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.

The Wrong Path: Involuntary Treatment and the Opioid Crisis [from The Crime Report]

PHLW's Leo Beletsky and Elisabeth Ryan wrote about the increasing use of "Section 35" commitments in Massachusetts over at The Crime Report.  This law allows people with substance use disorders to be committed involuntarily to a secure facility for up to 90 days.  This is not the way to handle the opioid crisis.

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In May, nine people committed to the Massachusetts Alcohol and Substance Abuse Center in Plymouth briefly walked out from the minimum-security facility. State authorities mounted a manhunt, using helicopters and dogs to apprehend these treatment “patients.”

The episode illustrates a dangerously-blurred line between substance use treatment and prison, based on a statute that allows for involuntary commitment of “alcoholics or substance abusers.”

In this case, the facilities housing criminals and patients were, in fact, one and the same.

The Massachusetts provision—Section 35—allows family members, doctors and police to petition a judge to civilly commit an individual with substance use disorder, where the condition creates a “likelihood of serious harm.”

Across the US, at least 33 states have similar statutes, though their precise parameters and level of deployment vary widely. In Massachusetts, an individual can be ordered to a course of treatment for up to 90 days.

The use of this mechanism has rapidly expanded as the opioid crisis has worsened, used primarily by desperate families seeking to get help for their loved ones.

In some of the over 8,000 Section 35 commitments a year in the state, the mechanism is being invoked by the very individual who is to be committed. This is because many see Section 35 as the only—or the most expedient and cheapest—way to access treatment.

That highlights the perversion of our drug treatment system.

It’s easier to voluntarily submit oneself to “involuntary” treatment, just to receive rapid and free access to assistance. This is despite the fact that the path is through a coercive, criminal justice-based structure, rather than through normal health care navigation channels.

Drug users committed under this provision have committed no crime. Treating them as criminals and depriving them of agency and liberty without adequate justification violates basic constitutional and ethical principles, as recent and previous litigation has posited. To make matters worse, these individuals are now subject to being physically restrained in treatment facilities, raising concerns about possible physical abuse.

The parallel provision in Massachusetts law applying to mental health cases, such as cases of suicide risk, imposes only a three-day commitment and requires authorization from a mental health clinician. In contrast, Section 35 authorizes a person to be held for up to 90 days and considers clinical judgment non-binding.

Further, the rules of evidence do not apply to Section 35 hearings. And, for police and physicians, “committing” individuals through Section 35 recently became easier because a standing order in some courts now allows those petitioners to simply fax the petition rather than appearing in person.

In the meantime, police, family support groups, and others are disseminating information and instructions on how to “section” SUD-affected individuals.

As it turns out, coerced and involuntary treatment is actually less effective in terms of long-term substance use outcomes, and more dangerous in terms of overdose risk.

Mandated evaluation of overdose data in Massachusetts has found that people who were involuntarily committed were more than twice as likely to experience a fatal overdose as those who completed voluntary treatment. (See page 48-49 inthis preliminary analysis.)

Though further research is needed to confirm these findings, there are several possible reasons for this. One is that recovery is much more likely when it is driven by internal motivation, not by coercion or force (i.e. the person must “want to change”).

Second, the state may actually route individuals to less evidence-driven programs on average (e.g. “detox”) than the kind of treatment accessed voluntarily (i.e. outpatient methadone or buprenorphine treatment).

Finally, those receiving care in outpatient settings may also receive services that help address underlying physical or mental health needs, which are often at the root of problematic substance use.

Another important concern is that mechanisms like Section 35 massively shift financial responsibility for substance use treatment from insurers directly to taxpayers. In Massachusetts, care provided under Section 35 has to be paid for by state public health dollars (or criminal justice dollars, depending on the location of commitment). In contrast, care received voluntarily is paid for by health insurers.

This is in addition to the fact that the gold standard for most people with opioid use disorder is outpatient treatment, which does not require “beds.” In other words, taxpayers are left holding the bag for something that is more costly, less effective, and more traumatizing. Misuse of those resources also raises questions about what alternative evidence-based investments could be made with those resources.

Despite these and other weighty concerns, policymakers in Massachusetts and elsewhere have looked to expand the scope of mechanisms like Section 35, because they seem them as a key tool in addressing the opioid crisis. The recent federal announcement of a public health emergency will likely accelerate this trend.

Though involuntary commitment represents an attractively decisive policy option, it is in fact the wrong solution to the crisis.

Across Massachusetts and throughout the U.S., families are desperate for solutions, but increased reliance on Section 35 is not the way to go. Many individuals who are in crisis are unable or unwilling to access help. There are formidable logistical, financial, and other barriers to receiving on-demand treatment and related services.

The way services are currently rendered is also a barrier.

Many users do not want to engage in existing programs because those programs use unproven methods and approach care in ways that traumatizes and denigrates patients. Others may simply not be ready to enter treatment.

Currently, there is no alternative mechanism that would trigger timely assistance and intensive case management of the kind that is necessary to support people in crisis and their families in non-coercive, evidence-driven way.

Any conversation about reducing over-reliance on involuntary commitment provisions like Section 35 must include a discussion of such alternatives.

See also: Leo Beletsky, Law Enforcement, Drugs and the ‘Public Health’ Approach

Leo Beletsky is an Associate Professor of Law and Health Sciences at Northeastern University. He’s on Twitter at @leobeletsky. Elisabeth Ryan is a Legal Fellow at the Center for Health Policy and Law, Northeastern University School of Law. She runs publichealthlawwatch.org, on Twitter at @phlawwatch. They welcome comments from readers.

Law Enforcement, Drugs, and the 'Public Health' Approach [from The Crime Report]

Leo Beletsky, George Consortium founding member and Associate Professor of Law and Health Sciences at Northeastern University School of Law, wrote "Law Enforcement, Drugs, and the 'Public Health' Approach," for The Crime Report in April 2016.  Watch tomorrow for a new piece about the law in Massachusetts that allows individuals with substance use disorders to be involuntarily committed to secure facilities for up to three months.  

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In a recent high-profile speech at the National Prescription Drug Abuse and Heroin Summit in Atlanta, President Barack Obama reaffirmed his Administration’s approach to addiction as a “public health problem, and not just a criminal problem.”

In its various iterations, the adage that “we can’t arrest our way out” of raging opioid overdose and addiction crisis now figures prominently in policy discussions at all levels of government.

This is, a welcome—and overdue—development. Opioid overdose, including deaths resulting from prescription drugs like Oxycontin as well as their chemical cousin heroin, is now killing as many as 80 Americans daily.

The precipitous rise in opioid misuse and overdose has occurred despite extraordinary financial and human investments in drug law enforcement, mass incarceration for drug-related crimes, and other criminal justice approaches. But the emerging rhetoric that an alternative, “public health” approach is necessary to curb the opioid crisis has yielded few actionable specifics for those on its front lines—police and other law enforcement officers.

As often happens, innovation has come from the bottom up.

One of the most widespread initiatives has been to equip police officers with the overdose antidote naloxone. First introduced as a tool for law enforcement in New Mexico in 2004, it has recently expanded to police forces across the country, on the principle that police are often the first to arrive at the scene of an overdose. (This is especially true in rural locales and other settings like tribal areas, where emergency medical service response times can be substantially longer than those of law enforcement personnel.)

Nationwide, law enforcement officers outnumber medical first responders by approximately a factor of three. Several hundred police agencies have now trained and equipped officers to resuscitate overdose victims, reversing over one thousand overdose events.

Aside from this direct role in rescue operations, law enforcement can also contribute to overdose prevention through other activities. These could include disseminating information about signs and symptoms of overdose, advice on accessing naloxone, promoting Good Samaritan (criminal amnesty for overdose victims and witnesses who call for help) policies, and referral to available addiction treatment programs.

A growing number of departments are embracing these kinds of outreach activities. For instance, Boston PD has recently formed an Opioid Response Unit, which provides education and resources to overdose victims and their families.

Another effort introduced in Gloucester, MA offers amnesty to anyone who presents at the police station seeking help to access substance use treatment. The so-called “Gloucester Angel Initiative” program has helped to launch a national movement: More than two dozen police departments have adopted similar policies, and recently formed The Police Assisted Addiction and Recovery Initiative (PAARI).

Finally, Law Enforcement Assisted Diversion (LEAD) programs offer a structure for pre-arrest diversion available to drug users and other non-violent offenders. First introduced in Seattle, LEAD provides access to a broad range of housing, job training, and other social services.

These efforts can offer unique benefits. Police professionals often have close interaction with hard-to-reach groups that are most at risk for substance abuse and overdose. They also promote operational collaboration with public health agencies, resulting in improved information sharing and other synergies.

In addition to direct public health benefits, police overdose response, public education, and referral programs can help both police agencies and the communities they serve.

A closer understanding of drug misuse, its root causes, and evidence-based prevention and treatment tools can empower criminal justice professionals and institutions to achieve better results. At the same time, a shift in police attitudes towards addiction can increase trust and communication with drug users and their families, as well as in the community at large. At a time of serious challenges to community-police relations, reaffirming law enforcement’s dedication to public wellbeing can strengthen collaboration with civil society, promote officer job satisfaction, and ultimately help police in their core public safety mission.

But a number of challenges remain before the “public health approach” rhetoric can be translated into evidence-based policing practice.

With the exception of Seattle’s LEAD program, the impact of these public health-oriented policing initiatives remains unclear. As we struggle to contain this crisis, their rapid dissemination has proceeded organically in the near-absence of robust evaluation that could inform their design and tailoring.

For example, it is not clear whether training and equipping police to conduct overdose rescues is equally cost-effective in urban areas already well-served by professional medical response, as it is in rural or tribal locales where medical first responders arrive with substantial delay.

While these innovations have certainly expanded the traditional law enforcement toolkit, they have yet to challenge our reliance on the more traditional drug law enforcement. Conducting interrogations at the scene of an overdose, using prescription drug monitoring data for investigative purposes, and charging small-time dealers with homicide for supplying drugs to overdose victims may be perceived by law enforcement officers as deterrents to substance misuse.

Unfortunately, rather than promoting public health, these actions can inadvertently fuel the very problems they seek to address.

Treating every overdose event as a crime scene and charging overdose witnesses with drug-induced homicide can deter help-seeking during overdose emergencies. Using prescription drug data to identify and prosecute patients can undermine trust between people with substance use problems and their providers, pushing vulnerable patients away from getting help at a time when they need it most.

At the policy level, proposals for higher-intensity enforcement measures and a renewed focus on legislation extending drug trafficking sentences run at cross purposes to 911 Good Samaritan laws and other amnesty measures.

To be clear, we do need accurate and timely information about dangerous street drugs and prescription drug patterns. But the work of gathering and applying this information must be done with a clear vision for the life-saving goal in our effort to mount an effective response to the opioid crisis. We must acknowledge what we have learned by now from experience: that wielding the stick of criminal justice against street-level drug use does little to stem it, while also driving users underground, away from helping hands.

To make a real impact in curbing the current crisis, police agencies can benefit most from evidence-driven guidance to translate the “public health” approach heralded by policymakers and community leaders into street-level operations. This is the real opportunity before us for shared innovation and exchange.

Leo Beletsky is an Associate Professor of Law and Health Sciences at Northeastern University. He’s on Twitter at @leobeletsky

The Tanning Tax is a Public Health Success Story [from Health Affairs Blog]

Elisabeth Ryan wrote a piece about the "tanning tax," posted today on the Health Affairs Blog.

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Among the lesser known provisions in the now-rejected Republican House and Senate health care bills was a plan to eliminate an excise tax on tanning bed use. Tanning first became fashionable when Coco Chanel popularized the practice in the 1920s, making lounging outside in the sun a symbol of leisure, relaxation, and health. In the late 1970s, pioneering businesses began to offer ultraviolet (UV) radiation beds as a shortcut to fashionable tanned skin; by the 1990s, indoor UV tanning services were ubiquitous staples of the American beauty industry.

Despite its popularity, research has shown that exposure to UV radiation is the primary environmental cause of skin cancer and tanning beds are “the main source of deliberate exposure to artificial UV radiation.” Melanoma risk is particularly high among individuals who use tanning beds for the first time before age 35. The practice remains most common with female college students in the United States, with more than 50 percent reporting having used indoor tanning beds. Furthermore, despite their higher risk for melanoma, tanning companies aggressively target this demographic through the use of tailored marketing and advertising techniques.

Both the House and Senate health care bills would have repealed the Affordable Care Act’s so-called “tanning tax,” a 10 percent consumer-paid tax on non-medical, UV light indoor tanning services. When the tax was enacted in 2010, the non-partisan Congressional Joint Committee on Taxation estimated that it would bring in $2.7 billion in revenue over 10 years, and would offset some of the costs of the ACA overall. After four years, however, the tax had only brought in about $367 million, far less than the approximate $1 billion originally projected by that time. Some detractors then declared the tax a “failure” and blamed it for the loss of tens of thousands of jobs.

Yet these arguments discount the notion that the revenue was perhaps a secondary goal of the tax, behind its ability to deter people from engaging in the dangerous pursuit of indoor tanning. Per medical and public health groups, the creation of the tax was “a clear signal from the federal government that indoor tanning is a dangerous and potentially lethal activity that Americans should avoid.” The American Academy of Dermatology hailed it as helping to “reduce health costs by discouraging indoor tanning and thereby reducing the future costs of treating skin cancers.” From the public health perspective, a lower-than-expected revenue could be indicative of a significant victory.

Unsurprisingly, the indoor tanning industry criticized the tax from the beginning and now blames the tax for closing upwards of 10,000 salon businesses. Salons have the option of collecting the tax directly from consumers or absorbing the tax themselves; one survey of tanning salon owners in Illinois showed that about 80 percent chose the former, adding 10 percent to the consumer charge up front. The owners in that survey also reported that younger clients were more likely to “notice or care” about the price increase than older clients. Indeed, the Centers for Disease Control and Prevention reported that the number of high school students who reported having artificially tanned has decreased by more than half since the enactment of the ACA, from 15.6 percent in 2009 to 7.3 percent in 2015. While this may signify a downturn from a business perspective, deterring younger clients from beginning or continuing indoor tanning is a particularly desirable public health goal, as “young women under the age of 25 who engage in indoor tanning have been shown to be over 60 percent more likely to develop skin cancers such as basal or squamous cell carcinoma compared to those who have never engaged in the behavior.”

Given Congressional Republicans’ failure to repeal the Affordable Care Act, the elimination of the tanning tax appears to be off the table, at least for now. But the industry may well push for repeal again, possibly through the tax reform initiative Congress seems poised to address. Before Congress acts, however, it should recall that although the revenues raised by the tax may be relatively small, its true goal should be to reduce indoor tanning, especially among young people. Although far more research is needed to establish causation, the apparent reduction in rates of tanning that has occurred since the tax’s enactment suggests that the tax may well be doing its job.