing to lose.(4)

The RTT bills are the latest tactic to undermine the FDA by suggesting that regulators are standing in the way of terminally ill patients. RTT 1.0 prohibits the FDA from interfering with “the production, manufacture, distribution, prescribing, or dispensing of an experimental [treatment]” that has passed initial safety testing on healthy volunteers and is intended for terminally ill patients who have exhausted medical options.

By adopting the premise that the FDA is a bureaucratic bottleneck, RTT misplaces the problem. The FDA has an efficient expanded access (EA) program for patients with life threatening conditions. Patients, in consultation with their physicians, can request access to experimental medicines from pharmaceutical companies. Once the company approves, patients can submit their applications to the FDA.

According to a recent report by the Government Accountability Office, of the nearly 5,800 EA requests received by the FDA from 2012 to 2015, the FDA allowed 99% to proceed, and for emergency single-patient requests, the agency typically responds within hours.(5) (In many cases, the FDA provides feedback on dosage and other safety issues.)

These numbers show that the FDA is hardly a barrier.

RTT overlooks these facts and undermines a broader principle. Congress empowered the FDA with the scientific authority to evaluate clinical trial evidence and the regulatory authority to approve drugs for marketing. This dual grant of authority is based on the policy that companies should not be able to profit from medicines before proving that the medicines are safe and effective. Even the EA program operates within this framework – early access to unapproved drugs is carefully balanced against the need for information about a drug’s safety and efficacy.

RTT 1.0 contains provisions that could destabilize this system.

First, RTT 1.0 prohibits the FDA from using any clinical outcomes from RTT uses to negatively impact its review of a drug. This absolute bar removes the flexibility that the FDA needs to evaluate safety information. Under the current EA program, agency reviewers generally give little weight to adverse events that occur from EA uses but still have the scientific discretion to consider whether certain outcomes – such as unexpected organ failures – could be useful for future patients in similar situations.(6)

Second, because the bill prohibits the FDA from interfering with the “distribution” of experimental treatments for terminally ill patients, RTT 1.0 leaves open the possibility of permitting companies to market unapproved drugs. The term “distribution,” which has various meanings,(7) is not defined in the bill and thus, could be a camel’s nose for deregulatory efforts to loosen the FDA’s prohibition on selling unapproved treatments.

Together, these two aspects of RTT 1.0 not only remove basic safeguards for current patients seeking access to experimental treatments but also undermine the research process that ensures that future patients will have access to drugs that are proven to be safe and effective. The removal of regulatory oversight is all the more problematic because RTT 1.0 also shields companies from all liability associated with RTT uses.

The Senate made attempts to address these concerns in its amended bill. First, while RTT 2.0 still prohibits the FDA from using clinical outcomes from RTT uses, the amended bill makes an exception for cases where it would be “critical” to determining the safety profile of a drug.

Second, RTT 2.0 requires manufacturers to adhere to FDA regulations concerning experimental treatments – specifically, regulations that prohibit companies from commercially distributing and promoting experimental drugs(8) and from charging more than "direct costs" for experimental drugs.(9)

The amended bill also does not release companies from liability if there was reckless or willful conduct or gross negligence.

A side-by-side comparison of the two RTT bills shows that RTT 2.0 includes several provisions intended to protect patients and maintain some regulatory oversight.  See chart here.

The comparison also reveals just how detrimental RTT 1.0 could be, particularly for patient safety, as the original RTT bill would leave patients vulnerable to opportunistic behaviors by companies and physicians.

However, despite these improvements, RTT 2.0 is still based on the same misguided premise of RTT 1.0 – that the FDA is a barrier – and the same skepticism towards the FDA. Under RTT 2.0, RTT is intended to act as “an alternative pathway alongside [the EA program]” such that both pathways are available for patients with “life-threatening diseases or conditions.” The only difference is that the EA pathway preserves the FDA’s role and the RTT pathway minimizes it. While RTT 1.0 is a swift blow to the FDA, RTT 2.0 sets the stage for a gradual weakening of the agency’s scientific and regulatory authority.

For an example, RTT 2.0 does not expressly prohibit companies from selling unapproved drugs but cites FDA regulations for experimental drugs. This presents a loophole where the FDA can be pressured into loosening its regulations on experimental drugs in the same way as under RTT 1.0. Given the current antiregulatory climate, this is not far-fetched. In fact, a former president of Goldwater Institute has suggested that allowing companies to profit from experimental treatments is aligned with the end goals of the RTT movement.(10)

Finally, adding to the point that RTT is merely a shell for antiregulatory sentiments, neither RTT bill would actually improve patient access to experimental drugs. Many of the patient-centered additions in RTT 2.0—such as the transparency and reporting requirements for companies and the FDA—could easily be incorporated into the EA program without legislative action and without removing the FDA’s oversight.

Unsurprisingly, the RTT bills fail to deliver on its promise to streamline patient access to experimental treatments because they remove a “hurdle” that is not much of a hurdle for patients in the first place, but a critical component of the drug development process.

Other barriers for patients exist. Companies, who are the initial decision makers, are generally reluctant to grant access to unapproved treatments. And even after getting EA approval, patients must be able to afford the costs as payers typically do not cover unapproved treatments. 

These issues are multifaceted and much more complex than the “solution” that RTT offers. Patient access to experimental treatments can be improved under the current EA program while maintaining the overall regulatory structure that balances access with safety and efficacy. In fact, there are already efforts to increase the transparency of companies’ EA policies and address other legitimate barriers. True solutions will require collaboration from regulators, manufacturers, and patients, and the FDA is best suited to facilitate improvements that will benefit both present and future patients.

Jeanie Kim is a research fellow at Yale Law School and the Collaboration for Research Integrity and Transparency (CRIT).

1 House RTT bill (H.R.878) (as of September 8, 2017).

2 Senate RTT bill (S.204) (as of September 8, 2017).

3 Joshua Sharfstein, Déjà Vu at the FDA, 95 The Milbank Quarterly (2017), available at https://www.milbank.org/quarterly/articles/deja-vu-fda/.

4 The Supreme Court rejected the argument that terminally patients have the right to access unapproved treatments. U.S v. Rutherford, 442 U.S. 544 (1979); see also Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), cert denied 552 U.S. 1159 (2008). Contrary to the optimism of the RTT movement, 90% of drugs that enter the first phase of clinical testing do not receive approval because of unexpected toxicity or lack of effectiveness, and even drugs that show promise in Phase 2 clinical trials are often not confirmed by Phase 3 trials. Katarzyna Smietana et al., Trends in clinical success rates, 15 Nature Reviews Drug Discovery 379 (2016), doi: 10.1038/nrd.2016.85; U.S. Food and Drug Admin, 22 Case Studies where Phase 2 and Phase 3 Trials has Divergent Results, January 2017, available at link (accessed September 8, 2017).

5 U.S. Government Accountability Office (GAO), Investigational New Drugs – FDA Has Taken Steps to Improve Expanded Access Program but Should Further Clarify How Adverse Events Data Are Used, GAO 17-564, at 17 (July 11, 2017), available at http://www.gao.gov/assets/690/685729.pdf.

6 U.S. Food and Drug Admin., Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers, at 18 (June 2016).

7 Under current FDA regulations, “distribution” is defined as "to sell, offer to sell, deliver, or offer to deliver a drug to a recipient." 21 C.F.R. § 203.3(h).

8 21 C.F.R. § 312.7.

9 21 C.F.R. § 312.8(d)(1).

10 Darcy Olsen, The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Need 205-206 (2015) (then-president of Goldwater Institute stated that “[a]llowing companies to charge for investigational drugs would make compassionate use instantly more attractive [for companies]”).

A Safer Way to Legalize Marijuana [from Health Affairs Blog]

George Consortium member Professor Rebecca Haffajee of the University of Michigan School of Public Health co-authored "A Safer Way to Legalize Marijuana" on the Health Affairs Blog today, proposing that legalized marijuana should still exclude smokable products in order to reduce health hazards.  

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Eight US states, the District of Columbia, and the country of Uruguay have recently legalized the recreational use of marijuana, with Canada and more US states poised to do the same. The new laws include limits on youth access, operation of motor vehicles when using, and high-volume purchases or possession. However, none of the laws consider which kinds of marijuana products should and should not be legally sold.

While we take no position on the overall desirability of marijuana legalization, we propose here that policy makers in favor of it consider only permitting the sale of tetrahydrocannabinol (THC) extracts intended for vaporization or eating, and prohibiting combustible marijuana product sales. While implemented laws allow growing of marijuana for personal use, the policy we propose here would prohibit only the sale of marijuana cigarettes and their makings—flowers, stems, and seeds—to discourage their commercialization and mass production.

Those crafting marijuana laws can draw upon lessons learned about the harms of combusted tobacco and the smoking control policies that followed. Given what we already know about the health hazards of combusted marijuana and the difficulty of controlling the sale of commercially established products, policy makers should capitalize on this opportunity to create a legal marijuana market that mitigates potentially significant harms associated with inhaling combusted marijuana while still facilitating desired benefits of recreational marijuana.

Diverging Trends: Recreational Marijuana Legalization Versus Increasing Restrictions On Tobacco Smoking

The trend toward marijuana liberalization has grown since the mid-1990s to most recently encompass recreational use. By 2018, more than 50 million Americans 21 or older will live in states with access to legal recreational marijuana. Proponents of legalization argue that it reduces the high social costs of criminal law enforcement, an ineffective deterrent to use, the burdens of which fall disproportionately on racial minorities. Creating a legal market for marijuana also facilitates taxes on sales, the revenue from which may be used for public benefit. Legalization, moreover, increases access to a drug less prone to dependence than alcohol or tobacco for therapeutic and pleasure-seeking purposes. Public support for legal marijuana access has risen three-fold in the United States since the 1970s to reach 60 percent in 2016. Likewise, in other countries such as New Zealand, Canada, and France, the majority of the public say they favor legalization of marijuana sales. As momentum to broaden marijuana access builds, policy maker focus ought to prioritize ways to reduce potential harms of marijuana products.

Alongside recreational marijuana use liberalization, policy interventions designed to limit tobacco smoking have proliferated, based on what we have learned about the harms of combusted tobacco—both for the user and those exposed second-hand. This apparent policy divergence from marijuana legalization presents an opportunity for those crafting marijuana policy to learn from the tobacco-smoking experience. After all, both products involve psycho-active substances that can be delivered to the bloodstream in multiple ways. Combustible marijuana likely poses similar risks to those of combustible tobacco, while vaporizing or eating marijuana products offers a “cleaner” delivery mechanism. Why repeat the devastating public health harms of smoking tobacco when policy makers can reasonably mitigate similar consequences of smoking marijuana?

Health Concerns Around Marijuana Combustion

Among the chief concerns with marijuana use, although not yet reflected in liberalization policies, are health harms associated with combustion. Combustion of any substance produces hundreds of chemical compounds, including many known toxins. In a recent comprehensive review of the scientific literature, the National Academies of Sciences, Engineering, and Medicine concluded that “smoked marijuana…is a crude THC delivery system that also delivers harmful substances.” The report and other reviews found strong evidence linking combusted marijuana to increased risk for chronic bronchitis.

Emerging studies link marijuana smoking to increased risk of cardiovascular mortality. Evidence identifying marijuana smoking as a risk factor for lung cancer is not as robust, although potential harms cannot be ruled out, particularly because marijuana smoke is carcinogenic. Research on harms from second-hand marijuana smoke is lacking, but analogizing from tobacco, it is reasonable to assume that chemicals and particulate matter released in marijuana smoke would be harmful to bystanders. Although a typical tobacco user smokes more often than a typical marijuana user, the relative harm of marijuana combustion may not be substantially lower than that for tobacco because some toxins released are higher per unit in a marijuana versus a tobacco cigarette.

Several factors undermine the existing evidence base on health outcomes associated with marijuana use, emphasizing the need to prioritize research in this area alongside policy development. The listing of marijuana as a Schedule I drug by the federal Drug Enforcement Agency has hampered fundingand execution of studies of its therapeutic benefits and harms. Additionally, evidence related to the harms of marijuana use generally comes from studies of lower-potency products (that is, with lower THC content) than are marketed today and can be anticipated in the future. Therefore, it is possible that the harms associated with combustion may differ from those reflected in the current literature.

Potential harms of combusted marijuana extend beyond marijuana alone. Combination marijuana and tobacco use, which can involve blending the substances into a single smoked product or smoking tobacco and marijuana separately but in close temporal proximity, is prevalent. Limiting the availability of combustible marijuana may reduce the amount of dual product use, thereby reducing the amount of and hazards associated with tobacco smoking.

Shifting To Vaporized And Edible Marijuana

Edible and vaporized marijuana products offer the potential to deliver therapeutic and euphoric benefits of marijuana while avoiding cardiopulmonary-related harms of combustion. Although precise estimates of the decreased risks associated with this substitution are not available, by analogy the health risks for smokeless and vaporized tobacco products are estimated to be roughly 90 percent less than those of combusted tobacco.

Valid concerns have been raised about the potential health harms from commercially marketed edibles, especially their attractiveness to, accessibility by, and increasing exposure and overdoses among children. We strongly support prohibitions on the sale of marijuana products—including edibles—to minors, clearly labeling product THC content and requiring child-proof packaging. Additionally, if marijuana is only legally available for sale in forms that do not resemble cigarettes, children may be less likely to cross over between products.

Combusting marijuana is an entrenched behavior that may be challenging to modify. Many marijuana users exhibit a preference for smoking, the primary delivery mode for the drug, and may be less satisfied if combustible products cannot be purchased. However, smoking marijuana is not yet as established in legal markets as is smoking tobacco, and newer users could vape or consume edibles instead of developing preferences for combustion. A subset of established marijuana smokers likely will opt for readily available non-combustibles, particularly when educated about the risks associated with combustion and as social preferences change over time. As well, vaping may serve as a harm-reduction strategy that mimics the individual behavior, social aspects, and psychotropic effects of smoking, and is found to be just as satisfying. Finally, extracted THC for sale as oils, waxes, and edibles is amenable to mass production to a greater degree than raw-form combustible marijuana, potentially facilitating lower prices and a shift toward consumption of these products post-legalization. Combatting and policing a black market for combustible marijuana would still be required, although regulatory enforcement would be limited to retail establishments instead of personal use.

Designing A Safer Marijuana Market From The Outset

Imagine that tobacco had been illegal for most of the 20th century, and its legalization were being considered today—and that we possessed our current knowledge about the health consequences of smoking tobacco. Few would advocate for its legal availability in combustible form, given that alternative available delivery modes—e-cigarettes and smokeless tobacco—can deliver the same psycho-active drug, nicotine, in forms far less likely to cause serious disease.

While we do not have the chance to design a legal nicotine market from scratch, our body politic has the opportunity to design the legal market for marijuana from the ground up. The legalization of recreational marijuana sales has thus far included all forms or only combustible forms (as in the case of Uruguay) of marijuana. Product availability in these new legal markets seems to have been guided by economic considerations and voter preferences, instead of measured consideration prior to legalization of the relative risks and harms of different types of marijuana products.

Policy makers in jurisdictions considering legalization are not bound by custom to make available all forms of marijuana for recreational use. Little prior interstate commerce of legal marijuana products exists, and most states have yet to legalize recreational use. The environment is ripe to experiment with different types of markets, and entrepreneurial policy makers could embark on implementing a safer legal marijuana market that omits combustibles, based on our current and developing knowledge.

Action In The Face Of Some Uncertainty

Marijuana policy makers would be wise to draw upon lessons learned from the experience with tobacco. In the tobacco policy realm, there is a broad consensus that it would be difficult to design a consumer product more harmful than a combustible cigarette—the product that kills one in two long-term users. The suspicion that cigarettes were a dangerous product was well-founded early in the 20th century in animal model studies and pioneering epidemiological surveys. While not risk-free, smokeless tobacco and e-cigarettes will not kill nearly so many of their users. Unfortunately, cigarettes are entrenched within the tobacco marketplace. A protracted battle has raged between public health on the one side, which would benefit by shifting nicotine consumption to safer products or eliminating nicotine use altogether, and incumbent commercial interests and established consumer preferences on the other, which favor selling the most dangerous product, with neither side declaring decisive victory.

While uncertainty still exists regarding the relative harms of different marijuana products and robust research is warranted, waiting for perfect scientific consensus about the scope and nature of harms related to marijuana combustion is unwise. The evidence base around marijuana combustion harms is already strong, and growing. Arriving at total consensus will take decades—as it took to link cigarettes to lung cancer—and waiting to embark on an alternative, very likely safer policy regime has real costs, measured in disease and death. Permitting the sale of THC extracts for consumption in edible or vaporized form will neither compromise therapeutic nor euphoric benefits of recreational marijuana use. In addition, creating variation in recreational marijuana policy regimes—between those already enacted that permit marijuana combustion and those enacted in the future that don’t—would create natural experiments ripe to study the differential effects and quantify harms versus benefits. Policy makers in favor of legalization should seize the opportunity to design a new market that permits recreational sale of marijuana only in edible or vaporized form, to minimize the potential for the kind of disease burden associated with smoked tobacco.

Authors’ Note

We thank Daniel J. Clauw, Mark A. R. Kleiman, and Lynn T. Kozlowski, for their valuable insights.

Briefly: Massachusetts Governor Proposes New Crime of Manslaughter for 'Drug Dealers'

By Elisabeth J. Ryan

Massachusetts Governor Charlie Baker filed legislation yesterday which would, among other things, create a new crime of manslaughter for drug dealers if a person dies from using their drugs.  Specifically, anyone who "manufactures, distributes, or dispenses" any controlled substance would be "strictly liable" if "a death...results from the injection, inhalation, or ingestion of that substance."  The punishment would be a mandatory minimum of 5 years to a maximum of life in state prison.  

The Governor presented this proposal as a new way to fight the opioid epidemic, saying, “[W]e should ensure that those who cause our citizens the most harm by illegally selling drugs that kill people are held accountable for their actions.”  The law, however, doesn’t apply to just opioids; it covers all controlled substances except marijuana. 

Similar laws and prosecutions in Canada and other states have faced significant backlash.

"Right to Try" May Do More Harm Than Good

By Wendy E. Parmet and Elisabeth J. Ryan

When the Senate approved the “Right to Try Act of 2017” on August 3, Republican sponsor Senator Ron Johnson hailed it as a law that helps “real people facing their mortality with no hope.”  The bill allows patients with “a life-threatening disease or condition” who have “exhausted approved treatment options” to go directly to pharmaceutical companies and request access to drugs or devices not yet approved through the traditional process.  The bill does not, however, require those drug companies to grant any such requests.  It also does not address how much drug companies can charge those patients for access. And the rhetoric hailing it as a savior for patients “with no hope” ignores the fact that the FDA already has an Expanded Access (Compassionate Use) procedure that allows patients to access investigational medical products outside of clinical trials.  In fact, the FDA has approved over 99% of such requests, some in as little as 24 hours in emergency situations.  So the “Right to Try Act of 2017” wouldn’t actually create any new access rights; rather it would end the FDA’s oversight role.  In addition, the “Right to Try Act” would immunize drug companies and prescribing physicians from liability that may arise from a patient’s use of an unapproved drug or device (or from the denial of access to those drugs and devices) except in cases of “reckless or willful misconduct, gross negligence, or an intentional tort.”

Thirty-seven states already have “right to try” laws, which have been pushed heavily by anti-regulatory, libertarian efforts.  These laws have often passed with virtually no opposition because many health professionals and politicians fear “being seen as opposing any one patient’s question to save his or her life.”  But states don’t actually have the authority to regulate drug approval and such laws affect little in practice.  In fact, as Professor Rachel Sachs stated, "It’s telling that although 37 states have adopted these laws, when asked to provide examples of success stories, one of the primary groups pushing for their adoption can only provide the testimonies of six patients who received access to experimental medicines through a single physician in a single state."

Federal legislation has the potential to seriously undermine not only regulatory protections, but also the “integrity of clinical trials, which remain the safest way for patients to try experimental drugs.”  To qualify for the bill’s “right to try,” patients must be “unable to participate in a clinical trial,” but what that means remains unclear. If the language is read broadly to include not only patients who fall outside a trial’s parameters, but also those who cannot access trials due to other reasons (such as distance from a trial site), the bill might reduce patients’ willingness to participate in clinical trials which are vital to protecting population health by gathering evidence as to the safety and efficacy of new drugs.  Perhaps the better solution would be to expand the population of eligible participants for clinical trials.  As Kelly McBride Folkers says in the prior linked article, “Not only are the sickest individuals often denied spots in a clinical trial, but people of color, women, those who live in rural communities, and those without adequate insurance are vastly underrepresented in clinical trial populations.  Their absence greatly diminishes the utility of the data gathered from these trials.”  Finally, the FDA needs more oversight of unapproved medical devices, not less.  “The agency’s guidance protects patients from exploitation, as well as from well-intended but misguided therapeutic attempts that can cause even more harm or pain than patients are already experiencing from their underlying disease or condition.”

Senator Johnson refused to allow a Senate vote on the FDA budget unless the “Right to Try” legislation was attached to it, fast-tracking its approval with minimal debate; the House may subject it to more scrutiny.  The bill, however, remains politically risky to oppose, which could result in harm far more difficult to articulate than “hope for the hopeless.” 

OSHA Erases Data on Worker Fatalities from Its Website

As part of The Pump Handle project by our collaborators at the Public Health Advocacy Institute, Kim Krisberg points out that the Occupational Safety and Health Administration has removed data about worker fatalities from its homepage:

"Politico: Ian Kullgren reports that OSHA has erased data on worker fatalities from its home page and replaced it with how companies can voluntarily cooperate with the agency. The worker fatalities didn’t only get buried on an internal web page, the list was also narrowed to only include workplace fatalities for which a citation was issued. Previously, OSHA had a running list of worker deaths on its home page that included the date, name and cause of death and included all deaths reported to the agency, regardless of any citations issued. A Department of Labor spokesperson told Politico that the change was to ensure the public data was more accurate. However, worker advocates disagree. Kullgren quoted Debbie Berkowitz, senior fellow at the National Employment Law Project, who said: “It’s a conscious decision to bury the fact that workers are getting killed on the job. That is totally what it is, so that [Labor Secretary Alexander] Acosta can say, ‘Hey, industry is doing a great job and we’re going to help them.'”

Not Your Grandfather's Preemption: Proposed Federal Preemption of State Medical Malpractice Cases

By Wendy E. Parmet and Elisabeth J. Ryan

During this past spring and summer’s debates over Republican efforts to repeal and replace the Affordable Care Act, GOP leaders insisted that states should be given greater flexibility over health care.  Their support for states’ rights relating to health care, however, seems to be fickle. In June, the same House of Representatives that supported the American Health Care Act, which would have allowed states to get rid of essential benefits, passed on a close vote of 218-210 H.R. 1215, “Protecting Access to Care Act of 2017.” This bill would preempt numerous aspects of state substantive, procedural, and evidentiary law in any “health care lawsuit…for which coverage was provided in whole or in part via a Federal program, subsidy, or tax benefit.”  In other words, the bill would apply to any lawsuit relating to healthcare that was paid for not only by Medicare, Medicaid, or the Veterans Administration, but also by any insurance plan purchased on an Affordable Care Act exchange for which the consumer received a tax credit or subsidy.  It may also apply to lawsuits relating to care paid for by any insurance plan – including any employer-sponsored plan – that receives any tax credits from the federal government. However, the full scope of the language is unclear because it was rushed through the House and subject to just one hour of general debate. 

Federal preemption of state health care laws is not new, as anyone who has heard of ERISA knows. Nor is GOP support for so-called malpractice reform. Republicans have long advocated for stringent tort reform bills, touting them as ways to lower health care costs, reduce liability insurance premiums, and discourage “frivolous” lawsuits.  In response, many states have adopted a wide variety of tort reform measures.

What is striking about HR 1215, beyond the inconstant commitment to states’ rights, is that this bill preempts the procedural and evidentiary rules that would apply in state court. In other words, unlike ERISA or parts of the Food, Drug and Cosmetic Act which preempt state causes of action, HR 1215 would leave tort law claims to be adjudicated in state court, according to state substantive law, but subject to federal caps and federal evidentiary and procedural laws. As one of us argued in another context, the constitutionality of this kind of federalization of state court procedures is highly questionable.

Yet, subject to certain limitations, and provisions that would allow states to impose even more stringent restrictions, HR 1215 would preempt or modify a wide range of procedures and evidentiary rules applicable in state court actions. Among other things, it would:

 - Impose a statute of limitations of 1 year from a patient’s discovery (or the time a patient “should have” discovered) of the injury;

 - Limit non-economic damages (including “physical and emotional pain, suffering… [and] disfigurement”) to $250,000 (Research has shown that patient care falls in states with similar caps.);

 - Eliminate joint and several liability, with each defendant only responsible for its own share of damages;

 - Specify the amount that attorneys may collect in contingency fees and allow a judge to restrict that amount even further, regardless of whether the judgement was via verdict, settlement, or any other kind of alternative dispute resolution;

 - Mandate that damages be paid in installments, prohibiting lump sum payments;

 - Forbid experts from testifying to the standard of acceptable practice in a defendant’s specialty and whether that defendant met that standard unless the expert was licensed to practice that specialty in the state at issue in the one year prior to the incident;

 - Make inadmissible any provider’s expressions of “apology…or a general sense of benevolence” to a patient;

 - Require the plaintiff to file a detailed “affidavit of merit” by a health professional, simultaneous with the filing of a complaint;

 - Require a plaintiff to give a potential defendant 90 days written notice before filing a   complaint.

In the past, Republican tort reform efforts died in the Senate due to the filibuster. For the moment, the filibuster remains, so HR 1215’s enactment seems unlikely. However, given the President’s repeated calls for ending the filibuster, and the uncertain fate of health reform, nothing can be taken for granted. For this reason, HR 1215 merits serious review, both for its impact on patient rights and for its proposed federalization of state court procedures.